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Numéro de publicationWO2002078548 A1
Type de publicationDemande
Numéro de demandePCT/GB2002/001270
Date de publication10 oct. 2002
Date de dépôt2 avr. 2002
Date de priorité30 mars 2001
Numéro de publicationPCT/2002/1270, PCT/GB/2/001270, PCT/GB/2/01270, PCT/GB/2002/001270, PCT/GB/2002/01270, PCT/GB2/001270, PCT/GB2/01270, PCT/GB2001270, PCT/GB2002/001270, PCT/GB2002/01270, PCT/GB2002001270, PCT/GB200201270, PCT/GB201270, WO 02078548 A1, WO 02078548A1, WO 2002/078548 A1, WO 2002078548 A1, WO 2002078548A1, WO-A1-02078548, WO-A1-2002078548, WO02078548 A1, WO02078548A1, WO2002/078548A1, WO2002078548 A1, WO2002078548A1
InventeursJames Browning
DéposantGyne Ideas Limited
Exporter la citationBiBTeX, EndNote, RefMan
Liens externes:  Patentscope, Espacenet
Surgical tool
WO 2002078548 A1
Résumé
A surgical tool for introducing a surgical implant into the human body for the treatment of female urinary incontinence is provided. The tool (1) comprises an elongate shaft (4) and implant carrier means. The elongate shaft (4) comprises a handle (2) at a proximal end and a point (6) at a distal end for penetrating body tissue. The carrier means is adapted to house the surgical implant (5) during insertion of the tool (1) into the body and includes an opening (9) or defect substantially along its longitudinal length which enables removal of the surgical implant (5) from the carrier means. The carrier means can therefore take the form of a C shape and include a medial opening (9). The implant carrier means extends substantially along all of the longitudinal length of the shaft (4).
Revendications  (Le texte OCR peut contenir des erreurs.)
1. A surgical tool for introducing a surgical implant into the human body for the treatment of female urinary incontinence, the tool comprising an elongate shaft and implant carrier means the elongate shaft having a handle at a proximal end for manipulating the shaft and a point at a distal end for penetrating body tissue, the implant carrier means adapted to house the surgical implant during insertion of the tool into the body wherein the implant carrier means extends substantially along all of the longitudinal length of the shaft.
2. A surgical tool as claimed in claim 1 wherein the implant carrier means is a sleeve adapted to accommodate the elongate shaft and the surgical implant.
3. A surgical tool as claimed in claim 1 wherein the implant carrier means is a recess on an exterior surface of the elongate shaft adapted to receive the surgical implant.
4. A surgical tool as claimed in claim 1 wherein the implant carrier means is a cavity within the elongate shaft.
5. A surgical tool as claimed in any preceding claim wherein the point at the distal end of the elongate shaft is separable from the shaft.
6. A surgical tool as claimed in any preceding claim further comprising releasable fastening means adapted to fasten the surgical implant to the tool during insertion into the body.
7. A surgical tool as claim 6 wherein the fastening means are a protrusion within the implant carrier means .
8. A surgical tool as claimed in claim 6 wherein the fastening means are a hook within the implant carrier means .
9. A surgical tool as claimed in claim 6 to 8 wherein the releasable fastening means are located at the distal end of the carrier means.
10. A surgical tool as claimed in any preceding claim wherein the carrier means is openable to provide access to a surgical implant within the carrier means.
11. A surgical tool as claimed in any preceding claim wherein the carrier means has an opening extending from an exterior surface of the carrier means into a cavity of the carrier means.
12. A surgical tool as claimed in claim 11 wherein the opening extends medially along the longitudinal length of the carrier means.
13. A surgical tool as claimed in claim 12 wherein the carrier means is substantially circular in cross section and the opening is approximately 1/8 to 3/8 of the circumference of the carrier means .
14. A surgical tool as claimed in any previous claim wherein the elongate shaft comprises surgical steel .
15. A surgical tool as claimed in claim 3 wherein the sleeve of the carrier means is comprised of surgical steel .
16. A surgical tool as claimed in claim 3 wherein the sleeve of the carrier means is comprised of polythene.
17. A surgical tool as claimed in any previous claim wherein the tool is of sufficient length to extend from an incision in the anterior wall of the vagina through the body and extend out through the abdominal wall.
18. A surgical tool as claimed in any preceding claim wherein the elongate shaft of the surgical tool is 20 to 40 cm long.
19. A surgical tool as claimed in claims 1 to 17 wherein the elongate shaft of the surgical tool is 6 to 20 cm long.
20. A surgical tool as claimed in claim 19 wherein the elongate shaft of the surgical tool is 6 to 15 cm in length.
21. A surgical tool as claimed in any preceding claim wherein the elongate shaft has a width of between 2 to 6 mm.
22. A surgical tool as claimed in claim 21 wherein the elongate shaft has a width of between 2 to 4 mm.
23. A surgical tool as claimed in any preceding claim wherein the elongate shaft is curved.
24. A surgical tool as claimed in claim 23 wherein the elongate shaft curves through an angle of 30°
25. A surgical tool as claimed in claims 23 to 24 wherein the opening extends along the inside of the curve of the elongate shaft.
26. A surgical tool as claimed in any preceding claim further comprising implant securing means.
27. A surgical tool as claimed in claim 26 wherein the implant securing means comprise one or more plastics strips extending around a surgical implant.
28. A surgical tool as claimed in any preceding claim wherein the elongate shaft is adapted to receive a soft tissue anchor on its distal end.
29. A surgical implant adapted for use with the surgical tool as previously claimed the surgical implant comprising a tape, the tape being resiliently flat.
30. A surgical implant as claimed in claim 29 wherein the tape may be radially confined such that the diameter of the tape is less than the width of the tape when flat.
31. A surgical implant as claimed in claims 29 or 30 the surgical implant further comprising anchoring means .
32. A surgical implant as claimed in claim 31 wherein the anchoring means are at least one soft tissue anchor.
33. A method of treating female urinary incontinence comprising the steps of;
placing one end of an implant into a first carrier means such that the implant is radially confined by the carrier means;
inserting a first tool comprising an elongate shaft and carrier means through an incision in the anterior vaginal wall, past one side of the urethra, and behind the pubic bone;
releasing the implant from the carrier means while withdrawing the first tool; placing the other end of the implant into a second carrier means such that the second end of the tape is radially confined by the carrier means;
inserting a second tool through the incision in the anterior vaginal wall, past the other side of the urethra and, behind the pubic bone;
releasing the implant from the carrier means while withdrawing the second tool; and
closing the incision.
Description  (Le texte OCR peut contenir des erreurs.)

"Surgical Tool"

This invention relates to a surgical tool for use in the treatment of female urinary incontinence, along with a surgical implant for insertion by the tool and a related method of treating female urinary incontinence .

Urinary incontinence affects a large number of women and, consequently, various approaches have been developed to treat female urinary incontinence. Those skilled in the art will be familiar with approaches ranging from pelvic floor exercises to surgical techniques such as Burch colposuspension in which sutures are placed around the bladder neck and Stamey-type endoscopic procedures in which loop sutures are placed so as to elevate the bladder neck.

This invention is particularly directed to improvement of a known procedure in which a sling is positioned loosely under the mid-urethra, commonly known as TVT (Tension free Vaginal Tape) . It is generally understood that this treatment alleviates urinary incontinence by occluding the mid-urethra (for example at a time of raised abdominal pressure by coughing or the like) .

The sling generally comprises a long mesh or tape and is provided in the body using two large curved needles which are provided at each end of the mesh or tape. Each of the needles is carried on an insertion tool (which is basically a handle facilitating manipulation of the needle) . The mesh or tape is usually made of knitted polypropylene (such as Prolene®) . Due to the cutting process used in the manufacture of the mesh or tape, the mesh or tape generally has poor finish and thus has rough edges. These rough edges are therefore usually covered with a polythene envelope to aid smooth insertion into the body. Such slings, needles and insertion tools are described, for example, in WO96/06567 and W097/13465.

In use, an incision is made in the anterior vaginal wall and the first of the needles is passed through the incision, past one side of the urethra, behind the pubic bone, through the rectus sheath and out through the lower anterior abdominal wall. Likewise, the second needle is passed through the same incision in the anterior vaginal wall, past the other side of the urethra, behind the pubic bone, through the rectus sheath and out through the lower abdominal wall. The needles are separated from their respective insertion tools and removed from the body via the openings made in the lower abdominal wall . The needles are removed from the tape such that only the tape and its polythene envelope are left in the body, passing from a first exit point in the lower abdominal wall, through the rectus sheath, behind the pubic bone, under the urethra, back behind the pubic bone, back through the rectus sheath and out through a second exit point in the lower abdominal wall.

The polythene envelope is then removed from the tape and the tape adjusted to a suitable, tension (such that the tape provides a sling that passes loosely under the urethra, as described above) by manoeuvring the free ends of the tape outside the exit points in the lower abdominal wall whilst the urethra is held using a rigid catheter inserted therein. The ends of the tape external the abdominal wall are then cut such that they fall just short of protruding from the exit points in the lower abdominal wall. The exit points in the abdominal wall and the incision in the upper vagina wall are then closed by sutures..

Whilst this method is highly effective in treating urinary incontinence, the applicant has recognised a number of problems with the tools and method by which the tape is inserted in the body. In particular, the needles and tape are generally provided in a single sterile package, with the tape attached to the proximal ends of the needles. Once the needles have been passed out through the lower abdominal wall, the tape is cut to separate the needle from the tape. The needles are then disposed of. Thus, a new needle and tape package is required for each treatment, making the treatment relatively expensive.

Furthermore, it can be appreciated that the whole needle passes out through the lower abdominal wall. Thus, the insertion tool must follow the needle's path through the body to a significant extent to push the needle out through the abdominal wall either entirely or at least sufficiently to allow the needle to be pulled by the surgeon from outside the abdominal wall . This may result in the connection between the needle and the insertion tool passing into and some way through the body. As the connection between the needle and the insertion tool is not smooth, this may cause additional trauma and/or increased risk of infection being introduced into the body.

In addition the needles used in the prior art are of substantial width and length which causes concerns among patients and in use can lead to increased trauma/damage to body tissues. Such a large needle also requires the surgeon to apply greater force to push the needle through the body tissues which may cause a further increase in trauma.

According to the present invention there is therefore provided a surgical tool for introducing a surgical implant into the human body for the treatment of female urinary incontinence, the tool comprising an elongate shaft and implant carrier means the elongate shaft having a handle at a proximal end for manipulating the shaft and a point at a distal end for penetrating body tissue, the implant carrier means adapted to house the surgical implant during insertion of the tool into the body wherein the implant carrier means extends substantially along all of the longitudinal length of the shaft.

Also according to the present invention, there is provided a method of treating female urinary incontinence in which a surgical implant is located in the carrier means of the tool during insertion of the elongate shaft through the incision in the anterior vaginal wall and into and through body tissue. The shaft of the tool being subsequently retracted whereby the implant is left in its desired position.

In other words, the tool comprises a carrier means capable of receiving the surgical implant and a point to allow movement of the tool through the body while causing the least trauma to the patient. The surgical implant may be a mesh or tape.

The carrier means may be a hollow, recess or cavity which extends along the length of a member, which may be the shaft of the tool, such that the tape or mesh is retained inside the member along the longitudinal length of the member. Where the carrier means is the shaft the hollow, recess or cavity may extend along substantially the entire length of the shaft, except perhaps at the point or handle of the tool .

Alternatively the carrier means may be a sleeve capable of receiving the surgical implant .

Preferably the carrier means is a sleeve capable of receiving both the surgical implant and shaft of the tool .

The sleeve may be formed from any suitable material including surgical steel or polyethene .

As the surgical implant can be retained in the carrier means during insertion into the body, the implant does not come into contact with body tissue during insertion. Rather, only after the implant is removed from the carrier means does the implant come into contact with body tissue.

During insertion of the tool into the body, the implant is housed in the carrier means. To ensure that the implant does not slide out of the carrier means, particularly during insertion of the tool into the body tissues, it is desirable for the tool to have releasable fastening means for fastening the implant to the tool during insertion. For example, the releasable fastening means may comprise a protrusion, peg or hook within the hollow, cavity or recess to which the implant may be releasably fastened.

Preferably the releasable fastening means are at the distal end of the shaft. The implant may be provided with a part adapted to be secured to the fastening means, such as a hole. For example, a hole on an end of the implant may be looped over a peg at the distal end of the insertion tool to secure the implant in the shaft. Once the insertion tool has been passed into the body, and the implant is located approximately at the desired position, the implant can be released from the fastening means .

The release of the tape may be implemented as desired.

The tool can then be withdrawn from the body.

Where the carrier means is a hollow member or a recess or cavity in an elongate member, it is preferable that the carrier means has an opening on a surface of the carrier means which links with the cavity or recess for receiving the mesh or to allow the mesh to be inserted into the central hollow of the carrier means of the tool.

The opening on the surface of the carrier means should be sufficiently open to allow the mesh to be inserted in the cavity or recess, but sufficiently closed to retain the mesh in the cavity or recess once it is in place. Preferably the carrier means has a defect or an opening extending along its length adopted to allow release and insertion of the implant .

More preferably the opening is approximately 1/8 to 3/8 of the perimeter of the carrier means.

The carrier means may therefore in cross-section, comprise an arc extending around 5/8 of the circumference of the carrier means. Once the tool has been inserted in the body, the tape is released, while the tool is withdrawn, the tape can be released from its position along the length of the carrier means through the opening along the length of the carrier means.

It is desirable for the carrier means to have a cross-section that allows suitable structural rigidity whilst keeping manufacturing simplicity and costs to a minimum. The arc of the carrier means may therefore be generally circular. However, it is also possible for the opening present in the carrier means to be an arc of an oval or triangle for example.

The tool may comprise any suitable material. If the tool to be re-usable, suitable materials must be easily sterilisable and hardwearing. For example, the tool may therefore comprise surgical steel. Alternatively should the tool only be for single use, the tool may be comprised of suitable plastics material. An example of suitable plastics material is polypropylene.

It is preferable to aid the insertion of the shaft and carrier means into the body that the tool has shape and dimensions that allow it to pass along such a route.

Preferably the shaft is of sufficient length such that it can extend from an incision in the anterior wall of the vagina and out through the lower abdominal wall at the same time. In particular, the shaft is preferably in the range of 20 to 40cm long.

Alternatively the shaft is of sufficient length for it to extend from an incision in the anterior wall of the vagina to the retropubic space or the rectus sheath wherein the shaft is of length in the range 6 to 20cm.

More preferably the shaft is of length ranging from 6 to 15 cm.

Preferably the shaft is curved. This helps to allow the tool to be inserted at a suitable angle into the anterior vaginal wall yet extend behind the pubic bone More preferably the shaft curves through an angle of 30°. In other words, the shaft may longitudinally comprise an arc of about 30°.

Preferably the elongate opening along the length of the carrier means extends along the inside curve of the carrier means .

More preferably where the elongate opening lies medially along the length of the carrier means.

It can be appreciated that such a medial opening causes the carrier means to be C-shaped. Further the tool may be right handed or left handed such that the tool curves through a suitable angle such that it is able to extend behind the pubic bone when passed through the incision in the vaginal wall, the elongate opening extending medially along the inside curve of the carrier means. Thus the open portion of the C- shape is located on the inside of the curved portion.

The shaft is preferably sufficiently narrow to cause as little trauma to the patient as possible on insertion of the tool, but provide the shaft with sufficient strength that it can be forced through the tissue of the retropubic space, possibly the rectus sheath and or the lower abdominal wall. The shaft preferably has a diameter of less than 6mm.

In a preferred embodiment, the shaft has a diameter of between 2 to 4 mm. The surgical implant generally comprises a tape or mesh formed from a polypropylene mesh, such as Prolene®.

As materials such as polypropylene can have some resiliency to the shape in which they are formed, or memory, the implant may be adapted to retain itself in the carrier means after insertion. In other words, the surgical implant may remain in the carrier means due to its inherent resiliency to return to its natural (flat) unconfined shape.

Alternatively, the surgical implant may have securing means adapted to radially confine the implant such that its diameter is less than the width of the implant when flat .

This is considered to be new in itself and, according to another aspect of the present invention, there is therefore provided a surgical implant for treating female urinary incontinence, the implant comprising a tape for insertion in the human body such that it passes under the urethra, the tape being resiliently flat, but when used in combination with securing means the tape may be radially confined such that the diameter of the tape is less than the width of the tape when flat.

Thus, a surgical implant, tape or mesh is provided in a form having reduced radial dimensions. The tape can then, for example, be inserted into the carrier means and the securing means removed. Due to natural resilience of the tape, the tape will then pres.s against the wall of the carrier means and remain secured within the carrier means during insertion. This can be achieved in a controlled manner and therefore more reliable manner when securing means are used to hold the implant for insertion into carrier means. It is also unnecessary to manually squeeze the tape into the carrier means of the surgical tool when securing means are used.

The tape may be confined as desired. For example, the tape may be folded or bunched before the securing means are put in place. However, it is preferable that the tape is rolled around its longitudinal axes. This is a neat way of packaging the tape and reduces the possibility of the mesh being damaged by sharp folds or such like. -Packaging of the tape in this way also improves the reliability with which the tape holds itself in the carrier means.

The securing means may comprise any suitable device for retaining the mesh or tape in its reduced diameter. However, it is particularly preferable that the securing means comprises one or more plastics, e.g. polythene bands. Such bands can be placed around the mesh and easily cut and removed once the mesh has been inserted into the carrier means. In use, it can therefore be appreciated that the surgical implant, radially confined by the securing means, is inserted into the carrier means.

It is preferable that two surgical tools are used and that each end of the tape is inserted in one of the tools. When the tape is located in the carrier means securing means around the tape may be removed.

As discussed it is preferable that the surgical tools are left- and right handed.

One of the tools can then be inserted through an incision in the anterior vaginal wall, past one side of .the urethra, behind the pubic bone and out through the lower abdominal wall. The tool can then be removed, releasing the surgical implant as it is withdrawn. This can then be repeated with the other tool (this second tool passes on the other side of the urethra) , leaving the implant extending behind the pubic bone, under the urethra, and back up behind the pubic bone. The incision wounds can then be closed e.g. with sutures.

According to another aspect of the present invention there is therefore provided a method of treating female urinary incontinence comprising:

placing one end of an implant into a first carrier means such that the implant is radially confined by the carrier means; inserting a first tool comprising an elongate shaft and carrier means through an incision in the anterior vaginal wall, past one side of the urethra, and behind the pubic bone;

releasing the implant from the carrier means while withdrawing the first tool;

placing the other end of the implant into a second carrier means such that the second end of the tape is radially confined by the carrier means;

inserting a second tool through the incision in the anterior vaginal wall, past the other side of the urethra and, behind the pubic bone;

releasing the implant from the carrier means while withdrawing the second tool; and

closing the incision.

Various embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a sectional view from the side of an insertion tool in accordance with the invention;

Figure 2 is a sectional view from the side of the distal end of the insertion tool of Figure 1; Figure 3 is a sectional view from the front of the insertion tool of Figure 1;

Figure 4 is a cross-sectional view along the line A-A of the insertion tool of Figure 1;

Figure 5 is a sectional view of the female human vaginal area with the insertion tool of Figure 1 inserted;

Figure 6 is a sectional view of a second embodiment of the insertion tool from the side of the insertion tool;

Figure 7 is a cross sectional view of a second embodiment of the insertion tool from the distal end of the tool;

Figure 8 is a sectional view of the female vagina area with the insertion tool of the second embodiment;

Figure 9 is a sectional view from the side of a further embodiment of the insertion tool; and

Figure 10 is a sectional view of the female vaginal area with the insertion tool of the further embodiment.

Referring to Figure 1, an insertion tool 1 has a handle 2 at a proximal end and a removable tip 3 at a distal end. Between the handle 2 and the removable tip 3 is an elongate shaft 4. The elongate shaft 4 acts as carrier means and is adapted to house a surgical implant which in this example a tape 5 to be implanted in the human body for the treatment of female urinary incontinence.

In this example, the handle 2 is integral with the carrier means which is the elongate shaft 4. The handle 2 is substantially triangular such that it has an ergonomic form and allows the tool 1 to be easily handled by a surgeon.

The tip 3 has a point 6 that allows the tool 1 to be driven through body tissue. However, the point 6 is "semi-blunt" or not unduly sharp, such that the tool can be passed through bodily tissue, but the risk of accidentally cutting through tissues unintentionally, such as the bladder wall, is reduced.

The tip 3 has an internal screw thread 7 adapted to mate with an external screw thread (not shown) on the distal end of the shaft 4 of the tool 1. When the tip 3 is screwed onto the distal end of the shaft 4, it allows the tool to be inserted in to bodily tissue, but when the tip 3 is unscrewed from the shaft 4, access can be gained to the inside of the distal end of the shaft 4.

The carrier means which is also the shaft 4 of this embodiment is shown in figure 1. The shaft 4 is approximately 40 cm long and 5 mm wide. As described the tip 3 may be unscrewed and removed from the shaft 4. This causes the shaft 4 to be openable at the distal end of the tool 1 following insertion of the tool and passage of the tip 3 of the tool 1 through the lower abdominal wall. Removal of the distal end portion allows access to the tape 5 within the carrier means of the shaft 4.

This ensures that only a relatively small portion of the tool 1 need be passed through the opening in the abdomen. This contrasts the needles used in the prior art and allows the present tool 1 to be of shorter length. The shorter length of the tool 1 means that patients will suffer less anxiety when shown the tool 1 when the procedure is being explained to them. In addition as there is no connection portion as present between the needle and the insertion tool of the prior art, patient trauma and risk of infection will be reduced.

Referring to Figure 2, the distal end of the shaft 4 is provided with a protrusion or hook 8 on its inside surface. The protrusion 8 is adapted to mate with a hole provided in the end of the tape 5 to secure the tape 5 to the shaft 4. In other words, the hole of the tape 5 is threaded or looped over the protrusion 8 to prevent the tape 5 from moving along the length of the shaft 4.

As described the carrier means of the shaft 4 is open or openable at the location of the fastening means 8 such that the tape can be released from the fastening means 8 by hand. For example, where the fastening means 8 is provided at the tip or distal end of the shaft 4 , the point may be removable to provide access to the fastening means 8. Thus, the tape 5 can be released from the fastening means 8 by removing or opening the tip 3 of the carrier means of the shaft 4 of the tool 1.

As the tape 5 is releasably attached to the tool 1, the tool can be re-used by simply sterilising the tool and providing a new tape 5. Thus, as only a new tape need be provided for each procedure, the cost of the procedure can be significantly reduced.

Referring to Figures 3 and 4, the shaft 4 comprises a hollow tube. The shaft 4 also being provided with an elongate opening 9 along its length. The opening 9 extends from the tip 3 at the distal end of the shaft 4 to the handle 2 at the proximal end of the tool 1. The opening 9 has an angular width of around 110°, or 3/8 of the perimeter in this example the circumference of the tool 1. In other words, the outer wall of the shaft 4 extends around approximately 250°, or an arc of 5/8 of the circumference of the tool 1.

The tape 5 is retained within the carrier means of the hollow of the shaft 4, the opening 9 dimensioned as set out above suitably retains the tape 5 within the hollow of the shaft 4, whilst allowing the tape 5 to be inserted and removed from the carrier means of the shaft 4 as required. The tape being releasably fixed to fastening means 8 to the distal end of shaft 4.

The tool 1 is, in this example, made from surgical steel . The shaft 4 has a diameter of around 5mm, which is sufficient to house the tape 5 and to provide enough strength to the tool such that it can be forced through the rectus sheath and the lower abdominal way, yet narrow enough to cause minimal trauma to a patent on insertion of the tool 1. The central axis of the shaft 4 curves through an angle ' of 30° from the proximal end adjacent the handle 2 to the distal end adjacent the tip 3. This allows the tool 1 to extend from an incision in the anterior vaginal wall to an exit point in the lower abdominal wall as described below. The opening 9 extends from the tip 3 to the handle 2 along the inside curved portion of the shaft 4. The opening 9 is shown in figure 4.

The tape 5 has a length of around 40 cm. In this example, the tape is formed of a polypropylene mesh such as Prolene® . During manufacture, the mesh is rolled around its longitudinal axis and secured with bands of polythene such that the tape 5 is supplied tightly rolled. The tape 5 is also provided with a hole at either end for attachment to the protrusion 8 of the carrier means of the shaft 4 of the insertion tool 1. In use, the tip 3 is first removed from the insertion tool 1. One end of the tightly rolled tape 5 is then attached to the protrusion 8 at the distal end of the insertion tool 1. A length of the tape 5 is then pressed into the housing 4 through the opening 9 , leaving a length of tape extending out through the elongate opening 9 at the proximal end of the carrier means of the elongate shaft 4, as shown in Figure 3. The hole at the other end of the tape 5 is then attached to the protrusion 8 at the distal end of a second insertion tool 1, and a length of the tape 5 toward that end pressed into the second insertion tool 1 through the opening 9. Thus, the tape 5 extends from the distal end of a first insertion tool 1, along the carrier means of the shaft 4 of that tool 1, out through the proximal end of the opening 9, in through the proximal end of the opening 9 of the second tool 1, along the carrier means of the shaft of the second tool 1 to the distal end of that tool 1. A sufficient length of tape 5 is provided between the insertion tools 1 to allow each insertion tool 1 to be manipulated without hindrance.

Referring to Figure 5, the first insertion tool 1 is then inserted through an incision 10 in the anterior vaginal wall 14, past one side of the urethra 11, through the bodily tissue behind the pubic bone 12 and out through the lower abdominal wall 13. Once the tip 3 of the insertion tool 1 has exited through the abdominal wall 13, the tip 3 is removed from the tool 1 such that access can be gained to the protrusion 8. The protrusion releasably fixing the tape 5 within the carrier means of the shaft 4. The tape 5 is then removed from the protrusion 8 and secured outside the abdominal wall 13 using forceps or such like. The tool 1 is then removed from the incision 10, the tape 5 being released through the elongate opening 9 as the tool 1 is withdrawn.

The second tool 1 is then inserted through the same incision 10, past the other side of the urethra 11, through the bodily tissue behind the pubic bone 12 and out through a second exit point in the lower abdominal wall 13. The tip 3 of the second surgical tool 1 is then removed and the tape disengaged from the protrusion 8 and the tape 5 secured outside the abdominal wall 13. This tool 1 is then also removed through the incision 10 releasing the tape 5 as it is withdrawn.

When in use the surgical tape 5 exits via the lower abdominal wall the tape is adjusted to the required length and tension by adjusting the tape 5 from outside the lower abdominal wall 13 whilst securing the urethra 11 using a rigid catheter or such like. The ends of the tape 5 external the abdominal wall 13 are then cut such that they fall just short of protruding from the abdominal wall 13. The incision 10 and exit wounds in the abdominal wall 13 are then closed, e.g. by sutures.

In a second embodiment the insertion tool 18 may alternatively comprise an implant carrier means 44 and a retaining instrument 40 the implant carrier means 44 including a handle 2 at a proximal end 20 and an anchor mounting portion at a distal end 22, the retaining instrument comprising an elongate shaft 4 which has a semi-blunt point 46 at its distal end and handle 42 at a proximal end. Between the handle 2 and the distal end 22 of the carrier means extends a cavity 24 capable of containing the surgical implant 5 together with a retaining instrument 40.

The carrier means 44 is further provided with an elongate opening 9 on its surface which extends along the length of the carrier means 44. The opening 9 extends from the distal end 22 of the carrier means 44 to the handle 2 at the proximal end 20 of the insertion tool 18 and enabling access into the cavity 24.

The opening 9 is of angular width to allow insertion and removal of the surgical implant 5 from the insertion tool 18. The opening 9 is around 3/8 of the circumference of the carrier means of the insertion tool 18.

The retaining instrument 40 can be passed through the cavity 24 of the carrier means 44 of the insertion tool 18 such that the semi-blunt point 46 of the retaining instrument 40 extends from the distal end 22 of the carrier means 44 of the insertion tool 18. The shaft 4 of the retaining instrument is curved through an angle of approximately 30°. The retaining instrument further includes an abutment 48 and a narrowed portion 50 extending from the abutment 48 to the semi-blunt point 46.

A soft tissue anchor 30 comprising a plurality of projections 32 extending radially from a hollow central portion 34 is attached to the surgical implant. The soft tissue anchor 30 can be passed over the semi-blunt point 46 of the placement tool 40 such that the soft tissue anchor 30 is held in place by the abutment 48 of the retaining instrument 40. The narrowed portion 50 of the retaining instrument 40 extends through the hollow central portion 34 of the soft of the soft tissue anchor 30 such that the semi-blunt point 46 extends beyond the first end 36 of the soft tissue anchor 30.

The retaining instrument 40 is therefore located inside the cavity 24 of the carrier means 44 such that the semi-blunt point 46 of the retaining instrument extends beyond the anchor mounting portion or the distal end 22 of the insertion tool 18. The insertion tool 18 is thus provided with a semi-blunt point 46 to allow it to be pushed through tissues. Location of the anchor as described above on the semi-blunt point 46 of the retaining instrument 40 such that the anchor 30 rests on the abutment 42 of the shaft 4 enables placement of the anchor 30 in the body tissues of the paraurethral tunnel or rectus sheath. As the surgical implant 5 is contained within the carrier means 44 of the insertion tool 18 during placement of the implant 5, the implant 5 is -not exposed to the tissues of the paraurethral tunnel during insertion of the insertion tool 18.

The retaining instrument 40 may be formed from surgical steel allowing it to be sterilised and reused or from plastics material. Reuse of the retaining instrument or production of the retaining instrument from disposable plastics material enables the procedure to be performed more cheaply than using existing devices .

Further as the retaining instrument or the carrier means is not required to push through the lower abdominal wall the insertion tool 18 can be less substantial and thus patients will suffer less trauma. In addition the insertion tool 18 does not require the lower abdominal wall to be punctured to enable release of the tape from the tool. This is obviously of considerable advantage to the patient.

In use the retaining instrument 40 is introduced into the cavity 24 of the insertion tool 18 such that the semi-blunt point 46 of the retaining instrument 40 extends beyond the distal end 22 of the shaft 4 of the insertion tool 16. The soft tissue anchor 30 is placed over the semi-blunt point 46 of the retaining instrument 40 as described above. An incision 10 is made in the anterior wall 14 of the vagina and the first insertion tool containing the implant 5 and retaining instrument 40 is inserted through an incision 10 in the anterior of the vaginal wall 14 passed on one side of the urethra 11 through the bodily tissue behind pubic bone 12 and into the fascia of the rectus sheath 100. It is apparent to the surgeon when the rectus sheath 100 has been penetrated as this stage of insertion presents significant resistance. Once the semi-blunt point 46 of the retaining instrument 40 and the soft tissue anchor 30 have passed through the rectus sheath 100 the resistance diminishes and the surgeon ceases to insert the insertion 18 and retaining instrument 40.

The retaining instrument 40 is then retracted from the body by withdrawing the retaining instrument 40 from the proximal end 20 of the insertion tool 18. Due to the projections 32 on the central portion 34, the soft tissue anchor 30 is retained in the rectus sheath 100 as the retaining instrument 40 is withdrawn.

Once the soft tissue anchor is suitably placed through the fascia of the rectus sheath 100, the insertion tool 18 can be withdrawn. As the soft tissue anchor 30 is fixed in the body the surgical implant 5 to which the soft tissue anchor is attached is retained in the body.

The insertion tool 18 can then be removed from the incision 10 in the anterior of the vaginal wall 14, the tape held in position by the soft tissue anchor 30.

As the insertion tool 18 is withdrawn the tape is removed from the cavity 24 of the carrier means 44 by passing the tape through the elongate opening 9 in the carrier means 44.

The insertion tool 18 is then disengaged from the surgical implant 5 by passing the surgical implant 5 through the angular opening 9 of the carrier means 44 of the insertion tool 18.

A second insertion tool is then inserted through the same incision 10 passed the other side of the pubic bone 12 to engage a second soft tissue anchor in the rectus sheath 100 as discussed above. Further to the second soft tissue anchor being engaged, the second insertion tool can then be removed from the body by retracting it through the incision in the anterior vaginal wall 14. The second insertion tool can then be removed from the surgical implant as described above by passing the implant through the elongate opening 9 of the carrier means 44 of the insertion tool.

The insertion 10 in the vaginal wall can then be closed by sutures.

A further embodiment the insertion tool is shown in figure 9. Again this embodiment of the insertional tool comprises carrier means and a retaining instrument wherein the retaining instrument comprises a handle 2 at a proximal end 20, a semi- blunt point 46 at a distal end 22, a shaft 4 extending from the handle to the semi-blunt point.

As shown in figure 9, the surgical implant 5 is rolled around the shaft 4 of the insertion tool such that the longitudinal edges 60 of the implant 5 are brought together forming the implant 5 into a cylinder, the shaft 4 of the insertion tool passing through the space in the middle of the cylinder. The semi-blunt point 46 of the shaft 4 located through an aperture 62 of the implant 5 such that the semi-blunt point 46 extends beyond a first end 64 of the implant 5 and the handle 2 extends beyond a second end 66 of the implant 5.

In this further embodiment of the present invention carrier means surrounding the implant 5 during insertion of the shaft 4 are provided by a polyethene sleeve 70. The sleeve 70 comprises a cylinder of polythene adapted to slide over the implant 5 and shaft 4 when the implant is rolled around the shaft as described above and a perforated section 76 that extends along the length of the sleeve.

The sleeve 70 is passed over the implant 5 such that the rolled implant 3 passes through the centre of the sleeve 70 and becomes contained by the sleeve 70. The sleeve 70 thus both secures the implant in a rolled state and acts as a carrier means during insertion of the implant into the body.

' In use an incision 10 is made in the anterior wall 14 of the vagina and a first shaft 4 of a first insertional tool with the implant rolled around the shaft 4 and secured by the carrier means, a polythene sleeve 70, the carrier means is inserted through the incision 10 in the anterior of the vaginal wall 14, passed on one side of the urethra 11, behind the pubic bone through the bodily tissue of the retropubic space.

Once the first end 64 of the implant 5 has been suitably located in the retropubic space the polyethene sleeve 70 can be pulled in a direction opposite to the that in which the perforations 76 are located on the polyethene sleeve 70 and towards the handle 2 of the tool.

This movement causes the polyethene sleeve 70 to tear along the perforated section 76 releasing the surgical implant and allowing it to come into contact with the body tissues.

As the implant is resilient in shape or is comprised of materials which have memory, on release of the implant 5 from the carrier means 70 the implant adopts a flat position from its rolled state. This acts to secure the implant in the body. The first insertion tool can then be removed from the incision in the vaginal wall along with the polyethene sleeve 70 which surrounded the surgical implant .

A second insertion tool is then inserted through the same incision 10 passed the other side of the pubic bone 12 to engage a second end of the tape 5 in the retropubic space as discussed above. The polyethene sleeve 70 surrounding the surgical implant can be removed from the second end 66 of the implant once the implant is suitably located on the other side of the pubic bone 12 as discussed above. The second insertion tool can then be removed from the body by retracting it through the incision in the anterior vaginal wall.

The present invention described herein is advantageous over the needles described in the prior art to introduce surgical implants used in the treatment of female urinary incontinence as it does not require all of the insertion tool to follow the tape through the abdominal wall.

In the further examples provided the present invention allows placement of the implant without the need to penetrate the lower abdominal wall. This significantly reduces the patients trauma. In addition as these further examples do not require to be pushed through the abdominal wall the insertion tool can be less substantial in its dimensions. This again reduces patient trauma.

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Classifications
Classification internationaleA61B17/00, A61B17/04, A61F2/00
Classification coopérativeA61B17/0469, A61B2017/00805, A61B17/0482, A61B2017/0409, A61B17/06109, A61B17/0401
Classification européenneA61B17/04G, A61B17/04A, A61B17/06N12
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