Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-05-18
2001-08-28
Layno, Carl (Department: 3737)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S149000, C607S063000, C607S072000
Reexamination Certificate
active
06282448
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an electronic stimulator, and more specifically to an electronic nerve and muscle stimulator and method useful for preventing venous thrombo embolism, venostasis, varicose veins, orthostatic hypotension, ankle edema, and leg discomfort resulting from prolonged sitting that can be self administered by a patient.
BACKGROUND OF THE INVENTION
There are a large number of diagnosed cases of deep vein thrombosis, DVT, in the United States annually. There are also a large number of fatal cases of pulmonary embolism, PE, many of which can be prevented with appropriate measures, such as pharmacological or mechanical. Prolonged sitting, such as when traveling or working long hours, can aggravate or promote DVT or PE. It can also cause ankle edema and leg discomfort. Studies have indicated that about one-fifth of the sudden natural deaths associated with commercial air travel that were brought to the London Coroner from Heathrow Airport were due to pulmonary embolism. There is a need for a device that helps to stimulate blood flow so as to prevent DVT and PE during the above mentioned circumstances. One such device is disclosed in U.S. Pat. No. 5,643,331 entitled “Method and Device For Prevention of Deep Vein Thrombosis” issuing to Katz on Jul. 1, 1997, which is herein incorporated by reference. Therein disclosed is an electrical stimulator generating a square wave pattern having a controllable duration ranging from 0.1 to 0.3 milliseconds, a controllable frequency ranging between 0.001 to 0.5 cycles per second, and a controllable intensity ranging from 1 to 20 milliamperes. An electrode is positioned externally at or near the tibial nerve at the popliteal fossa to deliver the electrical signal. This signal stimulates the nerve, causing a muscle contraction which helping to stimulate blood flow. The increased blood flow helps in preventing deep vein thrombosis, ankle edema, and venostasis. Additionally, there are numerous transcutaneous electric nerve stimulating devices, TENS units, used to control pain. There are also similar muscle and neurological stimulating devices, MANS units, also used to control or manage pain. All of these devices deliver relatively high frequency stimuli, for example 25 to 50 Hertz. They are generally not tolerated well by patients, especially when used for relatively long periods of time. Additionally, these devices are not completely suitable for the prevention of DVT or PE. Accordingly, while these units used for pain management or control are similar, they are not suited to relatively long term use and self-application by a patient for the prevention of DVT, orthostatic hypotension, PE ankle edema and leg discomfort. Therefore, there is a need for a device and method of application that can easily be self-administered by a patient during extended periods of sitting or inactivity, for example during traveling in a car or a plane, or sitting for many hours while working to help prevent DVT, PE ankle edema and leg discomfort. Additionally, there is a need for a device that is self adjusting preventing the need for a patient to determine appropriate settings. Additionally, there is a need for a device that will sense the muscle contraction and will not operate during on going muscle activity.
SUMMARY OF THE INVENTION
The present invention comprises a self-contained electrical device having pre-positioned electrodes making it easy to be self-applied by a patient and worn for extended periods of time during periods of inactivity or immobility, such as when paralyzed, hospitalized or sitting during traveling or working that is self adjusting. An elongated rectangular cuff or sleeve has straps and strips of hook and loop fastener material. Two electrodes having a predetermined position are connected to a control unit. Indicia or marking on the sleeve is placed between the two electrodes to aid in the proper positioning of the electrodes onto the leg of a patient or user. The indicia helps the user to position the electrodes without any specific knowledge of anatomy. The cuff or sleeve is sized to wrap around the calf of a user and to be securely held thereto in a proper predetermined position. The control unit attached to the cuff is preset to provide a substantially square wave signal to the electrodes having a duration of 0.3 milliseconds, a frequency of 0.1 to 0.5 Hertz with 5 to 15 repetitions delivered every 5 to 15 minutes. In one embodiment, the control unit has a structure permitting a user to control intensity only, and only within a range of 1 to 200 volts and 0.02 to 4 milliamperes at a 50 kilo Ohm output resistanc. In this embodiment, the intensity control is the only user controlled adjustment, which may also be the on/off control. In another embodiment the control is automatically adjusted. A motion detector or its equivalent, such as a stain gage or accelerometer is used to detect movement or contraction of the patients calf in response to a signal provided by the electrodes. The signal is adjusted according to the detected movement or contraction. In this embodiment, the activity sufficient to provide adequate blood flow can be detected and the signal or current output stopped during the activity.
Accordingly, it is an object of the present invention to provide a device that can be user applied and operated safely.
It is a further object of the present invention to provide a small, self-contained electronic stimulator for generating an effective muscle contraction of the calves by externally stimulating the muscle.
It is yet a further object of an embodiment of the present invention to provide a self adjusting powered neuro muscular stimulating device.
It is an advantage of the present invention that it is self-contained and can usually be placed into a predetermined position by a user.
It is a further advantage of the present invention that it can be worn under the clothes.
It is yet another advantage of the present invention that it can be worn over hosiery up to twenty-five denier.
It is a further advantage of an embodiment of the present invention that it does not require adjustment by the patient.
It is yet a further advantage of an embodiment of the present invention to prevent unnecessary operation during on going muscle activity.
It is a feature of an embodiment the present invention that a square wave is applied having a duration of 0.3 milliseconds, a frequency of 0.1 to 0.5 Hertz, with 5 to 15 repetitions delivered every 5 to 15 minutes with a self controlled current intensity of 1 to 200 volts and 0.02 to 4 milliamperes at approximately 50 kilo Ohms resistance.
It is another feature of one embodiment of the present invention that it has a single control adjusted by the user for overriding the self controlled intensity.
It is a feature of an embodiment of the present invention that a motion detector, such as a strain gage or accelerometer detects movement or contraction of a patient's calf.
These and other objects, advantages, and features will become readily apparent in view of the following detailed description.
REFERENCES:
patent: 3472233 (1969-10-01), Sarbacher
patent: 5487759 (1996-01-01), Bastyr et al.
patent: 5628722 (1997-05-01), Solomonow et al.
patent: 5643332 (1997-07-01), Stein
patent: 5674262 (1997-10-01), Tumey
patent: 5716330 (1998-02-01), Goldman
patent: 39 16994 A1 (1990-11-01), None
patent: 703101 (1979-12-01), None
Katz Amiram
Katz Orly
Fattibene Arthur T.
Fattibene Paul A.
Fattibene & Fattibene
Layno Carl
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