The present invention relates to a system and method for measuring and monitoring elapsed time. In particular, medical patient compliance with a prescribed regimen of treatment is monitored through elapsed time of equipment operation.
Millions of women suffer from urinary incontinence, which is the inability to retain urinary discharge. It has long been known that strengthening the muscles of the pelvic floor and urinary sphincter can be achieved through the use of the Kegel exercise. A patient who performs the Kegel exercise will repeatedly and voluntarily contract and relax the pelvic musculature for a predetermined length of time.
In spite of proven effectiveness of the Kegel exercise when practiced faithfully, this treatment has often failed because of lack of patient compliance. Exercises not properly completed will not yield satisfactory results. The tendency is to give up and learn to live with the problem.
Another option for women with urinary incontinence is to pursue more aggressive treatment alternatives such as drug therapy or surgery. These approaches, however, have had limited effectiveness over time.
Still another option is the use of electrical neuromuscular stimulation. It has been shown that electrical neuromuscular stimulation of dysfunctional muscles by means of a vaginal electrode can effectively prevent the unwanted flow of urine. Nerve fibers are electrically stimulated by means of transcutaneously applied pulses of electrical current to cause contraction of the dysfunctional muscle. Furthermore, through the use of such an electrode some patients can educate themselves to voluntarily or automatically impede the flow of urine.
It is often advantageous to be able to measure elapsed time of operation of equipment. Particularly in medicine, it is useful for a doctor to know how well a patient is complying with a prescribed regimen of treatment in order to be able to judge the treatment's efficiency.
A typical compliance monitor system might consist of a treatment detector, a treatment time counter, and a readout device. These are used, respectfully, to detect that a treatment is being used in an acceptable fashion, to count the time interval of the treatment, and to display and clear the treatment time counter reading.
When the readout device is separate from the treatment time counter, which is often the case in portable treatment devices, it is necessary to provide means of connecting the two in order to utilize the display and clear functionality. It is often desired to minimize the number of signal lines used for such connection for reasons of cost, size, and reliability.
There are prior references which discuss methods of storing and retrieving data related to a patient's use of a medical device. Petrofsky, U.S. Pat. No. 4,642,769, entitled METHOD AND APPARATUS FOR PROVIDING STIMULATED EXERCISE OF PARALYZED LIMBS, discloses a computer controlled system for controlling precise movement of paralyzed muscles through electrical stimulation. A physician programs a memory cartridge which is used by the patient at remotely located and computer controlled exercise equipment. The cartridge stores records of the intensity and length of a work out. The cartridge can record specific exercise data, such as a leg lift count, by incrementing the data in a memory location each time the leg is lifted. The exercise is automatically terminated after the count exceeds a prescribed maximum number. The physician can recall the data directly from the cartridge.
Kipnis, U.S. Pat. No. 4,738,268, entitled RELATIVE CLOCK TIME, discloses a time clock for determining the relative time between two or more events independently of wall clock time. Each time a patient begins recording data, stops recording data, or presses a separate button to indicate the patient believes a certain event is taking place, a time stamp is added to the data. This data is then recorded as digital information. After the recording is complete, the data is transferred to a physician through a modem.
Ogren, U.S. Pat. No. 4,738,268, entitled COLLECTION AND REPORTING SYSTEM FOR MEDICAL APPLIANCES, discloses a data collection and reporting system for medical appliances. The system includes a usage monitor device which is attached to a host medical instrument. The meter automatically logs clock times when the instrument is turned on or off. The meter includes an electronical flag indicator which indicates meter overflow. The meter flashes the flag indicator at a six month point to indicate the need for preventative maintenance. A portable data collector collects the data from the monitoring device through an eight pin telephone type cable.
Maher et al., U.S. Pat. No. 4,832,033, entitled ELECTRICAL STIMULATION OF MUSCLE, discloses an electrical stimulation system having a system controller and a personal, portable stimulator unit. The stimulator unit is programmed to store in its memory the characteristics of the applied stimulation patterns and a record of the number of times that the patient has applied them. Maher et al. discloses several interfaces between the system controller and the personal unit. In each of these configurations, the information is stored and transferred as a digital word.
Each reference discloses methods of storing and retrieving data related to a patient's use of a medical device. However, in each of these methods, the data is stored and transferred as a digital word. The equipment used to transfer this data is thus both bulky and expensive.
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USPTO Backgrounds