RU2275883C2 - Artificial urethral sphincter and method for surgically treating enuresis in male cases - Google Patents

Abstract

FIELD: medicine; medical engineering.

SUBSTANCE: device has controllable member applying compression to urethra. The whole integrated member is fabricated from titanium nickelide wire as two meander-like branches. The branches are transversely curved with respect to meander waves propagation direction conforming to anatomical urethra curvature. The waves are oppositely arranged with their concave parts meeting each other and are closed with adjacent ends between each other using C-shaped crosspiece. The crosspiece has elongated pedicles and is turned up from unipolar meander waves envelopes continuation line to allow touching urethra wall. Empty wave spaces are made for distributing granulated porous permeable titanium nickelide over urethra surface. Method involves mobilizing bulbar urethral segment in perineal access. The artificial sphincter is fixed by suturing meander-like branches to adventitious urethral membrane. Granulated porous permeable titanium nickelide layer covers urethral surface in empty meander wave spaces.

EFFECT: enhanced functional consistency; reduced operation invasiveness.

2 cl, 4 dwg

Description

The invention relates to medicine.

"Urinary incontinence in women, men and children is one of the main problems in urology ..." [From the decisions of the Plenum of the All-Russian Society of Urology, Yaroslavl, May 21-24, 2001]. This disease, due to the morphofunctional complexity of the sphincter apparatus and a number of other reasons, including political ones, has been little studied. Its “intimacy” aggravates the conditions for timely detection for conservative treatment. Delaying medical care leads to aggravation of the disease and the need for a radical (surgical) intervention. For these reasons, the arsenal of technical means and methods for providing surgical care is also scarce and does not correspond to the socially threatening prevalence of the disease.

The goal of urinary incontinence treatment is to restore normal urination, i.e. portioning, controllability of the moment according to imperative urges, complete emptying of the bladder and reliable locking of the urinary tract, as well as the elimination of leakage of urine between acts of urination.

To eliminate the insufficiency of the output section of the bladder (sphincter incontinence), suspend (sling) operations using flaps are performed [Hert G. Operative urogynecology. M., 2003, p. 211]. Also known are paraurethral injections that eliminate the pathological dislocation of the vesicourethral angles, as one of the main etiological factors of the disease. These methods are not reliable enough. After them, an infravesical obstruction may occur. Artificial urethral sphincters are known [Hert G. Operative urogynecology. M., 2003, p.220], the working element of which is a toroidal inflated cuff of elastic material. The cuff is installed on the urethra with the coverage of the neck of the bladder and the back of the urethra. The cuff is filled with fluid with adjustable and controlled pressure. To regulate the pressure, a pump and a cylinder receiver are used, implanted subcutaneously nonperitoneally together with connecting tubes and valves.

Activation (inflation) of the cuff, leading to squeezing of the urethra, is carried out by applying pressure from the pump after the end of the act of urination. The passage of the passage with imperative urges is also carried out by the patient by reducing pressure and deflating the cuff.

Implant the device via peritoneal access; women have convenient vaginal access. According to the anatomical indications (urethral length), the device is more suitable for the treatment of urinary incontinence in men. As similar functionally and most similar in technical essence, the specified device and method for restoring normal urination are accepted as prototypes of the proposed inventions.

The disadvantages of the prototypes: the device is difficult in structure and use, it requires distraction on the activation and control of the pressure level. Implantation of the device is technically complex and highly invasive.

The technical result of the proposed solutions is to increase functional viability, reduce the invasiveness of surgical intervention.

The specified technical result is achieved by the fact that in an artificial urethral sphincter containing an element of controlled compression on the urethra, the latter is made entirely of nickel-titanium wire in the form of two meander-like branches, curved across the direction of translation of the meander waves, along the anatomical curvature of the urethra. The branches are opposite in concavity toward each other and are closed by adjacent ends with a C-shaped jumper with elongated legs, the C-shaped jumper bent from the line of continuation of the unipolar envelope of the meander to the possibility of touching the urethral wall.

It is preferable to complete the free ends of the jaws with safety-free curls.

The specified technical result is also achieved by the fact that in the method of surgical treatment of urinary incontinence in men, including mobilization of the bulbar part of the urethra, installation and fixation of the artificial urethral sphincter, a titanium nickelide wire device made in the form of two anatomically curved meander-shaped jaws is used as an artificial urethral sphincter connected by adjacent ends using a C-jumper with elongated legs. The operation of installing the device in the urethra is performed from the perineal access. The fixation of the artificial urethral sphincter is performed by suturing the meander-like branches to the adventitia urethra and additionally applying granular porous permeable titanium nickelide to the meander waves.

The invention is confirmed by an analysis of the design and operation of the device.

In figure 1. schematically presents the appearance of the device.

The branches 1, made according to the anatomy of the urethra, are located opposite each other and are connected by ends with the legs 2 of the C-shaped jumper 3. To install the device in the urethra, the C-shaped jumper is taken outside the outline formed by lines 5 of the continuation of the unipolar envelope waves of the meander .

In working condition, i.e. being superimposed on the walls of the urethra (Fig. 2), branches 1 (Fig. 1) under the action of elastic unloading deformation forces (in the direction of the CO diagram of Fig. 3), a C-shaped jumper compresses the walls of the urethra, squeezes its lumen. This condition corresponds to the continent (retention) of urine. With the accumulation of urine in the bladder, i.e. by increasing intravesical pressure and the urge to urinate, volitional tension and increasing abdominal pressure (attempts), the patient can "turn on" the mechanism of the artificial sphincter to open and empty the bladder. In this case, the operating point in the diagram of Fig. 3 goes to the upper section of the OAB - elastic deformation of the load. With the emptying of the bladder and a decrease in pressure in the bladder and urethra, the working point of the diagram returns to the lower section and shifts to the origin, completing the hysteresis deformation cycle and automatically simulating the state of the artificial sphincter “closed”.

Thus, the action of the device is adequate to the biomechanics of the natural sphincter apparatus.

The essence of the remaining essential features of the device is as follows:

1. The material of the device is titanium nickelide provides a uniform deformation force in a wide range.

2. The meander-like shape of the jaws allows for a relatively small volume of material to distribute the compression effect over a large area, reduce specific pressure and avoid tissue necrotization. The anatomical shape of the jaws contributes to this.

3. The elongated legs of the C-shaped jumper transform the developed force according to the law of the lever.

4. Curls of wire 4 at the free ends of the jaws reduce the possibility of trauma to the surrounding tissue during installation and mobile interaction in the process.

In General, the device in the aggregate of the listed features is significantly structurally and fundamentally simpler than the prototype device, and therefore, more reliable in operation, which determines the increase in the viability of the treatment of the disease.

The proposed method for the surgical treatment of urinary incontinence concerns the implantation of a new device in a new set of surgical operations. Thus, both objects are connected by a single inventive concept.

Perineal access to the bulbar part of the urethra (figure 4) is less invasive, simpler and safer than the transperitoneal access of the prototype method. It is much easier to install the device; the artificial sphincter is superimposed on the urethra, while the toroidal cuff of the prototype device is installed in the urethra by a complex technique. Hemming the links of the meander structure to the adventitia membrane (figure 2) does not constitute technical difficulties for the surgeon.

It was found that duplication of fixation of the device on the urethra by applying a layer of granular porous permeable titanium nickelide increases reliability and prevents its migration in the long term, after germination of the formed matrix by surrounding tissues.

The illustrations show:

Figure 1. Artificial urethral sphincter. Appearance. 1 - meander-like branches, 2 - legs of the C-shaped jumper, 3 - C-shaped jumper, 4 - curls of the free ends, 5 - imaginary lines of continuation of the envelope waves of the meander.

Figure 2. Fragment of an overlay of an artificial urethral sphincter. 1 - branches of an artificial sphincter, 2 - urethra, 3 - granules of porous permeable titanium nickelide, γ - points of nodal fixation (hemming) of the device to the urethra.

Figure 3. Tension-strain diagram of titanium nickelide material.

Figure 4. Topography of internal organs in the field of imposing an artificial sphincter. 1 - artificial sphincter, 2 - bulbar part of the urethra, 3 - bladder, 4 - direction of perineal access (area of operation.)

The attainability of the technical result is confirmed by specific examples of the use of the proposed device and method for the surgical treatment of urinary incontinence in men in the urology department of City Clinical Hospital No. 25 of Novosibirsk.

Example:

Patient P., 75 years old (medical history No. 27 dated April 7, 2003), was admitted to the hospital with a diagnosis of complete urinary incontinence in a standing position, partial incontinence in a supine position. In the history of the disease - transurethral resection of adenoma of the paraurethral glands.

The patient underwent surgery for the treatment of urinary incontinence of the proposed method using the proposed device.

The device used is an artificial urethral sphincter (Fig. 1) with the following characteristics: overall length - 30 mm, wave height of four-wave jaws - 10 mm, jaw length - 12 mm, material - nickel-titanium alloy TV-10, wire diameter - 0.8 mm .

The device operates and the method is as follows during the operation.

Under epidural anesthesia with a median perineal access 6 cm long, the posterior urethra is layered naked and circularly isolated in the bulbar region for 4 cm to the prostate (Fig. 4). An artificial sphincter is installed on the urethra and fixed at individual points (Fig. 2) to the adventitia membrane with interrupted sutures with a polypropylene thread. In the gaps of the meander waves, a granular porous permeable titanium nickelide 3 in a volume of 0.4 cm ³ (FIG. 2) was placed on the surface of the urethra and covered with tissues.

During the operation, the action of the artificial sphincter was controlled by simulating the process of urination. To do this, through the urethral catheter, the bladder is filled with a solution of furatsilina in an amount of 200 ml, and the catheter is removed. At rest of the patient and with light pressure on the bladder through the abdominal wall, furatsilin did not take place. With an increase in pressure to 57 kgf, the sphincter opened, and furatsilin began to expire. With the cessation of pressure, the outflow ceased. The test results were regarded as satisfactory work of the artificial sphincter, and the operation was completed.

After two days of catheter urinary diversion, the patient began to urinate independently, in portions. There was no spontaneous leakage of urine (incontinence) between acts of urination. After 10 days, the sutures were removed and manual correction of the condition of the artificial sphincter through the skin was performed - branches were additionally tightened by deformation of the C-shaped jumper.

The patient was discharged from the hospital in satisfactory condition, without pain in the area of operation. In the distant, up to 6 months after the operation, the normal operation of the artificial urethral sphincter was traced: independent portioned urination and urine retention between passages in any position, with moderate physical exertion (coughing, sneezing).

The device is easy to manufacture. Both objects are worked out enough to meet the criteria of the invention of "industrial applicability".

Claims (3)

1. An artificial urethral sphincter containing an element of controlled compression on the urethra, characterized in that the element of controlled compression on the urethra is made entirely of nickel-titanium wire in the form of two meander-like branches, curved across the direction of translation of the meander waves along the anatomical curvature of the urethra opposite to the concavity each other and closed by adjacent ends with each other with a C-shaped jumper with elongated legs, and the C-shaped jumper is bent from the extension line unipolar wave envelope to meander possible touch urethral wall and wave meander gaps have to be placed on the surface of the urethra granular porous permeable TiNi. 2. The device according to claim 1, characterized in that the free ends of the branches are completed with safety-free curls. 3. A method for the surgical treatment of urinary incontinence in men, including mobilization of the bulbar part of the urethra, installation and fixation of the artificial urethral sphincter, characterized in that the mobilization of the bulbar part of the urethra is performed by perineal access, as the artificial urethral sphincter, use the device according to claims 1 and 2, fixation an artificial urethral sphincter is performed by suturing the meander-like branches to the adventitia of the urethra, on the surface of which a layer is applied to the gaps of the meander waves th granular porous permeable titanium nickelide.

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