EP2240224A1 - Injektionsspritze - Google Patents

Injektionsspritze

Info

Publication number
EP2240224A1
EP2240224A1 EP09708432A EP09708432A EP2240224A1 EP 2240224 A1 EP2240224 A1 EP 2240224A1 EP 09708432 A EP09708432 A EP 09708432A EP 09708432 A EP09708432 A EP 09708432A EP 2240224 A1 EP2240224 A1 EP 2240224A1
Authority
EP
European Patent Office
Prior art keywords
cannula
injection syringe
syringe barrel
protective cap
syringe
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Withdrawn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
EP09708432A
Other languages
German (de)
English (en)
French (fr)
Inventor
Brigitte Pickhard
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.)
MEIXNER MANFRED
Pharma Consult Ges mbH
Original Assignee
PICKHARD Brigitte
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 PICKHARD Brigitte filed Critical PICKHARD Brigitte
Publication of EP2240224A1 publication Critical patent/EP2240224A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104Caps for syringes without needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/323Connection between plunger distal end and needle hub proximal end, e.g. stud protruding from the plunger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5066Means for preventing re-use by disconnection of piston and piston-rod
    • A61M2005/5073Means for preventing re-use by disconnection of piston and piston-rod by breaking or rupturing the connection parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3145Filters incorporated in syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3202Devices for protection of the needle before use, e.g. caps

Definitions

  • the invention relates to an injection syringe with a syringe barrel, a piston rod inserted therein, which is connected by a coupling part with a plug, and provided in the proximal end of the syringe barrel assembly with a cannula mounted in a cannula holder, which received in a guide sleeve is, as well as a sealing insert for liquid-tight closure of the proximal end of the syringe barrel and a protective cap for protecting the cannula, wherein the protective cap on the inner circumference has axially extending ribs which engage in corresponding grooves of the guide sleeve for a rotary drive thereof.
  • proximal and distal are defined as viewed from the side of the patient.
  • An injection syringe with a tamper-evident closure that is to say with a protective cap which can only be removed while being rotated, and which connects the cannula to the syringe cylinder as a result of the rotation, is known from WO 03/057289 A1. Disadvantage of this construction is that the cannula is unprotected after use of the syringe, which on the one hand means a risk of injury, on the other hand causes the unwanted distribution of the remainder of the drug from the syringe barrel.
  • WO 2007/112470 A1 discloses an injection syringe with a syringe head which can be displaced into the syringe barrel. Immediately after using the syringe, the piston rod engages the syringe head and allows it to be drawn into the syringe barrel.
  • the disadvantage of this design is that the permanently connected to the syringe barrel cannula is provided only with a conventional cap. Unintentional impacts against the piston rod of the syringe Their use can cause the drug to enter the cannula and exit from it uncontrollably.
  • injection syringes which are either provided with tamper-evident closure or whose syringe heads can be moved by retracting the piston rod after injection into the syringe barrel.
  • a combination of the known constructions is not possible.
  • WO 1997 49444 A and WO 1996 03171 show tamper-evident closures which are placed on syringe barrels which, at the proximal end, become slimmer both in the outer circumference and on the inner circumference and thus form a fluid channel.
  • the present invention aims to avoid the disadvantages of syringes without tamper-evident closure and syringes without syringe barrel retractable into the syringe barrel and to provide a hypodermic syringe of the kind set forth which connects the cannula to the syringe barrel only upon removal of the cap, as well allows the syringe head to move together with the cannula after use in the cylinder.
  • the invention is characterized in that a cavity is formed in the sealing insert, which is closed at the proximal side and merges at the distal side into an opening, via which a tip of the coupling part with the cavity can be coupled.
  • the sealing insert is designed so that it has both a cavity through which it can be coupled to the piston rod and thus displaced into the syringe barrel, and is closed at its proximal side by a wall. This wall ensures the sealing of the syringe barrel until the injection syringe is used.
  • the wall is pierced with the distal end of the cannula, thereby providing the required connection between the volume of the syringe barrel and the cannula.
  • the cylinder plug and the sealing insert engage each other. When retracting the cylinder plug by the piston rod, the sealing insert and the guide sleeve firmly connected to it are moved into the syringe barrel.
  • the guide sleeve carries the assembly of cannula, needle holder and drive part with it.
  • the injection syringe specified requires fewer components and is thus easier to produce and safer to handle than an injection syringe, which is connected, for example according to US Pat. No. 6 613 016 Bl, to a tamper-evident closure according to, for example, WO 1997 49444 A.
  • a preferred embodiment of the invention is characterized in that the sealing insert is formed at the proximal end of the syringe barrel so that the guide sleeve is firmly inserted into the sealing insert, for example by a coaxial, annular coupling.
  • a cavity is formed in the sealing insert, which is open to the interior of the syringe barrel so that the tip of the piston rod can engage in the cavity after the injection process in the cavity.
  • the wall is formed to the cavity of the sealing insert as a membrane, so that on the one hand, the interior of the syringe barrel is sealed, and on the other hand, the pointed distal end of the cannula can puncture this membrane.
  • the cannula is axially symmetrically held by a cannula holder, which is inserted in a straight line axially slidable in the guide sleeve.
  • the distal end of the cannula terminates prior to actuation of the tamper-evident closure, through which the protective cap is rotated and the cannula holder is moved together with the cannula in the direction of sealing insert in front of this sealing insert.
  • the distal end of the cannula is sharpened by a diagonal cut, for example by a method with anti-coring.
  • a filter cap and a filter between cannula and filter cap are arranged at the distal end of the cannula, wherein the filter is held by the filter cap over the opening of the cannula and / or the opening of the cannula holder.
  • the distal side of the filter cap has an oblique cut to pierce the sealing insert. It is advantageous if the outer circumference of the guide sleeve resembles the inner periphery of the proximal end of the syringe barrel or the inner circumference of the distal end of the protective cap or both, because then the Fuhrungsh ⁇ lse is held axially symmetrical Kippfest.
  • the substantially tubular cap has a radial predetermined breaking point, which breaks under rotation of the cap, so that the outer portion of the cap can be removed and the inner remains firmly connected to the syringe barrel.
  • the firm connection of the distal portion of the protective cap with the syringe barrel is made possible in that this portion is placed over the syringe barrel over a substantial part of its length and, for example, rests positively against it and / or is latched over a corresponding annular bead of the syringe barrel.
  • the assembly of the syringe head, minus the dimension from the proximal end of the syringe barrel, to the distal end face of the sealing insert in the axial direction is shorter than or equal to the stroke of the piston rod.
  • the cylinder stopper has a blind hole, the bottom of which is thin.
  • the coupling part Since the coupling part is to release the piston rod after retraction of the assembly of the syringe head into the syringe barrel, the distal end of the coupling part goes in Holding claws into which the piston rod via a coupling head is coupled and disengaged.
  • the syringe cylinder has an inner annular bead, so that the coupling part strikes against it when the piston rod is retracted, and the piston rod disengages from the coupling part as the train continues to pull.
  • the distal end of the piston rod is designed as an end sleeve whose inner diameter corresponds to the outer diameter of the proximal end of the portion of the protective cap firmly connected to the syringe barrel.
  • the disengaged piston rod serves as a plug for the syringe barrel.
  • FIG. 2 shows a longitudinal section through the syringe head
  • FIG. 3 shows a longitudinal section through the entire syringe before use
  • FIG. 4 shows a longitudinal section through the entire syringe after connecting the cannula
  • FIG 6 shows a longitudinal section through the entire syringe with pierced cylinder plug
  • 9 shows a longitudinal section through the entire syringe after closing the syringe barrel
  • FIG. 10 shows a longitudinal section through the syringe head.
  • the injection syringe has a syringe cylinder 7, at its proximal end an assembly comprising a sealing insert 1, a guide sleeve 2 fixedly connected thereto, with cannula holder 3, cannula 4 and rotationally displaceable drive part 5 slidably mounted therein is arranged.
  • the proximal end of the assembled syringe is closed by a protective cap 6, which is attached in a sealing manner to the syringe cylinder 7 by a sealing ring 6c.
  • a group of a cylinder plug 8 and inserted therein coupling part 9 and piston rod 10 is arranged at the distal end of the syringe barrel 7, at the distal end of the syringe barrel 7, a group of a cylinder plug 8 and inserted therein coupling part 9 and piston rod 10 is arranged.
  • Fig. 3 shows the assembled and mounted syringe containing a liquid medicament 11 in the syringe barrel 7.
  • the cap 6 is still stationary and the cannula 4 is not yet connected to the syringe barrel.
  • the coupling part 9 is inserted into a blind hole 8a, which has a bottom 8b.
  • a proximal portion 6a of the protective cap 6 is rotated, whereby its connection to a distal portion 6b of the protective cap dissolves, and the cannula 4 is moved over the needle holder 3 and the drive member 5 in the direction of sealing insert 1 in a straight line and this without particles to pierce.
  • the injection syringe is ready for use.
  • the tip 9a of the coupling part 9 according to FIG. 6 pierces the bottom 8a of the cylinder plug 8, again without producing any particles.
  • the cylinder plug 8 moves in the direction of the sealing insert 1, as a result of which the medicament exits through the cannula 4 from the injection syringe.
  • Fig. 7 the injection syringe is shown after the injection.
  • the cylinder plug 8 is placed on the sealing insert 1, and the tip 9 a of the coupling part 9 engages in the sealing insert 1 a.
  • Fig. 2 shows that the sealing insert for this purpose has a cavity Ia, which has at its distal end an opening Ib whose diameter is smaller than the diameter of the cavity Ia.
  • Fig. 8 shows how the assembly of the syringe head is drawn into the syringe barrel 7. On the piston rod 10 is pulled and the coupling part 9 moves together with the sealing insert 1 and the guide sleeve 2 firmly connected to this in the space of the syringe barrel 7.
  • Fig. 9 it is shown that the piston rod 10 can be plugged onto the proximal opening of the syringe barrel 7, which is formed for example by the distal portion 6b of the protective cap 6 and closes it.
  • the distal end of the cannula 4 m may have a straight cut instead of an oblique cut, wherein the tip piercing the sealing insert 1 is provided by a filter attachment 13 which comprises a filter 14 at the distal end of the cannula assembly 4 and cannula holder 3,
  • this alternative embodiment has the advantage of having a particle trap behind all of the components where particles may enter the drug during preparation and during injection.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (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)
EP09708432A 2008-02-07 2009-01-19 Injektionsspritze Withdrawn EP2240224A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0020308A AT505616B1 (de) 2008-02-07 2008-02-07 Injektionsspritze
PCT/AT2009/000014 WO2009097634A1 (de) 2008-02-07 2009-01-19 Injektionsspritze

Publications (1)

Publication Number Publication Date
EP2240224A1 true EP2240224A1 (de) 2010-10-20

Family

ID=40361486

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09708432A Withdrawn EP2240224A1 (de) 2008-02-07 2009-01-19 Injektionsspritze

Country Status (14)

Country Link
US (1) US8728042B2 (enExample)
EP (1) EP2240224A1 (enExample)
JP (1) JP5574983B2 (enExample)
CN (1) CN101939038B (enExample)
AT (1) AT505616B1 (enExample)
AU (1) AU2009212083B2 (enExample)
BR (1) BRPI0908416A2 (enExample)
CA (1) CA2714034A1 (enExample)
ES (1) ES2352390T1 (enExample)
IL (1) IL207371A (enExample)
MX (1) MX2010008702A (enExample)
RU (1) RU2465021C2 (enExample)
WO (1) WO2009097634A1 (enExample)
ZA (1) ZA201005628B (enExample)

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Also Published As

Publication number Publication date
CN101939038A (zh) 2011-01-05
AU2009212083A1 (en) 2009-08-13
AT505616A4 (de) 2009-03-15
RU2465021C2 (ru) 2012-10-27
JP2011510764A (ja) 2011-04-07
IL207371A0 (en) 2010-12-30
BRPI0908416A2 (pt) 2015-08-04
CN101939038B (zh) 2013-03-06
ES2352390T1 (es) 2011-02-18
RU2010137119A (ru) 2012-03-20
WO2009097634A1 (de) 2009-08-13
JP5574983B2 (ja) 2014-08-20
CA2714034A1 (en) 2009-08-13
AT505616B1 (de) 2009-03-15
US20110046561A1 (en) 2011-02-24
IL207371A (en) 2013-09-30
MX2010008702A (es) 2010-08-31
US8728042B2 (en) 2014-05-20
ZA201005628B (en) 2011-04-28
AU2009212083B2 (en) 2013-07-11

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