Abstract:
This invention provides a method and system for the curative treatment of female uro-genital disorders. One aspect of the invention is that it allows the gynecologist to coagulate the entire endometrium and upper layers of the myometrium in one short procedure that can be performed in a physician&#39;s office or other outpatient setting, using local or regional anesthesia. A second aspect of the invention is that it can be used to tighten the urethral sphincter and bladder outlet.

Description:
INCORPORATED DISCLOSURES 
     This application claims the priority of U.S. Provisional Application No. 60/130405, Express Mail Mailing number EJ651971575US, filed on Apr. 19, 1999. 
    
    
     This invention is submitted in the name of the following inventor: 
     
       
         
               
               
               
             
           
               
                   
               
               
                 Inventor 
                 Citizenship 
                 Residence Address 
               
               
                   
               
             
             
               
                 Stuart D. Edwards 
                 United States 
                 658 Westridge Drive 
               
               
                   
                   
                 Portola Valley, CA 94028 
               
               
                   
               
             
          
         
       
     
     The assignee is Genesis Medical Technologies, a California corporation having an office in Sunnyvale, Calif. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to treating menorrhagia, female urinary incontinence and other related uro-genital conditions. 
     2. Related Art 
     Female uro-genital tract disorders include menorrhagia (excessive uterine bleeding) and urinary incontinence. Although both menorrhagia and urinary incontinence cause much embarrassment, they frequently remain untreated. 
     Causes of menorrhagia include disorders within the uterus itself such as fibroids, and (more rarely) endometrial cancer. When a specific cause cannot be identified, the condition is termed dysfunctional uterine bleeding. 
     Causes of female urinary incontinence include disturbances in the complex interplay of anatomic structures that control continence such as hypermobility or intrinsic sphincteric deficiency. Hypermobility is a lack of anatomic stability caused primarily by weak surrounding tissue; intrinsic sphincteric deficiency is the inability of the urinary sphincter muscles to function properly as a valve or otherwise. 
     The known art of treating female uro-genital disorders includes a variety of different treatments. Treatments for menorrhagia include drug therapy, dilation and curettage (D &amp; C), hysterectomy, myomectomy and hysteroscopic resection of the endometrium. Treatments for female incontinence include both maintenance measures (for example, diapers, pharmaceutical remedies, foley catheters, behavioral therapy and vaginal pessaries) and surgical treatments. 
     A first drawback to treatment of female uro-genital disorders involves the risks associated with the known art of surgical treatment of menorrhagia. Surgical approaches to the treatment of menorrhagia can be highly invasive, ineffective or high-risk procedures. In addition to causing sterility, procedures such as hysterectomy have a high complication rate, lengthy recovery time and place the patient at increased risk for osteoporosis. Procedures such as dilation and curettage are fertility-sparing, but are ineffective for removal of submucosal fibroids. Techniques such as hysteroscopic resection of the endometrium with ablation devices such as the electrode loop, the rollerball and the laser are highly technical and have only been adopted by a small number of highly trained gynecological surgeons. 
     A second drawback to the known art of treating female uro-genital disorders involves risks and inefficacy of surgical treatments of female urinary incontinence. Many of these treatments aim to (1) elevate and ensure support of the urethrovesical junction or (2) provide additional support to the bladderneck and associated structures by introducing bulking agents, foreign bodies and other substances. Most surgical treatments suffer from many of the same problems as do treatments of menorrhagia. Surgical treatment is not generally appropriate for all types of incontinence; it is particularly inappropriate for urge or mixed incontinence. Lastly, the support provided by bulking agents, foreign bodies and other substances tends to be very short term; such agents degrade and get absorbed into surrounding tissues, requiring retreatment. 
     A third drawback to the known art of treating female uro-genital disorders involves the relative inefficacy of maintenance approaches to urinary incontinence. These treatments all aim to provide a technique to help the patient deal with the condition and minimize lifestyle problems associated with incontinence. While these treatments may allow a patient to achieve a short-term measure of control, they do not remedy the underlying defect. 
     Accordingly, it would be advantageous to provide a method and system for treatment of female uro-genital disorders that is curative, easy to learn, requires only local or regional anesthesia, does not induce side effects and is not subject to drawbacks of the known art. This advantage is achieved in embodiments of an invention in which radiofrequency (RF) energy is applied to uro-genital tissues so as to cause shrinkage and remodeling, reshaping, bulking and other treatment effects. 
     SUMMARY OF THE INVENTION 
     This invention provides a method and system for the curative treatment of female uro-genital disorders by application of radiofrequency (RF) energy to targeted tissues. Application of this energy is selectively applied so as to ablate, tighten, shrink or reshape the tissue and thereby correct an unwanted condition. 
     A first embodiment of the invention involves using a radiofrequency generator and disposable treatment unit to deliver radiofrequency energy to the interior of the uterus, enabling a gynecologist or other medical personnel to coagulate the entire endometrium and upper layers of the myometrium in one short procedure that can be performed in a physician&#39;s office or other outpatient setting using local or regional anesthesia. 
     A second embodiment of the invention involves using a radiofrequency generator and a disposable treatment unit bearing two to four relatively small needle electrodes. The electrodes are positioned in the middle third of the urethra and energy is applied, causing shrinkage of the circular external urethral sphincter muscle. The tiny sites of treated muscle resorb, remodel and shrink in the weeks that follow treatment, causing a circumferential tightening of the urethral sphincter muscle. This treatment is curative of stress urinary incontinence that is, at least in part, secondary to sphincter muscle deficiency. 
     A third embodiment of the invention also involves using a radiofrequency generator and a treatment unit bearing two to four relatively small U-shaped electrodes. This treatment unit includes an irrigation balloon that is immediately proximate to the U-shaped electrodes. As saline irrigation cools and protects the bladder muscosa, RF energy is delivered to the submucosal bladder outlet musculature and connective tissue. The tiny sites of treated muscle resorb, remodel and shrink in the weeks that follow treatment, causing a circumferential tightening of the bladder outlet and a subsequent improvement in urinary continence via both decreased bladder outlet mobility and increased proximal urethra filling pressures. 
     A fourth embodiment of the invention also involves using a radiofrequency generator. The difference between this embodiment and the other embodiments is that the RF energy is delivered to the anterior and posterior regions of the vaginal wall. This has the effect of tightening of vaginal walls so as to increase support of the bladder outlet, proximal and mid-urethra. Moreover, circumferential tightening of the vaginal wall may provide physical and psychological improvement in the area of sexual function. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a block diagram showing a first embodiment of the distal end of a system that can be used for intrauterine ablation. 
     FIG. 2 is a block diagram showing a second embodiment of the distal end of a system that can be used for urethral remodeling. 
     FIG. 3 is a block diagram showing a third embodiment of the distal end of a system that can be used for remodeling the bladder outlet. 
     FIG. 4 is a block diagram showing a fourth embodiment of the distal end of a system that can be used for vaginal remodeling. 
     FIG. 5 is a block diagram showing the proximal end of systems for intrauterine ablation, urethral remodeling and bladder outlet remodeling. 
     FIG. 6 is a process flow diagram showing method for using a first embodiment for intrauterine ablation. 
     FIG. 7 is a process flow diagram showing a method for using a second embodiment for urethral remodeling. 
     FIG. 8 is a process flow diagram showing a method for using a third embodiment for remodeling the bladder outlet. 
     FIG. 9 is a process flow diagram showing a method for using a fourth embodiment for vaginal remodeling. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     In the following description, a preferred embodiment of the invention is described with regard to preferred process steps and data structures. Those skilled in the art would recognize, after perusal of this application, that embodiments of the invention can be implemented using circuitry or other structures adapted to particular process steps and data structures, and that implementation of the process steps and data structures described herein would not require undue experimentation or further invention. 
     System Elements 
     FIG. 1 is a block diagram showing a first embodiment of the distal end of a system that can be used for intrauterine ablation. 
     A system  100  includes a treatment element  110 , a shaft and a control apparatus. The treatment element  110  is mounted on the most distal end of the shaft in such a way that the treatment element  110  and shaft form one contiguous piece. This figure is restricted to describing the treatment element  110 . The shaft and control apparatus are described in greater detail in FIG.  5 . 
     The treatment element  110  includes a distal tip  111 , an irrigation port  112 , one or more electrodes  113  and a plurality of lumens  115  (not shown). 
     The distal tip  111  is composed of a long, relatively narrow tubular element composed of relatively stiff, biologically non-reactive plastic that is disposed for insertion into a uterus via the vagina and cervix. In a preferred embodiment, the distal tip  111  is an extension of the shaft  510  (described supra). 
     The irrigation port  112  is located at the most distal end of the distal tip  111 . A variety of liquids can be administered through the irrigation port  112 , including cooling liquids such as saline, Ringers or water, and pharmacological agents such as antibiotics, anti-inflammatories, anti-spasmodics and anesthetics. 
     In a preferred embodiment, suction can also be applied via the irrigation port  112  so as to remove fluids or to cause the interior of the uterus to be more closely conformed to the treatment element  110 . 
     The electrodes  113  include needle-like tips mounted either at the very end of the distal tip  111  or placed equidistantly from each other around the exterior diameter of the distal tip  111 . Each electrode  113  also includes a thermocouple  114  so that the temperature of each electrode  113  can be monitored separately. 
     In a preferred embodiment, the electrodes  113  are disposed to deliver RF  2  energy to the interior of a uterus. In other embodiments, the electrodes  113  may be disposed to deliver microwave, laser, ELF (extremely low frequency) or other therapeutic energies. 
     The lumens  115  are disposed to control the electrodes  113 , transmit the RF energy or channel the fluids to the irrigation port  112 . All of the lumens  115  traverse the entire length of the shaft. They terminate at the treatment element  110  either at an electrode  113 , a thermocouple  114  or the irrigation port  112 . 
     FIG. 2 is a block diagram showing a second embodiment of the distal end of a system that can be used for urethral remodeling. 
     A system  200  includes a treatment element  210 , a shaft and a control apparatus. The treatment element  210  is mounted on the most distal end of the shaft in such a way that the treatment element  210  and shaft form one contiguous unit. This figure is restricted to describing the treatment element  210 . The shaft and control apparatus are described in greater detail in FIG.  5 . 
     The treatment element  210  includes a distal tip  215 , a sponge  220 , a set of electrodes  225  and a plurality of lumens  230  (not shown) Depending upon the judgment of the physician, the treatment element  310  can be used in conjunction with the introducer  235  and sheath  240 . 
     The distal tip  215  is mounted on the distal terminus of the shaft and control assembly (described supra). In a preferred embodiment, the distal tip  215  is composed of relatively stiff, biologically inert material that is disposed so as to be inserted into a urethra. 
     The sponge  220  is mounted on the proximal end of the distal tip  215 . Although the relative length of the sponge  220  is comparable to the length of the distal tip  215 , the non-compressed total diameter of the sponge  220  is approximately twice the diameter of the distal tip  215 . In a preferred embodiment, the sponge  220  is disposed to be filled with saline or other cooling liquids that are delivered to the sponge  220  through one or more of the lumens  230 . This cooling fluid serves to minimize thermal damage to tissues when the electrodes  225  are deployed. Delivery of other fluids, such as drug solutions may also be achieved using the sponge  220 . 
     The electrodes  225  are take the form of very slightly arced needles that are approximately three fourths the total length of the distal tip  215 . The electrodes  225  are positioned so they emerge from the middle section of the sponge  220  with each electrode  225  being relatively equidistant to the others around the exterior diameter of the sponge  220 . The electrodes  225  emerge from the sponge at a  45  degree angle thereto, with the distal end of the electrodes  225  pointed in the general direction of the distal tip  215 . The proximal end of each electrode  225  is coupled to a lumen  230  that is disposed to conduct radiofrequency or other types of energy to the electrode  225 . The distal end of each electrode  225  is somewhat beveled so as to facilitate piercing the tissue. In a preferred embodiment, the system  200  includes four such electrodes; however, a greater or lesser number of electrodes are also possible. 
     Each electrode  225  includes at least one thermocouple  226 . The thermo-couple  226  continuously measures the temperatures of each individual electrode  115 . This constant temperature monitoring, combined with a computerized control algorithm allows each electrode  225  to be monitored separately in order to achieve safe and effective treatment temperatures. Any electrode  225  exceeding temperature safety limits can be immediately disengaged without aborting the entire procedure. 
     The plurality of lumens  230  traverse the entire length of the catheter from the control apparatus to the treatment element  210 . Some of these lumens  230  can be disposed to deliver a variety of drugs, such as antibiotics, anesthetics and other pharmaceutical agents as deemed appropriate by the physician. Other lumens  230  are disposed to deliver cooling fluids such as saline, Ringers, sterile water or other solutions deemed appropriate by the physician. Still other lumens  230  are disposed to deliver energy to the electrodes  225 . In a preferred embodiment, radiofrequency energy is used; however the lumens  230  of other embodiments may be used to deliver microwave, ultrasound, extremely low frequency (ELF), electromagnetic, laser and other forms of therapeutic energy. 
     The introducer  235  can be used in conjunction with the treatment element  210  and sheath  240 . Use of the introducer  235  and sheath  240  is entirely optional. The introducer  235  a relatively long hollow tube made from a disposable, biologically nonreactive material. The overall diameter of the introducer  225  is such that it can be easily passed into a urethra. The interior diameter is such that the sheath  240  and treatment element  210  may be disposed to fit snugly inside the introducer  235 . 
     The sheath  240  is a tube which is deployed inside the introducer  235 . A hemoseal  241  forms within the sheath  240 , thereby preventing the passage of urine, pus, cooling fluids or other substances out through the sheath  240 . 
     In a preferred embodiment, the introducer  235  and sheath  240  are passed into the urethra as a single unit (that is, with the sheath  240  contained inside the introducer  235 ) through the urethra. The introducer  235  is removed, leaving the sheath  240  in place. The treatment unit  210  is inserted into and through the sheath  240 , which is then pulled back several centimeters into the proximal urethra so that the treatment element  210  may be deployed. Following treatment, the treatment element  210  is drawn into the sheath  240  and removed from the urethra. 
     FIG. 3 is a block diagram showing a third embodiment of the distal end of a device that can be used for remodeling of the bladder outlet. 
     A system  300  includes a treatment element  310 , a shaft and a control apparatus. Similar to systems  100  and  200 , the treatment element  310  is mounted on the most distal end of the shaft in such a manner that the shaft and treatment element  310  form one contiguous unit. This figure is restricted to describing the treatment element  310 . The shaft and control apparatus are described in greater detail in FIG.  5 . 
     The treatment element  310  includes a distal tip  315 , an irrigation balloon  320 , a set of U-shaped electrodes  325  and a plurality of lumens  330 . The treatment element  310  is used in conjunction with the introducer  335  and sheath  340 . 
     The distal tip  315  is mounted on the distal terminus of the catheter and control assembly (described supra). In a preferred embodiment, the distal tip  310  is composed of relatively stiff, biologically inert material that is disposed so as to be inserted into a urethra. 
     The irrigation balloon  320  is composed of microporous, transparent, biologically inert material. The distal end of the irrigation balloon  320  is fused with the proximal end of the distal tip  315 ; the proximal end of the irrigation balloon  320  is fused with the body of the shaft, immediately adjacent to the distal end of the U-shaped electrodes  325 . The over length of the balloon  320  is approximately three times as long as the distal tip  315 ; the inflated diameter is approximately one and a half time the total length of the distal tip  315 . In a preferred embodiment, the irrigation balloon  320  is disposed to provide a cooling surface and deliver cooling liquids to the bladder outlet and adjacent tissues. 
     Other preferred embodiments of the irrigation balloon  320  also include an external mapping electrode network  321  (not shown) that aids in the identification of nervous pathways responsible for the “urge sensation” and the involuntary detrussor muscle contractions that define urge urinary incontinence. Once identified, these pathways can be subsequently modified using nerve ablation techniques. 
     The set of U-shaped electrodes  325  are mounted on the shaft almost immediately proximate to the irrigation balloon  320 . The proximal end of each U-shaped electrode  320  is coupled to a lumen  325 ; the distal end each U-shaped electrode  320  terminates in a beveled tip, with the beveled side facing away from the shaft in such a way that the hooked end can be easily deployed in the tissue of a bladder outlet. In a preferred embodiment, two—four U-shaped electrodes  325  are used. Other embodiments may deploy different arrays and different numbers of electrodes  325 . 
     Each U-shaped electrode  325  includes at least one thermocouple  326 . The thermocouple  326  continuously measures the temperatures of each individual electrode  325 . This constant temperature monitoring, combined with a computerized control algorithm allows each U-shaped electrode  325  to be monitored separately in order to achieve safe and effective treatment temperatures. Any U-shaped electrode  325  exceeding temperature safety limits can be immediately disengaged without aborting the entire procedure. 
     The plurality of lumens  330  traverse the entire length of the shaft and terminate at the treatment element  310 . Some of these lumens  330  can be disposed to deliver a variety of drugs, such as antibiotics, anesthetics and other pharmaceutical agents as deemed appropriate by the physician. Other lumens  330  are disposed to deliver cool fluids such as saline, Ringers, sterile water or other solutions deemed appropriate by the physician. Still other lumens  330  are disposed to deliver energy to the electrodes  325 . In a preferred embodiment, radiofrequency energy is used; however, in other embodiments, the lumens  330  may be used to deliver microwave, ultrasound, extremely low frequency (ELF), electromagnetic, laser and other forms of therapeutic energy. 
     The introducer  335  is used in conjunction with the treatment element  310  and sheath  340 . The indroducer  335  a relatively long hollow tube made from a disposable, biologically nonreactive material. The overall diameter of the introducer  225  is such that it can be easily passed into a bladder. The interior diameter is such that the sheath  340  and treatment element may be disposed to fit snugly inside the introducer  335 . 
     The sheath  340  is a tube which is deployed inside the introducer  335 . A hemoseal forms within the sheath  340 , thereby preventing the passage of urine, pus, cooling fluids or other substances out through the sheath  340 . 
     In a preferred embodiment, the introducer  335  and sheath  340  are passed into the bladder as a single unit (that is, with the sheath  330  contained inside the introducer  335 ) through the urethra. The introducer  335  is removed, leaving the sheath  340  in place. The treatment unit  310  and catheter are inserted into and through the sheath  340 , which is then pulled back several centimeters into the proximal urethra so that the treatment element  310  may be deployed. Following treatment, the treatment element  310  is drawn into the sheath  340  and removed from the urethra. 
     FIG. 4 is a block diagram showing a fourth embodiment of a device that can be used for vaginal remodeling. 
     A system  400  includes a treatment element  410 . The proximal end of the treatment element  410  is coupled to an RF generator. The distal end of the treatment element  410  is inserted into a vagina using a speculum. 
     The treatment element  410  includes a blade  420  and a handle  430  composed of relatively hard, biologically non-reactive plastic. In a preferred embodiment the blade  420  and handle  430  form a single contiguous unit. A plurality of lumens  440  (not shown) traverse the interior length of the blade  420  and handle  430 . 
     The blade  420  includes mating features  421 , a spring-loaded pin detail  422 , a plurality of relatively flat electrodes  423  and a plurality of irrigating fluid delivery pores  425 . 
     The mating features  421  are constructed to engage with features in the speculum following simple positioning of the speculum within the vagina. 
     The spring loaded pin detail  422  locks the blade  420  into the correct position in the inserted speculum. 
     The plurality relatively flat electrodes  423  are each coupled to one or more of a series of lumens  440  that traverse the entire interior of the treatment unit  410  and terminate at the energy port  432  on the handle  430 . In a preferred embodiment, these electrodes  423  are disposed to deliver RF energy. However, in other embodiments the electrodes  423  may also deliver microwave energy, ELF (extremely low frequency energy), laser and other forms of therapeutic energy. 
     Each electrode  423  includes at least one thermocouple  424  that is used to monitor the temperature of each electrode  423 . This constant temperature monitoring, combined with a computerized control algorithm, is utilized to independently control the electrodes  423 . If one of the electrodes  423  exceeds temperature safety limits, that particular one of the electrodes  423  can be disengaged without aborting the entire procedure. 
     The irrigating fluid delivery pores  425  are also coupled to some of the plurality of lumens  440  and are disposed to deliver cooling liquids so as to minimize thermal damage. 
     The handle  430  includes a retractable lock pin  43   1 , an energy port  432  and two irrigating fluid ports  433 . 
     The retractable lock pin  431  controls the spring-loaded pin detail  422  so that when the retractable lock pin  431  is engaged, it causes spring-loaded pin detail  422  to become locked into position in the speculum. 
     The energy port  432  is located at the proximal end of the handle  430  and is disposed to be coupled to an RF generator or other energy source. The energy port  432  is coupled to the proximal end of the plurality of lumens  440  that run through the interior of the handle  430  and blade  420  terminating a t the electrodes or cooling liquid ports  425 . 
     The irrigating fluid delivery port  433  is disposed to deliver irrigating fluids, drugs and other liquids such as may be deemed appropriate. The fluids are introduced through one of the irrigating fluid delivery port  433  through the lumens  440  to the irrigating fluid delivery pores  425 . The fluids are removed from the body through the other irrigating fluid delivery port  433 . 
     FIG. 5 is a block diagram showing the proximal end of devices for intrauterine ablation, urethral remodeling and, bladder outlet remodeling. 
     A system  500  is used to control the delivery of energy and fluids through the first, second and third embodiments described infra (that is devices for intrauterine ablation, urethral remodeling and, bladder outlet remodelling). 
     A system  500  includes a shaft  510  and control apparatus  515 . The control apparatus  515  houses all the elements needed to control the treatment element  110 , treatment element  210  or treatment element  310 . As such, the control apparatus  515  includes a handle  520 , a electrode control element  525 , an electric connector  530 , a fluid input port  535 , a fluid output port  540  and an inflation control port  545 . 
     The shaft  510  is a relatively long tubular element, coupled on the distal end to treatment element  110 , treatment element  210  or treatment element  310 , and coupled on the proximal end to the control apparatus  515 . The shaft  510  is comprised of relatively hard plastic and is disposed to house lumens  130 , lumens  230  or lumens  340 , which traverse the entire length of the shaft  510 . 
     The electrode control element  525  is mounted on the most distal portion of the control apparatus  525  immediately adjacent and contiguous with the handle  520 . The electrode control element  525  is coupled to proximal end of some of the lumens  130 , lumens  230  or lumens  340 . As such, the electrode control element  525  can be used to activate or deactivate electrodes includes in systems  100 ,  200  or  300 . These electrodes can be controlled either individually or in combination. 
     The electric connector  530  is mounted on the most proximal end of the control apparatus  525 . As such, it is coupled to the most proximal end of some of the lumens  130 ,  230  or  330  that traverse the interior of the shaft  510  and handle  520 . In a preferred embodiment, the electric connector  530  is disposed to be connected to an RF generator. In other embodiments, the electric connector  530  can be disposed to be connected to a generator of microwaves, ELF, laser or other therapeutic energy. 
     The fluid input port  535  is mounted immediately between the electric connector  530  and the fluid output port  540  on the top portion of the control apparatus  525 . The proximal end of some of the lumens  130 , lumens  230  or lumens  340  terminate at the fluid input port  525 . 
     In a preferred embodiment, the fluid input port  525  is disposed to be coupled to a source of irrigating fluid, cooling liquids or pharmaceutical liquids. Substances that can be introduced through the fluid input port  525  include sterile saline, sterile water, Ringers, antibiotic solutions, local or regional anesthetics and other agents. 
     Fluid output port  540  is immediately adjacent to the fluid input port  535 . The interior portion of the fluid output port  540  is coupled to some of the lumens  130 ,  230  or  330 . 
     In a preferred embodiment the fluid output port  530  may be coupled to a pump or other apparatus to remove fluids. 
     The inflation control port  545  is used with the system  300  for remodelling the bladder outlet. The inflation control port  545  is situated adjacent to the electric connector  530  on the bottom side of the control apparatus  525 . The interior of the inflation control port  525  is coupled to some of the lumens  330  that terminate in the irrigation balloon  320 . Positive or negative pressure may be applied to the inflation control port  525  so as to inflate or deflate the irrigation balloon  320 . 
     Method of Use 
     FIG. 6 is a process flow diagram showing method for using a first embodiment for intrauterine ablation. 
     A method  600  is performed to shrink discrete portions of the interior of a uterus, causing ablation of portions of the smooth muscle, so as to cause an improvement in menorrhagia and relate uterine conditions. Sterile technique is used throughout the procedure. 
     At a flow point  601 , the patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. The patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as Betadine or benzalkonium chloride. The position of the patient and choice of cleansing agent are responsive to judgments by the physician. 
     In a step  602 , the external genitalia may be pretreated with a topical anesthetic before insertion of the distal tip  111 . Depending upon the circumstances, a muscle relaxant or short term tranquilizer may be indicated. The choice of topical anesthetic or other pharmacological agent are responsive to the judgments of the physician. 
     At a step  603 , the electric connector  530  is coupled to a radio frequency generator or other source of therapeutic energy. 
     At a step  604 , inflation or fluid infusion apparatus is coupled to the fluid input port  535 . A pump or other apparatus may be coupled to the fluid output port  540 . In this way, cooling fluids and pharmacological agents may be administered. 
     At a step  605 , the distal tip  111  is lubricated. The distal tip  111  is introduced into the vagina, through the cervix and into the uterus. In a preferred embodiment, insertion may be facilitated by the use of a speculum, introducer tube and other apparatus. The choice of lubricant and additional apparatus is responsive to judgments by medical personnel. 
     At a step  606 , the treatment element  110  is positioned within the uterus so as to be in optimal contact with the tissue to be treated. 
     In a step  607 , the fluid input port  535  is manipulated so as to begin infusing a cooling fluid to the irrigation port  112 . 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 and prevents collateral thermal damage of the uterine walls and associated tissues. In alternative embodiments, other devices may be coupled to the fluid input port  535  to chill the cooling fluid or cause sonic cooling, gas expansion, magnetic cooling or others cooling methodologies. Other substances such lubricants, anesthetics, anti-spasmodics, anti-inflammatories, antiobiotics or other agents as deemed appropriate by the judgment of medical personal may also be administered via the fluid input port  535 . The choice of cooling fluid or methodology or pharmaceutical substances is responsive to judgments by medical personnel. 
     In a step  608 , the electrode control element  525  is manipulated so as to extend the electrodes  113  into the targeted uterine tissue. The electrodes  113  penetrate the mucosal (surface) tissue lining and enter more deeply into the underlying smooth muscle of the uterus. As the saline irrigation flows, radiofrequency energy is delivered through the electrodes  113 , creating areas of ablative lesions within the interior of the uterus. During this step, the temperatures of the electrodes  113  are monitored. If necessary, the radiofrequency energy supply to any electrode  113  can be discontinued. 
     In a preferred embodiment, the position of the treatment element  110  can be altered so and the physician may repeat the treatment sequence so as to selectively ablate other areas in the interior of the uterus. 
     This treatment causes the affected area to shrink and be relatively strengthened, so as to relieve menorrhagia and other related uterine disorders. The tiny sites of treated muscle will ultimately resorb, remodel and shrink over the ensuing weeks. 
     In a step  609 , the fluid output port  540  is manipulated so as to apply suction and remove excess fluids. 
     In a step  610 , the electrodes  113  are deactivated and drawn back into the treatment element  110 . 
     In a step  611 , the treatment element  110  is withdrawn from the uterus through the cervix and vagina. Other apparatus may be used to facilitate removal. 
     FIG. 7 is a process flow diagram showing a method for using a second embodiment for urethral remodeling. 
     A method  700  is performed to shrink the circular, external urethral sphincter muscle, so as to cause an improvement in its relative ability to retain urine. Sterile technique is used throughout the procedure. 
     At a flow point  701 , the patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. The patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as Betadine or benzalkonium chloride. The position of the patient and the choice of cleansing agent are responsive to judgments of the physician. 
     At a step  702 , the area surrounding the urinary meatus may be pretreated with a topical anesthetic before insertion of the distal tip  215 . Depending upon the circumstances, a muscle relaxant or short term tranquilizer may be indicated. The choice of topical anesthetic and other drugs is responsive to judgments by the physician. 
     At a step  703 , the electric connector  530  is coupled to a radio frequency generator or other source of therapeutic energy. 
     At a step  704 , inflation or fluid infusion apparatus is coupled to the fluid input port  535 . A pump or other apparatus may be coupled to the fluid output port  540 . In this way, cooling fluids and pharmacological agents may be administered. 
     In a step  705 , the treatment element  210  and shaft  510  are housed in the introducer  235  and sheath  240 . In other preferred embodiments, the introducer  235  and sheath  240  are not used. This step is optional. 
     At a step  706 , the distal tip  215  and exterior portion of the introducer  235  are lubricated. The distal tip  215  is 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. The introducer  235  and sheath  240  are passed into the urethra as a single unit. 
     In other preferred embodiments, the introducer  235  and sheath  240  are not used. In these embodiments, the distal tip  215  is lubricated and introduced without the use of additional apparatus. 
     In a step  707 , the introducer  235  is removed, leaving the sheath  240  in place. A hemoseal within the sheath  240  prevents the leakage of urine or irrigating fluids out through the sheath  240 . In embodiments that do not use the introducer  235  or sheath  240 , this step does not take place. 
     In a step  708 , the physician checks the position of the treatment element  210 . In a preferred embodiment, the treatment element  210  is positioned within the middle third of the urethra (based on simple urethral length measured determined prior using a scaled foley catheter). 
     In a step  709 , the fluid input port  535  is manipulated so as to begin infusing a cooling fluid to the sponge  220 . 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 and prevents collateral thermal damage to the urethral wall and associated structures. In alternative embodiments, other devices may be coupled to the fluid input port  535  to chill the cooling fluid or cause sonic cooling, gas expansion, magnetic cooling or others cooling methodologies. Other substances such lubricants, anesthetics, anti-spasmodics, anti-inflammatories, antibiotics or other agents as deemed appropriate by the judgment of medical personal may also be administered via the fluid input port  535 . The choice of cooling fluid or methodology or pharmaceutical substances is responsive to judgments by medical personnel. 
     In a step  710 , the electrode control element  525  is manipulated so as to extend the needle electrodes  225  into the targeted tissue. The needle electrodes  225  penetrate the mucosal (surface) tissue lining and enter more deeply into the underlying urethra sphincter musculature. As the saline irritation flows, radiofrequency energy is delivered through the electrodes  225 , creating four areas of ablative lesions within the sphincter muscle. During this step, the temperatures of the electrodes  225  is monitored. If necessary, the radiofrequency energy supply to any electrode  225  can be discontinued. 
     In a preferred embodiment, the position of the treatment element  210  can be altered so and the physician may repeat the treatment sequence within the urethral sphincter so as to create more areas of ablation lesions within the muscle. 
     This treatment causes the affected area to shrink and be relatively strengthened, so as to better retain urine. The tiny sites of treated muscle will ultimately resorb, remodel and shrink over the ensuing weeks, resulting in circumferential tightening of the urethral sphincter muscle and a subsequent improvement in urinary continence. 
     In a step  711 , the fluid output port  540  is manipulated so as to apply suction and remove excess fluids. 
     In a step  712 , the electrodes  225  are deactivated and drawn back into the treatment element  210 . If a sheath  240  was used, it is restored to its original position. 
     In a step  713 , the treatment element  210  and sheath  240  (if used) are withdrawn from the urethra. 
     FIG. 8 is a process flow diagram showing a method for using a third embodiment for remodeling of the bladder outlet. 
     A method  800  is performed to reduce the size of the bladder outlet (the base of the bladder), resulting in decreased mobility during episodes of increased intra-abdominal pressure and increased resistance to the passage of urine into the proximal urethra during such episodes, thereby reducing urinary incontinence. 
     At a flow point  801 , the patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. The patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as Betadine, or benzalkonium chloride. The positioning of the patient and choice of cleansing agent are responsive to the judgment of the physician. 
     At a step  802 , the area surrounding the urinary meatus may be pretreated with a topical anesthetic before insertion of the distal tip  315 . Depending upon the circumstances, a muscle relaxant or short term tranquilizer may be indicated. The choice of pharmaceutical agents to be used are responsive to judgments by the physician. 
     In a flow point  803 , the electric connector  530  is coupled to a radiofrequency generator or other source of therapeutic energy. 
     In a flow point  804 , inflation or fluid infusion apparatus is coupled to the inflation control port  545 . A pump or other apparatus may be coupled to the fluid output port  540 . In this way, cooling fluids and pharmacological agents may be circulated through the multiporous irrigation balloon  320 . 
     In a step  805 , the treatment element  310  and shaft  510  are housed in the introducer  335  and sheath  340 . 
     At a step  806 , the distal tip  315  and exterior portion of the introducer  335  are lubricated. The distal tip  315  is 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. The introducer  335  and sheath  340  are passed through the urethra and into the bladder as a single unit. 
     In a step  807 , the introducer  335  is removed, leaving the sheath  340  in place. A hemoseal within the sheath  340  prevents the leakage of urine or irrigating fluids out through the sheath  340 . 
     In a step  808 , the physician checks the position of the treatment element  310 . In a preferred embodiment, the treatment element  310  is positioned in the interior of the bladder, so as to be relatively proximate to the bladder outlet. The depth of insertion is determined by prior measurements obtained using a scaled foley catheter. 
     In a step  809 , the inflation control port  535  is manipulated so as to begin infusing a cooling fluid to the to the irrigation balloon  320 . As the balloon inflates, the fluid cools and protects the mucosal surfaces in the bladder. 
     In a step  810 , sheath  340  is pulled back several centimeters into the proximal urethra so that the electrodes may be deployed at the bladder outlet. In a preferred embodiment, the exposed U-shaped electrodes  325  become ensnared in the tissue comprising the interior of the bladder outlet. 
     In a step  811 , the U-shaped electrodes  325  penetrate the mucosal (surface) tissue lining of the bladder outlet and enter more deeply into the underlying musculature. As the saline irritation flows, radiofrequency energy is delivered through the U-shaped electrodes  325 , creating four areas of ablative lesions within the muscle. During this step, the temperatures of individual electrodes  325  are monitored. If necessary, the radiofrequency energy supply to any individual electrode  325  can be discontinued. 
     In a preferred embodiment, the position of the treatment element  310  can be altered so and the physician may repeat the treatment sequence within the bladder so as to create more areas of ablation lesions within the muscle. 
     In another preferred embodiment, the external mapping electrode network  321  may be engaged to identify nerves associated with the urge to urinate. Radiofrequency energy may be directed at these areas so as to ablate the identified nerves. 
     In another preferred embodiment, bulking agents, foreign bodies and other substances, such as organic microspheres, collagens, silicone, PVC and other organic breathable and unbreathable polymers are exuded from selected electrodes  325  into tissues comprising the bladder outlet. The type of microspheres and bulking substances and the locations where they are exuded are responsive to judgment by medical personnel. These substances can be used to strengthen these structures so as to prevent incontinence caused by stress. 
     These treatments cause the affected area to shrink and be relatively strengthened, so as to better retain urine. The tiny sites of treated muscle will ultimately resorb, remodel and shrink over the ensuing weeks, resulting in circumferential tightening of the urethral sphincter muscle and a subsequent improvement in urinary continence 
     In a step  811 , the inflation control port and/or the fluid output fluid output port  540  are manipulated so as to apply suction, deflate the irrigation balloon  320  and remove excess fluids. 
     In a step  812 , the sheath  340  is restored to its original position. 
     In a step  813 , the treatment element  310  and sheath  340  are withdrawn from the urethra. 
     FIG. 9 is a process flow diagram showing a method for using a fourth embodiment for vaginal remodeling. 
     A method  900  is performed to create a series of lesions in either the anterior vaginal wall, the posterior vaginal wall or both. Remodeling of the anterior wall treats incontinence based on bladder outlet hypermobility by increasing support for the bladder outlet, as well as the proximal and mid-urethra. Remodeling both the anterior wall and posterior wall provide circumferential vaginal wall tightening, resulting physical and psychological improvement in the area of sexual function. The method  900  is performed using sterile technique. 
     At a flow point  901 , the patient has voided and is positioned on a treatment table, in an appropriate position such as horizontal, jackknife or lithotomy. The patient&#39;s external genitalia and surrounding anatomy are cleansed with an appropriate agent such as Betadine, or benzalkonium chloride. The positioning of the patient and choice of cleansing agent are responsive to the judgment of the physician. 
     In a step  902 , the energy port  432  is coupled to an RF generator or other source of therapeutic energy. 
     In a step  903 , the irrigating fluid ports  433  are coupled to a source of irrigating fluid, a pump, a drug delivery apparatus or other equipment. The choice of fluid and apparatus is responsive to judgments on the part of the physician. 
     In a step  904 , a speculum is inserted in the patient&#39;s vagina. The blades of the speculum are placed in an open position. The physician determines optimal areas of treatment. These may include the anterior wall, the posterior wall or both. 
     In a step  905 , the blade  420  of the system  400  is inserted into the vagina through the speculum. The handle  430  is manipulated so as to cause the mating features  421  to engaged with the speculum. 
     In a step  906 , the retractable lock pin  431  is retracted, so as to cause the spring-loaded pin detail  422  to become locked into position in the speculum. 
     In a step  907 , at least one of the irrigating fluid ports  433  is engaged so as to delivery cooling fluid into the vagina through the irrigating fluid delivery pores  425 . The other port  433  may be engaged so as to remove fluid. 
     In a step  908 , the energy port  432  is manipulated so as to cause delivery of RF energy to discrete areas of the vaginal wall. 
     In alternative embodiments, other forms of energy may be delivered, such as microwave, laser, ELF (extremely low frequency) and other therapeutic energies. 
     In a preferred embodiment, the blade  420  may be disengaged and relocked into another position in the speculum, so as to delivry energy to another area of the vagina. 
     In a step  909 , one of the irrigating fluid ports  433  is manipulated so as to stop the flow of cooling fluid or other substances into the vagina. The other irrigating fluid port  433  is manipulated so as to remove excess fluid from the vagina. 
     In a step  910 , retractable lock pin  431  is manipulated so as to release the spring-loaded pin detail  422  from the speculum. The blade  420  is withdrawn from the vagina. The speculum is closed and removed. 
     Alternative Embodiments 
     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.