Method of reducing sebum production by application of pulsed...

Surgery – Instruments – Light application

Reexamination Certificate

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C606S002000, C606S013000, C606S017000

Reexamination Certificate

active

06235016

ABSTRACT:

BACKGROUND OF THE INVENTION
1) Field of the Invention
The invention relates to a system for the selective photothermolysis of the sebaceous glands and/or sebum-covered structures located in the dermal portion of the human skin. The system is advantageously used to disrupt the production of sebum in portions of the skin afflicted with acne, thereby reducing or eliminating the severity of the condition without the regular intake or regular topical application of drugs and without permanently destroying the sebaceous glands. The system can also be used to treat folliculitis, ringworm, and seborrhea.
2) Description of the Prior Art
Acne vulgaris is the most common skin disease, affecting nearly 80% of young adults aged 11 to 30. Not only can it cause disfiguration and permanent scarring, but it can have an adverse effect on psychological development, often resulting in profound emotional scarring. This may in turn lead to social phobias, withdrawal from society, and to clinical depression.
Research during the past thirty years has confirmed the multifactorial origins of the disease. The three factors leading to the development of acne are: 1) excessive sebum production, 2) abnormal desquamation of sebaceous follicle epithelium, or comedogenesis and, 3) the proliferation of the bacterium Propionibacterium acnes. If any of these factors are absent, acne vulgaris will not result. Treatments have been developed which attack one of the three key factors in the attempt to disrupt the process leading to acne. To date, however, most if not all rely upon a drug regimen, delivered either topically or internally. Side effects resulting from these treatments are sometimes minor but can be quite serious.
Tankovich, et al in U.S. Pat. No. 5,817,089 teach an apparatus for the treatment of acne and seborrhea. Their approach involves waxing the hair from the duct or otherwise opening the duct in order to allow a carbon-based solution to penetrate into the duct. After full penetration of the solution into the sebaceous gland or in the vicinity of the gland, laser irradiation vaporizes the carbon particles leading to the full or partial destruction of the basement membrane (the epithelium tissue of the Tankovich, et al teachings). This leads to the reduced sebum production needed for treatment of acne or seborrhea.
The invention taught herein relies upon the reduction of the production of sebum in the affected areas as the key to prevention of acne vulgaris and/or seborrhea. By prudent choice of laser wavelength, pulse parameters (i.e., power, pulse duration), and intensity, the laser can be utilized to selectively disrupt the productivity of the sebaceous glands in the targeted area without significant injury to surrounding dermal tissue or to the sebaceous glands' basement membrane. Optimally, the period of time which the sebaceous gland requires in order to repair its production capability will be on the order of two (2) months or longer. In the event that a large percentage of the sebaceous glands in the affected area are sufficiently disrupted, the incidence of acne vulgaris and/or seborrhea will be significantly reduced in the treated area for several months. Repeated treatment will enable the attending physician to successfully treat the patient without frequent application of drugs. As the sebaceous gland is not permanently destroyed, the patient will have normal natural skin protection in later life. The normal drop-off in sebum production experienced by most individuals upon maturation will signal a cessation of the laser treatments.
SUMMARY OF THE INVENTION
Accordingly, it is a primary objective of the invention to provide an improved means of treating acne vulgaris and/or seborrhea, one which does not involve the consumption or topical application of substances which can result in undesirable side effects.
Another object of the invention is to provide a means of treating acne vulgaris and/or seborrhea which is substantially pain free and which does not result in hypotropic or hypertropic pigmentation, or in cosmetic scarring.
Another object of the invention is to provide a means of treating acne vulgaris and/or seborrhea which is semi-permanent in longevity, “semi-permanent” being defined in this context as being effective, without follow-up treatment, in preventing recurrence of acne vulgaris and/or sebonfhea in the treated regions for periods of several weeks to several months without any permanent damage to the sebaceous gland system.
Another object of the invention is to provide a means of treating acne vulgaris and/or seborrhea which is both cost effective for the individual dermatologist to obtain for his/her practice and for the patient who may be without the benefit of third-party payment for the physician's services.
Another object of the invention is to provide a means of treating ringworm and/or folliculitis which does not involve the intake of antibiotics or the topical application of prescription drugs.
The forgoing objects are basically attained by providing an apparatus for selectively delivering energy to the sebaceous gland in order to photocoagulate a sufficient number of the sebum-producing cells such that the sebum production in the targeted area is insufficient to lead to a return of acne vulgaris and/or seborrhea for a period of several weeks to several months.
The foregoing objects are also attained by providing an apparatus which delivers the energy to the sebaceous gland in a time period short enough to avoid heating of the surrounding tissues, yet long enough to avoid photoacoustic damage to those same surrounding tissues.
The foregoing objects are also attained by providing an apparatus which can be constructed using diode lasers as the excitation source, these lasers being durable, relatively user-friendly, and lightweight; as well as having a low cost-to-output power ratio and a long lifetime. Diode laser-based systems may be air-cooled and 110-120 VAC-powered, eliminating the need for more expensive power and cooling connections. Diode laser-based systems will not require a laser technician to operate, thus reducing the overhead costs associated with their use even further. InGaAs diode lasers have outputs in the 900-1100 nm wavelength range and power levels sufficient for dermatological applications. InGaAsP diode lasers have outputs in the 1.2-1.6 nm wavelength range. Although they currently have more limited output power levels, developments in the near future may result in powers sufficient for dermatological applications. Additionally, other laser systems, such as the Cr: Mg
2
SiO
4
, or forsterite, laser, have outputs in the desired wavelength ranges.
The foregoing objects are also attained by providing an apparatus which can be constructed without using lasers. Filtered, low energy Xenon flashlamp systems can be used to provide light in the 900-1300 nm range which is suitable for selective photothermolysis of sebaceous glands without risking damage to overlying and surrounding tissues.
Other objects, advantages, and salient features of the present invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses a preferred embodiment of the invention.


REFERENCES:
patent: 3538919 (1970-11-01), Meyer
patent: 4388924 (1983-06-01), Weissman et al.
patent: 4617926 (1986-10-01), Sutton
patent: 5226907 (1993-07-01), Tankovich
patent: 5304170 (1994-04-01), Green
patent: 5405368 (1995-04-01), Eckhouse
patent: 5464436 (1995-11-01), Smith
patent: 5595568 (1997-01-01), Anderson et al.
patent: 5632741 (1997-05-01), Zavislan et al.
patent: 5647866 (1997-07-01), Zaias et al.
patent: 5817089 (1998-10-01), Tankovich et al.

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