RU2304935C1 - Gynecological instrument for concurrently carrying out genitals feeling and enuresis correction under stress - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: device has conductor having curved working end, removable handle and reticular implant enclosed into removable protection envelope. The curved working conductor end is shaped as arc from 1/2 to 3/4 of circle to introduce reticular implant in transobturator approach. The conductor has hydropreparation canal having outlet opening on its distal end and a recess or through slit-shaped place for fixing implant. The reticular implant and its protection envelope are connected at their ends and form fastening members as thickenings. The thickenings are drop-shaped of maximum cross-section size equal to 0.5-5 mm or ball-shaped of 0.5-5 mm diameter.

EFFECT: reduced risk of traumatic complications; usability of implants of various shapes and sizes; low price.

8 cl, 9 dwg

Description

The invention relates to surgical instruments and can be used in operative gynecology.

Surgical interventions to correct urinary incontinence with tension and prolapse of the genital organs play a leading role in the treatment of these diseases. According to the literature, a large share of all anti-stress operations (over 70%) are currently occupied by TVT and TOT operations. The mesh tools used in the TVT operation are described (Ulmsten U, Falconer C, Johnson P, et al. A multi-center study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998; 9: 210) and TOT (de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003; 44: 724-30). They are metal conductors with a blunt end, having bends taking into account the anatomical features of access, which facilitates their conduct. They are structurally fixed prolene mesh, covered with a cover. The disadvantage of these devices is the need to use additional techniques for safe conduct: with TVT - abduction of the neck of the bladder in the opposite direction from the instrument, and with TOT - the use of a guide at the beginning of the introduction of the conductor. The disadvantages are the inability to perform hydraulic preparation during the tooling, as well as the factory standard fixation to the wire conductor, which makes the tool kit disposable and increases the cost of the operation.

A surgical instrument is also known, comprising a curved elongated shaft with a retainer and a handle on the non-working end (see US 5112344 A, 05/12/1992). The instrument according to US 5112344 ensures the installation of a loop-like filament element in the patient’s tissues during the operation, but it cannot be used effectively for simultaneous correction of genital prolapse and urinary incontinence under tension.

Closer to ours, two inventions can be distinguished. One of them can be considered a surgical tool for the treatment of urinary incontinence in women, containing an elongated shaft with a curved working end and a mesh implant enclosed in a removable shell, connected to a clamp on the non-working end of the rod, equipped with a removable handle (RU 2161916 C2, 01.20.2001).

The disadvantage of the tool according to RU 2161916 is the shape of its working end, which is essentially bent by only a quarter of a circle. Such a bend (with the appropriate size of the instrument) is sufficient to pass from the vaginal wall behind the pubic bone to the outside of the abdominal wall, but it does not take into account all the features of the operation and cannot be used to simultaneously correct genital prolapse and urinary incontinence under stress.

Also closer to our invention can be considered a tool for the surgical treatment of stress urinary incontinence in women in combination with prolapse of the anterior vaginal wall, containing an elongated shaft with a latch on the curved working end, a handle placed on the inactive end of the shaft, and a mesh implant connected to the latch ( see RU 33305 U1, 10.20.2003).

The disadvantage of the instrument according to RU 33305 is its complexity and inconvenience in operation (it consists of several parts), as well as the invasiveness of the operation, due to the fact that due to the uneven outer surface, the mesh implant interacts with tissues with increased friction.

The aim of our development was to create a tool for carrying out a mesh of any shape and size during surgical interventions aimed at correcting not only urinary incontinence, but also concomitant prolapse of the genitals, which is safe, low invasiveness, simplicity and ease of use and provides maximum possibilities for the surgeon in choosing the access and methodology of the operation, as well as affordable for the general public.

This goal is achieved, firstly, by the presence of conductors with different curvatures, which allows for both post-caval and transobturator operations. Secondly, the possibility of carrying out hydraulic preparation, which makes it possible to precondition the solution to the advancement of the conductor, creating the ability to "push apart" the tissue and facilitate its "sliding" without a high risk of tissue injury. Moreover, the means for connecting the source of excess pressure is located along or at an angle to the longitudinal axis of the conductor. Thirdly, the presence of a special mechanism for fixing the implant with the conductor. This solution allows, on the one hand, to separate the tool and the material for the operation. On the other hand, use an implant of various shapes and sizes for all types of anti-stress operations and for surgical correction of genital prolapse. All of the above makes it possible to unify the methodology and tools for their implementation, thereby developing a "standard" of operations, and, ultimately, to increase the level of their implementation.

The technical result of the invention is to conduct the conductor in one direction without a return stroke, the ability to select the curvature of the conductor depending on the individual characteristics of the patient, the possibility of postadilon and transobturator urethropexia, hydrotreating at the stage of piercing the tissues and conducting the conductor with a convenient location of the source of overpressure, minimal injury the passage of tissues due to the attachment of the implant in the recess of the conductor or in the slot type "p apa-mama, "with the proposed sizes of the conductor and the fastener, the fixation section does not protrude beyond the limits of the conductor, which completely excludes tissue trauma from the fixation section; the possibility of using a mesh implant of various shapes and sizes, the possibility of simultaneous correction and incontinence of urine under voltage, and the concomitant cystocele, the constructive separation of the instrument into components - a conductor, a removable handle and a mesh implant, which allows practitioners to buy a mesh only once after buying a conductor and handle. implants, which makes the tool kit cheaper and more affordable.

The essence of the invention is expressed in the aggregate of essential features, in which a gynecological surgical instrument for the simultaneous correction of genital prolapse and urinary incontinence under tension consists of a conductor with a curved working end to which a removable handle is fixed, and a mesh implant connected to a conductor enclosed in a removable protective sheath , and differs from the closest analogues in that, firstly, the curved working end of the conductor has a different arc shape, which is necessary for the rear pubic and transobturator of the mesh implant, and secondly, the conductor has a channel for gidropreparovki implant fixation and place, and thirdly, the mesh implant and its protective cover are connected at the ends to form fastening members in the form of thickenings of various shapes for connection with the conductor.

In a preferred embodiment, the gynecological surgical instrument for simultaneously correcting the prolapse of the genital organs and urinary incontinence under tension comprises a conductor with a curved working end to which a removable handle is fixed, and a mesh implant enclosed in a removable protective sheath connected to the conductor, while the curved working end of the conductor has an arc shape from 1/3 to 1/2 of a circle for a reticulum conducting a mesh implant or an arc shape from 1/2 to 3/4 of a circle for a transobturator nets of the mesh implant, the conductor has a channel for hydrotreating with the outlet at the distal end and the fixation of the implant in the form of a recess or in the form of a through slot, and the mesh implant and its protective sheath are connected at the ends and form fasteners in the form of thickenings, for example, a drop shape with a maximum transverse dimension of 0.5-5 mm or, for example, a ball shape with a diameter of 0.5-5 mm.

In particular cases of implementation or use, the gynecological instrument may include a curved working end of the conductor, which has the shape of an arc for the lateral conduct of the mesh implant, which is 1/2 circle, or the shape of the arc for transobturative conduct of the mesh implant, which is 5/8 of a circle; the fixation site of the mesh implant located on the distal end of the conductor or on the proximal end of the conductor; mesh implant in the form of a tape; means for attaching a source of excess pressure, made, for example, in the form of a cannula oriented along or at an angle to the longitudinal axis of the conductor; a conductor, which may have a symmetrical or asymmetric end narrowing and / or pointed at the distal end; place of fixation on the conductor with the expansion of a symmetric or asymmetric shape.

The invention is illustrated by drawings, where

Figure 1 - a tool for post-conduction with proximal fixation of the implant on the conductor.

Figure 2 - a tool for transobturation with proximal fixation of the implant on the conductor.

Figure 3 - a tool for post-conduction with distal fixation of the implant on the conductor.

Figure 4 - a tool for transobturator conducting with distal fixation of the implant on the conductor.

5 is a mesh implant.

6 is a distal end of the conductor with an asymmetric sharpening.

Fig.7 - the distal end of the conductor with a symmetrical sharpening.

Fig - place of fixation of the implant on the conductor of a symmetrical shape.

Fig.9 is the place of fixation of the implant on the asymmetric conductor.

In the drawings, the positions indicated:

1 - conductor;

2 - curved working part of the conductor;

3 - removable protective cover of the implant;

4 - mesh implant;

5 - place of fixation of the implant on the conductor;

6 - removable handle;

7 - channel for hydraulic preparation;

8 - fastener of the mesh implant;

9 - a device for connecting a source of overpressure.

A gynecological surgical instrument for the simultaneous correction of genital prolapse and urinary incontinence with voltage comprises a conductor 1 with a curved working end 2, a removable handle 6, and a mesh implant 4 enclosed in a removable protective sheath 3.

The fixation of the mesh implant 4 is provided on different sections of the conductor - the proximal (non-working) and distal (working) ends. Figure 1 and 2 shows a variant of the location of the fixation point at the proximal end of the conductor 1, and figure 3 and 4 at the distal end.

The curved working end 2 of the conductor 1 has an arc shape from 1/3 to 1/2 of the circle for the lateral conduct of the mesh implant 4 or an arc shape of 1/2 to 3/4 of the circle for transobturative conduct of the mesh implant 4. In particular cases, the shape of the arc of the conductor 1 is 1/2 of the circle for the lateral conduct of the implant (figure 1 and figure 3) and 5/8 for transobturator (figure 2 and figure 4).

The conductor 1 has a channel 7 with an outlet at the distal end for hydropreparation, as well as asymmetric or symmetrical end narrowing and / or sharpening at the distal end for puncture of tissues (Fig.6, Fig.7).

The place of fixation 5 on the conductor can be made in the form of a recess or the form of a through slot with the expansion of a symmetric (Fig. 8) or asymmetric shape (Fig. 9).

The mesh implant 4 is structurally connected to its protective sheath 3 at the ends, where it forms fasteners 8 in the form of bulges having, for example, a drop shape with a maximum transverse dimension of 0.5-5 mm or, for example, a ball shape with a diameter of 0.5-5 mm (Fig. 5). In special cases, the mesh implant can be made in the form of a tape.

A device for connecting a source of overpressure 9, made, for example, in the form of a cannula oriented along or at an angle to the longitudinal axis of the rod 1 (Figs. 1 and 2), located on a removable handle 6.

In Figs. 1-4, the instrument is presented in various versions: in Fig. 1 - for transverse conduct with proximal fixation of the implant on the conductor, in Fig. 2 - for transobturator conduction with proximal fixation of the implant, in Fig. 3 - for transverse conduct with distal fixation of the implant on the conductor and figure 4 - for transobturator with distal fixation of the implant on the conductor.

To bring the tool into working condition, the implant 4, enclosed in a removable sheath 3, is connected to the fixation point 5 on the conductor 1, the removable handle 6 is connected to the latter. In this case, the conductor 1 and the mesh implant 4 are connected by introducing the fastener 8 into the fixation place 5, while there is a reliable mutual fixation of the conductor and the mesh implant of the "father-mother" type.

The conductor is used as follows.

Cerebral urethropexy.

Select the required type and size of the mesh implant 4, select a conductor 1 having sufficient curvature of the working part 2 for this type of operation and individual characteristics of the patient, select a conductor with the optimal position of the fixation point 5, choose a convenient removable handle 6. Bring the tool into working condition, as it was described above.

After cutting the front wall of the vagina and determining the neck of the bladder, conductor 1 is gradually paraurethrally guided through soft tissues, performing a hydraulic preparation through channel 7 on the conductor, pumping the solution through cannula 9. Upon reaching the lower edge of the symphysis, the tip of the instrument is leaned against the back surface of the symphysis and held along it until contact with aponeurosis. Then, all layers of the anterior abdominal wall are punctured and the conductor 1 with a fixed implant 4 is removed in the suprapubic region. A cystoscopy is performed to rule out injury to the bladder. After that, the fixing element 8 is released from the place of fixation 5 on the conductor. The conductor is separated from the handle 6 and output through the wound channel in the course of the initial movement. The operation is repeated on the other hand. The ends of the implant are cut off, which makes it possible to separate the cover 3 and the actual implant 4, and, pulling the implant with the necessary force, remove the protective cover by pulling on the free ends. Excess implant is cut off slightly below skin level. The front wall of the vagina is restored.

Transobturator urethropexy.

Select the required type and size of the mesh implant 4, select a conductor 1 having sufficient curvature of the working part 2 for this type of operation and individual characteristics of the patient, select a conductor with the optimal position of the fixation point 5, choose a convenient removable handle 6. Bring the tool into working condition, as it was described above.

After cutting the anterior vaginal stacks and determining the neck of the bladder, conductor 1 is gradually passed through soft tissues, performing a hydraulic preparation through channel 7 on the conductor, pumping the solution through cannula 9. After touching the branches of the pubic bone, the end of the conductor is leaned against it and, around the bone, pierce the obstruction hole . A fixed-mesh conductor is removed in the perineum near the inguinal fold. A cystoscopy is performed to rule out injury to the bladder. After that, the fixing element 8 is released from the place of fixation 5 on the conductor. The conductor is separated from the handle 6 and output through the wound channel in the course of the initial movement. The operation is repeated on the other hand. The ends of the implant are cut off, which makes it possible to separate the cover 3 and the actual implant 4, and, pulling the implant with the necessary force, remove the protective cover by pulling on the free ends. Excess implant is cut off slightly below skin level. The front wall of the vagina is restored.

The reverse operation is also possible, that is, conducting the conductor from the outside into the vaginal wound.

Cerebral urethropexy.

Patient K., 42 years old, examined. Clinical diagnosis: Poor pelvic floor muscle failure. Cystocele. Rectocele. Stress urinary incontinence.

Performed operation: Posilonny urethropexy. Front kolporrafiya. Colpoperineorography with levatoroplasty.

Under aseptic conditions, a longitudinal section of the anterior vaginal wall was made along the midline, 2 cm indenting from the external opening of the urethra for 7 cm, the edges were separated. A Foley catheter No. 18 is installed in the bladder, the neck of the bladder is determined. Four separate vicryl sutures in the transverse direction are applied to the pubocervical fascia.

Considering the need for back-sided conduct, a prolene mesh implant was used, covered with a protective cover and measuring 20-1.7 cm.At the same time, the prolene mesh and the protective cover are welded together at their ends and form a drop-shaped fastener with a maximum transverse size of 4 mm. To carry out the operation, a conductor was used with an arc shape of 1/2 a circle, with a hydraulic cooking channel having an outlet at the distal end. The conductor has a symmetrical sharpening at the distal end, as well as the place of fixation of the implant in the form of a recess at the distal end, having an expansion of a symmetrical shape. The removable handle has a cannula for attaching a Luer type syringe at the distal end, located along its longitudinal axis.

Before the operation, the tool was brought into working condition. For this, an implant fastener in the form of a drop with a maximum transverse size of 4 mm is connected to a fixation point at the distal end of the conductor having an extension of a symmetrical shape. In this case, the implant fastener was completely immersed in the place of fixation on the conductor and does not protrude beyond it. The conductor is connected to a removable handle, a 20 ml syringe with novocaine solution is attached to the cannula on the removable handle.

Using hydropreparation with a solution of novocaine at the level of the neck, the urinary conductor was paraurethrally through the soft tissues on the right, then after reaching the lower edge of the symphysis, the conductor continued to move along the posterior surface of the symphysis to the aponeurosis, then all layers of the anterior abdominal wall were punctured and the conductor with a fixed implant was withdrawn to the suprapubic region. Control cystoscopy was performed - the integrity of the urinary tract was confirmed. The fastener is released from the place of fixation on the conductor, captured by the clamp. A removable handle is separated and the conductor is withdrawn along the wound channel in the course of the initial movement.

Similarly held the other shoulder of the implant on the left side.

The bladder is filled with 300 ml of physiological saline, the Foley catheter is removed. The clamps capture the ends of the cover, tightened until the leakage of urine disappears with a sharp pressure in the suprapubic region. The ends of the implant with fasteners are cut off, the cover and the proper prolene mesh are separated. A Foley catheter was installed, pulling the ends of the cover, the latter was removed, the excess prolene mesh was cut off. The front wall of the vagina is restored with separate sutures.

A triangular flap was cut out from the back wall of the vagina, the edges were separated. Three separate vicryl sutures were applied to the muscles that raise the anus, and separate catgut sutures were placed on the vaginal mucosa, superficial muscles and perineal skin. Blood loss 80 ml.

Transobturator urethropexy.

Patient M., 52 years old, examined. Clinical diagnosis: Stress incontinence. Obesity 3 tbsp.

Operation performed: transobturator urethropexy.

Considering the need for transobturator conduction, an implant in the form of a 16-1.5 cm prolene flap enclosed in a protective cover was used. At the same time, at the ends of the implant, the prolene mesh and the protective cover are welded together and form a fastener in the form of a ball 5 mm in diameter. To perform the operation, a conductor with an arc shape of 3/4 of a circle, with a channel for hydraulic preparation, with an outlet at the distal end, was used. The conductor has an asymmetric sharpening at the distal end, as well as the place of fixation of the implant in the form of a through slot at the proximal end of the conductor, having an expansion of an asymmetric shape. The removable handle has a cannula for attaching a syringe of the Luer type at the distal end, located at an angle of 90 degrees to its longitudinal axis.

Before the operation, the tool was brought into working condition. For this, the implant fastener in the form of a ball 5 mm in diameter is connected as a “father-mother” type with a fixation point in the form of a through slot at the proximal end of the conductor having an asymmetric extension. In this case, the fastener was completely immersed in the place of fixation on the conductor and does not protrude beyond it. The conductor is connected to a removable handle, a 20 ml syringe with novocaine solution is attached to the cannula on the removable handle.

Under aseptic conditions, a Fola No. 18 catheter was inserted into the bladder. A longitudinal section of the anterior vaginal wall was made along the midline for 4 cm, 2 cm indent from the external opening of the urethra, the wound edges were gripped by clamps, and the bladder neck was determined.

Using hydropreparation with a solution of novocaine at the level of the bladder neck, the conductor was drawn at the level of the middle third of the urethra through the soft tissues on the right side, then after touching the branch of the pubic bone, the conductor continued to move along its inner surface, after which the tissue was punctured in the region of the obturator foramen and the distal end of the conductor removed in the perineum near the inguinal fold.

Control cystoscopy was performed - the integrity of the urinary tract was confirmed. The fastener is released from the place of fixation on the conductor, captured by the clamp. A removable handle is separated and the conductor is withdrawn along the wound channel in the course of the initial movement.

Similarly held the other shoulder of the implant on the left side.

The bladder is filled with 300 ml of physiological saline, the Foley catheter is removed. The clamps capture the ends of the cover, tightened until the leakage of urine disappears with a sharp pressure in the suprapubic region. The ends of the implant with fasteners are cut off, the cover and the proper prolene mesh are separated. A Foley catheter was installed, pulling the ends of the cover, the latter was removed, the excess prolene mesh was cut off. The front wall is restored with individual catgut sutures. Blood loss 30 ml.

Claims (8)

1. Gynecological surgical instrument for simultaneous correction of genital prolapse and urinary incontinence under tension, containing a conductor with a curved working end, to which a removable handle is fixed, and a mesh implant connected to a conductor enclosed in a removable protective sheath, characterized in that the curved working end the conductor has an arc shape from 1/3 to 1/2 of the circle for the reticulum conduction of the mesh implant or an arc shape from 1/2 to 3/4 of the circle for transobturation of the reticular about the implant, while the conductor has a channel for hydrotreating with the outlet at the distal end and the fixation of the implant in the form of a recess or in the form of a through slot, and the mesh implant and its protective sheath are connected at the ends and form fasteners in the form of thickenings having, for example , a droplet shape with a maximum transverse dimension of 0.5-5 mm or, for example, a ball shape with a diameter of 0.5-5 mm. 2. The tool according to claim 1, characterized in that the curved working end of the conductor has an arc shape for the lateral conduct of the mesh implant, which is 1/2 circle, or an arc shape for transobturation of the mesh implant, which is 5/8 of the circle. 3. The tool according to claim 1, characterized in that the fixation site of the mesh implant is located at the distal end of the conductor. 4. The tool according to claim 1, characterized in that the fixation site of the mesh implant is located at the proximal end of the conductor. 5. The tool according to claim 1, characterized in that the mesh implant is made in the form of a tape. 6. The tool according to claim 1, characterized in that it is provided with means for attaching a source of overpressure, made, for example, in the form of a cannula oriented along or at an angle to the longitudinal axis of the conductor. 7. The tool according to claim 1, characterized in that the conductor has a symmetric or asymmetric end narrowing and / or pointed at the distal end. 8. The tool according to any one of claims 1 to 7, characterized in that the place of fixation on the conductor has an extension, symmetric or asymmetric in shape.

Images