Title of Invention

A SURGICAL ASSEMBLY FOR SUPPORTING THE FEMALE URETHRA

Abstract

The present invention relates to a surgical assembly for supporting the female urethra, comprising: a) a composite band which comprises at least one suburethral support strip and a flat protective sheath, said strip being arranged, for example freely, inside this sheath; both ends of the composite band comprise a common part, for example a female common part, of a connecting means which can be locked and unlocked; the flat sheath comprises, along its length, two parts arranged on either side of a middle zone of separation; b) a needle, or similar tapered part, allowing the suburethral support strip to be engaged and pulled through the body tissues of the patient, this needle comprising at least one other part, for example a male part, of a connecting means, the connecting means of the composite band and each connecting means of the needle making it possible to connect the needle releasably to at least one of the ends of said composite band; said assembly being characterized in that: each part of the connecting means belonging to the composite band comprises an elastically deformable tube portion, and each part of the connecting means belonging to the needle is shaped so that is can be engaged with friction in said tube portion and/or can be inserted with retention in the wall of this tube portion.

Full Text

The present invention relates to the surgical treatment of female stress urinary incontinence. More particularly, the invention relates to a surgical assembly with which it is possible, at the end of the intervention or operation, to support the urethra by means of a suburethral strip whose two ends are each disposed in a suitable path of the patient"s body, for example in the retropubic space, towards the patient"s abdominal wall. FR 2 814 939 discloses a surgical assembly comprising a composite band which includes a strip, a sheath and a needle, the composite band comprising a part of a connecting means which snaps into another part of the connecting means situated on the proximal part of the needle. One of the disadvantages of this assembly is that the connection thus established can be undone only by performing a specific procedure that involves disengaging the two parts of the connecting means from one another, which for example requires the use of both hands. Moreover, this assembly can be used in three different ways of applying the strip, namely a so-called low approach, a so-called combined approach, and a so-called high approach. Now, it would be advantageous to have a surgical assembly which can be used for other approaches and in which the connection between the composite band and the needle would be easily releasable. The surgical assembly according to the invention comprises: a) a composite band which includes at least one suburethral support strip and a flat protective sheath, said strip being arranged, for example freely, inside this sheath; both ends of the composite band comprise a common part, for example a female common part, of a connecting means which can be locked and unlocked; the flat sheath comprises, along its length, two parts arranged on either side of a middle zone of separation; b) a needle, or similar tapered part, allowing the suburethral support strip to be engaged and pulled through the body tissues of the patient, this needle comprising at least one other part, for example a male part, of a connecting means, the connecting means parts of the composite band and each connecting means part of the needle making it possible to connect the needle releasably to at least one of the ends of said composite band. The subject of the present invention is a surgical assembly which is as defined above and which is of a universal nature in the sense that it can be used whatever the surgical approach and whatever the operating technique employed by the surgeon. According to the invention, the surgical assembly is characterized in that: each part of the connecting means belonging to the composite band includes an elastically deformable tube portion, and each part of the connecting means belonging to the needle is shaped so that it can be engaged with friction in said tube portion and/or can be inserted with retention in the wall of this tube portion. By virtue of the tube portion present in the parts of the connecting means of the composite band and to the parts of the connecting means specific to the needle, it is possible to establish a connection that can be unlocked by simple manual pulling in opposing directions. The connection can be released, for example, using just one hand. The needle can comprise parts of connecting means at its proximal and distal ends. In a preferred embodiment of the invention, the needle comprises connecting means at its distal end. Thus, in the assembly according to the invention, it is possible to apply the suburethral strip via the so-called low approach, or using the so-called combined approach, or using the so-called high approach, or, alternately, using the so-called transobturator approach. In particular, by virtue of the assembly according to the invention, it is possible to apply the suburethral strip by the so-called high approach or the so-called transobturator approach, also called "out-in", without having to section said strip. Each tube portion is preferably connected to the corresponding end of the composite band by means of an axial finger with a diameter slightly greater than the diameter of this tube portion, and able to be engaged in the latter with friction. Each finger can be provided with protruding circular ribs forming bosses. These bosses promote connection of this finger to said tube portion. Alternately, the finger can be provided with a thread. At least the proximal end of the needle can comprise a conical end part, with a diameter widening in the direction of the middle zone of the needle, and a cylindrical portion of smaller diameter than the diameter of the base of the conical portion, this cylindrical portion thus delimiting a shoulder with the base of the conical portion, the base of said conical portion having a diameter greater than the internal diameter of the tube portion and being able to be engaged with friction in said tube portion, causing a circumferential stretching of the wall of this tube portion, said conical portion additionally having a relatively pronounced slope and a reduced cross section, in such a way that it is able to pierce through the body tissues of the patient. The needle can be formed by a tapered and curved part of an instrument able to be engaged through the body tissues of the patient, by passing through the obturator foramen of the pelvis and emerging through the vagina. In this case, said tapered and curved part may comprise a rigid outer portion and a flexible inner portion which is able to slide along the radially inner face of said rigid outer portion, said rigid outer portion and flexible inner portion having distal ends; said flexible inner portion is movable with respect to said rigid outer portion between an advanced position and a retracted position; in said advanced position, the distal end of said flexible inner portion forms, with the distal end of said rigid outer portion, a conical portion with pronounced slope and relatively small cross section, permitting engagement of said tapered and curved part through the body tissues of the patient; in the retracted position, the distal end of the flexible inner portion is situated set back from the distal end of the rigid outer portion; the distal end of the rigid outer portion has a proximal recess delimiting a sharp-edged shoulder, giving it a "harpoon" configuration, and is able, in this retracted position, to penetrate slightly into the wall of said tube portion when this tube portion is engaged on it. The composite band can comprise a breakable linking means formed by an adhesive outer sleeve, which for example can be torn off by shearing, which joins the two inner ends of the two parts of the flat sheath respectively adjacent to the zone of separation. The present invention is now described with reference to the attached drawing, in which: Figure 1 shows a front view of the composite band of a surgical assembly according to the invention, Figure 2 shows a side view of a needle that can be used with this composite band, Figures 3 and 4 show, respectively, a side view of this composite band and a front view of the proximal part of this needle. Figures 5 to 8 show views of four successive steps involved in fitting or applying this surgical assembly by what is called a "high" approach. Figures 9A and 9B show side views of an instrument which can be used with the composite band for fitting or applying the surgical assembly comprising this composite band and this instrument by what is called a "transobturator" approach, and Figures 10 to 13 show views of four successive steps in fitting or applying a surgical assembly comprising this composite band and this instrument by said "transobturator" approach. According to Figures 1 to 3, a surgical assembly according to the invention comprises as a minimum: a composite band 104 comprising two tapered ends of triangular shape and flat. and a needle 103 comprising a penetrating distal end 132 and a flat proximal heel 131. The composite band 104 includes at least a suburethral support strip 102, two end-pieces 109, and a flat protective sheath 105 inside which the strip 102 is arranged freely, that is to say without being attached to the sheath 105. The support strip 102 comprises an openwork knit which preferably is unable to unravel and is obtained from monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester. The strip 102 is preferably formed from a macroporous knitted material. The latter is, for example, an openwork knit made of polypropylene monofilament having a thickness of between 0.12 and 0.16 millimeters and made up of two layers which are each formed by two threaded guide bars, one full guide bar and one empty guide bar, these two bars being moved symmetrically for open meshes according to the following plan: bar I: 01-12-32 bar II: 32-21-01 The strip 102 is cut in length in the warp direction of the knit. With a width of 12 mm, it has the following characteristics: a breaking strength in the warp direction of 105 N + 20%, an elongation at break in the warp direction of 92% +_ 20%, an elongation of 36% at 20 N, an onset of curling at a force of 6 N and an elongation of 15%. "Curling" means the spontaneous coiling of the strip 102 on itself, about its longitudinal axis, under longitudinal tensile stress. The strip 102 has useful advantages, in particular a low emission of particles as it is stretched, and curling which occurs only under a substantial force (6 N) . None of these aforementioned characteristics in any way impairs the porosity of the strip 102. The latter can also be made wholly or partly of absorbable or non-absorbable biological tissue or material, for example collagen. The flat protective sheath 105 is obtained from a synthetic material with a low coefficient of friction, for example PTFE. This sheath 105 comprises, along its length, two parts 151 and 152 arranged on either side of a zone of separation 106 in which there is a breakable means which links the two said parts, According to Figure 1, and in a particular embodiment, the breakable linking means is made up of an adhesive outer sleeve 171 which can be torn, for example by shearing, by means of a tab 172. This sleeve 171 includes two inner ends of the two parts 151 and 152 of the sheath 105 respectively adjacent to the zone of separation 106. The composite band 104 comprises means 180 for connecting its ends to the needle 103. Each connecting means 180 comprises an axial finger 181 provided with projecting circular ribs 182 forming bosses, and an elastically deformable tube portion 183 with an internal diameter slightly smaller than the diametet of the finger 181. The finger 181 is intended to be engaged with friction in the tube portion 183, the ribs 182 causing a provided for guiding the sliding of the portion 206 along the portion 205, particularly in the form of a groove made in the portion 205, in which a runner integral with the portion 206 slides. The portion 206 is movable with respect to the portion 205 between an advanced position shown in Figure 9A and a retracted position shown in Figure 9B; in the advanced position, the distal end of the portion 206 forms, with the distal end of the portion 205, a conical portion 284 with pronounced slope and relatively small cross section, permitting engagement of the part 203 through the body tissues of the patient; in the retracted position, the distal end of the portion 206 is situated set back from the distal end of the portion 205. As is shown in Figure 9B, the distal end of the portion 205 forms the greater part of said conical portion 284 but has a proximal recess 2 85 delimiting a sharp-edged shoulder. This distal end thus has a "harpoon" shape and is able to penetrate slightly into the wall of the tube portion 183 when this tube portion 183 is engaged on it. The distal end of the portion 206 has a shape such that it occupies said proximal recess in the advanced position and completes the conical portion 284. As is shown in Figures 10 to 13, the part 203 is engaged through the body tissues of the patient by passing through the obturator foramen of the pelvis until it emerges from the vagina 117, the portion 206 then being in the advanced position. The button 207 is then maneuvered in such a way as to retract the portion 206, then the tube portion 183 of one end of the band 104 is engaged on the harpoon-like distal end of the portion 205; this engagement permits penetration of this distal end into the wall of the tube portion 183, and consequently allows a connection to be established between this tube portion 183 and the distal end of the portion 205 {cf. Pig. 10). The instrument 200 is then withdrawn so that the half of the band 104 connected to the part 203 can be engaged through the path formed in the body by means of this instrument 200 (cf. Fig. 11), The end 184 of the needle is disconnected from the tube 183, and the same maneuvers are performed on the other side. The two sheath parts 151, 152 are then separated and withdrawn (cf. Fig. 12) and the strip 102 is put in place by pulling on its emerging ends (cf. Fig. 13). WE CLAIM: 1. A surgical assembly for supporting the female urethra, comprising: a) a composite band (104) which comprises at least one suburethral support strip (102) and a flat protective sheath (105), said strip (102) being arranged, for example freely, inside this sheath (105); both ends of the composite band (104) compnse a common part (183), for example a female common part, of a connecting means (183 to 185, 284) which can be locked and unlocked, the flat sheath (105) comprises, along its length, two parts (151, 152) arranged on either side of a middle zone of separation; b) a needle (103), or similar tapered part (203), allowing the suburethral support strip (102) to be engaged and pulled through the body tissues of the patient, this needle (103, 203) comprising at least one other part (184, 185, 284), for example a male part, of a connecting means, the connecting means of the composite band (104) and each connecting means of the needle (103, 203) making it possible to connect the needle (103, 203) releasably to at least one of the ends of said composite band (104); said assembly being characterized in that: each part (183) of the connecting means belonging to the composite band (104) comprises an elastically deformable tube portion (183), and each part (184, 185, 284) of the connecting means belonging to the needle (103, 203) is shaped so that is can be engaged with friction in said tube portion (183) and/or can be inserted with retention in the wall of this tube portion (183). 2. The assembly as claimed m claim 1, wherein the needle (103) comprises parts (184, 185) of connecting means at its proximal and distal ends, 3. The assembly as claimed in claim 1, wherein each tube portion (183) is connected to the corresponding end of the composite band (104) by means of an axial finger (181) with a diameter slightly greater than the diameter of this tube portion (183), and able to be engaged in the latter with friction. 4. The assembly as claimed in claim 3, wherein each finger (181) is provided with protruding circular ribs (182) forming bosses. 5, The assembly as claimed in claim 1, wherein at least the proximal end of the needle (103) comprises a conical end part (184), with a diameter widening m the direction of the middle zone of the needle (103), and a cylindrical portion (185) of smaller diameter than the diameter of the base of the conical portion (184), this cylindrical portion (185) thus delimiting a shoulder with the base of the conical portion (184), the base of said conical portion (184) having a diameter greater than the internal diameter of the tube portion (183) and being able to be engaged with friction in this tube portion (183), causing a circumferential stretching of the wall of this tube portion (183), said conical portion (184) additionally having a relatively pronounced slope and a reduced cross section, in such a way that it is able to pierce through the body tissues of the patient. 6 The assembly as claimed in claim 1, wherein the needle (203) is formed by a tapered and curved part of an instrument (200) able to be engaged through the body tissues of the patient, by passing through the obturator foramen of the pelvis and emerging through the vagina. 7. The assembly as claimed in claim 6, wherein said tapered and curved part (203) comprises a rigid outer portion (205) and a flexible inner portion (206) which is able to slide along the radially inner face of said rigid outer portion (205) said rigid outer portion (205) and flexible inner portion (206) having distal ends; said flexible inner portion (206) is movable with respect to said rigid outer portion (205) between an advanced position and a retracted position, in said advanced position, the distal end of said flexible inner portion (206) forms, with the distal end of said rigid outer portion (205), a conical portion (284) with pronounced slope and relatively small cross section, permitting engagement of said tapered and curved part (203) through the body tissues of the patient; in the retracted position, the distal end of the flexible inner portion (206) is situated set back from the distal end of the rigid outer portion (205), the distal end of the rigid outer portion (205) has a proximal recess delimiting a sharp-edged shoulder, giving it a "harpoon" configuration, and is able, in this retracted position, to penetrate slightly into the wall of said tube portion (183) when this tube portion (183) is engaged on it. 8. The assembly as claimed in claim 1, wherein the composite band (104) comprises a breakable linking means formed by an adhesive outer sleeve (171), which for example can be torn off by shearing, which joins the two inner ends of the two parts (151, 152) of the flat sheath (105) respectively adjacent to the zone of separation. 9. The assembly as claimed in claim I, wherein the support strip (102) comprises an openwork knit which is unable to unravel and is obtained from monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester. 10. The assembly as claimed in claim 1, wherein the support strip (102) is made wholly or partly of biological tissue or material, for example collagen, 11. The assembly as claimed in claim 1, wherein the protective sheath (105) is obtained from a synthetic material with a low coefficient of friction, for example PTFE. 12. The assembly as claimed in claim 1, wherein the needle (103, 203) comprises parts (184, 185, 284) of connecting means at its distal end.

Documents:

2616-chenp-2004 abstract duplicate.pdf

2616-chenp-2004 abstract.pdf

2616-chenp-2004 claims duplicate.pdf

2616-chenp-2004 claims.pdf

2616-chenp-2004 correspondence-others.pdf

2616-chenp-2004 correspondence-po.pdf

2616-chenp-2004 description (complete) duplicate.pdf

2616-chenp-2004 description (complete).pdf

2616-chenp-2004 drawings duplicate.pdf

2616-chenp-2004 drawings.pdf

2616-chenp-2004 form-1.pdf

2616-chenp-2004 form-18.pdf

2616-chenp-2004 form-26.pdf

2616-chenp-2004 form-3.pdf

2616-chenp-2004 form-5.pdf

2616-chenp-2004 others.pdf

2616-chenp-2004 pct search report.pdf

2616-chenp-2004 pct.pdf

2616-chenp-2004 petition.pdf

2616-CHENP-2004 POWER OF ATTORNEY 02-09-2009.pdf