WO2011032731A1 - Amortissement d'une tige de piston pour seringues partiellement remplies - Google Patents

Amortissement d'une tige de piston pour seringues partiellement remplies Download PDF

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Publication number
WO2011032731A1
WO2011032731A1 PCT/EP2010/050746 EP2010050746W WO2011032731A1 WO 2011032731 A1 WO2011032731 A1 WO 2011032731A1 EP 2010050746 W EP2010050746 W EP 2010050746W WO 2011032731 A1 WO2011032731 A1 WO 2011032731A1
Authority
WO
WIPO (PCT)
Prior art keywords
piston rod
piston
idle stroke
product container
separate part
Prior art date
Application number
PCT/EP2010/050746
Other languages
English (en)
Inventor
Daniel Künzli
Ulrich Moser
Ursina Streit
Markus Bollenbach
Original Assignee
Tecpharma Licensing 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 Tecpharma Licensing Ag filed Critical Tecpharma Licensing Ag
Publication of WO2011032731A1 publication Critical patent/WO2011032731A1/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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/20—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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • 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
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • 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
    • A61M2005/2086—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
    • 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
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • 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
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on 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
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M2005/3151—Means for blocking or restricting the movement of the rod or piston by friction
    • 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
    • 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

Definitions

  • the invention relates to a device for administering a liquid product, in particular a drug.
  • a device for administering a liquid product in particular a drug.
  • Such an administering device can in particular be a so-called auto-injector in which product is at least delivered and preferably a needle is also injected automatically.
  • German patent application No. 10 2007 013 838 discloses an injection device which is embodied as an auto-injector and in which a needle is automatically injected, the product is then automatically delivered, and once the product delivery is complete, the needle is automatically retracted into the housing.
  • the injection device disclosed in said German patent application, and/or its injecting, delivering and returning mechanism preferably forms a starting point or platform for the present invention.
  • Said German patent application includes a completely filled syringe, in which the syringe piston is arranged at a small axial distance from the distal end of a piston rod. When the delivery sequence of the device is triggered, the piston rod performs an idle stroke corresponding to said distance and then hits the piston, in order to slave it for the product delivery. Since the distance and therefore the idle stroke are very small, the advancing spring can only accelerate the piston rod over a very short path, hence the momentum of the piston rod when striking the piston cannot lead to problems.
  • the invention proceeds from the basic concept of replacing a completely filled syringe with a partially filled syringe in which - as opposed to the completely filled syringe ⁇ the piston is still situated in the distal position.
  • syringes are also referred to as pre-fillable syringes, such as for example Hypak ® by Becton Dickinson.
  • a 1 ml syringe which can for example be partially filled with 0.1 ml to 0.9 ml is preferred, wherein the content amount can for example be varied in 0.1 ml increments.
  • the injection device can thus be used with syringes filled with different doses, thus increasing the therapeutic range within which the injection device can be used.
  • the injection device is equipped with a syringe which is only partially filled, the idle stroke of the piston rod is increased and therefore the path in which the piston rod can accelerate.
  • the momentum of the piston rod when hitting the piston of a partially filled syringe is therefore greater than with a full syringe.
  • the syringe body which is for example formed from glass, could under certain circumstances be damaged by an increased momentum.
  • the invention proceeds from a device for administering a liquid product, in particular a drug.
  • the device can be an administering device or injection device, in particular an auto-injector.
  • the product to be delivered is at least automatically delivered.
  • the needle in an auto-injector is preferably moved from an initial position, in which it is situated within a housing, into an injecting position, in which the needle at least partially protrudes beyond the housing, in particular by a degree which corresponds approximately to the injecting depth.
  • the auto-injector can also comprise a means which moves the needle from the injecting position into an end position in which the needle is arranged completely within the housing.
  • the auto-injector can comprise a needle protecting sleeve which is slid over the needle situated in the injecting position, such that the needle is situated within the needle protecting sleeve. Retracting or covering with a needle protecting sleeve reduces the danger of injury after the injection device has been used. Accordingly, it is preferred if the injection device comprises means for shifting the needle from the initial position into the injecting position and means which ensure that the needle is covered after the injection, for which purpose means can in particular be provided which retract the needle into the housing or slide a needle protecting sleeve over the needle.
  • the device comprises a piston rod which can perform an idle stroke relative to a piston and, at the end of the idle stroke, slave the piston for a product delivery - in particular, a remaining stroke.
  • the piston is preferably mounted, such that it can be shifted, in a product container which can for example be a carpoule or a syringe.
  • the outer circumference of the piston abuts an inner circumference of the product container, forming a seal.
  • the portion of the product container which forms said inner circumference is preferably cylindrical, such that the piston can be shifted along the cylindrical portion and simultaneously abuts the container wall, forming a seal.
  • the distal end of the product container is embodied such that the product situated in the product container can be delivered using said distal end.
  • a needle is fixedly arranged on the distal end.
  • the distal end comprises a septum which can be pierced by a needle or cannula which can be attached to the distal end of the carpoule and as applicable also detached again.
  • the needle arranged on the distal end of the product container can be fluidically connected to the chamber which contains the drug.
  • a syringe- shaped product container can for example comprise a so-called finger flange at its rear end, which exhibits an outer diameter which is greater than the diameter of the cylindrical portion in which the portion is guided.
  • the proximal end of the product container comprises an opening which is at least large enough that the piston rod can be inserted into the product container through the proximal end of the product container.
  • the proximal end of the product container can preferably be considered as part of the portion along which the piston can be shifted, and can therefore also exhibit the inner diameter of this portion.
  • the product container together with the needle is preferably shifted, i.e. like the needle, from an initial position into an injecting position and optionally into an end position.
  • the product container - which for example exhibits the outer diameter of the portion along which the piston can be shifted - can be slid along a part of the administering device, such as for example the housing.
  • the product container is preferably accommodated in a product container holder, in which it is arranged axially fixed. For a movement of the needle, the syringe and the product container holder are shifted as a unit.
  • the product container holder can hold the syringe axially fixed, for example at the finger flange, or at or distally with respect to the portion along which the portion can be shifted, in particular at the portion at which the product container tapers.
  • PCT/EP2009/052323 shows a preferred product container holder.
  • the piston rod can abut against the piston directly or indirectly at the end of the idle stroke, thus slaving the piston for a remaining stroke.
  • at least a part of the piston rod is moved in the product container, in particular in the portion along which the portion can be shifted, during the idle stroke.
  • the idle stroke there is a distance between the piston and the piston rod in the longitudinal direction. During the idle stroke, this distance is reduced.
  • the piston rod is accelerated during the idle stroke by an advancing member, such as for example a gas generator or preferably an advancing spring, an increasing idle stroke such as results in the case of partially filled syringes would - without additional measures - accelerate the piston rod to a velocity which would generate a momentum which could be dangerous to the components of the injection device.
  • the distal end of the piston rod can be arranged, axially fixed, proximal with respect to the proximal end of the product container or level with the proximal end of the product container or protruding into the product container.
  • the piston rod protrudes into the product container at least during the idle stroke and in particular during the product delivery or remaining stroke.
  • the diameter of the preferably cylindrical piston rod is slightly smaller than the inner diameter of the product container and/or the portion of the product container along which the portion can be longitudinally guided.
  • the piston rod can be surrounded by an advancing spring which is supported at least at one end, in particular its distal end, on the piston rod.
  • the advancing spring is arranged within a sleeve-shaped portion of the piston rod.
  • the design comprising a sleeve-shaped piston rod is particularly space-saving.
  • the advancing spring can also be arranged within the cylindrical portion of the product container, at least during the product delivery, i.e. while the piston is slaved, i.e. during the remaining stroke, or however also during the idle stroke. This arrangement is even more space-saving.
  • the device also comprises a braking means, in particular a damping means, which brakes or damps the movement of the piston rod during the idle stroke.
  • a braking means in particular a damping means, which brakes or damps the movement of the piston rod during the idle stroke.
  • the surface area of a portion of the piston rod which is arranged outside the product container before the beginning of the idle stroke and within the product container after the idle stroke and optionally after the remaining stroke is particularly preferably rigid.
  • This surface area can alternatively or additionally be smooth or even or can in particular have no projections.
  • This surface area can preferably be shifted into the product container, free of an engagement with the product container, for the idle stroke and in particular also for the remaining stroke.
  • the device particularly preferably comprises an advancing structure, by means of which the needle and/or the product container can be shifted into an injecting position.
  • the piston rod is preferably accommodated in the advancing structure and in particular surrounded by the advancing structure at least in the initial position.
  • the piston rod can be shifted relative to the advancing structure and is connected, axially fixed, to the advancing structure at least in the initial position and in particular before a product delivery and before the idle stroke, for example also before and while the needle is injected.
  • the advancing structure can comprise a blocking element which engages with the piston rod, in particular with a recess formed on the piston rod.
  • the blocking element can for example be elastically formed on an arm, in particular integrally on the advancing structure.
  • the blocking element can in principle be moved transverse to the longitudinal axis and/or movement direction of the advancing structure or the product container or the needle, wherein in the initial position of the needle, the blocking element is for example surrounded by an element, such as for example the housing, which holds the blocking element in the engagement with the piston rod.
  • the element or the housing can comprise a recess, wherein the blocking element can latch into this recess at the end of the injecting movement and is simultaneously moved out of the engagement with the piston rod. This releases the piston rod for a movement relative to the advancing structure.
  • the released piston rod can perform first the idle stroke and then the remaining stroke by which the product is delivered.
  • the idle stroke and remaining stroke can be referred to as the delivery stroke. It is preferred if the piston rod is fixed relative to the advancing structure by means of the releasable engagement as it is shifted into the injecting position, and can be moved relative to the advancing structure during the idle stroke.
  • the advancing structure and the piston rod can be shifted by at least one advancing spring, in particular one each or by a common advancing spring.
  • the advancing spring or springs are preferably helical or coiled springs made of metal which act as pressure springs. Springs which act as tension springs are also in principle conceivable.
  • An arrangement comprising a flat spiral spring can optionally also be provided, such as is for example disclosed in EP 0 666 084 Bl .
  • an advancing spring can be provided which is supported at its proximal end on an element which does not form part of the advancing structure or the piston rod and is supported at the proximal end on the piston rod, wherein the force of the biased advancing spring is channelled into the advancing structure via the piston rod and the blocking element.
  • the advancing structure is preferably connected, axially fixed, to the product container or the product container receptacle or comprises the product container or the product container receptacle, such that a movement of the advancing structure generates a movement of the product container and the needle.
  • a spring which is supported distally on the advancing structure can be provided for advancing the advancing structure
  • an additional spring which is supported distally on the piston rod can be provided for advancing the piston rod.
  • the additional spring can for example be supported at its proximal end on the advancing structure.
  • An embodiment comprising two advancing springs is however less preferred, since two springs are generally more expensive than one.
  • the braking means preferably comprises a part which is separate from the piston rod and the product container, in particular a braking or damping member.
  • the braking means in particular the separate part, is arranged such that it is surrounded by the product container at least during the idle stroke and optionally in the initial position of the needle or before the idle stroke.
  • the path by which the piston is shifted relative to the product container during the idle stroke is for example smaller than the path which the piston rod travels relative to the product container during the idle stroke. This also includes the special scenario in which the piston is not moved at all, i.e. is fixed relative to the product container, during the idle stroke. The path of the piston would then be equal to zero.
  • the movement energy of the piston rod can be dissipated between the piston rod and the separate part or the product container during the idle stroke.
  • the movement energy can also be dissipated between the separate part and the product container.
  • the piston rod or the separate part which is axially fixed separately on the piston rod can for example be in a frictional engagement with the inner circumference of the product container, such that when the piston rod moves relative to the product container, the movement of the piston rod is damped.
  • the movement of the piston rod is braked and/or damped by the braking means both during the idle stroke and during the remaining stroke or while the piston and the piston rod are moved together relative to the product container without moving relative to each other.
  • the braking means is preferably embodied such that the movement of the piston rod is only damped during the idle stroke and in particular not during the remaining stroke or while the piston and the piston rod are moved together relative to the product container without moving relative to each other.
  • This can for example be realised by axially supporting the braking means at least partially on the piston.
  • the separate part of the braking means is preferably axially supported on the piston during the idle stroke, such that the piston rod can be moved relative to the separate pail during the idle stroke.
  • the piston is slaved, there is for example no relative movement between the separate part and the piston rod, such that a braking effect is not achieved at least by this braking means.
  • the braking effect of the piston and the fluid friction remain unaffected by this.
  • the braking means and in particular the unit consisting of the separate part and the piston rod are axially fixed relative to the piston while the piston is slaved.
  • a separate part which acts on the piston during the idle stroke is preferred, wherein a number of scenarios are conceivable. If, during the idle stroke, the braking force between the separate part and the piston rod is smaller than the force necessary to move the piston, the piston is not moved during the idle stroke. If, during the idle stroke, the braking force is approximately equal to or slightly greater than the force necessary to move the piston, the piston is moved relative to the product container and the piston rod is also moved relative to the piston. It is in general preferred if, after the idle stroke, the piston and the piston rod can be shifted together in the distal direction relative to the product container without moving relative to each other, before the piston has reached its distal end position, i.e. before the product is completely delivered.
  • the separate part is preferably elongated and supported on the piston.
  • the elongated part can slide through a passage, in particular a bore, of the piston rod which is formed at its distal end.
  • the elongated separate part can preferably also be referred to as the damping member.
  • the elongated separate part can preferably be shifted into an inner diameter formed by the advancing spring, such that when the piston is slaved, the advancing spring is situated at least partially in an annular gap formed by the piston rod and the elongated separate part.
  • the braking engagement which brakes and/or damps the movement of the piston rod is preferably formed in the region of the passage at which the separate part is longitudinally guided and which can also be referred to as the active region.
  • the inner diameter of the active region or the active region for the separate part can preferably be formed at the distal end of the piston rod. In general, this inner diameter can be provided by a bore.
  • one of the separate part and the piston rod comprises at least one deformable - for example, flexibly deformable - means
  • the other of the separate part and the piston rod comprises a means, in particular a rigid means, which co-operates with the deformable means in order to dissipate the movement energy of the piston rod during the idle stroke.
  • the movement energy of the piston rod is reduced by the energy required to deform the means.
  • Deforming dissipates energy, in particular converting it into heat, which does not however impair the function of the device.
  • the deformation can be an elastic deformation or a plastic deformation.
  • a solid body can for example be deformed, wherein energy is dissipated on the one hand by the friction between two surfaces and on the other hand by damping during deformation.
  • a gaseous body such as for example a gas-filled chamber, can likewise be deformed, which likewise dissipates energy.
  • the at least one deformable means is preferably a bulge which is formed on the outer circumference of the preferably elongated separate part and which forms an outer diameter which is greater than an inner diameter of the piston rod at which the separate part is guided, in particular in the active region.
  • the piston rod can for example exhibit an inner diameter which is adapted to accommodate the advancing spring, and an additional inner diameter for guiding the separate part. This inner diameter is in particular smaller than the diameter for the advancing spring.
  • the bulge of the separate part can preferably be compressed, such that it can slide along the inner diameter of the active region.
  • the outer diameter of the bulge of the separate part can thus be deformed such that it fits through the inner diameter of the active region of the piston rod.
  • the inner diameter of the active region preferably engages with the outer diameter of the bulge and/or of the separate part by means of a frictional fit. Movement energy is thus dissipated when the piston rod moves relative to the separate part.
  • a frictional element which forms the braking engagement can be provided on at least one of the separate part and the piston rod.
  • This frictional engagement can for example be formed by a rubber ring or similar elastic material which is fastened to the inner diameter of the active region and is in a frictional engagement with the separate part, which in this example can exhibit an even or smooth outer diameter.
  • This outer diameter can be essentially cylindrical or can taper in the longitudinal direction, in particular in the distal direction, such that damping at the end of the idle stroke is smaller than at the beginning of the idle stroke.
  • the surface area of the separate part can then be conical.
  • the at least one deformable means can be a slit of the preferably elongated separate part, with which an engaging member formed by the piston rod or the active region engages.
  • the engaging member is preferably formed in the region of the inner diameter of the active region which guides the separate part.
  • the slit can enclose the engaging member in a tight fit, such that the slit is deformed when the engaging member moves in the longitudinal direction of the slit.
  • the slit preferably extends along the longitudinal axis of the separate part, in particular parallel to it.
  • the slit can exhibit a width which is slightly smaller than the width of the engaging member.
  • the slit is broadened, in particular plastically or elastically deformed, when the engaging member is moved, thus dissipating movement energy.
  • the slit can exhibit a constant or variable width over its length, wherein the latter preferably broadens in the distal direction such that the braking effect, in particular the dissipation, is smaller at the end of the idle stroke than at the beginning.
  • this means that the slit can be configured such that the energy requirement for deforming the slit is greater at the beginning of the idle stroke than at the end of the idle stroke, wherein the energy requirement preferably decreases continuously from the beginning to the end of the idle stroke.
  • the outer circumference of the preferably elongated separate part can comprise a multitude of notches which are arranged successively in the longitudinal direction and with which at least one elastic latching element formed on the piston rod engages, wherein the at least one latching element is moved in and out of the engagement with the notches when the piston rod moves relative to the separate part.
  • the elastic latching element can for example be arranged on a spring arm which integrally connects the latching element and the piston rod. Latching in and out of the engagement dissipates movement energy of the piston rod.
  • the successively arranged notches can provide the separate part, at least in portions, with the form of a toothed rod.
  • the latching element which is preferably likewise tooth-shaped, can engage with this toothed rod profile.
  • the piston rod and the separate part can interlock with each other such that a rotational movement between the piston rod and the separate part is caused during the idle stroke.
  • An inner thread can for example be formed in the region of the inner diameter of the active region, which engages with an outer thread of the piston rod. Movement energy can be dissipated by the friction between the threads. Energy can also be dissipated in the region of a frictional engagement which exists between the piston rod and the separate part when the separate part rotates.
  • a particularly high dissipation can be achieved by the friction between the separate part and the piston, if this dissipation is not desired, a rotary disc fastened to the distal end of the separate part can be provided which is supported on the piston and can be rotated freely with respect to the separate part.
  • the braking means can comprise a gas-filled chamber and a ventilating channel, wherein the volume of the chamber is reduced during the idle stroke, hence gas flows from the chamber through the ventilating channel. Movement energy of the piston is damped by the gas flowing through the ventilating channel.
  • the channel exhibits a small flow cross-section relative to the cross-section of the chamber. The degree of damping can be adapted by varying the flow cross-section of the ventilating channel.
  • the gas-filled chamber can in particular be enclosed by the piston, in particular its proximal end, the piston rod, in particular its distal end, and the inner diameter of the product container.
  • the piston rod can abut the inner diameter of the product container, forming a seal, wherein in this case, the ventilating channel can be formed by a bore at the distal end of the piston rod.
  • the ventilating channel can be an annular channel which is formed between the inner diameter of the product container and the piston rod.
  • the use of partially filled syringes is enabled by the fact that a normal force exerted by the piston on the product container wall, in particular on the inner diameter of the product container, remains approximately constant or is reduced when a force is applied to a plunger, in particular the piston rod or the separate part, and acts in the distal direction.
  • the aspect can in particular be combined with the first aspect of the invention, but is also the subject of a separate solution to the underlying object.
  • the second aspect of the invention is preferably incorporated into a device for administering a liquid product, comprising: a piston which is accommodated, such that it can be shifted, in a product container and proximally seals a product situated in the product container and, when shifted in the distal direction, causes a product delivery, wherein the proximal end of the piston comprises a blind bore; and a plunger which protrudes into the bore and is supported on the blind bore, such that the normal force exerted on the product container wall remains approximately constant or is reduced.
  • the advancing force for the piston is introduced completely at the proximal end of the piston.
  • the normal force is substantially not increased, since an axial force applied to the plunger is introduced into the piston in the distal half of the piston. This rather elongates the piston, hence the piston tends to compress in the radial direction. This decreases the normal force on the container wall.
  • the plunger preferably comprises a portion which protrudes into the blind bore and is supported on the base of the blind bore, where it at least partially introduces the axial force onto the plunger.
  • the plunger introduces the axial force only at the base of the blind bore.
  • the distal end of the portion which protrudes into the blind bore can for example abut against the base of the blind bore.
  • the remaining portion which protrudes into the blind bore is in particular not in a positive-fit engagement with the circumference of the blind bore, wherein a frictional-fit engagement can but need not necessarily be excluded.
  • the plunger can comprise a shoulder which is additionally supported on the proximal end of the piston.
  • the shoulder can be supported at least when the piston is sufficiently deformed - by introducing the axial force, which acts in the distal direction, via the portion which protrudes into the blind bore - that the normal force on the product container wall remains constant or is reduced.
  • a small gap between the shoulder and the proximal end of the piston at the beginning of the deformation of the piston is preferred, wherein the portion of the plunger which protrudes into the blind bore can introduce a force into the piston. This can mean that the normal force on the container wall remains constant or at least does not drop far enough that the piston no longer fulfils its sealing effect.
  • Figure 1 a sectional representation of an injection device, with a cap removed and in a triggered state, wherein the needle is situated in an initial position;
  • Figure 2 a sectional representation of the injection device from Figure 1, in an injecting position of the needle and before an idle stroke of the piston rod;
  • Figure 3 a sectional representation of the injection device from Figure 1, after an idle stroke of the piston rod;
  • Figure 4 a sectional representation of the injection device from Figure 1, in a delivered state
  • Figures 5 A and 5B representations of a braking member from the device of Figures 1 to 4
  • Figures 6 A to 6C representations of the braking member and a piston rod from Figures 1 to 4;
  • FIGS. 7A and 7B representation of an alternative braking means for the device from
  • FIGS. 8 A to 8 C representations of an alternative braking means for the device from
  • FIGS. 9A and 9B representations of an alternative braking means for the device from
  • FIGS 10 to 15 representations of various operational states of an alternative braking means, in particular for the device from Figures 1 to 4;
  • Figure 18 representation of a co-operation in accordance with the invention between a plunger in accordance with the invention and a piston.
  • Figures 1 to 4 show an injection device such as is known for example from DE 10 2007 013 838, without the means comprising a time-constant delivery signal, but comprising a preferred embodiment of a braking means such as is shown in detail in Figures 5 A to 6C.
  • the injection device comprises a housing 1.
  • a syringe-shaped product container 2 is accommodated in the housing 1, and an injection needle 4 for delivering a liquid product 33 contained in the product container 2 is situated at the distal end of said product container 2.
  • the proximal end of the product container 2 comprises a piston 3 which can be shifted and delivers the product when moved relative to the product container 2 and in the direction of the injection needle 4, for which reason this is also referred to as a delivery movement.
  • the product container 2 is accommodated in the device such that it can be shifted in the distal direction, such that the injection needle 4 protrudes from the distal end of the injection device in accordance with the desired injecting depth. This can therefore be referred to as an injecting movement.
  • the product container 2 is connected, axially fixed, to a mounting 10 for the product container 2.
  • the product container 2 is supported in the distal direction, at a shoulder formed distally with respect to the product portion, on inwardly directed projections on the mounting, such as is for example described in PCT/EP2009/052323.
  • the housing 1 comprises a viewing window through which the user of the injection device can view the product container 2.
  • the mounting 10 surrounds the product container 2 in the shape of a sleeve, such that in order to expose the container 2 to view, it either comprises a viewing window itself or - as in this example - a transparent material.
  • the mounting 10 is connected, axially fixed, to a functional sleeve 11 arranged proximally with respect to it, by means of hooks formed on the proximal end of the mounting 10.
  • the proximal end of the product container 2 comprises a radially projecting finger flange which, in order to protect against damage, is without contact with respect to the proximal end of the mounting 10.
  • the distal end of the functional sleeve 11 comprises at least one axial abutment which is axially flush with the cylindrical piston guiding portion of the product container 2, i.e. which in particular does not abut against the projections of the finger flange.
  • the product container 2, functional sleeve 11 and mounting 10 are thus connected to each other, axially fixed, such that they can be moved as a single part. In the following, this combination is referred to as the advancing structure 2, 10, 1 1.
  • the functional sleeve 11 surrounds a piston rod 5 which can perform an idle stroke H L and can act on the piston 3 for a product delivery.
  • the piston rod 5 comprises a sleeve-shaped part which surrounds an advancing spring 6, wherein the advancing spring 6 is supported distally on the piston rod 5 and proximally on a switching sleeve 8, in particular on a skirting formed on it.
  • the injection device comprises a braking means 40 for the advancing movement which can be generated by the advancing spring 6 and/or for the idle stroke H L .
  • the distal region of the piston rod 5 comprises an active region 5a which is situated distally with respect to the sleeve- shaped portion 5b.
  • the active region 5a exhibits a smaller diameter than the sleeve-shaped portion 5b, thus forming a supporting area for the distal end of the advancing spring 6.
  • a braking member 40 of the braking means is longitudinally guided on the inner diameter of the active region 5a.
  • the braking member 40 is arranged between the piston 3 and the piston rod 5.
  • the braking member 40 is supported distally on the piston 3, such as for example at a radially projecting collar on the proximal end of the piston 3 and/or at the distal end of the portion of the braking member 40 which protrudes into a blind bore 3 a formed by the piston.
  • the braking member 40 comprises a number of bulges - in this case, six bulges 40a - which are arranged successively in the axial direction and can be deformed, in particular compressed, transverse to the longitudinal direction L. In the region of each of its bulges 40a, the braking member 40 exhibits a greater outer diameter than the inner diameter of the active region 5a.
  • the bulges 40a can be elastically compressed.
  • the bulges 40a are formed by opposing pairs of projections on the longitudinal axis L which are separated by a gap 40b. When the bulges 40a are compressed, the respective gaps 40b are reduced.
  • the gaps 40b can exhibit a rhombic shape, as shown here, although other shapes are also conceivable.
  • the bulges 40a are formed by two opposing wave-shaped portions on the longitudinal axis L which are connected to each other, in particular integrally, at their wave minima and form the maximum diameter of the braking member 40 in the region of the bulges 40a at their wave maxima. As shown in Figures 1 and 2, the most proximal of the bulges 40a is axially level with the active region 5a, thus reducing the diameter of the bulge 40a and the gap width of the gap 40b. Depending on the content amount in the product container 2 being used, one or even two other bulges 40a can be axially level with the active region 5 a in the states shown in Figures 1 and 2.
  • the bulges 40a can preferably be elastically compressed, such that the bulge 40a arranged in the active region 5a exerts an increased normal force on the inner diameter of the active region due to its elasticity, thus increasing the friction between the active region and the braking member 40.
  • the surface of the braking member 40 in particular in the region of the bulges 40a, to comprise a coating which forms a higher frictional coefficient with the active region 5a than the base material of the braking element 40.
  • the braking member 40 can be formed from a material which increases its friction with the active region 5 a.
  • the braking means shown in Figures 7 A to 15 can alternatively be provided in the injection device instead of the braking means shown in Figures 1 to 4 and/or Figures 5A to 6C.
  • the advancing spring 6 is biased such that it can advance the needle 4 and in particular the advancing structure 2, 10, 1 1 for an injecting movement and can advance the piston rod 5 for an idle stroke H L and can shift the piston 3 for a delivery movement.
  • the functional sleeve 11 comprises a blocking element 16 on which a shoulder is formed which is directed radially inwards and co-operates in the initial state with a shoulder which is formed on the distal end of the piston rod 5 and projects radially outwards, such that the piston rod 5 is blocked against moving relative to the functional sleeve 1 1.
  • the blocking element 16 is held in its engagement with the piston rod 5 by an area of the switching sleeve 8 which points radially inwards.
  • the blocking element 16 is elastically connected, in particular integrally, to the functional sleeve 11 via a spring arm.
  • the elastic arrangement can be configured such that the blocking element 16 tends to be moved radially outwards, wherein this is prevented by the area of the switching sleeve 8 which points radially inwards.
  • the proximal end of the functional sleeve 1 1 comprises at least one snap element (not shown) which in the initial state snaps into the switching sleeve 8 in order to prevent a movement of the functional sleeve 11 and therefore the advancing structure 2, 10, 1 1. For this reason, the biased spring 6 cannot yet be relaxed and the advancing structure 2, 10, 11 cannot yet be moved in the distal direction.
  • the injection device comprises an activating element 13 which is arranged such that it is axially fixed and can be rotated with respect to the housing 1.
  • the activating element 13 accommodates a restoring spring (not shown) which is distally supported on the proximal end of the switching sleeve 8 and proximally supported on the activating element 13.
  • the restoring spring has the function of charging the switching sleeve 8 and an operating sleeve 9 which acts axially on the switching sleeve 8 with a force which acts in the distal direction, such that the switching sleeve 8 and the operating sleeve 9 are pressed in the distal direction.
  • the activating element 13 comprises an activating block (not shown) which, in the switching state of the injection device shown in Figure 1, grips behind the snap element such that the snap element is blocked and/or secured against moving out of its engagement with the switching sleeve 8. It is thus possible to advantageously prevent the injection device from being inadvertently triggered.
  • the activating block can be moved out of its engagement with the snap element by rotating the activating element 13, for example by 90°, relative to the housing 1.
  • a return spring 7 which acts in the longitudinal direction of the device is distally supported on the switching sleeve 8 and proximally supported on the functional sleeve 1 1.
  • the return spring 7 surrounds the switching sleeve 8 and the functional sleeve 11.
  • the return spring 7 is in particular proximally supported on a collar 1 la which is formed by the functional sleeve 1 1 and interlocks radially outwards with a breach formed in the switching sleeve 8. In particular switching positions, the return spring 7 can therefore generate a relative movement between the switching sleeve 8 and the functional sleeve 11.
  • the return spring 7 is a pressure spring which can move the functional sleeve 1 1 in the proximal direction relative to the switching sleeve 8.
  • the return spring 7 is not biased or is preferably only biased with a small biasing force. In the state of the injection device shown in Figure 1, for example, the biasing force of the return spring 7 is smaller than the biasing force of the advancing spring 6.
  • the operating sleeve 9 is arranged distally with respect to the switching sleeve 8 and such that it can be moved relative to the housing 1.
  • the switching sleeve 8 and the operating sleeve 9 can reciprocally charge each other with a pressure force and can in particular be latched to each other and thus shift each other.
  • the operating sleeve 9 does not block the view onto the product container 2, it likewise comprises a window in the region of the window.
  • the operating sleeve 9 can be formed from a transparent material. In the initial state, the operating sleeve 9 is advanced distally beyond the distal end of the housing 1 by the restoring spring via the switching sleeve 8. The distal end of the operating sleeve 9 serves the function of being placed onto an injection point on a patient.
  • the mounting 10 comprises a switching cam 17 which engages with a cavity 18 of the operating sleeve 9 which, as shown in this example, can be a breach.
  • the switching cam 17 is elastically connected, in particular integrally, to the mounting 10, such as for example via an elastic arm.
  • the switching cam 17 is preferably biased such that it tends towards engaging with the cavity 18 and/or being moved radially outwards.
  • the switching cam 17, which projects radially outwards from the mounting 10, distally comprises an oblique area which can assist in pressing the switching cam 17 out of its engagement with the cavity 18.
  • the switching cam 17 also proximally comprises an abutment area which is transverse, in particular perpendicular, to the longitudinal direction and can pass into an axial abutment with the proximal boundary of the cavity 18, as a result of which the switching cam 17 cannot be moved out of the cavity 18.
  • the operating sleeve 9 comprises an axial abutment 19 against which the distal end of the mounting 10 can abut at the end of an injecting movement.
  • a cap which protects the interior of the injection device against contamination and in particular keeps the needle 4 sterile, can be arranged on the distal end of the injection device. The cap is removed before using the injection device, such that the needle 4 and the operating sleeve 9 are in particular exposed, as shown in Figure 1.
  • the force which is exerted on the injection device when the needle cap is removed is channelled via the mounting 10 onto the functional sleeve 11, where it is transferred via the snappers onto the switching sleeve 8 which is supported on the operating sleeve 9.
  • the operating sleeve 9 is for its part latched to the housing 1 via a projection Id formed by the distal housing part lb, such that removing the cap from the injection device has an undesirable impact on the mechanism.
  • the injection device is activated and/or unlatched by a rotational movement of the activating element 13, for example by 90°, wherein the snap elements are released for a movement which is directed radially inwards by moving, in particular rotating, the activating block out of its engagement with the snap elements. There is thus space for the snap elements to be deflected inwards.
  • the activating element 13 also comprises an activating cam which is moved so as to be axially flush with the snap element by the rotational movement of the activating element 13.
  • the snap element proximally comprises a contour
  • the activating cam arranged proximally with respect to the snap element distally comprises a contour, which can deflect the snap element radially inwards when the snap element 15 moves in an engagement with the activating cam.
  • the contours are two inclined planes which slide off on each other.
  • the user of the device places its distal end onto the injection point, which has preferably been disinfected beforehand. This shifts the operating sleeve 9 in the proximal direction relative to the housing I, preferably until the distal end of the operating sleeve 9 is approximately flush with the distal end of the distal housing part 1 b ( Figure 1).
  • the switching sleeve 8 is slaved in the proximal direction by the movement of the operating sleeve 9, wherein the snap elements are pressed out of their engagement with the switching sleeve 8, in particular radially inwards, by means of the activating cams.
  • the elements of the advancing structure 2, 10, 1 1 are also slaved in the proximal direction by the movement of the operating sleeve 9 in the proximal direction. Since the piston rod 5 is situated in a blocking engagement with the functional sleeve 11, the piston rod 5 is also slaved in the proximal direction.
  • the braking member which is accommodated in the product container 2 is similarly slaved in the proximal direction.
  • the force which the user of the device has to exert on the housing 1 in order for the operating sleeve 9 to be shifted in the proximal direction is substantially determined by the force of the restoring spring against which the switching sleeve 8 and the operating sleeve 9 are moved.
  • the spring is preferably a pressure spring and is formed from a plastic material. Alternatively, springs made of a spring steel material or other spring material can of course also be used.
  • the axial fastening between the activating element 13 and the housing 1 takes the form of an annular snap connection with the housing.
  • the triggering mechanism for example the switching sleeve 8 and the operating sleeve 9, is reset by the restoring spring when the injection device is removed from the injection point.
  • the movement of the operating sleeve 9 in the proximal direction forms a blocking window 20 which is distally delimited by the housing 1, in particular the projection Id, and proximally delimited by the operating sleeve 9. Since, during the movement of the operating sleeve 9 in the proximal direction, there is not yet any relative movement between the advancing structure 2, 10, 11 and the operating sleeve 9, the switching cam 17 remains in the cavity 18. Once the snappers have been unlatched from their engagement with the switching sleeve 8, the advancing spring 6 can be partially relaxed, thus shifting the advancing structure 2, 10, 11 in the distal direction, wherein the injection needle 4 protrudes beyond the distal end of the injection device.
  • the return spring 7 Since the functional sleeve 1 1 is moved relative to the switching sleeve 8 during this injecting movement, the return spring 7 is compressed, i.e. tensed.
  • the spring force of the advancing spring 6 is greater than the spring force of the return spring 7 during the entire injecting process, i.e. also at the beginning and at the end of the injecting process. This for example has the advantage of reducing the injecting force, which helps to prevent damage to the injection device.
  • the blocking element 16 engages with the cavity 18 by a movement which is directed radially outwards, as is intended to be shown by the arrows in Figure 2.
  • the blocking element 16 comprises a projection which is directed radially outwards.
  • the blocking element 16 fulfils a double function.
  • the blocking element 16 latches into the cavity 18, the blocking element 16 simultaneously unlatches from the piston rod 5 by the movement which is directed radially outwards, such that the latter is released for a delivery movement.
  • the movement of the advancing structure 2, 10, 1 1 in the axial direction, in particular in the proximal direction is blocked.
  • This process decouples the advancing spring 6 from the return spring 7, i.e. such that the advancing spring 6 does not have any effect on the bias of the return spring 7 in this state.
  • the switching cam 17 is pressed out of its engagement with the cavity 18 and shifted in the distal direction during the injecting movement, such that it latches into the blocking window 20, as shown in Figure 2.
  • the blocking element 16 which is latched into the cavity 18 is in contact with the proximal boundary of the cavity 18. Since the blocking element 16 and the switching cam 17 are at a defined distance due to being in an axially fixed arrangement with respect to each other, it is preferred if there is a small distance, which in this example measures 0.5 to 1 mm, between the proximal end of the switching cam 17 and the distal end of the blocking window 20 when a blocking element 16 is in engagement with the cavity. As is explained further below, this distance is used to generate a haptic or acoustic signal which is intended to signal that the product has been completely delivered.
  • the piston rod 5 can perform the idle stroke movement and/or the idle stroke H L relative to the product container 2, the functional sleeve 1 1 and the braking member 40.
  • the bulges 40a which are arranged distally with respect to the active region 5 a pass into engagement with the active region 5 a, such that these bulges 40a are sequentially compressed and pass the active region 5 a.
  • the piston rod 5 slaves the piston for the remaining stroke movement and/or the remaining stroke H R ( Figure 3). To this end, the distal end of the piston rod 5 abuts against the piston 3. Alternatively, the piston rod 5 can abut against the braking member 40, wherein the braking member 40 abuts against the piston 3, such that the latter is slaved.
  • the remaining stroke H R there is no relative movement between the braking member 40 and the piston rod 5, such that the braking means provided for the idle stroke H L only acts during the idle stroke H L . This damping is not required during the remaining stroke H R , since enough damping for the spring 6 is already available as a result of expelling the product 33 and the friction between the piston 3 and the inner circumference of the product container 2.
  • Figure 4 shows the injection device in a state after the delivery stroke is complete.
  • the outer circumferential area of the sleeve-shaped part of the piston rod 5 presses the blocking element 16 into the cavity 18, thus securing the blocking element 16 against unlatching from the cavity 18 during a product delivery.
  • the piston rod 5 can comprise a cavity or can be dimensioned in its length such that the securing of the blocking element 16 by the outer circumferential area of the piston rod 5 is removed after the product delivery is complete, such that the blocking element 16 can unlatch from the cavity 18.
  • the unlatching movement can be generated due to an elastically biased arrangement of the blocking element 16 or due to the geometry of the blocking element 16 which causes the blocking element 16 to be pressed out of the cavity 18.
  • the advancing spring 6 has been further relaxed, while the tension in the tensed return spring 7 has remained constant.
  • the spring force of the advancing spring 6 is then smaller than the spring force of the biased return spring 7.
  • the return spring 7 and the advancing spring 6 are coupled to each other again.
  • This coupling means that the small distance mentioned above disappears because the advancing structure 2, 10, 11 - i.e. in particular, the proximal end of the switching cam 17 - is moved abruptly onto the distal end of the blocking window 20.
  • a haptic and/or acoustic signal is generated. This movement over the small path does not yet however completely draw the needle 4 out of the patient.
  • the patient and/or the user of the device can then wait any amount of time until the needle is completely drawn out of the patient, since he can start the device's automatic needle return at will.
  • the needle it is not yet possible for the needle to move completely into the distal end of the housing 1, since the switching cam 17 is in engagement with the blocking window 20 and thus blocks the spring 7 against being relaxed.
  • the restoring spring can then move the operating sleeve 9 in the distal direction via the switching sleeve 8, wherein the advancing structure 2, 10, 1 1 is fixed relative to the operating sleeve 9, such that the switching cam 17, due to its distal configuration, is pressed radially inwards by means of the projection Id, out of the blocking window 20, driven by the spring in conjunction with the operating sleeve 9.
  • the needle 4 is free to return. Releasing the engagement also releases the return spring 7 for a return movement. Due to the greater spring force of the biased return spring 7, the entire advancing structure 2, 10, 1 1 is pressed in the proximal direction. This tenses the spring 6 again, wherein the spring force of the return spring 7 is greater than the spring force of the advancing spring 6 during the entire return process, i.e. even up until the end of the return process.
  • the injection device again has the same dimensions as at the beginning.
  • the cap can also be attached again and the injection device disposed of.
  • the needle is completely retracted into the distal end of the device.
  • the snap element is again latched to the switching sleeve 8, as at the beginning. It is not however possible to trigger the injection device again, since a biased advancing spring 6 - such as is shown for example in Figure 1 - would be necessary for this.
  • Figures 7 A and 7B show an alternative braking means, wherein the braking member 140 and the piston rod 105 are arranged in Figure 7 A such that the piston rod 105 can perform the idle stroke H L relative to the braking member 140.
  • the piston rod 105 comprises a spring arm which is integrally formed on the spring sleeve, wherein a latching element 105c which is directed inwards, i.e. towards the central or longitudinal axis L, is formed at the free end of said spring arm and acts in the active region of the piston rod 105, along which the braking member 140 is guided.
  • the braking member 140 comprises a number of notches 140a arranged in succession, which can be annular ly circumferential projections, as here, or simply just latching teeth.
  • Figure 8A shows a braking means in which the piston rod 205 can be moved by the idle stroke H L relative to the braking member 240.
  • the active region 205a comprises an inner thread portion. This inner thread portion engages with an outer thread 240a of the braking member 240.
  • the outer thread 240a exhibits a pitch which is large enough that self-inhibiting does not occur in the threaded engagement when the piston rod 205 is shifted axially relative to the braking member 240.
  • Figure 8B shows the braking means after the piston rod 205 has been moved by the idle stroke H L. .
  • Figure 9 A shows a braking means in which the piston rod 305 can be moved by the idle stroke H L relative to the braking member 340.
  • the outer circumference of the braking member 340 comprises a slit 340a which runs parallel to the longitudinal axis L and with which an engaging member formed in the active region by the piston rod 305 engages.
  • the width of the slit is approximately as large as or slightly smaller than the width of the engaging member, such that the slit 340a encloses the engaging member in a tight fit.
  • Figures 10 to 15 show an alternative braking means for the device from Figures 1 to 4, in which the functional sleeve 11 of Figure 1 is only allusively drawn in as well and is indicated by 411.
  • the product container 402 is at least partially filled with the liquid 433.
  • the liquid 433 is enclosed in a space between the piston 403 and a closed proximal end of the product container 402, which in the example embodiment bears an injection needle.
  • the proximal end of the piston rod 405 protrudes into the container 402, such that a hollow space 441 and a distance H L are formed between the distal end of the piston 403 and the proximal end of the piston rod 405.
  • the piston rod 405 can be moved in the delivery direction by the advancing spring 406.
  • the proximal end of the piston rod 405, i.e. active region, is formed as a sealing element comprising a disc-shaped front end and a laterally circumferential contour which a sealing ring 440 is fitted into.
  • the sealing ring 440 is preferably made of an elastic material, such that it abuts the inner wall of the container 402 in a tight fit.
  • the sealing element or the piston rod 405 comprises at least one ventilating channel (not shown) which can for example run parallel to the longitudinal axis L and through which the air trapped in the hollow space 441 can escape.
  • the at least one channel can be incorporated on the outer area of the sealing ring 440 and/or the contour and/or centxically on the distal end of the piston rod 405 and/or the inner side of the container 402.
  • the channel or channels can be continuous channels, with or without a membrane cover, or blind channels which only open a fluid connection between the hollow space 441 and the environment once a limiting pressure has been exceeded within the hollow space 441, wherein it is preferred if the limiting value for the pressure is selected such that the piston 403 is not yet pressed into the delivery movement and in particular also such that air cannot pass the piston 403 and enter the liquid 433.
  • Figures 11 and 12 show the injection device of Figure 10, after the piston rod 405 has been released by the functional sleeve 411.
  • the piston rod 405, together with the sealing element, is moved in the delivery direction, into the container 402, wherein the piston 403 is not moved in the delivery direction. Air escapes from the hollow space 441 through the ventilating channels (not shown), thus dissipating the movement energy of the piston rod 405.
  • the piston rod 405 hits the piston 403 at the end of the idle stroke H L - From this point on, the piston 403 is moved and/or slaved by the piston rod 405 in the delivery direction, and the liquid 433 is delivered by means of the remaining stroke movement. The movement of the piston 403 is continued until the piston 403 has performed the remaining stroke H R, i.e. until it has reached its most proximal position, which means that the container 402 has been completely emptied.
  • Figure 14 shows the arrangement during the remaining stroke H R
  • Figure 15 shows the arrangement at the end of the remaining stroke H R .
  • the ventilating channel (not shown) through which the air trapped in the hollow space 441 can flow out of the hollow space 441 is configured such that a pressure can be built up in the hollow space 441 which is large enough to move the piston 403 in the delivery direction, without the piston rod 405 contacting the piston 403, i.e. the advancing force in the delivery direction is transferred onto the piston rod 405 by the advancing spring 406.
  • the sealing ring 440 is formed from an elastic material, for example natural rubber, such that it abuts the inner side of the container 402 in a tight fit when the sealing element is inserted into the container 402.
  • a blind channel is formed in the region in which the sealing ring 440 abuts the contour, wherein said blind channel is open in the direction of the hollow space 441 and protrudes into the sealing ring 440 in the opposite direction. If the air in the hollow space 441 is then compressed by the movement of the piston rod 405 in the delivery direction, the pressure in the channel also rises.
  • the pressure force is large enough to lift the part of the sealing ring 440 which is still abutting the contour in a tight fit off of the base body of the seal and to connect the hollow space 441 to the environment.
  • the force necessary for this is dependent on the geometry of the channel, the elasticity of the material of the sealing ring 440 and the area of the sealing ring portion which has to be "lifted off of the base body of the seal in the region of the contour in order to enable the air to flow from the hollow space 441 into the environment.
  • a channel is merely an example; it is also possible to use a number of channels and to use channels which are configured completely differently, as long as they enable the hollow space 441 to be connected to the environment when a pressure is applied.
  • the channel and/or channels can of course also be configured to be continuous and can for example comprise a cover, on the side which is open towards the environment, which functions in the manner of a reflex valve and only releases air from the hollow space 441 into the environment.
  • the channel can also be formed in the base body of the seal, in the region of the contour, instead of in the sealing ring 440 or can be formed partly in the sealing ring 440 and partly in the base body of the seal.
  • the channel can also be formed in the wall of the container 402 and/or the sealing ring 440. It can however also be formed as a passage bore in the base body of the seal alone, or - albeit less than preferred - holes in the container 402 can form the channel or channels.
  • piston rod 405 can also be embodied as a hollow rod, such that the hollow space 441 can be ventilated by the piston rod 405, wherein the bore through the piston rod 405 can exhibit a constant diameter or can comprise any manner of expansions and/or constrictions.
  • Figures 16 and 17 show arrangements which are known from the prior art and in which a plunger 5 hits a piston 3 of a product container, in particular an ampoule or carpoule and/or a syringe, which is provided with a blind bore 3a. It is known for a piston rod 5 to protrude into the blind bore 3 a, wherein however the advancing force of the piston rod 5 is exerted on the proximal end of the piston 3 only. This compresses the piston 3 to the length L 2; hence it tends to expand transverse to the longitudinal direction, to the diameter d 2 , thus increasing the normal force F N . This results in a greater friction between the piston and the product container, such that excessive strains are placed on the product container.
  • Figure 18 shows an arrangement in accordance with the invention which comprises a plunger 5; 40 which can be a piston rod 5 or a part of the braking means such as for example a braking member 40.
  • the plunger 5; 40 comprises a portion which protrudes into the blind bore 3a of the piston 3.
  • the blind bore 3a extends into the piston 3 from the proximal end of the piston 3.
  • the distal end of the portion which protrudes into the blind bore 3a abuts against the base of the blind bore 3 a, hence a force exerted on the plunger 5; 40, such as for example a delivery force or advancing force for the piston 3, is at least partially and preferably completely introduced into the piston 3 at the base of the blind bore 3a.
  • the plunger 5; 40 comprises a shoulder which projects transverse to the longitudinal direction, wherein the portion of the shoulder which protrudes into the blind bore 3a projects in the distal direction.
  • the shoulder does not initially transfer an axial force onto the proximal end of the piston 3 but rather only once the force acting on the base of the blind bore 3a has deformed the piston 3 far enough that the shoulder passes into abutment with the proximal end of the piston 3. This avoids leakage between the product container wall and the piston 3, since the piston 3 is not excessively elongated.

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 dispositif d'administration d'un produit liquide, qui comprend une tige de piston qui peut réaliser une course à vide par rapport à un piston et, à la fin de la course à vide, asservir le piston pour la délivrance d'un produit, un moyen de freinage, notamment un moyen d'amortissement, freinant ou amortissant le mouvement de la tige de piston pendant la course à vide.
PCT/EP2010/050746 2009-09-21 2010-01-22 Amortissement d'une tige de piston pour seringues partiellement remplies WO2011032731A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009042389 2009-09-21
DE102009042389.3 2009-09-21

Publications (1)

Publication Number Publication Date
WO2011032731A1 true WO2011032731A1 (fr) 2011-03-24

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Country Status (1)

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WO (1) WO2011032731A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011162686A1 (fr) * 2010-06-24 2011-12-29 Shl Group Ab Dispositif de distribution de médicament avec moyens de freinage
WO2012031627A1 (fr) * 2010-09-09 2012-03-15 Tecpharma Licensing Ag Tige de piston télescopique pour seringues partiellement remplies
WO2013032389A1 (fr) * 2011-08-31 2013-03-07 Shl Group Ab Dispositif d'injection
US9468723B2 (en) 2010-06-24 2016-10-18 Shl Group Ab Medicament delivery device
WO2017153117A1 (fr) * 2016-03-11 2017-09-14 Carebay Europe Ltd. Ensemble support de seringue à deux corps avec amortisseur
WO2018046931A1 (fr) * 2016-09-09 2018-03-15 Owen Mumford Limited Dispositif d'injection
WO2018204144A1 (fr) * 2017-05-02 2018-11-08 Eli Lilly And Company Dispositif d'injection à agencement de piston et rampes convergentes
WO2019058135A1 (fr) * 2017-09-21 2019-03-28 Shore Product Group Limited Dispositif d'entraînement
US10350061B2 (en) 2015-11-13 2019-07-16 Johnson & Johnson Surgical Vision, Inc. Intraocular lens insertion device
EP3539594A1 (fr) * 2018-03-12 2019-09-18 E3D Agricultural Cooperative Association Ltd. Dispositif d'injection automatique doté d'un élément d'amortissement
EP3834865A1 (fr) * 2015-08-27 2021-06-16 E3D Agricultural Cooperative Association Ltd. Dispositif d'injection automatique réutilisable
US12102797B2 (en) 2021-05-25 2024-10-01 E3D A.C.A.L Ltd Automatic injection device with a dampening element

Citations (5)

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Publication number Priority date Publication date Assignee Title
WO2000024441A1 (fr) * 1998-10-26 2000-05-04 Pharmacia Ab Injecteur automatique
WO2003097133A1 (fr) * 2002-05-17 2003-11-27 Owen Mumford Limited Dispositif d'injection avec aiguille a retraction automatique
EP0666084B1 (fr) 1994-02-02 2004-04-07 Becton, Dickinson and Company Dispositif pour auto-injection automatique
US20080021410A1 (en) * 1998-05-15 2008-01-24 Fritz Kirchhofer Device for administering an injectable product
DE102007013838A1 (de) 2007-03-22 2008-09-25 Tecpharma Licensing Ag Injektionsvorrichtung mit zeitkonstantem Ausschüttsignal

Patent Citations (6)

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Publication number Priority date Publication date Assignee Title
EP0666084B1 (fr) 1994-02-02 2004-04-07 Becton, Dickinson and Company Dispositif pour auto-injection automatique
US20080021410A1 (en) * 1998-05-15 2008-01-24 Fritz Kirchhofer Device for administering an injectable product
WO2000024441A1 (fr) * 1998-10-26 2000-05-04 Pharmacia Ab Injecteur automatique
US6270479B1 (en) * 1998-10-26 2001-08-07 Pharmacia Ab Autoinjector
WO2003097133A1 (fr) * 2002-05-17 2003-11-27 Owen Mumford Limited Dispositif d'injection avec aiguille a retraction automatique
DE102007013838A1 (de) 2007-03-22 2008-09-25 Tecpharma Licensing Ag Injektionsvorrichtung mit zeitkonstantem Ausschüttsignal

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9468723B2 (en) 2010-06-24 2016-10-18 Shl Group Ab Medicament delivery device
WO2011162686A1 (fr) * 2010-06-24 2011-12-29 Shl Group Ab Dispositif de distribution de médicament avec moyens de freinage
US20130102971A1 (en) * 2010-06-24 2013-04-25 Shl Group Ab Medicament Delivery Device with Braking Means
US9248236B2 (en) 2010-06-24 2016-02-02 Shl Group Ab Medicament delivery device with braking means
WO2012031627A1 (fr) * 2010-09-09 2012-03-15 Tecpharma Licensing Ag Tige de piston télescopique pour seringues partiellement remplies
US10933193B2 (en) 2011-08-31 2021-03-02 Shl Medical Ag Injection device
US9656025B2 (en) 2011-08-31 2017-05-23 Shl Group Ab Injection device
WO2013032389A1 (fr) * 2011-08-31 2013-03-07 Shl Group Ab Dispositif d'injection
US11786658B2 (en) 2015-08-27 2023-10-17 E3D A.C.A.L. Ltd Reusable automatic injection device
EP3834865A1 (fr) * 2015-08-27 2021-06-16 E3D Agricultural Cooperative Association Ltd. Dispositif d'injection automatique réutilisable
US10350061B2 (en) 2015-11-13 2019-07-16 Johnson & Johnson Surgical Vision, Inc. Intraocular lens insertion device
US10265476B2 (en) 2016-03-11 2019-04-23 Shl Medical Ag Two body syringe carrier assembly with dampener
WO2017153117A1 (fr) * 2016-03-11 2017-09-14 Carebay Europe Ltd. Ensemble support de seringue à deux corps avec amortisseur
GB2553770A (en) * 2016-09-09 2018-03-21 Owen Mumford Ltd Injection device
WO2018046931A1 (fr) * 2016-09-09 2018-03-15 Owen Mumford Limited Dispositif d'injection
WO2018204144A1 (fr) * 2017-05-02 2018-11-08 Eli Lilly And Company Dispositif d'injection à agencement de piston et rampes convergentes
US11786660B2 (en) 2017-05-02 2023-10-17 Eli Lilly And Company Injection device with plunger arrangment and converging ramps
WO2019058135A1 (fr) * 2017-09-21 2019-03-28 Shore Product Group Limited Dispositif d'entraînement
EP3539594A1 (fr) * 2018-03-12 2019-09-18 E3D Agricultural Cooperative Association Ltd. Dispositif d'injection automatique doté d'un élément d'amortissement
US11040142B2 (en) 2018-03-12 2021-06-22 E3D A.C.A.L Ltd Automatic injection device with a dampening element
US12102797B2 (en) 2021-05-25 2024-10-01 E3D A.C.A.L Ltd Automatic injection device with a dampening element

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