RU2268688C2 - Device for supporting conservative treatment of enuresis in female patients - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: device has means for applying compression load to anterior vaginal wall for making urethrovesical angle correction. Compression is accomplished with elastic loading caused by device material relaxation strain. The material is selected as an alloy based on titanium nickelide. The device has support member designed as meander-like wire anatomically curved and connected to fixing member with C-shaped cross member. Endourethral branch is manufactured as double wire arranged in a way that the space between the wires has oval widening on proximal part. Branch curvature profile repeats support member profile in in-phase way to produce required compression distribution over urethra length.

EFFECT: small-sized article; improved usability features.

4 cl, 3 dwg

Description

The invention relates to medical equipment.

Incontinence in women with tension is a problematic disease involving social, psychological and medical aspects. Self-isolation from society, as a consequence of the disease, leads to a mental disorder. The mass disease (up to 38% of women surveyed of active working age) creates significant social consequences.

The medical aspect of the problem is determined by its insufficient study due to the complexity of the anatomy and physiology of the sphincter mechanism, as well as the artificial silence of the problem for political reasons until recently [P.P. Salov “Urinary incontinence” Novokuznetsk, 2003, p.12]. The current interpretation of the etiology of the disease is presumptive and ambiguous. This complicates the search for rational technical solutions and explains the scarcity of the registry of effective treatment tools and methods.

Previously, this disease was almost entirely attributed to doctors of surgical specialties aimed at surgical treatment of patients.

With the development of materials science, there has been a trend in the conservative treatment of the disease, especially its lung degrees. The noticeable success of this direction was indicated in connection with the advent and introduction of medical alloys based on titanium nickelide. A number of devices from titanium nickelide for the conservative treatment of urinary incontinence in women, developed by the method of successive approximations, is the prior art of this application.

A device for conservative treatment of urinary incontinence in women with tension is known [RF Patent No. 2150919, 7 A 61 F 6/08]. The device contains a support element made of nickel-titanium wire in the form of a meander-type wire structure rolled into a cylinder, passing at the proximal end into a closed cylindrical spiral with the anatomical dimensions of the patient's vagina. The distal portion of the support element is completed with a loop-shaped handle for ease of installation and evacuation of the device. The function of the device is to create pressure on the front wall of the vagina in the area from the outlet of the urethra to the cervix. Pressure is transmitted through the paraurethral tissue to the urethra, acting on it and changing the urethrovesical angle. Anomalies of the latter are part of a complex causal chain of pathogenesis. The specified effect leads to the restoration of the function of the sphincter apparatus.

The disadvantages of the device - high lateral rigidity and inadequate shape - make installation difficult without special aids and create discomfort for the patient, especially when changing the sitting position, vigorous walking and other movements in the pelvic area.

These shortcomings are partially eliminated in another known device (“Device for the conservative treatment of urinary incontinence in women”, application for invention No. 2001130908 with priority November 15, 2001. Decision to grant a patent). In it, the supporting 1 and fixing 2 sections (Fig. 1) are made of nickel-titanium wire in the form of flat spirals with meander waves, curved arcuate across the direction of wave translation. The spirals are parallel to the space shift and connected by 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 °.

The device is preferably installed in stationary conditions, without auxiliary tools, in the vagina, with the emphasis of the proximal end of the supporting section in the cervix, and the distal end of the fixing section in the posterior folds.

The device is functionally consistent in the treatment of uncomplicated forms of incontinence. The disadvantage of this device is its large size and, as a result, the patient’s lack of comfort.

Installing the patient’s device at home requires a certain skill.

By the greatest similarity, this analogue is selected as a prototype.

The technical result of the invention is to reduce the size, increase comfort when using.

The specified technical result is achieved by the fact that in the device for the conservative treatment of urinary incontinence in women, made in the form of a bent wire structure of a superelastic alloy based on titanium nickelide, containing a support element in the form of a flat meander spiral, curved arcuate across the direction of translation of the meander waves, the fixing element and the active element of the compression interaction of the support and fixing elements, the support element is additionally curved dome-shaped to the outside of the arc mea core spiral in the middle section of its length, the fixing element is made in the form of a jaw made of a double and bent at the proximal end of a wire located parallel to the support element, on the outside of the arc of the meander spiral bent in phase with the longitudinal bends of the support element, the active element of the compression interaction of the support and the fixing elements are made in the form of a C-shaped jumper cross-connected with their distal ends.

Preferably, the meander-like curvature of the middle portion of the C-shaped bridge.

It is preferable to equip the fixing element at the proximal end with the installation guide and endourethral retainer.

Preferably, the guide and endourethral fixation are formed by symmetrical bending of the double wire in the form of an oval pointed to the proximal end.

The essence of the invention is most clearly represented by an analysis of the design and interpretation of the installed device.

Like analogues, the proposed device is intended for compression on the anterior wall of the vagina, with which the urethra is anatomically and reflexively associated with the surrounding ligamentous-muscular structures of the sphincters. Compression, in the end, leads to a change (normalization) in the angular ratios of the location of the bladder and the upper parts of the urethra (synclination angle and urethrovesical angle). In contrast to the prototype, the device is fixed in the compression position by the fixing element - jaw 2 (figure 2), which is inserted through the outlet into the urethra (figure 3). The supporting element 1 under the action of the elastic deformation of the active C-shaped element 3 tends towards the fixing element and compresses the front wall of the vagina, peri- and paraurethral tissues and the wall of the urethra itself.

Comparison of the appearance of the devices (figures 1 and 2) indicates a significantly smaller size and occupied volume of the proposed. Consequently, when installed in the vagina, it creates less interference with natural functions and less discomfort to the patient.

The advantages of the titanium nickelide used in comparison with other materials are manifested in the same way as in the prototype device.

Detailed distinguishing features have the following necessary meanings:

- additional dome-shaped deformation 4 of the middle of the support portion, together with the in-phase curvature of the fixing element 2, determines the distribution of compression along the length of the urethra.

- the necessary rigidity of the locking element is created by doubling the wire structure (figure 2).

- the active C-shaped element 3 creates a compression force. The range of homogeneous strain stress expands with the introduction of additional curvature 5 of the site of the active element, for example, in the form of a meander. It is rational to have this section in the middle of this element and use it as the handle of the device for installation and evacuation.

- the cross-connection of the ends of the active element with the distal ends of the support and fixing elements is made for the convenience of controlling the device during installation and evacuation; the compression of the C-shaped element leads to the necessary opening of the device, the release leads to the convergence of the supporting and fixing elements and compression of the tissues.

- the installation guide and the endourethral fixator located at the end of the fixing element (jaws) create additional convenience and correct manipulation during installation, as well as preventing the possibility of retrograde migration during urination and actions of the sphincter muscle mechanism.

- for the wire structure and technology of the device, the formation of the guide and endourethral retainer (6, Fig. 2) is logical, simple and effective by symmetrical bending of the wire in the form of an oval pointed to the proximal end.

The advantage of the device is the relative ease of manufacture. The technological complex includes mainly bending actions with a minimum of tools.

The drawings show:

Figure 1. Device for conservative treatment of urinary incontinence in women (prototype). 1 - supporting element, 2 - fixing element, 3 - active element.

Figure 2. Device for conservative treatment of urinary incontinence in women. Appearance. 1 - supporting element, 2 - fixing element, 3 - active element, 4 - domed protrusion, 5 - additional curvature of the active element, 6 - guide and endourethral retainer of the fixing element.

Figure 3. Location scheme of the activated device.

Proof of the attainability of the technical result are specific examples of the invention in the conservative treatment of stress urinary incontinence in women in the Department of Urology of the medical unit No. 2 of Tomsk and the Department of Urology of Siberian State Medical University.

Example:

Patient K., 41 years old. Diagnosis of the disease: stress urinary incontinence (brisk walking, sudden movements), progressing for three years. I did not seek help, dispensing with sanitary pads. According to cystoscopy - moderate hyperemia in the triangle, more intense to the internal sphincter. The patient has a device for conservative treatment of urinary incontinence (Fig. 2) with the following characteristics: overall length 45 mm, branch length 30 mm, meander waves 4, the width of the supporting branch along the envelope 20 mm, the material of the device is a wire of diameter 0 , 8 mm from titanium nickelide TH-10.

The device works as follows: a patient in a gynecological chair introduces the device in an open form, the fixing element (jaws) in the outlet of the urethra. With its advancement towards the bladder, the domed protrusion of the supporting section is located on the front wall of the vagina to the cervix (Fig. 3). With the release of the C-shaped jumper, the supporting section compresses the front wall of the vagina by the action of elastic deformation force. The action of the device produces mechanical compression of the urethra and paraurethral tissues.

The result of the action appears immediately. Sphincterometric tests indicate an increase in obstructive pressure in the bladder from 12 mm Hg. up to 35 ÷ 40 mm Hg In practice, this is enough to hold urine during sudden movements, coughing, sneezing.

The device is securely fixed, does not migrate during urination and does not interfere with the passage of urine. The gratitude of patients treated is an assessment of the effectiveness of the device.

The production technology is simple and developed to the level of compliance of the device with the criteria of the invention "industrial applicability".

Claims (4)

1. A device for the conservative treatment of urinary incontinence in women in the form of a bent wire structure made of a superelastic alloy based on titanium nickelide, containing a supporting element in the form of a flat meander spiral curved arcuate across the direction of translation of the meander waves, a fixing element and an active element of the compression interaction of the supporting and fixing elements, characterized in that the supporting element is additionally curved dome-shaped to the outside of the arc of the meander spiral in the middle section of its length, fi the coding element is made of a double wire by bending it at the proximal end of the fixing element, located parallel to the supporting element, on the outside of the arc of the meander spiral, bent in-phase to the longitudinal bends of the supporting element, the active element of the compression interaction of the supporting and fixing elements is made in the form of a C-shaped jumper cross-connected with (their distal ends) supporting and fixing elements. 2. The device according to claim 1, characterized in that the middle section of the C-shaped jumper meander-shaped curved. 3. The device according to claim 1, characterized in that the locking element is equipped with a mounting guide at the proximal end and an endourethral retainer. 4. The device according to claim 3, characterized in that the guide and endourethral retainer are formed by symmetric bending of the double wire in the form of an oval, pointed to the proximal end of the locking element.

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