Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...
Reexamination Certificate
1999-12-15
2003-03-25
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Infrared, visible light, ultraviolet, x-ray or electrical...
C604S501000, C604S890100
Reexamination Certificate
active
06539250
ABSTRACT:
BACKGROUND OF THE INVENTION
a) Field of the Invention
The present invention relates to a programmable system means for regulating the introduction and transdermal delivery of medicaments and therapeutics utilizing and integral to a microprocessor embedded dispenser. More particularly, the present invention relates to programmable system means embodied in the therapeutic apparatus which comprises a carrier unit, containing at least one microprocessor controlled transdermal dispenser, connected to a computer interface module embedded with appropriate software. The programming means specifically and uniquely provide patient customized limits and instructions for a removable dispenser with the ability to exist and function for patient use as a responsive entity after programming completion.
b) Description of the Prior Art
In the prior art of transdermal drug delivery, the common approach to regimen management was to manufacture differing packages that would vary the concentration and amount of a drug to control the dispensing rate and duration respectively. Thus the healthcare professional commonly selects a preset dispenser that most closely approximates the needs of an individual patient.
In the prior art of programmable control for transdermal drug applicator systems, Bettinger, U.S. Pat. No. 5,474,527, discloses a microchip controlled patch with a multiplicity of medicinal vials that can responsively vary the drug selection, the initiation and cessation of dispensing, and the drug concentration. Bettinger leaves the patient locked into a responsive but preset regimen suitable for a wide group of patients, but only approximate for the needs of an individual patient.
In the prior art of programmable control for transdermal drug applicator systems, Sibalis et al., U.S. Pat. No. 5,865,786, disclose a microprocessor controlled wrist band worn transdermal dispenser preset with programmed instructions. This wrist band dispenser is susceptible to connection with some undisclosed external preprogrammed system, prepared in a doctor's office, by means of the prongs of a plug. Neither the preprogrammed system components nor its functions are described or disclosed. This plug interface between the dispenser and the preprogrammed system is highly specific and non universal. The preprogrammed system of Sibalis severely limits the dispenser use for preset regimens for a broad class of patients, unsuitable for individual patient customization.
SUMMARY OF THE INVENTION
In order to overcome the above-mentioned deficiencies and problems in the prior art, this invention teaches a programmable transdermal therapeutic apparatus comprising:
1) a detachable microprocessor system controlled medication dispensing device attached to and in close proximity to,
2) a detachable computer interface module, compatible with a personal computer, and further containing and storing
3) a query and translator program selected to be descriptive of a multiplicity of beneficial therapeutic regimens of at least one medication contained within and actively disposed within the medication dispensing device.
Thus when this detachable computer interface module is inserted into an active personal computer and the program is uploaded, this program is selected to query for an individual patient's attributes, to translate the patient's attributes into customized limits and instructions of a specific medication delivery regimen, and to download the regimen into the dispensing device.
This programmable transdermal therapeutic apparatus may comprise a medication dispensing device which is attached to and in close proximity to a detachable carrier unit, where the carrier unit is attached to this detachable computer interface module.
More specifically, this invention teaches a programmable transdermal therapeutic apparatus comprising:
1. a detachable carrier unit possessing: a) at least one disposable, removable transdermal dispenser comprising: i. at least one beneficial fluid, and ii. an embedded microprocessor system providing the means for actuation, pre-selected timing, rate, cycles, and duration of dispensing the beneficial fluids, and iii. dispenser activation means, connected by appropriate wiring means to, iv. independent power supply means connected by appropriate wiring means to the microprocessor system, and b) an auxiliary battery backup, connected by appropriate detachable wiring means to the transdermal dispenser, and c) the carrier unit possessing appropriate coupling means on a first side, furthermore the coupling means for temporary connection to,
2. a detachable computer interface module possessing: a) a first side with appropriate matching coupling means for temporary connection to the carrier unit, and b) a second opposing side with appropriate coupling means for temporary connection of the apparatus to a personal computer during programming of the microprocessor, and c) an appropriate download-capture mechanism, connected by appropriate detachable data wiring means to the removable transdermal dispenser, and further connected by appropriate data transport means to second side computer coupling means.
The therapeutic apparatus when in temporary direct compatible interconnection with a standard access port of a personal computing device, running software designed to query, interpret, and program the micro-processor memory provides for predetermined timing, rate, cycles, and duration of dispensing upon dispenser activation.
The disposable transdermal dispenser component of the present invention is activated when the protective storage shield is removed. Additionally, this microprocessor controlled dispenser possesses programming memory to begin system timing at the removal of the protective storage shield. Furthermore, this programming memory deactivates the dispenser upon the expiration date of the medications and the completion of the patient specified regimen.
The detachable carrier unit possesses an internal auxiliary battery. This battery serves as a power source for power backup and management, as well as to maintain an active dispenser during programming.
The computer interface module component of the present invention temporarily connects the carrier unit containing disposable dispenser to a personal computer through a standard access port. This computer interface module possesses at least one personal computer program internally resident on common computer input/output media.
The software run by the personal computing device is selected to possess the ability to query the personal computing device for time zone and location of system use and also to query the original equipment manufacturer internet site for the most current programming instructions and application data.
The software run by the personal computing device is further selected to possess the ability to query the pharmaceutical manufacturer internet site for drug recall information and to screen for drug interactions, alerting the healthcare professional as required.
This invention teaches a programmable transdermal therapeutic apparatus comprising a detachable computer interface module further possessing: a) a display for exhibiting independent alphanumeric data, where this alpha-numeric data is entered into this display with the use of and controlled by, b) a touchpad control containing multiple buttons selected for the ability to provide the functions of data display activation/deactivation, data category selection, and scrolling. Thus programming selection for an antidote based upon age, sex, weight, and particular chemical/biological hazard provides programming instruction to the dispenser of the therapeutic apparatus such that this antidote is administered to the patient upon dispenser activation.
The method of programming a transdermal dispenser of the present invention comprises the steps of:
1) booting up the personal computer,
2) inserting and connecting a computer interface module, connected by appropriate coupling means to a carrier unit conveying microprocessor controlled dispenser, to a personal computer,
3) permit
Casler Brian L.
Maynard Jennifer
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