Wearable conformal ultrasonic therapy system and use method

Abstract

The present invention provides a wearable conformal ultrasonic therapy system and a use method. The system comprises an acquisition module, a control module, and an ultrasonic therapy apparatus. The acquisition module is in communication connection with the control module and is used for monitoring physiological parameters of a human body in real time and sending the physiological parameters to the control module. The control module is in communication connection with the ultrasonic therapy apparatus and is used for determining a first therapeutic parameter based on the physiological parameters, adjusting a second therapeutic parameter according to the first therapeutic parameter to obtain a target therapeutic parameter, and sending a target parameter signal to the ultrasonic therapy apparatus, the second therapeutic parameter comprising a personalized therapeutic scheme of a therapeutic target area. The ultrasonic therapy apparatus is used for transmitting ultrasonic waves in response to the target parameter signal and carrying out ultrasonic therapy on the therapeutic target area. The system integrates the acquisition module, the control module, and the ultrasonic therapy apparatus, the whole system is wearable and conformal, ultrasonic closed-loop therapy is achieved, the accurate therapy of the therapeutic target area is achieved by adjusting therapeutic parameters, and the physiological parameters are controlled to be in a normal state.

Description

A wearable conformal ultrasound therapy system and use method Technical Field

[0001] The present invention relates to the technical field of ultrasound therapy, and in particular to a wearable conformal ultrasound therapy system and a method of use. Background Art

[0002] For the treatment of chronic metabolic diseases, such as diabetes and its complications, obesity, fatty liver, hepatitis, etc., the most widely used clinical method is combination therapy, which includes drug therapy for metabolic disorders. However, drug therapy is slow to take effect and has side effects such as hypoglycemia, weight gain, and gastrointestinal discomfort. In addition, it also includes organ transplantation, metabolic surgery, gene therapy, and exercise therapy, but there are problems such as donor shortage, high surgical costs, and easy recurrence. Today, with the continuous expansion of ultrasound technology in the medical field, ultrasound technology can not only be used to examine human organs and tissues, but also plays an increasingly important role in the treatment of chronic metabolic diseases.

[0003] In related technologies, ultrasound waves act on biological tissues to produce thermal, mechanical, and cavitation effects, which can stimulate organs such as the liver, fat, and pancreas, as well as visceral or peripheral nerves, thereby treating chronic metabolic diseases. However, existing wearable ultrasound therapy devices still have the following shortcomings: First, the transducers are mostly single-element transducers, which cannot conform to the anatomical morphology of the target organ; second, the transducer surface is rigid and cannot fully conform to the treatment area for treatment; third, physiological parameters cannot be dynamically monitored, making it impossible to determine the current treatment effect; and fourth, there is no system to record physiological and treatment parameters, making it impossible for patients to interact with the interface and obtain personalized treatment plans. Summary of the Invention

[0004] The present invention provides a wearable conformal ultrasound therapy system and a method of use to solve at least one of the above-mentioned technical problems.

[0005] In a first aspect, the present invention provides a wearable conformal ultrasound therapy system, comprising an acquisition module, a control module, and an ultrasound therapy device; the acquisition module is communicatively connected to the control module, and is used to monitor physiological parameters of a human body in real time and send the physiological parameters to the control module; the control module is communicatively connected to the ultrasound therapy device, and is used to determine a first therapy parameter based on the physiological parameter, and adjust a second therapy parameter according to the first therapy parameter to obtain a target therapy parameter, and send a target parameter signal to the ultrasound therapy device, wherein the second therapy parameter includes a personalized treatment plan corresponding to an ultrasound irradiated treatment target area, the personalized treatment plan includes a treatment cycle and single treatment parameters, and the single treatment parameters include ultrasound frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration, and a conformal area matching the shape of the lesion in the treatment target area; the ultrasound therapy device is used to emit ultrasound in response to the target parameter signal to perform ultrasound therapy on the treatment target area.

[0006] In one embodiment of the present invention, the control module includes a treatment plan customization unit, which includes: a determination subunit, used to determine the category of each of the physiological parameters, and determine the regional morphology of the treatment target area according to the category; a customization subunit, used to determine the first change trend of the corresponding historical physiological parameters and historical treatment parameters when the number of treatments reaches a preset first number threshold, and formulate the personalized treatment plan in combination with the first change trend and the regional morphology; an update subunit, used to determine the second change trend of the corresponding historical physiological parameters and historical treatment parameters after the number of treatments reaches the first number threshold and at each second number threshold, and update the personalized treatment plan in combination with the second change trend and the regional morphology.

[0007] In one embodiment of the present invention, the control module further includes a parameter determination unit and a parameter adjustment unit; the parameter determination unit is used to determine the first treatment parameter based on the physiological parameter and a preset physiological parameter-treatment parameter comparison table, and to determine the second treatment parameter corresponding to the treatment target area from the personalized treatment plan; the parameter adjustment unit is used to compare the first treatment parameter with the second treatment parameter, and adjust at least one of the frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration and conformal area of ​​the ultrasound according to the comparison result to obtain the target treatment parameter.

[0008] In one embodiment of the present invention, the control module also includes a data center and a user center; the data center is used to store user information, including physiological parameters and treatment parameters corresponding to each treatment under different treatment target areas of different users, and provide early warning services and feedback services for users, wherein the early warning service is to issue an early warning when the physiological parameters exceed the preset physiological parameter threshold, and the feedback service is to feedback the treatment effect based on the changing trend of the physiological parameters; the user center is used for user login, binding of treatment target areas and personalized treatment plans corresponding to the treatment target areas.

[0009] In one embodiment of the present invention, the ultrasonic treatment device includes a flexible control circuit, a multi-element flexible ultrasonic transducer and a wearable conformable substrate; the flexible control circuit is arranged on the inner side of the wearable conformable substrate for fixation, connected to the control module, and electrically connected to the multi-element flexible ultrasonic transducer, and is used to drive the multi-element flexible ultrasonic transducer to output the ultrasonic wave according to the target parameter signal; the multi-element flexible ultrasonic transducer is arranged on the inner side of the wearable conformable substrate for fixation, and is used to emit the ultrasonic wave to treat the treatment target area.

[0010] In one embodiment of the present invention, the flexible control circuit includes a data transmission circuit, an excitation circuit, a power supply and a switch; the power supply is used to power the ultrasonic treatment device; the switch is used to control the on and off of the flexible control circuit; the data transmission circuit is connected to the control module and is used to transmit the target parameter signal to the excitation circuit; the excitation circuit is electrically connected to the multi-element flexible ultrasonic transducer and is used to generate an excitation signal according to the target parameter signal and send it to the multi-element flexible ultrasonic transducer.

[0011] In one embodiment of the present invention, the multi-element flexible ultrasonic transducer includes multiple piezoelectric devices, serpentine interconnected electrodes, a flexible substrate and an ultrasonic coupling layer; the multiple piezoelectric devices form an array structure on the flexible substrate and are connected in parallel and / or in series through the serpentine interconnected electrodes to generate ultrasonic waves in response to the excitation signal; the ultrasonic coupling layer is in contact with one side of the flexible substrate and the other side is in contact with the surface of the treatment target area to transmit the ultrasonic waves to the treatment target area.

[0012] In one embodiment of the present invention, the flexible control circuit includes multiple array element control circuits, the multi-element flexible ultrasonic transducer is a multi-element planar transducer, and the multiple array element control circuits are respectively electrically connected to each array element in the multi-element planar transducer so that each array element can be individually addressed, and the emission range of the multi-element planar transducer is conformally controlled according to the shape of the lesion in the treatment target area, and the phased focusing of the multi-element planar transducer is controlled, wherein the phased focusing includes dual-frequency focusing, and the frequency difference is adjustable.

[0013] In one embodiment of the present invention, the acquisition module and the control module are integrated into the ultrasonic treatment device, or the acquisition module is a physiological parameter monitor, the control module is an intelligent terminal, and the physiological parameter monitor and the intelligent terminal are external to the ultrasonic treatment device.

[0014] In a second aspect, the present invention further provides a method for using a wearable conformal ultrasound therapy system, using the wearable conformal ultrasound therapy system as described in the first aspect, the method comprising: wearing an ultrasound therapy device so that the ultrasound therapy device covers the surface of a treatment target area irradiated by ultrasound, and placing an acquisition module at a physiological parameter monitoring position corresponding to the human body; turning on the wearable ultrasound therapy system, monitoring the physiological parameters of the human body through the acquisition module, and sending the data to a control module; the control module determining a first treatment parameter based on the physiological parameter, adjusting a second treatment parameter according to the first treatment parameter to obtain a target treatment parameter, and sending a target parameter signal to the ultrasound therapy device, wherein the second treatment parameter includes a personalized treatment plan corresponding to the treatment target area, the personalized treatment plan including a treatment cycle and single treatment parameters, the single treatment parameters including ultrasound frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration, and a conformal area matching the shape of the lesion in the treatment target area; the ultrasound therapy device emitting ultrasound in response to the target parameter signal to perform ultrasound treatment on the treatment target area.

[0015] Beneficial effects of the present invention:

[0016] (1) In this system, the acquisition module is connected to the control module in communication, and the control module is connected to the ultrasonic treatment device in communication. The acquisition module monitors the physiological parameters of the human body in real time, the control module determines the target treatment parameters based on the current physiological parameters, and the ultrasonic treatment device performs ultrasonic treatment on the treatment target area based on the target treatment parameters. The acquisition module, the control module, and the ultrasonic treatment device are integrated into one, forming a portable wearable device with simple and convenient operation, and realizing ultrasonic closed-loop treatment;

[0017] (2) The acquisition module dynamically monitors human physiological parameters and can track the patient's treatment status over a long period of time and provide feedback, so that the control terminal can customize personalized treatment plans for the treatment target area, achieving long-term physiological parameter monitoring and ultrasound closed-loop treatment, and solving problems such as drug side effects and lack of transplant donors that may occur in traditional treatments for chronic metabolic diseases;

[0018] (3) The first treatment parameter corresponding to the real-time physiological parameter is used to adjust the single treatment parameter in the personalized treatment plan, that is, the second treatment parameter, wherein the single treatment parameter includes the frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration of the ultrasound and a conformal area that matches the shape of the lesion in the treatment target area, thereby achieving conformal treatment of the treatment target area, and obtaining accurate target treatment parameters by adjusting the treatment parameters, thereby achieving accurate and efficient treatment of the treatment target area and controlling the physiological parameters to a normal state. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG1 is a schematic structural diagram of a wearable conformal ultrasound therapy system according to an exemplary embodiment of the present invention;

[0020] FIG2 is a schematic diagram of an ultrasonic conformal region according to an exemplary embodiment of the present invention;

[0021] FIG3 is a schematic diagram of another ultrasonic conformal region according to an exemplary embodiment of the present invention;

[0022] FIG4 is a schematic structural diagram of a control module according to an exemplary embodiment of the present invention;

[0023] FIG5 is a schematic structural diagram of an ultrasonic treatment device according to an exemplary embodiment of the present invention;

[0024] FIG6 is a schematic structural diagram of a flexible control circuit according to an exemplary embodiment of the present invention;

[0025] FIG7 is a schematic structural diagram of a multi-element flexible ultrasonic transducer according to an exemplary embodiment of the present invention;

[0026] FIG8 is a schematic diagram of internal interactions of a wearable conformal ultrasound therapy system according to an exemplary embodiment of the present invention;

[0027] FIG9 is a flow chart of a method for using a wearable conformal ultrasound therapy system according to an exemplary embodiment of the present invention;

[0028] FIG10 is a flowchart of a method for using a specific wearable conformal ultrasound therapy system according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION

[0029] The following describes the embodiments of the present invention through specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following examples and the features in the examples can be combined with each other unless they conflict. It should also be understood that the terms used in the examples of the present invention are for the purpose of describing specific embodiments, not for the purpose of limiting the scope of protection of the present invention. The test methods for which specific conditions are not specified in the following examples are generally carried out under conventional conditions or under the conditions recommended by the manufacturers.

[0030] Please refer to Figure 1. It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read. They are not used to limit the conditions for the implementation of the present invention, so they have no technical significance. Any modification of the structure, change in the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the efficacy and purpose of the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0031] When numerical ranges are given in the examples, it should be understood that unless otherwise specified herein, both endpoints of each numerical range and any value between the two endpoints may be used. Unless otherwise defined, all technical and scientific terms used herein are consistent with the prior art as understood by those skilled in the art and the description of the present invention. Any prior art methods, devices, and materials similar or equivalent to those in the examples of the present invention may also be used to implement the present invention.

[0032] For the treatment of chronic metabolic diseases, such as diabetes and its complications, obesity, fatty liver, and hepatitis, medication, organ transplantation, metabolic surgery, gene therapy, and exercise therapy can be used. However, medication is slow to take effect and has side effects. Other methods also have problems such as donor shortages, high surgical costs, and recurrence. In the prior art, ultrasound waves act on biological tissues to produce thermal, mechanical, and cavitation effects, which can stimulate organs such as the liver, fat, and pancreas, visceral nerves, or peripheral nerves, thereby treating chronic metabolic diseases. However, the inventors of this application have found that existing wearable ultrasound treatment devices still have the following shortcomings: First, the transducers are mostly single-element transducers, which cannot conform to the anatomical morphology of the target organ; second, the transducer surface is rigid and cannot fully conform to the treatment site for treatment; third, physiological parameters cannot be dynamically monitored, and the current treatment effect cannot be determined; fourth, there is no system to record physiological parameters and treatment parameters accordingly, so patients cannot interact with the interface and obtain personalized treatment plans.

[0033] Therefore, the present invention provides a wearable conformal ultrasound therapy system and a method of use. Please refer to Figure 1, which is a structural diagram of a wearable conformal ultrasound therapy system shown in an exemplary embodiment of the present invention. The system includes at least an acquisition module 1, a control module 2, and an ultrasound therapy device 3, which are described in detail as follows:

[0034] The acquisition module 1 is connected to the control module 2 for real-time monitoring of physiological parameters of the human body and sending the physiological parameters to the control module 2;

[0035] a control module 2, communicatively connected to the ultrasound treatment device 3, configured to determine a first treatment parameter based on the physiological parameter, adjust a second treatment parameter according to the first treatment parameter, obtain a target treatment parameter, and send a target parameter signal to the ultrasound treatment device 3, wherein the second treatment parameter includes a personalized treatment plan corresponding to the ultrasound irradiated treatment target area, the personalized treatment plan including a treatment cycle and single treatment parameters, the single treatment parameters including the ultrasound frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration, and a conformal area matching the shape of the lesion in the treatment target area;

[0036] The ultrasonic treatment device 3 is used to transmit ultrasonic waves in response to the target parameter signal to perform ultrasonic treatment on the treatment target area.

[0037] It should be noted that the system can be used to treat patients with chronic metabolic diseases, such as diabetes and its complications, obesity, fatty liver, hepatitis, etc., or other diseases that require long-term physical therapy, such as promoting chronic wound healing.

[0038] Among them, the treatment cycle in the personalized treatment plan refers to the number of treatments corresponding to the treatment target area within a period of time, for example, the treatment cycle is 15 treatments in 1 month, wherein whether the single treatment parameters are the same each time, whether they show a trend change, etc. are determined by the treatment effect of the treatment target area. In addition, the frequency of the ultrasound in the single treatment parameters refers to the number of times the ultrasound vibrates per second, the sound intensity refers to the sound energy flux passing through the unit area of ​​the treatment target area, the duty cycle refers to the ratio of the time of ultrasound emission to the treatment duration, the pulse repetition frequency refers to the number of ultrasound pulses emitted per second, the treatment duration refers to the specific duration of each ultrasound treatment operation, and the conformal area that matches the shape of the lesion in the treatment target area refers to the regional range of the ultrasound wave that is conformally emitted based on the area of ​​the lesion shape in the treatment target area. It should be understood that the single treatment parameters include but are not limited to the parameters listed above.

[0039] Please refer to Figures 2 and 3. Figure 2 is a schematic diagram of one ultrasound conformal region according to an exemplary embodiment of the present invention, and Figure 3 is a schematic diagram of another ultrasound conformal region according to an exemplary embodiment of the present invention. As shown in Figure 2, for example, if the treatment target is the liver, the region where the ultrasound conforms to the shape of the lesion in the liver is the shaded portion in Figure 2. Similarly, the shaded portion in Figure 3 is the conformal region where the ultrasound conforms to the shape of the lesion in the treatment target. In this way, different conformal ultrasound emissions are achieved for organs of different morphologies (treatment targets), enabling conformal treatment of different treatment targets.

[0040] In an embodiment of the present application, the acquisition module 1 monitors the physiological parameters of the human body in real time, the control module 2 determines the target treatment parameters based on the current physiological parameters, and the ultrasonic treatment device 3 performs ultrasonic treatment on the treatment target area according to the target treatment parameters. The acquisition module 1, the control module 2 and the ultrasonic treatment device 3 are integrated into a portable wearable device, which is simple and convenient to operate and realizes ultrasonic closed-loop treatment; the acquisition module 1 dynamically monitors the physiological parameters of the human body and can track the patient's treatment status and provide feedback over a long period of time, so that the control terminal 2 can customize a personalized treatment plan for the treatment target area, realize long-term physiological parameter monitoring and ultrasonic closed-loop treatment, and solve the problems of drug side effects and lack of transplant donors that may occur in traditional treatment methods for chronic metabolic diseases; the first treatment parameter corresponding to the real-time physiological parameter is used to adjust the single treatment parameter, i.e., the second treatment parameter, in the personalized treatment plan, wherein the single treatment parameter includes the frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration of the ultrasound wave and a conformal area that matches the shape of the lesion in the treatment target area, thereby realizing conformal treatment of the treatment target area, and obtaining accurate target treatment parameters by adjusting the treatment parameters, thereby realizing accurate and efficient treatment of the treatment target area.

[0041] In one embodiment, the acquisition module 1 and the control module 2 are integrated into the ultrasonic treatment device 3, or the acquisition module 1 is a physiological parameter monitor, the control module 2 is a smart terminal (or smart APP), and the physiological parameter monitor and the smart terminal are external to the ultrasonic treatment device 3.

[0042] In this embodiment, the acquisition module 1 and the control module 2 can be integrated into the ultrasonic treatment device 3 or can be independent of the ultrasonic treatment device 3. When the acquisition module 1 and the control module 2 are independent of the ultrasonic treatment device 3, it does not affect the wearable and portable nature of the entire ultrasonic treatment system.

[0043] Exemplarily, a physiological parameter monitor, such as a blood glucose monitor, has a sensor with a height of 5 mm, a diameter of 35 mm, and an implantation depth of 5 mm, and a blood glucose concentration measurement range of 2.2-27.8 mmol / L.

[0044] In one embodiment, please refer to Figure 4, which is a structural diagram of a control module shown in an exemplary embodiment of the present invention. As shown in Figure 4, the control module 2 includes a data center 21 and a user center 22. The data center 21 is used to store user information, and the user information includes physiological parameters and treatment parameters corresponding to each treatment under different treatment target areas of different users, as well as early warning services and feedback services. Among them, the early warning service is to issue an early warning when the physiological parameters exceed the preset physiological parameter threshold, and the feedback service is to feedback the treatment effect based on the changing trend of the physiological parameters; the user center 22 is used for user login, binding of treatment target areas and personalized treatment plans corresponding to the treatment target areas.

[0045] In this embodiment, the physiological parameter threshold refers to the warning threshold of the physiological parameter. For example, a blood glucose concentration exceeding 13.9 mmol / L is likely to lead to diabetic ketoacidosis. Therefore, when the user's blood glucose concentration is higher than 13.9 mmol / L, it is necessary to pay attention and trigger the warning service. As for the treatment effect of the treatment target area, the data center 21 can provide feedback to the user based on the stored trend of changes in each physiological parameter, realizing the integration of treatment and feedback. In addition, different users can log in to the user center 22 by using an account and bind at least one treatment target area. Each treatment target area can be bound to a customized corresponding personalized treatment plan. In this way, personalized treatment is achieved between different treatment target areas of different users, which not only ensures the precise treatment of the treatment target area but also enhances the treatment effect.

[0046] Please continue to refer to Figure 4. In one embodiment, the control module 2 includes a treatment plan customization unit 23, and the treatment plan customization unit 23 includes: a determination subunit 231, which is used to determine the category of each physiological parameter and determine the regional morphology of the treatment target area according to the category; a customization subunit 232, which is used to determine the first change trend of the corresponding historical physiological parameters and historical treatment parameters when the number of treatments reaches a preset first number threshold, and formulate a personalized treatment plan in combination with the first change trend and regional morphology; an update subunit 233, which is used to determine the second change trend of the corresponding historical physiological parameters and historical treatment parameters after the number of treatments reaches the first number threshold and at each interval of the second number threshold, and update the personalized treatment plan in combination with the second change trend and regional morphology.

[0047] In this embodiment, the categories of physiological parameters such as blood glucose concentration, blood pressure, pulse rate, respiratory rate, etc., the determination subunit 231 can determine its category based on the physiological parameters sent by the acquisition module 1, and then determine the regional morphology of the treatment target area according to the category. For example, if the physiological parameter is blood glucose concentration, the regional morphology of the treatment target area can be determined to be the morphology of the corresponding target organ.

[0048] In addition, the first threshold value corresponds to the number of treatments for the user's treatment target area reaching a preset first number, for example, 10 times, that is, the number of physiological parameters and treatment parameters of the user's treatment target area stored in the data center 21 reaches 10 data items. At this time, the treatment cycle, the frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration of the ultrasound waves for a single treatment, and the conformal area that matches the shape of the lesion in the treatment target area can be customized based on the change trends of the 10 historical physiological parameters and historical treatment parameters stored in the data center 21, as well as the regional morphology of the treatment target area. It should be understood that when the treatment status of the treatment target area is stable, the physiological parameters and treatment parameters have a changing trend, and the user's long-term treatment plan can be customized based on this changing trend.

[0049] The second threshold corresponds to the user's treatment of the target area increasing by a second number, for example, 5 times. This means that the physiological and treatment parameters of the target area stored in data center 21 for the user have increased by 5 data items. At this point, the previously personalized treatment plan can be updated based on the changing trends of the 5 additional data items and the regional morphology of the target area. Specifically, the personalized treatment plan can be updated to modify at least one of the treatment cycle, the frequency, intensity, duty cycle, pulse repetition frequency, treatment duration, and the conformal area matching the lesion shape in the target area. The treatment plan is updated dynamically and periodically, i.e., when the number of treatments reaches the first threshold and every time the second threshold is reached, the personalized plan is updated.

[0050] It should also be noted that as the number of treatments in the target area increases and the lesions are alleviated, in addition to fine-tuning the treatment cycle, ultrasound frequency, sound intensity, duty cycle, pulse repetition frequency, and treatment duration, the ultrasound conformal area can also be fine-tuned. For example, please continue to refer to Figure 2. When the blood glucose concentration shows a downward trend, the shaded part can be adapted to shrink in order to shrink the conformal area. In this way, conformal adjustment of the ultrasound emission area based on the treatment effect is achieved.

[0051] Please continue to refer to Figure 4. In one embodiment, the control module 2 includes a parameter determination unit 24 and a parameter adjustment unit 25; the parameter determination unit 24 is used to determine the first treatment parameter based on the physiological parameter and the preset physiological parameter-treatment parameter comparison table, and to determine the second treatment parameter corresponding to the treatment target area from the personalized treatment plan; the parameter adjustment unit 25 is used to compare the first treatment parameter with the second treatment parameter, and adjust at least one of the frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration and conformal area of ​​the ultrasound according to the comparison result to obtain the target treatment parameter.

[0052] In this embodiment, a second treatment parameter corresponding to the first treatment parameter of the treatment target area can be determined from the personalized treatment plan based on factors such as the date and number of current treatments. A personalized treatment plan is a long-term treatment plan for a patient, based on historical treatment data. The first treatment parameter represents the parameters of the current single treatment. Using real-time treatment parameters to adjust the treatment parameters in the personalized treatment plan allows for accurate target treatment parameters, achieving precise and efficient treatment of the treatment target area and controlling physiological parameters to normal levels.

[0053] It should also be noted that the data center 21, personal center 22, treatment plan customization unit 23, parameter determination unit 24 and parameter adjustment unit 25 in the control module 2 can communicate with each other, and the control module 2 includes but is not limited to the data center 21, personal center 22, treatment plan customization unit 23, parameter determination unit 24 and parameter adjustment unit 25.

[0054] In one embodiment, please refer to FIG5 , which is a schematic diagram of the structure of an ultrasonic treatment device according to an exemplary embodiment of the present invention. As shown in FIG5 , the ultrasonic treatment device 3 includes a flexible control circuit 31, a multi-element flexible ultrasonic transducer 32, and a wearable conformable substrate 33. The flexible control circuit 32 is fixed inside the wearable conformable substrate 31, connected to the control module 2, and electrically connected to the multi-element flexible ultrasonic transducer 32, and is used to drive the multi-element flexible ultrasonic transducer 32 to output ultrasonic waves based on target parameter signals. The multi-element flexible ultrasonic transducer 32 is fixed inside the wearable conformable substrate 33 and is used to transmit ultrasonic waves to treat the target area.

[0055] In this embodiment, the ultrasonic therapeutic device 3 integrates a flexible control circuit 31, a multi-element flexible ultrasonic transducer 32, and a wearable conformable substrate 33. The wearable conformable substrate 33 can be used for different treatment areas. For example, as shown in FIG5 , the wearable conformable substrate 33 can be a wearable vest. The multi-element flexible ultrasonic transducers 32 are evenly distributed on the front inner side of the vest, where the surface can contact the patient's skin. The flexible control circuit 31 is embedded in the back of the vest. The wearable conformable substrate 33 secures and protects the flexible control circuit 31 and the multi-element flexible ultrasonic transducer 32. Furthermore, both the flexible control circuit 31 and the multi-element flexible ultrasonic transducer 32 are flexible and can be connected via a flexible ACF (Anisotropic Conductive Film). This makes the ultrasonic therapeutic device 3 flexible, allowing it to fully conform to and conform to the treatment area, enhancing the therapeutic effect.

[0056] In addition, in addition to the vest style shown in Figure 5, the wearable conformable base 33 can also be other types, such as a waist protector worn on the abdomen, a neck brace worn on the neck, arm, etc., to be applied to different treatment areas.

[0057] In one embodiment, please refer to Figure 6, which is a structural diagram of a flexible control circuit shown in an exemplary embodiment of the present invention. As shown in Figure 6, the flexible control circuit 31 includes a data transmission circuit 311, an excitation circuit 312, a power supply 313 and a switch 314; wherein the power supply 313 is used to power the ultrasonic treatment device 3; the switch 314 is used to control the on and off of the flexible control circuit 31; the data transmission circuit 311 is connected to the control module 2, and is used to transmit the target parameter signal to the excitation circuit 312; the excitation circuit 312 is electrically connected to the multi-element flexible ultrasonic transducer 32, and is used to generate an excitation signal according to the target parameter signal and send it to the multi-element flexible ultrasonic transducer 32.

[0058] In this embodiment, the flexible control circuit 31 is integrated using a flexible PCB (circuit board), and the data transmission circuit 311 uses a Bluetooth or Wi-Fi module to achieve data transmission, which is convenient and fast and is less affected by the environment.

[0059] In one embodiment, please refer to Figure 7, which is a schematic diagram of the structure of a multi-element flexible ultrasonic transducer according to an exemplary embodiment of the present invention. As shown in Figure 7, the multi-element flexible ultrasonic transducer 32 includes multiple piezoelectric devices 321, serpentine interconnected electrodes 322, a flexible substrate 323, and an ultrasonic coupling layer 324. The multiple piezoelectric devices 321 form an array structure on the flexible substrate 323 and are connected in parallel and / or in series via the serpentine interconnected electrodes 322 to generate ultrasonic waves in response to an excitation signal. The ultrasonic coupling layer 324 is bonded to one side of the flexible substrate 323 and contacts the surface of the treatment target area on the other side, transmitting the ultrasonic waves to the treatment target area.

[0060] In this embodiment, a multi-element flexible ultrasonic transducer is used to transmit ultrasonic waves to irradiate target areas including but not limited to the liver, pancreas, fat, etc., to promote insulin release and activate the anti-inflammatory factor regulatory pathway in the body, thereby achieving the purpose of lowering blood sugar, losing weight, and alleviating fatty liver and hepatitis symptoms.

[0061] Exemplarily, the piezoelectric material of the piezoelectric device 321 can be selected from piezoelectric single crystal, piezoelectric ceramic, piezoelectric composite material or at least one of them. The diameter of a single piezoelectric device is 10-30 mm, the frequency is in the range of 0.1 MHz-2 MHz, and it is distributed in a two-dimensional array. In actual operation, the size of the specific area can be determined according to the actual body shape of the patient, and the number of arrays can be increased; the material of the flexible substrate 323 can be selected from polydimethylsiloxane, polyurethane, polyimide or at least one of them; the ultrasonic coupling layer 324 can use hydrogel, silicone or at least one of them; the material of the serpentine interconnect electrode 322 can use gold, silver, copper, nickel or at least one of them.

[0062] Please refer to Figure 8, which is a schematic diagram illustrating the internal interactions of a wearable conformal ultrasound therapy system according to an exemplary embodiment of the present invention. As shown in Figure 8, wireless transmission can be used between the physiological parameter monitor and the smart app, so that the physiological parameters collected by the physiological parameter monitor are sent to the smart app. Wireless transmission can also be used between the smart app and the data transmission circuit in the flexible control circuit of the ultrasound therapy device, so that the smart app generates a target parameter signal based on the target treatment parameter and sends it to the data transmission circuit. The data transmission circuit then sends the target parameter signal to the excitation circuit, which generates an excitation signal based on the target parameter signal and sends it to the multi-element flexible ultrasound transducer (i.e., the transducer in the figure), causing the transducer to emit ultrasound waves.

[0063] In one embodiment, the flexible control circuit 31 may include multiple array element control circuits, the multi-element flexible ultrasonic transducer 32 is a multi-element planar transducer, and the multiple array element control circuits are respectively electrically connected to each array element in the multi-element planar transducer so that each array element can be addressed individually, and the emission range of the multi-element planar transducer can be conformally controlled according to the shape of the lesion in the treatment target area, and the phased focusing of the multi-element planar transducer can be controlled, wherein the phased focusing includes dual-frequency focusing, and the frequency difference is adjustable.

[0064] In this embodiment, ultrasound waves can include plane waves, single-frequency focusing, and dual-frequency focusing. It should be noted that the multi-element flexible ultrasonic transducer is a multi-element planar transducer, and each element can be addressed individually, that is, each element can be controlled individually. When excited, there is a delay in the excitation signal between the elements, generating the expected focused beam, which can achieve phased focusing of the device. When the element is in focusing mode, it can emit dual-frequency ultrasound with an adjustable frequency difference. The phased focusing function can be achieved when a focused sound field is required (such as small-scale stimulation), and the area of ​​the emitting element can be conformally adjusted according to the lesion morphology of the treatment target area. As shown in the shaded area of ​​Figure 2, conformal area adjustment treatment is achieved through the design of multiple elements. In addition, when conforming to the adjustment, it corresponds to a plane wave.

[0065] In a possible embodiment, the ultrasonic treatment device may be provided with ultrasonic gear adjustment buttons, switches, etc., and the user can manually set the treatment gear and interrupt the treatment process through the switch. In addition, in the control module, the user can manually set the treatment parameters and at the same time, can also interrupt the treatment process through the control button.

[0066] In a possible embodiment, the ultrasonic treatment device 3 is provided with different gears, and between different gears, there is a difference in at least one of the ultrasonic frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration, and conformal area matching the shape of the lesion in the treatment target area. After obtaining the target treatment parameters, the target treatment gear can be determined based on the correspondence between the treatment parameters and the gears, and the ultrasonic treatment device 3 performs ultrasonic emission based on the received target gear signal.

[0067] Exemplarily, the parameter value ranges corresponding to the treatment gear can be: frequency f (0.02MHz-2MHz), sound intensity (0.01W / cm2-3W / cm2), duty cycle (0%-100%), pulse repetition frequency (10Hz-1MHz), dual-frequency difference Δf (10Hz-1MHz), treatment time (10min-30min), and conformal area matching the shape of the lesion in the treatment target area (0%-100%).

[0068] The present invention also provides a method for using a wearable conformal ultrasound therapeutic system. Referring to FIG. 9 , which is a flow chart illustrating a method for using a wearable conformal ultrasound therapeutic system according to an exemplary embodiment of the present invention, the method includes at least steps S910 to S940, which are described in detail as follows:

[0069] Step S910: Wear the ultrasound treatment device so that it covers the surface of the treatment target area irradiated by ultrasound, and place the acquisition module on the corresponding physiological parameter monitoring part of the human body;

[0070] Step S920, starting the wearable ultrasound therapy system, monitoring the physiological parameters of the human body through the acquisition module, and sending the data to the control module;

[0071] Step S930: The control module determines a first treatment parameter based on the physiological parameter, adjusts a second treatment parameter according to the first treatment parameter, obtains a target treatment parameter, and sends a target parameter signal to the ultrasound treatment device, wherein the second treatment parameter includes a personalized treatment plan corresponding to the treatment target area, the personalized treatment plan includes a treatment cycle and single treatment parameters, and the single treatment parameters include the frequency, intensity, duty cycle, pulse repetition frequency, treatment duration of the ultrasound wave, and a conformal area that matches the shape of the lesion in the treatment target area;

[0072] Step S940: The ultrasonic treatment device transmits ultrasonic waves in response to the target parameter signal to perform ultrasonic treatment on the treatment target area.

[0073] Please refer to FIG. 10 , which is a flowchart of a specific method for using a wearable conformal ultrasound therapy system according to an exemplary embodiment of the present invention. As shown in FIG. 10 , the method includes at least steps S1010 to S1060, which are described in detail as follows:

[0074] Step S1010: Put on the ultrasound treatment device, cover the surface of the ultrasound irradiated treatment target area with the multi-element flexible transducer, and place the physiological parameter monitor on the corresponding physiological parameter monitoring part of the human body;

[0075] Step S1020: The physiological parameter monitor monitors the first physiological parameter in real time and sends the result to the smart terminal;

[0076] Step S1030, determining whether the first physiological parameter exceeds a first threshold, wherein the first threshold is a warning threshold value of the physiological parameter; if so, proceeding to step S1041; if not, proceeding to step S1042;

[0077] Step S1041, interrupting treatment, issuing an early warning, and ending treatment;

[0078] Step S1042: starting a treatment gear according to the first physiological parameter and driving the multi-element flexible ultrasonic transducer;

[0079] Step S1050: The physiological parameter monitor monitors the second physiological parameter in real time and sends the result to the smart terminal;

[0080] Step S1060, determining whether the second physiological parameter is lower than a second threshold, wherein the second threshold is a normal value of the physiological parameter. If so, the treatment is terminated; if not, the next round of treatment is required.

[0081] It should be noted that the method of using the wearable conformal ultrasound therapy system provided in the above embodiment belongs to the same concept as the wearable conformal ultrasound therapy system provided in the above embodiment, and each step has been described in detail in the embodiment of the wearable conformal ultrasound therapy system and will not be repeated here.

[0082] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical principles disclosed herein are intended to be covered by the claims of the present invention.

Claims

1. A wearable conformal ultrasound therapy system, characterized in that: The system includes an acquisition module, a control module and an ultrasonic treatment device; The acquisition module is in communication with the control module and is used to monitor physiological parameters of the human body in real time and send the physiological parameters to the control module; The control module is communicatively connected to the ultrasonic treatment device, and is configured to determine a first treatment parameter based on the physiological parameter, and adjust a second treatment parameter according to the first treatment parameter to obtain a target treatment parameter, and send a target parameter signal to the ultrasonic treatment device, wherein the second treatment parameter includes a personalized treatment plan corresponding to a treatment target area irradiated by ultrasound, the personalized treatment plan including a treatment cycle and single treatment parameters, and the single treatment parameters including ultrasound frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration, and a conformal area matching the shape of a lesion in the treatment target area; The ultrasonic treatment device is used to transmit ultrasonic waves in response to the target parameter signal to perform ultrasonic treatment on the treatment target area.

2. The wearable conformal ultrasound therapy system according to claim 1, characterized in that The control module includes a treatment plan customization unit, and the treatment plan customization unit includes: a determination subunit, configured to determine a category of each of the physiological parameters, and determine a regional morphology of the treatment target area according to the category; a customization subunit, configured to determine a first change trend of corresponding historical physiological parameters and historical treatment parameters when the number of treatments reaches a preset first number threshold, and formulate the personalized treatment plan based on the first change trend and the regional morphology; An updating subunit is used to determine the second change trend of the corresponding historical physiological parameters and historical treatment parameters when the number of treatments reaches the first number threshold and every time the second number threshold is reached, and to update the personalized treatment plan in combination with the second change trend and the regional morphology.

3. The wearable conformal ultrasound therapy system according to claim 2, characterized in that: The control module also includes a parameter determination unit and a parameter adjustment unit; The parameter determination unit is configured to determine the first treatment parameter based on the physiological parameter and a preset physiological parameter-treatment parameter comparison table, and to determine the second treatment parameter corresponding to the treatment target area from the personalized treatment plan; The parameter adjustment unit is used to compare the first treatment parameter with the second treatment parameter, and adjust at least one of the frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration and conformal area of the ultrasound according to the comparison result to obtain the target treatment parameter.

4. The wearable conformal ultrasound therapy system according to claim 1, wherein: The control module also includes a data center and a user center; The data center is configured to store user information, including physiological parameters and treatment parameters corresponding to each treatment for different users and different treatment target areas, and provide users with early warning services and feedback services, wherein the early warning service is to issue an early warning when the physiological parameters exceed a preset physiological parameter threshold, and the feedback service is to provide feedback on the treatment effect based on the changing trend of the physiological parameters; The user center is used for user login, binding of treatment target areas and personalized treatment plans corresponding to the treatment target areas.

5. The wearable conformal ultrasound therapy system according to claim 1, wherein: The ultrasonic treatment device includes a flexible control circuit, a multi-element flexible ultrasonic transducer and a wearable conformable substrate; The flexible control circuit is arranged on the inner side of the wearable conformable base and fixed thereto, is connected to the control module, and is electrically connected to the multi-element flexible ultrasonic transducer, and is used to drive the multi-element flexible ultrasonic transducer to output the ultrasonic wave according to the target parameter signal; The multi-element flexible ultrasonic transducer is arranged on the inner side of the wearable conformable base and fixed thereon, and is used to transmit the ultrasonic waves to treat the treatment target area.

6. The wearable conformal ultrasound therapy system according to claim 5, characterized in that: The flexible control circuit includes a data transmission circuit, an excitation circuit, a power supply and a switch; The power supply is used to supply power to the ultrasonic treatment device; The switch is used to control the on and off of the flexible control circuit; The data transmission circuit is connected to the control module and is used to transmit the target parameter signal to the excitation circuit; The excitation circuit is electrically connected to the multi-element flexible ultrasonic transducer, and is used to generate an excitation signal according to the target parameter signal and send the excitation signal to the multi-element flexible ultrasonic transducer.

7. The wearable conformal ultrasound therapy system according to claim 6, characterized in that: The multi-element flexible ultrasonic transducer includes multiple piezoelectric devices, serpentine interconnected electrodes, a flexible substrate and an ultrasonic coupling layer; A plurality of the piezoelectric devices form an array structure on the flexible substrate and are connected in parallel and / or in series via the serpentine interconnected electrodes, so as to generate ultrasonic waves in response to the excitation signal; the ultrasonic coupling layer is in contact with one side of the flexible substrate and the other side is in contact with the surface of the treatment target area, so as to transmit the ultrasonic waves to the treatment target area.

8. The wearable conformal ultrasound therapy system according to claim 5, characterized in that: The flexible control circuit includes multiple array element control circuits. The multi-element flexible ultrasonic transducer is a multi-element planar transducer, and the multiple array element control circuits are electrically connected to each array element in the multi-element planar transducer, so that each array element can be individually addressed, and the emission range of the multi-element planar transducer is conformally controlled according to the shape of the lesion in the treatment target area, and the phased focusing of the multi-element planar transducer is controlled, wherein the phased focusing includes dual-frequency focusing, and the frequency difference is adjustable.

9. The wearable conformal ultrasound therapy system according to any one of claims 1 to 8, characterized in that: The acquisition module and the control module are integrated into the ultrasonic treatment device, or the acquisition module is a physiological parameter monitor, the control module is an intelligent terminal, and the physiological parameter monitor and the intelligent terminal are external to the ultrasonic treatment device.

10. A method for using a wearable conformal ultrasound therapy system, characterized in that: Using the wearable conformal ultrasound therapy system according to any one of claims 1 to 9, the method comprises: Wearing the ultrasound treatment device so that it covers the surface of the ultrasound irradiated treatment target area, and placing the acquisition module on the corresponding physiological parameter monitoring part of the human body; Turning on the wearable ultrasound therapy system, monitoring the physiological parameters of the human body through the acquisition module, and sending the data to the control module; determining, by the control module, a first treatment parameter based on the physiological parameter, and adjusting a second treatment parameter according to the first treatment parameter to obtain a target treatment parameter, and sending a target parameter signal to the ultrasound treatment device, wherein the second treatment parameter includes a personalized treatment plan corresponding to the treatment target area, the personalized treatment plan includes a treatment cycle and single treatment parameters, and the single treatment parameters include ultrasound frequency, sound intensity, duty cycle, pulse repetition frequency, treatment duration, and a conformal area that matches the shape of the lesion in the treatment target area; The ultrasonic treatment device transmits ultrasonic waves in response to the target parameter signal to perform ultrasonic treatment on the treatment target area.

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