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WO2003015853A1 - Ampoule pour dispositif d'injection - Google Patents

Ampoule pour dispositif d'injection Download PDF

Info

Publication number
WO2003015853A1
WO2003015853A1 PCT/DE2002/002900 DE0202900W WO03015853A1 WO 2003015853 A1 WO2003015853 A1 WO 2003015853A1 DE 0202900 W DE0202900 W DE 0202900W WO 03015853 A1 WO03015853 A1 WO 03015853A1
Authority
WO
WIPO (PCT)
Prior art keywords
ampoule
chamber
piston
hollow needle
injection
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.)
Ceased
Application number
PCT/DE2002/002900
Other languages
German (de)
English (en)
Inventor
Carsten Fründt
Peter Frey
Karl Schulz
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.)
Esteve Pharmaceuticals GmbH
Original Assignee
Riemser Arzneimittel 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 Riemser Arzneimittel AG filed Critical Riemser Arzneimittel AG
Priority to DE10293621T priority Critical patent/DE10293621D2/de
Publication of WO2003015853A1 publication Critical patent/WO2003015853A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst

Definitions

  • the invention relates to an ampoule for an injection device for the needleless injection of a medium into human or animal tissue, with an ampoule body, with a chamber arranged inside the ampoule body for receiving the medium and a longitudinally movable piston for variably limiting the volume of the chamber, with a the injection-released opening for the discharge of the medium when the piston is displaced in order to reduce the volume of the chamber, and with a nozzle for generating a high-pressure jet when the piston is displaced, the ampoule body having a coupling at one end for positive connection with the injection device and has at its other end the opening opened during the injection.
  • the invention relates to an injection device with an ampoule which can be positively connected to a base body for needleless injection of a medium into a human or animal tissue, with a chamber arranged in an ampoule body and having an opening, with a piston for reducing the volume of the chamber, with a in the base body, which is guided in a longitudinally displaceable manner and is prestressed by a spring element against a holding element, with a trigger for moving the holding element from a first position holding the pressure piece into a second position releasing the movement of the pressure piece, and with coupling means for moving the piston at one Movement of the pressure piece.
  • Such an injection device with such an ampoule is known from DE 199 55 201 AI and WO 98/15307.
  • the ampoule body is designed as a plastic or glass component.
  • the piston is designed as a plunger and penetrates one end into the ampoule body.
  • the opening with the nozzle is arranged.
  • the pressure piece in the base body has a support surface.
  • the trigger is actuated, the pressure piece comes against the end of the plunger protruding from the ampoule body by the force of the spring element and presses it into the chamber.
  • a high-pressure jet is generated at the nozzle, which penetrates into the subcutaneous tissue when the injection device with the nozzle is applied to the skin of a human or an animal.
  • the opening has a nozzle for generating the high-pressure jet and a channel connecting the chamber to the nozzle.
  • the ampoule is filled with the medium to be injected immediately before the injection.
  • a pre-filling of the ampoule with the medium to be injected is only possible with difficulty since the plunger plunger can be accidentally moved during handling when the ampoule is separated from the base body and the medium to be injected can escape from the opening if the ampoule is stored for a long period of time.
  • the invention is based on the problem of designing an ampoule of the type mentioned at the outset in such a way that it enables prefilling and simple permanent storage of the ampoule with the medium to be injected. Furthermore, an injection device of the type mentioned at the outset is to be created in which the base body can be permanently stored separately from the pre-filled ampoule.
  • the first-mentioned problem is solved according to the invention in that a stopper is arranged inside the chamber in the region of the opening and that the stopper closes the chamber in a storable state and a hollow needle immediately before the injection through the stopper to produce a connector connecting the chamber with the nozzle Channel and thus to create the opening or that the hollow needle penetrates the plug in the storable state and a cover of the hollow needle can be removed immediately before the injection to release the nozzle.
  • the stopper can, for example, close the ampoule according to the invention when it is ready for storage, so that the channel leading to the nozzle is only generated shortly before the injection.
  • no medium can escape from the chamber during storage of an already filled ampoule.
  • no air can enter the chamber via the nozzle, so that the ampoule according to the invention can be stored permanently in the pre-filled state.
  • the stopper can form a stop for the piston. As a result, impacts of the piston on the ampoule body can be damped and the remaining amount of the medium to be injected after the injection can be kept to a minimum.
  • the stopper is preferably made of a rubber-elastic material.
  • the ampoule according to the invention is stored either with a closed stopper or with a stopper penetrated by the hollow needle when the hollow needle is covered. Immediately before the injection, according to the invention, either the stopper is pierced with the hollow needle or the cover is removed from the hollow needle and thus the opening for the outlet of the medium is released.
  • the ampoule according to the preamble of claim 1 has particularly small dimensions if the piston is arranged completely inside the ampoule body. This prevents the piston from moving during storage, as in the known ampoules, and the medium to be injected being expelled from the chamber or air being sucked into the chamber.
  • the ampoule according to the invention can be made particularly short by a corresponding choice of the ratio of the diameter to the length of the chamber.
  • Contamination of the medium to be injected by the ampoule according to the invention can easily be avoided if the hollow needle is made of stainless steel.
  • the hollow needle facing away from the chamber is designed as a nozzle.
  • the hollow needle can be made of the same material as the needles of pre-filled syringes with a needle known from practice.
  • the generation of the channel connecting the chamber to the opening is particularly simple if an adapter can be connected to the ampoule body with the hollow needle for piercing the stopper before the high-pressure jet is generated.
  • the preparation of the ampoule according to the invention for injection requires particularly little effort, when the hollow needle completely penetrates the adapter.
  • the plug is pierced when the adapter is connected to the ampoule body, and the nozzle is simultaneously mounted.
  • the channel leading through the plug is created automatically when the piston moves, when the plug is at a distance from the hollow needle and when the hollow needle is attached to the ampoule body. This further reduces the risk of air entering the chamber.
  • the ampoule according to the invention can be produced from particularly inexpensive materials and at the same time in a pressure-stable and medium-appropriate manner if the ampoule body has a cylinder which laterally delimits the chamber and a sleeve which surrounds the jacket of the cylinder. As a result, all components in contact with the medium to be injected can be manufactured from a high-quality material, while the sleeve can be manufactured for the intended stability.
  • an adapter to be assembled before the injection can be avoided if the sleeve covers a free end of the cylinder in the region of the opening and has the hollow needle.
  • the ampoule body can be manufactured particularly inexpensively if the cylinder is made of glass and the sleeve is made of plastic.
  • the nozzle can be closed by a cap and if the cap and the ampoule body have means for their positive connection.
  • the cap also serves as a closure in order to prevent the medium from undesirably escaping from the chamber.
  • the nozzle can also be covered with an adhesive film.
  • Sealing the opening in the ampoule according to the invention, which is supported with a pierced stopper, is particularly simple if the cap, when connected to the ampoule body, has a needle penetrating the opening.
  • the ampoule body has an edge or a thread for connection to the cap or the adapter.
  • the plunger is difficult to access from the outside when handling the ampoule according to the invention and can therefore not be inadvertently shifted if an edge of the ampoule body pointing away from the chamber projects laterally beyond the plunger.
  • the ampoule according to the invention enables reliable movement of the plunger if the ampoule body has an insertion funnel at its end close to the plunger. This allows the piston to be easily moved by a plunger.
  • the second-mentioned problem namely the creation of an injection device of the type mentioned at the outset, in which the base body can be permanently stored separately from the prefilled ampoule, is invented thereby solved when the coupling means have a plunger arranged on the pressure piece and when the piston is arranged completely inside the ampoule.
  • the ampoule can be made particularly compact and stored without the risk of undesired movement of the piston.
  • the pre-filled ampoule can therefore be stored separately from the base body and connected to the base body immediately before the injection.
  • Pre-filled ampoules can also be used in this way both in the case of an injection device provided for single injection and in the case of an injection device provided for repeated use.
  • the pressure piece arrives at the piston with an intended pulse if the free end of the plunger is at a distance from the piston when the ampoule is assembled with the base body.
  • a reliable contact of the tappet on the piston during the generation of the pressure jet can be ensured if the tappet has a larger diameter at its free end than in its central region.
  • the piston is reliably prevented from sticking to the ampoule body if the coupling means have means for moving the piston when the ampoule is mounted on the base body.
  • the plunger has corresponding dimensions so that when the ampoule is mounted on the base body it comes against the piston and pushes it into the chamber by a small amount.
  • Fig.l an ampoule according to the invention before assembly on a base body in longitudinal section
  • FIG. 2 shows a greatly enlarged illustration of a free end of the ampoule from FIG. 1 before an injection in longitudinal section.
  • FIG. 3 shows a further embodiment of the ampoule according to the invention in longitudinal section before assembly on the base body
  • FIG. 4 shows a further embodiment of the ampoule according to the invention in longitudinal section before assembly on the base body
  • FIG. 1 shows an ampoule 2 of an injection device that can be connected to a base body 1.
  • the base body 1 has a pressure piece 5 biased by a spring element 3 against a holding element 4.
  • the pressure piece 5 is held in the base body 1 so as to be longitudinally displaceable.
  • the holding element 4 is mounted by means of a trigger 6 from a first position in which the pressure piece 5 is held against the force of the spring element 3 in its position shown, in a second position in which the movement of the pressure piece 5 is released.
  • a plunger 7 is arranged on the pressure piece 5, which has a larger diameter at its free end than at its central region.
  • the ampoule 2 has an ampoule body 8 with a chamber 9 for receiving a medium to be injected and one longitudinally displaceable piston 10 for delimiting the chamber
  • the ampoule body 8 also has a cylinder 11 made of glass and a sleeve 12 made of plastic which surrounds the jacket of the cylinder 11.
  • the sleeve 12 is biased against the cylinder 11 and supports forces acting on the cylinder 11. On his the piston
  • the plug 13 has a shape corresponding to the piston 10 and is penetrated by a hollow needle 14 arranged on the sleeve 12.
  • a cap 15 locked with the sleeve 12 covers a free end of the hollow needle 14.
  • FIG. 2 shows in a greatly enlarged illustration of the free end of the ampoule 2 from FIG. 1, the hollow needle 14 forms a channel 17 connecting the chamber 9 with a nozzle 16.
  • the cap 15 from FIG. 1 is not shown.
  • the end of the hollow needle 14 facing away from the chamber 9 is designed as a nozzle 16.
  • the hollow needle 14 forms an opening for the chamber 9 for the exit of a high-pressure jet during the injection of the medium in the chamber 9 into a subcutaneous tissue of a human or an animal.
  • the hollow needle 14 is fastened in an end of the sleeve 12 covering the cylinder 11.
  • the sleeve 12 has a vent hole 18.
  • the vent hole 18 can, of course, deviate from the direction shown to the outer surface of the sleeve 12.
  • the ampoule 2 can be filled and stored in the state shown in FIG. 1 with the medium to be injected.
  • the ampoule 2 is connected to the base body 1.
  • the base body 1 and the ampoule 2 have a thread 19.
  • the trigger 6 is held Circlip 20 and cap 15 removed.
  • the injection device is fully assembled.
  • the injection device with the nozzle 16 is then placed on the skin of humans or animals and the trigger 6 is depressed.
  • the pressure piece 5 comes against the piston 10 by the force of the spring element 3.
  • the piston 10 reduces the volume of the chamber 9, so that the medium is introduced into the subcutaneous tissue through the skin via the hollow needle 14 through the nozzle 16 as a high-pressure jet.
  • FIG. 3 shows a further embodiment of the ampoule 2, in which the stopper 13 is at a distance from the hollow needle 14.
  • the ampoule 2 is shown here in the filled and storable state.
  • the free end of the plunger 7 comes against the piston 10 of the ampoule 2 and moves it into the chamber 9.
  • a force is transmitted to the plug 13 via the medium and the latter is pushed against the hollow needle 14.
  • the hollow needle 14 penetrates the plug 13 and establishes the connection of the chamber 9 with the nozzle 16 designed as in the embodiment according to FIGS. 1 and 2.
  • this embodiment is constructed as shown in Figures 1 and 2. What is essential in contrast to the embodiment according to FIGS. 1 and 2 in this embodiment is that the plug 13 is closed when the ampoule 2 is stored in the filled state and is only pierced when the ampoule 2 is mounted on the base body 1.
  • FIG. 4 shows a further embodiment of the ampoule 2, in which the hollow needle 14 is arranged on an adapter 21.
  • the adapter 21 carries the nozzle 16 shown in FIG. 2.
  • the plug 13 is pierced and the Connection of the chamber 9 with the nozzle 16 via the hollow needle 14.
  • the adapter 21 and the ampoule body 8 have a thread 22 for their positive connection.
  • the ampoule 2 can be stored prefilled with the plug 13 closed. The plug 13 is therefore only pierced immediately before the injection.

Landscapes

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

Abstract

L'invention concerne une ampoule (2) destinée à un dispositif d'injection permettant d'injecter sans aiguille un fluide dans un tissu humain ou animal. Selon l'invention, un bouchon (13) est placé à l'intérieur d'une chambre (9) contenant le fluide. Lors de l'injection, ce bouchon (13) est percé par une canule (14). L'ampoule (2) peut être stockée remplie de fluide.
PCT/DE2002/002900 2001-08-07 2002-08-07 Ampoule pour dispositif d'injection Ceased WO2003015853A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE10293621T DE10293621D2 (de) 2001-08-07 2002-08-07 Ampulle für eine Injektionseinrichtung

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10137962.5 2001-08-07
DE2001137962 DE10137962A1 (de) 2001-08-07 2001-08-07 Ampulle für eine Injektionseinrichtung

Publications (1)

Publication Number Publication Date
WO2003015853A1 true WO2003015853A1 (fr) 2003-02-27

Family

ID=7694168

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE2002/002900 Ceased WO2003015853A1 (fr) 2001-08-07 2002-08-07 Ampoule pour dispositif d'injection

Country Status (2)

Country Link
DE (2) DE10137962A1 (fr)
WO (1) WO2003015853A1 (fr)

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008098860A1 (fr) * 2007-02-14 2008-08-21 Shl Medical Ab Contenant pour dispositif médical
CN102488944A (zh) * 2011-12-06 2012-06-13 广东康尔美医疗器械有限公司 一种无针注射器
US8277414B2 (en) 2004-05-28 2012-10-02 Cilag Gmbh International Injection device
US8313465B2 (en) 2004-05-28 2012-11-20 Cilag Gmbh International Injection device
US8313464B2 (en) 2004-05-28 2012-11-20 Cilag Gmbh International Injection device
US8317751B2 (en) 2005-04-06 2012-11-27 Cilag Gmbh International Injection device
US8343110B2 (en) 2004-05-28 2013-01-01 Cilag Gmbh International Injection device
US8366669B2 (en) 2005-04-06 2013-02-05 Cilag Gmbh International Injection device
US8834419B2 (en) 2008-06-19 2014-09-16 Cilag Gmbh International Reusable auto-injector
US8845594B2 (en) 2008-06-19 2014-09-30 Cilag Gmbh International Auto-injector with filling means
US8920365B2 (en) 2006-01-31 2014-12-30 Novo Nordisk A/S Seal for a prefilled medical jet injection device
US8939958B2 (en) 2008-06-19 2015-01-27 Cilag Gmbh International Fluid transfer assembly for a syringe
US8968236B2 (en) 2005-04-06 2015-03-03 Cilag Gmbh International Injection device
US9028453B2 (en) 2008-06-19 2015-05-12 Cilag Gmbh International Reusable auto-injector
US9028451B2 (en) 2006-06-01 2015-05-12 Cilag Gmbh International Injection device
US9072833B2 (en) 2006-06-01 2015-07-07 Cilag Gmbh International Injection device
US9358346B2 (en) 2005-08-30 2016-06-07 Cilag Gmbh International Needle assembly for a prefilled syringe system
CN105833393A (zh) * 2016-05-11 2016-08-10 内蒙古华希生物科技有限公司 无针注射犬病毒疫苗系统与应用
US9649441B2 (en) 2005-04-06 2017-05-16 Cilag Gmbh International Injection device (bayonet cap removal)
US9675757B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9675758B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9682194B2 (en) 2008-06-19 2017-06-20 Cilag Gmbh International Re-useable auto-injector with filling means
US9731080B2 (en) 2005-04-06 2017-08-15 Cilag Gmbh International Injection device
US9757520B2 (en) 2006-06-01 2017-09-12 Cilag Gmbh International Injection device
US9770558B2 (en) 2005-09-27 2017-09-26 Cilag Gmbh International Auto-injection device with needle protecting cap having outer and inner sleeves
US9895493B2 (en) 2004-05-28 2018-02-20 Cilag Gmbh International Injection device
US10709849B2 (en) 2013-06-11 2020-07-14 Cilag Gmbh International Guide for an injection device
US10799646B2 (en) 2013-06-11 2020-10-13 Cilag Gmbh International Injection device
US11123492B2 (en) 2013-06-11 2021-09-21 Cilag Gmbh International Injection device
US11173255B2 (en) 2013-06-11 2021-11-16 Cilag Gmbh International Injection device

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JP4658957B2 (ja) 2003-11-27 2011-03-23 ノボ・ノルデイスク・エー／エス ジェット式供給装置用衝撃チャンバ
GB2414403B (en) * 2004-05-28 2009-01-07 Cilag Ag Int Injection device
WO2007122193A1 (fr) * 2006-04-21 2007-11-01 Novo Nordisk A/S dispositif d'injection PAR jet À deux STADES
GB2503028B (en) 2012-06-15 2018-10-24 Consort Medical Plc Valved container assembly
CN111372630B (zh) * 2017-11-21 2023-05-26 赛诺菲 用于至少第一可注射药剂的容器和注射装置

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WO1998015307A1 (fr) 1996-10-09 1998-04-16 Equidyne Systems,Inc. Pistolet a injection hypodermique
US5954689A (en) * 1996-12-20 1999-09-21 Novo Nordisk A/S Jet injector
FR2775603A1 (fr) * 1998-03-03 1999-09-10 Tino Dalto Dispositif d'injection sous cutanee sans aiguille a pulverisation
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WO2000033899A1 (fr) * 1998-12-08 2000-06-15 Bioject, Inc. Seringue sans aiguille a cartouche pre-remplie
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Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8343110B2 (en) 2004-05-28 2013-01-01 Cilag Gmbh International Injection device
US9675758B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US8277414B2 (en) 2004-05-28 2012-10-02 Cilag Gmbh International Injection device
US8313465B2 (en) 2004-05-28 2012-11-20 Cilag Gmbh International Injection device
US8313464B2 (en) 2004-05-28 2012-11-20 Cilag Gmbh International Injection device
US9675757B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9895493B2 (en) 2004-05-28 2018-02-20 Cilag Gmbh International Injection device
US8366669B2 (en) 2005-04-06 2013-02-05 Cilag Gmbh International Injection device
US9731080B2 (en) 2005-04-06 2017-08-15 Cilag Gmbh International Injection device
US8968236B2 (en) 2005-04-06 2015-03-03 Cilag Gmbh International Injection device
US8317751B2 (en) 2005-04-06 2012-11-27 Cilag Gmbh International Injection device
US9649441B2 (en) 2005-04-06 2017-05-16 Cilag Gmbh International Injection device (bayonet cap removal)
US9358346B2 (en) 2005-08-30 2016-06-07 Cilag Gmbh International Needle assembly for a prefilled syringe system
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