Focused ultrasound acupoint health care device and method

Abstract

This invention relates to a focused ultrasound acupoint health care device, comprising an ultrasound output module, a control module, a power supply module, and a human-machine interface module. The device can precisely apply focused ultrasound waves to target acupoints, providing mechanical and thermal stimulation. It can automatically adjust the output power and duration of action based on the user's age, weight, height, and acupoint location. The device can be handheld or wearable and can be equipped with replaceable probes. In some embodiments, the device has a temperature monitoring function; output stops when the temperature of the contact area reaches a preset upper limit and resumes when it drops to a preset lower limit, thus reducing the risk of burns. This invention can be used for the health care, soothing, or promotion of bodily functions through acupoints.

Description

Technical Field

[0001] This invention relates to the fields of medical devices and traditional Chinese medicine external treatment technology, and in particular to a device that uses non-invasive focused ultrasound to stimulate acupoints of the human body to replace traditional Chinese medicine moxibustion, thereby providing health care, relief and assistance in improving bodily functions, as well as the application of the device. Prior Technology

[0002] Moxibustion is a traditional Chinese medicine external treatment method, typically using moxa wool as the main material. After being burned, it is placed on acupoints or affected areas to promote blood circulation and improve bodily functions through its heat stimulation and medicinal effects. This method has a long history and wide clinical application. However, in practice, due to the need for prolonged heating, there is often a risk of low-temperature burns, causing full-thickness skin damage. If not properly treated, this can also lead to infection. Furthermore, the effectiveness of moxibustion is greatly influenced by the practitioner's experience and skill; improper operation can also lead to unstable therapeutic effects.

[0003] Traditional ultrasound therapy is often used in the field of physical therapy, utilizing high-frequency sound waves to penetrate tissue and generate mechanical vibrations and thermal effects to promote local blood circulation and tissue repair. While it is non-invasive and controllable, its general applications are not specifically designed for traditional Chinese medicine acupoints, and it lacks the function of simultaneously providing mechanical and concentrated thermal stimulation. In addition, existing ultrasound devices mostly operate in single-point or single-mode configurations, making it impossible to optimize settings for different user needs, and they also lack protective mechanisms to prevent overheating or burns.

[0004] Therefore, existing technologies still have shortcomings in combining traditional Chinese medicine acupoint theory with modern non-invasive energy therapy. There is an urgent need for a device that can accurately act on acupoints, provide controllable mechanical and thermal stimulation, reduce the risk of burns, expand the scope of application, and make operation simpler and the effect more stable. Summary of the Invention

[0005] This invention provides a focused ultrasound acupoint health care device, comprising: an ultrasound output module 1 for generating and outputting focused ultrasound waves to a target acupoint to apply mechanical and thermal stimulation to the acupoint; a control module connected to the ultrasound output module 1 for setting, storing, and adjusting operating parameters, including at least one of ultrasound frequency, output intensity, pulse characteristics, duty cycle, and action time; a power supply module for providing the energy required for the device to operate; and a human-machine interface module for receiving user input and displaying the operating status.

[0006] In some embodiments, the ultrasonic output module 1 outputs a frequency range of 0.02 to 10 MHz.

[0007] In some embodiments, the device employs a handheld structure, a wearable structure, or a combination thereof.

[0008] In some embodiments, the ultrasonic output module 1 further includes a replaceable probe.

[0009] In some embodiments, the probe is flat or conical.

[0010] In some embodiments, the control module includes a pre-stored depth-power correspondence database, which stores target depth and corresponding power data for different genders, body types and acupoint locations, and allows users to manually select the appropriate combination.

[0011] In some preferred embodiments, the control module further calculates the personalized target depth and corresponding power based on a database, combined with the user's age, weight, height, and the location of the selected acupoints.

[0012] In some embodiments, the device further includes a temperature monitoring module for detecting the temperature of the area where the ultrasonic output module 1 contacts the user's skin, and automatically stopping the output when the temperature reaches a preset upper limit and resuming the output when the temperature drops to a preset lower limit, so as to prevent burns.

[0013] In some preferred embodiments, the preset upper limit is 45°C and the preset lower limit is 40°C.

[0014] In some embodiments, the device is suitable for stimulating acupoints on the human body for health maintenance, soothing, or promoting bodily functions. Simple Explanation of the Diagram

[0015] Figure 1 is a schematic diagram of the appearance of one embodiment of the handheld device of the present invention.

[0016] Figure 2 is a schematic diagram of the appearance of another embodiment of the handheld device of the present invention.

[0017] Figure 3 is a schematic diagram of the appearance of one embodiment of the wearable device of the present invention.

[0018] Figure 4 shows the relationship between the power of the ultrasound transducer and the treatment time. The curve shows the changing trend of the time required to achieve an equivalent therapeutic effect under different power conditions.

[0019] Figure 5 is a graphical display of the depth and corresponding power of some acupoints in men and women. Implementation

[0020] The focused ultrasound acupoint health care device of this invention utilizes the penetrability and energy concentration characteristics of focused ultrasound to direct sound wave energy to specific acupoints on the human body, thereby producing a dual stimulation effect of mechanical and thermal stimulation. During this process, in addition to the thermal effect inherent in general ultrasound, cavitation is induced in tissue fluid and blood vessels, which is one of the important technical mechanisms of this invention.

[0021] During the operation of the focused ultrasound acupoint health care device of the present invention, the ultrasound energy penetrates the skin and is transmitted to the blood vessels and tissue fluid around the target acupoint, which will generate cavitation due to the high-frequency alternating pressure field.

[0022] Cavitation phenomena can be divided into:

[0023] Stable cavitation: Existing gas nuclei or dissolved gases in a liquid expand under low pressure and contract under high pressure, forming periodically vibrating bubbles. The vibration of these bubbles generates microstreaming, exerting minute mechanical forces on the vascular endothelium and surrounding tissues.

[0024] Inertial cavitation: Under specific energy conditions, bubbles rapidly collapse at high pressure, releasing localized instantaneous high temperature and high pressure shock waves, further enhancing the tissue stimulation effect.

[0025] The aforementioned mechanical effects can temporarily increase the permeability of local blood vessels and cell membranes, promoting fluid exchange and circulation; at the same time, the local thermal effect generated by transient cavitation is superimposed on the overall warming effect of focused ultrasound, enhancing the stimulation effect of acupoints.

[0026] This invention utilizes adjustable ultrasonic frequency, duty cycle, and output power to control the degree of cavitation effect, ensuring that the desired health and functional stimulation is achieved within a comfortable and safe range.

[0027] Duty cycle refers to the proportion of time "ultrasonic emission" in one cycle, and is an important parameter for controlling the intensity of ultrasonic energy output.

[0028] Adjusting the duty cycle can control the intensity of heat and mechanical stimulation received by acupoints, adapt to the tolerance and health needs of different users, and reduce the risk of overheating or discomfort.

[0029] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, the scope of the present invention is not limited thereto.

[0030] Structural composition

[0031] The focused ultrasound acupoint health care device of the present invention is composed of multiple functional modules, including: (1) Ultrasonic output module 1: used to generate and output focused ultrasound to the target area to mechanically and thermally stimulate acupoints of the human body; the module may contain one or more focused ultrasound transducer elements and their supporting structures. (2) Control module: used to set, store and adjust the operating parameters of the device, including frequency, intensity, pulse characteristics and duration, etc.; the module can be connected to the ultrasonic output module 1 by a circuit or processor and control its operation. (3) Power supply module: used to provide the device with the required operating energy, which can be mains power, battery, rechargeable power supply or other energy supply forms. In some embodiments, the power supply module has an external power / data interface 5, which can be used for power and data transmission. (4) Human-machine interface module: used to receive user commands and display device status, including display screen 2 and control keys 3. It can be buttons, knobs, touch panels, display screens or any combination thereof.

[0032] Control module

[0033] The control module of this invention can be used to manage and execute the operating settings of the device. Its functions include: pre-storing multiple sets of operating parameter combinations and recording personalized settings for specific users, so as to facilitate quick retrieval and reuse later. The operating parameters may cover output frequency, output intensity, pulse characteristics, duty cycle, period, and other control items related to focus depth and energy output. By appropriately setting the above parameters, the device can output corresponding power according to different usage needs to achieve health benefits such as relaxation, soothing, or promotion of bodily functions.

[0034] How to use

[0035] The device of this invention can apply focused ultrasound waves to selected acupoints according to usage requirements. Before use, the device can be positioned or fixed at the target location, and an appropriate conductive medium (such as conductive gel) can be placed between the probe and the skin to reduce energy loss and improve transmission efficiency. After the device is activated, the focused ultrasound waves can operate according to a preset or user-selected mode. The action time and output power can be adjusted within a safe range, and single-point or multi-point simultaneous application can be selected. The usage frequency, action duration, and interval can be set according to different user conditions, application purposes, or professional advice to achieve the expected health care and soothing effects.

[0036] Parameter settings

[0037] The device of this invention provides multiple adjustable operating parameters to adapt to different usage scenarios and needs. These parameters may include, but are not limited to: ultrasound frequency (covering a range of low to high frequencies suitable for medical or healthcare applications, such as 0.02~10 MHz), output intensity (adjustable via duty cycle or other energy control methods), pulse characteristics (including pulse length, period, and cycle pattern), single-use duration (set within a safe and comfortable range, such as 5~30 minutes), and multi-point output function (capable of simultaneously acting on multiple target locations). These parameters can be pre-stored by the control system and quickly recalled when needed, or adjusted according to immediate requirements to ensure stable and effective operation under various application conditions.

[0038] Example

[0039] In one specific embodiment, the health care device of the present invention can have various external structures, including but not limited to: a handheld structure suitable for single acupoint operation (as shown in Figures 1 and 2), and a wearable structure that can act on multiple acupoints simultaneously and can be fixed to a limb (as shown in Figure 3), with a connecting ear for attaching a cord, strap, etc., to fix it to the body, suitable for long-term wear or multi-point health care purposes. The ultrasound probe can be made into a flat, conical, or other geometric shape, and can be replaced according to usage requirements.

[0040] In another specific implementation, the device's interface can use buttons, knobs, touch panels, or combinations thereof to facilitate adjustment of working modes and operating parameters. A specific correspondence exists between the required treatment time and the applied power, as shown in Figure 4. To achieve equivalent therapeutic effects, shorter treatment times require higher output power. For safety reasons, when the required power exceeds 20W, it is recommended that the device be operated by qualified medical personnel to reduce the risks caused by improper use. The device can be equipped with intelligent assistance functions to automatically set parameters upon first use or directly recall previously stored personalized parameter combinations. The preferred treatment time is 20 minutes, with a maximum of 30 minutes and a minimum of 5 minutes, and the device can be paused or resumed during operation.

[0041] The device can also be equipped with temperature display and control functions. For example, it can pause ultrasonic and heating outputs when the temperature exceeds a preset upper limit and automatically resume operation when the temperature returns to the set range. For instance, when the temperature exceeds 45℃, the ultrasonic and heating modules stop working, with audible and visual prompts. They resume operation when the temperature is below 40℃. The temperature can be adjusted to low, medium, and high. The heating module maintains a constant temperature of 30℃ (medium setting), low setting is off, and high setting is 35℃.

[0042] In another specific embodiment, the device of the present invention can be applied to acupoints for health care purposes by following the steps below:

[0043] Step 1: Select the appropriate acupoint location based on usage needs or professional advice, and place the ultrasonic probe of the device at that location.

[0044] Step 2 (optional): Apply an appropriate conductive medium (such as conductive gel) between the probe tip and the skin to improve energy transfer efficiency.

[0045] Step 3: Activate the device to apply focused ultrasound waves to the target acupoints to generate the required mechanical and thermal stimulation.

[0046] Step four: The treatment time is twice a day, 20 minutes each time, 15 days is one course of treatment, and a total of 1 to 3 courses of treatment are performed, with an interval of 2 days between each course of treatment.

[0047] Verification of the required power corresponding to the depth of acupoints

[0048] In the application of this invention, the tissue depth at different acupoint locations affects the energy transmission efficiency and required output power of focused ultrasound. To establish basic parameters, this invention conducts tests on different genders and body types (e.g., obese, standard, and thin) to obtain corresponding data on acupoint depth and required power (Tables 1, 2, and Figure 5). These data can serve as preset values ​​for system operation, providing an initial setting reference when personalized data is unavailable. In some embodiments, the device of this invention also has a reset function, for example, by means of a reset hole 4, which allows the device to return to its initial settings.

[0049] Table 1. Average depth of some acupoints in men and the required power. Males Acupuncture points Obese Group Average Group Thin Group MEAN Power (Watt) MEAN Power (Watt) MEAN Power (Watt) Tian Tu (CV-22) 3.9360 10.0000 2.8727 8.0000 2.3350 7.5000 Xuan Ji (CV-21) 0.9400 6.0000 0.6409 5.5000 0.3000 5.0000 Yu Zhong (KI-26) 2.9840 8.5000 2.2046 7.3000 1.4950 6.5000 Bu Lang (KI-22) 2.3320 7.5000 1.9500 7.0000 1.4600 6.5000 Qi Hu (ST-13) 5.2400 13.0000 4.1500 10.5000 2.8800 8.3000 Yin Men (LU-2) 6.7320 16.5000 5.1409 12.5000 3.2600 9.0000 Yuan Ye (GB-22) 4.5160 11.0000 3.0727 8.6000 2.1950 7.4000

[0050] Table 2. Average depth of some acupoints in women and the power required. Females Acupuncture points Obese Group Average Group Thin Group MEAN Power (Watt) MEAN Power (Watt) MEAN Power (Watt) Tian Tu (CV-22) 4.4600 11.0000 3.6889 9.7000 3.0143 8.6000 Xuan Ji (CV-21) 1.3667 6.3000 1.0333 6.0000 0.4143 10.5000 Yu Zhong (KI-26) 2.9333 8.4000 2.4611 7.7000 1.5286 6.5000 Bu Lang (KI-22) 2.9476 8.4000 2.4944 7.7000 1.7857 6.8000 Qi Hu (ST-13) 4.7333 11.5000 3.7500 9.8000 2.4571 7.7000 Yin Men (LU-2) 5.8400 14.3000 4.4222 11.0000 3.5143 9.5000 Yuan Ye (GB-22) 4.0600 10.3000 3.7222 9.7000 2.3857 7.6000

[0051] In actual use, the user's age, weight, height, and other personal factors will affect the actual depth of the acupoint. To make the settings of output power and focusing depth more accurate and suitable, this invention introduces the acupoint depth prediction fitting equation shown in Table 3, and performs personalized correction on the preset depth data based on the basic conditions input by the user, so as to obtain a target depth that is closer to the actual situation.

[0052] Table 3. Fitting equations for depth prediction of some acupoints Acupuncture points B0 B1 B2 B3 R2 F Tian Tu (CV-22) -0.4666 -1.1710 0.0075 0.0067 0.4181 18.3211 Xuan Ji (CV-21) -1.1390 -0.6100 0.0070 0.0026 0.5546 31.7466 Hua Gai (CV-20) -1.3504 -0.5413 0.0033 0.0050 0.5558 31.9106 Zi Gong (CV-19) -0.9634 -0.5905 0.0063 0.0023 0.5723 34.1204 Yu Tang (CV-18) -0.9877 -0.6959 0.0070 0.0023 0.5896 36.6336 Dan Zhong (CV-17) -1.0358 -0.8274 0.0084 0.0029 0.6336 44.0964 Zhong Ting (CV-16) -1.6082 -1.0709 0.0147 0.0060 0.6367 44.6807 R2: Coefficient of Determination Y = B0 + B1X1 + B2X2 + B3X3 Y: Predicted Depth of the Acupuncture Point (cm) X1: Age (Years), X2: Height (cm), X3: Weight (Kg)

[0053] The control module and intelligent auxiliary software of this invention can integrate and correct the target depth and depth-power mapping database to calculate the corresponding output power, ultrasonic frequency, duty cycle, pulse parameters, and duration. The calculation results can be directly applied to device operation or fine-tuned by the user according to personal comfort. During operation, the system can dynamically optimize based on real-time feedback signals from the sensors to ensure accurate energy delivery to the target depth, while improving the consistency, repeatability, and overall efficiency of the health care effects.

[0054] In summary, the focused ultrasound acupoint health care device of this invention can precisely act on acupoints in a non-invasive manner, providing both mechanical and thermal stimulation to enhance health care effects and comfort. Its parameters can be customized according to user needs, and it can operate on multiple acupoints simultaneously to improve efficiency. The device is lightweight and portable, suitable for home and travel use, and has good application prospects and market value.

[0055] 1: Ultrasonic output module 2: Display screen 3: Control Keys 4: Reset Hole 5: Power / Data Interface 6: Connecting Ears

[0056] none

Claims

1. A focused ultrasound acupoint health care device, comprising: an ultrasound output module for generating and outputting focused ultrasound waves to a target acupoint location to apply mechanical and thermal stimulation to the acupoint; a control module connected to the ultrasound output module for setting, storing, and adjusting operating parameters, the parameters including at least one of ultrasound frequency, output intensity, pulse characteristics, duty cycle, and action time; a power supply module for providing the energy required for the device's operation; and a human-machine interface module for receiving user input and displaying the operating status; wherein... The control module includes a pre-stored depth-power correspondence database, which stores target depth and corresponding power data for different genders, body types, and acupoint locations. The human-machine interface module allows the user to input or select at least one user condition and a target acupoint location. The user condition includes age, height, and weight. The control module calculates a personalized target depth based on the acupoint depth prediction fitting equation corresponding to the selected target acupoint location. The acupoint depth prediction fitting equation is: Y = B0 + B1X1 + B2X2 + B3X3, where Y is the predicted acupoint depth, X1 is age, X2 is height, X3 is weight, and B0, B1, B2, and B3 are coefficients corresponding to the target acupoint location. The control module generates or corrects the output power of the ultrasound output module based on the personalized target depth and the depth-power correspondence database.

2. The apparatus as claimed in claim 1, wherein the ultrasonic output module outputs a frequency range of 0.02 to 10 MHz.

3. The device as described in claim 1, which employs a handheld structure, a wearable structure, or a combination thereof.

4. The apparatus as claimed in claim 1, wherein the ultrasonic output module further includes a replaceable probe.

5. The apparatus as described in claim 4, wherein the probe is a flat probe or a conical probe.

6. The device as claimed in claim 1, further comprising a temperature monitoring module for detecting the temperature of the area in contact between the ultrasonic output module and the user's skin, and automatically stopping the output when the temperature reaches a preset upper limit, and resuming the output when the temperature drops to a preset lower limit, to prevent burns.

7. The apparatus as described in claim 6, wherein the preset upper limit is 45°C and the preset lower limit is 40°C.

8. The device as described in claim 1, used for the health care, soothing or stimulation of acupoints on the human body to promote bodily functions.

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