RU2269983C1 - Device for surgical treatment of women suffering from stress enuresis - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: device is made of super-elastic titanium nickelide and it has urethra position corrector provided with urethra supporting unit and device holders. Urethra supporting unit is made in form of cylindrical wire spiral flattened at the area of cross-section. The spiral has saddle-shaped curve. Lockers go ahead of edges of spiral and they are made in form of U-shaped wire petals. Petals are conjugated with convex surface of supporting unit and are oriented by 20-30° to convexity from the spiral. Length of any locker has to be 0,5-0,75 of length of urethra supporting unit.

EFFECT: reduced traumatism; improved efficiency of surgical treatment.

4 cl, 1 ex, 5 dwg

Description

The invention relates to medical surgical equipment.

Urinary incontinence in people, in particular most often in women, is a disease that does not lead to death or a serious direct violation of the physiology of the body, but leads patients to social ostracism, the psychoemotional suffering of which is no less severe than physical, and increases the possibility of any pathology. The prevalence of the disease (up to 38% of women of working age surveyed) and social significance led to the organization of the International Society for Incontinence, the Russian Society of Urology and regular discussion of research and treatment tasks. The intimacy of the disease and the unwillingness to see a doctor in the current view of treatment inefficiency complicate the problem.

Meanwhile, there is a (albeit probabilistic) theory of the etiology of the disease. It is believed that a typical etiological factor is ptosis (prolapse) of the urethrovaginal wall (for example, after childbirth). Ptosis leads to dislocation of the urethra, urethrovesical angles, and ultimately to dysfunction of the urethral sphincter. The international classification of stress urinary incontinence (NMPN) according to the degree of incontinence and signs of the pathology of the urethrovesical complex is accepted. In accordance with it, treatment methods are recommended. Mild forms of incontinence are treated conservatively, in more severe ones, surgical intervention is used.

Known methods of surgical treatment (Materials of the plenum of the Russian Society of Urology. Yaroslavl, May 21-24, 2001, Moscow, 2001) are based on the formation of additional support for the urethra and neck of the bladder by various techniques: fascial autosling, injection of substances (collagen, autogyro Teflon). These methods are ineffective due to tissue resorption of the bed of formed supports, prolonged infection in the wound area. The failure of the methods is mainly due to the shortcomings of the used technical means, which should be taken as analogues of the proposal.

Known prolene loops (slings) for the formation of additional support of the urethra [D.Yu. Pushkar, O.B. Laurent and others. "Diagnosis of stress urinary incontinence in women and operations HERE" Guide kaf. Urology MSMSU. M. 2002, p.20-23]. The operation according to the name of the used technical means, which is selected as a prototype, received the name "sling" and is considered the main one in the surgical treatment of urinary incontinence. The essence of the operation is as follows.

After premedication and anesthesia (often general anesthesia), an incision is made of the anterior vaginal wall in the projection of the middle part of the urethra. Through the incision, bypassing the urethra on the Foley catheter, the bladder and pubic bone, needles are passed, perforating the pelvic diaphragm and aponeurosis of the rectus abdominis muscle, into suprapubic skin incisions. Needle traction leads the ends of the prolene loop 2 (Fig. 1) to reach and corrective support of the urethral segment 3 (Fig. 2). The tension force is selected according to the disappearance of involuntary urination during a cough test. Due to the special properties of prolene, the loop is fixed to paraurethral tissues independently.

Thus, in the loop as a device for the surgical treatment of stress urinary incontinence in women, the middle section 1 is functionally identified as an element of the covering support of the urethra and the free ends 2 as the fixators of the device.

The disadvantages of the prototype, which are manifested in the operational stage and long-term results, are high traumatization and the often accompanying need for a general, not harmless to the patient, anesthesia, resorption of tissue of the sling channel due to low biocompatibility of prolene, recurrence of the disease.

The technical result of the invention is to reduce trauma, increase the viability of surgical treatment.

The specified technical result is achieved by the fact that in the device for the surgical treatment of stress urinary incontinence in women, containing the corrector of the position of the urethra as part of the support element of the urethra and the fixators of the device, superelastic titanium nickelide is selected as the material of the device. The support element of the urethra is made in the form of a cylindrical wire spiral flattened in cross section and is saddle-longitudinally curved. Two device latches protrude from the ends of the urethral support element and are associated with its curved surface. Each clamp is made in the form of a U-shaped wire lobe oriented at an angle of 20-30 ° relative to the end direction of the curved surface of the urethral support element, in the direction of curvature. The length of each device lock is a ratio of 0.5-0.75 with the length of the support element.

It is preferable to supplement the device latches with elements for increasing the supporting surface. It is preferable to perform the elements of increasing the supporting surface of the perforated foil retainers.

It is preferable that the elements of the increase in the supporting surface of the clips of the wire mesh.

The attainability of the technical result is due to a combination of essential features, in the original combination of the properties of each feature. The main role in the attainability of the technical result is played by the material, structure and shape of the device. During the operation, the task of which is to create an additional (artificial) support of the urethra and correction of urethrovesical angles, the device is implanted through a relatively small incision (up to 25 mm) of the anterior vaginal wall under the fascia. The possibility of such limited and, therefore, less traumatic access is facilitated by the property of elastic deformation of the material and the entire device. At the installation stage, the latches 2 (figure 2) are bent to the ends of the support element 1, reducing the overall length. In the device bed, the stresses of elastic deformation, the clamps return to their original (“cold”) state, supporting the urethra with a saddle-shaped recess of the support element and fixing the support in paraurethral tissues. An interval of elastic deformation of nickel-titanium fixatives is sufficient to implement such dynamics. The spiral shape of the support element complements the deformation capability. A positive consequence of these properties is a significant reduction in trauma, a multiple reduction in surgery time, elimination of the need for general anesthesia.

The saddle shape of the working surface of the support element, the angular orientation of the retainers and their length correspond to the anatomy of the involved organs and tissues.

The device is more stably positioned, and the specific pressure of the fixators on the fabric is reduced and, therefore, more gentle and safe when supplemented with elements to increase the supporting surface. Specific, most technologically advanced versions of these elements are perforated foil (Fig. 3), attached in any way to the contour sections of the U-shaped lobe, or wire mesh (Fig. 4) of any texture and method of attachment.

The illustrations show:

Figure 1. A device for the surgical treatment of stress urinary incontinence in women is a prototype. 1 - urethral support site, 2 - device fixation areas, 3 - urethra.

Figure 2. Device for the surgical treatment of stress urinary incontinence in women (proposal). 4 - urethral support element, 5 - device latches.

Figure 3. Device lock with foil support element.

Figure 4. Lock device with a support element made of wire.

Figure 5. The correction scheme of the urethra. 6 - the bladder.

The attainability of the technical result is confirmed by specific examples of the use of the invention in the clinical practice of surgical treatment of stress urinary incontinence in women in medical unit No. 2 of Tomsk.

Example.

Patient S., 73 years old, was admitted to the hospital with a diagnosis of stress urinary incontinence type 2a according to the international classification. Incontinence corresponds to this type when urine pressure in the bladder is exceeded 10 mm Hg. The duration of the disease is 15 years. Conservative treatment was unsuccessful, and the patient refused to repeat it.

After a clinical examination, the patient underwent surgery - correction of the urethrovesical segment using the proposed device.

A device for the surgical treatment of stress urinary incontinence in women (figure 2) is made of superelastic nickel-titanium wire with a diameter of 0.3 mm and has dimensions: length of the urethral support element is 1-18 mm, a separate retainer is 2-11 mm, the cross-sectional dimensions are flattened spiral support element 6 × 8 mm, the angle of bending of the latches from the direction of the curved surface of the support element 25 °. To increase the longitudinal stiffness of the support element, its concave portion is covered by a micro-movable longitudinal clamp made of nickel-titanium foil. The device latches are supplemented by supporting surfaces in the form of a nickel-titanium wire with a diameter of 0.1 mm, spirally wound in the transverse direction of the petals.

The device during the operation works as follows: under local anesthesia with a Foley catheter, an incision of the paraurethral tissue of the anterior vaginal wall at the mid-urethra, 25 mm long, was made. The edges of the wound are laid to the sides and in the thickness of the tissue, blunt tunnels are formed in a blunt way across the incision according to the dimensions of the device clamps. The latches of the device 5 are bent to the ends of the support element 4, and in the deformed state, the device is inserted by the latches into the tunnels, where under the action of the elastic return of the latches to the initial form, they are inserted to the end of the tunnels, and the urethral support element touches the tissues under the urethra and at the end of the backward deformation course and deforms the urethra to a normal position (figure 5). Foley's catheter removed. Control sphincterometry was performed, which confirmed a negative result of the cough test against a background pressure of 40 mmHg in the bladder. The Foley catheter is returned to the urethra for a period of 1 day. The wound is sutured with three interrupted sutures.

The duration of the operation is 10 minutes. Inspection of the patient after 3 months established independent urination, a normal continent with ordinary stress.

The device is structurally and technologically tested to the norm of compliance with the criterion of "industrial applicability".

Claims (4)

1. A device for the surgical treatment of stress urinary incontinence in women, comprising a urethral position corrector with an urethral support element and device clamps, characterized in that it is made of superelastic titanium nickelide, and the urethral support element is made in the form of a cylindrical wire coil flattened in cross section, which is saddle-shaped longitudinally curved, and the latches protrude from the ends of the spiral and are made in the form of U-shaped wire lobes conjugated with the curved surface of the element dderzhki oriented in the direction of the helix 20-30 ° to the convex, the length of each fastener device is the ratio of length 0.5-0.75 urethral support member. 2. The device according to claim 1, characterized in that its latches are additionally equipped with elements for increasing the supporting surface. 3. The device according to claim 2, characterized in that the elements of increasing the supporting surface of the clamps are made of perforated foil. 4. The device according to claim 2, characterized in that the elements of increasing the supporting surface of the clamps are made of wire mesh.

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