Prefilled, single dose, one time use, self-destructing, auto-disabling safety syringe with an injection molded barrel; method of manufacture and method of use

Abstract

The present invention relates to a single dose, one time use, self-destruction, auto-disabling safety syringe with an injection molded barrel. The invention successfully addresses and solves the problems of the prior art by combining the use of COC injection molding with the advantages presented by the ampoule cartridge and the traditional safety syringe all integrated into a single device. A pre-filled ampoule or barrel is molded with minimal draft enabling the syringe's piston plunger to be partially self-lubricated by the syringe's contents. The addition of an internal auto disabling coupler to the piston plunger allows the device to be used only a single time. In addition, the present invention's structure is such that its safety sleeve necessarily moves forward to cover the syringe's needle after use. The present invention's elements, as combined, solve the biocompatibility and safety problems of the prior art and provide an exact dose, prefilled, single time use, cartridge safety syringe.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a frontal view of the fully assembled preferred embodiment of the invention.

FIG. 2 is a frontal view of the empty barrel.

FIG. 3 is a frontal view of the barrel and the alternative embodiment of the coupling sub-assembly.

FIG. 4 is a frontal view of the pre-filled barrel and the alternative embodiment of the coupling sub-assembly.

FIG. 5 is a frontal view of the barrel and the alternative embodiment of the auto-disabled coupling sub-assembly in the fully distal position.

FIG. 6 is a frontal view of the cartridge barrel with the alternative embodiment of the auto-disabled coupling sub-assembly when the plunger is retracted in an attempt to reuse the syringe.

FIG. 7 is an isometric exploded view of the alternative embodiment of the coupling sub-assembly.

FIG. 8 is an isometric exploded view of the preferred embodiment of the coupler sub-assembly.

FIG. 9 is a frontal view of the alternative embodiment coupling sub-assembly interference with the barrel.

FIG. 10 is a frontal view of the sleeve and hub attached to the barrel.

FIG. 11 is a frontal view of the sleeve snap-assembled to the hub in the first locking position.

FIG. 12 is a frontal view of the sleeve fully extended to the distal position, encapsulating the hub and needle.

FIG. 13 is a frontal view of the sleeve removed from cartridge barrel, encapsulating the hub and needle.

FIG. 14 is an isometric exploded view of the preferred embodiment of the invention.

FIG. 15 is an isometric view of the preferred embodiment of the invention.

FIG. 16 is a frontal view of the needle cap on the syringe in the preferred embodiment of the invention.

FIG. 17 is a frontal view of a standard needle cap on the syringe in the general purpose alternative embodiment of the invention.

FIG. 18 is an isometric view of the small universal hub of an alternative embodiment of the invention with a staked needle.

FIG. 19 is an isometric cross-sectional view of the small universal hub of an alternative embodiment of the invention with a staked needle.

FIG. 20 is an isometric view of the universal hub of the preferred embodiment of the invention with a staked needle.

FIG. 21 is an isometric cross-sectional view of the universal hub of the preferred embodiment of the invention with a staked needle.

FIG. 22 is an isometric view of the luer hub of an alternative embodiment of the invention.

FIG. 23 is an isometric cross-sectional view of the luer hub and cap of an alternative embodiment of the invention.

FIG. 24 is a top view of syringe cartridge barrel.

FIG. 25 is a perspective view of the plunger with the raised rib and embossed logo.

Claims

1. A prefilled, single dose, one time use, self-destructing, auto-disabling safety syringe comprising: a. an injection molded, cyclic olefin copolymer, ampoule cartridge syringe barrel, the barrel comprising opposite proximal and distal ends, the proximal end being open so that it is capable of receiving a plunger, the barrel being molded so the proximal end extends into two opposing tabs perpendicular to the barrel, each tab comprising an ergonomic radius section following the extension point of the tab from the barrel, continuing into a single standing rib for comfortable non-slip use, the barrel comprising an outer surface and an inner surface, the outer surface being capable of receiving ink printing to identify its content, the proximal end's outer surface comprising a recessed well, the well comprising a sterilization indicator, the barrel's distal end comprising three forward positioned internal flat ribs and a universal receiving neck, the neck comprising an interior surface and an exterior surface, the interior surface comprising an internal retention rib, the barrel being suitable to receive an injectable liquid;b. a stopper made from non-reactive compression molded thermoplastic elastomer, the stopper comprising a piston-shaped exterior, a proximal end and a flat distal end configured so it significantly reduces the dead space volume in the barrel, the stopper's proximal end further comprising a threaded female receiving opening;c. a polypropylene coupler comprising a forward male threaded end, an increased diameter circular standing flat rib and a rear female end, the forward end comprising a centered protrusion and being capable of engaging the stopper's female receiving opening by inserting the forward end into the receiving opening and turning the coupler three hundred and sixty degrees clockwise, the flat rib being capable of seating the stopper and allowing the stopper to advance to a fully extended distal position in the barrel, the rear female end of the coupler's diameter being reduced and comprising an internally threaded receiving means and four longitudinally split side arms, the side arms comprising multiple standing flex fingers capable of engaging a coupler ring, the coupler being further capable of aspirating proximally and distally inside the barrel as one interconnected assembly, the coupler being capable of interacting with the barrel's internal flat ribs to allow the release of the coupler upon completion of the administration of the syringe's contents;d. a rigid, cylindrical coupler ring, the ring being capable of being firmly snap-fitted onto the coupler's side arms to create an inside dimension interference which allows a firm engagement of the coupler and the coupler ring, the coupler ring being capable of being disengaged from the coupler;e. a plunger comprising a cylindrical shaft, the shaft being smaller in diameter than the barrel, the shaft comprising opposite proximal and distal ends, the distal end being circular so it can be received by and be inserted into the barrel's proximal end opening, the proximal end ending in a cylindrical disk, the cylindrical disk comprising a circular raised rib along the exterior of the disk's diameter and a embossed logo capable of frictionally reducing slippage, the shaft being X-braced to a forward-positioned, standing raised rib that approximates the inner diameter of the barrel and centers the plunger along the inside diameter of the cartridge barrel upon insertion, the shaft's distal end further comprising a self-centering snap-assembled threaded male end comprising a snap attachment means, the threaded male end being capable of being inserted through the coupler ring and firmly snap-fitting into the coupler's threaded receiving means, the plunger being capable of releasing the coupler upon moving the plunger forward, after administration of the syringe's contents;f. the stopper, the coupler, the coupler ring, and the plunger forming an auto-disabling coupling sub-assembly, the sub-assembly being capable of pushing the single dose of medication located in the barrel between the barrel's neck and the stopper;g. the sub-assembly being capable of snap assembly into a single unit and being inserted into the proximal end of the cartridge barrel so that when the stopper, coupler, and coupler ring are advanced by the plunger to a distal position the coupler ring interference engages the three flat ribs of the barrel releasing the coupler ring from the coupler and allowing the flex fingers to expand, which in turn creates an interference from the stopper against the flat ribs of the barrel and allows the coupler's flex fingers to disengage from the plunger rendering the syringe useless;h. a plunger cap being capable of creating a sterile internal environment due to a dynamic interface triple seal lock;i. a polypropylene male needle hub comprising a rear end and a forward end, the hub being capable of being connected to the barrel by a male snap insertion to the barrel's universal receiving neck and held in place by an undercut of the male hub and the standing internal retention rib of the barrel's neck, the hub's rear end comprising a uniform internal surface capable of being aligned with the exterior of the barrel's neck creating a uniform surface interference for snap assembly, the hub further comprising opposing dual flex fingers and dual opposing flat ribs, the dual flex fingers being capable of engaging a sleeve, the hub's forward end comprising three raised ribs and a dimple, the raised ribs being capable of creating a sterile barrier, the dimple comprising uv-cured adhesive capable of adhering a needle, multiple spiral relief dimensional undercuts and a low dead space center opening;j. a needle or cannula capable of being inserted into and adhered to central opening of the needle hub and creating a mechanical lock with the dimple's spiral relief dimensional undercuts and uv-cured adhesive;k. a needle cap comprising an exterior shell, an interior, an engaging end and a closed end, the exterior shell being made of high-impact polypropylene, the interior comprising soft thermoplastic elastomer capable of engaging the needle in such a way that leakage of the barrel's contents is prevented, the engaging end being designed to firmly engage the three standing coaxial ribs on the needle hub's surface preserving the sterile environment, the cap further comprising four standing coaxial ribs extending horizontally around the outer circumference of the closed end being capable of creating a non-slip grip for ease of removal of the cap from the hub, the cap being capable of connecting to the hub's extended forward end's raised ribs in such a way that a sterile environment is created in the space between the needle and the cap; andl. a transparent cyclic olefin copolymer elliptical shaped sleeve, the sleeve being capable of sliding over the barrel for snap assembly to the needle hub's flex fingers, the sleeve's length being determined by the length of the needle, the sleeve comprising an inner side, an outer side, an open proximal end, an open distal end, and two opposing series of horizontal locking slats, the two opposing series of horizontal locking slats extending from the proximal end to the distal end of the sheath and comprising rectangular holes that extend from the inner side to the outer side between the slats, the slats being capable of engaging the hub's flex fingers, resulting in the slats being oriented ninety degrees away from the needle hub's dual opposing flat ribs and the sleeve and the hub being locked together, the hub's flex fingers being capable of locking onto any of the slats in forward distal positions as the sleeve is advanced and preventing the sleeve from moving proximally, the inner side of the proximal end comprising interference shelves capable of irreversibly engaging the needle hub when the sleeve is extended past the locking slats to a fully distal position, the fully distal position resulting in anti-needle stick protection as the sleeve is capable of extending past the needle, the outer side comprising a bioindicator and a raised rib extending along the center of each set of locking slats, the raised ribs being perpendicular to the slats, the distal end being molded so the distal end extends into two opposing tabs perpendicular to the sleeve, each tab comprising an ergonomic radius section following the extension point of the tab from the sleeve, continuing into a single standing rib for comfortable non-slip use, the tabs being capable of being rotated axially when the sleeve is engaged with the hub flex fingers allowing for the correct needle bevel orientation for injection, the sleeve's elliptical shape being capable of creating a lens effect, resulting in one hundred percent visibility of the contents of the barrel.

2. The prefilled, single dose, one time use, auto-disabling, self-destructing, safety syringe according to claim 1, wherein the plunger is manufactured from a material selected from the group consisting of polypropylene or cyclic olefin copolymer.

3. The prefilled, single dose, one time use, auto-disabling, self-destructing, safety syringe according to claim 1, wherein the hub is a staked hub and the needle is a traditional syringe needle.

4. The prefilled, single dose, one time use, auto-disabling, self-destructing, safety syringe according to claim 1, wherein the hub is a luer hub to which a needle or lumen can be attached, said luer hub comprising a two-part cap and a threaded base, the two-part cap being made of polypropylene and thermo plastic elastomer, and the two-part cap being capable of compressing the thermo plastic elastomer creating a sterile barrier upon screw tightening of the cap onto the hub.

5. The prefilled, single dose, one time use, auto-disabling, self-destructing, safety syringe according to claim 1, wherein the barrel, the plunger and the sleeve are shorter in length for small doses of injectable liquid, the hub is a small universal needle hub, and the small needle hub comprises small flex fingers and small dual opposing linear ribs.

6. The single dose, one time use, auto-disabling, self-destructing, safety syringe according to claim 1, wherein: a. the plunger comprises a chamfered male distal end capable of snap-insertion into a coupler's chamfered female receiving means;b. the coupler comprises a chamfered male distal end and a chamfered female receiving means at the proximal end, the male distal end being capable of firmly snap-fitting into a stopper's chamfered female receiving end, and the female receiving means being capable of firmly snap-fitting with the plunger's distal end;c. the plunger being elongated; andd. the stopper comprising a chamfered female receiving opening capable of firmly snap-fitting with the male distal end of the coupler so that the single dose can be drawn from a separate container prior to injection.

7. A method of using the prefilled, single dose, one time use, auto-disabling, self-destructing, safety syringe, comprising the steps of: a. providing a syringe as that claimed in claim 1 contained in a sterile blister package;b. removing the syringe from the sterile blister package;c. removing the needle cap;d. properly orienting the needle by twisting the sleeve tabs;e. administering the syringe's contents to a patient via injection by depressing the plunger to a full distal position or completed injection;f. holding the sleeve tabs;g. pulling back the barrel tabs resulting in encapsulating the hub and needle into the sleeve without the needle ever being exposed;h. allowing the coupling sub-assembly to disengage automatically resulting in the plunger being released from the internal coupler, further resulting in the syringe not being capable of being reused accidentally or intentionally under any conceivable set of circumstances; andi. placing the used syringe in a sharps container.