Implantation tape for treatment of urogynecologic diseases of women (versions)

FIELD: urology and gynecology, in particular, treatment of pelvic fundus prolapse.

SUBSTANCE: common feature with each of versions of implantation tape is that tape is adapted for creating loop around urethra, is made perforated for growing of fibroblasts therethrough, and comprises distal ends and central part adapted for embracing of urethra between the latter and wall of the vagina. Central part is widening toward one side, said widening portion being made in the form of perforated patch enabling growing of fibroblasts through perforations and adapted for positioning between wall of the vagina and urinary bladder fundus region. According to first version, patch is made triangular and may be connected with central part by apex part of triangle. Such shape allows patch to be deformed so as to impart any desirable anatomic form thereto without formation of undesired creases. Total length of tape, according to first version, is 350-650 mm, thickness is 0.5-1.5 mm, width of distal ends of tape is 4-12 mm. Length of patch from central part of tape perpendicular thereto is 15-45 mm. Width of the widest part of pitch is 15-45 mm. According to second version, patch is made rectangular or trapezium-shaped, and is connected with central part of tape along one side of rectangle or trapezium. Triangular recess is formed at the side of rectangle opposed to side along which it is connected with central part. Apex of recess is directed inward of patch for reducing the probability of forming undesired creases. Depth of recess is 0.2-1.0 the height of rectangle or trapezium, which is measured in direction perpendicular to longitudinal axis of tape central part.

EFFECT: increased efficiency in treatment of urogynecological diseases owing to employment of optimal tape shape and ratio of sizes.

15 cl, 4 dwg, 3 ex

 

The invention relates to medicine, in particular to urology and gynecology and registered to implant the tapes for the treatment of urogynecological disorders in women, for example for the treatment of prolapse of the pelvic floor.

The incidence of prolapse of the pelvic floor in women is on average not less than 15-20% of the population. With the elimination of this defect surgically, for example with implantation of mesh flap that strengthens the wall of the vagina [patent RU 2212860, publ. 27.09.2003]experiencing incontinence that requires a second surgical procedure.

It is known that in order to ensure the normal functioning of the bladder when performing colporrhaphy between useprofanity surfaces of the bladder and rectum are installing the implant of porous titanium nickelide [patent RU 2209605, publ. 10.08.2003]. Known operation has a high tissue trauma and expedient when expressed imbalances sizes front and rear walls loose vagina.

Known treatment of incontinence in women using a loop system, including a pair of anchors attached to the lower part of the pubic bone, to which the sewn ends of the flap passing loop around the urethra [patent US 6641524, publ. 04.11.2003]. The flap is made of mesh and has a rectangular shape, in particular with cut angle is mi. This system is not designed to strengthen the vaginal wall adjacent to the bladder.

Know the use of implant tape for treatment of urinary incontinence in women, when the tape do a loop around the muscle tissue of the abdomen to both sides of the urethra for the purpose of insertion of the tape into the soft tissue between the vaginal wall and the wall of the abdomen, while the tape stretch above the pubic bone with the release of the ends of the tape in the vagina [patent US 5112344, publ. 12.05.1992]. The tape is left in the body to around her formed of fibrous connective tissue. This scar tissue acts as a supporting ligament soft tissue, and after its formation the tape is removed from the body. In a similar way [patent RU 2161916, publ. 20.01.2001] use a perforated tape for ingrowth of fibroblasts. Such a tape can be made of polypropylene, in the form of a grid or with holes, forming a grid covered with a material to stimulate fibroblasts. The tape preferably has a width of about 10 mm, a length of about 400 mm, a thickness of about 0.7 mm, However, such tapes are used only for treatment of stress incontinence and are not intended to strengthen the vaginal wall adjacent to the bladder.

Known surgical instrument for the treatment of stress incontinence [patent US 6808486, publ 26.10.2004], in particular, including the tape implanted in the body in a manner similar to the above two. Used for loop tape, a length of about 60 cm and a width of about 1 cm, is made of a mesh of absorbable or non-absorbable polymer filaments and has a tubular cross-section. The Central part of the tape is performed by widening to 3 cm on the length of the Central part of about 2.5 cm, intended to cover the loop not only the urethra, and bladder neck with sphincter. As a prototype of the selected special case of such a tape, additionally intended to strengthen the vaginal wall adjacent to the bladder, preventing prolapse. This broadening in the Central part of the tape is made in the form of a flap rectangular or trapezoidal shape with dimensions of approximately 2.5×2.5 cm, located on one side of the tape fixed during the operation in the area of the bottom of the bladder. However, after implantation of the Central part of the tape together with the flap is bent loop in the same plane, and the portion of the bladder from the urethra to its bottom has a complex extending curved shape, i.e. curved in the other planes, which leads to the formation of undesirable folds in the graft after implantation.

Solved technical problem - optimization fo the we and the dimensional ratios implant tape, used for the treatment of urogynecological disorders, with the purpose of giving implanted tape desired anatomical shape without the formation of undesirable wrinkles.

You have two choices implant tape, intended for the treatment of urogynecological disorders in women, in common with the prototype of which is the fact that the tape is designed to loop around the urethra, made of perforated for ingrowth of fibroblasts and contains distal ends and a Central portion intended to cover the urethra between him and the wall of the vagina, while the Central part of the tape is made with a broadening of at least one way in the form of a flap, perforated for ingrowth of fibroblasts and intended for placement between the vagina and the area of the bottom of the bladder.

New in the first embodiment is that the flap is made in the form of a triangle (in the plan). This form allows you to give the flap a desired anatomical shape without the formation of undesirable wrinkles.

Preferably, the flap is connected with the Central part of the tape on the top of the triangle. While on the flap side of the triangle opposite the apex of the connection with the Central part of the tape may be made trapolin the first cut, the apex is directed to the inside of the flap.

The flap may be connected with the Central part of the tape on one side of the triangle. The vertex of the triangle opposite the side at which it is connected with the Central part of the tape may be made blunt.

The triangle can be made isosceles, with its equal sides are connected with the Central part of the tape.

Similar to prototype the second option is that the flap has a predominantly rectangular or trapezoidal shape (in plan) and is connected with the Central part of the tape on one side of a rectangle or trapezoid.

New second option is that side of a rectangle or a trapezoid, the opposite side, by which it is connected with the Central part of the tape, made of triangular neckline, the top of which is directed to the inside of the flap. This cut also reduces the likelihood of unwanted folds, since it is located in a place corresponding to the most curved surfaces of the bottom of the bladder.

The depth of the notch may be 0.2-1.0 of the height of a rectangle or trapezoid, measured in the direction perpendicular to the longitudinal axis of the Central part of the tape.

The width of the notch may be 0,4-1,0 from the length of a side of a rectangle or a trapezoid, in which RAS is halogen neckline.

The first and the second option there are several ways of carrying out the invention.

The flap can be made symmetrical with respect to an axis perpendicular to the longitudinal axis of the Central part of the tape.

All ribbon elements (distal ends, a Central portion and a flap that can be done:

for one whole;

- from a mesh or material with holes, forming a grid;

- made of polymer material, for example polypropylene or mersilene.

The tape may have the following dimensions:

- the total length of the tape - 350-650 mm at a thickness of 0.5-1.5 mm;

- the width of the distal ends of the tape - 4-12 mm;

- the length of the flap (maximum), measured from the Central part of the tape perpendicular to the direction of 15-45 mm when the width of the flap in its widest part - 15-45 mm

The invention is illustrated by drawings. Figure 1 presents the main view of one of the embodiments of the implant of the tape. Figure 2 is a schematic representation in section of the lower part of the abdomen women implanted with tape. Figure 3 and figure 4 presents the main types of other embodiments of the invention. The dashed line in figure 1, figure 3 and figure 4 shows other possible contour shape of the flap.

The invention is illustrated by examples.

Example 1 (see figure 1).

Implant strip includes distal ends 1 and 2, the Central is the actu 3, the flap 4 in the form of an isosceles triangle. All of these elements of the tape is made of a knitted polypropylene mesh PROLENE® firm "Ethicon, Inc., USA with a thickness of 0.7 mm, the Total tape length is 400 mm; width of distal ends 1, 2 and the Central part 3 - 10 mm; the length of the flap 4 from the Central part 3 - 35 mm; the width of the flap 4 in its widest part - 30 mm

Accommodation implanted tape in the belly of the woman shown in figure 2, where the organs of the body are indicated as follows: vagina 7, the bladder 8, the urethra 9, pubic bone 10, the wall of the abdomen 11.

The remote side of the flap 4 may have additional triangular cutout, shown by line 5.

Example 2 (see figure 3).

Implant strip includes the same elements and has similar dimensions as in example 1, except that the Central portion 3 is made wider than the distal ends 1, 2, its width is 14 mm

Example 3 (see figure 4).

Implant strip includes the same elements and has a similar size as in the previous examples, except that the flap 4 is made of a triangular cutout 6 depth of 14 mm and a width (on the remote edge of the flap 4) 24 mm

In all examples, the tape can be implanted in a known manner [patent RU 2161916, publ. 20.01.2001]. In this case it is better, when conducting operations use l the NTU, at the distal parts 1, 2 which is wearing a plastic sheath (not shown)which is removed after implantation. Without this sheath tape it is better to implant according to the original methodology Danilov-Free by using a special surgical instrument [the application for the invention EN 2003136127, filing date 11.12.2003].

Also the tape, in particular its distal ends 1 and 2, may have any cross-section, a rectangular or tubular, and is performed as a single-layer and multilayer. This tape can be made from mesh material and material with holes, forming a grid.

The examples above used only for illustration purposes, the possibility of carrying out the invention and in no way limit the scope of legal protection provided in the claims, the expert in the art capable of relatively easy exercise and other ways of carrying out the invention.

1. Implant tape for the treatment of urogynecological disorders in women, is used to form a loop around the urethra, made of perforated for ingrowth of fibroblasts containing distal ends and a Central portion intended to cover the urethra between it and the vaginal wall, when it is the Central part of the tape is made with a broadening of at least one way in the form of a flap, perforated for ingrowth of fibroblasts and intended for placement between the vagina and the area of the bottom of the bladder, wherein the flap is made in the form of a triangle, and the total tape length is 350-650 mm at a thickness of 0.5 to 1.5 mm, the width of the distal ends of the tape is 4-12 mm, and the length of the flap, as measured from the Central part of the tape perpendicular to the direction of 15-45 mm, while the width of the flap in its widest part of 15-45 mm

2. Tape according to claim 1, characterized in that the flap is connected with the Central part of the tape on the top of the triangle.

3. Tape according to claim 2, characterized in that the flap side of the triangle opposite the apex of the connection with the Central part of the tape, made of triangular neckline, the top of which is directed to the inside of the flap.

4. Tape according to claim 1, characterized in that the flap is connected with the Central part of the tape on one side of the triangle.

5. Tape according to claim 4, characterized in that the apex of the triangle, opposite the side at which it is connected with the Central part of the tape, made blunt.

6. Tape according to claims 1 to 5, characterized in that the flap is made symmetrical with respect to an axis perpendicular to the longitudinal axis of the Central part of the tape.

7. Tape according to claims 1 to 5, characterized in that tre is Golnik made isosceles, with its equal sides are connected with the Central part of the tape.

8. Tape according to claims 1 to 5, characterized in that all ribbon elements made in one piece.

9. Tape according to claims 1 to 5, characterized in that all the elements of the tape is made of mesh or material with holes, forming a grid.

10. Tape according to claims 1 to 5, characterized in that all the elements of the tape is made of polypropylene or mersilene.

11. Implant tape for the treatment of urogynecological disorders in women, is used to form a loop around the urethra, made of perforated for ingrowth of fibroblasts containing distal ends and a Central portion intended to cover the urethra between him and the wall of the vagina, while the Central part of the tape is made with a broadening of at least one way in the form of a flap mostly rectangular or trapezoidal shape, connected to the Central part of the tape on one side of a rectangle or trapezoid, perforated for ingrowth of fibroblasts and intended for placement between the vagina and the area of the bottom of the bladder, characterized the fact that the flap side of the rectangle or trapezoid, the opposite side, by which it is connected with the Central part of the tape, made tre is verbal neckline, the apex is directed to the inside of the flap, and the depth of the cut is 0.2 to 1.0 from the height of a rectangle or trapezoid, measured in the direction perpendicular to the longitudinal axis of the Central part of the tape, the width of the cutout is 0.4 to 1.0 on the length of the sides of the rectangle or trapezoid, which is cut, the total length of the tape is 350-650 mm at a thickness of 0.5 to 1.5 mm, the width of the distal ends of the tape is 4-12 mm, the maximum length of the flap, as measured from the Central part of the tape perpendicular to the direction of 15-45 mm, while the width of the flap in its widest part of 15-45 mm

12. Tape claim 11, characterized in that the flap is made symmetrical with respect to an axis perpendicular to the longitudinal axis of the Central part of the tape.

13. Tape claim 11, characterized in that all ribbon elements made in one piece.

14. Tape 14, characterized in that all the elements of the tape is made of mesh or material with holes, forming a grid.

15. Tape 14, characterized in that all the elements of the tape is made of polypropylene or mersilene.



 

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