Patent Publication Number: US-8968284-B2

Title: Apparatus and methods for treating female urinary incontinence

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 13/443,713, filed Apr. 10, 2012, Publication No. US-2012-0197247-A1, which is a continuation of U.S. patent application Ser. No. 11/431,213, filed May 10, 2006, now U.S. Pat. No. 8,177,781, which is a continuation of U.S. patent application Ser. No. 10/273,900, filed Oct. 16, 2002, now U.S. Pat. No. 7,306,591, which is a continuation-in-part of U.S. patent application Ser. No. 10/207,689, filed Jul. 25, 2002, now U.S. Pat. No. 7,291,129, which is a continuation-in-part of U.S. patent application Ser. No. 09/678,500, filed Oct. 2, 2000, now U.S. Pat. No. 6,470,219, each of which is incorporated by reference in their entirety. 
    
    
     INCORPORATION BY REFERENCE 
     All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
     FIELD 
     This invention relates to apparatus and methods for treating urinary incontinence, and more particularly, for treating female urinary incontinence in humans by applying a selected form of energy to tissue in the vicinity of the urethra and/or bladder outlet to cause a change in tissue compliance without substantially narrowing the urethral lumen and/or bladder outlet. 
     BACKGROUND 
     The term “urinary incontinence” refers to the involuntary leakage of urine from the body in an uncontrolled manner. One cause of incontinence is increased mobility of the bladder outlet (bladder outlet hypermobility) where the bladder and proximal urethra do not maintain their normal anatomic positions during transient periods of increased bladder pressure due to increased intra-abdominal pressure. In addition, there is a small region of circular muscle surrounding the middle portion of the urethra in the female called the “urethral sphincter,” which also participates in the controlled release of urine from the bladder. If the bladder outlet becomes too mobile and/or if the urinary sphincter or any other part of the urinary system malfunctions, the result may be urinary incontinence. 
     Urinary incontinence can generally be characterized into two types, one of which is called “stress incontinence” and the other “urge incontinence.” Stress incontinence refers to involuntary loss of urine during coughing, laughing, sneezing, jogging or other physical activity that causes a sufficient increase in intra-abdominal pressure. Urge incontinence refers to the involuntary loss of urine due to unwanted bladder contraction that may be associated with an uncontrollable desire to urinate. “Mixed incontinence” refers to a combination of both urge and stress incontinence. 
     Heretofore, many different types of treatment have been utilized to treat female urinary incontinence including surgical and non-surgical procedures including the injection, under cystoscopic and/or fluoroscopic visualization, of collagen or other material into the tissue surrounding or adjacent to the bladder outlet and/or proximal urethra. In addition, drug therapy also has been utilized, for example, drugs to treat the detrusor muscle, which is the bladder wall muscle responsible for contracting and emptying the bladder. All of these procedures and therapies have drawbacks, are relatively expensive, and in the case of injections, require the equipment and training necessary to perform cystoscopic and/or fluoroscopic visualization of the urethra and bladder outlet. There is therefore a need for a new and improved apparatus and method for treatment of female urinary incontinence. 
     In view of the drawbacks of previously-known devices, it would be desirable to provide apparatus and methods for treating female urinary incontinence using an elongated shaft configured to be introduced via the urethral orifice and advanced through the urethral lumen to enable energy delivery to surrounding tissue. 
     It further would be desirable to provide apparatus and methods for treating female urinary incontinence that allow a physician to remodel the urethral wall and/or bladder outlet without the need for a visualization device, e.g., a cystoscope or fluoroscope. 
     It still further would be desirable to provide apparatus and methods for treating female urinary incontinence by techniques that do not carry risks associated with surgical incisions, such as infection and herniation, and do not result in external scarring. 
     SUMMARY OF THE DISCLOSURE 
     In view of the foregoing, it is an object of the present invention to provide apparatus and methods for treating female urinary incontinence using an elongated shaft configured to be introduced via the urethral orifice and advanced through the urethral lumen to enable energy delivery to surrounding tissue. 
     It further is an object of the present invention to provide apparatus and methods for treating female urinary incontinence that allow a physician to remodel the urethral wall and/or bladder outlet without the need for a visualization device, e.g., a cystoscope or fluoroscope. 
     It still further is an object of the present invention to provide apparatus and methods for treating female urinary incontinence by techniques that do not carry risks associated with surgical incisions, such as infection and herniation, and do not result in external scarring or require dressings or bandages. 
     These and other objects of the present invention are accomplished by providing apparatus comprising a handle, an elongated shaft having a distal region, an expandable member, and means for treating the submucosal layer of the urethral wall and/or bladder outlet to cause a change in tissue compliance without substantially narrowing the urethral and/or bladder outlet lumen. 
     In a preferred embodiment, the handle is coupled to a proximal end of the elongated shaft and is manipulated by the physician to insert the distal region into a patient&#39;s urethra, either individually or using an appropriate introducer sheath. The handle includes an actuator for deploying the expandable member. 
     In accordance with one aspect of the present invention, the expandable member is deployable at a predetermined distance distal of the means for treating. The expandable member may comprise a balloon or mechanically actuated basket that is configured to be moved between a contracted position, which permits insertion of the expandable member through the urethra and into the patient&#39;s bladder, and a deployed position, wherein the expandable member anchors against the bladder outlet. The expandable member facilitates tactile alignment of the means for treating at a desired treatment site, without the need for direct visualization. 
     In one embodiment of the present invention, the means for treating comprises at least one needleless electrode embedded in a lateral surface of the elongated shaft. The needleless electrode is coupled to a radio frequency generator/controller that causes the electrode to reach a desired temperature to heat the urethral tissue. In accordance with principles of the present invention, cooling fluid is provided in the vicinity of the electrode to cool the urethral and bladder outlet mucosa during the provision of RF energy. The application of RF energy causes denaturation of collagen in small localized areas where treatment is delivered. Following cessation of energy delivery, these microscopic foci of denatured collagen renature and heal, ultimately creating minute areas of decreased tissue compliance without substantial anatomic change. 
     In an alternative embodiments of the present invention, the means for treating comprises an ultrasound transducer disposed on the elongated shaft. The ultrasound transducer is coupled to an ultrasound generator/controller. Ultrasound beams generated by the transducer may be focused in accordance with known techniques to cause a rise in tissue temperature at a desired distance beneath the mucosal layer of the urethra. Collagen denaturation and subsequent renaturation caused by the rise in temperature changes the tissue compliance in the vicinity of the urethra and/or bladder outlet without substantial anatomic change. 
     In a further alternative embodiment of the present invention, the means for treating comprises at least one hollow needle having contracted and deployed states and a cryogenic probe adapted to be inserted through the hollow needle. In the contracted state, the hollow needle is disposed within the confines of the elongated shaft, while in the deployed state, the hollow needle extends beyond the elongated shaft to pierce through urethral tissue and/or bladder outlet mucosa. The cryogenic probe is advanced through the hollow needle to a treatment site within the urethral tissue to locally freeze tissue and cause necrosis, which in turn causes remodeling of tissue in the vicinity of the urethra and/or bladder outlet. 
     Methods of using the apparatus of the present invention to induce localized areas of decreased tissue compliance, and to reduce or eliminate the effects of urinary incontinence, also are provided. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features of the invention, its nature and various advantages will be more apparent from the accompanying drawings and the following detailed description of the preferred embodiments, in which: 
         FIGS. 1A-1E  are, respectively, side and side sectional views of a device to treat urinary incontinence, cross-sectional views along lines A-A and B-B of  FIG. 1B , and a schematic view depicting use of apparatus of  FIG. 1A ; 
         FIGS. 2A-2C  are, respectively, a side view of a first embodiment of the present invention and side sectional views of alternative means for cooling the mucosa in conjunction with the apparatus of  FIG. 2A ; 
         FIG. 3  is a schematic view depicting the use of apparatus of  FIG. 2 ; 
         FIG. 4  is a side view of an alternative embodiment of the present invention; 
         FIG. 5  is a schematic view depicting the use of apparatus of  FIG. 4 ; 
         FIGS. 6A-6C  are, respectively, a side view of a further alternative embodiment of the present invention, and cross-sectional views along lines C-C and D-D of  FIG. 6A ; 
         FIG. 7  is a schematic view depicting the use of apparatus of  FIG. 6 ; 
         FIGS. 8A-8B  are side sectional views illustrating the use of an alternative expandable member; 
         FIG. 9  is a side view of a device that allows movement of a means for treating with respect to an expandable member; 
         FIGS. 10A-10D  are, respectively, a side sectional view of apparatus of  FIG. 9  in a first position, cross-sectional views along line E-E of  FIG. 10A  illustrating two alternative configurations, and a side sectional view of apparatus of  FIG. 9  in a second position; and 
         FIG. 11  is a side view of a device that allows movement of an expandable member with respect to a means for treating. 
     
    
    
     DETAILED DESCRIPTION 
     Referring now to  FIG. 1 , a device to treat urinary incontinence, described in U.S. Pat. No. 6,470,219, which is herein incorporated by reference in its entirety, is shown. Apparatus  20  comprises semi-rigid elongated tubular shaft  22  having proximal and distal extremities  23  and  24 , distal region  72 , and lumen  26  extending from proximal extremity  23  to distal extremity  24 . 
     Handle  31  has proximal and distal ends, and is configured to be grasped by the human hand. The distal end of handle  31  is coupled to proximal extremity  23  of elongated shaft  22 . The proximal end of handle  31  preferably comprises rear surface  33  through which electrical connector  34  extends. Handle  31  further comprises fluid-in port  36 , fluid-out port  37  and, optionally, auxiliary port  39 . 
     It will be apparent to those skilled in the art that handle  31  may comprise any suitable exterior shape that is configured to be grasped by a human hand, and is not intended to be limited by the exterior shapes depicted herein. An illustrative, alternative handle shape is depicted in commonly-assigned U.S. patent application Ser. No. 10/207,689, which is herein incorporated by reference in its entirety. 
     Plurality of needle electrodes  41 - 44 , which are sharpened at their distal extremities, are disposed within distal region  72  of elongated shaft  22  in a contracted state. Needle electrodes  41 - 44  assume a preformed shape in a deployed state, i.e., when they are no longer constrained within elongated shaft  22 , and preferably comprise a shape-memory material such as a nickel-titanium alloy. In the deployed state, needle electrodes  41 - 44  curve outwardly and downwardly to provide a fishhook-like configuration, as shown in  FIG. 1A . Needle electrodes  41 - 44  are disposed in suitable angular positions, as for example, spaced circumferentially in a single plane 90° apart. This is accomplished by slidably mounting needle electrodes  41 - 44  in plurality of PEEK hypotubes  46  in four spaced-apart lumens  47  of Pebax block  48 , as shown in  FIG. 1D . 
     Pebax block  48  is mounted in a fixed position in distal region  72  of elongated shaft  22 . Needle electrodes  41 - 44  extend proximally through hypotubes  46  and are mounted in fixed positions in four lumens  49  spaced apart in Pebax block  51 , as shown in  FIG. 1C . 
     Pebax block  51  is slidably mounted within elongated shaft  22 . Rod  53  has a distal extremity mounted in a fixed position in centrally disposed lumen  54  of block  51  and extends proximally from block  51  and into recess  56  of handle  31 . Slide block  58  has outwardly extending protrusion  59  coupled to rod  53 , as shown in  FIG. 1B . Knob  57  is slidably mounted on the exterior of handle  31  and is secured to protrusion  59 , e.g., using a screw. Movement of knob  57  longitudinally with respect to handle  31  causes needle electrodes  41 - 44  to be moved between extended and retracted positions in hypotubes  46 . 
     Cooling liquid preferably is supplied via elongated shaft  22  so that it is discharged in the vicinity of needle electrodes  41 - 44  via tubing  61 . Tubing  61  is in turn connected to fitting  36 . Tubing  62  is connected to fitting  37  and extends distally into lumen  26  of tubular member  22 , through block  51 , and terminates at block  48 , where it is placed in communication with return lumen  63  in block  48 . Tubing  61  continues through block  48  and opens into shaft  66 , which extends distally from block  48 . 
     Expandable member  55  is disposed on shaft  66  and illustratively comprises a balloon. As will be described hereinbelow with respect to  FIGS. 8A-8B , expandable member  55  alternatively may comprise a mechanically self-deployable basket. 
     Shaft  66  has openings  60  disposed within expandable member  55 . Openings  60  are in fluid communication with tubing  61  and are used to inflate expandable member  55 . Expandable member  55  is provided with plurality of openings  74  through which the cooling liquid introduced into expandable member  55  may escape and be discharged in the vicinity of needle electrodes  41 - 44  to cool the tissue being treated, as hereinafter described. The cooling liquid, after it has performed its function, is aspirated through central return lumen  63  to fitting  37 . Alternatively, openings  74  may be disposed directly in a lateral surface of shaft  22 , as depicted by openings  74 ′ in  FIG. 1B . 
     Fittings  36  and  37  are connected by tubing  75  to irrigation pump/controller  64 , as depicted in  FIG. 1A . Controller  64  supplies a cooling liquid, such as room temperature water, to fitting  36  and may also aspirate the liquid through fitting  37  after it has been used. 
     Plurality of insulated wires  65  are connected to electrical connector  34  with slack being provided within handle  31 . Electrical connector  34  is adapted to be connected to RF generator/controller  68  by cable  69 , as depicted in  FIG. 1A . 
     Wires  65  extend distally through lumen  26  of elongated shaft  22 , through lumens in blocks  48  and  51 , and are coupled to four thermocouple wires (not shown) extending through hollow needles  41 - 44 . The thermocouple wires are connected to thermocouples  67 , which are mounted in sharpened tips of needles  41 - 44  for measuring needle-tip temperatures, as shown in  FIG. 1B . 
     Referring now to  FIG. 1E , a preferred method for treating urinary incontinence using apparatus  20  is described. Atraumatic tip  71 , which is disposed distal of expandable member  55 , is inserted into urethra U of a patient with expandable member  55  and needles  41 - 44  being provided in contracted states. Elongated shaft  22  is distally advanced within urethra U so that expandable member  55  is positioned within bladder B, e.g., using markings  76  of  FIG. 1B . Expandable member  55  then is deployed, e.g., by inflating a balloon via fluid-in port  36 . Expandable member  55  then is retracted proximally so that expandable member  55  is anchored against bladder outlet O, as shown in  FIG. 1E . 
     After expandable member  55  has been seated against bladder outlet O, a physician distally advances knob  57  with respect to handle  31  to cause needles  41 - 44  to be advanced from their retracted positions within distal region  72  of elongated shaft  22 . Needles  41 - 44  move distally and sidewise beyond the outer cylindrical profile of elongated shaft  22  and into the urethral tissue in the vicinity of bladder outlet O, as shown in  FIG. 1E . 
     After needles  41 - 44  have been deployed, radio frequency energy is supplied from RF generator/controller  68 . As is well known to those skilled in the art, such a generator may be configured to provide impedance readings that give an indication of whether or not needle electrodes  41 - 44  have been properly positioned within the tissue. 
     Liquid is introduced in the vicinity of needle electrodes  41 - 44  via irrigation pump/controller  64  and openings  74 , as described hereinabove, to cool the mucosal layer of the urethral wall. Radio frequency energy then is supplied to the needle electrodes at a power level ranging from 1 to 10 watts for a period of time ranging from 60 to 90 seconds to achieve approximately an 70° C. temperature in the tissue being treated, while the overlying mucosal tissue is preserved by the cooling liquid flow. In accordance with one aspect of the present invention, it is desirable that the tissue not to reach a temperature of 100° C. Therefore, RF generator  68 , utilizing the information supplied from thermocouples  67 , is programmed to automatically turn off if the temperature reaches a pre-set temperature, e.g., 80° C. Otherwise, for the duration of the treatment, the RF power is adjusted to maintain the tissue being treated at the desired target temperature. 
     Once the first RF treatment has been completed, the radio frequency energy is turned off and knob  57  is retracted to withdraw needle electrodes  41 - 44  into their retracted positions within distal region  72  of elongated shaft  22 . The device then may be rotated a predetermined angle, the needles redeployed and another radio frequency energy treatment may be applied to surrounding tissue. During this entire procedure, irrigation liquid is introduced through openings  74  of expandable member  55  and/or openings  74 ′ of shaft  22 . As the irrigation fluid progressively fills the bladder during each RF treatment, the geometry of the bladder outlet changes as the bladder is filled such that repeated seating of the expandable member results in the electrode location moving progressively towards the bladder outlet. 
     In connection with the RF treatments described hereinabove, tiny sites of collagen in the vicinity of the treatment site renature over the ensuing weeks. Such treatment results in changes in tissue compliance of the bladder outlet and/or urethral walls to cause a significant improvement in urinary incontinence. 
     Referring now to  FIGS. 2-3 , a first embodiment of the present invention that utilizes a plurality of needleless electrodes to treat urinary incontinence is described. Apparatus  80  comprises elongated shaft  82  having proximal and distal ends and distal region  86  disposed adjacent to the distal end. Handle  84  is provided in accordance with handle  31  of  FIG. 1 , except as noted below, and is coupled to the proximal end of elongated shaft  82 . 
     Elongated shaft  82  further comprises at least one needleless electrode  90  capable of transmitting radio frequency energy. Needleless electrode  90  may comprise a hollow, curved surface, as depicted in  FIGS. 2B-2C , and preferably is manufactured from stainless steel. Needleless electrode  90  preferably is embedded into a lateral surface of elongated shaft  82  so that curved regions  107  and  108  of electrode  90  extend within an interior portion of elongated shaft  82 , while outer surface  101  of electrode  90  is disposed outside of and faces away from elongated shaft  82 , as shown in  FIGS. 2B-2C . 
     Elongated shaft  82  further comprises irrigation port  91  and optional aspiration port  92 , which are coupled to irrigation tubing  104  and aspiration tubing  105 , respectively. Irrigation tubing  104  and aspiration tubing  105  extend proximally from their respective ports  91  and  92 , through elongated shaft  82  and handle  84 , and are coupled to fluid-in and fluid-out ports  93  and  94 , respectively. Fluid-in and fluid-out ports  93  and  94  in turn are coupled to fluid controller  106 . 
     In  FIGS. 2A and 2B , irrigation and aspiration ports  91  and  92  are illustratively disposed in a lateral surface of elongated shaft  82  adjacent to electrode  90 . In an alternative embodiment shown in  FIG. 2C , irrigation and aspiration ports  91  and  92  may be omitted and irrigation and aspiration tubing  104  and  105  may be coupled to first and second curved ends  107  and  108  of hollow electrode  90 , respectively. In this embodiment, fluid infused into irrigation tubing  104  flows through hollow electrode  90  to provide a cooling effect upon outer surface  101 , then is aspirated through tubing  105 . 
     Apparatus  80  of  FIG. 2  further comprises wire  98  and thermocouple wire  99 , each having proximal and distal ends. The distal ends of wire  98  and thermocouple wire  99  are coupled to needleless electrode  90 , as shown in  FIGS. 2B-2C , while the proximal ends extend through elongated shaft  82  and handle  84 . Wire  98  and thermocouple wire  99  preferably are coupled to electrical connector  110  of handle  84 , which in turn is connected to RF generator/controller  109  by cable  111 . 
     Apparatus  80  further comprises expandable member  87  that is deployable at a predetermined distance distal of needleless electrode  90 . Expandable member  87  may comprise a balloon that is disposed on distal region  86  or, alternatively, a self-expanding mechanical basket as described hereinbelow with respect to  FIGS. 8A-8B . 
     Referring now to  FIG. 3 , a preferred method for using apparatus  80  of  FIG. 2A  is described. In a first step, atraumatic tip  85  at the distal end of elongated shaft  82  is inserted into a patient&#39;s urethra U with expandable member  87  in a contracted state. Expandable member  87  is positioned within bladder B, e.g., using measurement indicia  96  disposed near the proximal end of elongated shaft  82  (see  FIG. 2A ). Expandable member  87  is deployed and handle  84  is retracted proximally so that expandable member  87  is anchored against bladder outlet O. 
     In accordance with the present invention, retracting expandable member  87  against bladder outlet O positions needleless electrodes  90  at a desired treatment site within urethra U using only tactile feedback. Once properly positioned, liquid is introduced to irrigation port  91  via irrigation pump  106  to provide a cooling effect to mucosal layer M of the urethra. Radio frequency energy then is supplied to needleless electrode  90  to achieve a temperature of approximately 70° C. in the tissue being treated, i.e., the submucosal tissue S of the urethral wall. The overlying mucosal tissue M is preserved by the cooling liquid flow. Preferably, the submucosal tissue is not heated to a temperature significantly higher than 70° C. Therefore, RF generator  109 , utilizing the information supplied from thermocouple  97 , preferably is programmed to automatically turn off if the temperature reaches a pre-set temperature, as for example, 80° C. Otherwise, for the duration of the treatment, the RF power is adjusted to maintain the sub-mucosal tissue at the desired target temperature. 
     After this first RF treatment has been completed, the radio frequency energy is turned off and the device can be advanced into the bladder lumen and rotated a predetermined angle so that needleless electrode  90  may contact a new interior surface of urethra U. Once electrode  90  has been rotated to the desired angle, handle  84  is retracted proximally to seat expandable member  87  in bladder outlet O, and RF energy is provided to needleless electrode  90 , as described hereinabove. Upon completion of the procedure, expandable member  87  is contracted and elongated shaft  82  is removed from the patient&#39;s urethra. 
     As described hereinabove with respect to the embodiment of  FIGS. 1A-1E , the RF treatments produce collagen denaturation in small, localized areas where the treatment is delivered, followed by collagen renaturation and remodeling over the ensuing weeks and months, thereby resulting in changes in tissue compliance within the urethra and/or bladder outlet. 
     Referring now to  FIGS. 4-5 , a further alternative embodiment of the present invention is described wherein high intensity focused ultrasound (HIFU) is applied to treat urinary incontinence. HIFU involves directing high intensity ultrasound waves at the selected tissue to create heat in a precise area and cause coagulation and tissue necrosis. 
     In  FIG. 4 , apparatus  120  comprises elongated shaft  121  having proximal and distal ends and distal region  122  disposed adjacent to the distal end. Handle  128  is coupled to the proximal end of elongated shaft  121  and may comprise inflation port  137  that is in fluid communication with expandable member  123 , illustratively a balloon. Alternatively, expandable member  123  may comprise a self-expanding mechanical basket as described hereinbelow with respect to  FIGS. 8A-8B . 
     Elongated shaft  121  further comprises therapeutic ultrasound transducer  124  disposed on elongated shaft  121  just proximal of distal region  122 . Ultrasound transducer  124  is capable of transmitting at therapeutic ultrasound frequencies. Transducer  124  preferably comprises an annular phased array, and is coupled to a transmission cable (not shown) disposed in a lumen of elongated shaft  121 . The transmission cable extends proximally and is coupled to electrical connector  129  of handle  128 . Electrical connector  129  in turn is connected to ultrasound generator/controller  131  by cable  130 , as depicted in  FIG. 4 . 
     Referring now to  FIG. 5 , a preferred method of using apparatus  120  of  FIG. 4  is described. Atraumatic tip  132  at the distal end of elongated shaft  121  is inserted into a patient&#39;s urethra U with expandable member  123  in a contracted state. Expandable member  123  is positioned within a patient&#39;s bladder B, e.g., using measurement indicia  133  of  FIG. 4 . Expandable member  123  then is deployed and handle  128  is retracted proximally so that expandable member  123  is anchored against bladder outlet O. In accordance with the present invention, retracting expandable member  123  against bladder outlet O positions transducer  124  at a desired treatment site within urethra U using only tactile feedback. 
     Ultrasound generator/controller  131  is turned on and set to the desired frequency to cause transducer  124  to emit ultrasonic beams. Ultrasound beams  126  are focused to cause a rise in tissue temperature at a desired distance beneath mucosal layer M of urethra U. The heating of the desired submucosal tissue causes localized denaturation of the tissue. The change in submucosal tissue created by the denaturation and renaturation of the collagen results in changes in tissue compliance of the urethral wall and/or bladder outlet, thereby reducing urinary incontinence. 
     Referring now to  FIGS. 6-7 , a further alternative embodiment of the present invention is described whereby cryogenic therapy is used to treat urinary incontinence by controlled freezing of selected urethral tissue. 
     In  FIG. 6A , cryogenic therapy apparatus  140  comprises elongated shaft  142  having proximal and distal ends and reduced diameter distal region  144  disposed adjacent to the distal end. Handle  141  is coupled to the proximal end of elongated shaft  142  and may comprise inflation port  159  that is in fluid communication with expandable member  145 , illustratively a balloon. Alternatively, expandable member  145  may comprise a self-expanding mechanical basket as described hereinbelow with respect to  FIGS. 8A-8B . 
     Apparatus  140  further comprises at least one hollow needle  143  and cryogenic probe  152 . Needle  143  has proximal and distal ends and sharpened tip  147  disposed at the distal end. The proximal end of each hollow needle  143  is coupled to knob  146 . Although four hollow needles are illustrated in  FIG. 6C , it will be apparent to those skilled in the art that greater or fewer needles may be used. 
     Handle  141  further comprises proximal port  150  having at least one probe insertion hypotube  151 , as depicted in  FIG. 6B . Each probe insertion hypotube  151  corresponds to a respective needle  143 . Each probe insertion hypotube  151  comprises an outer diameter that preferably is slightly smaller than an inner diameter of hollow needle  143 . A proximal end of each probe insertion hypotube  151  is affixed to proximal port  150  while a distal end of each hypotube  151  extends into the proximal end of its respective hollow needle  143  to create an overlap between the distal end of the hypotube and the proximal end of the needle, as shown in  FIG. 6C . This overlap allows needles  143  to move with respect to probe insertion hypotubes  151  when knob  146  is actuated. 
     Cryogenic probe  152  has proximal and distal ends and tip  153  disposed at the distal end. Handle  154  is coupled to the proximal end of cryogenic probe  152  and is configured to be grasped by a physician. Cryogenic probe  152  is powered and controlled by cryogenic generator  156  via wire  155 , which is coupled to handle  154 . Cryogenic probe  152  comprises an outer diameter configured to be inserted into probe insertion hypotube  151  and through hollow needle  143 . 
     Referring now to  FIG. 7 , a preferred method of using apparatus  140  of  FIG. 6A  to treat urinary incontinence is described. Atraumatic tip  157  at the distal end of elongated shaft  142  is inserted into a patient&#39;s urethra U with needle  143  in a contracted state, i.e., retracted within the confines of elongated shaft  142 , and also with expandable member  145  provided in a contracted state. Expandable member  145  is positioned within a patient&#39;s bladder B, e.g., using measurement indicia  158 . Expandable member  157  then is deployed within bladder B and handle  141  is retracted proximally so that expandable member  157  is anchored against bladder outlet O. In accordance with one aspect of the present invention, retracting expandable member  157  against bladder outlet O positions needle  143 , when deployed, at a desired treatment site within urethra U using only tactile feedback. 
     Needle  143  then is actuated by distally advancing knob  146 , which urges needle  143  to extend beyond elongated shaft  142 , pierce mucosal layer M of urethra U, and extend into submucosal layer S. Needle  143  preferably comprises a shape-memory material that causes the distal end to curve to a predetermined shape when needle  143  is no longer confined within elongated shaft  142 . 
     Cryogenic probe  152  then is inserted into probe insertion hypotube  151  at proximal port  150  and is advanced distally via probe insertion hypotube  151  into hollow needle  143 . Cryogenic probe  152  is advanced distally until it extends distal of needle  143  and into submucosal layer S of the urethra, as shown in  FIG. 7 . Needle  143 , having a larger diameter relative to probe  152 , serves to dilate the submucosal tissue prior to insertion of the probe so that the probe encounters reduced resistance from the tissue. 
     Cryogenic generator  156  is turned on and set to the desired temperature, which preferably is between about −80° F. and −110° F., to cause local regions of the submucosal tissue to freeze. The local regions of tissue and tip  153  may freeze together for about three minutes, after which time probe  152  is defrosted and removed from within elongated shaft  142  and handle  141 . If desired, a physician then may re-insert probe  152  into a different insertion hypotube  151  and the procedure may be repeated through a different needle  143  to treat another region within submucosal layer S. In accordance with principles of the present invention, the application of cryogenic probe  152  to the submucosal tissue causes small localized regions of submucosal tissue to undergo necrosis, after which tissue healing ensues. This results in altered tissue elasticity, tensile strength, and tissue compliance in the urethra and/or bladder outlet, and causes a significant improvement in urinary incontinence. 
     Referring now to  FIGS. 8A-8B , an alternative expandable member is described for use with any of the treatment techniques described hereinabove. Apparatus  170  comprises self-expandable basket  172 , shown in a deployed state in  FIG. 8B , instead of a balloon. Basket  172  preferably comprises a plurality of flexible struts  171  joined to rod  176  via hinges  180 . Struts  171 , which may be covered by a biocompatible elastomeric membrane (not shown), are constrained in a contracted position within central lumen  177  of elongated shaft  181 , as illustrated in  FIG. 8A . Struts  171 , which preferably comprise a shape-memory material such as Nitinol, assume a predetermined curvature extending radially outward from elongated shaft  181  in the deployed state, i.e., when struts  171  are no longer effectively constrained within central lumen  177 , as shown in  FIG. 8B . 
     Rod  176  has proximal and distal ends and is disposed through central lumen  177 . Preferably, rod  176  includes atraumatic distal tip  178  disposed at the distal end. The proximal end of rod  176  is configured to be manipulated by a physician. 
     In operation, atraumatic tip  178  and elongated shaft  181  are inserted into the patient&#39;s urethra in a manner described hereinabove. Once distal end  184  of elongated shaft  181  is positioned within a patient&#39;s bladder, the proximal end of rod  176  is advanced distally by a physician to self-deploy mechanically expandable basket  172 , as depicted in  FIG. 8B . Once basket  172  is deployed within the bladder, elongated shaft  181  and rod  176  are retracted proximally to cause basket  172  to become anchored against the bladder outlet. 
     At this time, needles  183  may be deployed from elongated shaft  181  to penetrate the urethral wall to perform a radio frequency treatment of the tissue. Alternatively, needles  183  may be omitted and needleless radio frequency waves or ultrasound beams may be used to treat incontinence, as described hereinabove. 
     After the preferred treatment is completed, basket  172  is returned to the contracted configuration by retracting rod  176  proximally with respect to elongated shaft  181  to cause struts  171  to be contained within central lumen  177 . 
     Referring now to  FIGS. 9-10 , apparatus and methods for longitudinally advancing the spacing between the tissue treating elements and the expandable member are described. In  FIG. 9 , apparatus  200  is provided in accordance with apparatus  20  of  FIG. 1 , except as noted below. Apparatus  200  comprises handle  202  and knob  204 , which are similar in structure to handle  31  and knob  57  of  FIG. 1 , respectively. 
     Apparatus  200  further comprises elongated shaft  206  having proximal and distal ends and actuator  214  disposed about the proximal end. Measurement indicia  212  preferably are provided on a lateral surface of elongated shaft  206 . Illustratively, needle electrodes  210  are shown for providing energy to the submucosal layer of the urethral wall, although it will be apparent that needleless electrodes, an ultrasound transducer or cryogenic probe, as described hereinabove, may be substituted for needle electrodes  210 . 
     Apparatus  200  further comprises shaft  208  having proximal and distal ends and expandable member  209  disposed on the distal end. Shaft  208  preferably is affixed to an interior surface of handle  202  and may include inflation lumen  220  extending between the proximal and distal ends that communicates with expandable member  209 . 
     Referring now to  FIG. 10A , a side sectional view of the distal end of apparatus  200  is provided. Elongated shaft  206  preferably comprises central lumen  217  having an inner diameter slightly larger than an outer diameter of expandable member shaft  208 . Inflation lumen  220  is in fluid communication with expandable member  209 , while lumens  218  house needle electrodes  210  in the contracted state (see  FIG. 10A ). 
     Region  222  of shaft  208  may be threaded to provide threaded interface  219  between shaft  208  and central lumen  217  of elongated shaft  206 , as shown in  FIG. 10B . Threaded interface  219  provides for controlled longitudinal movement of elongated shaft  206  with respect to shaft  208  when actuator  214  of  FIG. 9  is rotated circumferentially. 
     Referring to  FIG. 10C , the threaded interface between elongated shaft  206  and shaft  208  is omitted and small gap  227  is provided between central lumen  217  and shaft  208 . Gap  227  allows for straight translation of elongated shaft  206  with respect to shaft  208  when actuator  214  is longitudinally advanced and handle  202  is held stationary. 
     Using the technique of  FIGS. 9-10 , a physician may perform a first treatment at a distance of about x 1  from the bladder outlet, as shown in  FIG. 10A , assuming that expandable member  209  is disposed within the bladder and then retracted against the bladder outlet. The physician then may perform a second treatment at a distance of about x 2  from the bladder outlet by actuator  214  as described hereinabove. Measurement indicia  212  may be used as a distance guide when a physician manipulates the distance between x 1  and x 2  using actuation handle  214 . 
     Referring now to  FIG. 11 , an alternative embodiment of apparatus configured to longitudinally advance the spacing between the tissue treating elements and the expandable member is described. In  FIG. 11 , apparatus  200 ′ is provided substantially in accordance with apparatus  200  of  FIGS. 9-10 , except as noted below. 
     In the embodiment of  FIG. 11 , shaft  208 ′ extends through elongated shaft  206 ′ and preferably is coupled to actuator  250  instead of being affixed to an interior surface of handle  202 ′, as described in the embodiment of  FIGS. 9-10 . Actuator  250  may be disposed about handle  202 ′ in a manner similar to the manner in which knob  57  of  FIG. 1  is disposed about handle  31 , as described hereinabove. Alternatively, actuator  250  may be disposed proximal of handle  202 ′. For example, shaft  208 ′ may extend through handle  202 ′, through an aperture or port (not shown) disposed at the proximal end of handle  202 ′, and then may be coupled to actuator  250  proximal of the handle. 
     Apparatus  200 ′ may comprise a threaded interface between shaft  208 ′ and a central lumen of elongated shaft  206 ′, as described in  FIG. 10B  hereinabove. The threaded interface provides for controlled longitudinal movement of shaft  208 ′ with respect to elongated shaft  206 ′ when actuator  250  is rotated circumferentially and handle  202 ′ is held stationary. 
     Alternatively, a small gap, such as described hereinabove with respect to  FIG. 10C , may be provided between the central lumen of elongated shaft  206 ′ and shaft  208 ′. This permits straight translation of shaft  208 ′ with respect to elongated shaft  206 ′ when actuator  250  is advanced or retracted and handle  202 ′ is held stationary. Measurement indicia (not shown) may be disposed on handle  202 ′ or shaft  208 ′ to determine the spacing between tissue treating elements  210 ′ and expandable member  209 ′. 
     Handle  202 ′ also may comprise a central lumen, e.g., as described hereinabove with respect to  FIGS. 10B-10C , that guides shaft  208 ′ through handle  202 ′. The central lumen of handle  202 ′ may be used alone or in conjunction with the central lumen of elongated shaft  206 ′ to serve as a guide for shaft  208 ′ along the length of the device. 
     While preferred illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein without departing from the invention. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.