Abstract:
In a device and method for the percutaneous treatment of urinary stress incontinence in women using a synthetic sub-urethral tape, the device includes a needle, an intermediate traction element, and a sleeved support tape; and the method includes forming an opening in the vaginal wall and forming suprapubic incisions, creating tracks and following one track with a needle and intermediate traction element from a suprapubic incision to the opening in the vagina, following the other track with a needle and optionally an intermediate traction element, verifying the tracks by cystoscopy, passing a sleeved tape through the tracks to form a loop under the urethra, adjusting the loop, removing the sleeve, and leaving the tape implanted.

Description:
FIELD OF THE INVENTION 
     The present invention relates firstly to a surgical device and secondly to a method for surgically treating urinary stress incontinence in women. 
     More particularly, the present invention relates to a device for percutaneous treatment of urinary stress incontinence in women using a synthetic sub-urethral tape. 
     BACKGROUND OF THE INVENTION 
     For a long time, urinary stress incontinence has been treated under local, regional or general anesthetic, by supporting the urethra or bladder neck, in particular by using a tape. 
     U.S. Pat. No. 5,899,909 describes a method and a device for treating incontinence. The device enables a tape surrounded by a sheath to be implanted beneath the urethral canal, the sleeve then being withdrawn after implanting the tape. That device comprises two large needles located at either end of the tape-sleeve assembly, the needles comprising means on their proximal ends for mounting on a handle or a manipulator during the surgical intervention. Further, the tape-sleeve assembly is fixed to the proximal end using a plastic ring. 
     The tape is implanted by introducing each of the two needles in succession either side of the urethra, via an incision made in the anterior vaginal wall. Using each of the needles and holding them by the handle or introducing means fixed at its proximal end, the surgeon manipulates each needle to loop round the bladder and the pubic bone and exit via the abdominal wall in the suprapubic region. 
     The plastic sleeve surrounding the tape is presented cut at its centre and thus comprises two sections, the two sections overlapping, and the sleeve is thus removed by pulling on the ends of each of the sections which exit via each of the suprapubic cutaneous incisions. 
     That device and those known methods suffer from a number of disadvantages. 
     The device requires the use of an introducing means which has been specially designed for that type of surgical intervention. Further, the surgical intervention itself suffers from a major disadvantage in that the bottom-to-top track of the two large needles introduced into the anterior vaginal wall and exiting in the suprapubic region is not easy to control precisely, in particular when going around the base of the bladder, and vesical perforations are far from uncommon. This is upheld by medical publications. Thus it is recommended that a cystoscopy be performed during the intervention after passage of each needle. The use of that device also necessitates the use of a further accessory element, namely a rigid probe guide. 
     Those two accessories (introducing means and rigid guide) must thus be available to the surgical team for each intervention and has to be prepared by washing, packaging and serialization for each use. 
     Further, there is also a risk of vascular lesions which cannot be hidden: lateral passage with respect to the bladder with a vaginal point of entry runs the risk of injuring the epigastric and iliac vessels in the retrocrural region, with the points of the needles. Such lesions have already been recorded. 
     Finally for that method, if the cystoscopy confirms that the track of the tape-sleeve assembly is incorrect, it is very difficult to form a repeat track with the same device under suitable conditions. Reversing is difficult and exacting, not only for the tape-sleeve assembly, but also for the large needles. During these repetitive movements, the tape can often be uncovered due to the non hermetic nature of the sleeve. If the track is unsuitable, the sleeve-tape assembly has to be sectioned, for example at the needles, and the device can no longer be used properly for producing a further track. 
     Thus no percutaneous treatment exists for female urinary stress incontinence which uses a tape which can lead to the devices and technique of the present invention. 
     SUMMARY OF THE INVENTION 
     The present invention provides a method for treating urinary incontinence in a woman suffering from urinary stress incontinence, said method comprising at least the following steps: 
     a) forming an opening in the anterior vaginal wall; 
     b) creating, from two small suprapubic incisions formed in the abdominal skin, a right track and a left track from the abdominal skin to the opening formed in the anterior vaginal wall; 
     c) using a needle and an intermediate traction element to follow one of the tracks; and following the other with the needle and optionally an intermediate traction element; 
     d) verifying by cystoscopy that the path of these tracks is outside the bladder and the urethra; 
     e) using a support tape surrounded by a plastic sleeve to follow the tracks by passage under half of the inferior surface of the urethra; 
     f) adjusting the loop formed by the sleeved tape under the inferior surface of the urethra; 
     g) removing the sleeve by pulling towards the outside via the small abdominal incisions; 
     h) leaving the freed tape implanted from the first to the second incision, going round the urethra and serving to support the urethra. 
     It also provides a device for treating feminine urinary incontinence essentially constituted by: 
     a) a penetrating needle having a partially curved distal portion termed the active portion, which is integral with a straight portion having a proximal end; 
     b) a hermetically sleeved support tape having a distal end and a proximal end; 
     c) at least one intermediate traction element disposed between the penetrating needle and the sleeved tape, and having a proximal end and a distal end. 
     Thus the present invention overcomes the disadvantages of the known devices and methods by proposing a different operating technique and an original device which is suitable for implementing this method. 
     The operating technique of the invention is easier, faster and safer in particular as regards the vessels. The risk of vascular lesion does not exist because of the orientation and the given direction of the needle right from the start. The risk of vesical puncture is small even in the case of previous interventions in this regard, as is particularly frequent in this type of pathology. Using the device and operating method of the invention, the percutaneous route is used to form top-to-bottom tracks using the needle, i.e., penetrating via abdominal cutaneous mini-incisions to exit via a previously formed vaginal opening. Detachment of the vagina allows the index finger of the surgeon to be insinuated up to the lower rim of the pubis and thus enables the track of the needle to be precisely directed. 
     The device of the invention enables this track to be made from top to bottom on both sides and enables the absence of vesical puncturing to be confirmed by cystoscopy before engaging the sleeve-tape system. 
     Further, the device of the invention is capable of being re-used very readily in the event of introduction into the body along a track which proves not to be optimal, for either of the tracks. The risk of septic contamination of the sleeved tape generated by repeating manoeuvres can be removed. It should be noted that the need to re-form one of these tracks is a very rare event when using the present method, which only occurs. in the case of very strong adhesions of the bladder to the posterior surface of the pubis due, for example, to previous surgical interventions. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Further characteristics and advantages will become apparent from the following detailed description made with reference to the accompanying drawings in which: 
     FIG. 1 shows, in profile, the location of the tape in position with respect to the abdominal wall, pubis, bladder, urethra and vagina; 
     FIGS. 2 a  to  2   h  are diagrams of certain steps in the operating procedure; 
     FIGS. 2 i  and  2   j  are diagrams of alternatives to certain of steps  2   a  to  2   h.    
    
    
     DETAILED DESCRIPTION 
     In FIG. 1, tape  1  is shown in position in the patient&#39;s body, its ends not yet having been cut off at the surface of the abdominal cutaneous wall  2 . Tape  1  is positioned along the posterior wall of the pubis  3  and forms a loop around the urethra  8  terminated by the urethral meatus  9 . An incision or opening has been made in the anterior wall  7  of the vagina  6 , beneath the uterus  5 . 
     Device 
     1) The penetrating needle is produced from stainless steel. It is constituted by two integral portions screw connected to each other. The active distal portion  13  of needle  12  is partially curved and has a round cross-section; its proximal end  15  is terminated by a male screw connecting piece. Each end of the proximal  16  and distal  17  ends of the straight portion  14  of the needle has a female screw connecting piece. The length of this straight portion is 20 to 25 cm. The diameter of the needle assembly does not exceed 25 mm. 
     The proximal portion  16  of the needle is flattened and ribbed. This enables the surgeon to grip it and allows the needle to be oriented correctly. 
     2) The intermediate traction element is constituted by a hollow PVC tube with a diameter which is identical to that of the needle. It is 40 to 50 cm long. Its distal end  19  and proximal end  20  comprise a male screw connecting piece. This screw connecting piece is integrally fixed to the traction element by adhesion and screwing. The intermediate traction element is blue in colour so that it can readily be located during cystoscopy in the event of a vesical puncture. 
     3) The tape-sleeve system. The support tape is hermetically surrounded by a plastic sleeve. The tape is constituted by a knitted macroporous material, for example a wide mesh monofilament polypropylene. The tape is between 10 and 14 mm wide; it is 30 to 50 cm long, preferably about 40 cm. 
     Tape  21  can have a re-absorbable hydrophilic film in its central portion which reduces the risk of erosion or sclerosis of the urethra to a minimum. This central zone is indicated by a coloured marker. 
     In a variation, the tape can be constituted by other biologically acceptable materials. 
     A plastic sleeve completely surrounds the tape in a sealed manner. It is constituted by a strong low friction material such as a fluoropolymer. Its proximal end is closed. The other is heat-shrunk over a female screw connecting piece. The centre of the sleeve has a means for cutting and separating such as a cutting filament located perpendicular to the longitudinal axis of the sleeve, or any other means which enables the sleeve to be separated at the end of the procedure into two halves which will slide eccentrically to completely free the tape. 
     Operating Procedure 
     The first stage is illustrated in FIG. 2 a : the patient is placed in the gynaecological position. A sterile operating area is made. A urethral balloon probe  11  is positioned in the bladder and connected to a sterile collecting bag to empty and collapse the bladder. A short vertical incision  10 , maximum 30 mm in length, is made in the middle of the vaginal wall  7  centred in the middle third of the urethral canal  9 . Each lip  26  of the vaginal incision  10  is detached from its subjacent tissues using scissors as shown in FIG. 2 b.    
     Detachment is carried out until the index finger  33  of the surgeon, introduced via the opening  27 , can reach the lower rim  32  of the pubis outside the urethra and the periurethral tissues (FIG. 2 c ). 
     Then a very small cutaneous incision  34  less than 10 mm in length is made in the abdominal skin  2  immediately above the pubis  3  either side of the medial line and about 20 mm beyond it, to allow percutaneous passage of needle  12  by skimming the posterior surface of pubis  3  in the direction of the vagina. 
     Index finger  33  of the surgeon is insinuated into the vaginal track already prepared by detachment and the active distal end of needle  12  will come into direct contact with this index finger  33 . The needle can then exit via the vaginal opening  27  and the bladder is completely safe. 
     In general, the right percutaneous track is made first. Distal end  19  of the intermediate traction element  18  exits after needle  12  from the vaginal opening. This distal end  19  of the traction element is unscrewed from the proximal end  16  of the needle (arrow in FIG. 2 d ). 
     The needle is then passed into the second side (left) (FIG. 2 e ) in the same manner as for the first side (right). Once the curved distal portion  13  of needle  12  is well outside the vaginal opening  27 , it can be detached by unscrewing (single arrow in FIG. 2 e ) its proximal straight portion. 
     The next stage consists of screwing to connect the distal end  19  of the intermediate traction element to the straight portion  14  of the needle (double arrow in FIG. 2 e ). 
     This straight portion  14  of needle  12  is then pulled out from the abdomen and as a result, a portion of the traction element to which it is attached is pulled along the second track in the direction of the arrow which is shown in FIG. 2 f.    
     The intermediate traction element thus forms a loop around the urethra and the two ends exit respectively via abdominal incisions  34 ,  35  (FIG. 2 g ). 
     Urethral probe  11  is then withdrawn and cystoscopy is used to verify the absence of puncturing by this traction element. 
     Once verified, the end with the female connecting piece of the sleeve-tape assembly  21  is screwed to the male connecting piece of the proximal end  20  of the intermediate traction element and the assembly is pulled to position the tape surrounded by its sleeve which forms a loop around the urethra, in the place of the traction element, and the two ends exit via the abdominal cutaneous orifices  34 ,  35 . 
     The two ends of the sleeve and tape are sectioned and the sleeve is separated into two halves at its middle at opening  27 ; the two halves are completely removed via incisions  34 ,  35 , finally freeing the support tape. 
     The denuded tape is then adjusted to be placed below the inferior face of the urethra, usually in its central portion, without traction and without crushing. 
     If cystoscopy establishes that the track of the loop formed by the intermediate traction element is unsuitable, and more specifically confirms a vesical puncture, the side of the loop where the track is unsuitable is withdrawn and a new track is formed with the needle, as before, to produce a suitable track on this side. 
     The device allows top-to-bottom passage of the needle on both sides and the risk of lesions to vessels is removed and the risks of vesical lesion is much reduced. 
     The top-to-bottom constitution of both sides is only possible because of the highly original nature of the penetrating needle which comprises two portions which can be screwed one onto the other. 
     The concept of an intermediate traction element in the device of the invention is particularly innovative and advantageous; it renders the needle and the sleeved tape both integral and independent. It allows prior formation of the whole of the looped track and verification of the proper positioning of the track before handling the tape-sleeve system. This advantage is rendered possible by the suitable length of the traction element. 
     If it proves necessary, it enables a new track to be formed for the right side and for the left side before any manipulation of the sleeved tape. 
     Terminal manipulation of the sleeved tape reduces the risk of septic contamination, the surgeon changing gloves and cleaning the operating area again if necessary before this terminal phase. 
     The intermediate traction element can have other embodiments: 
     The tube can be formed from any suitable material with mechanical characteristics which are similar to that of PVC. This tube, in PVC or the like, can also be separated into two portions of similar length, for example equal lengths, by cutting it at its centre. A short intermediate piece, for example of metal, with a diameter similar to that of the tube and having a male screw portion  24 ,  25 , can then be envisaged; such a part  23  is shown in FIG. 2 i , the male screw element corresponding to the internal diameter of the tube. Any other means which can directly and integrally connect the two tubular halves can also be envisaged, once the right and left tracks formed using the needle passed from top to bottom to the right and the left in succession are joined. 
     When using a tube, parts similar to part  23  can be used to removably fix the traction element to the needle and to the tape and the portions of the traction elements to each other. Parts carrying a male and a female connecting piece can also be envisaged, for ease of fixing. Other fixing systems other than screw systems can be provided for the removable or non removable fixings. 
     In this variation, a one-piece needle is used which can terminate in a male screw connecting piece. Passage of the track on each right and left side is made by screwing a portion of the traction element (FIG. 2I) to the proximal end of the needle. Cystoscopy then verifies the absence of punctures; then the two tubular halves are connected to each other using the small metal part to form a single traction element disposed in a loop beneath the urethra (FIG. 2 j ). The remainder of the intervention is identical. 
     In a variation, a fluoropolymer lace can constitute the traction element. In this case, it is connected to the needle via an eye at its proximal end and is folded back on itself after passage through the eye and sewn to itself. In this variation of the device, the lace, which is about 40 cm long, can be sectioned at its centre when carrying out the operation employing the fundamental general principle of forming a top-to-bottom track; and again it can be reconstituted by the surgeon by a simple mattress suture. 
     The sleeve material, which may be formed from Teflon or based on a fluoropolymer, provides the internal and external surfaces of the sleeve, firstly to endure good separation between said sleeve with advantageous non-stick properties and the tape and secondly to limit friction and avoid trauma during passage inside the patient&#39;s body. 
     A non-stick film opposite the lower surface of the urethra can be provided to protect the patient from the risk of erosion or sclerosis around the urethra. 
     The needle is unique and, for its penetration, does not need any additional instrument to grip it, which saves time in preparation for surgery and during surgery. 
     The ease of use and simplicity of the constituent elements of the device also have cost advantages. 
     The ensemble of the elements of the device of the invention can be re-used in the event of poor manipulation and if the track inside the patient&#39;s body is to be improved or optimised. This represents a considerable advantage over the prior art technique. 
     Since the tracks can be produced from top to bottom, the device improves safety for the patient and the quality of the therapeutic result. 
     The effect of the tape on continence and regulation have not been evaluated in the method of the invention for at least the following two reasons: 
     continence in the prone position is not comparable to that when upright; and 
     the efficacy of the tape is not only explained by a tightening effect (which risks causing dysuria) but also by a supporting effect on the inferior surface of the urethra and by a lateral bracing effect. In the prior art, continence was monitored after filling the bladder and coughing to adjust the tension of the tape. 
     Finally, using the device and operating procedure of the invention, the surgeon can choose the height of the position of the tape with respect to the urethral channel (proximal or central portion) for each patient based on clinical, urodynamic and possibly imaging and endoscopy data, a feat which cannot be achieved using a prior art technique.