WO2010033808A2 - Medical injector with post-autoreconstitution dose setting and autoplunger drive - Google Patents

Medical injector with post-autoreconstitution dose setting and autoplunger drive Download PDF

Info

Publication number
WO2010033808A2
WO2010033808A2 PCT/US2009/057485 US2009057485W WO2010033808A2 WO 2010033808 A2 WO2010033808 A2 WO 2010033808A2 US 2009057485 W US2009057485 W US 2009057485W WO 2010033808 A2 WO2010033808 A2 WO 2010033808A2
Authority
WO
WIPO (PCT)
Prior art keywords
plunger
state
stopper
spring
medical injector
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/US2009/057485
Other languages
English (en)
French (fr)
Other versions
WO2010033808A3 (en
Inventor
Richard A. Cronenberg
Asif Fayyaz
Atul Patel
Lionel Vedrine
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to US13/119,266 priority Critical patent/US8500682B2/en
Priority to ES09815269.7T priority patent/ES2619526T3/es
Priority to EP09815269.7A priority patent/EP2328640B1/en
Priority to CN2009801415112A priority patent/CN102186520B/zh
Priority to JP2011527999A priority patent/JP2012502765A/ja
Publication of WO2010033808A2 publication Critical patent/WO2010033808A2/en
Publication of WO2010033808A3 publication Critical patent/WO2010033808A3/en
Anticipated expiration legal-status Critical
Priority to US13/916,101 priority patent/US10034980B2/en
Ceased 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
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/3129Syringe barrels
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3156Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals

Definitions

  • Certain drugs or medicaments are preferably provided in powder or dry form (such as a lyophilized form), and require reconstitution prior to administration.
  • Lyophilized drugs typically are supplied in a freeze-dried form that needs to be mixed with a diluent to reconstitute the substance into a form that is suitable for injection.
  • Medicaments may also be provided in other dry or powder form that require reconstitution.
  • drugs may be provided as multipart systems which require mixing prior to administration.
  • one or more liquid (e.g., flowable (slurry or liquid)) components, and/or dry (e.g., powdered or granular) components may be provided in a drug container or delivery device which require mixing prior to administration.
  • the components can be mixed and used to form various administratable drugs, such as insulin.
  • a medical injector having a body; a reservoir containing first and second mixable components, a stopper associated with the reservoir, a predetermined extent of advancement of the stopper causing mixing of the first and second mixable components; a displaceable plunger disposed in the body; a spring disposed to advance the plunger; a first releasable retainer for releasably retaining the plunger in a first state against force of the spring; a first trigger for causing the first releasable retainer to release the plunger; a second releasable retainer for releasably retaining the plunger in a second state against force of the spring; and, a second trigger for causing the second releasable retainer to release the plunger.
  • Figure 1 is a perspective view of a medical injector formed in accordance with the subject invention
  • One or more by-pass channels 46 are formed in the wall of the reservoir 34.
  • the secondary stopper 38 is located at least partially proximally of the by-pass channels 46 so as to define a seal between the first and second chambers 40, 42 and to define a seal between the second chamber 42 and the by-pass channels 46.
  • the second chamber 42 comes into communication with the by-pass channels 46, thus allowing the second mixable component 30 to be urged into the first chamber 40 with further distal movement of the stopper 36.
  • the second chamber 42 is collapsed with none or substantially none of the second mixable component 32 remaining therein.
  • the secondary stopper 38 is located so as to define a seal between the first chamber 40 and the by -pass channels 46.
  • the first and second mixable components 30, 32 are mixed within the first chamber 40, such as through agitation of the medical injector 10, so as to produce an injectable solution, ready for injection.
  • a trigger 60 may be slidably disposed in the body 24, and the plunger 58 may include one or more deflectable latch tabs 62.
  • the latch tabs 62 In the initial first state of Figure 2, the latch tabs 62 have free ends 64 which interferingly engage ledges 66. Interengagement between the latch tabs 66 and the ledges 66 retains the plunger 58 in the first state against force of movement of the spring 56.
  • the trigger 60 includes one or more arms 68 which define a smaller diameter than the latch tabs 62. With sufficient distal advancement of the trigger 60, e.g. being caused by force being applied to proximal end 70 thereof, the arms 68 engage the latch tabs 62 and cause inward deflection thereof. With inward deflection of the latch tabs 62, the spring 56 is free to drive the plunger 58 distally and engage the stopper 36 in causing autoreconstitution.
  • the stop member 78 is axially spaced from the stop block 72.
  • the plunger 58 With the plunger 58 being released from the first state, the plunger 58 axially advances with the plunger stem 76 passing through the opening 74. During this movement, the plunger 58 advances the stopper 36 at least a sufficient distance to achieve reconstitution.
  • the stop block 72 is initially in the blocking state. Eventual distal advancement of the plunger 58 causes the stop member 78 to engage the stop block 72, as shown in Figure 3. The point of engagement between the stop member 78 and the stop block 72 is reached prior to the entire predetermined extent of movement of the plunger 58 for which the spring 56 is configured.
  • This secondary distal advancement may assist in priming a needle for use. It is preferred that autoreconstitution be completed prior to the stop member 78 coming into engagement with the stop block 72. With subsequent mounting of the needle 12 onto the medical injector 10, the reservoir 34 is vented, thus reducing the trapped volume therein. This permits the stopper 36 to be further advanced under force of movement of the spring 56 till trapped gases are purged. It is preferred that the stop member 78 come into engagement with the stop block 72 upon this secondary distal advancement.

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)
PCT/US2009/057485 2008-09-18 2009-09-18 Medical injector with post-autoreconstitution dose setting and autoplunger drive Ceased WO2010033808A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US13/119,266 US8500682B2 (en) 2008-09-18 2009-09-18 Medical injector with post-autoreconstitution dose setting and autoplunger drive
ES09815269.7T ES2619526T3 (es) 2008-09-18 2009-09-18 Inyector médico con un ajuste de dosis de post-autorreconstitución y el accionamiento del autoémbolo
EP09815269.7A EP2328640B1 (en) 2008-09-18 2009-09-18 Medical injector with post-autoreconstitution dose setting and autoplunger drive
CN2009801415112A CN102186520B (zh) 2008-09-18 2009-09-18 具有自动重构后剂量设置和自动柱塞驱动的医用注射装置
JP2011527999A JP2012502765A (ja) 2008-09-18 2009-09-18 自動再構成後の投与量設定および自動プランジャー駆動を有する医療用注射器
US13/916,101 US10034980B2 (en) 2008-09-18 2013-06-12 Medical injector with post-autoreconstitution dose setting and autoplunger drive

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US19246708P 2008-09-18 2008-09-18
US19238908P 2008-09-18 2008-09-18
US61/192,467 2008-09-18
US61/192,389 2008-09-18

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US13/119,266 A-371-Of-International US8500682B2 (en) 2008-09-18 2009-09-18 Medical injector with post-autoreconstitution dose setting and autoplunger drive
US13/916,101 Continuation US10034980B2 (en) 2008-09-18 2013-06-12 Medical injector with post-autoreconstitution dose setting and autoplunger drive

Publications (2)

Publication Number Publication Date
WO2010033808A2 true WO2010033808A2 (en) 2010-03-25
WO2010033808A3 WO2010033808A3 (en) 2010-07-01

Family

ID=42040160

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/057485 Ceased WO2010033808A2 (en) 2008-09-18 2009-09-18 Medical injector with post-autoreconstitution dose setting and autoplunger drive

Country Status (6)

Country Link
US (2) US8500682B2 (enExample)
EP (1) EP2328640B1 (enExample)
JP (1) JP2012502765A (enExample)
CN (1) CN102186520B (enExample)
ES (1) ES2619526T3 (enExample)
WO (1) WO2010033808A2 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2646085B1 (en) 2010-12-02 2019-07-10 Oval Medical Technologies Limited A drive assembly for an autoinjector and a method of assembling an autoinjector
US10500346B2 (en) 2013-09-03 2019-12-10 Sanofi Assembly for a drug delivery device

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010033790A2 (en) * 2008-09-18 2010-03-25 Becton, Dickinson And Company Medical injector with rotatable body portions
PL3545987T3 (pl) * 2008-09-18 2021-08-02 Becton, Dickinson And Company Iniektor medyczny ze sprzężonymi częściami korpusu
CN102665802B (zh) * 2009-10-26 2014-06-25 Shl集团有限责任公司 药剂输送装置
US20150217058A1 (en) 2012-09-24 2015-08-06 Enable Injections, Llc Medical vial and injector assemblies and methods of use
WO2014204894A2 (en) 2013-06-18 2014-12-24 Enable Injections, Llc Vial transfer and injection apparatus and method
USD866757S1 (en) * 2016-03-11 2019-11-12 Millennium Pharmaceuticals, Inc. Autoinjector
CN110809484B (zh) * 2017-06-29 2022-07-12 阿森迪斯药物股份有限公司 具有重构处理支承件的自动注射器
DE102019200563A1 (de) * 2019-01-17 2020-07-23 Lts Lohmann Therapie-Systeme Ag Applikator

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US4689042A (en) * 1985-05-20 1987-08-25 Survival Technology, Inc. Automatic medicament ingredient mixing and injecting apparatus
US5584815A (en) 1993-04-02 1996-12-17 Eli Lilly And Company Multi-cartridge medication injection device
FR2741810B1 (fr) * 1995-11-30 1998-02-20 Soc Et Et D Applic Tech Sedat Seringue pour l'injection d'un melange extemporane
US6203530B1 (en) * 1997-01-28 2001-03-20 Pos-T-Vac, Inc. Auto-injection device
US6096002A (en) * 1998-11-18 2000-08-01 Bioject, Inc. NGAS powered self-resetting needle-less hypodermic jet injection apparatus and method
ATE308354T1 (de) * 1999-04-16 2005-11-15 Becton Dickinson Co Stiftförmiger injektor mit merkmalen zur automatischen substanzkombination
US7621887B2 (en) 2000-10-10 2009-11-24 Meridian Medical Technologies, Inc. Wet/dry automatic injector assembly
DE10129585A1 (de) 2001-06-20 2003-01-09 Disetronic Licensing Ag Vorrichtung für eine dosierte Verabreichung eines injizierbaren Produkts
US8092420B2 (en) * 2004-11-24 2012-01-10 Becton, Dickinson And Company Automatic reconstitution injector device
BRPI0607012A2 (pt) * 2005-01-25 2009-12-01 Novo Nordisk As dispositivo de injeção
US7407494B2 (en) * 2005-01-31 2008-08-05 Bostroem Anders Device for delivering medicament
US8251947B2 (en) * 2006-05-03 2012-08-28 Antares Pharma, Inc. Two-stage reconstituting injector

Non-Patent Citations (2)

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None
See also references of EP2328640A4

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2646085B1 (en) 2010-12-02 2019-07-10 Oval Medical Technologies Limited A drive assembly for an autoinjector and a method of assembling an autoinjector
US10500346B2 (en) 2013-09-03 2019-12-10 Sanofi Assembly for a drug delivery device

Also Published As

Publication number Publication date
CN102186520A (zh) 2011-09-14
ES2619526T3 (es) 2017-06-26
US20120041367A1 (en) 2012-02-16
US20170113003A9 (en) 2017-04-27
EP2328640A2 (en) 2011-06-08
US10034980B2 (en) 2018-07-31
CN102186520B (zh) 2013-12-11
EP2328640A4 (en) 2013-05-01
US20130274706A1 (en) 2013-10-17
EP2328640B1 (en) 2016-12-21
JP2012502765A (ja) 2012-02-02
US8500682B2 (en) 2013-08-06
WO2010033808A3 (en) 2010-07-01

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