EP1610714A2 - Implant for treatment of a rectocele and device for placement of said implant - Google Patents

Implant for treatment of a rectocele and device for placement of said implant

Info

Publication number
EP1610714A2
EP1610714A2 EP20040742369 EP04742369A EP1610714A2 EP 1610714 A2 EP1610714 A2 EP 1610714A2 EP 20040742369 EP20040742369 EP 20040742369 EP 04742369 A EP04742369 A EP 04742369A EP 1610714 A2 EP1610714 A2 EP 1610714A2
Authority
EP
European Patent Office
Prior art keywords
implant
characterized
according
body
upper
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20040742369
Other languages
German (de)
French (fr)
Inventor
Emmanuel Delorme
Georges Eglin
Jean-Marc Beraud
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ANALYTIC BIOSURGICAL SOLUTIONS
Analytic Biosurgical Solutions - ABISS
Original Assignee
ANALYTIC BIOSURGICAL SOLUTIONS - ABISS
ANALYTIC BIOSURGICAL SOLUTIONS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to FR0303893A priority Critical patent/FR2852817B1/en
Priority to FR0303895A priority patent/FR2852818B1/en
Application filed by ANALYTIC BIOSURGICAL SOLUTIONS - ABISS, ANALYTIC BIOSURGICAL SOLUTIONS filed Critical ANALYTIC BIOSURGICAL SOLUTIONS - ABISS
Priority to PCT/FR2004/000765 priority patent/WO2004091442A2/en
Publication of EP1610714A2 publication Critical patent/EP1610714A2/en
Application status is Withdrawn legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B17/06109Big needles, either gripped by hand or connectable to a handle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045Support slings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3415Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00805Treatment of female stress urinary incontinence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06042Means for attaching suture to needle located close to needle tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B2017/06076Needles, e.g. needle tip configurations helically or spirally coiled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B2017/06085Needles, e.g. needle tip configurations having a blunt tip

Abstract

The invention relates to an implant for the treatment of a rectocele and/or prolapse of the vaginal cuff. Said implant has a thin and flexible structure, characterised in comprising a support body from which extend at least two upper suspension stabilisers (3), arranged to both sides of a sagittal plane (S) and two lower suspension stabilisers (4), arranged to both sides of the sagittal plane (S). The above is of application to a rectocele.

Description

IMPLANT FOR TREATING Rectocele AND DEVICE FOR THE IMPLEMENTATION OF THIS IMPLANT

The present invention relates to the technical field of treatment of rectal prolapse, especially in elderly women.

The prolapse phenomena result, generally, a loosening of suspension tissues of the genital or rectal organs, causing disorders that require surgery.

Thus, it was proposed reconstruction efforts natural suspension system of organs affected by prolapse, by implementing non-absorbable sutures or reinforcing strips. However, these techniques have not always been satisfactory, particularly because the use of major surgery, resulting in dissecting anatomical regions not affected by surgical repair, for the realization of points of nonabsorbable sutures.

In an attempt to overcome these drawbacks, patent application FR 2,785,521 has proposed to implement an implant comprising a supporting body, from which extend two suspension cords, provided, at their ends, parts anchor intended to undergo sutures on areas known to be anatomically stable. This implant is then introduced laparoscopically to alleviate the surgical procedure

However, it appeared that such an implant is not able to provide effective suspension, due in particular to the constraints applied to areas known to be anatomically stable. Moreover, this type of implant does not, in condition of use, high spatial stability.

Thus, it appeared the need, first, to have an implant with better stability implantation and, secondly, a technique that achieves optimal stability, while reducing up the trauma experienced by the patient. Thus, to achieve these objectives, the invention concerns an implant for the treatment of rectocele, having a thin, flexible structure and comprising a supporting body from which extend at least two upper suspension stabilizers disposed on sides of a sagittal plane of the support body and two lower suspension stabilizers arranged, also, on either side of the sagittal plane.

According to the invention, the longitudinal axes of the upper stabilizers form between them an angle greater than 45 ° and, most preferably but not strictly necessary, an angle between 100 ° and 180 ° and preferably between 115 ° and

170 °. It should be noted that according to a preferred embodiment, the sagittal plane is a symmetry axis of the implant and thus bisecting the angle.

The implementation of upper suspension stabilizers having such a relative orientation allows judiciously placing the latter in the trans-sacrosciatic region to ensure a good distribution of forces applied to the support body on the anatomical anchor points stabilizers, all ensuring better spatial orientation of the body of the carrier implanted in the patient.

According to a preferred but not strictly necessary to the invention, the upper suspension stabilizers and / or lower have a length greater than 100 mm and preferably greater than or equal to 120 mm. Such a length permits a good extension of suspension stabilizers in their respective insertion areas and takes advantage of the friction between the arm or suspension stabilizers and tissues through to ensure the maintenance of the implant.

According to another characteristic of the invention, the longitudinal axes of the lower stabilizers form, between them, preferably but not necessarily, a non-zero angle β. Thus, it must be considered that the lower stabilizers are not parallel. Preferably but not strictly necessary, the angle β. is greater than 10 ° to be preferably between 10 ° and 75 ° or, even, entrel00 ° and 180 °, depending on the pathology to be treated.

According to yet another feature of the invention, preferred but not strictly necessary, the support body has a substantially rectangular general shape. Preferred but not strictly necessary, the support body then has a length of between 60 mm and 90 mm and a width between 40 mm and 60 mm. According to one embodiment of the invention, the upper stabilizers extend substantially from the upper corners of the support body and lower stabilizers extend from the lower corners of the support body. According to another embodiment of the invention, the upper stabilizers extend substantially from the upper corners of the support body, while the lower stabilizers extend from the two long sides of the carrier body. Each of the lower outriggers then extends preferably, but not necessarily, at a distance from the upper edge of the supporting body of between 60% and 87% of the length of the support body. According to another feature of the invention the lower stabilizers have an enlarged area at their connection with the support body of the implant.

The invention also relates to a surgical technique for the treatment of rectocele. According to the invention, this technique is to implement an implant which comprises a supporting body from which extend at least two upper suspension stabilizers, disposed on either side of a sagittal plane, and at least two lower suspension stabilizers, also arranged on either side of the sagittal plane. The technique involves placing come, first, upper suspension stabilizers, or in the corresponding transgluteal region or in the corresponding sacrosciatic region and, on the other hand, the lower stabilizers in the transpuborectale region.

Preferably, this technique is implemented in the context of surgery, called minimally invasive, using access routes close to the organs to be treated as small as possible, so as to ensure a reduction of operating time and blood loss that reduces the risk of vaginal erosion by the prosthesis as the prosthesis is not strictly in front of the incision. It is thus possible to obtain short-operative, with minimal discomfort to the patient. In addition, the simplicity of this technique allows its easy reproduction and minimizes the learning necessary for surgeons to mastery.

In some pathologies encountered, it may be necessary to further increase the stability of the implant. Thus, according to one feature of the invention, the implant further comprises pairs of upper and lower suspensions of stabilizers a pair of average suspension stabilizers which are each located between an upper suspension stabilizer and a lower suspension stabilizer. The processing technique of the rectocele implementing such an implant to six suspension stabilizers then provided to place the implant in the body of the patient to be treated with a higher suspension stabilizers through the sacrosciatic region, π the suspension stabilizing means through the puborectale region, "the lower suspension stabilizers through the perineal region," and the support body at the utérosacrée region. The invention also relates to an input device that can be used, but are not absolutely necessary for the purposes of the invention, for the establishment of an implant, as described above.

According to the invention, the introducer includes an introducer which has a flexible structure and a shape similar to that of the implant and which comprises:

"A hollow body defining a cavity for receiving the implant support body,

"Tabular stabilizers extending from the hollow body and each defining a cavity for receiving a suspension stabilizer of the implant, • traction means extending from the end of each of the stabilizers introducer,

"And the cutting means of the hollow body at least of the introducer. According to a feature of the invention, the traction means comprise, for each tubular strap, a rigid needle.

According to the invention, the cutting means may be implemented in any appropriate manner, such as, for example, in the form of a line of weakness susceptible to tearing when a pulling is performed at two opposite tabular stabilizers of the introducer. According to a preferred but not strictly necessary to the invention, the cutting means comprise at least one opening for the passage of a cutting tool. Preferably, the body of the introducer includes a series of apertures lying on the one hand, close to a line corresponding to the sagittal plane of the implant and, secondly, between the tabular stabilizers.

According to another characteristic of the invention, the introducer includes an implant according to the invention, disposed in the cavity of the hollow body and tabular introducer stabilizers. Preferably but not strictly necessary, the implant is free within the introducer.

To facilitate the surgeon's work, according to another characteristic of the invention, the input device also comprises at least one ancillary tool which comprises an elongate or trocar perforator guide whereof one end is intended to be introduced into the body of the patient and the other end is provided with a handle.

According to one characteristic of the invention, the perforator guide has an arcuate shape in a plane. Preferred but not strictly necessary, the arcuate portion of the perforator extends over an angular sector greater than 140 ° and, preferably but not necessarily, less than 180 ° and preferably between 150 ° and 170 °. Preferably, the arcuate portion of the perforator guide then has a radius of curvature between 30 mm and 60 mm and, preferably, for the part of the perforator guide extending between the handle and the end intended to be introduced into the patient's body, between 40 mm and 50 mm, the end portion of the punch then having a variable radius of curvature. According to another embodiment, the perforator guide has, at its opposite end distal to the handle or a helical shape. Preferably, the perforator guide then has the shape of a portion of helical coil extending over an angle between 180 ° and 360 ° and preferably between 255 ° and 270 °. Similarly, preferably, the spire of the perforator guide has a radius of curvature between 20 mm and 40 mm, with a pitch of between 15 mm and 25 mm.

According to another characteristic of the invention, in order to reduce the trauma suffered by the body of the patient upon insertion of the implant, the insertion device further comprises a tubular jacket of complementary shape to that of perforator guide. This tubular sleeve is then intended to be engaged on the perforator guide and remain in the body of the patient after removal of the drill guide for defining a tunnel for passage of the traction means of the introducer. The tubular liner is then removed, after passage of the traction means during removal of the introducer.

According to the invention, the tubular liner may be made of any flexible biocompatible material, such as, for example but not exclusively, the PNC.

Various other features of the invention emerge from the description below effectaée reference to the accompanying drawings which illustrate various embodiments of an implant according to the invention, as well as introducers devices for facilitating placement of said implant.

Furthermore, it should be noted that the various features of the invention, described above and below can be combined together according to different variants, depending on the condition being treated.

The fig. 1 is an elevation, in plan view, of an implant according to the invention for the treatment of rectocele.

The fig. 2 is an elevational, partially broken away, of a punch guide may be used for the introduction of the implant according to the invention and having an arcuate shape.

The fig. 3 is an elevation of another embodiment of a drill guide according to the invention having a helically shaped insertion end.

Fig. 4 is a left view of the perforator guide according to fig. 3. Fig. 5 is a bottom view of the punch shown in Fig. 3.

Fig. 6 is a view of an introducer according to the invention, allowing the introduction of the implant shown in FIG. 1. -. .

Fig. 7 is a view, similar to FIG. 1 showing an alternative embodiment of the implant according to the invention. Fig. 8 is a view, similar to FIG. 6, showing an introducer for introduction of the implant shown in FIG. 7. Fig. 9 to 12 are views, similar to Fig. 2-3, showing Punches guides of alternative embodiments for the introduction of an implant according to the invention.

FIGS. 13 and 14 are views, similar to FIG. 1 showing alternative embodiments of an implant according to the invention.

Fig. 15 is an anatomical view showing exemplary layout in a woman of an implant according to FIG. 14.

The invention provides an especially designed implant for the treatment of rectocele and denoted overall by the reference 1 in FIG. 1. The implant 1 has a thin flexible structure and is made of a suitable biocompatible material, such as, for example, synthetic material, woven or not, or, still, knitted, based on polypropylene or polyester fibers . Such synthetic material can then be coated or not products to promote cell growth. Similarly, the implant according to the invention may be realized in natural materials, such as "fascia latta" or, again, any biological or synthetic absorbable material.

According to the invention, the implant 1 comprises a support body 2 from which extend two upper suspension stabilizers 3, arranged on either sides of a sagittal plane S. The implant also comprises two lower suspension stabilizers 4, also disposed on either side of the sagittal plane S. these stabilizers act by performed by the muscles necking

In the example shown, the support body 2 has a substantially rectangular shape, without that such a shape can be considered as strictly necessary for the purposes of the invention, and the upper suspension stabilizers 3 each extend from an upper corner of the body 2. the lower suspension stabilizers 4 extend, in turn, each from one side of the support body 2 of rectangular shape.

Thus, in view of the arrangement of the lower suspension stabilizers 4 there is a kind of small lower apron 9 at the body 2 of the implant 1.

In the example shown, the lower suspension stabilizers 4 are born on one side of the support body 2 at a distance d from the upper edge 30 of the support body 2, equal to, preferably but not strictly necessary, between 60% and 87% of the length L 2 of the support body.

Preferably, the support body 2 is chosen to have a length L 2 between 60 mm and 90 mm and a width between 40 mm and 60 mm.

According to a preferred feature of the invention, the longitudinal axes A 3 of the upper stabilizers 3 form a oc angle greater than 45 °, preferably between 100 ° and 180 ° in being, more preferably, between 115 ° and 170 °. Moreover, according to the exemplary embodiment illustrated in FIG. 1, the axes A of the lower suspension stabilizers 4 form between them an angle β, non-zero, preferably greater than 10 ° and, according to this exemplary embodiment, an angle β of between 100 ° and 180 °. It should be noted that, preferably, the sagittal plane S corresponds to the implant plane of symmetry of one and is thus bisecting the angles α and β.

To allow easy placement of suspension stabilizers in their area corresponding insertion while providing optimal friction surface with the tissues crossed, the upper suspension stabilizers 3 and lower 4, respectively have a length L 3, L measured between the distal end of each suspension stabilizer and the body support 2, preferably but not necessarily, greater than 100 mm and, more preferably, greater than 120 mm. The suspension stabilizers have more a width of, preferably but not exclusively, between 5 mm and 15 mm and equal to, for example, about ten millimeters. The implant 1, as described above, is intended to be set up at the rectovaginal septum of a patient. To this end, in order to minimize the dissection of this region and the resulting trauma, the invention provides the surgeon performing the treatment using one or more elongated perforating guides 10, such as those specifically illustrated in Fig. 2 and 3-5.

Generally, such punch guide 10 comprises a body or elongate mandrel 11 whose one end 12 is intended to be introduced into the body of the subject to be treated and whose other end 13 is provided with a handle 14. It should be noticed that the insertion end 12 is preferably constituted by a blunt, that is to say an atraumatic tip which is not likely to hurt or cut the tissues in which it is to be introduced. According to one embodiment illustrated in FIG. 2, the punch guide 10 has an arcuate Fonne in one plane. This arcuate shape in a plane is more particularly adapted for the introduction of suspension stabilizers in the transperineal and transglutéales areas. Preferred but not strictly necessary the arcuate portion of the perforator guide then has a radius of curvature R of between 30 mm and 60 mm and, preferably, for the part 15 of the punch guide 10 extending between the handle 14 and the end 12, between 40 mm and 50 mm, the end portion 16 of the punch guide 10 then having a variable radius of curvature.

According to another embodiment of the perforator guide 10, illustrated in Fig. 3 to 5, the elongated body 11 of the guide 10 has an end 17 of helical shape, also suitable for implementation of suspension stabilizers in the upper or lower areas of the closed holes. Preferably, the distal end 17 of the perforator guide then has the shape of a portion of helical coil extending over an angle γ between 180 ° and 360 ° and preferably between 255 ° and 270 °. Similarly, preferably, the coil 17 of the perforator guide has a radius of curvature between 20 mm and 40 mm, with a pitch of between 15 mm and 25 mm.

The implant 1 according to the invention is preferably arranged so as to show no residual voltage after its introduction to some of its at least suspension stabilizers. To facilitate this surgical procedure, the invention provides a variant of intervention to implement an introducer more particularly shown in Fig. 6 and designated generally by reference 20.

This introducer has a flexible structure and shape similar to that of the implant. The introducer 20 is preferably made of a biocompatible polymeric material, of the family of plastics having a low coefficient of friction, such as, for example, polyethylene. The introducer 20 then comprises a hollow body 21 defining a receiving cavity of the body 2 of the implant 1. The introducer 20 also comprises tabular outriggers 22 which extend from the hollow body 21 and which each define a cavity for receiving a suspension stabilizer 3, 4 and 5 of the implant 1. Each tubular strap 22 then has traction means 23 extending from the free end of the corresponding strap 22. The pulling means 23 can be realized in any suitable manner as, for example, by hooking systems of the stabilizers of the ends 22 of a punch guide 10. In the example shown in FIG. 6, the traction means 23 compremient, for each strap 22, a flexible or semi-rigid with an atraumatic needle or blunt end. Such a needle may be made of the same material as the constituent material of the introducer 20 or more generally of a material selected from synthetic polymers having, preferably, a low friction coefficient.

The introducer 20 comprises, finally, cutting means 24, whose function will become apparent hereinafter, the hollow body 21 at least of the introducer 20. The cutting means 24 can then be made in any appropriate way and, according to the illustrated example, comprise a series of six apertures 24 made at the periphery of the hollow body 21, between each of the tabular stabilizers 22, to allow passage of a cutting tool to ensure cutting of the hollow body 21 along lines 25 materialized by broken lines in fig. 6. The implant 1 is disposed inside the hollow body 21 and the tabular stabilizers 22 being preferably free inside thereof, so that the forces exerted on the introducer 20 are not transmitted to the implant 1 itself.

Surgical treatment of rectocele, by means of an implant 1 and guides Punches 10 as described above, is effected as follows.

The patient to be treated is first of all subject to anesthesia that may be general or regional or still; local, according to the preferences of the surgeon and the health status of the patient. The operating position of the patient on the operating table will be that of the usual vaginal surgery, namely the buttocks of the patient slightly outside the operating table and thighs moderately flexed on the abdomen.

First, rectal wick is in place and is performed a ischémiante injection. Then comes a dissection of the area to receive the support body 2 of the implant 1 is exerted a pull on the cervix, to expose the posterior vaginal cul de sac. Vaginal incision is made on the posterior part of the cervix, transversely on the cervical side of the vaginal fornix well exposed by traction. This incision can be described as horizontal retrocervical. The portion of lower vaginal section thus formed is gripped in whole by means of for example three clips of Alis which are towed down by exposing the vaginal recto plan.

A rectovaginal separation is gradually led by releasing the posterior vaginal wall. This separation is stopped in the lower middle above the anal cape. The detachment is continued laterally along the dissection plane and in contact with the levator browsing, from bottom to top, the pubo- coccygeus beam, then ileococcygeus beam to arrive at the coccygeal muscle and ligament sacrosciatic. This dissection is carried out cautiously by repressing the peri-rectal fat and the rectum inwards. Note that there is then no structure to cut and it is sufficient to repress inside perirectal fat remaining in contact with the muscular floor. The most convenient method to perform this dissection is to use a finger, a compress and a set of long narrow vaginal valves (valves Breisky changed), since they allow a gradual opening under control for space without excessive enlargement allowing the introduction of a finger for performing dissection.

Once this dissection work, it is possible to proceed with the introduction of the implant 1, either naked or encapsulated in the introducer 20. It is first conducted the establishment of a first upper suspension stabilizer 3. to this end, a drill guide 10 curved to the surgeon, as previously described in connection with fig. 2 and 3 to 5, can be used. The punch guide 10 is then driven through the buttock of the patient by a puctifonne incision situated about 15 mm behind the midpoint of the line extending from the anus to the ischium. A finger slipped into the edge looseness in contact with the sacroiliac ligament previously executed then receive the tip of the punch guide so as to drive the latter in the lower vaginal incision. A traction element 23 of the introducer 20, in connection with an upper suspension stabilizer 3 is fixed in an eye 19 provided by the end of the punch guide 10 and the latter is withdrawn in opposite direction, so as to drive with it tabular ramp 22 of the introducer 20 and the stabilizer or upper suspension arm 3 which it contains. The towed ramp then passes through the sacrosciatic ligament. It should be noticed that in the absence of introducer 20, the distal end of the upper suspension stabilizer is fixed directly to the drill guide 10 to be towed.

The same gesture is made for the establishment of the second ramp, upper 3. The upper stabilizers 3 and passed to ensure transgluteal suspension are then waiting on pliers.

The lower suspension stabilizers 4 are then passed through the puborectalis muscle on either side of the anal canal and exteriorized through the same port that the gluteal upper stabilizers 3.

Once the four suspension stabilizers 3, 4 engaged, the introducer 20 is cut so as to release the implant 1. The withdrawal of the different components of the introducer 20 by traction exerted in pairs on the tabular stabilizers 22 opposite allows to deposit the implant 1, without any constraints on it, so it is in a state that could be described as relaxed. The supporting body 2 of the implant 1 is then fixed to the utero-sacral ligaments and the deck 9 of the underside of the cervix, by one or more and preferably three points of absorbable suture.

The posterior vaginal incision is then sutured with absorbable sutures and a traction is exerted on the upper suspension stabilizers 3 passing through the region to sacrosciatic back is open the vaginal vault. Any surplus of upper suspension stabilizers 3 and lower 4 can then be sectioned and the buttock orifices closed by dots made of resorbable suture.

The end of surgery, it is established vaginal wick and a urinary catheter will be removed forty-eight hours after surgery. Post-micturition residue then being measured by sampling, to ensure that the bladder emptying is satisfactory, so as to allow an output of the patient. The intervention for the treatment of rectocele will last about an hour and it is appropriate to adopt a mean hospital stay of four days.

The activity of the patient will be limited for a month and it should avoid bathing during the same period. Finally it will be necessary to provide an abstinence period of six weeks after the operation.

The previously proposed technique allows to treat only the disease, namely the imbalance of the pelvic floor and thus restore a more normal anatomy as possible keeping the body pattern of the individual. This technique, advantageously, to keep healthy or do not adversely affect the pelvic organs. Indeed, the malignancy has been ruled by the preoperative assessment and it will be possible to make after surgery reliable gynecological monitoring.

Moreover, there is very low risk of pelvic genital cancer and, in addition, the treatment proposed by the invention does not complicate future access to the genitals and rectal area.

According to the exemplary embodiment of the implant shown in Fig. 1, the lower suspension stabilizers 4 extend from the sides of the supporting body, however this is not strictly necessary for the embodiment of an implant according to the invention. And FIG. 7 shows an implant 39 according to the invention with four suspension stabilizers, two upper and two lower 3 4 extend from the four corners of the support body 2.

According to this embodiment, the axis A 3 of the upper suspension stabilizers form an angle α with the same characteristics as those of the implant 1 described above, while the axes A of the lower suspension stabilizers 4 form a β included angle, preferably but not exclusively between 10 ° and 75 °.

Furthermore, the lower suspension stabilizers 4 have an enlarged shape at their proximal ends 40 from the support body 2 so as to form a pre-rectal suspension zone Fig. 8 illustrates an example of introducer 20 is more particularly adapted to the shape of the implant 39.

The operation for the treatment of rectocele through the implant 39 is conducted as described previously with respect to the dissection of the rectovaginal region receiving the support body 2 and setting up the upper suspension stabilizers 3 and 4 below.

The extended portions 40 of the lower suspension stabilizers 4 can be fixed by sutures to absorbable puborectale levator muscles in the region.

Similarly, it may be envisaged to ensure the passage of the lower suspension stabilizers 4 through the perineum. This positioning of the pre-rectal hammock trans-perineal secures, advantageously, the perineal plane with high transgluteal suspension, so as to strengthen the descendants perineum. In the examples of treatment and operation described above, the input device used includes simple drills guides 10. However, in an attempt to minimize the trauma by abrasion of the tissue zones crossed, it can be envisaged to an ancillary work associating the punch guide 10 to a flexible sleeve 50 of shape complementary to that of the guide 10, as illustrated in FIGS. 9 and 10 to 13. The sleeve 50 is engaged on the perforator guide 10 which then has a stop or guard 51 on which the sleeve 50 abuts during introduction of the punch guide 10 in the body of the patient. The sleeve 50 is retained in the body of the patient after removal of the drill guide 10 and before the introduction of the implant 1, 39 and the liner used to create a channel for the passage of a traction element 23 of the introducer 20 and wherein a ramp 23 and the tabular stabilizer or suspension arms 3, 4 or a stabilizer or associated suspension arm only 3, 4 may be dragged, so as to adjust the position of the implant 1, 39 without abrading the tissues traversed. He then used a jacket 50 for the implementation of each suspension stabilizer 3, 4, 5. The sleeves 50 are then removed along with the tabular 23 straps wrapping the implant suspension stabilizers or when implant is placed naked -after adjusting the position of the implant.

Thus, the implementation of the sleeves 50 avoids acute inflammatory phenomena and reduced tissue trauma, since the implantation sites are composed of highly specialized muscle tissues that have lost much of their regeneration and rapid healing capabilities . According to the embodiments of the implants described above the upper suspension stabilizers 3 and lower 4 extend from the body of the implant in divergent and thus confers to the implant a form that could be described as star. However, this star foraie is strictly necessary for the realization of an implant according to the invention and for certain diseases, it may be necessary to have an implant whose suspension stabilizers do not diverge but to whose free ends of the upper stabilizers 3 and lower 4 stabilizers are directed downwards. In such a case the longitudinal axes A 3 of the upper stabilizers then form an angle α greater than 180 ° and preferably greater than 200 °.

Fig. 13 shows such an embodiment of an implant 51 according to the invention whose upper suspension stabilizers 3 extend from the sides of the body 52 of the implant at a distance from its upper edge while the two lower stabilizers 4 extend from the lower corners of the support body 52. ​​This particular configuration then defines a sort of top panel 53, provided with two holes 54 for the passage of an insert strip stabilization or for the passage of the posterior stabilizers of a previous prosthesis used in conjunction with the implant according to the invention, once the stabilizers of said anterior prosthesis have trans-set the uterosacral ligaments. Moreover, according to the embodiment illustrated in FIG. 13, the axis A 3 of the upper suspension stabilizers 3 form an angle α more particularly between 210 ° and 260 °, while the axes A four lower suspension stabilizers 4 form an angle β less than 45 ° and preferably zero.

Fig. 14 illustrates yet another alternative embodiment of an implant 55 for the treatment of vaginal vault prolapse and rectocele whose suspension stabilizers are all oriented downwardly. According to this variant, the body 56 of the implant has a rectangular shape. Both stabilizers "of upper 3 and the two lower suspension stabilizers suspension 4 then extend respectively from upper and lower corners of the support body 56. According to this example stabilizers upper suspensions 3 are arcuate and moyemies fibers A 3 which are equivalent to axes a 3 in the case of an arm or a straight stabilizer form an angle α greater than 180 °. the angle α is measured between two tangents of the average fiber upper suspension stabilizers. it should be noted that the concavity of the upper suspension stabilizers 3 is oriented downward.

According to the embodiment shown Fig. 14, the implant 55 further includes average suspension stabilizers 57 disposed on either side of the sagittal plane S and between the upper 3 and lower stabilizers 4. The ends of the suspension means stabilizers are directed downwards and their as axes form an angle φ preferably greater than 200 ° and more preferably between 210 ° and 260 °. In addition, the ends of the upper stabilizers 3 and means 57 located on the same side of the sagittal plane S converge towards a point or at least substantially in the same direction as shown in Fig.14, this feature facilitates the procedure for implanting as is apparent from the result.

The establishment of the prosthesis as shown in Fig.14 and described above for the treatment of prolapse of the vaginal dome and rectocele comprises, after anesthesia of the patient dissection phase. Then it is used a clamp which Muze that a traction on the cervix at the end to expose the cul-de-sac posterior vaginal. Vaginal incision is made on the posterior surface of the cervical transversely on the cervical side of the vaginal cul-de-sac well exposed by traction. The wafer posterior vaginal section is gripped in its entirety by 3 clips ALIS which are towed down exposing the rectovaginal plane. The rectovaginal separation is gradually led by everting the posterior vaginal wall. This separation is stopped in the lower middle above the anal cape. Any dissection of the anal front plan is useless, see harmful because it is a non-anatomically but obviously created by surgery. It should be laterally dissect dissection plane and in contact with the levator browsing low éή up the pubococcygeus beam then ileococcygeus beam to arrive at the coccygeal muscle and ligament sacrosciatic. This dissection is carried out cautiously, pushing back the perirectal fat and the rectum inwards. There is no structure to be cut; simply repress inside the peri-rectal fat remaining in contact with the muscular floor. The most convenient is to use the finger, compress, and especially a set of two long narrow vaginal valves; they gradually open under visual control space without excessive enlargement of the dissected space which a finger.

Then a punch guide 10 is passed through the buttocks through an incision punctiform 60 located 15 mm behind the midpoint of the line extending from the anus to the ischium as shown in fig.15. The finger slipped into the edge looseness in contact with the sacroiliac ligament will receive the tip of the punch guide 10 and drive it into the posterior vaginal incision one end of an upper stabilizer 3 of the implant is fixed to the guide perforator 10 and pulled through the sacrospinous ligament (sacrosciatic suspension), the same gesture is made from the other side to the other upper stabilizer of the implant 55. the upper edge of the implant is then sutured by 2-4 points at the posterior surface of the isthmus and uterosacral ligaments. The two free ends of the upper outriggers 3 of the implant are then queued on clamp. Stabilizers suspension means 57, so-called puborectale suspension are passed through puborectaux muscles by a transperineal route using the same posterior inlet for the upper suspension stabilizers but with an orientation within to emerge 1/3 average height of vaginal prolapse through the puborectal muscle. lower suspension stabilizers, said perineal still are, in turn, passed to either side of the fork vulvar through a perforator guide 10 it is more prudent to introduce within outward (top to lower) than from bottom to top, as in this sense, in its stroke, the instrument is close to the rectum and may threaten.

End of the procedure, the posterior vaginal incision is sutured with absorbable suture and an average pulling force is exerted on the upper suspension stabilizers and means to open up in the vaginal vault, and position without undue tension pre hammock rectal.

The operation is then completed as has been described above.

Claims

1 - implant, for the treatment of rectocele and / or vaginal vault prolapse, having a thin and flexible structure, characterized in that it comprises a supporting body (2) from which extend at least:
B two upper suspension stabilizers (3), which are arranged on both sides of a sagittal plane (S) and whose longitadinaux axes (A 3) form between them an angle (α) greater than 45 ° , "and two lower suspension stabilizers (4), arranged on either side of the sagittal plane (S).
2 - implant according to claim 1, characterized in that the longitadinaux axes (A 3) of the upper struts (3) form an angle (α) between 100 ° and 180 °.
3 - implant according to claim 1, characterized in that the angle (α) is between 115 ° and 170 °.
4 - An implant according to Claim 1, characterized in that the free end of the upper struts (3) and lower stabilizers (4) are directed downwards.
5 - An implant according to Claim 4, characterized in that the longitadinaux axes (A 3) of the upper stabilizers form an angle (α) greater than 180 ° and preferably greater than 200 °.
6 - The implant of claim 4 or 5, characterized in that the upper struts (3) are arched.
7 - An implant according to one of Claims 4 to 6, characterized in that it comprises two means of suspension stabilizers (57) disposed on either side of the sagittal plane (S) and between the upper struts (3) and lower (4).
8 - An implant according to claim 7, characterized in that the ends of the upper stabilizer and the stabilizer means located on the same side relative to the sagittal plane (S) substantially converge towards the same point. 9 - An implant according to one of claims 1 to 8, characterized in that the longitadinaux axes (A 4) of the lower stabilizers (4) form between them an angle (β) non-zero. 10 - An implant according to Claim 9, characterized in that the angle (β) is greater than 10 °.
11 - The implant of claim 9_ characterized in that the angle (β) is between 10 ° and 75 °. 12 - An implant according to claim 9 5, characterized in that the angle (β) is between 100 ° and 180 °.
13 - An implant according to one of claims 1 to 12, characterized in that the upper struts (3) have a length greater than 100 mm and preferably greater than or equal to 120 mm. 14 - An implant according to one of claims 1 to 13, characterized in that the lower support struts (4) have a length greater than 100 mm and preferably greater than or equal to 120 mm.
15 - An implant according to one of claims 1 to 14, characterized in that the support body (2) has a substantially rectangular general shape. 16 - An implant according to claim 15, characterized in that the support body
(2) has a length (L) of between 60 and 90 mm and a width between 40 and 60 mm.
17 - An implant according to one of Claims 15 or 16, characterized in that the lower support struts (4) extend substantially from the lower corners of the support body (2).
18 - An implant according to claims 15 to 17, characterized in that the upper struts (3) extend substantially from the upper corners of the support body.
19 - Implant according to one of claims 15 to 17, characterized in that the lower support struts (4) extend from the two longitudinal sides of the supporting body (2).
20 - The implant of claim 19, characterized in that each of the lower support struts (4) extends at a distance (d) of the upper edge of the support body (2) being between 60% and 87% of the length (L 2) of the supporting body (2). 21 - Implant according to one of claims 15 to 17, characterized in that the upper struts (3) extend from both longitudinal sides of the supporting body (2). 22 - An implant according to one of claims 1 to 21, characterized in that the body of the implant has, in its upper region, at least two orifices for the passage of the rearward support struts of a previous prosthesis once ceux- these have transfixé uterosacral ligaments. 23 - Device for introducing an implant (1, 39) according to one of claims 1 to 22, characterized in that it includes an introducer (10) having a flexible structure and a shape similar to that of the implant and which comprises:
"A hollow body (21) defining a receiving cavity of the carrier body (2) of the implant (1),
"Tabular straps (22) extending from the hollow body (21) and each defining a cavity for receiving a suspension stabilizer (3, 4) of the implant (1, 39), • means traction (23) extending from the end of each of shoulder straps (22) of the introducer,
"And means (24) for cutting the hollow body (21) at least of the introducer (20).
24 - An introduction device according to claim 23, characterized in that the traction means comprise, for each tubular strap (22), a rigid needle (23).
25 - An introduction device according to claim 23 or 24, characterized in that the cutting means comprise at least one opening (24) for the passage of a cutting instrument.
26 - An introduction device according to one of claims 23 to 25, characterized in that it comprises an implant (1, 39) according to one of claims 1 to 20, disposed in the cavity of the hollow body (21) and tabular straps (22).
27 - An introduction device according to claim 26, characterized in that the implant (1, 39) is free inside the inserter device.
28 - An introduction device according to claims 23 to 27, characterized in that it further comprises a punch guide (10) or elongated trocar having one end (12) is intended to be introduced into the body of the patient and the other end (13) is provided with a handle (14). 29 - An introduction device according to claim 28, characterized in that the perforator guide (10) has an arcuate shape in a plane.
30 - An introduction device according to claim 29, characterized in that the arcuate portion (15) of the perforator (10) extends over an angular sector greater than 140 ° and preferably less than 180 °, so preferably, between 150 ° and 170 °.
31 - An introduction device according to claim 29 or 30, characterized in that the arcuate portion (15) of the perforator guide then has a radius of curvature between 30 mm and 60 mm and, preferably, for the part of the perforator guide extending between the handle and the end intended to be introduced into the patient's body, between 40 mm and 50 mm.
32 - An introduction device according to claim 28, characterized in that the perforator guide (10) has, at its end (17) opposite the handle or distal, helically. 33 - An introduction device according to claim 32, characterized in that the perforator guide (10) has the shape of a portion of helical coil extending over an angle between 180 ° and 360 ° and, preferably, including between 255 ° and 270 °.
34 - An introduction device according to claim 33, characterized in that the spire of the perforator guide has a radius of curvature between 20 mm and
40 mm, with a pitch of between 15 mm and 25 mm.
35 - An introduction device according to one of claims 28 to 34, characterized in that it further comprises a removable tubular jacket (50) of shape complementary to that of the perforator guide (10) intended to be engaged on the perforator guide (10) and to remain in the body of the patient after removal of the perforator guide (10) to define a tunnel for passage of the traction means (23) of the introducer (10). -
36 - Method for treating the rectocele in a woman, characterized in that it includes the following: "implement an implant (1, 39) according to claim 1
"Place the implant in the body of the patient to be treated with: - upper suspension stabilizers (3) through the gluteal region,
- lower suspension stabilizers (4) through the puborectale region, - the support body (2) at the utérosacrée region.
37 - Method for treating the rectocele in a woman, characterized in that it includes the following: π implement an implant (1, 39) according to one of claim 1 to 22 "place the implant in the body of the patient to be treated with:
- upper suspension stabilizers (3) through the sacrosciatic region,
- lower suspension stabilizers (4) through the puborectale region, - and the support body (2) at the utérosacrée region.
38 - Method for treating the rectocele in a woman, characterized in that it includes the steps of:
"Implement an implant (55) according to claim 7 or 8," placing the implant in the body of the patient to be treated with: - upper suspension stabilizers (3) through the sacrosciatic region,
- medium suspension of the stabilizers (57) through the puborectale region,
- lower suspension stabilizers (4) through the perineal region,
- and the supporting body (56) is in the rectovaginal septum,
39 - A method of treatment according to claim 38, characterized in that the upper part of the implant is supported by the rearward support struts of a previous prosthesis.
EP20040742369 2003-03-28 2004-03-26 Implant for treatment of a rectocele and device for placement of said implant Withdrawn EP1610714A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FR0303893A FR2852817B1 (en) 2003-03-28 2003-03-28 Implant for the treatment of rectocele and device for the implementation of this implant
FR0303895A FR2852818B1 (en) 2003-03-28 2003-03-28 Implant for the treatment of cystocele and device for the implementation of this implant
PCT/FR2004/000765 WO2004091442A2 (en) 2003-03-28 2004-03-26 Implant for treatment of a rectocele and device for placement of said implant

Publications (1)

Publication Number Publication Date
EP1610714A2 true EP1610714A2 (en) 2006-01-04

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EP20040742369 Withdrawn EP1610714A2 (en) 2003-03-28 2004-03-26 Implant for treatment of a rectocele and device for placement of said implant

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US (2) US7588598B2 (en)
EP (1) EP1610714A2 (en)
AU (1) AU2004229194B2 (en)
BR (1) BRPI0408903A (en)
CA (1) CA2520818A1 (en)
RU (1) RU2005131716A (en)
WO (1) WO2004091442A2 (en)

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US8337391B2 (en) 2012-12-25
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US20040249473A1 (en) 2004-12-09
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