WO2017101288A1

WO2017101288A1 - Use of high intensity focused ultrasound system in the prevention of primary hypertension

Info

Publication number: WO2017101288A1
Application number: PCT/CN2016/087081
Authority: WO
Inventors: 孔祥清; 孔有年
Original assignee: 南京广慈医疗科技有限公司
Priority date: 2015-12-17
Filing date: 2016-06-24
Publication date: 2017-06-22

Abstract

Disclosed is the use of a high intensity focused ultrasound system in the prevention of primary hypertension. The therapeutic process thereof comprises: carrying out ultrasonic position-setting measurement on a patient with a boundary hypertension or perirenal adipose tissue with a hypertension tendency; setting the treatment window and parameters of the high intensity focused ultrasound system; setting the treatment window and the corresponding parameters according to patient parameters; making the local temperature of the perirenal adipose tissue reach 40-70ºC during treatment; after setup is complete, the system is started, treats one side of the perirenal adipose tissue according to the set parameters, and then treats another side of the perirenal adipose tissue according to the same method and parameters. A secondary center found by the inventor which regulates activity of a systemic sympathetic system is treated by the high intensity focused ultrasound system, which reduces activity of the systemic sympathetic system, thereby delaying or reversing the trend of elevated blood pressure in patients with a boundary hypertension or with a hypertension tendency, and preventing the occurrence of primary hypertension.

Description

Use of high-intensity focused ultrasound system for prevention of essential hypertension

Technical field

The invention belongs to the field of treatment of hypertension, and particularly relates to the use of a high intensity focused ultrasound system for preventing essential hypertension.

Background technique

The high-intensity focused ultrasound (HIFU) treatment system (hereinafter referred to as HIFU treatment system) is mainly composed of power source, treatment control, positioning and real-time evaluation, and motion control systems. The treatment principle is mainly to use the thermal effect generated by the high-intensity ultrasound focused on the biological tissue to make the tissue at the focal region instantaneous coagulative necrosis, the tissue outside the focal region has no significant damage, and the coagulated necrotic tissue can be gradually absorbed or scarred. This new technique of topical treatment is currently limited to the treatment of malignant and benign solid tumors of tissues and organs. A number of clinical trials have confirmed that the treatment system can effectively cause coagulative necrosis of tumor tissue, reduce tumor volume, and increase the probability of successful surgical resection of tumors. It has a palliative therapeutic effect on tumors.

The HIFU treatment system not only has a "resection" effect on tumor tissues, but also has the same effect on non-neoplastic body tissues, but the power used is different from the local temperature control of the target tissue. The application of this aspect is still blank.

Essential hypertension is one of the major chronic diseases that currently endanger human health and life, and its incidence is increasing with economic development and life expectancy. A number of studies have confirmed that hypertension is the most important risk factor for cardiovascular disease risk, and it is one of the most important controllable risk factors. An estimated 62% of strokes worldwide, 49% of coronary heart disease and 14% of non-fatal cardiovascular events are attributable to blood pressure failure. Economically, by 2030, the economic loss from hypertension-related cardiovascular deaths is about $6 million to $9 million per year. If the economic losses caused by cardiovascular disease and the disability caused by it are counted, the figures are even more alarming. Hypertension has become a major public clinical problem in both developed and developing countries due to complications such as poor control of hypertension, death and socioeconomic expenditures.

Hypertension is a progressive disease associated with multiple risk factors. The usual diagnostic criteria for previous hypertension are systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg, but the latest JNC-7 report, in addition to clear blood pressure elevation and cardiovascular disease, further clarifies that the correlation begins with blood pressure. ≥115/75mmHg, and the risk of cardiovascular disease doubles with every 20/10mmHg increase in blood pressure. According to this, JNC-7 redefines the classification of hypertension and presses the systole 120-130 mmHg or diastolic blood pressure between 80-89 mmHg is clearly defined as pre-hypertension (the diagnostic criteria for previous hypertension is systolic blood pressure ≥140 mmHg and / or diastolic blood pressure ≥90 mmHg).

According to the Framingham study, pre-hypertension patients are 3.2 times more likely to progress to hypertension than normal blood pressure, and approximately 38-40% of prehypertensive patients can progress to hypertension within 4 years. Scholars studied the risk factors of prehypertension and found that physical factors, patient behavior and metabolic factors were all related. Physical factors include the patient's age, gender, family history of hypertension, and education, as well as baseline systolic or diastolic blood pressure. Behavioral factors include daily salt intake, alcohol intake, and physical activity. Metabolic related factors mainly include overweight or obesity, high triglycerides and high cholesterol, and whether or not diabetes is associated. At present, it is only possible to delay the increase of blood pressure by recommending patients to control diet, increase exercise and improve lifestyle. However, patients often have poor compliance and poor implementation and poor compliance, so they cannot fully follow the doctor's advice. There was no significant improvement in the proportion of patients with hypertension.

Summary of the invention

It is an object of the present invention to provide a high intensity focused ultrasound system for the prevention of essential hypertension based on the prior art.

Another object of the present invention is to provide a method of preventing essential hypertension using a high intensity focused ultrasound system.

The object of the invention can be achieved by the following measures:

The use of high intensity focused ultrasound systems in the prevention of essential hypertension.

The invention utilizes a high-intensity focused ultrasound system to treat a secondary center discovered by the inventors to regulate the activity of the systemic sympathetic system, thereby reducing the activity of the systemic sympathetic system, thereby greatly delaying the progression of the pre-hypertension patient to the stage of hypertension, and reducing the cardiovascular disease of the patient. The risk of complications.

A method for achieving the use of the present invention, that is, a method for preventing essential hypertension using a high intensity focused ultrasound system, comprising the following steps:

1) Ultrasonic localization measurement of bilateral renal peritoneal adipose tissue in patients with critical hypertension or patients with high blood pressure, and determination of sagittal length, sagittal width, horizontal width and height of treatment site ;

2) According to the patient's weight, height, subcutaneous fat layer thickness parameters, the treatment window and corresponding parameters of the high-intensity focused ultrasound system are set, so that the local temperature of the perirenal adipose tissue reaches 40-70 ° C during treatment, and the treatment site is perirenal adipose tissue. On both sides, the treatment range is 1/3 to all of the entire tissue;

3) After the treatment window and corresponding parameters are set, the high-intensity focused ultrasound system is activated to treat one side of the perirenal adipose tissue according to the set parameters;

4) After the treatment of one side of the perirenal adipose tissue is finished, the other side is treated according to the same method and parameters.

In the above treatment process and method, the target of treatment is bilateral renal adipose tissue, and the preferred target of treatment is bilateral perirenal parenchyma, which can achieve therapeutic purposes as much as possible. To reduce the damage to the adjacent tissues (structures of the kidneys, blood vessels, and ureters) during the treatment process.

The perirenal lower fat referred to in the present invention is an adipose tissue located in a portion of the perirenal adipose tissue located below the lower pole of the kidney.

The method is targeted at patients with critical hypertension or patients with high blood pressure, and the patients with critical hypertension, also known as marginal hypertension, refer to the blood pressure of the patient's blood pressure between normal blood pressure and confirmed hypertension. The blood pressure is slightly higher, and all important organs, such as heart, brain and kidney, have no obvious organic damage, but they are easy to develop into hypertension. Clinical observations show that about 71.5% of patients with critical hypertension are prone to develop high. Blood pressure, critical hypertension, the final development of the diagnosis of hypertension is 2 to 5 times higher than normal hypertension. Patients with a predisposition to hypertension include, but are not limited to, patients with a higher risk of hypertension who are assessed for their living conditions or health status according to the prior art, or patients with a genetic history.

In a preferred embodiment, the treatment time on the side of the target of treatment is from 9 to 70 minutes, further preferably from 10 to 60 minutes, most preferably from 20 to 40 minutes. The treatment time in the present invention refers to the sum of the ultrasonic emission times of the high intensity focused ultrasound system.

During the treatment of steps 3) and 4), the local temperature of the renal adipose tissue at the target of treatment is brought to a temperature of about 40 to 70 ° C, preferably 45 to 60 ° C, by a high intensity focused ultrasound system. In the process, the previously set treatment window and corresponding parameters may also be appropriately adjusted according to a specific treatment process, so that the local temperature of the target target of treatment can reach a predetermined requirement or be faster or better.

In a preferred embodiment, the therapeutic target of treatment is in the range of 1/3 to 2/3 of bilateral perirenal adipose tissue.

The therapeutic window of the high intensity focused ultrasound system of the present invention includes the various treatment points constituting the therapeutic range of the high intensity focused ultrasound system, the size of the treatment points, and the mutual position between the treatment points. Corresponding parameters of the high intensity focused ultrasound system of the present invention include, but are not limited to, the power of the high intensity focused ultrasound system, the time of transmission, the time interval of transmission, the number of shots, and the like.

The patient needs to fast and ban drinking for 3 hours before treatment. The patient is given a loose patient's suit, and the body position is prepared before treatment. The patient needs to maintain a fixed limb state during the treatment.

The beneficial effects of the invention:

1) The high-intensity focused ultrasound system is used to treat a secondary center that regulates the activity of the systemic sympathetic system, reducing the activity of the systemic sympathetic system, thereby delaying the progression of hypertensive patients to the stage of hypertension, and preventing hypertension.

2) Reduce the risk of cardiovascular complications in patients by controlling their blood pressure and/or blood glucose levels.

3) By treating the secondary center to reduce systemic sympathetic system activity, reduce insulin resistance, reduce systemic fibrosis, and possibly other diseases with abnormal sympathetic nervous system activity (such as sudden cardiac death, various ventricular arrhythmias, heart failure, etc.) ) also has a therapeutic effect.

DRAWINGS

1 is a schematic view of the high-intensity focused ultrasound system of the present invention for preventing essential hypertension;

Figure 2 is a schematic diagram of the lower adipose tissue of the kidney;

Figure 3 is a graph showing the effect of high intensity focused ultrasound system on the destruction of renal adipose tissue in blood pressure of hypertensive model animals.

detailed description

The present invention will be further described below in conjunction with the drawings and embodiments, but the scope of the present invention is not limited to the embodiments described below.

Example 1: Animal test

We have implemented 50 animal tests.

Animal experiments indicated that the hypertensive model animals were randomly divided into two groups, one group was treated accordingly (test group, 30 heads), and the other group was used as a control group (20 heads).

Ultrasound localization of perirenal adipose tissue in experimental pigs was performed before operation. The sagittal length, sagittal width, horizontal width and height of the seminal pelvis were measured and the treatment of high intensity focused ultrasound system was established. Window range.

In the experimental group, the sagittal length, the sagittal width, the horizontal width and the height of the perirenal fat were 2.1 cm, 3.0 cm, 1.3 cm and 2.5 cm, respectively. The therapeutic window range of the high-intensity focused ultrasound system is set to 17 points, each point is 15.5X15.5X13.0mm ³ ; the distance between adjacent points is 3.0mm, the step is 3.0mm, and the layer spacing is 6.0mm; The power parameter of the high-intensity focused ultrasound system is set to 120W, the emission time is 699ms, the interval is 10ms, and the number of shots is 50 times, so that the local temperature of the perirenal adipose tissue reaches 55 °C during treatment, and the treatment range is 1/2 of the whole tissue. The total firing time is 9 minutes and 54 seconds; after the end of one side treatment, the other side is treated according to the same method and parameters.

Experimental group Pig 2: sagittal length, sagittal width, horizontal width and height of the perirenal fat were 2.3 cm, 4.1 cm, 3.2 cm and 2.2 cm, respectively. The therapeutic window range of the high-intensity focused ultrasound system is set to 16 points, each point is 15.5X15.5X13.0mm ³ ; the distance between adjacent points is 3.0mm, the step is 3.0mm, and the layer spacing is 6.0mm; The power parameter of the high-intensity focused ultrasound system is set to 120W, the emission time is 699ms, the interval is 10ms, and the number of shots is 50 times, so that the local temperature of the perirenal adipose tissue reaches 55 °C during treatment, and the treatment range is 1/2 of the whole tissue. The total firing time is 11 minutes and 38 seconds; after the end of one side treatment, the other side is treated according to the same method and parameters.

Experimental group pig 3-30: Ultrasound localization measurement of the sagittal length, sagittal width, horizontal width and height of the semi-renal lower adipose tissue of pigs 3-30, and according to the experimental group pigs 1 and 2 Method to set their respective high intensity focus super The parameters of the sound system treatment window and power parameters, emission time, interval and number of shots make the local temperature of the perirenal adipose tissue reach 55 °C during treatment, and the treatment range is 1/2 of the whole tissue.

After 8 weeks of follow-up, the results showed that the blood pressure of the treatment group was significantly flat, while the untreated control group showed a significant increase in blood pressure (Fig. 2).

Claims

The use of high intensity focused ultrasound systems in the prevention of essential hypertension.
The use according to claim 1, characterized in that the treatment process comprises the steps of:

1) Ultrasonic localization measurement of bilateral renal peritoneal adipose tissue in patients with critical hypertension or patients with high blood pressure, and determination of sagittal length, sagittal width, horizontal width and height of the site ;

2) According to the patient's weight, height, subcutaneous fat layer thickness parameters, set the treatment window and corresponding parameters of the high-intensity focused ultrasound system, so that the local temperature of the perirenal adipose tissue reaches 40 ~ 70 ° C during treatment, the treatment site is bilateral, treatment The range is 1/3 to all of the entire organization;

3) After the treatment window and corresponding parameters are set, the high-intensity focused ultrasound system is activated to treat one side of the perirenal adipose tissue according to the set parameters;

4) After the end of one side treatment, the other side is treated according to the same method and parameters.
The use according to claim 2, characterized in that the target of the treatment target is bilateral perirenal parenchyma.
The use according to claim 2, characterized in that the treatment time on the side of the target site of treatment is from 9 to 70 minutes, in particular from 20 to 40 minutes.
The use according to claim 2, characterized in that the local temperature of the therapeutic target site is brought to a temperature of 45 to 60 ° C during the treatment.
The use according to claim 2, characterized in that the therapeutic range of the target of treatment is from 1/3 to 2/3 of the bilateral perirenal adipose tissue.
A method for preventing essential hypertension using a high intensity focused ultrasound system, comprising the steps of:

1) Ultrasonic localization measurement of bilateral renal peritoneal adipose tissue in patients with critical hypertension or patients with high blood pressure, and determination of sagittal length, sagittal width, horizontal width and height of treatment site ;

2) According to the patient's weight, height, subcutaneous fat layer thickness parameters, the treatment window and corresponding parameters of the high-intensity focused ultrasound system are set, so that the local temperature of the perirenal adipose tissue reaches 40-70 ° C during treatment, and the treatment site is perirenal adipose tissue. On both sides, the treatment range is 1/3 to all of the entire tissue;

3) After the treatment window and corresponding parameters are set, the high-intensity focused ultrasound system is activated to treat one side of the perirenal adipose tissue according to the set parameters;

4) After the treatment of one side of the perirenal adipose tissue is finished, the other side is treated according to the same method and parameters.
The method according to claim 7, wherein said therapeutic target site is bilateral perirenal parenchyma.
The method according to claim 7, characterized in that the treatment time on the side of the treatment target is from 9 to 70 minutes, in particular from 20 to 40 minutes.
The method according to claim 7, wherein the local temperature of the therapeutic target site is brought to a temperature of 45 to 60 ° C at the time of treatment.
The method according to claim 7, wherein the therapeutic target of the therapeutic target is from 1/3 to 2/3 of the bilateral perirenal adipose tissue.