Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-06-16
2002-06-18
Oropeza, Frances P. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06408211
ABSTRACT:
BACKGROUND OF THE INVENTION
Introduction
This invention is in the field of devices used to apply microcurrent treatment such as used for application of microcurrent treatment to portions of the human body. Microcurrent therapy is distinct from other methods of applying electromagnetic fields to living tissue. The name microcurrent therapy stems from the use of microamperes as opposed to milliamperes used in TENS devices such as the D'Alerta device disclosed below.
This invention is directed to providing a device that is useful in microcurrent therapy. The device is then used then used in a biological application to provide relief or treatment to tissue and joints. In order to provide context to the use of the invention, the description will include references to the use of the device in connection with the extended application of a microcurrent running through the tissue of the user of the device. Analogous to the variations in the response of various individuals with various maladies to drug therapy, there are many variations in individual response to microcurrent therapy. Although the present invention provides a device that can provide a sustained current flow within a desired microcurrent range, this does not remove all of the other biological variations between users.
One of the requirements of the patent process is to provide the best mode of using the invention. The inventor of the present invention has not invented microcurrent therapy nor has the inventor personally directed controlled studies that determined optimal placement and current application regimes for microcurrent devices. Thus the best mode provided by the inventor for the present invention relates to the microcurrent therapy device and the method of indicating a current flow through the tissue. It is expected that as this field is further developed by those skilled in developing such microcurrent therapies, that one skilled in the art of making microcurrent therapy devices will be able to adapt the disclosed invention to provide the specific requested microcurrent therapy.
DESCRIPTION OF THE PRIOR ART
A device for use in the application of therapeutic microcurrent to tissue is disclosed in U.S. Pat. No 5,354,321 to Mario Berger. The '321 patent discloses a Patch Arrangement for Galvanic Treatment. The Abstract of the Berger patent asserts that the '321 invention is based on the object to employ electrotherapy through stable galvanization without an external voltage source to provide an efficient and practical device. Rather than repeat all that is taught in the Berger patent, the U.S. Pat. No. 5,354,321 is hereby incorporated by reference.
The Berger patent builds on earlier inventions to apply metal plates to the surface of the skin on both sides of the effected area. By selecting a particular arrangement of dissimilar metals and insulators, one can produce a flow of current through skin and the tissue below the skin as this portion of the body provides an electric bridge between plates of dissimilar metals. The circuit path between the two dissimilar metal plates allows a small current on the order of microcurrents to flow through the tissue until this Galvanic current is no longer present. The Berger patent asserts that the use of a series of pairs of dissimilar metals can be used to improve the prior art devices by increasing the Galvanic current effect.
As noted in column three of the Berger '321 patent, there may be times where an electrically conductive material will be applied between the skin and the metal electrodes in order to reduce the electrical resistance between the metal electrodes and the skin. The material will need to be electrically conductive but can be any one of a number of materials that can be left in contact with the skin such as a material containing or soaked with an electrolyte. Perspiration carries various electrolytes. Thus a piece of fabric soaked in perspiration would serve as an electrically conductive material.
Unfortunately, skin, tissue, and perspiration are not manufactured items with constant electrical properties. These materials vary both between individuals and even at different times and places for the same individual. An individual that has dry skin in the winter is likely to have different electrical properties in the skin than the same person would have in the summer while playing tennis and perspiring heavily. The use of a conductive gel helps with dry skin but adds its own source of variability in its level to conductivity. Various gels are used for medical reasons to promote “good contact” between the skin and various monitoring devices. While it may not matter the specific electrical conductivity of a dab of gel for use in getting “good contact” for a monitoring device, the same is not true for a microampere current flow that is intended to be kept within a narrow range of current flow rates.
Since there are several factors which lead to variability in the electrical properties of skin, tissue, and the gels used to promote good contact, it then follows that the electrical properties of the skin and tissue vary from one person to another and even for one person from one week to another. The variation in electrical properties cause variations in the flow rate of current and the effective life of the current source for therapeutic device. The use of various types of conductive gels, the thickness and uniformity of application of the gel, the amount of perspiration on the skin—all add to the variability. Yet, another source of variability is the cleanliness of the surface of the metal pads in the Gerber device.
The net effect of all these variations causes considerable variation in current flow. In some cases the current flow from a Galvanic device can be below the level of current flow desired for therapeutic action. In other cases the same device can provide a current flow that not only exceeds the desired levels but actually causes a painful burning sensation.
U.S. Pat. No. 5,423,874 to D'Alerta discloses a Patch for Applying Pain Reducing Electrical Energy to the Body. The D'Alerta patent describes another type of device, a TENS device that is used to block the sensation of pain without any rejuvenative effect to the tissue. This D'Alerta '874 patent is incorporated by reference into this description but will be briefly described.
One of the many differences between the '874 device and the Berger Galvanic device in that the '874 includes “on-board circuitry” to provide additional control beyond the constant application of a decaying Galvanic voltage potential. The '874 patent includes an integrated circuit and other circuitry for creation of a series of 50 volt square waves. (In other words the voltage quickly rises to 50 volts DC, is maintained at that voltage for a fixed period of time, falls quickly to 0 volts and then stays at 0 volts for a fixed period of time before repeating the pattern.)
Although the D'Alerta device is for delivering current at milliampere rather than microampere levels (approximately 1000× the levels of current delivered in a microcurrent device), the D'Alerta device is included here to highlight a use of an LED indicator light. The D'Alerta device provides a 50 volt pulse to the skin and is easily perceived by the user. The LED light as placed in
FIG. 7
as Element CR
1
indicates whether the timing clock signal on pin
3
of IC
1
and the battery VI are operating. Thus, the indicator LED of the D'Alerta device is not in line with the current path through the user between the Anode Pad and the Cathode Pad and thus does not indicate the successful application of current through the user's skin.
PROBLEMS WITH PRIOR ART SOLUTIONS
The name microcurrent therapy stems from the use of microamperes as opposed to milliamperes used in TENS devices. One of the results of using such low current levels is that the user of a microcurrent therapy device (“MCTD”) is often unable to tell when the device is applying a therapeutic dose of microcurrent or when t
Daniels & Daniels, P.A.
Flynn Kevin E.
Newcare Products, LLC
Oropeza Frances P.
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