Abstract:
Methods and devices for treating female urinary incontinence by injecting bulking material into the female urethral wall. Some devices include a handle, an elongate member attached to the handle, and a vacuum generating syringe removably secured to the handle. The elongate member can include a distal portion projecting distally from the handle, the distal portion having a wide proximal region, a narrowing shoulder, and a narrow distal region. The elongate member can include one or more vacuum ports on either side of the shoulder region. The shoulder can include a distally facing needle aperture allowing passage of a needle for injecting bulking agent. A rotatable connection between the elongate member and the handle facilitates rotatable positioning of the elongate member to permit injection of bulking material at different locations around the urethral wall. In use, the urethral tissue can be pulled to conform against the device elongate member by generating a vacuum through the elongate member ports, inserting the needle through the elongate member and needle aperture, and predictably injecting bulking material inside of and along the immobilized urethral wall. The self contained vacuum generator, simple design and wide allowable margin of needle travel allow for use in a practitioner&#39;s office.

Description:
RELATED APPLICATIONS 
     The present application is a non-provisional of U.S. Provisional patent Application No. 60/747,759, filed May 19, 2006, titled VACUUM ASSIST URETHRAL BULKING AGENT PLACEMENT DEVICE, herein incorporated by reference in its entirety. 
    
    
     FIELD OF INVENTION 
     The present invention is related generally to medical devices for treating incontinence through injection of a bulking agent. More specifically, the present invention is related to devices and methods for injecting bulking agent within the urethral wall to treat female urinary incontinence. 
     BACKGROUND 
     There are several approaches for treating female urinary incontinence. One approach involves the submucosal injection of a biocompatible bulking agent into tissue sites adjacent the urethral canal, and/or the bladder neck in order to modify the shape of the tissue sites and/or to provide for improved closure or occlusion between the urethra and the bladder. One particularly suitable bulking agent for this application is sold under the brand name Durasphere® EXP, and is manufactured by Carbon Medical Technologies, St. Paul Minn. 
     U.S. Pat. Nos. 6,277,392 (Klein et al.) and 5,451,406 (Lawin et al.), both herein incorporated by reference, describe how bulking agent may be submucosally injected using a suitably sized and shaped needle, which is connected to a syringe containing the bulking agent. The needle may be inserted into the patient either outside of and adjacent to, or directly into, the urethra. The tip of the needle may then be positioned in a submucosal tissue site adjacent the urethral canal and/or bladder neck. The bulking agent may then be injected into the submucosal tissue site. The process is normally repeated several times around the circumference of the urethra. An endoscope may be used to view the patient&#39;s urethra during the process. 
     Clinicians face several challenges in performing this process. One challenge is determining the proper placement of an injection guide device and hence the injection needle. Some injection guide devices require visualization and possible trial and error in order to properly set the depth of the guide device, so as to accurately locate the injection target along the urethral wall. Another challenge is injecting the bulking agent at the correct depth into the urethral wall. If the bulking agent is injected too close to the surface, the bulking agent may rupture through the urethra tissue and into the canal. If the bulking agent is injected too far beneath the surface, the bulking agent may be ineffective. Some devices require rather specialized support accessories, such as a ready source of vacuum or visualization equipment, which may be common in some medical specialists&#39; offices, but may not be available to all practitioners. 
     What would be desirable is a device for injecting bulking agent that can reliably and repeatedly inject the bulking agent at the proper location, with little need for complex added equipment, and not require undue complexity in manipulating the device. 
     SUMMARY 
     The present invention provides a method for augmenting tissue within a urethral wall of a urethra. One method includes displacing a first portion of the urethral wall by applying suction to the urethral wall to form an immobilized transition wall region conforming to a suction applying device, followed by advancing a needle having a lumen therethrough to contact the transition wall region. 
     The method can also include inserting the needle into the urethral wall at the transition wall region along a path that is substantially parallel to the urethral wall distal of the transition region. The suction force application may then be stopped. A bulking agent can then be injected through the needle lumen and into the urethral wall. 
     In some such methods, the needle travels a first distance during the inserting, in which the injecting is performed at a second distance beneath the urethral wall, wherein the first distance is at least about twice or three times the second distance. That is, the needle can travel a path at least about twice or three times the distance that the needle lies beneath the urethral wall, as the needle may then be traveling parallel to the immobilized urethral wall. 
     The present invention can also provide another method for augmenting tissue within a urethral wall, where the urethra has an interior, a center longitudinal axis, and an inner surface. The method can include applying suction to a first tissue surface region, and pulling the first tissue region in the direction of the urethral interior to form a transition urethral wall region which conforms to a shape which places the transition region in the path of a bulking agent delivery needle. A second tissue surface region lies proximal of the transition region. A needle can be advanced into the urethra, the needle further inserted into the transition region, and a bulking agent injected within the urethral wall. The inserting may be along a longitudinal axis of the urethral lumen. The injecting can be at a depth at least about two or three times the shortest distance from the needle tip to the urethral wall. 
     The suction can be provided by a vacuum generated within a vacuum creating device operably coupled to a vacuum lumen in a bulking agent injection tool. The vacuum creating device is preferably a vacuum generating syringe. The needle inserting may occur through a needle receiving channel disposed in an elongate body portion of the tool. The elongate body may be rotatably disposed within a handle, with the suction being supplied by a vacuum generated in a vacuum creating device operably coupled to the handle. The vacuum may be generated in a syringe operably coupled to the handle. The needle can be retracted within the rotatable body after the injection, the body rotated, and a vacuum applied to a different tissue wall location. The needle can then be inserted into the different wall region, and additional bulking agent injected. 
     In some devices, a rotation selection knob forms a proximal portion of the rotatable body, having clock face indicia displayed on the selector knob. Some devices have a limited number of stable positions for the selector knob, and a mechanism for urging the selector knob into one of those limited number of positions. In one such device, the number of positions is 12, evenly spaced apart from each other. 
     The present invention can also provide an apparatus for augmenting female urethral tissue, the apparatus including a handle and an elongate member rotatably coupled to the handle. The rotatable member can have a distal portion extending distally from the handle, the distal portion having a distal region, a proximal region, and a shoulder region therebetween. The distal portion can include at least one outwardly facing vacuum port. The distal region can have a vacuum lumen in fluid flow communication with the vacuum ports and with a vacuum source. A channel for receiving a needle can be disposed within the body, with the channel having a distal aperture disposed proximal of at least one of the vacuum ports. The distal needle aperture lies within the shoulder region in some embodiments. The elongate member distal region has a substantially uniform width over its length in most embodiments. 
     In some embodiments, the rotatable elongate member has a center of rotation, in which the needle receiving channel is offset from the center of rotation, such that rotating the elongate body rotates the channel about the center of rotation. The rotatable elongate member may be disposed substantially orthogonal to the handle. The device may further include a vacuum generating device operably coupled to the handle for providing a vacuum to the vacuum lumen. The vacuum generating device can include a syringe operably coupled to the handle. 
     These and other objects and advantages of the invention will be readily understood as the following description is read in conjunction with the accompanying drawings wherein like reference numerals have been used to designate like elements throughout the several views. 
    
    
     
       DESCRIPTION OF DRAWINGS 
         FIG. 1  is a perspective view of a urethral needle guide device having a handle, a rotatable body, and clips for receiving a vacuum producing syringe. 
         FIG. 2  is a fragmentary, bottom, perspective view of the device of  FIG. 1 , showing the body distal portion having the side-facing vacuum ports and the shoulder region having the distally facing needle aperture. 
         FIG. 3  is a fragmentary, exploded view of the body and handle of  FIG. 1 , showing sealing O-rings and the outer profile of a vacuum lumen within for providing the vacuum to the annular vacuum lumen of the body. 
         FIG. 4  is another, fragmentary, exploded view of the device of  FIG. 3 , showing the elongate body and the annular vacuum channel. 
         FIG. 5  is a fragmentary, cross-sectional view of the urethral needle guide device of  FIG. 1 , showing the vacuum lumen, the injection/needle lumen, and the O-rings for maintaining the vacuum. 
         FIG. 6  is a fragmentary, perspective view of the body of  FIG. 1 , better illustrating the annular vacuum channel. 
         FIG. 7  is a perspective view of a prototype according to the present invention, showing the vacuum producing syringe clipped to the handle and coupled to the device vacuum tube through a Luer fitting. 
         FIG. 8  is a side view of a syringe which can be used to inject bulking material through the device of  FIG. 1 , and another needle guiding device having a long needle lumen allowing for hands free retention of the retracted bulking agent injection syringe. 
         FIG. 9  is a fragmentary perspective view of another embodiment of the invention having a variable depth retainer. 
         FIG. 10  is a fragmentary cross-sectional view of a female urethra. 
         FIG. 11  is an exploded view of another urethral needle guide device similar in some respects to that of  FIG. 1 , but having a different rotatable body and needle guide cap. 
         FIG. 12  is a fragmentary, perspective view of the device of  FIG. 11 , having the needle guide cap snapped in place over the rotatable body. 
         FIG. 13  is a fragmentary, perspective view of the rotatable body and cap of  FIG. 11 , shown from the front. 
         FIG. 14  is a fragmentary, cross-sectional view of the handle, rotatable body, needle guide cap, and needle of  FIG. 11 , with a septum disposed between the cap and rotatable body. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  shows a vacuum assist device  30  having generally a handle  32 , a rotatable body  34 , and clips or arms  36  for receiving and releasably retaining a vacuum producing syringe. Rotatable body  34  includes a proximal rotation selection knob  38  and an elongate member  40 . Elongate member  40  includes a wider, proximal region  42 , a shoulder or transition region  44 , and a narrower distal region  46 . Shoulder region  44  has an aperture therein allowing the passage of a tissue bulking needle therethrough. Handle  32  includes a handle upper portion  50 , a bend  51 , and a vacuum line aperture  54  therethrough. Handle  32  also includes a handle lower portion  52  on which spaced apart syringe clips  36  are provided. 
       FIG. 2  shows device  30  in greater detail. Device  30  includes rotation selection knob  38 , handle upper portion  50 , and vacuum line aperture  54 , as previously described. Vacuum line aperture  54  can be used for passage of a vacuum tube from the vacuum syringe on the lower end of the handle, upward to the vacuum lumen or lumens of the device elongate member  40 . Elongate member  40  shows proximal region  42 , transition or shoulder region  44 , and distal region  46 , in greater detail. Distal region  46  may be seen, in this embodiment, to be substantially uniform in width over its length and have a rounded distal tip. Distal region  46  also is shown to have, in this example of the invention, four side-facing vacuum ports  60 . In this embodiment, proximal, wider region  42  also has a single side facing vacuum port  62  which can serve to immobilize tissue against elongate member  40 . Transition or shoulder region  42  may be seen to have a distally projecting aperture  64  for allowing the passage of a tissue bulking needle distally therethrough. Tissue conformed to shoulder  44  will have the needle passing through it at a substantially non-parallel, that is acute, angle, in some embodiments. The shoulder and conformed tissue thus form a plane or surface which intersects a distal extension of the needle lumen, where the needle lumen is preferably substantially parallel to the center longitudinal axis of the inserted device portion. Elongate body  40  is rotatably disposed within orifice  49  of handle upper portion  50 . Vacuum ports  60  can act to conform the urethral wall tissue to elongate body  40 , including a transition region of tissue passing in front of needle aperture  64 . Vacuum ports  60  and  62  can act to hold the tissue in place to inhibit sliding of the device relative to the tissue during treatment. 
       FIG. 3  shows an exploded view of device  30 . The handle orifice  49  for receiving elongate member  40  is better seen as is a vacuum lumen outer profile  66  in communication with vacuum aperture  54 , previously described. Ridges or finger grips  55  are provided on handle  32 . Rotation selection knob  38  includes an optional vacuum lumen external port  70  and a needle port  72  for admitting the tissue bulking needle. Optional vacuum or visualization port  70  may be blocked or non-existent in some embodiments. In some embodiments, vacuum port  70  may have a removable plug for sealing the port. Port  70  may be used to pass a visualization device, for example, a fiber optic probe, to the end of the vacuum lumen to allow for visual inspection of the device position. In a preferred embodiment, as shown in  FIG. 3 , needle admission port  72  is off-center with respect to a center of rotation of elongate body  40  and needle exit aperture  64  (shown in  FIG. 2 ). Needle admission port  72  is also preferably longitudinally in line with shoulder portion  44 . Having needle port  72  off-center allows the rotation of rotation selection knob  38  to cause the port to rotate to different angular or clock positions in the urethral channel for injecting bulking material into different locations. A groove  74  on elongate body  40  allows a snap fit of the handle to rotatable body  34 . An annular vacuum channel  76  serves to transmit the vacuum from the vacuum source to the vacuum ports  60  in elongate member distal portion  46 . Such an annular channel allows transmission of vacuum even when the rotatable member is rotated in different clockwise positions. O-rings  80  and  82  provide a seal on either side of annular vacuum channel  76 . Several bumps  79  are present on the surface of handle  32  surrounding orifice  49 . Bumps  79  can be used to urge rotation selection knob  38  into one of a limited number of stable positions, discussed further below. Some embodiments may have 4 or 12 bumps evenly spaced from each other. 
       FIG. 4  is a view of device  30  similar to that of  FIG. 3 , with the distal side of rotation selection knob  38  being better shown, illustrating the dimples  78  which engage bumps  79  shown in  FIG. 3 . In one embodiment, there are 12 dimples spaced evenly apart from each other, in the 12 hourly clock face positions. The dimples and bumps engage each other to urge rotation selection knob  38  into one of 12 different stable positions. In some embodiments, visual indicia are provided on the proximal face of rotation selection knob  38  to indicate at which clock position the needle is positioned. O-rings  80  and  82  are disposed on either side of annular vacuum channel  76 , that is, one proximal and one distal of the channel, for maintaining the vacuum. 
       FIG. 5  shows a longitudinal cross-sectional view through device  30 . Optional vacuum port  70  and needle port  72  are as previously described. An elastomeric seal or septum  73  can seal needle port  72  to allow passage of the bulking agent delivery needle while maintaining the vacuum. O-rings  80  and  82  may be seen in place, providing seals on either side of annular vacuum channel  76 . A vacuum lumen  92  extends between port  70  and the multiple side facing vacuum ports  60  and side facing vacuum port  62 . A needle lumen  90  terminates in distal needle aperture  64 , and rotates as elongate body  40  is turned, about a center of rotation  139  of elongate body  40 . Vacuum ports  60  and  62  thus extend along elongate body  40 , proximal of and distal of needle aperture  64 . In one embodiment, as shown in  FIG. 5 , a rigid lumen outer profile  66  extends within handle  50 , providing a vacuum passage  67  from vacuum aperture  54  to annular channel  76 . The vacuum can be provided to aperture  54  from a flexible tube  212  coupled to a syringe  200  (both shown in  FIG. 7 ). 
     A lens  61  may be located at the distal end of lumen  70 , to allow for visualization in some embodiments. Lens  61  may be used in conjunction with an integral fiber optic device or used in conjunction with an inserted, removable fiber optic device, depending on the embodiment. In some embodiments, a small electronic viewing device may be used in place of lens  61  to visualize the urethra, bladder, and the treatment progress. In one example, a camera element is used. In another example, a CCD type camera may be used. A pressure sensor  63  is also shown, which can be coupled via a signal transmission line (not shown and not requiring separate illustration) to a more proximal portion of the device. A ring shaped sensor may be used in some embodiments and a less extensive sensor may be used in other embodiments. Pressure sensors are well known to those skilled in the art, and can include strain gauges, piezo-electric elements, and the like. The pressure sensor may be used to measure inwardly (radially) directed urethral wall pressure bearing against the elongate member  40 . The pressure may be measured before, during, and after the tissue bulking procedure, in order to gauge the progress of the bulking agent injection near and around elongate member  40 . 
       FIG. 6  shows device  30  and elongate member  40  in even greater detail. Rotation selection knob  38  and vacuum channel  76  are shown. A vacuum port  77  is also shown, extending into annular channel  76  for bringing the externally produced vacuum through to the annular channel, then to vacuum lumen  92  and vacuum ports  60  (shown in  FIG. 5 ). Groove  74  may be seen, as previously described, allowing the snap fit of elongate member  40  within the handle. 
     Urethral needle guide device  30  may be made from a variety of materials well known to those skilled in the art. The rigid portions, including the handle and rotatable body, may be made from polyethylene, PTFE, Polyether block amide (available from Arkema under the brand name PEBAX®), Delrin® polymer (available from DuPont) and/or mixtures of various polymers. The O-rings are of conventional construction, and can be provided in various shapes to maintain the vacuum seal. Vacuum generating syringes used in the present invention may be made of various suitable polymers, for example, polycarbonate. While polymers are preferred for construction of disposable and some sterilizable devices, non-disposable devices may be made of stainless steel. 
       FIG. 7  shows a prototype of a vacuum assist urethral needle guide device  130 . Device  130  includes a handle  152 , a rigid vacuum lumen outer profile  166 , a rotation selection knob  138  carrying a vacuum port  170 , and a needle admission or entry port  172 . Rotation selection knob  138  is rotatable within an upper handle portion  150 . An elongate body portion  140  may be seen having a proximal, wide region  142 , a transition or shoulder region  144 , and a distal region  146 . Elongate body  140  can carry the vacuum ports (present, but not easily seen in  FIG. 7 ), as previously described. Transition region  144  can carry the distally facing needle exit aperture, as described above. Needle aperture  172  is located off-center of the center of rotation of rotation selection knob  138  (and of elongate body  140 ), allowing different angular positions of the urethra to be injected by rotating selection knob  138  to different angular positions. Handle  152  includes clips or arms  136 , as previously discussed. Clips  136  may be seen releasably holding a vacuum producing syringe  200 . Syringe  200  can be of standard manufacture, and include a barrel  202 , and a plunger  204 . Syringe  200  also includes a locking distal portion  206 , and a male Luer tip  208 . Male Luer tip  208  can be received within a matching female lockable Luer fitting  210  coupled to a flexible vacuum tube  212 . Vacuum tube  212  can extend through the handle aperture as previously described. The vacuum can be provided from vacuum tube  212 , through a vacuum lumen in handle  152 , through an annular channel, and into the interior of elongate member  144 , as described above with respect to  FIG. 3 . Other vacuum generating devices can be coupled to the handle in other embodiments. In one such example, a battery powered vacuum pump is coupled to the handle at port  70  (shown in  FIG. 3 ). Either the vacuum syringe or the small battery powered pump eliminates the need to tether the vacuum assisted urethral treatment device through a vacuum line to a wall source or to a large floor mounted vacuum pump. 
       FIG. 8  illustrates a syringe  250  that can be used to inject a bulking agent into the urethra, in conjunction with the device of  FIG. 1 . Syringe  250  includes a hypodermic needle  252  having proximal wings  254  and coupled to a barrel  256 . Barrel  256  is coupled to needle  252  using wings  254  to torque the connection. A shaft  260  is used for pushing a plunger (not visible in  FIG. 8 ) with aid of thumb pad  262  and barrel ears  258 . Any syringe capable of forcing the bulking agent down needle  252  and having a sufficiently long needle may suffice. One acceptable syringe has a capacity of about 1 ml and is about 7½ centimeters long. Some needle sizes used are of about 20 gauge. Some embodiments have a needle size of between about 18 and 25 gauge. Some embodiments have a capacity of between about 1 ml and about 3 ml. In one embodiment, the syringe has a capacity of at least about 1 ml, a needle size of at least about 20 or 22 gauge, and a needle length of at least about 6 cm and less than about 20 cm. 
     Another needle guiding device  251  is also illustrated, having a handle  280 , a handle upper portion  278 , a rotatable body including a distal portion  270  and a proximal portion  272 . Proximal portion  272  can be longer than those discussed previously in the present application. Proximal portion  272  can include a pair of stops  276  within a needle lumen  282 . A proximal needle admission port  274  is also shown, having a slotted shape to allow entry of wings  254 . The length of needle  252  can be such that when fully inserted, it extends sufficiently far to inject bulking agent. The length of rotatable body proximal portion  272  can be such that needle  252  can be retracted from the urethral tissue and be supported within proximal portion  272 . This allows the treating physician to retract the needle and remove the hand used to retract the needle, freeing the hand for other uses. The hand may then be used to rotate the rotatable body to the next ‘clock’ position, followed by applying vacuum, inserting the needle, releasing the vacuum, and injecting more bulking agent. In some embodiments, the needle and needle guide device are cooperatively sized and provided as a kit. In some kits, the kit is sized such that the needle, when fully advanced, does not extend substantially past the distal-most point of the guide device. Some embodiment kits are sized such that the syringe will not fall out when the needle is retracted into the guide device and the physician&#39;s hand is removed from the syringe. 
       FIG. 9  illustrates another embodiment of the invention having a variable depth feature. The penetration depth of the elongate member into the urethra can be varied and controlled by setting the position of a stop member along the elongate member. Device  330  includes handle  50  and rotation selection knob  38  as previously described. Device  330  also includes an elongate rotatable member  340  having a proximal portion having a distal region  346 , a shoulder region  344 , and a proximal region  342 . Several short radial or transverse grooves  343  are formed in elongate member  340  along the top. A longitudinal groove (not visible in  FIG. 9 ) also extends along the top and intersects grooves  343 . A locking disc  347  is also provided, having an outer portion and an inner portion  349  for engaging grooves  343 . Locking disc  347  serves as a stop member, limiting penetration depth into the urethra. Locking disc  347  also has a tongue or spline (not visible in  FIG. 9 ) configured to ride in the longitudinal groove and be rotated into the appropriate groove  343  when the desired urethral penetration depth is attained. Once rotated into position, a friction fit can keep locking disc  347  in place to control the penetration depth. 
     Device  330  has thus been modified to allow hands-free depth control by adding locking disc  347  to elongate body  440 . The elongate body  340  has been lengthened to provide greater versatility and operator space. Disc  347  could be locked in the desired position as determined by the practitioner. It would be based on urethral length and intended injection site. 
     The locking mechanism can be one of many designs such as a cam lock wherein the elongate body cross-section is slightly out of round and the disc has a hole to match. Under this design, the frictional fit developed when the disc assembled onto the elongate body is rotated, locks, and holds the disc in place on the elongate body. 
     In yet another design, a spring loaded pawl (arm) could be attached to the proximal side of the disc. The elongate body would have teeth or indexing groove(s) spaced along its length adjacent the pawl and conforming to its stop member. When the pawl is activated or lifted, the disc can be moved (slid) to a new position, released into an adjacent tooth or groove and thus locked into a new position. 
     Embodiments having the adjustable penetration depth can allow the practitioner to establish and set the injection distance into the urethra and maintain it while performing the procedure. 
       FIG. 10  illustrates a urethra  370  having an inner mucosal wall  374 , a submucosal layer  372 , and an external sphincter  388 . Urethra  370  extends from a far proximal region  380 , through an intermediate region  382 , and terminates in a far distal region  384  in a bladder  386 . As used herein, unless specified otherwise, the terms “proximal region”, “intermediate region”, and distal region” are used relative to each other to describe relative urethral wall locations. As used herein, unless specified otherwise, the terms “proximal region”, “intermediate region”, and distal region” are not used to limit these locations to the far proximal region, the urethral region in the exact middle between the far proximal and far distal regions, or the far distal region, respectively. 
       FIG. 11  illustrates another embodiment of the invention in a needle guide device  400 , shown in an exploded configuration. Device  400  is similar in many respects to the device illustrated in  FIGS. 1-6 , having a handle  402  with an aperture  404  surrounded by a series of engagement bumps  406 . A rotatable body  412 , rotation selection knob  413 , O-rings  408  and  410 , and a needle guide cap  414  are included in device  400 . Needle guide cap  414  has a needle receiving aperture  416  for receiving a hypodermic needle  418 . 
       FIG. 12  illustrates device  400  in an assembled configuration, having handle  402 , rotatable body  412 , needle  418 , and needle guide cap  414  as previously described. Needle  418  is secured to a proximal Luer fitting hub  420  having wings  422 . Needle guide cap  414  has guide arms  424  fitting into matching guide recesses  426  which direct cap  414  into proper engagement with rotation selection knob  413 . Cap  414  also has locking engagement arms  428  each snapping into place over an engagement tab  430  on rotation selection knob  413 . 
       FIG. 13  illustrates rotatable body  412  and rotation selection knob  413  in more detail. Rotation selection knob  413  includes four arcuate latching engagement fingers  434  each having an engagement depression  436  for engaging bumps  406  shown in  FIG. 11 . The spring action of finger  434  allows holes  436  to be repeatedly forced up and over bumps  406 , then settle into and engage the next bump as rotation selection knob  413  is rotated. Needle  418 , needle receiving aperture  416 , guide arm  424 , guide recess  426 , locking engagement arm  428 , engagement aperture  432 , and engagement tab  430  are as previously described. 
       FIG. 14  illustrates device  400  in cross section. Needle  418  is inserted through needle aperture  416  in needle guide cap  414 . Needle  418  punctures a polymeric septum  415  disposed between needle guide cap  414  and the proximal face of selection knob  413 . Rotation selection knob  413  is assembled with depressions  436  engaged with bumps  406 . Handle  402 , rotatable body  412 , and needle hub  420  are as previously described. In some embodiments, needle guide cap  414  has an elongate needle guide proximal portion, similar to that shown at  272  in  FIG. 8 . This elongate needle guide proximal portion can be sufficiently long to allow needle  418  to be withdrawn entirely into rotatable body  412 . This allows needle  418  to rest hands free in the cap and proximal guide portion without the needle bending or breaking. This enables the treating physician to grip handle  402  with one hand while rotating the selection knob  413  with the other hand. Needle  418  is carried with rotating rotation selection knob  413  to the next injection position. 
     Referring again to  FIG. 2 , in use, elongate member  40  may be inserted into the female urethra. The urethral wall will likely be snugly fit about proximal portion  42  and may be somewhat distended by it. The urethral wall will distally pass over more distal portion  46 . A vacuum can be induced by simply pulling on the barrel of the syringe, previously discussed. A vacuum will thus be generated through ports  60  and  62  disposed along elongate member  40 . This will predictably pull the urethral wall to conform against elongate distal portion  46  and proximal portion  42 . This places a region of the urethral wall directly and predictably in front of shoulder or transition region  44 . This conformed tissue region can thus form a plane or curved surface which intersects a linear distal extension of the needle lumen, where the needle lumen is substantially parallel with the center axis of rotation of rotatable body  40 . With the vacuum being applied to secure the tissue in place against the elongate body, the needle can be advanced to pierce the tissue surface and extend further into the tissue. The needle can be advanced along a path which lies at a relatively constant depth beneath the urethral wall, for a travel distance that can be two, three, or more multiples of the depth. Once the needle is in place, the vacuum may be released, and the bulking agent can be injected. As used herein, the phrase “bulking agent” can include beads, particles, polymers, pre-polymers, and so called muscle enhancers and constriction agents. In some methods, a liquid, for example saline or water, is injected through the device and into the urethra or bladder at a different point in the procedure, in addition to the bulking agent injected into the urethral wall. 
     A bulking agent syringe can be advanced through rotation selection knob  38  with the needle extending distally from needle distal port  64 . As can be seen in  FIG. 2 , the distance of the needle penetration beneath the urethral wall will be substantially constant over the length of elongate member distal portion  46 . Of course, at the point of entry, the needle may even approach a perpendicular angle of entry, but will run substantially parallel to the urethral wall once the penetration travel distance becomes greater. 
     The tissue bulking injection device needle can be advanced along substantially the entire length of elongate distal portion  46  without fear of injecting too deeply beneath the urethral wall, as the distance beneath the urethral wall is substantially constant over the length of elongate portion distal region  46 . In some methods, the needle is advanced to the maximum distal extent, and the tissue bulking material is injected while the injecting needle is retracted proximally. Once sufficient material has been injected, rotation selection knob  38  can be rotated after the needle has been withdrawn within proximal portion  42 . In one method, proximal portion  42  and rotation selection knob  38  are rotated about 120°, followed by pulling vacuum, following the distal advancement of the needle through needle aperture  64  into another portion of tissue. In some methods, the rotation selection knob is rotated to place the needle at the 2 O&#39;clock, 6 O&#39;clock, and 10 O&#39;clock positions. This can be repeated until the entire urethral circumference has been sufficiently treated. 
     Some methods can utilize a device pressure sensor, previously described. The urethral wall pressure can be measured before beginning the procedure, and monitored during the bulking process. In some methods, the bulking is continued until the inward pressure of the urethral wall reaches a target level, whereupon the bulking is stopped. 
     In one embodiment, three positions of 2 O&#39;clock, 6 O&#39;clock, and 10 O&#39;clock, about 120° apart, are selected and injected using the present device and methods. In some previous devices, a needle was used to inject the bulking material into the urethral wall to approach the wall at an angle with respect to the longitudinal central axis of the urethra. In these methods, the advancement of the injecting needle too far would inject undesirably deep beneath or through the urethral wall.  FIG. 2  shows that as long as the urethral wall is conformed along distal portion  46 , then the added insertion depth will be parallel to the urethral wall, not transverse or at an angle to it. This depth may be calculated and set in advance by varying the diameter of the rotatable body and the offset of the needle lumen along the shoulder or transition portion of the urethral needle guide device. 
     Various examples of devices and methods have been presented in order to illustrate, not limit the present invention. It is anticipated that various modifications will occur to those skilled in the art without departing from the spirit and scope of the invention as defined by the following claims.