WO2006063172A2 - Breech loaded fixed needle syringe and automatic injection device having the same - Google Patents

Breech loaded fixed needle syringe and automatic injection device having the same Download PDF

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Publication number
WO2006063172A2
WO2006063172A2 PCT/US2005/044492 US2005044492W WO2006063172A2 WO 2006063172 A2 WO2006063172 A2 WO 2006063172A2 US 2005044492 W US2005044492 W US 2005044492W WO 2006063172 A2 WO2006063172 A2 WO 2006063172A2
Authority
WO
WIPO (PCT)
Prior art keywords
injection
syringe
piston
needle
plunger
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/US2005/044492
Other languages
English (en)
French (fr)
Other versions
WO2006063172A3 (en
WO2006063172A8 (en
Inventor
Richard David Gillespie, Iii.
Doug Owen Crow
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.)
West Pharmaceutical Services Inc
Pharma Pen Holdings Inc
Original Assignee
West Pharmaceutical Services Inc
Pharma Pen Holdings Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to BRPI0518960-8A priority Critical patent/BRPI0518960A2/pt
Priority to MX2007006975A priority patent/MX2007006975A/es
Priority to AU2005313993A priority patent/AU2005313993A1/en
Priority to CA002591420A priority patent/CA2591420A1/en
Priority to JP2007545641A priority patent/JP2008522754A/ja
Priority to EP05853420A priority patent/EP1819387A4/en
Application filed by West Pharmaceutical Services Inc, Pharma Pen Holdings Inc filed Critical West Pharmaceutical Services Inc
Publication of WO2006063172A2 publication Critical patent/WO2006063172A2/en
Publication of WO2006063172A3 publication Critical patent/WO2006063172A3/en
Priority to IL183768A priority patent/IL183768A0/en
Anticipated expiration legal-status Critical
Publication of WO2006063172A8 publication Critical patent/WO2006063172A8/en
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
    • A61M5/1782—Devices aiding filling of syringes in situ
    • 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
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/3243—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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • 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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31516—Piston or piston-rod constructions, e.g. connection of piston with piston-rod reducing dead-space in the syringe barrel after delivery
    • 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
    • A61M5/3129—Syringe barrels

Definitions

  • the present disclosure is related to fixed needle syringes. More particularly, the present disclosure is related to breech loaded fixed needle syringes and automatic injection devices having the same.
  • Fixed needle syringes typically include a needle fixed to and in fluid communication with a medicine compartment.
  • a plunger often acting on an elastomeric piston in the medicine compartment, is used fill the medicine compartment by drawing-in or aspirating (hereinafter "aspirating") drug solutions from another container such as a medicine vial or ampoule, purge any air from the medicine compartment, and expel medicine from the compartment into the tissue at the injection site.
  • aspirating aspirating
  • the needle of the syringe is inserted through a septum of a medicine vial. Then, the plunger is pulled to draw medicine from the vial into the medicine compartment of the syringe.
  • the needle in such fixed needle syringes is designed to withstand the stress imparted during insertion through the septum and designed to allow sufficient fluid flow during the aspiration process.
  • the gauge of the needle for a syringe filled at the time of use is, typically, limited by the column strength of the needle when inserting and withdrawing the needle from the medicine vial. Long, thin needles are more prone to fail in buckling while attempting to puncture the septum of the medicine vial. Thus, a fixed needle syringe filled by aspiration typically has a larger gauge needle than would otherwise be necessary to avoid needle buckling.
  • the gauge is a limiting factor in aspirating drug solutions from another container, as the flow of fluid from the medicine vial into the syringe is determined, in part, by the inner diameter and length of the needle, the viscosity of the drug solution, and the differential pressure available to cause fluid flow; the maximum pressure during aspiration being atmospheric pressure.
  • a high viscosity drug requires a larger inner diameter needle, and hence a larger gauge needle, to aspirate the drug solution from the medicine vial into the syringe within a reasonable time frame as compared to a low viscosity drug.
  • fixed needle syringes filled by aspiration typically have a larger gauge needle than would otherwise be necessary to avoid filling delays.
  • [001O]It is an object of the present disclosure to provide a user-filled fixed needle syringe having a small gauge needle.
  • a fixed needle syringe having a medicine compartment, a hypodermic needle, a plunger, and a piston.
  • the hypodermic needle is in fluid communication with the medicine compartment.
  • the piston is slideably disposed in the medicine compartment.
  • the plunger is removeably securable to the piston.
  • the plunger has a bore defined therethrough, where the bore allows access to the piston through the plunger.
  • a method of injecting a medicine includes urging medicine from a medicine supply needle into a medicine compartment of a fixed needle syringe through a hollow plunger and a piston element of the syringe; removing the hollow plunger from the piston; inserting the fixed needle syringe in a first assembly so that a hypodermic needle resides proximate a lower seal of the first assembly; and securing a second assembly to the first assembly so that a driven rod of the second assembly is proximate the piston element.
  • An injection kit is also provided.
  • the kit includes an injection assembly, a retraction assembly, and a breech loadable fixed needle syringe.
  • FIG. 1 is a sectional view of an exemplary embodiment of a fixed needle syringe according to the present disclosure
  • FIG. 2 is a partially exploded perspective view of the fixed needle syringe of FIG. 1 in use with an automatic injection device;
  • FIG. 3 is a sectional view of the fully assembled automatic injection device of FIG. 2.
  • Syrjnge 10 includes a hypodermic needle 12 in fluid communication with a medicine compartment 14.
  • syringe 10 can include a removable protective cover 16 disposed over hypodermic needle 12.
  • Syringe 10 also includes a piston 18 slideably disposed in medicine compartment 14.
  • syringe 10 includes a syringe end cap 20 at a breech end 22 of medicine compartment 14 to prevent inadvertent withdrawal of piston 18 from the medicine compartment.
  • syringe 10 is configured so that compartment 14 can be filled with medicine through piston 18.
  • hypodermic needle 12 does not need to be sized to have enough column strength to withstand the stresses associated with inserting the hypodermic needle into a medicine vial.
  • the point of hypodermic needle 12 is not at risk of dulling as a result of inserting into the medicine vial. As a result of the above, the size of hypodermic needle 12 can be reduced, while still maintaining adequate flow during injection into the patient.
  • Syringe 10 has a small inner and outer diameter hypodermic needle 12 that reduces user discomfort during needle insertion and injection.
  • hypodermic needle 12 has an inner and outer diameter that are matched to the viscosity of the medicine being injected and the column forces imposed on the hypodermic needle during injection - rather than the forces imposed on the hypodermic needle during aspiration.
  • hypodermic needle 12 has a slenderness ratio that is maximized to reduce the discomfort associated with needle insertion into the user.
  • the slenderness ratio is defined as the length in inchestRoi] of the hypodermic needle divided by outer diameter of the hypodermic needle in inches.
  • the slenderness ratio of hypodermic needle 12 is limited only by the strength needed to penetrate the tissue at the injection site.
  • Hypodermic needle 12 can have a slenderness ratio of at least about 60.
  • hypodermic needle 12 can have a slenderness ratio of up to about 120.
  • hypodermic needle 12 has a slenderness ratio of about 85.
  • hypodermic needle 12 can have a slenderness ratio of between about 60 and about 120, and any subranges therebetween.
  • hypodermic needle 12 has a flow ratio that is below a level at which medicine compartment 14 can be filled, within a practical amount of time, via aspiration through the needle.
  • the flow ratio is defined as the maximum flow rate in cubic centimeters per minute (cc/min) through the hypodermic needle during aspiration divided by the length in inches of the hypodermic needle.
  • the maximum pressure differential during aspiration is approximately 14.7 pounds per square inch at sea level.
  • a practical amount of time is less than about 30 seconds. Thus, if it takes longer than 30 seconds to fill medicine compartment 14 via aspiration, it is deemed, for the purposes of this application, impractical.
  • Hypodermic needle 12 can have a flow ratio of less than about 2.0. In some embodiments, hypodermic needle 12 can have a flow ratio of less than about 1.8. Preferably, hypodermic needle 12 has a flow ratio of less than about 1.5. Since medicine compartment 14 is not filled via aspiration through hypodermic needle 12, syringe 10 advantageously is not limited to high flow ratios and, rather, can have a flow ratio of less than about 2.0.
  • hypodermic needle 12 has a maximum flow rate during aspiration that is less than about 2 cc/min.
  • Syringe 10 includes a plunger 24 moveably disposed through an opening 26 in syringe end cap 20.
  • plunger 24 can be removably secured to piston 18.
  • piston 18 can include an internal thread 28 and plunger 24 can include a corresponding external thread 38. In this manner, threads 28, 38 can be used to selectively secure and/or un-secure plunger 24 and piston 18.
  • Plunger 24 includes a hollow or bore 30 defined therethrough.
  • bore 30 allows access to plunger 18 through rod 24.
  • bore 30 includes one or more needle guiding surfaces 32 defined therein.
  • a supply needle (not shown) that is used in lieu of the injecting hypodermic needle 12 to access the medicament solution from its supply container is inserted into bore 30, through piston 18, and into medicine compartment 14.
  • Piston 18 is made of a self-sealing, pierceable material such as that commonly used as a medicine vial septum and can include materials such as, but not limited to silicone or butyl rubber.
  • compartment 14 can be filled through piston 18 at breech end 20.
  • Surfaces 32 if present, can assist in guiding the supply needle into piston 18.
  • the supply needle (not shown) can be withdrawn from medicine compartment 14, through piston 18, and from bore 30. Any air or other gases within medicine compartment 14 can be removed by simply turning syringe 10 so that the air is proximate hypodermic needle 12 (e.g., hypodermic needle 12 is directed vertically), and depressing plunger 24 to expel the air through hypodermic needle 12.
  • the user simply removes protective cover 16, if present, inserts hypodermic needle 12 into the body, and depresses plunger 24 to inject the desired dose of medicine from compartment 14.
  • plunger 24 can include one or more gripping portions 34. Gripping portions 34 can be used to steady plunger 24 during the filling and/or use of syringelO.
  • syringe 10 In addition to being useful during manual injection discussed above, it is contemplated by the present disclosure for syringe 10 to find use with an automatic injection and retraction device 40, such as that shown in FIGS. 2 and 3.
  • Some automatic injection devices have the capability of generating more force on the piston than can be normally applied manually, making it possible to utilize a smaller hypodermic needle to effectuate the same injection flow rate as compared to what the human hand can accomplish. It has been determined by the present disclosure that this design feature is easier to exploit to the advantage of the injection recipient if the aforementioned limitations associated with drug aspiration through a small gauge hypodermic needle are removed.
  • Device 40 includes a power-injection assembly 42 and a power-retraction assembly 44 as shown in FIGS. 2 and 3. Device 40 reduces tissue damage and discomfort associated with the injection through the use of syringe 10 having hypodermic needle 12 with the smaller outer diameter as discussed above with respect to the syringe.
  • syringe 10 When use of device 40 is needed, syringe 10 can be filled in the manner discussed above. Next, plunger 24 can be removed from syringe 10 and the syringe, once the guard 16 has been removed, can be operatively disposed in device 40.
  • Device 40 is, preferably, an automatic injection apparatus that extends hypodermic needle 12 from within the device, injects a single, pre-measured dose of medicine from compartment 14 into a user, and automatically retracts the hypodermic needle into the assembly after the injection is completed.
  • Injection assembly 42 can operate substantially as disclosed in commonly owned and assigned U.S. Application Serial No. 10/601 ,212, filed June 20, 2003, the contents of which are incorporated by reference herein.
  • injection assembly 42 can be as shown in FIGS. 2 and 3.
  • injection assembly 42 includes an injection spring 46, a driven rod 48, an activation button 50, a splitter device 52, and a coupling 54.
  • Injection spring 46 is disposed about driven rod 48 between a spring retainer 49 and coupling 54, where the coupling selectively engages the injection spring to driven rod 48.
  • Activation button 50 is configured to selectively release the energy in injection spring 46 to driven rod 48.
  • driven rod 48 includes a locking end 56 and a driving end 58.
  • Driving end 58 is configured to act on piston 18 to urge medicine from compartment 14 as will be described in detail below.
  • locking end 56 includes two or more tines 60 that are resiliently biased outward so that the tines are remote from one another. Tines 60 engage a locking surface 62 on spring retainer 49 when biased from one another.
  • Activation button 50 includes a releasing surface 64. Force in the injecting direction 66 applied to activation button 50 causes releasing surface 64 to compress tines 60 toward one another such that driven rod 48 is disengaged from locking surface 62.
  • Injection spring 46 is maintained in a normally compressed or stressed condition between spring retainer 49 and coupling 54. Upon release of tines 60, the stored energy in spring 46 acts on spring retainer 49 and coupling 54 to drive driven rod 48 in an injection direction 66.
  • Injection spring 46 drives driven rod 48 in injection direction 66 until coupling 54 abuts splitter device 52.
  • the force of splitter device 52 on coupling 54 causes the coupling to disengage from driven rod 48.
  • the disengagement of coupling 54 from driven rod 48 frees the driven rod from the force of injection spring 46 and, thus, allows the driven rod to be moved in a direction opposite the injection direction 66 by power-retraction assembly 44.
  • Device 40 can be configured to inject medicine from compartment 14 intramuscularly, interoccularly, subcutaneously, and/or intradermally.
  • splitter device 52 can be secured in injection assembly 42 for movement along injection direction 66. Varying the location of splitter device 52 along injection direction 66 can change the stroke of injection assembly 42 by changing the point at which the splitter device uncouples injection spring 46 from driven rod 48.
  • injection assembly 42 includes a cap 68 disposed over activation button 50.
  • Cap 68 can mitigate inadvertent depression of activation button 50 and, thus, can prevent premature activation of injection assembly 42.
  • injection and retraction assemblies 42, 44 are secured to one another in a snap fit manner so that the assemblies cannot be removed from one another after assembly.
  • injection assembly 42 can include one or more outwardly depending tabs 68 that are received in a corresponding number of openings 70 defined in retraction assembly 44.
  • tabs 68 act on the retraction assembly to elastically deform the inner dimension of the tube. Once tabs 68 are received by openings 70, the inner dimension of retraction assembly 44 returns to its original dimension to secure the tabs in the openings.
  • injection assembly 42 and retraction assembly 44 preferably maintain compartment 14 hermetically sealed therebetween.
  • injection assembly 42 can include a sealing member 72 such as, but not limited to an o-ring. Once injection and retraction assemblies 42, 44 are secured together, sealing member 72 cooperates with the interior of the retraction assembly to form a hermetic radial seal. In the illustrated embodiment, sealing member 72 is positioned below openings 70 to provide the hermetic seal below the snap fit connection between tabs 68 and openings 70.
  • Power-retraction assembly 44 includes a second or retraction spring 74 and a lower seal 76.
  • Retraction spring 74 is substantially weaker than injection spring 46.
  • needle 12 When assembled, needle 12 is positioned proximate lower seal 76.
  • injection spring 46 overcomes the force of retraction spring 74 to compress the retraction spring and move compartment 14 in injection direction 66 so that needle 12 pierces lower seal 76 and tissue at the injection site.
  • injection spring 46 moves driving end 58 of driven rod 48 in injection direction 66 to expel medicine from compartment 14 through needle 12.
  • driven rod 48 has moved in injection direction 66 a sufficient distance for coupling 54 to contact splitter device 52, which disengages the coupling from the driven rod and terminates the influence injection spring 46 has upon the driven rod.
  • injection spring 46 is disengaged, the now compressed retraction spring 74 urges needle 12, compartment 14, and driven rod 48 in a direction opposite injection direction 66 until the needle recedes behind lower seal 76.
  • device 40 and syringe 10 can be provided in an unassembled state in a terminally sterilized kit (not shown) for assembly and use.
  • the kit can include injection assembly 42 and retraction assembly 44, as well as syringe 10.
  • the kit can also include one or more injection site cleaning swabs, such as a pre-packaged alcohol swab.
  • injection assembly 42, retraction assembly 44, and syringe 10 can be contained in a sealed package, such as a plastic or TYVEC package. In some embodiments, the package can be terminally sterilized.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Fuel-Injection Apparatus (AREA)
PCT/US2005/044492 2004-12-09 2005-12-08 Breech loaded fixed needle syringe and automatic injection device having the same Ceased WO2006063172A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
MX2007006975A MX2007006975A (es) 2004-12-09 2005-12-08 Jeringa con aguja fija con retrocarga y dispositivo de inyeccion automatica del mismo.
AU2005313993A AU2005313993A1 (en) 2004-12-09 2005-12-08 Breech loaded fixed needle syringe and automatic injection device having the same
CA002591420A CA2591420A1 (en) 2004-12-09 2005-12-08 Breech loaded fixed needle syringe and automatic injection device having the same
JP2007545641A JP2008522754A (ja) 2004-12-09 2005-12-08 後装式固定針シリンジ及びそれを有する自動注入装置
EP05853420A EP1819387A4 (en) 2004-12-09 2005-12-08 REAR-LOADED FIXED NEEDLE SYRINGE AND AUTOMATIC INJECTION DEVICE COMPRISING THE SAME
BRPI0518960-8A BRPI0518960A2 (pt) 2004-12-09 2005-12-08 seringa de agulha fixa carregada por culatra e dispositivo de injeÇço automÁtica possuindo a mesma
IL183768A IL183768A0 (en) 2004-12-09 2007-06-07 Breech loaded fixed needle syringe and automatic injection device having the same

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US60/634,486 2004-12-09

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EP (3) EP1819387A4 (enExample)
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EP1819380B1 (en) 2018-04-04
CN101484198A (zh) 2009-07-15
IL183768A0 (en) 2007-09-20
EP1819386A4 (en) 2010-05-26
WO2006063172A3 (en) 2006-07-27
US20060178642A1 (en) 2006-08-10
CN101146562A (zh) 2008-03-19
MX2007006973A (es) 2007-08-15
US7674246B2 (en) 2010-03-09
US20060178631A1 (en) 2006-08-10
EP1819387A2 (en) 2007-08-22
WO2006063124A3 (en) 2007-08-23
CA2590281A1 (en) 2006-06-15
EP1819380A4 (en) 2012-05-30
WO2006063123A2 (en) 2006-06-15
EP1819387A4 (en) 2011-11-02
WO2006063124A2 (en) 2006-06-15
CA2591278A1 (en) 2006-06-15
JP5198072B2 (ja) 2013-05-15
MX2007006975A (es) 2007-08-15
JP2008522750A (ja) 2008-07-03
BRPI0518978A2 (pt) 2008-12-16
CN101180090B (zh) 2011-06-29
CN101180090A (zh) 2008-05-14
EP1819386A2 (en) 2007-08-22
JP2008522754A (ja) 2008-07-03
CA2591420A1 (en) 2006-06-15
JP4588072B2 (ja) 2010-11-24
EP1819380A2 (en) 2007-08-22
JP2008522751A (ja) 2008-07-03
IL183766A0 (en) 2007-09-20
WO2006063172A8 (en) 2010-03-04
US7758548B2 (en) 2010-07-20
AU2005314035A1 (en) 2006-06-15
BRPI0518961A2 (pt) 2008-12-16
AU2005313993A1 (en) 2006-06-15
EP1819386B1 (en) 2014-09-03
IL183767A0 (en) 2007-09-20
BRPI0518960A2 (pt) 2008-12-16
MX2007006974A (es) 2007-10-11
US20060178629A1 (en) 2006-08-10
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WO2006063123A3 (en) 2006-08-17
AU2005314034A1 (en) 2006-06-15

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