Electrolytic substance infusion device

Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...

Reexamination Certificate

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C604S890100, C604S501000

Reexamination Certificate

active

06738662

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to a treatment device for application to body tissue for treatment of injuries and illnesses and, more particularly, it relates to a treatment device which electrolytically infuses a substance into the body tissue upon application of an electric field by the device thereby providing an enhanced and synergistic anti-microbial benefit or improvement to the injury or illness.
2. Description of the Prior Art
Many microorganisms including, but not limited to, virus, bacteria, fungus, etc., exist in the human body. It has been estimated that approximately one-third (⅓) of the United States population harbors pathogenic microorganisms such as several species and strains belonging to the Herpes Simplex family of viruses. The Herpes Simplex family of viruses is responsible for such disease outbreak states as “Cold Sores”. These lesions are often instigated by a systemic malady such as a cold or flu. The lesions can also be provoked by sunlight, emotional stress, and are aggravated by various food substances including caffeine and chocolate.
When an outbreak occurs, the outbreaks occur most frequently around the mouth area and produce large, unsightly, painful sores. During the time that the sore is exposed, the condition is highly contagious and the virus is transmitted readily through both direct contact and indirect contact. Furthermore, the lesions take one (1) to two (2) weeks to heal and occur with a frequency of every few months to every few years, depending on the individual.
To date, there is no known cure for the “Cold Sores” malady. The pathogenic microorganisms that cause the malady, such as Herpes Simplex virus, lay dormant, hiding from the body's natural immune system in the nerve cells until an outbreak occurs. Several therapies have been explored which range from topical antibiotic salves to intravenously administered systemic doses of antibiotics. These therapies have demonstrated only limited success at reducing the duration and severity of a “Cold-Sore” outbreak.
Concerning the treatment of warts, it has been noted that a virus, which lives in the root of the wart, causes warts. The site where the virus lives can actually be one (1 mm) millimeter to two (2 mm) millimeters below the surface of the surrounding tissue. Unfortunately, simply removing or dissolving the tumorous protrusion above the root does not remove the remaining root which still harbors the virus. With conventional treatment methods, eventually, the wart will return.
In the past, iontophoresis machines were constructed to treat warts and other viruses. These machines are very large to treat large areas of tissue and have been nonportable due to their size and required skilled operation by a trained practitioner to achieve the appropriate dose and rate. The conventional iontophoresis machines also required constant monitoring to maintain the desired rate during the procedure.
The conventional iontophoresis machines focus on delivering molecular compounds (drugs) to subcutaneous regions of infected tissue. The drugs are immunomodulators, which cause the T-cells, and K-cells to more actively attack an infection. Some infections like Herpes and warts, hide inside cells during their progeny producing (multiplying) phase and are therefore as resistant to profused antiviral drugs as to the systemically or topically administered versions.
Still other seeming predicate devices give the illusion of antimicrobial action by simply denaturing normal viable cells in the treated region. These devices are less effective and typically render tissue damage due to the medications or the generated free radicals. This tissue damage caused by excessive current density or in some cases the iontophoresis delivery of antiviral drugs, is actually counter productive to the therapy as a whole. A number of virus (particularly the ones producing warts) will remain largely dormant within host cells until the host cell begins to die. This impending death of the host cell triggers the virus to produce progeny, which go on to infect adjacent cells. Thus by killing the host cell, one actually causes the infection to broaden.
Some of the existing systems are so complex or cumbersome as to render them un-useable for anything other than laboratory work. Some previous techniques to fight Herpes required control areas flooded with Methylene Blue and then exposed to a certain wavelength of light. This is only practical in a laboratory environment and is far too sophisticated and expensive for general use. Still other previous systems required large bench-top units which had to be operated by trained personnel and some utilized control pharmaceutical substances which are costly and showed insufficient efficacy to warrant commercialization. Furthermore, pre-existing silver iontophoresis devices offer no or limited control over the dose, rate and penetration.
Therefore, a need exists for a device, which provides an effective treatment for warts by treating the root of the wart through the wart's tumorous protrusion. Additionally, there exists a need for a device, which provides an electrolytic substance infusion device for treating cold sores and other lesions. Furthermore, a need exists for a device, which treats any tissue-based viral, bacterial, or fungal infection through electrolytic substance infusion.
SUMMARY
The present invention is a device for treating an illness or injury of tissue of a body. The device comprises at least a first electrode contactable with the tissue and at least a second electrode contactable with the tissue. A control system is electrically connected to the first electrode and the second electrode with the control system creating an electric field between the first electrode and the second electrode through the body. Silver, acting as an antimicrobial substance is on or comprised of at least a portion of the first electrode with the substance being ionized upon application of the electric field thereby profusing the ionic silver into the tissue.
In another embodiment of the present invention, the substance is selected from the group consisting of any ionic substance including, but not limited to, zinc, copper and silver. Furthermore, preferably, the device treats maladies selected from the group consisting of Herpes-type outbreaks, colds-type maladies, skin cancers, sub-dermal tumors, warts, acne, cold sores, and germicidal or dermatological infections.
The device further comprises an indicator signal for indicating activation of the control system and indication that a satisfactory does is/has been delivered. Furthermore, preferably, the device further comprises an embedded microcontroller or other circuitry for controlling the delivery rate, application waveform and the dose of the silver ions.
In yet another embodiment of the present invention, the device further comprises a small compact housing with the power source positioned within the housing and the first and second electrodes being mounted on the housing.
In another embodiment of the present invention, the microcontroller is activated upon the first and second electrodes contacting the skin. The applied field or waveform is then generated by the embedded microcontroller from the low-voltage battery contained within the box. The microcontroller directly controls the dc/dc switching converter to maintain the desired voltage to produce the optimal infusion rate and waveform.
This completely self-contained auto-turn-on device makes highly effective silver iontophoresis for the treatment of dermatological infections both very portable and very inexpensive.


REFERENCES:
patent: 3831598 (1974-08-01), Tice
patent: 3918459 (1975-11-01), Horn
patent: 3964477 (1976-06-01), Ellis et al.
patent: 4305390 (1981-12-01), Swartz
patent: 4411648 (1983-10-01), Davis et al.
patent: 4474570 (1984-10-01), Ariura et al.
patent: 4774833 (1988-10-01), Weibler et al.
patent: 4808152 (1989-02-01), Sibalis
patent: 4821700 (1989-04-01), Weibler et al.
patent: 5254081 (1993-10-01),

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