WO2009089638A1 - Unité d'aiguille comportant un manchon disposé entre un porte-aiguille et un manchon d'emballage d'aiguille - Google Patents

Unité d'aiguille comportant un manchon disposé entre un porte-aiguille et un manchon d'emballage d'aiguille Download PDF

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Publication number
WO2009089638A1
WO2009089638A1 PCT/CH2008/000544 CH2008000544W WO2009089638A1 WO 2009089638 A1 WO2009089638 A1 WO 2009089638A1 CH 2008000544 W CH2008000544 W CH 2008000544W WO 2009089638 A1 WO2009089638 A1 WO 2009089638A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
needle
carrier
unit according
needle carrier
Prior art date
Application number
PCT/CH2008/000544
Other languages
German (de)
English (en)
Inventor
Kevin Mori
Jürg HIRSCHEL
Celine KÄNEL
Annette Drunk
Ulrich Moser
Markus Tschirren
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 WO2009089638A1 publication Critical patent/WO2009089638A1/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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/3205—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
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

Definitions

  • Needle unit with a arranged between the needle carrier and Nadelverpackungshülse
  • the invention relates to a needle unit which is attached or attachable to an injection device.
  • the needle unit is preferably provided for injection devices with which a product, such as a liquid medicament, can be injected into a patient.
  • the needle unit is preferably intended for subcutaneous or transcutaneous injection, as is common, for example, for hormones, insulin preparations and the like.
  • the needle unit may already be attached to an injection device, such as a disposable injection device, upon delivery.
  • the needle unit is a disposable product.
  • the needle unit may be attachable by a user of the injection device, such as a Mehrwegi ⁇ j tion device, for each one injection or only a few injections to the injection device and in a simple manner to an unused needle unit.
  • Needle units are known from the prior art, which have an outer sleeve, namely a so-called packaging sleeve, in which the rest of the needle unit, namely a needle carrier and a needle attached thereto, is received.
  • the invention may, for. B. starting from the following starting position:
  • the needle unit Before injection, the needle unit is attached to the injection device.
  • the user grasps the packaging sleeve and inserts the needle unit onto the injection device. Then he removes the packaging sleeve, so that the needle unit is now ready for an injection. After use, the packaging tube is again placed on the needle unit.
  • the object of the invention is to provide a needle unit, in which by means of the packaging sleeve forces and / or moments can be applied to the needle unit to solve, for example, the needle unit of the Inj edictions device.
  • the object is achieved by the needle unit according to claim 1.
  • the object is further achieved by the method according to claim 20.
  • the needle unit according to the invention is attached or attachable to an injection device.
  • the needle unit may already be attached, for example, when delivered to the injection device.
  • the needle unit can also be sold as a single part, which - in order to take the hygienic aspect into account - can be attached to the injection device only for one or a few injections, in particular by the user of the injection device.
  • the needle unit is also removable again from the injection device, at least if it is a reusable injection device. This also applies to disposable injection devices with which multiple injections are für Stahllirbar. In disposable injection devices in which only a single or a few injections are feasible, the needle unit can also be left on the injection device and disposed of together with the injection device.
  • the needle unit can be used in injection devices with a single-chamber ampoule or advantageously with a two-chamber ampoule, in which the medicament must first be mixed or mixed together before injection from two components.
  • Zweischampullen usually have a first chamber for a first component and a second chamber for a second component, wherein in the initial state, the two components z. B. are separated by a membrane or a piston.
  • the separate storage of the ingredients can increase the shelf life of the drug because the blended drug is of relatively short shelf life.
  • the mixing can z. B. done by inserting the two-chamber ampule in a suitable for such ampoules device.
  • a two-chamber ampule with a corresponding device is described, for example, in DE 103 40 585 A1, to which reference is hereby made.
  • the blending process there is a risk of stinging when the needle unit has already been attached to the injection device and the needle is exposed.
  • the needle unit comprises a needle carrier on which preferably an injection needle for a subcutaneous injection is arranged axially fixed.
  • the needle protrudes in the distal direction from the needle carrier, in particular so far that the needle is subcutaneously pierceable into the patient.
  • the needle carrier is preferably also used to attach the needle unit to the injection device.
  • the needle carrier may, for example, be attachable with an axial movement or screwable with a screwing motion or with a combination of both, to the injection device.
  • the needle carrier may be in one piece or preferably also in several parts.
  • the needle carrier may have a proximally-facing extension, which may be formed by the needle or a separate part and with which a septum of an ampoule of the injection device pierceable, whereby a fluidic connection of the injection needle is made with the product to be administered, have ,
  • the needle carrier may have a mounting portion for attaching the needle unit to the injection device.
  • the attachment portion may be a separate part, which, as also preferred for the extension, rotatably and axially fixed to the needle carrier.
  • the needle unit further comprises a first sleeve, which is arranged in particular in the delivery state of the needle unit on the needle carrier.
  • the first sleeve can also be referred to as Nadelabdeckkappe, which can cover the needle so that a user of the device can not sting.
  • the needle carrier can have a fastening section for the first sleeve, which can be provided in particular in addition to the fastening section for the injection device.
  • the attachment portion for the first sleeve can be rotatably and axially fixedly connected to the needle carrier, that is, be a separate part. But basically, the needle carrier and attachment section can also be one-piece.
  • the needle carrier has a separate extension, the part that holds the needle, which may also be referred to as a needle carrier, and a sleeve-shaped part that receives the extension, the needle carrier, and partially the needle and forms one or both attachment portions ,
  • the parts of which the needle carrier consists are preferably rotatable and axially fixed to each other.
  • the multi-part of the needle carrier has manufacturing advantages. Basically, the z. B. made of plastic needle carrier but also be one piece, the axially fixed with a separate z. B. made of metal needle is connected.
  • the first sleeve may be at least partially disposed over the needle carrier.
  • the first sleeve can lie with its inner actuallysfiambae on an outer peripheral surface of the needle carrier or its attachment part.
  • the first sleeve may be non-positively and / or positively connected to the needle carrier.
  • the needle unit further comprises a second sleeve, which is arranged on, in particular on the first sleeve.
  • the second sleeve is preferably a packaging sleeve in which the remaining parts of the needle unit can be accommodated.
  • the second sleeve is preferably arranged partially over the first sleeve and / or the needle carrier.
  • the inner peripheral surface of the second sleeve may abut an outer peripheral surface of the first sleeve.
  • the second sleeve is disposed completely over the first sleeve and the needle carrier.
  • the second sleeve can be positively and / or positively connected to the first sleeve be connected.
  • the first sleeve for.
  • the second sleeve can be arranged radially between the needle carrier and the second sleeve.
  • the second sleeve is in a delivery state, that is, prior to use of the needle unit, attached to the first sleeve and the first sleeve on the needle carrier.
  • the first sleeve can be removed from the needle unit and, with the first sleeve removed, the second sleeve can be fastened to the needle carrier.
  • the second sleeve can have first fastening properties with respect to the needle carrier and can have second fastening properties when the first sleeve is removed.
  • Preferred first fastening properties are that the second sleeve is axially movable relative to the first sleeve and in particular rotationally fixed or rotatable.
  • the first sleeve can be axially movable and in particular rotationally fixed or rotatable relative to the needle carrier.
  • Preferred second fastening properties that is, when the first sleeve is removed and the second sleeve is fastened to the needle carrier, are that the second sleeve is axially fixed relative to the needle carrier and in particular rotationally fixed or rotatable.
  • the second sleeve is so axially fixed to the needle carrier that the connection is not or only by excessive force, d. H. in particular can be solved only by destroying the needle unit.
  • the second sleeve can in particular be frictionally and / or positively connected to the needle carrier.
  • the second sleeve is removable from the first sleeve. The thus separated first sleeve can now be disposed of, since it is preferably no longer necessary for further use of the needle unit.
  • the force for removing the second sleeve from the first sleeve is less than the force required to remove the first sleeve from the needle carrier such that the first sleeve remains on the needle carrier when the second sleeve is removed from the first sleeve becomes.
  • the second sleeve may be withdrawn from the first sleeve with a force acting in the distal direction, possibly also in combination with a rotational movement.
  • the first sleeve can be removed from the needle carrier with a force acting in the distal direction, possibly also in combination with a rotational movement. This force can also be combined with a rotational force.
  • the force required to remove the needle assembly from the injection device is greater than the force required to remove the second sleeve from the needle assembly first sleeve and greater than the force for removing the first sleeve from the needle carrier. Furthermore, it is preferable that the force for removing the needle carrier from the injection device is smaller than the force that can be transmitted via the connection of the second sleeve to the needle carrier. As a result, the needle unit can be completely removed from the injection device after attaching the second sleeve to the needle carrier.
  • the needle carrier may have a cylindrical or conical portion, namely a fastening portion, on which the first sleeve is arranged and on which the second sleeve can be arranged after the first sleeve has been removed.
  • the first sleeve can be arranged for example by means of a transition fit or press fit, so that a non-positive, in particular frictional connection exists.
  • the first sleeve can be fixed by means of the wedge effect of the cone on the needle carrier so that there is also a frictional connection. It is preferred for the conical section that it has a cone angle which causes self-locking.
  • the first sleeve may also have such a cylindrical or conical portion on which the second sleeve is detachably arranged.
  • the needle carrier and / or the first sleeve may each have a latching member, wherein the latching member of the needle carrier, the first sleeve is in particular releasably latched and latched with the locking member of the needle carrier or with the locking member of the first sleeve, the second sleeve in particular detachably is.
  • the latching member of the needle carrier can engage through an opening of the first sleeve, whereby it can come into engagement with the second sleeve.
  • first and the second sleeve - if a locking is to take place with a locking member - each have elements, such as recesses, with which a latching connection can be made with a locking member.
  • the detent members described herein may project radially outwardly from an outer peripheral surface of the needle carrier and / or the first sleeve.
  • the needle carrier may have a locking member, with which the second sleeve can be locked in particular insoluble.
  • This locking member may be an additional to the locking member described above. Alternatively, it may also be the locking member described above.
  • first sleeve may have a recess which prevents the first sleeve from coming into engagement with a locking member for the second sleeve formed on the needle carrier.
  • a recess may be, for example, a slot extending from the proximal end of the first sleeve.
  • the first sleeve may have an opening or a recess into which the locking member provided for it can engage.
  • the needle carrier and / or the first sleeve may have radially outwardly facing Abragungen which engage in the overlying, in particular immediately above part and thus form a rotation between the underlying and the immediately above part.
  • a rotation can be provided alternatively or in addition to one or more locking members.
  • the anti-rotation are radially outwardly projecting, extending in the longitudinal direction of the needle unit ribs or webs.
  • the overlying part may have corresponding elements, such as depressions, in which the anti-rotation device can intervene.
  • the sleeves described herein are preferably rotationally symmetric.
  • the sleeves may have lateral surfaces which are closed or have openings.
  • the second sleeve which preferably serves as a packaging sleeve, it is advantageous if this has a closed lateral surface, ie a lateral surface without openings.
  • the distal end of the second sleeve is closed.
  • a closed second sleeve having only at its proximal end an opening which is closed by a closure, in particular a removable lid.
  • Such a closure may, for. Legs adhered peel-off or a cup-shaped lid.
  • the first sleeve prefferably has an axial length to enclose a needle projecting distally of the needle carrier on the needle carrier so as to prevent accidental sticking.
  • the first sleeve in its position arranged on the needle carrier projects so far in the distal direction that its distal end projects beyond the distal needle tip of the needle.
  • the distal end face of the first sleeve can be closed.
  • the needle unit may further comprise a needle guard sleeve slidable between a distal position in which its distal end protrudes beyond the distal needle tip and a proximal position in which the distal needle tip protrudes beyond the distal end of the needle guard ,
  • the needle protection sleeve can be attached with its distal end to an injection site of a patient. This is z. B. advantageous if the user of the needle unit does not want to see the needle, because he z. B. is afraid of needles.
  • an elasticity means in particular a spring, can be arranged between the needle protection sleeve and the needle carrier against whose force the needle protection sleeve can be displaced proximally and which presses the needle protection sleeve distally.
  • a preferred spring may be seen in the form of a helical or coil spring, which may be formed in particular from metal or plastic.
  • the needle protection sleeve can be locked axially so that the needle protection sleeve is no longer displaceable so far the distal end of the needle protrudes beyond the distal end of the needle guard.
  • the invention further relates to a method for securing a needle unit.
  • a puncture be made into a patient's injection site while the procedure is being performed, the procedure may be performed without piercing a patient.
  • the needle unit is attached to an injection device.
  • the second sleeve which is arranged on the first sleeve is removed from the needle unit.
  • the now exposed first sleeve is now removed from the needle unit.
  • the second sleeve is attached to the needle unit again.
  • the packaging sleeve Prior to an injection, the packaging sleeve may be connected to the needle carrier in such a way that the packaging sleeve is allowed to rotate in rotation and can be easily removed without great force, such as, for example, a distal distal withdrawal movement. Due to the free rotation of the packaging sleeve no torque can be transmitted from the packaging sleeve to the needle carrier.
  • the packaging sleeve should be re-attached to the needle carrier.
  • the packaging sleeve should be both rotationally fixed and axially fixed relative to the needle carrier, so that moments and forces, ie rotational and axial movements can be transferred to the needle carrier.
  • Nadelabdeckkappe In the initial position, ie in the delivery state of the needle unit, the Nadelabdeckkappe is located directly on the needle carrier. In addition, ie on the Nadelabdeckkappe the packaging sleeve is arranged.
  • the Nadelabdeckkappe has the particular function that the packaging sleeve is not already in one for the 2008/000544
  • Packing sleeve provided snap the needle carrier can pass and thus still freely rotatable and still slightly removable axially. There is therefore still an insoluble axial and rotary fuse.
  • the needle unit is now attached to the injection device, in particular clicked. Subsequently, the packaging sleeve is removed in the distal direction of the Nadelabdeckkappe. Thereafter, the Nadelabdeckkappe is also deducted in the distal direction and can be disposed of. This will expose the needle.
  • the device is now ready for an injection. After performing the injection, it is advantageous to re-attach the packaging sleeve to the needle carrier to reduce the risk of injury and disposal.
  • the packaging sleeve can be snapped directly into the designated snapper on the needle carrier. Once this is done, the packaging sleeve is connected to the needle carrier both rotationally and axially positively and non-positively. It can thus moments and forces are transmitted from the packaging sleeve on the needle carrier, the z. B. necessary for removing the complete needle unit from the pen.
  • the needle cap has a safety function.
  • a blending and / or priming operation must be performed prior to injection, such as, for example.
  • Figures Ia to Ic different views of a disassembled needle module according to a first embodiment, Figures 2a to 2b, the needle module of the figures Ia to Ic in one 44
  • Figures 4a and 4b show different views of the needle module of Figures Ia to Ic in a state in which the second sleeve is removed from the needle module
  • Figures 5a to 5c show different views of the needle module of Figures Ia to Ic with a patch on the needle carrier second sleeve, with the first sleeve removed
  • Figures 6a and 6b show different views of a needle module according to a second
  • FIGS. 1 a to 1 c the needle carrier 1, the first sleeve 3 and the second sleeve 4 are shown separated from one another and arranged in alignment, in which they can be plugged onto one another.
  • a needle 2 is axially fixed to the needle carrier 1 and protrudes distally as far as required for subcutaneous injection beyond the distal end of the needle carrier 1.
  • the needle carrier 1 is fastened to an injection device (not shown). In a state fixed to the injection device, there is a fluidic connection between its product container and the needle 2, so that the product contained in the product container can be injected via the needle 2 into a patient.
  • the needle carrier has at its proximal part a cylindrical element, which serves as a fastening part for attachment to the injection device, and a distally adjoining this part fastening part Ig for fixing the first sleeve 3 and the second sleeve 4.
  • the mounting part Ig is slightly conical and tapers towards distal.
  • the first sleeve 3 is also conical and also tapers in the distal direction, whereby it can be plugged onto the fastening part Ig.
  • locking elements Id and Ie are arranged, which protrude radially outward from the peripheral surface of the needle carrier 1. About the circumference three locking elements Id are evenly distributed. Alternatively, one, two, four, five or even more locking members Id on the fastening part Ig 8 000544
  • the locking members Id serve to releasably secure the first sleeve 3, which is also referred to as Nadelabdeckkappe, to the needle carrier 1.
  • the latching members Ie are used for fastening a second sleeve 4 to the needle carrier 1.
  • the second sleeve 4 has a recess 4e, which in this example rotates annularly around the inner circumference of the second sleeve 4.
  • the latching members Ie can, as will be described later, engage in the recess 4e for fastening the second sleeve 4.
  • the fastening part Ig has in this example three locking elements Ie distributed uniformly over the circumference, wherein it may also be one, two or four or even more uniformly distributed over the circumference detent members Ie.
  • the locking members Id and Ie are offset from each other in the circumferential direction.
  • a web If extending in the longitudinal direction of the needle module and projecting radially outward from the fastening part is arranged on the fastening part Ig, which web serves as an anti-twist device for the second sleeve 4.
  • the second sleeve 4 has for this purpose at its inner periphery to the webs If corresponding recesses 4f, in which the webs If engage and form an anti-rotation, when the second sleeve 4 is attached to the needle carrier 1.
  • the first sleeve 3 has openings 3d, in which serve the locking members Id for releasably securing the first sleeve 3 to the needle carrier 1.
  • the first sleeve 3 has recesses 3 b, which extend from the proximal end in the longitudinal direction of the first sleeve 3.
  • the recesses 3b are positioned so that in a plugged state of the first sleeve 3 on the needle carrier 1, the locking members Ie are positioned in the recesses 3b.
  • the second sleeve 4 which is also referred to as a packaging sleeve, has, in the part which also has the depressions 4e and 4f, a conically tapered inner peripheral surface in the distal direction, as does the first sleeve 3.
  • the needle module is shown in a delivery state.
  • the second sleeve 4 completely surrounds the remaining parts of the needle module, ie the remaining parts of the needle module are arranged completely within the second sleeve 4.
  • the second sleeve 4 protrudes with its proximal end proximally over the proximal end of the needle carrier 1.
  • the second sleeve 4 is open only at its proximal end, which in the delivery state this opening is closed by a removable cover or a peelable release liner (not shown). This has the advantage that the parts located within the second sleeve 4 can be kept sterile.
  • the second sleeve 4 is non-positively connected to the first sleeve 3. Both the outer circumference of the first sleeve 3 and the inner circumference of the second sleeve 4 are correspondingly conical and taper in the distal direction. Thus, the second sleeve 4 can be pushed axially onto the first sleeve 3 and thus jammed for a frictional, in particular frictional connection with the first sleeve 3.
  • the angle of taper is preferably selected so that the connection between the second sleeve 4 and the first sleeve 3 is self-locking.
  • the first sleeve 3 is attached with a conical inner circumference to the conical mounting part Ig.
  • connection shown here is on the one hand non-positively, because of the conicity and on the other form fit, since the locking members Id engage in the recesses 3b and thus form a latching connection.
  • the locking members Ie are arranged between the recesses 3b.
  • the latching elements Ie have a width measured in the circumferential direction which approximately corresponds to the width of a recess 3b measured in the circumferential direction.
  • the latching members Ie protrude radially into the recesses 3b and thus form an anti-rotation between the first sleeve 3 and the needle carrier 1.
  • the second sleeve 4 is withdrawn from the first sleeve 3.
  • the connection between the needle carrier 1 and the first sleeve 3 is stronger than the connection between the first sleeve 3 and the second sleeve 4, whereby when pulling the second sleeve 4, the first sleeve 3 remains on the needle carrier 1.
  • connection between the needle carrier 1 and the injection device is stronger than both the connection between the first sleeve 3 and second sleeve 4 and between the needle carrier 1 and the first sleeve 3.
  • the needle carrier 1 remains on the injection device.
  • the needle 2 is free for injection.
  • the sleeve 3 can now be disposed of.
  • the second sleeve 4 After injection, the second sleeve 4 is pushed directly onto the needle carrier 1. As a result, the latching members Ie engage in engagement with the recess 4e and the webs If in engagement with the recesses 4f. By the engagement of the webs If in the recesses 4 f, a rotation is provided, whereby a force exerted on the second sleeve 4 torque or a force exerted on the second sleeve 4 rotary motion is transmitted to the needle carrier 1, whereby this of the Inj tion device z. B. can be unscrewed or loosened.
  • the latching connection between the latching members Ie and the recess 4e is so strong that it is not solvable. At least it is stronger than the force needed to withdraw the needle module from the injection device.
  • the locking members are more flattened in the direction of slipping as in peeling.
  • the needle carrier 1 comprises a part which receives the needle 2 axially fixed, and from which the needle 2 extends in the distal direction.
  • the distal end of this part has a trumpet-widening widening 8, from which the needle 2 extends. This expansion serves to protect the needle 2 from damage if transverse forces or bending moments are exerted on the needle 2 during the injection.
  • the needle carrier 1 further comprises an axially and rotationally fixed associated projection Ia, which projects in the proximal direction of the needle carrier 1. This extension Ia has a tip and openings at the proximal end.
  • the tip is used to perforate a septum of a product container and the openings serve to direct the product via a fluid channel to or through the needle 2.
  • a housing Ib is axially and non-rotatably connected to the needle carrier 1, which forms the fastening part for the injection device and the fastening part Ig for the first and second sleeves 3, 4.
  • the combination of parts I 5 Ia and Ib may be referred to as needle carrier 1.
  • the multi-part design has particular advantages in the preparation of. With regard to the attachment of the first sleeve 3 and the second sleeve 4 on the needle carrier 1 reference is made to the comments on the figures Ia to 5 c and the associated description.
  • the embodiment shown in FIGS. 6 a to 14 has, in addition to the embodiment from FIGS. 1 a to 5 c, a spring 6 and a needle protection sleeve 5.
  • the needle protection sleeve 5 is displaceable between a distal position, as shown in Figure 6a and in which it is pressed by the spring 6 against an axial stop, and a proximal position against the biasing force of the spring 6.
  • the needle guard 5 serves to make it easier for persons suffering from needle phobia to make an injection.
  • the needle module has a cover 7 arranged at its poximal end in the form of a peel-off film which closes the interior of the second sleeve 4 in a sterile manner.
  • the embodiment in FIG. 6a is the delivery state of the needle module.
  • FIGS. 7 to 14 show the sequence of use of the needle module from FIG. 6a.
  • the peel-off film 7 is removed.
  • the user engages around the needle module on the outer circumference of the second sleeve 4.
  • the needle module is attached to the Inj etations device 9 and then the second sleeve 4 withdrawn ( Figure 9).
  • the first sleeve 3 remains here on the needle carrier. 1
  • the injection device is used with a two-chamber ampoule, now is a suitable time for mixing the two-chamber ampoule, since the first sleeve 3 protects against puncture injuries.
  • the needle protection sleeve 5 is now attached with its distal end to the injection site of the patient (not shown) and the injection device 9 is pressed.
  • the needle 2 pierces while the needle guard 5 moves in the proximal direction relative to the needle carrier 1 ( Figure 11).
  • the needle guard 5 pushes in the distal direction ( Figure 12).
  • the second sleeve 4 is then pushed onto the needle carrier 1 with a movement in the poximal direction, where it locks axially fixedly and non-rotatably (FIG. 13).
  • the used needle module can now be removed from the injection device 9 (FIG. 14).

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (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)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une unité d'aiguille disposée ou pouvant être disposée sur un dispositif d'injection. L'unité d'aiguille comporte un porte-aiguille (1), un premier manchon (3) disposé sur le porte-aiguille (1), et un deuxième manchon (4) disposé sur le premier manchon (3). Le premier manchon (3) est amovible, et lorsque celui-ci est retiré, le deuxième manchon (4) peut être fixé au porte-aiguille (1).
PCT/CH2008/000544 2008-01-04 2008-12-18 Unité d'aiguille comportant un manchon disposé entre un porte-aiguille et un manchon d'emballage d'aiguille WO2009089638A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008003185.2 2008-01-04
DE200810003185 DE102008003185A1 (de) 2008-01-04 2008-01-04 Nadeleinheit mit einer zwischen Nadelträger und Nadelverpackungshülse angeordneten Hülse

Publications (1)

Publication Number Publication Date
WO2009089638A1 true WO2009089638A1 (fr) 2009-07-23

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PCT/CH2008/000544 WO2009089638A1 (fr) 2008-01-04 2008-12-18 Unité d'aiguille comportant un manchon disposé entre un porte-aiguille et un manchon d'emballage d'aiguille

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DE (1) DE102008003185A1 (fr)
WO (1) WO2009089638A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD787053S1 (en) 2016-04-14 2017-05-16 Becton, Dickinson And Company Pen needle inner shield
USD787054S1 (en) 2016-04-14 2017-05-16 Becton, Dickinson And Company Pen needle hub
USD787669S1 (en) 2016-04-14 2017-05-23 Becton, Dickinson And Company Pen needle outer cover
USD804023S1 (en) 2016-04-14 2017-11-28 Becton, Dickinson And Company Pen needle inner shield
USD825749S1 (en) 2016-04-14 2018-08-14 Becton, Dickinson And Company Pen needle outer cover

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2999436B1 (fr) 2012-12-14 2016-02-05 Transformation Des Elastomeres A Usages Medicaux Et Ind Soc D Systeme de protection d'aiguille d'un dispositif d'injection.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0903157A2 (fr) * 1997-09-12 1999-03-24 Becton, Dickinson and Company Aiguille jetable pour seringue en forme de stylo
EP1741459A1 (fr) * 2005-07-08 2007-01-10 Biofluid Systems S.A. Dispositif multifonctionnel pour aiguilles de seringue
WO2007047403A1 (fr) * 2005-10-13 2007-04-26 Becton, Dickinson And Company Ensemble aiguille et embout jetable
WO2008083037A1 (fr) * 2006-12-26 2008-07-10 Stat Medical Devices, Inc. Pointe d'aiguille à stylo

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5669889A (en) * 1996-07-03 1997-09-23 Becton, Dickinson And Company Needle shield assembly having a single-use lock
DE19915272A1 (de) * 1999-04-03 2000-10-05 Vetter & Co Apotheker Spritze für medizinische Zwecke
DE10340585A1 (de) 2003-09-03 2005-04-07 Tecpharma Licensing Ag Verabreichungsvorrichtung mit Mehrkammerampulle und Mischsperre

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0903157A2 (fr) * 1997-09-12 1999-03-24 Becton, Dickinson and Company Aiguille jetable pour seringue en forme de stylo
EP1741459A1 (fr) * 2005-07-08 2007-01-10 Biofluid Systems S.A. Dispositif multifonctionnel pour aiguilles de seringue
WO2007047403A1 (fr) * 2005-10-13 2007-04-26 Becton, Dickinson And Company Ensemble aiguille et embout jetable
WO2008083037A1 (fr) * 2006-12-26 2008-07-10 Stat Medical Devices, Inc. Pointe d'aiguille à stylo

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD787053S1 (en) 2016-04-14 2017-05-16 Becton, Dickinson And Company Pen needle inner shield
USD787054S1 (en) 2016-04-14 2017-05-16 Becton, Dickinson And Company Pen needle hub
USD787669S1 (en) 2016-04-14 2017-05-23 Becton, Dickinson And Company Pen needle outer cover
USD804023S1 (en) 2016-04-14 2017-11-28 Becton, Dickinson And Company Pen needle inner shield
USD825749S1 (en) 2016-04-14 2018-08-14 Becton, Dickinson And Company Pen needle outer cover

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