RU2735060C1 - Method of vaginal rejuvenation - Google Patents

Abstract

FIELD: medicine; gynecology.

SUBSTANCE: laser ND:YAG with wavelength of 1064 nm is used, wherein the procedure is carried out in several stages. At the first two stages, irradiation parameters are successively changed in "cold", "warm" and "hot" modes. Performing step-by-step treatment of the vaginal canal, first 3.5–4 cm is performed on parameters corresponding to the "hot" mode, reducing parameters every 3 cm to "warm" and "cold" modes. At the first stage, sequential circular irradiation of every 5 mm of vagina is performed using a conical mirror with gold sputtering with a scanner speed of 80–200 revolutions, power of 22–28 W, at number of cycles 2–5. At the second stage, the front, back and side walls of every 5 mm of the sheath are successively irradiated using an angular mirror at a scanner speed of 150–200 revolutions, power 15–25 W, at number of cycles 2–3. At the third stage, a sequential irradiation of the vulva and the paraurethral area is performed using a maniple with a spot size of 6 mm with a pulse duration of 100 ms, pause duration 50 ms and power 15–25 W.

EFFECT: method provides rejuvenation of vaginal tissues, lift and enhancement of their elasticity due to selective denaturation of submucous collagen, collagen fiber reduction and neocollagenogenesis acceleration.

1 cl, 5 dwg

Description

The invention relates to medicine, namely to gynecology, and is intended for non-ablative vaginal rejuvenation. They use Nd: YAG (1064 nm) - laser, in Q-switched mode of special burst pulses. The procedure is carried out in three stages. At the first stage, sequential circular irradiation of each 5 mm of the vagina is carried out using a conical mirror with gold plating, sequentially changing the power parameters (in the modes - "hot", "warm", "cold") depending on the section of the vagina. Scanner speed 80-200 rpm, power 22-28 W, number of cycles 2-5. At the second stage, sequential irradiation of the anterior, posterior or lateral walls of each 5 mm of the vagina using an angular mirror is carried out, sequentially changing the power parameters (in the modes - "hot", "warm", "cold") depending on the vaginal section. Scanner speed 150-200 rpm, power 15-25 W, number of cycles 2-3. At the third stage, sequential irradiation of the vulva and the paraurethral area is carried out using a maniple with a spot size of 6 mm, a power of 15-25 W, a pulse duration of 100 ms, a pause duration of 50 ms.

EFFECT: method provides rejuvenation of the structure of vaginal tissues by achieving selective denaturation of submucous collagen, which leads to an instant reaction of contraction of collagen fibers and acceleration of neocollagenogenesis, to tightening tissues and increasing their elasticity.

The invention relates to medicine, specifically to gynecology, and can be widely used for non-ablative vaginal rejuvenation.

Vaginal relaxation syndrome (VRS) is a condition characterized by a loss of optimal vaginal structure and is commonly associated with vaginal delivery and the natural aging process. Pregnancy and childbirth contribute to the deterioration of the VRS as well as the onset of menopause, which causes a decrease in hormonal levels and vaginal atrophy. The loss of collagen, elastin, and hydration results in discomfort, dryness, dyspareunia, and stress urinary incontinence.

Currently known methods of vaginal rejuvenation using Er: YAG (2940 nm) and CO ₂ (10600 nm) lasers. [https: //www.fotona.com,http: //www.dekalaser.ru, 1, 2]

For fractional ablative photothermolysis, techniques are used using fractional CO ₂ lasers (this type includes the MonaLisa Touch technique - performed using a SmartXIde 2 V2LR laser system and a D-pulse (DEKA, Italy)). The laser beam, acting on the walls of the vagina and vulva, simultaneously has multipoint ablative and coagulative damage to the underlying tissues of various depths, which contributes to the healing reaction and accompanying fibrosis. The duration of the positive clinical effect may depend on the time of scar tissue reorganization (most often not more than 1 year). [3, 4]

The techniques have difficulties in controlling the depth of laser beam penetration and possible frequent complications in the form of uncontrolled fibrosis.

Laser radiation with a wavelength of 2940 nm, generated by an Er: YAG laser, is used in the IncontiLase technique using the energy of the Fotona XS Dynamis installation in a thermal mode with super-long burst SMOOTH pulses (FOTONA, Slovenia). Laser energy transferred to water molecules leads to an increase in water temperature and heating up to 60 ° C-63 ° C, which is the threshold for protein coagulation. The vagina is in contact with the urethra along the front wall, and with the rectum along the back. The significant disadvantages of this technology include the possible fibrosis of not only the walls of the vagina, but also the tissues of the contacting organs. [5, 6, 7]

At the VI All-Russian Congress with international participation "Outpatient practice - at the epicenter of women's health", held on March 18-21, 2014, Stefano Salvatore, head of the urogynecological department at the clinical research institute at the Hospital of St. Raphael in Milan (Italy), during his report noted : "The techniques of exposure to the erbium laser are effective, but they have a number of side effects, such as fibrosis and" laser stitching "of adjacent organ structures (due to adhesion of the fibrous-fibrous structure of the adventitia membranes), which is an undesirable component of treatment." It should be noted that the use of this technique of VSR laser therapy and urinary incontinence has a positive clinical effect for a fairly short time (up to 6 months). This feature is associated with the lack of course procedures due to the increased risk of side effects and complications.

The innovation of the present method of conservative treatment of VRS is the use of the energy of the ND: YAG laser (1064 nm) of the Magic3Max laser system in the Q-switched mode of special burst pulses (MeLSiTek, Russia). Previously in medicine, laser systems with a wavelength of 1064 nm were not used in the treatment of age-related or postpartum changes in vaginal tissues. A burst pulse is a series of pulses following each other through a pause. The duration of one pulse is 10 ns, the pause between pulses is 30 μs. The energy of one pulse does not exceed 1 mJ. The laser always works in one mode - it generates a pulse with an energy of 1 mJ 30,000 times per second. These parameters of the laser operation guarantee no tissue damage and no ablation effect.

The technique of the present invention is based on the action of precisely controlled laser pulses that deliver energy to the vaginal canal and to the entrance to the cavity, causing heating of the tissue and collagen therein. At a wavelength of 1064 nm, the absorption of laser radiation by water is weak. Due to the penetration depth (up to 5 mm), thermal damage is limited by the amount of thermal diffusion, and since the volume of heated tissue is large, the temperature is averaged and does not reach the threshold damaging values. This allows not to coagulate the target tissues, but to start the primary process of accelerated regeneration. As a result, the process is limited by thermal exposure. In addition, the key mechanism for stimulating collagen production is the photomechanical effect, which can only be achieved when using a special burst pulse - a series of pulses following each other through a pause. The total tissue changes under the influence of the spreading heat are commonly called photothermal reconstruction. Changes in tissues under the influence of the impulse lead to the accumulation of microdamages to the protein structures of the submucosal layer (elastin, collagen) and minimal destruction of the microvasculature. The subsequent reaction causes a complex process of collagen restructuring with the involvement of matrix metalloproteinases, induction of myofibroblasts, stimulation of neocollagenogenesis and neoangiogenesis. The tissues become more elastic and elastic, and the vaginal laxity and the effects of vaginal relaxation syndrome are reduced. As a result of these processes, the normal collagen architecture is restored. It should be noted that the result of the application of this technique is a true structural rejuvenation of the vaginal tissues, with the preservation of positive clinical results for the longest possible period of time. In addition, heating collagen causes it to contract, the fibers become shorter and thicker and, therefore, the irradiated tissue contracts and contracts at an early stage.

Contraindications for the procedure:

- pregnancy;

- taking medications that cause photosensitivity (photosensitizers);

- trauma and / or active infections in the area of treatment;

- vaginal bleeding and active menstruation.

The procedure consists of three to four to five treatment sessions with an interval of 15-30 days between sessions.

For the procedures, a scanner and a set of gynecological instruments are used:

- Scanner for even distribution of energy to the vaginal mucosa;

- Vaginal dilator;

- Handle with a conical mirror;

- Handle with a corner mirror;

- Optical handpiece with a working spot diameter of 6 mm.

The procedure is carried out in three stages.

Preparation for the procedure includes processing the patient's vagina (vestibule, entrance to the cavity and vaginal canal) with an aqueous solution of chlorhexidine 0.05%, after which the vaginal mucosa is thoroughly dried.

Implementation of the methodology of the present invention:

• Stage I - processing on a conical mirror

Step-by-step processing of the vaginal canal is performed with energy distribution to all walls, with a sequential gradient decrease in parameters, power - 22-28 W, number of cycles - 2-3, scanner rotation speed - 100-200 revolutions, processing step 5 mm. The total length of the tool is 10 cm. The number of positions for machining is 20. In each position, machining is performed, consisting of 2-5 cycles.

It is recommended to carry out the first 3.5-4 cm at the parameters corresponding to the "hot" mode, reducing the parameters every subsequent 3 cm to the "warm" and "cold" modes, respectively.

The number of channel passes does not exceed 3.

Initial parameters for the treatment of patients with severe atrophy:

- Speed - 200 rpm;

- Power 15-18 W;

- Number of cycles 2-3;

As a rule, treatment in the deep parts of the vagina is carried out at maximum parameters, in the middle third the power and the number of cycles decrease.

In case of poor sensitivity of the patient to the procedure, it is necessary to reduce the rotation speed of the scanner to 150, and in the absence of effect to 80-100, increase the power to 28 W.

The number of processing cycles can be increased up to 5.

• Stage II, processing on an angular mirror.

It is aimed at targeted step-by-step processing of the problem area - at the front, back or side walls. Especially important for the treatment of urinary incontinence and the treatment of grade 1-2 genital prolapse.

A step-by-step processing of the vaginal wall is performed with a sequential gradient decrease in parameters, the power is 15-25 W, the number of cycles is 2-3, the rotation speed of the scanner is 150-200 revolutions, the processing step is 5 mm. The total length of the tool is 10 cm. The number of positions for machining is 20. In each position, machining is performed, consisting of 2-5 cycles.

It is recommended to carry out the first 3.5-4 cm at the parameters corresponding to the "hot" mode, reducing the parameters every subsequent 3 cm to the "warm" and "cold" modes, respectively.

The number of wall passes does not exceed 3.

• Stage III, treatment of the vulva and paraurethral area.

It is carried out using a maniple with a spot size of 6 mm in a pulsed mode.

Standard parameters of the procedure:

- Beam diameter 6 mm;

- Pulse duration - 100 ms;

- Pause duration 50 ms;

- Power 15-25 W;

- Number of impulses up to 10,000;

Surface treatment is carried out with slow movements within 1 cm ² with an even distribution of energy over the area until a sensation of pronounced warmth appears.

A control examination is carried out 48 hours after each procedure, during the second visit, before the second treatment procedure (15 days after the first procedure) and 3 months after the end of treatment, when patients are asked to independently evaluate the effectiveness of the laser treatment of the vagina.

The advantages of the claimed method

1. Unlike other laser techniques used to treat VRS, the claimed technique is non-ablative (without damaging the vaginal mucosa).

2. The use of a wavelength of 1064 nm of a Nd: YAG laser in the Q-switched mode of special burst pulses makes it possible to increase the selectivity of the action.

3. The technique is very comfortably tolerated by patients and does not require anesthesia.

4. The technique is safe and does not cause complications if it is performed correctly and the exposure regimes are observed.

5. The technique is highly effective, which is confirmed by the data of clinical testing.

DATA ON THE CONDUCTED CLINICAL APPROBATION OF THE "MAGIC GYNO" METHOD.

Efficiency and safety studies were carried out on the basis of FBUZ POMC FMBA of Russia, polyclinic No. 1. The procedures were performed using a Magic 3Max laser system, Magic Gyno burst pulse (ND: YAG laser, wavelength 1064 nm).

The treatment with the laser system was carried out according to the methods described above. Was performed 61 sessions of laser exposure in 25 patients. The age of the patients is from 30 to 74 years. The average age of the patients is 42 years.

The procedures were carried out with an interval of at least 28 days. Each patient underwent 3 procedures.

Evaluation of the effectiveness of the treatment was carried out according to the results of the completed questionnaires for the programs: IZhSF - index of female sexual function, PISQ-12, PFDI-20, as well as the results of an objective examination (Fig. 1, 2, 3).

The patients are divided into groups depending on the nosology:

1. Genitourinary syndrome in menapause - 12%

2. Pelvic organ prolapse (prolapse of the vaginal walls 1-2 tbsp in combination with stress urinary incontinence) - 64%

3. Relaxed vaginal syndrome - 16%

4. Scleroatrophic lichen of the vulva - 8%.

During the study, it was proved that as a result of the application of the proposed laser technology, the treated tissues are enriched with new collagen, tightened and become more elastic (Fig. 4, 5). Changes based on objective data were noted after 1 session of exposure, but these changes are less pronounced than after 2 and 3 sessions (especially for the symptoms of urinary incontinence).

Conclusions based on the results of clinical testing:

1. According to the results of a clinical study of the ND: YAG laser (1064 nm) of the Magic3Max laser system in the mode of special packet pulses Magic Gyno, this method of treatment was recognized as safe and effective for genitourinary syndrome in menopause, prolapse of the vaginal walls 1-2 tbsp in combination with stressful component of urinary incontinence, sexual dysfunction in relaxed vagina syndrome.

2. It is advisable to use this technology in patients over the age of 25, after the end of the maturation of the reproductive system.

3. Before carrying out laser exposure, it is necessary to conduct an examination in the amount of general clinical analyzes, analysis of the smear for microflora and oncocytology, ultrasound examination of the pelvic organs.

4. It is necessary to conduct psychological preparation of patients before the procedure, explaining to them that the maximum effectiveness of the procedure is achieved 6 months after the last session, which is explained by the processes of neocollagenesis in the body.

5. Consider the most optimal performance of at least 3 procedures with an interval of up to 30 days.

6. This laser effect ensures the restoration of neurohumoral regulation of the vaginal mucosa and promotes the formation of new vessels, which leads to the elimination of symptoms of mucosal atrophy.

Brief description of graphics

1. FIG. 1 Changes in subjective symptoms in patients with urogenital disorders

2. FIG. 2 Assessment of sexual function

3. FIG. 3 Assessment of improvement in quality of life depending on the patient's age

4. FIG. 4 Before starting treatment

5. FIG. 5 After 4 sessions of laser treatment

Literature:

1. Bezmenko A.A., Schmidt A.A., Koval A.A., Lipova E.V., Calm L.B. A method for conservative treatment of stress urinary incontinence in women using Er-YAG laser. Invention patent RU 2551616 C1 dated 03/27/2014

2. Apolikhina I.A., Gorbunova E.A., Odinokova V.A. Minimally invasive innovative laser technologies in gynecological practice. Obstetrics and gynecology. 2014. No. 11. S. 17-22.

3. Yamskova V.P., Krasnov M.S., Yamskov I.A. To the question of the mechanisms underlying the processes of restoration and repair in tissues // Cell technologies in biology and medicine. - 2010. - No. 1. - S. 32-35.

4. Vyalov SL, Pshenisnov KP, Kuindoz P., Montadon D., Pitte B. Modern concepts of the regulation of the wound healing process (literature review). Annals of Plastic, Reconstructive and Aesthetic Surgery, No. 1, 1999, pp. 49-56.

5. Shakhno E.A. Physical foundations of the use of lasers in medicine. Tutorial. SPb. NRU NTMO, 2012, pp. 49-60.

6. Lappa A.V., Kazakov A.A., Veresov S.I., Privalov V.A. et al. Contact Thermometry in Intensive Fields of Laser Radiation // Thermal Therapy, Laser Welding, and Tissue Interaction, Stephen G. Bown et al., Proceedings of SPIE. - 1998. - Vol. 3565. - P. 90-100.

7. Miller B.C. Selective heating of an inhomogeneous biological medium under the influence of laser pulsed light. Medical Physics No. 4, 2010. S. 59-64.

Claims (1)

A method of vaginal rejuvenation using an ND: YAG laser, in the Q-switched mode of burst pulses, consisting in sequential circular irradiation of the anterior, posterior and lateral walls of the vagina, characterized in that an ND: YAG laser with a wavelength of 1064 them is used, and the procedure carried out in several stages, at the first two stages, the irradiation parameters are successively changed in the "cold", "warm", "hot" modes; step-by-step processing of the vaginal canal is performed, the first 3.5-4 cm are carried out on the parameters corresponding to the "hot" mode, reducing the parameters every subsequent 3 cm to the "warm" and "cold" modes, while at the first stage, sequential circular irradiation is carried out for every 5 mm of the vagina using a conical gold-plated mirror with a scanner speed of 80-200 revolutions, a power of 22-28 W, with the number of cycles 2-5; at the second stage, sequential irradiation of the anterior, posterior and lateral walls of each 5 mm of the vagina is carried out using an angular mirror at a scanner speed of 150-200 revolutions, with a power of 15-25 W, with a number of cycles of 2-3; at the third stage, sequential irradiation of the vulva and paraurethral areas using a maniple with a spot size of 6 mm with a pulse duration of 100 ms, a pause duration of 50 ms and a power of 15-25 W.

Images