# Patent

## Title
Intravenous liquid flow regulator

## Abstract

A tamper evident protector cap for a pre-filled syringe or cartridge barrel stoppered by an elastomeric closure. The protector cap securely retains the elastomeric closure during in-line processing, handling and shipment. The protector cap includes frangible brackets which on tampering break away from the protector cap evidencing that product integrity might have been jeopardized and the product should not be used.

## Background
1. Field of the Invention

This invention relates to a tamper evident protector cap for a pre-filled syringe barrel. More particularly, the invention relates to a cap for a syringe barrel containing a liquid medication therein for securely holding a closure in the tapered tip of the syringe barrel and serving as a tamper evident indicator.

2. Reported Developments

Pre-filled syringe barrels or cartridges containing injectable solutions therein are stoppered by elastomeric closures, such as soft rubber stoppers at the distal, tapered end thereof, while the proximal end of the barrels are closed by slidable plungers. The pre-filled syringe barrels or cartridges are sterilized, such as by autoclaving, and packaged ready for use.

It has been observed that during in-line processing, handling, and sterilizing the pre-filled barrels some elastomeric closures were missing from the tips of the barrels resulting in rejects. Also, during shipment of the finished product and handling by healthcare professionals some untipped barrels were observed which necessitated the discarding of batches containing failed samples. For product integrity a corrective measure was indicated to prevent the elastomeric closure from becoming dislodged from the tip of the barrel.

More importantly, it has also been recognized that untipped barrels (whether the damage occurred during shipment or handling) attracts the suspicion that the product was tampered with. Such possible tampering is a concern for both the FDA and the manufacturers who are required to insure safety, efficacy and product integrity.

In accordance with the present invention a protective cap is provided for a syringe or cartridge barrel. The syringe or cartridge barrel, comprising a cylindrical chamber containing a pharmaceutical or biological liquid in the form of an injectable solution, terminates in a tapered tip having a bore therethrough. The tapered tip is equipped with a female luer connector barrel to which a male luer connector or an injection needle may be attached. The bore in the tapered tip is stoppered by an elastomeric closure, such as a soft rubber plug. The protective cap covering the tapered tip comprises a cylindrical top portion; and a bottom skirt portion having: two semi-circular walls facing each other and spaced 180.degree. from each other; and two frangible brackets facing each other and spaced 180.degree. from each other, each of the brackets terminating in a horizontal leg adapted to engage the female luer connector barrel. The two semi-circular walls provide strength and rigidity to the protector cap, while the brackets are designed to disengage the female luer connector barrel thereby allowing easy removal of the protector cap. At the point of disengagement the brackets break away from the skirt portion of the protector cap indicating that the protector cap has been removed from the tip of the syringe or cartridge barrel.

FIG. 1 is a perspective view of a syringe barrel equipped with the tamper evident protector cap of the present invention;

FIG. 2 is a perspective view of the tamper evident protector cap removed from the syringe barrel;

FIG. 3 is a side elevational view of the tamper evident protector cap taken along the line 3--3 of FIG. 2;

FIG. 4 is another side elevational view of the tamper evident protector cap turned 90.degree. from that shown in FIG. 3;

FIG. 5 is a bottom plan view of the tamper evident protector cap; and

FIG. 6 is a top plan view thereof.

FIG. 1 shows a typical syringe or cartridge barrel generally designated by the numeral 10, made of glass or a polymeric material having an inner surface 12 defining a cylindrical chamber 13 for retaining a pharmaceutical or biological liquid therein. The barrel has a distal end 14 terminating in a tapered tip 15 having a bore therethrough to which an injection needle or a luer connector with a tubing conduit can be attached, and a proximal end 16 for receiving a plunger 18 which retains the pharmaceutical or biological liquid in the barrel and which, upon use, expels the pharmaceutical or biological liquid from the barrel when an external pressure is exerted on the plunger. The tapered tip 15 having a bore therein is stoppered by a resilient closure 20, such as an elastomeric closure or a soft rubber stopper, for hermetically sealing the distal end of the barrel. At its proximal end 16 the barrel is equipped with an integral flange 22 to facilitate the handling of the barrel. When the pharmaceutical or biological liquid is an injectable solution, the barrel along with its content is sterilized, preferably by autoclave. After sterilization the barrel is packaged and stored ready for use when needed. Delivery of the injectable solution is accomplished by removing the resilient closure from the tapered tip and attaching an injection needed or a luer connector onto the tapered tip of the barrel.

Surrounding the tapered tip 15, a female luer connector barrel 17 is provided for attachment of a male luer connector or an injection needle thereto. The luer connector barrel comprises an open distal end 19, and a closed proximal end 21.

To prevent the risk of fall out of the resilient closure from the tip of the barrel and to insure product integrity against tampering, a protector cap, generally designated by the numeral 24, covers the tip 15 of barrel 10 and securely holds resilient closure 20 in the barrel.

Reference is now made to FIGS. 2-6 wherein: FIG. 2 is a perspective view of the protector cap; FIG. 3 is a side elevational view of the protector cap; FIG. 4 is another side elevational view of the protector cap turned 90.degree. from that shown in FIG. 3; and FIG. 5 and FIG. 6 are bottom plan and top plan view, respectively, of the protector cap. Protector cap 24 comprises: a cylindrical top portion 26 terminating in a circular surface 27, and a bottom somewhat larger cylindrical skirt portion, generally designated by the numeral 28. Skirt portion comprises: a distal top portion 30 extending into top cylindrical portion 26; two semi-circular walls 32 and 32' facing each other and spaced 180.degree. from each other; two frangiblc brackets 34 and 34' facing each other and spaced 180.degree. from each other, each of the frangible brackets terminating in a horizontal leg 36 and 36'.

The protector cap 24 is made of a polymeric material including: polyolefins such as polyethylene and polypropylene; polystyrene, polycarbonate, polymethylpentene, cyclic olefin copolymers, acrylic polymers and methacrylic polymers.

As shown in FIG. 1, protector cap 24 encloses the resilient closure 20 and locks over the luer connector barrel 17. The two frangible brackets 34 and 34' having horizontal legs 36 and 36' engage the proximal end 21 of the luer connector barrel 17 when the protector cap 24 is placed on the tapered tip 15 of the syringe or cartridge barrel 10. The positioning of the protector cap onto the tip of the barrel is accomplished by snapping the protector cap downward so that the horizontal legs 36 and 36' lock over the luer connector barrel 17. Once the protector cap is snapped on the luer connector barrel, it will securely hold the resilient closure in place.

FIGS. 3 and 4 show side elevational views of the protector cap subsequent to its removal from the tip of the barrel. Upon removal of the protector cap by a twisting or lifting motion the frangible brackets 34 and 34' crack and horizontal legs 36 and 36' are released from holding onto the proximal end of the luer connector barrel 21. If the protector cap is tampered with, the healthcare professional will readily observe the separated brackets not holding onto the tapered tip of the syringe or cartridge barrel. The product then will not be used and will be returned to the manufacturer with complaints.

The tamper evident protector cap may also be secured to the tip of the syringe barrel by a bonding adhesive or a solvent. It is also contemplated that the resilient closure or plug may be manufactured integral with the tamper evident protector cap wherein the resilient closure is to be made of a thermoplastic elastomer allowing the use of a two shot mold manufacturing. Syringe or cartridge barrel                  10 Inner surface of syringe or cartridge barrel 12 Cylindrical chamber defined by the inner surface 13 Distal end of barrel                         14 Tapered tip of barrel                        15 Proximal end of barrel                       16 Luer connector barrel                        17 Plunger                                      18 Open distal end of luer connector barrel     19 Resilient closure                            20 Closed proximal end of luer connector barrel 21 Flange of the barrel                         22 Protector cap, generally designated          24 Top cylindrical portion of protector cap     26 Flat circular surface of protector cap       27 Bottom cylindrical skirt portion of protector cap, generally 28 designated Distal top portion of the skirt portion      30 Two semi-circular walls of skirt portion     32 & 32' Two frangible brackets                       34 & 34' Two horizontal legs on the frangible brackets 36 & 36'

Various modifications of the present invention disclosed will become apparent. This invention is intended to include such modifications to be limited only by the scope of the claims.

## Claims

1. A tamper evident protector cap for a pre-filled glass or plastic syringe or cartridge barrel stoppered by an elastomeric closure at its tapered distal end comprising: being spaced 180.degree. from each other; two frangible brackets facing each other and being spaced 180.degree. from each other, having a top portion and a bottom portion; and the bottom portion of each of said bracket is adapted to engage the tapered distal end of a pre-filled syringe or cartridge barrel.

2. The tamper evident protector cap of claim 1 made of a polymeric material selected from the group consisting of polyethylene, polypropylene, polystyrene, polycarbonate, polymethylpentene, cyclic olefin copolymers, acrylic polymers and methacrylic polymers.

3. A tamper evident protector cap and a syringe or cartridge barrel combination wherein said syringe or cartridge barrel comprises: having a bore therethrough, said bore is stoppered by an elastomeric closure, said cylindrical chamber containing an injectable solution therein, wherein said tip is equipped with a female luer connector barrel to which a male luer connector or an injection needle may be attached, said female luer connector barrel comprises an open distal end and a closed proximal end; retaining an expelling the injectable solution from the cylindrical chamber; with said syringe or cartridge barrel and comprises: to and retaining said elastomeric closure in said bore; cylindrical top portion and being integral therewith; two semicircular walls facing each other and being spaced 180.degree. from each other covering said female luer connector barrel; two frangible brackets facing each other and being spaced 180.degree. from each other each of which terminates in a horizontal leg, said horizontal legs engaging the closed proximal end of said female luer connector barrel, wherein upon disengagement of said tamper evident protector cap from said female luer connector barrel, said brackets break away from the skirt portion of the protector cap thereby indicating that the tamper evident protector cap has been removed.

4. The tamper evident protector cap and the syringe or cartridge barrel combination of claim 3 wherein the tamper evident protector cap is made of a polymeric material selected from the group consisting of polyethylene, polypropylene, polystyrene, polycarbonate, polymethylpentene, cyclic olefin copolymers, acrylic polymers and methacrylic polymers.

5. The tamper evident protector cap and the syringe or cartridge barrel combination of claim 3 wherein said elastomeric closure is a soft rubber stopper.

6. The tamper evident protector cap and the syringe or cartridge barrel combination of claim 3 wherein said injectable solution is a pharmaceutical or biological liquid.

7. The tamper evident protector cap and the syringe or cartridge barrel combination of claim 3 wherein said combination containing the injectable solution therein is sterilized by autoclave.