Apparatus and methods for treating female urinary incontinence

Description of equivalent WO 2004010843 A2

APPARATUS AND METHODS FOR TREATING FEMALE URINARY INCONTINENCE

0002Reference to Related Applications

0003[0001] The present application is a continuation-in- part of U.S. patent application Serial No. 10/207,689, filed July 25, 2002, which is a continuation-in-part of U.S. patent application Serial No. 09/678,500, filed October 2, 2000.

0004Field of the Invention

0005[0002] 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.

0006Background of the Invention [0003] 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. [0004] 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. [0005] 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.

0007[0006] 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. [0007] 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 .

0008[0008] 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.

0009Summary of the Invention

0010[0009] 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. [0010] 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. [0011] 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.

0011[0012] 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. [0013] 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's urethra, either individually or using an appropriate introducer sheath. The handle includes an actuator for deploying the expandable member. [0014] 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'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. [0015] 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.

0012[0016] 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 . [0017] 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 . [0018] 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.

0013Brief Description of the Drawings

0014[0019] 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: [0020] 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. IB, and a schematic view depicting use of apparatus of FIG. 1A; [0021] 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_; [0022] FIG. 3 is a schematic view depicting the use of apparatus of FIGS . 2 ;

0015[0023] FIG. 4 is a side view of an alternative embodiment of the present invention; [0024] FIG. 5 is a schematic view depicting the use of apparatus of FIGS. 4;

0016[0025] 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;

0017[0026] FIG. 7 is a schematic view depicting the use of apparatus of FIGS. 6;

0018[0027] FIGS. 8A-8B are side sectional views illustrating the use of an alternative expandable member; [0028] FIG. 9 is a side view of a device that allows movement of a means for treating with respect to an expandable member;

0019[0029] 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

0020[0030] FIG. 11 is a side view of a device that allows movement of an expandable member with respect to a means for treating.

0021Description of the Preferred Embodiments

0022[0031] Referring now to FIGS. 1, a device to treat urinary incontinence, described in U.S. patent application Serial No. 09/678,500, 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.

0023[0032] 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.

0024[0033] 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- ssigned U.S. patent application Serial No. 10/207,689, which is herein incorporated by reference in its entirety. [0034] 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 circu ferentially 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. ID. [0035] 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. IC. [0036] 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. IB. 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. [0037] 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. [0038] 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. [0039] 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. IB.

0025[0040] 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.

0026[0041] 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.

0027[0042] 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. IB. [0043] Referring now to FIG. IE, 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. IB. 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 0, as shown in FIG. IE. [0044] After expandable member 55 has been seated against bladder outlet 0, 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. IE.

0028[0045] 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. [0046] 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. [0047] 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 . [0048] 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. [0049] 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 FIGS. 1, except as noted below, and is coupled to the proximal end of elongated shaft 82.

0029[0050] 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. [0051] 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. [0052] 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. [0053] Apparatus 80 of FIGS. 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.

0030[0054] 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. [0055] 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'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. [0056] In accordance with the present invention, retracting expandable member 87 against bladder outlet 0 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 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 submucosal tissue at the desired target temperature . [0057] 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's urethra. [0058] 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 .

0031[0059] 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. [0060] 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. [0061] 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.

0032[0062] 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's urethra U with expandable member 123 in a contracted state. Expandable member 123 is positioned within a patient'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. [0063] 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 ϋ. 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.

0033[0064] 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.

0034[0065] 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.

0035[0066] 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.

0036[0067] 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. [0068] 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.

0037[0069] 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's urethra TJ 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'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. [0070] 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.

0038[0071] 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. [0072] 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. [0073] 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. [0074] 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. [0075] In operation, atraumatic tip 178 and elongated shaft 181 are inserted into the patient's urethra in a manner described hereinabove. Once distal end 184 of elongated shaft 181 is positioned within a patient'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 . [0076] 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. [0077] 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.

0039[0078] 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 FIGS. 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 FIGS. 1, respectively.

0040[0079] 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.

0041[0080] 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. [0081] 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) . [0082] 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.

0042[0083] 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.

0043[0084] Using the technique of FIGS. 9-10, a physician may perform a first treatment at a distance of about Xi 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 x₂ 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_x and x₂ using actuation handle 214. [0085] 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. [0086] 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. [0087] 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.

0044[0088] 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' . [0089] 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.

0045[0090] 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.