Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-05-30
2001-09-11
Evanisko, George R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C600S546000
Reexamination Certificate
active
06289245
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an apparatus for electrical therapy for medical purposes, more particularly, to an apparatus for urinary incontinence treatment using an EMG (Electromyography) signal.
Urinary incontinence is a common problem throughout the world and is particularly prevalent in the female population and in the aged. A large number of women suffer from urinary incontinence due to childbirth or general deterioration of body structures as an aging process and so on. It is known that about 20-30% of women over 50 years old suffer from urinary incontinence. Resulting from urinary incontinence is embarrassment, discomfort and distress, loss of sleep and the necessity for large monetary disbursements by the patients for absorbent pads, diapers, rubber sheeting and for cleaning of soiled clothing.
These days the treatment for urinary incontinence includes surgery, physical rehabilitation and drug therapy.
The surgery treatment methods are invasive and thus most patients hesitate to choose this option over others. In addition, the drug therapies are known to provide very limited effectiveness. However, treatment for urinary incontinence is viewed differently by society as many non-invasive and non-pharmaceutical treatment methods are being introduced lately. Among such treatment methods, a biofeedback therapy and a neuromuscular electrical stimulation method are most commonly recognized as major treatment methods. These treatments have been proven very effective, safe to use and relatively inexpensive. In biofeedback therapy, repetitive contractions of pelvic floor muscles improve the strength of the pelvic floor muscles. Neuromuscular electrical stimulation method applies current pulses to pelvic floor muscles so that the motor nerve fibers are electrically stimulated. For more effective treatment for urinary incontinence, it is desirable that both biofeedback and neuromuscular electrical stimulation methods are performed at the same time, rather than one of them being independently performed.
For biofeedback treatment method for urinary incontinence, a patient follows pre-defined training courses to contract her pelvic floor muscles. At this time, it is very important to let the patient know how strong the pelvic floor muscles can contract according to her will.
This is because the effectiveness of the treatment increases along with the patient's positive attitude and willingness by objectively recognizing the improvement of the contractile force as the training progresses. In addition, doctors can create an effective training program in accordance with the observation of the training progress.
EMG signals are measured by the intensity of EMG proportional to the contractile force of the pelvic floor muscles. In doing so, one or more conductive electrodes are contacted with the surface of the vaginal wall. The electrode senses the voltage driven by the muscles, and the frequency of human EMG signals lies in the band between 20 and 800 Hz, which includes higher frequency components than other EMG signals.
FIG. 1
illustrates the typical waveform of such an EMG signal. However, such instantaneous transition of the EMG signals as seen in
FIG. 1
is not required for analyzing the contractile force, but important is the overall transition of the amplitude of EMG signals as seen in
FIG. 2
, namely an envelope signal. Such an envelope of EMG signal has low frequency components, that is below 10 Hz.
However, the sampling frequency needs to be over 1,600 Hz in order to eliminate possible errors due to A/D conversion, because the raw EMG signal data contains high frequency components. However sampling using such a high frequency causes to complicate the structure of the device and raises the manufacturing cost.
In addition, the existing electrical therapy devices, such as urinary incontinence treatment devices, constipation/fecal incontinence treatment devices and low-frequency physical therapy devices, are very similar in their operating principles. Although, it is common to construct separate devices for each treatment purpose because each device has a unique form of electrode.
SUMMARY OF THE INVENTION
Accordingly, the object of the present invention is to provide a less expensive and more effective apparatus for urinary incontinence treatment.
Another object of the present invention is to provide a compact in its structure and portable apparatus for urinary incontinence treatment.
Still Another object of the present invention is to provide an electrical therapy apparatus for medical purposes such as urinary incontinence treatment, constipation/fecal incontinence treatment or low-frequency physical therapy.
Yet another object of the present invention is to provide a urinary incontinence treatment apparatus which lets the patient recognize the state of his/her muscular contraction more easily.
To achieve the above-mentioned objects, the present invention provides a medical treatment apparatus.
According to one aspect of the present invention, an apparatus for medical treatment is operatively coupled to at least one electrode adapted to be contacted to a portion of a body or inserted into a body cavity for sensing an EMG signal therefrom. The apparatus comprises: an envelope detector for receiving the EMG signal captured by the electrodes, and for filtering the EMG signal to produce an EMG envelope signal; and a display unit for displaying an information on medical treatment based on the EMG envelope signal. In one embodiment of the present invention, the apparatus further comprises: a memory for storing treatment-related data including a predefined training goal waveform information, and wherein the display unit displays the information on medical treatment based on the predefined training goal waveform information in addition to the EMG envelope signal. In another embodiment of the present invention, the apparatus may also comprise a main controller for controlling the envelope detector, the memory and the display unit. Here, the display unit may comprise a screen and a display controller coupled to the screen. Also, a first waveform of the EMG envelope signal and a second waveform of the training goal signal are concurrently displayed on the screen during medical treatment for easy comparison. In yet another embodiment of the present invention, the apparatus may also include a memory for storing treatment-related data including the training goal waveform information; and a main controller for controlling the envelope detector, the memory and the display unit, and the display unit includes a screen and a display controller coupled thereto the screen. Also, the apparatus may include an operation unit coupled to the main controller for inputting user's manipulation data to the main controller. The operation unit includes a first setting means for inputting an information related to a stimulation signal waveform to be delivered to the patient's body through the electrode; a second setting means for setting the operational mode of the apparatus. The operational mode of the apparatus may include a stimulation mode for carrying the stimulation signal to the patient's body, a measurement mode for sensing the EMG signal from the patient's body and a combination mode for performing the stimulation and measurement modes alternatively. Here, the operation unit includes a third setting means for selecting either automatic or manual switching between the stimulation and measurement modes, if the combination mode is selected by the second setting means; and a forth setting means for determining the time length from when the stimulation signal is applied to the patient's body to when the switching to the measurement mode is made, if the automatic switching is selected by the third setting means.
According to another aspect of the present invention, provided is an apparatus for medical treatment being operatively coupled to at least one electrode adapted to be contacted to a portion of a body or inserted into a body cavity for sens
Lee Soo Yeol
Mo Seung Kee
Evanisko George R.
Sheridan & Ross P.C.
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