Disposable syringe

BACKGROUND OF THE INVENTION

The invention is directed to the art of hypodermic syringes and more particularly relates to a single-use disposable hypodermic syringe.

The prior art relating to the invention generally provides disposable syringes which are complex in both construction and mode of operation, and which furthermore are difficult to mass-produce in large quantities. Prior art syringes which provide a stiletto for insertion into the needle are generally designed to have the stiletto inserted into the needle from the pointed end. Inasmuch as the needle ordinarily has a quite small opening, it becomes readily apparent that the insertion of the stiletto in this manner requires the use of either time consuming hand labor or high-precision manufacturing equipment. Applicant’s invention enables the manufacture of such syringes without the use of such high-precision equipment, by providing for insertion of the stiletto into the end opposite the pointed end, using an expanded bore area in the base portion of the syringe as a guide. This guide enables the use of less than precision equipment in the manufacture and assembly of applicant’s syringe, and lends itself to the use of highly automated, mass-production techniques.

Prior art disposable syringes also generally provide a structure made from a plurality of components which must be assembled to form a complete structure. For example, the needle of the syringe is generally separate from the base member and must be attached thereto by suitable fastening means. Ap- 30 plicant’s invention dispenses with the need for such assembly steps by providing a single unitary structure for said needle and base member, thereby again enabling ease of manufacture.

at the other end thereof. The base member has an expanded bore area within about the base portion of the needle opening. The stiletto is then inserted into the container through the base member, through the needle, and into the recess formed at the top of the cap. The container for the liquid and the capping member are formed from a heat deformable material, such as elastomeric plastic, capable of being heat sealed. After the insertion of the stiletto, the container is filled with the injectable liquid, with the open end thereof then, being heat sealed into a closed position. The recess of the capping member with the stiletto extended therein is likewise heat sealed in a manner to fasten the stiletto to the capping member. The syringe is now in a readily useable state. Removal of the capping member will result in the simultaneous removal of the stiletto from the needle, thereby presenting a sterile needle ready for its intended use.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is an exploded, sectional view of the components of the syringe.

FIG. 2 is a side view of the completed syringe with its component parts in place.

FIG. 3 is a sectional view of the completed syringe taken along lines 3-3 of FIG. 2.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The disposable syringe shown in FIG. 1 essentially consists of four components; a member 1, a collapsible fluid container 2, a stiletto 3, and a cap 4. Member 1 can be made from any suitable rigid material, which is preferably heat resistant. The member 1 is of unitary construction and has a needlelike portion 5 and an enlarged base portion 6. A longitudinal bore 7 of small diameter extends through the base portion 6 and needlelike portion 5 of member 1. The bore 7 is of a substantially constant diameter excepting at the terminus 8 of the base portion 6 wherein it rapidly increases in diameter to form an expanded bore area within said base portion 6.

Container 2 is both hollow and collapsible, and is made from any suitable, heat-sealable, flexible material which may be heat resistant, such as an elastomeric plastic material. The container is attached to the lower portion of member 1 at 10 by suitable fastener means such as an adhesive. Container 2 45 has an opening 9 on the upper surface thereof which is in alignment with the base 7 and expanded bore area 8 in the base .portion 6 of member 1, to enable the free flow of the injectable material from the container through member 1. The lower end 11 of container 2 is open in its preassembly assembly, but after loading with the injectable material, is adapted to be hermetically sealed by suitable closure means, such as being folded over upon itself and heat sealed as shown in FIGS. 2 and 3.

Stiletto 3 is a solid rod of rigid material, preferably of a heatdeformable plastic. Stiletto 3 has a cross-sectional diameter which is substantially the same as the diameter of bore 7 and is of a length equal to at least the distance between the top of cap 4 and the bottom of base portion 6 of member 1 when the 60 ^caP ^is *ⁿ P^lace· ^CaP 4 has a longitudinally extending portion adapted to completely cover the member 1 and includes suitable fastening means for maintaining the cap in place, such as the circumferentially extending raised portion 12 on the inner lip surface of cap 4 which is adapted to be snapped into place 65 in the circumferentially extending recess 13 extending about the outer lower surface of base portion 6. Cap 4 further has a recess 14 on its top portion adapted to receive the stiletto 3. Cap 4 is made from the same heat-deformable material as the stiletto 3. '

The method of fabrication of the syringe is as follows. Container 2 in its open, unfilled position is attached to the preformed member 1 at 10 by suitable adhesive means, the opening 9 of container 2 being in alignment with bore 7 in member 1. In this position the container 2 is open and does

SUMMARY OF THE INVENTION

An object of the invention is to provide a novel hypodermic syringe.

Another object of the invention is to provide a single-use disposable hypodermic syringe.

A further object of the invention is to provide a single-use disposable hypodermic syringe which is fully sealed, with the needle and injectable material being maintained in a sterile condition at all times.

A still further object of the invention is to provide a sealed single-use disposable syringe which can be stored for long periods of time and can be easily shipped and handled, even relatively roughly, without in anyway destroying the immediate usefulness and efficacy of the single-use disposable syringe when it is desired to be put into use.

Yet another object of the invention is to provide a single-use disposable hypodermic syringe which has a sanitary construction with a stiletto, attached to the cap, and adapted to be inserted into the needle to maintain the Syringe into a sterile condition.

Another object of the invention is to provide a syringe of the character referred to herein which is of extremely simple and inexpensive construction and suitable for fabrication by massproduction techniques at extremely low cost per item, both as to initial tooling and as to the actual production cost per item, and thereby being conducive to widespread production and distribution, and use of the invention for the purposes outlined herein.

The invention generally comprises a syringe having a needle and base member, a capping member, a stiletto attached to the capping member and adapted to be inserted in the needle and a collapsible container for fluid attached to the base member. The capping member has a recess at its top adapted to receive the stiletto. The cap is snapped in place over the 70 needle and into a circumferential recess on the base member. The needle and base member are formed as an integral, unitary structure. The syringe assembly is designed to be assembled under sterile conditions. The container is initially open at one ___________ __________ ________ end thereof and attached to the underside of the base member 75 not hold the injectable material.

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Cap 14 is now snapped into place on member 1 by locating the raised portion 12 thereof in recess 13 of member 1. At this point, the subassembly of member 1. container 2 and cap 4, along with the stiletto 3 are sterilized by suitable, well-known sterilizing means, such as heat treatment, antiseptic washing, etc. From this point forward, the assembly of the syringes is performed under sterile conditions. The stiletto 3 is then inserted through the container 2 and its opening 9 into the bore 7 integral member 1, and into the recess 14 of cap 4, thereby plugging the bore 7.

The assembly is then turned upside down and the container 2 is filled with a premeasured dose of the injectable fluid 15. The container 2 is then hermetically sealed, as for example, by folding over the end 11 of container 2 and heat sealing same as shown at 16 in FIG. 3. The upper end of the stiletto which is nested in recess 14 is now joined to the cap 4, as for example, by crimping, or by folding over the top of the cap 4 with stiletto 3 therein and heat sealing, as shown at 17 in FIG. 3.

FIG. 3 shows the hypodermic syringe in its assembled form and ready for use. When one desires to use the syringe, the cap 4 is pulled off, thereby simultaneously removing stiletto 3 from base 7.

It is readily apparent that the construction of the syringe and its method of assembly described hereinabove lends itself very well to automation by mass-production techniques? Heretofore, disposable syringes with stiletto inserted in the needle always provided for insertion of the stiletto into the needle from above. The top of the needje had to have a small opening of the bore because this was point which pierced a patient’s skin and entered his body. Because the opening in the needle was so small (necessarily), it made the insertion of a stiletto into the opening rather difficult and time consuming. In any attempt to automate the fabrication of the syringes, one would have had to have very precise tooling and machines, which would have had to hold exceedingly small tolerances.

Applicant's invention dispenses with the need for such close tolerance automated machinery and assembly procedures by virtue of the fact that the stiletto is inserted from below through an expanded bore area in the base member which serves as the locating guide.

It should be noted that the cap 4 has several functions, including keeping the needle in a sterile condition, preventing deformation of the needle, and carrying the stiletto which is inserted in the needle.

It should be understood that the FIGS, and the specific description thereof set forth in this application are for the purpose of illustrating the present invention and are not to be construed as limiting, the present invention to the precise and detailed specific structure shown in the FIGS, and specifically described hereinbefore. Rather, the real invention is intended to include substantially equivalent constructions embodying the basic teachings and inventive concept of the present invention.