Method for eliminating high-oncogenicity human papilloma virus for prevention of cervical cancer for implementing it

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, treating a cervical pathology associated with a high-oncogenicity human papilloma virus (HPV) infection. To eliminate the HPV for the purpose of the prevention of cervical cancer, a cervical mucosa is coated with a layer of a carbon dye and exposed to a laser light. What is used is a pulse-periodic generation mode having the following parameters: power flow density 2-10 J/cm2, radiation pulse duration 10-4 -10-2 sec, pulse repetition rate 1-5 Hz, wave length 0.8-1.1 mcm. A device for implementing the method comprises a laser working in the above mode with the above parameters, a modulator, a control and indication unit for laser parameter setting by the modulator, a parameter measurement unit for laser control, a controlled microinjector, a carbon dye delivery and radiation system actuated by the controlled microinjector, a probing laser for controlling the carbon dye layer thickness.

EFFECT: group of inventions provides eliminating the HPV from the cervical surface, controlling the thermal exposure area, its safety with avoiding an uncontrolled, irreversible injury of the cervical surface and the uterine itself.

8 cl, 1 dwg, 5 ex

 

The invention relates to medicine, namely to the treatment of cervical pathology associated with papillomaviruses infection of HPV. Treatment of anogenital HPV lesions are directed, generally, to the destruction papillomatosis foci by one method or another.

In the prior art it is known the use of laser radiation with a high coefficient of absorption of radiation in biological tissues (usually applied radiation CO2-laser) for the treatment of HPV infection (Zuev V. M. "Application of CO2laser for the treatment of benign diseases of the cervix". Obstetrics and gynecology, 1985, No. 6, p.69-71 [1]; a Method of treatment of dysplasia of the cervix. a.c. 1267648, B. I. 40, 1986 authors: Zuev V.M., Salyuk, VA and others [2]). Methods of treatment of cervical laser is called laser coagulation or laser vaporization.

The advantage of laser photocoagulation is the object with which the laser beam affects the defective cells, while the healthy parts of the cervix remain outside the area of surgical intervention. Laser coagulation is carried out under the control of a colposcope, which allows the doctor to adjust the direction of the laser beam and the depth of its penetration into the tissue of the cervical mucous. The disadvantage of the existing method of treatment is that the procedure is performed at the stage ill the tion, when erosive changes of the mucosal surface of the cervix, there are already colposcopic.

A known method of surgical treatment of background and precancerous diseases of the cervix (the Patent for invention №2330630 authors: Ezhov .. and others [3]), taken as a prototype. In the known method using laser radiation with λ=1.06 µm with a low coefficient of absorption of radiation in the tissue. The treatment process is applied to pathological surface of the cervix carbon dye having a high absorption coefficient of laser radiation, and subsequent exposure to laser radiation. The mode of operation of the laser is continuous, the energy flux density on the irradiated tissues (300-600) j/cm2. The laser light absorbed in the carbon dye, heats the latest and initiates thermal coagulation of tissue. As burnout (removal) carbon dye and cleansing from it the surface of the tissue spot of laser radiation move to the next sector until complete burnout (removal) carbon dye from the surface of the tissue. If necessary, the procedure was repeated two weeks until full recovery of the stratified squamous epithelium that is controlled by colposcopic.

The disadvantages of this method include the fact that the laser operates in continuous yunam mode radiation, therefore, for thermo-chemical activation of carbon dye and make it out (remove) it is necessary to provide a high energy density laser radiation up to 600 j/cm2. When this energy density after cleansing tissues from carbon dye chances uncontrolled consequential damages of powerful laser radiation purified from the dye portion of the tissue both in terms of depth and area.

In addition, famous for the invention may not be reproduced in practice. This is due to the fact that in the known invention as parameters of a laser beam on the irradiated tissues is the energy density in j/cm2(dose effect). To obtain the energy density (dose), and possibly with a laser power of 1 W for five minutes and a laser power of 100 W for 6 sec. In the first case, to achieve a therapeutic effect will fail due to insufficient power to run thermochemical reaction and, consequently, inability to achieve therapeutic effect, in the second case, the radiation power of the laser is so great that there is the threat of uncontrolled, irreversible and severe damage not only the surface of the cervix, but also damage the uterus.

To eliminate the above drawback we propose to use the laser with the length of any radiation from the range (0,8-1,1) microns, operating in the pulse-periodic mode radiation which in the tissue following parameters: density of the flow of energy in the radiation pulse (2-10) j/cm2the duration of the radiation pulse (10-4-10-2), the pulse frequency of the radiation (1-5) Hz.

At such parameters of laser radiation after burnout (removal) carbon dye subsequent radiation exposure (from the point of view of damage) on the cleared area of the biological tissue is minimal, since the absorption in it is minimal (uses a laser with minimal absorption coefficient in the tissue), and the energy flux density is insufficient for such damage. This allows you to control the heat-affected zone on the mucosal surface of the cervix as depth and area. This procedure can be successfully used for elimination (removal) of human papillomavirus with the mucosal surface of the cervix not only when already colposcopic observed picture eroded surface of the cervix, but even at the stage of initial diagnosis of viral infection, when visual changes yet. This improves the efficiency of the treatment process and allows then successfully vaccinate patients who underwent the procedure of elimination of human papilloma virus.

The claimed device (the IG. 1) works as follows. The control unit 1 set operating parameters of the device: the flux density of the pulse energy of the laser radiation in the range (2-10) j/cm2the duration of the laser pulse from the range (10-4-10-2), the pulse frequency of the laser radiation in the range (1-5) Hz. These parameters are entered in the modulator 2, the control operation of the laser oscillator 4. Unit 3 power supply is used to power all the circuits of the device. Operation of the laser emitter is controlled by the unit of measurement of parameters of laser radiation 6. Through the delivery device 5, with microinjector 8 is driven (metered) supply of carbon dye to the operative site. Control medically necessary thickness of a layer of carbon dye on the surface of the tissue is carried out by the magnitude of the reflected signal of the probe radiation from the auxiliary laser 7 running on the wavelength, with a high coefficient of reflection of laser radiation from the tissue (0.63 µm). After burnout (removal) of carbon dye, increases the reflected signal of the probe laser radiation and the impact of the working laser radiation is immediately terminated.

Clinical example 1.

The patient. 31. The diagnosis of Leukoplakia of cervix on the background of HPV 16 is the IPA, confirmed using DNA-PCR and cytologically. The pathological surface of the cervical area of 1.7 cm2suffered carbon dye, which was irradiated by laser radiation. The parameters of laser radiation: wavelength of laser radiation of 1.06 microns; the mode of emission of the pulse-periodic; the duration of the radiation pulse 10-3with the density of the flow of energy in the radiation pulse 2 j/cm2the repetition rate of the pulses of 5 Hz. When conducting the expanded colposcopy after 4 weeks of cervical pathology have been identified, including the presence of human papilloma virus.

Clinical example 2.

The patient. 33 years. Diagnosis: cervical Ectopia. HPV - 16, 18 types. On the surface of the cervix to the square of 2.5 cm2deposited carbon dye, which was irradiated by laser radiation. The parameters of laser radiation: wavelength of laser radiation of 1.06 microns; the mode of emission of the pulse-periodic; the duration of the radiation pulse 10-3with the density of the flow of energy in the radiation pulse 5 j/cm2the repetition rate of the pulses of 2 Hz. When conducting the expanded colposcopy in 6 weeks cervical pathology have been identified, including the presence of human papilloma virus.

Clinical example 3.

The patient. 32 years. Diagnosis: cervical Ectopia. HPV - 16. On the surface of the cervix m the TCI on area of 2.1 cm 2deposited carbon dye, which was irradiated by laser radiation. The parameters of laser radiation: wavelength of laser radiation 0.8 μm; the mode of emission of the pulse-periodic; the duration of the radiation pulse 10-4with the density of the flow of energy in the radiation pulse 10 j/cm2the frequency of pulse emission of 1 Hz. When conducting the expanded colposcopy after 4 weeks of cervical pathology have been identified, including the presence of human papilloma virus.

Clinical example 4.

The patient. 33 years. The diagnosis of Leukoplakia of cervix uteri. HPV - 16. On the surface of the cervix to the square 2.3 cm2deposited carbon dye, which was irradiated by laser radiation. The parameters of laser radiation: wavelength of laser radiation to 1.1 μm; the mode of emission of the pulse-periodic; the duration of the radiation pulse 10-4with the density of the flow of energy in the radiation pulse 6 j/cm2the pulse frequency of the radiation 4 Hz. When conducting the expanded colposcopy after 4 weeks of cervical pathology have been identified, including the presence of human papilloma virus.

Clinical example 5.

The patient. 33 years. Diagnosis: cervical Ectopia. HPV - 16. On the surface of the cervical area of 2.1 cm2deposited carbon dye, which was irradiated by laser radiation. Parameters lasern the th radiation: wavelength of laser radiation 0.95 microns; the mode of emission of the pulse-periodic; the duration of the radiation pulse 10-3with the density of the flow of energy in the radiation pulse 5 j/cm2the pulse frequency of the radiation 3 Hz. When conducting the expanded colposcopy after 5 weeks of cervical pathology have been identified, including the presence of human papilloma virus.

1. Method of elimination of human papilloma virus HPV for cervical cancer prevention, which consists in the fact that put on cervical mucous layer of carbon dye and is exposed to the laser radiation, characterized in that use laser operating in the pulse-periodic mode of generation of laser radiation with parameters: the density of the flow of energy in the radiation pulse 2-10 j/cm2the duration of the radiation pulse 10-4-10-2with the pulse frequency of the radiation 1-5 Hz and a wavelength in the range of 0.8-1.1 µm.

2. The method according to claim 1, characterized in that it further include a layer of carbon dye additional probing radiation.

3. The method according to claim 2, characterized in that additionally control the thickness of the carbon layer of dye on the mucous of the cervix by the magnitude of the reflected signal, said additional probe radiation.

4. The method according to claim 2, distinguishing the I, that use of the probing laser operating at wavelength high reflection coefficient of the laser radiation from the tissue.

5. The method according to claim 4, characterized in that the wavelength is equal to 0.63.

6. The device for implementing the method of elimination of human papilloma virus HPV for cervical cancer prevention, containing a laser operating in the pulse-periodic mode of generation of laser radiation with parameters: the density of the flow of energy in the radiation pulse 2-10 j/cm2the duration of the radiation pulse 10-4-10-2with the pulse frequency of the radiation 1-5 Hz and a wavelength in the range of 0.8-1.1 µm, a modulator, a device control unit that is designed to set the operating parameters of the laser through the modulator, the unit of measurement of parameters of laser radiation, designed to control the laser operation managed microinjector, the delivery device carbon dye laser radiation intended for the controlled delivery of carbon dye through a managed microinjector; and probe laser that is designed to control the thickness of the carbon dye.

7. The device according to claim 6, characterized in that the laser operates at wavelength with highest, to is the ratio of reflection of laser radiation from the tissue.

8. The device according to claim 7, characterized in that the wavelength is equal to 0.63.



 

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1 dwg, 1 ex

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1 ex

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