Method and instrument for treating the cases of female enuresis

FIELD: medicine; medical engineering.

SUBSTANCE: method involves implanting a ribbon into the body on each side of the urethra between the vaginal wall and abdominal wall. The ribbon is drawn above the pubic bone. The ribbon is introduced on both sides of the urethra to make a loop around the urethra. It is arranged on each side of the urethra between the vaginal wall and abdominal wall and stretched by pulling its ends brought outside of the abdominal wall. The ribbon is introduced pulling it inside through two holes produced in soft tissues with needle-shaped member using tubular envelope prefitted on the needle-shaped member. The tubular envelope is left in the hole when pulling the needle-shaped member from the hole in the direction reversed with respect to PIERCE direction. Ribbon is pulled into the hole in the introduced tubular envelope drawing the corresponding end. Then the tubular envelope is removed from the body in the direction of ribbon end. Surgical instrument has implantable ribbon and rod having handle on the first end with curved needle-shaped member on the second end and through hole on the free end with an ear which sizes are enough for passing from the internal surface of the vagina wall above the posterior back side of the pubic bone to the external surface of the abdominal wall. The instrument additionally has removable tubular envelope which dimensions allow the ribbon under implantation, moving through the hole. The removable tubular envelope is fittable over curved needle-shaped member as far as possible from the rod side to the prominent free end of the curved needle-shaped member projecting from the tubular envelope.

EFFECT: enhanced effectiveness of treatment; reduced instrument production costs; simplified design.

23 cl, 8 dwg

 

The invention relates to urology, namely to surgical instruments and methods for treating urinary incontinence in women.

The prior art method of treating urinary incontinence in women without opening the abdominal cavity, according to which of 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. Surgical instrument for carrying out this method comprises a rod with a handle on one end and a curved portion at the other end designed for insertion into the body through the vagina.

Known surgical instrument and method for the treatment of urinary incontinence in women selected as prototypes [patent RU 2161916, publ. 20.01.2001]. The method is carried out by implantation of tape on each side of the urethra between the vaginal wall and the wall of the abdomen by pulling above the pubic bone. The tape is introduced into the soft tissues through the vagina first one concomi then its other end respectively with one and other sides of the urethra for a loop around the urethra, you have between the urethra and the vaginal wall, and pull the tape over her released to the outside from the side of the abdomen ends. In the particular case, the introduction of the tape is carried out by drawing in sharp bore with a tubular sheath tape, which is then pulled out of the body. Known surgical instrument for carrying out the method comprises a rod with a handle at the first end and a curved needle-like element at the second end for insertion into the body. Needle-like element has a size sufficient for passing from the inner surface of the vaginal wall on the back side of the pubic bone to the outside of the abdominal wall. There are different special cases of the execution. Needle-like tool at its one end can be connected with one end of the tape to be implanted in the body, with one end of the tape may be passed through the loops in the joining head element. The handle may include two arms diametrically protruding from the terminal. The rod can be made reusable and consist of material, sterilisable in an autoclave, and the needle-like elements are disposable and made of plastic material, stainless steel or similar material. Needle-like element can be bent, there is society, a quarter of a circle and to be tapered toward the free end, and with a pointed or blunt free end. The tape can be enclosed in a plastic shell, such as polyethylene.

Known technical solutions above, along with the merits have some drawbacks. The need to detach the needle-like element complicates the design of a surgical instrument that increases its cost. Subsequent pulling the detached needle-like element forceps from the side wall of the abdomen is inconvenient and requires a significant effort that is getting worse by the fact that at the same time it is necessary to extend through the soft tissue tape, which is also additionally injure the tissue in the area punctured holes.

Solved the technical problem is to simplify the design of a surgical instrument for the treatment of urinary incontinence in women, reduce its cost and, as a consequence, the cost of treatment and increase the convenience of operation for the surgeon and for the patient.

Features a method of treating urinary incontinence in women, which is carried out by implantation of the tape to the body on each side of the urethra between the vaginal wall and the wall of the abdomen by pulling above the pubic bone. The tape is introduced into the soft tissues che is ez vagina first one end and then the other end respectively with one and the other side of the urethra for a loop around the urethra, you have between the urethra and the vaginal wall, and pull the tape at its ends, is released to the outside wall of the abdomen. The introduction of the ribbon carried out by drawing in two holes, sharp in the soft tissues of the head element, using a tubular membrane, which is then pulled out of the body. What's new is that when puncturing holes in it simultaneously retract the tubular shell, which is pre-placed on the needle-like element, and when pulling the needle-like element from the hole in the direction opposite to the direction of the puncture, the tubular casing left in the hole, with the hole in the drawn tubular shell pulls the tape at its respective end, after which the tubular casing is pulled from the body in the direction of the end of the tape.

Each hole can be pierced, needle-like element in the direction from the vaginal wall to the wall of the abdomen. Needle-like element is then pulled from the hole in the opposite direction.

After perforation holes to the end of the needle-like element on the outside of the abdominal wall may be attached to the first end of the thread for which the thread is put through the hole in the drawn tubular shell, the movement of the pulling head of the tool from the hole, when Atomstroy the end of the thread left on the outside wall of the abdomen. Then the first thread end is cut off from the end of the needle-like element and is attached to the first end of the thread corresponding end of the tape, which is then drawn into the hole in the drawn tubular sheath by pulling the threads out of the hole in the tubular shell at the second end of the thread.

For the implementation of the proposed method offers a surgical instrument for the treatment of urinary incontinence in women, containing implantable ribbon and a rod with a handle at the first end with a curved needle-like element at the second end, having at the free end through hole in the form of loops and dimensions for the passage from the inner surface of the vaginal wall on the back side of the pubic bone to the outside of the abdominal wall. What's new is that the tool further comprises a removable tubular shell sizes for the movement of the threaded through hole implantable tape, and a removable tubular sheath made with the possibility of sitting on the curved needle-like element to another side of the rod and to the projection of the free end of the curved needle-like element of the tubular shell.

The tool may further comprise a thread to pull implantable tape, with a through hole in the form of loops performed under the thread.

The tubular sheath may be performed flexibly is, for example, from plastic.

The tubular sheath may be made rigid, for example made of steel.

The handle may be made in the form of a roller, the ends of which are diametrically from the terminal.

The rod can be made with the possibility of multiple use, for example of steel.

Needle-like element can be made in both steel and plastic.

Better when needle-like element is bent in an arc about a quarter of a circle.

Needle-like element can be pointed at the free end of the cone.

The tip on the free end of the needle-like element better to dull the radius.

Needle-like element to the free end can be performed with a constant cross-section and/or to have a circular cross-section.

One end of the tubular shell on the outside can be made sharp by cone taper approximately equal to the taper pointed at the cone of the free end of the head element.

The tool may include a removal mechanism, configured to bias the tubular sheath in her impaled all the way to needle-like element position along the needle-like element in the direction towards its free end.

Thus, the mechanism of withdrawal can include a slider located on the rod is made with the possibility of translational movement to the Oia along rod.

Thus the slider can be connected to a thrust or rods with a thrust washer mounted with clearance on the needle-like element so that the tubular sheath abuts with its one end in the thrust washer when planted until it stops on its head element position of the tubular shell.

The slider may include a pin that is included in the guide groove made on the rod longitudinally of the rod.

The invention is illustrated by drawings, where figure 1 and 2 shows an example of the surgical tool on the side and top respectively. Some surgical stage of the proposed method using such a surgical instrument is presented in figure 3-8.

The invention is illustrated on the example of the structure of a surgical instrument and the method of implantation of the tape using such a tool.

Surgical instrument (see figure 1 and 2) comprises a cylindrical rod 1 with a handle 2 at its one end and a curved needle-like element 3 mounted on the other end of the rod 2 and is equipped with a free stick of tubular casing in the form of a removable tube 4, the first end 5 of which is tapered, the taper of which corresponds approximately to the taper pointed at the cone of the free end 6 of the needle-like element 3 (the edge blunted by radius - not shown) done with the authorized therein a through hole, performs the function of the lug 7. On the needle-like element 3 having a circular cross-section and polished surface, with a gap planted thrust washer 8, designed to rest on her second end 9 of the removable tube 4 and connected with the annular slide 10 two rigid in the longitudinal direction of the rods 11. The annular slider 10 is fixed from rotation around a cylindrical rod 1 by a pin 12, a part of which includes a longitudinal guide groove 13. Cylindrical rod 1 provided with the second guide groove 14, diametrically opposite the guide groove 13, while the end position of the ring of the RAM 10 in the direction of the pull handle 2 11 part into the guide grooves 13, 14 near the end of a cylindrical rod 1 on which is mounted needle-like element 3.

Details of the surgical instrument, intended for repeated use, is made from a material that can be sterilized in an autoclave, for example stainless steel. Removable tube 4 can be made disposable from relatively cheap material, such as polyethylene or polycarbonate. Needle-like element 3 may be reusable and may narashima to connect with a cylindrical rod 1, or may be disposable and connect with a cylindrical rod 1 is Ishenim connection for example screwed into the center threaded hole in the cylindrical core 1 (not shown). The kit with the surgical instrument includes nylon thread 15 (see figure 4-7) and the tape 16 (see Fig.6 and 7), having the ability to pass freely through the opening in the removable tube 4.

Surgical phase of operation in accordance with the claimed process is largely similar to that described in method that is selected as a prototype [patent RU 2161916, publ. 20.01.2001]for the differences described below. Figure 3-8 schematically shows the lower part of the abdomen of a woman with a body - vagina 17, the bladder 18, the urethra 19, pubic bone 20, the wall of the stomach 21.

The first stage of the surgery to implant the tape 16 shown in figure 3, consists in piercing the vaginal wall 17, needle-like element 3 mounted on it by a removable tube 4 until it stops in the thrust washer 8 (at the end position of the ring of the RAM 10 to the handle 2) with the implementation of the first incision in the wall and also piercing the soft tissue on one side of the urethra 19. When the puncturing implement pressure by hand on the handle 2.

Next (see figure 4), needle-like element 3, together with the removable tube 4 is passed near the back side of the pubic bone 20 and then through the wall of the abdomen 21 above the pubic bone 20. For the passage of the needle-like element 3 through the wall the ku belly 21 it can be made the incision, if the free end 6 is sharp enough to pierce the abdominal wall 21 from the inside. Then one end of the thread 15 is passed through the eyelet 7 with the formation of strong hinges 22.

After that (see figure 5), needle-like element 3 is pulled from the hole in the removable tube 4 in the opposite direction, leaving the removable tube 4 in the body and thereby retracting the thread 15 of the loop 22 into the hole in the removable tube 4. In the initial stage of the pulling needle-like element 3 is performed by the thrust of the handle 2, securely holding the one ring, the slider 10.

After a full pull needle-like element 3 from the hole in the removable tube 4 and detach from his outstretched thus through the opening in the removable tube 4 thread loop 15 22 loose and disconnect the filament 15 of needle-like element 3 (see Fig.6). Once this form strong loop 22, to which is attached the first end of the tape 16.

Then the tape 16 stretch through the opening in the removable tube 4 by pulling the threads 15 of the holes in the tubular shell at the second end of the thread 15, the loop 22 is disconnected (see Fig.7). After this removable tube 4 is pulled out of the body from the abdominal wall 21, seizing forceps for the first end 5 and holding in place the tape 16.

As mentioned above, the second end of the tape 16 is inserted into the punctured hole on the other side of the urine is spasatelnogo channel 19 and the tape 16 is located on each side of the urethra 19. The tape 16 is tightened, forming a loop around the urethra 19, located between the urethra 19 and the vaginal wall 17 (see Fig). Then cut off the excess tape on the outside of the abdominal wall 21, and the tape 16 is left as an implant in the body for the formation of artificial ligaments and forming a support for the urethra 19 that is required to correct urinary incontinence.

As in the prototype, it is better when the ribbon is a grid or form has a grid of holes with a size of about 1 mm with a preferred width of about 10 mm to fibroblasts could grow into a tape for recording into the surrounding tissue. In particular, it is better when the material of the tape is used PROLENE - knitted polypropylene mesh with a thickness of 0.7 mm, manufactured by the firm "Ethicon, Inc."® (USA). Another type of tape can be a strip of material, which provides a complete resorption of the tape after a certain period of time. In this case, thanks to the development fibroblastoma expansion, stimulated tape, can be achieved by strengthening the tissues needed to correct urinary incontinence.

Specialist in the field of medicine is relatively easy able to exercise and other ways of carrying out the invention within formula. For example, without the use of threads 15, i.e. puncture done by the keys in the direction from the abdominal wall to the vagina with a reverse pulling needle-like element together with the more narrow ribbon 16, directly threaded and fastened his end using loops 7.

1. A method of treating urinary incontinence in women, which is carried out by implantation of the tape to the body on each side of the urethra between the vaginal wall and the wall of the abdomen by pulling on the pubic bone while the tape is introduced into the soft tissues through the vagina first one end and then the other end respectively with one and the other side of the urethra for a loop around the urethra, which come between the urethra and the vaginal wall, and pull the tape at its ends, is released to the outside wall of the abdomen, when the introduction of the tape is carried out by drawing in two holes, sharp in the soft tissues of the head element, using a tubular membrane, which is then pulled out of the body, wherein when the puncturing holes in it simultaneously retract the tubular shell, which is pre-placed on the needle-like element, and when pulling the needle-like element from the hole in the direction opposite to the direction of the puncture, the tubular casing left in the hole, with the hole in the drawn tubular shell pulls the tape at its respective end, after which the tubular sheath is pulled out t the La in the direction of the end of the tape.

2. The method according to claim 1, characterized in that each hole is pierced with a needle-like element in the direction from the vaginal wall to the wall of the abdomen, and then pull the needle-like element from the hole in the opposite direction.

3. The method according to claim 2, characterized in that after perforation holes to the end of the needle-like element on the outside of the abdominal wall attach the first end of the thread for which the thread is put through the hole in the drawn tubular shell, the movement of the pulling head of the tool from the hole, the second end of thread left on the outside of the abdominal wall, after which the first end of the filament is cut off from the end of the needle-like element and is attached to the first end of the thread corresponding end of the tape, which is then drawn into the hole in the drawn tubular sheath by pulling the threads out of the hole in the tubular shell at the second end of the thread.

4. Surgical instrument for the treatment of urinary incontinence in women, containing implantable ribbon and a rod with a handle at the first end with a curved needle-like element at the second end, having at the free end through hole in the form of loops and dimensions for the passage from the inner surface of the vaginal wall on the back side of the pubic bone to the outside of the abdominal wall, characterized in that it further contains is it removable tubular shell sizes for the movement of the threaded through hole implantable tape, moreover, a removable tubular sheath made with the possibility of sitting on the curved needle-like element to another side of the rod and to the projection of the free end of the curved needle-like element of the tubular shell.

5. The tool according to claim 4, characterized in that it further comprises a thread to pull implantable tape, with a through hole in the form of loops performed under the thread.

6. The tool according to claim 4, wherein the tubular sheath is flexible.

7. The tool according to claim 6, characterized in that the tubular sheath is made of plastic.

8. The tool according to claim 4, wherein the tubular sheath is made hard.

9. The tool of claim 8, wherein the tubular sheath is made of steel.

10. The tool according to claim 4, characterized in that the handle is made in the form of a roller, the ends of which are diametrically from the terminal.

11. The tool according to claim 4, characterized in that the rod is made with the possibility of multiple use.

12. The tool according to claim 11, characterized in that the rod is made of steel.

13. The tool according to claim 4, characterized in that the needle-like element is made of steel or plastic.

14. The tool according to claim 4, characterized in that the needle-like element is bent in an arc about a quarter of a circle.

15. The tool according to claim 4, characterized in, is the needle-like element is pointed at the free end of the cone.

16. The tool according to claim 4, characterized in that the tip on the free end of the needle-like element blunt radius.

17. The tool according to claim 4, characterized in that the needle-like element to the free end is made with a constant cross-section.

18. The tool according to claim 4, characterized in that the needle-like element to the free end is made with a circular cross section.

19. The tool according to claim 4, characterized in that one end of the tubular shell on the outside made pointed down the cone with a taper approximately equal to the taper pointed at the cone of the free end of the head element.

20. The tool according to claim 4, characterized in that it contains a mechanism for withdrawal made with the possibility of displacement of the tubular sheath in her impaled all the way to needle-like element position along the needle-like element in the direction towards its free end.

21. The tool according to claim 20, wherein the removal mechanism includes a slider located on the rod made with the possibility of translational movement along rod.

22. The tool according to item 21, wherein the slider is connected by a thrust or rods with a thrust washer mounted with clearance on the needle-like element so that the tubular sheath abuts with its one end in the thrust washer when planted until it stops on its head element position Tr is batoy shell.

23. The tool according to item 21, wherein the slider includes a pin that is included in the guide groove made on the rod longitudinally of the rod.



 

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