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Method and apparatus for treatment of cutaneous and subcutaneous conditionsUSPTO Application #: 20080103565Title: Method and apparatus for treatment of cutaneous and subcutaneous conditions Abstract: The present invention provides method and apparatus for treating tissue in a region at depth while protecting non-targeted tissue by cyclically applying cooling to the patients skin, and preferably to the region, and by applying radiation to the patient's skin above the region to selectively heat tissue during and/or after cooling is applied. At least one of cooling and radiation my be applied by successively passing a continuous output applicator over the patient's skin. Treatment may also be enhanced by applying mechanical, acoustic or electrical stimulation to the region. (end of abstract) Agent: Nutter Mcclennen & Fish LLP - Boston, MA, US Inventors: Gregory B. Altshuler, Ilya Yaroslavsky, Andrey V. Belikov, Konstantin Prikhodko USPTO Applicaton #: 20080103565 - Class: 607101000 (USPTO) Related Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Thermal Applicators, Electromagnetic Radiation (e.g., Infrared), Microwave Or Rf (high Frequency) The Patent Description & Claims data below is from USPTO Patent Application 20080103565. Brief Patent Description - Full Patent Description - Patent Application Claims CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10/465,757 now U.S. Pat. No. 7,276,058, filed Jun. 19, 2003 which claims priority to U.S. Patent Application Ser. No. 60/389,871, filed Jun. 19, 2002 entitled "Method And Apparatus For Treatment Of Cutaneous And Subcutaneous Conditions", all of which are incorporated herein by reference in their entirety. BACKGROUND [0002] 1. Field of the Invention [0003] This invention relates to methods and apparatus for the photothermal treatment of tissue and, more particularly, to methods and apparatus for treating cutaneous and subcutaneous conditions at depth. [0004] 2. Description of the Related Art [0005] The benefits of being able to raise and/or lower the temperature in a selected region of tissue for various therapeutic and cosmetic purposes has been known for some time. For instance, heated pads or plates or various forms of electromagnetic radiation, including visible, infrared and microwave radiation, electricity, and ultrasound have previously been used for heating subdermal muscles, ligaments, bones and the like to, for example, increase blood flow, to otherwise promote the healing of various injuries and other damage, and for various therapeutic purposes, such as frostbite or hyperthermia treatment, treatment of poor blood circulation, physical therapy, stimulation of collagen, cellulite treatment, adrenergic stimulation, wound healing, psoriasis treatment, body reshaping, non-invasive wrinkle removal, etc. The heating of tissues has also been utilized as a potential treatment for removing cancers or other undesired growths, infections and the like. Heating may be applied over a small localized area, over a larger area, for example to the hands or feet, or over larger regions of tissue, including the entire body. [0006] Since most of the techniques described above involve applying energy to tissue at depth through the patient's skin surface, peak temperature generally occurs at or near the patient's skin surface and decrease, sometimes significantly, with depth. Further, while microwaves or ultrasonic and other acoustic radiation have been used in the past, such radiation has had limited use because, particularly for microwaves, they may be potentially mutagenic, may potentially otherwise result in cell or systemic damage and, particularly for acoustic sources, are relatively expensive. They may also not be practical for large-area treatment. [0007] While optical and near infrared (NIR) radiation (collectively referred to hereinafter as "optical radiation" is generally both less expensive and, being non-mutagenic, safer than microwaves radiation, the use of optical radiation has heretofore not been considered suitable for most applications involving heating of tissue at depth, the term "tissue at depth" as used herein meaning tissue at the border zone of the dermis and hypodermis or subcutaneous region, some of which tissue may be in the lower dermis, mostly at a depth deeper than 1 mm, and tissue below this border zone to a depth of up to about 50 mm The reason why this radiation has not been considered suitable is because such radiation is both highly scattered and highly absorbed in surface layers of tissue, precluding significant portions of such radiation from reaching the tissue regions at depth to cause heating thereof. In view of the energy losses due to scattering and absorption, substantial optical (including NIR) energy must be applied in order for enough such energy to reach a region of tissues at depth to have a desired effect. However, such high energy can cause damage to the surface layers of tissue and pain/discomfort to the patient, making it difficult to achieve desired photothermal treatments in tissue regions at depth. For these reasons, optical radiation has heretofore had at most limited value for therapeutic and cosmetic treatments on tissue at depth. [0008] While heating or cooling of tissue at depth alone has proved useful for many treatments, the combination of heating and cooling applied intermittently to the skin surface (known as contrast therapy) is also known and has been suggested for skin improvement, pain relief, inflammation reduction, and healing of injury. Of particular importance is the application of these techniques for reducing subcutaneous fat deposits and treating cellulite (gynoid lipodystrophy). However, use of cooling or heating, either alone or in combination for treatment of conditions at depth, for example for skin improvement, cellulite improvement, fat reduction, and treatment of other conditions has been limited by the body's pain/discomfort tolerance and by the damage limits of treated organs and adjacent, especially cutaneous, tissue that need to be kept intact. [0009] A need therefore exists for improved method and apparatus for photothermal treatment of tissue regions at depth, and in particular for treatment of deep dermis and subcutaneous regions of tissue, which treatments provide improved treatment results, while both reducing patient pain and discomfort and protecting adjacent and other non-treatment tissue from damage. SUMMARY OF THE INVENTION [0010] In accordance with the above, this invention provides a method and apparatus for treating at least a selected target region at depth, as this term has previously been defined, of a patient's body, while protecting non-targeted tissue by utilizing a suitable mechanism to cool the patient's skin surface to a temperature below normal body temperature for a selected duration; utilizing a suitable mechanism to selectively apply radiation to the patient's skin above said region before, during and/or after cooling; and repeating the cooling and radiation application for a selected number of cycles, the temperature to which the patient's skin is cooled and the duration of cooling being sufficient to cool the treatment region to a selected temperature below normal body temperature during at least cooling portions of cycles. The cooling duration should be at least about 10 seconds, normally being between approximately 10 seconds and 20 minutes. Where radiation is applied after cooling, the radiation may be applied for approximately one second to 4 minutes. The cooling may be performed continuously while the radiation is applied at intervals during the cooling. Where the selected region is subcutaneous fat, the selected temperature should be low enough to result in at least a selective phase change of at least a portion of the fat. In this case, the radiation should be of sufficient power and duration and of appropriate wavelength to heat the treatment region to at least a temperature where the phase of the fat cells is altered. Alternatively, the radiation may be of sufficient power and duration and of appropriate wavelength to heat the treatment region to a temperature where at least one of the biophysical and biochemical characteristics of cells in the region is altered. Alternatively, the radiation should be of sufficient power and duration and of appropriate wavelength to heat tissue above the treatment region to protect the tissue, but not to significantly heat the treatment region. For another embodiment, the treatment involves cycling cooling and heating of the treatment region, radiation being applied after cooling and the radiation being of sufficient power and duration and of appropriate wavelength to heat the region to an appropriate temperature to effect the treatment. For some embodiments, a selected condition of the patient is detected and utilized to control at least a portion of the operation. Stimulation of the selected region may also be utilized before, during and/or after at least one of the operations, such stimulation being generally at least one of mechanical, acoustic and electrical. The period and/or phase of the treatment cycles may be correlated with a sub-circadian rhythm of the patient. [0011] For some embodiments, the radiation is from a continuous wave source and cooling is also performed from a substantially continuously operating source. For these embodiments, cooling and radiation application are each performed by passing an applicator outputting the appropriate source over the patient's overlying the treatment region at a selected rate. The same applicator may be used to perform both cooling ad radiation application for these embodiments and the applicator my perform both operations during the same pass or separate passes. [0012] In accordance with another aspect of the invention, radiation is selectively delivered to the patients body above the selected region to heat the region; patient tissue above the selected region is concurrently cooled to a temperature below that of the selected region; and the region is cooled to a temperature below normal body temperature before and/or after the heating of the region. [0013] In accordance with still another aspect of the invention, treatment is performed by cyclically applying radiation and cooling to the surface of the patient's skin above the selected region through at least one applicator providing substantially continuous cooling/radiation output, which applicator is passed over the patient's skin over the region multiple times for each cooling/radiation cycle. [0014] Other advantages, novel features, and objects of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings, which are schematic and which are not intended to be drawn to scale. In the figures, each identical, or substantially similar component that is illustrated in various figures is represented by a single numeral or notation. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0015] Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying drawings in which: [0016] FIG. 1 is a diagram illustrating the temperature/depth profile of the skin and subcutis at various times after the onset of surface cooling; [0017] FIG. 2 is a diagram illustrating temperature in the human body as a function of cooling time for various depths; [0018] FIG. 3 is a diagram illustrating the onset time of patient discomfort and of patient pain as a function of skin surface temperature; [0019] FIG. 4 is a schematic diagram of apparatus suitable for practicing the teachings of this invention; [0020] FIGS. 5a-5d are diagrams illustrating cooling temperature (T cooling), heating temperature (T heating), temperature in an upper layer of the skin (T upper) and target temperature at depth (T target) relative to normal core body temperature (T core normal) for successive cooling/heating cycles in a protective mode; Continue reading... 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