WO2012151314A2 - Seringues de sécurité rétractables commandées par dépression - Google Patents

Seringues de sécurité rétractables commandées par dépression Download PDF

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Publication number
WO2012151314A2
WO2012151314A2 PCT/US2012/036178 US2012036178W WO2012151314A2 WO 2012151314 A2 WO2012151314 A2 WO 2012151314A2 US 2012036178 W US2012036178 W US 2012036178W WO 2012151314 A2 WO2012151314 A2 WO 2012151314A2
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
plunger
syringe barrel
barrel
negative pressure
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/US2012/036178
Other languages
English (en)
Other versions
WO2012151314A3 (fr
Inventor
Orlando Soto
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.)
REVOLUTIONS MEDICAL Corp
Original Assignee
REVOLUTIONS MEDICAL Corp
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 REVOLUTIONS MEDICAL Corp filed Critical REVOLUTIONS MEDICAL Corp
Publication of WO2012151314A2 publication Critical patent/WO2012151314A2/fr
Anticipated expiration legal-status Critical
Priority to US14/071,495 priority Critical patent/US20140066858A1/en
Publication of WO2012151314A3 publication Critical patent/WO2012151314A3/fr
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
    • A61M5/31—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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle 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
    • A61M5/31—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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/323—Connection between plunger distal end and needle hub proximal end, e.g. stud protruding from the plunger
    • 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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3231—Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks
    • 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
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3241—Needle retraction energy is accumulated inside of a hollow plunger rod
    • A61M2005/3242—Needle retraction by vacuum
    • 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

Definitions

  • the present disclosure relates generally to hypodermic syringes wherein the hypodermic needle is retracted after use into a vacuum created within the interior of the hypodermic syringe. Retraction of the needle is designed to prevent an accidental needle prick.
  • hypodermic syringes are commonly used in the healthcare industry to inject therapeutics below the skin of patients. Despite their utility, hypodermic syringes present significant safety risks to healthcare practitioners, patients, and anyone who could accidentally be pricked by the exposed needle of a hypodermic syringe. The resulting injury could be as simple as a minor skin laceration, or as deadly as an infection from a virus in the patient's blood.
  • All of the syringes disclosed include a hypodermic needle mounted on a carrier which slides in the barrel. The plunger is locked to this carrier after the injection has been given and is withdrawn up into the barrel by withdrawal of the plunger.
  • the vacuum is provided in the syringe as shipped and breaking a seal activates the mechanism.
  • the vacuum is created by movement of the plunger within the barrel.
  • One drawback to the device by Smith et al. is that the entire volume of the barrel has to be evacuated and the resulting force that can be applied over the entire cross sectional area is relatively small. Further, the retraction mechanism of Smith et al. requires numerous moving parts that are prone to failure and contribute to increased manufacturing costs. For example, the vacuum created by the syringes of Smith et al. is prone to failure.
  • a vacuum-operated safety syringe is needed that benefits from a simpler and more cost-effective design.
  • a vacuum-operated safety syringe is needed that utilizes superior one-way valves to more effectively maintain a vacuum within the syringe and thereby improve the ability of the syringe to safely and effectively retract the needle assembly.
  • Applicants have developed a safety syringe with a vacuum-operated retractable needle that benefits from an exceedingly simple design that requires minimal moving parts.
  • Applicants have also developed superior one-way valves relative to such valves currently used in existing syringes.
  • the one-way valves that are incorporated into the present safety syringes more effectively maintain a vacuum within the syringe and thereby improve the ability of the syringe to safely and effectively retract the needle assembly.
  • the dislcosed safety syringe may be produced at low cost relative to existing syringes.
  • Another significant advantage of the present safety syringe is that it may be safely and reliably operated relative to existing syringes by a healthcare practitioner.
  • the disclosed safety syringe can also be used in non-medical applications, such as chemical handling processes and or in analytical applications.
  • the vacuum operated safety syringe of the present disclosure retracts its needle into the interior of a hollow plunger or syringe barrel to prevent the healthcare practitioner from accidentally getting stuck by the exposed needle.
  • the retractable needle protects various people, including healthcare practitioners, their patients, and sanitation workers involved with disposal of medical waste.
  • the safety syringe may prevent or reduce injuries ranging from minor skin lacerations to serious contamination by medications, germs, or viruses.
  • the syringe is a disposable, single-use device, and may be available in various sizes and shapes. It is an object of the present disclosure to provide an improved vacuum operated safety syringe with a retractable-needle.
  • the safety syringe includes a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and plunger handle posts (e.g., of non-hollow shape) that fit into the syringe barrel.
  • negative pressure i.e., vacuum
  • one or more one-way valves prevent airflow into the interior of the syringe barrel and thereby maintain the vacuum that is created during the act of injection, while no positive pressure is built up during loading of the syringe.
  • the safety syringe includes a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a hollow plunger (e.g., of cylindrical shape) that fits into the syringe barrel.
  • negative pressure is created within the interior of the syringe barrel during the act of injection as the hollow plunger is depressed through the syringe barrel towards the retractable needle assembly.
  • One or more one-way valves prevent airflow into the interior of the syringe barrel and thereby maintain the vacuum that is created during the act of injection (while avoiding positive pressure build up during loading of the syringe).
  • the retractable needle assembly Upon substantial or complete depression of the hollow plunger through the syringe barrel, one or more orifice(s) in the wall of the hollow plunger enter the interior of the syringe barrel.
  • the negative pressure of the interior of the syringe barrel evacuates air from the interior of the cylindrical plunger and distributes negative pressure throughout both the syringe barrel and the cylindrical plunger.
  • the retractable needle assembly Upon engagement of the hollow syringe barrel with the retractable needle assembly, the retractable needle assembly is drawn into the interior of the hollow plunger by the vacuum created in the hollow plunger or syringe barrel by the act of injection.
  • the safety syringe includes a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a plunger that fits into the syringe barrel, where the interior of the plunger is manufactured to be at negative pressure.
  • negative pressure i.e., vacuum
  • the retractable needle assembly is drawn into the interior of the plunger by the pre-existing negative pressure that was incorporated within the interior of the plunger at the time of manufacture.
  • a syringe including: a retractable needle assembly; a syringe barrel for the withdrawal or injection of fluids; and a plunger including one or more plunger handle posts that fit into the syringe barrel.
  • the syringe barrel and plunder handle posts are configured and arranged such that negative pressure is created within the interior of the syringe barrel during an act of injection as the plunger handle posts are depressed through the syringe barrel towards the retractable needle assembly.
  • Some embodiments include a one-way valve which prevents airflow into an interior volume of the syringe barrel and thereby maintain the negative pressure that is created during an act of injection, while no positive pressure is built up during loading of the syringe.
  • the syringe barrel includes an end cap including at least one one-way valve.
  • a syringe including: a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a hollow plunger that fits into the syringe barrel.
  • the syringe barrel is configured and arranged such that negative pressure is created within the interior of the syringe barrel during an act of injection as the hollow plunger is depressed through the syringe barrel towards the retractable needle assembly.
  • Some embodiments include one or more one-way valves prevent airflow into the interior of the syringe barrel and thereby maintain the negative pressure that is created during the act of injection.
  • an orifice in the wall of the hollow plunger enters the interior of the syringe barrel such that the syringe barrel in placed in pneumatic communication with an internal volume of the hollow plunger to facilitate retraction of the needle assembly.
  • the one way valve includes: a seal member configured such that the plunger passes through the seal ember into the syringe barrel.
  • the seal member is retained in a groove in the syringe barrel and is configured to provide an air tight seal when negative pressure is created in the internal volume of syringe barrel by movement of the plunger in a distal direction toward the needle assembly.
  • the groove and the shaft are configured and arranged such that: an increase of negative pressure created when the plunger is moved in the distal direction causing the airtight seal to become more robust, and the airtight seal is broken such that pressure in the syringe barrel is released when the plunger is actuated in a proximal direction away from the needle assemble.
  • the one way valve includes a purge valve affixed to the syringe barrel covering an orifice in the syringe barrel, the purge valve configured to: provide an airtight seal when negative pressure is created in the internal volume of the syringe barrel, and release the airtight seal when positive pressure is created in the internal volume.
  • the purge valve includes an elastomeric band disposed about the syringe barrel and covering the orifice in the syringe barrel.
  • the purge valve includes: a valve member that extends through an orifice in the syringe barrel, seals against the syringe barrel in response to negative pressure in the syringe barrel, and unseals in response to positive pressure in the syringe barrel; and a valve retaining member that retains the valve member in position when the valve member is unsealed.
  • a syringe including: a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a plunger that fits into the syringe barrel, where the interior of the plunger is manufactured to be at negative pressure.
  • the retractable needle assembly upon on complete depression of the plunger through the syringe barrel, and engagement of the syringe barrel with the retractable needle assembly, the retractable needle assembly is drawn into the interior of the plunger by the preexisting negative pressure that was incorporated within the interior of the plunger at the time of manufacture.
  • the syringe is pre-filled.
  • the retractable needle assemble is pre-retracted.
  • the plunger includes a needle catch configured to attach to the needle assembly when the plunder is depressed.
  • the needle catch includes a bung member that is configured to be pierced by a portion of the needle assembly extending into the syringe barrel when the plunder is depressed.
  • the needle catch includes a bung member that is configured to attach to a portion of the needle assembly extending into the syringe barrel when the plunder is depressed.
  • a method is disclosed including, using the syringe of any of any of the types described herein: dispensing a fluid from the syringe; upon dispensing the fluid, causing at least a portion of the needle assemble to retract into the syringe barrel. Some embodiments include, prior to dispensing the fluid from the syringe, loading the syringe with the fluid.
  • FIGS. 1-7 Various embodiments of safety syringes are shown in FIGS. 1-7.
  • the drawings in FIGS. 1-7 are not necessarily to scale, emphasis instead is generally being placed upon illustrating the principles of this aspect of the disclosure.
  • FIG. 1 depicts a safety syringe, comprising plunger handle posts 11, that retracts cannula assembly 1 and 2 into the interior of syringe barrel 4 upon complete depression of plunger handle posts 11 by the user.
  • the top panel shows the plunger handle prior to depression.
  • the middle panel shows the plunger partially depressed.
  • the bottom panel shows the plunger fully depressed, and the needle retracted.
  • FIG. 2 depicts a safety syringe, comprising a hollow plunger 27, that retracts cannula assembly 1 and 2 into the hollow plunger 27, upon complete depression of the hollow plunger 27 by the user.
  • the top panel shows the plunger handle prior to depression.
  • the middle panel shows the plunger partially depressed, with an inset showing a detail of the valve.
  • the bottom panel shows the plunger fully depressed, and the needle retracted.
  • FIG. 3 depicts a safety syringe, comprising a hollow plunger 37 and one-way purge valve 310, that retracts cannula assembly 31 and 32 into the hollow plunger 37, upon complete depression of the hollow plunger 37 by the user
  • the top panel shows the plunger handle prior to depression.
  • the middle panel shows the plunger partially depressed, with an inset showing a detail of the valve.
  • the bottom panel shows the plunger fully depressed, and the needle retracted.
  • FIG. 4 depicts a safety syringe, comprising a hollow plunger 47, one-way valve including the purge valve 410, valve retainer 45, and orifice(s) 411, that retracts cannula assembly 41 and 42 into the hollow plunger 47, upon complete depression of the hollow plunger 47 by the user.
  • the top panel shows the plunger handle prior to depression.
  • the middle panel shows the plunger partially depressed, with an inset showing a detail of the valve.
  • the bottom panel shows the plunger fully depressed, and the needle retracted.
  • FIG. 5 depicts a safety syringe, comprising a hollow plunger 57, that retracts cannula assembly 51 and 52 into the hollow plunger 57, upon complete depression of the hollow plunger 57 by the user.
  • the top panel shows the plunger handle prior to depression.
  • the middle panel shows the plunger partially depressed.
  • the bottom panel shows the plunger fully depressed, and the needle retracted.
  • FIG. 6 depicts a safety syringe, comprising a hollow plunger 67 that is preconditioned at negative pressure, and that retracts cannula assembly 61 and 62 into the inner diameter of plunger 67, upon complete depression of plunger 67 by the user.
  • the top panel shows the plunger handle prior to depression.
  • the middle panel shows the plunger partially depressed.
  • the bottom panel shows the plunger fully depressed, and the needle retracted.
  • FIG. 7 depicts a safety syringe that is pre-filled with liquid, and features an initially retracted, deployable needle.
  • the top panel shows the plunger handle prior to depression with the needle retracted.
  • the middle panel shows the plunger partially depressed.
  • the bottom panel shows the plunger fully depressed.
  • the present disclosure relates generally to vacuum-operated safety syringes designed to prevent an accidental needle prick, where the needle of the syringe is retracted after use into a vacuum created within the hollow plunger or the syringe barrel of the syringe.
  • Applicants have developed syringes in which the retraction of the needle assembly is achieved using minimal moving parts according to an elegant design.
  • negative pressure i.e., vacuum
  • a hollow plunger e.g., of cylindrical shape
  • the interior of the syringe barrel during the act of injection as the plunger is depressed through the syringe barrel towards the retractable needle assembly.
  • the retractable needle assembly Upon complete depression of the plunger through the syringe barrel, the retractable needle assembly is drawn into the syringe barrel by the vacuum created in the interior of the syringe barrel.
  • one or more one way valves are utilized to prevent airflow into the interior of the syringe barrel and thereby maintain the vacuum that is created during the act of injection. These one way valves may also operate to allow air to escape from the syringe during loading, thereby reducing or elimination unwanted build up of positive pressure.
  • the plunger of the safety syringe is manufactured to be pre-conditioned at negative pressure.
  • plastic refers to a class of materials including injection molded polypropylene plastic, synthetic resins, polyolefm resins such as polyethylene and polypropylene, polyvinyl chloride, PET (polyethylene terephthalate), EVA (ethylene-vinyl acetate copolymer), EVOH (ethylene-vinyl alcohol copolymer), polyamide, polyvinylidene chloride, polyvinyl fluoride, polytrifluorochloroethylene, polyester, nylon, mixtures thereof and laminated bodies thereof, the material is not limited especially if it is known for use as a medical equipment material and does not interact with the medicine or liquid accommodated in the barrel of the syringe.
  • the term "elastomer” refers to elastic materials having sealing property (in other words, gas-tight property) can be used.
  • the following elastomers can be used: injection molded thermoplastic elastomer, natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, styrene-butadiene-styrene block copolymer, hydrogenated styrene-butadiene copolymer, hydrogenated styrene-ethylene-butylene-styrene block copolymer, ethylene-a-olefm copolymer rubber, thermoplastic elastomer, elastomers of polyurethane family, elastomers of polyamide family, elastomers of polyester family, vulcanized isoprene rubber, vulcanized butyl rubber, vulcanized styrene-butadiene-sty
  • a safety syringe includes a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and plunger handle posts (e.g., of nonhollow shape) that fit into the syringe barrel.
  • the plunger handle posts are cylindrical.
  • negative pressure i.e., vacuum
  • one or more one-way valves prevent airflow into the interior of the syringe barrel and thereby maintain the vacuum that is created during the act of injection.
  • the safety syringe as depicted in FIG. 1, includes a cannula assembly 1 and 2 made up of a cannula 1 (e.g., a needle) held by a hub 2 that are located at the distal end of the syringe barrel 4.
  • the cannula 1 can be of various sizes.
  • cannula 1 is permanently attached to the hub 2.
  • the proximal end of the cannula assembly 1 and 2 are positioned in the center of a washer 3.
  • the washer 3 creates a water tight seal at the hub 2 and syringe barrel 4.
  • a needle catch 5 can be permanently attached to a piston bung 6.
  • a barrel seal 8 is affixed to a needle catch adapter 7.
  • the needle catch assembly 5 and 6 is held in the inner diameter of the needle catch adapter 7.
  • the bung 6 creates an air tight seal with the inner diameter of the needle catch adapter 7.
  • the size of features on needle catch 5 is such that there is some amount of interference with the inner diameter of the needle catch adapter 7.
  • syringe barrel end cap 9 is affixed to proximal end of syringe barrel 4 to provide an airtight seal between the two.
  • the plunger handle posts 11 can be affixed to needle catch adapter 7.
  • the plunger handle posts 11 can be supplied loose. Plunger handle posts 11 are affixed to needle catch adapter 7 by inserting it through end cap seals 10. End cap seals 10 create air tight seals with plunger handle posts 11.
  • the safety syringe of FIG. 1 is designed to retract the cannula 1 into the interior of the syringe barrel 4 upon complete depression of plunger handle posts 11 by the user.
  • the retraction of cannula 1 is accomplished by the creation of a vacuum in the interior of the syringe barrel 4 upon depression of plunger handle posts 11 by the user.
  • one or more one-way valving is used to create a vacuum in the interior of the syringe barrel 4 during depression of the plunger handle while allowing air to escape during retraction of the handle (e.g., during loading of the syringe from a liquid reservoir, not shown).
  • the end cap 9 may have one-way valving to allow for purging of trapped air in the interior of the syringe barrel 4.
  • the one way valving enables air to exit the syringe barrel 4 upon retraction of the plunger handle posts 11 away from the cannula 1 , but air cannot enter the syringe barrel 4 upon depression of the plunger handle posts 11 toward the cannula 1.
  • depression of the plunger handle posts 11 creates a vacuum in the interior of the syringe barrel 4 upon complete depression of plunger handle posts 11 by the user, which thereby draws the cannula 1 into the interior of syringe barrel 4.
  • the airtight seals 10 may be one way valve type seals (e.g., of the type illustrated in Fig. 2), to provide the one way valving.
  • the plunger handle posts 11 are retracted away from the cannula 1.
  • plunger handle posts 11 are then depressed toward from cannula 1 , where the needle catch 5 engages the hub 2 and becomes affixed.
  • the plunger 7 is depressed negative pressure is created on the proximal side of the barrel seal 8. While depressing the plunger the shoulder feature on the needle catch adapter 7 will displace the washer 3 so that the cannula assembly 1, 2 is free to move.
  • the syringe as shown in FIG. 1 can incorporate any
  • the plunger handle posts 11, needle catch adapter 7, barrel seal 8, and syringe barrel end cap 9 as shown in FIG. 1 can be replaced with the hollow plunger as shown in FIGS. 2-5.
  • the plunger handle posts 11, needle catch adapter 7, barrel seal 8, and syringe barrel end cap 9 as shown in FIG. 1 can be replaced with a plunder, which is pre-conditioned at negative pressure, as shown in FIG. 6.
  • the syringe as shown in FIG. 1 can include the cannula assembly and the needle catch bungas illustrated in FIGS. 4 and 5.
  • Syringe barrel 4 may incorporate any valve described in FIGS.
  • the syringe barrel 4 as shown in FIG. 1 can include a oneway valve as described in FIG. 3, such as the purge valve 310.
  • the syringe barrel 4 as shown in FIG. 1 can include a one-way valve as described in FIG. 4, including the purge valve 410, valve retainer 45, and orifice(s) 411.
  • the safety syringe of FIG. 1 can be assembled from components made from a variety of materials.
  • cannula 1 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing).
  • the cannula 1 is of various sizes (e.g., in the range of fractions of a centimeter or less to tens of centimeters or more).
  • the hub 2 is made of plastic (e.g., injection molded polypropylene plastic).
  • the cannula 1 may be assembled to the hub 2 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • washer 3 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the syringe barrel 4 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the needle catch 5 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the bung 6 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the bung 6 can be molded separately. In some embodiments, the bung 6 can be overmolded onto needle catch 5.
  • the needle catch adapter 7 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the barrel seal 8 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the barrel seal 8 can be molded separately. In some embodiments, the barrel seal 8 can be overmolded onto needle catch adapter 7.
  • syringe barrel end cap 9 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • end cap seal 10 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, end cap seal 10 is made of rubber. In some embodiments, plunger handle 11 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • various embodiments of safety syringes include a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a hollow plunger (e.g., of cylindrical shape) that fits into the syringe barrel.
  • negative pressure is created within the interior of the syringe barrel during the act of injection as the hollow plunger is depressed through the syringe barrel towards the retractable needle assembly.
  • One or more one-way valves prevent airflow into the interior of the syringe barrel and thereby maintain the vacuum that is created during the act of injection, while allowing air to escape during the loading of the syringe.
  • the retractable needle assembly Upon substantial or complete depression of the hollow plunger through the syringe barrel, one or more orifice(s) in the wall of the hollow plunger enter the interior of the syringe barrel.
  • the negative pressure of the interior of the syringe barrel evacuates air from the interior of the cylindrical plunger and distributes negative pressure throughout both the syringe barrel and the cylindrical plunger.
  • the retractable needle assembly Upon engagement of the hollow syringe barrel with the retractable needle assembly, the retractable needle assembly is drawn into the interior of the hollow plunger by the vacuum created in the hollow plunger or syringe barrel by the act of injection.
  • a safety syringe includes a cannula 21.
  • the cannula 21 may be permanently attached to a hub 22 to form a cannula assembly 21 and 22.
  • the cannula assembly 21 and 22 are located at the distal end of the syringe barrel 24.
  • the proximal end of the cannula assembly 21 and 22 are positioned in the center of a washer 23.
  • the washer 23 creates a water tight seal at the hub 22 and syringe barrel 24.
  • the needle catch 25 is permanently attached to piston bung 26.
  • the barrel seal 28 is affixed to plunger 27.
  • the needle catch assembly 25 and 26 is held in the inner diameter of plunger 27.
  • the bung 26 creates an air tight seal with he inner diameter of the plunger 27.
  • the size of features on the needle catch 25 is such that there is some amount of interference with the distal orifice diameter of the plunger 27.
  • the proximal end of the syringe barrel 4 which the plunger 27 passes through can be a separate piece assembled to the majority of the syringe barrel 24 providing an airtight seal between the two pieces.
  • the plunger shaft passes through one, two, or more shaft seals 29 to provide an air tight seal between the syringe barrel 4 and the plunger 27.
  • the shaft seal 29 is retained in the groove 210 to provide an air tight seal when negative pressure is created in the internal volume of syringe barrel 24 by the plunger 7 moving in the distal direction.
  • the geometry of the groove 210 and the shaft seal 29 is such that the increase of negative pressure created when the plunger 27 is moved in the distal direction causes airtight seal to become more robust.
  • the geometry of the groove 210 and the shaft seal 29 is such that trapped air may be released when the plunger is actuated in a proximal direction.
  • the safety syringe of FIG. 2 is designed to retract cannula assembly 21 and 22 into the internal volume of the plunger 27 upon complete depression of the plunger 7 by the user.
  • the plunger 27 is depressed where the needle catch 25 engages the hub 22 and becomes affixed.
  • negative pressure is created on the proximal side of the barrel seal 28.
  • an orifice 211 Prior to release of the cannula assembly 21 and 22 an orifice 211 enters the negative pressure volume of the syringe barrel 24 joining the negative pressure volume of the syringe barrel 4 and the internal volume of plunger 27.
  • the syringe as shown in FIG. 2 can incorporate any permutation of the features described in FIG. 1 and FIGS. 3-7.
  • the hollow plunger 27 as shown in FIG. 2 can be replaced with the plunger handle posts, needle catch adapter, barrel seal 8, and syringe barrel end cap as shown in FIG.1.
  • the hollow plunger 27 as shown in FIG. 2 can be replaced with the plunger as shown in FIG. 6, which is pre-conditioned at negative pressure.
  • the syringe as shown in FIG. 2 can include the cannula assembly and the needle catch bung as described in FIGS. 4 and 5.
  • the syringe barrel 24 as shown in FIG. 2 can include a one-way valve as described in FIG. 3, including the purge valve 310.
  • the syringe barrel 24 as shown in FIG. 2 can include a one-way valve as described in FIG. 4, including the purge valve 410, valve retainer 45, and orifice(s) 411.
  • the interior of the syringe barrel as shown in FIG. 2 is pre-filled with fluid.
  • the syringe barrel as shown in FIG. 2 is pre-filled with fluid and/or features a pre-retracted and deployable cannula assembly, e.g., as illustrated in Fig. 7.
  • the safety syringe of FIG. 2 can be assembled from components made from a variety of materials.
  • cannula 1 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing).
  • cannula 21 is of any suitable size as described above.
  • the hub 22 is made of plastic (e.g., injection molded polypropylene plastic).
  • the cannula 21 may be assembled to hub 22 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • washer 23 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the syringe barrel 24 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the needle catch 25 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the bung 26 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the bung 26 can be molded separately.
  • the bung 26 can be overmolded onto needle catch 25.
  • the plunger 27 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the plunger 27 has one or more orifice(s) 211.
  • the barrel seal 28 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the barrel seal 28 can be molded separately. In some embodiments, the barrel seal 28 can be overmolded onto the plunger 27.
  • the shaft seal 29 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the shaft seal 29 is made of rubber.
  • the safety syringe in one embodiment, includes cannula 31.
  • the cannula 31 is permanently attached to the hub 32 to form a cannula assembly 31 and 32.
  • the cannula assembly 31 and 32 are located at the distal end of the syringe barrel 34.
  • the proximal end of the cannula assembly 31 and 32 are positioned in the center of washer 33.
  • a washer 33 creates a water tight seal at the hub 32 and the syringe barrel 34.
  • the needle catch 35 is permanently attached to the piston bung 36.
  • the barrel seal 38 is affixed to plunger 37.
  • the needle catch assembly 35 and 36 is held in the some size inner diameter of plunger 37.
  • the proximal end of the syringe barrel 34 which the plunger 37 passes through can be a separate piece assembled to the majority of the syringe barrel 34 providing an airtight seal between the two pieces.
  • the plunger shaft passes through one, two or more shaft seals 39 to provide an air tight seal between the syringe barrel 34 and the plunger 37.
  • a purge valve 310 is affixed to the syringe barrel 34 covering an orifice 312 in the syringe barrel 34. This provides an airtight seal when negative pressure is created in the internal volume of the syringe barrel 34 that is proximal to the barrel seal 8, but the seal is released when positive pressure is created in said volume.
  • the safety syringe of FIG. 3 is designed to retract the cannula assembly 31 and 32 into the internal volume of plunger 37 upon complete depression of plunger
  • the plunger 37 by the user. After filling of the device, the plunger 37 is depressed where the needle catch 35 engages the hub 32 and becomes affixed. As the plunger 37 is depressed negative pressure is created on the proximal side of the barrel seal 38. Prior to release of the cannula assembly 31 and 32, an orifice 311 enters the negative pressure volume of the syringe barrel 34 joining the negative pressure volume of the syringe barrel 34 and the internal volume of the plunger 37. While depressing the plunger 37 the shoulder feature on plunger 37 will displace the washer 33 so that the cannula assembly 31 and 32 is free to move.
  • the syringe as shown in FIG. 3 can incorporate any
  • the hollow plunger 37 as shown in FIG. 3 can be replaced with the plunger handle posts, needle, catch adapter, barrel seal, and syringe barrel end cap as shown in FIG. 1.
  • the hollow plunger 37 as shown in FIG. 3 can be replaced with the plunger 67 as shown in FIG. 6, which is pre-conditioned at negative pressure.
  • the syringe as shown in FIG. 3 can include the cannula assembly and the needle catch bung as described in FIGS. 4 and 5.
  • the syringe barrel 34 as shown in FIG. 3 can include a one-way valve as described in FIG.
  • the interior of the syringe barrel as shown in FIG. 3 is pre-filled with fluid.
  • the syringe barrel as shown in FIG. 3 is pre-filled with fluid and/or features a pre-retracted and deployable cannula assembly, e.g., as illustrated in FIG. 7.
  • the safety syringe of FIG. 3 can be assembled from components made from a variety of materials.
  • cannula 31 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing).
  • the cannula 1 is of any suitable size, as described above.
  • the hub 32 is made of plastic (e.g., injection molded polypropylene plastic).
  • the cannula 31 may be assembled to hub 32 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • the washer 33 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the syringe barrel 34 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the needle catch 35 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the bung 36 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the bung 36 can be molded separately.
  • the bung 36 can be overmolded onto needle catch 35.
  • the plunger 37 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the plunger 37 has one or more orifice(s) 11.
  • the barrel seal 38 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the barrel seal 38 can be molded separately. In some embodiments, the barrel seal 8 can be overmolded onto plunger 37.
  • the shaft seal 39 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the shaft seal 39 is made of rubber.
  • the purge valve 310 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the purge valve 310 is made of plastic (e.g., injection molded plastic,
  • the purge valve 310 is made of metal (e.g., steel or spring type steel) with an elastomeric material laminated to the inside. In some embodiments, the purge valve 310 is made of metal (e.g., steel or spring type steel) and overmolded with an elastomer (e.g., injection molded thermoplastic elastomer).
  • metal e.g., steel or spring type steel
  • an elastomer e.g., injection molded thermoplastic elastomer
  • the safety syringe includes cannula 41.
  • the cannula 41 is permanently attached to the hub 42 to form a cannula assembly 41 and 42.
  • the cannula assembly 41 and 42 is located at the distal end of the syringe barrel 44.
  • the proximal end of the cannula assembly 41 and 42 are positioned in the center of washer 43.
  • a washer 43 creates a water tight seal at the hub 42 and syringe barrel 44.
  • a barrel seal 48 is affixed to plunger 47.
  • a needle catch bung 46 is held at an inner diameter of the plunger 47.
  • the needle catch bung 46 creates an air tight seal with a some size inner diameter of plunger 47.
  • the proximal end of syringe barrel 4 which the plunger 47 passes through can be a separate piece assembled to the majority of the syringe barrel 44 providing an airtight seal between the two pieces.
  • the plunger shaft passes through one, two or more shaft seals 49 to provide an air tight seal between the syringe barrel 4 and the plunger 47.
  • a purge valve 410 is affixed to the proximal end of syringe barrel 44.
  • the purge valve 410 can be attached to the syringe barrel 44 with the valve retainer 45 or directly to syringe barrel 44.
  • the purge valve 410 covers an orifice 411 in syringe barrel 44 providing an airtight seal when negative pressure is created in the internal volume of the syringe barrel 44 that is proximal to the barrel seal 48, but the seal is released when positive pressure is created in said volume.
  • the safety syringe of FIG. 44 is designed to retract the cannula assembly 41 and 42 into the internal volume of plunger 47 upon complete depression of the plunger 47 by the user.
  • the plunger 47 is depressed and the needle catch bung 46 engages the cannula 41 and becomes affixed.
  • the needle catch bung 46 and cannula 41 can become affixed via piecing or other interlocking geometry.
  • the cannula 41 includes a sharp proximal end that pierces into (but not through) the bung 46.
  • the plunger 47 handle in the distal direction will push the needle catch bung 46 through the distal orifice diameter of plunger 47 thus releasing the needle catch bung 46 along with the affixed cannula assembly 41 and 42.
  • the needle catch bung 46 and cannula assembly 41 and 42 will be aspirated in to the plunger 47 portions which is proximal to the distal orifice in plunger 47 by the negative pressure previously created.
  • the bung 46 may frictionally (or otherwise) engage the inner surface of the plunger 47 to
  • the syringe as shown in FIG. 4 can incorporate any
  • the hollow plunger 47 as shown in FIG. 4 can be replaced with the plunger handle posts, needle catch adapter, barrel seal, and syringe barrel end cap as shown in FIG. 1.
  • the hollow plunger 47 as shown in FIG. 4 can be replaced with the plunger 67 as shown in FIG. 6, which is pre-conditioned at negative pressure.
  • the syringe as shown in FIG. 4 may include the cannula assembly and the needle catch assembly as described in FIGS. 1- 2.
  • the syringe barrel 44 as shown in FIG. 4 may include a one-way valve as described in FIG. 3.
  • the syringe barrel 44 as shown in FIG. 4 can omit a one-way valve as described in FIG. 4.
  • the interior of the syringe barrel as shown in FIG. 4 is pre-filled with fluid.
  • the interior of the syringe barrel as shown in FIG. 4 is pre-filled with fluid.
  • the syringe barrel as shown in FIG. 4 is pre-filled with fluid and/or features a pre-retracted and deployable cannula assembly, e.g., as illustrated in FIG. 7.
  • the safety syringe of FIG. 4 can be assembled from components made from a variety of materials.
  • the cannula 41 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing). In various embodiments, the cannula 41 is of any suitable size, as described above.
  • the hub 42 is made of plastic (e.g., injection molded polypropylene plastic). In some embodiments, the cannula 41 may be assembled to the hub 42 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • the washer 43 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the syringe barrel 44 is made of plastic (e.g., polypropylene plastic or injection molded
  • valve retainer 45 is made of plastic (e.g., polypropylene plastic, injection molded plastic, or injection molded polypropylene plastic). In some embodiments, the valve retainer 45 is made of metal (e.g., steel, stainless steel, or spring steel). In some embodiments, the needle catch bung 46 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the plunger 47 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic). In some embodiments, the plunger 47 has one or more orifice(s) 412.
  • the barrel seal 48 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the barrel seal 48 can be molded separately. In some embodiments, the barrel seal 48 can be overmolded onto plunger 47. In some embodiments, one or more shaft seals may be included, e.g., made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, one or more shaft seals are made of rubber. In some embodiments, the purge valve 410 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the purge valve 410 is made of plastic (e.g., injection molded plastic, polypropylene plastic, or injection molded polypropylene plastic). In some embodiments, the purge valve 410 is made of metal (e.g., steel or spring type steel) with an elastomeric material laminated to the inside. In some embodiments, the purge valve 410 is made of metal (e.g., steel or spring type steel) and overmolded with an elastomer (e.g., injection molded thermoplastic elastomer).
  • plastic e.g., injection molded plastic, polypropylene plastic, or injection molded polypropylene plastic
  • the purge valve 410 is made of metal (e.g., steel or spring type steel) with an elastomeric material laminated to the inside. In some embodiments, the purge valve 410 is made of metal (e.g., steel or spring type steel) and overmolded with an elastomer (e.g., injection molded thermoplastic elastomer).
  • the safety syringe in one aspect, includes a cannula 51.
  • the cannula 51 is permanently attached to a hub 52.
  • the cannula assembly 51 and 52 are located at the distal end of the syringe barrel 54.
  • the proximal end of the cannula assembly 51 and 52 are positioned in the center of a washer 53.
  • the washer 53 creates a water tight seal at the hub 52 and the syringe barrel 54.
  • the barrel seal 58 is affixed to plunger 57.
  • a needle catch bung 56 is held a some size inner diameter of plunger 57. Needle catch bung 56 creates an air tight seal with an inner diameter of plunger 57.
  • the proximal end of the syringe barrel 54 which the plunger 57 passes through can be a separate piece assembled to the majority of the syringe barrel 54 providing an airtight seal between the two pieces.
  • the plunger shaft passes through one, two or more shaft seals 55 to provide an air tight seal between the syringe barrel 54 and the plunger 57.
  • the shaft seal 55 is retained in groove 510 to provide an air tight seal when negative pressure is created in the internal volume of syringe barrel 54 by the plunger 57 moving in the distal direction.
  • groove 510 and shaft seal 59 are such that the increase of negative pressure created when the plunger 57 is moved in the distal direction causes the airtight seal to become more robust.
  • the geometry of groove 510 and shaft seal 59 is such that trapped air may be released when the plunger is actuated in a proximal direction.
  • the safety syringe of FIG. 5 is designed to retract the cannula assembly 51 and 52 into the internal volume of plunger 57 upon complete depression of the plunger 57 by the user.
  • the plunger 57 is depressed where the needle catch bung 56 engages the cannula 51 and becomes affixed.
  • the needle catch bung 56 and the cannula 51 can become affixed via piecing or other interlocking geometry.
  • the needle catch bung 56 and cannula 1 can become affixed via piecing or other interlocking geometry.
  • the cannula 51 includes a sharp proximal end that pierces into (but not through) the bung 56.
  • the plunger 57 handle in the distal direction will push the needle catch bung 56 through the distal orifice diameter of plunger 57 thus releasing the needle catch bung 56 along with the affixed cannula assembly 51 and 52.
  • the needle catch bung 6 and the cannula assembly 51 and 52 will be aspirated in to the plunger 57 portion which is proximal to the distal orifice in the plunger 57 by the negative pressure previously created.
  • the bung 56 may frictionally (or otherwise) engage the inner surface of the plunger 57 to mechanically secure and retain the cannula assembly within the plunger.
  • the syringe as shown in FIG. 5 can incorporate any
  • the hollow plunger 57 as shown in FIG. 5 can be replaced with the plunger handle posts, needle catch adapter, barrel seal, and syringe barrel end cap as shown in FIG. 1.
  • the hollow plunger 57 as shown in FIG. 5 can be replaced with the plunger 67 as shown in FIG. 6, which is pre-conditioned at negative pressure.
  • the syringe as shown in FIG. 5 may include the cannula assembly and the needle catch assembly as described in FIGS. 1- 2.
  • the syringe barrel 54 as shown in FIG. 5 may include a one-way valve as described in FIG. 3, including purge valve 310.
  • the syringe barrel 54 as shown in FIG. 5 may include a one-way valve as described in FIG. 4, including the purge valve 410, the valve retainer 45, and the orifice(s) 411.
  • the interior of the syringe barrel 54 as shown in FIG. 5 is pre-filled with fluid.
  • the syringe barrel as shown in FIG. 5 is pre-filled with fluid and/or features a pre-retracted and deployable cannula assembly, e.g., as illustrated in FIG. 7.
  • the safety syringe of FIG. 5 can be assembled from components made from a variety of materials.
  • the cannula 51 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing.
  • the cannula 51 is of any suitable size, as described above.
  • the hub 52 is made of plastic (e.g., injection molded polypropylene plastic).
  • the cannula 51 may be assembled to the hub 52 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • the washer 53 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the syringe barrel 54 is made of plastic (e.g., polypropylene plastic or injection molded
  • the one or more shaft seals 5 are made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the one or more shaft seals 55 are made of rubber. In some embodiments, the needle catch bung 6 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the plunger 57 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic). In some embodiments, the plunger 57 has one or more orifice(s) 59.
  • the barrel seal 58 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the barrel seal 58 can be molded separately. In some embodiments, the barrel seal 58 can be overmolded onto plunger 57.
  • an elastomer e.g., injection molded thermoplastic elastomer
  • the barrel seal 58 can be molded separately. In some embodiments, the barrel seal 58 can be overmolded onto plunger 57.
  • a safety syringe in one embodiment, includes a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a plunger that fits into the syringe barrel, where the interior of the plunger is manufactured at negative pressure.
  • vacuum is preconditioned in the interior of the plunger prior to use.
  • negative pressure i.e., vacuum
  • the retractable needle assembly Upon complete depression of the plunger through the syringe barrel, and engagement of the syringe barrel with the retractable needle assembly, the retractable needle assembly is drawn into the interior of the plunger by the negative pressure that was incorporated within the interior of the plunger at the time of manufacture.
  • the safety syringe as depicted in FIG. 6, includes a cannula 61.
  • the cannula 61 is permanently attached to the hub 62 to form a cannula assembly 61 and 62.
  • the cannula assembly 61 and 62 are located at the distal end of the syringe barrel 64.
  • the proximal end of cannula assembly 61 and 62 is positioned in the center of a washer 63.
  • the washer 3 creates a water tight seal at the hub 62 and the syringe barrel 64.
  • a needle catch 65 is
  • the barrel seal 68 is affixed to plunger 67.
  • the needle catch assembly 65 and 66 is held in an inner diameter of the plunger 67.
  • the bung 66 creates an air tight seal an inner diameter of plunger 67.
  • the size of features on the needle catch 5 is such that there is some amount of interference with the distal orifice diameter of the plunger 67.
  • the internal volume of plunger 67 sealed with the piston bung 67 is at negative pressure.
  • the safety syringe of FIG. 6 is designed to retract cannula assembly 61 and 62 into the internal volume of the plunger 67 upon complete depression of the plunger 67 by the user. After filling of the device, the plunger 67 is depressed so that the needle catch 65 engages the hub 62 and becomes affixed. While depressing the plunger 67 the shoulder feature on plunger 67 will displace the washer 63 so that cannula assembly 61 and 62 is free to move.
  • the syringe as shown in FIG. 6 can incorporate any
  • the syringe as shown in FIG. 6 can include the cannula assembly and the needle catch bung as described in FIGS. 4 and 5.
  • the syringe barrel 64 as shown in FIG. 6 can include a one-way valve as described in FIG. 3, such as the purge valve 310.
  • the syringe barrel 64 as shown in FIG. 6 can include a one-way valve as described in FIG. 4, including the purge valve 410, valve retainer 45, and orifice(s) 411.
  • the interior of the syringe barrel as shown in FIG. 6 is not pre-filled with fluid.
  • the interior of the syringe barrel as shown in FIG. 6 is pre-filled with fluid.
  • the syringe barrel as shown in FIG. 6 is pre-filled with fluid and/or features a pre-retracted and deployable cannula assembly, e.g., as illustrated in FIG. 7.
  • the safety syringe of FIG. 6 can be assembled from components made from a variety of materials.
  • the cannula 61 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing). In various embodiments, the cannula 61 is of any suitable size, as described above.
  • the hub 62 is made of plastic (e.g., injection molded polypropylene plastic). In some embodiments, the cannula 61 may be assembled to hub 62 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • the washer 63 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the syringe barrel 64 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the needle catch 65 is made of plastic (e.g., polypropylene plastic, injection molded plastic, or injection molded polypropylene plastic).
  • the bung 66 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the bung 66 can be molded separately. In some embodiments, the bung 66 can be overmolded onto needle catch 65.
  • the plunger 67 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the barrel seal 68 is made of an elastomer (e.g., injection molded thermoplastic elastomer). In some embodiments, the barrel seal 68 can be molded separately. In some embodiments, the barrel seal 8 can be overmolded onto plunger 67.
  • a pre-filled safety syringes includes a retractable needle assembly, a syringe barrel for the withdrawal or injection of fluids, and a hollow plunger (e.g., of cylindrical shape) that fits into the syringe barrel.
  • the retractable needle assembly may be pre-retraced, such that the device ships with the needle safely housed within the syringe body. The retractable needle assembly is initially deployed by depressing the plunger.
  • negative pressure is created within the interior of the syringe barrel during the act of injection as the hollow plunger is depressed through the syringe barrel towards the retractable needle assembly.
  • One or more one-way valves prevent airflow into the interior of the syringe barrel and thereby maintain the vacuum that is created during the act of injection.
  • one or more orifice(s) in the wall of the hollow plunger enter the interior of the syringe barrel.
  • the negative pressure of the interior of the syringe barrel evacuates air from the interior of the cylindrical plunger and distributes negative pressure throughout both the syringe barrel and the cylindrical plunger.
  • a safety syringe includes a cannula 71.
  • the cannula 71 is permanently attached to a hub 72 to form a cannula assembly 71 and 72.
  • the cannula assembly 71 and 72 are initially located internal to the syringe barrel 74 at the distal end of the syringe barrel 74.
  • the proximal end of the cannula 71 is held in the center of a needle shuttle bung 711.
  • a syringe barrel feature locates needle assembly 71, 72 centrally to the syringe barrel 74.
  • Needle shuttle seal 79 is permanently attached to a needle shuttle 710 to form a needle shuttle assembly 79 and 710.
  • the needle shuttle bung 711 is held by the needle shuttle assembly 79 and 710 creating a seal between the needle shuttle bung 711 and the syringe barrel 74.
  • Barrel seal 78 is affixed to plunger 77.
  • Needle catch bung 6 is held in a certain size inner diameter of plunger 77.
  • Needle catch bung 76 creates an air tight seal with a certain size inner diameter of plunger 77.
  • the prefilled fluid exists in the space between the needle shuttle assembly 79, 710 and 711 and the plunger assembly 76, 77 and 78.
  • the proximal end of the syringe barrel 74 which the plunger 77 passes through can be a separate piece assembled to the majority of the syringe barrel 74 providing an airtight seal between the two pieces.
  • the plunger 77 shaft passes through one, two or more shaft seals 75 to provide an air tight seal between the syringe barrel 74 and plunger 77.
  • Purge valve 710 is affixed to the proximal end of syringe barrel 74.
  • Depressing plunger 77 in a distal direction causes the fluid, shuttle assembly 79, 710, 711 and cannula assembly 71, 72 to move in a distal direction until the hub 72 becomes engaged with the distal end of syringe barrel feature 73. Further depressing the plunger 77 causes the proximal end of the cannula 71 to pass through the needle shuttle bung 711. This allows the pre- filed fluid to pass through the internal diameter of the cannula 71. The needle shuttle bung 711 will come to rest after the cannula 71 has passed through it and mayor may not be in contact with the hub72 at this time.
  • the plunger 77 is depressed where the needle catch bung 76 engages the cannula 71 and becomes affixed.
  • the needle catch bung 76 and the cannula 71 can become affixed via piecing or other interlocking geometry. At this time fluid flow through the inner diameter of cannula 71 will stop.
  • negative pressure is created on the proximal side of the barrel seal 8.
  • the orifice 711 on the plunger 77 Prior to release of the cannula assembly 71 and 72, the orifice 711 on the plunger 77 enters the negative pressure volume of the syringe barrel 74 joining the negative pressure volume of the syringe barrel 4 and the internal volume of the plunger 77.
  • plunger 77 While depressing the plunger 77 further, features on plunger 77 or needle catch bung 76 will displace the shuttle assembly 79,710 causing needle shuttle bung 711 to be released from shuttle 10 so that the cannula assembly 71, 72 and attached needle shuttle bung 71 1 are free to move. After release of the cannula assembly 71, 72 and the needle shuttle bung 71 1 further travel of the plunger 77 handle in the distal direction will push the needle catch bung 76 through the distal orifice diameter of plunger 77 thus releasing the needle catch bung 6 along with the affixed cannula assembly 71, 72 and needle shuttle bung 711.
  • the syringe as shown in FIG. 7 can incorporate any
  • the hollow plunger 77 as shown in FIG. 7 can be replaced with the plunger handle posts, needle catch adapter, barrel seal, and syringe barrel end cap as shown in FIG. 1.
  • the hollow plunger 77 as shown in FIG. 7 can be replaced with the plunger 67 as shown in FIG. 6, which is preconditioned at negative pressure.
  • the syringe as shown in FIG. 7 may include the cannula assembly and the needle catch assembly as described in FIGS. 1-2.
  • the syringe as shown in FIG. 7 can include the cannula assembly and the needle catch bung as described in FIGS. 4-5.
  • Syringe barrel 74 may incorporate any valve described in FIGS. 3 and 4, as described herein, to allow air to escape from the proximal side of the barrel seal when the plunger is withdrawn, but which seals airtight when the plunger is depressed.
  • the syringe barrel 74 as shown in FIG. 7 can include a one-way valve as described in FIG. 3, including purge valve 310.
  • the syringe barrel 74 as shown in FIG. 7 can include a one-way valve as described in FIG. 4, including the purge valve 410, valve retainer 45, and orifice(s) 41 1.
  • the interior of the syringe barrel 74 as shown in FIG. 7 is shown in FIG. 7 is not pre-filled with fluid, allowing the syringe to operate in the conventional fashion.
  • the safety syringe of FIG. 7 can be assembled from components made from a variety of materials.
  • cannula 71 is made of stainless steel tubing (e.g., medical hypodermic stainless steel tubing).
  • cannula 1 is of any suitable size, as described above.
  • hub 72 is made of plastic (e.g., injection molded polypropylene plastic).
  • the cannula 1 may be assembled to hub 72 by any method known to one of ordinary skill (e.g., over molding, UV glue bonding, or other any other bonding method).
  • the syringe barrel 4 is made of plastic (e.g.,
  • the shaft seals 75 are made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the bung 76 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • needle plunger 77 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic).
  • the barrel seal 8 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • barrel seal 78 can be molded separately.
  • barrel seal 78 can be overmolded onto needle catch adapter 77.
  • the needle shutter seal 79 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • the needle shuttle 710 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • end cap seals 10 is made of plastic (e.g., polypropylene plastic or injection molded polypropylene plastic)..
  • the needle shuttle bung 711 plunger handle 711 is made of an elastomer (e.g., injection molded thermoplastic elastomer).
  • Devices of the types described herein may be used for any suitable purpose including, but not limited to, injections and or phlebotomy.
  • a range includes each individual member.
  • a group having 1-3 cells refers to groups having 1, 2, or 3 cells.
  • a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth.

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  • Heart & Thoracic Surgery (AREA)
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  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne généralement des seringues de sécurité commandées par dépression conçues pour empêcher une piqûre accidentelle avec une aiguille, l'aiguille de la seringue rentrant après utilisation dans un vide créé dans le plongeur creux et/ou le corps de la seringue. La rentrée de l'ensemble à aiguille s'effectue au moyen de parties mobiles minimales selon une conception on ne peut plus simple. Selon un aspect, une pression négative est créée (à savoir du vide) dans un plongeur creux (ex. de forme cylindrique) et/ou l'intérieur du corps de seringue pendant l'acte d'injection lorsque le plongeur est enfoncé dans le corps de seringue en direction de l'ensemble à aiguille rétractable. Lors de l'enfoncement intégral du plongeur dans le corps de seringue, l'ensemble à aiguille est aspiré dans le corps de seringue par le vide créé à l'intérieur dudit corps. Dans certains modes de réalisation, une ou plusieurs valves anti-reflux empêchent le flux d'air à l'intérieur du corps de seringue et maintiennent ainsi le vide qui est créé pendant l'acte d'injection. Dans certains modes de réalisation, le plongeur de la seringue de sécurité de l'invention est fabriqué pour être pré-conditionné à une pression négative.
PCT/US2012/036178 2011-05-02 2012-05-02 Seringues de sécurité rétractables commandées par dépression Ceased WO2012151314A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/071,495 US20140066858A1 (en) 2011-05-02 2013-11-04 Vacuum-operated retractable safety syringe

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161481610P 2011-05-02 2011-05-02
US61/481,610 2011-05-02

Related Child Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/036195 Continuation WO2012151330A1 (fr) 2011-05-02 2012-05-02 Seringue de sûreté rétractable actionnée sous vide

Publications (2)

Publication Number Publication Date
WO2012151314A2 true WO2012151314A2 (fr) 2012-11-08
WO2012151314A3 WO2012151314A3 (fr) 2016-08-25

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/036178 Ceased WO2012151314A2 (fr) 2011-05-02 2012-05-02 Seringues de sécurité rétractables commandées par dépression

Country Status (1)

Country Link
WO (1) WO2012151314A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016523664A (ja) * 2013-07-01 2016-08-12 クレデンス メドシステムズ インコーポレイテッド 安全注射器
US10010677B2 (en) 2014-04-24 2018-07-03 Credence Medsystems, Inc. System and method for safety syringe
US10300217B2 (en) 2013-11-15 2019-05-28 Credence Medsystems, Inc. System and method for drug delivery with a safety syringe

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US5000736A (en) * 1990-03-22 1991-03-19 Harry Kaufhold, Jr. Disposable syringe with automatic needle retraction
US6193695B1 (en) * 2000-01-14 2001-02-27 Wayland J. Rippstein, Jr. Disposable safety syringe having a retractable needle
US6458105B1 (en) * 2001-02-22 2002-10-01 Maxxon, Inc. Disposable syringe having a retractable needle
US20030212371A1 (en) * 2002-05-10 2003-11-13 Martin E. Smith Disposable safety syringe
US6846301B2 (en) * 2002-11-01 2005-01-25 Maxxon, Inc. Disposable safety syringe
US8152762B2 (en) * 2006-04-20 2012-04-10 Safeshot Technologies, Llc Plunger activated vacuum release mechanism for a syringe

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9919110B2 (en) 2013-07-01 2018-03-20 Credence Medsystems, Inc. Safety syringe
US10350368B2 (en) 2013-07-01 2019-07-16 Credence Medsystems, Inc. Safety syringe
US9814842B2 (en) 2013-07-01 2017-11-14 Credence Medsystems, Inc. Safety syringe
US9814843B2 (en) 2013-07-01 2017-11-14 Credence Medsystems, Inc. Safety syringe
US9861762B2 (en) 2013-07-01 2018-01-09 Credence Medsystems, Inc. Safety syringe
US9861763B2 (en) 2013-07-01 2018-01-09 Credence Medsystems, Inc. Safety syringe
EP3016703A4 (fr) * 2013-07-01 2017-03-22 Credence Medsystems Inc. Seringue de sécurité
US11285271B2 (en) 2013-07-01 2022-03-29 Credence Medsystems, Inc. Safety syringe
JP2016523664A (ja) * 2013-07-01 2016-08-12 クレデンス メドシステムズ インコーポレイテッド 安全注射器
US10300217B2 (en) 2013-11-15 2019-05-28 Credence Medsystems, Inc. System and method for drug delivery with a safety syringe
US11147928B2 (en) 2013-11-15 2021-10-19 Credence Medsystems, Inc. System and method for drug delivery with a safety syringe
US10010677B2 (en) 2014-04-24 2018-07-03 Credence Medsystems, Inc. System and method for safety syringe
US10926036B2 (en) 2014-04-24 2021-02-23 Credence Medsystems, Inc. System and method for safety syringe
US10173010B2 (en) 2014-04-24 2019-01-08 Credence Medsystems, Inc. System and method for safety syringe
US12144970B2 (en) 2014-04-24 2024-11-19 Credence Medsystems, Inc. System and method for safety syringe

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