Abstract:
A treatment device for treating a treatment area of a body lumen includes an elongated member insertable into the body lumen, a delivery member guidable along a longitudinal axis of the elongated member, and a treatment part for contacting the treatment area, wherein the delivery member is configured to deliver the treatment part to the treatment area.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 14/451,784 filed on Aug. 5, 2014, and claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/994,499 filed on May 16, 2014, the entire content of each of which is incorporated by reference herein. 
     
    
     TECHNOLOGICAL FIELD 
       [0002]    The disclosure here pertains generally to a method and apparatus for treating urethral stricture. More particularly, the disclosure is directed to a trans-urethral urethroplasty method and apparatus. 
       BACKGROUND DISCUSSION 
       [0003]    Known treatment options for urethral stricture, which is an abnormal narrowing of the urethra, include urethroplasty surgery as well as minimally invasive procedures such as dilation, stent implantation, and urethrotomy. Due to the invasiveness of urethroplasty surgery, it is only recommended in extreme cases of urethral stricture. However, minimally invasive procedures currently in use to treat urethral stricture can be of limited long-term effectiveness because they do not promote epithelial function at the treatment site. Accordingly, a need exists for a practical, minimally invasive treatment of urethral stricture which promotes epithelial function at the treatment site. 
       SUMMARY 
       [0004]    One aspect of the disclosure here involves a treatment device for treating a treatment area of a body lumen, the treatment device including an elongated member insertable into the body lumen, a delivery member guidable along a longitudinal axis of the elongated member, and a treatment part for contacting the treatment area, wherein the delivery member is configured to deliver the treatment part to the treatment area. 
         [0005]    Another aspect involves a treatment device for treating a treatment area of a body lumen, the treatment device including a delivery member, and a treatment membrane wrapped around the delivery member, wherein opposite overlapped edges of the treatment membrane are attached together. 
         [0006]    A further aspect of the disclosure involves a clip device for preparing a membrane, the clip device including a clip part configured to pinch opposite overlapped edges of the membrane together, and a cavity with an adjustable inner circumference configured to set a circumference of the membrane. 
         [0007]    An additional aspect of the disclosure involves a therapeutic device for treating a treatment area of a body lumen, the therapeutic device including a delivery member possessing at least one attachment part, and a treatment membrane wrapped on the delivery member and detachably attached to the at least one attachment part of the delivery member. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
         [0008]    Additional features and aspects of the method and apparatus for treating urethral stricture disclosed here will become more apparent from the following detailed description considered with reference to the accompanying drawing figures in which like elements are designated by like reference numerals. 
           [0009]      FIG. 1  is a schematic illustration of an apparatus for delivering a treatment membrane to a treatment area. 
           [0010]      FIGS. 2   a  and  2   b  illustrate partially sectional views of an exemplary delivery procedure using the apparatus of  FIG. 1 .  FIG. 2   a  illustrates a view of a first step of the procedure, and  FIG. 2   b  illustrates a view of a second step of the procedure. 
           [0011]      FIGS. 3   a - 3   c  illustrate partially sectional views of an exemplary delivery procedure using the apparatus of  FIG. 1 .  FIG. 3   a  illustrates a view of a first step of the procedure,  FIG. 3   b  illustrates a view of a second step of the procedure, and  FIG. 3   c  illustrates a view of a third step of the procedure. 
           [0012]      FIGS. 4   a - 4   c  illustrates partially sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 4   a  illustrates a view of a first step of the procedure,  FIG. 4   b  illustrates a view of a second step of the procedure, and  FIG. 4   c  illustrates a view of a third step of the procedure. 
           [0013]      FIGS. 5   a - 5   d  illustrates partially sectional views of an exemplary delivery procedure using the apparatus of  FIGS. 4   a - 4   c  for delivering a treatment part to a treatment area.  FIG. 5   a  illustrates a view of a first step of the procedure,  FIG. 5   b  illustrates a view of a second step of the procedure,  FIG. 5   c  illustrates a view of a third step of the procedure, and  FIG. 5   d  illustrates a fourth step of the procedure. 
           [0014]      FIGS. 6   a - 6   f  illustrate cross-sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 6   a  illustrates a longitudinal cross-sectional view of a delivery member used in the procedure,  FIG. 6   b  illustrates an axial cross-sectional view of a delivery member used in the procedure,  FIG. 6   c  illustrates a longitudinal cross-sectional view of an elongated member used in the procedure,  FIG. 6   d  illustrates an axial cross-sectional view taken along line  6   d  of  FIG. 6   c ,  FIG. 6   e  illustrates an axial cross-sectional view taken along line  6   e  of  FIG. 6   c , and  FIG. 6   f  illustrates a view of a step of the procedure. 
           [0015]      FIGS. 7   a - 7   d  illustrate partially sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 7   a  illustrates a view of a first step of the procedure,  FIG. 7   b  illustrates a view of a second step of the procedure,  FIG. 7   c  illustrates a view of a third step of the procedure, and  FIG. 7   d  illustrates a view of a fourth step of the procedure. 
           [0016]      FIGS. 8   a - 8   e  illustrate partially sectional views of an exemplary delivery procedure using the apparatus of  FIGS. 7   a - 7   d  for delivering a treatment part to a treatment area.  FIG. 8   a  illustrates a view of a first step of the procedure,  FIG. 8   b  illustrates a view of a second step of the procedure,  FIG. 8   c  illustrates a view of a third step of the procedure,  FIG. 8   d  illustrates a view of a fourth step of the procedure, and  FIG. 8   e  illustrates a view of a fifth step of the procedure. 
           [0017]      FIGS. 9   a - 9   e  illustrate partially sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 9   a  illustrates a view of a first step of the procedure,  FIG. 9   b  illustrates a view of a second step of the procedure,  FIG. 9   c  illustrates a view of a third step of the procedure,  FIG. 9   d  illustrates a view of a fourth step of the procedure, and  FIG. 9   e  illustrates a view of a fifth step of the procedure. 
           [0018]      FIGS. 10   a - 10   e  illustrate partially sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 10   a  illustrates a view of a first step of the procedure,  FIG. 10   b  illustrates a view of a second step of the procedure,  FIG. 10   c  illustrates a view of a third step of the procedure,  FIG. 10   d  illustrates a view of a fourth step of the procedure, and  FIG. 10   e  illustrates a view of a fifth step of the procedure. 
           [0019]      FIGS. 11   a - 11   e  illustrate partially sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 11   a  illustrates a view of a first step of the procedure,  FIG. 11   b  illustrates a view of a second step of the procedure,  FIG. 11   c  illustrates a view of a third step of the procedure,  FIG. 11   d  illustrates a view of a fourth step of the procedure, and  FIG. 11   e  illustrates a view of a fifth step of the procedure. 
           [0020]      FIGS. 12   a - 12   e  illustrate partially sectional views of an exemplary delivery procedure using an apparatus for delivering a treatment part to a treatment area.  FIG. 12   a  illustrates a view of a first step of the procedure,  FIG. 12   b  illustrates a view of a second step of the procedure,  FIG. 12   c  illustrates a view of a third step of the procedure,  FIG. 12   d  illustrates a view of a fourth step of the procedure, and  FIG. 12   e  illustrates a view of a fifth step of the procedure. 
           [0021]      FIGS. 13   a - 13   f  illustrate various views of an exemplary mounting procedure using an apparatus for mounting a treatment membrane to a delivery member.  FIG. 13   a  illustrates a perspective view of a first step of the procedure,  FIG. 13   b  illustrates a perspective view of second step of the procedure,  FIG. 13   c  illustrates a perspective view of a third step of the procedure,  FIG. 13   d  illustrates an axial cross-sectional view of the third step of the procedure,  FIG. 13   e  illustrates a perspective view of a fourth step of the procedure, and  FIG. 13   f  illustrates an axial cross-sectional view of the fourth step of the procedure. 
           [0022]      FIGS. 14   a  and  14   b  illustrate various views of an exemplary mounting procedure using an apparatus for mounting a treatment membrane to a delivery member.  FIG. 14   a  illustrates a view of a first step of the procedure, and  FIG. 14   b  illustrates a view of a second step of the procedure. 
           [0023]      FIGS. 15   a  and  15   b  illustrate various views of an exemplary mounting procedure using an apparatus for mounting a treatment membrane to a delivery member.  FIG. 15   a  illustrates a view of a first step of the procedure, and  FIG. 15   b  illustrates a view of a second step of the procedure. 
           [0024]      FIGS. 16   a - 16   d  illustrate various views of an exemplary mounting procedure using an apparatus for mounting a treatment membrane to a delivery member.  FIG. 16   a  illustrates a perspective view of the procedure,  FIG. 16   b  illustrates a cutaway view along line  16   b  of  FIG. 16   a ,  FIG. 16   c  illustrates bottom view of the procedure, and  FIG. 16   d  illustrates a top view of the procedure. 
           [0025]      FIGS. 17   a - 17   c  illustrate various views of an exemplary mounting procedure using an apparatus for mounting a treatment membrane to a delivery member.  FIG. 17   a  illustrates a first perspective view of the procedure,  FIG. 17   b  illustrates a second perspective view of the procedure, and  FIG. 17   c  illustrates a side view of the procedure. 
           [0026]      FIGS. 18   a  and  18   b  illustrate perspective views of an exemplary attaching procedure using an attachment part of a delivery member.  FIG. 18   a  illustrates a view of a first step of the procedure, and  FIG. 18   b  illustrates a view of a second step of the procedure. 
           [0027]      FIGS. 19   a - 19   d  illustrate perspective views of an exemplary attaching and detaching procedure using an attachment part of a delivery member.  FIG. 19   a  illustrates a view of a first step of the procedure,  FIG. 19   b  illustrates a view of a second step of the procedure,  FIG. 19   c  illustrates an enlargement of section  19   c  of  FIG. 19   b , and  FIG. 19   d  illustrates a third step of the procedure. 
           [0028]      FIGS. 20   a  and  20   b  illustrate partially sectional views of an exemplary detaching procedure using an attachment part of a delivery member.  FIG. 20   a  illustrates a view of a first step of the procedure, and  FIG. 20   b  illustrates a view of a second step of the procedure. 
           [0029]      FIGS. 21   a - 21   e  illustrate perspective views of an exemplary attaching and detaching procedure using an attachment part of a delivery member.  FIG. 21   a  illustrates a view of a first step of the procedure,  FIG. 21   b  illustrates a view of a second step of the procedure,  FIG. 21   c  illustrates a view of a third step of the procedure,  FIG. 21   d  illustrates a view of a fourth step of the procedure, and  FIG. 21   e  illustrates a perspective view of the attachments parts used in the procedure. 
           [0030]      FIG. 22  illustrates a longitudinal side view of an attachment part of a delivery member. 
           [0031]      FIGS. 23   a - 23   j  illustrate longitudinal side views of alternative attachment part embodiments.  FIG. 23   a  illustrates a view of a first alternative embodiment,  FIG. 23   b  illustrates a view of a second alternative embodiment,  FIG. 23   c  illustrates a view of a third alternative embodiment,  FIG. 23   d  illustrates a view of a fourth alternative embodiment,  FIG. 23   e  illustrates a view of a fifth alternative embodiment,  FIG. 23   f  illustrates a view of a sixth alternative embodiment,  FIG. 23   g  illustrates a view of a seventh alternative embodiment,  FIG. 23   h  illustrates a view of an eighth alternative embodiment,  FIG. 23   i  illustrates a view of a ninth alternative embodiment, and  FIG. 23   j  illustrates a view of a tenth alternative embodiment. 
           [0032]      FIGS. 24   a - 24   c  illustrate partially sectional views of an exemplary method and apparatus for positioning the delivery member relative to the treatment area.  FIG. 24   a  illustrates a view of a first step of the method,  FIG. 24   b  illustrates a view of a second step of the method, and  FIG. 24   c  illustrates a view of a third step of the method. 
           [0033]      FIGS. 25   a - 25   c  illustrate partially sectional views of another exemplary method and apparatus for positioning the delivery member relative to the treatment area.  FIG. 25   a  illustrates a view of a first step of the method,  FIG. 25   b  illustrates a view of a second step of the method, and  FIG. 25   c  illustrates a view of a third step of the method. 
           [0034]      FIGS. 26   a  and  26   b  illustrate partially sectional views of another exemplary method and apparatus for positioning the delivery member relative to the treatment area.  FIG. 26   a  illustrates a view of a first step of the method, and  FIG. 26   b  illustrates a view of a second step of the method. 
           [0035]      FIGS. 27   a - 27   f  illustrate partially sectional views of another exemplary method and apparatus for positioning the delivery member relative to the treatment area.  FIG. 27   a  illustrates a view of a first step of the method,  FIG. 27   b  illustrates a view of a second step of the method,  FIG. 27   c  illustrates a view of a third step of the method,  FIG. 27   d  illustrates a view of a fourth step of the method,  FIG. 27   e  illustrates a view of a fifth step of the method, and  FIG. 27   f  illustrates a view of a sixth step of the method. 
           [0036]      FIGS. 28   a  and  28   b  illustrate partially sectional views of exemplary methods for fixing the elongated member relative to the body lumen.  FIG. 28   a  illustrates a view of a first step of the method, and  FIG. 28   b  illustrates a view of a second step of the method. 
           [0037]      FIGS. 29   a - 29   h  illustrate partially sectional views of an exemplary method and apparatus for attaching and detaching the treatment membrane with the delivery device.  FIG. 29   a  illustrates a view of a first step of the method,  FIG. 29   b  illustrates a view of a second step of the method,  FIG. 29   c  illustrates a view of a third step of the method,  FIG. 29   d  illustrates a view of a fourth step of the method,  FIG. 29   e  illustrates a view of a fifth step of the method,  FIG. 29   f  illustrates a view of a sixth step of the method,  FIG. 29   g  illustrates a view of a seventh step of the method, and  FIG. 29   h  illustrates a view of an eighth step of the method. 
           [0038]      FIGS. 30   a - 30   h  illustrate partially sectional views of another exemplary method and apparatus for attaching and detaching the treatment membrane with the delivery device.  FIG. 30   a  illustrates a view of a first step of the method,  FIG. 30   b  illustrates a view of a second step of the method,  FIG. 30   c  illustrates a view of a third step of the method,  FIG. 30   d  illustrates a view of a fourth step of the method,  FIG. 30   e  illustrates a view of a fifth step of the method,  FIG. 30   f  illustrates a view of a sixth step of the method,  FIG. 3   g  illustrates a view of a seventh step of the method, and  FIG. 30   h  illustrates a view of an eighth step of the method. 
           [0039]      FIGS. 31   a - 31   d  illustrate various views of another exemplary method and apparatus for attaching and detaching the treatment membrane with the delivery device.  FIG. 31   a  illustrates a longitudinal side view of a first step of the method,  FIG. 31   b  illustrates an enlargement of section  31   b  of  FIG. 31   c ,  FIG. 31   c  illustrates a longitudinal view of a second step of the method, and  FIG. 31   d  illustrates a longitudinal side view of a third step of the method. 
           [0040]      FIGS. 32   a - 32   c  illustrate various views of another exemplary method and apparatus for attaching and detaching the treatment membrane with the delivery device.  FIG. 32   a  illustrates a partially sectional view of a first step of the method,  FIG. 32   b  illustrates a partially sectional view of a second step of the method, and  FIG. 32   c  illustrates a longitudinal side view of the apparatus used in the method. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    Set forth below is a detailed description of the method and apparatus for treating urethral stricture disclosed here. The method and apparatus for treating urethral stricture is described and illustrated in terms of several embodiments disclosed as examples of the method and apparatus for treating urethral stricture. 
         [0042]    Generally speaking, embodiments of the method involve delivering a treatment membrane, such as buccal mucosa harvested from the inner cheek of the patient, preputium harvested from the patient, or any other biocompatible sheet, to the treatment area of the body lumen, i.e., the area of urethral stricture in the patient&#39;s urethra. Prior to delivery of the treatment membrane to the area of the urethral stricture, the area is incised or dilated so that the treatment membrane receives sufficient nutrition for engraftment. 
         [0043]    In embodiments of this method of treating the treatment area of the body lumen, i.e., the urethra, an elongated member  10  is inserted into the urethra. In an embodiment, the elongated member  10  is an indwelling catheter, as illustrated in  FIG. 1 . This elongated member  10  is configured to guide a delivery member  20  which possesses an outer portion on which is mounted a treatment membrane  30 . In an embodiment, the treatment membrane  30  is buccal mucosa harvested from the patient&#39;s inner cheek. 
         [0044]    In an embodiment, the delivery member  20  is then moved to the treatment area  40 , e.g., the area of urethral stricture in the patient&#39;s urethra. For example, in the  FIG. 1  embodiment, the delivery member  20  is slid along the outer surface of the elongated member  10  until it reaches the treatment area. The delivery member  20  includes a fixing member capable of fixing the delivery member  20  to the elongated member  10 . In various embodiments discussed in detail below, the fixing member is an expandable member. 
         [0045]    Exemplary movements of the elongated member  10  and the delivery member  20  in the insertion and moving steps are illustrated in  FIGS. 2(   a )- 2 ( b ) and in  FIGS. 3(   a )- 3 ( c ). In both procedures, in the step of inserting the elongated member  10  into the urethra, the elongated member  10  carries the delivery member  20  in an insertion direction. In the method of  FIGS. 2(   a )- 2 ( b ), in the step of moving the delivery member  20  to the treatment area  40 , the delivery member  20  is moved in the insertion direction, while in the method of  FIGS. 3(   a )- 3 ( b ), in the step of moving the delivery member  20  to the treatment area  40 , the delivery member  20  is moved in a direction opposite the insertion direction. Specifically, when the treatment area is located on the bulbar urethra, operator could easily deliver the delivery member by simply pushing the delivery member toward the proximal end of the bulbar urethra which lumen is narrow due to the external urethral sphincter. An X-ray marker can be incorporated into the delivery member  20  so that the operator can determine the position of the delivery member  20  while it is being moved. The delivery member  20  can be moved relative to the elongated member  10  by operating an operation member  50  attached to the delivery member  20 . The operation member  50  can be, for example, a wire, a sheath, and/or a tube for inflating the delivery member in embodiments in which the delivery member is inflatable. The operation member  50  can be attached to the delivery member  20 , or separate from the delivery member  20 , in which case the operation member  50  is used as separate pusher and/or puller of the delivery member  20 . In any event, the operation member  50  is configured to be operable by the operator separately from the elongated member  10 , such as by having a proximal end which remains outside the urethra. 
         [0046]    In an embodiment, the outer portion of the delivery member  20  is pressed against the treatment membrane  30  to contact the treatment membrane  30  with the treatment area for a predetermined period of time. In the  FIG. 1  embodiment, the delivery member  20  includes an expandable member comprising an inflatable balloon  60  which is moved to the treatment area, and the step of pressing the outer portion of the delivery member  20  against the treatment membrane  30  comprises expanding the expandable member by inflating the inflatable balloon  60 . The expandable member can also be an inflatable sponge, or can operate by mechanical expansion, for example, in the manner of a stent. 
         [0047]    After the predetermined period of time, the delivery member  20  is withdrawn from the treatment area. The predetermined time is a sufficient time for the treatment membrane  30 , which is buccal mucosa in an embodiment, to graft to the treatment area due to pressure provided by the delivery member  20  and the pre-incision or pre-dilation of the treatment area by a physician. 
         [0048]    In the  FIG. 1  embodiment, the delivery member  20  includes the expandable member, and so the expandable member is moved to the treatment area at the same time the delivery member  20  is moved to the treatment area  40 . When using the apparatus of this embodiment, the step of pressing the outer portion of the delivery member  20  against the treatment membrane  30  comprises expanding the delivery member. Additionally, in this embodiment, after the predetermined period of time, the delivery member is contracted and then the elongated member  10  is moved out of the urethra to carry the delivery member away from the treatment area and out of the urethra. 
         [0049]    In an alternative embodiment illustrated in  FIGS. 4(   a )- 4 ( c ), the delivery member  20  is attached to the expandable member. In the embodiment, the delivery member  20  is a curved plate which is attached to an outer surface of the expandable member/inflatable balloon  60 . Furthermore, the inflatable balloon  60  is operated and inflated through a balloon guide  70 , which is, for example, a tube through which the balloon  60  can be inflated and which has a proximal end which projects out of the urethra so that it can be independently operated by the operator. 
         [0050]    In further alternative embodiments, the apparatus can include an expandable member which is an inflatable balloon  60  separate from the delivery member  20 . In this case, the expandable member/inflatable balloon  60  can be moved to the treatment area  40  before or after the delivery member  20  is moved to the treatment area  40 . Additionally, in this case, to withdraw the delivery member after the predetermined period of time, the expandable member  60 , which is either kept at the treatment area  40  while expanded during the predetermined time, or moved back to the treatment area  40  and expanded during or after the predetermined period of time, can be moved out of the urethra to carry the delivery member  20  away from the treatment area  40  and out of the urethra. 
         [0051]      FIGS. 5(   a )- 5 ( d ) illustrate such an embodiment in which, first, the delivery member  20  is slid along the elongated member  10  to the treatment area  40 , and then the inflatable balloon  60  is slid along the elongated member  10  to the treatment area  40 . The position of the inflatable balloon  60  relative to the delivery member  20  can be determined by, for example, comparing markings on the operation member  50  and the balloon guide  70  which are disposed in relative positions which line up when the delivery member  20  and the inflatable balloon  60  are at the same axial position. These markings can be, for example, X-ray markers on the operation member  50  and the delivery member  20 . Alternatively, a structural positioning system, such as a stop on the delivery member  20  configured to engage with the distal end of the inflatable balloon  60  to stop further movement of the inflatable balloon  60  in the distal direction, can be provided for relative positioning of the inflatable balloon  60  relative to the delivery member  20 . 
         [0052]    In each of the embodiments which includes an expandable member such as an inflatable balloon  60 , the apparatus can be configured so that, when the inflatable balloon  60  is expanded, relative sliding movement between the delivery member  20  and the elongated member  10  in the axial direction is prevented by virtue of the inflatable balloon  60  pressing on both the delivery member  20  and the elongated member  10 . In each of the embodiments in which the elongated member  10  is a catheter, the catheter&#39;s lumen allows urine to pass through the urethra when the inflatable balloon  60  is expanded. Additionally, in each case, to withdraw the delivery member after the predetermined period of time, the operation member  50  is pulled to guide the delivery member  20  away from the treatment area  40  and out of the urethra. 
         [0053]    In an alternative embodiment illustrated in  FIGS. 6(   a )- 6 ( f ), the delivery member possesses an inner portion  80  separate from the outer portion which presses against the treatment membrane. This inner portion  80  possesses a protrusion  90  which protrudes inwardly. The elongated member  10  possesses a groove  100  extending in an axial direction of the elongated member  10  and a plurality of spaced-apart notches  110  extend perpendicularly from the groove  100 . In use, in the step of moving the delivery member to the treatment area, the protrusion  90  slides within the groove  100  in the axial direction, and after this step, the delivery member is rotated to cause the protrusion  90  to rotate into one of the plurality of notches  110 , thereby preventing relative sliding movement between the delivery member and the elongated member in the axial direction. Additionally, the step of pressing the outer portion of the delivery member against the treatment membrane comprises moving the outer portion (which can have a curved plated shape such as shown in the  FIG. 4  embodiment) relative to the inner portion  80  of the delivery member having the protrusion. Alternatively, the step of pressing the outer portion of the delivery member against the treatment membrane can comprise expanding an expandable member provided between the elongated member  10  and the delivery member. 
         [0054]      FIGS. 7(   a )- 7 ( d ) illustrate an embodiment in which the expandable member is moved to the treatment area after the delivery member is moved to the treatment area. In this embodiment, an endoscope  120  can be used as the elongated member to monitor the position of the delivery member  20  relative to the treatment area  40 , and so in some embodiments using the endoscope  120 , x-ray markings are not used. However, some embodiments use both the endoscope  120  and x-ray markings for positioning. Additionally, in this embodiment, after the step of moving the delivery member  20  to the treatment area  40 , the elongated member/endoscope  120  is withdrawn from the urethra. .An elongated member  10  and inflatable balloon  60  are then moved, either sequentially or simultaneously, to position the inflatable balloon relative to the delivery member  20 . The inflatable balloon  60  can be fixed to the elongated member  10  such that the elongated member  10  and inflatable balloon  60  are always moved simultaneously, but this is not required The position of the inflatable balloon  60  relative to the delivery member  20  can be determined by, for example, comparing markings on the operation member  50  and the balloon guide  70  which are disposed in relative positions which line up when the delivery member  20  and the inflatable balloon  60  are at the same axial position. These markings can be, for example, X-ray markers on the operation member  50  and the delivery member  20 . Alternatively, a structural positioning system, such as a stop on the delivery member  20  configured to engage with the distal end of the inflatable balloon  60  to stop further movement of the inflatable balloon  60  in the distal direction, can be provided for relative positioning of the inflatable balloon  60  relative to the delivery member  20 . 
         [0055]    The embodiment of  FIGS. 8(   a )- 8 ( e ) is similar to the embodiment of  FIGS. 7(   a )- 7 ( d ) except that the outer portion of delivery member  20  (which is a curved plate in the embodiment) faces a side of the urethra opposite the treatment area  40 . This affords a clear view of the treatment area  40  by the endoscope  120 . In this embodiment, after the step of moving the delivery member  20  to the treatment area  40  and before the step of pressing the outer portion of the delivery member  20  against the treatment membrane  30 , the delivery member  20  is rotated to a position in which the outer portion of the delivery member  20  faces the treatment area  40 . 
         [0056]    In the apparatus of the embodiment of  FIGS. 9(   a )- 9 ( e ), a one-way expandable member  150  is used as the delivery member, with the treatment membrane  30  being mounted to this one-way expandable member  150 . The one-way expandable member  150  has an annular inner surface that is fixed and an expandable annular outer surface. The one-way expandable member  150  is removably mounted to an expandable intermediate member  160 , which is mounted to elongated member/endoscope  120 . The expandable intermediate member  160  is a two-way expandable member in that it expands at both its annular inner surface and its annular outer surface. 
         [0057]    In the method illustrated in  FIGS. 9(   a )- 9 ( e ), before the step of inserting the elongated member/endoscope  120  into the urethra, the delivery member/one-way expandable member  150  is mounted onto the expandable intermediate member  160  and the elongated member/endoscope  120 , and the expandable intermediate member  160  is expanded to prevent relative movement between the delivery member/one-way expandable member  150  and the elongated member/endoscope  120 . The elongated member  120  is then moved in the axial direction to move the delivery member  150  and intermediate member  160  to the treatment area  40 . The delivery member  150  is then expanded to press the outer portion of the delivery member  150  against the treatment membrane  30 , thereby contacting the treatment membrane  30  with the treatment area  40 . The intermediate member  160  is then contracted, and the delivery member  150  is dismounted from the intermediate member  160  and the elongated member  120  by pulling back the elongated member  120 , which still carries the intermediate member  160 , thus leaving the delivery member  150  at the treatment area  40 . An indwelling catheter can then be inserted into the delivery member  150  for urine drainage while the delivery member  150  is in position. After the predetermined period of time, which, as discussed above, is a sufficient time for the treatment membrane  30  to graft to the treatment area  40 , the steps are reversed, i.e., the indwelling catheter is removed, the intermediate member  160  is moved to the treatment area  40  via the elongated member/endoscope  120  and expanded to prevent relative movement between the delivery member  150  and the elongated member  120 , the delivery member  150  is contracted, and then the elongated member  120 , with the intermediate member  160  and delivery member  150  mounted thereon, is removed from the urethra. An alternative process for removing the delivery member  150  involves pulling on an operation member, such as an inflation tube (not shown) attached to the delivery member  150  and used for expanding and contracting the delivery member  150 . 
         [0058]      FIGS. 10(   a )- 10 ( e ) illustrate an embodiment of a method which uses a similar apparatus as the embodiment of  FIG. 9(   a )- 9 ( e ). However, in the method of  FIGS. 10(   a )- 10 ( e ), when the treatment area  40  is visible through the elongated member/endoscope  120  and before the delivery member  150  and intermediate member  160  reach the treatment area  40 , the intermediate member  160  is contracted, and the delivery member  150  is dismounted from the intermediate member  160  and the elongated member  120  and moved to the treatment area  40  via the operation member  50 . The delivery member  150  can be moved to the treatment area  40 , with the intermediate member  160 , or, in alternative embodiment, without the intermediate member  160 . The delivery member  150  is then expanded to press the outer portion of the delivery member  150  against the treatment membrane  30 , thereby contacting the treatment membrane  30  with the treatment area  40 . As in the embodiment of  FIGS. 9(   a )- 9 ( e ), an indwelling catheter is inserted in the delivery member  150  and the delivery member  150  is kept in position for the predetermined period of time and removed after the predetermined period of time. The process for removing the delivery member  150  from the treatment area  40  after the predetermined period of time is the same as that described above with respect to the embodiment of  FIGS. 9(   a )- 9 ( e ) such as by pulling on the unillustrated inflation tube attached the delivery member  150 . 
         [0059]    In the apparatus of the embodiment of  FIGS. 11(   a )- 11 ( e ), a two-way expandable member  170  is used as the delivery member, with the treatment membrane  30  being mounted to this two-way expandable member  170 . The two-way expandable member  170  expands at both its annular inner surface and its annular outer surface. The two-way expandable member  170  is removably mounted to the elongated member/endoscope  120 . 
         [0060]    In the method illustrated in  FIGS. 11(   a )- 11 ( e ), before the step of inserting the elongated member/endoscope  120  into the urethra, the delivery member/two-way expandable member  170  is mounted onto the elongated member/endoscope  120 , and the delivery member/two-way expandable member  170  is expanded to prevent relative movement between the delivery member/two-way expandable member  170  and the elongated member/endoscope  120 . The elongated member  120  is then moved in the axial direction to move delivery member/two-way expandable member  170  to the treatment area  40 . The delivery member/two-way expandable member  170  is then contracted to allow relative movement between the delivery member/two-way expandable member  170 . The delivery member/two-way expandable member  170  is then pulled back, resulting in dismounting of the delivery member/two-way expandable member  170  from the elongated member/endoscope  120 , and then the delivery member/two-way expandable member  170  is again expanded to press the outer portion of the delivery member/two-way expandable member  170  against the treatment membrane  30 , thereby contacting the treatment membrane  30  with the treatment area  40 . An indwelling catheter is then inserted into the delivery member/two-way expandable member  170 . After the predetermined period of time, which, as discussed above, is a sufficient time for the treatment membrane  30  to graft to the treatment area  40 , the steps are reversed, i.e., the indwelling catheter is removed, the delivery member/two-way expandable member  170  is contracted, the endoscope/elongated member is then reintroduced into the delivery member/two-way expandable member  170  and the delivery member/two-way expandable member  170  re-expanded, and then the elongated member/endoscope  120 , with the delivery member/two-way expandable member  170  mounted thereon, is removed from the urethra. In the embodiment, the delivery member/two-way expandable member  170  may be removed by pulling on the unillustrated inflation tube attached to the delivery member/two-way expandable member. 
         [0061]    The method illustrated in  FIGS. 12(   a )- 12 ( e ) is similar to that illustrated in  FIGS. 11(   a )- 11 ( e ) except that the delivery member is a one-way expandable member  180  having a fixed outer surface, i.e., only the inner surface changes size to be able to mount to and dismount from the endoscope  120 . The method of use is the same as that illustrated in  FIGS. 11(   a )- 11 ( e ) except that the delivery member/one-way expandable member  180  is not re-expanded after removal of the elongated member/endoscope  120  until after the elongated member/endoscope  120  has been reinserted into the delivery member/one-way expandable member  180  for removal of the delivery member/one-way expandable member  180 , or at all in the case in which the delivery member/one-way expandable member  180  is removed by pulling on an unillustrated inflation tube attached to the delivery member/one-way expandable member  180 . In this embodiment, the delivery member/one-way expandable member  180  is large enough outer diameter for successful engraftment of the treatment membrane  30  to the treatment area  40 . 
         [0062]    In embodiments in which the delivery member is an expandable member having an adjustable outer circumference, i.e., an expandable outer surface, in order to mount the treatment membrane  30  to the delivery member/expandable member  200 , the treatment membrane  30  is wrapped around the expandable member  200 , the opposite overlapped edges of the expandable member  200  are pinched, and then the opposite overlapped edges of the expandable member  200  are attached together by, for example, suturing or heat sealing.  FIGS. 13(   a )- 13 ( b ) illustrate an exemplary process in which the pinching of the opposite overlapped edges of the treatment membrane  30  together is done with a clip part  220  of a clip device  210 . Alternatively, the treatment membrane  30  can first be wrapped around a mold and the opposite overlapped edges attached together, then the mold is removed, then the treatment membrane  30  mounted to the expandable member  200 . 
         [0063]    The circumference of the treatment membrane  30  can be set by setting the circumference of the expandable member  200  to be the desired circumference of the treatment membrane  30 . And by using a clip device  210  which includes an indicator  230 , such as a ruler which provides an indication of a size of the expandable member  200 , as illustrated in  FIGS. 14(   a )- 14 ( b ), the expandable member  200  can be expanded during the mounting process based on the indication. Furthermore, by using a clip device  210  which also includes a limiter  240  which limits the size of the expandable member  200 , as illustrated in  FIGS. 15(   a )- 15 ( b ), expansion of the expandable member  200  can be automatically stopped based on a setting of the limiter  240 . 
         [0064]    As illustrated in  FIGS. 16(   a )- 16 ( b ), the clip device  210  can further include a cavity  250 , in which case the method will further include positioning the treatment membrane  30  and the expandable member  200  in the cavity and, if necessary, expanding the expandable member  200  while the treatment membrane  30  and the expandable member  200  are positioned in the cavity  250 . In an embodiment, a plurality of clip devices  210  having different sized cavities can be made available, and the circumference of the treatment membrane  30  can be set by selecting the clip device  200  having the appropriately-sized cavity. 
         [0065]    The clip device  210  illustrated in  FIGS. 16(   a )- 16 ( b ) also possesses suturing holes  260  configured to align with the opposite overlapped edges of the treatment membrane  30 . When such suturing holes  260  are provided, the opposite overlapped edges of the treatment membrane can be attached by performing a suturing operation through the suturing holes  260 . The clip device  210  illustrated in  FIGS. 16(   a )- 16 ( b ) further possesses suturing holes  270  configured to align with opposite ends of the treatment membrane  30 . When such suturing holes  270  are provided, the opposite ends of the treatment membrane can be at least partially closed by performing a suturing operation through the suturing holes  270 . In more detail, as shown in the  FIG. 16   c  view of the bottom of the clip device  210 , one suturing hole  270  is provided at each end of the bottom, while as shown in the  FIG. 16   d  view of the bottom of the clip device  210 , two suturing holes are provided at each end of the top. A suture passing through the suturing holes  270  of one end of the clip device  210  can tighten that end of the treatment membrane  30  around that end of the expandable member  200 . Since, as illustrated in  FIG. 13(   a ), the expandable member  200  can have smaller-circumference ends serving as attachment parts, tightening each end of the treatment membrane  30  around the smaller-circumference ends of the expandable member  200  can serve to immobilize the treatment membrane  30  with respect to the expandable member  200 . The treatment membrane  30  can then be released from the expandable member  200  at the appropriate time of the procedure by pulling on the strings which are used to provide the sutures through the suturing holes  270 . 
         [0066]    In the clip devices  210  described above, the clip part  220  of the clip device  210  possesses two opposed clip portions which are forced together by a spring force. With this configuration, the step of pinching the opposite overlapped edges of the treatment membrane  30  with the clip part  220  comprises providing a force which opposes the spring force to move the opposed clip portions apart, moving the opposite overlapped edges of the treatment membrane  30  to a pinching operation position, and releasing the force which opposes the spring force to allow the spring force to force the opposed clip portions together at the pinching operation position to thereby pinch the opposite overlapped edges. 
         [0067]    In an alternative embodiment, a clip device, such as the clip device  280  illustrated in  FIGS. 17(   a )- 17 ( c ), can be provided, in which the clip part comprises completely separable opposed clip portions  290 . With such a clip device  280 , the step of pinching the opposite overlapped edges of the treatment membrane  30  with the clip part comprises separating the opposed clip portions  290 , moving the opposite overlapped edges of the treatment membrane  30  to a pinching operation position, and bringing the opposed clip portions  290  together at the pinching operation position to thereby pinch the opposite overlapped edges. Furthermore, the circumference of the treatment membrane  30  can be selected by selecting opposed clip portions  290  with the appropriately sized cavity portions  300 . A spring mechanism can also be used in this embodiment to assist in bringing the opposed clip portions  290  together. 
         [0068]    The delivery member can also include attachment parts to assist in attaching and detaching the treatment membrane to and from the delivery device. In the embodiment illustrated in  FIGS. 18(   a )- 18 ( b ), the delivery member/expandable member  200  includes an attachment part  310  at each end, and the opposite edges of the treatment membrane  30  are sutured directly to the attachment parts  310 .  FIGS. 19(   a )- 19 ( d ) illustrate a similar embodiment in which the treatment membrane  30  is attached to each attachment part  320  by virtue of suturing opposite edges of the treatment membrane such that openings are defined through which the attachment parts  320  protrude. The curved shape of the attachment parts  320  assists in keeping the treatment membrane  30  attached even though it is not directly sutured to the attachment parts  320  in this embodiment. In these embodiments, the delivery member  200  and attached treatment member  30  can be considered to together constitute a therapeutic device. 
         [0069]    As illustrated in  FIG. 19(   d ), in the embodiment in which curved attachment parts  320  are used, the delivery member  200  be rotated to cause the curved attachment parts to  320  retract through the openings defined by the sutures and thereby detach the treatment membrane  30  from the delivery member  200 . The delivery member  200  can then be withdrawn from the urethra. Furthermore, in embodiments in which the delivery member  200  is an expandable member, the expandable member can additionally or alternatively be contracted in the detachment process, as illustrated in  FIGS. 20(   a ) and  20 ( b ). 
         [0070]      FIGS. 21(   a )- 21 ( c ) illustrate a further embodiment in which each attachment part  330  is formed as two oppositely curved portions, and the treatment membrane  30  is detached by rotating the delivery member  200  in first one direction, and then the other direction. 
         [0071]      FIG. 22  illustrates an alternative embodiment in which the attachment parts comprise slits  340  in the delivery member  200 . Such slits  340  can be configured to engage portions of the treatment membrane  30  or sutures in the treatment membrane  30 , and can detach from such portions by rotating the delivery member  200 . 
         [0072]    Further alternative embodiments of attachment parts include tabs for suturing opposite ends of the treatment membrane thereto illustrated in  FIG. 23(   a ), tips for piercing opposite ends of the treatment membrane as illustrated in  FIG. 23(   b ), hooks for hooking across the treatment membrane as illustrated in  FIGS. 23(   c ) and  23 ( d ), and straight attachment parts, such as those illustrated in  FIGS. 18   a ) and ( 18   b ) but provided across the treatment membrane as illustrated in  FIG. 23(   e ). Additionally, the attachment parts can be strings for binding opposite ends of the treatment membrane as illustrated in  FIGS. 23(   f ) and  23 ( g ), suction cups for suctioning opposite ends of the treatment membrane as illustrated in  FIG. 23(   h ), adhesive sheets for adhering to opposite ends of the treatment membrane as illustrated in  FIG. 23(   i ), and suction holes for suctioning across the treatment membrane as illustrated in  FIG. 23(   j ). The various attachment parts can be located on opposite ends of the treatment membrane, across the treatment membrane, or both. 
         [0073]    Various methods for ensuring that the delivery member is provided at the delivery area are discussed above. Additional methods which can be adapted to the previously discussed embodiments are illustrated in  FIGS. 24-28 . 
         [0074]    In the method illustrated in  FIGS. 24(   a )- 24 ( c ), prior to insertion of the elongated member and delivery member into the urethra, a measuring member  400 , such as a wire or tube with a blunt distal end and measurement markings starting from the distal end, is inserted into the urethra until its distal end reaches the subject&#39;s bladder neck  450  (as determined by resistance of the measuring member  400  to further insertion). An endoscope  120  is then used to view the measurement markings next to the treatment area  40 . Such measurement markings can be used to determine the length between the bladder neck  450  and the treatment area  40 . Next, the delivery member  20  is fixed to the elongated member  10  at an appropriate position based on the known length from the bladder neck  450  to the treatment area  40  which would cause the treatment membrane  30  to line up with the treatment area  40  when the blunt distal portion of the elongated member  10  reaches the bladder neck  450 . Measurement markings can be provided on the elongated member  10  for positioning of the delivery member  20  relative to the elongated member  10 . 
         [0075]    In the method illustrated in  FIGS. 25(   a )- 25 ( c ), prior to insertion of the elongated member and delivery member into the urethra, a measuring member  500 , such as a wire or tube or sheath with measurement markings starting from the distal end, is inserted into the urethra until its distal end reaches the treatment area  40 , as determined by an endoscope  120 . The operator can then use the measurement markings on the measuring member  500  to visually determine the length from the treatment area to the external urethra meatus  550 . With this information, the operator can more precisely position the delivery member  20  and treatment membrane  30 . For example, in an embodiment in which the elongated member  10  is inserted into the urethra, and then the delivery member  20  moved along the elongated member  10 , measurement markings on the operation member  50  can be used to determine that the delivery member  20  has moved within the urethra the same length as the length between the treatment area  40  and the external urethra meatus  550 . In this case, the delivery member  20  will have been moved to the treatment area  40 . The operator can also determine the length between the treatment area and another anatomical landmark. The anatomical landmark includes, for example, the bladder neck, the external urethra meatus, or the membranous urethra. 
         [0076]    After these steps, the delivery member  20  is fixed to the elongated member  10  to avoid unexpected movement of the treatment membrane mounted on the delivery member from the treatment area  40  during the predetermined period of time. 
         [0077]    The proper positioning of the delivery member  20  can also be monitored by using a clear indwelling catheter for the elongated member  10  and providing an endoscope  120  within the clear indwelling catheter so that the operator can visually determine that the delivery member  20  has been provided at the treatment area. Alternatively, as illustrated in  FIGS. 26(   a )- 26 ( c ), a clear indwelling catheter having measurement markings starting from the blunt distal end can be used as the elongated member  10 . In this method, the distance between the bladder neck and the treatment area  40  is first measured, for example, in the manner described with respect to  FIG. 24(   a ). Then, the endoscope  120  can be provided within the inserted elongated member  120  to view the position of the delivery member relative to the measurement markings on the elongated member  120  to help with proper positioning of the delivery member  20  relative to the treatment area  40 . 
         [0078]    Another type of clear elongated member that can be used as a delivery member is a clear sheath  600 , as illustrated in  FIGS. 27(   a )- 27 ( f ). The method in this embodiment is similar to the method used in  FIGS. 11(   a )- 11 ( f ) except that, instead of being mounted directly to the endoscope  120 , the delivery member  170  is mounted to the clear sheath  600 , and the endoscope  120  is positioned within the clear sheath  600  to view the position of the delivery member  170  relative to the treatment area  40 . When the endoscope  120  is withdrawn, the clear sheath  600  remains. After the indwelling catheter  650  is inserted into the clear sheath  600  and the delivery member  170 , the clear sheath  600  is withdrawn. 
         [0079]      FIGS. 28(   a ) and  28 ( b ) illustrate methods for fixing the position of the elongated body/indwelling catheter  10  relative to the treatment area  40 . In  FIG. 28(   a ), a stopper  700  is fixed to the appropriate position on the elongated body/indwelling catheter  10  to engage with the external urethra meatus. In more general terms, the elongated body  10  is fixed to at least one side of the edge of the body lumen. This can also be accomplished by suturing the external urethra meatus to the side of the elongated body  10 , as illustrated in  FIGS. 28(   b ). Additionally or alternatively, the distal end of the elongated body/indwelling catheter  10  can be fixed relative to the bladder neck  450  by, for example, hooking or hanging. Fixation of the delivery member  20  to the elongated body/indwelling catheter  10  further ensure to avoid unexpected movement of the treatment membrane mounted on the delivery member from the treatment area  40  during the predetermined period of time. 
         [0080]      FIGS. 29(   a )- 29 ( h ) and  30 ( a )- 30 ( h ) illustrate alternative methods of attaching and detaching the treatment membrane  30  with the delivery member  20  using a snare device. In  FIGS. 29(   a )- 29 ( h ), the snare device  800  is a string extending back and forth through a pipe and looped at one end. Pushing and pulling the string at the other end of the pipe increases and decreases the size of the loop. In the illustrated embodiment, the loop is provided around the distal end of the treatment membrane and pulled tight to contract that end of the treatment membrane around one of the smaller-circumference ends of the delivery member (the distal end in the embodiment). At the appropriate time, the loop is expanded to detach the treatment membrane  30  from the delivery member  20 . In the method of  FIGS. 30(   a )- 30 ( h ), a snare device  850  having two loops to snare both smaller-diameter ends of the delivery member  20  is used. In this embodiment, as an alternative to expanding the loops to detach the treatment membrane  30  from the delivery member  20 , the loops can instead be cut. 
         [0081]    Alternatively, as illustrated in  FIGS. 31(   a )- 31 ( c ), snare loops  900  can be formed by providing openings  950  in the smaller-circumference ends of the delivery member  20  and running strings through the respective sets of openings  950 . By pulling both strings for a particular loop, that loop can be tightened to attached the treatment membrane  30  to the delivery member  20 . At the appropriate time, a single string for each loop can be pulled to remove the strings entirely and allow the treatment membrane  30  to detach from the delivery member. 
         [0082]    As a further alternative, one or more puncturing members  1000  can be provided on the delivery member  20 , as shown in  FIGS. 32(   a )- 32 ( c ). When the delivery member  20  is expanded, the puncturing devices  1000  puncture the treatment membrane to attached the treatment membrane  30  to the delivery member  20 . The puncturing devices  1000  can also be configured to puncture the wall of the urethra. In this embodiment, in order to detach the treatment membrane  30 , the delivery member  20  is contracted to pull the puncture devices  1000  out of the treatment membrane  30  and/or the wall of the urethra. 
         [0083]    The detailed description above describes features and aspects of embodiments of a trans-urethral urethroplasty method and apparatus disclosed by way of example. The invention is not limited, however, to the precise embodiments and variations described. Changes, modifications and equivalents can be employed by one skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.