Abstract:
A method and apparatus for treatment of the skin or other biologic tissue includes the ability to subject said skin or other tissue to temperature modulation and radiation, simultaneously. The apparatus that delivers warm or cold material to the treatment site to effect this modulation of temperature may be attached to the apparatus that delivers radiation or it may be a separate entity, that could be utilized with a variety of radiation generating equipment.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates generally to a method and apparatus that allows an area of biologic tissue such as the skin to be affected by alteration of its normal temperature, and by a variety of different kinds of radiation. The method and apparatus allow these effects of temperature change and irradiation to occur simultaneously.  
         BACKGROUND OF INVENTION  
         [0002]    Radiation from various portions of the spectrum is currently utilized in the treatment of a variety of skin conditions. Lasers, intense pulsed light sources and other radiation emitting devices have been used to treat conditions including birthmarks, tattoos, benign vascular lesions, pigmented lesions, scars, warts, stria distensae, wrinkles and other benign or malignant skin lesions. Lasers and other light sources are also currently used for the removal of unwanted hair on various parts of the body.  
           [0003]    For some of these conditions, cooling of the skin is used adjuctively to the delivery of light. Cooling is accomplished in a variety of ways. Cooling is used to reduce side effects and discomfort associated with the delivery of light in the above mentioned clinical situations. Some cooling of the skin is accomplished by the use of cold packs, or ice before and/or after light is delivered to the treatment site. Simultaneous cooling and lasing is currently accomplished by several methods.  
           [0004]    One method of simultaneous cooling and lasing (Cool Laser Optics, Coherent Versapulse, Palomar Epitouch, Light Shear, Chill-Tip) utilizes an apparatus that subjects the treatment site to cooling delivered by a lens that is substantially transparent to the wavelength of light to be delivered to the skin. The lens must be in contact with the treatment site. This same lens is made cold by having a recirculating coolant contact an aspect of the lens other than the lens surface contacting the treatment site. A similar apparatus is used where the coolant does not recirculate, but rather is kept cool by ice that is held within the apparatus. Another apparatus sprays coolant at the lens. An index matching gel is sometimes used between the cooling lens and the surface being treated.  
           [0005]    A problem with contact lens apparatus is an inability to make good skin contact on concave aspects of the skin surface. Although some contact cooling units have a flexible contact surface, certain areas of the skin, such as naso-ocular angle still cannot be contacted adequately. Another problem is that the lens is substantially transparent to the light being delivered. The lenses are commonly made of quartz glass or sapphire to maximize thermal conductance.  
           [0006]    The pulsed spray cooling of the Dynamic Cooling Device (DCD) needs no contact with the treatment surface, but has other problems. DCD uses volatile liquid to spray at the skin. These substances may, or may not, have some hazard potential for the environment or for individuals inhaling these vapors. Whether these concerns are valid will require long term evaluation, and due to these concerns DCD will not be considered suitable or appropriate for some practitioners and patients.  
           [0007]    In some instances, pre-cooled transparent gels are applied for similar purposes as stated above but without any method for maintaining a cool temperature of the gel after application to the skin.  
           [0008]    Another kind of cooling utilizes a sprayed cryogenic liquid (dynamic cooling). The cryogenic liquid is sprayed at the treatment site just before the laser light is delivered to the skin. Evaporation of the sprayed cryogenic liquid cools the skin&#39;s surface.  
           [0009]    Cryogenic liquids used with DCD may cause technical problems due to frosting or icing in the delivery system. Furthermore, very exact timing is necessary with DCD to achieve the desired cooling without interfering with the transmittance of light through vaporizing sprayed cryogenic liquid or frosting of the skin. This exact timing as well as the exact quantity of cryogenic liquid sprayed is microprocessor controlled, and any alteration due to suboptimal functioning could reduce or eliminate the benefit of treatment or cause unanticipated injury.  
           [0010]    These various methods of cooling are utilized in an expanding list of laser amenable conditions. Specifically, contact cooling units with a cooling lens component were originally designed for use with laser treatment for lower extremity telangiectasia. These cooling units are now also used with laser treatment for other benign vascular lesions, such as port wine birthmarks, and also for laser removal of hair. Similarly, the spray cooling units are utilized for treating vascular lesions and for hair removal. Additionally, contact and spray cooling are used for laser treatment of facial wrinkles.  
           [0011]    All of the above apparatus and techniques are used to cool tissues. None allow the treatment site to be warmed.  
           [0012]    There are lasers (Erbium YAG) that cause debris to be scattered during treatment. Some of these lasers have air flow directed through and out of the end of the laser hand piece. The purpose of this air flow is to prevent debris from entering the laser hand piece and clouding the laser optics inside the hand piece. The temperature of this air flow is not controlled nor is its purpose to modulate the temperature of the treatment site.  
         SUMMARY OF THE INVENTION  
         [0013]    Against the forgoing background it is a primary object of the present invention to enhance the ability to alter the temperature of the skin during laser or other irradiation of the skin. Existing technology only has the ability to reduce the skin&#39;s temperature.  
           [0014]    It is another object of the present invention to allow heating of the skin during laser irradiation or alternatively to allow cooling.  
           [0015]    It is still another object of the present invention to provide heating and/or cooling of the skin without making contact with the skin.  
           [0016]    It is yet another object of the present invention to vary the temperature of the skin up or down depending on what kind of radiation is being utilized, and what condition is being treated.  
           [0017]    Simply from the standpoint of simultaneous cooling and lasing the present invention has the additional object of avoiding problems that exist with the current cooling modalities that were mentioned above.  
           [0018]    A further object of the present invention is to deliver warm or cool air to the skin surface without any potential for environmental or personal hazard.  
           [0019]    It is an additional object of the present invention to avoid the use of complex technology in the delivery of a cooling medium to the treatment site so as to minimize cost to the user and maximize reliability, efficiency, and safety.  
       
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0020]    Other and further objects, advantages and features of the present invention will be understood by reference to the following specification in conjunction with the accompanying drawings, in which like reference characters denote like elements of structure and:  
         [0021]    [0021]FIG. 1 is an elevational view in part and a cross sectional view in part of the temperature modulating device according to the present invention;  
         [0022]    [0022]FIG. 2 is an elevational view in part and a cross sectional view in part of a combined temperature modulating device and radiation tool according to the present invention;  
         [0023]    [0023]FIG. 3 is an elevational view in part and a cross sectional view in part of another embodiment of a combined temperature modulating device and radiation tool according to the present invention;  
         [0024]    [0024]FIG. 4 is a top view of FIG. 3;  
         [0025]    [0025]FIG. 5 is an elevational view in part and a cross sectional view in part of still another embodiment of a combined temperature modulating device and radiation tool according to the present invention;  
         [0026]    [0026]FIG. 6 is a top view of FIG. 5;  
         [0027]    [0027]FIG. 7 is a cross sectional view of a vortex tube for the embodiments of FIGS. 1 through 6;  
         [0028]    [0028]FIG. 8 is an elevational view of a semi-rigid stand useful with apparatus of FIG. 1; and  
         [0029]    [0029]FIG. 9 is an elevational view of an articulated arm useful for delivery of radiation in the embodiments of FIGS. 1 through 6.  
     
    
     DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0030]    The present invention provides apparatus and a method for treatment of biologic tissue that alters the temperature of the tissue either by cooling or by heating or by both while the tissue is being irradiated.  
         [0031]    The benefits attributed to cooling laser treatment sites relate to decreased pain and side effects caused by the heat produced by certain high power laser systems or non laser light sources.  
         [0032]    The benefits resulting from heating the treatment site include increased blood flow and the ability to reduce the amount of laser power needed. By reducing laser power less side effects result.  
         [0033]    With reference to the drawings and, in particular, to FIG. 1, there is provided an apparatus generally represented by reference numeral  10  that delivers a temperature controlled medium  11  to a treatment site  12  of biologic tissue  13 . Apparatus  10  includes a source  14  that delivers medium  1   1  via a delivery device  15  to treatment site  12 . The temperature of medium  11  is controlled to be above or below the normal temperature of the biological tissue during irradiation of treatment site  12  by radiation  16 .  
         [0034]    Radiation  16  is provided from a radiation tool generally designated by reference numeral  17 . Radiation tool  17  includes a radiation source  18  that delivers radiation  16  via a delivery device  19 .  
         [0035]    Although the present invention contemplates the use of any type of radiation that is useable to treat biologic tissue, the invention will be described herein where source  35  is a laser. For laser embodiments, delivery device  19  may comprise tubing such as fiber optic cable or other suitable conveyor of laser radiation.  
         [0036]    The present invention also contemplates that medium  11  may be any suitable medium in liquid or gas state that can be controlled to warm and/or cool the temperature of the biologic tissue  13  above or below its normal temperature. Also, medium  11  is transparent to radiation  16 . In the preferred embodiment, medium  11  is air and source  14  is shown as a source of compressed air.  
         [0037]    The temperature and/or flow rate of air  11  are controlled by means situated either at compressed air source  14  or at any suitable location along its flow toward treatment site  12 . In a preferred embodiment, the flow rate is controlled at air source  14  and the temperature is controlled by means of a vortex tube  20 .  
         [0038]    Delivery device  15  is connected at its proximal end to air source  14  by means of a suitable coupler such as a quick connect/disconnect device (not shown). Delivery device  15  has a delivery tube  21  that is covered by an insulating material  18  made of similar material, running its entire length up to, but not including, vortex tube  20 .  
         [0039]    Vortex tube  20  controls the temperature of air  11  during its delivery. With reference to FIG. 7, vortex tube  20  typically has an inlet  23 , a hot air vent  24  and an outlet  25  through which air  11  exits at a desired temperature. Inlet  23  is coupled to the distal end of delivery device  15  by plastic or polyurethane clamps or screw mounts (not shown). A manually adjustable valve  26  is situated at the hot air end of vortex tube  20  for control of the temperature of air  11  that exits outlet  25 . Vortex tubes are available from The Air Research Technology Company of Fairfield, Ohio For the case of human skin tissue, the temperature of air  11  is in a range that controls the temperature of the biological tissue at treatment site  12  in a tissue temperature range that extends above and below the normal temperature of the tissue. For many clinical situations, the tissue temperature range will be from slightly above the freezing temperature of water and to about a high fever temperature, for example, about 32.5° F. to about 105° F. It is also contemplated that the temperature and/or flow of air may be controlled by valve  26  to be steady or variable during a treatment to accommodate clinical situations having different cooling and/or warming requirements. Depending on these modulating parameters and the heat transfer characteristics of air  11  as it moves from the point of control to treatment site  12 , the actual temperature of the air  11  may vary from the above mentioned tissue temperature range.  
         [0040]    A hand grip  27  preferably envelopes vortex tube  20 . The enveloping is preferably from just above the distal end of hand grip  27  up to and including its proximal end and its connection to delivery device  15 . Hand grip  27  permits manipulation of the direction of delivery device  15  as air  11  is delivered to the biologic tissue  13 . Hand grip  27  is made of plastic, ASS, or anodized aluminum. In this embodiment, the vortex tube  20  is preferably directed at an angle that permits radiation  16  to pass through air  11  to treatment site  12 . In this embodiment, the distal end of the vortex tube  20  is directed at an angle that permits the radiation  16  to pass through air  11  as it is delivered to the treatment site  12 .  
         [0041]    Delivery device  15  may be formed in a variety of lengths and diameters. In a preferred embodiment, delivery device  15  is about 12 feet long with an inside diameter of about ½ inch and an outside diameter of sabout ⅝ inch. It may be made from flexible polyurethane, or some other similar material. Vortex tube  17  is preferably flexible, but may be inflexible in some embodiments.  
         [0042]    In other embodiments, vortex tube  17  may be omitted and the temperature of air  11  will be controlled by the source  14  or by a cooling or heating device (not shown) that is disposed between the source and treatment site  12 .  
         [0043]    Referring to FIG. 8, there is provided a semi-rigid stand  45  for holding delivery device  15  in a semi-rigid position. Stand  45  includes a rigid base  46  that is attached to a floor, wall, ceiling or portable structure that has some degree of rigidity. A semi-rigid gooseneck tubing  47  is attached to and extends from base  46 . Delivery device  15  is attached to gooseneck tubing  47  by one or more clasps  48 . The gooseneck tubing can be flexed with some exertion of force to move from one position to another. It is semi-rigid in the sense that it holds a position until such force is exerted. In operation, the gooseneck is positioned for delivery of air  11  to treatment site  12 . This position is then held due to the semi-rigid nature of semi-rigid stand  45 .  
         [0044]    In another embodiment shown in FIG. 2, the distal end of air delivery device  15  is coupled to radiation delivery device  19  by clamps  28 . The coupling is in a manner that permits manual manipulation of the direction of both the delivery device  15  of temperature modulation apparatus  10  and delivery device  19  of radiation tool  17  in concert with each other as they simultaneously deliver air  11  and radiation  16  to treatment site  12 . Clamps  28  may be made of plastic, polyurethane or metal. In this embodiment, the distal end of the delivery device  15  is generally angled in such a manner as to permit radiation  16  to pass directly through air  11  being directed at treatment site  12 .  
         [0045]    In another embodiment shown in FIGS. 3 and 4, a hand-held housing or hand piece  32  encases delivery devices  15  and  19  of apparatus  10  and radiation tool  17  in a generally parallel manner. This permits the simultaneous manual manipulation of both radiation delivery device  19  and air delivery device  15 . In this embodiment, the distal end of air delivery device  15  is angled as indicated at  33  in a manner which permits radiation  16  to pass directly through the air  11  being delivered to biologic tissue  13 . The housing  32  may be made of plastic or metal, or other similar material. A lens arrangement (not shown) may optionally be provided for the delivery of radiation  16  to treatment site  12 . One or more spacers  29  are provided to hold delivery devices  15  and  19  in place within housing  32 .  
         [0046]    In another embodiment, shown in FIGS. 5 and 6, a hand-held housing or hand piece  35  encases the delivery device  19 . Hand piece  35  includes a cylindrical or annular cavity  36  that surrounds delivery device  19 . Spacers (not shown) may be provided to hold delivery device  19  in place within hand piece  35 . The cooling or warming air  11  is introduced into cavity  36  from delivery device  15  via an in-line coupling  37  at the side of hand piece  35  or other suitable point. The in-line coupling  37  may be made of nylon or metal or other similar material. As air  11  is introduced into cavity  36 , it completely surrounds the delivery device  19  and then exits at the distal end of hand piece  35  onto treatment site  12 . The radiation  16  is simultaneously delivered by delivery device  19  through air  11  to treatment site  12 .  
         [0047]    The delivery device  19  that conveys radiation  16  from radiation source  18  in the embodiments of FIGS. 1 through 6 may comprise tubing such as fiber optic cable or other suitable conveyor of laser radiation. Such cable or other conveyor may suitably be implemented in an articulated arm  50  shown in FIG. 9. Articulated arm  50  includes a base  51  that receives radiation from radiation source  18 . The radiation is directed through a series of arm elements  52 ,  53 ,  54  and  55  to a laser hand piece  57 . A set of knuckles  56  is provide to enclose mirrors or prisms that redirect the laser radiation from one arm element to the next in the series and joint that allow motion along one or more axes.  
         [0048]    The method of the present invention involves delivering radiation to treatment site  12  of biologic tissue  13  and simultaneously delivering a temperature modifying medium to the treatment site. The temperature of the medium is controlled above and below the normal temperature of the tissue. The temperature of the medium can also be modulated during its delivery to the treatment site. Additionally, the flow rate of the medium can be controlled or adjusted.  
         [0049]    The present invention having been thus described with particular reference to the preferred forms thereof, it will be obvious that various changes and modifications may be made therein without departing from the spirit and scope of the present invention as defined in the appended claims.