RU2102090C1 - Method for treating bronchial asthma - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves performing temporary electric block of vagus nerves with permanent current voltage of 1-3 V and electric current strength of 30-80 mA. Electric block is carried out by applying electrodes implanted under the nerves and connected to receiving device having direct current source. The receiving device is implanted into subcutaneous fat of the upper part of the chest. Electric block is carried out under remote control using radio frequency method by means of transmitting device so that switching-on is carried out both at the time an attack occurs when applied directly to patients and in periods between attacks by acting periodically in automatic mode to prevent bronchial spasm attacks. It is also possible, when needed, to switch the electric block on by patient himself on special occasion. To prevent attacks with preceding electric blocks of vagus nerves, the transmitting device has programming timer unit for switching-on blocking during the current day. Time for switching on is programmed in advance having in view attack periodicity and duration characteristics during day in given patient. More accurate current control mode is available in performing electric blocking by means of special type transmitter control unit. EFFECT: enhanced effectiveness of treatment course. 1 dwg

Description

 The invention relates to medicine, namely to methods for treating bronchial asthma.

 A known method of treating bronchial asthma by crossing the vagus nerves. This method is effective, but has a significant drawback: in the vagus nerves, fibers go not only to the lungs, but also to the majority of the internal organs of the abdominal cavity, and therefore the intersection of nerves leads to serious consequences, and sometimes to death of the patient.

 The closest in essence is a method of treating bronchial asthma, which consists in crossing only those branches of the vagus nerves that go to the roots of the lungs. However, this method also has a number of significant disadvantages. For denervation of the root of the lung, an opening of the chest is required, and this is very traumatic compared with the operation of the stem vagotomy, in which the nerves intersect on the neck. Patients with bronchial asthma, as a rule, have chronic inflammatory diseases of the lungs and bronchi, therefore thoracotomy often provokes the development of acute pneumonia and other life-threatening complications in the postoperative period. In addition, denervation of the lung root often gives only a temporary effect due to the fact that over time, the innervation of the lungs is restored.

 Objectives of the invention: 1) to achieve blockage of the vagus nerve conduction only temporarily, for a period of bronchospasm attack, 2) to achieve stability and repeatability of the blocking effect, regardless of the time elapsed since the operation, 3) to achieve the possibility of prophylactic temporary blockages of the vagus nerve conduction in order to prevent attacks asphyxiation.

 The goals are achieved in that the nerve conduction is blocked not by surgical intersection, but by the electric method, for which two electrodes are implanted under the nerves connected to a direct current source, which enters the receiving device implanted in the subcutaneous tissue of the upper chest . The blocking voltage is switched on remotely by the radio frequency method using a transmitting device. The inclusion of electro-blocking can be carried out both at the time of an asthma attack, and in the interictal period automatically for prophylactic purposes. For this, the transmitting device has a programmable timer for switching on the electric blocker. The electric blocking program is set so that it prevents the development of seizures in a particular patient within a day. Against the background of the operation of nerve blocking in automatic mode, an extraordinary inclusion of the blocker is possible directly by the patient himself, if necessary.

 A comparative analysis of the patent literature of the selected prototype with the proposed method revealed that a common sign of them is the blocking of conduction along the vagus nerves.

The following differences were identified:
The blocking of nerve conduction by the electrical method is carried out temporarily for the period of the attack. This allows you to get rid of the blockage of the vagus nerve conduction harmful to the patient in the interictal period, because in the vagus nerves, vital nerve fibers pass to most abdominal organs. In the prototype and in the analogue, transection of the vagus nerves leads to irreversible consequences, which further worsens the patient’s health;
e / blocking can be carried out in order to prevent attacks, periodically, in an automatic mode, depending on the frequency of asthma attacks during the day and their duration in this patient;
after disabling electrical blocking, conduction along the vagus nerves is quickly restored;
for the implementation of electrical blocking does not require a violation of the integrity of the vagus nerves (electrodes are implanted under the nerves), while in the prototype they intersect nerve fibers surgically;
electrical blocking, regardless of the length of time that has passed since the operation, effectively temporarily blocks nerve conduction. In the prototype, due to the restoration of innervation after a few months, it is possible to resume attacks of suffocation;
the invasiveness of the implantation of the electrodes and the receiving device is less than the operation of partial denervation of the roots of the lungs, since in the first case there is no need to open the chest from two sides (the electrodes are implanted in the cervical part of the vagus nerves).

 The drawing shows a diagram of an implementation of a method for treating bronchial asthma: 1 lung, 2 right vagus nerve, 3 left vagus nerve, 4 - blocking electrodes to the right vagus nerve, 5 blocking electrodes to the left vagus nerve, 6 receiving device, 7 transmitting device.

 The method is based on the well-known in physiology phenomenon of electrical blocking of nerve conduction when a constant electric current is passed through it. Vagus nerves play an important role in the implementation of bronchospasm. The proposed method is as follows. Nonpolarizing electrodes, two under each nerve, are implanted under the right and left vagus nerves. The distance between the contacts of the electrodes on each nerve is about 0.3 cm. The blocking electrodes from each nerve are connected to a receiving device, which is implanted into the subcutaneous tissue of the upper chest. During an attack of bronchospasm, a transmitting device is turned on, which remotely by radio-frequency means includes a direct current source contained in the receiving device. At the same time, a constant electric current begins to flow through the vagus nerves, causing electrical blocking of the conduction of nerve impulses, including pathological ones that support spasm of bronchioles. The bronchospasm is stopped. Blocking current parameters: voltage 1-3 V, current 30-80 mA. After stopping the attack, the transmitting device is turned off. In this case, the current disappears in the vagus nerve chain and nerve conduction quickly resumes. To prevent attacks, the electrical lock can be carried out automatically, for which the transmitting device has a programmable timer for turning on the electric lock during the day. If necessary, the patient may include an electric lock and on their own against the background of an automatic mode.

 Example 1

Patient H. 29 l. suffered from bronchial asthma for 12 years. Diagnosis: bronchial asthma, infectious allergic form, severe course. Chronic pneumonia Pneumosclerosis Respiratory failure of 1 degree. The disease developed against a background of chronic pneumonia with partial exacerbations. Every year, 2-3 times she was forced to be treated in hospitals in connection with an exacerbation of the underlying disease. The frequency of asthma attacks during remission of the disease was up to 4-5, and during exacerbation 8-9. In the period of exacerbation, more than half of the seizures were stopped only by intravenous administration of aminophylline 2.4% - 10.0 20.0. Twice in the past 3 years, the patient developed an asthmatic condition. Before surgery, she received the following treatment: Kenalog 40 2.0 1 time every 3-4 weeks, polcartolone 8 mg x 4 p. aminophylline 0.15 g x 4 p. theophedrine 0.5 g x 2 p. Berotek up to 0.8 mg per attack. The results of the examination before surgery: pneumotachometry (in due): VC 66.1; FEV ₁ 41.7; MOC ₂₅ 31.4; MOC ₅₀ 38.6; MOC ₇₅ 34.4 mixed breathing dysfunction. A significant reduction in bronchial patency throughout. For therapeutic purposes, the patient was implanted with a vagus nerve stimulator, nerve blocking with a current of 38 mA, 1 V, lasting 2 minutes, in accordance with the circadian rhythm of asthma attacks, was started. One month after the start of treatment, the patient's condition improved. The attacks have acquired a mild course. So, if before surgery their duration on average was at least 30-40 minutes, then after a month's course of electrical blocking of the vagus nerves 10-20 minutes. Doses of medications needed for treatment have decreased: polcartolone 4 mg x 3 r. aminophylline 0.15 g x 2 p. theofedrine is canceled, Berotek began to use rarely - no more than 0.2 mg per attack. The number of attacks per day decreased from 9 to 3. The attacks were well stopped and directly by the electric blocker. The indicators of pneumotachometry improved: VC 71.2; FEV ₁ 56.3; MOC ₂₅ 50.4; MOC ₅₀ 52.6; MOC ₇₅ 48.3 a moderate decrease in bronchial patency throughout. Examined a year after the operation. The duration of remissions of the disease increased by at least 3 times. Exacerbation of bronchial asthma was observed only in the winter due to exacerbation of chronic pneumonia. Inpatient treatment was not required. After a course of bronchodilator antibacterial therapy, a stable remission of the disease was again achieved. The patient's need for medications remained the same as a month after the start of treatment, that is, significantly lower than before the operation. The number of attacks per day averaged 2-3. The attacks were easily stopped either by the vagus nerve blocker or by inhalation of a berotek (0.2 mg). The pneumotachometry values were significantly better than before the operation: VC 70.8; FEV ₁ 58.8; MOC ₂₅ 52.2; MOC ₅₀ 57.7; MOS ₇₅ 51.4 a slight decrease in patency of the bronchi.

 Example 2

Patient I. 62 l. suffered from asthma for 7 years. Diagnosis: bronchial asthma of mixed form, moderate. Coronary heart disease. The disease developed after a mental trauma and was characterized by a progressive course. The frequency of asthma attacks during the period of remission of the disease was 4-5, and during exacerbation up to 8 per day. She took the following medicines: aminophylline 0.3 x 3 p. theofedrine 0.5 x 3 p. salbutamol up to 3-4 inhalations per attack (up to 160 mg). The results of the examination before surgery: pneumotachometry (from due): VC 58.8; FEV ₁ 40.8; MOC ₂₅ 39.9; MOC ₅₀ 43.3; MOS ₇₅ 35.7 mixed breathing dysfunction, a significant decrease in bronchial patency throughout. Due to the prolonged exacerbation of the disease and the impossibility of achieving stable remission by conservative methods, an electrical blocker of the vagus nerves was implanted. 2 weeks after the operation, electrical blocking with a current of 40 mA, 1.6 V, lasting up to 2-3 minutes, was started. Attacks of suffocation effectively stopped. A month after such treatment, the seizures began to acquire a much lighter character. The need for medications, eufillin, decreased, theofedrine was canceled, salbutamol required no more than two inhalations per attack (up to 80 mg). A persistent remission of the disease was achieved. The number of attacks per day decreased from 8 to 4. The pneumotachometry indicators improved: VC 67.8; FEV ₁
54.6; MOC ₂₅ 40.2; MOC ₅₀ 46.4; MOS ₇₅ 53.3 - a moderate decrease in patency of the bronchi. The patient was treated with a vagus nerve blocker for a year. Her condition after a year: the duration of remissions of the disease increased from 30-40 days to 120-150. Exacerbations of bronchial asthma were easily stopped by a course of bronchodilator therapy (inhalation of mucolytics, aminophylline injections) on an outpatient basis. The patient noted a relief of the course and coronary heart disease: heart pain became less frequent. Of the medications, a year after the start of treatment, only 0.15 g of aminophylline was taken at night, and salbutamol one inhalation per attack (40 mg). Indicators of pneumotachometry in a year: VC 72.0; FEV ₁ 56.6; MOS ₂₅ - 54.6; MOC ₅₀ 54.4; MOS ₇₅ 58.6 a slight decrease in bronchial patency throughout. The number of seizures per day after a year is no more than three.

 Example 3

Patient L., 51, suffered from bronchial asthma for 8 years. Diagnosis: bronchial asthma, atopic form, moderate. The patient had a pronounced polyallergy for antibacterial drugs. A year ago, she suffered anaphylactic shock due to an injection of ampicillin. Before the operation, she received the following treatment: annually 2 sessions of hemosorption, ultraviolet irradiation of blood and plasmapheresis. Daily amufillin 0.15 g x 3 p. theofedrine 0.5 g x 3 p. astefen 0.25 g x 2 p. salbutamol 2-3 inhalations per attack (up to 120 mg), intravenous injection of aminophylline 2.4% 10.0 in severe attacks. The frequency of asthma attacks during the period of remission of the disease was 3-5, and during exacerbation - up to 9-11 per day. The results of the examination before surgery: pneumotachometry (in due): VC 69.8; FEV ₁ 58.2; MOC ₂₅ 44.5; MOC ₅₀ 42.1; MOS ₇₅ 39.9 obstructive function of external respiration. A significant reduction in bronchial patency throughout. For therapeutic purposes, the patient was implanted with an electrical blocker of the vagus nerves, and its use in attacks has begun. Applied mode: 45 mA, 1.8 V, 2 minutes. Attacks of suffocation satisfactorily stopped. In the postoperative period, the patient developed an asthmatic condition due to the smell of penicillin. Electrical blocking of the vagus nerves was applied every 10 minutes of a break for 2 minutes of blocking for 40 minutes, the asthmatic state was stopped. No other drugs were used. After a month from the start of treatment of the patient with electro-blocking of the vagus nerves, her condition improved. The number of seizures per day decreased from 8 to 4. Seizures became easy, short-lived. The need for medicines decreased: aminophylline 0.15 g x 2 p. theofedrine canceled, astafen 0.25 g, salbutamol no more than 1 inhalation per attack (40 mg). The pneumotachometry indicators improved: VC - 73.3, FEV ₁ 62.4; MOC ₂₅ 56.6; MOC ₅₀ 62.4; MOS ₇₅ 51.1 a slight decrease in bronchial patency. Inspected after a year. The condition is satisfactory. There were no exacerbations of the disease. The frequency of attacks is not more than 4 per day. Attacks are stopped by an electric blocker or one inhalation of sulbutamol (40 mg). The need for medications significantly decreased compared to preoperative: aminophylline, theofedrine - canceled, astafen 0.25 g. Due to the fact that there were no severe attacks, I did not use intravenous administration of aminophylline to stop them. Indicators of pneumotachometry in a year: VC 72.3; FEV ₁ 59.7; MOS ₂₅ - 50.2; MOC ₅₀ 46.8; MOS ₇₅ 53.4 a slight decrease in patency of the bronchi. There were no asthmatic conditions during the year.

 Before being introduced to the clinic, the method was developed in experiments on guinea pigs. To simulate bronchial asthma, animals were sensitized with horse serum, and then, under the conditions of an acute experiment, during the development of experimental bronchospasm, electrical blocking of the vagus nerves was performed. The tone of the bronchi was measured by the method. In most experiments, the electrical blocking of the vagus nerves led to the relief of bronchospasm. These data are fully consistent with the generally accepted notion that the vagus nerves regulate the tone of the bronchi.

Claims (1)

 A method of treating bronchial asthma, which consists in blocking the conduction of the vagus nerves, characterized in that, in order to reduce trauma and negative side effects, as well as to prevent seizures and increase the reliability of their relief, blocking is carried out electrically, temporarily, by passing through the vagus nerves using implanted beneath them are DC electrodes with a voltage of 1 3 V and a power of 30–80 mA; moreover, the electric blocking is carried out both at the time of the attack and as a preventive measure. periodically, in automatic mode, in the interictal period.