Surgery – Instruments – Light application
Reexamination Certificate
2000-03-13
2003-05-27
Peffley, Michael (Department: 3739)
Surgery
Instruments
Light application
C606S010000, C606S002000
Reexamination Certificate
active
06569155
ABSTRACT:
BACKGROUND OF THE INVENTION
Use of light to denature very specific kinds of tissue has been called wavelength-selective photo-thermolysis. The use of lasers for this purpose has been well described in the literature. See, for example, R. G. Wheland, “Laser-assisted hair removal”,
Lasers in Dermatology
, Vol. 15, pp. 469-477, and references cited. By choosing a laser with the right wavelength and energy per unit area (fluence), a particular light-absorbing target substance (chromophore) in living tissue, such as melanin or possibly hemoglobin, will absorb energy from the treatment beam and become hot enough to destroy functionality in the tissue containing the chromophore. Tissue in the same area that does not have high concentration of the target chromophore will not be as affected.
Hair H, see
FIG. 1C
, includes two basic parts, the shaft S, which is the portion of the hair above the epidermis E, and the root R, which is the portion below the surface of the epidermis. Various tissues surround the root of the hair. Hair color is primarily due to the presence of melanin in the hair. Melanin is created at the base of the hair follicle F and is passed into the hair as it grows. The presence of melanin has made it possible to use certain lasers and other light sources for hair removal with melanin as the target chromophore. The hair follicle and surrounding structure (referred to collectively as hair tissue T) are selectively heated when the melanin in the hair tissue and in the hair root itself and is exposed to treatment radiation. The hair tissue is thermally damaged as a result of the localized heating after treatment; many of the exposed hairs atrophy and are sloughed from the epidermis.
The early work in this field was centered around a wavelength with very high melanin absorption, the pulsed ruby laser (694 nm). Long pulse ruby lasers (as opposed to Q-switched ruby lasers) typically have a pulse duration, or a series of pulses, in the 1 millisecond range. Although the wavelength is highly absorbed in melanin, the wavelength selection has significant limitations with darker skin types as the epidermis can blister or induce a pigmentary change from the superficial melanin heating.
Dermatologists have used cooling devices in dermatologic applications prior to laser treatment. The purpose is to chill the skin with the understanding that exposure to treatment radiation will elevate the epidermal temperature. Chilling lowers the initial temperature so that the post treatment temperature at the epidermis will not create a heat-induced blister or pigmentary change. U.S. Pat. No. 5,735,844 describes apparatus which uses a cooled lens, through which radiation passes, pressed against the patient's skin to cool the epidermis.
Many different approaches to hair removal have been explored since the early ruby laser evaluation. A common trend is a continual shift towards longer wavelengths, which have less melanin absorption, as it allows treatment of patients with a darker range of skin tones. Initially, alexandrite (755 nm) was evaluated and later a diode approach (810 nm). The alexandrite laser offers some improved clinical capabilities over the ruby laser if one considers treatment of darker skin types. However, from engineering and system performance measures, the two systems are similar in terms of size, utility requirement, treatment speed, and system cost. In contrast, the high pulse energy diode laser allows the system to be much smaller than previous systems with an ability to run off of standard power. A high pulse energy diode has many attractive attributes over other laser approaches, such as flashlamp excited solid-state devices and therapeutic filtered flashlamps. One of the most desirable traits is the high efficiency associated with diode generated laser radiation. As a result of improved efficiency, the system can be smaller and lighter weight.
One of the performance limitations working against a diode laser for an application like hair removal is the need for high peak power for short bursts. In general, diode lasers may be pulsed at peak power levels higher than the rated continuous power. However, the peak rating is not a significantly higher power level (perhaps two to three times) than the continuous level. A constraint that a hair removal application has is the need to deliver significant energy deep into the dermis to sufficiently heat the hair tissue to induce a thermal injury so that the hair will slough off. Light scatters as it propagates through the tissue. As a result of this severe exposure, large area treatments (greater than 20 mm
2
) have been explored to overcome the reduction (due to scatter) in intensity as the light travels deeper into the dermis. A large treatment area can generate a fairly homogeneous intensity profile under the center of the treatment area as light propagates into the dermis.
A commercially-available diode laser system for hair removal is sold by Coherent of Santa Clara, Calif. as Lightsheer and allows the physician to treat the darker skin types than ruby lasers with a lower risk of post operative blistering. The Lightsheer system employs many diode bars (between 50 to 100) to create high peak power (2-4 kW) and a large square treatment area (about 0.81 cm
2
). The Lightsheer system is used in pulsed operation with treatment rates up to about 1.6 cm
2
/sec. The system has a pulse duration between 5 and 30 ms, which closely matches the thermal relaxation time of typical hair follicles.
SUMMARY OF THE INVENTION
A radiation delivery module includes a body supportable on a skin surface of a patient to define a skin surface plane. A radiation source is mounted to the body and produces a beam of tissue-damaging radiation directed transverse to and at the skin surface plane. The radiation beams creates a radiation spot having a length and a width at the skin contacting plane, the length preferably being about 10 or more times, but at least about 5 times, the width. A number of radiation sources, each directing a radiation beam component at the radiation spot, may be used. The radiation source may include a rod lens as a focusing optical element. The radiation delivery module may also include means for translating the radiation source so that the radiation spot moves in a direction generally perpendicular to the length of the radiation spot.
Another aspect of the invention relates to a method for treating dermal tissue. A tissue-damaging radiation beam is directed the skin of a patient to create a radiation spot on the skin having a length of preferably about 10 or more times, but at least about 5 times, its width. The radiation beam is moved along the skin in a direction transversed to the length. The directing step may be carried out with the radiation beam having a focal point located below the skin surface. The radiation beam is preferably moved in a direction which is perpendicular to the length of the radiation spot. The invention may be carried out using a radiation delivery module, including a body carrying a translatable radiation source, positioned at a chosen location on the skin surface of the patient. The radiation source may be moved relative to the body while the body is stationary relative to the skin surface. A number of radiation sub-sources, each producing a radiation beam component, may be used to produce the radiation beam. The radiation beam may be produced using a diode laser.
Other features and advantages of the invention will appear from the following description in which the preferred embodiment has been set forth in detail in conjunction with the accompanying drawings.
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patent
Connors Kevin P.
Sasnett Michael W.
Altus Medical, Inc.
Peffley Michael
Townsend and Townsend / and Crew LLP
Vrettakos Peter J
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