Abstract:
A fiber optical device suitable for treating a wide variety of medical conditions that involve shrinking or tightening of cartilaginous tissue, connective tissue, or muscle tissue comprises an optical fiber capable of laser energy delivery to a predetermined tissue site along with a biocompatible cooling fluid. Illustrative treatable medical conditions are female and male unitary incontinence, female stress urinary incontinence, gastro esophageal reflux disease, obesity, Type 2 diabetes, fecal incontinence, and the like. A preferred laser energy source is a CTH:YAG laser.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/706,536, filed on Sep. 27, 2012, which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to the effective and uniform shrinkage of tissues to treat medical conditions, such as female stress urinary incontinence or “FSUI”, heart valve prolapse, gastro esophageal reflux disease or “GERD”, obesity, Type 2 diabetes, male or female urinary incontinence, male or female fecal incontinence and other medical conditions, which are collectively or individually defined in this Specification and the Claims as “Medical Conditions”. The treatment of such Medical Conditions, which affect millions of people in the United States and up to hundreds of millions in other countries, are costly in lives and a significant cost to the healthcare system. 
       BACKGROUND OF THE INVENTION 
       [0003]    Many people suffer from Medical Conditions which do not arise from a bacterial or viral infection and have not been conclusively linked to a genetic, hereditary, environmental, dietary or other cause. Some of these Medical Conditions, such as GERD and Type 2 diabetes can be treated with drugs, but the long term use of drugs can cause side effects, and the Medical Condition cannot be completely relieved in many patients. Other Medical Conditions, such as heart valve prolapse, obesity and FSUI can be treated with open heart valve surgery, stomach reduction or “Lap Band” surgery, which can cause adverse effects or death, or the surgical implantation of slings to support the uterus, which can cause infections and other adverse effects, respectively. There is presently no effective therapy for male or female urinary incontinence or male or female fecal incontinence in the elderly. 
         [0004]    We accept some of these Medical Conditions as inevitable consequences for some people, and we rely upon surgeries and drugs that are available, despite their cost, adverse effects and the risk of death. 
         [0005]    It is an objective of the present invention to safely and effectively apply thermal energy, preferably certain wavelengths of laser energy, to effectively and uniformly shrink certain tissues without damaging adjoining tissues to treat the Medical Conditions described above and others in minimally invasive procedures. 
         [0006]    Cartilage, tendons, ligaments, layers of muscle cells and elastic fibers become loose over time, resulting in sphincters not closing properly, causing Medical Conditions such as FSUI, heart valve prolapse, gastro esophageal reflux disease or “GERD”, the premature release of digested or partially digested food from the stomach due to a leaking pyloric valve, causing the loss of the feeling of fullness, overeating and obesity, urinary and fecal incontinence in the elderly and other Medical Conditions. 
         [0007]    Weight loss, along with exercise, has been shown to at least partially reduce or reverse Type 2 diabetes, which affects about 60 million people in the U.S. and many millions more outside the U.S. 
         [0008]    The cause of loosening of muscle cell and connective tissue layers in sphincters, and the loosening of cartilage, tendons and ligaments is not known, and occurs in some young and middle aged people, so it is not due only to old age. 
         [0009]    Cartilage, tendons, ligaments, muscle cell layers and connective tissue layers all contain collagen, a constituent of all soft tissues, to a greater or lessor degree. All of these collagen bearing tissues can be shrunk by thermal cross-linking of collagen. However, if thermal energy is applied to a very small area, like spot welding, the shrinkage effect is not long-lasting. A more uniform and effective means of shrinkage of collagen bearing tissues can be achieved by photo-mechanical cross-linking of collagen, using incoherent or coherent (laser) light. However, continuous emission of incoherent or coherent light energy does not allow any time for the tissue to cool, which can overheat and damage the tissue to be shrunk and adjoining tissues. 
         [0010]    CTH:YAG lasers, commonly known as “Holmium” lasers, and fiber-optic laser energy delivery devices used with such lasers, can be used for treating a variety of conditions. One of these conditions is the treatment of herniated spinal discs in minimally invasive, outpatient procedures, by applying Holmium laser energy to vaporize a portion of the excess, benign growth of the nucleus pulposa tissue of a spinal disc, causing the disc to herniated or bulge and press upon nerves in the spinal column; the excess growth of the lobes of the prostate, causing benign prostatic hyperplasia or “BPH”, obstructing urine flow; and the fragmentation of urinary or biliary stones. 
         [0011]    Tissues can be shrunk, in proportion to their collagen content, by thermal energy, preferably by photo-mechanical cross-linking of collagen, at temperatures of about 45° to 53° C., preferably at about 48° to 50° C., without affecting their otherwise normal condition or function. 
         [0012]    For example, shrinking loose chordae tendinae, which close the leaflets of heart valves, such as the mitral, aortic and tricuspid valves, shrinking muscle cell layers in sphincters which can close at least partially the esophagus, pyloric valve of the stomach, urethra, rectum and anus, as well as shrinkage of the annulus of heart valves, can treat or relieve, for example, such Medical Conditions as heart valve prolapse, GERD, obesity, Type 2 diabetes, and urinary or fecal incontinence. Tissues which can be shrunk to treat a Medical Condition, individually or collectively, are defined in this Specification and the Claims as “Target Tissues”. 
         [0013]    Shrinkage by photo-mechanical cross-linking of collagen in tissues is best achieved by certain wavelengths of pulsed laser energy, which allows time between pulses for the tissue to cool and produces a longer lasting effect than thermal cross-linking of collagen by continuously applied radio-frequency (“RF”), ultrasound (“US”) microwave (“MW”) and other forms of thermal energy. 
         [0014]    In laboratory testing of application of Holmium laser energy on animal cartilage, we found that cartilage not under tension was shrunk by about 30%. If the cartilage was under tension, the same amount of Holmium laser energy shrank cartilage by about 10-15%. 
         [0015]    Of course, if the collagen content is relatively low, or in areas of highly vascularized tissue, with extensive blood flow to carry away the heat, a larger amount of Holmium laser energy or a longer laser energy emission time may be required to obtain such a shrinkage effect. 
         [0016]    The use of thermal energy to alter Target Tissues by shrinkage is individually or collectively defined in this Specification and the Claims as to “Alter” or “Altering” a Target Tissue or Tissues. 
         [0017]    Altering Target Tissues can be achieved by delivery of various forms of thermal energy, including pulsed laser energy, continuous wave laser energy, pulsed intense incoherent light, continuous wave intense incoherent light, electrically based thermal energy (such as from an electric arc, electrical impedance or resistance), piezo electric (“PE”), electro-shock wave (ESW), radiofrequency (“RF”), microwave (“MW”) or ultrasound (US) energy, the insertion of one or more needles, each containing an optical fiber for delivery of laser energy to a desired depth within a Target Tissue, focusing multiple beams of laser, x-ray, photons, PE, ESW, microwave or ultrasound energy to intersect at a desired point in a Target Tissue (with minimal adverse effect from each individual beam of energy on intervening tissues), a sterile, biocompatible heated liquid (such as water or saline), and other types of thermal energy, are individually or collectively defined to in this Specification and the Claims as “Thermal Energy”. 
         [0018]    The Thermal Energies listed above can be delivered to or directed at a Target Tissue, by devices such as optical fibers, lenses, electrodes, wires, cables, tubes, antennae, needles, each containing an optical fiber, straight-firing (0°) optical fiber devices, angled firing (up to 60° from longitudinal axis of the fiber) optical fiber devices and side firing (60° to 90° from longitudinal axis of fiber) optical fiber devices and others. 
         [0019]    An electrically or x-ray based source of thermal energy, such as those described above, emit Thermal Energy continuously, not allowing time for the tissue to cool. Also, electrically based Thermal Energy does not produce uniform or complete shrinkage of some Target Tissues, as many electrically based devices tend to follow and dissipate within pathways through tissue with greater salinity (conductivity), such as blood in blood vessels. 
         [0020]    Hot gasses or liquids, continuous wave intense light and continuous wave laser energy do not allow time for a Target Tissue to cool and cause thermal damage by heat conduction or diffusion to adjacent tissues. US and MW energy is also usually continuous wave and passes through a Target Tissue to a different extent, based on the density of the tissue, resulting in an erratic effect. 
         [0021]    While some continuous wave thermal energy can be gated or pulsed by turning the delivery device “on” and “off”, or periodically interrupting it with an impenetrable barrier, the amount of Thermal Energy delivered is reduced. For example, if the device is “on” for one second and “off” for one second, to allow time for the tissue to cool, the amount of Thermal Energy delivered to a Target Tissue is reduced by 50%. 
         [0022]    If the Thermal Energy is “on” for one second and “off” for nineteen seconds, to allow time for the tissue to cool, the amount of Thermal Energy delivered to a Target Tissue is reduced by 95%. Thus, to produce 20 watts of power for one second, with 19 seconds for the tissue to cool, would require a 400 watt laser, which could be costly. Rapidly pulsed RF energy usually raises the temperature of tissue to only about 47° C., rendering it incapable of effectively Altering a Target Tissue, unless very high power RF generators are used, which could be unsafe. 
         [0023]    This is not true in the case of certain pulsed lasers, such as Excimer lasers, Chromium, Thulium, Holmium:YAG lasers (often referred to as “CTH:YAG” lasers or simply as “Holmium” lasers), Erbium:YAG lasers, CO 2  lasers and other pulsed lasers, all of which deliver very short, very high peak power pulses of laser energy. Such laser energy, e.g., Excimer, Erbium and CO 2  lasers, require relatively high hydroxyl ion content optical fibers, ultra-low hydroxyl ion content optical fibers, or hollow, silver internally coated optical fibers, respectively, which are expensive. The ability of Excimer, Erbium and CO 2  lasers to efficiently deliver laser energy through such optical fibers is usually limited to about 10 watts. 
         [0024]    Also, the light extinction depth of Excimer, Erbium:YAG and CO 2  lasers is very short, only about 5 to 50 microns, and may not reach sufficiently far into a Target Tissue to Alter the Target Tissue. Holmium laser energy, on the other hand, penetrates tissue to a depth of 0.4 millimeters or 400 microns, making Holmium lasers ideal for shrinking Target Tissues to treat various Medical Conditions. 
         [0025]    For example, a Holmium laser, producing light energy at a wavelength of 2100 nm, a wavelength of light which is highly absorbed by water, a constituent of all cells, can generate an average of power of up to 100 watts or more of power in pulses of 350 microseconds in duration. At a pulse repetition rate of 10 pulses per second (“Hertz”), a second consists of ten segments of 100,000 microseconds. After each 250 or 350 microsecond pulse of Holmium laser energy, there are 99,750 or 99,650 microseconds for the tissue to cool, until the next laser energy pulse occurs. As a result, coagulation and charring of adjoining tissues is largely avoided, reducing edema and often hastening healing. 
         [0026]    Even with thermal diffusion, in a fluid field, consisting of sterile water or saline, at an energy level of about 20 watts over a laser energy emission period of about 30 seconds, with thermal diffusion, Holmium laser energy&#39;s aggregate thermal effect on a Target Tissue is only about 1 to 2 mm in depth, depending on the tissue&#39;s vascularity. 
         [0027]    The short, 0.4 mm tissue penetration depth and short, 250 or 350 microsecond pulses of Holmium lasers provide the ability to precisely, effectively Alter most Target Tissues, with time between pulses for the tissue to cool, without damage to the Target Tissue or adjacent tissues, including blood vessels, ducts and nerves. 
         [0028]    Diode, KTP and Nd:YAG lasers, for example, which produce continuous or near-continuous wave energy, penetrate tissue to their light extension depth of about 2 to 4 mm. With thermal diffusion, about 20 watts of laser power of these lasers emitted for about 30 seconds generally penetrates tissue to an aggregate depth of about 5 to 8 mm, several times deeper than Holmium laser energy, and do not allow time for the tissue to cool. 
         [0029]    Also, beams of Holmium laser energy diverge from their emission point, Altering a larger area of a Target Tissue than many other types of Thermal Energy, producing a more uniform shrinkage effect. 
         [0030]    However, if the Target Tissue is deeper than about 1-2 mm, to avoid thermal damage to intervening tissues, (a) Thermal Energy can be selected based on its light or thermal extinction depth in a particular type, color and density of a Target Tissue, (b) multiple beams of Thermal Energy, converging at a desired depth in a Target Tissue or (c) one or more needles, each containing an optical fiber to transmit laser energy, may be inserted into a Target Tissue to a desired depth to more effectively shrink the Target Tissue. 
         [0031]    In a clinical study of the Holmium laser and optical fiber devices, Hanfe et al., Int. J. Med. Sci. 7:120-123 (2010), in the denervation of nerves in the facet joints of the vertebra, 194 patients were treated with a burr to debride or grind-off the outer layer of the capsules of the facet joints, and laser energy was used to coagulate and denervate the exposed nerve endings of the facet joints. At their last visit at three or six years after the therapy, an average of 71% of the patients had at least a 50% reduction of back pain. 
         [0032]    By comparison, in the abstract in English of a paper, which was published in German, on a clinical study of 93 patients in which RF energy was used to denervate the nerves of their facet joints, only 50% of the patients had significant pain relief immediately after the RF therapy, only 38% had significant pain relief at 3 months and only 25% of the patients had significant pain reduction at 73 months after the RF therapy (Jerosch et al., Abstract: Z Orthop lhre Grenzgeb, May-June 1993, (3):241-7). 
         [0033]    Thermal Energy can be delivered at a desired location in contact with or close to a Target Tissue. aimed in a desired direction and emitted at a desired energy level and for a desired period of time to Alter by shrinking a Target Tissue, after which this process may be repeated at another point or aimed in another direction. 
         [0034]    A Thermal Energy delivery device may also be positioned at a desired location in contact with or close to a Target Tissue, aimed in a desired direction and, while Thermal Energy at a desired level and for a desired period of time is emitted, the delivery device may be longitudinally moved back and forth (advanced and withdrawn) at a desired rate of movement over a desired distance for a desired time period, concomitantly or in any desired sequence or order, to apply Thermal Energy longitudinally to the Target Tissue, after which this process may be repeated at another point or aimed in another direction. The above process is defined in this Specification and the Claims as “Moving” or to “Move” a device delivering Thermal Energy. 
         [0035]    A Thermal Energy delivery device may also be positioned at a desired location in contact with or close to a Target Tissue, aimed in a desired direction and, while Thermal Energy at a desired energy level and for a desired period of time is emitted, the Source of Thermal Energy may be repetitively rotated laterally over an arc of a desired length, and back to the starting point, at a desired rate of rotation and for a desired time period, to apply the Thermal Energy radially or latitudinally to the Target Tissue, after which this process may be repeated at another point or aimed in another direction. The above process is defined in this Specification and the Claims as “Rotating” or to “Rotate” a Thermal Energy delivery device. 
         [0036]    Also, a Thermal Energy delivery device can be positioned at a desired location, in contact with or close to a Target Tissue, aimed in a desired direction and, while Thermal Energy at a desired energy level and for a desired period of time is emitted, the delivery device may be Moved and Rotated, concomitantly or in any desired sequence or order, to Alter a Target Tissue by shrinkage, after which this process may then be repeated at another point or aimed in another direction. The above process of Stationing, Moving and Rotating a Source of Thermal Energy is defined in this Specification and the Claims as “Sweeping” or to “Sweep” a of Thermal Energy delivery device. 
         [0037]    Any or all of the above processes of Stationing, Moving, Rotating and Sweeping any of the Thermal Energy delivery devices can be separately employed, concomitantly applied, or employed in any desired order or sequence. 
         [0038]    The Thermal Energy delivery device, the direction in which it is aimed, the time period of Thermal Energy emission, the distance and rate of movement, the time period thereof, the length of each arc, the rate of rotation and the time period thereof, in Stationing, Moving, Rotating and/or Sweeping a Thermal Energy delivery device are based upon (a) the type, density, color, thermal absorption coefficient and volume of the Target Tissue to be Altered, by shrinkage and (b) the environment or field in which the process is performed, whether in an aqueous field, which cools the Target Tissue, in a air or CO 2  gas field with or without a spray of sterile water or saline, in a cooled gas environment, preferably a cryogenically cooled gas, to cool the Target Tissue. Such environments are individually or collectively defined in this Specification and the Claims as the “Environment” in which the Altering by shrinkage of a Target Tissue occurs. 
         [0039]    If the Environment does not include the infusion of a sterile, biocompatible irrigating fluid or a spray of such fluid to cool the Target Tissue, a much lower level of Thermal Energy is used to avoid charring and damage to the Target Tissue and adjacent tissues, as is described hereinbelow. 
         [0040]    Also, in this Specification and the Claims, the following terms: (a) to treat, delay progression of or prevent a Medical Condition are individually or collectively defined herein as “Treating” or to “Treat” a Medical Condition; (b) a person suffering from a Medical Condition is defined herein as a “Patient”; and (c) delivering Thermal Energy at, onto the surface of or into a Target Tissue is individually or collectively defined herein as “Onto” said Target Tissue. 
         [0041]    A variety of Medical Conditions can be Treated by Stationing, Moving, Rotating and/or Sweeping a Source of Thermal Energy Onto a Target Tissue, such methods of delivering Thermal Energy include the following: 
         [0042]    A method for Treating a Medical Condition of a Patient comprised of at least one of: Stationing, Moving, Rotating and Sweeping a Source of one of: pulsed laser energy and continuous wave laser energy, delivered Onto a Target Tissue at an angle of one of: 0°, up to 60° and 60° to 90° from the longitudinal axis of the optical fiber in the Thermal Energy delivery device, one or more needles, each containing an optical fiber for delivery of laser energy to a desired depth within a Target Tissue, and multiple beams of at least one of: laser, x-ray, proton, RF, MW, U.S. and ESW energy, focused to intersect at a desired point, to shrink at least one of: (a) the chordae tendinae of a heart valve, (b) the annulus of a heart valve, (c) the sphincter of the esophagus, (d) the sphincter of the pyloric valve of the stomach, (e) the sphincter of the male or female urethra, (f) the sphincter of the male or female rectum, (g) the sphincter of the male or female anus, and (h) the tendons and ligaments that hold the uterus in place, the Medical Condition being at least one of: (i) heart valve prolapse, (ii) GERD, (iii) obesity, (iv) Type 2 diabetes, (v) male or female urinary incontinence, (vi) male or female fecal incontinence and (vii) FSUI, as well as other Medical Conditions which can be Treated by shrinking a Target Tissue. 
         [0043]    For example, to Alter by shrinkage a Target Tissue, the Thermal Energy may be oriented to emit laser energy at one of: (a) Onto the Target Tissue or (b) aimed to emit Thermal Energy at about 3 o&#39;clock (where 12 o&#39;clock is at the top surface of the Target Tissue) and, if desired, the Thermal Energy beam may be Rotated through an arc of about 90° (from about 1:30 to 4:30 o&#39;clock) to 120° (from about 1 to 5 o&#39;clock), while Thermal Energy is emitted at a desired power level for a desired period of time, after which the thermal energy beam is successively aimed to emit at 6, 9 and 12 o&#39;clock and the above described 90° to 120°. Rotating process is repeated at each such o&#39;clock position. 
         [0044]    If desired, the of Thermal Energy delivery device may be successively Moved, before, during, or after each Rotating process, to another of a series of locations, at which the Rotating process can be repeated. Or, if desired, the Thermal Energy deliver device may be successively Moved, Rotated and/or Swept between a series of two or more locations, in any desired sequence, individually or in any combination of the above processes. 
         [0045]    A Thermal Energy delivery device may be introduced into the body by one of: (a) a body orifice, (b) an open surgical procedure, (c) a surgically created passageway, (d) an endoscopic procedure, (e) a laparoscopic procedure and in other ways. 
         [0046]    The term “Rotated” as used herein, means repetitive rotations of the Source of Thermal Energy from its starting point to its end point and back, during the selected rotation time period, such as 0.5 to 2 cycles per second, preferably about one cycle per second, so the operator can time each arc by his or her mentally counting “one thousand”, “two thousand”, etc. 
         [0047]    Target Tissues can be Altered by Stationing, Moving, Rotating and/or Sweeping a Thermal Energy delivery device, in any desired sequence or combination, Onto a Target Tissue. One of the preferred types of Thermal Energy is laser energy, preferably pulsed laser energy, most preferably pulsed CTH:YAG or Holmium laser energy, which may be transmitted through a straight-ahead firing, an up to 60° angled firing, or a 60° to 90° side firing laser energy delivery device, as described below. 
         [0048]    In the first side firing embodiment of a laser energy delivery device of the present invention, the proximal end of a conventional, end-firing optical fiber is optically coupled to a source of laser energy and a metal tip for diverting laser energy laterally from the axis of the optical fiber is fixedly attached by crimping and/or an adhesive to the distal end of the optical fiber. The metal tip is preferably made entirely of or coated with a material highly reflective to the wavelength of laser energy being used, such as silver or gold, stainless steel which has been plated with silver or gold, with a thickness of preferably at least five or more thousandths of an inch, stainless steel with an insert of gold or silver, preferably with a thickness of ten to twenty or more thousandths of an inch, or stainless steel coated with a dielectric. 
         [0049]    Preferably, the protective buffer coating and any polymer cladding are removed from the distal end portion of the optical fiber, prior to attachment of the metal tip. Alternatively, the metal tip can also be attached by an adhesive and/or crimping to the protective buffer coating covering the optical fiber, if desired. 
         [0050]    The metal tip defines a central cavity, into which the distal end of the optical fiber extends. The distal end surface of the cavity is inclined at an angle of about 35° to 50°, preferably at an angle of about 45°. The open portion of the cavity allows laser energy, reflected by the inclined, reflective metal surface, to be emitted from the cavity in the metal tip at an angle of about 90° from the axis of the optical fiber, in accordance with Snell&#39;s Law. 
         [0051]    For ease of manufacture and durability, the entire metal tip is preferably made of a highly reflective material, such as gold or silver having a purity of at least about 90%, both of which are easily malleable, preferably silver, which has about the same reflectivity as gold, but is much less expensive. Most preferably, the gold and silver are at least about 95.5% pure. 
         [0052]    In the side firing device described above, the optical fiber extends from the Source of laser energy, through a passageway or channel, which extends lengthwise through a metal or rigid plastic handpiece, for ease of use. 
         [0053]    The optical fiber extends through the passageway and is fixedly attached within the proximal end of the handpiece by an adhesive or the like, which serves to sealingly close the proximal end of the passageway in the handpiece. Alternatively the optical fiber may be removably attached within the proximal end of the handpiece by a compression fitting, as known in the art, which sealingly closes the proximal end of the handpiece. 
         [0054]    In addition to sealingly closing the distal end of the handpiece, the compression fitting, when loosened, enables the side firing device to be removed, cleaned and resterilized for use in another procedure, and enables the handpiece to be cleaned, resterilized and used again or vice versa. The optical fiber extends distally from the handpiece a desired distance, with its distal end modified to emit laser energy laterally from the axis of the optical fiber, as described above. 
         [0055]    Optionally, the optical fiber of the side firing device can extend through a plastic cannula extruded with a central or eccentric channel for the optical fiber and one or more surrounding channels for other purposes. The plastic cannula can be made of a flexible, semi-flexible, semi-rigid or rigid biocompatible plastic, preferably a very flexible plastic. 
         [0056]    The proximal end of the plastic cannula may be fixedly attached by an adhesive or other means within (a) the distal end of the connector of the optical fiber at or near the laser, (b) preferably at least about 6 cm proximal from the proximal end of the handpiece or (c) within the distal end of the handpiece. 
         [0057]    The distal end of a multi-channel cannula can extend (a) up to the proximal end of the crimped portion of a metal tip, (b) over the crimped portion of a metal tip, (c) over the crimped portion and over a metal tip, up to the area of laser energy emission or (d) over the crimped portion and up to the distal end of a metal tip, with a port for emission of laser energy over a 45° inclined surface of a metal tip. For example, the optional, multi-channel plastic cannula can be extruded with a central channel for the optical fiber to center the side firing device within a blood vessel, bronchi, hollow organ or duct, or with an eccentric channel for the optical fiber to position the side firing device close to the wall of the blood vessel, bronchi, hollow organ or duct. 
         [0058]    The central or eccentric channel for the optical fiber can have, for example, three surrounding longitudinal channels, one channel for infusion of a biocompatible irrigation fluid, such as sterile saline or water, to clean and cool the laser energy emitting surface of the side firing device and the Target Tissue, one channel for infusion of a biocompatible fluid, such as sterile, saline or water, to inflate a concentric, eccentric or back mounted balloon, which may be attached to the exterior of the multi-channel cannula proximal to the proximal end of the metal tip, to either (a) center the side firing device, for example, in the annulus of a prolapsed heart valve, the sphincter of the esophagus, the sphincter of the pyloric valve of the stomach, the sphincter of the male or female urethra, the sphincter of the male or female rectum or the male or female anus, or (b) to position the laser energy emitting surface of the side firing device close to at least one of the above, with one channel to enable a sterile, biocompatible fluid to inflate the balloon and one channel to enable such fluid to be withdrawn from and deflate the balloon. 
         [0059]    If a plastic cannula is extruded with two surrounding channels and extends from the handpiece to a point just proximal to the laser energy emission port of the side firing device, one channel can be used for infusion of a sterile biocompatible irrigation fluid to cool and flush debris from the optical components at the distal end of the side firing surface of the device and cool the Target Tissue, and one channel can be used to inflate and deflate a balloon mounted on the side firing device, as described above. 
         [0060]    In the cannula described above with only two surrounding channels, the balloon can be manufactured with one or more holes or vents to allow the air to escape into the atmosphere when one channel in the cannula is used to inflate the balloon with a fluid. 
         [0061]    If the cannula is extruded with three channels, one channel can be used to cool and clean the optical components at the distal end of a side firing device and cool the Target Tissue, one channel can be used to inflate the balloon and one channel can be used to deflate the balloon. 
         [0062]    Of course, any number of channels can be used to achieve their respective, desired functions. 
         [0063]    As mentioned above, the balloon can be concentric to center the side firing device in a body orifice, blood vessel, duct, hollow organ or surgically created passageway; eccentric, preferably wider on the side opposite the side from which laser energy emitted, and narrower on the side from which laser energy is emitted, to position the laser energy emitting side of the side firing device close to the Target Tissue; or the balloon may be mounted on the side of the side firing device opposite the side from which laser energy is emitted, to force the side firing device against the Target Tissue. 
         [0064]    A luer fitting may be sealingly and fixedly attached within and extends through the body of the handpiece and is in fluid communication with the central passageway in the handpiece and the irrigation fluid channel of the multi-channel cannula. To inflate a balloon, a separate luer fitting can be attached to the plastic cannula in fluid communication with the channel in the plastic cannula for inflation of the balloon, and a third luer fitting can be attached to the cannula in fluid communication with the fluid return channel, to enable the returned fluid to flow through a tube, for example, into a syringe, collection bottle or drain. 
         [0065]    Alternatively, all luer fittings can be attached to the multi-channel cannula, each in fluid communication with one channel of the multi-channel cannula, at one point or points at least about 6 cm proximal to the proximal end of the handpiece, so the luer fittings and the attached fluid lines do not interfere with the surgeon&#39;s use of the handpiece to Station, Move, Rotate and Sweep the distal, side firing portion of the device. 
         [0066]    To provide support for the luer fittings at their junction with each of their respective channels of the hollow, multi-channel cannula, a rigid plastic or metal collar can be adhesively attached to the multi-channel cannula and the luer fitting fluid lines. All three luer fittings may be attached with a radial collar, a collar extending longitudinally along the exterior of the multi-channel cannula, or a separate collar for each luer fitting may be employed. 
         [0067]    If the multi-channel cannula extends over the laser energy emitting portion of the side firing device, the multi-lumen cannula must have a port for emission of laser energy opposite the surface from which laser energy is emitted. 
         [0068]    In the second embodiment of a laser energy delivery device embodying the present invention, an optical fiber, optically coupled to a source of laser energy, from whose distal end portion the plastic buffer coating and any polymer cladding has been removed, a process called “baring” the optical fiber or producing an optical fiber with a “bared” distal end portion. The optical fiber extends through a hollow passageway extending lengthwise through the body of a handpiece. The optical fiber is fixedly attached to the handpiece, preferably within the proximal end of the handpiece, in a manner which sealingly closes the proximal end of the passageway, or allows the optical fiber to be sealingly and removeably attached in the proximal end of the handpiece, as described above. 
         [0069]    After baring the distal end portion of the optical fiber, the distal end of the optical fiber is beveled at an angle of about 35° to 45°, preferably at an angle of about 38° to 44°, and most preferably at an angle of about 40° to 41° for optimal reflection and laser energy transmission efficiency. A distally closed-ended capillary tube is disposed over and fixedly and sealingly attached by an adhesive, thermal fusing, a combination of the foregoing or other means known in the art, to the bared distal end portion of the optical fiber. Fixedly and sealingly disposing a closed-ended capillary tube over the distal end of the optical fiber creates an air environment opposite the beveled, distal end surface of the optical fiber. 
         [0070]    The difference in the refractive index of air, versus the refractive index of the quartz or fused silica core of the optical fiber, enables total internal reflection of the light energy to occur laterally at an angle of double the bevel angle, according to Snell&#39;s Law. If the distal end of the optical fiber is beveled at an angle of 40° to 41°, laser energy is emitted at an angle of about 80° to 82° out of a side laser energy emission port. 
         [0071]    Likewise, the optional plastic cannula described above, the optional balloon configurations described above, the use of the channels described above and the luer fittings communicating with each of the surrounding channels of the multi-channel cannula, as described above, can be used with this second embodiment of the side firing device. Alternatively, the plastic cannula can extend over the side firing device, with a port for emission of laser energy positioned in the path of laser energy emission, as described above. 
         [0072]    However, in the third embodiment of the device of the present invention, if laser energy at wavelengths of about 1400 to 1500 nanometers (nm) or 1800 to 3000 mm, which wavelengths are highly absorbed by water, is emitted through an optical fiber, whose distal end has been beveled at an angle of 35° to 45°, preferably at an angle of about 40° to 41° for optimal reflection and laser energy transmission efficiency, in an aqueous liquid environment, we have found that the closed-ended capillary tube can be eliminated for some applications. The first portion of the laser energy emitted vaporizes a portion of the aqueous irrigation liquid infused through an endoscope, or a channel in the optional multi-channel plastic cannula described above, and creates a steam bubble to form opposite the beveled, distal end surface of the optical fiber. 
         [0073]    The steam bubble has an index of refraction sufficiently lower than that of the refractive index of the quartz or fused silica core of the optical fiber to cause the laser energy to be internally reflected, according to Snell&#39;s Law, at an angle of about 80° to 82° out of the side port in the liposuction cannula, as described above. However, the laser energy emitting surface of this embodiment of the present invention must be positioned close to but not in contact with the Target Tissue, or much of the laser energy will be wasted vaporizing any intervening aqueous irrigation liquid. Contacting the Target Tissue can cause tissue to adhere to the laser energy emitting surface of the side firing device, reducing its transmission efficiency. 
         [0074]    Likewise, the optional multi-channel cannula described above, the optional balloon configurations described above, the surrounding channels described above, optionally extending the multi-channel cannula over the side firing device, with a port for emission of laser energy, as described above, and the luer fittings in fluid communication with each of the surrounding channels of the cannula, can be used with this embodiment of the side firing device. 
         [0075]    For use in surgically created passageways, or in endoscopic or laparoscopic procedures, an aiming beam of a desired color, for example, red or green, such as from a helium neon (HeNe), a diode laser or other laser emitting about 1 to 5 milliwatts of power, as known in the art, can be transmitted through the optical fiber and reflected at about the same angle as the therapeutic laser energy, which may be of an invisible wavelength, to enable the operator to see the direction in which the therapeutic laser energy is being emitted. Green is preferred, as red may be more difficult to discern in an area containing blood. 
         [0076]    Laser energy at wavelengths of about 300 to 400 nm are used through optical fibers with a relatively high hydroxyl ion content of 600 to 800 ppm, called high-OH fibers to prevent excessive loss of laser energy at these wavelengths. Laser energy at wavelengths of about 400 to 1400 nm and about 1500 to 1800 nm can be used through conventional optical fibers with a hydroxyl ion content of 100 to 600 ppm or, preferably, for more efficient transmission efficiency, through or optical fibers with a low hydroxyl ion content, of about 0.1 to 100 ppm; to reduce transmission losses. 
         [0077]    An optical fiber with a low hydroxyl ion (water) content of less than about 100 parts per million, preferably about 1 to 100 parts per million (“ppm”), called a low-OH fiber, is used with lasers whose wavelength is 1400 to 1500 or 1800 to 2300 nm, to prevent excessive loss of laser energy. And, an optical fiber with an extremely low hydroxyl ion content of about 0.01 to 1 ppm, called an ultra low-OH fiber, is used with lasers emitting energy at a wavelength of 2300 to 3000 nm, to avoid excessive loss of laser energy at these wavelengths. 
         [0078]    Contrary to common wisdom in the laser field, we discovered that all wavelengths of laser energy from about 300 nm to 3000 nm, used through optical fibers with hydroxyl ion contents applicable to each, as described above, can be effectively used in the side firing device described above, in which the distal end of the optical fiber is beveled at an angle of about 35° to 45°, most preferably at an angle of about 40° to 41°, and is fixedly and sealingly encased by a distally closed-ended capillary tube to create the air environment, which is required for total internal reflection of laser energy to occur. 
         [0079]    A variety of lasers fall within wavelengths of about 300 nm to 3000 nm. For example, lasers emitting at 300 to 400 nm, include, for example, excited dimer lasers, called “eximer” lasers, including Xenon Chloride (XeCl) lasers emitting at a wavelength of about 308 nm and Xenon Fluoride (XeFl) lasers emitting at a wavelength of about 351 nm, which wavelengths are highly absorbed by molecular bonds, causing disruption and vaporization of tissue. However, the light extinction depth of excimer laser energy is only about 5 microns, excimer lasers are generally limited to powers of only about 10 watts, and they use highly toxic gasses, which can be dangerous in a medical facility. 
         [0080]    Lasers emitting at 400 nm to 1400 nm and from 1500 nm to 1800 nm include, for example, an argon laser emitting at about 488 to 514 nm, a KTP laser emitting at a wavelength of 532 nm, which is highly absorbed by a red pigment, such as oxygenated hemoglobin in blood, a diode laser emitting at wavelengths of about 600 nm to 1400 nm, an alexandrite laser emitting at a wavelength of 810 nm, and a Nd:YAG laser emitting at a wavelength of 1064 nm, which wavelengths are absorbed to a modest extent by pigments and to a limited extent in water. These lasers have light extinction depths ranging from 800 to 4000 microns. 
         [0081]    Lasers emitting at 1400 to 1500 nm and from 1800 to 3000 nm include, for example, a certain diode laser emitting at a wavelength of about 1470 nm, a Thulium:YAG laser emitting pulsed or continuous wave laser energy at a wavelength of about 2000 nm, a Chromium, Thulium, Holmium or CTH:YAG laser, commonly referred to as a “Holmium laser”, emitting pulsed laser energy at a wavelength of about 2100 nm, a YSGG:YAG laser emitting pulsed laser energy at a wavelength of about 2106 nm, the light extinction depth of the CTH:YAG and YSGG:YAG lasers in tissue is about 400 microns, and an Erbium:YAG laser emitting pulsed laser energy at a wavelength of about 2900 nm, whose light extinction depth in tissue is only about 50 microns, all of which wavelengths are highly absorbed by water, a constituent of all tissues, as well as the irrigation liquids commonly used in endoscopic procedures. 
         [0082]    While all of the above-described wavelengths of laser energy can be used in the side firing device of the present invention, provided the core of the optical fiber has a sufficiently low hydroxyl-ion content of an appropriate amount for effective transmission of each laser&#39;s wavelength, pulsed Holmium laser energy is preferred, as its depth of penetration in tissue is ideal for use in arteries, veins, bronchi and other Target Tissues with a wall thickness of about 1 to 2 mm. And, it&#39;s very short, about 350 microsecond pulses of laser energy, leave time for the tissue to cool between pulses of laser energy. 
         [0083]    If the wall thickness of a Target Tissue is larger than 1 to 2 mm, (a) a longer emission time may be used, to enable thermal diffusion of the laser energy to occur, (b) a laser whose wavelength penetrates tissue to a greater depth can be employed, (c) multiple beams of laser energy or other Thermal Energy may converge at a desired point within the Target Tissue, or (d) one or more needles, each containing an optical fiber, may be inserted to deliver laser energy at a desired depth within the Target Tissue. 
         [0084]    The handpiece can have a raised button, whose color may be significantly different from that of the handpiece, which the operator can see and sense by tactile feel, as known in the art. The button can be positioned on the side of the handpiece from which the laser energy is emitted or, preferably, on the side of the handpiece opposite the side from which the laser energy is emitted. If so positioned, when the handpiece is gripped, the forefinger or thumb of the operator, touching the button, points in the direction in which the laser energy will be emitted, as known in the art. 
         [0085]    In a preferred version of the second embodiment of the present invention, we discovered that the beveled, distal end surface of the optical fiber may be encased within a closed-ended capillary tube with a substantially thinner wall thickness, which causes the laser energy to be more widely diverged, enabling a greater volume of Target Tissue to be Altered and allows the side firing device to be rotated through an arc of only about 90° to achieve the same effect. In this embodiment, the wall thickness of the capillary tube is not greater than 350 microns, compared to a typical wall thickness of about 500 to 600 microns of the capillary tube in the second embodiment of the side firing devices described above. 
         [0086]    Today, all side firing devices, of which we are aware, are made with optical fibers with a core diameter of about 500 to 600 microns, as conventional wisdom in the medical laser field is such core diameters are necessary to efficiently capture and transmit 100 or more watts. 
         [0087]    Contrary to common wisdom, we have tested successfully optical fibers with core diameters less than 500 microns and discovered that 100 watts of Holmium and other wavelengths of laser power can be efficiently transmitted through optical fibers as small as 365 microns or even smaller. In the process of constructing and testing optical fibers with a core diameter of 365 microns, we created the smallest side firing devices ever made, with an O.D. of no more than 1.5 mm (conventional side firing devices with an internal fluid channel are usually 2.0 mm to 2.5 mm in O.D. 
         [0088]    These smaller diameter core fibers enable side firing devices to be used through a metal cannula with a bend near its distal end, a conventional guiding catheter or a rigid endoscope, whose distal end may be flexible and bent or articulated by wires or other means, by up to 90° or more, provided the bend radius is not smaller than 1 to 1.5 cm, as described below, which could cause laser energy to leak at the bend and damage the cannula, guiding catheter or flexible endoscope. 
         [0089]    Another improvement we conceived is the use of a thin, heat shrinkable plastic tube, which is shrunk over the distal end portion of the optical fiber, the junction of the optical fiber with the proximal end of the metal tip or the proximal end portion of the capillary tube and terminates just proximal to the area of laser energy emission from the metal tip or capillary tube. The heat shrunk tube reduces the risk of the capillary tube of the second embodiment of the present invention from being dislodged from the optical fiber, as a safety measure. An adhesive may also be applied to the area to be covered by the heat shrinkable tube, prior to the heat shrinking process, as an additional safety measure. 
         [0090]    The unique construction of any of the side firing devices described above may be employed to effectively and uniformly Alter a Target Tissue by shrinkage. These side firing devices can be used in one or more novel methods of use to achieve a significantly more effective, safe and uniform Altering by shrinkage of a Target Tissue to Treat a Medical Condition of a Patient, as described below. 
         [0091]    After Stationing a side firing device or other Source of Thermal Energy opposite a Target Tissue, the button on the handpiece can be positioned, for example, at 3 o&#39;clock, causing Thermal Energy to be emitted at 9 o&#39;clock, after which the button can be successively positioned at 6, 9 and 12 o&#39;clock, causing Thermal Energy to be emitted at 12, 3 and 6 o&#39;clock. This process can be started at any of such positions. 
         [0092]    Thermal Energy can be emitted, for example, at a power level of about 3 to 40 watts, preferably about 8 to 20 watts, provided the emission of Thermal Energy is in an aqueous Environment or is concomitantly accompanied by the infusion of a sterile, biocompatible irrigating fluid or a spray of a sterile, biocompatible irrigation fluid, preferably sterile water or saline or a cold or cryogenically cooled biocompatible gas, such as CO 2  or nitrogen, to cool the Target Tissue. 
         [0093]    However, if the Target Tissue is not concomitantly cooled, lower laser power must be applied, for example, at about 0.05 to 10 watts, preferably at about 0.1 to 3 watts, to avoid a build-up of thermal energy that could damage the Target Tissue or adjacent tissue. The level of laser energy and its duration is dependent on the area and volume of Target Tissue to be Altered, and the rate of Moving, Rotating and/or Sweeping the laser energy delivery device and the time period thereof, and is determined by the physician performing the procedure. 
         [0094]    The button on the handpiece can be positioned, for example, at 12 o&#39;clock, and laser energy or other Thermal Energy may be emitted for about 5 to 30 seconds, preferably for about 10 to 20 seconds, at 6 o&#39;clock, while repetitively Rotating the cannula back and forth through an arc of about 90° to 120°, from up to about 4 to 8 o&#39;clock, as the side firing device or other Thermal Energy delivery device is positioned or Moved. Then, the button can be successfully positioned at 3, 6 and 9 o&#39;clock and the above described process of delivering the Thermal Energy can be repeated. 
         [0095]    If the side firing device or other Thermal Energy delivery device is Moved, each longitudinal movement can be for about 1 to 5 seconds, preferably about 2 to 3 seconds, in each direction, depending upon the distance the side firing device is to be extended from the distal end of a cannula, endoscope, laparoscope or though a surgically created passageway, as determined by the physician performing the procedure. 
         [0096]    If the side firing device or other Thermal Energy delivery device is Rotated through an arc of about 90° to 120° while positioned and/or Moved, its rate of rotation is preferably about one arc per second, for the reasons described above. 
         [0097]    To Treat certain Medical Conditions of a Patient, it may be difficult, impossible or impractical to use a side firing device. In such instances, a prior art optical fiber may be inserted through a rigid endoscope or laparoscope, or through a rigid endoscope or laparoscope whose distal end portion, about 5 to 10 cm in length, may be articulated or bent at an angle up to at least 90°, usually by manipulating wires contained in the distally flexible device, as known in the art, provided the bend radius is not smaller than 1 to 1.5 cm, as described below. The above described scopes can be positioned, Moved, Rotated and/or Swept, individually or in any desired combination or sequence, to Alter the Target Tissue to Treat the Medical Condition. 
         [0098]    Also, in the treatment of certain Medical Conditions, an optical fiber may extend from a source of laser energy through a handpiece and a prior art, hollow metal or rigid plastic cannula, preferably made of medical grade stainless steel. The proximal end of the optical fiber is fixedly attached within the distal end of the handpiece by an adhesive, as known in the art. 
         [0099]    The prior art cannula&#39;s distal end portion can be straight (0°) or bent at an angle of, for example, 10°, 20°, 30°, 40°, 50° or 60°, or any other desired angle, providing the bend radius does not exceed 1 to 1.5 cm, as described below. Such a cannula and the optical fiber extending therethrough, may be inserted through a body orifice or a surgically created passageway and used under direct viewing, (a) through a rigid endoscope or laparoscope, (b) through an endoscope or laparoscope with a distal, flexible portion, or (c) guided by ultrasound, fluoroscopic or x-ray imaging. The optical fiber device can be Stationed, Moved, Rotated and/or Swept, in any desired sequence, individually or in any desired combination, to Alter a Target Tissue to Treat a Medical Condition of a Patient. 
         [0100]    However, if a Thermal Energy delivery device is used in an air or biocompatible gas environment, without the infusion or a spray of a sterile, biocompatible irrigation fluid, it must be used at the low energy levels described above to avoid excessive thermal damage to the Target Tissue or adjoining tissues. 
         [0101]    If used in an air or biocompatible gas environment, we found that the prior art, cannula/optical fiber device described above can contain a space between the exterior of the optical fiber and the inner surface of the cannula for infusion of a sterile, biocompatible fluid, such as saline, water, a cooled gas, preferably a cryogenically cooled gas, such as CO 2  or Nitrogen, to cool the optical fiber and the Target Tissue. 
         [0102]    A luer fitting, in fluid communication with the space between the exterior of the optical fiber and the interior of the cannula, as known in the art, may be attached to the handpiece or the cannula, as described above, can be used to infuse the cooling fluid. Cooling the optical fiber and the Target Tissue enables a substantially greater level of laser energy to be safely used. 
         [0103]    Other variations of the above described devices can be made and other Sources of Thermal Energy to Alter a Target Tissue can be used to Treat a variety of Medical Conditions of Patients, without departing from the principles set forth herein and without limiting the intent and scope of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0104]      FIG. 1  is an external, side view of the first embodiment of the device of the present invention, with an expanded, partial, cross-sectional, side view of the distal end portion of the device. 
           [0105]      FIG. 2  is a partial, cross-sectional, side view of the distal end portion of the second embodiment of the device of the present invention. 
           [0106]      FIG. 3  is a partial, cross-sectional, side view of the distal end portion of the third embodiment of the device of the present invention. 
           [0107]      FIG. 4  is a partial, cross-sectional, side view of the distal end portion of an improved embodiment of the device of  FIG. 2 . 
           [0108]      FIG. 5  illustrates the laser energy emission area resulting from positioning and Rotating the embodiment of the device of  FIG. 2 . 
           [0109]      FIG. 6  is a partial, cross-sectional, side view of the distal end portion of a further improved embodiment of the device of  FIG. 2 . 
           [0110]      FIG. 7  is a partial, cross-sectional, side view of another improved embodiment of the device of  FIG. 6 . 
           [0111]      FIG. 8  is a cross-sectional, end view at plane A-A of the device of  FIG. 7 . 
           [0112]      FIG. 9  is a partial, cross-sectional side view of another improved embodiment of the device of  FIG. 2 . 
           [0113]      FIG. 10  is a cross-sectional, end view at plane B-B of the device of  FIG. 9 . 
           [0114]      FIG. 11  is a partial, cross-sectional, side view of another improved embodiment of the device. 
           [0115]      FIG. 12  is a cross-sectional, end view at plane C-C of the device of  FIG. 11 . 
           [0116]      FIG. 13  is a partial, cross-sectional, side view of another improved embodiment of the device. 
           [0117]      FIG. 14  is a partial, cross-sectional, top view of the handpiece and luer fittings of the present devices. 
           [0118]      FIG. 15  is a schematic representation of four methods of use of the device of the present invention. 
           [0119]      FIG. 16  is a partial, external, side view of four prior art optical fiber/cannula devices. 
           [0120]      FIG. 17  is a partial, external, side view of four improved optical fiber/cannula embodiments of the device of the present invention. 
           [0121]      FIG. 18  is a cut-through, top view of the female reproductive system. 
           [0122]      FIG. 19  is a cut-through, side view of a sectioned heart. 
           [0123]      FIG. 20  is a partially cut-through, side view of the esophagus, stomach and duodenum. 
           [0124]      FIG. 21(   a ) is a cut-through, side view of the male penis and urethra. 
           [0125]      FIG. 21(   b ) is a cut-through, side view of the female bladder and urethra. 
           [0126]      FIG. 22  is a cut-through, side view of the rectum and anus. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0127]    The first embodiment of side firing device  10  suitable for practicing the present invention is illustrated in  FIG. 1 . Device  10  is comprised of laser energy source  11  and optical fiber  12 . Connector  13  operably couples optical fiber  12  to laser energy source  11 . Optical fiber  12  is fixedly and sealingly attached within the proximal end of handpiece  14  by adhesive  26 , as known in the art, and extends through a hollow, longitudinal, passageway (not separately shown) in handpiece  14  and is in fluid communication with hollow metal or rigid plastic cannula  15 , preferably of medical grade stainless steel, whose proximal end is fixedly attached by adhesive  26  within the distal end of handpiece  14 . 
         [0128]    The distal end  16  of cannula  15 , as shown in  FIG. 1 , is rounded. Distal end  16  of cannula  15  may also be blunt, sharp, double-bevel needle-shaped, trocar shaped or of any other desired shape, as known in the art. Using a needle-like or sharp-ended cannula within a patient entails considerable risk to the patient, should be used under endoscopic, ultrasound or x-ray imaging and requires greater care by the surgeon. 
         [0129]    Alternatively, optical fiber  12  may be removeably and sealingly attached within the proximal end of handpiece  14  by a compression fitting (not separately shown), as known in the art, enabling side firing device  10  to be removed, cleaned, sterilized and reused, if desired. 
         [0130]    Button  17  on handpiece  14 , in this embodiment, is preferably positioned on the side of handpiece  14  opposite the side of handpiece  14  from which the emission of laser energy occurs through laser energy emission port  18  in cannula  15 , as shown by arrows  19 , resulting in laser energy spot area  31  on or within a Target Tissue. While button  17  may also be positioned on the side of handpiece  14  from which the emission of laser energy occurs, button  17  will be less able to be visualized during use. 
         [0131]    Luer or other fluid connector fitting  20 , which is fixedly attached within and extends through the wall of handpiece  14 , is in fluid communication with the longitudinal passageway (not separately shown) in handpiece  14 , hollow cannula  15  and port  18  positioned over the source of emission of laser energy. Luer fitting  20  enables a sterile, biocompatible fluid, such as saline or water, to be infused through longitudinal passageway (not separately shown) in handpiece  14  into hollow cannula  15 , to clean and cool the laser energy emitting surface of side firing device  10  and cool the Target Tissue. 
         [0132]    As shown in the cut-through, expanded view A-A of the distal end portion of device  10 , buffer coating  21  and any optional polymer cladding (not separately shown) of optical fiber  12  have been removed from the distal end portion of optical fiber  12 , which extends into cavity  22  in hollow metal end piece  23 . Metal end piece  23  is fixedly attached to the bared distal end portion of optical fiber  12  by adhesive  26 , crimping of the proximal end portion of metal end piece  23  to optical fiber  12  (not separately shown) or both, or by other means known in the art. 
         [0133]    As illustrated in expanded view A-A, metal end piece  23  and optical fiber  12  are disposed within metal or plastic hollow cannula  15 , whose distal end  16  may be rounded, as shown, sharp, conical, blunt or of any other desired shape. Cavity  22  in metal end piece  23  is formed with a reflective, inclined surface  24  opposite distal end face  25  of optical fiber  12 . Reflective surface  24  of metal end piece  23  is inclined at an angle of about 35° to 50°, preferably about 45°, to reflect the laser energy from inclined reflective surface  24  at an angle of about 90° from the axis of optical fiber  12 , according to Snell&#39;s law, out of port  18 , as shown by arrows  19 . 
         [0134]    Metal end piece  23  can be made entirely of a metal highly reflective to the wavelength of laser energy to be used, such as highly pure gold or silver, or metal end piece  23  can be made of a material such as medical grade stainless steel, which is plated with a highly reflective metal, such as highly pure gold or silver with a thickness of about 5 thousandths of an inch or more, or coated with a dielectric highly reflective to the wavelength of laser energy to be used, as known in the art. 
         [0135]    Alternatively, an insert (not separately shown) with a thickness of about 10 to 20 thousandths of an inch or more of a metal highly reflective to the wavelength of laser energy being used, such as highly pure gold or silver, may be force-fitted or attached by an adhesive, or both, in a recess (not separately shown) in the distal end of the cavity  22  in metal end piece  23 . 
         [0136]    Polished copper, brass, aluminum or stainless steel, which cost less than gold or silver, may also be used. However, stainless steel is not a highly efficient reflector, and copper and aluminum are not as reflective as gold or silver and are subject to tarnish and/or oxidation, which reduced their reflectivity. 
         [0137]    95.5% pure Silver is about 97% reflective at wavelengths of about 500 to 2400 nm, and about 95.5% reflective at 430 nm. 95.5% pure Gold is less than 50% reflective below wavelengths of 500 nm, 81.7% reflective at 550 nm, 91.9% reflective at 600 nm, 95.5% reflective at 650 nm and about 97% reflective at 700 nm and longer wavelengths. Highly pure platinum is extremely expensive and is only 71.4% to 81.8% reflective at wavelengths of 500 to 2000 nm and is 88.8% reflective at 3000 nm. Highly pure silver is preferred, because it is highly reflective and is considerably less expensive than gold or platinum. 
         [0138]    However, for greater durability, a lower cost of manufacture and resistance to erosion by the emission of laser energy, metal end piece  23  is preferably made entirely of at least 90% pure gold or silver, preferably of very pure silver with a purity of about 95.5%. For comparison, “Sterling” silver is 92.5% pure. 
         [0139]    The second embodiment of side firing device  10  of the present invention is shown in  FIG. 2 . In this embodiment, distal end  16  of hollow cannula  15  is shaped like the distal end of a double beveled syringe needle, which cuts rather than making a puncture or hole through the skin, hastening healing and reducing bleeding and the risk of an infection. To prevent tissue from lodging in the opening at distal end  16  of cannula  15 , plug  27  of an adhesive or other material, preferably heat resistant to any stray laser energy, may be used to fill distal end  16  of cannula  15 , as known in the art. 
         [0140]    Distal end  16  of hollow cannula  15  can also be blunt, round, conical or any other desired shape, as the use of a sharp or needle-like device within a patient requires imaging during its use and great care by the surgeon. 
         [0141]    Buffer coating  21  and any optional polymer cladding have been removed from the distal end portion of optical fiber  12 , and the distal end of optical fiber  12  has been ground and polished into beveled, distal end surface  28  at an angle of about 35° to 45°. The beveled, distal end portion of optical fiber  12  is sealingly encased within hollow, closed-ended capillary tube  29 , which creates air pocket  30  opposite beveled, distal end surface  28  of optical fiber  12 . Air pocket  30  has a lower refractive index than that of the core of optical fiber  12 , which is necessary for total internal reflection or “TIR” of laser energy at double the bevel angle of distal, beveled end surface  28 , according to Snell&#39;s Law. 
         [0142]    According to common wisdom in the medical laser field, the most effective bevel angle of an optical fiber for total internal reflection of laser energy is 37°. Contrary to common wisdom, however, distal end surface  28  of optical fiber  12  is preferably beveled at an angle of about 40° to 41°, which we have discovered by testing various bevel angles at 1° intervals, to be the most efficient bevel angle of an optical fiber for total internal reflection of laser energy at relatively high power levels. 
         [0143]    If beveled, distal end surface  28  of optical fiber  12  is ground and polished at an angle less than 40°, the laser energy will be less optimally reflected and more scattering of laser energy will occur. If distal end surface  28  of optical fiber  12  is beveled at an angle greater than 42°, the transmission of laser energy will be substantially lower. 
         [0144]    Capillary tube  29  typically has a wall thickness of 500 microns or more, as it may be eroded during use, causing device  10  to fail. The proximal end portion of closed-ended capillary tube  29  may be fixedly and sealingly attached to the bared distal end portion of optical fiber  12  by thermal fusion (not separately shown) or by adhesive  26 , neither of which extend into the area of laser energy emission from beveled, distal end surface  28  of optical fiber  12 . While not preferred, if capillary tube  29  is fused to optical fiber  12  near beveled, distal end surface  28  of optical fiber  12 , care must be taken to avoid deforming beveled distal end surface  28  of optical fiber  12  by exposure to high glass fusing temperatures. 
         [0145]      FIG. 3  illustrates the third embodiment of side firing device  10  of the present invention. In this embodiment, no capillary tube  29  is utilized to sealingly encase the beveled, distal end surface  28  of optical fiber  12 . As a result, no air pocket is created opposite beveled, distal end surface  28  of optical fiber  12 . 
         [0146]    Laser energy at wavelengths of 1400 to 1500 nm and 1800 to 11,000 nm are highly absorbed by aqueous liquids, such as sterile saline or water, which are commonly used as an irrigation fluid in endoscopic procedures. If ten or more watts of laser power at these wavelengths is transmitted through optical fiber  12 , such wavelengths of laser energy cause a steam and/or gas bubble (not separately shown) to form, with each pulse of laser energy, opposite beveled, distal end surface  28  of optical fiber  12 , from the vaporization of the aqueous irrigation liquid, blood, other body fluids and/or tissue. 
         [0147]    The refractive index of the steam and/or gas bubble opposite beveled, distal end surface  28  of optical fiber  12  is sufficiently lower than the refractive index of the quartz or fused silica core of optical fiber  12 , to enable the laser energy to be totally internally reflected from beveled, distal end surface  28  of optical fiber  12 , laterally from the axis of optical fiber  12  at an angle of 80° to 82°, as shown by arrows  19 , according to Snell&#39;s Law, and the balance of the pulse of laser energy passes through the stream and/or gas bubble to the Target Tissue. Consequently, no capillary tube  29  must be disposed over the 41° to 42° beveled, distal end surface  28  of optical fiber  12  to create an air interface and TIR. 
         [0148]    However, laser energy at 300 to 1400 and 1500 to 1800 nm cannot be used through device  10  of this third embodiment of the present invention, as such wavelengths are not highly absorbed by water and no steam and/or gas bubble with a refractive index tower than the core of optical fiber will be formed, and the laser energy will be emitted straight-ahead. 
         [0149]    As shown, distal end  16  of cannula  15  is pointed or conically shaped. As mentioned above, the use of a pointed or sharp-ended cannula in a Patient entails significant risk and should be used under endoscopic, ultrasound or x-ray viewing. 
         [0150]      FIG. 4  illustrates side firing device  10  in which the distal end of optical fiber  12  is beveled into a chisel like shape, with each distal, beveled end surface  28  at an angle of 40° to 42° from the axis of optical fiber  12 . The proximal end of capillary tube  29  is fixedly attached to the bared distal end surface of optical fiber  12 , buffer coating  21  and any polymer cladding (not separately shown) having earlier been removed from the distal end portion of optical fiber  12 . 
         [0151]    Capillary tube  29  creates air pocket  30  opposite both distal beveled end surfaces  28  of optical fiber  12 , necessary for total internal reflection (TIR) of laser energy, according to Snell&#39;s Law. As indicated by arrows  19 , laser energy is simultaneously emitted from both ports  18  in cannula  15  exits at an angle of about 80° to 82° from the axis of optical fiber  12 , simultaneously creating laser energy spot areas  31 . 
         [0152]    In this embodiment, to achieve the same effect on a Target Tissue, the level of laser energy must be doubled. 
         [0153]      FIG. 5  illustrates a further improved embodiment of side firing device  10  of  FIG. 2 . In this embodiment, bared optical fiber  12  is fixedly and sealingly encased within a distally closed-ended capillary tube  29 , which has a substantially thinner wall thickness than the typical 500 micron or larger wall thickness of capillary tube  29  shown in  FIG. 2 . The wall thickness of capillary tube  29  in this embodiment is preferably about 350 microns or less. 
         [0154]    This reduces the amount of cylindrical lensing that occurs and converges the divergent output of laser energy from beveled, distal end surface  28  of optical fiber  12  at a closer point, providing an effectively wider angle of divergence at a given distance from laser energy emission port  18 , as illustrated by arrows  19 . This results in a significantly larger laser energy spot area  31  on or within a Target Tissue (not separately shown) than laser energy spot area  31  shown from side firing device  10  of  FIG. 2 . 
         [0155]    However, this embodiment of the present invention is preferably used at low levels of laser energy. Side Firing device  10  of  FIG. 5  should not be used to Treat a Medical Condition of a Patient which requires the emission of a very high level of laser energy for a substantial period of time, such as 40 to 100 watts for 10 minutes or longer, as thinner capillary tube  29  is more likely to be degraded by hydrothermal erosion and laser energy back reflected from the Target Tissue, causing device  10  to fail. 
         [0156]    Hydrothermal erosion is created by the formation of a steam bubble, when each pulse of laser energy at wavelengths of 1400 to 1500 and 1800 to 11,600 nm is emitted, and a powerful acoustic shock wave is created by the collapse of the bubble, which can erode capillary tube  29 . 
         [0157]      FIG. 6  illustrates a sixth embodiment of side firing device  10  of the present invention. Side firing device  10  is made with an unusually small optical fiber, with a core diameter of 350 microns or smaller, and can be bent at an angle of up to 90° or more when used, for example, through a conventional guiding catheter (not separately shown) to access from the internal aorta, at an angle of up to 180°, the left ventricle of the heart (not separately shown), to shrink the chordae tendinae of a prolapsed mitral, aortic or tricuspid valve to treat the valve&#39;s prolapse, sometimes called regurgitation or leakage. However, optical fibers with a core diameter of 500 microns or larger may not be sufficiently flexible to be used through such a guiding catheter. 
         [0158]    Common wisdom in the laser field that is only optical fibers with core diameters of 500 microns or larger can be effectively used to transmit up to 100 watts or more of laser power, and have a sufficient surface to be beveled to effectively reflect laser energy at an angle of 70° to 90°. Contrary to common wisdom, however, by testing optical fibers of successively smaller diameter, we discovered that optical fibers with a core diameter of 350 microns or smaller could be effectively beveled and used with appropriate cladding materials through bends of up to 90° or more with up to about a 95% laser energy transmission efficiency, provided the bend radius is not less than 1 to 1.5 cm, as will be explained later. 
         [0159]    As a result, as seen in  FIG. 6 , we created what we believe is the smallest diameter side firing device  10  ever made, with an O.D. of 1.4 mm or less, compared to prior art side firing devices  10  with an O.D. of 2 mm to 2.5 mm, enabling this smaller diameter side firing device  10  to be used in arteries, veins, bronchi, ducts, hollow organs, body orifices and surgically created passageways with an I.D. of 1.6 mm or smaller, which may optionally be cannulated. 
         [0160]    As seen, optical fiber  12  has a core diameter of 365 microns, whose distal end surface  28  has been beveled at an angle of 40 to 41° from the axis of optical fiber  12 . Buffer coating  21  and any optional polymer cladding (not separately shown) has been removed from the distal end portion of optical fiber  12 , and capillary tube  29  fixedly and sealingly encases the distal end portion of optical fiber  12 , as described above, creating air pocket  30  to enable total internal reflection of light to occur through port  18 , as shown by arrows  19 . 
         [0161]    For use at relatively high laser energy levels, as shown, capillary tube  29  can have a wall thickness of about 500 microns. For use at relatively lower levels of laser energy, capillary tube  29  can have a wall thickness of 350 microns or less, as shown in  FIG. 4 . 
         [0162]    The proximal end portion of capillary tube  29  can be fixedly attached to bared optical fiber by thermal fusion (not separately shown), by adhesive  26  or both. Adhesive  26  is preferably made of a material with a high melting point, which meets USP Class VI specifications for use in medical devices and which is substantially transparent to the wavelengths of laser energy commonly used in medical procedures, such as KTP, diode, Nd:YAG, Thulium:YAG and CTH:YAG or Holmium lasers, so as not to absorb laser energy and melt, allowing capillary tube  29  to move with respect to optical fiber  12  and be dislodged therefrom. 
         [0163]    Adhesive  26  has a high melting point, and is substantially transparent to and does not absorb the wavelengths of laser energy commonly used in medical procedures, such as 532 mm KTP, 980 mm diode, 1046 nm Nd:YAG or 2100 nm CTH:YAG laser energy, not absorbing more than an average of 6% of such laser energy. Preferably, the adhesive is an optically transparent, two-component epoxy adhesive. 
         [0164]    As a safety measure, heat shrinkable tubing  32  is shrunk over the distal end portion of buffer coating  21  and the proximal end portion of capillary tube  29 , terminating before laser energy emission port  18 . Adhesive  26  can also be optionally used to fixedly attach heat shrinkable tubing  32  in place, as an additional safety measure, to help prevent the accidental separation of capillary tube  29  from optical fiber  12 . 
         [0165]      FIG. 7  illustrates the seventh embodiment of device  10  of the present invention. In this embodiment, flexible plastic, round, hollow, doubled-walled, multi-channel tube  33  extends from about the distal end of or within the distal end of handpiece  14  (not separately shown) over optical fiber  12  and, as shown, terminates just before the proximal end of heat shrunk tubing  32 . 
         [0166]    Round, hollow, double-walled, multi-channel tube  33  consists of round inner wall  34  and round outer wall  35 . The I.D. of inner wall  34  of tube  33  is just slightly larger than the O.D. of optical fiber  12 . To space inner wall  34  apart from outer wall  35 , tube  33  is extruded with two or more longitudinally extending ribs  36  (not separately shown in  FIG. 8 ). Preferably four ribs  36  are extruded, creating four channels  37 ,  38 ,  39 ( a ) and  39 ( b ) (not separately shown), as described below in  FIGS. 8-12 . 
         [0167]      FIG. 8  illustrates the construction of flexible, round, hollow, double-walled, multi-channel tube  33  of device  10  at a plane A-A of  FIG. 7 . Inner wall  34  of tube  33  is circular with an I.D. just slightly larger than that of optical fiber  12  of the devices of  FIGS. 1-4 , the relatively smaller diameter optical fiber  12  of  FIG. 6  described above, and the diameter of optical fiber  12  of  FIGS. 9-12  described below. 
         [0168]    In this embodiment, for example, four ribs  36  extend longitudinally through and separate inner wall  34  from outer wall  35  of tube  33 , with ribs  36  preferably located at 2, 4, 8 and 10 o&#39;clock, creating channels  37 ,  38 ,  39 ( a ) and  39 ( b ). 
         [0169]    Channel  37  may be in fluid communication with fluid passageway in handpiece  14  and luer fitting  20  (neither of which are separately shown), and a sterile biocompatible fluid, such as saline or water, can be infused through channel  37  to clean and cool the laser energy emitting surface of capillary tube  29  and cool the Target Tissue. 
         [0170]      FIG. 9  illustrates the eighth embodiment of device  10  of the present invention. In this embodiment, double walled, hollow tube  33  extends from about the distal end or within the distal end of handpiece  14  (not separately shown), over optical fiber  12  and heat shrunk tubing  32  and co-terminates with the distal end of heat shrunk tubing  32 , proximal to the area of laser energy emission from capillary tube  29 , as shown by arrows  19 . 
         [0171]    Balloon  40  eccentrically encases a portion of the distal end portion of hollow, double-walled tube  33 . The wider portion of eccentric balloon  40  presses the laser energy emitting surface of capillary tube  29  closer to the Target Tissue and minimizes the loss of laser energy in vaporizing any intervening aqueous irrigation fluid. Irrigation fluid infused through channel  37  also forces bodily liquids (not separately shown) away from the laser energy emission area of capillary tube  29 , as shown by arrows  19 . 
         [0172]    A biocompatible irrigation fluid, such as sterile saline or water, may also be infused through channel  38  and exits vent  41  in outer wall  35  ( FIG. 10 ) to inflate balloon  40 . In this embodiment, balloon  40  has one or more vent holes  42 . When the irrigation fluid is infused through channel  38  to inflate balloon  40 , one or more vent holes  42  enable air to be purged from channel  38  and escape from balloon  40 . When irrigation fluid is seen exiting tiny hole or holes  42 , the operator knows the air has been purged from channel  38 . 
         [0173]    In this embodiment, channels  39 ( a ) and  39 ( b ) are not used, and the proximal ends of channels  39 ( a ) and  39 ( b ) and the distal ends of channels  38 ,  39 ( a ) and  39 ( b ) are closed by plugs  27  of adhesive  26  or other material known in the art (not separately shown). 
         [0174]    Balloon  40  can also be back-mounted to force the energy emission port  18  of device  10  close or closer to the Target Tissue, as described in  FIG. 11 , below. 
         [0175]    As described in  FIG. 22  below, balloon  40  can also be concentric to center device  10  in a body orifice, hollow organ or surgically created passageway and insure an equal amount of laser energy will be emitted to the inner surface of the orifice, hollow organ or passageway at each area of laser energy emission, where this effect is desired. 
         [0176]      FIG. 10  illustrates the construction of double-walled, hollow tube  33  of device  10  at plane B-B of  FIG. 9 . In this embodiment, outer wall  35  of double-walled, hollow tube  33  has vent  41 , allowing a sterile, biocompatible fluid, such as saline or water, to be infused through channel  38  and exit through vent  41  to inflate eccentric (or concentric or back-mounted) balloon  40  which encases the portion of device  10  proximal to its laser energy emitting surface. 
         [0177]      FIG. 11  illustrates the ninth embodiment of device  10  of the present invention. In this embodiment, inner wall  34  of double-walled, hollow tube  33  is circular to accept capillary tube  29  sealingly encasing optical fiber  12 , which are disposed eccentrically within double-walled, hollow tube  33 , by a relatively thicker walled plug  27 , versus that of a relatively thinner walled plug  27 ( a ) ( FIG. 12 ), positioning the laser energy emitting surface of capillary tube  29  closer to the Target Tissue. Vent  41  in outer wall  36  allows a sterile, biocompatible fluid, for example, saline or water, to be infused through channel  38  and vent  41  to inflate balloon  40 . 
         [0178]    Balloon  40  is mounted on the back side of hollow, double-walled tube  33 , opposite the side of device  10  from which laser energy is emitted from capillary tube  29 , as shown by arrows  19 . The inflation of balloon  40  forces side firing device  10  close to the Target Tissue, and the infusion of fluid through channel  37  forces blood away from the path of laser energy emission. 
         [0179]      FIG. 12  further illustrates the construction of device  10  at plane C-C of  FIG. 11 . In this embodiment, fluid infused through channel  38  and vent  41  in outer wall  35  to inflate balloon  40 , exits balloon  40  through vent  45  in outer wall  35  into return channel  39 ( a ), through a luer fitting and flows to a drain or a collection bottle (not separately shown). 
         [0180]    Alternatively fluid return channel  39 ( a ) can empty into a plastic tube which can be clamped shut, as known in the art, when balloon  40  has been inflated, and which can be unclamped and a vacuum applied to empty balloon  40  and channels  38  and  39 ( a ) when the procedure has been completed to enable device  10  to be safely removed from the patient. The distal ends of channels  38 ,  39 ( a ) and  39 ( b ) remain closed by cylindrical plugs  27 . 
         [0181]    Optional end cap  43 , which may be made of metal or a rigid plastic, as shown, is rounded to provide an atraumatic distal end of device  10 . End cap  43  may be blunt, sharp, pointed or of any other desired shape. Circular flange  44  of end cap  43  is fixedly attached between outer wall  35  and inner wall  34  of hollow, double-walled tube  33  by adhesive  26  and effectively plugs the distal ends of channels  38 ,  39 ( a ) and  39 ( b ). 
         [0182]      FIG. 13  illustrates how luer fitting  20 ( a ) enables a sterile, biocompatible fluid to pass through luer fitting  20 ( a ) and opening  48  into passageway  46  in handpiece  14  and flow through channels  37  and  38  of double-walled, hollow tube  33  to cool and clean debris from capillary tube  29  (not separately shown) and cool the Target Tissue. 
         [0183]    Luer fitting  20 ( a ) is fixedly attached to luer tube  47 ( a ) by adhesive  26 . Luer tube  47 ( a ) is attached to handpiece  14  by adhesive  26 , and is in fluid communication through opening  48  with passageway  46  in the body of handpiece  14 . 
         [0184]    As seen in  FIG. 14 , luer fittings  20 ( b ) and  20 ( c ) of device  10  are in fluid communication with double-walled, hollow tube  33 , which has four channels,  37  and  38 , as shown in  FIGS. 13 , and  39 ( a ) and  39 ( b ), as shown in  FIG. 14 . These channels are created by four ribs  36  extending longitudinally through and separating inner wall  34  from outer wall  35  of double-walled, hollow tube  33 . 
         [0185]    Fluid also passes through luer fitting  20 ( b ), which is fixedly attached by adhesive  26  to luer tube  47 ( b ), and flows through opening  48  into channel  39 ( a ) of hollow, double-walled tube  33  and vent  50  (as seen in  FIG. 12 ) in outer wall  35  of double-walled tube  33  to inflate balloon  40  (not separately shown). Excess fluid used to inflate balloon  40  exits balloon  40  through vent  45  (as seen in  FIG. 12 ) in outer wall  35  of double-walled tube  33  and flows out through channel  39 ( b ) and luer fitting  20 ( c ) to a drain (not separately shown). 
         [0186]    Luer tubes  47 ( b ) and  47 ( c ), whose distal ends are cut at an angle or bias, as shown, are attached by adhesive  26  to outer wall  35  of double-walled tube  33 . 
         [0187]    Luer tubes  47 ( b ) and  47 ( c ) are extruded with circular flanges  49 ( a ) and  49 ( b ), respectively, which are fixedly attached by adhesive  26  or other adhesive known in the art to outer wall  35  of hollow, double-walled tube  33  over openings  48  and  51 , respectively, in outer wall  35 , and are in fluid communication with channels  39 ( a ) and  39 ( b ), respectively. Plugs  27  close the proximal ends of channels  39 ( a ) and  39 ( b ), which may comprise adhesive  26  or the like. 
         [0188]    Since luer fittings  20 ( b ) and ( c ) are attached to outer wall  35  of double walled, hollow tube  33 , instead of being attached to handpiece  14 , luer fittings  20 ( b ) and  20 ( c ) and luer tubes  47 ( b ) and  47 ( c ), respectively, do not interfere with the surgeon&#39;s handling of handpiece  14  of side firing device  10 . 
         [0189]    To provide extra support to luer tubes  47 ( a ) and  47 ( b ) and to flanges  49 ( a ) and  49 ( b ), optionally, metal or rigid plastic collar  52  may be attached to outer wall  35  of double-walled tube  33 , flanges  49 ( a ) and  49 ( b ) and the bottom, proximal portion of luer tubes  47 ( b ) and  47 ( c ) by adhesive  26 . 
         [0190]    For ease of use, luer tubes  47 ( a ) and  47 ( b ) and luer fittings  20 ( b ) and  20 ( c ) are disposed on outer wall  35  of double-walled, multichannel tube  33  a desired distance proximally from the proximal end of handpiece  14 . The distal ends of channels  39 ( a ) and  39 ( b ), proximal to luer tubes  47 ( b ) and  47 ( c ), are closed by plugs  27  of adhesive  26  or other adhesive known in the art. 
         [0191]    Any other number of ribs  36  may be used, creating any desired number of fluid channels, and ribs  36  may be positioned at any points, as desired, so long as none are in the path of laser energy emission from capillary tube  29  (not separately shown). 
         [0192]    As mentioned earlier, 350 micron or smaller, thinner walled capillary tube  29  shown in  FIG. 6  can be utilized in any of the embodiments of the present invention shown in  FIG. 2  or  3 . If side firing device  10  is to be used to emit a low level of laser power in a non-aqueous environment or in the absence of cooling liquid spray, it should be used, for example, at about 0.01 to 3 watts. Likewise, capillary tubes  29  with a wall thickness greater than 350 microns, for example, about 400 to 600 microns, can be used in side firing devices  10  if laser energy at higher levels is to be used, for example, at about 20 to 100 watts. 
         [0193]      FIG. 15  illustrates four laser devices  10 ( a - d ). The energy emission pattern  53  and laser energy spot area  31 , resulting from positioning laser energy emission port  18  of side firing device  10 ( a ), without moving device  10 ( a ) or port  18 , while laser energy is emitted at a desired energy level for a desired period of time, in a desired direction. 
         [0194]      FIG. 15  also illustrates larger laser energy emission pattern  53  and larger laser energy spot area  31  resulting from positioning device  10 ( c ) and Moving, by repetitively advancing and withdrawing side firing device  10  and laser energy emission port  18  at a desired rate of movement, from first point  54  to second point  55 , while laser energy at a desired level for a desired period of time is emitted in a desired direction. The rate of Movement, the level of laser energy emitted and the time period of such emission is dependent, in the physician&#39;s discretion, upon the volume and depth of the Target Tissue to be Treated or the Interruption or Altering effect desired to be achieved on the Target Tissue. 
         [0195]      FIG. 15  also illustrates the laser energy emission pattern  53  and laser energy spot area  31 , resulting from positioning side firing device  10 ( c ) and repetitively Rotating device  10  and laser energy emission port  18  through an arc of about 90 to 120°, while laser energy is emitted at a desired level and for a desired period of time, in a desired direction, at a rotation rate of about 0.5 to 2 seconds per cycle, preferably about 1 cycle each second, enabling the surgeon to mentally count, one thousand, two thousand, etc. per arc during the laser energy emission period. 
         [0196]      FIG. 15  also illustrates the larger laser energy emission pattern  53  and larger laser energy spot area  31  obtained by combining the above described Moving and Rotating processes of device  10 ( d ), together or in any desired order or sequence, and Sweeping the laser beam, at a desired level of laser energy, for a desired period of time, while laser energy is emitted in a desired direction, at a desired rate of Movement and Rotation from first point  54  to second point  55 , to Alter a large area or swath of Target Tissue. 
         [0197]    As seen in devices  10 ( a - d ) of  FIG. 15 , laser energy diverges as it exits port  18 , and the laser beam is narrow close to the laser energy&#39;s exit point from port  18 . The benefit of combining the Moving process of device  10 ( c ) with the Rotation process of device  10 ( d ) in the Sweeping process described above as a wide area or swath of Target Tissue is irradiated, resulting in a more uniform shrinkage of a Target Tissue to Treat a Medical Condition of a Patient. 
         [0198]      FIG. 16  illustrates four prior art laser energy delivery devices  10 ( a )-( d ). The four devices  10 ( a )-( d ) each contain optical fiber  12 , which passes through handpiece  14 , is fixedly attached within the proximal or distal end of handpiece  14 , closely fits within (or is fixedly attached by adhesive  26  to) the interior of rigid plastic or metal cannula  15 , which is preferably made of medical grade stainless steel. 
         [0199]    Optical fiber  12  co-terminates at about the distal end of cannula  15 , whose proximal end is fixedly attached within the distal end of handpiece  14 . In each of devices  10 ( a )-( d ), laser energy is emitted from the flat, distal end of optical fiber  12  straight ahead at an angle of 0° from the axis of the optical fiber. 
         [0200]    Alternatively, optical fiber  12  can be removably attached to the proximal end of handpiece  14  by a compression nut (not separately shown) as known in the art, enabling optical fiber  12  to be extended distally from the distal end of cannula  15  for cleaning and, if needed, clipping and cleaving to remove any deformed portion of optical fiber  12 . 
         [0201]    As can be seen, cannula  15  of device  10 ( a ) is straight, to emit laser energy straight ahead at an angle of 0° from the axis of cannula  15 . Cannula  15  of device  10 ( b ) has a bend proximal to its distal end, as shown, at an angle of 20° from the axis of the main body of cannula  15 . Cannula  15  of device  10 ( c ) has a bend proximal to its distal end, as shown, at an angle of 40° from the axis of the main body of cannula  15 , and cannula  15  of device  10 ( d ) has a bend proximal to its distal end at an angle of 60° from the axis of the main body of cannula  15 . Cannula  15  may also have a bend proximal to its distal end of 10°, 30°, 50° or any other desired angle from the axis of the main body of cannula  15 . 
         [0202]    However, depending on the core diameter of optical fiber  12 , the level of laser energy to be transmitted through optical fiber  12  and the temperature at which the cavity or lasing element of the laser is maintained, the radius of the bend must not be less than a certain radius, or leakage of laser energy through the quartz or fused silica cladding (not separately shown), which surrounds optical fiber  12 , may occur. The cladding may contain a dopant, such as fluorine to lower its refractive index. 
         [0203]    Escaping laser energy may cause cannula  15  to overheat and cause damage to cannula  15  and the instrument channel and optics of an endoscope (not separately shown), through which cannula  15  may be used. For example, if the cavity or lasing element (not separately shown) of the source of laser energy  11  is cooled by a heat exchange device (not separately shown) to a temperature of about 2 to 5° C., if optical fiber  12  has a core diameter of 365 microns and 10 watts of Holmium laser energy is to be transmitted through optical fiber  12 , the bend radius must not be less than 1 cm. 
         [0204]    If the cavity or lasing element (not separately shown) of the source of laser energy  11  is cooled by a chiller (not separately shown) to a temperature close to freezing, about 0° C., if optical fiber  12  has a core diameter of 365 microns and 10 watts of Holmium laser energy is to be transmitted through optical fiber  12 , the bend radius must not be less than 1.5 cm. As a result, bends in the distal end portion of cannula  15  must be made at a shallow angle. 
         [0205]    While there is no button  17  on handpiece  14  of the 0° emitting or straight cannula  15 , cannulas  15  bent at angles of 20°, 40°, 60°, as shown, or at any other desired angles, have button  17  on the side of handpiece  14  opposite from the direction of the bend, so the surgeon knows in what direction cannula  15  is being extended and the direction of laser energy emission. Button  17  should be raised and have a color different from that of handpiece  14 , so it can be seen and be recognized by tactile feel by the surgeon. 
         [0206]    Devices  10 ( a )-( d ) of  FIG. 16  may be used where it is impractical to deliver laser energy from any of the side firing devices  10  described in  FIG. 1-5 ,  7 ,  9  or  11 . While Devices  10 ( a - d ) of  FIG. 16  are prior art devices, their use in the Stationing, Moving, Rotating and Sweeping methods, described above, to shrink a Target Tissue to treat a Medical Condition are novel and unique to the practice of the present invention. 
         [0207]    A disadvantage of prior art devices  10  of  FIG. 16  is they have no provision for delivering a sterile, biocompatible fluid to cool and clean the distal end of optical fiber  12  and cool the Target Tissue, as the devices  10  of  FIG. 16  are typically used in an aqueous Environment, such as sterile water or saline. As a result, if side firing devices  10  of  FIG. 1-5 ,  7 ,  9  or  11  or devices  10  of  FIG. 16  are used in air or a CO 2  Environment, for example, in a laparoscopic or endoscopic procedure, a much lower level of laser power, 0.05 to 10 watts, preferably 0.1 to 3 watts, should be used to prevent excessive heating, coagulation or charring of the Target Tissue and thermal damage to adjacent tissues. 
         [0208]      FIG. 17  illustrates the solution to the problem described above with respect to  FIG. 16 , and represents an improved version of prior art devices  10 ( a )-( d ) of  FIG. 16 . In this embodiment of the present invention, cannula  15  of devices  10 ( a - d ) can be made of a thin, rigid metal, preferably medical grade stainless steel, for use under x-ray guidance through a body orifice, hollow organ, surgically created passageway or in a laparoscopic procedure, positioned and guided by an endoscope (not separately shown), through which cannula  15  may be inserted, or the endoscope may be inserted through a separate puncture. 
         [0209]    Alternatively, cannula  15  of devices  10 ( a - d ) can be made of a thin, flexible biocompatible plastic (not separately shown), for use through a flexible, articulated endoscope (not separately shown) or an endoscope of which the distal 5 to 15 cm may be bent or articulated at a described angle by wires (not separately shown) extending from a handpiece (not separately shown) to the distal end of the endoscope. 
         [0210]    Preferably, devices  10 ( a )-( d ) are made of a flexible memory metal, such as nitinol, an alloy of about 56% nickel and about 44% titanium by weight, such as those made by Memry, Inc. of Bethel, Conn., which are heat treated to “remember” their heat treated shape, to which they return after being straightened-out, for example, by passing through the instrument channel of an endoscope. Some semi-rigid plastics may also retain the memory of their initially molded shape, and can be used in devices  10 ( a )-( d ). 
         [0211]    In the embodiments of devices  10 ( a )-( d ) of the present invention shown in  FIG. 17 , luer fitting  20  is fixedly attached within the wall of handpiece  14  and is in fluid communication with hollow passageway  46  in handpiece  14 , as described in  FIG. 14 , and is in fluid communication with the space between the exterior of optical fiber  12  and the interior of cannula  15 , creating fluid channel  47 , enabling a sterile, bio-compatible fluid, such as saline or water, to be infused through fluid channel  47  to clean and cool the distal end of optical fiber  12  and to cool the Target Tissue, concomitantly with the delivery of laser energy. 
         [0212]    Optical fiber  12  is fixedly attached within the proximal end of handpiece  14 , the proximal end of cannula  15 , is fixedly attached within the distal end of handpiece  14  and luer fitting  20  can be fixedly attached to and in fluid communication with passageway  46  in handpiece  14 , and fluid channel  47 , as shown in  FIG. 17 . Likewise, collar  52  as described in  FIG. 14 , can be used to support and prevent damage to luer fitting  20 , if luer fitting  20  is attached to cannula  15 , as described above. 
         [0213]    As can be seen, devices  10 ( a )-( d ) of  FIG. 17  have bends at the same angles as devices  10 ( a )-( d ) of  FIG. 16 . Again, such bends and others at any other desired angles may be employed, subject to the bend radius limitation described above. 
         [0214]    The embodiments of devices  10 ( a )-( d ) of the present invention shown in  FIG. 17  can be used in the positioning, Moving, Rotating and/or Sweeping processes described above, individually or in any combination or sequence. The use of devices  10 ( a )-( d ) shown in  FIG. 17  are beneficial in instances where the use of side firing devices  10  of the present invention shown in  FIG. 1-5 ,  7 ,  9  or  11  is difficult or impractical. 
         [0215]    Alternatively, luer fitting  20  may be attached to cannula  15 , distal to handpiece  14 , as described in  FIGS. 13 and 14 , and luer fitting  20  may optionally be supported by collar  52 , as described in  FIG. 14 . 
         [0216]    The “working” length of devices  10  of  FIG. 1-5 ,  7 ,  9 ,  11 , or  17  are typically 15 cm to 80 cm in length, extending distally from the distal end of handpiece  14 . 
         [0217]    All of the side firing devices  10  of the present invention described in  FIG. 1-5 ,  7 ,  9  or  11  may be utilized with or without rigid plastic or metal cannula  15 , with or without double-walled, hollow tube  33 , or with or without collar  52  to support luer fitting  20 . These appurtenances, and the thinner walled capillary tube  29  of  FIG. 4 , are to enable any or all of the above embodiments of the present invention to better accomplish their desired purpose. 
         [0218]    While the aforementioned laser energy emission patterns  53  and laser energy spot areas  31  are described as resulting from the emission of laser energy, any other Thermal Energy delivery device may be used in any of the above-described processes of positioning, Moving, Rotating and/or Sweeping the Thermal Energy delivery device, alone or in any desired combination and in any desired sequence or order, to shrink a Target Tissue to Treat a Medical Condition of a Patient. 
         [0219]    The uses of device  10  of  FIGS. 1-5 ,  7 ,  9 ,  11 ,  16  and  17  of the present invention are shown in some of  FIGS. 21-25  below and are intended to illustrate the methods of use of this invention in Treating a Medical Condition of a Patient. All of devices  10  illustrated in  FIGS. 1-5 ,  7 ,  9 ,  11 ,  16  and  17  have a common purpose, namely to efficiently and uniformly shrink Target Tissues to Treat a Medical Condition, when used by the methods of use described above. 
         [0220]      FIG. 18  illustrates the elements of the female reproductive System  60 . Uterus  61  is held in place by round ligaments  62 . The termination points  63  of round ligaments  62  are also shown. Uterus  61  is also held in place by broad ligaments  64 , which terminate at peritoneum  65 , defining the bottom of the abdominal cavity. 
         [0221]    Vagina  66 , cervix  67 , fallopian tube  68  and ovary  69  are also shown. 
         [0222]    Any of side firing devices  10  or  FIG. 1-3 ,  5  or  7  may be inserted through a puncture in the abdomen, up to broad ligaments  64  or round ligaments  62 , observed by a laparoscope inserted through a separate puncture in the abdomen, or inserted through the instrument channel of an endoscope, inserted through a puncture in the abdomen. Adjacent tissues may be moved away by one or more blunt or round-ended obturators, which are inserted through one or more separate punctures in the abdomen. 
         [0223]    As shown, device  10  of  FIG. 1-3 ,  5  or  7  may be Moved and advanced or withdrawn, Moved to the left or right and Rotated, concomitantly or in any desired sequence, to Sweep Holmium laser energy beam  31  (or other Source of Thermal Energy) over and shrink broad ligaments  64 , as indicated by arrows  19 . During lasing, a cooling fluid, such as sterile water or saline, should be infused through device  10 , or through a separate cannula or needle, a laparoscope or an endoscope (none of which are separately shown). 
         [0224]    Also as shown, any of devices  10 ( a - d ) of  FIG. 16  or  17 , preferably those of  FIG. 17 , as they have a fluid channel to cool the Target Tissue, may be inserted, as described above, and device  10  and Holmium laser beam  31  (or other laser beam) may be Moved, as shown by arrows  19 , to Sweep laser energy beam  31  along and Alter by shrinkage round ligaments  62 . 
         [0225]    If a cooling fluid is not infused through device  10 , a cooling fluid may be infused through a laparoscope, endoscope, cannula or needle, as described above. In the absence of a cooling liquid to cool the Target Tissue, only low levels of laser energy should be used, for example, about 0.1 to 3 watts. 
         [0226]    Shrinkage of both of round ligaments  62  and both of broad ligaments  64  lifts uterus  61  and Treats (reduces or eliminates) female stress urinary incontinence or “FSUI”. 
         [0227]    In  FIG. 19 , sections of heart  70  show the left ventricle  71 ( a ) and right ventricle  71 ( b ). Chordae tendinae  72 ( a ) extend from anterior papillary muscle  73 ( a ) and posterior papillary muscle  73 ( b ) and terminate at anterior cusps  74 ( a ) and posterior cusps  74 ( b ) of the aortic valve, chordae tendinae  72 ( b ) extend from anterior papillary muscle  73 ( c ) and posterior papillary muscle  73 ( d ) to anterior cusps  75 ( a ) and posterior cusps  75 ( b ) of the mitral valve, and chordae tendonae  72 ( c ) extend from anterior papillary muscle  73 ( e ) and posterior papillary muscle  73 ( e ) to anterior cusps  86 ( a ) and posterior cusps  86 ( b ) of the tricuspid valve. 
         [0228]    Also shown are aorta  87 , right auricle  88 ( a ) and left auricle  88 ( b ), and the openings to the coronary arteries  89 . 
         [0229]    The optimal time to apply Holmium laser energy (or other Thermal Energy) to shrink the chordae tendinae  82 ( a )-( c ) to Treat a prolapsed mitral, aortic or tricuspid heart valve, respectively, is during systole, when papillary muscles  83 ( a - d ) are relaxed, releasing tension on chordae tendonae  82 ( a )-( c ), respectively, as these tendons shrink to a greater degree when not under tension, as described heretofore. 
         [0230]    However, if only about 10% shrinkage of chordae tendinae  82 ( a ), ( b ) or ( c ) is desired, they may be shrunk during diastole, when papillary muscles  83 ( a - d ) contract and joint chordae ( a - c ) under tension. 
         [0231]    Preferably, this procedure is performed during bypass surgery or other open-heart procedure, before the heart is arrested, observed by color Doppler ultrasound imaging, as described heretofore. After shrinking chordae  82 ( a ), ( b ) or ( c ), depending on which valve is prolapsed, after shrinking of the appropriate chordae  82 ( a ), ( b ) or ( c ), if blood is still seen leaking from a prolapsed valve, laser energy emission port  18  of device  10  may be withdrawn to the top of the valve, called the annulus (not separately shown), to shrink the annulus and help stop the leaking. 
         [0232]      FIG. 20  illustrates stomach  90 , esophageal sphincter  91  of esophagus  92 , pyloric valve sphincter  93  of pyloric valve  94  and duodenum  95 . Any of side firing devices  10  of  FIG. 1-5 ,  7 ,  9  or  11  may be disposed within a gastroscope (not separately shown) and advanced up to sphincter  91  of esophagus  92  and/or sphincter  93  of the pyloric valve  94 . Preferably, device  10  of  FIG. 9  or  11  should be used, as these devices have a round or concentrically shaped balloon  40 , an eccentrically shaped balloon  40 , or a back mounted balloon  40 , to (a) center laser energy emission port  18  of device  10  in esophageal sphincter  91  and/or pyloric valve  94 , to bring the laser energy emission port  18  of device  10  close to esophageal sphincter  91  and/or pyloric valve sphincter  93 , or (c) press the energy emission port  18  of device  10  very close to esophageal sphincter  91 , and/or pyloric valve sphincter  93 , respectively. 
         [0233]    As described above, balloon  40  may be inflated and device  10  may be positioned and aimed to emit Holmium laser energy (or any other Thermal Energy), for example, at 3 o&#39;clock and, while laser energy is emitted, with concomitant infusion of a cooling fluid, as described above, device  10  is Rotated through an arc of about 90°, from about 1:30 to 4:30 o&#39;clock and back, at the rate of about one arc per second. The balloon is deflated and device  10  is positioned and aimed to emit laser energy, for example, at 6 o&#39;clock, the balloon is inflated and, while laser energy is emitted, with concomitant infusion of a cooling fluid, device  10  is Rotated through an arc of about 90°, from about 4:30 to 7:30 o&#39;clock, and back. After which this balloon inflation, positioning, aiming, lasing and balloon deflation process is repeated with device  10  Stationed and aimed, successively, at 9 o&#39;clock and then at 12 o&#39;clock. 
         [0234]    The above positionings and aimings can be made in any designed sequence to shrink sphincters  91  and/or  93 . Also, instead of four cycles of 90° each, three cycles of 120° each, two cycles of 180° each, or any other number and length of cycles may be used. 
         [0235]    If device  10  is Rotated through an arc greater than 90°, balloon  40  may be damaged. Alternatively, the proximal and distal ends of balloon  40  may be attached to a circular gasket (not separately shown), which maintains a water tight seal with and is moveably disposed between two ridges (not separately shown) on the exterior of device  10 . This enables device  10  to be Rotated within balloon  40 , through an arc greater than 90°, without damaging balloon  40 , and without having to successively inflate and deflate balloon  40  in the positioning, aiming and lasing process. 
         [0236]    Preferably, during the emission of laser energy, the infusion of an irrigation fluid, such as sterile water or saline, infused through the gastroscope, as well as through device  10  to flush debris from and cool the optical components of device  10  and cool the Target Tissue. This enables 3 to 40 watts of Holmium laser power, preferably about 5 to 20 watts, to be used in each of sphincter  91  and/or  93 , whichever it is desired to Treat. 
         [0237]    Tightening esophageal sphincter  91  reduces or prevents acidic liquids from stomach  80  to enter and erode esophagus  92  to Treat gastro-esophageal reflux disease or “GERD”. 
         [0238]    Tightening sphincter  93  causes a reduction in the volume of food released from stomach  90  into duodenum  95 . Retaining food in stomach  90  maintains the feeling of fullness or satiety, the patient ceases eating and weight is lost or, at least, weight gain is reduced or prevented. 
         [0239]    Reducing weight (and exercising) has been shown to reduce or eliminate Type 2 diabetes, which affects millions of people throughout the world, causes a variety of adverse effects and is a major cost to the healthcare system, as described above. 
         [0240]    If no cooling fluid is infused, much lower levels of laser energy for shorter periods of time is required to avoid damage to sphincters  91  and  93 , as well as adjoining tissues, as described heretofore. 
         [0241]    As described in co-owned U.S. Pat. No. 6,635,052, which is fully incorporated herein by reference, one or more needles, with sharp or syringe-like distal ends (not separately shown), composed of a resilient material, such as a memory metal or Nitinol, which, when straightened during passage through the instrument channel of an endoscope or a lumen of a rigid, semi-rigid or flexible cannula  15 , resumes their initial bent shape, for example, of about 70° to 90°. Each needle contains an optical fiber and may be inserted into esophageal sphincter  91  and/or pyloric valve sphincter  93  to Alter by shrinkage sphincters  91  and/or  93 . 
         [0242]    Whereas, in the present invention, shrinkage of a Target Tissue to Treat a Medical Condition is accomplished externally, without insertion of devices  10  of  FIG. 1-5 ,  7 ,  9  or  11  into sphincters  91  and/or  93 . 
         [0243]    As described in co-owned U.S. Pat. No. 6,740,107, which is fully incorporated herein by reference, the distal end portion of a side firing optical fiber device is contained within an eccentrically shaped balloon, which is inserted into the femoral artery in the groin and is moved through a conventional guiding catheter into the left ventricle to treat mitral valve prolapse. The eccentricity of the balloon, when inflated by the infusion of a radioopaque fluid, enables the cardiologist by x-ray imaging to determine the direction of laser energy emission. 
         [0244]    Whereas, in the present invention, devices  10  of  FIG. 1-5 ,  7 ,  9  or  11  are designed for Treating heart valve prolapse during open heart surgery or bypass surgery, and are not designed for insertion into the femoral artery in the groin and being advanced through a guiding catheter into a ventricle of the heart to treat valve prolapse in a percutaneous procedure under x-ray imaging, which requires a device  10  with a much longer working length than 80 cm. 
         [0245]      FIG. 21(   a ) illustrates the male penis  100 , urethra  101  and urethral sphincters  102 . Any of rigid side firing devices  10  of  FIG. 1-5 ,  7 ,  9  or  11  may be disposed in a rigid endoscope which is lubricated and inserted into urethra  101  of penis  100 . Device  10  is extended from the instrument channel of the endoscope and is Stationed opposite urethral sphincter  102 . While Holmium laser energy (or other Source of Thermal Energy) is emitted, device  10  is Rotated, as described above, while a cooling fluid of sterile saline or water is infused through the endoscope, as well as from device  10  to clean and cool the optical components of device  10  and to cool the Target Tissue. If no cooling fluid is infused, an extremely low level of laser energy must be used, as described above. 
         [0246]    The Alteration of urethral sphincter  102  by shrinkage is performed to Treat male urinary incontinence. 
         [0247]      FIG. 21(   b ) illustrates the female urinary system  110 . Bladder  111 , urethra  112  and sphincters  113  are shown. To Treat female urinary incontinence, the same procedure described with respect to  FIG. 21(   a ) is performed to Alter by shrinkage urethra  102 , as described above. 
         [0248]      FIG. 22 , illustrates the male or female rectal system  120 . Any of rigid, side firing devices  10  of  FIG. 1-5 ,  7 ,  9  or  11  may be disposed in the instrument channel of a rigid endoscope (not separately shown), which is lubricated and inserted into anus  121  and is advanced up to rectal sphincter  122 . Side firing device  10  is extended from the endoscope and positioned opposite rectal sphincter  122 . While Holmium laser energy (or other Thermal Energy) is emitted, accompanied by infusion of sterile water or saline through the endoscope, as well as device  10 , for the reasons set forth above, device  10  is Rotated to Alter by shrinkage rectal sphincter  122  at one or more o&#39;clock positions, as described above. 
         [0249]    Then, the endoscope is withdrawn to just proximal to anal sphincter  123 , and the above described procedure is repeated. Of course, anal sphincter  123  may be shrunk before rectal sphincter  122  is shrunk, if so desired by the surgeon. 
         [0250]    As seen in  FIG. 22 , for example, side firing device  10  of  FIG. 9  or  11 , with a concentric, inflated balloon, centers side firing device  10  in anal sphincter  123 . While Holmium laser energy (or other Thermal Energy) is emitted, side firing device  10  is Rotated, as described above, and cooling fluid, such as sterile water or saline, is infused through endoscope, as well as through device  10 , for the reasons set forth above, to Alter by shrinkage sphincters  122  and  123  to Treat male or female fecal incontinence. Of course, anal sphincter  123  can be shrunk before rectal sphincter  122 . 
         [0251]    While this invention is susceptible of embodiment in many different forms, these are shown in the drawings and will be described in detail herein specific embodiments thereof, with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not to be limited to the specific embodiment illustrated. 
         [0252]    Numerous variations and modifications of the embodiments described above can be effected without departing from the spirit and scope of the novel features of the invention. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims, all such modifications as fall within the scope of the claims.