Surgery – Container for blood or body treating material – or means used... – Materials mixed within container
Reexamination Certificate
1999-08-27
2003-01-21
Mendez, Manuel (Department: 3763)
Surgery
Container for blood or body treating material, or means used...
Materials mixed within container
C604S082000
Reexamination Certificate
active
06508801
ABSTRACT:
FIELD OF INVENTION
This invention relates generally to methods and apparati for rapid pediatric resuscitation and/or emergency management of serious pediatric medical conditions.
BACKGROUND OF THE INVENTION
“Resuscitation” as used herein, generally refers to any form of pediatric advanced critical care or intervention necessitated by conditions including, but not limited to: cardiopulmonary arrest and/or arrhythmias, respiratory compromise, shock or shock-like states, intentional or unintentional drug or toxin ingestion/overdose, metabolic disorders, seizures, trauma and other potentially life threatening events. Each year there are thousands of pediatric resuscitations from these circumstances within the United States alone. However, despite such intervention, children still die. It is the hope of every care provider to decrease these statistics where possible.
One way to minimize loss of life sounds simple enough; minimize potential sources of error and eliminate sources of distraction. Anything that will allow the physician to concentrate more on a pediatric patient's condition and less on ancillary matters can improve the chance for a successful resuscitation. It is to this goal that the present invention is addressed.
Currently medical professionals have at their disposal approximately 20 different medications that are used during pediatric resuscitation and/or during the emergency management of pediatric medical conditions. These medications include, but are not limited to, epinephrine, atropine, lidocaine hydrochloride, etomidate, midazolam, ketamine, fentanyl citrate, morphine sulfate, thiopental sodium, succinylcholine chloride, pancuronium bromide, vecuronium bromide, lorazepam, diazepam, naloxone, adenosine, calcium gluconate, dextrose, sodium bicarbonate, phenyltoin, phenobarbital sodium, fosphenyltoin, mannitol and other medications indicated for similar therapeutic uses. These medications have been extensively researched and are currently indicated or recommended as part of the advanced pediatric resuscitation protocols as outlined by the American Academy of Pediatrics and the American Academy of Emergency Physicians.
However, in contrast to the relatively standard, regimented and documented dosing of such medications to adult patients during a resuscitation attempt, the dosages for pediatric patients can vary widely. This can be attributed to the relative difference in lean body mass within the pediatric population as a whole. Since the body weight of most adults is in excess of what is deemed necessary to calculate the maximum recommended dose of a given medication, standard dosages are generally the rule and not the exception during adult resuscitation. On the other hand, significant variation in the lean body mass of pediatric patients can exist below the “standard dosage” typically administered to adult patients (i.e., given similar medical conditions, a premature infant would generally not receive the same dose of medication as a fully matured adolescent). If a patient is below that weight which results in the “standard dosage” (as is the case with most pediatric patients) then, the respective requirements for pharmacotheraphy during resuscitation will be determined by factors such as that patient's weight. The variation in weight, along with corresponding variation in dosage, combined with the nature of pediatric resuscitation in general, has been shown to result in a significant number of errors in medication administration. In fact, one study indicated that both out-of-hospital and in-hospital care providers inaccurately dose medications during pediatric resuscitation in 64% and 83% of the time, respectively, with dosing errors ranging from 2% to 769% of the correct amount.
At this time, there are several methods employed by pediatric and emergency specialists to assist with pediatric resuscitation. Traditional approaches include rote memorization of the required medications and appropriate dosages (which carries with it the highest potential for egregious error), memory adjuncts such as reference cards and tables, or the relatively new Broselow Pediatric Emergency Tape (which lists standard resuscitation medications and their dosages on a tape with weight corresponding to length/height as measured during the course of resuscitation). This device is disclosed in, for example U.S. Pat. Nos. 4,823,469 and 4,713,888.
While the foregoing methods are effective if utilized appropriately, they have significant limitations. For instance, a medical professional may be required to perform serial conversions from weight in milligrams to a corresponding solution volume in milliliters depending on the number of medications required. In addition, each medication may vary in quantity, concentration and subsequent volume of the medication administered. This is primarily due to the fact that most resuscitation medications are manufactured in different concentrations and dosage forms, and thereby lack dosage and/or concentration uniformity. As a consequence of these dosage variations and the emergent nature of the situation, insufficient time for a detailed system of “checks” during dose computation, information and/or drug acquisition and subsequent administration, a patient may receive either an insufficient or an excessive quantity of an appropriate medication. When one is dealing with infants and small children, a simple error or an incorrect placement of a single decimal point may mean the difference between regaining life or losing a life entirely.
Accordingly, there is a need in the art for methods and tools which give the care providers and their patients the optimal chance for a successful outcome.
The present invention fulfills these and other needs by providing rapid, uniform and systematic method of, and apparatus for, administering pediatric resuscitation medications.
SUMMARY OF THE INVENTION
In accordance with the present invention, a standardized pediatric resuscitation formulation is provided. The formulation includes an active agent useful in pediatric resuscitation which is provided in a predetermined amount. A pharmaceutically acceptable carrier and, optionally, a diluent or other excipient, can be provided as well. This carrier or carrier and diluent are provided in an amount which is sufficient to result in a predetermined concentration of the active agent. The concentration of this active agent is selected such that a standardized dose when multiplied by the patient's “unit”, such as weight, will deliver an amount of the active agent which is appropriate for pediatric resuscitation. If two particular active agents are provided as part of a system of standardized doses, for example, the concentrations of drug in each may be widely different. That is, the amount of active agent per unit of carrier may vary significantly from one medication to the other. Similarly, the appropriate amount of each active agent to be administered to a patient to accomplish pediatric resuscitation may vary widely. Perhaps several milligrams of a first drug are administered where only a few tenths of a milligram of a second drug are needed. However, the volume of the formulation of each, administered for pediatric resuscitation, would be identical when standardized in accordance with the present invention. Thus, in each case, a patient who is 10 kg by weight might receive 1 ml of each of the drug formulations for the appropriate medical condition. Again, however, the concentration of each drug in those doses and the absolute amount of active agent administered in each case may be significantly different from one drug to the other. Methods of administering these standardized formulations and kits or other set-ups containing the standardized formulations are also contemplated.
The present invention will allow for the care provider to quickly determine the correct medication dosage for a pediatric patient without the need to reference complicated dosage charts or recall mathematical formulation conversions.
The present invention permits accurate and relatively e
Lerner David Littenberg Krumholz & Mentlik LLP
Mendez Manuel
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