Surgery – Instruments – Light application
Reexamination Certificate
1999-03-12
2003-01-21
Gibson, Roy (Department: 3739)
Surgery
Instruments
Light application
C606S016000, C606S017000, C607S089000
Reexamination Certificate
active
06508813
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the utilization of electromagnetic (EM) radiation for treating selected dermatologic problems, and more particularly to a system which utilizes temperature detection at a waveguide though which radiation is being applied to the patient's skin to perform various control functions and to a head usable in such system or elsewhere, which head includes efficient reflectors for back-scattered radiation and/or for otherwise enhancing irradiation of a target volume containing the dermatologic problem.
BACKGROUND OF THE INVENTION
Lasers, lamps and other sources of electromagnetic radiation are being increasingly utilized to treat various dermatological conditions, and in particular for the removal of unwanted hair, spider veins, leg veins, other veins or blood vessels which are visible through the patient's skin, lesions, port-wine stains, tattoos and the like. One problem with such treatments is that the only way to get the radiation to a target volume in the dermis where treatment is desired is to transmit the radiation to such volume through the overlying epidermis. Further, since many of the treatments involve absorption of energy by melanin in the dermal volume being treated, for example in a hair follicle, and there is also melanin in the epidermis, particularly in the portion thereof at the dermal/epidermal (DE) junction, the EM radiation used for treatment is generally also absorbed to varying degrees in the epidermis. Further, the deeper in the dermis the treatment is desired and/or the larger the element being treated, the more energy must be used, this generally involving use of a more powerful laser or other radiation source with higher fluence and/or operating such source for longer time durations. However, as the energy applied through the epidermis increases, the potential for damage to the epidermis as a result of energy absorption therein also increases.
Therefore, one limitation on the energies which can be used for various dermatological treatments in the dermis, and in particular on the depths in the dermis at which treatment can be performed, and on the size of the elements which can be treated, is that the energy applied cannot be so high as to cause appreciable damage to the epidermis. Various ways around this problem have been proposed in the prior art, most of which involve some cooling of the epidermis prior to and/or during treatment to limit or prevent thermal damage thereto. Examples of such procedures include applying cryogenic or other cooling sprays to the skin, applying a cooling gel to the skin, applying radiation through a cold-pack in contact with the skin or through an applicator which is cooled by flowing water, flowing air, or the like. However, these prior art systems have not been wholly satisfactory. One reason for this is that, since most of the absorption is in the melanin located in the lower portions of the epidermis, it is desirable to have cooling through the entire epidermal layer, which is typically about 0.1 mm thick. However, it is not desirable that the cooling extend significantly below the DE junction into the dermal layer since cooling in the dermal layer can potentially inhibit the desired thermal damage to follicles, blood vessels or the like in this region. Further, there are significant variations in radiation absorption by a patients skin, not only among different individuals, people having darker skin absorbing more radiation and being more prone to epidermal damage than people with lighter skin, but even for different areas on the body of a single individual. Therefore, cooling which is not customized to the treatment area generally results in the cooling not being to the proper depth, a problem which can interfere with treatment and/or permit thermal damage to the epidermis.
It would therefore be desirable if the temperature at a selected depth in the skin, for example the DE junction, could be measured, and this temperature utilized to control skin temperature, for example through the epidermis, by some combination of controlling the laser energy applied to skin and/or controlling cooling applied to the skin. However, while infrared sensors have for example been utilized in the past to detect temperature at the surface of the skin, such detection does not provide an accurate indication of temperature even at the skin surface, these readings varying with such factors as skin layer thickness, skin roughness and skin color in addition to temperature. Infrared sensors also provide virtually no information as to skin temperature at a depth below the surface. Therefore, such detection has heretofore been used only for gross controls, for example to turn off the laser if an emergency temperature threshold is exceeded or the like, but not to fine tune energy application and/or cooling so as to maintain a desired temperature at a selected depth, for example at the DE junction, thereby facilitating a desired treatment without epidermal damage.
A need therefore exists for an improved technique which permits more accurate determinations of skin temperature at various depths, including at the DE junction, so as to permit more accurate and more automatic control of EM radiation treatments for various dermatological conditions. In particular, because of variations in skin pigmentation, differences in epidermal depth, and other dermatological differences among patients, laser dermatology procedures are now performed almost exclusively by physicians or other highly trained individuals, and such individuals must exercise great care to assure that epidermal damage does not occur, while still achieving the desired therapeutic effect. More accurate measurement of temperature at desired depths would make treatments by such skilled personnel easier to perform and would permit such procedures to be safely performed by less highly trained, and therefore less expensive, personnel. Such skin temperature measurements could also be utilized to determine skin type/pigmentation for the patient and/or for the part of a patient's body being treated and/or for other purposes.
Where cooling of the epidermis is achieved by placing a cooled applicator or other cooled body in contact with the patient's skin, the contact must be made with sufficient pressure to assure good thermal contact between the cooled body and the skin. However, differences in skin thickness and elasticity, differences in bone backing and other factors affect the pressure required to achieve good thermal contact for different patients and for different areas on the body for the same patient. This is another reason why highly trained and skilled individuals are required for performing the treatments and contributes to the high cost of the treatment. It would therefore be preferable if an automatic technique could be provided for detecting, and thus assuring, good thermal contact between a cooling element and the patient's skin. Such a technique or mechanism, by assuring good thermal contact with the skin before the radiation source is fired, could solve two critical safety problems for radiation dermatology. First, it assures adequate cooling of the epidermis before heating thereof through energy absorption; and second, it assures that the radiation will not be accidentally applied to the eyes or other unwanted place.
Related but opposite problems arise in performing certain skin resurfacing/wrinkle removal procedures where the objective is to heat and destroy only the most surface layer of the skin, for example the epidermis, with minimal damage to underlying layers. This requires tight control of factors such as laser energy, pulse duration and repetition rate. However, variations in patient's skin make such tight control difficult even for highly trained and skilled personnel. Similar problems also arise in other dermatological procedures involving lasers or other radiation sources.
Another related problem in using an EM radiation source for dermatological treatment is that the skin reflects back a signific
Gibson Roy
Palomar Medical Technologies, Inc.
Wolf Greenfield & Sacks P.C.
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