Patent Application
20120292219
This invention relates generally to fluid vials potentially containing medicine, vital fluids, and/or nutritional supplements and, more particularly, to a top loading fluid vial container for containing a fluid vial that incorporates information, such as a calculation aid to provide dosage level based upon weight, age, volume, or area, or product information.
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 a fluid vial, such as an injectable fluid vial with a top loading security container having a calculation aid for dosing.
The present invention provides a top loading container for housing and maintaining an injectable fluid vial suspended within. The top loading container includes a calculation aid formed specific to the fluid vial. The top loading container is formed from a bottom, a top, and an inset side wall there between. The top is adapted to be securable to a fluid vial so that the fluid vial rests in a suspended position within the interior of the top loading container. 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 the inner label with at least one transparent window allowing selective viewing of the dosing and base line indicia and predetermined dosing rate.
An objective of the instant invention is to provide a top loading container for a conventional fluid vial housing providing sufficient surface area for inclusion of printed indicia, such as a dosing calculation aid and providing a means of protecting the fluid vial from tampering.
Another objective of the invention is to provide a top loading 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 top loading 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 top loading container for a fluid vial housing or 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 top loading container having a lid that allows for securely engaging a portion of a fluid vial housing or an injectable fluid vial housing.
Yet another objective of the invention is to provide an insulated top loading container for a fluid vial housing or an injectable fluid vial housing wherein an insulator moderates fluid temperature change.
Still another objective of the invention is to provide a top loading container for a fluid vial housing or an injectable fluid vial housing that includes a first portion which engages a portion of a fluid vial housing or an injectable fluid vial housing to maintain the vial housing in a centrally disposed position.
Another objective of the invention is to provide a top loading container for a fluid vial housing or an injectable fluid vial housing which is tamper resistant.
Another objective of the invention is to provide a top loading container for a fluid vial housing or an injectable fluid vial housing having a lid that includes a tamper-evident cover.
Still another objective of the invention is to provide a top loading container that is economical to manufacture and recyclable.
Still another objective of the invention is to provide a top loading container which provides identification and other product information to a fluid vial housing or an injectable fluid vial housing having a surface which cannot be directly labeled.
Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.
Referring to
The top section 20 includes an access opening 28 constructed and arranged to receive and secure to the second upper portion 14, see
A conventional injectable vial has a glass body 222 with a needle piercing cap 224 having a grommet 226 that allows passage of a needle 128 from a conventional syringe 230. 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. For instance, the vial may contain an injectable fluid that has a short shelf life or is temperature and light sensitive. The result is a fluid vial that is very small having limited room for a label 232. The problem with the vial being small is that the amount of information that could be placed on the label 132 can 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. In addition, some fluids stored within a fluid vial require that nothing be attached to the surface of the vial. While nothing can be attached to the vial surface, proper identification and delivery or use directions is needed. Such materials require an outside container for identification purposes. Use of a secondary bottle with outside labeling, however, runs the risk of mishandling and/or incomplete usage as the vial may be separated from the outside container. In cases of separation, the user is unaware of the contents of the liquid inside and must discard the vial for safety reasons.
Referring to
While such frictional fit coupling is illustrated, other mechanisms of securing the first lower portion 12 to the second upper portion 14 can be used. For example, the first lower portion 12 may contain tabs (not illustrated) constructed and arranged to be insertable within tab receiving areas (not illustrated) located within or along the second upper portion 14. Once inserted, the two sections are locked together. The first lower portion 12 may be released from the second upper portion 14 by engaging the tabs, such as through pushing them out of the tab receiving areas. Alternatively, the first lower portion 12 may contain internal, or female threading and the second upper portion 14 may contain external, or male threading. Once inserted, the second continuous inner upper wall edge 44 rests at or near the entry wall ridge 36.
The second upper portion 14 of the top loading container 10 contains an opening 50 sized and shaped to receive a fluid vial, such as the injectable fluid vial 220. As illustrated on
The flexibility of the neck 53 further allows each finger-like projection 52 to snap back to its original configuration, thereby encircling the inserted injectable fluid vial 220. In this configuration, the injectable fluid vial 220 is secured to the second upper portion 14, suspending the injectable fluid vial 220 within the interior 34 of the top loading container 10. Preferably, when the second upper portion with the injectable fluid vial 220 secured thereto is inserted into the first bottom portion 12, a space is maintained between the injectable fluid vial 220 and the inner surface of the inset sidewall 16 and/or the continuous outer upper wall 38 and/or the second continuous inner upper wall 40. In this manner, there is minimal contact between the injectable fluid vial 220 and the top loading container 10. Additionally, the injectable fluid vial 220 is maintained suspended from the upper portion 14 and extending into the lower portion 14.
The top loading container 10 includes sufficient spacing around the fluid vial 220 to include insulation if fluid within the vial needs temperature stabilization. The top loading container 10 may further include bottle securing members, such as spacers 56 and/or or support structures such as a cushion 58 made of a material such as a soft pliable plastic pad or puck at the bottom so as to prevent the vial from movement, and reducing the likelihood of damage during transpiration, see
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. Alternatively, the fluid vial inserted therein may include a safety lock ring. In such case, the neck 53 of the top loading container 10 may be attached to a liquid storage bottle above a safety seal ring 61 attached to a bottle top cap 63, see
Referring now to
The inner label 60 includes one or more types of indicia, such as multiple rows of weights 68 and dosing 70 indicia placed on the front surface 72. 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 indicia 74 having children weights from 30 lbs to 62 lbs and a dosing line of indicia 76 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 vial 120.
Further to this example a second row 78 of indicia indicates weights from 64 lbs to 96 lbs and a dosing rate indicia line 80 of 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 container top loading 10 to the vial 220 including color coating of labels, color coating of containers, or coordinated sizes to make sure that the vial 220 and the top loading 10 are matched. The upper portion 14 and the lower portion 12 can be permanently secured to together so that the vial 220 secured within the top loading container 10 cannot be removed. In such a configuration, only the cap section 224 of the vial 220 is accessible. Further, the vial can be permanently captured within the container wherein the fluid is drawn directly from the grommet 226 without removal of the vial.
Label 60 includes the use of a permanent adhesive 82 along the leading edge 64 and adhesive 84 along the tailing edge 66. Alternatively the adhesive can be placed all across the back of the label 60; 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 64 and 66 respectively, as the film is resistant to tearing. A label made from thin paper will likely need adhesive on a substantial portion of the back surface 62 to prevent premature removal. Once the leading edge 64 is secured the label 60 is wrapped around the container, as shown in
Referring now to
The leading edge 94 is temporarily attached to the inner label 60 by the adhesive dot 86 allowing the label 84 to wrap around the inset sidewall 16 of the top loading container until the trailing edge 92 overlaps the leading edge 94 wherein the permanent adhesive 90 attaches to bond the label in a continuous loop. In this manner the temporary adhesive 86 maintains the outer label in position only until it dries and dissolves wherein outer label 84 is free to rotate around the inner label 60. The outer label includes a window aperture 96 that 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 label 84 is shown with an upper box 98 having a description of weight 100 showing a weight row 102 depicting the measurement term 104 which in this example is lbs. A second row describing the dose 106 and the unit size 108 which in this example is units. The label 84 is rotated to allow the window 96 to be placed over the 44 lbs weight indicating a dosage rate 92 of 2.5 units. Similarly a second level of indicia 110 indicates a weight of 78 lbs and a dosage rate of 6.5 units 96.
The outer label 84 includes 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 columns 74 and 78 may be shaded or placed in a color to correspond with the weight row 102 and lbs row 104 assuring 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 box 98 may include a single window 110 or may include a second box 112 which duplicates the first box with a different weight amount 114. As shown in
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.
Dilaudid—Hydromorphone, a narcotic pain medication has an initial dose: 0.001 mg/kg; from 1-12 years=0.015 mg/kg initial dose.
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.
Garamycin—Gentamicin an antibiotic having Pediatric Dose for Bacterial Infection: 0 to 4 weeks, birthweight<1200 g: 2.5 mg/kg IV or IM every 18 to 24 hours; 0 to 1 week, birthweight>=1200 g: 2.5 mg/kg IV or IM every 12 hours; 1 to 4 weeks, birthweight 1200 to 2000 g: 2.5 mg/kg IV or IM every 8 to 12 hours; 1 to 4 weeks, birthweight>=2000 g: 2.5 mg/kg IV or IM every 8 hours; and >1 month: 1 to 2.5 mg/kg IV or IM every 8 hours. Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis 1.5 mg/kg IV or IM once within 30 minutes of starting the procedure. For high risk patients, in addition to gentamicin, ampicillin 50 mg/kg (maximum 2 G) is given IV or IM 30 minutes prior to the procedure, followed by ampicillin 25 mg/kg IV/IM or amoxicillin 25 mg/kg orally 6 hours later. In penicillin-allergic patients, vancomycin 20 mg/kg IV is infused over 1 to 2 hours instead of ampicillin/amoxicillin.
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.
Kefzol—Cefazolin, an antibiotic. Dosing—Postnatal=20 mg/kg; 1 month or older=6.25-25 mg/kg.
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. In addition, the label may contain other indicia as well, including the identification and other important information regarding the contents of the fluid within the vial. For fluid vials stored within the top loading container 10 which do not have a labeled attached thereto, the top loading container 10 becomes the primary source of content information. In cases of a drug, the name, dosing, side effects, and proper methods of taking the drug, or any handling instructions can be may be listed. In cases where the contents stored within the top loading container 10 are light sensitive, the container may be made of a materials that prevents contact with light or may be colored to minimize light penetration.
The inner label 60 and outer label 84 can 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.
While detailed embodiments of the instant invention are disclosed herein, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific functional and structural details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representation basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.
One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.
This application is a continuation-in-part of U.S. patent application Ser. No. 13/036,935, filed Feb. 28, 2011, entitled “Injectable Fluid Vial Housing,” which claims a priority date of Jul. 8, 2010, based upon U.S. Provisional Patent Application No. 61/362,667 entitled “Injectable Fluid Vial Housing,” the contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61362667 | Jul 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13036935 | Feb 2011 | US |
| Child | 13560426 | US |
