EP1465549A2 - Implantable prosthesis for correcting effort-related urinary incontinence in women - Google Patents

Implantable prosthesis for correcting effort-related urinary incontinence in women

Info

Publication number
EP1465549A2
EP1465549A2 EP03712240A EP03712240A EP1465549A2 EP 1465549 A2 EP1465549 A2 EP 1465549A2 EP 03712240 A EP03712240 A EP 03712240A EP 03712240 A EP03712240 A EP 03712240A EP 1465549 A2 EP1465549 A2 EP 1465549A2
Authority
EP
European Patent Office
Prior art keywords
prosthesis according
strip
strips
prosthesis
bulge
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Withdrawn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
EP03712240A
Other languages
German (de)
French (fr)
Inventor
Richard Cancel
Richard Wallace
Gérard Sassi
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.)
Individual
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Publication of EP1465549A2 publication Critical patent/EP1465549A2/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure 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
    • A61F2/0036—Closure 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners

Definitions

  • the present invention relates to a prosthesis intended to correct stress urinary incontinence in women.
  • Patent application FR-A-2787990 relates to a prosthesis consisting of two identical right and left hemi-prostheses, each hemi-prosthesis comprising a mesh fixed to the vaginal wall, to which a wire is hung, the other end of which is fixed to the base of the rectus muscles.
  • the mesh is a sub-urethral element on which the bladder neck rests.
  • the prostheses of the prior art represent a certain number of risks for the patient, and in particular the risk of a tearing of the bladder or of damage caused to the bladder neck or to the urethra at the time of the installation of the prosthesis.
  • Suburethral materials present also drawbacks to use, preventing or hindering urination.
  • the prosthesis according to the invention overcomes the drawbacks of prostheses of the prior art, and a first objective of the invention is to provide a prosthesis which can be placed definitively by means of a simple surgical operation, without risk of damaging the organs and in particular without risk of tearing of the bladder or the urethra.
  • a second objective of the invention is to propose a prosthesis which corrects the hypermobility of the urethra during an effort, this hypermobility causing a phenomenon of incontinence.
  • a third objective of the invention is to maintain the natural angle at the level of the bladder neck.
  • the object of the present invention is therefore to provide a prosthesis intended to correct urinary stress incontinence in women, characterized in that it comprises two right and left para-urethral hemi-prostheses, each of said hemi-prostheses being constituted by a biocompatible material and in the form of a strip, one end of which has a bulge and the other end of which, called a free end, is intended to be fixed to the aponeurosis of the great rights, as well as means of fixation of this so-called free end to the aponeurosis of the great rights.
  • said bulge is a pad secured to only one of the two ends of each strip.
  • these bulges or pads are supported under the perineal musculo-aponeurotic floor on either side of the urethra and the strips are located in the Retzius space in front of the bladder, cross the abdominal wall above the pubic symphysis and are attached to the aponeurosis of the rectus.
  • the prosthesis according to the invention is also characterized in that it does not include a sub-urethral apparatus.
  • the strips and pads are made of a material acceptable for long-term implants. This material is preferably polypropylene of acceptable grade for implants intended to remain in place in the human body for an indefinite period of time.
  • the section of each of the strips is between 1 and 15 mm, preferably 4 to 10 mm, advantageously equal to 6.5 mm.
  • the length of the strips, not including the bulge is between 100 mm and 300 mm, preferably 170 to 270 mm, advantageously equal to 210 or 220 mm.
  • the length of the bulge is between 10 mm and 30 mm, preferably 20 mm, and the section of the bulge is between 5 mm and 20 mm, preferably 10 mm.
  • the bulge is octagonal in shape.
  • the strips comprise non-return notches, which are preferably made of a material acceptable for the manufacture of long-lasting implants.
  • This material is preferably silicone of acceptable grade for implants intended to remain in place in the human body for an indefinite period of time.
  • the non-return notches are molded over all or part of each strip. They are preferably overmolded over a length of 30 to 80 mm, preferably about 60 mm at a distance of 10 to 50 mm, preferably 30 mm from the end of the strip having a bulge.
  • the section of the strip-non-return notch assembly is, at the location of the overmolding, greater than the section of the bare strip.
  • the section of the non-return strip-notch assembly is between 3 and 20 mm, preferably 5 to 15 mm, advantageously equal to 11 mm.
  • the strips are provided with non-return notches (7) which are hollowed out or cut manually or mechanically from the material constituting the strip.
  • these non-return notches are hollowed out at a distance of 10 to 40 mm, preferably 30 mm, from the base of the pad.
  • they are provided over a length of 30 to 70 mm, preferably 50 mm.
  • the strip is molded in a notched mold.
  • the notches circularly start the strip.
  • the notches are spaced from each other by a space of 2 mm.
  • a propylene wire is welded between the 2 polypropylene strips.
  • the means for fixing the strips to the aponeurosis of the great rights are wires.
  • the so-called free end of the strip is secured to a fixing wire.
  • This fixation wire is used for the positioning of the prosthesis by means of a needle through the eye of which the said fixation wire is passed, the passage of the needle through the Retzius space causing the establishment of the prosthesis.
  • the fixing wire is then used to suture the strip on the aponeurosis of the great rights.
  • these fixing means are means for bonding the strips.
  • these fixing means are autostatic means.
  • FIG. 1 is a top view in perspective of one of the two hemi-prostheses constituting the prosthesis according to the invention comprising non-return molded notches;
  • FIG. 2 is a top view of one of the two hemi-prostheses constituting the prosthesis according to the invention comprising non-return notches hollowed out in the material constituting the strip;
  • Figure 3 shows a detail of Figures 1 and 2, namely the bulge (5).
  • FIGS. 1 and 2 each show one of the two hemi-prostheses constituting the prosthesis of the invention.
  • hemi-prostheses (1) each consist of a strip (2) of which one end (3), called free, is intended to be fixed to the fascia of the great right and whose other end (4) has a pad (5) intended to be placed in a para-urethral box fitted during the intervention.
  • the strip (2) must be of sufficient length to cross the Retzius space from the aponeurosis of the rectus to the urethra.
  • the length of the strip (2), not including the pad (5) is between 100 and 300 mm.
  • the function of the strip (2) is to hold the pad (5) in place: it is a fastening strip. It also has a traction function, due to its tensioning, and it is the combination of these fixing and traction functions which ensure the perfect holding in place of the hemi-prosthesis and its efficiency.
  • the strip (2) also has non-return silicone notches which are overmolded on the polypropylene strip and further reinforce the holding in place of the strip. In addition, over time, the unmolded parts of the polypropylene strip (2) will be colonized in the human body by cells and this colonization further strengthens the holding in place of the strip.
  • Figure 1 shows a strip provided with non-return notches (7) molded onto the strip. These non-return notches (7) will have a mechanical function of retaining the strip near the pad.
  • FIG. 2 shows a strip provided with non-return notches (7) hollowed out in the strip or formed in the strip during molding, by a special mold comprising corresponding lugs. These non-return notches have the same mechanical function of retaining the strip near the pad.
  • Figure 3 shows a bulge (5) which is a pad that can be made of the same material as the strip or in another biocompatible material for long-term implants. It can be molded at the same time as the strip (2) or separately and in the latter case, be secured to the strip (2) by any suitable means, in particular by welding.
  • This cushion (5) has the particular function of preventing hypermobility of the urethra at the precise moment of the effort. Its elongated octagonal shape is a preferred variant of the invention.
  • each hemi-prosthesis (1) requires a light surgical intervention, during which a longitudinal sub-urethral incision of three centimeters is made and then a detachment is made in order to provide a para-urethral stall, on the right and on the left. , up to the pelvic fascia. It is in this cubicle that the bulge located at the end of each hemi-prosthesis will be positioned.
  • a skin incision to the left and right of the pubic symphysis is made and extended to the aponeurosis of the rectus in order to penetrate the Retzius space.
  • a needle is used through which a wire (6) is passed which is connected to the free end (3) of the strip (2).
  • the needle is passed through the Retzius space, keeping bone contact and allows the insertion of the strip (2).
  • the vaginal incision is closed with absorbable wires.
  • the effectiveness of the tension of the strip (2) is then adjusted and tested. We fill the bladder with 300cc of physiological saline and the bladder is pressed until the tension of the strip (2) prevents the passage of the liquid.
  • the free end (3) of the strip (2) is then fixed to the aponeurosis of the great rights by a suture.
  • the prosthesis according to the invention can therefore be put in place easily, and requires only slight intervention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Disclosed is a prosthesis for correcting effort-related urinary incontinence in women, comprising one left and one right para-urethral hemi-phrosthesis (1), each of which is made of a biocompatible material in the form of a strip (2). One end (4) of said strip (2) has an extension (5) while the other end (3), called the loose end, is fixed to the aponeurosis of the rectus abdominis muscle. The inventive prosthesis is also provided with fixing means (6) for fixing said loose end (3) to the aponeurosis of the rectus abdominis muscle.

Description

PROTHESE IMPLANTABLE DESTINEE A CORRIGER L'INCONTINENCE URINAIRE D'EFFORT CHEZ LA FEMME. IMPLANTABLE PROSTHESIS FOR CORRECTING URINARY EFFORT INCONTINENCE IN WOMEN.
La présente invention concerne une prothèse destinée à corriger l'incontinence urinaire d'effort chez la femme.The present invention relates to a prosthesis intended to correct stress urinary incontinence in women.
L'incontinence urinaire d'effort est une pathologie qui apparaît le plus souvent à la suite d'un traumatisme obstétrical. Les ligaments soutenant la vessie se distendent, et la vessie se déplace vers le bas, sortant de l'enceinte pelvienne qui, en temps normal, la soutient. L'angle de la vessie au niveau du col vésical s'ouvre, et lors d'un effort du type éternuement, l'urètre qui n'est plus protégé par l'enceinte pelvienne, subit la totalité de la pression engendrée par l'effort et un phénomène d'incontinence se produit.Stress urinary incontinence is a pathology that appears most often following an obstetrical trauma. The ligaments supporting the bladder become distended, and the bladder moves downward, leaving the pelvic wall, which normally supports it. The angle of the bladder at the level of the bladder neck opens, and during a sneeze-type effort, the urethra, which is no longer protected by the pelvic enclosure, undergoes all of the pressure generated by the effort and a phenomenon of incontinence occurs.
Ce phénomène est connu depuis longtemps, et différentes solutions ont été envisagées dans l'art antérieur. La demande internationale O00/15140 propose une prothèse intra-urétrale, le document EP-A-498912 propose une prothèse sous urétrale destinée à être implantée pour une période de temps limitée au niveau du vagin. La demande de brevet FR-A-2787990 concerne une prothèse constituée de deux hémi-prothèses droite et gauche identiques, chaque hémi-prothèse comprenant une résille fixée à la paroi vaginale, à laquelle est accroché un fil dont l'autre extrémité est fixée à la base des muscles grands droits. La résille est un élément sous-urétral sur lequel repose le col vésical. Les prothèses de l'art antérieur représentent un certain nombre de risques pour le patient, et notamment le risque d'un déchirement de la vessie ou d'un dommage causé au col vésical ou à l'urètre au moment de la mise en place de la prothèse. Les matériaux sous-urétraux présentent aussi des inconvénients à l'usage, en empêchant ou en gênant la miction.This phenomenon has been known for a long time, and various solutions have been envisaged in the prior art. The international application O00 / 15140 proposes an intra-urethral prosthesis, the document EP-A-498912 proposes a prosthesis under urethral intended to be implanted for a limited period of time in the vagina. Patent application FR-A-2787990 relates to a prosthesis consisting of two identical right and left hemi-prostheses, each hemi-prosthesis comprising a mesh fixed to the vaginal wall, to which a wire is hung, the other end of which is fixed to the base of the rectus muscles. The mesh is a sub-urethral element on which the bladder neck rests. The prostheses of the prior art represent a certain number of risks for the patient, and in particular the risk of a tearing of the bladder or of damage caused to the bladder neck or to the urethra at the time of the installation of the prosthesis. Suburethral materials present also drawbacks to use, preventing or hindering urination.
La prothèse selon l'invention permet de surmonter les inconvénients des prothèses de l'art antérieur, et un premier objectif de l'invention est de fournir une prothèse qui puisse être mise en place de manière définitive au moyen d'une opération chirurgicale simple, sans risque d'abîmer les organes et notamment sans risque de déchirure de la vessie ni de l'urètre. Un second objectif de l'invention est de proposer une prothèse qui corrige l'hypermobilité de l'urètre au moment d'un effort, cette hypermobilité entraînant un phénomène d' incontinence .The prosthesis according to the invention overcomes the drawbacks of prostheses of the prior art, and a first objective of the invention is to provide a prosthesis which can be placed definitively by means of a simple surgical operation, without risk of damaging the organs and in particular without risk of tearing of the bladder or the urethra. A second objective of the invention is to propose a prosthesis which corrects the hypermobility of the urethra during an effort, this hypermobility causing a phenomenon of incontinence.
Un troisième objectif de l'invention est de maintenir l'angle naturel au niveau du col vésical.A third objective of the invention is to maintain the natural angle at the level of the bladder neck.
La présente invention a donc pour objet de fournir une prothèse destinée à corriger l'incontinence urinaire d'effort chez la femme caractérisée en ce qu'elle comprend deux hémi-prothèses para-urétrales droite et gauche, chacune desdites hémi-prothèses étant constituée en un matériau biocompatible et se présentant sous la forme d'une bandelette dont l'une des extrémités présente un renflement et dont l'autre extrémité, dite libre, est destinée à être fixée sur l'aponévrose des grands droits, ainsi que des moyens de fixation de cette extrémité dite libre à l'aponévrose des grands droits.The object of the present invention is therefore to provide a prosthesis intended to correct urinary stress incontinence in women, characterized in that it comprises two right and left para-urethral hemi-prostheses, each of said hemi-prostheses being constituted by a biocompatible material and in the form of a strip, one end of which has a bulge and the other end of which, called a free end, is intended to be fixed to the aponeurosis of the great rights, as well as means of fixation of this so-called free end to the aponeurosis of the great rights.
Suivant un mode de réalisation particulier de l'invention, ledit renflement est un coussinet solidarisé à une seule des deux extrémités de chaque bandelette. Lorsque la prothèse est en position, ces renflements ou coussinets prennent appui sous le plancher musculo-aponévrotique périnéal de la femme de part et d'autre de l'urètre et les bandelettes sont situées dans l'espace de Retzius en avant de la vessie, traversent la paroi abdominale au-dessus de la symphyse pubienne et sont fixées à l'aponévrose des grands droits.According to a particular embodiment of the invention, said bulge is a pad secured to only one of the two ends of each strip. When the prosthesis is in position, these bulges or pads are supported under the perineal musculo-aponeurotic floor on either side of the urethra and the strips are located in the Retzius space in front of the bladder, cross the abdominal wall above the pubic symphysis and are attached to the aponeurosis of the rectus.
La prothèse selon l'invention est aussi caractérisée en ce qu'elle ne comprend pas d'appareil sous- urétral.The prosthesis according to the invention is also characterized in that it does not include a sub-urethral apparatus.
Les bandelettes et les coussinets sont fabriqués en un matériau acceptable pour les implants de longue durée. Ce matériau est de préférence du polypropylène de grade acceptable pour les implants destinés à rester en place dans le corps humain pendant une période de temps indéfinie.The strips and pads are made of a material acceptable for long-term implants. This material is preferably polypropylene of acceptable grade for implants intended to remain in place in the human body for an indefinite period of time.
Suivant un mode de réalisation avantageux de l'invention, la section de chacune des bandelettes est comprise entre 1 et 15 mm, de préférence 4 à 10 mm, avantageusement égale à 6,5 mm.According to an advantageous embodiment of the invention, the section of each of the strips is between 1 and 15 mm, preferably 4 to 10 mm, advantageously equal to 6.5 mm.
Suivant un mode de réalisation préféré de l'invention, la longueur des bandelettes, non inclus le renflement, est comprise entre 100 mm et 300 mm, de préférence 170 à 270 mm, avantageusement égale à 210 ou 220 mm.According to a preferred embodiment of the invention, the length of the strips, not including the bulge, is between 100 mm and 300 mm, preferably 170 to 270 mm, advantageously equal to 210 or 220 mm.
Avantageusement, la longueur du renflement est comprise entre 10 mm et 30 mm, de préférence 20 mm, et la section du renflement est comprise entre 5 mm et 20 mm, de préférence 10 mm. Suivant une variante de l'invention, le renflement est de forme octogonale.Advantageously, the length of the bulge is between 10 mm and 30 mm, preferably 20 mm, and the section of the bulge is between 5 mm and 20 mm, preferably 10 mm. According to a variant of the invention, the bulge is octagonal in shape.
Suivant un mode de réalisation avantageux de l'invention, les bandelettes comprennent des crans antiretour, qui sont de préférence dans un matériau acceptable pour la fabrication des implants de longue durée. Ce matériau est de préférence du silicone de grade acceptable pour les implants destinés à rester en place dans le corps humain pendant une période de temps indéfinie. Suivant une première variante de l'invention, les crans anti-retour sont surmoulés sur tout ou partie de chaque bandelette. Ils sont de préférence surmoulés sur une longueur de 30 à 80 mm, de préférence environ 60 mm à une distance de 10 à 50 mm, de préférence 30 mm par rapport à l'extrémité de la bandelette comportant un renflement. Le cran anti-retour étant surmoulé au-dessus du corps de la bandelette, la section de l'ensemble bandelette-cran antiretour est, à l'endroit du surmoulage, supérieure à la section de la bandelette nue. De préférence, la section de l'ensemble bandelette-cran anti-retour est comprise entre 3 et 20 mm, de préférence 5 à 15 mm, avantageusement égale à 11 mm.According to an advantageous embodiment of the invention, the strips comprise non-return notches, which are preferably made of a material acceptable for the manufacture of long-lasting implants. This material is preferably silicone of acceptable grade for implants intended to remain in place in the human body for an indefinite period of time. According to a first variant of the invention, the non-return notches are molded over all or part of each strip. They are preferably overmolded over a length of 30 to 80 mm, preferably about 60 mm at a distance of 10 to 50 mm, preferably 30 mm from the end of the strip having a bulge. The non-return notch being overmolded above the body of the strip, the section of the strip-non-return notch assembly is, at the location of the overmolding, greater than the section of the bare strip. Preferably, the section of the non-return strip-notch assembly is between 3 and 20 mm, preferably 5 to 15 mm, advantageously equal to 11 mm.
Suivant une autre variante de l'invention, les bandelettes sont munies de crans anti-retour (7) qui sont creusés ou découpés manuellement ou mécaniquement dans le matériau constitutif de la bandelette. De préférence, ces crans anti-retours sont creusés à une distance de 10 à 40 mm, de préférence 30 mm, de la base du coussinet. Avantageusement, elles sont ménagées sur une longueur de 30 à 70 mm de préférence 50 mm.According to another variant of the invention, the strips are provided with non-return notches (7) which are hollowed out or cut manually or mechanically from the material constituting the strip. Preferably, these non-return notches are hollowed out at a distance of 10 to 40 mm, preferably 30 mm, from the base of the pad. Advantageously, they are provided over a length of 30 to 70 mm, preferably 50 mm.
Suivant une autre variante de l'invention, la bandelette est moulée dans un moule à encoches. De préférence, les encoches entament circulairement la bandelette. Suivant un mode de réalisation préféré, les encoches sont écartées les unes des autres par un espace de 2 mm.According to another variant of the invention, the strip is molded in a notched mold. Preferably, the notches circularly start the strip. According to a preferred embodiment, the notches are spaced from each other by a space of 2 mm.
Suivant un autre mode de réalisation de l ' invention, un fil de propylène est soudé entre les 2 bandelettes de polypropylène . Suivant un mode de réalisation préféré de l'invention, les moyens de fixation des bandelettes à l'aponévrose des grands droits sont des fils. Dans ce mode de réalisation, l'extrémité dite libre de la bandelette est solidarisée à un fil de fixation. Ce fil de fixation est utilisé pour la mise en place de la prothèse au moyen d'une aiguille dans le chas de laquelle on passe ledit fil de fixation, le passage de l'aiguille dans l'espace de Retzius entraînant la mise en place de la prothèse. Le fil de fixation sert ensuite à la suture de la bandelette sur l'aponévrose des grands droits.According to another embodiment of the invention, a propylene wire is welded between the 2 polypropylene strips. According to a preferred embodiment of the invention, the means for fixing the strips to the aponeurosis of the great rights are wires. In this embodiment, the so-called free end of the strip is secured to a fixing wire. This fixation wire is used for the positioning of the prosthesis by means of a needle through the eye of which the said fixation wire is passed, the passage of the needle through the Retzius space causing the establishment of the prosthesis. The fixing wire is then used to suture the strip on the aponeurosis of the great rights.
Suivant un autre mode de réalisation de l'invention, ces moyens de fixation sont des moyens de collage des bandelettes.According to another embodiment of the invention, these fixing means are means for bonding the strips.
Suivant un troisième mode de réalisation de l'invention, ces moyens de fixation sont des moyens autostatiques .According to a third embodiment of the invention, these fixing means are autostatic means.
D'autres caractéristiques et avantages de la prothèse selon l'invention ressortiront de l'exemple de réalisation non limitatif qui suit, qui se lit au regard des figures annexées.Other characteristics and advantages of the prosthesis according to the invention will emerge from the following nonlimiting exemplary embodiment, which can be read with reference to the appended figures.
- la figure 1 est une vue du dessus en perspective de l'une des deux hémi-prothèses constitutives de la prothèse selon l'invention comportant des crans anti-retour surmoulés ;- Figure 1 is a top view in perspective of one of the two hemi-prostheses constituting the prosthesis according to the invention comprising non-return molded notches;
- la figure 2 est une vue de dessus de l'une des deux hémi-prothèses constitutives de la prothèse selon l'invention comportant des crans anti-retour creusés dans le matériau constitutif de la bandelette ;- Figure 2 is a top view of one of the two hemi-prostheses constituting the prosthesis according to the invention comprising non-return notches hollowed out in the material constituting the strip;
- la figure 3 montre un détail des figures 1 et 2, à savoir le renflement (5).- Figure 3 shows a detail of Figures 1 and 2, namely the bulge (5).
Les deux hémi-prothèses droite et gauche de l'invention étant strictement identiques, les figures 1 et 2 montrent chacune l'une des deux hémi-prothèses constitutives de la prothèse de l'invention.The two right and left hemi-prostheses of the invention being strictly identical, FIGS. 1 and 2 each show one of the two hemi-prostheses constituting the prosthesis of the invention.
Ces hémi-prothèses (1) sont constituées chacune par une bandelette (2) dont une extrémité (3), dite libre, est destinée à être fixée à l'aponévrose des grands droits et dont l'autre extrémité (4) présente un coussinet (5) destiné à venir se placer dans une logette para-urétrale aménagée lors de l'intervention.These hemi-prostheses (1) each consist of a strip (2) of which one end (3), called free, is intended to be fixed to the fascia of the great right and whose other end (4) has a pad (5) intended to be placed in a para-urethral box fitted during the intervention.
La bandelette (2) doit être d'une longueur suffisante pour traverser l'espace de Retzius depuis l'aponévrose des grands droits jusqu'à l'urètre. De préférence, la longueur de la bandelette (2), non compris le coussinet (5), est comprise entre 100 et 300 mm. Lorsque sa mise en place est achevée, cette bandelette est sous tension.The strip (2) must be of sufficient length to cross the Retzius space from the aponeurosis of the rectus to the urethra. Preferably, the length of the strip (2), not including the pad (5), is between 100 and 300 mm. When its installation is complete, this strip is energized.
La bandelette (2) a pour fonction de maintenir le coussinet (5) en place : c'est une bande d'accrochage. Elle a également une fonction de traction, du fait de sa mise sous tension, et c'est la combinaison de ces fonctions de fixation et de traction qui assurent la parfaite tenue en place de l' hémi-prothèse et son efficacité. La bandelette (2) présente en outre des crans anti-retour en silicone qui sont surmoulés sur la bandelette en polypropylène et renforcent encore la tenue en place de la bandelette. De plus, au cours du temps, les parties non surmoulées de la bandelette (2) en polypropylène seront colonisées dans le corps humain par des cellules et cette colonisation renforce encore la tenue en place de la bandelette.The function of the strip (2) is to hold the pad (5) in place: it is a fastening strip. It also has a traction function, due to its tensioning, and it is the combination of these fixing and traction functions which ensure the perfect holding in place of the hemi-prosthesis and its efficiency. The strip (2) also has non-return silicone notches which are overmolded on the polypropylene strip and further reinforce the holding in place of the strip. In addition, over time, the unmolded parts of the polypropylene strip (2) will be colonized in the human body by cells and this colonization further strengthens the holding in place of the strip.
La figure 1 montre une bandelette munie de crans anti-retours (7) surmoulés sur la bandelette. Ces crans anti-retour (7) vont avoir une fonction mécanique de rétention de la bandelette à proximité du coussinet. La figure 2 montre une bandelette munie de crans anti-retours (7) creusés dans la bandelette ou ménagés dans la bandelette lors du moulage, par un moule spécial comprenant des ergots correspondants. Ces crans anti-retour ont la même fonction mécanique de rétention de la bandelette à proximité du coussinet. La figure 3 montre un renflement (5) qui est un coussinet pouvant être réalisé dans le même matériau que la bandelette ou dans un autre matériau biocompatible pour implants de longue durée. Il peut être moulé au même moment que la bandelette (2) ou de manière séparée et dans ce dernier cas, être solidarisé à la bandelette (2) par tout moyen approprié, notamment par soudure. Ce coussinet (5) a notamment pour fonction d'empêcher l'hypermobilité de l'urètre au moment précis de l'effort. Sa forme octogonale allongée est une variante préférée de l'invention.Figure 1 shows a strip provided with non-return notches (7) molded onto the strip. These non-return notches (7) will have a mechanical function of retaining the strip near the pad. FIG. 2 shows a strip provided with non-return notches (7) hollowed out in the strip or formed in the strip during molding, by a special mold comprising corresponding lugs. These non-return notches have the same mechanical function of retaining the strip near the pad. Figure 3 shows a bulge (5) which is a pad that can be made of the same material as the strip or in another biocompatible material for long-term implants. It can be molded at the same time as the strip (2) or separately and in the latter case, be secured to the strip (2) by any suitable means, in particular by welding. This cushion (5) has the particular function of preventing hypermobility of the urethra at the precise moment of the effort. Its elongated octagonal shape is a preferred variant of the invention.
La mise en place de chaque hémi-prothèse (1) nécessite une intervention chirurgicale légère, pendant laquelle on effectue une incision longitudinale sous- urétrale de trois centimètres puis on pratique un décollement afin de ménager une logette para-urétrale, à droite et à gauche, jusqu'à l'aponévrose pelvienne. C'est dans cette logette que viendra se positionner le renflement situé à l'extrémité de chaque hémi-prothèse.The placement of each hemi-prosthesis (1) requires a light surgical intervention, during which a longitudinal sub-urethral incision of three centimeters is made and then a detachment is made in order to provide a para-urethral stall, on the right and on the left. , up to the pelvic fascia. It is in this cubicle that the bulge located at the end of each hemi-prosthesis will be positioned.
Une incision cutanée à gauche et à droite de la symphyse pubienne est réalisée et prolongée jusqu'à l'aponévrose des grands droits afin de pénétrer l'espace de Retzius. Pour la mise en place de chaque hémi-prothèse (1), on utilise une aiguille à travers laquelle on passe un fil (6) qui est relié à l'extrémité libre (3) de la bandelette (2). L'aiguille est passée dans l'espace de Retzius en gardant le contact osseux et permet la mise en place de la bandelette (2). On ferme l'incision vaginale par des fils résorbables. L'efficacité de la tension de la bandelette (2) est ensuite réglée et testée. On remplit la vessie par 300cc de sérum physiologique et on appuie sur la vessie jusqu'à ce que la tension de la bandelette (2) interdise le passage du liquide. L'extrémité libre (3) de la bandelette (2) est alors fixée à l'aponévrose des grands droits par une suture.A skin incision to the left and right of the pubic symphysis is made and extended to the aponeurosis of the rectus in order to penetrate the Retzius space. For the establishment of each hemi-prosthesis (1), a needle is used through which a wire (6) is passed which is connected to the free end (3) of the strip (2). The needle is passed through the Retzius space, keeping bone contact and allows the insertion of the strip (2). The vaginal incision is closed with absorbable wires. The effectiveness of the tension of the strip (2) is then adjusted and tested. We fill the bladder with 300cc of physiological saline and the bladder is pressed until the tension of the strip (2) prevents the passage of the liquid. The free end (3) of the strip (2) is then fixed to the aponeurosis of the great rights by a suture.
La prothèse selon l'invention peut donc être mise en place de manière facile, et ne nécessite qu'une intervention légère . The prosthesis according to the invention can therefore be put in place easily, and requires only slight intervention.

Claims

REVENDICATIONS
1) Prothèse destinée à corriger l'incontinence urinaire d'effort chez la femme caractérisée en ce qu'elle comprend deux hémi-prothèses para-urétrales (1) droite et gauche, chacune desdites hémi-prothèses (1) étant constitué en un matériau biocompatible et se présentant sous la forme d'une bandelette (2) dont l'une des extrémités (4) présente un renflement (5) et dont l'autre extrémité (3), dite libre, est destinée à être fixée sur l'aponévrose des grands droits, ainsi que des moyens de fixation (6) de ladite extrémité libre (3) à l'aponévrose des grands droits .1) Prosthesis intended to correct urinary stress incontinence in women, characterized in that it comprises two right and left para-urethral hemi-prostheses (1), each of said hemi-prostheses (1) being made of a material biocompatible and in the form of a strip (2) one end (4) of which has a bulge (5) and the other end (3) of which is said to be free and is intended to be fixed to the aponeurosis of the great rights, as well as means of fixing (6) of said free end (3) to the aponeurosis of the great rights.
2) Prothèse selon la revendication 1, caractérisée en ce que ledit renflement (5) est un coussinet (5) solidarisé à une seule des deux extrémités (3,4) de chaque bandelette (2).2) Prosthesis according to claim 1, characterized in that said bulge (5) is a pad (5) secured to only one of the two ends (3,4) of each strip (2).
3) Prothèse selon l'une quelconque des revendications 1 ou 2 , caractérisée en ce que la bandelette doit être d'une longueur suffisante pour traverser l'espace de Retzius depuis l'aponévrose des grands droits jusqu'à l'urètre.3) Prosthesis according to any one of claims 1 or 2, characterized in that the strip must be of sufficient length to cross the Retzius space from the aponeurosis of the rectus to the urethra.
4) Prothèse selon l'une quelconque des revendications 1 à 3, caractérisée en ce que lesdites bandelettes (2) et lesdits renflements (5) sont fabriqués en un matériau acceptable pour les implants de longue durée.4) Prosthesis according to any one of claims 1 to 3, characterized in that said strips (2) and said bulges (5) are made of a material acceptable for long-term implants.
5) Prothèse selon la revendication 4, caractérisée en ce que ledit matériau est du polypropylène. 6 ) Prothè se se lon l ' une quelconque des revendications 1 à 5 , caractérisée en ce que lesdites bandelettes ( 2 ) comprennent des crans anti-retour ( 7 ) .5) Prosthesis according to claim 4, characterized in that said material is polypropylene. 6) Prosthesis according to any of claims 1 to 5, characterized in that said strips (2) comprise non-return notches (7).
7 ) Prothè se selon l ' une que lconque de s revendications 1 à 6 , caractérisée en ce que lesdits crans anti-retour ( 7 ) sont fabriqués dans un matériau acceptable pour les implants de longue durée .7) Prosthesis according to one that lconque of s 1 to 6, characterized in that said non-return notches (7) are made of a material acceptable for long-term implants.
8) Prothèse selon la revendication 7, caractérisée en ce que ledit matériau est du silicone de grade acceptable pour les implants destinés à rester en place dans le corps humain pendant une période de temps indéfinie.8) Prosthesis according to claim 7, characterized in that said material is silicone of acceptable grade for implants intended to remain in place in the human body for an indefinite period of time.
9) Prothèse selon l'une quelconque des revendications 1 à 8, caractérisée en ce que la section desdites bandelettes (2) est comprise entre 1 et 15 mm, de préférence 4 à 10 mm, avantageusement égale à 6,5 mm.9) Prosthesis according to any one of claims 1 to 8, characterized in that the section of said strips (2) is between 1 and 15 mm, preferably 4 to 10 mm, advantageously equal to 6.5 mm.
10) Prothèse selon l'une quelconque des revendications 1 à 9, caractérisée en ce que la longueur des bandelettes (2), non inclus le renflement (5), est comprise entre 100 mm et 300 mm, de préférence 170 à 270 mm, avantageusement égale à 220 mm.10) Prosthesis according to any one of claims 1 to 9, characterized in that the length of the strips (2), not including the bulge (5), is between 100 mm and 300 mm, preferably 170 to 270 mm, advantageously equal to 220 mm.
11) Prothèse selon l'une quelconque des revendications 1 à 10, caractérisée en ce que lesdits crans anti-retour (7) sont surmoulés sur tout ou partie de chaque bandelette (2).11) Prosthesis according to any one of claims 1 to 10, characterized in that said non-return notches (7) are molded over all or part of each strip (2).
12) Prothèse selon la revendication 9, caractérisée en ce que la section de l'ensemble bandelette (2) - cran anti-retour (7) est comprise entre 3 et 20 mm, de préférence 5 à 15 mm, avantageusement égale à 11 mm.12) Prosthesis according to claim 9, characterized in that the section of the strip assembly (2) - notch non-return (7) is between 3 and 20 mm, preferably 5 to 15 mm, advantageously equal to 11 mm.
13) Prothèse selon l'une quelconque des revendications 1 à 10, caractérisée en ce que lesdits crans anti-retour (7) sont des encoches entamant la surface de la bandelette (2) .13) Prosthesis according to any one of claims 1 to 10, characterized in that said non-return notches (7) are notches entering the surface of the strip (2).
14) Prothèse selon l'une quelconque des revendications 11 à 13, caractérisée en ce que lesdits crans anti-retour (7) sont réalisés sur une longueur de 30 à 80 mm, de préférence environ 60 mm, à une distance de 10 à 50 mm, de préférence 30 mm par rapport à l'extrémité de la bandelette (2) comportant un renflement (5).14) Prosthesis according to any one of claims 11 to 13, characterized in that said non-return notches (7) are produced over a length of 30 to 80 mm, preferably about 60 mm, at a distance of 10 to 50 mm, preferably 30 mm relative to the end of the strip (2) having a bulge (5).
15) Prothèse selon l'une quelconque des revendications 1 à 14, caractérisée en ce que la longueur du renflement (5), est comprise entre 10 mm et 30 mm, de préférence 20 mm, et la section du renflement (5), est comprise entre 5 mm et 20 mm, de préférence 10 mm.15) Prosthesis according to any one of claims 1 to 14, characterized in that the length of the bulge (5) is between 10 mm and 30 mm, preferably 20 mm, and the section of the bulge (5), is between 5 mm and 20 mm, preferably 10 mm.
16) Prothèse selon l'une quelconque des revendications 1 à 15, caractérisée en ce que lesdits moyens de fixation (6) des bandelettes (2) à l'aponévrose des grands droits sont des fils.16) Prosthesis according to any one of claims 1 to 15, characterized in that said fixing means (6) of the strips (2) to the fascia of the great rights are son.
17) Prothèse selon l'une quelconque des revendications 1 à 15, caractérisée en ce que lesdits moyens de fixation (6) des bandelettes (2) à l'aponévrose des grands droits sont des moyens de collage des bandelettes ( 2 ) . 18) Prothèse selon l'une quelconque des revendications 1 à 15, caractérisée en ce que lesdits moyens de fixation (6) des bandelettes (2) à l'aponévrose des grands droits sont des moyens autostatiques. 17) Prosthesis according to any one of claims 1 to 15, characterized in that said fixing means (6) of the strips (2) to the aponeurosis of the great rights are means of bonding the strips (2). 18) Prosthesis according to any one of claims 1 to 15, characterized in that said fixing means (6) of the strips (2) to the aponeurosis of the great rights are autostatic means.
EP03712240A 2002-01-14 2003-01-14 Implantable prosthesis for correcting effort-related urinary incontinence in women Withdrawn EP1465549A2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0200385 2002-01-14
FR0200385A FR2834629B1 (en) 2002-01-14 2002-01-14 IMPLANTABLE PROSTHESIS FOR CORRECTING URINARY EFFORT INCONTINENCE IN WOMEN
PCT/FR2003/000105 WO2003057074A2 (en) 2002-01-14 2003-01-14 Implantable prosthesis for correcting effort-related urinary incontinence in women

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EP (1) EP1465549A2 (en)
JP (1) JP2005512755A (en)
AU (1) AU2003216721A1 (en)
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WO (1) WO2003057074A2 (en)

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JP2005512755A (en) 2005-05-12
FR2834629A1 (en) 2003-07-18
US20050000524A1 (en) 2005-01-06
AU2003216721A1 (en) 2003-07-24
WO2003057074A2 (en) 2003-07-17
WO2003057074A3 (en) 2004-03-11
US7217238B2 (en) 2007-05-15

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