Signals and indicators – Indicators – Operator movable
Reexamination Certificate
2002-06-25
2004-08-24
Gutierrez, Diego (Department: 2859)
Signals and indicators
Indicators
Operator movable
C116S309000, C215S230000
Reexamination Certificate
active
06779480
ABSTRACT:
BACKGROUND OF THE INVENTION
Field of Use
The field of use for the dial indicator cap described in this specification is for determining the required amount of a substance, such as a medication, as a function of a variable, such as the weight of a patient. However, the concept and structure described and claimed in this specification is useful for determining the amount of a first substance as a function of a second substance for myriad applications. An example of another application is the volume of oil to be added to a volume of gasoline for a two-cycle engine, which is determined by the the manufacturer's specified ratio of oil to gasoline multiplied by the gasoline volume. For purposes of illustration of an embodiment of the invention claimed in this specification, a medication application will be the application described in the “Summary of an Embodiment of the Invention,” the “Brief Description Of The Drawings”, and the “Detailed Description And Operation Of The Invention” sections of this specification.
SUMMARY OF AN EMBODIMENT OF THE INVENTION
Inaccurate prescriptive medication suspension, such as antibiotics, and over-the-counter liquid medication dosing in the pediatric patient population (3 years of age and younger) is common and costly. The medical literature is abundant with statistics and objective data supporting the finding that inaccurate medication dosing in the pediatric patient population is a common problem. For example, a significant number of pediatric patients are: hospitalized with medication dosing errors; die as a result of dosing errors; taken to emergency rooms with persistent fever-related illnesses due to under-dosage with acetaminophen; and treated for over-dosage with acetaminophen. Studies confirm that a large majority of caregivers: fail to give the required dosage of the over-the-counter medication acetaminophen; do not accurately read and follow labeling instructions; fail to increase dosage as the pediatric patient's age or weight increases; or give less than the manufacturer's recommended dosage. It is also known that: over-the-counter pediatric medications have no specific instructions for dosing a child under the age of 2; for most over-the-counter pediatric medication in liquid form, the dosing instructions are by “age” for children under the age 2 and by “weight” for children above the age 2, which is conflicting and unclear; and when the medication bottle is removed from the packaging and the packaging is discarded, the complicated dosing instructions, which are generally on the packaging, are no longer available to the caregiver.
There must be greater assurance that the medication recommended for the pediatric population is dosed correctly. Medication labeling is the only tool available to assure the consumer of accurate dosing. However, labeling has proven to be ineffective, confusing, costly, and controversial. Improving the label will not dramatically improve the rate of accuracy in dosing medications. A simple, inexpensive, consumer friendly device for dosing accuracy should replace the current standard of labeling. And, the dosing information should be integral to the medication container. The dial indicator cap is such a simple, inexpensive, consumer friendly device to replace or supplement the labeled dosage information. Indeed, like the label, it is integral to the medication container.
The dial indicator cap is a unique, innovative combination of a closure cap for a medication container and a device for determining dosage for prescriptive and over-the-counter medications. It utilizes existing closure cap design concepts with minimal modification. The dial indicator cap either minimizes the need for detailed labeling or is an adjunct to labeling. It provides an almost error proof method for the consumer to determine dosage. Even when used in conjunction with a label, it becomes the primary source for proper dosing. The basic closure for medication bottles remains the same. The invention of this specification comprises a range of pediatric patient weights and corresponding dosage amounts imprinted on the top, outer surface of the closure cap. A rotatable disk is axially aligned with and superimposed over the closure cap with a first viewing window that when rotated displays the various weights imprinted on the top, outer surface of the closure cap and a second viewing window that when rotated displays the corresponding medication dosage imprinted on the top, outer surface of the closure cap. The consumer simply rotates the disk to display the pediatric patient's weight in the first viewing window and then views the dosage in the second viewing window. A click-stop index means, which is designed to cause a clicking action between the viewing disk and closure cap, locks-in the weight and corresponding dosage information. A consumer in an “English” units system will find milliliters and pounds to be the most convenient and understandable units of measure. Therefore, it is preferred that these units be imprinted on the top of the closure cap so that all necessary information for precise dosing is contained on the dose cap and conversion to other units is not necessary. In a “metric” unit system, it will, be preferred that the numbers be imprinted in metric units. Current labeling practices allow the use of metric units in an “English” unit country such as the United States of America, further compounding the probability of dosing errors.
The purchaser of a prescription medication or an over-the-counter medication in a container capped with the dial indicator cap, needs to only know the child's weight. The purchaser who is usually the parent dials in the child's weight so it is visible through a first window and then reads the precise dose shown in a second window. The dose is then poured into a suitable measuring instrument and administered to the child.
Some of the objects of the dial indicator cap are to: be a replacement or adjunct for the confusing, costly, detailed labeling system currently in use; be the primary source for determining dosage as a function of weight or some other factor; simplify parental dosing instructions; be an inexpensive modification of existing closure caps while allowing incorporation of currently used child safety cap features; be consumer friendly; improve caregiver compliance with dosing instructions; ensure precise dosing of all pediatric medications; allow adjustment to dosing with a child's advancing weight and age; reduce dosing errors and related costs; meet the expectations of the consumer and medical community; meet or exceed Food and Drug Administration regulations and policies on dosing; allow accurate dosing for children under 2 years old; maintain all dosing instructions as an integral part of the medication container, so packaging materials may be discarded without concern; significantly improve and safeguard the health and safety of pediatric children; and improve the efficacy of pediatric medication by assisting accurate dosing.
Each dial indicator cap is tailored to a specific medication according to the manufacturer's specifications. The cap may be tailored, for example, to accommodate all prescriptive antibiotic suspensions for children and all over-the-counter pediatric liquid medications.
This “Summary of an Embodiment of the Invention” section describes a medication application embodiment of the invention claimed in this specification only for purposes of illustration. It is to be understood that this invention may be used for myriad other applications.
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Courson Tania C.
Gray Plant Mooty Mooty and Bennett, P.A.
Gutierrez Diego
Reid Malcolm D.
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