US20060178642A1 - 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 PDFInfo
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- US20060178642A1 US20060178642A1 US11/297,159 US29715905A US2006178642A1 US 20060178642 A1 US20060178642 A1 US 20060178642A1 US 29715905 A US29715905 A US 29715905A US 2006178642 A1 US2006178642 A1 US 2006178642A1
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- needle
- piston
- medicine
- injection
- syringe
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- 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
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- 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.
- 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 amount of pain and/or discomfort associated with injection of a medicine is, at least in part, dependent upon the size or gauge (“gauge”) of the needle.
- gauge the size or gauge
- 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.
- 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.
- 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 .
- Syringe 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 is limited by the forces imposed on hypodermic needle 12 during aspiration.
- syringe 10 disassociates the forces imposed on hypodermic needle 12 during aspiration from those imposed during injection. By doing so, the size of hypodermic needle can be reduced.
- 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.
- 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 inches[ RG1] 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 syringe 10 .
- 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 Ser. No. 10/601,212, filed Jun. 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.
Abstract
Description
- This application claims priority of U.S. Provisional Application Ser. No. 60/634,486 filed on Dec. 9, 2004 and is related to commonly owned and assigned U.S. application Ser. No. 10/601,212, filed Jun. 20, 2003, the contents of both of which are incorporated by reference herein.
- 1. Field of the Invention
- 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.
- 2. Description of Related Art
- 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.
- During the aspiration process, 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. Thus, 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 amount of pain and/or discomfort associated with injection of a medicine is, at least in part, dependent upon the size or gauge (“gauge”) of the needle. Unfortunately, the larger the needle gauge, the greater the damage to tissue at the injection site and more pain inflicted upon the person receiving the injection.
- 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.
- Further, 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. Again, fixed needle syringes filled by aspiration typically have a larger gauge needle than would otherwise be necessary to avoid filling delays.
- Many medicines can be injected using automatic injection devices having a fixed needle syringe therein. Typical automatic injection devices allow the medically untrained user to automatically inject a medicine by manually trigging the automatic injection. Some prior automatic injection devices also automatically retract the needle after injection.
- Accordingly, it has been determined by the present application that there is a continuing need for fixed needle syringes and automatic injection devices that overcome or mitigate the aforementioned and other deleterious effects of prior devices.
- It is an object of the present disclosure to provide a user-filled fixed needle syringe having a small gauge needle.
- It is another object to provide a fixed needle syringe that can be loaded with fluid medicament without the need to aspirate the medicament through the same needle that is later used to penetrate the tissue and provide a conduit for flow into the injection site.
- It is another object to provide a fixed needle syringe that removes the size limitations on the hypodermic needle associated with the dual use of the hypodermic needle of the prior art, i.e. the prior art's requirement for the same needle to be used as a conduit from the original medicine vial into the fixed needle syringe and also from the fixed needle syringe into the recipient of the injection.
- It is a further object to provide a breech loadable medicine cartridge having a movable piston with a threaded inner area and a pierceable membrane.
- It is a further object to provide a fixed needle syringe having a moveable piston with a self-sealing, pierceable membrane.
- It is still a further object to provide a medicine cartridge having a syringe guide removeably connectable to a movable piston, where the syringe guide has an inner diameter that receives a hypodermic needle for penetrating the piston membrane and filling the cartridge through the membrane penetration.
- These and other objects of the present disclosure are provided by 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 is also provided. The method 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.
- The above-described and other features and advantages of the present disclosure will be appreciated and understood by those skilled in the art from the following detailed description, drawings, and appended claims.
-
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 ofFIG. 1 in use with an automatic injection device; and -
FIG. 3 is a sectional view of the fully assembled automatic injection device ofFIG. 2 . - Referring to the figures and in particular to
FIG. 1 , an exemplary embodiment of a fixedneedle syringe 10 according to the present disclosure is shown. Syringe 10 includes ahypodermic needle 12 in fluid communication with amedicine compartment 14. In some embodiments,syringe 10 can include a removableprotective cover 16 disposed overhypodermic needle 12. - Syringe 10 also includes a
piston 18 slideably disposed inmedicine compartment 14. Preferably,syringe 10 includes asyringe end cap 20 at abreech end 22 ofmedicine compartment 14 to prevent inadvertent withdrawal ofpiston 18 from the medicine compartment. - Advantageously,
syringe 10 is configured so thatcompartment 14 can be filled with medicine throughpiston 18. - It has been determined by the present disclosure that the size of the hypodermic needle is limited by the forces imposed on
hypodermic needle 12 during aspiration. Advantageously,syringe 10 disassociates the forces imposed onhypodermic needle 12 during aspiration from those imposed during injection. By doing so, the size of hypodermic needle can be reduced. - Thus,
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. In addition, the point ofhypodermic 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 ofhypodermic 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. Preferably,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. - In some embodiments,
hypodermic needle 12 has a slenderness ratio that is maximized to reduce the discomfort associated with needle insertion into the user. As used herein, the slenderness ratio is defined as the length in inches[RG1] of the hypodermic needle divided by outer diameter of the hypodermic needle in inches. Here, the slenderness ratio ofhypodermic 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. In some embodiments,hypodermic needle 12 can have a slenderness ratio of up to about 120. Preferably,hypodermic needle 12 has a slenderness ratio of about 85. Thus,hypodermic needle 12 can have a slenderness ratio of between about 60 and about 120, and any subranges therebetween. - In other embodiments,
hypodermic needle 12 has a flow ratio that is below a level at whichmedicine compartment 14 can be filled, within a practical amount of time, via aspiration through the needle. As used herein, 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. Under normal atmospheric conditions, the maximum pressure differential during aspiration is approximately 14.7 pounds per square inch at sea level. As used herein, a practical amount of time is less than about 30 seconds. Thus, if it takes longer than 30 seconds to fillmedicine 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. Sincemedicine compartment 14 is not filled via aspiration throughhypodermic 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. - For example at a flow ratio of less than about 2 and a needle length of about 1 inch,
hypodermic needle 12 has a maximum flow rate during aspiration that is less than about 2 cc/min. -
Syringe 10 includes aplunger 24 moveably disposed through anopening 26 insyringe end cap 20. In some embodiments,plunger 24 can be removably secured topiston 18. For example,piston 18 can include an internal thread 28 andplunger 24 can include a corresponding external thread 38. In this manner, threads 28, 38 can be used to selectively secure and/orun-secure plunger 24 andpiston 18. -
Plunger 24 includes a hollow or bore 30 defined therethrough. Advantageously, bore 30 allows access toplunger 18 throughrod 24. Preferably, bore 30 includes one or more needle guiding surfaces 32 defined therein. In use, a supply needle (not shown) that is used in lieu of the injectinghypodermic needle 12 to access the medicament solution from its supply container is inserted intobore 30, throughpiston 18, and intomedicine 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. - In this manner,
compartment 14 can be filled throughpiston 18 atbreech end 20.Surfaces 32, if present, can assist in guiding the supply needle intopiston 18. - Once
medicine compartment 14 is filled, the supply needle (not shown) can be withdrawn frommedicine compartment 14, throughpiston 18, and frombore 30. Any air or other gases withinmedicine compartment 14 can be removed by simply turningsyringe 10 so that the air is proximate hypodermic needle 12 (e.g.,hypodermic needle 12 is directed vertically), and depressingplunger 24 to expel the air throughhypodermic needle 12. In use, the user simply removesprotective cover 16, if present, insertshypodermic needle 12 into the body, and depressesplunger 24 to inject the desired dose of medicine fromcompartment 14. - In some embodiments,
plunger 24 can include one or moregripping portions 34. Grippingportions 34 can be used tosteady plunger 24 during the filling and/or use ofsyringe 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 andretraction device 40, such as that shown inFIGS. 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 inFIGS. 2 and 3 .Device 40 reduces tissue damage and discomfort associated with the injection through the use ofsyringe 10 havinghypodermic needle 12 with the smaller outer diameter as discussed above with respect to the syringe. - When use of
device 40 is needed,syringe 10 can be filled in the manner discussed above. Next,plunger 24 can be removed fromsyringe 10 and the syringe, once theguard 16 has been removed, can be operatively disposed indevice 40. -
Device 40 is, preferably, an automatic injection apparatus that extendshypodermic needle 12 from within the device, injects a single, pre-measured dose of medicine fromcompartment 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 Ser. No. 10/601,212, filed Jun. 20, 2003, the contents of which are incorporated by reference herein. - Alternately,
injection assembly 42 can be as shown inFIGS. 2 and 3 . Here,injection assembly 42 includes aninjection spring 46, a drivenrod 48, anactivation button 50, asplitter device 52, and acoupling 54. -
Injection spring 46 is disposed about drivenrod 48 between aspring retainer 49 andcoupling 54, where the coupling selectively engages the injection spring to drivenrod 48. -
Activation button 50 is configured to selectively release the energy ininjection spring 46 to drivenrod 48. In the illustrated embodiment, drivenrod 48 includes a lockingend 56 and a drivingend 58. Drivingend 58 is configured to act onpiston 18 to urge medicine fromcompartment 14 as will be described in detail below. - In one embodiment, locking
end 56 includes two ormore tines 60 that are resiliently biased outward so that the tines are remote from one another.Tines 60 engage a lockingsurface 62 onspring retainer 49 when biased from one another.Activation button 50 includes a releasingsurface 64. Force in the injectingdirection 66 applied toactivation button 50causes releasing surface 64 to compresstines 60 toward one another such that drivenrod 48 is disengaged from lockingsurface 62. -
Injection spring 46 is maintained in a normally compressed or stressed condition betweenspring retainer 49 andcoupling 54. Upon release oftines 60, the stored energy inspring 46 acts onspring retainer 49 andcoupling 54 to drive drivenrod 48 in aninjection direction 66. -
Injection spring 46 drives drivenrod 48 ininjection direction 66 until coupling 54 abutssplitter device 52. The force ofsplitter device 52 oncoupling 54 causes the coupling to disengage from drivenrod 48. The disengagement of coupling 54 from drivenrod 48 frees the driven rod from the force ofinjection spring 46 and, thus, allows the driven rod to be moved in a direction opposite theinjection direction 66 by power-retraction assembly 44. -
Device 40 can be configured to inject medicine fromcompartment 14 intramuscularly, interoccularly, subcutaneously, and/or intradermally. For example,splitter device 52 can be secured ininjection assembly 42 for movement alonginjection direction 66. Varying the location ofsplitter device 52 alonginjection direction 66 can change the stroke ofinjection assembly 42 by changing the point at which the splitter device uncouplesinjection spring 46 from drivenrod 48. - In the illustrated embodiment,
injection assembly 42 includes acap 68 disposed overactivation button 50.Cap 68 can mitigate inadvertent depression ofactivation button 50 and, thus, can prevent premature activation ofinjection assembly 42. - In a preferred embodiment, injection and
retraction assemblies injection assembly 42 can include one or more outwardly dependingtabs 68 that are received in a corresponding number ofopenings 70 defined inretraction assembly 44. Asinjection assembly 42 is inserted intoretraction assembly 44,tabs 68 act on the retraction assembly to elastically deform the inner dimension of the tube. Oncetabs 68 are received byopenings 70, the inner dimension ofretraction assembly 44 returns to its original dimension to secure the tabs in the openings. - In the assembled state,
injection assembly 42 andretraction assembly 44 preferably maintaincompartment 14 hermetically sealed therebetween. For example,injection assembly 42 can include a sealingmember 72 such as, but not limited to an o-ring. Once injection andretraction assemblies member 72 cooperates with the interior of the retraction assembly to form a hermetic radial seal. In the illustrated embodiment, sealingmember 72 is positioned belowopenings 70 to provide the hermetic seal below the snap fit connection betweentabs 68 andopenings 70. - Power-
retraction assembly 44 includes a second orretraction spring 74 and alower seal 76.Retraction spring 74 is substantially weaker thaninjection spring 46. When assembled,needle 12 is positioned proximatelower seal 76. During use,injection spring 46 overcomes the force ofretraction spring 74 to compress the retraction spring and movecompartment 14 ininjection direction 66 so thatneedle 12 pierceslower seal 76 and tissue at the injection site. In addition,injection spring 46moves driving end 58 of drivenrod 48 ininjection direction 66 to expel medicine fromcompartment 14 throughneedle 12. - At the point where
piston 18 has been moved to complete the injection of medicine fromcompartment 14, drivenrod 48 has moved in injection direction 66 a sufficient distance forcoupling 54 to contactsplitter device 52, which disengages the coupling from the driven rod and terminates theinfluence injection spring 46 has upon the driven rod. Onceinjection spring 46 is disengaged, the now compressedretraction spring 74 urges needle 12,compartment 14, and drivenrod 48 in a direction oppositeinjection direction 66 until the needle recedes behindlower seal 76. - In the embodiment where injection and
retraction assemblies needle 12 into the retraction assembly rendersdevice 40 safe from inadvertent injury by theneedle 12 and, thus, renders thedevice 40 safe for disposal. - In one embodiment of the present disclosure,
device 40 andsyringe 10 can be provided in an unassembled state in a terminally sterilized kit (not shown) for assembly and use. Here, the kit can includeinjection assembly 42 andretraction assembly 44, as well assyringe 10. In addition, as a matter of convenience to the user; the kit can also include one or more injection site cleaning swabs, such as a pre-packaged alcohol swab. For example,injection assembly 42,retraction assembly 44, andsyringe 10 can be contained in a sealed package, such as a plastic or TYVEC package. In some embodiments, the package can be terminally sterilized. - It should also be noted that the terms “first”, “second”, “third”, “upper”, “lower”, and the like may be used herein to modify various elements. These modifiers do not imply a spatial, sequential, or hierarchical order to the modified elements unless specifically stated.
- While the present disclosure has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the scope thereof. Therefore, it is intended that the present disclosure not be limited to the particular embodiment(s) disclosed as the best mode contemplated, but that the disclosure will include all embodiments falling within the scope of the appended claims.
Claims (26)
Priority Applications (1)
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US11/297,159 US20060178642A1 (en) | 2004-12-09 | 2005-12-08 | Breech loaded fixed needle syringe and automatic injection device having the same |
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- 2005-12-08 CN CNA2005800467361A patent/CN101484198A/en active Pending
- 2005-12-08 BR BRPI0518978-0A patent/BRPI0518978A2/en not_active Application Discontinuation
- 2005-12-08 EP EP05853420A patent/EP1819387A4/en not_active Withdrawn
- 2005-12-08 CA CA002591420A patent/CA2591420A1/en not_active Abandoned
- 2005-12-08 US US11/297,225 patent/US7758548B2/en active Active
- 2005-12-08 US US11/296,973 patent/US7674246B2/en active Active
- 2005-12-08 CA CA002591278A patent/CA2591278A1/en not_active Abandoned
- 2005-12-08 JP JP2007545641A patent/JP2008522754A/en active Pending
- 2005-12-08 JP JP2007545616A patent/JP4588072B2/en active Active
- 2005-12-08 CN CN2005800470010A patent/CN101180090B/en active Active
- 2005-12-08 AU AU2005314034A patent/AU2005314034A1/en not_active Abandoned
- 2005-12-08 WO PCT/US2005/044410 patent/WO2006063123A2/en active Search and Examination
- 2005-12-08 BR BRPI0518961-6A patent/BRPI0518961A2/en not_active Application Discontinuation
- 2005-12-08 MX MX2007006974A patent/MX2007006974A/en unknown
- 2005-12-08 CA CA002590281A patent/CA2590281A1/en not_active Abandoned
- 2005-12-08 US US11/297,159 patent/US20060178642A1/en not_active Abandoned
- 2005-12-08 MX MX2007006975A patent/MX2007006975A/en unknown
- 2005-12-08 EP EP05853354.8A patent/EP1819380B1/en active Active
- 2005-12-08 JP JP2007545617A patent/JP5198072B2/en active Active
- 2005-12-08 AU AU2005313993A patent/AU2005313993A1/en not_active Abandoned
- 2005-12-08 EP EP05853353.0A patent/EP1819386B1/en active Active
-
2007
- 2007-06-07 IL IL183768A patent/IL183768A0/en unknown
- 2007-06-07 IL IL183766A patent/IL183766A0/en unknown
- 2007-06-07 IL IL183767A patent/IL183767A0/en unknown
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