Low-frequency pulse ultrasonic treatment device and method for preventing internal arteriovenous fistula stenosis

Abstract

The invention discloses a low-frequency pulse ultrasonic treatment device and method for preventing internal arteriovenous fistula stenosis. The device mainly comprises five core components, namely a host, an ultrasonic transducer, a display module, a power supply and a switch. A power amplifier module and a control module are integrated in the host, the power amplifier module comprises an ultrasonic generation module and a pulse modulation module, and accurate low-frequency pulse ultrasonic signals with the sound intensity of 210mW / cm < 2 >, the pulse frequency of 1MHz, the pulse repetition frequency of 100Hz and the pulse number of 100 can be generated. The ultrasonic transducer is designed to be of a circular structure, high-performance piezoelectric ceramic materials are used in the ultrasonic transducer, and efficient electro-acoustic energy conversion is achieved. The display module adopts a touch screen design and provides a visual parameter setting and state monitoring interface. The device has the beneficial effects of non-invasive treatment, high safety, simplicity and convenience in operation, remarkable prevention effect and the like, the hemodynamic state of the internal fistula part can be effectively improved, internal fistula stenosis is prevented, and the life quality of a hemodialysis patient is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a low-frequency pulsed ultrasound therapy device and method for preventing arteriovenous fistula stenosis. Background Technology

[0002] Vascular access is the lifeline for hemodialysis patients, and its functional status directly affects hospitalization rates, mortality rates, and medical costs. Autogenous arteriovenous fistulas (AVFs) are the preferred vascular access for hemodialysis patients, and their patency and functional integrity are fundamental prerequisites for the successful implementation of maintenance hemodialysis. However, fistula stenosis has become a major complication affecting its lifespan and dialysis quality, with an incidence rate as high as 30% to 50% in clinical practice, severely limiting the long-term effectiveness of hemodialysis treatment and patients' quality of life.

[0003] Currently, clinical practices for preventing arteriovenous fistula stenosis mainly include several technical approaches such as regular ultrasound monitoring, drug therapy, physical dilation methods, and traditional continuous wave ultrasound therapy. While regular ultrasound can detect stenosis trends early to some extent, this method is essentially a passive monitoring approach and cannot provide timely and effective intervention, making it difficult to prevent the formation or further aggravation of stenosis. Drug therapy typically involves systemic administration of anticoagulants or antiplatelet drugs. This treatment method not only carries a significant risk of bleeding but also has extremely limited effectiveness for existing stenosis. Physical dilation methods such as percutaneous endovascular angioplasty can directly address the stenosis, but as invasive procedures, they easily lead to damage to the vascular intima, causing serious complications such as thrombosis. Furthermore, the dilation effect is difficult to maintain, resulting in a high recurrence rate. Traditional continuous wave ultrasound therapy is mainly used to promote tissue repair or relieve pain and has not yet been specifically optimized for the unique pathophysiological mechanisms of arteriovenous fistula stenosis.

[0004] A comprehensive analysis of existing technologies reveals that current prevention and treatment methods cannot effectively address the fundamental problem of arteriovenous fistula stenosis, and generally carry certain safety risks and limitations in clinical application. Therefore, the medical device field urgently needs to develop a novel, safe, reliable, easy-to-operate, and long-term-use non-pharmacological, non-surgical treatment solution to effectively prevent arteriovenous fistula stenosis, thereby improving the quality of life for hemodialysis patients, significantly extending the lifespan of the fistula, and reducing related medical costs and patient burden. Summary of the Invention

[0005] To achieve the above objectives, the present invention provides a low-frequency pulsed ultrasound therapy device for preventing arteriovenous fistula stenosis. include: The main unit integrates a power amplifier module and a control module. The power amplifier module includes an ultrasonic generator module and a pulse modulation module. The ultrasonic generator module contains an oscillation circuit and a frequency synthesizer. The pulse modulation module contains a pulse generator and a modulation circuit. The control module uses a microprocessor and integrates a safety protection circuit. The ultrasonic transducer has a circular structure and uses piezoelectric ceramic material inside. It is connected to the main unit via a dedicated connecting cable. The display module adopts a touch screen design and is integrated into the host, including a parameter display area, a status indicator area, and an operation control area; The power supply is a switching power supply with an input voltage range of AC100V-240V and an output of DC24V / 3A. The switch is a rocker switch with an indicator light, used to control the on / off state of the power supply.

[0006] Furthermore, the ultrasonic wave intensity generated by the ultrasonic generator module is 210 mW / cm². 2 The pulse frequency is 1MHz, the pulse repetition frequency set by the pulse modulation module is 100Hz, and the number of pulses is 100.

[0007] Furthermore, the ultrasonic transducer has a diameter of 50mm and a thickness of 15mm. The outer shell is made of medical-grade stainless steel, and the piezoelectric ceramic material is PZT-8.

[0008] Furthermore, the display module is a 7-inch high-definition color touch screen with a resolution of 1024×600 pixels. The parameter display area displays the ultrasound frequency, sound intensity, pulse repetition frequency, treatment time, and remaining time in real time.

[0009] Furthermore, the dedicated connecting cable is a shielded cable, 1.5 meters long, with a multi-core shielding structure inside.

[0010] Furthermore, the power supply is equipped with internal filtering and voltage regulation circuits, with voltage ripple less than 50mV, and integrates a soft-start function.

[0011] The treatment method for preventing arteriovenous fistula stenosis using the above-mentioned device includes the following steps: Apply the gel patch to the skin surface at the patient's arteriovenous fistula; After sterilization, the ultrasonic transducer is placed on a gel patch. Treatment parameters were set via the display module, with the ultrasound frequency at 1MHz and the sound intensity at 210mW / cm². 2 The pulse repetition frequency is 100Hz, the number of pulses is 100, and the single treatment time is 20 minutes. When the treatment program is started, the main unit generates a low-frequency pulse ultrasound signal, which is applied to the fistula site through the ultrasound transducer.

[0012] The preferred treatment plan is 20 minutes of treatment per day, 3 times a week, for 12 consecutive weeks as a complete course of treatment.

[0013] The beneficial effects of this invention are: This invention achieves effective prevention of arteriovenous fistula stenosis by employing low-frequency pulsed ultrasound technology, offering significant technical advantages and clinical application value compared to existing technologies. The device utilizes precisely controlled sound intensity of 210 mW / cm². 2 Low-frequency pulsed ultrasound with a pulse frequency of 1MHz, a pulse repetition frequency of 100Hz, and a pulse count of 100 times provides moderate mechanical stimulation to the blood vessels at the arteriovenous fistula site. This significantly improves local hemodynamics, effectively reduces damage to the vascular intima caused by turbulence and shear stress, and fundamentally blocks the pathological process of intimal hyperplasia, achieving proactive prevention of arteriovenous fistula stenosis. Compared with traditional passive monitoring and post-treatment models, this invention realizes a shift in treatment philosophy from passive response to proactive prevention, enabling effective intervention before stenosis forms, and significantly improving the long-term patency rate and lifespan of the arteriovenous fistula.

[0014] The treatment method provided by this invention is characterized by its non-invasiveness, high safety, and good patient tolerance, completely avoiding the risks of vascular damage and surgical complications associated with traditional physical dilation methods. Patients experience no pain or discomfort during treatment, and the procedure can be safely performed in outpatient settings or at home, greatly improving the convenience and accessibility of treatment. The device is simple and intuitive to operate, and medical staff can master it with minimal training, significantly reducing the technical threshold and labor costs. By establishing a standardized treatment plan of 20 minutes daily, 3 times a week, for 12 consecutive weeks, it can not only effectively prevent the occurrence of arteriovenous fistula stenosis but also reduce dialysis interruptions and frequent medical interventions caused by fistula dysfunction, thereby reducing overall medical costs and improving the quality of life and treatment adherence of hemodialysis patients. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only for this invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram of the overall structure of the ultrasound therapy device of the present invention; Figure 2 This is a schematic diagram of the overall structure of the ultrasound therapy device of the present invention.

[0017] In the diagram: 1. Main unit; 2. Ultrasonic transducer; 3. Display module; 4. Power supply; 5. Switch. Detailed Implementation

[0018] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. It should also be noted that, to make the embodiments more comprehensive, the following embodiments are the best and preferred embodiments, and those skilled in the art can use other alternative methods to implement some well-known technologies; moreover, the accompanying drawings are only for more specific description of the embodiments and are not intended to specifically limit the present invention.

[0019] It should be noted that the use of terms such as "an embodiment," "an embodiment," "an exemplary embodiment," and "some embodiments" in the specification indicates that the described embodiment may include a specific feature, structure, or characteristic, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, when a specific feature, structure, or characteristic is described in connection with an embodiment, implementing such a feature, structure, or characteristic in conjunction with other embodiments (whether explicitly described or not) should be within the knowledge of those skilled in the art.

[0020] Generally, terms can be understood at least partly from their use in context. For example, depending at least partly on the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in a singular sense, or a combination of features, structures, or characteristics in a plural sense. Additionally, the term "based on" can be understood not necessarily to convey an exclusive set of factors, but rather, alternatively, depending at least partly on the context, to allow for the presence of other factors that are not necessarily explicitly described.

[0021] See Figures 1 to 2 The present invention provides a low-frequency pulse ultrasound therapy device for preventing arteriovenous fistula stenosis, which mainly consists of a main unit 1, an ultrasound transducer 2, a display module 3, a power supply 4, and a switch 5. It performs non-invasive treatment on the arteriovenous fistula site through precisely controlled low-frequency pulse ultrasound, effectively preventing the occurrence of fistula stenosis.

[0022] The main unit 1, serving as the core control unit of the entire treatment device, integrates a power amplifier module, a control module, and a display module 3. The power amplifier module consists of an ultrasound generator module and a pulse modulation module. The ultrasound generator module employs a high-precision oscillation circuit and frequency synthesizer design, capable of stably generating a 1MHz frequency ultrasound signal. The pulse modulation module, through a pulse generator and dedicated modulation circuit, modulates the continuous ultrasound signal into a pulse signal with specific parameters according to precise instructions from the control module, achieving precise control of a pulse repetition frequency of 100Hz and a pulse count of 100 times. The control module uses a high-performance microprocessor as its core processing unit, with a built-in dedicated algorithm program capable of real-time monitoring and adjustment of the ultrasound intensity output, ensuring that the intensity is stably maintained at 210mW / cm² during treatment. 2Within the safe and effective range.

[0023] The ultrasonic transducer 2, a key component for energy output, features a circular design with a diameter of 50mm and a thickness of 15mm, perfectly conforming to the anatomical structure of the fistula site in the human arm. The core component inside the transducer is high-performance piezoelectric ceramic material PZT-8, which boasts excellent electroacoustic conversion efficiency, effectively converting electrical signals into mechanical vibration energy. The transducer housing is made of medical-grade stainless steel with a specially polished surface, ensuring both good biocompatibility and ease of cleaning and disinfection. The transducer connects to the main unit 1 via a dedicated shielded cable, 1.5 meters long, with an internal multi-core shielding structure to effectively prevent electromagnetic interference and ensure the stability and accuracy of signal transmission.

[0024] Display module 3 features a 7-inch high-definition color touchscreen with a resolution of 1024×600 pixels, offering excellent visual effects and ease of operation. The display interface is divided into three main areas: a parameter display area, a status indicator area, and an operation control area. The parameter display area shows the current treatment parameters in real time, including key information such as ultrasound frequency, sound intensity, pulse repetition frequency, treatment time, and remaining time. The status indicator area uses different colored indicator lights to show the device's operating status: green for normal operation, yellow for standby, and red for malfunction or abnormality. The operation control area includes a power switch, treatment start / pause button, parameter adjustment button, and reset button. All buttons are touch-sensitive for simple and intuitive operation.

[0025] Power Supply 4 adopts a switching power supply design with an input voltage range of AC100V-240V and an output of DC24V / 3A. It features multiple protection functions including overvoltage, undervoltage, overcurrent, and short circuit protection. Internally, the power supply incorporates filtering and voltage regulation circuits to ensure output voltage stability, with a voltage ripple of less than 50mV, fully meeting the power requirements of precision medical equipment. The power module also integrates a soft-start function to prevent damage to the equipment from the inrush current at startup.

[0026] Switch 5 is the main power control switch, featuring a rocker switch design with an indicator light. It has a capacity of 10A / 250VAC and boasts excellent electrical performance and mechanical lifespan. The built-in indicator light illuminates when the equipment is powered on, providing operators with a clear indication of the power status.

[0027] Example 1: Prevention and treatment of arteriovenous fistula stenosis in hemodialysis patients The patient was a 60-year-old male with chronic renal failure who had a radial artery-cephalic vein fistula in his left forearm three months prior and was preparing to begin regular hemodialysis. To prevent fistula stenosis, the low-frequency pulsed ultrasound therapy device of this invention was used for preventative treatment.

[0028] Pre-treatment preparation: Place the main unit 1 on a stable treatment table, connect the power supply 4 and turn on the switch 5. After the device performs a self-test, it enters standby mode. Medical staff first perform routine cleaning of the patient's fistula area, then apply an appropriate amount of ultrasound coupling agent to the skin above the fistula, and apply the gel patch to the skin surface at the fistula site. Disinfect the surface of the ultrasound transducer 2 with 75% alcohol wipes, then gently place the transducer on the gel patch, ensuring close contact between the transducer and the skin.

[0029] Treatment parameter settings: Parameters are set via the touchscreen interface of display module 3. The ultrasound frequency is set to 1MHz and the sound intensity is set to 210mW / cm². 2 The pulse repetition frequency is set to 100Hz, the number of pulses is set to 100, and the treatment time per session is set to 20 minutes. After the parameters are set, the system automatically saves the settings and displays them in the parameter display area.

[0030] Treatment Process: Upon pressing the treatment start button, the control module inside the main unit 1 immediately activates the ultrasound generation module and pulse modulation module, generating a low-frequency pulse ultrasound signal that conforms to the set parameters. The ultrasound transducer 2 converts the electrical signal into mechanical vibration, which is transmitted to the fistula site through the coupling agent and skin tissue. During the treatment, the display module 3 shows the treatment progress and remaining time in real time. The patient feels comfortable and experiences no pain or discomfort. After 20 minutes of treatment, the device automatically stops outputting and emits a treatment completion prompt tone.

[0031] Treatment plan: Treatment will be administered for 20 minutes daily, three times a week, for a total of 12 weeks as one complete course of treatment. During the treatment period, color Doppler ultrasound examination will be performed weekly to monitor blood flow and vascular morphology changes in the arteriovenous fistula.

[0032] Treatment Outcome: After 12 weeks of regular treatment, the patient's arteriovenous fistula maintained smooth blood flow within the normal range, with no obvious signs of vascular stenosis. Ultrasound examination showed that the anastomosis and venous segment of the fistula remained stable, with normal blood flow velocity, and no intimal thickening or stenosis was found. The patient was able to undergo hemodialysis treatment smoothly, with good dialysis results and a significant improvement in quality of life.

[0033] Example 2: Preventive treatment for patients at high risk of arteriovenous fistula stenosis The patient is a 45-year-old woman with diabetic nephropathy and a history of vascular disease, placing her in a high-risk group for arteriovenous fistula stenosis. A radial artery-cephalic vein fistula was established in her right forearm 6 months prior. Ultrasound examination revealed rapid blood flow velocity and mild turbulence within the fistula, indicating a potential risk of stenosis.

[0034] For this high-risk patient, the device of this invention was used for enhanced preventative treatment. The treatment parameters remained the same as in Example 1, but the treatment frequency was adjusted to four times a week, 20 minutes each time, to enhance the preventative effect. During treatment, special attention was paid to monitoring the patient's tolerance and treatment response, and the stability of the treatment parameters was closely observed through the display module 3.

[0035] After 16 weeks of intensive treatment, the patient's arteriovenous fistula function remained good, blood flow parameters gradually improved, and turbulence was significantly reduced. Ultrasound examination showed that the vessel diameter remained stable, the intima was smooth, and no stenosis lesions had formed. The patient's hemodialysis treatment was successful, and the adequacy indicators met the target, demonstrating the preventive effect of the device of this invention in high-risk patients.

[0036] As can be seen from the above embodiments, the low-frequency pulse ultrasound therapy device of the present invention can effectively prevent the occurrence of arteriovenous fistula stenosis. The treatment process is safe, comfortable, and easy to operate, making it suitable for widespread clinical application. The coordinated operation of all components of the device ensures the accuracy and reliability of the treatment, providing a novel fistula maintenance solution for hemodialysis patients.

[0037] This invention encompasses any substitutions, modifications, equivalent methods, and solutions made within the spirit and scope of this invention. To provide the public with a thorough understanding of this invention, specific details are described in detail in the following preferred embodiments; however, those skilled in the art will fully understand the invention even without these details. Furthermore, to avoid unnecessary misunderstanding of the essence of this invention, well-known methods, processes, procedures, components, and circuits are not described in detail.

[0038] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A low frequency pulsed ultrasound therapeutic device for preventing stenosis of an internal arteriovenous fistula, characterized by, It comprises: a host (1) with an integrated power amplifier module and a control module, the power amplifier module including an ultrasonic generator module and a pulse modulation module, the ultrasonic generator module containing an oscillation circuit and a frequency synthesizer, the pulse modulation module containing a pulse generator and a modulation circuit, the control module using a microprocessor and integrating a safety protection circuit; an ultrasonic transducer (2) in a circular structure, internally using piezoelectric ceramic material, connected to the host (1) through a special connecting line; a display module (3) designed with a touch screen, integrated in the host (1), including a parameter display area, a state indication area and an operation control area; a power supply (4) as a switching power supply, with an input voltage range of AC 100V-240V and an output of DC 24V / 3A; a switch (5) as a boat-shaped switch with an indicator light, used to control the on-off of the power supply (4).

2. The low frequency pulsed ultrasound treatment device according to claim 1, characterized in that, The ultrasonic wave produced by the ultrasonic generating module has a sound intensity of 210 mW / cm 2 , a pulse frequency of 1 MHz, and the pulse modulation module is set to have a pulse repetition frequency of 100 Hz and a pulse number of 100.

3. The low frequency pulsed ultrasound therapy device of claim 1, wherein, The diameter of the ultrasonic transducer (2) is 50mm, the thickness is 15mm, the shell is made of medical-grade stainless steel material, and the piezoelectric ceramic material is PZT-8.

4. The low frequency pulsed ultrasound therapy device of claim 1, wherein, The display module (3) is a 7-inch high-definition color touch screen with a resolution of 1024x600 pixels, and the parameter display area displays the ultrasonic frequency, sound intensity, pulse repetition frequency, treated time and remaining time in real time.

5. The low frequency pulsed ultrasound therapy device of claim 1, wherein, The special connecting line is a shielded cable with a length of 1.5 meters and a multi-core shielded structure inside.

6. The low frequency pulsed ultrasound therapy device of claim 1, wherein, The power supply (4) is internally provided with a filter circuit and a voltage stabilizing circuit, with a voltage ripple less than 50mV, and integrates a soft start function.

7. A method of preventing stenosis of an internal arteriovenous fistula using the device of any one of claims 1 to 6, characterized in that, It comprises the following steps: Apply a gel patch to the skin surface of the patient's internal fistula; After disinfecting the ultrasonic transducer (2), place it on the gel patch; The treatment parameters are set by the display module (3), the ultrasonic frequency is 1 MHz, the acoustic intensity is 210 mW / cm 2 , the pulse repetition frequency is 100 Hz, the pulse number is 100, and the single treatment time is 20 minutes. Start the treatment program, and the host (1) generates low-frequency pulse ultrasonic signals to act on the internal fistula site through the ultrasonic transducer (2).

8. The method of treatment according to claim 7, wherein, The treatment regimen is 20 minutes of treatment per day, 3 times a week, and 12 weeks of continuous treatment as a complete course of treatment.

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