Abstract:
The invention comprises a method and apparatus for treatment of a body part. More particularly, a method and apparatus for heat treatment of tissue using a catheter inserted into a body part is described along with means for positioning the catheter and means for positioning a set of electrodes relative to a tissue sample for treatment. Still more particularly, radio frequency energy at about 400 to 500 kilohertz is used to provide heat for the tissue treatment.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation of U.S. patent application Ser. No. 09/356,110 filed Jul. 16, 1999, which is included herein by this reference thereto. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention relates to treatment of tissue, particularly in the sphincters, esophagus, sinuses and other internal body orifices and structures. Such treatment can be performed using ablation, coating, expansion, plumping, shaping, shrinking, or related techniques.  
         [0004]     2. Related Art  
         [0005]     Human beings are subject to a number of disorders in the sphincters, sinuses, esophagus and other internal orifices. Disorders in the rectum and colon include hemorrhoids (external and internal), fecal incontinence, prolapsed rectal muscles, rectal muscle spasms, anal fissures, polyps, diverticulosus, diverticulitus, and pilonital cysts. Other internal disorders in nearby regions of the male body include prostate cancer, blockage of the urethra and incontinence. Other internal disorders in nearby regions of the female body include incontinence, vaginal bleeding, vaginal cysts, vaginal fibroids, prolapsed uterus, and related tumors or cancerous tissue. Disorders of the pharynx include tumors and polyps in the hypopharynx, oropharynx and nasopharynx. Disorders in adjacent structures include Barrett&#39;s esophagus, laryngeal tumors and laryngeal polyps.  
         [0006]     Known methods for the treatment of these disorders include surgery, pharmaceutical remedies, chemotherapeutic regimens, radiation, photodynamic therapy and lifestyle modification. These methods only occasionally achieve the goal of successful treatment of disorders in orifices, sphincters, esophagus and sinuses. Moreover, these methods suffer from several drawbacks.  
         [0007]     Drawbacks to surgical treatment include its highly invasive nature, associated risks, possible iatrogenic effects, and high cost. Drawbacks to pharmaceutical and chemotherapeutic treatments include their relative ineffectiveness (particularly in the oral cavity and adjacent respiratory structures) and associated side effects. Moreover, these approaches are contraindicated for many patients. Drawbacks to lifestyle modification include relatively poor patient compliance and relative ineffectiveness. Drawbacks to photodynamic therapy include its frequent unavailability and limited applicability. Drawbacks to radiation include side effects such as exhaustion, radiation burns, chronic dry mouth and permanent distortion of the taste buds. Accordingly, it would be advantageous to provide techniques for treatment of these disorders that are not subject to these known drawbacks.  
         [0008]     The use of radio frequency (RF) to ablate tissue in the body (such as heart muscle) is known in the art of cardiac treatment. However, known systems using RF energy are sill subject to several drawbacks. One known problem is that it can be difficult to block the flow of bodily 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 successful tissue ablation and etching.  
         [0009]     A second known problem in the art involves directing and positioning the electrodes in the body cavity or orifice. Difficulties in accurately positioning the electrodes in the target orifice detract from treatment. Frequently, unhealthy tissue can remain unablated while healthy tissue is removed. 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 ablate diseased tissue.  
         [0010]     A third known problem in the art involves difficulty in the simultaneous use of complimentary technology. Known systems do not provide for optimal, simultaneous use of auxiliary tools for visualization, feedback technology and drug administration.  
         [0011]     Accordingly, it would be advantageous to provide improved techniques for treatment of disorders in the esophagus, sphincters, sinuses and other internal body orifices. For example, it would be advantageous to provide devices bearing different arrays of curvilinear electrodes that can be retracted or extended into the target tissue that can also support apparatus for drug administration and tissue visualization. Such devices would allow medical personnel to (1) visualize the tissue to be ablated or etched, (2) seal off the area from fluids and gases that would disturb the area to be ablated (3) ablate all diseased tissue while sparing healthy tissue and (4) provide for the localized administration of drugs to numb the area and treat the disorder. These advantages are achieved in an embodiment of the invention in which medical personnel use a catheter bearing multiple controls for visualization and drug administration, balloon-like air sacs for sealing the area and multiple arrays of curvilinear electrodes that can be extended and retracted as needed.  
       SUMMARY OF THE INVENTION  
       [0012]     The invention provides a method and system for treatment of body structures or tissue. The particular treatment can include one or more of, or some combination of ablation, coating, expansion, plumping, shaping, shrinking, or related techniques. The particular body structures or tissue can include one or more of, or some combination of regions, including a sphincter, sinus or orifice such as the rectum, colon, esophagus, vagina, penis, larynx or pharynx.  
         [0013]     In one aspect of the invention, an environment proximate to or surrounding the targeted treatment region can be isolated or controlled by blocking the flow of gases or liquids using an inflatable balloon positioned immediately adjacent to the tissue that is to be ablated. The inflatable balloon can also serve to anchor the catheter in place and prevent the catheter from being expelled from the body. The inflatable balloon can also insure that locally administered drugs remain in the area where most needed.  
         [0014]     In a second aspect of the invention, positive pressure is used to inflate the balloon. Inflation of the balloon triggers the extension of at least one curvilinear electrode into the targeted tissue. Negative pressure deflates the air sac and helps retract the curvilinear electrodes so as to allow the catheter to be removed from the body without damaging adjacent body structures. Alternately, the electrode(s) can be extended or retracted from the tissue, independently from the act of inflation or deflation of the balloon.  
         [0015]     In a third aspect of the invention, the electrodes are coupled to sensors that measure properties of the target region, such as temperature and impedance. Measurement of these properties permits the use of feedback technique to control delivery of the RF energy and administration of fluids for cooling and hydrating the affected tissues. The electrodes can also be coupled to radio opaque markers to aid in fluoroscopic positioning.  
         [0016]     In a fourth aspect of the invention, the catheter includes an optical path that can be coupled to external viewing apparatus. In this way, the position of the electrodes in the body can be determined using fiber optic techniques. The external viewing apparatus can also be coupled to an ultrasound probe included in the catheter. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]      FIG. 1  is a block diagram of a system for ablating tissue using a catheter and electrode assembly according to the invention;  
         [0018]      FIG. 2  is a process flow diagram of a method for treatment for Barrett&#39;s esophagus according to the invention;  
         [0019]      FIG. 3  is a process flow diagram of a method for treatment of fecal incontinence according to the invention;  
         [0020]      FIG. 4  is a process flow diagram of a method for treatment of female urinary incontinence according to the invention;  
         [0021]      FIG. 5  is a process flow diagram of a method for treatment of male urinary incontinence according to the invention;  
         [0022]      FIG. 6  is a process flow diagram of a method for treatment of a hemorrhoid or pilonital cyst according to the invention; and  
         [0023]      FIG. 7  is a process flow diagram of a method for treatment of an anal fissure according to the invention;  
         [0024]      FIG. 8  shows an alternate embodiment of the apparatus of  FIG. 1  according to the invention; and  
         [0025]      FIG. 9  shows a balloon having micropores according to the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0026]     System Elements  
         [0027]      FIG. 1  is a block diagram of a system for ablating tissue associated with the rectal sphincter, esophagus, urethra and other internal body structures using a catheter and electrode assembly.  
         [0028]     A catheter and electrode assembly  100  for treating tissue includes a catheter  110 , an expandable cage structure  120  and a control and delivery linkage  130 . The catheter  110  includes a distal segment  111  and a proximal segment  112 . The distal segment includes a tapered tip  113  for easy insertion into an orifice. The tapered tip  113  may be either flexible or rigid depending upon the orifice into which the catheter  110  is to be inserted. The overall length of the shaft of the catheter  110  (including the expandable cage structure  120 ) from the tapered tip  113  to the junction where the catheter  110  is coupled to the control and delivery linkage  120  is about 65 centimeters. The diameter of the catheter  110  is about 0.4 centimeters. In an alternative embodiment, the length and diameter of the shaft of the catheter  110  may vary substantially depending upon the application.  
         [0029]     The catheter  110  includes an expandable cage structure  120 . The cage structure  120  includes a set of struts  121 , a set of curvilinear electrodes  122  and an inflatable balloon  123 .  
         [0030]     One end of each one of the struts  121  is coupled to the distal segment  111  of the catheter  110 ; the opposite end of each one of the set of struts  121  is coupled to the proximal segment  112  of the catheter. Taken together, the distal segment  111 , the cage structure  120  and the proximal segment  112  are linearly contiguous and form one continuous unit. The inflatable balloon  123  is surrounded by the set of struts  121 .  
         [0031]     The set of curvilinear electrodes  122  is embedded in the set of struts  121 . The electrodes  123  each include a metallic tube  124  defining a hollow lumen  125 , shaped similarly to a curvilinear needle and a sensor  126 . In addition to ablating tissue by delivering RF energy, the electrodes  113  are disposed to deliver at least one flowable substance to the area of the body where ablation is to take place. In a preferred embodiment, the flowable substance includes saline with a concentration of less than about 10% NaCl, which aids in hydration of body structures. However, in alternative embodiments, the deliverable flowable liquids includes other substances, including anesthetic drugs, anti-inflammatory agents, chemotherapeutic agents, systemic or topical antibodies, collagen and radioactive substances, such as labeled tracers.  
         [0032]     Exact positioning of the electrodes  122  is achieved by inflating the balloon  123 . Inflation of the balloon  123  causes expansion of the expandable cage structure  120 , allowing one or more of the set of electrodes  122  to be extended directly into the targeted tissue.  
         [0033]     The assembly  110  is operated by manipulating the control and delivery linkage  130 . The control and delivery linkage  130  includes a port  131 , two female couplings  132  and  133 , a mechanical switch  135  and a hand set  136 .  
         [0034]     The port  131  can be coupled to both a RF source and a visualization apparatus, such as fiber optic devices or fluoroscopy equipment, to allow internal viewing of the orifice. The two female couplings  132  and  133  can be coupled to a syringe or other device to which positive pressure can be applied to inflate the balloon  123 . In a preferred embodiment, one or more of the female couplings  132 ,  133  and  134  can also be coupled to drug administration apparatus. Manipulation of the mechanical switch  135  causes the extension of the electrodes  122 . The female couplings  132 ,  133  and  134 , mechanical switch  135  and port  131  are all located immediately adjacent to the hand set  136  to allow easy operation.  
         [0035]     First Method of Operation  
         [0036]      FIG. 2  is a process flow diagram of a method for treatment of Barrett&#39;s esophagus.  
         [0037]     A method  200  is performed using a catheter and electrode assembly  100 .  
         [0038]     In a step  201 , the tapered tip  113  of the catheter  110  is inserted into the oral cavity. Due to the potential for inducing pain or a gag reflex, the oral cavity is preferably pretreated with lidocaine spray or other topical anesthetic before insertion; depending upon the circumstances, a muscle relaxant may be indicated. In an alternative embodiment, the tapered tip  113  of the catheter  110  is inserted into a surgically created stoma.  
         [0039]     The preferred size of the catheter  110  will be responsive to the orifice through which the catheter is inserted. The choice of pharmaceutical agents to be infused prior to or during treatment will be responsive to judgments by medical personnel, and may include lubricants, anesthetics, antispasmodics, anti-inflammatories, antibiotics or other agents.  
         [0040]     In a step  202 , the catheter  110  is threaded through the throat into the esophagus. Precautions are preferably taken to ensure that the catheter  110  is not threaded through the trachea into the lungs.  
         [0041]     In a step  203 , the catheter  110  is positioned near the Barrett&#39;s esophagus. In the preferred embodiment, viewing apparatus coupled to the port  131  may be used to examine the region and determine which specific tissues are targeted for ablation. Healthy tissue composed of white squamous cells is distinguished from unhealthy pink columnar cells indicative of Barrett&#39;s esophagus.  
         [0042]     In a step  204 , a syringe is connected to the female coupling  132 ,  133  or  134 .  
         [0043]     In a step  205 , the syringe is used to exert positive pressure and inflate the balloon  123  with a flowable substance, such as air or liquid. Inflation of the balloon  123  serves several purposes. In addition to positioning the electrode  122 , the balloon  123  also helps anchor the catheter  110  and prevents gas or liquids arising in the stomach from contaminating the region.  
         [0044]     In a step  206 , inflating of the balloon  123  causes expansion of the set of struts  121 . Any corrections in the positioning of the catheter  110  are made at this time, using the visual apparatus coupled through the port  131 .  
         [0045]     In a step  207 , one or more electrodes  122  are selected for extension into the columnar cells targeted for treatment. The particular treatment can include one or more of, or some combination of, ablation, coating, expansion, plumping, shaping, shrinking, or related techniques. The mechanical switch  134  is used to extend at least one electrode  122  into the targeted columnar cells.  
         [0046]     In a step  208 , RF energy is provided to the electrodes so as to ablate the targeted columnar cells. In a preferred embodiment, the RF energy has a frequency between 435 and 485 kilohertz. The tissue immediately near the electrodes receives the RF energy. The strength and duration of time the energy is applied are responsive to judgments by medical personnel. In alternative embodiments, the electrodes may deliver other forms of energy, such as heat, microwaves, infrared or visible laser energy. In other alternative embodiments, the electrodes are controlled by a feedback technique using at least one sensor  126 , such as an impedance or temperature sensor.  
         [0047]     To perform ablation, the tissue is heated for a short period of time until ablation occurs. Application of RF energy causes cell death by dehydration or denaturation of cellular proteins.  
         [0048]     To perform expansion, plumping, or shaping, the tissue is suffused with a flowable substance, such as a gas or liquid, a collagen, or another substance that can be absorbed by the body structure or tissue. The flowable substance can be exuded from the catheter, either using a separate flow line, or using the electrodes themselves. In a preferred embodiment, the tissue is heated for a short time, and thereafter cooled, so as to cause the flowable substance to crosslink or otherwise transform into a bulking, plumping, or shaping agent.  
         [0049]     To perform coating, the flowable substance can be exuded so as to adhere to (or be adsorbed by) an epithelial layer of cells. In a preferred embodiment, the tissue is heated for a short time, and thereafter cooled, so as to cause the flowable substance to crosslink or otherwise transform into a solid mass coating or covering the epithelial layer.  
         [0050]     To perform shrinking, the tissue is suffused with the flowable substance, with the flowable substance being selected so as to act as a receiving antenna or dielectric for the RF energy. RF energy is applied, which is differentially absorbed by the flowable substance; this causes the flowable substance to heat and to shrink the tissue is suffused, either by cell death, dehydration, or denaturation of cellular proteins.  
         [0051]     In a step  209 , flowable substances are provided through the holes in the electrodes  122 , the micropores of the balloon  123  or from the struts  121 , if needed to immediately cool down the region and prevent collateral thermal damage. The nature, temperature and amount of the flowable substance are responsive to judgments by medical personnel.  
         [0052]     In a step  210 , the electrodes  122  are retracted back into the set of struts  121 .  
         [0053]     In a step  211 , the balloon is deflated by negative pressure on the syringe.  
         [0054]     Deflation of the balloon  123  causes the expandable cage structure  120  to collapse.  
         [0055]     In a step  212 , the catheter  110  is withdrawn from the oral cavity. In an alternative embodiment, the catheter  110  is withdrawn from a stoma.  
         [0056]     Second Method of Operation  
         [0057]      FIG. 3  is a process flow diagram of a method for treatment of fecal incontinence.  
         [0058]     A method  300  is performed using a catheter and electrode assembly  100 . This method requires the use of four to eight electrodes and a blunt tapered tip  113 .  
         [0059]     In a step  301 , an enema is performed to clear the region of fecal matter. The rectum and surrounding area are washed with a cleansing agent, such as benzalonium chloride. A topical anesthetic may be applied to prevent pain associated with insertion; depending upon the circumstances, a muscle relaxant may be indicated. The tapered tip  113  of the catheter  110  is inserted into the anus.  
         [0060]     The preferred size of the catheter  110  will be responsive to the orifice through which the catheter is inserted. The choice of pharmaceutical agents to be infused prior to or during treatment will be responsive to judgments by medical personnel, and may include lubricants, anesthetics, antispasmodics, anti-inflammatories, antibiotics or other agents.  
         [0061]     In a step  302 , the catheter  110  is threaded into the anus so that the electrodes  122  are positioned neat the dentate line.  
         [0062]     In a step  303 , the catheter  110  is positioned neat the area to be treated. In the preferred embodiment, viewing apparatus, such as an anoscope coupled to port  131  may be used to examine the region and determine which specific tissues are targeted for ablation. In an alternative embodiment, the area can be accessed using a colorectal ultrasound probe. It is important to distinguish between the voluntary and involuntary sphincter because fecal incontinence is frequently causes by defects in the involuntary sphincter. One of the goals of treatment is to avoid exacerbating the incontinence problem by injuring the voluntary sphincter.  
         [0063]     In a step  304 , a syringe is connected to the female coupling  132 ,  133  or  134 .  
         [0064]     In a step  305 , the syringe is used to exert positive pressure and inflate the balloon  123  with air or with a liquid. Inflation of the balloon  123  serves several purposes. In addition to positioning the electrode  122 , the balloon  123  also helps anchor the catheter  110  and prevents gas, liquid or fecal matter from contaminating the region. If necessary, a second balloon can be used to anchor the catheter distally.  
         [0065]     In a step  306 , inflation of the balloon  123  causes expansion of the set of struts  121 . Any corrections in the positioning of the catheter  110  are made at this time, using the visual apparatus coupled through the port  131 .  
         [0066]     In a step  307 , four or more electrodes  122  are selected for extension into the involuntary sphincter. The mechanical switch  135  is used to extent the electrodes  122  into the involuntary sphincter. Thermal injury to sensitive female structures is avoided by selecting electrodes  122  in area other than the anterior portion of the anus. In both sexes, treatment is directed to the area one to two centimeter above and up to one centimeter below the dentate line. Highly innervated regions of tissue are avoided so as to minimize pain.  
         [0067]     In a step  308 , RF energy is provided to the electrodes until thermal lesions are created in the targeted area(s). In a preferred embodiment, the RF energy has a frequency between 435 kilohertz and 485 kilohertz. The RF energy is received by the tissue immediately near the electrodes. The tissue is heated for a short period of time until ablation occurs. Application of RF energy causes cell death by dehydration and denaturization of cellular proteins. The strength and duration of time the energy is applied are responsive to judgments by medical personnel. In alternative embodiments, the electrodes may deliver other forms of energy, such as heat, microwaves, infrared or visible laser energy. In other alternative embodiments, the electrodes are controlled by a feedback technique using at least one sensor  126 , such as an impedance or temperature sensor.  
         [0068]     In a step  309 , flowable substance are provided through holes in the electrodes  122 , the struts  121  or the micropores of the balloon  123  if needed to immediately cool down the region and prevent collateral thermal damage. The nature, temperature and amount of the flowable substance are responsive to judgments by medical personnel.  
         [0069]     In a step  310 , the electrodes  122  are retracted back into the set of struts  121 .  
         [0070]     In a step  311 , the balloon  123  is deflated by negative pressure on the syringe. Deflation of the balloon  123  causes the expandable cage structure  120  to collapse.  
         [0071]     In a step  312 , the catheter is withdrawn from the anus.  
         [0072]     Third Method of Operation  
         [0073]      FIG. 4  is a process flow diagram of a method for treatment for female urinary incontinence.  
         [0074]     A method  400  is performed using a catheter and electrode assembly  100 .  
         [0075]     In a step  401 , the area around the urethral meatus is cleansed. The tapered tip of the catheter  110  is well lubricated and introduced into the urethral meatus in an upward and backward direction, in much the same way one would introduce a Foley catheter. Due to the potential for inducing pain, the outer opening of the urethra may be pretreated with a topical anesthetic before treatment. The choice of pharmaceutical agents to be infuse prior to or during treatment will be responsive to judgments by medical personnel and may include lubricants, anesthetics, antispasmodics, anti-inflammatories, antibiotics or other agents.  
         [0076]     In a step  402 , the catheter  110  is threaded through the urethra until the tapered tip  113  reaches the neck of the bladder using strict aseptic technique.  
         [0077]     In a step  403 , viewing apparatus coupled to part  131  may be used to examine the region and determine which area of the urethral sphincter is targeted for treatment. Ultrasound or fluoroscopy can also be used for positioning.  
         [0078]     In a step  404 , a syringe is connected to the female coupling  132 ,  133  or  134  included in the control and delivery linkage  130 .  
         [0079]     In a step  405 , the syringe is used to exert positive pressure and inflate the balloon  123  with air or liquid. Inflation of the balloon  123  serves several purposes. In addition to positioning the electrode  122 , the balloon  123  also helps anchor the catheter  110 . In an alternative embodiment, a second balloon  123  is used to help position the bladder neck and seal it off.  
         [0080]     In a step  406 , vacuum can be added to conform the tissue to the electrodes. This step is particularly advantageous for patients whose pelvic floor muscles are in poor condition. This step is optional.  
         [0081]     In a step  407 , inflation of the balloon  123  causes expansion of the expandable cage structure  120 . Expansion of the cage structure brings the electrodes  122  into immediate contact with the urinary sphincter. Any correction to the position of the catheter  110  is made at this time, using the visual apparatus coupled through part  131 .  
         [0082]     In a step  408 , one or more electrodes  122  are selected for extension into tissue targeted for ablation. The mechanical switch  135  is used to extend at least one electrode  122  into the targeted tissue.  
         [0083]     In a step  409 , RF energy is provided to the electrodes to create lesions on the targeted tissue. In a preferred embodiment, the RF energy has a frequency between 435 and 485 kilohertz. The RF energy is received by the tissue immediately near the electrodes for a period of time less than ten minutes. The device can be repositioned by rotation or translation so the RF energy is delivered to multiple sites to create a pattern of lesions over several centimeters of tissue. The duration of time and frequency of energy are responsive to judgments of medical personnel. Creation of these lesions has the effect of causing the involuntary sphincter to shrink so that urine does not seep through. In alternative embodiments, muscle contraction can be achieved by application of chemical stimulation.  
         [0084]     In a step  410 , flowable substances are provided through holes in the electrodes  122 , the struts  121  and/or micropores of the balloon  123 , if needed, to lower the temperature of the region and prevent collateral thermal damage. The nature, temperature and amount of flowable substance are responsive to judgments by medical personnel.  
         [0085]     In a step  411 , the electrodes  122  are retracted back into the set of struts  121 .  
         [0086]     In a step  412 , the balloon  123  is deflated by application of negative pressure on the syringe. Deflation of the balloon  123  causes collapse of the expandable cage structure  120 .  
         [0087]     In a step  413 , the catheter  110  is withdrawn from the urethra.  
         [0088]     Fourth Method of Operation  
         [0089]      FIG. 5  is a process flow diagram of a method for treatment of male urinary incontinence.  
         [0090]     A method  500  is performed using a catheter and electrode assembly  100 .  
         [0091]     In a step  501 , the tapered tip  113  of the catheter  110  is well lubricated. The area of the glans penis around the urinary meatus is washed with a cleansing agent, such as benzalonium chloride. Due to the potential for inducing pain, the area surrounding the urinary means may be pretreated with a topical anesthetic before insertion; depending upon the circumstances, a muscle relaxant may be indicated.  
         [0092]     The preferred size of the catheter  110  will be responsive to the orifice through which the catheter is inserted. The choice of pharmaceutical agents to be infused prior to or during treatment will be responsive to judgments by medical personnel, and may include lubricants, anesthetics, antispasmodics, anti-inflammatories, antibiotics or other agents.  
         [0093]     In a step  502 , the catheter  110  is introduced into the urethra along the anterior wall. The catheter is advanced 17.5-25 centimeters. Since the length from the bladder to the end of the glans penis varies, the distance that the catheter is advanced in responsive to the judgment of medical personnel.  
         [0094]     In a step  503 , the catheter  110  is positioned near the target area for treatment. In the preferred embodiment, viewing apparatus coupled to the port  131  may be used to examine the region and determine which specific tissues are targeted for treatment.  
         [0095]     In a step  504 , a syringe is connected to the female coupling  132 ,  133  or  134 .  
         [0096]     In a step  505 , the syringe is used to exert positive pressure and inflate the balloon  123  with air or liquid. Inflation of the balloon  123  serves several purposes. In addition to positioning the electrode  122 , the balloon  123  also helps anchor the catheter  110 . If necessary, a second balloon  123 , located distally, can also be inflated to anchor the balloon  123  in the bladder.  
         [0097]     In a step  506 , inflation of the balloon  123  causes expansion of the set of struts  121 . Any corrections in the positioning of the catheter  110  are made at this time, using the visual apparatus coupled through port  131 .  
         [0098]     In a step  507 , one or more electrodes  122  are selected for extension. The mechanical switch  135  is used to extend at least one electrode into the targeted tissue.  
         [0099]     In a step  508 , RF energy is provided to the electrodes so as to create lesions upon targeted regions of the urethra and bladder. In a preferred embodiment, the RF energy has a frequency between 435 and 485 kilohertz. The RF energy is received by the tissue immediately near the electrodes. The device can be repositioned by rotation or translation so that RF energy is delivered to multiple sites to create a pattern of lesions over several centimeters of tissue. Creation of these lesions has the effect of causing the involuntary sphincter to shrink so that urine does not seep through. In alternative embodiments, muscle contraction (and the consequence shrinkage of the involuntary sphincter) can be achieved by application of chemical stimulation. In other alternative embodiments, the electrodes are controlled by a feedback technique using at least one sensor  126 , such as an impedance or temperature sensor.  
         [0100]     In a step  509 , flowable substances are provided through the holes in the electrodes  122 , the struts  121  and/or the micropores in the balloon  123  if needed to immediately cool down the region and prevent collateral thermal damage. The nature, temperature and amount of the flowable substance are responsive to judgments by medical personnel.  
         [0101]     In a step  510 , the electrodes  122  are retracted back into the set of struts  121 .  
         [0102]     In a step  511 , the balloon  123  is deflated by negative pressure on the syringe. Deflation of the balloon  123  causes the expandable cage structure  120  to collapse.  
         [0103]     In a step  512 , the catheter  110  is withdrawn from the glans penis.  
         [0104]     Fifth Method of Operation  
         [0105]      FIG. 6  is a process flow diagram of a method for treatment of a hemorrhoid.  
         [0106]     A method  600  is performed using a catheter and electrode assembly  100 .  
         [0107]     In a step  601 , the tapered tip  113  of the catheter  110  is well lubricated. An enema is performed to clear the area of fecal matter. The rectum and surrounding area are washed with a cleansing agent such as benzalonium chloride. Due to the potential for inducing pain, the area surrounding the rectum may be presented with a topical anesthetic before insertion; depending upon the circumstances, a muscle relaxant may be indicated.  
         [0108]     The preferred size of the catheter  110  will be responsive to the orifice through which the catheter is inserted. The choice of pharmaceutical agents to be infused prior to or during treatment will be responsive to judgments by medical personnel, and may include lubricants, anesthetics, antispasmodics, anti-inflammatories, antibiotics or other agents.  
         [0109]     In a step  602 , the catheter  110  is introduced into the anus and advanced along the walls of the sphincter. Since hemorrhoids and pilonital cysts may occur anywhere along this passage, the distance that the catheter is introduced is responsive to the judgment of medical personnel.  
         [0110]     In a step  603 , the catheter is positioned near the internal hemorrhoid, external hemorrhoid or cyst that is targeted for ablation. In the preferred embodiment, viewing apparatus coupled to the port  131  may be used to examine the region and determine which specific tissues are targeted for ablation. Ultrasound or fluoroscopy may also be employed to help position the catheter  110 .  
         [0111]     In a step  604 , a syringe is connected to the female coupling  132 ,  133  or  134 .  
         [0112]     In a step  605 , the syringe is used to exert positive pressure and inflate the balloon  123  with air or with a liquid. Inflation of the balloon  123  serves several purposes. In addition to positioning the electrode  122 , the balloon  123  also helps anchor the catheter  110 , seal off the region and prevent contamination with fecal matter.  
         [0113]     In a step  606 , inflation of the balloon  123  causes expansion of the set of struts  121 . Any corrections in the positioning of the catheter  110  are made at this time, using the visual apparatus coupled through port  131 .  
         [0114]     In a step  607 , one or more electrodes  122  are selected for extension. The mechanical switch  135  is used to extend at least one electrode  122  into the targeted tissue.  
         [0115]     In a step  608 , RF energy is provided to the electrodes so as to ablate the hemorrhoid or cyst. In a preferred embodiment, the RF energy has a frequency between 435 and 485 kilohertz. The RF energy is received by the tissue immediately near the electrodes. The tissue is heated for a short period of time until ablation occurs. In an alternative embodiment, the electrodes are controlled by a feedback technique using at least one sensor  126 , such as an impedance or temperature sensor.  
         [0116]     In a step  609 , flowable substances are provided through the holes in the electrodes  122 , the struts  121  and/or the micropores of balloon  123  if needed to immediately cool down the region and prevent collateral thermal damage. The nature, temperature and amount of the flowable substance are responsive to judgments by medical personnel.  
         [0117]     In a step  610 , the electrodes  122  are retracted back into the set of struts  121 .  
         [0118]     In a step  611  the balloon  123  is deflated by negative pressure on the syringe. Deflation of the balloon  123  causes the expandable cage structure  120  to collapse.  
         [0119]     Steps  605  through  611  are repeated as necessary until all hemorrhoids or cysts are removed.  
         [0120]     In a step  612 , the catheter  110  is withdrawn from the anus.  
         [0121]     Sixth Method of Operation  
         [0122]      FIG. 7  is a process flow diagram of a method for treatment of an anal fissure.  
         [0123]     A method  700  is performed using a catheter and electrode assembly  100 .  
         [0124]     In a step  701 , the tapered tip  113  of the catheter  110  is well lubricated. An enema is performed to clear the region of fecal matter. The anus and rectal area are washed with a cleansing agent such as benzalonium chloride. Due to the potential for inducing pain, the area surrounding the anus may be pretreated with a topical anesthetic before insertion; depending upon the circumstances, a muscle relaxant may be indicated.  
         [0125]     The preferred size of the catheter  110  will be responsive to the orifice through which the catheter is inserted. The choice of pharmaceutical agents to be infused prior to or during treatment will be responsive to judgments by medical personnel, and may include lubricant, anesthetics, antispasmodics, anti-inflammatories, antibiotics or other agents.  
         [0126]     In a step  702 , the catheter  110  is introduced into the anus and advanced along the walls of the sphincter. The distance that the catheter  110  is introduced is responsive to the judgment of medical personnel.  
         [0127]     In a step  703 , the catheter  110  is positioned near an anal fissure. In the preferred embodiment, viewing apparatus coupled to the port  131  may be used to examine the region and determine which specific tissues are targeted for ablation and where collagen should be deposited. Ultrasound or fluoroscopic imaging can also be used to position the catheter  110 .  
         [0128]     In a step  704 , a syringe is connected to the female coupling  132 ,  133  or  134 .  
         [0129]     In a step  705 , the syringe is used to exert positive pressure and inflate the balloon  123  with air or with a liquid. Inflation of the balloon  123  serves several purposes. In addition to positioning the electrode  122 , the balloon  123  also helps anchor the catheter  110 . In an alternative embodiment, a second balloon  123  can be inflated, if necessary to help anchor the catheter  110 .  
         [0130]     In a step  706 , inflation of the balloon  123  causes expansion of the set of struts  121 . Any corrections in the position of the catheter  110  are made at this time, using the visual apparatus coupled through port  131 .  
         [0131]     In a step  707 , one or more electrodes  122  are selected for extension. The mechanical switch  135  is used to extend at least one electrode  122  into the targeted tissue.  
         [0132]     In a step  708 , collagen is deposited into the fissure.  
         [0133]     In a step  709 , RF energy is provided to the electrodes so as to harden the collagen for filling the fissure. In a preferred embodiment, the RF energy has a frequency between 435 kilohertz and 485 kilohertz. The RF energy is received by the tissue immediately near the electrodes. The tissue is heated for a short period of time until the collagen is sufficiently hardened. In an alternative embodiment, the electrodes are controlled by a feedback technique using at least one sensor  126  such as an impedance or temperature sensor.  
         [0134]     In a step  710 , other flowable substances are provided through the holes in the electrodes  122 , the struts  121  and/or the micropores of the balloon  123 , if needed to immediately cool down the region and prevent collateral damage. The nature, temperature and amount of the flowable substance are responsive to judgments by medical personnel.  
         [0135]     In a step  711 , the electrodes  122  are retracted back into the set of struts  121 .  
         [0136]     In a step  712 , the balloon  123  is deflated by negative pressure on the syringe. Deflation of the balloon  123  causes the expandable cage structure  120  to collapse.  
         [0137]     In a step  713 , the catheter  110  is withdrawn from the anus.  
       ALTERNATIVE EMBODIMENTS  
       [0138]     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.