Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...
Reexamination Certificate
1999-03-17
2001-04-24
Bockelman, Mark (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Infrared, visible light, ultraviolet, x-ray or electrical...
C604S501000
Reexamination Certificate
active
06223076
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to a hyperhidrosis treatment device, and more particularly, to a method and apparatus for conveniently and quickly providing enhanced iontophoretic application of antiperspirant chemicals to regions of the human body in a simple and economic manner.
Treatment of excess sweating is commonly done in one of two ways. For individuals with a mild case of sweating, effective treatment may be had through the application of chemical antiperspirants. For those inflicted with a more severe case of excess sweating or even hyperhidrosis, iontophoretic treatment may be necessary. Iontophoretic treatment involves the electrical introduction of ions into the skin to block the sweat duct.
An iontophoretic device for the treatment of hands, palms and axilla is disclosed in U.S. Pat. No. 4,325,367. In this device a support structure houses a pair of aluminum alloy electrodes in generally close proximity to one another as well as a source of electrical power. The electrodes are arranged so that, for example, the palm of a hand can be placed on the device and simultaneously contact both electrodes. A moisture absorbing pad is interposed between each of the electrodes and the skin of the user. In operation, the pads are moistened with water and the user places his hand on the pads. Current is applied from the electrodes, through the pads, to the user, thereby providing iontophoretic treatment.
Another iontophoretic device is disclosed in U.S. Pat. No. 5,224,927. In this device, the electrical current applied between a pair of electrodes is periodically reversed at very low frequencies to mitigate tissue damage. Again, a moisture absorbing pad is interposed between each of the electrodes and the skin of the user. In operation, the treatment site may be prepared using an appropriate ionic surfactant such as an amphoteric or a cationic surfactant and electrical current in the form of a low frequency AC signal is applied to the treatment area through either water moistened pads or ionicsurfactant moistened pads.
In the well known DRIONIC compact iontophoretic device, which employs various aspects of both U.S. Pat. Nos. 4,325,367 and 5,224,927, long term treatment of severe cases of hyperhidrosis is provided through a series of iontophoretic treatments. The mean-average treatment time to effectively stop sweat is approximately seven hours. The treatment regimen calls for a series of approximately half-hour individual treatment sessions spread over the course of several days. The actual length of a session and time between sessions depends on the user's tolerance to electric current. During each treatment, metal ions, e.g., aluminum ions from the electrodes, are driven deep into the eccrine sweat pores to stop sweat. The cumulative effect of the series of treatments may stop sweat for up to six weeks. Moreover, the DRIONIC device relies on amplified voltages of 60 volts and safety control circuits.
While the DRIONIC device is intended for the extremely heavy sweater, the use of such a formidable and time consuming device may be an undesirable treatment for people suffering from only a mild case of excess sweating. Most of these individuals will chose the daily use of a wide variety of well-known over-the-counter topical antiperspirants to control heavy sweating. However, a problem associated with over-the-counter topical antiperspirants is the lack of sufficient penetration into the skin of the eccrine-pore-blocking antiperspirant chemical. Thus these topical antiperspirants have limited efficacy. It has been reported that over-the-counter topical antiperspirants are effective for only about fifty percent of those who use them. The those other fifty percent receive little or no benefit from such antiperspirants. In those people who enjoy some benefit from store bought antiperspirants, this efficacy is only between twenty and forty percent.
Hence, there has been a long existing need in the art for a system capable of administering deep-penetrating iontophoretic application of antiperspirant chemicals to the human body in a short period of time. There also exists a need for such a device that operates at a low power rating and thus relatively independent of a user's tolerance for electrical current. There further exists a need for such a device that is conducive to daily use. The present invention fulfils all of these needs and others.
SUMMARY OF THE INVENTION
Briefly, and in general terms, the present invention is directed to improvements in the treatment of excess sweating and hyperhidrosis through the use of an iontophoresis administration of antiperspirant chemicals into the human body.
In a first aspect, the present invention embodies a sweat treatment device for effecting iontophoresis at a specified region of tissue. The device includes a source of electric current, a controller and a pair of electrodes. The electrodes are mounted in generally close proximity to one another and are separated by an insulating member. The electrodes carry an antiperspirant element and are responsive to the source of electrical current through the controller. One of the electrodes is connected to the source of electrical current and is arranged to act primarily as a cathode. The other electrode is connected to the source of electrical current and is arranged to act primarily as an anode. The device further includes a pair of pads. Each of the pads is positioned in adjacent contact with one of the electrodes and carries sodium salicylate. The electrodes are sized and arranged so that the tissue to be treated can extend across the insulating member and simultaneously contact both of the pads.
By carrying an appropriate salt of salicylic acid, such as sodium salicylate, the pads provide for enhanced permeability of the tissue being treated. The sodium salicylate increases the permeability of the tissue and facilitates electrical driving of the ions contained in the antiperspirant elements carried by the electrodes deeper into the tissue to precipitate the skin protein and stop sweat. Thus the device provides increase efficacy. The salicylic salt and antiperspirant chemicals would typically be replaceable.
In a more detailed aspect of the invention, the pads further carry an aluminum-based antiperspirant. In another facet, the pad antiperspirant consists of one of either aluminum-chlorohydrate or aluminum-zirconium. In yet another aspect, the electrodes are formed of sheet stock metal having an irregular, nonsmooth, surface. This nonsmooth surface creates a greater overall surface area on the electrode thereby increasing the number of antiperspirant ions available for infusion by ionthophoresis. In still another facet, the sheet stock metal consists of aluminum, aluminum alloy, magnesium or magnesium alloy. In yet another aspect, the electrodes comprise sandblasted sheet stock metal. On other aspects the electrodes comprise powered metal formed on the sheet stock metal and the electrodes comprise aluminum oxide.
In another facet, the invention is related to an enhanced device for applying iontophoresis treatment to a selected region of a biological subject. The device includes first and second electrodes mounted in generally close proximity to one another and separated by an insulating member. The device also includes a pair of pads, each positioned in adjacent contact with one of the electrodes. Each of the pads carry an antiperspirant. The electrodes are sized and arranged so that the region to be treated can extend across the insulating member and simultaneously contact both of the pads. The device further includes an electrical energy source for conducting an electrical current through the region in a first direction from the first electrode to the second electrode; and a controller for intermittently reversing, at a relatively low frequency which prevents skin damage, between approximately 20 times per second and approximately once every three minutes, the polarity of the electrodes to cause the electrical current to flow in a second direction op
Bockelman Mark
Fulwider Patton Lee & Utecht LLP
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