US20060205995A1 - Apparatus and method for treating female urinary incontinence - Google Patents

Abstract

The present invention provides a surgical implant and method for supporting the urethra where the implant includes a suburethral support suspended between two soft tissue anchors. The surgical implant is introduced into at least one incision made on the upper wall of a vagina with the first soft tissue anchor inserted on a first side of the urethra behind the pubic bone, and the second soft tissue anchor inserted on a second side of the urethra behind the pubic bone, such that the suburethral support is suspended from the soft tissue anchors and supports the urethra. Each of the first and second soft tissue anchors are inserted in, and fix in, the soft tissue of the perineum without penetrating the obturator foramen.

Description

RELATED APPLICATIONS
• This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/510,488 filed Mar. 28, 2005, entitled “Apparatus And Method For Treating Female Urinary Incontinence,” and a continuation-in-part of co-pending U.S. patent application Ser. No. 11/199,061, filed Aug. 8, 2005, entitled “Apparatus And Method For Treating Female Urinary Incontinence,” which is a continuation of U.S. patent application Ser. No. 10/398,992, filed Apr. 11, 2003, entitled “Apparatus And Method For Treating Female Urinary Incontinence,” and which issued as U.S. Pat. No. 6,960,160 on Nov. 1, 2005, the entire contents of each of which are incorporated herein in their entireties.
FIELD OF THE INVENTION
• This invention relates to an apparatus and method for treating female urinary incontinence and, in particular, to a surgical implant having a sling that passes under the urethra in use and supports the urethra to alleviate incontinence, along with related apparatus and methods for inserting the surgical implant in the body.
BACKGROUND OF THE INVENTION
• 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 and Stamey type endoscopic procedures in which the sutures are placed so as to elevate the bladder neck.
• One known procedure positions a sling loosely under the urethra. 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).
• As is known, a sling is provided in the body using two large curved needles which are provided at each end of the sling, where the sling comprises a long mesh or tape. Each of the needles is carried on an insertion tool (which is basically a handle facilitating manipulation of the needles). The mesh or tape is usually made of knitted polypropylene (such as Prolene®). The mesh or tape is generally covered with a plastics sleeve or polythene envelope to aid smooth insertion, the mesh or tape having rough surfaces to aid retention in the body.
• 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 incision, 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 also from the mesh or tape such that only the tape and its plastics sleeve 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 plastics sleeve 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 maneuvering 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 tape is then cut such that it just falls short of protruding from the exit points in the lower abdominal wall. The exit points and the incision in the upper vaginal wall are then closed by sutures. The tape is held in position by virtue of friction between the tape's rough edges and the surrounding body tissue (such as the rectus sheath and the body tissue behind the pubic bone) and subsequent natural adhesion of the tape with the body tissue as it re-grows around the mesh material.
• Whilst highly effective in treating urinary incontinence, this procedure has a number of problems. One such problem is that the needles used for inserting the tape are comparatively large, with the needles having, for example, a diameter of around 5-6 mm and a length of around 200 mm. As well as causing concern for patients viewing such needles before or during the procedure (which is carried out under local anesthetic), this can also lead to a high vascular injury rate.
• Similarly, the requirement that the needles exit the lower abdominal wall is disadvantageous due to the trauma to the patient in this area and pain of such abdominal wounds. A further disadvantage is that the tape comprises a relatively large foreign body mass to be retained within the patient and this can lead to related inflammation, infection translocation, erosion, fistula and such like.
• Similarly, the nature of the large needles and tape, along with the tools required to insert these in the body, lead to the procedure having a relatively high cost.
• In another known procedure which may be used to correct urinary incontinence, as shown inFIGS. 24 and 25, an incision is made in the perineal skin over a patient'sfirst obturator foramen134 and anincision117 is made in the wall of the patient'svagina116, a surgical instrument is inserted through the cutaneous incision, over thefirst obturator foramen134 and passed through the obturator foramen (134) at a “safe” zone (138) close to the inferior pubic ramus (140), through the obturator muscle, and through the vaginal incision. A surgical implant is attached to the surgical instrument and the surgical instrument with the implant attached is retracted such that one end of the implant is pulled out of the body via the incision over the obturator foramen. A second incision is provided over the patient's second obturator foramen and the procedure repeated such that the implant is provided under theurethra118 with a first end of the implant extending out of the first incision made over the first obturator foramen and a second end of the implant extending out of the second incision made over the second obturator foramen.
• The requirement that the needles exit the body over the obturator foramen is disadvantageous due to the trauma to the patient in this area and pain of such wounds. A further disadvantage is that the implant comprises a relatively large foreign body mass to be retained within the patient and this can lead to related inflammation, infection translocation, erosion, fistula and such like. Furthermore, anatomical damage to nerves and blood vessels may occur during procedures which penetrate the obturator foramen.
SUMMARY OF THE INVENTION
• According to one aspect of the present invention there is provided a surgical implant for supporting the urethra, the implant comprising: a suburethral support suspended between at least two soft tissue anchors attached at either side of the suburethral support, each soft tissue anchor having retaining means for retaining each anchor in tissue and suspending means for suspending each side of the suburethral support from a soft tissue anchor such that the suburethral support passes under the urethra in use.
• In one embodiment, a method of supporting a urethra comprises the steps of: introducing a surgical implant comprising first and second soft tissue anchors and a suburethral support portion therebetween into at least one incision made on the upper wall of a vagina; inserting the first soft tissue anchor on a first side of the urethra behind the pubic bone, and inserting the second soft tissue anchor on a second side of the urethra behind the pubic bone, such that the suburethral support is suspended from the soft tissue anchor and supports the urethra. Each of the first and second soft tissue anchors are inserted in and fix in the soft tissue of the perineum without penetrating the obturator foramen.
• In another embodiment, a method of supporting a urethra comprises the steps of: introducing a surgical implant into at least one incision made on the upper wall of a vagina the surgical implant comprising first and second ends and a suburethral support section therebetween; inserting a first end of the surgical implant on a first side of the urethra and positioning the first end into soft tissue of the perineum without penetrating the obturator foramen; and inserting a second end of the surgical implant on a second side of the urethra and positioning the second end into the soft tissue of the perineum without penetrating the obturator foramen such that the suburethral support section is positioned under the urethra and provides support thereto.
• In another embodiment, a method of supporting a urethra comprises: mechanically coupling, with a surgical implant, a first soft tissue portion of a perineum on a first side of the urethra to a second soft tissue portion of the perineum on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portion, and orientating a portion of the surgical implant underneath the urethra to provide support thereto, wherein the obturator foramen is not penetrated.
• In an embodiment of the surgical implant of the present invention the soft tissue anchor is capable of anchoring in the soft tissue of the perineum.
• Preferably the soft tissue anchors comprise soft tissue anchors capable of anchoring in tissue of the retropubic space and/or tissue of the perineum at multiple points via a Christmas tree type configuration of deflectable wings.
• A soft tissue anchor according to these embodiments comprises a central portion and the retaining means includes a plurality of projections the projections extending radially from the central portion along a substantial portion of the length of the central portion allowing fixation at a plurality of layers.
• Preferably the projections extend radially from the central portion at an angle inclined toward the second end of the central portion.
• Preferably the projections are of a shape that they are able to provide additive traction to the soft tissue anchor and allow it to grip fibro-fatty soft tissue and blood vessels of the para-uretheral tunnel below the level of the rectus sheath and/or the soft tissue of the perineum.
• In a preferred embodiment of the surgical implant the retaining means are moveable from an inserting position to a retaining position.
• It is preferable if at least one of the retaining means of the implant is moveable from a collapsed position to an extended position as it enables the retaining means to actively move into tissue in at least one layer of the tissue following suitable location of the implant. The movement of the retaining means from a collapsed position to an extended position allows the means to move into and be retained in tissue which has been undisturbed or which has not been disrupted during placement of the implant. The collapsed position of the implant can be achieved by rolling up, folding, bending, or enclosing the implant in a restrained position.
• It is more preferable if the retaining means can be moved from a collapsed position to an extended position at two or more layers in the tissue as this provides for gripping of the tissue by the implant at multiple sites which may require increased force to be used to dislodge the soft tissue anchors of the implant from the anchored positions in the fibro-fatty soft tissue of the retropubic space or from the soft tissue of the perineum.
• Suitably the retaining means may be at least one projection which can project from the implant into the tissues of the retropubic space or the soft tissue of the perineum in at least one plane the projection being moveable from a collapsed position to an extended position.
• In particular embodiments of the implant the retaining means comprise a plurality of projections extending laterally from the longitudinal axis of the implant.
• Suitably the projections may extend from the longitudinal axis of the implant such that they point away from the bladder when the implant is positioned such that the suburethral support passes under the urethra.
• In particular embodiments of the implant the projections may be curved such that they point away from bladder when the implant is positioned such that the suburethral support passes under the urethra.
• In particular embodiments of the implant, the implant may be curved such that the longitudinal edges of the soft tissue anchors of the implant and thus the retaining means in use are directed away from the bladder.
• In embodiments of the surgical implant wherein the retaining means are mechanical in nature in an inserting position the mechanical means are collapsed and in a retaining position the mechanical retaining means are in an extended position.
• In embodiments of the surgical implant wherein the retaining means are chemical in nature, for example glue, in an inserting position the glue is in a state which minimizes its adhesion to the surrounding tissue and in a retaining position the glue is in a state which allows the glue to adhere to the surrounding fibro-fatty tissue in the retropubic space or in the soft tissue of the perineum. Thus in moving from an inserting position to a retaining position the presentation or the nature of the glue is changed to cause the glue to adhere the implant to the surrounding tissue.
• The glue may be encapsulated (inserting position) within a capsule such that the glue cannot interact with the tissue during placement of the implant. When the implant is suitably located, the capsule of glue may be burst (retaining position) to release the glue and allow the implant to be fixed to the surrounding tissue.
• In particular embodiments the glue is held in a releasable container. The glue containing releasable container may prevent the glue interacting with surrounding tissues until an appropriate point in the surgical procedure. At this point the surgeon may use means, for example a point on the introducing tool to release the glue from the container, for example by puncturing the container and enabling the glue to adhere the implant to the surrounding tissue.
• Alternatively in particular embodiments of the implant the glue may be activated by some means, for example heat, light, cold or ultrasound. The implant may be moved into the fibro-fatty tissue of the retropubic space or the soft tissue of the perineum without the glue adhering the implant to the surrounding tissue (inserting position) then following the activation of the glue or change in state of the glue by some means, not limited to heat, light, cold or ultrasound, the glue will adhere the implant to the surrounding tissues (retaining position).
• It is preferable if the implant has minimal mass to reduce the likelihood of inflammation or rejection of the implant when it is located in the body. Further, it is preferable that the implant comprises as little material as allows support of the urethra during periods of increased intra-abdominal pressure to minimize the abrasion or the urethra and the likelihood of adhesions forming at the urethra.
• In addition, it is advantageous if the tissue anchors and the suburethral support are integral with each other as it allows easier manufacture of the implant. As the distance from the supporting region under the urethra to the fixing points in the fibro-fatty tissue of the retropubic space and/or in the soft tissue of perineum are relatively short in comparison to the distances between the suburethral support and the fixing points described in the implants of the prior art, the overall size of the implant of the present invention can be reduced.
• The production of an implant from a portion of tape material is advantageous as it allows easier manufacture than implants comprising multiple portions comprising of different materials which have to be fixed together. This design minimizes the risk of failure of the implant due to the simplicity of the implant and provides for easier packaging and sterilization of the implant.
• The soft tissue anchors of the implant must be anchored in the tissues of the retropubic space or the tissue of the perineum with adequate tensile strength to counter dislodging by coughing until suitable integration of tissue occurs with the implant.
• At least two forces are exerted on the surgical implant portion which extends under the urethra. A first force is the force exerted by the urethra during increased intra-abdominal pressure. The surgical implant has to be secured in the fibro-fatty tissue of the retropubic space or the soft tissue of the perineum such that it is capable of supporting the urethra and occluding the urethra at periods of increased intra-abdominal pressure, to minimize incontinence.
• A second force is the force exerted on the surgical implant during periods of increased intra-abdominal pressure which acts in a direction opposite to the direction in which the anchors are inserted into the retropubic space or the soft tissue of the perineum. This force can be considered to be a force of dislodgement.
• Suitably the implant is anchored in the fibro-fatty tissues of the retropubic space and/or the soft tissue of the perineum such that the implant can resist forces of dislodgement created during periods of increased intra-abdominal pressure.
• Coughing and other causes of increased abdominal pressure typically cause increased pressures of around 200-400 cm water. This has been determined by the Applicant to be equivalent to around a force of 3.75 N through each tape arm.
• Suitably the implant is anchored in the fibro-fatty tissues of the retropubic space or soft tissue of the perineum such that the implant can resist forces of dislodgement created during periods of increased intra-abdominal pressure of up to 3 N.
• In particular embodiments, the implant may be anchored in the fibro-fatty tissues of the retropubic space or soft tissue of the perineum such that the implant can resist forces of dislodgement of up to 5 N.
• In further embodiments the implant may be anchored in the fibro-fatty tissues of the retropubic space or soft tissue of the perineum such that it can resist forces of dislodgement of up to 10 N.
• In embodiments of the implant a soft tissue anchor may comprise a plurality of retaining means.
• In embodiments of the implant a soft tissue anchor may be tapered.
• Curvature of the longitudinal edges of the soft tissue anchor such that they are directed away from the bladder minimizes medial presentation of the retaining means such as projections to the bladder minimizing erosion of the bladder.
• In a particular embodiment of the implant a soft tissue anchor may be shaped as a serrated arrowhead wherein the base portion of the arrowhead is conjoined to the suburethral support.
• The serrated arrowhead may be provided by cutting a flat tape such that the serration's of the arrowhead exist in two dimensions only.
• Suitably the soft tissue anchor may have a pointed end at a first end, a base portion at a second end, wherein the longitudinal edges extend between the pointed end and the base and the longitudinal edges are notched to provide a row of projections extending outward from the longitudinal edges.
• In other words the anchor may have a pointed tip at a first end and a base portion at a second end, the first end being the end of the anchor furthest from the suburethral support and the base portion being conjoined to the suburethral support. The longitudinal edges of the anchor extend from the pointed tip to the base wherein the longitudinal edges are notched to from a row of tooth like projections extending from the longitudinal edge.
• In yet a further embodiment the soft tissue anchor may comprise a substantially flat head the bottom surface nearest the suspending means of the flat head providing the retaining means which, in use is held in the rectus sheath.
• In a further embodiment the soft tissue anchor may comprise a sharp point allowing it to pierce or penetrate the rectus sheath, and retaining means comprising a surface or protrusion directed rearwardly with respect to the sharp point which does not cause the soft tissue to part and thus prevents the soft tissue anchor from being pulled back out through the rectus sheath soft tissue in the direction opposite to that in which it is inserted into the soft tissue.
• Preferably the sharp point is provided by the apex of a conical head portion and retaining means are provided by a substantially flat base of the conical head.
• Suitably a soft tissue anchor as described herein for anchoring into the fibro-fatty tissues of the retropubic space may be used to anchor in the soft tissue of the perineum.
• In any embodiment the soft tissue anchor may be comprised of plastics material.
• Typically the soft tissue anchor may be comprised of polypropylene.
• Alternatively the soft tissue anchor is comprised of absorbable material so as to form temporary fixation in soft tissue.
• The soft tissue anchor may comprise a point formed of absorbable material including polyglactin, the sharp point thus capable of facilitating insertion of the anchor, yet being absorbed by the body later.
• Preferably the soft tissue anchor may be integral with the suspending means.
• More preferably the soft tissue anchor is integrally formed from polypropylene or other polymeric material the attachment between the anchor and the suspending means being formed as a single unit.
• An integral construction of the soft tissue anchor and suspending means has the advantage of simplifying the construction of the soft tissue anchor and suspending means, which can reduce the possibility of defective manufacture etc. and reduce costs and the chance of the soft tissue anchor and suspending means becoming detached once implanted in the body.
• Alternatively the soft tissue anchor is attached to the suspending means by a thin metal tube crimped or otherwise attached around the suspending means and central portion of the soft tissue anchor.
• The suburethral support of the first aspect of the invention passes under the urethra, loosely supporting the urethra, the suburethral support being held in position by suspending means attached to each of its free ends on either side of the urethra, the suspending means being attached at the opposite end to at least one soft tissue anchor.
• Preferably the suburethral support is comprised of flat polymer tape.
• Preferably the suburethral support has dimensions sufficient only to pass around the urethra.
• More preferably the suburethral support has dimensions of length 15-35 mm, width 5-15 mm and thickness 50-350 mm.
• In one embodiment the suburethral support has dimensions oflength 25 mm,width 10 mm and thickness 100 mm.
• Preferably the suburethral support has at least two junctions to attach the suburethral support to the suspending means.
• Preferably the distance between the soft tissue anchor(s) and the suburethral support is adjustable.
• The surgical implant is preferably of a length in the range 12 cm to 16 cm.
• More preferably the soft tissue anchor (or anchors) can be positioned first and the suburethral support then positioned by adjusting the length of the suspending means.
• Preferably the suburethral support is provided with at least one attachment tab to which suspending means are releasably or permanently attached.
• In particular embodiments of the surgical implant the suburethral support is provided by a mesh. Advantageously when the suburethral support is provided by a mesh, the mesh is resilient to such an extent that it mimics the physiological elasticity of the tissues which would normally support the urethra.
• In embodiments of the implant wherein the suburethral support is formed from mesh the strands of the mesh may be spaced apart to form spaces of 1 to 10 mm. Suitably the strands may have a diameter of less than 600 mm. Suitably the strands of the mesh may be arranged to form a warp knit diamond or hexagonal net mesh.
• In particular embodiments of the implant the suburethral support may be formed from polyester or polypropylene. Alternatively, the suburethral support may be formed from absorbable material or may be encapsulated by an absorbable coating. In particular embodiments, such a coating may be applied to only one side of the implant.
• In further embodiments the suburethral support may be formed from biocomponent microfibres comprising a core and surface material. For example, the surface material may be readily absorbable by the body while the core material may remain in the body for a longer period of time. Suitably the surface material may be polylactic acid and the core material may be polypropylene.
• The suburethral support of the implant may be absorbable at a different rate than the soft tissue anchors of the implant, for example the soft tissue anchors may be absorbed within six weeks of implantation, while the soft tissue anchors may remain for 9 months.
• Preferably the suburethral support comprises an attachment tab comprising a tunneled element and an aperture, the tunneled element being located at each of the free ends of the suburethral support on either side of the urethra at a position that the suspending means are capable of being introduced through, the tunneled element co-operating with the aperture such that suspending means can be passed through the tunneled element and then through the aperture, the aperture being present on the opposite surface of the suburethral support to that which contacts the urethra the aperture having an edge capable of co-operating with a ring element and the ring element being capable of being fitted around the aperture trapping the suspending means between the ring element and the edge of the aperture such that the suspending means remain fixed in an adjusted position wherein the suburethral support hangs loosely under the urethra.
• Alternatively the attachment tab comprises at least one slot through which suspending means can be passed, the suspending means being permanently attached to the slot by tying.
• Alternatively the attachment tab comprises jamming slots that the suspending means can be permanently attached by being threaded through the jamming slots such that the suspending means are held in an adjusted position.
• Alternatively the suburethral support is capable of being suitably positioned under the urethra by altering the position of the soft tissue anchors within the body such that at least one soft tissue anchor is secured in the soft tissue or in the rectus sheath and a subsequent anchor is inserted into the soft tissue or rectus sheath to a suitable depth such that the suburethral support hangs loosely under the urethra.
• Alternatively the suspending means may be attached to the suburethral support by heating such that the suburethral support and/or suspending means melt and form a join.
• Alternatively the attachment tabs may have closure means for gripping the suspending means.
• The suspending means may be any means suitable for connecting each end of the suburethral support to the soft tissue anchor (or respective soft tissue anchors).
• Preferably the suspending means comprises a plastics strip.
• Preferably the plastics strip has smooth edges.
• Preferably the plastics strip comprises material such as polypropylene or other suitable non-absorbable or absorbable polymer tape.
• Preferably the plastics strip is 3-5 mm in width.
• Preferably the plastics material comprises pores which extend through the plastics material from a first surface of the plastics material to a second opposite surface of the plastics material said pores ranging in width across the surface of the plastics material from 50 mm to 200 mm, the pores allowing tissue in-growth to secure the strip in the body.
• Alternatively the plastics material may comprise pits, that indent but do not extend through the plastics material, on at least one of the surfaces of the plastics material, the pits ranging in width from 50 mm to 200 mm, the pits allowing tissue in-growth to secure the strip in the body.
• Preferably the plastics material comprises pits or pores ranging in width across the surface of the plastics material from 100 mm to 150 mm.
• Preferably the pits or pores are distributed across the complete surface of the plastics material.
• Alternatively the pits or pores are distributed only in a particular portion of the surface of the plastics material.
• Preferably the pits or pores are created by post synthesis modification of the plastics material.
• More preferably the pits or pores are created by post synthesis treatment of the plastics material by a laser.
• Alternatively the pits or pores of between 50-200 mm are created during synthesis of the plastics material by spaces between the waft and weave of mono-filament or multi-filament yarns when the filaments are woven to form a mesh.
• Alternatively pits or pores formed during the synthesis of plastics material are formed by the inter-filament spaces created when mono-filaments are twisted to create multi-filaments, the multi-filaments then being woven to form a mesh.
• In an embodiment the suspending means is provided with a plurality of microgrooves of width between 0.5-7 μm and of depth 0.25-7 μm on at least one surface of the plastics strip.
• Preferably the microgrooves are 5 μm in width and 5 μm in depth.
• Preferably the plurality of microgrooves are aligned such that they are substantially parallel with each other.
• Preferably the plurality of microgrooves are aligned such that they are separated by ridges which range in size between 1-5 μm in width.
• More preferably the microgrooves are separated by ridges of 5 μm in width.
• Preferably the ridges are formed by square pillars and the base of the microgroove is substantially perpendicular to the square pillars.
• Alternatively the ridges are formed by square pillars and the base of the microgroove is beveled in relation to the pillars.
• Preferably the microgrooves are present on at least one surface of the suspending means.
• More preferably the microgrooves are present on a plurality of surfaces of the suspending means.
• These microgrooves act to orientate and align the proliferating fibroblasts on the surface of the plastics material and cause axial alignment of collagen fibres and formation of at least one strong ordered neoligament.
• The orientation and alignment of the proliferating cells is capable of adding mechanical strength to the tissue which forms around the plastics material such that it is more able to support the urethra.
• Preferably the suburethral support of the present invention has neither pores, pits or grooves to discourage the formation of peri-urethral adhesions.
• Suitably the implant may be comprised of non-absorbable material. Alternatively the implant may be comprised of absorbable material. In particular embodiments of the implant, the implant is comprised of polypropylene.
• Preferably the implant is comprised of resilient material such that if the implant is not restrained it adopts the original shape defined during production of the implant.
• It would be advantageous if the implant was capable of longitudinal extension such that it still provides suitable support to the urethra during periods of increased abdominal pressure, but is able to move and extend in a similar fashion to tissues which physiologically support the urethra.
• In suitable embodiments of the implant, there may be provided a resilient zone wherein the resilient zone provides for the resilient extension of the surgical implant in a longitudinal direction such that the surgical implant behaves in a similar manner to dynamic bodily tissue.
• In particular embodiments of the implant the resilient zone is located in at least one of the anchors of the implant.
• Alternatively the resilient zone is interposed between an anchor and the suburethral support.
• The resilient zone of the implant may be capable of allowing the resilient extension of at least part of the implant due to its geometric design.
• Alternatively the resilient zone of the implant may be capable of allowing resilient extension of at least part of the implant due to its micro material design.
• In particular embodiments of the implant, the resilient zone of the implant may be capable of allowing the resilient extension of the implant due to a combination of its geometric and micro material design.
• The geometric design may include multiple strips of material.
• In particular embodiments the geometric design may include multiple strips of material arranged into bows, the bows being capable of deforming and providing resilient extension to the implant.
• Alternatively the geometric design may comprise a concertina portion such that a part of the implant can extend in a direction substantially perpendicular to the folds of the concertina.
• In other words the implant may comprise a folded portion, the fold perpendicular to the longitudinal axis of the implant, which allows limited extension of the implant in a longitudinal direction. In an extended position a folded portion is moved away from a second folded position. In a closed portion the folded portions are brought together. Different amounts of force in a longitudinal direction may be required to move the concertina portion from a closed to an open position.
• Suitably resilient extension of a portion of the implant may occur when an extension force of 1 to 5 N is applied to the implant along its length.
• Resilient extension of a portion of the implant may occur when an extension force of 2 to 3 N is applied to the implant along its length.
• The resilient zone may provide for the extension of the implant along its longitudinal length of around 2 to 5 mm.
• In embodiments of the surgical implant the unextended implant may be of length 6 to 22 cm.
• More preferably the unextended implant is of length 8 to 20 cm.
• Most preferably the surgical implant is ofunextended length 10 to 15 cm.
• It will be understood that in embodiments of the implant which do not include a resilient zone, the unextended length is equal to the length of the implant.
• In particular embodiments of the implant each soft tissue anchor is of at least 1 cm in length and not greater than 8 cm in length.
• Suitably each anchor may be 5 cm in length.
• Suitably the suburethral support may be of at least 2 cm in length.
• According to a second aspect of the present invention there is provided a method of supporting the urethra comprising the steps of, introducing a surgical implant as described above into an incision made on the upper wall of the vagina, inserting a soft tissue anchor on a first side of the urethra behind the pubic bone, inserting a second soft tissue anchor on a second side of the urethra behind the pubic bone, such that the suburethral support is suspended from the soft tissue anchor and supports the urethra.
• The invention also provides the use of the method of supporting the urethra in treating urinary incontinence or uterovaginal prolapse.
• In one embodiment of the method the soft tissue anchors are inserted in the rectus sheath.
• In an alternative embodiment of the method the soft tissue anchors are inserted in the fibro-fatty soft tissue of the retropubic tissue space and do not penetrate the rectus sheath.
• In an alternative embodiment of the method the soft tissue anchors are inserted in and fix in the soft tissue of the perineum.
• As indicated above, the above methods have the advantage that only a single vaginal incision is required for introduction of the surgical implant and the need for exit of the surgical implant and thus exit wounds is removed, for example exit wounds in the abdomen or at the obturator foramen are not required.
• In particular embodiments of the method wherein the soft tissue anchors are inserted in and fix in the soft tissue of the perineum, the surgical implant does not penetrate the endopelvic fascia.
• In none of the embodiments of the method does the surgical implant penetrate of extend through the obturator foramen.
• Suitably in one embodiment of the method wherein the soft tissue anchors are inserted and fix in the soft tissue of the perineum there is provided a method of supporting the urethra comprising the steps of: introducing a surgical implant comprising first and second soft tissue anchors and a suburethral support therebetween into at least one incision made on the upper wall of the vagina, inserting a first soft tissue anchor on a first side of the urethra in a lateral direction away from the urethra, inserting a second soft tissue anchor on a second side of the urethra in an opposite lateral direction from the first soft tissue anchor and away from the urethra, such that the suburethral support is suspended from the first and second soft tissue anchors and supports the urethra, wherein each of the first and second soft tissue anchors is positioned in the soft tissue which comprise the perineum.
• In another embodiment a method of supporting the urethra comprises the steps of: introducing a surgical implant into at least one incision made on the upper wall of the vagina the surgical implant comprising first and second ends and a suburethral support section therebetween; inserting a first end of the surgical implant on a first side of the urethra and positioning the first end into the soft tissue of the perineum without penetrating the obturator foramen; inserting a second end of the surgical implant on a second side of the urethra and positioning the second end into the soft tissue of the perineum without penetrating the obturator foramen such that the suburethral support section is positioned under the urethra and provides support thereto.
• In a further embodiment the method of supporting a urethra, comprises the steps of: introducing a first end of a surgical implant into at least one incision made in a vaginal wall, the surgical implant comprising first and second ends and a suburethral portion there between; inserting the first end of the surgical implant on a first side of the urethra and positioning the first end into tissue of a perineum without penetrating the endopelvic fascia; introducing the second end of a surgical implant into the at least one incision made in a vaginal wall; inserting a second end of the surgical implant on a second side of the urethra and positioning the second end into tissue of the perineum without penetrating the endopelvic fascia such that the suburethral support portion is positioned underneath the urethra and provides support thereto.
• Suitably a portion of the surgical implant grips at least one of first and second soft tissue portions of the perineum.
• Suitably location of a first soft tissue anchor on a first side of the urethra in a first tissue of a perineum and a second soft tissue on a second side of the urethra in a second tissue of the perineum, wherein the urethra is positioned between said first and second soft tissue portions and the surgical implant is positioned underneath the urethra to provide support thereto, mechanically couples a first tissue of the perineum to the second tissue of the perineum.
• In this method no part of the surgical implant penetrates the obturator foramen. In particular, no part of the surgical implant extends through the obturator foramen.
• The soft tissue anchor(s) or ends do not penetrate or fix into bone.
• In one embodiment of the method of anchoring the soft tissue anchors in the soft tissue of the perineum, a soft tissue anchor of an implant is inserted through an incision in an upper wall of a vagina and inserted towards a first obturator foramen behind an inferior pubic ramus until about half of the length of the implant is inserted. The soft tissue anchor of the implant is thus placed such that the soft tissue anchor is located in the soft tissue of the perineum. A second soft tissue anchor may then be inserted into the vaginal incision and inserted towards a second obturator foramen behind an inferior pubic ramus until the second half of the implant is inserted. The second soft tissue anchor of the implant is thus placed such that the soft tissue anchor is located in the soft tissue of the perineum.
• In an embodiment of the method a first end of a surgical implant may be inserted through an incision in an upper wall of a vagina and inserted towards a first obturator foramen behind an inferior pubic ramus such that around 7 cm of the implant is inserted. A second end of a surgical implant may then be inserted through an incision in an upper wall of a vagina and inserted towards a second obturator foramen behind an inferior pubic ramus such that around 7 cm of the implant is inserted.
• The locating of a soft tissue anchor in the soft tissue of the perineum may be advantageous as it is less likely that the bladder may be perforated than in retropubic methods where the needle passage is medial and therefore near to the bladder.
• Typically the suburethral support is placed midurethra, without tension, but in a position to support the urethra. However, as will be understood by those skilled in the art, the suburethral support may be positioned at an alternative suitable anatomical location such as to be therapeutically effective should for example the midurethra be damaged or have significant scar tissue.
• In an embodiment of the method, the soft tissue anchors do not penetrate the obturator muscle.
BRIEF DESCRIPTION OF THE DRAWINGS
• The above and further advantages of the invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which:
• FIG. 1 is an illustration of a surgical implant for anchoring in the rectus sheath,
• FIGS. 2aand2bare line drawings of the suspending means attached to the suburethral support, positioned underneath the urethra,
• FIG. 3 is an illustration of one embodiment of a suburethral support,
• FIG. 4 is an illustration of a second embodiment of a suburethral support,
• FIG. 5 shows suspending means being threaded through an attachment tab of a suburethral support,
• FIGS. 6A, B and C show alternative methods of attaching suspending means to a suburethral support,
• FIGS. 7A, 7B and7C are illustrations of a soft tissue anchor for insertion through the rectus sheath,
• FIGS.8A-C are sequential illustrations of insertion of a soft tissue anchor ofFIG. 7,
• FIG. 9 is an illustration of a soft tissue anchor mounted on an introducing tool for insertion through the rectus sheath,
• FIG. 10 is an illustration of a retropubic soft tissue anchor for use in the fibro-fatty tissues of the para-urethral tunnel,
• FIG. 11 is an illustration of the placement of a soft tissue anchor ofFIG. 10,
• FIG. 12 is an illustration of an implanting tool and a soft tissue anchor inserted into the rectus sheath,
• FIG. 13 is an illustration of the surgical implant implanted into the rectus sheath,
• FIG. 14 is an illustration of the prior art contrasted with the technique wherein the anchor is inserted in the rectus sheath,
• FIG. 15 is an illustration of the tool used to insert the surgical implant,
• FIG. 16 is an illustration of the surface architecture of the suspending means,
• FIG. 17 illustrates a diagrammatic side view of an embodiment of an implant with portions of glue provided on the soft tissue anchors,
• FIG. 18(a) illustrates an embodiment of an implant comprising a suburethral support formed from mesh,
• FIG. 18(b) is a further illustration of the embodiment of the implant ofFIG. 18(a),
• FIG. 19 is an embodiment of an implant comprising resilient zones,
• FIG. 20 illustrates a diagrammatic view of an implant wherein the soft tissue anchors are provided with grooves and pores and portions of glue,
• FIG. 21 is a diagrammatic representation of the anatomy of the pelvic region illustrating the obturator foramen, inferior pubic ramus, pubic symphysis and the safe transorbturator exit zone as used in prior art methods,
• FIG. 22 is a cross-section illustration ofFIG. 26 that illustrates insertion of an embodiment of a surgical implant wherein the soft tissue anchors are fixed in the soft tissue of the perineum,
• FIG. 23 is a cross-section illustration ofFIG. 26 that illustrates an embodiment of a surgical implant wherein the soft tissue anchors are fixed in the soft tissue of the perineum,
• FIG. 24 illustrates a prior art device anchored in the skin above the obturator foramen,
• FIG. 25 illustrates a prior art device anchored in the skin above the obturator foramen,
• FIG. 26 illustrates placement of an embodiment of a surgical implant in the soft tissue of the perineum without insertion into the obturator foramen wherein the implant is in the body,
• FIG. 27 illustrates placement of an embodiment of a surgical implant in the soft tissue of the perineum without insertion through the obturator foramen,
• FIG. 28 illustrates an embodiment of a surgical implant comprising a marker on the suburethral support and soft tissue anchors comprising projections and glue, and
• FIG. 29 illustrates a further embodiment of a surgical implant comprising a marker on the suburethral support.
DETAILED DESCRIPTION
• Referring toFIG. 1, a surgical implant for treating female urinary incontinence has asuburethral support10, suspendingmeans20 and at least two soft tissue anchors30, thesuburethral support10 being positioned in use, loosely under the urethra. The suburethral support has a length L of around 25 mm and a width W of around 10 mm such that it passes around the urethra with a minimum of excess material, although other similar dimensions would also be suitable. In this example, thesuburethral support10 is made from flat polymer tape. At each side11,13 of thesuburethral support10 suspendingmeans20 are provided which attach to thesuburethral support10 at afirst end22,24.
• The suspending means20 are attached at asecond end26 to a respectivesoft tissue anchor30.
• As shown inFIGS. 7a-7C, thesoft tissue anchor30 of the embodiment described comprises acentral portion32 and fourwinged sections34 which are attached to the central portion at afirst end38 by resilient hinge means36 and radially extend from thecentral portion32 such that when viewed from the front the anchor device resembles a cross.
• As shown inFIG. 8A thewing sections34 of thesoft tissue anchor30 having a resting position in which they are inclined towards the rear40 of thecentral portion32 at an angle of around 45°. InFIG. 8B during penetration of the anchor through tissue (thepoint60 of the introducing tool enabling the soft tissue anchor to be pushed through the tissue and rectus sheath120) thewing sections34 of thesoft tissue element30 may adopt a deflected position which means the penetration of the soft tissue anchor through the tissue andrectus sheath120 is more effective.
• As shown inFIG. 8C once therectus sheath120 has been pierced the resilient hinge means36 cause thewing sections34 to return to their resting position.
• Movement of the soft tissue anchor in a direction opposite to which it was introduced into the soft tissue causes the wing section to be deflected until an endstop46 is reached which prevents thewing sections34 moving beyond a point substantially perpendicular to thecentral portion32 and prevents retraction of thesoft tissue anchor30 from the soft tissue.
• Thesoft tissue anchor30 further comprises ahollow portion48 which extends from thefirst end38 to the secondrear end40 of thecentral portion32 through which an introducingtool50 may be placed, as shown inFIGS. 8A-8C.
• The introducingtool50 extends through thehollow portion48 such that it extends as asharp point60 from thefirst end38 of thesoft tissue anchor30 such that thesharp point60 allows penetration of the tissue by thesoft tissue anchor30.
• Stud likeprojections42 which extend radially from thecentral portion32 are angled such that they extend further radially from thecentral portion32 as they extend towards the rear40 of thecentral portion32, this inclination allowing thesoft tissue anchor30 to pass more easily into the soft tissue.
• A recessedportion44 is positioned toward therear end40 of thecentral portion32 to facilitate attachment of the suspending means20 to thesoft tissue anchor30.
• The suspending means30 may be respectively attached to thesoft tissue anchor30 at this recessedpoint44 by crimping a tube around the suspending means20 to fix the suspending means20 to thesoft tissue anchor30.
• In the embodiment shown the soft tissue anchor may be suitably positioned in therectus sheath120 using an introducingtool50. As shown inFIG. 15 thetool50 comprises ahandle52 andelongate body54. Theelongate body54 is curved through an angle of approximately 30° to facilitate positioning of thesoft tissue anchor30 in the rectus sheath or surrounding soft tissue of the human body from an incision in the upper wall of the vagina (as described below). Thesoft tissue anchor30 is located on the elongate body at a narrowedportion58 of the introducing tool such that the soft tissue anchor is held in place by anabutment56 such that the narrowedportion58 may extend through thehollow portion48 of thesoft tissue anchor30 such that thepoint60 of theinsertion tool50 protrudes from thefirst end38 of the soft tissue anchor and allows the soft tissue anchor to be inserted into the human body through the soft tissues and more specifically through therectus sheath120 during the placement of the soft tissue anchor.
• The placement of thesoft tissue anchor30 on theinsertion tool50 is shown inFIGS. 8B and 8C, which shows thesoft tissue anchor30 being pushed through soft tissue fascia, such as therectus sheath120. Once the soft tissue anchor has penetrated therectus sheath fascia120, as shown inFIG. 8B, the introducingtool50 can be withdrawn, as shown inFIG. 8C, leaving thesoft tissue anchor30 in place.
• As shown inFIG. 10 the soft tissue anchor may alternatively be comprised of acentral portion70 and a plurality ofprojections72 the projections extending radially from thecentral portion70 and arranged along a substantial portion of the length of thecentral portion70. Theprojections72 may be of any shape such that they provide resistance within the fibro-fatty soft tissue and blood tissues of the para-urethral tunnel in the direction opposite to that in which the soft tissue anchor is introduced.
• This resistance is also provided by the multiple layers, typically between 5-10 layers ofprojections72 which extend from thecentral portion70.
• Using these multiple layers ofprojections72 it is not necessary to insert the soft tissue anchor through therectus sheath120. Instead the soft tissue anchor should be positioned as high in the retropubic space as possible in the fibro-fatty soft tissue.
• In embodiments of the anchors suitable for anchoring in the soft tissue of the perineum, the soft tissue anchors may be provided with projections which allow penetration of the soft tissue of the perineum and which provide resistance to removal of the anchors from the soft tissue of the perineum.
• In the embodiment of the method wherein the anchors are anchored in the soft tissues of the perineum, an embodiment of an anchor comprises multiple layers ofprojections72. The multiple layers of projections enable the anchors to be fixed in the soft tissue of the perineum with suitable fixation without requiring the extending through the obturator foramen.
• In the embodiment of the soft tissue anchor comprising multiple layers ofprojections72 which resembles a Christmas tree, as shown inFIG. 10, the introducing tool comprises a collar which releasably retains the projections during insertion into the retropubic space. The collar may comprise a semi-sharp beveled needle. Following insertion of the Christmas tree like anchor into the fibro-fatty soft tissue of the retropubic space the introducing tool is withdrawn removing the collar from around the plurality ofprojections72 of the soft tissue anchor, which due to their memory expand outwards from thecentral portion70 and grip the fibro-fatty soft tissue of the retropubic space at multiple layers. The collar of the introducing tool which extends around the soft tissue may contain a cross-sectional opening such that once the tool is withdrawn the collar may be removed from the surgical implant by passing the implant through the cross-sectional opening.
• Accordingly the invention also provides an introducing tool for use in inserting the soft tissue anchor.
• Suspending means20 attached to the soft tissue anchors are formed from a strip of plastics material such as polypropylene which is sufficiently soft to avoid damaging the urethra or surrounding body tissue and suitably inert such that it can be left in the human body for a long period of time without causing adverse reactions. Again, other suitable materials will be apparent to those skilled in the art.
• The polypropylene mesh strip of 3-5 mm in width which forms the suspendingmeans20 has smooth edges to avoid adhesion of the soft tissue to the strip, reducing problems associated with leaving foreign material in the human body for long periods of time.
• As shown inFIG. 16 the polypropylene mesh strip further comprises pores or pits80 ranging in width across the surface of the strip from 50mm to 200 mm, which extend through the strip from a first surface of thestrip26 to a secondopposite surface28 of the strip thepores80 allowing tissue in-growth to secure the suspending means20 in the body.
• Thepores80 are created by post synthesis treatment of the polypropylene mesh material by a laser.
• The polypropylene mesh which forms the suspendingmeans20 also comprisesmicrogrooves82 of width 5 μm and of depth 5 μm on the surfaces of the polypropylene mesh.
• Themicrogrooves82 are aligned such that they are substantially parallel with each other and separated by ridges of around 5 μm in width.
• The ridges are formed by square pillars the base of the microgroove being substantially perpendicular to the square pillars or beveled in relation to the pillars. Themicrogrooving82 being present on both surfaces of the suspending means to orientate and align the proliferating fibroblasts on the surface of the plastics material and cause axial alignment of collagen fibres and formation of at least one strong ordered neoligament.
• This orientation and alignment of the proliferating cells adding mechanical strength to the tissue which forms around the plastics material such that it is more able to support the urethra.
• The suburethral support is not provided with pores, pits or grooves to discourage the formation of peri-urethral adhesions.
• Once the soft tissue anchors have been suitably positioned in either the soft tissue of the para-urethral tunnel or through therectus sheath120 the length of the suspending means20 can be altered such that thesuburethral support10 hangs loosely under the urethra.
• As shown InFIGS. 2aand2bthe suspendingmeans20 are attached at afirst end22,24 to the sides12,14 of thesuburethral support10, which extend on either side of the urethra.
• As shown inFIGS. 6a-6ca preferred method of altering the length of the suspending means20 attached to thesuburethral support10 comprises a tunneledelement25 at each of the free ends22,24 of thesuburethral support10 on either side of the urethra. The tunneledelement25 extends from the edges of thesuburethral support10 to anaperture15, the aperture being present on theopposite surface16 of thesuburethral support10 to the surface which contacts theurethra17, theaperture15 having anedge18 able to co-operate with aring element19 such that the ring element which has memory can be pushed onto theedge18 of theaperture15 trapping the suspending means20 between the edge of theaperture18 and thering element19 thus securing thesuburethral support10 along a particular desired length of the suspending means20 such that thesuburethral support10 hangs loosely under the urethra.
• FIG. 5 shows an alternative method of attaching the suspending means20 to thesuburethral support10, the suspending means20 being threaded through jammingslots21 such that the suspendingmeans20 are permanently attached to the jammingslots21 by being pulled into the jammingslots21 as shown inFIG. 5 such that the suspending means is held tightly in position.
• Alternatively as shown inFIG. 6 the suspendingmeans20 may be passed through slots and the suspending means permanently attached to the slots by tying.
• In use, as shown inFIG. 12 thesoft tissue anchor30 is placed on the introducingtool50 as described above. Anincision117 is made in theupper wall116 of the vagina, as shown inFIG. 11, and the introducing tool112 is passed through theincision117, past one side of theurethra118, behind thepubic bone119 and into therectus sheath120. It is apparent to the surgeon when therectus sheath120 has been penetrated as this stage of insertion presents significant resistance. Once thehead58 of the introducingtool50 and thesoft tissue anchor30 have passed through therectus sheath120, the resistance diminishes and the surgeon ceases to insert the introducingtool50.
• The introducingtool50 is retracted from the body releasing thesoft tissue anchor30. Due to thewing sections34 on thecentral portion32 of thesoft tissue anchor30, thesoft tissue anchor30 is retained by therectus sheath120 as the introducingtool50 is retracted. Thus, the suspending means remains in the body, secured by the soft tissue anchor which is opposed by therectus sheath120, as shown inFIG. 13.
• This procedure is repeated, with a secondsoft tissue anchor30 and suspendingmeans20, with the introducingtool50 being passed through theincision117 and past the other side of theurethra118. Thus, two suspendingmeans20 are provided, attached to therectus sheath120, one passing either side of theurethra118.
• The suspending means20 are passed through the tunneledelements25 of thesuburethral support10, and the suspendingmeans20 are pulled through theaperture15 until thesuburethral support10 is positioned such that it passes under theurethra118. The suspending means20 are then fixed in place by placing aring element19 over theedge18 of theaperture15 such that the suspending means are trapped between theedge18 and thering element19 securing them in place.
• Alternatively as shown inFIG. 5 the suspending means may be fixed in the attachment tabs by threading them through jammingslots21 or tying, as described above. The optimal lengths of the suspendingmeans20 are such that thesuburethral support10 passes under theurethra118, but exerts no pressure on theurethra118 unless thebladder121 is displaced. The optimal positioning of thesuburethral support20 is roughly as illustrated inFIG. 14. When the bladder is displaced, thesuburethral support10 aids closure of theurethra118, thus alleviating urinary incontinence.
• In this example, a portion of the surgical implant is impregnated with methylene blue, which is a harmless water soluble dye. At the end of the procedure a small amount of fluid is expelled from thebladder121. Should this fluid contain any dissolved methylene blue, it is very likely that the bladder has been perforated on placing thesoft tissue anchor30. In this case, cystoscopy should be carried out. If no methylene blue is present, the need for cystoscopy is advantageously obviated. Other suitable water-soluble dyes may, of course, be used.
• Referring toFIG. 14, it can be appreciated that the surgical implant of the present invention, when inserted in the human body, may extend from therectus sheath120, through the paraurethral space130 on one side of theurethra118, around the urethra and back to therectus sheath120 on the other side. In contrast, the prior art device comprises atape200 that also extends through theabdominal wall127 and represents a far greater implanted mass.
• Referring toFIG. 11, in use, the further embodiment of soft tissue anchor illustrated inFIG. 9 for placement in fibro-fatty soft tissue of the retropubic space is placed on an introducing tool. Anincision117 is made in theupper wall116 of the vagina, as shown inFIG. 11, and the introducing tool112 is passed through theincision117, past one side of theurethra118, and located in the fibro-fatty soft tissue and blood vessels of the para-urethral tunnel. In this case the surgeon does not introduce the soft tissue anchor as far into the body as described previously and therectus sheath120 is not penetrated. Once the soft tissue anchor has been suitably positioned in the soft tissue the surgeon ceases to insert the introducing tool and retracts the introducing tool from the body releasing the projections of thesoft tissue anchor72. The release of theprojections72 of soft tissue anchor by the introducing tool allows the projections to grip the soft tissue surrounding the soft tissue anchor and provide resistance to movement of the soft tissue anchor in a direction opposite to that which it was inserted.
• This procedure is repeated, with a second soft tissue anchor such that theprojections72 of the soft tissue anchor also provide resistance to movement of the soft tissue anchor in a direction opposite to that which it was inserted the introducing tool being passed through theincision117 and past the other side of theurethra118.
• Thus, two suspendingmeans20 are provided, which are held in the soft tissue comprising fibro-fatty tissue and blood vessels.
• As described above the suspendingmeans20 are passed through the attachment tabs of thesuburethral support10, and thesuburethral support10 positioned such that it passes under theurethra118.
• As described above, in one embodiment of the present invention, a soft tissue anchor(s) is inserted in and fixed in the soft tissue of the perineum.
• The perineum corresponds to the outlet of the pelvis inferior to the pelvic diaphragm (levator ani and coccygeus). The boundaries of the perineum are provided by the pubic arch and the arcuate ligament of the pubis; the tip of the coccyx; and on either side the inferior rami of the pubis (140) and ischium, and the sacrotuberous ligament. A line joining the anterior parts of the ischial tuberosities divides the perineum into two portions, the posterior anal triangle portion and the smaller anterior urogenital triangle.FIG. 21 is an illustration of the anatomy of the pelvis indicating the pubic symphysis (142), the inferior pubic ramus (142), the obturator foramen (134) and the region (138) of the obturator foramen though which devices of the prior art extend.
• In this embodiment of the method of the present, the surgical implant does not penetrate or extend through the obturator foramen (134).
• A surgical implant for use in the embodiment of the method wherein the soft tissue anchors are inserted in and anchor in the soft tissue of the perineum may be the same as the implant described in relation to the method of supporting the urethra by anchoring in the tissues of the retropubic space.
• As illustrated inFIG. 17, in one embodiment of a surgical implant suitable for anchoring in the tissue of the perineum, the soft tissue anchors (30) are provided with glue (210) for fixation of the implant to the surrounding tissues. Prior to insertion, the implant may be curled or folded around a midline (212) of a soft tissue anchor (30) of the implant, and then a tool may be inserted through an aperture (214) at a first end of the implant (216) such that the implant can be inserted into the body via a vaginal incision (117) on an upper wall of a vagina (116). Once the first end (216) of the implant is suitably located in the soft tissue of the perineum on a first side of the urethra (118), the soft tissue anchor (30) may be uncurled such that the glue comes into contact with the surrounding tissue to adhere the tissue to the implant. The second anchor portion is then inserted through the vaginal incision and suitably located in soft tissue of the perineum on a second side of the urethra (118). The second soft tissue anchor may then be uncurled such that the glue comes into contact with the surrounding tissue to adhere the tissue to the implant.
• Alternative embodiments of implants suitable for insertion into the soft tissue of the perineum are illustrated inFIGS. 18a,18b,19,20,28 and29. As illustrated, the soft tissue anchor portions (30) can comprise projections, glue or a combination of glue and projections to allow anchorage of the soft tissue anchors in the soft tissue of the perineum.
• As illustrated inFIGS. 19, 28 and29, a marker (220) may be provided on the implant to aid location of the implant within the body following insertion. The marker may be, for example, a protrusion of the suburethral support, or a marked line on the implant. Other suitable means provided on the suburethral support to indicate the midpoint of the implant may be provided as would be appreciated to those skilled in the art.
• As illustrated inFIG. 19, resilient zones (222) can be formed from several strip portions conjoined at a first end to the suburethral support and at a second opposite end to soft tissue anchor of the implant.
• When not under tension these strip portions are bow shaped and are arranged such that they form a series of alternate and side by side convex and concave strips arranged in substantially the same plane as the implant.
• On application of an extending force of up to 3 N to the implant along its length, the implant can show 2-3 mm of extension, as the bowshaped portions of the tape are pulled into straight strips, the ends of the bowshaped strips being brought together, enabling extension of the tape. The movement of the strips from the resting bowshape into the tensioned straight strips of implant allows the implant to resiliently extend along its length.
• The maximum length to which the implant can be extended, is when the convex and concave strips are pulled such that these strips are brought into alignment with the longitudinal axis of the implant. Depending on the nature and length of the bow shaped portion, the extended length and the force required to promote extension of the implant can be controlled.
• On release of the extending force these now straightened strips of implant of the resilient zone return to their previous non-extended bowshape causing the implant to resiliently return to its non-extended length.
• The ability of the implant to show limited extension following the application of an extending force means that the implant more accurately mimics the movement of dynamic bodily tissue.
• In order that the bowshape like portions of the implant can be pulled such that they are straightened, the material of the implant must be resilient to an extent, The amount of resilience of the material will influence the resilience of the implant to an extending force.
• FIGS. 22, 23,26 and27 illustrate an embodiment of the method wherein the soft tissue anchors are inserted in and fix in the tissue of the perineum. It should be noted thatFIGS. 22 and 23 are cross-sections ofFIG. 26, taken along the line A-A. In accordance with one embodiment of the method, the patient is suitably placed in a modified lithotomy position with hips flexed and the legs (136) elevated. A small incision (117) is made in the upper wall of the vagina (116) followed by pariurethral dissection. A first soft tissue anchor (30) is inserted through the vaginal incision (117) and advanced laterally on a first side of the urethra (118), as illustrated inFIG. 27, into the tissues of the perineum towards and behind the inferior pubic ramus (140), but not through, the obturator foramen (134). The length of surgical implant which is to be inserted into the body for anchorage in the soft tissue of the perineum may be indicated by providing a marker on the implant. In an embodiment of a surgical implant for use in this method around 7 cm of the surgical implant is inserted on each side of the urethra.
• The surgical implant and method for anchorage in the soft tissue of the perineum contrasts the devices and methods of the prior art in which the devices are required to be of sufficient length to extend through the obturator foramen (134) in a “safe” zone (138) close to the inferior pubic ramus (140) as illustrated inFIG. 21 and through the skin.
• Provision of an implant capable of anchoring in the soft tissue of the perineum without requiring to pass through the obturator foramen is advantageous as it minimizes the likelihood of anatomical damage to nerves and blood vessels which may occur during procedures which penetrate the obturator foramen.
• Following insertion of a first soft tissue anchor, a second soft tissue anchor is inserted into said vaginal incision on the second side of the urethra and then advanced in an opposing lateral direction to the first soft tissue anchor, as illustrated inFIG. 27, into the tissues of the perineum towards, but not through, the obturator foramen (134).
• Suitably a centering marker (220) provided on the suburethral support is aligned under the urethra such that the first and second anchors are suitably provided into the soft tissue of the perineum.
• In the embodiment of the method of locating the anchors in the soft tissue of the perineum illustrated, the soft tissue anchors are not anchored above the endopelvic fascia (139).
• Again this device contrasts that described by the prior art device in that it does not extend through the abdominal wall or the obturator foramen and thus does not represent as much implanted mass.
• Various embodiments of the present invention can be envisaged within the scope of the invention, for example the soft tissue anchor may comprise a cone or a half cone such that a circular or semi-circular base is provided as a retaining means to prevent retraction of the soft tissue anchor in a direction opposite to that in which it is inserted into the tissue.
• Alternatively the soft tissue anchor may comprises a substantially flat or disc shaped head. In this case the introducing tool may have a conical head with a sharp point at its apex and a slot for receiving the flat or disc shaped head.
• In yet another example, the soft tissue anchor may be formed of two sections. The upper section, i.e. the portion of the anchor that forms thesharp point10, may be made from an absorbable material, such as polyglactin such that a sharp point is provided for insertion of the anchor into the body, but this sharp point is later absorbed by the body so as to eliminate any discomfort or disadvantage caused by a sharp pointed object being retained inside the body.
• The soft tissue anchor may be made from metal, such as titanium, as this is a hard material that can easily be formed into the head having the sharp point at its apex, and is sufficiently malleable to provide a tube that may be crimped to the suspending means.

Claims (14)

1. A method of supporting a urethra comprising the steps of

introducing a surgical implant comprising first and second soft tissue anchors and a suburethral support portion therebetween into at least one incision made on the upper wall of a vagina,

inserting the first soft tissue anchor on a first side of the urethra behind the pubic bone, and

inserting the second soft tissue anchor on a second side of the urethra behind the pubic bone, such that the suburethral support is suspended from the soft tissue anchor and supports the urethra,

wherein each of the first and second soft tissue anchors are inserted in and fix in the soft tissue of the perineum without penetrating the obturator foramen.

2. The method as recited inclaim 1 wherein at least one of the first and second tissue anchors comprises a central portion and retaining means wherein the retaining means comprise a plurality of projections, the projections extending radially from the central portion along a substantial portion of the length of the central portion allowing fixation of the anchor at a plurality of layers within the soft tissue of the perineum.

3. The method as recited inclaim 1 wherein at least one of the first and second tissue anchors comprises biocompatible glue.

4. The method as recited inclaim 1 wherein the first soft tissue anchor is inserted on a first side on the urethra behind the pubic bone in a lateral direction away from the urethra and positioned in the soft tissue of the perineum, and the second soft tissue anchor is inserted on a second side of the urethra in an opposite lateral direction from the first soft tissue anchor and away from the urethra and positioned in the soft tissue of the perineum, such that the suburethral support is suspended from the first and second soft tissue anchors and supports the urethra.

5. The method as recited inclaim 1 wherein the surgical implant does not penetrate the endopelvic fascia.

6. The method as recited inclaim 1 further comprising providing at least one of the first and second soft tissue anchors with portions to grip the soft tissue of the perineum at multiple layers.

7. The method as recited inclaim 1 wherein the surgical implant comprises polymer tape.

8. The method as recited inclaim 1 wherein the surgical implant comprises bioabsorbable material.

9. A method of supporting a urethra comprising the steps:

introducing a surgical implant into at least one incision made on the upper wall of a vagina the surgical implant comprising first and second ends and a suburethral support section therebetween;

inserting a first end of the surgical implant on a first side of the urethra and positioning the first end into soft tissue of the perineum without penetrating the obturator foramen; and

inserting a second end of the surgical implant on a second side of the urethra and positioning the second end into the soft tissue of the perineum without penetrating the obturator foramen such that the suburethral support section is positioned under the urethra and provides support thereto.

10. The method ofclaim 9 wherein the surgical implant does not penetrate the endopelvic fascia.

11. A method of supporting a urethra, comprising:

mechanically coupling, with a surgical implant, a first soft tissue portion of a perineum on a first side of the urethra to a second soft tissue portion of the perineum on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portion, and

orientating a portion of the surgical implant underneath the urethra to provide support thereto, wherein the obturator foramen is not penetrated.

12. The method as recited inclaim 11, further comprising causing a portion of the surgical implant to grip at least one of the first and second tissue portions.

13. The method as recited inclaim 11 wherein the surgical implant does not penetrate the endopelvic fascia.

14. A method of supporting a urethra comprising:

positioning a surgical implant in a perineum to mechanically couple a first tissue portion of the perineum on a first side of the urethra to a second tissue portion of the perineum on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portions; and

positioning a portion of the surgical implant underneath the urethra to provide support thereto,

wherein substantially all of the mechanical coupling is provided by interaction of the first and second tissue portions with respective portions of the surgical implant.

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