US 3559645 A
Abstract available in
Claims available in
Description (OCR text may contain errors)
United States Patent  References Cited UNITED STATES PATENTS 3/1945 Watson et  Inventor Kathryn C.Scha1ler 20301 Lorne St., Canoga Park, Calif. 91306 ] Appl. No. 741,426
2,668,534 2/1954 Barradas et a1. 2,744,527 5/1956 Barrett et a1. Primary ExaminerWamer H. Cam AnomeyJohn .1. Posta, Jr.
 Filed July 1,1968  Patented Feb. 2, 1971  DISPOSABLE SYRINGE 6 Claims, 3 Drawing Figs. 52]
ABSTRACT: A syringe contains a premeasured amount of medication in a hermetically sealed syringe which has a stiletto inserted in the needle and retained in the cap of the syringe, thereby being removed from the needle as the cap is removed 511 lnt.C1................ 50 Field of PATENTEU FEB 2 Ian INVENTOR. KATHRYN 0. SCHALLER K v v /1 ATTORNEY FIG.-l
' 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 difflcult 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. Applicants 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 separatefrom the base member and must be attached thereto by suitable fastening means. Applicants 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.
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. I
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 mass production 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 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 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 along lines 3-3 of FIG. 2.
DESCRIPTION OF THE PREFERRED EMBODIMENT The disposable syringe shown in FIG. I 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 I 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 isboth 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 I at 10 by suitable fastener means such as an adhesive. Container 2 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 cap is in place. Cap 4 has a longitudinally extending portion 1 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 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-defonnable material as the stiletto 3. a
The method of fabrication of the syringe is as follows. Container 2 in its open, unfilled position is attached to the preformed member I at 10 by suitable adhesive means, the opening 9 of container 2 being in alignment with bore 7 in member I. In this position the container 2 is open and does not hold the injectable material.
Cap 14 is now snapped into place on member I 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 IS. The container 2 is then hermetically sealed, as for example, by
folding over the end 1 l 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,
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 needle had to have a small opening of the bore because this was point which pierced a patients 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.
Applicants 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.
1. A single use disposable syringe comprising an integral, needlelike member having an enlarged base portion and an elongated needle portion;
said needle like member having a bore therein extending through the entire length of said base portion and said needle portion;
said bore having a substantially constant cross-sectional diameter extending along the entire length of said needle portion and along only a portion of the length of the base portion;
said bore flaring out at its terminus in the base portion to form a rounded, expanded recess;
a collapsible container attached to said base portion and having a first opening and a second opening whereby a passage is created allowing free communication between the outside of the container and the concave recess in the base portion;
a cap covering said needlelike member and attached to the base portion;
a stiletto attached to said cap and located within said bore, wherein the said stiletto having a cross-sectional diameter substantially equivalent to the cross-sectional diameter of said bore as it extends along the length of said needle portion; and
wherein said rounded, expanded recess is adapted to receive and guide the stiletto into the needle portion.
2, A syringe as set forth in claim 1 wherein said container is filled with an injectable fluid.
3. A syringe as set forth in claim 2 wherein said stiletto is attached to the cap by a heat sealing method.
4. A method for assembling a disposable syringe having a hollow needle with a base portion, a collapsible container of injectable fluid, a closure cap and a stiletto adapted to plug the opening comprising:
attaching the collapsible container to the base portion;
releasingly attaching the closure cap to the base portion;
inserting the stiletto first through the container, then through the base portion, and then through the needle; fastening the stiletto to the closure cap;
filling the container with an injectable liquid; and
sealing said container.
5. The method as set forth in claim 4 wherein the stiletto is fastened to the cap by a heat sealing means.
A 6. The method as set forth in claim 5 wherein the container is' sealed by heat sealing means.