EP4138954A1 - Auto-injecteur comportant un moyen de libération d'évacuation - Google Patents

Auto-injecteur comportant un moyen de libération d'évacuation

Info

Publication number
EP4138954A1
EP4138954A1 EP21718581.8A EP21718581A EP4138954A1 EP 4138954 A1 EP4138954 A1 EP 4138954A1 EP 21718581 A EP21718581 A EP 21718581A EP 4138954 A1 EP4138954 A1 EP 4138954A1
Authority
EP
European Patent Office
Prior art keywords
sleeve
coupling
autoinjector
drive
spring
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
EP21718581.8A
Other languages
German (de)
English (en)
Inventor
Markus Tschirren
Gabriel KALBERMATTER
Leos URBANEK
Marcel ALLENSPACH
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 EP4138954A1 publication Critical patent/EP4138954A1/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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • 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
    • A61M5/315—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
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • 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
    • A61M5/3159—Dose expelling manners
    • A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver

Definitions

  • the present invention relates to the field of medical injection devices for administering liquid substances, in particular medicaments or medical substances such as insulin and hormone preparations.
  • the invention relates to an auto-injector with an energy store for distributing a predetermined dose from a product container that is used once.
  • Injection devices or injection devices for the simplified administration of a substance include, inter alia, so-called autoinjectors, which have an energy store with which the distribution can be carried out automatically, that is to say without external force to be supplied or applied by a user.
  • the energy store stores the energy required for an automatic substance release advantageously in mechanical form.
  • Such an energy store can be a spring, which is installed in the injection device in a tensioned state and releases energy by releasing it. The energy is transferred to a piston rod or a pressure element which pushes a piston into a product container.
  • the energy store can also be provided in order to automate the process of piercing an injection needle. Alternatively, the piercing process can take place manually, that is to say exclusively by a user, without using energy stored in the injection device for this purpose.
  • the injection device can comprise a product container holder for receiving a product container, wherein the product container can be held in the product container holder radially, axially and preferably also non-rotatably.
  • the product container holder can be connected to the housing of the injection device in an axially and rotationally fixed manner, or it can be movable relative to the housing during a piercing and / or needle withdrawal process.
  • the product container can be a carpule for single or repeated detachable connection to disposable injection needles or a disposable pre-filled syringe with an injection needle permanently connected to it.
  • the product container has a hollow cylindrical product container section which displaceably supports a piston or stopper.
  • the piston can form a sealing gap with the inner circumference of the product container section and be displaced in a distal direction by means of the 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 taken place, stands distally over the distal end of the injection needle or is moved into this position relative to the housing while a needle protection sleeve spring is released in order to prevent accidental access to the injection needle and thereby reduce the risk of injury.
  • the needle protection sleeve can also serve as a triggering element for triggering the discharge of the product, the needle protection sleeve being displaced in the proximal direction relative to the housing for this purpose.
  • the auto-injector can be triggered by actuating a trigger button of the auto-injector, the needle protection sleeve at least serving as a privacy screen before the auto-injector is used.
  • the patent application WO 2016/205963 describes an exemplary autoinjector, comprising a housing with a longitudinal axis and a product container arranged axially fixed in the housing.
  • the autoinjector further comprises a needle protection sleeve which is displaceable in a longitudinal direction between a proximal and a distal position and which is coupled to a needle protection spring.
  • a spiral or mainspring in which energy for the automatic pouring out of product can be stored, is connected via a first end to the housing and via a second end to a drive element arranged coaxially to the longitudinal axis in the form of a rotating threaded rod.
  • the threaded rod engages via a thread in a non-rotating propulsion member in the form of a propulsion sleeve which, when displaced in the distal direction, moves the stopper of the product container at an at least approximately constant dispensing speed.
  • a holding element with two flexible holding arms engages in recesses in the propulsion element and prevents the same from moving.
  • the arms of the holding element are held in said engagement by a locking sleeve.
  • the locking sleeve is moved away from the position of the recesses by a proximal movement of the needle protection sleeve, so that the holding arms can be released radially and release the propulsion member.
  • the torque of the spiral spring is on the drive element at the proximal end of the propulsion member and the propulsion force on Holding element on, which leads to a static material load on the drive element and the holding arms and can result in possible signs of fatigue.
  • the patent application WO 2009/037141 A1 describes an autoinjector with syringe movement for highly viscous drugs, in which a needle protection sleeve, when placed on the injection point, pushes a release sleeve by a small release stroke in the proximal direction, thereby releasing a radial toothing between the release sleeve and a drive member .
  • the drive member is driven by a spiral spring and pushes it in the axial direction via a threaded connection with a proximal thread of an internal piston rod, which first ensures an automatic piercing movement and then distributes medicaments.
  • the piston rod further comprises a distal part with a larger diameter than the threaded proximal part of the piston rod.
  • the patent application WO 2017/089254 A1 describes an autoinjector with a mainspring, which is released from the outside by the user via an engagement at the proximal end of a threaded rod.
  • product in the present context includes any flowable medical formulation which is suitable for controlled administration by means of 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 medicament can therefore be a composition with a single active ingredient or a premixed or co-formulated composition with several active ingredients from a single container.
  • drugs such as peptides (e.g.
  • insulins drugs containing insulin, GLP-1-containing and derived or analogous preparations
  • proteins and hormones biologically obtained or active substances, substances 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 basic, auxiliary and carrier substances.
  • distal denotes a side or direction directed towards the front, penetration-side end of the administration device or towards the tip of the injection needle.
  • proximal refers to the posterior, dem single-sided end opposite end of the administration s device facing side or direction.
  • injection system or “injector” in the present description are 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 dispensed.
  • the injection needle does not remain in the tissue for a prolonged period of several hours.
  • the object of the invention is to specify an autoinjector with a torsion spring drive for automatically pouring out a liquid from a pre-filled syringe fixed to the housing, in which a torque of the torsion spring is reliably blocked or absorbed until the planned discharge.
  • the object is achieved by an auto-injector and a drive unit with the features of the independent claims. Preferred embodiments of the invention are the subject of the dependent claims.
  • An autoinjector comprises a one-part or multi-part housing with a longitudinal axis and a prefilled pre-filled syringe with a product container and an injection needle or cannula permanently attached to it.
  • the pre-filled syringe is received in the housing in an axially non-displaceable manner, with a tip of the injection needle protruding by an insertion depth in the distal direction over a distal end of the housing.
  • the autoinjector further comprises a torsion spring pretensioned for the one-time distribution of a maximum content of the product container, 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 drive element to move a piston in the product container.
  • the autoinjector comprises a coupling that does not include the propulsion element and is independent of the propulsion element, with coupling elements that are exclusively different from the propulsion element, which blocks a rotation of the drive element before the discharge and, as a result of the movement of the needle protection sleeve during piercing, releases the drive element or a rotational element connected to it for rotation .
  • the clutch therefore does not block the linear movement of the propulsion element, but directly the torque of the torsion spring on the drive element. This avoids the non-rotatable connection or coupling of the drive and propulsion element from being loaded during the entire storage period of the autoinjector and possibly being damaged as a result.
  • all coupling elements of the coupling are located distal or on the needle protection sleeve side of the torsion spring, so that the drive element does not expand beyond a proximal end of the torsion spring.
  • no recess is provided in the propulsion element for the engagement of a retaining element; the propulsion element can thereby be screwed differently during assembly onto a thread in accordance with an intended dispensing stroke or an axial starting position of the plug.
  • the propulsion link is not screwed over the entire length of the gear, which means that fractions of a maximum delivery stroke can be easily adjusted.
  • the coupling comprises a first, inwardly directed coupling element, which selectively engages in a second, outwardly directed coupling element via locking surfaces which act against rotation about the longitudinal axis and are preferably aligned parallel to the longitudinal axis, this engagement by an axial coupling stroke or a axial relative movement of the two coupling elements is released.
  • this axial movement no additional radial space is required in the auto-injector, in contrast to radial decoupling in which a first coupling element is moved away from a second coupling element in the radial direction.
  • the clutch stroke can be manual or spring-assisted, without translation the clutch stroke corresponds to an actuation stroke of the needle guard during piercing, and thus at least a piercing depth of the injection needle, which in turn is at least 3 mm and preferably at least 5 mm.
  • the torque of the torsion spring is blocked by the coupling elements with blocking surfaces parallel to the longitudinal axis of the autoinjector or recorded. An axial extension of these blocking surfaces is less than the extent of the coupling stroke, but is advantageously at least 2 mm, preferably at least 4 mm, and can actually also correspond to at least the penetration depth.
  • the propulsion element has a non-rotationally symmetrical cross-section with an axial guide element in the form of a groove, plane, or rib parallel to the longitudinal axis, via which the propulsion element is guided axially linearly through the housing or a counter-guide element held in the housing in a rotationally fixed manner.
  • the propulsion element is coupled to the drive element via a thread and moves only axially in the discharge direction and not in a screwing propulsion movement. This avoids friction between a distal end face of the propulsion member and the piston, and it is easier to provide the drive element and / or the propulsion element with a thread adapted to generate a changed dispensing force or with a special thread surface coating than the housing.
  • the propulsion element can be screwed to different lengths when screwing into or when screwing onto the thread of the drive element in accordance with an intended delivery stroke or an axial starting position of the stopper. If the housing and / or the axial guide element allows several discrete rotational positions of the propulsion element, i.e. if the propulsion element is guided through the housing in a first as well as in a second orientation rotated 180 ° or even only 90 ° about the longitudinal axis compared to the first can, a partial discharge stroke with a resolution of less than one thread turn, especially half or even only a quarter of a thread turn, can be set.
  • the drive element has a threaded rod with an external thread and the propulsion element has a propulsion sleeve with the axial guide element and an internal thread adapted to the external thread.
  • the internal thread extends over a length corresponding to the maximum discharge stroke, and the external thread is shortened to a few turns at the proximal end of the threaded rod or comprises a thread segment of less than one turn.
  • the external thread extends over the maximum length of the discharge stroke and the internal thread is correspondingly shortened.
  • the torsion spring as the elastic means for generating a torque is preferably a spiral spring, but can also be designed as a leaf spring, drive spring, cone spring, spiral torsion spring, torsion bar or combinations thereof.
  • the auto-injector On delivery or before the auto-injector is put into operation, it is biased to the maximum or sufficient for a single distribution of the entire or at least a predetermined content of the product container. Accordingly, the auto-injector does not have a dose selection mechanism.
  • a prefilled, disposable pre-filled syringe comprises the product container and an injection needle permanently attached to it and is held in an axially fixed manner in the housing of the autoinjector.
  • the auto-injector, or at least the pre-filled syringe and the syringe holder, are accordingly only intended for one-time use.
  • the coupling comprises a coupling sleeve with inwardly directed teeth or projections as first coupling elements, which engages radially in second coupling elements which are non-rotatably connected to the drive element or are formed in one piece.
  • the second coupling elements comprise outwardly directed teeth or recesses on the drive element or on a spring coil connected non-rotatably to the drive element and the torsion spring.
  • the coupling sleeve is an independent component of the autoinjector and in particular does not include any locking elements for locking a needle protection sleeve in a needle protection position after the injection has taken place.
  • the coupling sleeve has a holding element which is released by an actuation movement or an actuation stroke of the needle protection sleeve.
  • the coupling sleeve with the first coupling elements is then moved axially and preferably in the proximal direction relative to the second coupling element by a spring, preferably a needle protection spring, in a coupling stroke and the drive element is released.
  • the coupling stroke of the coupling sleeve is preferably limited by a distally directed stop on the mechanism holder, which means that an acoustic signal can be generated which signals the beginning of the distribution to the user.
  • one end of the torsion spring is coupled in a rotationally fixed manner to a shaft of a spring coil and a spring flange delimits a receiving area or a volume of the torsion spring distally.
  • the second coupling elements are at least the length or amplitude of the coupling stroke from the distal spring flange spaced apart and arranged on an extension of the spring coil which is coupled to the drive element in a rotationally fixed manner and comprises a coil sleeve or a coil flange.
  • the coupling sleeve is a locking sleeve and has a locking member for locking the needle protection sleeve in a needle protection position at the end of the injection.
  • the second coupling elements are advantageously arranged on a drive sleeve as a drive element, and their proximal end is spaced from a distal spring flange by at least the length of the coupling stroke.
  • the drive sleeve is in threaded engagement with a drive member in the form of a piston rod.
  • the drive sleeve and locking sleeve have a link control with a first and second guide element, for example a radially oriented guide cam which engages in a guide groove.
  • the guide elements are designed and interacting in such a way that after the rotation of the drive sleeve has been released, an initial rotation of the drive sleeve by a maximum of 45 ° pushes the locking sleeve by a locking stroke of at least 1 mm in the proximal direction. This can ensure that the locking sleeve safely reaches its locking position even with the most unfavorable tolerances.
  • the guide cam is advantageously attached to the drive sleeve and the guide groove is provided in the locking sleeve and oriented at an angle to the longitudinal axis.
  • the autoinjector optionally includes a permanently installed rotation sensor for the continuous detection of at least one rotation position, and preferably of at least two rotation positions per revolution of the drive element during delivery, as well as a processor unit for determining an axial piston position of the piston in the product container or a residual volume in the product container from the successively detected rotational positions.
  • a rotation of a drive member directly caused by the torsion spring during the distribution is measured continuously and preferably with a resolution of half a revolution or less, and the propulsion and the piston position are determined therefrom. With an improved resolution, the remaining volume or the amount of drug dispensed can be determined precisely, which is particularly important in cases in which the dispensing does not proceed as planned or is even canceled by the user.
  • the progress of a discharge can also be recorded in real time, and fluctuations in the advance speed in particular can be recognized without delay.
  • the auto-injector further optionally comprises an optical, acoustic, or tactile signaling or display unit with an electronically controlled actuator.
  • the actuator is controlled or activated by the processor unit after an axial piston position has been determined, which corresponds to an at least approximately complete discharge, and after a predetermined holding time has subsequently elapsed. This generates a signal which indicates the end of the injection and confirms to the user that the autoinjector can now be safely moved away from the puncture site. Accordingly, the autoinjector does not have a purely mechanically triggered end click, in which a stop element is accelerated by a spring.
  • the holding time is typically a few seconds, preferably at least 3 seconds, and ensures that the injected amount of drug is completely absorbed or resorbed by the subcutaneous tissue and that no liquid reaches the tissue surface after moving the autoinjector through the puncture site.
  • the autoinjector preferably has an electronics module with a printed circuit board and arranged thereon a sensor unit for the detection of states or processes, a processor unit for processing signals from the sensor unit, a communication unit for wireless communication of data from the processor unit to a third-party device, and a battery to power the aforementioned units.
  • Communication with a stationary third-party device for example an expert system in a delocalized or cloud-based infrastructure, can take place, for example, via a 5G or 4G / LTE cellular network, in particular a narrowband Internet-of-Things NB-IoT.
  • the electronics module further comprises an optical, acoustic and / or tactile display unit such as, for example, an optical display in which a light guide guides the light from a light source on the printed circuit board to the surface of the housing.
  • a state displayed by the display unit can include information about the drug, a device state of the autoinjector, a module state of the electronics module, or a process state of an ongoing or completed injection process.
  • the display unit of the electronics module can be kept simple and refer to a few LEDs, for example in traffic light colors or to illuminate selected pictograms, and / or an acoustic signal generator to generate language-independent Limit sounds or melodies. This is particularly advantageous in conjunction with the advanced graphic display options and voice output options of a smartphone, since the smartphone, which is wirelessly coupled to the electronics module, takes on the refined communication with the user that goes beyond a status display.
  • Fig.l the components of a first variant of an autoinjector
  • FIG. 2 shows a longitudinal section through the autoinjector from FIG. 1 before the injection
  • FIG. 3 shows a cross section through the autoinjector from FIG.
  • FIG. 4 shows a longitudinal section through the autoinjector from FIG. 1 during the injection
  • FIG. 5 shows a longitudinal section through the autoinjector from FIG. 1 after the injection
  • FIG. 7 shows a longitudinal section through the autoinjector from FIG. 6 before the injection
  • FIG. 8 shows a cross section through the autoinjector from FIG. 7,
  • FIG. 9 shows a longitudinal section through the autoinjector from FIG. 6 during the injection
  • FIG. 10 shows a drive element of the autoinjector from FIG. 6,
  • FIG. 11 shows a longitudinal section through the autoinjector from FIG. 6 after the injection.
  • Fig.l is an exploded view of the components of an autoinjector according to a first variant of the invention.
  • the autoinjector has a sleeve-shaped, elongated housing with a longitudinal axis L and comprising a distal housing part 10a and a proximal closure or end cap 10b that is permanently snapped onto it.
  • the distal housing part 10a and the closure cap 10b have the same cross section over the entire length of the autoinjector, and the closure cap comprises a single end face perpendicular to the longitudinal axis.
  • a product container in the form of a pre-filled syringe 11 with an injection needle permanently attached to the product container is held in a syringe holder 12, the syringe holder being received in the housing 10a in an axially and rotationally fixed manner.
  • the pre-filled syringe 11 is of a The retaining spring section of a mechanism holder 13 firmly anchored in the housing 10b is pressed in the distal direction into engagement with a shoulder of the syringe holder 12.
  • the pre-filled syringe 11 is arranged in relation to the housing 10a in such a way that the tip of the injection needle protrudes beyond the distal end of the housing 10a by a length corresponding to the subcutaneous or intramuscular penetration depth and is at least laterally protected or covered by a needle protection sleeve 14 before and after the injection will.
  • the needle protection sleeve 14 is pushed along the longitudinal axis L by an actuation stroke and against the force of a needle protection spring 15 in the proximal direction and thereby triggers a product discharge, as shown in detail below.
  • the needle protection sleeve comprises two sleeve arms 14a, which are arranged offset or rotated by 90 ° about the longitudinal axis L with respect to two recesses 10c of the housing, which are referred to as viewing windows.
  • the needle protection sleeve 14 can be displaced relative to the housing 10 from the actuated position along the longitudinal axis L in the distal direction into a needle protection position and there can be blocked against being pushed back again.
  • the needle protection spring 15 is a metal spring which acts as a compression spring and is designed as a helical spring.
  • a spring package 20 comprises a spiral spring 20a, a spring coil 20b, and a spring sleeve 20c.
  • the outer end of the spiral spring 20a is anchored non-rotatably on the spring sleeve 20c, which in turn is received non-rotatably in the housing 10a.
  • the outermost two turns of the spiral spring can be fixed tangentially, for example welded, so that the outermost turn itself acts as an integrated spring sleeve.
  • the inner end of the spiral spring 20a is non-rotatably connected to the spring coil 20b.
  • the spring coil 20b comprises a spring shaft and a distal and a proximal spring flange which axially delimit the spring volume.
  • the spring package 20 can be mounted completely pretensioned as an independent component in the housing of the autoinjector and accommodate spiral springs of different widths, as described in detail in the patent application WO 2016/205963 mentioned at the beginning. At this point, WO 2016/205963 is fully integrated into the present application by reference.
  • the auto-injector can be assembled from two sub-units or assemblies for easier assembly.
  • a distal syringe unit of the autoinjector comprises a first, distal housing part 10a, the needle protection sleeve 14, the device cap 16 and the syringe holder 12, while a proximal drive unit comprises the closure cap 10b, the mechanism holder 13, the needle protection spring 15, switching sleeve 17, locking sleeve 18, Drive and Propulsion element, and includes the one-time chargeable spring pack 20 for the automatic substance delivery.
  • the pre-filled syringe is introduced into the syringe unit and the two sub-units are then brought together, with the two housing parts 10a, 10b snapping into place.
  • the outer end of the spiral spring 20a is anchored on the spring sleeve 20c or, in particular if no spring sleeve is provided, on the mechanism holder or directly on the closure cap.
  • a spring flange can also be attached to the spring sleeve, to the mechanism holder, or to the housing via its outer circumference.
  • the pre-filled syringe 11 comprises a cylindrical syringe body as a product container, at the distal end of which a hollow injection needle is firmly connected to a syringe shoulder.
  • the injection needle of the pre-filled syringe is covered by a needle protection cap 11a, which is designed as a so-called Rigid Needle Shield (RNS) and comprises a rubber-elastic needle protection element and a sheath made of hard plastic.
  • RMS Rigid Needle Shield
  • the needle protection cap protects the injection needle against mechanical influences and contamination, and keeps the injection needle and the product sterile.
  • a device or pull-off cap 16 is arranged at the distal end of the autoinjector, which is axially pulled off and / or twisted off and completely removed together with the needle protection cap 11a before the autoinjector is used.
  • the syringe holder 12 comprises two fingers, which are fastened at their proximal ends to a holder sleeve of the syringe holder and at their distal ends each have an axial support element for the syringe shoulder.
  • the syringe holder shown can be adapted to the diameter of a pre-filled syringe to be accommodated with a nominal filling volume of 1.5 ml, 2.25 ml, or 4 ml, so that when the syringe size is changed, apart from the syringe holder, no components of the autoinjector need to be exchanged, or at least the distal housing part 10a is the same for all syringe sizes.
  • the fingers can be flexible and can be pushed away radially by the needle protection cap when the prefilled syringe is inserted axially.
  • the syringe holder can also be designed in two parts or can be supplemented by an adapter, as disclosed in patent application PCT / EP2020 / 052127.
  • PCT / EP2020 / 052127 is fully integrated into the present application by reference.
  • the spiral spring 20a or the spring coil 20b sets a drive element 21 in a rotational movement and a propulsion element 22 in a preferably purely axial propulsion movement.
  • a threaded element engages itself over the discharge stroke extending thread with a variable thread pitch.
  • the thread element comprises a thread segment with an extension in the direction of rotation or circumferential direction of less than half a turn, with one flank of the thread segment preferably having different helix angles so that a different area of the flank of the thread segment is touched by the thread when the thread pitch progresses Rotation changes.
  • variable thread can have a larger pitch in the starting area of the discharge and a smaller pitch at the end, so that a constant discharge force results despite the decreasing spring force, as disclosed in the patent application WO 2016/205961.
  • WO 2016/205961 is fully integrated into the present application by reference.
  • a switching sleeve 17 is arranged in a form-fitting manner with a proximal end of the sleeve arms 14a of the needle protection sleeve 14 and with a distal end of the needle protection spring 15 and is at least partially surrounded by the latter.
  • the switching sleeve 17 is preferably snapped onto the proximal end of the sleeve arms of the needle protection sleeve 14 or even formed in one piece with it.
  • a locking sleeve 18 is arranged inside and coaxially to the switching sleeve 17, which is coupled to the switching sleeve 17 via a sawtooth-shaped locking member 18a resiliently attached to an arm pointing in the distal direction, in such a way that an actuating movement of the needle protecting sleeve 14 and the switching sleeve 17 also moves the locking sleeve 18 moved proximally.
  • the locking member 18a is securely released by the switching sleeve 17 for inward movement.
  • the locking member 18a engages behind a proximally directed edge of the autoinjector or engages in an axially fixed recess of the autoinjector and thus locks the locking sleeve 18 against distal movement.
  • the switching sleeve 17 is pushed by the needle protection spring 15 in the distal direction over the locking member 18a, whereupon the locking member engages behind a proximally directed edge of the switching sleeve 17 through the spring action of the arm in a locking position and the switching sleeve and the needle protection sleeve locked or blocked against renewed movement in the proximal direction.
  • the proximal stop of the needle protection sleeve on the housing or the proximal stop of the switching sleeve on the mechanism holder can be defined by suitably attached short axial ribs or projections on one of the two stopping components will.
  • at least one coupling element interacting with the needle protection sleeve and / or a triggering element attached to the switching sleeve for the correct triggering of the discharge would also have to be axially adjusted or removed.
  • the syringe holder 12 is preferably made of a transparent material so that the contents of the syringe can be visually inspected through the viewing window 10c in the housing 10a.
  • a magnifying glass preferably formed by a variable thickness in the material of the syringe holder in the area of the viewing window, allows suspended particles in the liquid to be identified and the state of the medicament to be assessed.
  • an excessively long device cap extending over the area of the viewing window into the proximal half of the autoinjector can be provided.
  • the autoinjector comprises a drive element or a rotary member in the form of a threaded rod 21a with an external thread which extends at least over a length corresponding to the delivery stroke.
  • the threaded rod 21a is non-rotatably coupled to the spring shaft 20b or is even formed in one piece with it.
  • a propulsion element in the form of a propulsion sleeve 22a has at a proximal end on an inner side a threaded element for engaging the external thread, comprising a threaded section with preferably fewer turns than the external thread, or a thread segment with an extension in the direction of rotation less than one turn, preferably less than half a turn.
  • the propulsion sleeve 22a in the mechanism holder 13 or in the housing is secured against rotation by an axial groove or some other deviation from a rotationally symmetrical outside, so that the rotation of the drive element generated by the rotary spring 20a is converted into a linear propulsion movement.
  • the propulsion sleeve 22a can have an internal thread which extends over a length corresponding to the discharge stroke, and the thread of the threaded rod 21a can be reduced to a threaded element for engaging the internal thread, comprising a threaded section with preferably fewer turns than the internal thread, or a thread segment with a length of less than one turn, preferably less than half a turn.
  • a coupling sleeve 23 has a hollow cylindrical body and a holding element with two flexible holding arms 23 a attached in the distal direction, at the end of which there is a holding cam 23 b projecting radially inward.
  • the spring coil 20b has a distal extension 20d comprising a coil sleeve which is arranged concentrically to the spring shaft and which acts tangentially against rotation about the longitudinal axis radially outwardly directed blocking surfaces on four forms distributed over the circumference of the bobbin case.
  • the blocking surfaces can also be formed by impressions on the periphery of a coil flange of the extension 20d arranged concentrically to the spring shaft.
  • FIG. 2 shows a longitudinal section through the auto-injector according to FIG. 1 in the ready-to-inject state, after the device cap has been removed, in which the injection needle 1 lb is laterally covered by the needle protection sleeve 14.
  • the retaining cams 23b of the retaining element engage in recesses of the axially fixed mechanism holder 13 and are prevented from moving outward by an inner circumference of the locking sleeve 18, whereby the coupling sleeve 23 cannot move axially either.
  • the locking sleeve 18 When the discharge is triggered, the locking sleeve 18 is moved away from the position of the recesses by a proximal movement of the needle protection sleeve 14, so that the holding arms 23a can be released radially and release the coupling sleeve 23.
  • FIG. 3 shows a cross section through the autoinjector axially at the level of a proximal end of the coupling sleeve in front of the distribution, indicated in FIG. 2 by a broken vertical line.
  • the coupling sleeve comprises four inwardly directed projections 23c, each offset by 90 °, as the first coupling element, which engage in a rotationally fixed manner via radially aligned locking surfaces 24a in four corresponding recesses on a distal extension 20d of the spring coil as the second coupling element.
  • FIG. 4 shows a combined longitudinal section through the autoinjector immediately after activation or at the beginning of the distribution.
  • the cutting plane of the lower half corresponds to the sectional plane from FIG. 2 and is rotated by 60 ° about the longitudinal axis in relation to the sectional plane of the upper half.
  • the needle protection sleeve 14 is moved proximally by contact with the injection point and thereby also pushes the locking sleeve 18 in the proximal direction, under tension of the needle protection spring 15 can move axially.
  • the proximal end of the needle protection spring 15 is supported on the coupling sleeve 23 and pushes it proximally by one coupling stroke, the coupling stroke in this variant being different from the actuation stroke of the needle protection sleeve 14.
  • the locking sleeve 18 is moved proximally relative to the switching sleeve 17 by a locking stroke corresponding to the clutch stroke up to a first stop with the mechanism holder 13.
  • the locking of the needle protection sleeve is activated in that the locking member 18a engages with an inwardly directed projection in a recess of the mechanism holder and makes a distal movement of the locking element impossible.
  • the coupling sleeve is available at the end of the distribution for a final stroke up to a second stop and thus for a mechanical end-click.
  • the holding arms 23a are released from a proximal end edge of the propulsion sleeve 22a for a second release movement radially inward.
  • the blocking surfaces of the extension 20d of the spring coil are located on indentations of a coil flange which is offset from the distal spring flange by at least the coupling stroke in the distal direction, or on indentations on a coil sleeve which are offset from the distal spring flange by at least the coupling stroke in the distal direction.
  • the sectional plane of the lower half corresponds to the sectional plane from FIG. 2 and is rotated by 90 ° about the longitudinal axis compared to the sectional plane of the upper half.
  • the needle protection sleeve 14, which moves in a safety movement when removing the autoinjector from the puncture site from a rear end position by a needle protection spring into a front end position is, covers the injection needle 11b from the side.
  • Radially inwardly directed projections on resilient arms of the locking member 18a engage in recesses in the mechanism holder 13, thereby preventing a movement of the locking sleeve 18 in at least the distal direction.
  • the locking sleeve rests proximally on a distal end face of the mechanism holder, so that the locking sleeve cannot move in the proximal direction either.
  • Radially outwardly directed projections on the resilient arms of the locking member 18a engage behind a proximal edge of the switching sleeve 17, so that the switching sleeve cannot be moved in the proximal direction either.
  • the locking sleeve can also be locked axially by a locking or snap element different from the locking sleeve.
  • the inner and outer embossments of the coupling sleeve and their respective counterparts can be different in terms of design, number and / or axial arrangement.
  • the expressions can take the form of axial ribs and the recesses on the spring coil or spring sleeve can correspondingly take the form of axial slots, or both expressions and recesses are designed as teeth.
  • the recesses on the spring sleeve can also be attached directly to the housing; the corresponding connection can, but does not have to be released during the coupling stroke.
  • the inner and outer characteristics of the coupling sleeve can also be designed differently, as long as only the axial extension and arrangement of the inner projections allow the engagement to be released by a coupling stroke and the external characteristics with the rotational alignment of the retaining arms of the coupling sleeve are compatible.
  • FIG. 6 is an exploded view of the components of an autoinjector according to a second variant of the invention.
  • the components which differ in comparison to FIG. 1, comprise a drive element in the form of a drive sleeve 21b which, distal to the torsion spring 20a, is connected to the spring coil 20b in a rotationally and axially fixed manner or is even formed in one piece with it.
  • the drive sleeve has a threaded element which engages in an external thread of a piston rod 22b extending over a length corresponding to the dispensing stroke.
  • the threaded element comprises a threaded section of an internal thread with preferably fewer turns than the external thread, or a thread segment with an extension in the direction of rotation of less than one turn, preferably less than half a turn.
  • the piston rod is located in an interior of the drive sleeve and functions as a propulsion element; it has a longitudinal groove into which the mechanism holder 13 fixed to the housing engages, so that by a Rotational movement of the drive sleeve in a known manner results in a purely axial forward movement of the piston rod.
  • the sleeve-shaped drive element can have an internal thread which extends over a length corresponding to the discharge stroke, and the thread of the threaded rod at the proximal end can be reduced to a thread section with a few turns or comprise a thread segment of less than one turn.
  • FIG. 7 shows a combined longitudinal section through the auto-injector according to FIG. 6 in the ready-to-inject state, after the device cap has been removed.
  • the cutting plane of the lower half is rotated by 90 ° about the longitudinal axis compared to the cutting plane of the upper half.
  • the switching sleeve 17, which is urged in the distal direction by the needle protection spring 15 to a proximal end of the needle protection sleeve 14, is guided in the mechanism holder 13 in a rotationally fixed manner.
  • the locking sleeve 18 is coupled to the switching sleeve 17 in a rotationally fixed manner.
  • the drive sleeve 21b has on its outside as a second coupling element an expression in the form of two opposing, axially aligned locking ribs 21c.
  • FIG. 8 shows, in the distal viewing direction, a cross section through the autoinjector axially at the level of the formations of the drive sleeve, indicated in FIG. 7 by a broken vertical line.
  • the locking sleeve 18 comprises two sperm grooves at this point, in which the locking ribs 21c engage via locking surfaces 24b and which prevent or block a rotation of the drive sleeve at least in the relaxation direction of the torsion spring (in the direction of view of FIG. 8 in the counterclockwise direction) and thus a propulsion of the piston rod 22b .
  • FIG. 9 shows a longitudinal section through the autoinjector immediately after it has been triggered or at the beginning of the distribution.
  • the needle protection sleeve 14 is displaced proximally by contact with the injection site and thereby also pushes the switching sleeve 17 and the locking sleeve 18 in the proximal direction, under tension of the needle protection spring 15 and with the release of the drive sleeve 21b as described.
  • the drive sleeve 21b can have a further embodiment in the form of a pin or cam which, as a first guide element, engages in a second guide element in the form of a guide groove of the locking sleeve 18 after the coupling stroke has taken place.
  • these guide elements cause an initial rotation of the drive sleeve to move the locking sleeve 18 with respect to the switching sleeve 17 by a locking stroke further proximally into an end position of the locking sleeve in which the locking of the needle protection sleeve is activated by the locking member 18a with an inwardly directed
  • the projection engages in a circumferential groove of the axially fixed drive sleeve 21b.
  • the axial end position assumed by the locking sleeve can be seen in FIG. 9; the locking sleeve is axially locked in this position.
  • the guide groove is not oriented parallel to the longitudinal axis of the autoinjector or is angled in this regard or in the form of a helical section.
  • FIG. 10 shows a variant of the first guide element in the form of an extension 21d in the proximal direction of the expression which forms the locking rib 21c.
  • the area of the extension is angled with respect to the longitudinal axis, accordingly the sperm nut of the locking sleeve shown in FIG. 8 is so wide that it can also accommodate the extension 21d as a second guide element.
  • the drive sleeve 21b and thus a surface of the extension 21d angled with respect to the longitudinal axis begin to rotate.
  • the locking sleeve is thereby pushed further in the proximal direction, in particular with respect to the switching sleeve, until the locking member of the locking sleeve engages behind a circumferential edge of the drive sleeve and makes it impossible to move the locking sleeve in the distal direction.
  • An angled first guide element does not have to adjoin the locking rib 21c directly, but can also be offset in the circumferential direction and move in a separate guide groove that differs from the sperm nut.
  • the needle protection sleeve 14 which is moved in a securing movement when the autoinjector is removed from the puncture site from a rear end position by a needle protection spring into a front end position, covers the injection needle 11b laterally.
  • the locking member 18a with radially inwardly directed projections on resilient arms of the The locking sleeve engages in a circumferential recess in the drive sleeve 21b, which prevents the locking sleeve from moving in at least the distal direction.
  • the locking sleeve rests proximally on a distal end face of the spring sleeve 20c, so that the locking sleeve cannot move in the proximal direction either.
  • Radially directed projections on the resilient arms engage behind a proximal edge of the switching sleeve 17, so that the switching sleeve cannot be moved in the proximal direction either.

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

La présente invention concerne un auto-injecteur comprenant : un boîtier ; un récipient de produit (11) fixé axialement dans le boîtier ; un ressort de torsion (20a) ; un élément d'entraînement (21, 21a, 21b) ; un élément de propulsion (22, 22a, 22b) ; et un manchon de protection d'aiguille (14) ; et lorsque l'auto-injecteur est pressé contre un site d'injection, le manchon de protection d'aiguille (14) effectue un mouvement d'actionnement dans la direction proximale. Afin d'évacuer un liquide depuis le récipient de produit (11) à travers une aiguille d'injection (11b) dans le site d'injection, le ressort de torsion (20a) amène l'élément d'entraînement (21) en rotation et l'élément d'entraînement rotatif provoque un déplacement de l'élément de propulsion (22) et un piston dans le récipient de produit dans la direction distale. L'auto-injecteur comprend un raccord qui, en conséquence du déplacement d'actionnement du manchon de protection d'aiguille (14), libère l'élément d'entraînement (21) pour rotation. Le raccord comprend un premier élément de raccordement (23c) qui s'engage dans un deuxième élément de raccordement (21c) par l'intermédiaire d'une surface d'encliquetage axiale (24a, 24b), cet engagement pouvant être séparé par une course de raccordement axiale des deux éléments de raccordement.
EP21718581.8A 2020-04-22 2021-04-16 Auto-injecteur comportant un moyen de libération d'évacuation Pending EP4138954A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20170759.3A EP3900759A1 (fr) 2020-04-22 2020-04-22 Injecteur automatique à libération de distribution
PCT/EP2021/059856 WO2021213901A1 (fr) 2020-04-22 2021-04-16 Auto-injecteur comportant un moyen de libération d'évacuation

Publications (1)

Publication Number Publication Date
EP4138954A1 true EP4138954A1 (fr) 2023-03-01

Family

ID=70390952

Family Applications (2)

Application Number Title Priority Date Filing Date
EP20170759.3A Withdrawn EP3900759A1 (fr) 2020-04-22 2020-04-22 Injecteur automatique à libération de distribution
EP21718581.8A Pending EP4138954A1 (fr) 2020-04-22 2021-04-16 Auto-injecteur comportant un moyen de libération d'évacuation

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP20170759.3A Withdrawn EP3900759A1 (fr) 2020-04-22 2020-04-22 Injecteur automatique à libération de distribution

Country Status (4)

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US (1) US20230050314A1 (fr)
EP (2) EP3900759A1 (fr)
CN (1) CN115397490A (fr)
WO (1) WO2021213901A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD866757S1 (en) * 2016-03-11 2019-11-12 Millennium Pharmaceuticals, Inc. Autoinjector
EP4275719A3 (fr) * 2023-09-07 2024-04-24 Ypsomed AG Mécanisme de sécurité pour auto-injecteur

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE602005008404D1 (de) * 2005-06-01 2008-09-04 Shl Medical Ab Medikamentenabgabevorrichtung
AU2008300703B2 (en) 2007-09-18 2011-03-17 Shl Group Ab Automatic injection device with needle insertion
CH711240A2 (de) * 2015-06-23 2016-12-30 Tecpharma Licensing Ag Autoinjektionsvorrichtung.
TW201726193A (zh) 2015-11-27 2017-08-01 賽諾菲阿凡提斯德意志有限公司 自動注射器（二）
EP3548117B1 (fr) * 2016-12-01 2021-07-07 Novo Nordisk A/S Dispositif d'administration de médicament avec fonction de ressort de torsion

Also Published As

Publication number Publication date
CN115397490A (zh) 2022-11-25
EP3900759A1 (fr) 2021-10-27
US20230050314A1 (en) 2023-02-16
WO2021213901A1 (fr) 2021-10-28

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