Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2001-11-20
2004-02-24
Thaler, Michael H. (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C600S029000
Reexamination Certificate
active
06695855
ABSTRACT:
The present invention relates to a device for treating a prolapse by vaginal suspension.
Genital, urinary and rectal prolapses result from a slackening of the tissues supporting the organs, and of the perineum, and cause stress urinary incontinence in elderly women.
Surgical treatment of these prolapses involves connecting one or more of these organs (bladder, vagina, uterus, rectum) to anatomically stable zones, in particular, anteriorly, at Cooper's ligament, on the postero-superior margin of the pubis or, posteriorly, at the area of the promontory, that is to say the antero-superior angle of the sacrum, by “suspending” these organs on these anatomically stable zones.
Surgical treatment of prolapses is presently carried out using nonabsorbable sutures or strengthening strips.
Sutures have the advantage of being easy to put in place during treatment of a prolapse by open surgery, of having a low cost and of having extensive possibilities of use.
However, they have the disadvantage of providing a punctiform and somewhat inelastic fixation of the suspension thread, which is likely to cause shearing of the tissues on which they are placed, leading to rupturing of the anchoring arrangement. The result of this is that their efficacy is limited over time. Moreover, they are complicated to put into place when treating prolapses by laparoscopy, given the need to form numerous knots.
Strips have the advantage of being easy to put into place irrespective of the route employed (open surgery or laparoscopy), of being effective, and of allowing the stresses which are exerted to be distributed at a plurality of anchoring points. They are also capable of rapid incorporation in the anchoring wall and in the surrounding tissues by means of tissue growth.
However, these strips have the disadvantage of having to be twisted when the respective implantation walls are not parallel. The twisted zone acts in scarcely favorable conditions, moving along the band when tension is applied, with the latter becoming thinner at its center, making it difficult to put into place and accentuating the shearing effect. A band of relatively rigid material, such as monofilament polypropylene, has edges which may possibly damage the surrounding tissues along the entire length of the band.
Treatment of a prolapse by vaginal suspension is a delicate operation in view of the relative fragility of the wall of the vagina, and existing devices for performing such suspension, particularly by laparoscopy, are not entirely satisfactory.
The present invention aims to remedy this deficit.
To this end, the device to which the invention relates comprises a unit formed by an elongate part of flexible open-worked material, a suture thread connected to a longitudinal end of said part, and a suture needle connected to this thread; the part has a length which is such that it permits posterior suspension of the vagina at the promontory, that is to say at the antero-superior portion of the sacrum; this part comprises, at its end connected to the suture thread, (i) a distal portion whose width is such that it can cover at least a wide area of the posterior half of the wall of the vagina and it can be sutured very laterally, that is to say in a manner not transfixing the paravagina, and (ii) a rounded cut-out formed in its lateral edge at the distal end, this cut-out having dimensions which are such that it permits engagement of the part around the base of the wall of the vagina, over at least a wide area of the posterior half of this wall, while at the same time leaving the rectum at a sufficient distance so as not to risk compressing the latter; the suture thread is connected to the part in such a way that it is offset laterally in relation to said cut-out.
The device according to the invention is put into place as follows. After inserting optic and surgical trocars, an arciform incision is made in the anterior surface of Douglas' pouch (vaginorectal), then the prerectal fascia is dissected, continuing laterally as far as the posterior fasciculi of the levator muscles, each side of the rectum. A vaginal valve can be fitted to facilitate dissection to the pelvic floor at the level of the sacrosciatic ligament.
The needle is lowered between the vagina and the rectum starting from Douglas' pouch, to the level of the pelvic floor, and is then engaged laterally through the levator muscles in such a way as to ensure a solid point of sliding for the thread; the latter is then slid by pulling on the needle in order to cause the part of open-worked material to descend into the dissected space, until this part positions itself against the posterior surface of the vagina. The cut-out in the distal portion of this part permits wide engagement of this portion around the base of the vagina without compression of the rectum, and the width of this same portion permits contact of the part with the posterior surface of the vagina over a wide area.
The part is then fixed at one side to the pelvic floor by means of the aforementioned thread on the posterior surface of the vagina by successive suturing points as far as the uterosacral ligament with the aid of this same thread. The same maneuvers are repeated on the other side with a second ligature of 25 cm starting from the other distal end of the part.
The part is then fixed to the promontory via its proximal end, to provide the suspension.
Thus, by means of its shape, this part permits distal fixation not to the wall of the vagina but to the levator muscles and the uterosacral ligaments, in other words at stable positions, so as to obtain engagement under optimum conditions.
The open-worked structure of the part makes it possible to limit to the greatest possible extent the risks of exacerbated tissue reaction (fibrosis) and to obtain rapid integration with the tissues by means of these growing through the meshes.
Preferably, the device according to the invention comprises not only the aforementioned unit consisting of the part of open-worked material, the suture thread and the suture needle, intended to be placed at the level of the posterior surface of the vagina, but also a second unit formed by a part of open-worked material, a suture thread and a suture needle, and intended to be placed at the level of the anterior surface of the vagina, to complement the first unit.
This second unit comprises an elongate part of flexible open-worked material, a suture thread connected to a longitudinal end of the part, and a suture needle connected to this thread; said part has a length which is such that it permits an anterior suspension of the vagina at the promontory and comprises, at its end connected to said thread, two oblique lateral edges converging toward each other in the direction of this end, such that the part has a portion which narrows gradually toward this end; the suture thread is connected to this end.
This second unit is put into place as follows. The anterior surface of the vagina is dissected at the level of the vesicovaginal pouch, then the paravagina is perforated below the adnexa. The needle of this second unit is engaged along the anterior surface of the vagina and engaged through a tissue, as close as possible to the base of this vagina, so as to constitute a stable point of sliding for the thread; the latter is then slid to allow the part to descend along the anterior surface of the vagina. The portion of this part which narrows in the distal direction corresponds to the distal shape of the vesicovaginal pouch, which permits engagement of said part at as far as possible a point, for engagement in a relatively thick and resistant tissue.
Using a running suture with the aid of this same thread, the part made of open-worked material is fixed along one of its edges to the lateral wall of the vagina at the height of the uterine isthmus. The other edge is sutured in an identical manner with a running suture using a second thread of 25 cm in length. In order to avoid transfixing the vagina while at the same time ensuring mechanically satisfactory anchoring, the engagement of th
Roberts P
Sofradim Production
Thaler Michael H.
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