Data processing: generic control systems or specific application – Specific application – apparatus or process – Article handling
Reexamination Certificate
1997-06-02
2001-06-19
Ellis, Christopher P. (Department: 3651)
Data processing: generic control systems or specific application
Specific application, apparatus or process
Article handling
C700S244000, C700S236000, C222S246000, C368S010000
Reexamination Certificate
active
06249717
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains generally to devices and methods for dispensing medication, and more particularly to a liquid medication dispenser apparatus that monitors compliance with a treatment plan and determines a compliance score indicative of whether the liquid medication was dispensed at predetermined times and at predetermined dose levels.
2. Description of the Background Art
Medication recipients frequently need to take a set dose of medication or medications at regular intervals of time. Failure by persons to take the required medication dosages at the appropriate time intervals results in incorrect blood serum levels of the medication, and can ultimately lead to unfavorable clinical outcomes. For several reasons, incorrect liquid medication dosages are often taken by patients. Liquid medication dosages are typically measured by pouring the medication into a tea spoon or small container prior to taking the medication. This manner of dosage measurement is prone to inaccuracy and can result in wasted medication and unpleasant messes due to spills during measurement. Further, the amount of liquid medication remaining in a container cannot be easily determined, unlike solid medications wherein the patient can count the number of pills present, and thus the patient can run out of medication, resulting in missed or skipped medication dosages. Additionally, patients who must take numerous medications on a regular basis can easily loose track of the time at which a particular medication was most recently taken, resulting in omission by the patient of required dosages or exceeding the dosage requirement. Frequently, the timing requirements vary for dosages of different medications and further lead to patient confusion and error in taking the different medications at correct time intervals.
Accordingly, there is a need for a liquid medication dispenser which alerts patients of the correct time intervals for taking liquid medications, which keeps track of and displays the number of dosages of liquid medication taken, and which quickly, consistently and accurately measures and dispenses dosages of liquid medication. The present invention satisfies these needs, as well as others, and generally overcomes the deficiencies found in the background art.
BRIEF SUMMARY OF THE INVENTION
The present invention pertains to a liquid medication dispenser that monitors treatment compliance. It is designed to be extremely convenient and easy to use by the patient, while still providing state-of-the-art features for the health care provider. It measures and dispenses liquid medication doses, recording the time and sizes of doses, as well as information pertaining to compliance with a programmed treatment plan, for up to one year or longer. The device can be programmed, and information retrieved from the device, using a personal computer. Information downloaded from the device can then be used to evaluate patient compliance with the programmed treatment plan. The device utilizes a disposable, motor driven pump and medication reservoir to provide a very wide range of volumes, while maintaining full accuracy and reducing the risks of patient errors as might occur with a manual dispensing system.
In general terms, the invention comprises a medication cassette with an interchangeable and disposable reservoir and fluid path assembly, means for adjusting the amount of medication delivered, timer means for measuring time, memory means for storing data, display means for providing visual and audio output to a user, and control processor means for monitoring and recording the time and number of medication dosages dispensed, for alerting the user of the time for taking medication dosages, for monitoring he amount of medication remaining in the medication cassette, and for computing a compliance score. Preferably audible alarm means for alerting a user, and a communications interface for linking the control processor means with an external computer, are also included with the invention. A liquid dispensing valve assembly and pump are used for dispensing liquid medication from the reservoir and through the fluid path assembly.
By way of example, and not of limitation, the control processor means preferably comprises a conventional microprocessor, or other programmable data processor, which may be in digital or analog format. The timer means comprises first and second timers interfaced with the microprocessor, with the first timer preferably comprising a 32 KHz timing circuit for real time monitoring by the microprocessor, and the second timer preferably comprising a 4 MHz clock for basic processing by the microprocessor. The microprocessor may additionally include an internal “watchdog” timer. The display means preferably comprises a multi-field liquid crystal display (LCD) or light emitting diode (LED) display operatively connected to the microprocessor. The audio alarm means preferably comprises a conventional piezoelectric watch alarm device, and is operatively coupled to the microprocessor. The liquid dispensing pump has a pump motor with a rotation sensor associated with the rotating shaft of the motor. The rotation sensor is preferably an optical rotation encoder and is operatively coupled to the microprocessor to allow monitoring of medication dispensing events. The memory means preferably comprises at least 2K of random access memory (RAM) which is accessible by the microprocessor. The communications interface preferably comprises an optical interface operatively coupled to the microprocessor, and which receives an interface cable for connection to a personal computer.
It is an object of the invention to provide a liquid medication dispensing apparatus which uses standard 50 ml medication bottles, has a disposable fluid path fully enclosed in the dispenser's plastic case for easy carrying, has a 0.1 ml to 5 ml dose range, has 0.1 ml resolution, exhibits high accuracy at 5 ml, has only two user keys—a Display/Dose key and an Alarm/Increment key, employs a liquid crystal display (LCD), has at least one year memory at 2 doses per day (uploadable to a personal computer), has at least several months of battery life, uses common “AA” type alkaline batteries for power, and uses a pump technology for wide volume range and less patient error.
The invention provides for dispensing a measured dose of a liquid therapeutic drug to a patient and records the timing and amount of dose dispensed. The dose and/or timing history can be reviewed by a patient, physician or other health care provide, either as raw data or as a calculated “compliance score.” The invention is particularly suited for dispensing a liquid immunosuppressive drug to a transplant patient, and can be adapted for dispensing multiple drugs.
Further objects and advantages of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon.
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Britts Robert A.
Levy Ralph
McEnroe Debra L.
Nicholson Laurence R.
Pouletty Philippe
Butler Michael E.
Ellis Christopher P.
Flehr Hohbach Test Albritton & Herbert LLP
SangStat Medical Corporation
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