WO2022184388A1 - Auto-injecteur comprenant un manchon de protection d'aiguille - Google Patents

Auto-injecteur comprenant un manchon de protection d'aiguille Download PDF

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Publication number
WO2022184388A1
WO2022184388A1 PCT/EP2022/053054 EP2022053054W WO2022184388A1 WO 2022184388 A1 WO2022184388 A1 WO 2022184388A1 EP 2022053054 W EP2022053054 W EP 2022053054W WO 2022184388 A1 WO2022184388 A1 WO 2022184388A1
Authority
WO
WIPO (PCT)
Prior art keywords
spring
sleeve
housing
needle
product
Prior art date
Application number
PCT/EP2022/053054
Other languages
German (de)
English (en)
Inventor
Leos URBANEK
Markus Tschirren
Jürg HIRSCHEL
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 WO2022184388A1 publication Critical patent/WO2022184388A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback

Definitions

  • the invention relates to an auto-injector, which is often also referred to as an auto-injection device, with which a product contained in a product container can be poured out automatically after it has been triggered.
  • the liquid product is in particular a medicament.
  • the invention relates to an auto-injector with a needle guard.
  • the term "medicament” includes any flowable medicinal formulation suitable for controlled administration through a means such as a cannula or hollow needle, for example comprising a liquid, solution, gel, or fine suspension containing one or more medicinally active ingredients contains.
  • Medicament may be a single active ingredient composition or a premixed or co-formulated multiple active ingredient composition from a single container.
  • Medicament includes 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 substances substances based on hormones or genes
  • nutritional formulations enzymes and other substances in both solid (suspended) or liquid form but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier materials.
  • EP2745866B2 describes an auto-injector with a needle guard.
  • the auto-injector according to the invention has a housing and a product container arranged in the housing.
  • the product container can in particular be a syringe which has a syringe body on whose distal end an injection needle is fixedly arranged.
  • the preferably cylindrical syringe body surrounds a plunger which is slidable with respect to the syringe body and towards the distal end for dispensing product is shifted, as a result of which the liquid product, in particular medication, arranged between the piston and the injection needle is poured out of the product container through the injection needle.
  • the syringe body can have a flange, which can also be referred to as a finger flange, at its proximal end, ie the rear end or the end opposite the injection needle.
  • a syringe designed in this way is available as a standard syringe, so that a specially adapted syringe does not necessarily have to be developed for the autoinjector.
  • the plunger sealingly abuts the inner diameter of the syringe body.
  • the auto-injector according to the invention can have one or no dose selection.
  • all of the product held in the product container or part of the product held in the product container is therefore poured out.
  • the housing is preferably elongated and forms the longitudinal axis of the autoinjector.
  • the housing is preferably sleeve-shaped and/or cylindrical, in particular circular-cylindrical.
  • the product container is arranged in the housing.
  • the container may be slidably mounted within the housing, e.g. H. be displaceable in the distal direction relative to the housing for automatic lancing, so that the needle tip emerges from an opening at the distal end of the autoinjector and can be automatically lancing into the patient.
  • the needle tip can optionally be moved into the distal end of the device after the product has been dispensed, in particular the product container can be moved in the proximal direction relative to the housing.
  • the product container is immovably accommodated in the housing along the longitudinal axis, in particular by means of a product container holder or syringe holder, which holds the product container in an axially fixed manner and is connected, in particular latched, to the housing in an axially fixed manner.
  • the needle tip preferably projects beyond the distal end of the housing in the distal direction. As a result, the needle can be pierced into the puncture site by moving the housing towards the patient.
  • a needle protection sleeve is preferably provided, which forms the distal end of the autoinjector and has an opening for the injection needle, the needle being able to pass through the opening.
  • the needle guard can be arranged in its initial position relative to the needle tip such that the needle guard projects distally over the needle tip or that the needle tip projects distally over the distal end of the needle shield.
  • the needle guard can be moved relative to the housing from its starting position in the proximal direction by an actuating stroke into an actuated position, in particular into the housing, so that the needle emerges or further emerges from the distal end or through the opening of the needle guard.
  • the needle guard by a Nadelschutzhub from the actuated position relative to the housing in the distal direction in a Needle protection position are shifted in which the distal end of the Nadeltikhulse is distal over the needle tip to prevent that after the device has been used or after the product has been poured out, there is a risk of injury that would result from an exposed needle tip.
  • the needle guard can z. B. against the force of a spring, which can be referred to as a needle guard spring, in the proximal direction, the spring z. B. is the third spring described below or a separate spring, which can move the needle guard from the actuated position in the distal direction, ie into the needle guard position.
  • the auto-injector can be a z. B. resiliently arranged locking member which locks the needle guard in its needle guard position in particular with respect to the housing and blocks a retraction of the needle guard in the proximal direction or in the housing.
  • the locking member locks the needle guard at least in such a way that the needle cannot protrude from the distal end of the needle guard.
  • the needle guard can z. B. from the needle protection position only so far in the proximal direction that the needle tip does not protrude from the distal end of the needle guard.
  • the auto-injector also includes a propulsion element, which acts on the piston at least during the dispensing of the product, in particular bears against the piston.
  • the auto-injector includes first and second springs that act on the propulsion member to dispense product from the product container.
  • the propulsion member can, for. B. be sleeve-shaped.
  • the prestressing of the first and second springs can be determined in such a way that they can pour the product out of the product container by displacing the propulsion member by one pouring stroke. This means that a higher pouring force can be achieved.
  • a high dispensing force is required in particular for dispensing a viscous product.
  • the first and the second spring can be arranged in series. It can thus be ensured that the entire product can be poured out of the product container by displacing the propulsion member by the delivery stroke.
  • a spring sleeve can be provided, the first spring being supported in the distal direction on the propulsion member and in the proximal direction on the spring sleeve and the second spring in the distal direction on the spring sleeve and in the proximal direction on the housing or one fixed to the housing Element, in particular on a closure cap, is also supported in particular on an element which is only temporarily fixed axially to the housing.
  • the spring sleeve can be sleeve-shaped. The purpose of this construction is that the first and the second spring require a small installation space in the autoinjector.
  • the closure cap can be at the proximal end of the housing and/or form the proximal end of the autoinjector.
  • the closure cap can particularly preferably be connected to the housing with a form fit, alternatively with a force fit or with a material fit be.
  • the element is preferably latched to the housing.
  • a separate closure cap has the advantage that assembly of the device is made easier, with at least some of the components being able to be introduced into the housing for assembly via the proximal end, which is then closed with the closure cap.
  • the first spring can be supported in the distal direction inside the propulsion member and in the proximal direction inside the spring sleeve. More preferably, the first spring may be supported in the distal direction at the distal end inside the driving member and in the proximal direction at the proximal end inside the spring sleeve. Further, the first spring may be at least partially received in the distal direction by the driving member and at least partially in the proximal direction by the spring sleeve.
  • the second spring can be supported on an outer surface of the spring sleeve in the distal direction and on the inside of the housing or the closure cap in the proximal direction.
  • the spring sleeve can be designed in such a way that the spring sleeve can hold and guide the first and/or the second spring.
  • the distal end of the second spring may preferably be located distal to the proximal end and proximal to the distal end of the first spring.
  • the first spring is designed in such a way that the first spring can be arranged inside the propulsion member. While the product is being poured out, the first spring can reach or dip into the interior of the product container by means of the propulsion element. The second spring remains outside of the product container while the product is being dispensed or does not dip into the product container.
  • the prestressing of the first and second springs can particularly preferably be determined in such a way that the first spring causes a greater partial delivery stroke of the delivery stroke than the second spring.
  • the prestressing of the first and second springs can be determined in such a way that the second spring causes a greater partial delivery stroke of the delivery stroke than the first spring.
  • the prestressing of the first and the second spring can be determined in such a way that the first and the second spring each bring about an equally large partial delivery stroke of the delivery stroke.
  • the sum of the prestressing of the first and second springs can be greater than the prestressing of the third spring in the starting position.
  • the propulsion member is arranged in a proximal position in the autoinjector in the starting position.
  • the spring tension can be selected in such a way that the liquid product, in particular the entire medication in the product container, can be poured out.
  • the first and second springs are preferably in the form of helical springs which act as compression springs and are preferably made of metal.
  • the first and second springs are prestressed so strongly, particularly in the initial state of the auto-injector, that they or the energy stored in them is sufficient to essentially completely pour out the product from the product container by moving the propulsion member by one delivery stroke.
  • the displacement of the propulsion element by the discharge stroke also causes the piston to be displaced. If there is a clearance between the piston and the propulsion member in the starting position, the discharge stroke of the piston will be less than the discharge stroke of the propulsion member, which is preferred since the piston remains unloaded until use, thereby avoiding unwanted premature product discharge. In principle, however, it is also possible for the propulsion member to bear against the piston in the starting position and not just when the product is being dispensed.
  • the delivery stroke of the piston corresponds to the delivery stroke of the propulsion member.
  • the proximal end of the first spring which due to its function can also be referred to as a dispensing spring, can be supported on the housing or on an element fixed to the housing, in particular on the closure cap, in particular also on the element which is only temporarily fixed axially to the housing.
  • the auto-injector has a third spring.
  • the third spring can exert a spring force acting on a holding element counter to the dispensing direction or in the proximal direction.
  • the third spring z. B. with its proximal end on the holding element.
  • the third spring can, for. B. be a coil spring acting as a compression spring, which is supported with its proximal end on the holding element.
  • the third spring is preferably made of metal.
  • the third spring can with its distal end z. B. on the housing or an element fixed to the housing.
  • the third spring is particularly preferably supported with its distal end on the needle protection sleeve or on an element which, in particular when the needle protection sleeve is displaced relative to the housing, is displaced with the needle protection sleeve.
  • the element can be a switching module or a switching sleeve, as will be described further below.
  • the element can be arranged kinematically and/or geometrically between the needle guard and the distal end of the third spring.
  • the advantage here is that the needle guard can be moved from its actuated position into the needle guard position by means of the third spring.
  • the holding element has a first engagement member, which is in particular resilient and/or arranged on a resilient arm and which engages in the propulsion member, in particular in a recess of the propulsion member, in a detachable manner.
  • the propulsion member is axially fixedly coupled to the holding element, the axially fixed coupling between the propulsion member and the holding element being released when the holding element, in particular the first engagement member, is disengaged or pushed out of engagement with the propulsion member, in particular the recess of the propulsion member.
  • the auto-injector is thus in the triggered position.
  • the needle protection sleeve acts on the third spring, the needle protection sleeve being used to trigger the product discharge from its initial position relative to the housing and along the longitudinal axis of the autoinjector in the proximal direction, i. H. is displaceable against the dispensing direction, in particular by the actuating stroke.
  • the needle guard is preferably moved from its starting position to its actuated position by the actuating stroke in that its distal end is pressed against the puncture site of the patient, with the housing being displaced relative to the needle guard in the direction of the puncture point, so that the needle guard completes the actuating stroke relative to the housing.
  • the needle protruding from the distal end of the needle guard is also inserted into the puncture site.
  • the auto-injector is removed from the puncture site, whereby the needle protective sleeve moves relative to the housing from its actuated position by the needle protective stroke into the Needle guard position is shifted, in particular by means of the spring energy stored in the third spring. Removing the auto-injector from the puncture site also pulls the needle out of the puncture site.
  • a switching module can be arranged kinematically between the third spring and the needle guard, the switching module being carried along by the needle guard in the proximal direction when the needle guard is displaced from its starting position in the proximal direction or into the actuated position, and the Needle guard shifts in the distal direction when the spring acting on the switching module moves the switching module in the distal direction.
  • the switching module or a part thereof, such as e.g. B. a switching sleeve can be in one piece with the needle guard or z. B. positively connected such. B. snapped, or be loosely attached to the needle guard.
  • the switching module can be a single part or comprise several parts, whereby a multi-part switching module can have at least the switching sleeve and a locking sleeve.
  • the locking sleeve can be relative to the Needle protection sleeve and / or the switching sleeve z. B. along the longitudinal axis.
  • the third spring can be supported on the switching sleeve and the switching sleeve on the needle guard.
  • the switching sleeve and the needle guard can be connected in an axially fixed and preferably non-rotatable manner, it being possible for the third spring to be supported on the switching sleeve.
  • the switching sleeve and the needle guard sleeve can be designed in one piece, it being possible for the third spring to be supported on the switching sleeve.
  • a z. B. unidirectionally acting locking member which preferably the above locking member, which locks the needle guard in its needle guard position, may be provided, the z. B. is formed by the locking sleeve and engages in and/or on the switching sleeve, in particular in a recess or on an edge.
  • the locking member is preferably designed such that the switching sleeve entrains the locking sleeve via the locking member during its movement relative to the housing in the proximal direction, in particular during the movement of the needle guard from its starting position to the actuated position, and during its movement relative to the housing is displaced in the distal direction relative to the locking sleeve in a locking position, in particular during the displacement of the Nadeltikhulse from its actuated position in the Nadeltikposition, wherein in the locking position, the or another locking member, such as. B. the above, a movement of the switching sleeve relative to the locking sleeve in the proximal direction blocks. This advantageously prevents the needle protection sleeve from being able to be pushed back from its needle protection position into the housing in order to release the needle tip again.
  • the switching sleeve can have a first recess in which the locking member of the locking sleeve releasably engages when the needle guard is shifted from its initial position to its actuated position.
  • the switching sleeve can have a second recess or an edge, in particular a proximal edge, into which the locking member or possibly the other locking member engages or engages when the needle protection sleeve is in its needle protection position.
  • the first and second recesses or edges can preferably be arranged at a distance from one another along the longitudinal axis which corresponds approximately to the needle guard stroke.
  • the switching sleeve can have a first recess into which the locking member or locking members of the locking sleeve engages releasably when the needle guard is shifted from its initial position to its actuated position. That The locking member of the locking sleeve can abut the proximal end of the switching sleeve when the needle shield is in its needle shielding position.
  • reversing the arrangement of the recess and the locking member is also possible.
  • the locking member and possibly the other locking member can be resiliently arranged, in particular each on a resilient arm.
  • the switching sleeve can preferably surround and/or guide the locking sleeve.
  • the holding element can have a second engagement element, which can be moved into an, in particular axially fixed, engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, by the disengagement movement of the first engagement element, with which the first engagement element disengages from the propulsion element.
  • the first engagement element and the second engagement element of the holding element are preferably matched to one another in such a way that the second engagement element already engages, preferably axially fixed, in the needle guard or the switching module when the first engagement element has not yet completely disengaged from the propulsion element.
  • the needle guard or the switching module in particular the locking sleeve, a z. B. further recess into which the second engaging member of the holding element, z. B. for the axially fixed coupling between the holding element and the switching module, in particular the locking sleeve, or the needle guard engages.
  • the propulsion member can have a recess into which the first engagement member engages for the axially fixed coupling between the propulsion member and the holding element.
  • the first engaging member and the second engaging member are formed on a common resilient arm, the first engaging member, e.g. B. radially towards the longitudinal axis and the second engagement member, z. B. radially, point away from the longitudinal axis.
  • the first and second engagement members can be arranged, preferably radially, between the propulsion member and the needle guard sleeve or the switching module, in particular the locking sleeve.
  • the auto-injector can particularly preferably include a signal stop.
  • the signal stop can be formed by the housing or by a mechanism holder which is connected to the housing at least in an axially fixed manner, preferably also in a rotationally fixed manner.
  • the third spring can exert a spring force acting counter to the dispensing direction on the holding element.
  • the retaining member In the deployed position, the retaining member is decoupled from the propulsion member.
  • the first engaging member of the holding member may be disengaged from the propelling member.
  • the second engagement element of the retaining element is coupled to the switching module, in particular the locking sleeve, in an axially fixed manner.
  • This acoustic and/or tactile signal indicates the start of the distribution.
  • the signal stop can be designed as a resonance body, whereby the auditory impression of the acoustic signal can be changed within certain limits by the design of material thicknesses and shapes of the signal stop.
  • the signal stop is preferably arranged along the longitudinal axis of the autoinjector in such a way that it is arranged in alignment with the holding element. The result of this is that the retaining element strikes the signal stop with a movement along the longitudinal axis of the autoinjector.
  • the needle guard or the switching module in particular the locking sleeve, can hold the first engagement member of the holding element in engagement with the recess of the propulsion member, with the recess for the second engagement member of the holding element being occupied by moving the needle guard from its initial position to its actuated position relative to the longitudinal axis is displaced towards the second engagement member.
  • the first engagement member is held in engagement with the propulsion member by the inner periphery of the needle guard or switching module, particularly the locking sleeve, against which the second engagement member abuts.
  • the propulsion member can be moved in the distal direction relative to the holding element and/or housing by means of the first and second springs when the first engaging member of the holding element is out of engagement with the propulsion member and the second engaging member of the holding element is in engagement with the needle guard or the switching module.
  • the distance between the second engagement element of the holding element and the recess for the second engagement element in the starting position of the autoinjector along the longitudinal axis can be approximately the distance that corresponds to the actuating stroke of the needle guard.
  • a further aspect of the invention relates to the design of a product container holder, in particular a tip holder for an auto-injector, in particular for an auto-injector in which the product container cannot be displaced in relation to the housing, or for an auto-injector of the type described above.
  • the invention is based on a syringe module which is intended in particular for use in an autoinjector.
  • an autoinjector can be provided which has such a syringe module.
  • the syringe module includes a syringe and a syringe holder.
  • the syringe has a syringe body, a plunger and a needle, the needle e.g. B.
  • the syringe also has a needle cap which z. B. can be a so-called soft needle shield or preferably a rigid needle shield.
  • a soft needle shield is preferably formed from a rubber-elastic plastic, with a rigid needle shield being formed from a sleeve made from hard plastic, in which a sleeve made from a rubber-elastic plastic is arranged.
  • the sleeve made of rubber-elastic plastic and the sleeve made of hard plastic together form the rigid needle shield.
  • the needle protective cap which covers the needle and is fastened to the needle holding section, which in particular extends conically in the direction of the needle tip, keeps the needle preferably protected from dirt and sterile.
  • a gap is formed between the tapered portion and the needle guard, particularly the hard plastic sleeve.
  • the syringe holder has at least one engagement element, in particular a shoulder, on which the tapered section of the syringe is supported in the distal direction and which engages in the gap between the needle protective cap and the tapered section.
  • the contact of the tapering section on the at least one shoulder prevents the syringe from being able to move in the distal direction relative to the syringe holder.
  • the syringe body may include a finger flange at its proximal end, with a gap being formed between the finger flange and the syringe body when the tapered portion abuts the shoulder, leaving the finger flange substantially unstressed. This advantageously prevents the finger flange from being overloaded and breaking the syringe body.
  • the syringe holder has at least one holding element, in particular an outwardly directed projection, with which the syringe holder can be or is connected, in particular snapped or can be snapped on, to a housing of the autoinjector in an axially fixed manner.
  • the syringe holder can have at least one cam, which is arranged resiliently, in particular on an arm and z. B. is arranged distally of the holding member.
  • the at least one cam can inhibit or prevent a needle guard from moving from its initial position to its actuated position in such a way that when a limit force exerted on the needle guard along the longitudinal axis L of the autoinjector is exceeded, the at least one cam is pressed out of engagement with the needle guard, whereby the needle guard can be displaced abruptly into its actuated position relative to the housing.
  • the housing of the auto injector can, for. B. have a holding portion which rests against the syringe holder, in particular an outer surface or an outer periphery of the syringe holder and which prevents the at least one engagement member, in particular the at least one shoulder of the syringe holder, from moving away from the longitudinal axis transversely to the longitudinal axis.
  • the holding section can be cylindrical and surround the at least one engagement member, preferably two or three or four engagement members, so that the at least one engagement member is arranged within the holding section. For the assembly or insertion of the syringe into the syringe holder, the syringe holder is outside of the engagement with the holding section of the housing.
  • the syringe module or the syringe holder When the syringe is fully inserted into the syringe holder, in particular when the at least one engagement member engages in the gap between the tapered section and the needle protective cap, the syringe module or the syringe holder is brought into engagement with the holding section, so that it is prevented that moving the at least one engagement member out of engagement with the tapered portion transverse to the longitudinal axis, in particular away from or outward from the longitudinal axis.
  • the at least one engagement element in particular the at least one shoulder, can be designed to be resilient, in particular on an arm on the syringe holder, with the syringe being pushed into the syringe holder, which is preferably sleeve-shaped, via the proximal end with the needle first. wherein the needle guard deflects the at least one engagement member transversely to the longitudinal axis outwardly, ie away from the longitudinal axis, wherein when the needle guard has been moved completely past the at least one engagement member, the at least one engagement member into the gap between the tapered portion and the needle guard snaps.
  • the syringe holder is moved with the syringe into engagement with the holding portion of the housing of the autoinjector, whereby the at least one Engaging member is held in engagement with the gap between the needle shield and the tapered portion and can no longer spring out of this engagement.
  • the holding section may include a holding shoulder which prevents the syringe holder from being displaced in the distal direction relative to the housing.
  • the holding section of the housing can be designed in the form of a sleeve and can be arranged inside the housing.
  • a stop in particular an actuating stop, can be provided between the sleeve-shaped holding section of the housing and the sleeve-shaped housing to limit the axial movement of the needle protective sleeve in the proximal direction.
  • the holding section of the housing preferably protrudes in the distal direction beyond the distal end of the housing.
  • the holding section can have one or more grooves which, in conjunction with the rail or rails provided on the needle protection sleeve, form an anti-twist device between the housing and the needle protection sleeve.
  • the rail of the needle guard is preferably provided on an inner surface of the needle guard.
  • the groove of the holding section is preferably arranged on an outer surface of the holding section.
  • the needle guard can preferably be moved axially between the holding section of the housing and the housing in a rotationally fixed manner.
  • the one or more grooves may be provided on the needle shield and the one or more rails may be provided on the retaining portion of the housing to provide insurance between the housing and the needle shield.
  • the groove of the needle guard is preferably provided on an inner surface of the needle guard.
  • the rail of the holding section is preferably arranged on an outer surface of the holding section.
  • FIG. 1 shows an exploded view of an embodiment of an injection device according to the invention.
  • 2a-2b show the autoinjector from FIG. 1 in a starting position, with FIGS. 2a and 2b being sectional views running through the longitudinal axis L of the device, with the sectional views being angularly offset about the longitudinal axis L by 90 degrees.
  • FIGS. 3a-3b show the auto-injector from FIGS. 2a-2b, with a needle protection sleeve being in its actuated position and the signal to start dispensing being generated.
  • FIGS. 4a-4b show the auto-injector from FIGS. 2a-2b in the dispensed position.
  • FIGS. 5a-5b show the autoinjector from FIGS. 2a-2b, with the needle protection sleeve being in its needle protection position.
  • the autoinjector has a sleeve-shaped, elongated housing 2 with a longitudinal axis L, which has a closure cap 12 at its proximal end, which is positively connected to the housing 2 in a rotationally and axially fixed manner and forms the proximal end of the autoinjector.
  • the closure cap 12 is snapped onto the housing 2 .
  • the closure cap 12 has a latching element 12a, which is latched into a recess 2a on the housing 2, preferably in such a way that the closure cap 12 cannot be detached from the housing 2, or cannot be easily detached.
  • a pull-off cap 4 is arranged at the distal end of the auto-injector in its starting position (FIGS. 2a-2b), which is pulled off or twisted off and removed before the use of the auto-injector.
  • a product container 13 in the form of a syringe is accommodated in the housing 2 so that it cannot be displaced along the longitudinal axis L in relation to the housing 2—apart from the assembly of the autoinjector.
  • the product container 13 has a sleeve-shaped syringe body which encloses a plunger 13b (FIGS. 2a-2b) which rests sealingly against the inner circumference of the syringe body.
  • the syringe body has an injection needle 13a (FIGS. 2a-2b) which is in particular non-detachably connected to the syringe body and whose distal end is formed by the needle tip.
  • the liquid product by moving the plunger 13b ( Figure 2a-2b) in a discharge direction, d. H. pours the product out of the product container 13 through the hollow injection needle 13a (FIGS. 2a-2b) in the distal direction or towards the injection needle 13a (FIGS. 2a-2b).
  • the syringe body At its proximal end, the syringe body has what is known as a finger flange, which projects radially outwards over the outer circumference of the cylindrical syringe body.
  • the product container 13 is accommodated in a product container holder, referred to as the syringe holder 1, in such a way that it is secured at least against movement along the longitudinal axis L in the distal direction relative to the syringe holder 1.
  • the syringe holder 1 is positively connected to the housing 2, in particular latched.
  • the housing 2 has recesses into which the latching elements, which are formed here at the proximal end of the syringe holder 1, engage.
  • the syringe holder 1 has at least one inwardly projecting shoulder lb on which a tapering portion of the product container 13, the distal of the cylindrical
  • the product container 13 is pressed at its proximal end into engagement with the shoulder 1b by a holder acting on the syringe body.
  • the holder is formed by a retaining spring section 5c of a mechanism holder 5.
  • the mechanism holder 5 is arranged in relation to the housing 2 along the longitudinal axis L, in particular in a non-displaceable and/or non-rotatable manner.
  • the sleeve-shaped mechanism holder 5 can be snapped onto the housing 2 .
  • the retaining spring section 5c allows differences in the length of the product container 13, which can arise due to manufacturing tolerances, to be compensated for, with the product container 13 being securely seated on the shoulder 1b.
  • the product container 13 is arranged in relation to the housing 2 in such a way that the needle tip protrudes distally beyond the distal end of the housing 2 .
  • the needle 13a ( Figures 2a-2b) is formed by a needle protective cap 14, which in the example shown is a so-called rigid needle shield known to those skilled in the art, alternatively a soft needle shield is covered to protect the needle 13a ( Figures 2a-2b) from contamination or to keep the needle 13a ( Figures 2a-2b) and the medication sterile.
  • the needle protective cap 14 is arranged on a needle holding portion of the syringe body with the tapered portion of the syringe body located between the needle holding portion and the cylindrical portion of the syringe body.
  • the peel-off cap 4 is releasably snapped onto the housing 2 or a needle guard 3, this snap-fit being released when the peel-off cap 4 is removed from the housing 2 or the needle guard 3.
  • the pull-off cap 4 also has, in particular, a snap hook 4a which engages in a gap between the syringe body, in particular its tapering area, and the proximal end of the needle protective cap 14 .
  • the snap hook 4a hooks into the proximal end of the needle cap 14, thereby releasing the needle cap 14 from the product container 13 and removing it together with the cover cap 4 from the auto-injector.
  • the snap hook 4a can hook into a lateral surface of the needle protective cap 14 or into a lateral surface of the needle protective cap 14 .
  • the auto-injector has a needle protection sleeve 3, which can be displaced relative to the housing 2 and along the longitudinal axis L by an actuating stroke in the proximal direction into an actuated position in order to trigger product dispensing.
  • a needle protection sleeve 3 which can be displaced relative to the housing 2 and along the longitudinal axis L by an actuating stroke in the proximal direction into an actuated position in order to trigger product dispensing.
  • the distal end of the needle guard 3 projects distally beyond the needle tip of the needle 13a, so that access to the needle tip is initially prevented.
  • the needle guard 3 By moving the needle guard 3 by the actuating stroke, the needle guard 3 is pushed far enough in the proximal direction that the needle 13a protrudes from the distal end of the needle guard 3, in particular with a length that corresponds to the injection depth of the needle into the puncture site.
  • the needle 13a should preferably protrude beyond the distal end of the needle protection sleeve 3 to such an extent that a subcutaneous injection can take place.
  • the housing 2 can form a stop 2c against which the needle guard 3 rests in the actuated position.
  • the needle guard 3 can be displaced relative to the housing 2 from the actuated position along the longitudinal axis L by a needle guard stroke in the distal direction into a needle guard position (FIGS. 6a-6b).
  • a needle guard stroke in the distal direction into a needle guard position (FIGS. 6a-6b).
  • the needle protection position the distal end of the needle protection sleeve 3 protrudes distally beyond the needle tip, so that access to the needle tip is prevented and the risk of injury is reduced.
  • the needle guard 3 can be blocked from being pushed back out of the needle guard position again.
  • the syringe holder 1 has a projection 1a which points radially outwards, the projection 1a engaging in a slot-shaped recess in the needle protective sleeve 3 which is arranged between the housing 2 and the syringe holder 1 .
  • the needle guard 3 in particular the proximal end of the slot-shaped recess, rests against the projection la, causing the needle guard to move 3 in the distal direction is prevented.
  • a cam 1c which is arranged resiliently on the syringe holder 1 and is formed by the syringe holder 1, can engage in this slot-shaped recess, alternatively in another recess of the needle protective sleeve 3.
  • the cam lc is designed so that when attempting to shift the needle guard 3 from the home position to the actuated position, the cam lc initially prevents the shifting of the needle guard 3, with the cam lc being pushed out when the needle guard 3 moves to the Pushing back applied force exceeds a certain threshold, whereby the needle guard 3 is suddenly pushed back into the actuated position.
  • the needle 13a (FIGS. 2a-2b) can suddenly be pierced into the puncture point.
  • the housing 2 has a cylindrical holding section 2b ( Figures 2a-2b), which in particular surrounds the distal end of the syringe holder 1 in a cylindrical manner and rests against it, as a result of which the at least one shoulder lb is held in engagement with the tapering area of the syringe body.
  • the housing 2 has in the area of the holding section 2b ( Figures 2a-2b) a translation stop in the form of a holding shoulder 2e ( Figures 2a-2b) which prevents the syringe holder 1 from being displaceable relative to the housing 2 in the distal direction , when the syringe holder 1 rests against the holding shoulder 2e ( Figures 2a-2b).
  • the cylindrical holding section 2b (FIGS. 2a-2b) can have a groove 2d which, in conjunction with a rail 3c which is attached to the inside of the needle protective sleeve 3, forms an anti-twist device for the needle protective sleeve 3.
  • the auto-injector also has a sleeve-shaped propulsion member 7, which acts on the piston 13b during the dispensing of the product. Furthermore, a first spring 9a and a second spring 9b are provided, which act on the propulsion member 7 .
  • the first spring 9a and the second spring 9b are designed as a compression spring, in particular as a helical spring made of metal.
  • the prestressing of the first 9a and the second spring 9b can be determined in such a way that the product can be poured out of the syringe 13 by moving the propulsion member 7 by one delivery stroke.
  • the first 9a and the second spring 9b are arranged in series.
  • a spring sleeve 11 is also provided, the first spring 9a being supported in the distal direction on the propulsion member 7 and in the proximal direction on the spring sleeve 11 and the second spring 9b in the distal direction on the spring sleeve 11, in particular on a projection 11b the spring sleeve 11 and is supported in the proximal direction on the closure cap 12.
  • the prestressing of the first spring 9a and the second spring 9b is determined in such a way that the first spring 9a performs a greater partial delivery stroke of the delivery stroke than the second spring 9b.
  • the spring sleeve 11 has a guide pin 11a which is inserted through the proximal end of the first spring 9a into the core of the first spring 9a.
  • the guide pin 11a prevents the first spring 9a from buckling sideways during and at the end of the discharge stroke of the propulsion member 7.
  • a holding element 6 is provided.
  • a third spring 10 is supported with its proximal end on the holding element 6 .
  • the holding element has two arms 6c, with a first engagement element 6a and a second engagement element 6b being arranged on each arm 6c.
  • the first engagement element 6a points radially towards the catching axis F, wherein the second engagement element 6b points radially away from the catching axis F.
  • the first engagement element 6a engages in a recess 7a, which is formed by the propulsion element 7, whereby a movement of the propulsion element 7 relative to the holding element 6 in the distal direction or in the pouring direction is prevented. This keeps the first spring 9a and the second spring 9b in their tensioned state.
  • the auto-injector has a switching module 8 , 15 which has a switching sleeve 15 and a locking sleeve 8 surrounded by the switching sleeve 15 .
  • the first engagement element 6a is held in engagement with the first recess 7a by the inner circumference of the locking sleeve 8, which bears against the second engagement element 6b.
  • the switching sleeve 15 is axially firmly connected to the proximal end 3a of the needle guard 3 or at least rests against the proximal end 3a of the needle guard 3 .
  • the third spring 10 is a metal spring that acts as a compression spring and is designed as a helical spring.
  • the third spring 10 is supported with its proximal end on the holding element 6, in particular on a projection 6d of the holding element 6.
  • the holding element 6 is mounted in the housing 2 in an axially displaceable and non-rotatable manner.
  • the third spring 10 also surrounds the mechanism holder 4 at least partially.
  • the sum of the preloads of the first spring 9a and the second spring 9b is greater than the preload of the third spring 10.
  • the holding element (6) is axially fixed to the propulsion member (7), so that the first spring 9a and the second spring 9b are prestressed and the third spring 10 is supported on the holding element (6).
  • the holding element (6) is held in the starting position by means of prestressing of the third spring 10 .
  • the switching element 15 has a recess 15a, in which a locking element 8a of the locking sleeve 8 engages.
  • the locking member 8a is preferably sawtooth-shaped and protrudes radially from the catch axis F away.
  • the locking member 8a is arranged resiliently on an arm which is formed by the locking sleeve 8.
  • the switching sleeve 15 is also carried along by the actuating stroke, as a result of which the third spring 10 is tensioned. If the needle guard 3 is not fully moved into the actuated position, the third spring 10 can move the switching sleeve 15 and the needle guard 3 back to the starting position, wherein the engagement of the locking member 8a and the locking sleeve 8 is carried along by the switching sleeve 15.
  • the pull-off cap 4 is removed from the auto-injector together with the protective needle cap 14.
  • the distal end of the needle guard 3 is applied to the puncture site of a patient, with the housing 2 being displaced toward the puncture site, causing the needle guard 3 to move from its initial position by the actuation stroke in the proximal direction relative to the housing 2 to the actuated position .
  • the third spring 10 is tensioned, with the switching sleeve 15 being entrained by the needle guard 3 by the actuating stroke.
  • the locking sleeve 8 has a recess 8b ( Figures 3a-3b) which is brought into the position of the second engagement element 6b of the holding element by moving the locking sleeve 8 by the actuating stroke along the longitudinal axis L, as shown in Figures 3a-3b.
  • the first engagement element 6a is moved out of engagement with the propulsion member 7 with a movement transversely to and away from the longitudinal axis L, while at the same time the second engagement element 6b is moved into engagement with the locking sleeve 8, in particular its recess 8b.
  • the propulsion member 7 is released for movement by the delivery stroke in the delivery direction.
  • the holding element 6 which can be moved at least a little relative to the housing 2 and along the longitudinal axis L, can be moved in the proximal direction by the third spring 10 , wherein the retaining element 6 takes the locking sleeve 8 with it by a start signal stroke via the engagement of the second engagement element 6b in the recess 8b, whereby the locking sleeve 8 strikes a signal stop 5a, which is formed by the mechanism holder 5, and thereby an acoustic and/or emits a tactile signal, which signals to the user of the device that the product distribution has started.
  • the locking member 8a By shifting the locking sleeve 8 by the actuating stroke and/or start signal stroke, the locking member 8a is released for movement transversely and towards the longitudinal axis L, since the mechanism holder 5 has a recess 5b which allows such a movement of the locking member 8a when the locking sleeve 8 has been shifted by the actuating stroke and/or signal stroke or when the needle guard 3 is in its actuated position.
  • the engagement of the second engagement element 6b in the first recess 8b remains, as a result of which movement of the locking sleeve 8 in the distal direction relative to the housing 2 is prevented.
  • the engagement elements 6b remain in the position deflected away from the longitudinal axis L by the laterally attached cams, which are prevented by the mechanism holder 5 from being deflected back toward the longitudinal axis L.
  • the propulsion member 7 is moved in the distal direction relative to the housing 2 by the prestressing of the first 9a and the second spring 9b, so that the product is poured out of the product container 13b.
  • the prestressing of the first spring 9a and the second spring 9b is determined in such a way that the first spring 9a causes a greater partial delivery stroke of the delivery stroke than the second spring 9b.
  • the first spring 9a preferably makes 2/3 and the second spring 9b preferably makes 1/3 of the discharge stroke.
  • the end of the dispensing of the product can be indicated by a signal, in particular by a visual and/or acoustic and/or tactile signal.
  • the third spring 10 can move the switch sleeve 15 and needle guard 3 from the actuated position to the needle guard position by the needle guard stroke, pushing the locking member 8a out of engagement with the recess 15a, with the switch sleeve 15 moved relative to the locking sleeve 8 in the distal direction.
  • the locking member 8a snaps onto the switch sleeve 15 or the locking member 8a engages the proximal edge of the switch sleeve 15, the locking member 8a preventing the needle guard 3 from being pushed back into its actuated position.
  • the switching member 15 strikes the locking member 8a, which prevents movement of the needle guard 3 into the actuated position.
  • the locking sleeve 8 is supported axially on the signal stop 5a of the mechanism holder 5 .

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 pour délivrer un produit liquide, en particulier un médicament, comprenant : a) un boîtier (2) et un récipient de produit (13) disposé dans le boîtier (2), en particulier une seringue, comportant un piston mobile (13b), le piston (13b) pouvant être déplacé dans une direction de sortie pour sortir le produit contenu dans le récipient de produit (13) ; b) un élément d'entraînement (7) qui agit sur le piston (13b) pendant la sortie du produit, et un premier ressort (9a) et un deuxième ressort (9b) qui agissent sur l'élément d'entraînement (7) ; c) un manchon de protection d'aiguille (3) qui peut être déplacé depuis sa position de départ par rapport au boîtier (2) et le long d'un axe longitudinal (L) de l'auto-injecteur dans la direction proximale, en particulier avec une course d'actionnement, afin de déclencher la sortie du produit, un troisième ressort (10) est tendu et, en particulier, la sortie de produit est déclenchée, le manchon de protection d'aiguille (3) agit sur le troisième ressort (10) ; caractérisé en ce que d) la précontrainte du premier et du deuxième ressort (9) est déterminée de telle sorte qu'elle permette de délivrer le produit à partir du récipient de produit (13b) en déplaçant l'élément d'entraînement (9) avec une course de sortie.
PCT/EP2022/053054 2021-03-04 2022-02-09 Auto-injecteur comprenant un manchon de protection d'aiguille WO2022184388A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH00235/21A CH717046A2 (de) 2021-03-04 2021-03-04 Autoinjektor mit einer Nadelschutzhülse.
CH00235/21 2021-03-04

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WO2022184388A1 true WO2022184388A1 (fr) 2022-09-09

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11730888B2 (en) 2010-02-18 2023-08-22 Sanofi-Aventis Deutschland Gmbh Auto-injector
US11752266B2 (en) 2015-06-03 2023-09-12 Sanofi-Aventis Deutschland Gmbh Syringe support and autoinjector
US12005240B2 (en) 2011-02-18 2024-06-11 Sanofi-Aventis Deutschland Gmbh Auto-injector

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100249705A1 (en) * 2007-07-06 2010-09-30 Shl Group Ab One Shot Injector with Dual Springs
US20150018776A1 (en) * 2012-03-30 2015-01-15 Tecpharma Licensing Ag Injection device having a dose indicating element that can be moved relative to a housing
EP2745866B1 (fr) 2014-01-30 2016-10-05 TecPharma Licensing AG Sécurité de déclenchement pour un injecteur de voiture
US20180147352A1 (en) * 2015-05-22 2018-05-31 Owen Mumford Limited Automatic injection device with plunger velocity regulator
US20200108206A1 (en) * 2014-07-29 2020-04-09 Tecpharma Licensing Ag Autoinjector having a settable dose

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100249705A1 (en) * 2007-07-06 2010-09-30 Shl Group Ab One Shot Injector with Dual Springs
US20150018776A1 (en) * 2012-03-30 2015-01-15 Tecpharma Licensing Ag Injection device having a dose indicating element that can be moved relative to a housing
EP2745866B1 (fr) 2014-01-30 2016-10-05 TecPharma Licensing AG Sécurité de déclenchement pour un injecteur de voiture
US20200108206A1 (en) * 2014-07-29 2020-04-09 Tecpharma Licensing Ag Autoinjector having a settable dose
US20180147352A1 (en) * 2015-05-22 2018-05-31 Owen Mumford Limited Automatic injection device with plunger velocity regulator

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11730888B2 (en) 2010-02-18 2023-08-22 Sanofi-Aventis Deutschland Gmbh Auto-injector
US12005240B2 (en) 2011-02-18 2024-06-11 Sanofi-Aventis Deutschland Gmbh Auto-injector
US11752266B2 (en) 2015-06-03 2023-09-12 Sanofi-Aventis Deutschland Gmbh Syringe support and autoinjector

Also Published As

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