Abstract:
The method of the present invention relates to treating female urinary incontinence and involves passing opposite ends of a tape into a female patient&#39;s body and then positioning at least a portion of the tape between the vaginal wall and the urethra, whereby the tape forms a supportive loop beneath the urethra. The ends of the tape are extended through the patient&#39;s abdominal wall and outside of the patient&#39;s body and then the position and tension of the supportive loop are adjusted to achieve a clinically acceptable degree of urinary continence.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This application is a continuation application of U.S. application Ser. No. 09/051,311, filed Jul. 27, 1998, which was the National Stage of International Application No. PCT/SE96/01269, filed Oct. 8, 1996 and published in the English language. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The invention relates to a surgical instrument and a method using same for treating female urinary incontinence.  
         BACKGROUND OF THE INVENTION  
         [0003]    U.S. Pat. No. 5,112,344 discloses a surgical incontinence device and method, wherein the disclosed device includes a shank having a handle at one end thereof, and a curved needle-like element which is constructed to be connected with the shank to form a curved portion.  
           [0004]    WO-A-9606567, the content of which is hereby incorporated by reference herein, discloses a surgical incontinence device that allows for alleviating female urinary incontinence while restoring continence by attaching two curved needles to a tape that is intended to be permanently implanted into the tissue between the vaginal wall and the abdominal wall of a patient, thus strengthening the tissue required to restore the urinary continence. The method disclosed in WO-A-9606567 involves the steps of passing the tape into the tissue between the vaginal wall and the abdominal wall and leaving the tape permanently in the body, thereby providing reinforcement of the tissue that is required to restore urinary continence, either by the tape itself acting as an artificial ligament or by the development of fibrous tissue.  
         BRIEF SUMMARY OF THE INVENTION  
         [0005]    The method of the present invention relates to treating female urinary incontinence and involves passing the first and second ends of a tape into a female patient&#39;s body and then positioning at least a portion of the tape between the vaginal wall and the urethra. After such positioning, the tape forms a supportive loop beneath the urethra. The ends of the tape are then extended over the patient&#39;s pubic bone and through her abdominal wall such that the ends of the tape extend outside of the patient&#39;s body. The position and tension of the supportive loop are adjusted to achieve a clinically acceptable degree of urinary continence. The ends of the tape may be passed into the patient&#39;s body via the vagina. The tape may be at least partially enclosed by a removable sheath, which is removed after the tape is positioned and adjusted. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]    The invention will be explained in more detail with reference to the accompanying drawings which disclose the surgical instrument according to the invention and wherein.  
         [0007]    [0007]FIG. 1 is a side view of the surgical instrument according to the invention,  
         [0008]    [0008]FIG. 2 is a plan view of the surgical instrument,  
         [0009]    [0009]FIG. 3 is an exploded side view of one of the needles and tape and shrinkage hose to be connected with said needle,  
         [0010]    [0010]FIG. 4 is a side view of the needle in FIG. 3 with the tape connected therewith,  
         [0011]    [0011]FIG. 5 is an enlarged fragmentary axial cross sectional view of a coupling of the instrument for connecting an exchangeable needle thereof,  
         [0012]    [0012]FIG. 6 is a side view of the two needles and a tape interconnecting said needles,  
         [0013]    FIGS.  7  to  13  illustrate diagrammatically several surgical steps of the method according to the invention, and  
         [0014]    [0014]FIG. 14 in the same way illustrates the final step of the method. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0015]    In the following description, the same reference numerals have been used to describe the various features of the instrument of the present invention as were used in WO-A-9606567. To facilitate the following discussion, however, the order of the figures has been changed and the reference numerals used to describe the female urinary system have been altered.  
         [0016]    With reference to FIGS.  1 - 6 , the surgical instrument of the present invention comprises a cylindrical tubular shank  10  having at one end thereof a handle  11 . At the other end of the shank there is a socket  14 . A cylindrical shaft  15  (see FIGS. 2 and 5) is rotatably mounted in the shank and can be rotated manually by means of a knob  16  mounted to one end of the shaft. The other end of the shaft  15  forms a cylindrical portion  17  (see FIG. 5) of smaller outside diameter than the shaft, which joins a portion  18  having external threads, a smooth end portion  19  of further reduced diameter joining the threaded portion  18 , end portion  19  forming a guide pin at said other end of the shaft. Portions  18  and  19  are received in the portion of socket  14  projecting from the shank. The surgical instrument as described so far is in agreement with the instrument disclosed in WO-A-9606567 except that the end portion  14 ′ of socket  14  is flattened from opposite sides (see FIGS. 1 and 2), so that the cross section of said end portion is non-circular.  
         [0017]    The surgical instrument also includes an exchangeable and disposable needle  21  which at one end thereof is attached to the shank at one end of the needle and extends over substantially a quarter of a circle to the other, free end thereof in order to follow substantially the profile of the pubis between the vagina and the abdominal wall. The needle has uniform circular cross section and has a smooth, preferably polished outside surface. At the free end thereof the needle forms a point  22  by being terminated by a conical portion.  
         [0018]    For attachment of needle  21  to shank  10  the needle forms at said one end thereof a straight portion  30  which is cylindrical but has milled flat faces  31  (see FIG. 3) over that part of said portion  30 , extending from the adjacent end of the needle, which shall be received by socket portion  14 ′. The needle should be oriented in a predetermined rotational position in relation to the shank, and more particularly it should project at right angles to the plane of handle  11 . This rotational position is secured by the non-circular shape of socket portion  14 ′ and the end portion of the needle having the flat faces  31 , which fits into socket portion  14 ′. The end portion of the needle having the flat faces  31  joins the body of the needle over the conical portion  32 , which tapers towards a shoulder  33  (see FIG. 3).  
         [0019]    An axial blind hole extends from the end surface of the needle said hole having a threaded portion  23  and inwardly thereof a narrower, cylindrical portion  24 . Guide pin  19  is dimensioned to be guidingly received by said latter portion when the threaded portion  18  for attaching needle  21  to the rest of the surgical instrument is screwed into threaded portion  23  of the blind hole by rotating shaft  15  by manual rotation of knob  16 , the end surfaces of the shank and the needle being pressed against each other. Also this attachment is in agreement with that described in WO-A-9606567.  
         [0020]    When the method as described in WO-A-9606567 is practiced, two needles  21 A and  21 B (see FIG. 6) are each connected to each end of a tape  26 . According to the present invention, the tape  26  of the preferred embodiment comprises a mesh or netting forming openings of the order of 1 mm. A suitable material for the tape  26  is PROLENE®, a knitted polypropylene mesh having a thickness of 0.7 mm manufactured by Ethicon, Inc., Sommerville, N.J., USA. This material is approved by FDA in USA for implantation into the human body. The netting (tape)  26  preferably has a width of approximately 10 mm and is enclosed in a thin polyethylene sheath  34  which, in flattened condition, has substantially the same width as the tape  26  although a difference in width is shown in FIG. 2 in order to make the provision of the sheath  34  more clear. The length of the netting  26  should be approximately 400 mm. The netting  26  and the sheath  34  are interconnected by means of two rows  35  of stitching. The end portion of the sheath  34  is attached to the conical portion  32  (see FIG. 3) of the needle  21  by means of a suitable strong glue, and the interconnection of the needle  21  and sheath  34  is covered by a shrink hose  36  (see FIGS. 3 and 4) made of rubber, which extends from the shoulder  33  over the conical portion  32  and partly over the cylindrical end portion  30  of the needle  21 . The shrink hose  36  is substantially flush with the surface of the needle  21  at the shoulder  33 . By this arrangement the netting  26  is securely attached to the needle  21 .  
         [0021]    The purpose of sheath  34  is, above all, to facilitate the insertion of the netting  26  in the manner described in WO-A-9606567, i.e., when the netting  26  is pulled at the ends thereof from the vaginal wall to the abdominal skin and to avoid that rough edges of the netting irritate or damage the body tissues.  
         [0022]    When the tape has been positioned in the correct position as a sling around the urethra (as described hereinafter in connection with the method of the present invention shown in FIGS.  7 - 14 ) the polyethylene sheath  34  shall be removed, and in order to facilitate the removal the sheath  34  should be perforated at the longitudinal center thereof as indicated by a dot-and-dash line  37  in FIG. 6, so that the two halves of the sheath  34  can be withdrawn from the body by pulling at the respective outer ends thereof, the halves being separated at the perforation under the influence of the pulling force.  
         [0023]    The purpose of the polyethylene sheath  34  is also to protect the netting  26  during attachment to the needles  21 A,  21 B and during handling before and during insertion into the body.  
         [0024]    The longitudinal center of the tape  26  and sheath  34  should be indicated by a visible colour mark  38 , (see FIG. 6, so that the surgeon readily can see when the netting  26  is symmetrically located with reference to urethra during the surgery.  
         [0025]    The method of the present invention will now be described in detail with reference to FIGS.  7 - 14 . In FIGS.  7 - 14 , the relevant parts of the female lower abdomen are disclosed diagrammatically, the vagina being designated  40 , the vaginal wall  42 , the urinary bladder  44 , the urethra  46 , the pubic bone  48 , and the abdominal wall  50 .  
         [0026]    The first step of the surgery for implanting tape  26  is disclosed in FIG. 7 and comprises penetration of the vaginal wall  42  by needle  21 A a cut having first been made in said wall  42 , and, also penetration of the soft tissue at one side of urethra  46 , the needle  21 A then, according to FIG. 8, being passed close to the back of the pubic bone  48  and then through the abdominal wall  50  above the pubic bone  48 . A cut can be done through the abdominal wall  50  for the passage of the needle  21 A therethrough, but if the needle  21 A is pointed, it may be sufficient to let the needle  21 A penetrate into the abdominal wall  50 , from the inside thereof, and to make a registering cut in the abdominal wall  50  on the outside thereof.  
         [0027]    The shank  10  of the instrument is now disconnected from needle  21 A, FIG. 9, by rotating shaft  15  at knob  16  so that the threaded portion  18  of the shaft  15  is unscrewed from the threaded portion  23  in needle  21 A, the needle  21 A then being withdrawn from the abdominal wall  50  by means of forceps and the tape  26  being pulled into and through the tissue as illustrated in FIG. 10.  
         [0028]    The other needle  21 B is now attached to the shank  10 , FIG. 11, and is passed through a cut in the vaginal wall  42  to pass through the soft tissue at the other side of the urethra  46 . The needle  21 B is passed through the abdominal wall  50  (see FIG. 12) and then, after having been disconnected from the shank  10 , is withdrawn from the abdominal wall  50  (see FIG. 13), all in the same way as in the earlier procedure with the first needle  21 A.  
         [0029]    Tape  26  is now located at each side of urethra  46  as shown in FIG. 13 and is tightened with the loop formed by the tape  26  located on the inside surface of the vaginal wall  42  (see FIG. 14). The surplus of the tape  26  at the outside of the abdominal wall  50  is cut off. Then, the tape  26  is left as an implant in the body to form an artificial ligament attached to the abdominal wall  50  and providing the support for the urethra  46  as required in order to restore urinary continence.  
         [0030]    Another kind of tape  26 , which may be used in the method according to the present invention, can be more closely woven than the tape  26  mentioned above and can be of such material that the tape  26 , after a shorter or longer period, will be completely resorbed. By the development of fibroblast proliferation stimulated by the tape  26  the reinforcement of the tissue required in order to restore the urinary continence will be obtained.