Injectable fluid vial housing

A container for housing an injectable fluid vial. The container includes a calculation aid formed specific to the injectable fluid vial. The container is formed from a bottom, a top, and an inset side wall therebetween with a resealable lid. The top includes an opening constructed and arranged to receive the fluid vial housing. Alternatively, the container is formed from two half sections that are hinged together for holding the fluid vial housing therebetween. An inner label is permanently attached to the sidewall having at least one row of dosing indicia coordinated with a base line indicia selected from the group of weight, age, fluid volume or area. An outer label is rotatably secured over said inner label with at least one transparent window allowing selective viewing of the dosing and base line indicia and predetermined dosing rate.

FIELD OF THE INVENTION

This invention relates generally to injectable fluid vials potentially containing medicine, vital fluids, and/or nutritional supplements and, more particularly, to a fluid vial container that incorporates a calculation aid to provide dosage level based upon weight, age, volume, or area.

BACKGROUND OF THE INVENTION

Dosing of injectable fluids by prescription based upon a patient's weight, age or other means of estimating the patient's fluid volume is known in the art. However, the means of calculation the dosing amount is cumbersome and potentially contributing to the incorrect dosing of an intended recipient should any of the base line factors change or an error made in calculation.

Although methods are known by which dose calculating aides may be integrated with typically sized bottles, injectable fluid vials tend to be substantially smaller and thereby greatly limit the practical area available to do so.

The currently available dosage calculations presented on charts and pinwheels are not readily available to the general public. Further, the dosage amount may be based on volume, area or age which can change leaving the individual to seek professional assistance to recalculate the dosage amount. Even if a physician's reference manual is available, the reference can present a confusing array of dosages that may not be understood by the general consumer.

For example, a first responder may carry a host of injectable fluids that are stored in vials to treat various types of accident victims. Upon reaching an accident victim, the first responder is assaulted with a confusing array of possible injuries yet is called upon to immediately provide relief for pain or otherwise stabilize the injured individuals. However, in the midst of the confusion a doctor may not be reached and the first responder may be called upon to determine dosage levels based upon weight, age, fluid volume or area. It is unrealistic to expect a first responder, or even a seasoned physician, to remember all the required doses for all injectable fluids.

The proper dosing of any medication is imperative as is the need to assure that the medication being injected will actually assist the patient. For this reason it is well recognized that dosing calculations performed well before application lessen the possibility of over/under dosing.

The Applicant recognized the need for proper elixir dosing based upon weight versus age for children. U.S. Pat. Nos. 6,276,533 and 6,581,773 discloses the need for a weight based dosing regimen for pediatric elixirs, and disclosed a container mounted rotating calculation aid to provide proper dosing at the time of delivery. It is now well recognized that a 12 year old boy may weight 60 lbs or 160 lbs wherein dosing based upon age could lead to over/under dosing.

A number of patents were issued to inventor Key which disclose an apparatus and method of constructing a rotating label system including U.S. Pat. Nos. 5,884,421; 6,086,697; 6,237,269; 6,631,578; 6,385,878; 6,402,872; 6,649,007; 7,087,298; and 7,172,668. The disclosures provide for a rotating label that is placed around a container, the rotating label including a viewing window to view indicia placed on an inner label. The patents are directed to a system and method for constructing a rotatable label and attaching the label to a container. Key does not disclose a container for housing another container, and thus would not disclose any teaching for the matching of two containers.

Tamper resistant vial containers are also known, such as the placement of a plastic or a metal seal over the mouth of the container beneath the screw cap. U.S. Pat. No. 4,871,977 discloses a barb or hook inside an open upper end of a vial, providing a cap adapted for insertion into the vial having a mating hook formed about a lower edge thereof, and providing sealing rings formed on the outer surface thereof, thereby yielding a tamper-resistant, leak-proof sealing between the enclosure and the vial.

U.S. Pat. Nos. 4,586,622 and 4,449,640 describe an open-top vial covered by a cap having a depending peripheral skirt, in such a way that an inner surface of the cap skirt and an outer surface of the cap are provided with complementary mating interlock elements. The cap comprises an integral tear member, defined by at least one weakened, partially circumferential weakened junction lines, such that pulling away the tear member along the junction line allows both annual removal of the cap and ready visual confirmation that vial integrity has been breached.

U.S. Pat. Nos. 4,211,333 and 4,306,357 disclose a vial having a flange about its opening so that, below the flange and spaced apart therefrom, a shoulder defines an indented neck therebetween. An overcap extends over the flange and about the neck to form a skirt about the neck. The skirt has at least a portion thereof extending inwardly in gripping reaction with the neck and limited in removal by contact with the underside of the flange, whereby the cap cannot be removed without destroying a structural integrity thereof.

No known prior art exists for combining an injectable fluid vial with a security container having a calculation aid for dosing.

SUMMARY OF THE INVENTION

The present invention provides a container for housing an injectable fluid vial, the container includes a calculation aid formed specific to the injectable fluid vial. The container is defined by a bottom, a top, and an inset side wall therebetween. The top includes a covered opening constructed and arranged to receive the injection fluid vial housing. Alternatively, the container is formed from two half sections that are hinged together for holding the fluid vial housing therebetween. An inner label is permanently attached to the inset sidewall providing a dosing surface with at least one row of base line indicia selected from the group of weight, age, fluid volume or area and at least one row of a predetermined dosing rate. An outer label is rotatably secured over the inner label with at least one transparent window allowing selective viewing of the dosing and base line indicia.

An objective of the instant invention is to provide a container for a conventional injectable fluid vial housing providing sufficient surface area for inclusion of a dosing calculation aid and providing a means of protecting the fluid vial from tampering.

Still another objective of the invention is to provide a container having an inset sidewall to allow for ease of rotation of a rotating dosing calculation aid.

Another objective of the instant invention is to provide a more accurate and/or convenient method by which injectable medication, vital fluid, and/or nutritional supplement dosing may be determined.

Yet still another objective of the invention is to provide a container for an injectable fluid vial housing that can be keyed so that it will only hold a particular fluid vial so as to reduce or eliminate the possibility that the wrong calculation aid is used with a fluid vial.

Another objective of the invention is to provide a container having a lid that allows for concealment of an injectable fluid vial housing when not in use and further protecting the needle entry grommet from contamination.

Yet another objective of the invention is to provide an insulated container for an injectable fluid vial housing wherein the insulator moderates fluid temperature change.

Still another objective of the invention is to provide a container for an injectable fluid vial housing that includes spacers to contain the vial housing in a centrally disposed position and cushion the vial from impact.

Another objective of the invention is to provide a container for an injectable fluid vial housing having a lid that is tamper resistant.

Another objective of the invention is to provide a container for an injectable fluid vial housing having a lid that includes a tamper-evident cover.

Still another objective of the invention is to provide a container that is economical to manufacture and recyclable.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Now referring to the Figures in general and specificallyFIGS. 1 and 2, set forth is a container10formed from continuous inset sidewall12having bottom section14and top section16. The bottom section14may be attached to the inset sidewall12or preferably formed integral thereto having a lower transition area18. The lower transition area18is formed by use of an inset sidewall12having an outer diameter less than the outer surface sidewall20of the bottom section14; the transition area18is preferably formed at a right angle to the inset sidewall12and outer surface sidewall20. Similarly an upper transition area24is formed at a right angle to the inset sidewall12. The inset sidewall12has an outer diameter less than the outer surface sidewall22of the upper section16. The use of right angle transition areas18and24allow the use of a rotating label, as will be further explained in this specification, with sufficient tolerance to allow ease of rotation without disengagement from the container.

The upper section16includes an access opening30constructed and arranged to receive a lid26into a snap-lock position by use of engagement tab32positioned along the entry wall36and reciprocal engagement tab34positioned along the inner edge of the lid26. The engagement tabs allowing the lid to frictionally engage the entry wall to enclose the contents of the container. The opening30on the upper section16is sized for receipt of a conventional fluid vial120. The upper section16includes the lid26attached by a living hinge28.

A conventional fluid vial120has a glass body122with a needle piercing cap124having a grommet126that allows passage of a needle128from a conventional syringe130. Fluid vials are typically small glass containers which are known for the non-leaching characteristics providing stability to the contents of the vial. Small vials are used due to the limited amount of fluids that are stored in the vial, due to expense, sterility, storage stability or any combination thereof. The result is a fluid vial that is very small having limited room for a label132. For instance, the vial may contain an injectable fluid that has a short shelf life, is temperature and light sensitive. The problem with the vial being small is that the amount of information that could be placed on the label132can be limited. When dosing is required, such as during an emergency, the ability of the individual that is calculating the dosing amount must have readily access to the proper dosing level for the individual so as to allow for effective use of the fluid. The conventional glass vial does not protect against temperature and light degradation unless specifically colored or coated.

The container of the instant invention is preferably sized to hold a conventional fluid vial120. The container10includes sufficient spacing around the fluid vial120to include insulation15if fluid within the vial needs temperature stabilization, or the container10may simply include spacers so as to prevent the vial from movement and provide impact cushion. While the main function of the container will be for increasing the labeling readability and incorporation of a calculation aid, it should be noted that a container can also provide an anti-tamper lid such as a ratchet design, key lock opening, and so forth, not shown. Further, the use of plastic shrink wrap around the container lid26provides evidence of improper tampering.

Referring now toFIGS. 3-5, the container10has an inner label40it is attached to the inset sidewall12by placement of adhesive on the back41of leading edge42secured to the inset sidewall12. Similarly, adhesive is placed on the back41of trailing edge of the label40and when the label is wrapped around the container it is securely joined to the container in a permanent fashion.

The inner label40includes multiple rows of weights and dosing indicia placed on the front surface43. The indicia illustrated is for example only and can be displayed in volume, units, weight, age, ml, units, etc. . . . and any combination thereof that the manufacturer or physician employs. The example illustrated depicts a base line indicia46having children weights from 30 lbs to 62 lbs and a dosing line of indicia being the calculated dose for an individual based upon the weight. For example a 58 lb child may be injected with 4 units of the contained fluid held within the vial120.

Further to this example a second row50of indicia indicates weights from 64 lbs to 96 lbs and a dosing rate indicia line52of 4.5 units to 8.5 units. In this example an 82 lb child would have a dosing rate of 7 units. While the underlying label provides the dosing indicia on tables that can be commonly found in physicians handbooks the particular label allows for customization of indicia that is appropriate only for fluid within the vial to allow the individual that will be injecting the fluid an instant reference of the appropriate amount without further calculation or reference materials. Various mechanisms can further be used to coordinate the container10to the vial120including color coating of labels, color coating of containers, or coordinated sizes to make sure that the vial120and the container10are matched. The vial120can be permanently secured within the container10so that only the cap section124of the vial120is accessible. Further, the vial can be permanently captured within the container wherein the fluid is drawn directly from the grommet126without removal of the vial.

Label40includes the use of a permanent adhesive43along leading edge42and adhesive45along tailing edge44. Alternatively the adhesive can be placed all across the back of the label40; the amount of permanent adhesive to accomplish the necessary securement is dependent on the label material. A plastic film requires adhesive along the leading and trailing edges as the film is resistant to tearing. A label made from thin paper will likely need adhesive on a substantial portion of the back surface41to prevent premature removal. Once the leading edge is secured the label40is wrapped around the container, as shown inFIG. 5, with the trailing edge abutting the leading edge. The label40is held within the transition sections18and24covering the inset sidewall12.

Referring now toFIGS. 6-8set forth is the upper label60having a leading edge62having temporary adhesive dot placed along the back surface61thereof and an area of permanent adhesive66placed along the back surface61of the trailing edge68. The outer label60is wrapped around the inner label40allowing the adhesive66placed along the back surface61of the trailing edge68to overlap the front surface63of the leading edge62of the outer label60, and be attached thereto. The temporary adhesive dot64will dry and disintegrate within twenty four hours of application wherein the adhesive bond is lost. The adhesive placed along the back surface61of the trailing edge68will dry with a permanent adhesion to the frontal surface63of the outer label60. The outer label60can then be rotated which will easily break any bond left with the temporary adhesive dot64allowing the outer label60to be rotated relative to the inner label40. One skilled in the art will recognize that various types of adhesive can be used to accomplish the intended results, further the location of the adhesive need not be on the exact positions depicted yet still accomplish the same result. For instance, the leading edge of the outer label may have an adhesive dot64placed on the back surface61and the adhesive strip placed on the trailing edge68of the front side surface63.

The leading edge62is temporarily attached to the label40by the adhesive dot64allowing the label60to wrap around the inset sidewall12of the container10until the trailing edge68overlaps the leading edge62wherein the permanent adhesive66attaches to bond the label in a continuous loop. In this manner the temporary adhesive64maintains the outer label in position only until it dries and dissolves wherein outer label60is free to rotate around the label40. The outer label includes a window aperture70that is constructed and arranged to be placed over the calculation aid indicia so as to reveal only the indicia as specified by the label. By way of example, outer label60is shown with an upper box72having a description of weight74showing a weight row76depicting the measurement term80which in this example is lbs. A second row describing the dose82and the unit size84which in this example is units. The label60is rotated to allow the window70to be placed over the 44 lbs weight indicating a dosage rate92of 2.5 units. Similarly a second level of indicia94indicates a weight of 78 lbs and a dosage rate of 6.5 units96.

The outer label60includes sufficient area so that descriptions can be added in various sections A, B, & C without the need for miniaturization of print. To further enhance the readability of the label, weight columns46and50may be shaded or placed in a color to correspond with the weight row76and lbs row80assuring that the alignment of the word “weight” the weight amount, and the “units” in lbs can be easily distinguished. The dosage label, the amount, and the label may be un-shaded for ease of readability. The dosage box72may include a single window70or may include a second box98which duplicates first box with a different weight amount99. As shown inFIG. 9the outer label60can be rotated so that the window aperture70now depicts the weight100of 48 lbs with a dosage102of 3 units and the second box depicts a weight of 82 lbs104with a dosage rate106of 7 units.

For example, an individual with Type 1 diabetes requires daily doses of insulin to keep blood glucose levels from going too high. Insulin is a hormone produced by the beta cells of the pancreas that permits glucose to enter cells and helps the body use glucose for energy. People who are Type 1 diabetic must use manufactured insulin, usually in an injectable form, to replace the natural insulin that is no longer produced by their body. At mealtime the individual may calculate the carbohydrate coverage insulin dose at a meal, wherein the CHO insulin dose=Total grams of CHO in the meal÷grams of CHO disposed by 1 unit of insulin (the grams of CHO disposed of by 1 unit of insulin is the bottom number or denominator of the Insulin:CHO ratio). Thus, if an individual having type 1 diabetes plans for 60 grams of carbohydrate for lunch wherein their Insulin CHO ratio is 1:10. The CHO insulin dose=Total grams of CHO in the meal (60 g)÷grams of CHO disposed by 1 unit of insulin (10)=6 units. The individual will need 6 units of rapid acting insulin to cover the carbohydrate. The base line indicia can be displayed in the form carbohydrate levels allowing the individual to determine insulin dosage rate without further calculation aid.

By weight, basal and bolus doses for an estimated daily insulin dose is made by calculating the Total Daily Insulin Requirement (in units of insulin)=Weight in Pounds÷4. Assuming a child weights 80 lbs the total insulin dose=80 lb÷4=20 units of insulin/day. The indicia can track weight allowing the individual to determine dosage without further calculation aid.

Common children's injectables that are determined by weight include, by way of example:

NeoProfin—Ibuprofen, a nonsteroidal anti-inflammatory drug. Dosing, having a weight greater than or equal to 0.5 kg and less than 1.5 Kg: 10 mg/kg IV initial dose, followed by two doses of 5 mg/kg each, after 24 hours and 48 hours.

Avinza—Morphine, a narcotic pain medication. Dosing to Pediatric=0.5 mg/kg with a Max Dose: 0.1 mg/kg. Greater than or equal to 1 month, but less than 12 years: 0.005-0.02 mg/kg IM.

Dilantin—Phenytoin, an antiepileptic drug. Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years old and adolescents may require the minimum adult dose (300 mg/day).

Fuzeon—enfuvirtide, an antiviral medication in a group of HIV medicines. In pediatric patients 6 years through 16 years of age, the recommended dosage is 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen.

Increlex—Mecasermin is an insulin-like growth factor-1 (IGF-1) −2 years old to adult (closed epiphyses): initial dose: 0.04 to 0.08 mg/kg twice daily by subcutaneous injection. If well tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose to the maximum of 0.12 mg/kg given twice daily.

Omnitrope—Somatropin, Human Grown Hormone. Pediatric Grown Hormone Deficiency: Generally, a dosage of 0.16-0.24 mg/kg weight/week is recommended. PraderWilli Syndrome: Generally, a dosage of 0.24 mg/kg week is recommended. Small for Gestational Age (SGA): generally, a dosage of up to 0.48 mg/kg body weight/week is recommended.

Rocephin—Ceftriaxone, an antibiotic for the treatment of skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day. For the treatment of acute bacterial otitis media, a single intramuscular dose of 50 mg/kg. For the treatment of serious miscellaneous infections, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours (total daily dose should not exceed 2 grams). In the treatment of meningitis, the recommended initial dose is 100 mg/kg.

The examples illustrate but a few use of the calculation aid and demonstrate that even a trained medical profession is confronted with numerous injectables that have dissimilar dosing requirements. Further, this application is not limited to the type of medication or the use of either an insulated container or cushioned container further allows the fluid vials to hold most any type of fluid that benefits from a calculation chart or table.

The inner label40and outer label60can be made of paper or plastic film or any other appropriate material. A plastic label, or plastic film, provides for ease of use with the plastic file allowing ease of rotation. The paper label allows for individualized printing by a caregiver from a conventional printer to allow customization of the level to a particular dosing rate. For instance, if combination of medications can be combined, the caregiver may prepare a dosage rate specifically for a patient. A computer software program allows for the inclusion of specific instructions onto the inner and outer label, the program employing a template that assures proper alignment of the base indicia and dosage rate. A kit can be provided which includes laser or ink jet labels, template software, and container blanks to allow proper positioning of all indicia in relation to the label opening aperture of the instant invention.

FIGS. 10 and 11depict a second embodiment for the container150for housing an injectable fluid vial housing120wherein the container is formed in the shape of an open top bottle. The container150has a first half152hingedly coupled156to a second half154. When placed in closed position the container resembles an open bottle with a bottom section158, a top section160, and a side wall162therebetween. In the closed position, the sidewall162is continuous and similar to the first embodiment, an upper transition section164forms a right angle wall between the upper section160and the sidewall162, and a lower transition section166forms a right angle wall between the lower section158and the sidewall162.

The top section160includes a collar170that forms around the neck121of the fluid vial and spacers172formed along the inner sidewall163maintain the fluid vial120in a centrally disposed position. The container can be sized to accept different width fluid vials wherein the spacers172flex to accommodate oversized fluid vials. The bottom158may also be positioned a distance from the bottom of the fluid vial127allowing for taller fluid vials. If the fluid needs to be maintained at a stable temperature, the spacing and open area sounding the fluid vial within the container can include an insulating material.

When the fluid vial120is captured within the container150, only the cap124of the fluid vial is available, all labeling is now provided on the sidewall162as previously described in the first embodiment. Further, the label placed around the sidewall provides a tamper-evident shield to assure that the fluid vial placed within the container has not been tampered with.