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WO2025152115A1 - Système de thérapie par ultrasons et son utilisation - Google Patents

Système de thérapie par ultrasons et son utilisation

Info

Publication number
WO2025152115A1
WO2025152115A1 PCT/CN2024/073058 CN2024073058W WO2025152115A1 WO 2025152115 A1 WO2025152115 A1 WO 2025152115A1 CN 2024073058 W CN2024073058 W CN 2024073058W WO 2025152115 A1 WO2025152115 A1 WO 2025152115A1
Authority
WO
WIPO (PCT)
Prior art keywords
module
ultrasonic
output
treatment system
ultrasound
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CN2024/073058
Other languages
English (en)
Chinese (zh)
Inventor
何烨
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai A & S Science Technology Development Co Ltd
Original Assignee
Shanghai A & S Science Technology Development Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai A & S Science Technology Development Co Ltd filed Critical Shanghai A & S Science Technology Development Co Ltd
Priority to PCT/CN2024/073058 priority Critical patent/WO2025152115A1/fr
Priority to PCT/CN2025/070746 priority patent/WO2025152804A1/fr
Publication of WO2025152115A1 publication Critical patent/WO2025152115A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy

Definitions

  • Bats carry hundreds of giant viruses, such as SARS, rabies, Ebola, and the new coronavirus, but their virus load is relatively small and does not cause corresponding symptoms, so they can coexist with the virus. What is even more surprising is the lifespan of bats, which is much longer than land mammals of similar size. The reason for bats' longevity is their ability to control inflammation, and the underlying mechanism may provide new ways to delay aging.
  • the innate immune response can sense cytoplasmic DNA and foreign RNA, responding to the upregulation of interferon genes and the production of other inflammatory cytokines such as TNF- ⁇ . Bats have undergone species evolutionary adaptation, weakening the perception of cytoplasmic DNA through the loss of PYHIN genes and mutations in regulatory sites in STING.
  • TNF- ⁇ and other inflammatory cytokines in bats are reduced, while anti-inflammatory cytokines such as IL-10 are upregulated.
  • anti-inflammatory cytokines such as IL-10 are upregulated.
  • the activation of NLRP3 inflammasomes is inhibited in bats, resulting in reduced production of IL-1 ⁇ and IL-18, and enhanced RNA sensing in bats.
  • these adaptive changes in bats enable them to tolerate viruses while suppressing inflammatory responses.
  • bats are one of the very few mammals that use ultrasound to locate and hunt.
  • Other mammals that use ultrasound to locate include naked mole rats, which are also super long-lived mammals that coexist with a large number of viruses. Therefore, the ability of bats and naked mole rats to tolerate viruses, inhibit inflammatory responses, and live longer may be related to ultrasound.
  • the present invention provides an ultrasonic treatment system and its application.
  • the host comprises the following modules:
  • the length of the piezoelectric module and the horn module is half of the wavelength
  • the frequency range of the ultrasonic treatment system output is consistent with the frequency range of the ultrasonic waves output by bats.
  • the host further comprises: (5) a display module, through which parameters of ultrasound treatment are set, the parameters including frequency, sound intensity, time and/or duty cycle, and functions of starting ultrasound treatment and terminating treatment are provided;
  • the treatment head further comprises: (iii) a packaging module: packaging and fixing the piezoelectric module and the horn module therein; and/or,
  • the ultrasound treatment system further comprises a positioning module for positioning a treatment area.
  • the ultrasonic wave waveform output by the ultrasonic treatment system is a sine wave
  • the frequency range of the ultrasonic treatment system is 20-50kHz
  • the output amplitude is 0.1-1.6W/ cm2
  • the pulse width range is 10-1000ms
  • the period range is 20-2000ms
  • the corresponding duty cycle is 1/2-1/200.
  • the frequency range of the ultrasonic treatment system output is 30-40 kHz
  • the output amplitude is 0.15-0.25 W/cm 2
  • the pulse width range is 50-200 ms
  • the period range is 300-500 ms.
  • the ultrasound treatment system satisfies one or more of the following conditions:
  • the display module includes a liquid crystal screen
  • the signal module generates an ultrasonic baseband signal by means of DDS;
  • the output module adopts MOS tube to amplify the output of the signal
  • the piezoelectric module includes four piezoelectric ceramic chips
  • the piezoelectric ceramic wafer is a P42 piezoelectric ceramic
  • the piezoelectric ceramic chips are arranged alternately according to positive and negative electrodes.
  • the packaging module satisfies one or more of the following conditions:
  • the front cover is made of aluminum alloy
  • the rear cover is made of stainless steel
  • the housing is convenient to hold and is preferably cylindrical; and,
  • the fixing member is a set screw, which fastens and connects the modules; the set screw preferably has prestress.
  • the shape of the horn module is rectangular, circular, spherical, honeycomb, needle-shaped or ball-headed.
  • the horn module satisfies one or more of the following conditions:
  • the output surface of the horn module is wrapped with a silicone rubber film
  • the horn module uses a tangent circular surface transition to process the coarse and fine transition positions;
  • the horn module further comprises a flange for mounting the housing; the flange is preferably located at a node point.
  • the technical solution provided by the present invention is: a method for stimulating the body's immune response by using the ultrasonic treatment system of the present invention, wherein ultrasonic stimulation is performed on the target immune organ such as the spleen or the brain, comprising the following steps:
  • the ultrasound treatment system outputs a frequency range of 20-50kHz, an output amplitude of 0.1-1.6W/ cm2 , a pulse width range of 10-1000ms, a cycle range of 20-2000ms, a corresponding duty cycle of 1/2-1/200; and an ultrasound stimulation time range of 60-600s.
  • the technical solution provided by the present invention is: application of the ultrasonic treatment system as described in the present invention in preparing a device for stimulating the immune response of the body.
  • the stimulation of the body's immune response is anti-tumor, anti-viral, prevention and improvement of inflammatory aging, extension of life span and/or treatment of autoimmune diseases.
  • the present invention uses low-frequency and low-intensity ultrasound to act on the body's immune system, forming a specific immune environment in the body, such as high expression of interferon ⁇ , strong immune response, enhanced autophagy, and reduced inflammation level. It can fight tumors, fight viruses, prevent and improve inflammatory aging, prolong life, and treat autoimmune diseases.
  • FIG. 3 is a schematic diagram of the structure of a horn tool head with a rectangular or spherical output surface.
  • FIG. 6 is a schematic diagram of the mounting structure of the housing of the horn tool head.
  • Figure 7 shows the structure of the treatment head.
  • Figure 9 shows the horn tool head structure.
  • FIG10 is a schematic diagram of a sine wave.
  • FIG. 11 is a schematic diagram of sinusoidal wave modulation.
  • FIG. 12 is a schematic diagram of the output ultrasonic wave processed by the smooth transition algorithm.
  • FIG. 13 is a diagram showing the installation method of the positioning module and the treatment head.
  • FIG. 15 shows the tumor size and its growth curve.
  • Figure 16 shows the pathological analysis of the tumor.
  • FIG. 17 shows the statistics and analysis of mouse blood cytokines.
  • the technical solution proposed by the present invention is to utilize ultrasound to stimulate the immune effect of the body.
  • Ultrasonic stimulation changes the body's immune environment, resulting in a series of immune responses, high expression of interferon ⁇ , virus tolerance, and improved ability to control inflammation. Based on the bat's ability to emit ultrasonic waves and other related physiological characteristics, the inventor developed a dedicated ultrasonic therapy system.
  • the main evaluation indicators are as follows:
  • the inventor designed relevant animal experiments, using ultrasound to stimulate the body and verify its immune effect.
  • Experiment 1 A mouse liver tumor model was designed. After more than a year of animal experiments and repeated optimization of technical parameters, the treatment group has increased interferon ⁇ by 42%, interferon ⁇ by 35%, interferon ⁇ by 34%, CD4+T by 72%, and IL-15 by 42% compared with the control group. At the same time, the growth of tumor cells has also been inhibited. These experiments prove that ultrasound stimulates the immune system, allowing the body to produce interferon, and also increases other beneficial immune factors and immune cells, thereby inhibiting tumor cells.
  • the ultrasonic treatment system of the present invention is composed of a main unit and a treatment head.
  • the host part includes the following modules (the schematic diagram is shown in Figure 1):
  • Display module It is mainly composed of an LCD screen. Human-computer interaction is achieved through the LCD screen.
  • the parameters of ultrasound treatment can be set through the LCD screen, including frequency, sound intensity, time, duty cycle, etc., and the functions of starting and stopping ultrasound treatment are provided.
  • Signal module Generates ultrasonic baseband signal through DDS.
  • the main control unit generates the electrical signal to drive ultrasound according to parameters such as frequency, sound intensity, time, and duty cycle.
  • Power module Mainly responsible for converting AC power into DC voltage and providing constant DC voltage for each component.
  • Output module uses MOS tube to amplify the output signal.
  • Matching module matches the output electrical signal with the transducer to achieve consistency in voltage and current phases.
  • the treatment head mainly generates vibrations through piezoelectric vibrators, which are then output through the tool head. Both the piezoelectric vibrator and the tool head are designed to be half the wavelength. It includes the following modules:
  • Piezoelectric ceramics are components that convert electrical energy into mechanical energy and are the core of ultrasonic therapy systems. Device.
  • the piezoelectric ceramics of this device use 4 annular ceramic chips, and the chip material is P42.
  • P42 piezoelectric ceramics have a high acoustic-to-electric conversion efficiency and are suitable for immunotherapy.
  • the 4 annular piezoelectric ceramic chips are calculated according to the required sound power. If the number is too small, the power is too small and the immune effect cannot be achieved. If the thickness of the single chip is increased, the difficulty of making the piezoelectric chip will increase, which is not conducive to immunotherapy.
  • the piezoelectric chip has positive and negative poles. The 4 chips need to be arranged alternately during installation, as shown in Figure 2.
  • Horn tool head Different shapes can be designed according to treatment needs. For example, a rectangular shape can be designed for spleen treatment. It can also be designed as a spherical surface to make the transducer focusable, as shown in Figure 3.
  • the structure of the horn tool head with a rectangular output surface is shown in Figure 4; the structure of the horn tool head with a spherical output surface is shown in Figure 5.
  • the horn tool head can be replaced to meet different output waveform requirements, such as honeycomb, needle, ball head, etc. Note that the design of the horn needs to meet the theoretical requirements of half wavelength.
  • the thick and thin transition of the horn tool head adopts a tangent circular surface transition method, which makes the transmission efficiency of ultrasound on the horn higher.
  • a flange on the horn tool head which is used to mount the housing.
  • the flange is located at the wave node position, which has the least effect on the transducer vibration, as shown in Figure 6.
  • Front cover Made of aluminum alloy.
  • Rear cover Made of stainless steel.
  • Shell Designed in cylindrical shape, convenient for handheld operation.
  • Set screw fasten and connect each module.
  • the set screw must have a certain prestress, and the prestress must be within a certain range. It is necessary to install double-stacked self-locking washers or disc washers. Generally, C-shaped washers should not be used to prevent loosening during use. Use a torque wrench when installing the screw so that the torque reaches the prestress range.
  • the treatment head of the present invention (structure shown in FIG. 7 ) generates ultrasonic waves after the piezoelectric ceramic is energized. Since the density of the stainless steel rear cover is large (about 7.9 g/cm 3 ), and the density of the aluminum alloy front cover is small (about 2.8 g/cm 3 ), the displacement amplitude of the forward output ultrasonic wave is large, and the amplitude of the output ultrasonic wave is further increased by the horn tool head in the front, so that the treatment head of the present invention has the characteristics of high output efficiency and ultrasonic concentration. At the same time, the tool head is designed to a corresponding size according to the shape of the treatment part, so that the entire treatment head meets the needs of immunotherapy.
  • Piezoelectric ceramics (structure shown in Figure 8) have dielectric and elastic properties in addition to piezoelectricity, and have been widely used in medical imaging, acoustic sensors, acoustic transducers, ultrasonic motors, etc. Piezoelectric ceramics use the fact that the internal positive and negative charge centers of the material are relatively displaced under mechanical stress, causing polarization, resulting in opposite signs on the surfaces of the two ends of the material. It is made by the piezoelectric effect of bound electric charge and has sensitive characteristics.
  • the output surface of the horn tool head (structure shown in FIG. 9 ) is an elongated rectangle, which is designed to a corresponding size according to the shape of the treatment site, so that the entire treatment head meets the needs of immunotherapy.
  • the ultrasonic waveform output by this device is a pulse-modulated sine wave.
  • the schematic diagram of the sine wave is shown in Figure 10.
  • the horizontal axis is time and the vertical axis is the output amplitude.
  • the frequency range of the output of this device is 20-50kHz, and the output amplitude, that is, the sound intensity range of ultrasound, is 0.1-1.6W/ cm2 .
  • the schematic diagram of sine wave modulation is shown in Figure 11.
  • the emission time in the modulated waveform is the pulse width, from one emission starting point to the next emission starting point is the cycle, and the pulse width divided by the cycle is the duty cycle.
  • the pulse width range of this device is 10-1000ms, the cycle range is 20-2000ms, and the corresponding duty cycle is 1/2-1/200.
  • the total treatment time of this device ranges from 60 to 600s.
  • the ultrasonic wave output by this device has also been processed by a smooth transition algorithm.
  • the schematic diagram is shown in Figure 12. For each pulse output, it gradually increases from small to large. After reaching the output amplitude, a pulse width is treated stably. At the end of the pulse, it gradually decreases from large to small.
  • This output method can make patients feel more comfortable and more tolerant, and also makes the device work more stably and less prone to damage. At the same time, it is more in line with the characteristics of bats outputting ultrasound, and bionics is more realistic.
  • the output ultrasound amplitude, duty cycle and other parameters can be edited, and a treatment sequence can be generated according to the needs of treatment, making the device more intelligent and humane. If new characteristics of bats outputting ultrasound are discovered later, bionics can be continued by changing the treatment sequence.
  • the positioning module is used to locate the treatment area and is an optional module.
  • a miniature B-ultrasound probe can be used, generally.
  • the B-ultrasound probe and the B-ultrasound host work together to detect the internal organs and tissues of the human body.
  • the internal organs of the human body can be seen on the image of the positioning module, and the sound channel of the ultrasonic treatment can also be determined according to the positional relationship.
  • select the appropriate treatment sound channel and the appropriate treatment organ for immunotherapy The installation method of the positioning module and the treatment head is shown in Figure 13.
  • the schematic diagram of the therapeutic ultrasound and the treatment organ on the image of the positioning module is shown in Figure 14.
  • the mouse liver tumor model was used to verify that low-frequency, low-intensity ultrasound acts on the body's immune system and stimulates the body's immune response, thereby inhibiting viruses and having anti-tumor effects.
  • the experimental groups are shown in Table 1.
  • mice All experimental mice were inoculated with tumors at the same time, and samples were taken for testing and treatment at the same time. The experiment was terminated when the maximum diameter of the tumor was greater than 1500 mm3 or the longest diameter of the tumor was greater than 15 mm.
  • the spleen of the experimental mouse was ultrasonically treated using the special ultrasonic treatment system developed by the present invention.
  • the tool head used in this experiment is a rectangular tool head, which is suitable for the treatment of the spleen.
  • the skin of the mouse was prepared before the experiment, and then B-ultrasound positioning was used to mark the treatment site (spleen) on the body surface. The mouse was treated after anesthesia.
  • No. 1 The ratio of CD4+T cells in the blood of mice in experimental groups A, B, and C was B>A>C, which were 20.48 ⁇ 8.05, 26.41 ⁇ 5.45, and 15.31 ⁇ 9.08, respectively; compared with the normal model control group C, the ratio of CD4+T cells in the blood of mice in experimental group A increased, but there was no statistical significance, while the ratio of CD4+T cells in the blood of mice in experimental group B increased significantly, and P ⁇ 0.05 was statistically significant.
  • No. 3 The ratio of CD40+ immune cells in the blood of mice in experimental groups A, B, and C was A>B>C, which were 30.68 ⁇ 4.67, 28.91 ⁇ 7.92, and 25.13 ⁇ 5.13, respectively; compared with the normal model control group C, the ratio of CD40+ immune cells in the blood of mice in experimental groups A and B increased slightly, but there was no statistical significance.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un système de thérapie par ultrasons et son utilisation. Le système de thérapie par ultrasons comprend un hôte et une tête de thérapie. L'hôte comprend un module de signal, un module d'alimentation électrique, un module de sortie et un module d'adaptation. La tête de thérapie comprend un module piézoélectrique et un module de transformateur d'amplitude. La longueur du module piézoélectrique et la longueur du module de transformateur d'amplitude sont la moitié de la longueur d'onde. La plage de fréquences de sortie du système de thérapie par ultrasons est conforme à la plage de fréquences des ondes ultrasonores délivrées par des battes. Selon la présente invention, des ultrasons basse intensité basse fréquence agissent sur le système immunitaire d'un organisme, et des environnements immunitaires spécifiques présentant une expression élevée d'interféron alpha, une forte réponse immunitaire, une autophagie améliorée, un niveau d'inflammation régulé vers le bas, etc, sont formés dans l'organisme. Par conséquent, le système de thérapie par ultrasons peut être utilisé pour résister aux tumeurs et aux virus, prévenir et améliorer le vieillissement inflammatoire, prolonger la durée de vie et traiter des maladies auto-immunes.
PCT/CN2024/073058 2024-01-18 2024-01-18 Système de thérapie par ultrasons et son utilisation Pending WO2025152115A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/CN2024/073058 WO2025152115A1 (fr) 2024-01-18 2024-01-18 Système de thérapie par ultrasons et son utilisation
PCT/CN2025/070746 WO2025152804A1 (fr) 2024-01-18 2025-01-06 Système de thérapie par ultrasons et son utilisation

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PCT/CN2025/070746 Pending WO2025152804A1 (fr) 2024-01-18 2025-01-06 Système de thérapie par ultrasons et son utilisation

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JP2003275684A (ja) * 2002-03-26 2003-09-30 Matsushita Electric Works Ltd 超音波発生装置、及びこの超音波発生装置を用いた超音波美容器
JP2006087686A (ja) * 2004-09-24 2006-04-06 Matsushita Electric Works Ltd 超音波美容装置
CN104780858A (zh) * 2012-11-06 2015-07-15 迈迪生医疗器械公司 用于控制对身体组织的超声能量传送的系统和方法
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