Patent Abstract:
The invention provides a method and system for treating disorders in parts of the body. A particular treatment can include on or more of, or some combination of: ablation, nerve modulation, three-dimensional tissue shaping, drug delivery, mapping stimulating, shrinking and reducing strain on structures by altering the geometry thereof and providing bulk to particularly defined regions. The particular body structures or tissues can include one or more of or some combination of region, including: the bladder, esophagus, vagina, penis, larynx, pharynx, aortic arch, abdominal aorta, thoracic, aorta, large intestine, sinus, auditory canal, uterus, vas deferens, trachea, and all associated sphincters. Types of energy that can be applied include radiofrequency, laser, microwave, infrared waves, ultrasound, or some combination thereof. Types of substances that can be applied include pharmaceutical agents such as analgesics, antibiotics, and anti-inflammatory drugs, bulking agents such as biologically non-reactive particles, cooling fluids, or dessicants such as liquid nitrogen for use in cryo-based treatments.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a division of U.S. patent application Ser. No. 09/407,658, filed Sep. 28, 1999. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    This invention relates to treating body tissue, particularly to treating body tissue by altering the shape, density, relative geometry or tension of that body tissue using energy or substances deployed from an interstitial location in the body.  
           [0004]    2. Related Art  
           [0005]    Urinary incontinence results from a number of factors. Increasing age, injury from childbirth and related stresses can cause the relative tone of the bladder and accessory muscles to weaken, which, in turn, causes an impaired inability to retain urine. Weight gain and overall deterioration of muscle tone can cause increased abdominal pressure which overcomes sphincter resistance. Nerve pathways that cause the “urge” to urinate can be hyperactive. The relative tension of the urethra can change with age, causing poor urinary control. Injury to the detrusor muscles or to the trigone area also results in impaired urinary continence.  
           [0006]    These factors do not usually occur by themselves. The typical patient usually presents with two or more of them. Therefore, it is desirable to provide a treatment that can address many of these factors.  
           [0007]    Given the complex etiology of varied causal factors, the ideal treatment for urinary incontinence requires a device that can perform many different functions. For example, a treatment for female urinary incontinence might rely upon some or all of the following:  
           [0008]    (1) reshaping the bladder to alter the urethro-vesical angle and re-suspend the bladder neck, (2) manipulation of the detrusor muscles, (3) mapping and modulating nervous pathways responsible for urinary urgency, (4) reducing strain on he bladder neck by changing the structural geometry, (5) shrinking discrete and non-discrete areas of the bladder by creating thermal lesions, (6) three-dimensional modeling of tissue by adding bulk so as to achieve better closure, (7) strengthening the structure integrity of a tissue by providing a pattern of scar tissue, and (8) application of pharmaceutical agents both as a curative and to promote healing post treatment.  
           [0009]    The use of a catheter to apply radio frequency (RF) and other types of energy to ablate tissue in the body (such as heart muscle tissue) is known in the art of cardiac treatment. However, known systems using RF and other types of energy are still subject to several drawbacks.  
           [0010]    A first problem in the known art involves providing a device that can perform all of the aforementioned functions. While known systems can perform one or more of these functions, nothing in the related art is capable of performing all of these functions. Patients are frequently required to return for multiple treatments until a cure is finally effected.  
           [0011]    A second problem in the known art involves identification, modulation and/or stimulation of nerves in a targeted tissue. Known systems do not provide for protection of sensitive nerves during treatment or allow nerves during treatment or allow nerves to be identified and stimulated. This is particularly problematic because many tissue disorders, especially those involving tone or contractile ability of a sphincter, arise from afferent and efferent nerves are either under-stimulated or over-stimulated.  
           [0012]    A third problem in the known art involves providing a treatment surface that can reach all of the desired treatment areas, such as the entire surface of the detrusor muscles. While the use of a catheter to deploy energy is known, none is disposed to flexibility adapt to the interior shape of an organ so as to provide optimal uniform treatment.  
           [0013]    A fourth problem is the known art involves removal of tissue and substances used in treatment. Known systems do not provide for removal of excess substances used in treatment such as cooling fluids, collagen or bulking substances. Similarly, known systems do not provide for removal of substances that hinder or otherwise obstructs the healing process such as pus, purulent discharges, suppuration and pockets of infection.  
           [0014]    A fifth problem in the known art involves directing and positioning the electrodes in the body cavity orifice. Difficulties in accurately positioning the electrodes in the target orifice detract from treatment. Frequently; unhealthy tissue remains untreated while healthy tissue is compromised. Difficulties in directing and positioning the electrodes are particularly problematic because one of the goals of treatment is to minimize collateral damage to healthy tissue and to completely treat diseased tissue.  
           [0015]    A sixth problem in the known art involves minimizing thermal injury to the patient. Some known systems rely upon simultaneous application of energy and infusion of a cooling liquid into the targeted area for treatment. While such infusion of liquid minimizes thermal injury to the patient, it is not applicable to all parts of the body. For example, infusion of cooling liquids into an internal body cavity such as a bladder, uterus, or stomach can rupture the targeted organ or cause osmotic imbalance within the tissue.  
           [0016]    A seventh problem in the known art involves difficulty in the simultaneous use of complimentary technology. Known systems do not provide for optimal, simultaneous use of auxiliary tools for visualization, monitoring pH and pressure or drug administration.  
           [0017]    An eighth problem in the known art is that it can be difficult to block the flow of body fluids and gases into an area of the body where tissue ablation is taking place. Bodily fluids can dissipate and detrimentally absorb the energy to be applied to the tissue to be ablated. Dissipation of bodily fluids detracts from the goal of treatment of diseased tissue.  
           [0018]    Accordingly, it would be advantageous to provide a method and apparatus for treatment or body structures, especially internal body structures involving unwanted features or other disorders, that does not require relatively invasive surgery, and is not subject to other drawbacks noted with regard to the known art. This advantage is achieved in an embodiment of the invention in which a relatively minimally invasive catheter is inserted into a body, a variety of different treatments of the body structures is applied using electrodes and a cooling element, and the unwanted features or disorders are relatively cured.  
         SUMMARY OF THE INVENTION  
         [0019]    The invention provides a method and system for treating disorders of the genitourinary tract and other disorders in other parts of the body. A particular treatment can include one or more of, or some combination of ablation, nerve modulation, three-dimensional tissue shaping, drug delivery, mapping, stimulating, shrinking (by creation of a pattern of thermal lesions) and reducing strain on structures by altering the geometry thereof and providing bulk to particularly defined regions.  
           [0020]    The particular body structures or tissues can include one or more of, or some combination of regions, including the bladder, esophagus, vagina, penis, larynx, pharynx, aortic arch, abdominal aorta, thoracic aorta, large intestine, small intestine, sinus, auditory canal, uterus, vas deferens, trachea and all associated sphincters.  
           [0021]    In one aspect of the invention, a catheter is deployed in the body. It may enter the body via orifice, a stoma, or surgically created opening that is made for the purpose of inserting the catheter. Insertion may be facilitated with the use of a guide or wire or a generic support structure or visualization apparatus.  
           [0022]    In a second aspect of the invention, the treatment can include application of energy and substances to effect changes in the target tissue. Types of energy that can be applied include radio frequency, laser, microwave, infrared waves, ultrasound or some combination thereof. Types of substances that can be applied include pharmaceutical agents such as analgesics, antibiotics and anti-inflammatory drugs, bulking agents such as biologically nonreactive particles, cooling fluids, and dessicants such as liquid nitrogen for use in cryo-based treatments. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0023]    [0023]FIG. 1 is a block drawing of a system for treatment of female urinary incontinence using a first device;  
         [0024]    [0024]FIG. 2 is a process flow drawing of a method for treatment of female incontinence using a first device;  
         [0025]    [0025]FIG. 3 is a block drawing of a system for treatment of female urinary incontinence using a second device;  
         [0026]    [0026]FIG. 4 is a process flow drawing of a method for treatment of female urinary incontinence using a second device;  
         [0027]    [0027]FIG. 5 is a block drawing of system for treatment of female urinary incontinence using a third device; and  
         [0028]    [0028]FIG. 6 is a flow drawing of a method for treatment of female urinary incontinence using a third device.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0029]    In the following description, a preferred embodiment of the invention is described with regard to referred process steps and data structures. Embodiments of the invention can be implemented using general-purpose processors or special purpose processors operating under program control, or other circuits, adapted to particular process steps and data structures described herein. Implementation of the process steps and data structures described herein would not require undue experimentation or further invention.  
         [0030]    System Elements  
         [0031]    [0031]FIG. 1 is block drawing of a system for treatment of female urinary incontinence using a first device.  
         [0032]    A system  100  includes a catheter  110 , a treatment element  114 , a control assembly  130  and a shielding element  140 . In an alternate embodiment, the shielding element  140  is not present.  
         [0033]    The Catheter  
         [0034]    The catheter  110  includes a distal segment  111  and a proximal segment  112  The distal segment  111  and proximal segment  112  form one continuous piece. Two or more lumens  113  (not shown) run the entire interior length of the catheter  110  and are coupled to the control assembly  140 . It is through these lumens  113  that energy is conducted and flowable substances are exuded.  
         [0035]    The distal segment  111  includes a treatment element  114  and a tapered tip  115 . In a preferred embodiment, the tapered tip  115  is rigid so as to allow easy insertion into a urethra. In other preferred embodiments, the tapered tip  115  may be of varying degrees of flexibility depending where it is in the body it is deployed. In alternative embodiments, the catheter  110  may be introduced into the target tissue using an introducer sheath  116  or guide wire  117  (not shown). The most distal end of the tapered tip  115  includes an aperture  118 . Substances that flow through the lumens  113  may be applied to the tissue through this aperture  118 .  
         [0036]    In the preferred embodiment, the distal segment  111  is disposed for insertion into a cavity of the body such as a female urethra and bladder. In alternative embodiments, the cavity may include one or more of, or some combination of the following:  
         [0037]    any portion of the bronchial system, the cardiovascular system, the genito-urinary tract, the lymphatic system, the pulmonary system, the vascular system, the locomotor system, the reproductive system or other systems in the body; any biological conduit or tube, such as a biologic lumen that is patent or one that is subject to a stricture;  
         [0038]    any biologic operational structure, such as a gland, or a muscle or other organ (such as the colon, the diaphragm, the heart, a uterus, a kidney, a lung, the rectum an involuntary or voluntary sphincter);  
         [0039]    any biologic structure, such as a herniated body structure, a set of diseased cells, a set of dysplastic cells, a surface of a body structure, (such as the sclera) a tumor, or a layer of cells (such as fat muscle or skin); and  
         [0040]    any biologic cavity or space or the contents thereof, such as a cyst, a gland, a sinus, a layered structure, or a medical device implanted or inserted into the body.  
         [0041]    The Treatment Element  
         [0042]    The treatment element  114  includes a set of curvilinear electrodes  119  and three sets of irrigation and aspiration ports  124 .  
         [0043]    The electrode  119  contained in the set of electrodes are evenly spaced around the tapered tip  115 . Each electrode  119  includes a metallic tube  120  defining a hollow lumen  121  and is disposed so that it curves away from the tapered tip  115  and has a barbed end, much like a fishhook. Being arced in this direction allows the device to be inserted easily into an orifice without causing unintended tissue damage. Once the device is inserted, the barbed ends of electrodes  119  grab the tissue of the bladder neck and upper urethra in a claw-like manner and bunch it together. Energy is delivered through the electrodes to the bunched tissue, causing shrinkage to occur in the area surrounding the treatment element  114 . This three dimensional shaping improves continence by improving the structural integrity of the tissue.  
         [0044]    In a preferred embodiment, there are four electrodes  119 . Other preferred embodiments may have more or less than four electrodes. Each electrode  119  is coupled to at least one sensor  122  capable of measuring such factors as temperature, conductivity, pressure, impedance and other variables. In a preferred embodiment, each electrode is also coupled to a radiopaque marker  123  for use in fluoroscopic visualization.  
         [0045]    In a preferred embodiment, the electrodes  119  can be operated separately or in combination with each other. Treatment can be directed at a single area or several different areas of a bladder or other orifice by operation of selective electrodes. Different patterns of sub-mucosal lesions, mucosal lesions, ablated, bulked, plumped desiccated or necrotic regions can be created by selectively operating different electrodes. Production of different patterns of treatment makes it possible to remodel tissues and alter their overall geometry with respect to each other.  
         [0046]    Each electrode  119  can be disposed to treat tissue by delivering one or more of, or some combination or any of the following in either a unipolar or bipolar mode:  
         [0047]    Radiofrequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range;  
         [0048]    Chemical treatments, such as acids, antibiotics enzymes, radioactive tracers or other bioactive substances;  
         [0049]    Infrared energy, such as from an infrared laser or diode laser;  
         [0050]    Microwave energy, such as electromagnetic energy in about the 915 megahertz or 2.45 gigahertz range;  
         [0051]    Sonic energy, including ultrasound;  
         [0052]    Photodynamic therapy (PDT)  
         [0053]    Non-infrared laser energy  
         [0054]    Cryothermia  
         [0055]    In addition to treating tissues by delivering energy, the set of electrodes  119  are disposed to delivery at least one flowable substance to the area of the body where treatment is to take place. In a preferred embodiment, the flowable substance includes water which aids in cooling of body structures during RF application. However, in alternative embodiments, the deliverable flowable liquids include other substances, including saline, anesthetic drugs, anti-inflammatory agents, chemotherapeutic agents, systemic or topical antibiotics, collagen and radioactive substances such as labeled tracers. In one alternative embodiment, saline is used to increate the local conductivity of tissue, enhancing the penetration of RF energy so as to create larger lesions. The saline can be delivered through the needle submucosally so as to achieve greatest effect.  
         [0056]    Three rings of irrigation and aspiration ports  124  circle the distal end of the catheter  110 . Each ring contains numerous irrigation and aspiration ports  124 , evenly distributed around the width of the catheter. One ring of irrigation and aspiration ports  124  lies between the aperture  118  and the set of electrodes  119 ; the other two rings of irrigation and aspiration ports  124  are located on the proximal side of the electrodes  119 . Application of positive pressure makes irrigation and cooling of tissues is possible. Alternatively, application of negative pressure causes the tissue to be uniformly conformed around the treatment element  114 , thereby achieving the most optimal therapeutic value of the energy and substances.  
         [0057]    The Control Assembly  130   
         [0058]    The control assembly  130  includes a visualization port  131 , an apparatus port  132 , an electrical energy port  133 , an electrode selection and control switch  134 , one or more irrigation and aspiration control ports  135 , an therapeutic energy port  136  and a handle  137 .  
         [0059]    The visualization port  131  can be coupled to visualization apparatus, such as fiberoptic device, flouroscopic device, an oscope, a laparoscope or other type of catheter.  
         [0060]    The apparatus port  132  can be coupled to other medical devices that may be useful during treatment such as a pH meter, a pressure monitor, drug administration apparatus, or other device used to monitor or treat the patient.  
         [0061]    In a preferred embodiment, devices coupled to both the visualization port  131  and the apparatus ports  132  are controlled from a location outside the body, such ss by an instrument in an operating room or an external device for manipulating the inserted catheter  110 .  
         [0062]    In an alternative embodiment the apparatus port  132  may be coupled to devices that are implanted or inserted into the body during a medical procedure. For example, the apparatus port  132  may be coupled to a programmed AICD (artificial implanted cardiac defibrillator), a programmed glandular substitute (such as an artificial pancreas) or other device for use during surgery or other medical procedures.  
         [0063]    The electrical energy port  133  includes conductive element such as an electrical adapter that can be coupled to a source of alternating or direct current such as a wall socket, battery or generator.  
         [0064]    The electrode section and control switch  134  includes an element that is disposed to select and activate individual electrodes  119 .  
         [0065]    The irrigation and aspiration control ports  135  can be coupled to a pump or other apparatus to deliver fluid through the aperture  118  or apply suction through the set of irrigation and aspiration ports  134 .  
         [0066]    The therapeutic energy port  136  includes a receptor port for coupling to a source of any of the following types of therapeutic energy:  
         [0067]    radiofrequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range;  
         [0068]    chemical treatments, such s acids, antibiotics, enzymes, radioactive tracers or other bioactive substances;  
         [0069]    infrared energy, such as from an infrared laser or diode laser;  
         [0070]    microwave energy, such as electromagnetic energy in about the 915 megahertz or 2.45 gigahertz range;  
         [0071]    sonic energy, including utrasound;  
         [0072]    photodynamic therapy (PDT);  
         [0073]    non-infrared laser energy; and  
         [0074]    cryothermia  
         [0075]    The handle  137  is disposed for manipulation by medical or veterinary personnel and can be shaped for being held in the hand. The visualization port  131 , the apparatus port  132 , the electrical energy port  133 , the electrode selection and control switch  134  and the one or more irrigation and aspiration control ports  135  and the therapeutic energy port  136  are all mounted in the handle  137  to allow for easy operation.  
         [0076]    The Shielding Element  
         [0077]    The shielding element  140  lies on the proximal side of treatment element  114  and is disposed to isolate the treatment area. It can also help position the catheter  110  in the body. For example, in a preferred embodiment in which the catheter  110  is inserted into the urethra, the shielding element  140  can prevent the catheter  110  from being inserted further into the urethral canal and prevent substances used in treatment from escaping. In an alternative embodiment, the shield element  140  is optional.  
         [0078]    [0078]FIG. 2 is a process flow drawing of a method for treatment of female urinary incontinence using a first device.  
         [0079]    A method  200  is performed by a system  100 , including a catheter  110  and a control assembly  140 . Although the method  200  is described serially, the steps of the method  200  can be performed by separate elements in conjunction or in parallel, whether asynchronously, in a pipelined manner, or otherwise. There is no particular requirement that the method  200  be performed in the same order in which this description lists the steps, except where so indicated.  
         [0080]    At a flow point  200 , electrical energy port  133  is coupled to a source of electrical energy. The patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. Due to the potential for inducing pain, the area surrounding the urinary meatus may be pretreated with a topical anesthetic before insertion of the catheter  110 ; depending upon the circumstances, a muscle relaxant or short term tranquilizer my be indicated. The position of the patient and choice of pharmaceutical agents to be used are responsive to judgments by medical personnel.  
         [0081]    At a step  201 , the patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as BETADINE, or benzalkonium chloride.  
         [0082]    At a step  202 , the visualization port  131  is coupled to the appropriate visualization apparatus, such as a fluoroscope, an endoscope, a display screen or other visualization device. The choice of visualization apparatus is responsive to judgments by medical personnel.  
         [0083]    At a step  203 , the apparatus port  132  is coupled to an external medical device such as a pH meter, a pressure gauge, or other such equipment. The choice of apparatus is responsive to judgments by medical personnel.  
         [0084]    At a step  204 , the therapeutic energy port  136  is coupled to a source of any of the aforementioned types of therapeutic energy.  
         [0085]    At a step  205 , the tapered tip  115  is well lubricated and introduced into the urethral meatus in an upward and backward direction, in much the same way a Foley catheter  110  is introduced.  
         [0086]    In a step  206 , the catheter  110  is threaded through the urethra until the treatment element  114  is at the further reaches of the trigone region. An introducer sheath  116  or guidewire  117  may also be used to facilitate insertion.  
         [0087]    In a step  207 , the position of the catheter  110  is checked using visualization apparatus coupled to the visualization port  131 . The position of the treatment element  114  is adjusted, if necessary, so that the electrodes  119  have grabbed onto the tissue and are bunching it together. This apparatus can be continually monitored by medical professionals throughout the procedure.  
         [0088]    In a step  208 , irrigation and aspiration control port  135  is manipulated so as to exude a cooling liquid such as sterile water, saline or glycerin from the aperture  118  into the lower region of the bladder. This cooling fluid lowers the relative temperature of the targeted tissues and prevents collateral thermal damage. In alternative embodiments, other devices may be coupled to the apparatus port  132  to chill the cooling fluid or to cause sonic cooling, gas expansion, magnetic cooling or others cooling methodologies. The choice of cooling fluid or methodology is responsive to judgments by medical personnel.  
         [0089]    In a step  209 , electrodes  119  are selected using the electrode selection and control switch  134 . In a preferred embodiment, all electrodes are deployed at once. In another preferred embodiment, electrodes may be individually selected. This step may be repeated at any time prior to step  217 .  
         [0090]    In a step  210 , suction apparatus is coupled to the irrigation and aspiration control ports  135  so that suction may be effected through the irrigation and aspiration ports  124 . The tissue surrounding the treatment element  114  may be aspirated so as to conform it to the treatment element  114 . The aspiration also removes excess cooling fluid that was supplied in step  209 .  
         [0091]    In a step  211 , the therapeutic energy port  136  is manipulated so as to cause a release of energy from the electrodes  119 . The duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates a pattern of lesions in the mucosal and sub-mucosal tissues of the trigone region. The affected area shrinks and is relatively strengthened, so as to better retain urine. Alternatively, a different method of treatment can be affected by partially or completely ablating nerves responsible for the sensation of urinary urgency.  
         [0092]    In a step  212 , the catheter  110  is repositioned so that the treatment element  114  is closer to the bladder neck. Prior to repositioning the catheter  110 , the electrodes  119  are either retracted or covered by the introducer sheath  116  to prevent unintended damage to tissue while the catheter is being moved.  
         [0093]    In a step  213 , the energy port  137  is manipulated so as to cause a release of energy from the electrodes  119 . The duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates another pattern of lesions in the mucosal and sub-mucosal tissues of the trigone area. The affected tissue shrinks and is relatively strengthened, so as to better retain urine. By creating a selective pattern of lesions in various areas as in steps  211  and  115 , the three-dimensional modeling of the trigone area can be affected. Alternatively, a different method of treatment can be effected by partially or completely ablating nerves responsible for the sensation of urinary urgency.  
         [0094]    In a step  214 , the catheter  110  is re-positioned for a final time so that the treatment element  114  is immediately adjacent to the bladder neck. Prior to repositioning the catheter  110 , the electrodes  119  are either retracted or covered by the introducer sheath  116  to prevent unintended damage to tissue while the catheter is being removed.  
         [0095]    In a step  215 , the energy port  137  is manipulated so as to cause a release of energy from the electrodes  119 . The duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates another pattern of lesions in the sub-mucosal and mucosal tissues around the bladder neck. The affected tissue shrinks and is relatively strengthened, so as to better retain urine. Taken together with the lesions, created in step  211 , and  213 , the trigone area has been completely remodeled so that the bladder has shrunk and re-suspended itself. The relative pressure on the bladder neck is relieved. The scar tissue created by application of the energy is stronger and better able to resist abdominal pressure on the sphincter.  
         [0096]    In a step  216 , the irrigation and aspiration control port  135  is manipulated so as to stop the flow of cooling liquid from the aperture  118 .  
         [0097]    In a step  217 , pharmaceutical agents may be locally administered by manipulating the irrigation and aspiration control ports  135 . These agents may include lubricants, anesthetics, anti-spasmodics, anti-inflammatories, antibiotics or other agents as deemed appropriate by the judgment of medical personal. This step may occur any time prior to withdrawal of the catheter  110 , to either pre-treat tissue or post treat tissues.  
         [0098]    In a step  218 , the catheter  110  is withdrawn from the urethra.  
         [0099]    [0099]FIG. 3 is a block drawing of a system for treatment of female urinary incontinence using a second device.  
         [0100]    A system  300  includes a catheter  310 , a microporous treatment balloon  320 , a control assembly  330 , and a shielding element  340  (not shown). In an alternative embodiment, the shielding element  340  is not present.  
         [0101]    The Catheter  310   
         [0102]    The catheter  310  includes two or more lumens  311  (not shown) and a translation member  312 . The two or more lumens  311  and translation member  312  traverse the entire interior length of the catheter  310 . The catheter  310  and lumens  311  are coupled at a distal end to a treatment balloon  320 ; they are coupled at a proximal end to a control assembly  330 . The translation member  312  is coupled to the distal end of the treatment balloon  320 ; it is coupled at the proximal end to a control assembly  330 .  
         [0103]    In a preferred embodiment, the catheter  310  and treatment balloon  320  are introduced into cavity of the body, such as a female urethra and bladder using an introducer sheath  313  or a guide tube  314 . In alternative embodiments, the cavity may include one or more of, or some combination of the following:  
         [0104]    any portion of the bronchial system, the cardiovascular system, the genito-urinary tract, the lymphatic system, the pulmonary system, the vascular system, the locomotor system, the reproductive system or other systems in the body;  
         [0105]    any biological conduit or tube, such as a biologic lumen that is patent or one that is subject to a stricture;  
         [0106]    any biologic operational structure, such as a gland, or a muscle or other organ (such as the colon, the diaphragm, the heart, a uterus, a kidney, a lung, the rectum, an involuntary or voluntary sphincter);  
         [0107]    any biologic structure, such as a herniated body structure, a set of diseased cells, a set of dysplastic cells, a surface of a body structure, (such as the sclera) a tumor, or a layer of cells (such as fat, muscle or skin); and  
         [0108]    any biologic cavity or space or the contents thereof, such as a cyst, a gland, a sinus, a layered structure, or a medical device implanted or inserted in the body.  
         [0109]    The Microporous Treatment Balloon  320   
         [0110]    The microporous treatment balloon  320  is comprised of a relatively flexible and heat resistant material such as Kevlar, polyurethane, polyvinyl chloride (PVC), polyamide, PET, nylon or other materials. The shape of the balloon can be manipulated by varying the degree of inflation and the amount of tension placed on the translation member  312 . By varying the degree of inflation and the tension on the translation member, the surface of the treatment balloon can be brought in contact with the entire interior surface of the muscles, including the detrusor muscles and the top of the bladder. In this way, it is possible to treat the entire organ simultaneously.  
         [0111]    The treatment balloon  320  also includes a flexible basket-like structure  321  and a set of surface electrodes  322 . The basket-like structure  321  has horizontal and vertical members that completely encompass the balloon  320 . The set of surface electrodes  322  are evenly distributed on all the members of the basket-like structure  321 . Each electrode  322  includes a sensor  323  to measure temperature, pressure, impedance, flow, nervous activity, pH, conductivity or other property of the tissue or treatment. Each surface electrode  322  is also coupled to a radiopaque marker  324  for use in fluoroscopic visualization.  
         [0112]    In an alternative embodiment, the surface electrodes  322  and sensors  323  are embedded directly into the exterior surface of the microporous treatment balloon  320 . In this preferred embodiment, the basket-like structure  321  is optional.  
         [0113]    In both the preferred and alternative embodiments, the electrodes  322  can be operated separately or in combination with each other. Treatment can be directed at a single area, several different areas, or the entire interior of a bladder or other orifice by operation of selective electrodes. Different patterns of sub-mucosal lesions, mucosal lesions, ablated, bulked or plumped, desiccated or necrotic regions can be created by selectively operating different electrodes. Production of different patterns of treatment makes it possible to remodel tissues and alter their overall geometry with respect to each other.  
         [0114]    Each electrode  322  can be disposed to treat tissue by delivering one or more of, or some combination or any of the following in either a unipolar or bipolar mode:  
         [0115]    radiofrequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range;  
         [0116]    chemical treatments, such as acids, antibiotics, enzymes, radioactive tracers or other bioactive substances;  
         [0117]    infrared energy, such as from an infrared laser or diode laser;  
         [0118]    microwave energy, such as electromagnetic energy in about the 915 megahertz or 2.45 gigahertz range;  
         [0119]    sonic energy, including ultrasound;  
         [0120]    photodynamic therapy (PDT);  
         [0121]    non-infrared laser energy; and  
         [0122]    cryothermia  
         [0123]    In addition to treating tissues by delivering energy, the set of electrodes  322  and the micropores in the balloon  320  are disposed to deliver at least one flowable substance to the area of the body where treatment is to take place. In a preferred embodiment, the flowable substance includes sterile water, which aids in cooling and hydration of body structures. In other preferred embodiments, the flowable substance includes saline with a concentration of less than about 10% NaCl, which locally enhances tissue conductivity, resulting in selective areas of ablation or creation of thermal lesions at or below the surface of the tissue. However, in alternative embodiments, the deliverable flowable liquids include other substances, including anesthetic drugs, anti-inflammatory agents, chemotherapeutic agents, systemic or topical antibiotics, collagen and radioactive substances such as labeled tracers. In other alternative embodiments, the sensors on the electrodes are used for mapping the foci or pathways of electrical activity in the bladder, the bladder neck or urethra. This information is used to guide delivery of energy.  
         [0124]    In other alternative embodiments, the balloon  320  is not microporous. In this alternative embodiment, electrodes  322  or other energy delivery devices may be mounted upon or proximate to a surface of the balloon.  
         [0125]    The Control Assembly  330   
         [0126]    The control assembly  330  includes a visualization port  331 , an apparatus port  332 , an electrical energy port  333 , an electrode selection and control switch  334 , one or more irrigation and aspiration control ports  335 , an therapeutic energy port  336  and a handle  337 .  
         [0127]    The visualization port  331  can be coupled to visualization apparatus, such as a fiber optic device, a fluoroscopic device, an anoscope, a laparoscope, an endoscope or other type of catheter.  
         [0128]    The apparatus port  332  can be coupled to other medical devices that may be useful during treatment such as a pH meter, a pressure monitor, drug administration apparatus, or other devices used to monitor or treat the patient.  
         [0129]    In a preferred embodiment, devices coupled to both the visualization port  331  and the apparatus ports  332  are controlled from a location outside the body, such as by an instrument in an operating room or an external device for manipulating the inserted catheter  310 .  
         [0130]    In an alternative embodiment the apparatus port  332  may be coupled to devices that are implanted or inserted into the body during a medical procedure. For example, the apparatus port  332  may be coupled to a programmed AICD (artificial implanted cardiac defibrillator), a programmed glandular substitute (such as an artificial pancreas) or other device for use dozing surgery or other medical procedures.  
         [0131]    The electrical energy port  333  includes a conductive element such as an electrical adapter that can be coupled to a source of alternating or direct current such as a wall socket, battery or generator.  
         [0132]    The electrode selection and control switch  334  includes an element that is disposed to select and activate individual electrodes  322 .  
         [0133]    The irrigation and aspiration control ports  335  can be coupled to a pump or other apparatus to inflate or deflate the balloon and deliver fluids through the micropores of the treatment balloon  320 .  
         [0134]    The therapeutic energy port  336  includes a receptor port for coupling to a source of any of the following types of therapeutic energy:  
         [0135]    radio frequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range;  
         [0136]    chemical treatments, such as acids, antibiotics, enzymes, radioactive tracers or other bioactive substances;  
         [0137]    infrared energy, such as from an infrared laser or diode laser; microwave energy, such as electromagnetic energy in about the 915 megahertz or 2.45 gigahertz range;  
         [0138]    sonic energy, including ultrasound;  
         [0139]    photodynamic therapy (PDT);  
         [0140]    non-infrared laser energy; and  
         [0141]    cryothermia  
         [0142]    The handle  337  is disposed for manipulated by medical or veterinary personnel and can be shaped for being held in the hand. The visualization port  331 , the apparatus port  332 , the electrical energy port  333 , the electrode selection and control switch  334  and the one or more irrigation and aspiration control ports  335  and the therapeutic energy port  336  are all mounted in the handle  337  to allow for easy operation.  
         [0143]    The Shielding Element  340   
         [0144]    The shielding element  340  lies on the proximal side of the microporous treatment balloon  320  and is disposed to isolate the treatment area. It can also help position the catheter  310  in the body. For example, in a preferred embodiment in which the catheter  310  is inserted into the urethra, the shielding element  340  can prevent the catheter  310  from being inserted further into the urethral canal or bladder and prevent substances used in treatment from escaping. In an alternative embodiment, the shielding element  340  is optional.  
         [0145]    [0145]FIG. 4 is a process flow drawing of a method for treatment of female urinary incontinence using a second device.  
         [0146]    A method  400  is performed by a system  300  including a catheter  310 , a treatment balloon  320  and a control assembly  330 . Although the method  400  is described serially, the steps of the method  400  can be performed by separate elements in conjunction or in parallel, whether asynchronously, in a pipelined manner, or otherwise. There is no particular requirement that the method  400  be performed in the same order in which this description lists the steps, except where so indicated.  
         [0147]    At a flow point  400 , electrical energy port  333  is coupled to a source of electrical energy. The patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. Due to the potential for inducing pain, the area surrounding the urinary meatus may be pretreated with a topical anesthetic before insertion of the catheter  310 ; depending upon the circumstances, a muscle relaxant or short term tranquilizer may be indicated. The position of the patient and choice of pharmaceutical agents to be used are responsive to judgments by medical personnel.  
         [0148]    At a step  401 , the patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as BETADINE, or benzalkonium chloride.  
         [0149]    At a step  402 , the visualization port  431  is coupled to the appropriate visualization apparatus, such as a fluoroscope, an endoscope, a display screen or other visualization device. The choice of visualization apparatus is responsive to judgments by medical personnel.  
         [0150]    At a step  403 , the apparatus port  332  is coupled to an external medical device such as a pH meter, a pressure gauge, or other medical equipment. The choice of apparatus is responsive to judgments by medical personnel.  
         [0151]    At a step  404 , the therapeutic energy port  336  is coupled to a source of any of the aforementioned types of therapeutic energy.  
         [0152]    In a step  405 , suction, inflation or fluid infusion apparatus is coupled to the irrigation and aspiration control ports  335  so that the treatment balloon may be later be inflated and deflated and substances may be administered.  
         [0153]    At a step  406 , the most distal end of the treatment balloon  320  is lubricated and introduced into the urethral meatus in an upward and backward direction, in much the same way a Foley catheter is introduced. The choice of lubricant is responsive to judgments by medical personnel. In a preferred embodiment, the balloon  320  is completely deflated during insertion.  
         [0154]    In a step  407 , the catheter  310  is threaded through the urethra until the microporous balloon  320  has completely passed the bladder neck and is entirely in the bladder. An introducer sheath  313  or guide tube  314  may also be used to facilitate insertion.  
         [0155]    In a step  408 , the position of the catheter  310  is checked using visualization apparatus coupled to the visualization port  331 . This apparatus can be continually monitored by medical professionals throughout the procedure.  
         [0156]    In a step  409 , the irrigation and aspiration control port  335  is manipulated so as to inflate the microporous treatment balloon  320 . In a preferred embodiment, the treatment balloon  320  is inflated with a cooling liquid such as sterile water, saline or glycerin. This cooling fluid lowers the relative temperature of the targeted tissues that are in physical contact and prevents collateral thermal damage. In alternative embodiments, other devices may be coupled to the apparatus port  132  to chill the cooling fluid or cause sonic cooling, gas expansion, magnetic cooling or others cooling methodologies. The choice of cooling fluid or methodology is responsive to judgments by medical personnel.  
         [0157]    In a step  410 , electrodes  322  are selected using the electrode selection and control switch  334 .  
         [0158]    In a step  411 , the translation member  312  is manipulated to alter the shape of the most distal end of the balloon so as to bring the distal end of the balloon in optimal physical contact with the top of the bladder.  
         [0159]    In a step  412 , individual nerves within the bladder are identified using sensors  323 . This step is optional.  
         [0160]    In a step  413 , the therapeutic energy port  336  is manipulated so as to cause a release of energy from the electrodes  322 . The duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates a pattern of lesions in the mucosal or sub-mucosal tissues of the bladder or portions thereof. The affected area shrinks and is relatively strengthened, so as to better retain urine.  
         [0161]    In a step  414 , the therapeutic energy port  336  is manipulated, so as to cause a release of energy from the electrodes  322  that is directed at the nerves that were identified in step  412 . Manipulation and modulation of these nerves may directly or indirectly affect incontinence related to an uncontrolled urge to urinate. This step is optional.  
         [0162]    In a step  415 , bulking agents such as organic microspheres, collagens, silicone, PVC and other organic breathable and unbreathable polymers are exuded from selected electrodes  322  positioned near the base of the bladder. The type of microspheres and bulking substances and the locations where they are exuded are responsive to judgment by medical personnel. These bulking agents can be used to strengthen these structures so as to prevent incontinence caused by stress.  
         [0163]    In a step  416 , pharmaceutical agents may be locally administered by manipulating the irrigation and aspiration control ports  335 . These agents may help include lubricants, anesthetics, anti-spasmodics, anti-inflammatories, antibiotics or other agents as deemed appropriate by the judgment of medical personal. This step may occur any time prior to withdrawal of the catheter  310 , to either pre-treat tissue or post-treat tissues.  
         [0164]    In a step  417 , the irrigation and aspiration control port  335  is manipulated so as to reverse the flow of cooling liquid into the microporous treatment balloon  320  and cause it to deflate.  
         [0165]    In a step  418 , the catheter  310  is withdrawn from the urethra.  
         [0166]    [0166]FIG. 5 is a block drawing of a system for treatment of female urinary incontinence using a third device.  
         [0167]    A system  500  includes a catheter  510 , treatment element  520 , a control assembly  530  and a shielding element  540 . In an alternative embodiment, the shielding element  540  is not present.  
         [0168]    The Catheter  510   
         [0169]    The catheter  510  includes two or more lumens  511 , a translation member  512  and a tapered tip  513 . The lumens  511  and translation member  512  run the entire interior length of the catheter  510 . The proximal end of the lumens  511  is coupled to the control assembly  530 ; the distal end of the lumens  511  is coupled to the treatment element  520 . It is through these lumens  511  that energy is conducted and flowable substances are exuded. The proximal end of the translation member  512  is coupled to the control assembly  530 ; the distal end of the translation member  512  is coupled to the taper tip  513 .  
         [0170]    In a preferred embodiment, the tapered tip  513  is rigid so as to allow easy insertion into a urethra. In other preferred embodiments, the tapered tip  513  may be of varying degrees of flexibility depending where it in the body it is deployed. In alternative embodiments, the catheter  510  may be introduced into the target tissue using an introducer sheath  514  or a guide wire  515 .  
         [0171]    Ina preferred embodiment, the tapered tip  513  is disposed for insertion into a cavity of the body such as a female urethra and bladder. In alternative embodiments, the cavity may include one or more of, or some combination of the following:  
         [0172]    any portion of the bronchial system, the cardiovascular system, the genito-urinary tract, the lymphatic system, the pulmonary system, the vascular system, the locomotor system, the reproductive system or other systems in the body;  
         [0173]    any biological conduit or tube, such as a biologic lumen that is patent or one that is subject to a stricture;  
         [0174]    any biologic operational structure, such as a gland, or a muscle or other organ (such as the colon, the diaphragm, the heart, a uterus, a kidney, a lung, the rectum and or voluntary sphincter);  
         [0175]    any biologic structure, such as a herniated body structure, a set of diseased cells, a set of dysplastic cells, a surface of a body structure, (such as the sclera) a tumor, or a layer of cells (such as fat, muscle or skin); and  
         [0176]    any biologic cavity or space or the contents thereof, such as a cyst, a gland, a sinus, a layered structure, or a medical device implanted or inserted in the body.  
         [0177]    The Treatment Element  520   
         [0178]    The treatment element  520  includes a set of umbrella-like struts  521 , a set of electrodes  522 , a set of irrigation and aspiration ports  525  and a set of sensors  526 . The set of umbrella-like struts  521  are several centimeters long. One end of the struts  521  is not attached to any part of the device. The other end of the strut  521  is coupled to the distal end of the translation member  512  at the tapered tip  513  in such a way that when tension is applied to the proximal end of the translation member  512 , the umbrella-like struts  521  open up in much the same way as an umbrella.  
         [0179]    A set of electrodes  522  is evenly distributed on the outer surface of each strut  521 . Each free-floating end of a strut  521  includes at least one electrode  522 . Each electrode  522  includes a metallic tube  523  defining a hollow lumen  524 . In a preferred embodiment, the set of electrodes  522  are needle electrodes; other preferred embodiments include surface electrodes or a combination of needle electrodes and surface electrodes.  
         [0180]    Each electrode  522  is coupled to at least one sensor  526  capable of measuring such factors as temperature, conductivity, pressure, impedance and other variables. In a preferred embodiment, each electrode  522  is also coupled to a radiopaque marker  527  for use in fluoroscopic visualization.  
         [0181]    In a preferred embodiment, the electrodes  522  can be operated separately or in combination with each other. Treatment can be directed at a single area or several different areas of a bladder or other orifice by operation of selected electrodes. Different patterns of sub-mucosal lesions, mucosal lesions, ablated, bulked, plumped, desiccated or necrotic regions can be created by selectively operating different electrodes. Production of different patterns of treatment makes it possible to remodel tissues and alter their overall geometry with respect to each other.  
         [0182]    Each electrode  522  can be disposed to treat tissue by delivering one or more of, or some combination or any of the following in either a unipolar or bipolar mode:  
         [0183]    radiofrequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range;  
         [0184]    chemical treatments, such as acids, antibiotics, enzymes, radioactive tracers or other bioactive substances;  
         [0185]    infrared energy, such as from an infrared laser or diode laser;  
         [0186]    microwave energy, such as electromagnetic energy in about the 915 megahertz or 2.45 gigahertz range;  
         [0187]    sonic energy, including ultrasound;  
         [0188]    photodynamic therapy (PDT)  
         [0189]    non-infrared laser energy; and  
         [0190]    cryothermia  
         [0191]    In addition to treating tissues by delivering energy, the set of electrodes  522  are disposed to deliver at least one flowable substance to the area of the body where treatment is to take place. In a preferred embodiment, the flowable substance includes sterile water which aides in cooling and hydration of body structures. In another preferred embodiment, the flowable substance includes saline with a concentration of less than about 10% NaCl. Saline is used to increate the local conductivity of tissue, enhancing the penetration of RF energy so as to create larger lesions. The saline can be delivered through the needle electrode sub-mucosally so as to achieve greatest effect. However, in alternative embodiments, the deliverable flowable liquids include other substances, including anesthetic drugs, antiinflammatory agents, chemotherapeutic agents, systemic or topical antibiotics, collagen and radioactive substances such as labeled tracers.  
         [0192]    A set of irrigation and aspiration ports  525  are also evenly distributed on the outer surface of each strut  521 . Each free-floating end of a strut  521  also includes at least one irrigation and aspiration port  525 . Suction can be applied through these ports so as to bring the targeted tissue in closer physical proximity to the electrodes  522 . The irrigation and aspiration ports  525  can also be used to administer cooling fluids in such a way as to minimize thermal damage. Drugs, bulking agents and other flowable substances can be infused through the irrigation and aspiration ports  525 .  
         [0193]    The Control Assembly  530   
         [0194]    The control assembly  530  includes a visualization port  531 , an apparatus port  532 , an electrical energy port  533 , an electrode selection and control switch  534 , one or more irrigation and aspiration control ports  535 , a therapeutic energy port  536  and a handle  537 .  
         [0195]    The visualization port  531  can be coupled to visualization apparatus, such as a fiber optic device, a fluoroscopic device, an anoscope, a laparoscope, an endoscope or other type of catheter.  
         [0196]    The apparatus port  532  can be coupled to other medical devices that may be useful during treatment such as a pH meter, a pressure monitor, drug administration apparatus, or other device used to monitor or treat the patient.  
         [0197]    In a preferred embodiment, devices coupled to both the visualization port  531  and the apparatus ports  532  are controlled from a location outside the body, such as by an instrument in an operating room or an external device for manipulating the inserted catheter  510 .  
         [0198]    In an alternative embodiment the apparatus port  532  may be coupled to devices that are implanted or inserted into the body during a medical procedure. For example, the apparatus port  532  may be coupled to a programmed AICD (artificial implanted cardiac defibrillator), a programmed glandular substitute (such as an artificial pancreas) or other device for use during surgery or other medical procedures.  
         [0199]    The electrical energy port  533  includes a conductive element such as an electrical adapter that can be coupled to a source of alternating or direct current such as a wall socket, battery or generator.  
         [0200]    The electrode selection and control switch  534  includes an element that is disposed to select and activate individual electrodes  522 .  
         [0201]    The irrigation and aspiration control ports  535  can be coupled to a pump or other apparatus to deliver fluid through the irrigation and aspiration ports  525  or electrodes  522  or to apply suction through the set of irrigation and aspiration ports  525 .  
         [0202]    The therapeutic energy port  536  includes a receptor port for coupling to a source of any of the following types of therapeutic energy:  
         [0203]    radiofrequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range;  
         [0204]    chemical treatments, such as acids, antibiotics, enzymes, radioactive tracers or other bioactive substances;  
         [0205]    infrared energy, such as from an infrared laser or diode laser;  
         [0206]    microwave energy, such as electromagnetic energy in about the 915 megahertz or 2.45 gigahertz range;  
         [0207]    sonic energy, including ultrasound;  
         [0208]    photodynamic therapy (PDT);  
         [0209]    non-infrared laser energy; and  
         [0210]    cryothermia  
         [0211]    The handle  537  is disposed for manipulated by medical or veterinary personnel and can be shaped for being held in the hand. The visualization port  531 , the apparatus port  532 , the electrical energy port  533 , the electrode selection and control switch  534  and the one or more irrigation and aspiration control ports  535  and the therapeutic energy port  536  are all mounted in the handle  537  to allow for easy operation.  
         [0212]    The Shielding Element  540   
         [0213]    The shielding element  540  lies on the proximal side of treatment element  520  and is disposed to isolate the treatment area. It can also help position the catheter  510  in the body. For example, in a preferred embodiment in which the catheter  510  is inserted into the urethra, the shielding element  540  can prevent the catheter  510  from being inserted further into the urethra canal and prevent substances used in treatment from escaping. In an alternative embodiment, the shielding element  540  is optional.  
         [0214]    [0214]FIG. 6 is a process flow drawing of a method for treatment of female urinary incontinence using a third device. Although the method  600  is described serially, the steps of the method  600  can be performed by separate elements in conjunction or in parallel, whether asynchronously, in a pipelined manner, or otherwise. There is no particular requirement that the method  600  be performed in the same order in which this description lists the steps, except where so indicated.  
         [0215]    A method  600  is performed by a system  500  including a catheter  510 , a treatment element  520  and a control assembly  530 .  
         [0216]    At a flow point  600 , electrical energy port  533  is coupled to a source of electrical energy. The patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. Due to the potential for inducing pain, the area surrounding the urinary meatus may be pretreated with a topical anesthetic before insertion of the catheter  510 ; depending upon the circumstances, a muscle relaxant or short term tranquilizer may be indicated. The position of the patient and choice of pharmaceutical agents to be used are responsive to judgments by medical personnel.  
         [0217]    At a step  601 , the patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as BETADINE, or benzalkonium chloride.  
         [0218]    At a step  602 , the visualization port  531  is coupled to the appropriate visualization apparatus, such as a fluoroscope, an endoscope, a display screen or other visualization device. The choice of visualization apparatus is responsive to judgments by medical personnel.  
         [0219]    At a step  603 , the apparatus port  532  is coupled to an external medical device such as a pH meter, a pressure gauge, or other medical equipment. The choice of apparatus is responsive to judgments by medical personnel.  
         [0220]    At a step  604 , the therapeutic energy port  535  is coupled to a source of any of the aforementioned types of therapeutic energy.  
         [0221]    In a step  605 , suction, inflation or fluid in fusion apparatus is coupled to the irrigation and aspiration control ports  535  so that cooling fluids and pharmacological agents may be administered.  
         [0222]    At a step  606 , the tapered tip  513  is lubricated and introduced into the urethral meatus in an upward and backward direction, in much the same way a Foley catheter is introduced. The choice of lubricant is responsive to judgments by medical personnel. In a preferred embodiment, the treatment element  520  is completely closed to facilitate insertion.  
         [0223]    In a step  607 , the catheter  510  is threaded through the urethra until the treatment element  520  has completely passed the bladder neck and is entirely in the bladder. An introducer sheath  513  or guide tube  514  may also be used to facilitate insertion.  
         [0224]    In a step  608 , the position of the catheter  510  is checked using visualization apparatus coupled to the visualization port  531 . This apparatus can be continually monitored by medical professionals throughout the procedure.  
         [0225]    In a step  609 , the irrigation and aspiration control port  535  is manipulated so as to exude a cooling fluid. In a preferred embodiment, the cooling fluid may include sterile water, saline or glycerin. This cooling fluid lowers the relative temperature of the targeted tissues that are in physical and prevents collateral thermal damage. In alternative embodiments, other devices may be coupled to the apparatus port  532  to chill the cooling fluid or cause sonic cooling, gas expansion, magnetic cooling or others cooling methodologies. The choice of cooling fluid or methodology is responsive to judgments by medical personnel.  
         [0226]    In a step  610 , tension is applied to the translation member  512  to cause extension of the struts  522 . Extension of the struts  522  brings the electrodes  522  into physical proximity with the walls of the bladder.  
         [0227]    In a step  611 , the irrigation and aspiration control ports  535  are manipulated so as to apply suction through the irrigation and aspiration ports  525  and bring the walls of the bladder in even closer proximity to the treatment element  520 .  
         [0228]    In a step  612 , electrodes  522  are selected using the electrode selection and control switch  534 . In a preferred embodiment, all electrodes are selected. In another embodiment, individual electrodes may be deployed.  
         [0229]    In a step  613 , individual nerves within the bladder are identified using sensors  526 . This step is optional.  
         [0230]    In a step  614 , the therapeutic energy port  536  is manipulated so as to cause a release of energy from the electrodes  522 . The duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates a pattern of lesions in the mucosal and/or sub-mucosal tissues of the bladder or portions thereof. The affected area shrinks and is relatively strengthened, so as to better retain urine.  
         [0231]    In a step  615 , the therapeutic energy port  536  is manipulated so as to cause a release of energy from the electrodes  522  that is directed at the nerves that were identified in step  613 . Manipulation and modulation of these nerves may directly or indirectly affect incontinence related to an uncontrolled urge to urinate. This step is optional.  
         [0232]    In a step  616 , bulking agents such as organic microspheres, collagens, silicone, PVC and other organic breathable and unbreathable polymers are exuded from selected electrodes  522  into tissues near the base of the bladder. The type of microspheres and bulking substances and the locations where they are exuded are responsive to judgment by medical personnel. These bulking agents can be used to strengthen these structures so as to prevent incontinence caused by stress. This step is optional.  
         [0233]    In a step  617 , pharmaceutical agents may be locally administered by manipulating the irrigation and aspiration control ports  535 . These agents may help include lubricants, anesthetics, anti-spasmodics, anti-inflammatories, antibiotics or other agents as deemed appropriate by the judgment of medical personnel. This step may occur any time prior to withdrawal of the catheter  510 , either to pre-treat tissue or post-treat tissues.  
         [0234]    In a step  618 , the irrigation and aspiration control port  535  is manipulated so as to reverse the flow of cooling liquid.  
         [0235]    In a step  619 , tension is applied to the translation member  512  to cause the umbrella like struts  521  to collapse and close around the catheter  510 .  
         [0236]    In a step  620 , the catheter  510  is withdrawn from the urethra.  
       GENERALITY OF THE INVENTION  
       [0237]    The invention has substantial generality of application to various fields for biopsy or treatment of medical conditions. These various fields include, one or more of, or a combination of, any of the following (or any related fields):  
         [0238]    As noted above, the invention can be used in any area of the body, including the biologic systems and locations noted herein. The invention can be used for the general purpose of reducing, plumping, or reshaping body structures, tissues, or regions of the body otherwise empty (or filled with biologic substances).  
         [0239]    For examples, the invention can be used in one or more of, or some combination of, the following:  
         [0240]    in the head and neck, such as the cheeks, eyes, sinuses, middle ear, nostrils, inner ear, Eustachian tubes, pharynx, larynx, or other structures;  
         [0241]    for the purpose of reforming damaged body parts, for the purpose of reshaping misshapen body parts, dilating occluded tissues, or for cosmetic affects; and  
         [0242]    for the purpose of replacing the volume filled by body parts that are missing, whether due to congenital defect, infection, or surgery.  
       ALTERNATIVE EMBODIMENTS  
       [0243]    Although preferred embodiments are disclosed herein, many variations are possible which remain within the concept, scope, and spirit of the invention, and these variations would become clear to those skilled in the art after perusal of this application.

Technology Classification (CPC): 0