Disposable Safety Syringe Having Means for Retracting Its Needle Cannula Into Its Medication Cartridge

1. FIELD OF THE INVENTION

This invention relates to a disposable safety syringe, such as a dental syringe, having a pre-filled fluid medication cartridge and a double-ended hypodermic needle cannula, and, more particularly, to means by which the needle cannula may be relocated from an axially extended position, at which to inject the fluid contents of the medication cartridge into a targeted tissue area, to a retracted position, at which the cannula is withdrawn into and completely shielded by the medication cartridge at the interior of the syringe cylinder.

2. PRIOR ART

Dental syringes of the type having a pre-filled cartridge of fluid medication and a double-ended hypodermic needle are well-known in the art for injecting such medication from the cartridge to a targeted tissue area of a patient. However, at the completion of the injection, the needle is typically locked in an axially extended position projecting outwardly from a distal bore formed through the syringe cylinder.

In some cases, the syringe may be used to treat a patient having a communicable disease. Prior to disposing the syringe, the hypodermic needle is frequently broken or destroyed to prevent reuse. Dental office workers are especially susceptable to accidental and potentially infectious needle strikes due to the careless handling or breaking of the needle and disposing of the syringe after use. The resulting mini-accident caused by an accidental needle strike typically requires a blood test for such diseases as AIDS and hepatitis. The corresponding cost and ineffiency of testing dental office workers who have received such an accidental needle strike result in considerable waste, which may be particularly damaging to a dental facility which is striving for economy.

The following patent applications, which are assigned or will be assigned to the assignee of the present patent application, disclose syringes having a pre-filled medication cartridge and a needle which is retractable within the syringe cylinder:

Application Ser. No. 39,715 filed Apr. 20, 1987 and entitled "Dental syringe having an automatically retractable needle"; application Ser. No. 101,251 filed Sept. 25, 1987 and entitled "Disposable, presterilizable syringe for a pre-filled medication cartridge"; and Application Docket No. HMTC-34 entitled "Retractable needle syringe with integral spring".

Briefly, the present invention relates to a disposable safety syringe, such as a dental syringe, or the like, by which a hypodermic needle cannula may be retracted into an evacuated medication cartridge at the interior of the syringe cylinder so as to prevent reuse of the syringe and permit the syringe to be safely handled and discarded without subjecting health care workers to an accidental needle strike and the spread of a contagious and, possible life threatening, disease. The syringe includes a hollow cylinder having proximal and distal ends and a bore formed through the distal end. A pair of inwardly projecting needle retaining shoulders are hingedly connected to the distal end of the cylinder to define a bore therebetween. A double-ended needle cannula extends through and is retained within the distal bore by means of a thermal bond to prevent movement of the cannula relative to the bore. A first end of the cannula extends into the interior of the cylinder, and an opposite, second end of the cannula extends outwardly from the cylinder for administering an injection at a targeted tissue area.

A pre-filled fluid medication cartridge is loaded into the cylinder through the proximal end so as to be spaced axially from the first end of the needle cannula. The cartridge contains a piston which is movable through the cartridge to expulse the fluid contents. A combination needle sheath/piston stem has a relatively wide sleeve formed at one end and a pair of flexible gripping arms projecting axially from the opposite end Initially, the wide sleeve of the needle sheath/piston stem surrounds and sheaths the second end of the needle cannula to prevent the contamination thereof and avoid an accidental needle strike.

In operation, the medication cartridge is advanced distally through the syringe cylinder until the first end of the needle cannula penetrates the cartridge to communicate with the fluid contents thereof. The second end of the cannula is unsheathed, and the flexible gripping arms of the needle sheath/piston stem are detachably connected to the piston at the interior of the medication cartridge to complete a piston assembly. An axial force is then applied to the piston stem to correspondingly drive the piston distally through the cartridge to expulse the contents thereof via the cannula, such that the piston is penetrated by the first end of the cannula. After the medication cartridge has been emptied, the axial force is reapplied to the piston stem to cause the cartridge to move distally through the syringe cylinder and into contact with the needle retaining shoulders at the distal end of the cylinder. The axial force is transferred from the cartridge to the distal end of the cylinder, whereby to cause the needle retaining shoulders to rotate relative to the needle cannula and thereby break the bond formed between the shoulders and the cannula. The distal bore is thereby opened to release the cannula therefrom. The piston stem then moves the piston proximally through the cartridge to correspondingly retract the cannula through the opened distal bore and into the medication cartridge, wherein the cannula is completely shielded and irretrievably located.

FIG. 1 is an exploded view of the disposable safety syringe which forms the present invention;

FIG. 2 is an enlarged detail of the syringe of FIG. 1;

FIG. 3 is a cross-section showing the syringe of FIG. 1 in the assembled relationship;

FIG. 4 illustrates the operational step of moving a medication cartridge distally through the syringe cylinder until a needle cannula penetrates the cartridge at the interior of the syringe cylinder;

FIG. 5 illustrates the detachable connection of a piston stem to a piston of the medication cartridge by which the piston can be moved axially through the cartridge;

FIGS. 6a and 6b illustrate enlarged details for detachably connecting the piston stem to the piston of FIG. 5;

FIG. 7 illustrates the operational step of moving the medication cartridge distally through the syringe cylinder and into contact with the distal end of the cylinder for breaking the bond formed between the needle cannula and a distal bore; and

FIG. 8 illustrates the operational step of moving the piston proximally through the medication cartridge for retracting the needle cannula through the distal bore and into said cartridge.

The disposable safety syringe 1 of the present invention is best described while referring to the drawings, where FIG. 1 illustrates an exploded view of the syringe components. More particularly, syringe 1 includes a hollow cylinder or barrel 2 having an open proximal end and a partially closed distal end. A major flange 3 extends around the open proximal end of the syringe cylinder 2. A relatively narrow flange 4 extends around the periphery of cylinder 2 intermediate the proximal and distal ends. An integral, flexible sealing gasket 6 projects outwardly through the open proximal end of cylinder 2. The details of gasket 6 will be described in greater detail hereinafter when referring to FIG. 2. Proximal and distal locking detents 8 and 10 project inwardly from opposite sides of the cylinder 2. The functions performed by locking detents 8 and 10 will be better described when referring to FIG. 3. Briefly, however, a notch (best illustrated in FIG. 3) is formed through cylinder 2 around the top and sides of locking detents 8 and 10 to permit detents 8 and 10 to rotate slightly in an outward direction relative to cylinder 2.

The distal end of cylinder 2 includes a narrow bore 12 which receives and retains a double-ended hypodermic needle cannula 18 to permit fluid to be delivered from the syringe 1 to a targeted tissue area of a patient. Needle cannula 18 includes a fluid port 19 (best shown in FIG. 3) which enables substantially all of the fluid from syringe 1 to be injected into the targeted tissue area. The distal bore 12 is defined by a pair of oppositely disposed needle retaining shoulders 14 and 16 which, as will soon be explained, are hingedly connected to the distal end of cylinder 2 so as to be adapted for rotation in an outward direction relative to the cylinder (best illustrated in FIG. 7).

A pre-filled medication cartridge or ampule 20 is of suitable size so as to be loaded into the syringe cylinder 2 through the open proximal end thereof so that the contents of cartridge 20 may be delivered to the targeted tissue area via needle cannula 18. Cartridge 20 is typically formed from a transparent material (e.g. glass, or the like) and is filled with a fluid medication, such as Novacaine, or the like. A rubber seal 22 extends across a distal end of cartridge 20, and a metal end cap 24 secures seal 22 to the cartridge. A neck 25 of relatively reduced diameter is formed around the periphery of cartridge 20 below end cap 24. A piston 26 is located at the proximal end of cartridge 20. Piston 26 is slideable axially through the cartridge to expulse the fluid contents thereof (via cannula 18). The piston 28 of cartridge 26 includes a proximally projecting plug member 28, the purpose and advantage of which will be described when referring to FIGS. 6a and 6b.

Syringe 1 also includes a combination needle sheath and piston stem 30. The combination needle sheath and piston stem 30 has a substantially hollow, elongated body with a relatively wide sleeve 32 formed at one end and a pair of oppositely disposed, flexible gripping arms 34 projecting from the opposite end. A small locating bump 36 projects outwardly from each gripping arm 34. As is best shown in FIG. 3, the combination needle sheath/piston stem 30 functions as a needle sheath, such that sleeve 32 receives and surrounds one end of the needle cannula 18. As is best shown in FIG. 5, needle sheath/piston stem 30 also functions as a piston stem, such that the pair of gripping arms 34 are releasably connected to the piston 26 of medication cartridge 20 to form a piston assembly.

FIG. 2 shows an enlarged detail of the flexible sealing gasket 6 which is integrally connected to the proximal end of syringe cylinder 2. More particularly, gasket 6 is hingedly connected to cylinder 2 so as to be adapted for rotation from an outwardly projecting position (as illustrated in FIG. 1) to an inwardly projecting position relative to the interior of cylinder 2 (as shown in phantom and designated by the reference numeral 6-1 of FIG. 2). The means and advantage for rotating sealing gasket 6 into the interior of cylinder 2 is now described while referring to FIG. 3.

FIG. 3 shows the disposable safety syringe 1 in an assembled configuration so as to be suitable for packaging and shipment to health care workers. In the assembled relationship, the needle cannula 18 is retained within the distal bore 12 of syringe cylinder 2 by a thermal bond that is formed between the cannula and the opposing needle retaining shoulders 14 and 16. One end of cannula 18 extends proximally into the interior of cylinder 2 and is adapted to penetrate the seal of the medication cartridge 20. The opposite end of cannula 18 extends distally and outwardly from the cylinder 2 for injecting the contents of cartridge 20 into the targeted tissue area. The distally extending end of needle cannula 18 is initially surrounded and protected by the needle sheath 30 so as to preserve the sterility of cannula 18 and prevent an accidental needle strike. More particularly, the relatively wide sleeve 32 of needle sheath 30 is placed over the proximal end of cylinder 2 until a flanged end of sheath 30 engages the intermediate flange 4 of cylinder 2. It may be desirable to heat seal sleeve 32 to flange 4 to prevent a premature removal of needle sheath 30 from cylinder 2.

The medication cartridge 20 is loaded through the open proximal end of and advanced distally through the syringe cylinder 2 until the proximal locking detent 8 is received in a snap-fit engagement within the neck 25 of cartridge 20. Accordingly, cartridge 20 is initially retained within cylinder 2 in spaced, axial alignment with the needle cannula 18, such that a small portion of the cartridge 20 extends outwardly from the proximal end of cylinder 2.

At the same time that medication cartridge 20 is loaded into the syringe cylinder 2, the flexible sealing gasket 6 is engaged by cartridge 20 and rotated from the outwardly projecting position of FIG. 1 to the inwardly projecting position (represented by reference numeral 6-1) of FIG. 2. That is, the distal advancement of cartridge 20 through cylinder 2 automatically rotates gasket 6, so that an air-tight seal is formed between cylinder 2 and cartridge 20 to preserve the sterility of needle 18 by preventing contaminated air from reaching cannula 18 via the space between the cylinder 2 and the cartridge 20.

The operation of the syringe 1 of the present invention is now described while referring to FIGS. 4-8 of the drawings. In FIG. 4, the user places his index and middle fingers under the major flange 3 of syringe cylinder 2 and his thumb against the end of medication cartridge 20 which extends outwardly from the cylinder 2 (best represented in FIG. 2). The user then uses his thumb to exert an axial force upon the medication cartridge 20 (in the direction of the reference arrow) by which to rotate proximal locking detent 8 out of engagement with the neck 25 of cartridge 20 and thereby permit cartridge 20 to be driven distally through cylinder 2. The continued application of the axial force to cartridge 20 causes the cartridge to slide through cylinder 2 until the respective proximal ends of cartridge 20 and cylinder 2 lie adjacent one another and the proximally extending end of cannula 18 penetrates the rubber seal 22 to communicate with the fluid contents of cartridge 20, so that an injection of the contents may be subsequently administered. Accordingly, the distal locking detent 10 is received in a snap-fit engagement within the neck 25 of cartridge 20, and the cartridge 20 is retained in spaced proximity to the needle retaining shoulders 14 and 16 at the distal end of syringe cylinder 2.

In FIG. 5 of the drawings, the user removes the needle sheath/piston stem 30 to unsheath the distally extending end of needle cannula 18. The user then grasps the cylinder 2 of syringe 1 with one hand and uses his opposite hand to attach needle sheath/piston stem 30 to the piston 26 of medication cartridge 20 to complete a piston assembly comprising a piston head 26 and an elongated piston stem 30.

More particularly, and referring concurrently to FIGS. 5 and 6 of the drawings, the user applies an axial force (in the direction of the reference arrow in FIG. 5) to the piston stem 30 to move the flexible gripping arms 34 through the proximal end of medication cartridge 20 and adjacent the plug member 28 of piston 26. As is best shown in FIG. 6a, each gripping arm 34 terminates at an inwardly projecting retaining finger 40. As the piston stem 30 is moved through the cartridge 20 (in the manner illustrated in FIG. 6b) to drive the piston 26 distally through the cartridge, the locating bumps 36 of gripping arms 34 will contact the interior walls of cartridge 20, whereby to cause the flexible gripping arms 34 to rotate inwardly towards plug member 28. A rotation of the gripping arms 34 correspondingly causes the inwardly projecting retaining fingers 40 to be rotated into engagement with and releasably retained by a relatively narrow neck 42 formed around the plug member 28 of piston 26. Therefore, so long as the locating bumps 36 on gripping arms 34 of piston stem 30 are located within the interior of medication cartridge 20, the retaining fingers 40 will be held within the neck 42 of plug member 28 to prevent the detachment of piston stem 30 from piston 26.

In FIG. 7 of the drawings, the user administers an injection by keeping his index and middle fingers located behind the major flange 3 of cylinder 2 and relocating his thumb to the sleeve 32 of piston stem 30. The user then applies an axial force to sleeve 32 (in the direction of the reference arrow) to drive the piston 26 distally through medication cartridge 20 to expulse the fluid contents thereof through the needle cannula 18 and into the targeted tissue area of the patient. It may be noted that by virtue of the fluid port 19 in cannula 18, substantially all of the fluid may be expulsed from cartridge 20 as the piston 26 is advanced to the distal end of the cartridge. Moreover, the proximally extending end of the needle cannula 18 penetrates and is thereby connected to piston 26 when the piston is moved completely through cartridge 20 to expulse the fluid therefrom.

Once the medication cartridge 20 has been emptied and the injection completed, the user continues to apply an axial force to the sleeve 32 of piston stem 30. Accordingly, the piston 26 (which has already been driven to the distal end of cartridge 20) transfers the axially applied force to the cartridge, so as to cause the distal locking detent 8 to rotate out of engagement with the neck 25 of cartridge 20 and thereby permit an additional distal movement of the cartridge through the syringe cylinder 2. The continued application of the axially applied force to sleeve 32 advances medication cartridge 20 distally through cylinder 2 until the metal end cap 24 thereof is moved into contact with needle retaining shoulders 14 and 16. The axially applied force is then transferred from the cartridge 20 to the inwardly projecting needle retaining shoulders 14 and 16 to cause said shoulders to rotate (in the direction of the reference arrows) around their respective integral (i.e. living) hinges at the distal end of cylinder 2 to thereby break the thermal bond between needle cannula 18 and shoulders 14 and 16. With the bond broken and the needle 18 no longer retained between shoulders 14 and 16, the needle cannula 18 is free to move relative to shoulders 14 and 16 through the distal bore 12 of syringe cylinder 2.

To this end, FIG. 8 of the drawings shows the needle cannula 18 of syringe 1 being withdrawn through the distal bore 12 to be retracted within and completely surrounded by the empty medication cartridge 20. More particularly, the user grasps and pulls the piston stem 30 proximally through cylinder 2, whereby the needle is relocated from an axially extended position (shown in phantom and designated by reference numeral 18-1) to an inwardly retracted position. When the piston stem (shown in phantom and designated 30-1) is pulled to the proximal end of medication cartridge 20, such that the locating bumps 36 are removed therefrom, the retaining fingers 40 of the respective gripping arms 34 are automatically rotated (in the direction of the reference arrows) out of engagement with the neck 42 of piston plug member 28. Therefore, the piston stem 30 may be detached from piston 26 and discarded. However, the piston 26 remains disposed within the proximal end of cartridge 20, such that the needle 18 is retained at an inaccessible location within the interior of the cartridge. Accordingly, the syringe 1 is now suitable for disposal with the needle cannula 18 safely retracted within and completely shielded by both the medication cartridge 20 and the cylinder 2, whereby to prevent a reuse of the syringe 1 and its cannula 18 and avoid an accidental needle strike and the spread of a communicable and, possibly life threatening, disease by eliminating the need to handle or cut the cannula as has heretofore been required with conventional syringes.

It will be apparent that while a preferred embodiment has been shown and described, various modifications and changes may be made without departing from the true spirit and scope of the invention. For example, the syringe 1 of the present invention has been described as having application as a dental syringe. Nevertheless, this should not be regarded as a limitation of the scope of the invention, and the claims which are apppended hereto are applicable to other syringes which use a pre-filled medication cartridge, where it is desirable to retract the needle cannula within the cartridge in order to render the syringe safe for handling and/or disposal .