RU2232562C2 - Device for applying conservative treatment of enuresis in female patients - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: device is manufactured from flexible titanium nickelide wire curved as two flat arc-shaped spirals separated one from the other by an anatomically predefined distance and connected to binding element manufactured as wavy meander from wire of the same type with the adjacent ends. One spiral serves as supporting member in posterior vaginal wall and the second one thrusts against the anterior vaginal wall below the uterine cervix and causes anterior wall deformation and change of vesiculourethral angle.

EFFECT: reduced transverse rigidity.

2 cl, 5 dwg

Description

The invention relates to the field of medicine - urological oncology, specifically to devices for conservative treatment of urinary incontinence in women.

Incontinence in people, in particular and 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, psycho-emotional suffering, which is no less serious than physical, and increases the possibility of any pathology.

This problem is so serious with the prevalence of the disease and the social consequences that the International Society for Urinary Incontinence was organized, and in Russia it was comprehensively discussed at the next plenary meeting of the Board of the Russian Society of Urology [1].

Stress urinary incontinence (NMPN) in women of active working age was noted according to a survey and examination in 38% of respondents. With such a massive disease, depending on its severity and etiology, various treatment methods are used: surgical, medication, physiotherapy, as well as conservative instrumental ones. The latter with mild forms of the disease are preferred, as they are free from surgical trauma, drug intoxication, long-term and systemic physiotherapy.

A device for conservative treatment of urinary incontinence in women is known - a pessary made of an inert material in the form of an oblong rod with a smooth bending of the end sections to the sides opposite from the middle of the rod [2]. Installed in the vagina, the device with one (distal) end is fixed in the rear wall, and the second abuts against the front wall of the vagina below the cervix (Fig. 1). Compression of the second (supporting) end of the device causes deformation of the front wall, changes the vesicourethral angle, an anomaly of which leads to sphincter dysfunction and urinary incontinence, to a normal value and thereby helps to restore the sphincter closure function.

Due to the stiffness of the pessary material, inadequate pressure acts on the walls of the vagina and sphincter apparatus of the bladder, leading to a violation of the trophism of the walls of these organs, subsequent atrophy of their muscular apparatus and, possibly, to an increase in the incidence of urinary incontinence. Locking the device for a long time is not possible. A significant drawback is the need to remove the device before each act of urination.

A more complete device for the conservative treatment of urinary incontinence in women is in the form of a combination of wire structures made of titanium nickelide, which has a superelastic effect [3]. By the greatest similarity of the technical essence, it is selected as a prototype of the proposal. Three functional areas are identified in the device: support - in the form of a closed cylindrical spiral of anatomical dimensions, fixing - in the form of a meander structure rolled into a cylinder and a loop-shaped handle for ease of installation and evacuation of the device. All three sections are arranged in series and are made by a single piece of wire with a smooth conjugate transition between them, with the first two sections having both cylindrical shapes, coaxial.

The device is inserted into the vagina, having the supporting area proximally on the front surface of the cervix. In this case, the mucous membrane of the vagina, gently prolabbing between the elements of the meander structure of the fixing area, reliably keeps it from migrating and slipping out. The dynamics of the etiotropic effect is similar to that of the above analogue.

The disadvantages of the prototype device are the high lateral stiffness of the supporting section, its inadequacy to the anatomical shape of the vagina - properties that make installation difficult without special aids and create discomfort for the patient, especially when changing the sitting posture, energetic walking and other movements in the pelvic area.

The technical result of the invention is a reduction in the transverse rigidity of the device, improving adaptive qualities to the individual anatomical features of the patient.

The specified technical result is achieved by the fact that in the device for the conservative treatment of urinary incontinence in women, containing a bent wire structure of elastic titanium nickelide with supporting and fixing sections of anatomical dimensions, the supporting and fixing sections are each made in the form of a flat spiral, curved arcuate along its elements, and connected at adjacent ends with a link made in the form of a wave-like curved wire, and the angle between the directions of the waves of the link and each th spiral is 120-150 °.

Preferably, the displacement of the extreme proximal elements of the flat spiral of the support section from its generatrix towards the convexity by a relative distance of 1-1.5 spiral steps. Achievability of the technical result is due to a combination of distinctive features characterizing the design of the device, in combination with the properties of the material used - elastic titanium nickelide.

The spiral-curved shape of the support and fixing sections and their parallel orientation adjacent to the axes are maximally adequate and adaptive to the anatomical shape of the vagina with various individual and physiological variations of it (for example, during dynamic movements in the pelvic region). Correctly selected stiffness of the material allows in such cases to deform the arc of the spirals in its radial direction with gentle gentle influence on the mucous membrane. In this case, the compression force of the supporting portion on the vaginal wall (Fig. 4), leading to a change in the vesicourethral angle and restoration of the sphincter obturator function, is realized to a sufficient degree. Similar arguments are true for the fixing section (figure 3, position 2, figure 4), the function of which is to stabilize the device, prevent its migration and create a reactive force to the action of the reference section.

The wave-curved shape of the wire of the connecting link 3 (Fig. 3) allows for the initial installation of the device to select anatomically adequate overall dimensions of the device and the distance between the supporting and fixing sections. Changing the length of the connecting link (bending or unbending waves) requires for parallel orientation of these sections to change the angle between the directions of translation of the waves of the connecting link and spirals (α in figure 3). Based on statistical measurements, an interval of variation of angles of 120-150 ° is revealed experimentally. The separation of the extreme proximal elements of the flat spiral of the supporting portion toward the convex side is preferable to guarantee the necessary compression action on the anterior vaginal wall and to prevent angular migration of the device.

The illustrations show:

Figure 1. Device for conservative treatment of NMPN in women (pessary).

Figure 2. Device for conservative treatment of NMPN in women (bent analog); 1 - supporting section, 2 - fixing section, 3 - handle.

Figure 3. Device for conservative treatment of NMPN in women (proposal); 1 - supporting section, 2 - fixing section, 3 - connecting link.

Figure 4. Device for conservative treatment of NMPN in women in an established position.

Figure 5. X-ray of the installed device.

An example of a specific implementation and the attainability of a technical result.

Patient N., 52 years old, was admitted to the therapeutic department of the 2nd Medical Unit of Tomsk in December 2000 with a diagnosis of diabetes mellitus with concomitant urinary incontinence with tension (coughing, sneezing, weight lifting, fast walking) of moderate severity. This condition progresses over the past three years. An appeal to the hospital about this for the first time. The patient has a history of two births.

Inspection confirmed the presence of NMPN. Sphincterometry index 19-21 mm Hg Surgery for general health is contraindicated.

For conservative treatment of the patient, a device was used (Fig. 3) with the following characteristics: length of support 1 and fixing 2 sections 20 mm each, length of link 3-30 mm. The material of the wire is titanium nickelide ТН-10, the diameter of the wire of the supporting and fixing sections is 1.1 mm, the diameter of the wire of the connecting link is 0.7 mm. The angles between the directions of translation of the spirals of the supporting and fixing sections and waves of the link 130 °.

The device works as follows: on a gynecological chair, after visual inspection, the device is inserted by hand without auxiliary tools into the vagina, being guided by touching the front wall, until it stops in the cervix of the proximal element of the supporting section (Fig. 4). In this case, the protruding elements of the supporting section are located in the region of the posterior wall of the bladder and the vesicourethral segment. The distal end of the fixing section 2 (figure 3) is fixed by focusing in the rear column of folds.

Compression of the supporting area leads to deformation of the vaginal wall, a change in the direction of normalization of the vesicourethral angle, contributing to an improvement in the function of the internal sphincter.

Sphincterometric control showed an increase to 28-32 mm Hg. When coughing, spontaneous excretion of urine was not noted. During walking and sitting, the patient does not experience discomfort. Urination occurs without removing the device.

Sources of information

1. Materials of the plenum of the Russian Society of Urology. Yaroslavl, May 21-24, 2001, M., 2001

2. Kang D.V. Guide to obstetric and gynecological urology. - M.: Medicine. 1978, p. 363.

3. RF patent No. 2150919, 7 A 61 F 6/08.

Claims (2)

1. A device for the conservative treatment of urinary incontinence in women, containing a bent wire structure of elastic titanium nickelide with supporting and fixing sections of anatomical sizes, characterized in that the supporting and fixing sections are each made in the form of a flat spiral, curved arcuate along its elements, and connected adjacent ends with a link made in the form of a wave-like curved wire, and the angle between the directions of translation of the waves of the link and each spiral is 120-150 °. 2. The device according to claim 1, characterized in that the extreme proximal elements of the flat spiral of the support section are separated from its generatrix in the direction of convexity by a relative distance of 1-1.5 spiral steps.

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