Background Of The Invention Prior art labeling systems for syringes typically used by medical personnel are highly prone to human error, often resulting in what is referred to as"syringe swaps"or giving a patient the wrong medication due to mislabeling of the syringe and often resulting in serious health complications or even the death of the patient.

It has been estimated that over half the amount of malpractice cases are attributable to these syringe swaps. One prior art labeling system commonly used by hospitals and other medical facilities requires medical personnel to manually write the required information on a blank label, such as the type of medication and concentration. Then, the label must be manually applied to the correct syringe.

One major disadvantage to this method is that the medical personnel might inadvertently write the wrong information on the label. Another major disadvantage is that the medical personnel might put the label on the wrong syringe. In addition, the current method of labeling syringes has the additional disadvantage of requiring extra time and materials.

It is highly desirable to have a new and improved method and apparatus for labeling medication which minimizes the time and necessary materials. Further, it is highly desirable to have a pre-labeled device designed for easy insertion onto a syringe which already contains the required information such as type of medication and concentration, resulting in a significant reduction of mislabeling. Further, a device designed to prevent the problem of labeling the wrong syringe is needed. Still further yet, it is highly desirable to have a device and method for using the device which can help medical personnel quickly and easily check whether the labeled syringe has the indicated medication. Thus, it is highly desirable to have an improved device and method which significantly reduces the prior art problems of dangerous syringe swaps.

Summary Of The Invention The invention provides in one aspect a method for the identification of a syringe containing medication comprising the steps of: mounting and then sealing the flip top lid onto a medicine vial whereby the rubber seal is protected; removing the flip top lid from the medicine vial whereby medicine may be removed from the vial by the syringe; and mounting the flip top lid comprising a label containing indicia of medicine identification onto the plunger base of a syringe whereby the syringe is labeled.

The invention provides in another aspect a flip top lid for labeling or identifying the contents of a syringe of a type which withdraws medication from a vial or the like. The flip top lid comprises an inner surface and an outer surface, with the lid having a label for displaying information of the medicine in the vial on

one of the surfaces. The lid further comprises attachment means for mounting the lid onto a plunger base of the syringe whereby the label containing the information is displayed upon the syringe.

The invention provides in yet another aspect a flip top lid for labeling the contents of a syringe, the flip top lid comprising: an inner surface and an outer surface; the inner surface comprising attachment means for sealing said lid to a medicine vial; said outer surface of said lid having a label containing tactile identification indicia of said type of medicine in said vial; said lid having means for mounting said lid onto said plunger base of said syringe whereby said tactile indicia is contacted by medical personnel when said syringe is handled.

The invention provides in still another aspect a method for labeling the contents of a syringe, the method comprising the steps of: utilizing a non-toxic colored dye to color medications whereby designated colors represent a class of medications.

These and other aspects of the invention are herein described in particularized detail with reference to the accompanying Figures.

Detailed Description Of The Figures In the accompanying Figures: FIG. 1 is a schematic perspective view of a conventional syringe assembly and conventional medicine vial and a label cap of the present invention; FIG. 2 is a schematic perspective view of the label cap mounted on the syringe assembly as shown in FIG. 1;

FIG. 3 is a side elevational view of the label cap mounted on the syringe assembly as shown in FIG. 2; FIG. 4 is a cross sectional view in the direction 4-4 of the assembly as shown in FIG. 3; FIGS. 5A-5H show substantially enlarged perspective views of a label cap having a tactile identification system of the present invention; FIG. 6 is a side elevational view of an alternative embodiment of a label cap mounted on a medication vial; FIG. 7 is a schematic perspective view of an alternative embodiment of the label cap of the present invention as shown in FIG. 6; FIG. 8 is a side elevational view of the label cap as shown in FIG. 6 mounted on the syringe assembly; FIG. 9 is a schematic perspective view of an alternative embodiment of a label cap of the present invention; FIG. 10 is a schematic perspective view of an alternative embodiment of a label cap of the present invention; FIG. 11 is a schematic perspective view of an alternative embodiment of a label cap of the present invention; FIG. 12 is a schematic perspective view of an alternative embodiment of a label cap of the present invention; and FIG. 13 is a schematic perspective view of an alternative embodiment of a label cap of the present invention.

Detailed Description Of Preferred And Alternate Embodiments Turning to the drawings, and particularly FIGS. 1 and 2, there is shown a typical hypodermic syringe generally indicated at 10, which is very well known in the art. The syringe 10 comprises a cylindrical barrel 12 having a flanged opening 14 and a needle 16 extending from a distal end of the barrel 12. A slidable plunger 20 is inserted inside the flanged opening 14 of barrel 12. The plunger 20 comprises a plurality of ribs 22 and a plunger base 24.

Referring to Fig. 1, a conventional medicine vial or bottle for storing medicine of various types and concentration levels is shown. The vial 30 contains a label 32 adhesively secured to the front of the vial, indicating the type of drug and concentration contained therein. The top portion 34 of the vial 30 contains a flip top lid 40 in the shape of a flat disc and having a rim 42 on the outer periphery which allows easy removal by the user to expose the penetrable rubber seal 36 of the vial 30. The rubber seal 36 of the medicine vial allows the insertion of a syringe needle 16 into the vial for removal of the medication contained therein.

The flip top lid 40 is affixed to the top portion 34 of the medicine vial 30 by a metal or plastic seal 38 shaped to conform to the top portion of the vial. The underside surface 41 of the flip top lid 40 contains a circular boss 44 about which the metal or plastic seal 38 is affixed thereto. The metal seal 38 together with the flip top lid 40 forms a contiguous seal over the top surface of the vial 30 in order to protect the rubber seal 36 from exposure to the elements and form a tamper resistant package. The metal seal 38 has a frangible circular portion 39 surrounding the circular boss 44 which is designed to break away and expose the rubber seal 36 of the vial 30 upon removal of the flip top lid 40. Another type of prior art flip top lid

(not shown) comprises a circular array of legs instead of a boss, and the array of legs are inserted down and between the rubber seal and the underside of the metal ring 38 whereby the rubber seal is protected.

In order to remove the medication from the vial 30, the flip top lid 40 is first removed by a user by the exertion of an upward force on the flip top rim 42 generally by the user's thumb in order to break the metal seal 38 formed between the lid 40 and the top portion 34 of the vial 30. Once the flip top lid 40 is removed, the rubber seal 38 is exposed and ready for insertion of a syringe needle 16 therein.

Prior art flip top lids (not shown) were simple plastic discs which were disposed of by the user after use and had the primary function of protecting the seal 36. The flip top lid 40 of the present invention has dual utility, in that it protects the rubber seal 38 of the medicine vial 30 from tampering and the elements as well as provide a label for a syringe 10, as described further below. The flip top lid may comprise a boss 44 or other attachment means to attach the lid to the vial 30 and protect the rubber seal 36. Upon removal of the flip top lid 40 from the vial 30, the lid 40 may be easily installed upon the plunger base 24 of a conventional syringe assembly 10 as described further below. The flip top lid 40 may further comprise attachment means such as a clip 50. As shown in Figs. 2-4, the flip top lid is inverted and clipped to a rib 22 of the plunger 20 by the clip 50. The clip 50 may be integrally molded with the flip top lid 40. The clip comprises an arm 52 which extends orthogonally from the flip top lid 40 at a length sufficient to clear the height of the plunger base 24. Gripping means 56 on the distal end of the arm 52 further comprise a slot 54 for receiving and clamping the rib 22 in order to secure the flip top lid 40 to the plunger base 24. Once installed upon the plunger base 24, the flip

top lid 40 displays a label 60, which contains the necessary information to label the syringe such as drug name and concentration.

The flip top lid 40 may be made of plastic or any other suitable material, and may be formed by injection molding or other suitable manufacturing technique. It is preferred that the flip top lid 40 be made of colored plastic, with a designated color representing a type of drug. For example, the color red may represent muscle relaxants, the color green may represent atropine/glycopyrrolate or other antisialagogues, the color blue may represent narcotics, the color yellow may represent induction agents, the color white may represent heparin, the color lavender may represent cardiac pressers, and the color black may represent any toxic agent such as potassium or aminophylline. Thus the color of the flip top lid is a very quick and easy way for medical personnel to recognize the type of drug contained in the syringe or in the medicine vial. Other color combinations could be used or even a simpler coding system (i. e., fewer colors could be used). The simpler coding system could comprise for example 3 colors, the color red being used to identify dangerous drugs which could result in serious injury or death if given improperly, the color yellow to identify drugs which could result in injury to a patient if given improperly, and the color green being used to identify relatively safer drugs.

The invention may additionally comprise the color coding of the medication itself to further enhance the identification system either alone, or in conjunction with other labeling methods as described herein. Under the invention, inert colored dyes are added to the various medications to color code drugs of a given type or a generic class. For example, an inert red dye may be added to muscle relaxants, an inert

green dye may be added to antisialagogues, an inert blue dye may be added to narcotics, a yellow inert dye may be added to induction agents, a inert white dye may be added to heparin, an inert lavender dye may be added to cardiac pressers, and a black dye may be added to any toxic agent such as potassium or aminophylline. The inert dyes are preferably added to the drugs during the manufacturing stage to reduce costs. The inert dyes may comprise any suitable synthetic or organic dye such as analine blue, phenyltheline or other analine dyes.

The flip top lid 40 may also preferably comprise a tactile identification system on the label 60, and thus comprise a raised tactile feature on the label to facilitate distinguishing the various types of drugs from one another. Thus, two sharp spikes 120 in series would represent Pancuronium as shown in FIG. 5A, two dull ridges 122 would represent antisialagogues as shown in FIG. 5B, a single dull ridge 124 would represent narcotics as shown in FIG. 5C, a raised star-like pattern 126 would represent induction agents as shown in FIG. 5D, a plurality of ridges with a sharp central spike 128 would represent any toxic agent such as potassium as shown in FIG. 5E, a pair of concentric ridges 130 may be used to represent cardiac pressers as shown in FIG. 5F, a raised circular projection 132 may represent insulin as shown in FIG. 5G, and a sharp spike 134 would be used to represent muscle relaxants as shown in FIG. 5H. The tactile features are raised surface projections, and have a raised height on the order of about 1-5 millimeters. These projections may be formed during the manufacture of the flip top lid such as by injection molding or any other suitable method. Thus the color coding system and the tactile identification system could be used either independently or in conjunction with each other to further identify the medication.

Figures 6-8 show an alternate embodiment of the flip top lid 70 of the present invention. The alternative embodiment of the flip top lid 70 comprises a planar disc 72, a plurality of legs 74, and a boss 44 or other attachment means used to attach the metal seal 38 to the lid 70. Each leg 74 has a hooked distal end 76 of a sufficient length to fit snugly around the base 24 of the plunger 20 on the syringe 10 and allow for clearance of the boss 44. In addition, the hooked ends 76 of the plurality of the legs 74 of the flip top lid 70 are designed to be seated in a circumferential groove 78 located on the rim of the medicine vial. In operation, the flip top lid 70 is removed from the medicine vial in the conventional manner to break the seal 38 and unseat the hooked distal ends 76 of the legs 74. The flip top lid 70 containing a label 60 to identify the drug type and concentration and any other important indicia, is now ready for installation upon the plunger base 24 of a syringe 10. The hooked distal ends 76 of the flip top lid 70 are snapped onto the base 24 of the plunger 20 such that the hooked ends operate to securely fasten or latch the flip top lid 70 onto the plunger base 24. In order to accomplish this, it is preferred that the flip top lid 70 comprise a sufficiently resilient plastic or other suitable material. The flip top lid 70 may also optionally be color coded and may also optionally contain the raised tactile identification system, as described above. In addition, the flip top lid 70 may be optionally used in conjunction with the color coding of medications as described earlier.

Figure 9 shows an additional embodiment of the flip top lid. In Figure 9, the flip top lid 80 comprises a planar top surface 82 upon which the label 60 or tactile identification system may be indicated thereon, and an extended circumferential collar 84 having a plurality of undercuts 86 located along the interior

surface of the collar 84. The height of the collar 84 is sufficient to fit onto a conventional medicine vial 30. The top surface of the flip top lid 80 may also optionally comprise a plurality of holes or slots 85 to facilitate injection molding of the undercuts 86 of the lid 80. The flip top lid 80 may be molded from a suitable soft resilient plastic or other suitable material which are well known in the art. The underside of the flip top lid 80 comprises a conventional boss 44 or other attachment means for securing the metal seal 38 thereon. The flip top lid 80 together with the metal seal form a contiguous seal about the medicine vial. To remove the flip top lid 80 from the vial, the user exerts a slight upward force upon the collar 84 of the lid in order to break the perforated metal seal 38 away from the vial 30 and expose the rubber seal 36. The flip top lid 80 containing the label 60 may now be installed easily by the user upon the plunger base 24 of a syringe 10. A slight force is needed by the user to install the flip top lid 80 over the plunger base 24. The undercuts 86 of the lid 80 secure the lid to the plunger base 24 and are spaced to allow clearance of the ribs 22 of the plunger 20. The flip top lid 80 may also optionally be color coded and may also optionally contain the raised tactile identification system, as described above. In addition, the flip top lid 80 may be optionally used in conjunction with the color coding of medications as described earlier.

Figure 10 shows a slight variation of the flip top lid 80 as shown in Figure 9, except the collar has a plurality of cut-outs 88 forming a plurality of sections which allow for easier removal from the medication vial 30. The cutouts 88 also allow for easier installation upon the plunger base 24. Slots 85 may also be optionally formed upon the top surface 82 of the lid 80. The flip top lid 80 may also optionally be

color coded and may also optionally contain the raised tactile identification system, as described above. In addition, the flip top lid 80 may be optionally used in conjunction with the color coding of medications as described earlier.

Figure 11 shows an alternative embodiment of the flip top lid 80 shown in Figure 9, except the flip top lid does not have undercuts 86. The flip top lid 80 instead has two opposed slots 90 located on the collar 84. A modified plunger base 24 comprises opposed tabular extensions 92 for reception into the opposed slots 90 of the collar. To install the flip top lid 80 onto the plunger base 24, the tabular extensions 92 are aligned with the slots 90 of the lid 80 and then the user exerts a slight force whereby the tabular extensions 92 are snapped through the slots 90 of the collar 84 and the lid 80 is secured onto the plunger 20. The flip top lid 80 may also optionally be color coded and may also optionally contain the raised tactile identification system, as described above. In addition, the flip top lid 80 may also be optionally used in conjunction with the color coding of medications as described earlier.

Figure 12 shows still another embodiment of the flip top lid 100 comprising a planar disc upper surface 102 having a label 60 and a boss 44 or other attachment means on the opposite surface for sealing the medicine vial 30 as described above.

The lid 100 further comprises a pair of dog ears 102 which fold down for installation onto a pair of opposed male pins 104 on the plunger base 24. Each dog ear 102 has a female pin receptacle 106 aligned for insertion onto the male pins 104 whereby an interference fit occurs. The flip top lid 100 may also optionally be color coded and may also optionally contain the raised tactile identification system, as

described above. In addition, the flip top lid 100 may be optionally used in conjunction with the color coding of medications as described earlier.

Figure 13 is yet another embodiment of the flip top lid 100 comprising a planar disc upper surface 102 having a label 60 and a boss 44 or other attachment means on the opposite surface for sealing the medicine vial 30 as described above.

The lid 100 further comprises a pair of orthogonal opposed male pins 110 which are positioned for insertion into a pair of opposed female U shaped slots 112 on the periphery of the plunger base 24 whereby an interference fit occurs. The flip top lid 100 may also optionally be color coded and may also optionally contain the raised tactile identification system, as described above. In addition, the flip top lid 100 may be optionally used in conjunction with the color coding of medications as described earlier.

In still another embodiment of the invention, a conventional or prior art flip top lid 120 is modified by adding a donut shaped ring 122 on the interior side of the lid 120 and which surrounds the boss 44 or other attachment means used to protect and seal the medicine vial 30. The donut shaped ring 122 comprises a layer of adhesive or glue with a sufficient bonding strength to adhere the lid 120 to a syringe plunger base 24. The layer of adhesive is protected by a layer of material which is then removed by the user prior to installation upon the syringe plunger base 24.

This donut shaped ring 122 must have a height the same or greater than the boss 44 or sealing means for proper bonding to the syringe plunger base 24. The donut shaped ring 122 may be molded or made by other conventional ways known in the prior art. The flip top lid 120 may also optionally be color coded and may also optionally contain the raised tactile identification system, as described above. In

addition, the flip top lid 120 may be optionally used in conjunction with the color coding of medications as described earlier.

Although the invention has been disclosed and described with respect to certain preferred embodiments, certain variations and modifications may occur to those skilled in the art upon reading this specification. Any such variations and modifications are within the purview of the invention notwithstanding the defining limitations of the accompanying claims and equivalents thereof.