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)

Applications Claiming Priority (3)

Publications (1)

Family

ID=8871275

Family Applications (1)

Country Status (6)

Families Citing this family (11)

Family Cites Families (8)

• 2002
  • 2002-01-14 FR FR0200385A patent/FR2834629B1/fr not_active Expired - Fee Related
• 2003
  • 2003-01-14 WO PCT/FR2003/000105 patent/WO2003057074A2/fr not_active Application Discontinuation
  • 2003-01-14 JP JP2003557437A patent/JP2005512755A/ja active Pending
  • 2003-01-14 AU AU2003216721A patent/AU2003216721A1/en not_active Abandoned
  • 2003-01-14 EP EP03712240A patent/EP1465549A2/fr not_active Withdrawn
• 2004
  • 2004-07-12 US US10/889,562 patent/US7217238B2/en not_active Expired - Fee Related

Non-Patent Citations (1)

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