Cap-type ultrasonic treatment device and method of use

Abstract

The application discloses a cap type ultrasonic treatment device and a use method. The device comprises a wearable cap type support structure, a flexible ultrasonic transducer array, a distributed drive circuit, a control module, a temperature monitoring module and a power supply module. The flexible ultrasonic transducer array is integrated inside the support structure, the distributed drive circuit independently drives each transducer unit, and the control module dynamically adjusts the ultrasonic output parameters according to the data fed back by the temperature monitoring module. The method realizes safe and controllable head ultrasonic treatment by wearing the device, setting treatment parameters, outputting ultrasonic energy, real-time monitoring of scalp temperature and automatic adjustment of output based on temperature feedback. The application adopts a flexible cap type wearable design, realizes stable adhesion with the head and uniform coverage of ultrasonic energy, has an intelligent temperature control protection function, improves the use comfort and safety, and is suitable for daily head ultrasonic intervention in a family and mobile scene.

Description

Technical Field

[0001] This invention relates to the field of medical devices and wearable ultrasound therapy technology, and in particular to a cap-type ultrasound therapy device and its usage method. Background Technology

[0002] Ultrasound technology, as a non-invasive physical modulation method, features adjustable penetration depth, high spatial resolution, good safety, and the ability to act on deep tissues. In recent years, it has received widespread attention in fields such as rehabilitation therapy, tissue repair, biostimulation, and neuromodulation. With the development of wearable medical devices and smart health technologies, ultrasound therapy is gradually extending from traditional medical institution settings to home, portable, and daily applications. Especially in areas such as head health management, neuromodulation, tissue care, and auxiliary intervention for chronic diseases, users are increasingly demanding ultrasound therapy devices that can be worn stably for extended periods and are suitable for everyday life.

[0003] Currently, most existing ultrasound therapy devices employ a desktop main unit combined with a handheld probe. Their ultrasound transducer, drive circuit, and control system are relatively large, requiring manual adjustment of the treatment position and angle by the operator. These devices are primarily used in hospitals, rehabilitation centers, or specialized physiotherapy facilities. The complex operation of these devices makes it difficult to meet users' needs for continuous or periodic treatment in various settings such as home, office, rest, or travel. For individuals requiring long-term physical intervention in the head area, traditional devices typically require dedicated treatment time, resulting in poor flexibility and hindering widespread adoption and long-term adherence.

[0004] However, applying ultrasound technology to everyday wearable treatments in the head region still faces a series of key technical challenges.

[0005] First, existing ultrasound devices generally suffer from large size and poor wearability. Traditional ultrasound transducer units and their associated circuits often employ rigid structural designs, making it difficult to achieve a stable fit with the curved surface of the head and failing to meet the comfort requirements for prolonged wear. Meanwhile, how to integrate the ultrasound transmitting unit, drive circuit, control module, power module, and heat dissipation structure within a cap-shaped device, while simultaneously considering device weight, energy consumption, heat dissipation performance, and wearing stability, remains a crucial technical challenge that urgently needs to be addressed.

[0006] Secondly, the uniformity and stability of ultrasound coverage in the head area are insufficient. The human head has a complex curvature structure, and there are significant differences in head shape among different users. Traditional fixed or handheld probes cannot guarantee continuous and stable contact with the target area, which can easily lead to problems such as insufficient local coupling, uneven distribution of ultrasound energy, and treatment area displacement, thus affecting the consistency and repeatability of treatment effects. In addition, current technologies lack multi-probe collaborative layouts and adaptive fitting structures suitable for wearable scenarios, making it difficult to achieve stable coverage of large head areas.

[0007] Furthermore, existing equipment still has shortcomings in terms of intelligent control and safety management. Most ultrasound therapy devices adopt a fixed parameter output mode, which cannot be adjusted in real time according to the wearing status, contact quality, or user usage. They lack dynamic monitoring and feedback control mechanisms for transducer operating temperature, probe contact status, and ultrasound output status. During prolonged wear, local overheating, poor contact, or abnormal ultrasound output may occur, affecting treatment safety and user experience. At the same time, existing equipment generally lacks intelligent control systems suitable for home and mobile scenarios, making it difficult to achieve personalized, automated, and convenient use.

[0008] Therefore, there is an urgent need in the field for a miniaturized cap-type ultrasound therapy device that can highly integrate the ultrasound transducer system, control system and power supply system, and a method of use that can achieve intelligent adjustment of ultrasound parameters and stably fit the head area. Summary of the Invention

[0009] In view of this, the purpose of the present invention is to provide a cap-type ultrasound therapy device and a method of use. The device adopts a wearable cap structure and a flexible ultrasound transducer array, combined with distributed drive and temperature feedback control, to solve the problems of large size, poor head fit, and lack of safe temperature control of existing ultrasound devices.

[0010] To achieve the above objectives, the present invention provides the following technical solution: The cap-shaped ultrasound therapy device provided by the present invention includes: A wearable hat-like support structure designed to achieve a stable and flexible fit to the user's head; A flexible ultrasonic transducer array is integrated inside the wearable cap-style support structure for outputting ultrasonic energy to the head region; A distributed driving circuit is electrically connected to the flexible ultrasonic transducer array and is used to independently drive each transducer unit in the flexible ultrasonic transducer array. A control module, connected to the distributed drive circuit, is used to set and adjust ultrasound treatment parameters; A temperature monitoring module, connected to the control module, is used to monitor the scalp area temperature in real time and feed the temperature data back to the control module; and A power supply module is electrically connected to the distributed drive circuit, control module and temperature monitoring module to provide electrical energy; The control module compares the temperature data fed back by the temperature monitoring module with at least one preset temperature threshold, and dynamically adjusts the output of the distributed drive circuit based on the comparison result.

[0011] Furthermore, the flexible ultrasonic transducer array includes multiple ultrasonic transducer units arranged in a matrix or ring, with a center-to-center distance of 15-22 mm between adjacent transducer units and a size of 8-12 mm for each transducer unit.

[0012] Furthermore, the distributed drive circuit adopts a surround layout and is integrated around each ultrasonic transducer unit to provide an independent and controllable drive signal for each transducer unit.

[0013] Furthermore, the wearable hat support structure includes a hat body and an adjustment and fixing structure; the wearable hat support structure is made of elastic fabric, medical silicone or flexible composite material; the adjustment and fixing structure is located at the edge of the hat body and includes an elastic adjustment band, a buckle or Velcro structure.

[0014] Furthermore, the control module is integrated into the top or side area of ​​the wearable cap-style support structure and includes at least one of a touch interaction module or a wireless communication module for human-computer interaction setting of ultrasound treatment parameters.

[0015] Furthermore, a coupling layer is provided in the area where the flexible ultrasound transducer array contacts the scalp; a flexible buffer structure is provided on the inner side of the wearable cap-style support structure.

[0016] Furthermore, the number of the plurality of ultrasonic transducer units is 12-24, arranged in a matrix, and the overall coverage area of ​​the flexible ultrasonic transducer array is 30-50 square centimeters; and the flexible layer of the flexible ultrasonic transducer array is made of polydimethylsiloxane or thermoplastic polyurethane material.

[0017] Furthermore, the control module is also configured to: When the temperature fed back by the temperature monitoring module reaches the first temperature threshold, the ultrasonic output power is automatically reduced by the first power reduction ratio. When the temperature reaches a second temperature threshold that is higher than the first temperature threshold, the output power is automatically reduced by a second power reduction ratio, wherein the second power reduction ratio is greater than the first power reduction ratio. When the temperature reaches a third temperature threshold that is higher than the second temperature threshold, the ultrasonic output should be stopped immediately. Wherein, the first temperature threshold, the second temperature threshold, the third temperature threshold, the first power reduction ratio, and the second power reduction ratio are all preset values; Furthermore, after automatically reducing or stopping the output, treatment will automatically resume when the temperature recovers to below the first temperature threshold.

[0018] The method of using the cap-type ultrasound therapy device provided by the present invention includes the following steps: Step 1: Wear the wearable cap-style support structure on the user's head, and use the adjustment and fixing structure to keep the flexible ultrasonic transducer array stably attached to the scalp area. Step 2: Set at least one ultrasound treatment parameter through the control module and start the treatment program; Step 3: The distributed drive circuit drives the flexible ultrasound transducer array to output ultrasound energy to the head region according to the treatment program. Step 4: During the ultrasonic energy output process, the temperature monitoring module monitors the temperature of the scalp area in real time and feeds the temperature data back to the control module; Step 5: The control module compares the received temperature data with at least one preset temperature threshold, and dynamically adjusts the output of the ultrasonic energy according to the comparison result.

[0019] Furthermore, a preparation step is included before step 1: Clean the head treatment area and check the condition of the coupling layer at the bottom of the flexible ultrasound transducer array. If the surface of the coupling layer is dry, add medical ultrasound coupling agent. In step 1, the contact pressure between the wearable cap-style support structure and the scalp is controlled within a preset pressure range by adjusting and fixing the structure. The ultrasound treatment parameters set in step 2 include ultrasound frequency, output power, duty cycle, pulse repetition frequency, and treatment time. Among these, ultrasound frequency, output power, duty cycle, pulse repetition frequency, and single treatment time are all preset values.

[0020] The beneficial effects of this invention are as follows: This invention provides a cap-type ultrasound therapy device and its usage method. The device includes a wearable cap-type support structure, a flexible ultrasound transducer array, a distributed drive circuit, a control module, a temperature monitoring module, and a power supply module. The flexible ultrasound transducer array is integrated inside the support structure, the distributed drive circuit independently drives each transducer unit, and the control module dynamically adjusts the ultrasound output parameters based on data feedback from the temperature monitoring module. This method achieves safe and controllable head ultrasound therapy by wearing the device, setting treatment parameters, outputting ultrasound energy, monitoring scalp temperature in real time, and automatically adjusting the output based on temperature feedback. This invention adopts a flexible cap-type wearable design, achieving stable fit to the head and uniform coverage of ultrasound energy, and has intelligent temperature control protection, improving comfort and safety, and is suitable for daily head ultrasound intervention in home and mobile settings. Compared with existing technologies, it has the following beneficial effects: 1. Flexible, one-piece cap design enhances head fit and wearing comfort. This invention employs a flexible cap-style wearable structure, highly integrating the ultrasound treatment module, control module, and power supply module within the wearable cap-style support structure. Compared to traditional desktop or handheld ultrasound devices, it can stably conform to the curved structure of the head, reducing energy unevenness caused by probe misalignment during treatment. The entire device is made of lightweight, flexible materials, ensuring a comfortable and secure fit without interfering with the user's daily activities in scenarios such as working, studying, resting, and traveling, making it suitable for long-term continuous use.

[0021] 2. Flexible ultrasound transducer array design improves ultrasound coverage uniformity and treatment stability. This invention breaks through the traditional single ultrasound probe structure, adopting a flexible array-type ultrasound transducer unit layout. Each transducer unit operates independently and is arranged in zones according to the physiological curve of the head, achieving large-area uniform coverage of ultrasound energy in the head region and avoiding the problem of excessively strong or weak ultrasound energy in certain areas. Simultaneously, by surrounding each ultrasound transducer unit with a distributed drive circuit, replacing the traditional centralized drive structure, the signal transmission distance is shortened, energy loss and external electromagnetic interference are reduced, and the stability of ultrasound output parameters and system operating efficiency are improved. The multi-element synergistic output enhances the overall treatment effect and adapts to the needs of different head shapes and head regions.

[0022] 3. Intelligent temperature monitoring and safety protection functions enhance user safety. This invention incorporates a flexible temperature monitoring module inside a wearable cap-like support structure, enabling real-time monitoring of skin temperature in the ultrasound application area. When the local temperature is compared to at least one preset temperature threshold, if it exceeds this threshold, the system automatically reduces the ultrasound output power or pauses operation to prevent local overheating that could cause skin discomfort or tissue damage. This linkage between ultrasound output and temperature feedback enhances the safety and stability of the device during prolonged wear.

[0023] 4. Strong adaptability to multiple scenarios, meeting daily usage needs. This invention is applicable to various usage scenarios, including home, office, rest, rehabilitation, and mobile travel, allowing for routine ultrasound treatments without the need for professional operation. The device supports wireless power supply and portable use, meeting users' continuous usage needs during fragmented time periods, thus improving treatment convenience and user compliance. Furthermore, through optimized human-computer interaction design, ultrasound parameter adjustment, working mode switching, and device status display are integrated into the control module. Users can directly set parameters such as ultrasound frequency, power, duty cycle, and treatment time, enhancing operational convenience and intelligence, and meeting the personalized needs of different users in different usage scenarios.

[0024] The above and other objects, advantages, and features of the present invention will be more fully set forth and demonstrated through the following detailed description of specific embodiments in conjunction with the accompanying drawings. Those skilled in the art, upon referring to the following detailed description and the accompanying drawings, will be able to better understand and realize the above advantages of the present invention. Other objects, features, and advantages of the present invention will become clearer after being described in detail in the detailed description section in conjunction with the accompanying drawings. Attached Figure Description

[0025] To make the objectives, technical solutions, and beneficial effects of this invention clearer, the following drawings are provided for illustration.

[0026] Figure 1 A schematic diagram of the overall structure of a cap-type ultrasound therapy device; Figure 2 Design drawing of a cap-type ultrasound therapy device; Figure 3 A cross-sectional view of the layered structure of a cap-type ultrasound therapy device; Figure 4 This is a schematic diagram of an array of ultrasonic transducers and their surrounding drive circuits. Figure 5 A system workflow diagram for a cap-type ultrasound therapy device; Figure 6 This is a schematic diagram of the feedback control principle of the temperature monitoring module.

[0027] In the diagram, 21 represents the touch interaction module; 22 represents the USB-C charging port; 23 represents the wearable cap-style support structure; 24 represents the adjustment and fixing structure; 31 represents the protective fabric layer; 32 represents the control circuit layer; 33 represents the base layer; 34 represents the flexible layer (PDMS); 35 represents the distributed drive circuit; 36 represents the ultrasonic transducer unit; 37 represents the coupling layer; 38 represents the skin contact surface; 41 represents the distributed drive circuit; 42 represents the ultrasonic transducer unit; and 43 represents the flexible serpentine wire. Detailed Implementation

[0028] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, so that those skilled in the art can better understand and implement the present invention. However, the embodiments described are not intended to limit the present invention.

[0029] Example 1

[0030] like Figure 1 As shown, the cap-type ultrasound therapy device provided in this embodiment includes: A wearable hat-like support structure designed to achieve a stable and flexible fit to the user's head; A flexible ultrasonic transducer array is integrated inside the wearable cap-style support structure for outputting ultrasonic energy to the head region; A distributed driving circuit is electrically connected to the flexible ultrasonic transducer array and is used to independently drive each transducer unit in the flexible ultrasonic transducer array. A control module, connected to the distributed drive circuit, is used to set and adjust ultrasound treatment parameters; A temperature monitoring module, connected to the control module, is used to monitor the scalp area temperature in real time and feed the temperature data back to the control module; and A power supply module is electrically connected to the distributed drive circuit, control module and temperature monitoring module to provide electrical energy; The control module compares the temperature data fed back by the temperature monitoring module with at least one preset temperature threshold, and dynamically adjusts the output of the distributed drive circuit based on the comparison result.

[0031] The flexible ultrasonic transducer array in this embodiment includes multiple ultrasonic transducer units arranged in a matrix or ring, with a center-to-center distance of 15-22 mm between adjacent transducer units and a size of 8-12 mm for each transducer unit; and the flexible ultrasonic transducer array adopts a serpentine conductor island bridge structure to achieve overall extensibility.

[0032] In this embodiment, the overall extensibility is achieved through a serpentine wire island bridge structure, thereby adapting to different head shapes and maintaining a stable fit.

[0033] In this embodiment, the distributed drive circuit adopts a surround layout and is integrated around each ultrasonic transducer unit to provide an independent and controllable drive signal for each transducer unit; and the distributed drive circuit adopts a low power consumption design to reduce the heat generation problem during operation.

[0034] The distributed drive circuit in this embodiment adopts a low-power design to reduce heat generation during device operation and improve the stability of wearable use. In wearable devices, low power consumption reduces heat dissipation, improving wearing comfort and safety.

[0035] The wearable hat support structure in this embodiment includes a hat body and an adjustment and fixing structure; the hat body is made of elastic fabric, medical silicone or flexible composite material; the adjustment and fixing structure is set on the edge of the hat body and includes at least one of elastic adjustment strap, buckle or Velcro; and the surface of the wearable hat support structure is provided with ventilation holes or mesh heat dissipation area.

[0036] The wearable hat-style support structure in this embodiment refers to an overall support component worn on a user's head, wherein the hat body is the main body of the wearable hat-style support structure; optionally, it can be used to fix circuits or batteries. A thin base layer can also be locally provided inside the wearable hat-style support structure to enhance structural strength. The edges of the wearable hat-style support structure are also provided with an adjustment and fixing structure to adapt to different head circumferences and maintain device stability. This base layer structure is a thin, relatively rigid support piece that can be used to locally fix circuits or batteries, serving as a local reinforcement, and can have a thickness of 0.1-0.5 mm and an area of ​​1-4 cm². 2 The substrate is connected using flexible hinges.

[0037] In this embodiment, the wearable hat-style support structure has ventilation holes or mesh heat dissipation areas on its surface to reduce stuffiness during prolonged wear, thus improving comfort during extended periods of wear.

[0038] The temperature monitoring module in this embodiment includes multiple flexible temperature sensors disposed inside the wearable hat-style support structure for real-time acquisition of scalp temperature and comparison with a preset temperature threshold; the temperature monitoring module acquires temperature data at a frequency of once every 1-3 seconds.

[0039] In this embodiment, the temperature monitoring module can collect scalp temperature data every 2 seconds.

[0040] In this embodiment, the control module is integrated into the top or side area of ​​the wearable cap-style support structure and includes at least one of a touch interaction module or a wireless communication module for human-computer interaction setting of ultrasound treatment parameters; and the wireless communication module supports Bluetooth connection to interact with external terminal devices for treatment status display, parameter recording and remote control.

[0041] The power supply module in this embodiment supports wireless charging or Type-C interface charging; the power supply module has built-in overcharge protection, over-discharge protection, short circuit protection and temperature protection circuits; and depending on the ultrasonic working mode, the device's battery life can reach several hours to several days.

[0042] In this embodiment, a coupling layer is provided in the area where the flexible ultrasonic transducer array contacts the scalp; a flexible buffer structure (such as memory foam) is provided on the inner side of the wearable cap-like support structure to improve wearing comfort. In the area where the flexible ultrasonic transducer array contacts the scalp, an independent coupling layer (such as hydrogel) is further provided, and the thickness of the coupling layer (such as hydrogel) is maintained at 0.8-1.0 mm to ensure stable acoustic coupling between the ultrasonic transducer unit and the scalp.

[0043] In this embodiment, a total of 18 flexible ultrasonic transducers are arranged in a 6×3 matrix. Each transducer has a circular structure with a diameter of 10 mm and a thickness of 1.2 mm. The center-to-center distance between adjacent transducers is 18 mm. The acoustic radiation area of ​​a single transducer is approximately 0.785 cm². 2 The total effective ultrasonic radiation area formed by the 18 transducers is approximately 14.1 cm². 2 .

[0044] To maximize the range of ultrasound coverage in the head region, the transducers are evenly distributed in an array, with the outermost edge forming a coverage area of ​​approximately 100 mm × 46 mm, corresponding to a total coverage area of ​​approximately 46 cm². 2 The overall coverage area includes the gap area between the transducers. In actual operation, due to the diffusion of the ultrasonic beam and the superposition of the sound fields of adjacent transducers, the gap area can also receive ultrasonic energy coverage, thus forming a continuous head treatment area.

[0045] The control module in this embodiment is further configured as follows: When the temperature fed back by the temperature monitoring module reaches the first temperature threshold, the ultrasonic output power is automatically reduced by the first power reduction ratio. When the temperature reaches a second temperature threshold that is higher than the first temperature threshold, the output power is automatically reduced by a second power reduction ratio, wherein the second power reduction ratio is greater than the first power reduction ratio. When the temperature reaches a third temperature threshold that is higher than the second temperature threshold, the ultrasonic output should be stopped immediately. Wherein, the first temperature threshold, the second temperature threshold, the third temperature threshold, the first power reduction ratio, and the second power reduction ratio are all preset values; Furthermore, after automatically reducing or stopping the output, treatment will automatically resume when the temperature recovers to below the first temperature threshold.

[0046] In the device provided in this embodiment, the first temperature threshold T1, the second temperature threshold T2, the third temperature threshold T3, and the first power reduction ratio R1 and the second power reduction ratio R2 are all preset values, which can be selected according to the actual treatment scenario and user tolerance. T1, T2, and T3 should satisfy T1 < T2 < T3, and R1 < R2 to avoid control logic conflicts.

[0047] As a preferred embodiment, the value range of T1 is 36°C ≤ T1 < 39°C, the value range of T2 is 39°C ≤ T2 < 41°C, and the value range of T3 is 41°C ≤ T3 ≤ 43°C; the value range of R1 is 5% - 25%, and the value range of R2 is 40% - 60%.

[0048] Best embodiment: Set T1 to 38°C, T2 to 39°C, and T3 to 41°C; set R1 to 10% - 20%, and R2 to 50%. When the temperature reaches 38°C, the system automatically reduces the ultrasonic output power by 10% - 20%; when it reaches 39°C, the output power is automatically reduced by 50%; when it reaches 41°C, the ultrasonic output is immediately stopped. After the temperature returns to below 38°C, the system automatically resumes treatment.

[0049] Another feasible embodiment: Set T1 to 37°C, T2 to 40°C, and T3 to 42°C; set R1 to 15%, and R2 to 55%. When the temperature reaches 37°C, the ultrasonic output power is automatically reduced by 15%; when it reaches 40°C, the output power is automatically reduced by 55%; when it reaches 42°C, the ultrasonic output is immediately stopped. After the temperature returns to below 37°C, the system automatically resumes treatment.

[0050] The above thresholds and ratios all fall within the said ranges and satisfy the logical constraints of T1 < T2 < T3 and R1 < R2, without causing control conflicts. Those skilled in the art can reasonably select specific values within the said ranges according to actual needs (such as user skin sensitivity, environmental temperature, treatment intensity, etc.), as long as the thresholds increase and the power reduction ratios increase. The usage method of the cap - type ultrasonic treatment device based on the above - mentioned provided in this embodiment includes the following steps: Step 1, wear the wearable cap - type support structure on the user's head, and keep the flexible ultrasonic transducer array in stable contact with the scalp area through the adjustment and fixation structure; Step 2, set at least one ultrasonic treatment parameter through the control module and start the treatment program; Step 3, the distributed drive circuit drives the flexible ultrasonic transducer array to output ultrasonic energy to the head area according to the treatment program; Step 4: During the ultrasonic energy output process, the temperature monitoring module monitors the temperature of the scalp area in real time and feeds the temperature data back to the control module; Step 5: The control module compares the received temperature data with the preset temperature threshold and dynamically adjusts the output of the ultrasonic energy based on the comparison result.

[0051] In this embodiment, a preparation step is included before step 1: Clean the head treatment area and check the condition of the coupling layer at the bottom of the flexible ultrasound transducer array. If the surface of the coupling layer is dry, add medical ultrasound coupling agent. In step 1, the contact pressure between the wearable cap-style support structure and the scalp is controlled within a preset pressure range by adjusting and fixing the structure. The ultrasound treatment parameters set in step 2 include ultrasound frequency, output power, duty cycle, pulse repetition frequency, and treatment time. Among these, ultrasound frequency, output power, duty cycle, pulse repetition frequency, and single treatment time are all preset values.

[0052] In this embodiment, the amount of medical ultrasound coupling agent added in the preparation step is 0.5-1.0 ml; in step 1, the contact pressure between the wearable cap-type support structure and the scalp is controlled between 2-4 kPa; the ultrasound treatment parameters set in step 2 are as follows: ultrasound frequency 0.8-1 MHz, output power 0.5-1.2 W / cm², duty cycle 30%-50%, pulse repetition frequency 500 Hz-1 kHz, and single treatment time 15-30 minutes.

[0053] The power supply module in this embodiment can use a flexible thin-film lithium battery, supporting wireless charging or Type-C interface charging; it can also use button batteries, replaceable dry batteries, etc. The flexible ultrasonic transducer array can use piezoelectric ceramic units (such as PZT), piezoelectric composite material units, or piezoelectric single crystal units; the center-to-center distance between adjacent units can be 15-22 mm, and the size of a single unit can be 8-12 mm. The ultrasonic transducer unit can use piezoelectric ceramics to form the basic ultrasonic transmitting unit of the flexible ultrasonic transducer array. The distributed drive circuit is an ultrasonic drive circuit, which adopts a surround layout. Each transducer unit and the drive circuit are connected by flexible serpentine wires to improve overall flexibility; it is integrated around each transducer unit to provide independently controllable drive signals. The wearable cap-like support structure can use a flexible cap body made of elastic fabric, medical silicone, or flexible composite material; the control module is integrated into the top or side of the cap body, including at least one of touch buttons, a flexible display screen, LED indicators, and a wireless communication module (such as Bluetooth). The adjustment and fixing structure can use an elastic adjustment strap, a Velcro structure, an adjustable back fixing strap, or a snap-on adjustment strap. The coupling layer can be a hydrogel layer, a medical-grade silicone layer, or an ultrasonic coupling patch, with a thickness maintained between 0.8 and 1.0 mm. The temperature monitoring module can employ a flexible thermistor, a miniature thermocouple, or a flexible infrared sensor, with a sampling frequency of 1-3 seconds. In this embodiment, the sampling frequency can be dynamically adjusted according to the temperature rise rate; a maximum sampling frequency of 0.5 seconds can be supported.

[0054] Example 2

[0055] The cap-shaped ultrasound therapy device provided in this embodiment overcomes the shortcomings of existing head ultrasound therapy devices, such as large size, poor fit, uneven ultrasound effect, insufficient comfort during long-term wear, and difficulty in being used in home and mobile settings. This device uses a wearable cap-shaped ultrasound therapy module as its core, combined with an intelligent control module, a temperature monitoring module, and a flexible power supply module, to achieve stable, uniform, and safe ultrasound therapy in the head area. Figure 1 As shown, the hat body has an adjustable strap at the rear to accommodate different head circumferences; a touch interaction module is integrated on the side of the hat body, which is electrically connected to the internal control module; in addition, a USB-C charging port is also located on the side of the hat body, which is electrically connected to the power supply module. Adjusting the strap to fit the head circumference, setting parameters via the touch screen, and replenishing power via the charging port demonstrates a portable and wearable design. The device adopts a lightweight and flexible structural design, adaptable to different head shapes, and meets the daily wearing needs of various usage scenarios such as home, office, rest, and mobile travel.

[0056] The cap-shaped ultrasound therapy module comprises a flexible ultrasound transducer array, a distributed drive circuit, and a flexible, fitting structure. Multiple ultrasound transducer units are arranged in an array according to the physiological curves of the head, ensuring stable contact with the scalp and achieving large-area, uniform ultrasound action. The ultrasound output parameters are adjustable, allowing for adjustments to the ultrasound frequency, power, duty cycle, and pulse mode according to different treatment needs, improving treatment efficacy while ensuring safety. All modules are integrated collaboratively within the cap-shaped structure, further enhancing the device's portability and wearing comfort while maintaining stable ultrasound output.

[0057] The cap-shaped ultrasound therapy module provided in this embodiment is the core functional module for achieving ultrasound effects on the head area. It performs non-invasive physical intervention on head tissues through the mechanical effects, micro-vibration effects, and local tissue stimulation of ultrasound. This module can achieve uniform coverage of ultrasound energy in the head area and is suitable for long-term stable use in wearable scenarios without affecting the user's daily activities.

[0058] The flexible ultrasound transducer array provided in this embodiment uses a flexible ultrasound transducer array, which, compared to a traditional single ultrasound probe, can achieve synchronous ultrasound output in multiple regions, avoiding the problem of excessively strong or weak local ultrasound energy, thereby improving the uniformity and stability of ultrasound action in the head region. Each transducer works independently, and parameters can be adjusted according to the needs of different regions to achieve precise ultrasound treatment.

[0059] The flexible layer is made of polydimethylsiloxane (PDMS) or thermoplastic polyurethane (TPU), possessing excellent flexibility and biocompatibility. The ultrasonic array consists of multiple ultrasonic transducer units, which can be arranged in a matrix or ring to conform to the curvature of the head. The center-to-center spacing between units is 15-22 mm, and the size of a single transducer unit is 0.8-1.5 cm. The effective working area can be expanded according to the size of the wearable cap-like support structure. Each piezoelectric unit is independently encapsulated with a flexible encapsulation layer, and overall extensibility is achieved through a flexible serpentine conductor island bridge structure, thus adapting to different head shapes and maintaining a stable fit. Figure 3 As shown, Figure 3 This is a cross-sectional view of the layered structure of a cap-type ultrasound therapy device. From the outside in, the layers are: a protective fabric layer, a control circuit layer, a base layer, a flexible layer, and a distributed drive circuit (the diagram shows a schematic continuous layer; the actual layout is a distributed arrangement surrounding the ultrasound transducer unit; see [reference]). Figure 4 The structure comprises an ultrasonic transducer, a coupling layer (such as hydrogel), and a skin-contact surface, all tightly stacked. This structure combines rigid electronic components with flexible materials, ensuring both stable ultrasound transmission and comfortable wear while maintaining electrical safety. Furthermore, a coupling layer (such as hydrogel) or hydrogel layer is placed in the area where the transducer contacts the scalp to improve ultrasound transmission efficiency and enhance wearing comfort. A flexible cushioning structure is used on the inner side of the wearable cap-like support structure to reduce localized pressure caused by prolonged wear.

[0060] The distributed drive circuit provided in this embodiment adopts a surround layout, integrated around each ultrasonic transducer unit, providing an independent and controllable drive signal for each transducer unit. To clearly illustrate the overall stacking relationship of the device, Figure 3 The driving circuit is schematically shown as a continuous layered structure, but its actual discontinuous, ring-shaped distribution can be combined with... Figure 4 The distributed drive circuit is arranged around each ultrasound transducer unit, and the units are interconnected and connected to the control module via flexible serpentine wires. This surrounding layout shortens the signal transmission path, reduces loss and interference, enables independent driving of each transducer unit, ensures uniform ultrasound energy output over a large area of ​​the array, and improves treatment stability. The distributed drive circuit structure in this embodiment effectively shortens the signal transmission path, reduces energy loss, and improves ultrasound output stability.

[0061] The distributed drive circuitry enables precise adjustment of parameters such as ultrasound frequency, power, duty cycle, pulse repetition frequency, and duration to adapt to different treatment needs. Simultaneously, a low-power design reduces heat generation during operation, improving the stability of wearable use.

[0062] 2. Hat-shaped fitting structure module The cap-shaped fitting structure module serves as the wearable support structure for the entire device, ensuring stable fixation and flexible fit between the ultrasound therapy module and the head area. It is constructed from lightweight, flexible materials, balancing structural stability, breathability, and wearing comfort.

[0063] Core components: (1) Cap structure like Figure 2 As shown, the wearable hat-like support structure features ventilation holes or a mesh heat dissipation area on its surface, and is integrally molded with the internal wearable hat-like support structure. The rear adjustment strap is fixedly connected to the edge of the wearable hat-like support structure. This device is lightweight, flexible, and aesthetically pleasing for everyday wear. The breathable structure reduces stuffiness during prolonged wear, making the device suitable for various scenarios such as home, office, and travel, thus improving wearing comfort and user acceptance.

[0064] The wearable cap-style support structure is made of elastic fabric, medical-grade silicone, or flexible composite materials, and can adapt to different head circumferences and head curvatures. The wearable cap-style support structure has multiple ultrasonic transducer mounting areas inside, and provides space for flexible circuit wiring to ensure a compact overall structure.

[0065] The wearable hat-style support structure has ventilation holes or mesh heat dissipation areas on its surface to reduce stuffiness during long-term wear and improve daily use comfort.

[0066] (2) Adjusting the fixed structure The wearable hat-style support structure has an adjustable fixing structure at its edge. This structure can be an adjustable fixing strap or Velcro structure to achieve stable fixation for different user head shapes and prevent the device from shifting during walking, working, or resting.

[0067] II. Control Module Control Module: This module coordinates the operation of the entire cap-style ultrasound therapy device and includes parameter adjustment, status monitoring, and intelligent control functions. It can be integrated into the top or side of the wearable cap's support structure and operated via a touch-screen interface or wireless connection to a mobile terminal. Figure 5 As shown, the process begins with wearing the device, followed by parameter setting, treatment initiation, and ultrasound output. Simultaneously, a temperature monitoring module collects scalp temperature in real time and feeds it back to the control module. The control module compares the temperature with a preset threshold and dynamically adjusts the drive circuit output (reducing power or stopping the treatment). Finally, the treatment ends. This process demonstrates closed-loop automatic control logic, enabling real-time and safe adjustment of ultrasound output without manual intervention.

[0068] Users can adjust ultrasound treatment parameters, including ultrasound power, frequency, duty cycle, pulse mode, and treatment time, through the control module. Simultaneously, the module receives data from the temperature monitoring module in real time and compares it with preset temperature thresholds to achieve dynamic adjustment of the ultrasound output. The control module employs a low-power microcontroller and a wireless communication module, supporting Bluetooth or wireless terminal connections to display treatment status, record parameters, and remotely control the device, further enhancing its intelligence and ease of use. III. Auxiliary Function Modules 1. Temperature monitoring module The temperature monitoring module is used to monitor skin temperature changes in the ultrasound treatment area in real time to ensure safety during long-term use. This module uses a miniature thermistor or flexible temperature sensor, positioned inside the wearable cap-like support structure close to the scalp. Temperature data is transmitted to the control module in real time. When the monitored temperature exceeds a preset threshold (e.g., 36-39℃), the system automatically reduces the ultrasound output power or pauses operation to prevent local overheating that could cause skin discomfort or tissue damage. Treatment automatically resumes once the temperature returns to a safe range. Figure 6 As shown, the flexible temperature sensor collects scalp temperature and transmits it to the control module. The control module compares the data with three preset threshold levels (T1, T2, T3) and sends commands to the distributed drive circuit accordingly. The drive circuit then adjusts the ultrasonic power or stops output. The system automatically recovers after the temperature drops. This diagram illustrates the three-level protection mechanism: gradually reducing power until shutdown, effectively preventing localized overheating and ensuring safe long-term use.

[0069] 2. The power supply module serves as the main power supply unit. This power supply module includes a USB-C charging port (located on the side of the cap, see...). Figure 2 This module connects to an external power source to charge the built-in battery. It supports wireless charging or Type-C charging. The battery module is integrated into the wearable hat-style support structure, reducing overall weight while maintaining battery life. The power module also incorporates overcharge protection, over-discharge protection, short-circuit protection, and temperature protection circuits to enhance safety during long-term wear and daily use. Depending on the ultrasound operating mode, the device's battery life can range from several hours to several days.

[0070] Example 3

[0071] This embodiment combines the structural assembly and basic performance testing of the cap-type ultrasound therapy device, as detailed below: This embodiment provides a cap-type ultrasound therapy device including a wearable cap support structure, a flexible ultrasound transducer array, a control module, a temperature monitoring module, and a power supply module. The wearable cap support structure is made of medical-grade elastic fabric and polydimethylsiloxane (PDMS) composite material, with an overall thickness of 2-4 mm to accommodate different head circumferences. Inside the wearable cap support structure, 18 flexible ultrasound transducer units are arranged according to the curvature of the head, using a 6×3 matrix arrangement. Each transducer has a diameter of 1 cm, and the center-to-center distance between adjacent transducer units is 18 mm.

[0072] Each ultrasonic transducer unit is made of piezoelectric ceramic material, operates at a frequency of 1MHz, and has an output power range of 0.5-1.2 W / cm². Each unit is individually encapsulated using an ultra-thin PDMS encapsulation layer. A flexible hydrogel coupling layer is located at the bottom of each transducer. This coupling layer can be a pre-formed solid hydrogel layer, a coated medical ultrasound coupling agent layer, or a combination of both (e.g., a small amount of liquid coupling agent is coated onto the surface of the solid hydrogel layer to enhance adhesion). This enhances ultrasound transmission efficiency and wearing comfort.

[0073] The distributed drive circuitry adopts a surround layout, with each circuit positioned around the perimeter of each transducer and connected to the control module via flexible, serpentine wires. The control module, integrated into the top of the wearable cap-like support structure, utilizes a low-power microcontroller to adjust the ultrasound frequency, power, duty cycle, and treatment time. The power supply module has a capacity of 3000-4000 mAh and supports wireless charging.

[0074] During the experiment, the device was worn on the surface of a human head model, and its operation was monitored using an infrared thermal imager and an ultrasonic power tester. The results showed that the output of each transducer unit was stable, the ultrasonic coverage area was uniform, and after 60 minutes of continuous operation, the surface temperature of the wearable cap-like support structure remained below 38°C, with no localized overheating. Furthermore, the wearable cap-like support structure stably conformed to head models with different curvatures, and no significant slippage or detachment occurred during wear.

[0075] Experimental results show that the cap-type ultrasound therapy device of the present invention has good flexibility and fit, stable ultrasound output and wearing comfort, and can meet the needs of long-term wearable ultrasound therapy.

[0076] This embodiment provides a specific preparation process and usage method for a cap-type ultrasound therapy device, and further illustrates the invention through specific structural parameters and operating steps.

[0077] The method of using the cap-type ultrasound therapy device provided in this embodiment includes the following steps: First, a startup check is performed on the device to confirm that the flexible ultrasonic transducer array, drive circuit, temperature monitoring module, and power supply module are in normal working condition, and to ensure that the remaining power of the device is above 30%. In this embodiment, the power supply module has a capacity of 3000-4000 mAh, an operating voltage of 7.4 V, and a continuous battery life of 4-6 hours.

[0078] Next, the treatment area on the head is cleaned to remove oil, sweat, and impurities from the scalp to improve the efficiency of ultrasound energy transmission. For users with long hair, the hair strands can be parted appropriately to allow the ultrasound transducer unit to be closer to the scalp area. Then, the condition of the hydrogel coupling layer inside the wearable cap-like support structure is checked. If the surface of the pre-formed solid hydrogel coupling layer is dry, 0.5-1.0 ml of medical ultrasound coupling agent is added to improve acoustic coupling, maintaining the coupling layer thickness at 0.8-1.0 mm to ensure stable acoustic coupling between the ultrasound transducer unit and the scalp.

[0079] When wearing the device, place the cap-style ultrasound therapy device over the head from front to back. Adjust the tightness using the adjustable fixing structure on the back of the cap to fit a head circumference of 54-62cm. The contact pressure between the wearable cap-style support structure and the scalp is controlled between 2-4 kPa, ensuring a stable fit between the flexible ultrasound transducer array and the scalp while avoiding localized pressure discomfort. In this embodiment, the wearable cap-style support structure is hemispherical, with a top diameter of 18 cm, a height of 14 cm, and a total weight of 280-320 g.

[0080] The device contains 18 flexible ultrasonic transducer units arranged in a 6×3 matrix. Each transducer is circular, with a diameter of 10 mm and a thickness of 1.2 mm. The center-to-center spacing between adjacent transducers is 18 mm. The overall coverage area of ​​the flexible ultrasonic transducer array is approximately 46 cm². 2 After the equipment is started, it automatically detects the contact status of the transducers. When there are areas of poor contact, the system will automatically issue a prompt. The user can then adjust the position of the wearable cap-style support structure to ensure that all transducers are in normal contact.

[0081] After wearing the device, the user sets the ultrasound treatment parameters via the top LCD touchscreen, including ultrasound frequency, output power, duty cycle, pulse repetition frequency, and treatment time. In this embodiment, the recommended parameters are: ultrasound frequency 0.8-1MHz, output power 0.5-1.2 W / cm². 2 Duty cycle 30%-50%, pulse repetition frequency 500 Hz-1 kHz, single treatment time 15-30 min.

[0082] After setting the parameters, the treatment program is started. Eighteen flexible ultrasound transducers synchronously output ultrasound energy according to preset parameters, performing ultrasound therapy on the head area through mechanical vibration and micro-stimulation. During treatment, users can engage in light daily activities such as reading, working, or resting. The equipment operates at a noise level below 35 dB, not affecting normal communication or user experience.

[0083] During treatment, the temperature monitoring module collects scalp temperature data every 2 seconds and transmits it to the control module in real time. In this embodiment, four flexible thermistor sensors are installed inside the wearable cap-like support structure, with a detection accuracy of ±0.2℃. The system has a preset first-level warning temperature of 38℃ and a second-level control temperature of 39℃. When the local temperature reaches 38℃, the system automatically reduces the ultrasound output power by 10%-20%; when the temperature reaches 39℃, it automatically reduces the output power by 50%; when the temperature reaches 41℃, the system immediately stops all ultrasound output to prevent local overheating from causing skin discomfort or tissue damage.

[0084] Meanwhile, the system monitors the transducer's operating status, battery status, and equipment fit in real time. If equipment misalignment, abnormal flexible wiring, abnormal battery temperature, or remaining battery power below 5% is detected, the system automatically stops operating and issues a warning.

[0085] After the preset treatment time is reached, the system automatically stops ultrasound output and enters standby mode. After use, the user should remove the cap-shaped device and clean and disinfect the inside of the wearable cap-shaped support structure and the hydrogel contact area with 75% alcohol wipes. After air drying for 5-10 minutes, store it in a dry environment with a temperature of 10-30℃ and a relative humidity of less than 70% for later use.

[0086] The above-described embodiments are merely preferred embodiments provided to fully illustrate the present invention, and the scope of protection of the present invention is not limited thereto. Equivalent substitutions or modifications made by those skilled in the art based on the present invention are all within the scope of protection of the present invention. The scope of protection of the present invention is defined by the claims.

Claims

1. A cap-type ultrasound therapy device, characterized in that, include: A wearable hat-like support structure designed to achieve a stable and flexible fit to the user's head; A flexible ultrasonic transducer array is integrated inside the wearable cap-style support structure for outputting ultrasonic energy to the head region; A distributed driving circuit is electrically connected to the flexible ultrasonic transducer array and is used to independently drive each transducer unit in the flexible ultrasonic transducer array. A control module, connected to the distributed drive circuit, is used to set and adjust ultrasound treatment parameters; A temperature monitoring module, connected to the control module, is used to monitor the temperature of the scalp area in real time and feed the temperature data back to the control module; as well as A power supply module is electrically connected to the distributed drive circuit, control module and temperature monitoring module to provide electrical energy; The control module compares the temperature data fed back by the temperature monitoring module with at least one preset temperature threshold, and dynamically adjusts the output of the distributed drive circuit based on the comparison result.

2. The cap-type ultrasound therapy device as described in claim 1, characterized in that, The flexible ultrasonic transducer array includes multiple ultrasonic transducer units arranged in a matrix or ring, with a center-to-center distance of 15-22 mm between adjacent transducer units and a size of 8-12 mm for each transducer unit.

3. The cap-type ultrasound therapy device as described in claim 1, characterized in that, The distributed drive circuit adopts a surround layout and is integrated around each ultrasonic transducer unit to provide an independent and controllable drive signal for each transducer unit.

4. The cap-type ultrasound therapy device as described in claim 1, characterized in that, The wearable hat support structure includes a hat body and an adjustment and fixing structure; the wearable hat support structure is made of elastic fabric, medical silicone or flexible composite material; the adjustment and fixing structure is set at the edge of the hat body and includes an elastic adjustment band, a buckle or Velcro structure.

5. The cap-type ultrasound therapy device as described in claim 1, characterized in that, The control module is integrated into the top or side area of ​​the wearable cap-style support structure and includes at least one of a touch interaction module or a wireless communication module for human-computer interaction setting of ultrasound treatment parameters.

6. The cap-type ultrasound therapy device as described in claim 1, characterized in that, The flexible ultrasound transducer array has a coupling layer in the area where it contacts the scalp; the inner side of the wearable cap-style support structure has a flexible buffer structure.

7. The cap-type ultrasound therapy device as described in claim 2, characterized in that, The number of the multiple ultrasonic transducer units is 12-24, arranged in a matrix, and the overall coverage area of ​​the flexible ultrasonic transducer array is 30-50 square centimeters; and the flexible layer of the flexible ultrasonic transducer array is made of polydimethylsiloxane or thermoplastic polyurethane material.

8. The cap-type ultrasound therapy device as described in claim 1, characterized in that, The control module is also configured to: When the temperature fed back by the temperature monitoring module reaches the first temperature threshold, the ultrasonic output power is automatically reduced by the first power reduction ratio. When the temperature reaches a second temperature threshold that is higher than the first temperature threshold, the output power is automatically reduced by a second power reduction ratio, wherein the second power reduction ratio is greater than the first power reduction ratio. When the temperature reaches a third temperature threshold that is higher than the second temperature threshold, the ultrasonic output should be stopped immediately. Wherein, the first temperature threshold, the second temperature threshold, the third temperature threshold, the first power reduction ratio, and the second power reduction ratio are all preset values; Furthermore, after automatically reducing or stopping the output, treatment will automatically resume when the temperature recovers to below the first temperature threshold.

9. A method of using the cap-type ultrasound therapy device according to any one of claims 1 to 8, characterized in that, Includes the following steps: Step 1: Wear the wearable cap-style support structure on the user's head, and use the adjustment and fixing structure to keep the flexible ultrasonic transducer array stably attached to the scalp area. Step 2: Set at least one ultrasound treatment parameter through the control module and start the treatment program; Step 3: The distributed drive circuit drives the flexible ultrasound transducer array to output ultrasound energy to the head region according to the treatment program. Step 4: During the ultrasonic energy output process, the temperature monitoring module monitors the temperature of the scalp area in real time and feeds the temperature data back to the control module; Step 5: The control module compares the received temperature data with at least one preset temperature threshold, and dynamically adjusts the output of the ultrasonic energy according to the comparison result.

10. The method of use as described in claim 9, characterized in that, A preparation step precedes step 1: Clean the head treatment area and check the condition of the coupling layer at the bottom of the flexible ultrasound transducer array. If the surface of the coupling layer is dry, add medical ultrasound coupling agent. In step 1, the contact pressure between the wearable cap-style support structure and the scalp is controlled within a preset pressure range by adjusting and fixing the structure. The ultrasound treatment parameters set in step 2 include ultrasound frequency, output power, duty cycle, pulse repetition frequency, and treatment time. Among them, ultrasound frequency, output power, duty cycle, pulse repetition frequency, and single treatment time are all preset values.

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