EP2129416A1 - Ensemble ressort dans un dispositif d'injection - Google Patents

Ensemble ressort dans un dispositif d'injection

Info

Publication number
EP2129416A1
EP2129416A1 EP08714769A EP08714769A EP2129416A1 EP 2129416 A1 EP2129416 A1 EP 2129416A1 EP 08714769 A EP08714769 A EP 08714769A EP 08714769 A EP08714769 A EP 08714769A EP 2129416 A1 EP2129416 A1 EP 2129416A1
Authority
EP
European Patent Office
Prior art keywords
spring
injection device
return spring
propulsion
sleeve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08714769A
Other languages
German (de)
English (en)
Inventor
Ursina Streit
Markus Bollenbach
Patrick Hostettler
Daniel Künzli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tecpharma Licensing AG
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
Priority claimed from DE102007013837A external-priority patent/DE102007013837A1/de
Application filed by Tecpharma Licensing AG filed Critical Tecpharma Licensing AG
Publication of EP2129416A1 publication Critical patent/EP2129416A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—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
    • A61M5/31—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
    • A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M2005/206—With 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
    • A61M2005/2073—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
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
    • 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 is in the field of injection devices for administering a liquid product, in particular a medicament.
  • the invention relates to an injection device according to the preamble of claim 1 and a method according to the preamble of claim 13.
  • An injection device is known from US Pat. No. 3,797,489 which has a propulsion spring acting on a product container or a piston of the product container and a spring counteracting the propulsion spring via the product container.
  • This counteracting spring has three objects, namely, as a damper, as a safety device and as a means for retracting the needle by a small amount.
  • the propulsion spring is coupled with the counteracting spring both during the plunge process via a fixed coupling with the product container and during the dispensing movement via the liquid of the product container. In the mentioned device, the balancing of the spring forces is a great challenge.
  • injection devices are known in each case in which the propulsion spring is moved away from the return spring after the product has been distributed, ie. H. is decoupled after completion of the dispensing movement for retraction of the injection needle.
  • the object of the invention is to provide an injection device and a working method for such an injection device, with which an advantageous product distribution is possible.
  • the invention relates to an injection device for administering a preferably liquid product, such as. B. a drug for hormone or diabetes therapy.
  • the injection device may in particular be an auto-injector.
  • a mechanism may be provided which allows an automatic piercing of the needle and a subsequent product release.
  • an automatic retraction of the needle takes place in the autoinjector, wherein it may be desirable that the user of the device for this still has to perform a handle.
  • the injection device comprises a propulsion spring with which an injection needle can be advanced from a starting position into a puncturing position from the distal end of the injection device and with which a product from a product container can be dispensed with a dispensing movement.
  • the propulsion spring for example, a tensioned on spring coil spring from z.
  • a spring steel or other suitable metal As a spring steel or other suitable metal.
  • plastic springs or rubber-elastic springs may be suitable as a propulsion spring.
  • the propulsion spring can be with one end, such. B. the proximal end to a housing of the injection device or another relative to the housing axially fixed or movable element.
  • Such a movable element may, for. B. be a switching sleeve.
  • the propulsion spring can be supported with its other, in particular its distal end to a piston rod.
  • the piston rod may be at least partially sleeve-shaped, wherein the propulsion spring may be at least partially disposed in the sleeve-shaped part, so that the sleeve-shaped part in particular partially surrounds the spring.
  • the propulsion spring may be so coupled to the production of a piercing movement with the needle, that this Ausbowt the piercing, ie, from the distal end of the device and moves into a piercing position. The amount that the needle protrudes beyond the distal end of the device corresponds to the puncture depth of the needle.
  • the propulsion spring may be coupled to the needle via the piston rod, which is axially fixedly connected to a propulsion structure during the piercing movement.
  • the propulsion structure may, for.
  • a holder for the product container and / or a functional sleeve in which the piston rod is received include.
  • the needle is located at the distal end of the product container.
  • the needle is fluidic with the Connected inside the product container.
  • the product is closed with a piston displaceable relative to the product container.
  • the propulsion spring can be used for product distribution, i. H. for generating a dispensing movement z. B. act on the piston via the piston rod.
  • the dispensing movement is preferably completed when the piston abuts the distal end of the product container.
  • the injection device further comprises a return spring with which the injection needle from the puncture position in the distal end of the injection device against the force of the propelling spring is retractable.
  • the needle is fully retractable, as this minimizes the risk of injury to a user of the device or for third parties.
  • the return spring counteracts the force of the propulsion spring, propulsion spring and return spring are coupled.
  • the return spring may have a similar construction as the propulsion spring.
  • the return spring may be coupled to the needle, for example via the propulsion structure.
  • the return spring is supported, in particular with its proximal end on the functional sleeve and thus acts on the propulsion structure, whose parts are preferably axially fixed to each other.
  • the return spring may be disposed proximal of the product container, which should not preclude that the return spring may be disposed distally of the product container.
  • the invention is characterized in that the return spring is decoupled from the propulsion spring during the dispensing movement. Coupling is to be understood herein as meaning that the springs can exert forces on one another and tension one another. In return, decoupled springs can exert no forces on each other.
  • Injection device has the advantage that the propulsion spring does not act against the force of the return spring by the coupling, whereby a better product discharge takes place from the product container.
  • the return spring and the advancing spring are preferably coupled for retraction and / or for advancing, ie for piercing the injection needle.
  • This has the advantage that due to the coupling, the resulting forces from the sum of the force vectors of the individual springs is relatively small, so that the load exerted on the injection device during insertion or withdrawal of the needle is reduced.
  • the propulsion spring can be tensioned by the return spring for drawing in the injection needle.
  • the return spring of the feed spring can be tensioned for advancing the I ⁇ jekomsnadel.
  • the propulsion spring is coupled via the functional sleeve to the return spring.
  • the return spring with the propulsion spring z. B. coupled via the functional sleeve on the axially fixedly connected product container with the distal therein piston after a product distribution.
  • retreating relaxes the return spring and thereby biases the feed spring.
  • the feed spring relaxes and tensions the return spring.
  • the spring force of the return spring for retracting the injection needle is greater than the spring force of the propulsion spring and / or the spring force of the propulsion spring for piercing the injection needle is greater than the spring force of the return spring.
  • the injection device further comprises a blocking element, which is movable radially for decoupling of the driving spring and return spring in a locking engagement, in particular in a recess.
  • a blocking element which is movable radially for decoupling of the driving spring and return spring in a locking engagement, in particular in a recess.
  • the recess can z. B. be arranged in a housing or a housing-fixed element.
  • the recess is formed in a relative to the housing of the device along the longitudinal axis displaceable actuating sleeve.
  • the actuating sleeve can be attached with its distal end to the injection site of the patient, whereby it moves relative to the housing in the proximal direction.
  • the movement of the actuating sleeve in the proximal and distal directions can each trigger certain switching operations in the injection device.
  • the blocking element can be formed, for example, on the functional sleeve.
  • the blocking element is connected via a resilient arm elastically connected in one piece with the functional sleeve.
  • the blocking element is biased so that it tends to engage in the recess.
  • the blocking element is in engagement with the recess, forming, for example, the functional sleeve on the blocking element, the actuating sleeve and an adjoining the actuating sleeve switching sleeve a fixed clamping for the return spring. Accordingly, the power flow from the proximal end of the return spring over this clamping to the distal end of the return spring run.
  • the same or another blocking element be in releasable engagement with the piston rod, and in a disengaged engagement, the piston rod drivable by the propulsion spring is movable relative to the blocking element and can displace the piston of the product container towards the outlet of the product container , If it is a different blocking element, for example, this as well as the other blocking element may be formed on the functional sleeve.
  • the piston rod performs a relative movement to the functional sleeve in the product distribution.
  • the locking element is provided both for engagement in a recess and for engagement in the piston rod, it is preferred that upon engagement of the locking element into engagement with the recess approximately simultaneously disengages the locking element from the piston rod and releases them for a product distribution.
  • the blocking element at the end of the dispensing movement is radially movable out of the locking engagement, so that the propulsion spring and the return spring coupled to each other, wherein the return spring has a higher spring force than the relaxed by the Aus usually Gay propulsion spring, whereby the propulsion spring can be tensioned with the return spring.
  • the coupling for the withdrawal is effected by the removal of the device from the injection site, in which the actuating sleeve z. B. is pressed in the distal direction by the force of a separate return spring, whereby the blocking element is moved out of the recess of the actuating sleeve.
  • the blocking element can not be moved out of engagement with the actuating sleeve during product dispensing.
  • This can be z. B. be achieved in that during the product distribution, the piston rod slides past the locking element, wherein the locking element is blocked for disengagement from the engagement with the actuating sleeve of the outer peripheral surface of the piston rod.
  • the piston rod has an opening or the piston rod is dimensioned with respect to its length so that the blocking element can be moved out of engagement with the actuating sleeve at the end of the product discharge.
  • the locking element is designed so that it is pressed during the movement of the actuating sleeve in the distal direction out of engagement with the actuating sleeve.
  • the injection device may comprise a snap element, which axially fixedly latched with a housing-fixed element or the switching sleeve after retraction of I ⁇ jetechnischsnadel, wherein the snap element and the blocking element are formed on the functional sleeve.
  • the product container and the blocking element are axially fixed, so that they are displaceable in particular like a single part along the longitudinal axis of the injection device.
  • the invention further relates to a method for extending and retracting an injection needle at the distal end of an injection device, wherein in the extended state, a product is released, with a preloaded propulsion spring partially relaxed and thereby biased coupled to the propulsion spring return spring, the propulsion spring further relaxed and thereby Product released and the preloaded return spring relaxed while the coupled with the return spring propulsion spring is tense.
  • the method is characterized in that the propulsion spring and the return spring are decoupled during product distribution.
  • Advantageous developments of the method result from the operation of the device. The method is complete, ie with all its procedural steps, outside the human or animal body feasible.
  • FIGS. 1 a and 1 b show a sectional view of an injection device according to the invention with an attached cap, wherein FIG. 1 b is a view rotated by 90 ° relative to FIG. 1 a, about the longitudinal axis;
  • FIG. 2a and 2b are sectional views of the injection device with a cap removed, wherein FIG. 2b is a view rotated by 90 ° with respect to FIG. 2a about the longitudinal axis;
  • FIG. 3a and 3b are sectional views of the injection device according to the invention in an activated state, FIG. 3b being a view rotated by 90 ° with respect to FIG. 3a about the longitudinal axis,
  • Figures 4a and 4b are sectional views of the injection device according to the invention in a triggered state
  • Figure 4b is compared to Figure 4a rotated by 90 ° about the longitudinal axis view
  • Figures 5a and 5b are sectional views of the invention Inj edictions device in a pierced state
  • Figure 5b a 5a is rotated 90 ° about the longitudinal axis with respect to FIG. 5a
  • FIG. 6a and 6b are sectional views of the injection device according to the invention in a distributed state, wherein FIG. 6b is a view rotated by 90 ° with respect to FIG. 6a about the longitudinal axis,
  • FIG. 7a and 7b are sectional views of the injection device according to the invention in a state in which the injection device is a the end of the 7b has signaled clicking sound, wherein FIG. 7b is a view rotated by 90 ° with respect to FIG. 7a about the longitudinal axis,
  • FIG. 8a and 8b are sectional views of the injection device according to the invention in which a retraction of the injection needle is activated, wherein FIG. 8b is a view rotated with respect to FIG. 8a by 90 ° about the longitudinal axis, FIG.
  • FIG. 9a and 9b are sectional views of the injection device according to the invention in a final state, wherein FIG. 9b is a view rotated by 90 ° with respect to FIG. 9a about the longitudinal axis;
  • FIG. 10 shows a sectional view of the signaling unit from FIGS. 1 to 9,
  • FIG. 11 is a perspective view of the signaling unit of FIG. 10;
  • FIG. 12 shows an injection device according to the invention with another embodiment of a signaling unit
  • FIG. 13 is a sectional view of the signaling unit of FIG. 12;
  • FIG. 14 is a further sectional view of the signaling unit of FIGS. 12, and
  • Figures 15 and 16 show a further embodiment of a signaling unit according to the invention.
  • FIGS. 1 a and 1 b show an injection device of a preferred embodiment.
  • the injection device has a housing 1 which comprises a proximal housing part 1 a and a distal housing part 1 b fixedly connected axially to the proximal housing part with a latching connection I c.
  • the latching connection Ic is formed from a window contained in the proximal housing part, in which an elastic tongue formed by the distal housing part Ib is snapped.
  • a product container 2 is accommodated, at the distal end of which an injection needle 4 for dispensing a liquid contained in the product container 2 Product is located.
  • the product container 2 has a displaceable piston 3, the movement of which causes a product discharge relative to the product container 2 and in the direction of the injection needle 4, for which reason it is also possible to speak of a dispensing movement.
  • the product container 2 is received in the device such that it is displaceable in the distal direction, so that the injection needle 4 emerges from the distal end of the injection device. Therefore, here can be talk of a plunge.
  • the product container 2 is axially fixedly connected to a holder 10 for the product container 2.
  • the holder 10 surrounds the product container 2 in the form of a sleeve so that, in order to reveal the view of the container 2, it either itself has a viewing window or, as in this example, a transparent material.
  • the product container 2 is axially fixedly connected to a clip 11 arranged proximally of it on the proximal end of the holder 10.
  • the product container 2 has at its proximal end a radially projecting collar which is grasped by the clamp.
  • the functional sleeve 11 has at its distal end on a radially projecting collar, which is also encompassed by the clip.
  • product container 10, functional sleeve 11 and holder 10 are axially fixed together, so that they can be moved as a single part.
  • this combination is referred to as a propulsion structure 2, 10, 11.
  • the functional sleeve 11 surrounds a piston rod 5, which can act on the piston 3 for a product discharge.
  • the piston rod 5 has a sleeve-shaped part, which surrounds a propulsion spring 6, wherein the propulsion spring 6 is supported distally on the piston rod 5 and proximally on a switching sleeve 8, in particular on a base 8a formed thereon.
  • a signaling unit is arranged with the one for the piercing and / or the dispensing, preferably at least three or more haptic and / or acoustic signals can be generated.
  • the signaling unit comprises a connected to the switching sleeve 8 grid rod 23 and a surrounding the grid bar 23 engaging sleeve 22 which is axially fixedly connected to the piston rod 5, in particular latched.
  • the engagement sleeve 22 has an engagement member 26 which in a formed by the grid bar 23 groove 27 engages.
  • the grid rod 23 has at its proximal end a head 24 which is movable in a direction formed by the activation element 13 sliding guide 25 in the proximal direction.
  • the head is with its distal end in engagement with a base 8a formed by the shift sleeve 8, wherein the engagement prevents the head 24 and thus the grid bar 23 in the distal direction relative to the shift sleeve 8 is movable.
  • Figs. 10 and 11 in which the signaling unit shown in Figs. 1 to 9 is shown in detail.
  • the signaling unit of FIGS. 10 and 11 may be replaced by another signaling unit according to FIGS. 12 to 14 and yet another signaling unit according to FIGS. 15 and 16.
  • the injection device shown in FIGS. 1 to 9 need not be substantially changed for this purpose.
  • the functional sleeve 11 has a locking element 16, on which a radially inwardly directed shoulder is formed, which cooperates in the initial state with a radially outwardly projecting shoulder formed at the distal end of the piston rod 5, so that the piston rod 5 for movement relative to the functional sleeve 11 is locked.
  • the blocking element 16 is of a radially inwardly facing surface of the
  • Shift sleeve 8 held in engagement with the piston rod 5. This is preferred
  • Locking element 16 via a spring arm elastically connected to the functional sleeve 11, in particular in one piece.
  • the resilient arrangement may be configured such that the blocking element 16 tends to move radially outwards, this being prevented by the radially inwardly facing surface of the switching sleeve 8.
  • the functional sleeve 11 has at its proximal end at least one snap element 15, which snaps in the initial state to prevent movement of the functional sleeve 11 and thus the propulsion structure 2, 10, 11 in the shift sleeve 8.
  • the injection device has at the proximal end of its housing 1 an activation element 13, which is axially fixed and rotatable to the housing 1.
  • the activation element 13 receives a return spring 21, which is supported distally at the proximal end of the shift sleeve 8 and proximally to the activation element 13.
  • the return spring 21 has the task of applying the switching sleeve 8 and an axially acting on the switching sleeve 8 actuating sleeve 9 with a force acting in the distal direction, so that switching sleeve 8 and actuating sleeve 9 are pressed in the distal direction.
  • the activation element 13 has an activation safeguard 14 which, in the switching states of the injection device shown in FIGS. 1a, 1b and 2a, engages behind the snap element 15 such that the snap element 15 is blocked or secured for movement out of engagement with the shift sleeve 8 is. Thus, an accidental triggering of the injection device can advantageously be prevented.
  • the activation fuse By rotation of the activation element 13 z. B. by 90 ° relative to the housing 1, the activation fuse can be moved out of engagement with the snap element 15.
  • a return spring 7 acting in the longitudinal direction of the device is distally supported on the shift sleeve 8 and proximally on the functional sleeve 11. As shown in this example, the return spring 7 surrounds the shift sleeve 8 and the functional sleeve 11. The return spring 7 is supported proximally, in particular on a collar 11a formed by the functional sleeve 11, which protrudes radially outwardly through an opening formed in the shift sleeve 8 attacks. In certain switching positions, therefore, the return spring 7 can cause a relative movement between the shift sleeve 8 and the functional sleeve 11.
  • the return spring 7 is a compression spring, which can move the functional sleeve 11 relative to the switching sleeve 8 in the proximal direction.
  • the return spring 7 is not or preferably biased only with a small biasing force. For example, in the state of the injection device shown in Figures Ia and Ib, the biasing force of the return spring 7 is less than the biasing force of the propelling spring. 6
  • the actuating sleeve 9 is arranged relative to the housing 1 movable.
  • the shift sleeve 8 and the actuating sleeve 9 can each act on each other with a compressive force, in particular be locked together and thereby move. So that the actuating sleeve 9 does not block the view of the product container 2, it also has a window in the region of the window 12.
  • the actuating sleeve 9 may be formed of a transparent material.
  • the actuating sleeve 9 is advanced in the initial state of the return spring 21 via the switching sleeve 8 distally over the distal end of the housing 1.
  • the distal end of the actuating sleeve 9 serves to be attached to an injection site of a patient.
  • the holder 10 has a switching cam 17 which engages in a recess 18 of the actuating sleeve 9, which, as shown in this example, may be a breakthrough.
  • the switching cam 17 is elastic with the holder 10, such. B. via a resilient arm, in particular integrally connected.
  • the switching cam 17 is preferably biased to tend to engage the recess 18 or to move radially outwardly.
  • the radially projecting from the holder 10 outwardly switching cam 17 has distally an oblique surface, which can help to push the switching cam 17 out of engagement with the recess 18.
  • the switching cam 17 proximally a transversely, in particular perpendicular to the longitudinal direction stop surface, which can get into an axial stop with the proximal boundary of the recess 18, through which the switching cam 17 can not be moved out of the recess 18.
  • the actuating sleeve 9 has an axial stop 19, on which the distal end of the holder 10 can strike at the end of a piercing movement.
  • a cap 32 is arranged which protects the interior of the injection device against contamination, in particular keeps the needle 4 sterile. Before using the injection device, the cap 32 is pulled off, so that in particular the needle 4 and the actuating sleeve 9 are exposed, as shown in FIGS. 2a and 2b.
  • the state of the injection device shown in Figures 2a and 2b differs from the state shown in Figures Ia and Ib only in that the cap 32 is removed.
  • the force exerted at the withdrawal of the needle cap 32 on the injection device is passed over the holder 10 on the functional sleeve 11 and there over the Snapper 15 passed to the switching sleeve 8, which is supported on the actuating sleeve 9.
  • the actuating sleeve 9 is in turn latched to the housing 1 via a projection Id formed by the distal housing part 1, so that the removal of the cap 32 from the injection device does not have any undesired effect on the mechanism.
  • the actuating sleeve 9 can not or only very slightly pushed into the distal end of the injection device, since this sliding movement is forwarded via the switching sleeve 8 to the snapper 15, wherein the snapper 15 at a movement in Proximal direction is prevented by the activation element 13.
  • the injection device is shown in an activated state, that is to say that the injection device can be triggered.
  • the injection device with a rotary movement of the activation element 13 z. B. by 90 °.
  • the snap elements 15 are released for a radially inwardly directed movement characterized in that the activation fuse 14 moves out of engagement with the snap elements 15, in particular is rotated.
  • the activation element 13 like the snap element 15, has an activation cam 13a, which is brought into axial alignment with the snap element 15 by the rotational movement of the activation element 13.
  • the snap element 15 has proximally and the activating cam 13a arranged proximally thereof has distally a contour which, during the movement of the snap element 15 in engagement with the activation cam 13, can deflect the snap element 15 radially inwards.
  • the contours are two sloping planes sliding off each other.
  • the user of the device places it with the distal end on the preferably previously disinfected injection site.
  • the actuating sleeve 9 is displaced relative to the housing 1 in the proximal direction, preferably so far until the distal end of the actuating sleeve 9 is approximately flush with the distal end of the distal housing part Ib.
  • the switching sleeve 8 is taken in the proximal direction, wherein the snap elements 15 by means of Activation cam 13a are pressed out of engagement with the shift sleeve 8 in particular radially inward.
  • the spring 21 is preferably a compression spring and formed from a plastic material. Alternatively, of course, springs made of a spring steel material or other spring material can be used.
  • the axial attachment of the activation element 13 to the housing 1 is in the form of a Ringschnappthetic with the housing.
  • the triggering mechanism is removed from the injection site upon removal of the injection device, e.g. the switching sleeve 8 and the actuating sleeve 9 by the return spring 21st
  • the movement of the actuating sleeve 9 in the proximal direction forms a blocking window 20, which is delimited distally from the housing 1, in particular the projection Id and proximally from the actuating sleeve 9.
  • the switching cam 17 remains in the recess 18th
  • the propulsion spring 6 can partially relax, whereby the propulsion structure 2, 10, 11 in the distal
  • Spring force of the propulsion spring 6 is during the entire piercing operation, i. also at the beginning and at the end of the piercing operation greater than the spring force of the return spring. 7
  • Inj tion device contributes.
  • the blocking element 16 has a radially outwardly directed
  • the blocking element 16 fulfills a dual function. When snapping the
  • Locking elements 16 in the recess 18 simultaneously locks the locking element 16 with the radially outwardly directed movement of the piston rod 5, so that this for a
  • the feed spring 6 is decoupled from the return spring 7, that is, the
  • Feed spring 6 in this state has no influence on the bias of the return spring 7. This is followed by a dispensing movement in which the signaling unit dispenses a time-constant clicking sound which can also be felt by the user of the device.
  • Shift sleeve 8 caught and not supported on the housing.
  • Einstechvorgang is about the functional sleeve 11 to the collar of the product container. 2 directed.
  • the puncturing process is positively controlled, since the functional sleeve 11 drives the product container 2 until the end of the discharge and the piston rod 5 can dispense into the recesses 18 only after the engagement of the blocking elements 16.
  • the piercing movement is stopped by the stop 19 on the actuating sleeve 9.
  • this distance is used to generate a haptic or acoustic signal intended to signal complete product release.
  • the small distance z arises from the difference between the distance which prevails between the stop face of the control cam 17 pointing in the proximal direction and the stop face pointing in the proximal direction, and the distance between the proximal boundaries of the recess 18 and the stop window 20.
  • the injection device is shown in a state after a successful product distribution.
  • the outer peripheral surface of the sleeve-shaped portion of the piston rod 5 pushes the locking element 16 into the recess 18, whereby the locking element 16 is secured against disengagement from the recess 18 during product dispensing.
  • the piston rod 5 may have a recess or be dimensioned in length so that after the product has been discharged, the securing of the blocking element 16 through the outer peripheral surface of the piston rod 5 is eliminated, so that the blocking element 16, as shown in Figure 6b, from the recess 18 can disengage.
  • the disengagement can be due to an elastically biased arrangement of the locking element 16 or due to the geometry of the locking element 16, which causes a pushing out of the locking element 16 from the recess 18, caused.
  • the propulsion spring 6 has further relaxed, while the tension of the tensioned return spring 7 has remained constant.
  • the spring force of the propulsion spring 6 is now lower than the spring force of the prestressed return spring 7.
  • the needle 4 is free for retreat.
  • the return spring 7 is released for a return movement. Due to the higher spring force of the prestressed return spring 7, the entire propulsion structure 2, 10, 11 is pressed in the proximal direction.
  • the spring 6 is tensioned again, wherein the spring force of the return spring 7 during the entire retraction operation, that is, even to the end of the retraction process, is greater than the spring force of the propulsion spring. 6
  • Figures 9a and 9b the injection device is shown in a final state. In this state, the injection device again has the same dimensions as at the beginning. Thus, the cap 32 can be replaced and disposed of the injection device.
  • the grid bar 23 has a grid 30, which comprises a plurality of latching elements 31, which are arranged along the longitudinal direction with gradually decreasing intervals. These distances are reduced by the decreasing spring force.
  • the grid bar is connected with its proximal end, in particular with its head, at least in one direction axially fixedly connected to the shift sleeve 8 (eg, FIG.
  • the grid rod 23 is surrounded by a grid sleeve 22 which is connected to the distal end of the propulsion spring 6 and / or to the distal end portion of the piston rod 5.
  • the engagement sleeve has an engagement element 26 which engages in an annular groove 27.
  • the engagement element 26 engages in the starting position in the groove 27 a.
  • the first section has no further locking element but is substantially cylindrical or Tapered so that no signals are emitted during the piercing movement. In principle, embodiments in which this is possible are advantageous.
  • the length of the first portion is dimensioned such that the engagement member 26 has substantially completely traversed the first portion upon completion of the puncturing movement.
  • a further engagement member 26 may be provided on the radially opposite side, on which the engagement member 26 is arranged.
  • a further engagement member 26 may be provided on the radially opposite side, on which the engagement member 26 is arranged.
  • no further engagement member 26 is provided, but only a support formed by the sleeve wall, which serves as an abutment.
  • FIGS. 12 to 14 an alternative embodiment of the signaling unit for the injection device from FIGS. 1 to 9 is shown.
  • the grid 30 is arranged in a groove 29, namely on its flank.
  • the locking elements 31 are in the circumferential direction of the groove edge.
  • an axially movable carriage 28 is arranged, which is axially fixedly coupled to the piston rod 5.
  • the locking elements 31 each have distances from each other, which take into account the changing force of the propulsion spring for a time-constant delivery of signals.
  • the distance of the saw teeth is therefore chosen so that the individual clicks are made at regular intervals, although the carriage 28 with the piston rod 5 at the end of the distribution has a lower Ausfact für than at the beginning.
  • Figures 15 and 16 show a further embodiment of the signaling unit, in which the grid 30 is formed from recesses, in particular windows, which are also mounted with changing distances on the piston rod 5.
  • the engagement member 26 is resiliently arranged on the functional sleeve 1 1. In the distribution movement, the
  • the advantage of this embodiment is that the engagement member 26 can be formed by the blocking element 16, so that this embodiment manages with very few parts. Bezu ⁇ s Drliste

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'injection, en particulier un auto-injecteur comprenant : a) un ressort d'avancement (6) qui permet de déplacer une aiguille d'injection (4) d'une position de départ jusqu'à une position de piqûre à partir de l'extrémité distale du dispositif d'injection, et d'évacuer le produit se trouvant dans un contenant à produit (2) au moyen d'un mouvement d'évacuation; et b) un ressort de rappel (7) qui permet de retirer l'aiguille d'injection (4) de la position de piqûre, en particulier de manière complète, jusqu'à l'extrémité distale du dispositif d'injection contre la force du ressort d'avancement (6). Cette invention est caractérisée en ce que le ressort de rappel (7) est désaccouplé du ressort d'avancement (6) lors du mouvement d'évacuation.
EP08714769A 2007-03-22 2008-03-19 Ensemble ressort dans un dispositif d'injection Withdrawn EP2129416A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007013837A DE102007013837A1 (de) 2007-03-22 2007-03-22 Federanordnung in einer Injektionsvorrichtung
PCT/CH2008/000119 WO2008113199A1 (fr) 2007-03-22 2008-03-19 Ensemble ressort dans un dispositif d'injection

Publications (1)

Publication Number Publication Date
EP2129416A1 true EP2129416A1 (fr) 2009-12-09

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ID=41265586

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EP08714769A Withdrawn EP2129416A1 (fr) 2007-03-22 2008-03-19 Ensemble ressort dans un dispositif d'injection

Country Status (3)

Country Link
US (1) US8398594B2 (fr)
EP (1) EP2129416A1 (fr)
CN (1) CN101678167B (fr)

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Also Published As

Publication number Publication date
US20100137798A1 (en) 2010-06-03
CN101678167B (zh) 2013-09-18
CN101678167A (zh) 2010-03-24
US8398594B2 (en) 2013-03-19

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