WO2015014909A1

WO2015014909A1 - Surgical device and method for treatment of female urinary incontinence under local anesthesia

Info

Publication number: WO2015014909A1
Application number: PCT/EP2014/066424
Authority: WO
Inventors: Simone DESHAYES-DEVONEC
Original assignee: Deshayes-Devonec Simone
Priority date: 2013-07-30
Filing date: 2014-07-30
Publication date: 2015-02-05

Abstract

The invention concerns a surgical device (200) for the treatment of female urinary incontinence, comprising at least one hollow needle (50) so as to ensure a fluid connection through its length, the hollow needle (50) comprising a first portion (52) configured to create an insertion path between the urethra and the vagina wall and a second portion (51) shaped to form at least partially a handle (40), characterised in that the surgical device (200) comprises at least one detecting system (201) configured to be connected to the second portion (51) of the at least one hollow needle (50), the detecting system (201) comprising at least a valve (4) and a depressurized tube (6) cooperating with each other so as to create a vacuum in the hollow needle (50). The disclosure concerns also several methods of insertion of the surgical instrument (200).

Description

Surgical device and method for treatment of female urinary

incontinence under local anesthesia

The present invention relates to a therapeutic device and a method for treatment of female urinary incontinence preferentially under local anesthesia.

The patent application US5899909 discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which are connected at one end to one end of a mesh intended to be implanted into the body. The above mentioned surgical instrument presents deficiencies: the large diameter of the needles, a long mesh implanted skin to skin, the mesh structure of the suspension means over its whole length. The large diameter needle is responsible of the following drawbacks: insertion of a 5 millimeter large needle requires general anesthesia; a 5 millimeter large needle may create more serious injuries than a smaller one, when engaged in a wrong path; a 5 millimeter needle may induce more local traumatism, not to say injury, than a smaller one, to anatomical structures contributing to continence (nerve and blood supply) along the path used to insert the needle. Moreover the surgical instrument described in this document comprises a long mesh implanted, from skin entry point to skin exit point, which has the following drawbacks: an increase of the friction of the mesh with the surrounding tissues along the path of implantation. Implantation requires a greater pulling force, adjustability of the tape is more difficult, due to the high friction passage through the fascia and muscles of the abdominal wall. During adjustment of the tension of the tape, transmission of the pulling force exerted on the tape from the supra-pubic region to the urethra is less sensitive. Indeed, the distance between the supra-pubic region and the urethra is the range of 10 to 15 centimeters for each arm of the loop mesh.

To facilitate insertion of the tape, a removable plastic sheath has been designed to cover the tape (see the patent application US2005/0148813). The plastic protecting sheath may be torn during its removal, again, because of the high friction passage through the fascia and muscles of the abdominal wall. Adjustment of the tape may be modified by pulling on the plastic sheath to remove it. This may result in the transmission of an excessive tension to the tape and thus, correction of the previous adjustment may become necessary. The new adjustment of the tape freed of the plastic sheath is more difficult, since the tape does not glide as well as it did, with the protecting gliding sheath in place. Moreover, the duration of the procedure is increased. Furthermore, a long mesh implanted skin to skin represents a large amount of prosthetic material and increases the risk of infectious complications. The proximity of the mesh cut at the level of the skin increases as well the risk of bacterial contamination by germs commonly present on the skin. Finally, according to paragraph [0011], the PROLENE^® mesh structure (i.e. a mesh structure in polypropylene) is supposed to have elongation properties providing the tension free support of the TVT (Tension free Vaginal Tape). However, in the patent application WO96/06567, it is described that the 8 to 10 mm large woven tape has apertures between weft and warp in order that fibroblasts can grow into the tape for anchoring of the tape in the surrounding tissue and that the polypropylene is suitable for the tape and can be coated with fibroblast stimulating substances". As soon as the healing process has occurred with colonization of the tape by surrounding tissue, any elongation of the tape is mechanically impossible and the tension free support of the TVT has lost its theoretical concept. Moreover, after the operation, delayed adjustment either early or late is difficult: after a few days, mobilization of the mesh is already difficult, due to mesh colonization by surrounding tissue. Moreover, the skin to skin mesh loop does not allow the natural gliding of surrounding tissues along the mesh, since surrounding tissues are fixed, in block, along the whole length from its entry point to its exit point through the skin. In this configuration, delayed adjustment either early or late is difficult, if not impossible.

The patent application US2003/0149440 discloses a surgical instrument comprising a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements each of which have a blunt tip. The distal end of the needle comprises an interlocking coupling means for accepting a guide needle or alternatively a mesh. The above-mentioned instrument presents the same deficiencies as already mentioned for the instrument disclosed in the patent application US5899909, i.e. deficiencies related to a large diameter needle, a long mesh, colonization of the tape by surrounding tissue, rendering elongation of the tape mechanically very difficult if at all possible. Removal of this model of tape, for infection, for excessive tension, for vaginal or bladder erosion provides convincing evidence of colonization of the mesh transformed into a rigid non extendable prosthesis. Indeed, the features of the handle and connecting means to receive the curved needle-like element with a blunt tip are the same according to figures of both publications. The instruments described in US2003/0149440 differ from the previous instrument (patent application US5899909) in that the distal end of the needle comprises an interlocking coupling means. Among the four embodiments, only one embodiment described in paragraph [0060] and in figures 9a through 9k, discloses the interlocking coupling means accepting a guide needle, which is an anesthesia needle. This anesthesia needle has a smaller diameter than the one of the curved needle like elements in the order of 5 millimeters. Indeed, the diameter of the anesthesia needle is about 2 millimeters. For those skilled in the art of performing local anesthesia, a 2 millimeter diameter needle is usually not recommended, but rather needles with smaller diameters 18 to 25G (according to the international Gauge classification), i.e. with a diameter equal or inferior to 1 millimeter. For this reason, the feasibility of the local anesthesia using this type of needle, as advocated in claim 1 of the above mentioned patent application (patent application US2003/0149440), is questionable. Indeed, a less invasive miniaturized material would be preferable. Once the anesthesia step has been performed, the next steps remain to be performed: connection of the anesthesia needle with the curved needle-like element, cystoscopy to control any injury of the bladder, passage of the tape, adjustment of the tape. The addition of more steps increases the duration of the procedure. A short duration procedure, in a single step combining local anesthesia, safety control, bypassing of a bony structure, passage of the tape would be preferable and more appropriate with the carrying out of the procedure under local anesthesia.

More recently, mini-tapes have been proposed to avoid some of the deficiencies of the classical tapes inserted skin to skin via the a retro-pubic route (TVT) or a trans-obturator route (TOT) and a length of tape left inside the body in the order of 20 to 30 centimeters. According to mini-tapes commercially available on the market, the length of mini-tapes varies from 3 centimeters to about 8 centimeters. Each of the two ends of the mini-tape is connected to a harpoon. After positioning at the tip of a curved handle, each harpoon is released and anchored in the fascia and muscle of the obturator fossa on each side of the pelvis. The tape has a shorter length, i.e., less prosthetic material is left in place. However, the handle used for the insertion of the tape and of the harpoons does not incorporate an anesthesia needle to perform the procedure under local anesthesia. The shaft of the handle has a diameter ranging from 2.5 to 3.5 millimeters. Immediate adjustment may not be possible. When immediate adjustment is possible, the latter cannot be performed under local anesthesia. Indeed, local anesthesia offers the ideal condition, because, it is the condition closest to the normal physiological condition. Delayed adjustment is not possible after implantation. Durability of the results is not as long as the one of classical tapes, because anchoring of mini-tapes is less efficient than the one of classical skin to skin tapes, as they are colonized by surrounding tissues along their whole length. The patent US5112344 discloses a surgical instrument for the application of a filamentary element into the body for the purpose of treating female incontinence, said instrument comprising a substantially rigid tubular shaft having a handle at one end and being curved towards its other end to form a curved portion, a flexible needle element slidably received in the shaft and adapted at one end to receive a filamentary element and having an enlarged portion at the other end, whereby when the needle element is fully received in the shaft the enlarged portion of the needle defines a non-incisive convergent surface at the other end of the shaft. The curved portion of the rigid tubular shaft allows its insertion after an incision of the vagina and further bypassing the pubic bone. However the flexible needle element is not hollow and does not allow the injection of an anesthetic solution along the path of the rigid curved shaft, and does not allow any safety means to control the absence of bladder or vessel transfixion along the path of the tubular shaft. The eye at the proximal end of the flexible needle element allows the insertion and the gliding of one of the free ends of a filamentary element through the rigid tubular shaft, but the instrument would not allow the insertion of a filamentary element connected to one end of a tape. A 1 centimeter large tape would not engage the narrow lumen of the rigid curved shaft and would not allow the backwards retrieval of the tubular shaft from the vagina. Also, the shaft could not be pulled by its distal end out of the skin incision through the body wall, since the handle affixed to its opposite proximal end would bump against the vagina. The instrument is conceived for "looping a filamentary element around the muscle tissue of the abdomen to either side of the urethra with the (free) ends extending into the vagina" (column 2, lines 53-55), but is not conceived for looping a tape below the urethra and for gliding each of the threads connected to each end of a tape until the free end of each thread exits the skin of one incision of the abdominal wall in the supra-pubic area.

The patent application US2012/0123427 discloses a non-coring co-axial assembly comprising an outer needle and a stylet with two hubs for the alignment of the bevel tips of the outer needle and the stylet (claim 22). The co-axial assembly is used for the access to a vertebral body through a straight path (paragraphs [0025], [0033], [0062], [0065]), for the penetration inside the vertebral body and from inside the vertebral body, for the access to various sites by a needle cannula with a distal bend portion rotatable in various planes (paragraphs [0017], [0025], [0069]). This assembly comprises five elements: a trocar or introducer stylet, preserving from tissue coring, to be inserted in an outer cannula introducer stylet, an outer cannula receiving, a needle cannula, receiving itself the inner needle introducer stylet to prevent from tissue coring. This needle assembly does not permit the outer cannula to bypass a bony structure through a continuous curved path with an entry point and a distant exit point in a patient. The rigid outer needle is straight and cannot follow the path of the highly flexible curved portion of the needle cannula. The outer cannula drills its own straight path (paragraph [0033]) for which it has been designed with a large Gauge diameter (paragraph [0066]) to provide the necessary rigidity to perforate bone and a beveled tip stylet to assist in bone penetration (paragraph [0066]). A handle is affixed to the outer cannula (paragraph [0066]) and does not allow the outer cannula to exit the body at a point different from its entry point. The device cannot be used under local anesthesia and requires the assistance of radiological guidance (paragraph [0005]). This co-axial needle assembly cannot be proposed to insert under local anesthesia a prosthetic material to treat female stress urinary incontinence.

The prior art above-described presents some drawbacks such as the use of large diameter needles. Indeed, the insertion of such large diameter needles requires general anesthesia in order to create a path for the tape through the patient body. The bladder is often perforated in the creation of the path for the needles and the diagnosis of bladder perforation requires cystoscopy by an expert physician.

Moreover the system used for supporting the urethra by a tape or a mini- tape is difficult to localize and to take out in case of complications such as bladder or vagina or urethra erosion or local infection. Furthermore, the tape or mini-tape is non- adjustable after implantation, because the surrounding tissues of the body grow through the tape. It is not possible to remove the tape without damaging normal tissues surrounding the tape during reoperation and not possible to readjust the tape beyond two weeks after implantation.

The purpose of the present invention is to solve whole or part of the above mentioned drawbacks.

The invention provides a surgical device for female urinary incontinence, comprising at least one hollow needle so as to ensure a fluid connection through its length, the hollow needle comprising a first portion configured to create an insertion path between the urethra and the vagina wall and a second portion shaped to form at least partially a handle, characterised in that the surgical device comprises at least one detecting system configured to be connected to the second portion of the at least one hollow needle, the detecting system comprising at least a valve and a depressurized tube cooperating with each other so as to create a vacuum in the hollow needle.

Thanks to the surgical device of the invention, it is possible to check if the bladder has been perforated or not while creating an insertion path between an entry or an exit point at the level of an anterior wall of the vagina below the urethra and respectively an exit or an entry point at the level of the skin in the suprapubic area or at the level of the external crease of each labia majora. Indeed, in creating vacuum via the hollow needle, if the depressurized tube does not aspirate urine, the bladder is intact; if the depressurized tube aspirates urine the bladder is perforated.

Moreover, thanks to the invention and its detecting system, cystoscopy is no more mandatory to detect the transfixion of the bladder and the injury of a large vessel. The operator's role is simplified and limited to hand guidance of the hollow needle, to maneuver of the valve in order to deliver anesthesia and/or to apply vacuum, and to visually control of the depressurized tube. The operator's learning is limited to the appropriate connection of the components of the detecting system.

Thus, the surgical device of the invention prevents from misdiagnosis of bladder perforation.

The insertion path in the invention, is defined as a path through which the hollow needle goes in order to position a tape below the urethra configured to support the said urethra and temporarily compress said urethra under stress conditions.

According to a feature of the invention, the detecting system is configured to be connected directly or indirectly to the second portion of the hollow needle.

Advantageously, the detecting system is connected indirectly to the second portion of the needle when the detecting system is connected to the internal needle according to a first embodiment of surgical device of the invention, which will be detailed later.

According to another feature of the invention, the valve of the detecting system is positioned at one end of the second portion of the hollow needle and connected to the depressurized tube, the valve comprising at least two ways connected respectively to the hollow needle and the depressurized tube, the valve being configured to allow the creation of a vacuum in a first position in which the at least two ways of the valve are opened, and to stop creation of vacuum in a second position in which the at least two ways of the valve are closed.

According to another feature of the invention, the valve is a three-way valve, at least one way being shaped to receive an anesthesia syringe for the injection of an anesthetic fluid through the hollow needle. Thanks to this configuration, it is possible to use the detecting system as well as for anesthesic purposes. Any supplementary instrument or device dedicated to the anesthesia of the patient during the surgery is avoided.

According to another feature of the invention, the distal end of the hollow needle situated on the first portion is opened.

According to another feature of the invention and as mentionned above, the hollow needle comprises a first portion and a second portion.

According to another feature of the invention, the first portion of the hollow needle comprises at least one transversal eye configured to create a draft. The transversal eye is dedicated to safety aspiration of liquid after the insertion of the hollow needle and more particularly during the retrieval of the hollow needle. Preferentially the transversal eye is a blind hole.

Obviously in the invention the term "draft" is used to define a difference of pressure causing a movement of fluid in a conduit.

According to another feature of the invention, the at least one transversal eye is a through-hole shaped to receive a thread.

According to another feature of the invention, the first portion of the hollow needle is curved, in order to create a curved path for the insertion of the hollow needle in the tissues.

According to another feature of the invention, the end of the first portion of the hollow needle is beveled, in order to facilitate the insertion of the hollow needle in the tissues.

According to another feature of the invention, the first portion of the hollow needle comprises a shrinkable sheath shaped to maintain a thread on the hollow needle.

According to another feature of the invention, the said surgical device comprises the said surgical device comprises a first and a second threads, a tape configured to be positioned between the urethra and the vaginal wall, the tape being connected to one end by the first thread and at another end by the second thread, at least one of the first and/or the second threads being connected to the first portion of the hollow needle.

According to another feature of the invention, the first and/or the second thread is fixed permanently or not to the hollow needle.

According to another feature of the invention, the first and/or the second threads are at least partially monofilament threads. The monofilament threads are prefered because they allow gliding of the surrounding tissues and thus delayed early or late adjustment of the tension of tape by pulling on them and moreover strict limitation of urethra compression under stress conditions only i.e. that is reversible and temporay compression.

According to another feature of the invention, the first and/or the second thread are at least partially barbed threads.

According to another feature of the invention, the first and/or the second thread comprises a proximal non-barbed portion connected to the tape and a distal barbed portion connected or not to the curved first portion of the hollow needle.

Advantageously, the barbs of the barbed portion of the first and/or the second threads prevent the first and/or the second threads from backwards gliding, and secure the appropriate tension given to the first and/or the second threads after adjustment.

According to another feature of the invention, the first and/or the second threads are made of a non-bio-degradable bio-compatible polymer such as polypropylene or polyamide or polyvinylidene fluoride, or metallic material.

Advantageously, the polypropylene or polyamide or polyvinylidene fluoride threads are well-known for their biocompatibility, and their soft surface providing excellent gliding to the thread through tissues. The excellent, even in long term, gliding, facilitates sewing and knotting during an initial operation, when the thread is implanted or during a new operation even years after the initial operation, after cutting of one arm of a knot, the thread is easily removed by pulling on it.

According to another feature of the invention, the first and/or the second threads have no or very limited longitudinal elasticity.

Preferentially, the diameter of the first thread and/or the second thread is in the order of 0.5 millimeter, (0 or 1 according to the international classification of the diameter of surgical threads). This thread diameter provides the appropriate resistance to the first thread and/or the second thread, to glide easily through the fascia and muscles of the abdominal wall and to pull the tape through the fascia of the perineum muscles, without any risk of rupture of the said first thread and/or the second thread.

The first thread and/or the second thread can be coated with a biocompatible dye such as methylene blue.

Advantageously, the dye is used as a marker for immediate diagnosis of bladder cavity transfixion by the first and/or the second threads.

In the present invention, methylene blue coating will immediately dilute in urine. Catheterization of the bladder will immediately inform the operator if the bladder has been perforated or not, showing blue urine in the former case or normal urine in the latter case. Thus, using dye coating of the first and/or the second thread, cystoscopy control can be avoided. This is especially appealing for surgeons who are not familiar with cystoscopy, and may miss the diagnosis of bladder transfixion by the threads or by the tape while performing control cystoscopy.

According to another feature of the invention, the tape is a woven or non-woven tape.

According to another feature of the invention, the length of the tape is such that the first and the second threads, connected to and sustaining the tape will pass through the abdominal wall, and the tape will not pass.

More precisely, the length of the tape is limited to about 10 centimeters and preferentially between about 10 to 12 centimeters, so that the said tape buckles below the urethra and passes through the fascia of the perineum muscles, without any possibility to pass through the fascia and muscles of the abdominal wall.

According to another feature of the invention, the width of the tape is in the order of 10 mm, and the thickness of the tape is less than 1 millimeter.

Advantageously, polypropylene or polyvinylidene fluoride is suitable for a synthetic woven tape.

Advantageously, autologous fascia or biocompatible collagen is suitable for a non-woven tape.

According to another feature of the invention, each end of the tape forms a narrow angle to facilitate the passage of the tape through the fascia of the perineum muscles. The first and the second thread are attached each at the summit of the narrow angle of each end of the tape.

According to another feature of the invention, the two ends of the tape can be coated, preferentially with a biocompatible dye to facilitate the diagnosis of bladder transfixion by the tape.

According to another feature of the invention, the said surgical device comprises at least one anchoring means configured to be positioned under the skin of a patient, the anchoring means being linked to at least one of the first and/or the second threads.

According to another feature of the invention, the anchoring means is shaped in order to allow percutaneous localization by palpation.

Thanks to the positioning of the anchoring means under the skin, it is possible to readjust the tension of the threads later after the surgical operation without excessive manipulations and under local anesthesia. According to another feature of the invention, the anchoring means is non-biodegradable.

According to another feature of the invention, the anchoring means is biocompatible.

According to another feature of the invention, the anchoring means is a bead. Alternately, the anchoring means is a suture clip.

According to another feature of the invention, the said surgical device comprises a support member threaded onto at least one of the first and/or the second threads, and positioned between the tape and the anchoring means, the support member being configured to support the anchoring means and to maintain the anchoring means in position so as the said anchoring means being palpable through the skin of the patient.

According to another feature of the invention, the support member is made in the same material as the tape.

According to another feature of the invention, the support member presents a circular shape or any geometrical shape that can support a bead or a clip for example.

According to another feature of the invention, the said surgical device comprises at least a first hollow needle and a second hollow needle, and at least a first and a second detecting system, each hollow needle being connected permanently or temporarily to respectively the first and the second threads, and each hollow needle being connected permanently or temporarily to respectively the first and the second detecting system.

According to another feature of the invention, the said surgical device comprises at least one internal needle shaped to be inserted inside the hollow needle, the internal needle being connected to at least one detecting system.

According to another feature of the invention, the internal hollow needle is coaxial with the hollow needle.

According to another feature of the invention, the internal needle is hollow in order to inject and/or aspirate fluids.

According to another feature of the invention, the said surgical device comprises a right angle blade configured to allow the incremental progression of the internal needle in the hollow needle, the right angle blade being positioned on the internal needle between the second portion of the hollow needle and the detecting system. According to another feature of the invention, the surgical device comprises a third portion between the first portion and the second portion, the third portion being breakable.

As already detailed hereinbefore, the surgical device of the invention allow overcoming the drawbacks of the prior art cited and presents the following general advantages:

- local anesthesia feasibility comes from the use of miniaturized instrumentation, i.e., small diameter needles, and of minimal prosthetic material, i.e., a short tape connected to threads;

- for immediate personal adjustment for each patient, under conditions close to physiological conditions;

- minimizing local trauma to anatomical structures contributing to urinary continence with the use of miniaturized non traumatic tools. Respect of already ill pelvic tissue altered by aging;

- reduction of the risk of immediate local injury during insertion and of the risk of delayed complications related to inappropriate insertion, by the use of miniaturized material, the use of the safest route to avoid urethra or bladder injury, the control of the absence of vessel or bladder injury along the curved path from the entry point to the distant exit point;

- control cystoscopy is not mandatory;

- reduction of the amount of prosthetic material, by facilitating insertion and gliding due to less friction with surrounding tissue along the path of the prosthetic material, and reducing the risk of infectious complications and facilitating extraction of the prosthetic material, when needed;

- the concept allows the realization of the 4 following steps within the carrying out of a single maneuver: 1- anesthesia of the path, 2-safety control versus the bladder and vessels, 3- guidance of the curved path along its whole length, from its entry point to its exit point, said path bypassing a bony structure 4- insertion of threads and tape. The procedure is shortened. A short duration procedure is more suitable for its carrying out under local anesthesia;

- preservation of normal mobilization of surrounding tissues along the threads facilitates temporary and reversible compression of the urethra. Urethra compression prevents from urine leakage and on the opposite, the absence of permanent urethra compression by the tape allows normal voiding, i.e., preserves from dysuria complaints by the patient after implantation, and from urine infection related to incomplete bladder emptying; - immediate adjustment of the tension of the threads is facilitated. This prevents from immediate or late complications related to excessive correction or on the opposite insufficient correction;

- reproduction of validated classical techniques to guarantee long term efficacy. Offer to patient the best compromise between efficacy and safety. Offer the patient the best compromise between classical TVT (tension free vaginal tape) or TOT (trans-obturator tape) technique with the highest efficacy and more recent mini-tapes with a lower efficacy;

- delayed adjustment of the tension of the tape according to clinical result either early adjustment or late adjustment

The invention will be better understood thanks to the detailed specification hereinafter, which describes several embodiments of the invention as examples and based on the following figures:

- Figure 1A is a general view of the surgical device according to a first embodiment of the invention,

- Figure IB is a general view of the surgical device according to a second embodiment of the invention,

- Figure 1C is a general view of the surgical device represented in figure IB according to a first variation of the second embodiment of the invention,

- Figure ID is a general view of the surgical device according to a variation of the valve of the detecting system represented in figures IB and 1C,

- Figure IE is a general view of the surgical device according to a variation of the valve of the detecting system represented in figure 1A,

- Figure 2 is a partially exploded lateral view of the surgical device represented in figure 1A,

- Figure 3A: is a close view of proximal end of the internal needle represented in figure 1A,

- Figure 3B is a close view of distal end of the internal needle protruding out of distal end of the hollow needle represented in figure 1A,

- Figure 3C is a close view of the distal end of the device represented in figure IB,

- Figure 3D is a close view of the distal end of the device according to a variation of the embodiment represented in figure 3C,

- Figure 4A is a lateral view of one hollow needle as represented in figure 1A, in a first extreme position, - Figure 4B is a lateral view of the hollow needle represented in figure 4A, in a second opposite extreme position,

- Figure 5 is an exploded lateral view of one hollow needle represented in figure 1A,

- Figure 6A is a close view on one side of the hollow needle before the break of the said hollow needle represented in figure 1A,

- Figure 6B is a close view on the other side of the hollow needle before the break of the said hollow needle represented in figure 6A,

- Figure 6C is a close view on one side of the hollow needle after the break of the said hollow needle represented in figure 5,

- Figure 6D is a close view on the other side of the hollow needle after the break of the said hollow needle represented in figure 6C,

- Figures 7A to 7C are lateral views of the female pelvis illustrating the curved path of one hollow needle according to the first or the second embodiment or the respective variations of the first or the second embodiments, the hollow needle being inserted via a method of insertion according to the retro-pubic route,

- Figure 8A is a front view of the female pelvis represented in figures 7A to 7C after the insertion of the surgical device of the invention according to a method of insertion according to retro-pubic route.

- Figure 8B is a front view of the female pelvis after the insertion of the surgical device of the invention according to a method of insertion according to the trans-obturator route.

- Figure 9A is a close view of the anchoring means of the device of the invention according to the first or the second embodiment or the respective variations of the first or the second embodiments,

- Figure 9B is a close view of the anchoring means of the device of the invention, according to a variation of the anchoring means represented in figure 9A,

- Figure 10A is a partially exploded front view of the surgical device according to the first embodiment represented figure 1A and configured for the trans- obturator route on the left side of a patient according the second method of insertion represented in figure 8B,

- Figure 10B is a close view of the right angle blade of the surgical device represented in figure 10A,

- Figure IOC is a partial general view of the surgical device according to the second embodiment represented in figure IB, and configured for methods of insertion according to trans-obturator route represented in figure 8B, - Figure 10D is a close view of the distal end of the surgical device according to the second embodiment represented in figure IB and configured for methods of insertion according to the trans-obturator route represented in figure 8B,

- Figure 10E is a close view of the distal end of the device according to a variation of the embodiment represented in figure 10D,

- Figure 11 is a front view of the female pelvis and the surgical device as represented in figure 10A and inserted according to the method of insertion represented in figure 8B,

- Figure 12 is a close view of free end of a thread inserted inside the lumen of the proximal end of the curved first portion of the hollow needle of the surgical device,

- Figures 13A to 13C are partial lateral views of a female pelvis and the surgical device according to a variation of the first embodiment represented in figure 1A, and inserted according to a method of insertion according to retro-pubic route,

- Figure 14 is a partial front view of a female pelvis and the surgical device as represented in figure 10A, and inserted via the method of insertion represented in figure 8B,

- Figure 15A is a lateral view of the female pelvis and a device according to a variation of the first embodiment represented in figure 1A, and inserted according to the method of insertion represented in figure 8A.

- Figure 15B is a close view of the device represented in figure 15A,

- Figure 16A is a partial frontal view of the female pelvis and a device according to a variation of the first embodiment represented in figure 1A, and inserted according to the method of insertion represented in figure 8B.

- Figure 16B is a close view of the device represented in figure 16A,

- Figure 17A is a close view of the valve of the detecting system according to the second embodiment represented in figure ID, in the "anesthesia position", and,

- Figure 17B is a close view of the valve of the detecting system according to the second embodiment represented in figure ID, in the "safety position".

The surgical device according to any of the embodiments illustrated in figures 1 to 17B and described hereinafter comprises two hollow needles 50 so as to ensure a fluid connection through its length. Each hollow needle 50 forms a guide la, lb.

The external diameter of the hollow needle 50 should be the best compromise to provide maximum rigidity to the hollow needle 50 and minimal trauma to the patient. Maximum diameter and rigidity are desirable to insert the hollow needle 50 through tissues and to bypass the bony structure, without deformation of the shape of the hollow needle 50 and without deviation from the normal path in the midline sagittal plane of the patient. Minimal diameter is desirable to minimize trauma to the patient and to allow the insertion of the hollow needle 50 under local anesthesia. An external diameter in the order of 1 millimeter or 18 G is appropriate (according to the Gauge international nomenclature of the external diameter of hollow needles used in medicine). The highest quality steel or biocompatible material is required to guarantee maximum rigidity with the smallest diameter.

As represented particularly in the figures 1A to 2, each hollow needle 50 comprises a curved first portion 52 configured to create an insertion path between an urethra and a vagina wall, and a straight second portion 51 shaped to form at least partially a handle 40.

The radius of the curvature and the length of the curved first portion 52 are adapted to the route of insertion and to the position and shape of the bony structure, said curved first portion 52 has to bypass.

The second portion 51 is straight and passes through the handle 40 of the hollow needle 50. The straight second portion 51 is fixed inside the handle 40, and cannot be rotated along its longitudinal axis. The length of the straight second portion 51 is longer than the one of the handle 40.

The handle 40 is positioned in the mid-part of the straight second portion

51, so that, the length left before penetration inside the handle 40 allows the incremental "I" mobilization of the internal needle 60 inside the hollow needle 50 (see figures 4A and 4B) and so that, the length left after exit from the handle 40 allows the manipulation of the handle 40 at a sufficient distance from the perineum of the female patient, to facilitate the insertion maneuver of the hollow needle 50 by the operator.

As illustrated in figure 1A or IB, the handle 40 comprises a flat upper face 41 and a curved lower face 42. The shape of the handle 40 can be compared to the one of a semi-ellipsoid after cutting of an ellipsoid along its longitudinal axis. Fixation of the hollow needle 50 to the handle 40 is such that the plane of the curvature of the first portion 52 of the hollow needle 50 is perpendicular to the plane of the upper surface 41 of the handle 40. This fixed orientation of the plane of the hollow needle 50, perpendicular to the plane of the upper surface 41 of the handle 40 provides a safe manipulation of the guide la, lb. Indeed, the curvature of the first portion 52 of the hollow needle 50 of the guide la, lb must be maintained in a midline vertical plane, in a female patient installed in gynecologic position to perform the therapeutic procedure.

In this invention the gynecologic position is defined like a position in which the patient is lying and her legs are up and wide opened.

In the gynecologic position, the midline sagittal plane of the patient and the plane of the curvature of the first portion 52 of the hollow needle 50 are vertical. This prevents from path deviation from the midline sagittal plane during insertion of the guide la, lb and from the possible related complications including injury of external iliac blood vessels.

Each hollow needle 50 is connected to one thread 10a, 10b. The hollow needle 50 forming the guide la is connected to the first thread 10a by a distal end 11a of the said first thread 10a and the hollow needle 50 forming the guide lb is connected to the second thread 10b by a distal end lib of the said second thread 10a. The distal end 11a, lib of one thread 10a, 10b is connected to one hollow needle 50. Each thread 10a, 10b comprises a proximal end 12a, 12b which is connected to a tape 20. The tape 20 has a left end 21a connected to the proximal end 12a of the first thread 10a and a right end 21b connected to the proximal end 12b of the second thread 10b. The two threads 10a and 10b form with tape 20 a flexible buckle 22 connected to the two rigid hollow needles 50.

In the invention, right and left are defined according to right and left sides versus the mid-sagittal plane of a patient.

In any of the embodiments of the invention, the first and the second threads 10a, 10b have a monofilament structure and are made of a non-biodegradable bio-compatible polymer or metallic material. Moreover, the first and the second threads 10a, 10b have no or very limited longitudinal elasticity.

The preferred diameter of the first and the second thread 10a, 10b is in the order of 0.5 millimeter, (0 or 1 according to the international classification of the diameter of surgical threads).

The length of each thread 10a, 10b, is in the order of 20 to 25 centimeters.

In a non-illustrated variation of an embodiment of the invention, the first and/or the second threads 10a, 10b can be coated with a biocompatible dye such as methylene blue.

In a non-illustrated variation the first and/or the second thread 10a, 10b are barbed threads. Each thread 10a, 10b has a proximal non-barbed portion connected to the tape 20 and a distal barbed portion connected or not to the curved first portion 52 of the hollow needle 50. The proximal non-barbed portion supports the tape 20 and allows the gliding of surrounding tissues along the flat surface of said non-barbed portion, whereas the barbed portion supports the tape 20 as well, but allows anchoring through the fascia and muscles of the abdominal wall 83a or of the obturator fossa 91. The barbs of the barbed portion of the thread 10a, 10b prevent the thread from backwards gliding, and secure the appropriate tension given to the thread after adjustment. The distance between the superficial perineal fascia 88a and the skin exit point of the thread in the supra-pubic area 84 or in the external crease of the labia majora 92c may vary in the order of 5 centimeters from one patient to another patient according to the patient anatomy.

According to the invention, the tape 20 is a woven or non-woven tape 20. The length is limited to about 10 centimeters, so that the tape 20 buckles below the urethra 82 (see figures 8A and 8B), and passes through the fascia of the perineum muscles 88, without any possibility to pass through the fascia and muscles 83a of the abdominal wall 83. The length of the tape 20 is such that the first and the second threads 10a, 10b, connected to and sustaining the tape 20, will pass through the abdominal wall 83, and the tape 20 will not.

Moreover, the width of the tape 20 is about 10 mm, and the thickness of the tape 20 is less than 1 millimeter.

Preferentially, polypropylene is suitable for a woven tape and biocompatible collagen or autologous fascia is suitable for a non-woven tape.

Furthermore, each end 21a, 21b of the tape 20 forms a narrow angle to facilitate the passage of the tape 20 through the fascia of the perineum muscles 88. The first and the second threads 10a, 10b are attached each at the summit of the narrow angle of each end of the tape 20.

According to any of the embodiments of the invention, the two ends 21a, 21b of the tape 20 can be coated with a biocompatible dye to facilitate the diagnosis of bladder 81 transfixion by the tape 20.

In order to detect bladder transfixion, the surgical device 200 of the invention comprises a detecting system 201 configured to be situated on the second portion 51 of the hollow needle 50, the detecting system 201 comprising at least a valve 4 and a depressurized tube 6 cooperating with each other so as to create a vacuum in the hollow needle 50. The vacuum is used so as to aspirate liquid, urine or blood, through the lumen of the hollow needle 50, in order to detect a transfixion of the bladder 81. According to the invention, the detecting system 201 can be placed on the second portion 51 of the hollow needle 50 according to the second embodiment of the surgical device 200 (see figure IB) but can also be placed on the second portion 51 of the hollow needle 50 according to the first embodiment of the surgical device 200 (figure 1A) on the end of the internal needle 60.

The valve 4 is a two-way or a three-way valve directly connected to the end of the second portion 51 of the hollow needle 50 (figures IB and ID) or directly connected to the internal needle 60 (figures 1A and IE). The valve 4 comprises a first way 4a and a second way 4b as illustrated in figure IB and a third way 4c as shown in figures 17A and 17B. The third way 4c of the valve 4 is shaped to receive an anesthesia syringe for the injection of an anesthetic fluid through the hollow needle 50.

The valve 4 further comprises a lever 4d controlling the fluid connection between the depressurized tube 6 and the hollow needle 50. Vacuum comes from the sealed depressurized tube 6 connected to the proximal Luer end 53 of the hollow needle 50, via a thin flexible tubing 5. The flexible tubing 5 is prolonged on one proximal end 5a by a needle 7, in order to allow the puncture of the rubber cap 6c of depressurized tube 6, and on its opposite distal end 5b, the flexible tubing 5 is connected to second way 4b of the valve 4. The valve 4 is connected via the first way 4a to the proximal Luer end 53 of the hollow needle 50.

The threads 10a, 10b can be attached to the hollow needle 50 by gluing, melting to the material of the hollow needle 50, or by a thermo-retractable plastic inner sleeve 74 (see figures 6B and 6C) or by insertion in a through-hole transversal eye 58b formed at the end of the curved first portion 52 of the hollow needle 50 (see figures 10E and 3D). Obviously those methods of thread's fixing can be applied to all embodiments of the invention without any difficulty.

According to the invention, the surgical device 200 comprises at least one anchoring means configured to be situated under the skin of a patient and being palpable through the skin, the anchoring means being attached to at least one of the first and/or the second threads.

More specifically and as represented in figures 9A and 9B, the surgical device 200 comprises anchoring means.

The anchoring means 100 comprise a support member 101 and a bead

102.

The support member 101 is a mesh washer. The support member 101 is woven with polypropylene with pores large enough to allow the passage of the first and second threads 10a, 10b and to allow the growth of surrounding tissue through the pores. Thus, the support member 101 becomes fixed into the sub-cutaneous tissue, where it has been placed. The support member 101 has a diameter in the order of 15 millimeters. The support member 101 represents a stable plate-form in the subcutaneous tissue 92d below the skin incision in the supra-pubic area 84, or, below the skin incision in the external crease 92a of the labia majora to support the bead 102 plus a clip 103 or a clip 103 alone. The support member 101 is perforated or not in its center.

The bead 102 is made of a biocompatible non bio-degradable material such as, metal, glass, or polymer, e.g., polypropylene or polyamide or silicone. Its diameter is in the order of 6 to 7 millimeters. The bead 102 is perforated in its center by a channel 102a. The diameter of the channel 102a is in the order of 1 millimeter or less. The threads 10 glide inside said channel 102a.

Alternately, the bead 102 can be replaced by a suture clip (nonrepresented).

The anchoring means 100 further comprise stop elements 103 such as clip configured to lock the position of the first and/or the second thread 10a, 10b over the bead 102.The stop elements 103 are made of bio-compatible steel like Titanium.

Alternately, a locking bead (non-represented) can also be proposed as locking means of the first and/or the second threads 10a, 10b. In this case, the first and/or the second threads 10a, 10b are blocked reversibly inside channel 102a of bead 102. The blocking effect can be obtained by several means and is not limited to the above-mentioned examples.

According to one aspect of the invention, the proximal end 56 of the hollow needle 50 has a Luer female connection 53. The cone shape of the lumen of the Luer connection 53 facilitates the introduction of the sharp bevel tip 61 of the internal needle 60, in the case of the first embodiment of the surgical device 200 further described. The distal tip 57 of the hollow needle 50 is sharp with a bevel 54 to facilitate progression in the tissues along the path, especially through the tight and strong fascia of the rectus muscles 83a as they anchor on the pubic bone 80 (see figure 7B).

The first embodiment of the surgical device 200 of the invention will now be described in reference to the figures 1A, IE, 2, 3A, 3B, 4A, 4B, 5, 6A, 6B, 6C, 6D.

The surgical device 200 according to the first embodiment comprises all the features as already described above, as common part with the second embodiment. The main difference between the first and the second embodiment is that the surgical device 200 according to the first embodiment comprises an internal needle 60 hosted in the hollow needle 50. The internal needle 60 and the hollow needle 50 are coaxial.

The internal needle 60 is an anesthesia needle and a safety needle, as described hereinafter.

The internal needle 60 is a hollow, single piece and straight shaped needle.

The internal needle 60 is flexible and has a straight shape memory along its whole length, so that it comes back to its straight shape along its whole length after the release of bending. The straight shape facilitates first its insertion through the Luer connection 53 of the proximal end 56 of the hollow needle 50, and its gliding inside the straight second portion 51 of the hollow needle 50. When arriving at the level of the curved first portion 52 of the hollow needle 50, the flexibility of the internal needle 60 facilitates its progression to the tip 57 of the hollow needle 50, without any need of orientation of the internal needle 60. Orientation of the internal needle 60 is driven by the hollow needle 50.

The length of the shaft of the internal needle 60 exceeds the length of the shaft of the hollow needle 50 by 10 to 15 mm. When the internal needle 60 is mounted inside the hollow needle 50, and the proximal ends of the two needles are in contact, the tip 61 of the internal needle 60 protrudes from the distal tip 57 of the hollow needle 50 by 10 to 15 mm (see figures 4A and 4B). This allows the injection of the anesthetic solution inside tissues along the path of the surgical device 200.

The protrusion is limited to 10-15 millimeters only, to avoid any deviation of the internal needle 60 from the path imposed by the hollow needle 50. Indeed, the internal needle 60 is flexible and any bending consecutive to a longer protrusion out of the hollow needle 50 could lead to a deviation from the desired path.

The outer diameter of the internal needle 60 allows its insertion inside the lumen of the hollow needle 50 and along the whole length of the latter.

The outer diameter of the internal needle 60 is in the order of 0.4 millimeter or 23 G according to the international Gauge classification. A smaller diameter of the internal needle 60 may be required according to the method of insertion selected.

The internal diameter of the hollow needle 50 allows the insertion of the internal needle 60. The internal diameter of the hollow needle 50 allows the insertion of an internal needle 60 with an external diameter inferior to 0.5 millimeter or 23 G, according to the international Gauge classification.

As a safety needle, the internal needle 60 allows the incremental progression of the hollow needle 50, as shown in figure 4A and 4B. Moreover, the internal needle 60 helps the insertion of the hollow needle 50 in the right path of insertion.

As seen in figure 3A, the surgical device 200 comprises a right angle blade 64 configured to allow the progression of the internal needle 60 in the hollow needle 50 by reproducible increments of 10 to 15 millimeters. The right angle blade 64 being positioned on the internal needle 60 between the second portion 51 of the hollow needle 50 and the detecting system 201, and more precisely, the right angle blade 64 is fixed to the Luer connection 63 of the proximal end 60a of the internal needle 60.

The right angle blade 64 has two sides, a long side 65 and a short side 66. The long side 65 is parallel to the axis of the internal needle 60. The horizontal long side 65 is fixed by one proximal end 65a to the Luer connection 63 at the proximal end 60a of the internal needle 60. The non-fixed portion 65c of the long side 65 of the blade has a length of 10 to 15 millimeters. The length of the non-fixed portion 65c of the blade is equal to the length difference between the internal needle 60 and the hollow needle 50. The opposite distal end 65b of the long side 65 of the blade forms the summit 67 of the right angle. The vertical short side 66 has also one upper end 66a forming the summit 67 of the right angle, while the opposite lower end 66b of the vertical short side 66 is free. The lower free end 66b has a slit 68. The slit 68 is parallel to the main axis of the short side 66 and is positioned in its center. The slit 68 has an opening 69 on the free lower edge 66b of the short side 66 of the blade. The slit 68 is large enough to allow the easy gliding of the hollow needle 50 through the slit 68.

The right angle blade 64 is in plastic material flexible enough to facilitate the mounting of the long side 65 of the right angle blade 64 over the hollow needle 50.

The proximal end 60a of the internal needle 60 is a female Luer connection 63 configured to cooperate with a counterpart male Luer tip of a syringe containing the anesthetic solution.

As shown in figure 3B, the distal end 60b of the internal needle 60 comprises a sharp bevel tip 61 to facilitate the hollow needle's progression and minimize trauma of soft tissues. The bevel distal opening 61 is dedicated to the injection of the anesthetic solution. The distal end 60b of the internal needle 60 further comprises an eye 62 opened transversally relatively of the internal needle 60. If the bevel 61 is occluded by tissue coring during progression of the internal needle 60, aspiration will be still possible through the lateral eye 62. In case the internal needle 60 perforates the bladder 81, or a large blood vessel, aspiration of urine or blood will be noticed.

During progression of the hollow needle 50, the operator can control in real time the correct path, by alternative injection-aspiration movements with the syringe connected to the internal needle 60.

According to a first variation of the first embodiment of the surgical device 200 of the invention, the hollow needle 50 can be broken into two pieces at the level of a third portion or breaking point 55 located at the junction between the curved first portion 52 and the straight second portion 51 as shown in figure 5. Before the hollow needle 50 is broken, the curved first portion 52 and the straight second portion 51 are tightly fixed together as shown in the figures 6A, 6B.

In these figures 6A, 6B, the straight second portion 51 and the curved first portion 52 of the hollow needle 50 are tight and secured by a thermo-retractable outer sleeve 73. A tearing thread 75 parallel to the axis of the hollow needle 50 and lying below the thermo-retractable outer sleeve 73 is fastened to the hollow needle 50 by the thermo-retractable outer sleeve 73. The tearing thread 75 has a long proximal end 75a exiting from the proximal edge 73a of the thermo-retractable sleeve 73 and a short distal end with a knot 75b exiting from the distal edge 73b of the thermo-retractable outer sleeve 73. The break point 55, i.e., the junction between the two portions 51 and 52 of the hollow needle 50 is not visible and is represented by a dotted line. The thread 10a, 10b exits from the outer thermo-retractable sleeve 73.

The figures 4A and 4B represent the hollow needle 50 according to the first variation of the first embodiment. More particularly, it is shown two extreme positions of the internal needle 60 versus the hollow needle 50.

In figure 4A, the internal needle 60 is inside the hollow needle 50, the flexible long side 65 of the right angle blade 64 has been pulled up to pass over the Luer connection 53 at the proximal end 56 of the hollow needle 50, so that the short side 66 of the blade 64 goes beyond the Luer connection 53. After release of the pulling of the long side 65 of the blade 64, the slit 68 of the short side 66 of the right angle blade 64 engages the hollow needle 50.

The original relative position of the two needles 50, 60 is such that, the vertical short side 66 of the blade is in contact with the Luer connection 53 of the hollow needle 50. Thus, the distal bevel tip 61 of the internal needle 60 does not protrude out of the bevel 54 of the hollow needle 50. Both bevel tips 61 and 54 are at the same level.

In figure 4B, the incremental progression of the hollow needle 50 along its longitudinal axis is represented by the arrow. The progression comprises the following steps:

- Fixing with one hand the position of the hollow needle 50 and pushing with the other hand the internal needle 60, until the said internal needle 60 bumps against the hollow needle 50. Bumping comes from the contact between the Luer connection 63 of the internal needle 60 and the Luer connection 53 of the hollow needle 50. At this stage, the vertical short blade 66 is close to the handle 40 of the hollow needle 50, and the sharp bevel tip 61 of the internal needle 60 extends outside the distal tip 57 of the hollow needle 50 by 10 to 15 millimeters. This length corresponds exactly to the length of the non-fixed portion 65c of the horizontal long side 65 of the right angle blade 64, which drives the incremental progression of the hollow needle 50. This length is the length of the increment "\" as shown in the figure 4B;

- Fixing with one hand the position of the internal needle 60 and to glide forwards with the other hand the hollow needle 50 until it bumps against the internal needle 60. Bumping comes from the contact between the Luer connection 53 at the proximal end 56 of the hollow needle 50 and the vertical short side 66 of the right angle blade 64. At this stage the relative position of the two needles 50, 60 is as shown in Fig 4A;

- Reproducing the first and second steps. The repetition of these two steps, allows the incremental progression of the hollow needle 50 along the path chosen by the operator, until the distal tip 57 of the hollow needle 50 exits out of the skin in the supra-pubic area 84 (see figures 7A and 7B). Once the distal tip 57 of the hollow needle 50 is out of the skin, the internal needle 60 is retrieved and the hollow needle 50 is broken into two pieces.

The Figure 5 illustrates the hollow needle 50 broken into two portions, after removal of the internal needle 60 according to the first variation of the first embodiment of the surgical device 200 of the invention.

The figure 6B shows the connecting means 70 of the first portion 52 and the second portion 51 of the hollow needle 50. A hollow tenon 71 with a square section is designed to engage the counterpart mortise 72 with an identical square section. Their tight assembly was earlier secured by a tight mounting by friction between the tenon 71 and the mortise 72 and by the thermo-retractile plastic outer sleeve 73 positioned (see figure 6A) on both side of the break point 55 and along a 10 to 15 millimeter length of the straight second portion 51 and the curved first portion 52 of the hollow needle 50. The outer sleeve 73 played the role of a safety means. The outer sleeve 73 was torn easily and was discarded to allow the break of the hollow needle 50, while the inner thermo-retractable sleeve 74 securing the thread 10a, 10b to the proximal end 52a of the curved first portion 52 of the hollow needle 50 remains intact. Tearing of the outer sleeve 73 was obtained by pulling on the long proximal end 75a of the tearing thread 75 (see figure 6A). Tearing of the outer sleeve 73 starts at its proximal edge 73a and finishes at its distal edge 73b, which blocked the knot at the distal end 75b of the tearing thread 75. The lumens 76 of the tenon 71 and the mortise 72 are in alignment with the lumen of the hollow needle 50, in order to allow the passage of the internal needle 60.

The first embodiment and the first variation of the first embodiment are configured for an insertion of the tape 20 via a retro-pubic route (first method of insertion as detailed after in the description).

According to a second variation of the first embodiment of the surgical device 200 of the invention, the hollow needle 50 (figure 10A) can be configured for an insertion of the tape 20 according to a trans-obturator route (second method of insertion as detailed after in the description).

The features of the hollow needle 50 differ from the hollow needle 50 according to the first embodiment and its first variation in that:

- the straight second portion 51 of the hollow needle 50 is shorter than the one of the hollow needle 50 as shown in figure 5, its length is in the order of 3 to 4 centimeters,

- the straight second portion 51 does not transfix the handle 40,

- the handle 40 is transfixed by a plain shaft 42. The plain shaft 42 is fixed to the mid part of the straight second portion 51 of the hollow needle 50, according to an angulation of 90 degrees.

- the shape of the curved first portion 52 differs in that the radius of its curvature is shorter than the one presented in figure 1A for example. The length of the curved first portion 52 is longer, close to third quarter of a circle, instead of one quarter of a circle for the curved first portion 52 of the hollow needle 50 represented in figure 1A for example,

- the length of the internal needle 60 is shorter, but the length difference between the hollow needle 50 and the internal needle 60, is the same as the 10 to 15 millimeters length difference between the corresponding two needles represented in figure 1A for example.

The hollow needle 50 according to a second variation of the first embodiment allows the insertion of the first thread 10a through the left obturator fossa 90a (see figure 11).

The figure 10B shows the right angle blade 64 fixed to the internal needle 60 in position inside the hollow needle 50. The right angle blade 64 fixed to the proximal Luer end 63 of the internal needle 60 has the same design as the one shown in figure 3A. The cone shape opening 63b of the Luer female connection 63 is visible.

According to a variation of the second variation of the first embodiment of the surgical device 200 of the invention, the hollow needle 50 can be breakable in the same way as the first variation of the first embodiment of the invention. The figure 12 shows the insertion of the free distal end 11a, lib of a thread 10a, 10b inside the lumen 52c at the proximal end of the curved first portion 52 of the hollow needle 50 after break of the hollow needle 50. The thread 10a, 10b is glided until its free distal end 11a, lib exits out of the distal end 52b of the curved first portion 52 of hollow needle 50.

The second embodiment of the surgical device 200 of the invention is represented in Figure IB and 1C. The description of the second embodiment will be detailed in reference to the figures IB, ID, 1C, 3C, 3D, IOC, 10D, 10E.

The main difference between the first embodiment and the second embodiment of the surgical device 200 of the invention is that there is no internal needle 60 placed in the hollow needle 50.

Moreover the following features have been removed:

- the third breakable portion or the break point 55,

- the connecting means 70 between the straight second portion 51 and the curved first portion 52 of the hollow needle 50,

- the tenon 71 and the mortise 72,

- the outer thermo-retractable sleeve 73,

- the tearing thread 75.

The hollow needle 50 according to the second embodiment remains a guide needle, as it is in the first embodiment.

Moreover, the hollow needle 50 comprises a transversal eye 58 configured to create a draft such as the one created by the transversal eye 62 of the internal needle 60 of the first embodiment. The transversal eye 58 is positioned below the bevel 54 and above a thermo-retractable sleeve 74 (see figures IB and 3C). The transversal eye 58 is a blind hole.

In this second embodiment the thread 10a, 10b is fixed permanently to the hollow needle 50 (for example, by a thermo-retractable sheath 74). The hollow needle 50 drives the thread 10a, 10b through tissues. In this second embodiment with a blind transversal eye 58, the surgical device 200 comprises two hollow needles 50 as show in figure IB, the first thread 10a being fixed to a first hollow needle 50 forming a guide 3a and the second thread 10b is fixed to a second hollow needle 50 forming a guide 3b (see figure IB). Each thread 10a, 10b is driven by the homo-lateral guide 3a, 3b.

According to a first variation of the second embodiment of the invention illustrated in figures 1C and 3D, the hollow needle 50 comprises a transversal eye 58b which is a through-hole. The through-hole transversal eye 58b is configured to receive a thread 10a, 10b, the thermo-retractable sleeve 74 becoming optional or being suppressed. Advantageously, urine or blood will be aspirated through the through- hole transversal eye 58b as well as through transversal eye 58, in case of bladder or vessel puncture during needle retrieval following the insertion of the hollow needles 50. Indeed, the lateral position of the through-hole transversal eye 58b and transversal eye 58 prevent from tissue coring during the hollow needle retrieval following the insertion of the hollow needles 50 through tissues of the pelvis, whereas bevel 54 of the hollow needles 50 may core tissue during insertion through tissues and thus may not aspirate urine or blood.

Optionally and as illustrated in figure 3D, the through-hole transversal eye 58b is dedicated to the driving of thread 10a, 10b and to aspiration of liquid, whereas the transversal eye 58 is only dedicated to safety aspiration of liquid during hollow needle retrieval following the insertion of the hollow needle 50.

Free distal end 11a, lib of thread 10a, 10b is driven without need of a permanent fixation to the hollow needle 50, successively through superficial perineal fascia 88a and muscles of the perineum 88, through soft tissue in the retro-pubic space 89, and through fascia and muscles 83a of the abdominal wall 83, until free distal end 11a, lib of thread 10a, 10b exits out of the skin in the supra-pubic area 84. Moreover, in this second embodiment of the surgical device 200, the same single hollow needle 50 can be used to insert successively thread 10a and thread 10b, one on each side of the urethra. The second embodiment and the first variation of the second embodiment are configured for an insertion of the tape 20 via a retro-pubic route (first method of insertion as detailed after in the description).

According to a second variation of the second embodiment of the invention illustrated in figures 10 C, 10D, and 10E, the hollow needle 50 can be configured for an insertion of the tape 20 according to a trans-obturator route (second method of insertion as detailed after in the description).

In this second variation of the second embodiment of the invention of the surgical device 200, two symmetrical hollow needles 50 are mandatory, a right hollow needle 50 for the right side of the patient and a left hollow needle 50 for the left side of the patient. The structural modifications are the same applied to the second variation of the first embodiment, such as the handle 40 extend perpendicularly in relation to the hollow needle 50.

According to an aspect of the invention, thanks to the detecting system 201 of the surgical device 200, the detection of a transfixion of a blood vessel or the bladder for example can be easily detected; the use of the detecting system 201 comprises the following steps:

(a) when the surgical device 200 of the invention (according to any of the embodiments of the surgical device 200 of the invention detailed hereinbefore) is used according to the first method of insertion (retro-pubic route), according to the direction of insertion in-out and preferentially in the case of local anesthesia performed prior to the insertion of the surgical device 200 of the invention:

using a separate thin needle and a syringe to anesthetize the path between the vaginal wall 85 and the skin in the supra-pubic area 84,

- emptying the bladder

locking the two-way valve 4 with the lever 4d in a closed position and connecting second way 4b of the valve 4 to distal end 5b of the flexible tubing 5,

puncturing the rubber cap 6c of depressurized tube 6 with a needle 7 placed at the opposite proximal end 5a of flexible tubing 5, the opposite way 4a of valve 4 being secured to the proximal Luer end 53 of the hollow needle 50,

puncturing the already anesthetized fascia 88a and muscles of the perineum 88 laterally to the urethra 82 with the bevel 54 of the hollow needle 50 forming a first guide la, 3a and then, pushing the hollow needle 50 through fascia 88a and muscles of the perineum 88, and

pushing further through soft tissues in the retro-pubic space 89, until contact of bevel 54 of the hollow needle 50 with already anesthetized fascia and muscles 83a of abdominal wall 83,

puncturing the fascia and muscles 83a of abdominal wall 83 until distal end 52b of the hollow needle 50 exits out of the skin in the supra-pubic area 84,

disconnecting free or attached distal end 11a, lib of the threads 10a, 10b from distal tip of first portion 52 of the hollow needle 50,

filling the bladder with saline solution,

retrieving backwards the hollow needle 50 until bevel tip 54 of the hollow needle 50 disappears below the skin 84 of the supra-pubic area inside subcutaneous tissue 84c (Figure 8A),

- rotating the lever 4d of the valve 4, from its closed position to the opened position, so that vacuum of depressurized tube 6 is transmitted to distal end 52b of the hollow needle 50,

before pulling the hollow needle through the retro-public space

89 until distal end 52b exits out of the vagina incision 85a. Vacuum disappears as the tip of the hollow needle 50 forming the first guide la comes in contact with air.

Repeating the same maneuver with the other hollow needle 50 forming the second guide lb, 3b, on the contra-lateral side of urethra 82.

In case the tip 52b of the hollow needle 50 punctures the full bladder 81 or a large vessel along the path in retro-pubic space 89, respectively urine or blood is instantaneously aspirated inside the depressurized tube 6 and the presence of liquid in the tube 6 is immediately noticed by the operator. The path is then corrected.

(b) when the surgical device 200 of the invention (according to any of the embodiments detailed hereinbefore) is used according to the first method of insertion (retro-pubic route), according to the direction of insertion in-out and in the case of local anesthesia is not performed prior to the insertion of the surgical device 200 of the invention:

a three way valve 4 is used (see figures ID, IE, 17A and 17B), instead of a two-way valve 4 as described above,

- puncturing the superficial fascia 88a and muscles 88 of the perineum with the hollow needle 50 forming the first guide la, 3a proceeding to the anesthetic infiltration of said fascia and muscles 88 according to right angle black arrow direction, with the lever 4d in alignment with the third way 4c of the valve 4 (figure 17A),

from this position, rotating the lever 4d in alignment with the second way 4b of the valve 4 (figure 17B), so that vacuum is applied to the hollow needle 50 according to straight black arrow direction; progression of needle 50 through fascia and muscles 88 of the perineum, followed by progression through soft tissue in the retro-pubic space 89, until contact of the tip 52b of the hollow needle 50 with the internal side of fascia and muscles of the abdominal wall 83,

- puncturing the abdominal wall 83, and, rotating the lever 4d in alignment with the third way 4c to deliver anesthesia to fascia and muscles of the abdominal wall 83, followed by the progression of the hollow needle 50 through said fascia and muscles 83, until distal end 52b exits out of the skin in the suprapubic area 84,

- repeating the same maneuver with the hollow needle 50 forming the second guide lb, 3b on the contra-lateral side of urethra 82.

In case the tip 52b of needle 50 punctures the bladder 81 or a large vessel along the path in the retro-pubic space 89, respectively urine or blood is instantaneously aspirated inside depressurized tube 6 and the presence of liquid in tube 6 is immediately noticed by the operator. The path is then corrected.

In the embodiments with the first and the second threads 10a, 10b permanently fixed to the two hollow needles 50 (see figures 1A and IB) forming respectively the guides la, lb (figure 1A) and 3a, 3b (Figure IB), distal ends 11a, lib of threads 10a, 10b are cut from thermo-retractable sleeve 74 and each of them is secured by a forceps in the supra-pubic area 84.

In the embodiments with the first and the second threads 10a, 10b with free distal ends, the same hollow needle 50 is used to insert the contra-lateral thread 10b, on the contra-lateral side of the urethra, according to the same path as already described above.

According to the above-mentioned aspect of the invention, the detecting system 201 of the surgical device 200 can be advantageously combined with the injection of anesthetic fluid. The internal needle 60 can support this function as does the hollow needle 50 as described above, depending on the embodiment of the surgical device 200. After locking of Luer lock connection of the internal needle 60 to the valve 4 as shown in figure 17A, 17B, the internal needle 60 can be operated to deliver anesthetic fluid or to detect bladder or vessel perforation. According to the first embodiment illustrated in figure 1A, the anesthetic fluid is delivered through a syringe connected to proximal Luer end 63 of internal needle 60.

Alternately, intermittent anesthetic fluid injected or vacuum is created by the syringe being maneuvered by the physician during progression of the hollow needle 50 and the internal needle 60, by increments in the retro-pubic space 89.

Alternately and as illustrated in figures 17A and 17B, the valve 4 is a three-way valve 4, comprising a third way 4c, the third way 4c being shaped to receive an anesthesia syringe 8 for the injection of an anesthetic fluid through the hollow needle 50 (figure ID) or internal needle 60 (figure IE). The anesthetic solution can be injected, according to the direction as shown by the right angle black arrow in figure 17A via a flexible tubing 9, after connection of proximal end of said flexible tubing 9 to a syringe 8 containing the anesthetic solution and distal end of said flexible tubing 9 to the third way 4c of a three-way valve 4. The first way 4a of the valve 4 is connected to proximal Luer end 53 of the hollow needle 50. In this case, anesthesia will be delivered (see figures 3C, 3D) primarily through the blind 58 or through-hole transversal eye 58b of the hollow needle 50 and secondly through the opening at its bevel 54. Thus, anesthesia will not be delivered exclusively in front of the sharp bevel 54 of the hollow needle 50; anesthesia will be delivered primarily through the eye 62 and secondly through bevel tip 61 of the internal needle 60 (see figure 3B).

The anesthetic solution can be delivered using a separate material and a classical technique, i.e., before insertion of the hollow needle 50: the path between, entry point 85b at the level of the vagina wall 85 and exit point at the level of the skin 84 the supra-pubic area, is infiltrated using a fine needle connected to a syringe filled with the anesthetic solution. In this latter case, the detecting system 201 has lost the anesthesia function, but keeps the other function of safety control of the absence of bladder 81 or large vessel injury.

According to one other aspect of the invention, whatever the structural embodiments detailed above as shown in figures 1A to IE, 9A, 9B, 10A to 10E, the surgical device 200 of the invention is configured to position a tape 20 under the urethra of a patient according to several method of insertion possible described hereinafter.

There are two types of path in which the methods of insertion are regrouped.

The first path is the retro-pubic route, which is used by the six first method of insertion. The retro-pubic route is basically a path of insertion wherein the surgical device 200 passes behind the pubic bone : there is one entry point and one exit point.

The second path is the trans-obturator route, which is used by the six last methods of insertion. The trans-obturator route is a path of insertion wherein the surgical device 200 passes laterally in each trans-obturator hole : there are one entry point and two exit points or two entry points and one exit point.

In the invention the terms "in-out" is meant for an insertion of the threads from the vaginal wall to the skin of the suprapubic area or the external crease of the labia majora.

In the invention the terms "out-in" is meant for an insertion of the threads from the skin of the suprapubic area or the external crease of the labia majora to the vaginal wall.

Now will be described the first method of insertion in reference to the figures 7 A, 7B, 7C and 8A.

The hollow needle 50 of the surgical device 200 is inserted starting from the vagina and through a retro-pubic route (in-out route). In this first method of insertion the hollow needles 50 are breakable and the threads 10a, 10b are already connected to the hollow needles 50.

Reference is made to the figures 7A to 7C.

In this sagittal projection of the female pelvis, the relevant anatomical structures are: pubic bone 80, bladder 81, urethra 82, fascia and muscles or rectus muscles 83a of the abdominal wall 83, skin of the supra-pubic area 84, skin incision in the supra-pubic area 84a, vagina wall 85, vagina incision 85a, vagina entry point 85b, urethral meatus 86, bladder neck 87, fascia and muscles of the perineum 88, superficial perineal fascia 88a, retro-pubic space 89, sub-cutaneous tissue of the supra-pubic area 84c.

In a female patient installed in gynecologic position, a catheter is inserted in the bladder 81. The bladder 81 is emptied and further filled with a small volume of saline solution in the order of 120 milliliters. The catheter is retrieved from the bladder. The skin of the supra-pubic area 84 is infiltrated with a local anesthetic solution and a 10 millimeter skin incision 84a is performed horizontally and perpendicular to the sagittal midline above the pubic bone rim 80a (see figure 7A).

Then, the anterior vaginal wall 85 is infiltrated with an anesthetic solution in the midline below the urethra 82. The vaginal wall 85 is incised on the sagittal midline. The vagina incision 85 has a 2 centimeter length starting 15 millimeters below the urethral meatus 86. The vaginal wall 85 is dissected laterally on both sides of the urethra 82 until contact with the superficial perineal fascia 88a. The reason to prefer the insertion of the hollow needle 50 and the internal needle 60 starting from the vagina as entry point 85b and not from the skin in the supra-pubic area 84 is the precision of the vagina route over the supra-pubic route, especially laterally to the urethra 82 and at the level of the bladder neck 87. Thus, the risk of urethra or bladder neck injury is reduced. Moreover, nerve and blood supply of anatomical structures contributing to urinary continence concentrate in the immediate surroundings of the urethra 82 and the bladder neck 87 so that, the latter will be more easily preserved by using the vagina as entry point 85b. On the opposite, starting insertion of the hollow needle 50 and the internal needle 60 from the supra-pubic area 84 provides precision, at the level of the supra-pubic entry point 84b without any relationship with continence physiology, but on the opposite, less precision versus the bladder neck and the urethra at the vaginal exit point 85c, where nerve and blood supplies converge and should not be injured.

The first hollow needle 50 is positioned in contact with the superficial perineal fascia 88a. The operator fixes with one hand the former position of the handle 40 and pushes with the other hand the internal needle 60 through the superficial fascia 88a. Tissues are infiltrated with the local anesthetic. When the internal needle 60 abuts the hollow needle 50, the operator fixes with one hand the position of the internal anesthesia needle 60 and with the opposite hand glides forwards the hollow needle 50 along the internal needle 60, until the hollow needle 50 abuts the short side 66 of the right angle plate 64 fixed to the internal needle 60. Thus, the hollow needle 50 with a larger diameter than the one of the internal anesthesia needle 60 progresses along an anesthetized path. The same maneuver is repeated as described in figures 4A and 4B.

Each time the anesthetic solution has been injected with the syringe, the operator aspirates to control the absence of urine or blood in the syringe. Thus any deviation from the path resulting in bladder puncture or blood vessel puncture is immediately diagnosed by the operator and the direction will be corrected.

The operator keeps the path in the direction of the above mentioned supra-pubic horizontal midline skin incision 84a.

After the break of the hollow needle 50 (see figure 7B), the curved first portion 52 of the hollow needle 50 exits out of the skin incision 84a in the supra-pubic area. Once the distal tip 57 of the hollow needle 50 has passed the abdominal muscles 83a in the supra-pubic area 84, the operator pushes the hollow needle 50 through the midline incision 84a, until at least 2 centimeters of the hollow needle 50 exits from the skin.

The distal end of the hollow needle 50 is secured above the skin in the supra-pubic area 84 by a clamp to prevent from any backwards gliding of the coaxial hollow needle 50. Indeed, the hollow needle 50 has a small diameter, the friction of the hollow needle 50 with surrounding tissues along the path is low and any uncontrolled even minor traction on the thread 10 connected to the hollow needle 50 could pull it back.

The internal needle 60 is retrieved from the hollow needle 50. The operator tears and discards the safety means, i.e. the thermo-retractable plastic outer sleeve 73, at the break point 55 of the hollow needle 50, and breaks the hollow needle 50 into two portions.

The curved first portion 52 of the hollow needle 50 is discarded and the thread 10a, 10b is pulled out of the skin incision 84a in the supra-pubic area.

The straight second portion 51 with the handle 40 (as shown in figure 7A) is discarded. The operator pushes the curved first portion 52 (as shown in figure 7B) through the vagina incision 85a, and pulls with the other hand the distal end 52b of the curved first portion 52 until the thread 10a, 10b glides out of the skin of the suprapubic area 84. A clamp secures the thread 10a, 10b out of the skin 84 and the thread 10a, 10b is cut distally close to its connection with the curved first portion 52 of the hollow needle 50. The curved first portion 52 is discarded (see figure 7C).

The same maneuver is repeated with the second hollow needle 50 forming the guide lb, starting from the vagina incision 85a and continued on the contra lateral side of the urethra. The second hollow needle 50 forming the guide lb is passed in the same way in the retro-pubic space 89 and exits through the same midline skin incision in the supra-pubic area 84. The second thread 10b is glided through the supra-pubic skin incision 84a, secured by a second clamp and cut in a similar manner as the first thread 10a was.

Reference is made to figure 8A. In this front view of the female perineum and pelvis, the relevant anatomical structures are the anterior vaginal wall 85, vagina incision 85a, the superficial perineal fascia 88a and muscles of the perineum 88, the urethra 82, the retro-pubic space 89, the fascia and muscles 83a of the abdominal wall in the supra-pubic area, skin incision in the supra-pubic area 84b, sub-cutaneous tissue in the supra-pubic area 84c. The operator passes the free distal end 11a, lib of each of the two threads 10a and 10b emerging from the incision in the supra-pubic area 84a, first through a biocompatible support member 101 perforated or not in its center, and second through the channel 102a perforated in the center of a biocompatible non- biodegradable bead 102. The bead 102 lies on the support member 101 in the subcutaneous tissue 84c in the supra-pubic area. Perforation of the support member 101 in its center may not be necessary, since the size of the pores of the support member 101 allows the easy insertion and gliding of the threads 10a, 10b through the pores.

At this stage the bladder 81 (as shown in figure 7A) is catheterized and filled until the patient feels the sensation of a full bladder. The catheter is removed and the patient is asked to cough. This results in urine leakage.

The two threads 10a, 10b are pulled until a resistance is felt by the operator, as the two ends 21a, 21b of the tape 20 engage the superficial fascia 88a and the muscles of the perineum 88. A straight, 15 millimeter large blade (not shown in the figure 8A) is engaged below and parallel to the urethra 82 through the buckle 22 formed by the tape 20 below the urethra 82. The threads 10a, 10b are pulled again until the operator feels a resistance again, as the buckle 22 has disappeared from the vagina and the tape 20 is in contact with the blade. The position of the tape 20 and the threads 10a, 10b is secured by a clamp placed on the two threads 10a, 10b at their exit point 102b from the bead 102.

The patient is asked to cough again. Most of the time urine leakage has disappeared. If urine leakage persists, some more tension is given to the threads 10a, 10b, until urine leakage disappears. The new position of the threads 10a, 10b and of the tape 20 is fixed by the clamp. At this time of the operation, some patients may be able to relax enough to urinate in the gynecologic position, demonstrating the absence of compression of the urethra 82.

A clip 103 is placed on each thread 10a, 10b at the exit point 102b from the bead 102 and below the clamp. The clamp is removed.

The rotation of the clamp on its longitudinal axis over the bead 102 pulls the threads 10a, 10b and allows millimeter precise adjustment of their tension. Adjustment is realized in real time, is personally adapted to each patient, and is performed under local anesthesia, i.e., under conditions close to normal physiological conditions.

Once adjustment has been secured by the clips 103, the skin incision in the supra-pubic area 84a and the vagina incision 85a are closed. A supra-pubic incision 84a is closed over the bead 102 with two or three stitches of a biodegradable thread. The non-biodegradable suspension threads 10a, 10b are cut as they emerge out of the skin in the supra-pubic area 84 or at a 15 millimeter distance from the skin, leaving a 15 millimeter long free portion outside of the skin. This second option may be chosen by the operator, when the adjustment has been difficult to establish. In this situation a delayed early adjustment may be performed up to a week later and under local anesthesia of the supra-pubic area 84.

To perform the new adjustment, the stitches are removed from the incision. The threads 10a, 10b will be clipped again, either with more tension by clipping below the previous clip 103, or with less tension, by pulling the thread 10 out of the bead 102 and clipping the relaxed thread 10 below the bead 102 and above the support member 101. After the delayed early adjustment the threads 10 are cut as they emerge from the skin.

In case urine leakage would reappear several years after the operation, a delayed late adjustment may be performed. The operator will localize the bead 102 by palpation of the skin in the supra-pubic area 84 and will perform under local anesthesia an incision of the skin 84a over the bead 102. The bead 102 will be freed from surrounding fatty tissue and will be pulled, so that the clips 103 and threads 10a, 10b will be visualized. From this point, the maneuver will be the same as described above to perform a delayed early adjustment.

Now will be described the second method of insertion.

The second method of insertion is the same as the first method of insertion, retro-pubic route in-out direction, using breakable hollow needles 50 but the threads 10a, 10b are not connected to the hollow needles 50 at the start. Once the operator has broken the two hollow needles 50 into two portions, the operator inserts the free end 11a, lib of the thread 10a, 10b into the lumen 52c of the curved first portion 52 of the hollow needle 50 (see figure 12) and glides the thread 10a, 10b until it exits out of the bevel 54 of said hollow needle 50 in the supra-pubic area 84. The curved first portion 52 is pulled out of the skin in the supra-pubic area 84 and it is discarded. The operator reproduces the same with the opposite hollow needle 50 inserted on the opposite side of the urethra 82.

Now will be described the third method of insertion, in reference to the figures 13A to 13C.

The third method of insertion is the same the first method of insertion, in a retro-pubic route and following an in-out direction, but the hollow needles 50 is non-breakable and the threads 10a, 10b are not connected to the hollow needle 50 at the start. According to this third method of insertion only one hollow needle 50 is required.

After insertion of the hollow needle 50 starting from the vagina and continued through the retro-pubic route, the distal tip of a flexible catheter is connected to the distal tip of the hollow needle 50 in the supra-pubic area. Retrieval of the hollow needle 50 pulls the flexible catheter in the path, until the distal tip of the flexible catheter exits out of the vagina. The free end of each thread 10a, 10b is inserted, in a retrograde way, through the distal tip of the flexible catheter, one thread 10a, lObon each side of the urethra.

Reference is made to figure 13A to 13C.

The internal needle 60 is retrieved from the hollow needle 50. The distal tip 52b of the hollow needle 50 is connected to a flexible catheter 104 with a thin diameter. The thin diameter and the flexibility allows the in force insertion and connection of the cone shaped distal tip 104a of the flexible catheter into the bevel 54 at the distal end of the hollow needle 50. The flexible catheter 104 entry point is at the level of the skin incision in the supra-pubic area 84a. The hollow needle 50 is pulled backwards from the vagina incision 85a. The flexible catheter 104 connected to the distal tip 52b of the hollow needle 50 follows the same path enters the skin incision 84a in the supra-pubic area, passes the fascia and muscles 83a of the abdominal wall 83, enters the retro-pubic space 89, and bypasses the pubic bone 80, until the distal tip 104a of the flexible catheter exits laterally to the urethra 82 out of the vagina incision 85a.

The hollow needle 50 and flexible catheter 104 are disconnected and the hollow needle 50 is discarded. The free distal end 11a, lib of one of the two threads 10a, 10b connected to the tape 20 (not shown in the figure) is inserted, in a retrograde way, into the lumen 104b of the distal tip 104a of the flexible catheter.

The thread 10a, 10b is glided until it exits at the proximal end 104c of the flexible catheter (not shown in the figure). The flexible catheter 104 is pulled back from its entry point in the supra-pubic area 84b. The flexible catheter 104 is discarded. The same procedure is used to pass the second thread 10b, 10a on the contra-lateral side of the urethra 82 (not shown in the figure). From this stage the procedure consists in the adjustment of the position of the threads 10a, 10b and the tape 20 as already described in figure 8A.

Now will be described the fourth method of insertion.

The fourth method of insertion is very close to the third method of insertion, according to a retro-pubic route and following an in-out direction, with a non-breakable hollow needle and threads connected or not to the hollow needle at the start. The main difference is that no flexible catheter 104 is used.

The hollow needle 50 is inserted through a retro-pubic route starting from the vagina 85 in the direction of the skin 84 of supra-pubic area (in-out technique). The hollow needle 50 may have either a blind transversal eye 58, with threads 10a, 10b connected to the distal end 52b of the hollow needle 50 by a thermo-retractable sleeve 74 (see figure 3C) or a through-hole transversal eye 58b with free distal end 11a, lib of threads 10a, 10b glided through.

The thread 10a, 10b is pushed from the vagina incision 85a to the skin incision 84a in the supra-pubic area 84. According to the mode of thread link, distal end 11a, lib of thread 10a, 10b is either cut from the thermo-retractable sleeve 74, or retrieved out of through-hole transversal eye 58b and secured by a forceps in the supra-pubic area 84. The same procedure is repeated for the contra-lateral side of the urethra 82.

Now will be described the fifth method of insertion in reference to the figures 15A and 15B.

The fifth method is the same as the third method, but the hollow needle 50 is non-fractionable and the threads 10a, 10b are not connected to the hollow needle 50. The retro-pubic route is used but following an out-in direction starting from the supra-pubic area as entry point and vagina wall as exit point, thus no need for a flexible catheter as detailed in the third method. After insertion of the hollow needle 50, starting from a skin incision in the retro-pubic area to the vagina as exit point and retrieval of the internal needle 60, the free end of each thread 10a, 10b is inserted, in a retrograde way, through the distal tip 57 of the hollow needle 50, one thread on each side of the urethra.

Reference is made to the figures 15A and 15B.

The distal tip 57 of the hollow needle 50 progresses from the skin incision 84a in the supra-pubic area, in the retro-pubic space 89, laterally to the urethra 82, until said distal tip 57 exits out of the vaginal incision 85a below the urethra 82. The internal needle 60 is retrieved from the hollow needle 50.

Each of the two threads 10a, 10b connected to and supporting the tape 20 has a free end 12a, 12b not connected to the hollow needle 50. The free end 12a, 12b of each thread 10a, 10b is inserted, in a retrograde way, through the distal tip 52b of the hollow needle 50. There is no need for a flexible catheter. The thread 10a, 10b is glided inside the lumen of the distal tip 57 of the curved first portion 52 of the hollow needle 50 and along the hollow needle 50 until the thread 10a, 10b exits at the proximal end 56 of the hollow needle 50. One thread 10a, 10b is inserted on each side of the urethra 82 (see figure 15a). The hollow needle 50 is pulled out of the skin incision in the supra-pubic area 84. The thread 10a, 10b is secured out of the skin by a clamp. From this stage the procedure consists in the adjustment of the position of the threads and the tape as already described above in figure 8A.

Now will be described the sixth method of insertion.

The sixth method of insertion is very close to the fifth method of insertion. The hollow needle 50 is non-fractionable, threads 10a, 10b are not connected to the hollow needle 50. The hollow needle 50 is inserted through a retro- pubic route, starting from an incision in the supra-pubic area 83 in the direction of the vagina incision 85a (out-in technique). The hollow needle 50 comprises the through- hole transversal eye 58b and a blind transversal eye 58 positioned below or proximally to the through-hole transversal eye 58b. Distal end 52b of the hollow needle 50 is inserted through the skin incision in the supra-pubic area 85a to exit out of the incision in the vagina 85a. Free distal end 11a, lib of thread 10a, 10b is glided through the through-hole transversal eye 58b. Free distal end 11a, lib of thread 10a, 10b is pulled backwards, from the vagina incision 85a to the skin incision 84a in the suprapubic area 84. Free distal end 11a, lib of thread 10a, 10b is retrieved out of the through-hole transversal eye 58b and is secured by a forceps in the supra-pubic area 84. The same procedure is repeated on the contra-lateral side of the urethra 82. The surgical device 200 according to this method of insertion cannot have threads 10a, 10b fixed to hollow needle 50 for retro-pubic route; indeed, threads 10a, 10b must have free ends, so that they can be glided through the through-hole transversal eye 58b, before they are pulled upwards from the vagina incision 85a to the incision in the supra-pubic area 84.

Now will be described the seventh method of insertion in reference to the figures 8B and 11.

In the seventh method of insertion, the hollow needle 50 is inserted starting from the vagina and through a trans-obturator route (in-out route). The hollow needles 50 are fractionable and the threads 10a, 10b are connected to the hollow needles 50.

Reference is made to figure 8B.

In this front view of the female pelvis, the relevant anatomical structures are: the vagina wall 85, vagina incision 85a, urethra 82, fascia and muscles of the perineum 88, obturator fossa 90, fascia and muscles occluding the obturator fossa 91, labia majora 92, external crease 92a of the labia majora, sub-cutaneous tissue 92d of the skin incision in the external crease 92a of the labia majora.

As seen in figure 8B, on each side of the pelvis, a thread 10a, 10b passes laterally to the urethra 82, through the fascia and muscles of the perineum 88, through the fascia and muscles of the obturator fossa 91, and exits through the skin incision in the crease of the labia majora 92b. The adjustment step differs slightly from the first embodiment in that both threads 10a, 10b are pulled and are adjusted the same, but each of the threads 10a, 10b is anchored separately, one at a time, at the level of the incision in the external crease of each of the labia majora 92b, in the subcutaneous tissue 92d below the skin of the external crease 92b.

Reference is made to figure 11.

A local anesthesia is performed in the crease of the labia majora 92a and in the direction of the obturator fossa 90 on both sides. The height of the incision is at the level of the obturator fossa 90 previously localized by the operator. Concerning local anesthesia and dissection of the vaginal wall 85 (not shown in the figure) laterally to the urethra 82 on both sides, the procedure is the same as the one already described in Figure 7A to 7C. The hollow needle 50 is inserted via the vagina incision 85a (not shown in the figure) and through the superficial fascia of the perineum muscles 88 (not shown in the figure) and then rotated around the ischio-pubic branch 93 of the pelvis bony structure 94, in order to pass through the fascia and muscles occluding the obturator fossa 91. Further, the sub-cutaneous tissue 92d is traversed by the distal tip 57 of the hollow needle 50, said distal tip 57 exiting from the skin incision 92b in the external crease 92a of the labia majora 92. Starting from this step, the procedure is the same as already described in figures 7A to 7C, until the distal tip 57 of the hollow needle 50 is secured outside of the skin incision 92b in the external crease 92a by a clamp, to prevent from any backwards gliding of the hollow needle 50.

The internal needle 60 (not shown in the figure) is retrieved from the hollow needle 50. The operator tears and discards the safety means, i.e. the thermo- retractable plastic outer sheath 73 (not shown in the figure); at the break point 55 of the hollow needle 50, and breaks the hollow needle 50 into two portions. The straight second portion 51 with the handle 40 is discarded.

The operator pushes the curved first portion 52 through the vaginal incision 85a (not shown in the figure), and pulls with the other hand the distal end 52b of the curved first portion 52, until the thread 10a, 10b exits out of the skin incision 92b in the external crease 92a of the labia majora 92. A clamp secures the thread 10a, 10b out of the skin incision 92b and the thread 10a, 10b is cut distally, close to the curved first portion 52 of the hollow needle 50. The curved first portion 52 is discarded.

Now will be described the eighth method of insertion in reference to the figures 8B and 12.

The eighth method is the same as the seventh method of insertion, according to a trans-obturator in-out route. The hollow needles 50 are fractionable, but threads are not connected to the hollow needles 50 at the start. The free end of each thread is inserted, in an antegrade way, through the proximal tip of the curved first portion of the hollow needle, one thread on each side of the urethra.

The procedure is the same as the one in the seventh method of insertion, until the operator has broken respectively the hollow needle 50 into two portions. The operator inserts the free end 11a, lib of the thread 10a, 10b into the lumen 52c of the curved first portion 52 of the hollow needle 50 (see figure 12) and glides the thread 10a, 10b until it exits out of the bevel 54 of said hollow needle 50 in the external crease 92a of the labia majora. The curved first portion 52 is pulled out of the skin in the external crease 92a of the labia majora and it is discarded. The operator reproduces the same with the opposite hollow needle 50 inserted on the opposite side of the urethra 82. At this time, the procedure continues in the same way as in the seventh method of insertion with the adjustment of the tape 20 and threads 10a, 10b.

Now will be described the ninth method of insertion in reference to the figure 14.

The ninth method of insertion is the same as the seventh method of insertion according to a trans-obturator in-out route, but the hollow needle 50 is non- fractionable and the threads are not connected to the hollow needle 50. A flexible catheter 104 is required.

According to the in-out technique, after incision of the vagina 85 below the urethra 82 and dissection of each side of the urethra, the handle 40 holding the hollow needle 50 and the internal needle 60, is inserted via a trans-obturator route (see figure 14) starting from the vagina incision 85a, as entry point 85b and exiting laterally in the crease of each of the labia majora 92a.

Reference is made to the figure 14.

In this front view of the female pelvis, the relevant anatomical structures are: vagina incision 85a, urethra 82, superficial fascia of the perineum muscles 88, ischio-pubic branch 93 of the pelvis bony structure 94, obturator fossa 90, fascia and muscles 91 occluding the obturator fossa, skin incision 92b in the external crease of the labia majora, external crease 92a of the labia majora, labia majora 92, urethra 82. The internal needle 60 was retrieved from the hollow needle 50. The distal tip 52b of the hollow needle 50 is connected to the distal tip 104a of a flexible catheter 104 with a thin diameter. The thin diameter and the flexibility allows the in force insertion and connection of the cone shaped distal tip 104a of the flexible catheter into the bevel 54 at the distal tip 57 of the hollow needle 50. The flexible catheter 104 entry point is skin incision 92b of the external crease 92a of each of the labia majora 92.The hollow needle 50 is pulled backwards from the vagina incision 85a. The flexible catheter 104 connected to the distal tip 52b of the hollow needle 50 follows the same path around the ischio-pubic branch 93 and through the fascia and muscles 91 occluding the obturator fossa 90. The distal tip of the flexible catheter 104a passes laterally to the urethra 82 and exits from the vagina incision 85a.

The following steps (not shown) reproduce the ones already described for the retro-pubic route in figures 13B and 13C: insertion of the free end 11a, lib of a thread 10a, 10b in a retrograde way into the lumen 104b of the distal tip 104a of the flexible catheter. The thread 10a, 10b is glided until it exits at the proximal end 104c of the flexible catheter. The flexible catheter 104 is pulled back from its entry point through the skin in the crease 92b of the labia majora 92a. The flexible catheter 104 is discarded. The same procedure is used to pass the second thread on the contra-lateral side of the urethra 82. From this stage the procedure consists in the adjustment of the position of the threads 10 and the tape 20 as already described in fig 8B.

Now will be described the tenth method of insertion in reference to the figure 14.

The tenth method of insertion is very close to the ninth method of insertion, according to a trans-obturator in-out route, the hollow needle 50 is non- fractionable and the threads are not connected to the hollow needle 50. A flexible catheter 104 is not required.

The hollow needle 50 is inserted through a trans-obturator route starting from the vagina wall incision 85a in the direction of the external crease 92a of the labia majora 92 (in-out technique). The hollow needle 50 may have, either the blind transversal eye 58 with thread 10a, 10b connected to the distal end 52b of needle 50 by a thermo-retractable sleeve 74 (figures IOC and 10D), or, the through-hole transversal eye 58b with the free distal end 11a, lib of thread 10a, 10b glided through the through-hole transversal eye 58b, and eventually a third eye 58b positioned below or proximally to the through-hole transversal eye 58b (figurelOE). Thread 10a, 10b is pushed from vagina incision 85a to skin incision in the external crease 92a of labia majora 92. According to the mode of thread connection, distal end 11a, lib of thread 10a, 10b is either cut from thermo-retractable sleeve 74 or retrieved out of through-hole transversal eye 58b and secured by a forceps at the level of the external crease 92a of the labia majora 92. The same procedure is repeated for the contra-lateral side of the urethra 82 with the symmetrical hollow needle 50.

Now will be described the eleventh method of insertion in reference to the figure 16A and 16B.

The eleventh method of insertion is the same as the eighth method of insertion according to a trans-obturator out-in route, and the hollow needles are non- fractionable and the threads are not connected to the hollow needles. After insertion of the hollow needle, starting from a skin incision to exit in the external crease of each of the labia majora, the free end of each thread is inserted, in a retrograde way, through the distal tip of the hollow needle, one thread on each side of the urethra.

Reference is made to the figures 16A and 16B.

In this front projection of the female pelvis (see figure 16A), the relevant anatomical structures are: the crease of the labia majora 92a, obturator fossa 90, vagina wall 85, vagina incision 85a, urethra 82, ischio-pubic branch 93 of the pelvis bony structure 94, fascia and muscles occluding the obturator fossa 91.

The distal tip 57 of the hollow needle 50 progresses from a skin incision in the external crease 92a of the labia majora 92, bypasses the ischio-pubic branch of the pelvis bony structure 94, until said distal tip 57 exits out of the vaginal incision 85a below the urethra 82. The internal needle 60 (not shown in the figure) is retrieved from the hollow needle 50.

Each of the two threads 10a, 10b connected to and supporting the tape 20 has ends 11a, lib, which are not connected to the hollow needle 50 (see figure 16B). The free ends 11a, lib of each thread 10a, 10b are inserted, in a retrograde way, through the distal tip 52b of the hollow needle 50. The thread 10a, 10b is glided inside the lumen of the distal tip 57 of the curved first portion 52 of the hollow needle 50 and along the latter, until the thread 10a, 10b exits at the proximal end 56 of the hollow needle 50. One thread 10a, 10b is inserted on each side of the urethra 82. The hollow needle 50 is pulled out of the skin incision in the external crease 92a of the labia majora 92 (see figure 16A). The thread 10a, 10b is secured out of the skin by a clamp. From this stage the procedure consists in the adjustment of the position of the threads and the tape 20 as already described in figure 8B.

Now will be described the twelfth method of insertion. The twelfth method of insertion is very close to the eleventh method of insertion.

The hollow needle 50 is inserted through a trans-obturator route starting from an incision in the external crease of the labia majora 92a in the direction of the vagina wall incision 85a (out-in technique). The hollow needle 50 comprises a through- hole transversal eye 58b and eventually a third eye 58b (figure 10E) positioned below or proximally to the through-hole transversal eye 58b. Distal end 52b of the hollow needle 50 for the trans-obturator route (see figure IOC) is inserted through the skin incision in the external crease 92a of the labia majora 92, to exit out of the incision in the vagina 85a. Free distal end 11a, lib of thread 10a, 10b is glided through the through-hole transversal eye 58b. Free distal end 11a, lib of thread 10a, 10b is pulled backwards by hollow needle 50 from the vagina incision 85a to the skin incision in the external crease 92a of the labia majora 92. Free distal end 11a, lib of thread 10a, 10b is retrieved out of the through-hole transversal eye 58b and secured by a forceps at the level of the external crease 92a of the labia majora 92. The same procedure is repeated for the contra-lateral side of the urethra 82 with the symmetrical hollow needle 50.

Besides the application to treatment of female stress urinary incontinence, the device and method according to the present invention can be applied to other forms of incontinence in humans, provided necessary modifications are brought to the surgical device of the invention:

- Post-prostatectomy urinary incontinence in males: the bulbous urethra is supported by a tape positioned below the bulbous portion of the urethra and each end of the tape is supported by a thread inserted through the trans-obturator route or the retro-pubic route or both routes, to finally exit respectively through the skin of the perineum laterally to each side of the scrotum or the skin in the supra-pubic area. The in-out method is preferred for this embodiment: an incision is performed on the midline of the anterior part of the perineum below the scrotum and the dissection is carried out until contact with the bulbous-cavernosum muscles. From this stage of the procedure, the tape is positioned below the muscles in contact with the bulbous urethra and the threads will be glided laterally to the roots of the corpus cavernosum (internally or externally), and through the obturator fossa on each side of the patient and/or through the retro-pubic space, to exit respectively the skin laterally to each side of the scrotum or the skin in the supra-pubic area,

- Fecal incontinence in females and males: the anal canal is supported by a tape. Each end of the tape is supported by a thread gliding in the ischio-rectal fossa, then progressing through the obturator fossa before exiting in the perineum laterally to the external crease of the labia majora on each side in females or laterally to the scrotum on each side in males. The in-out method is preferred for this embodiment: an incision is performed on the mid-line of the posterior part of the perineum between the anal margin and the coccyx and the dissection is carried out laterally to the anal canal. The tape is positioned below the anal canal and the threads will be glided anteriorly and laterally in the ischio-rectal fossa, laterally to the vagina in females or laterally to the prostate in males and through the obturator fossa on each side of the female or male patient and/or through the retro-pubic space, to exit respectively the skin of the anterior part of the perineum respectively laterally to each side of the labia majora in females or of the scrotum in males and/or the skin in the supra-pubic area in females as well in males.

Obviously, the invention is not limited to the embodiments and methods described and represented with the annexed figures. Modifications remain possible, in particular from the point of view of the constitution of the each element or by substitution of technical equivalents, without leaving for all that the scope of the invention.

Claims

1. Surgical device (200) for female urinary incontinence, comprising at least one hollow needle (50) so as to ensure a fluid connection through its length, the hollow needle (50) comprising a first portion (52) configured to create an insertion path between the urethra and the vagina wall and a second portion (51) shaped to form at least partially a handle (40), characterised in that the surgical device (200) comprises at least one detecting system (201) configured to be connected to the second portion (51) of the at least one hollow needle (50), the detecting system (201) comprising at least a valve (4) and a depressurized tube (6) cooperating with each other so as to create a vacuum in the hollow needle (50).

2. Surgical device according to claim 1, wherein the valve of the detecting system (201) is positioned at one end of the second portion (51) of the hollow needle (50) and connected to the depressurized tube (6), the valve (4) comprising at least two ways (4a, 4b) connected respectively to the hollow needle (50) and the depressurized tube (6), the valve (4) being configured to allow the creation of a vacuum in a first position in which the at least two ways (4a, 4b) of the valve (4) are opened, and to stop creation of vacuum in a second position in which the at least two ways (4a, 4b) of the valve (4) are closed.

3. Surgical device according to any of the claims 1 or 2, wherein the valve (4) is a three-way valve, at least one way (4c) being shaped to receive an anesthesia syringe for the injection of an anesthetic fluid through the hollow needle (50).

4. Surgical device according to any of the claims 1 to 3, wherein the first portion (52) of the hollow needle (50) comprises at least one transversal eye (58, 58b) configured to create a draft.

5. Surgical device according to claim 4, wherein the at least one transversal eye (58b) is a through-hole shaped to receive a thread (10a, 10b).

6. Surgical device according to any of the claims 1 to 5, wherein the said surgical device comprises a first and a second threads (10a, 10b), a tape (20) configured to be positioned between the urethra and the vaginal wall, the tape (20) being connected to one end (21a) by the first thread (10a) and at another end (21b) by the second thread (10b), at least one of the first and/or the second threads (10a, 10b) being connected to the first portion (52) of the hollow needle (50).

7. Surgical device according to claim 7, wherein the first and/or the second threads (10a, 10b) are at least partially monofilament threads.

8. Surgical device according to any of the claims 7 or 8, wherein the first and/or the second threads (10a, 10b) are at least partially barbed threads.

9. Surgical device according to any of the claims 7 to 9, wherein the said surgical device comprises at least one anchoring means (102) configured to be positioned under the skin of a patient, the anchoring means (102) being linked to at least one of the first and/or the second threads (10a, 10b).

10. Surgical device according to claim 9, wherein the anchoring means comprises a support member (101) threaded onto at least one of the first and/or the second threads (10a, 10b), and positioned between the tape (20) and the anchoring means (102), the support member (101) being configured to support the anchoring means (102) and to maintain the anchoring means (102) in position so as the said anchoring means (102) being palpable through the skin of the patient.

11. Surgical device according to any of the claims 7 to 10, wherein the said surgical device (200) comprises at least a first hollow needle (50) and a second hollow needle (50), and at least a first detecting system (201) and a second detecting system (201), each hollow needle (50) being connected permanently or temporarily to respectively the first and the second threads (10a, 10b), and each hollow needle (50) being connected permanently or temporarily to respectively the first and the second detecting system (201).

12. Surgical device according to any of the claims 1 to 10, wherein the first portion (52) of the hollow needle (50) is curved.

13. Surgical device according to any of the claims 1 to 11, wherein the said surgical device comprises at least one internal needle (60) shaped to be inserted inside the hollow needle (50), the internal needle (60) being connected to at least one detecting system (201).

14. Surgical device according to claim 12, wherein the said surgical device comprises a right angle blade (64) configured to allow the incremental progression of the internal needle (60) in the hollow needle (50), the right angle blade (64) being positioned on the internal needle (60) between the second portion (51) of the hollow needle (50) and the detecting system (201).

15. Surgical device according to any of the claims 1 to 13, wherein the hollow needle (50) comprises a third portion (55) between the first portion (52) and the second portion (51), the third portion (55) being breakable.