Subcutaneous focused ultrasound device

Abstract

The application provides a subcutaneous focusing ultrasonic device, and relates to the field of focusing ultrasonic cosmetic technology, which comprises a handle part, an ultrasonic working head arranged at the distal end of the handle part, the ultrasonic working head being configured to be attached to the surface of human skin and emit ultrasonic pulses to the human skin along a first direction to form an ultrasonic focus in subcutaneous tissue, the first direction being perpendicular to the surface of human skin, a flexible connecting part connected between the handle part and the ultrasonic working head, the flexible connecting part being configured to be able to stretch and contract along the first direction to compensate for the depth deviation of the ultrasonic focus caused by the change of holding pressure, and an adjusting system configured to adjust the length change of the flexible connecting part along the first direction, when the holding pressure on the handle part increases, the adjusting system makes the flexible connecting part contract along the first direction, and when the holding pressure on the handle part decreases, the adjusting system makes the flexible connecting part elongate along the first direction. The stability of the ultrasonic focus in the treatment process in the related art is improved.

Description

Technical Field

[0001] This application relates to the field of focused ultrasound cosmetic technology, and more specifically, to a subcutaneous focused ultrasound device. Background Technology

[0002] A focused ultrasound device is an energy-generating device that works by focusing physical sound waves. Its ultrasonic working head (blade) is designed to concentrate ultrasonic energy at a fixed physical depth outside the sound emission window in a fixed medium. This location forms the ultrasonic focal point, where the sound energy density is the highest and the thermal effect conversion is most significant, making it the main target for treatment.

[0003] In cosmetic treatments such as anti-aging and wrinkle reduction, the operator needs to align the ultrasonic transducer's emission window with the skin surface and generate ultrasonic pulses. Through appropriate energy parameter settings, the ultrasonic pulses can form a focal point under the skin, rapidly raising the temperature of the focal point and surrounding subcutaneous tissue to 60-70°C. This alters tissue properties and activates collagen regeneration, achieving the desired therapeutic effect. During this process, the focal point has the highest temperature and is also the area with the highest treatment risk. Precision treatment requires strict control of the ultrasonic focal point within the target tissue layer, such as the dermis (usually 1-2 mm below the epidermis) or the fascia (usually 4-5 mm below the epidermis). The operator typically uses ultrasound diagnostics before the procedure to determine the depth of the patient's specific tissues and, based on this, the target area, selecting an ultrasonic transducer with the appropriate focal depth.

[0004] However, existing technologies face a core problem that has long remained unresolved: the inability to maintain the stability of the ultrasound focus depth under the skin during treatment. This stems from the fact that the actual depth of the ultrasound focus within the tissue depends not only on the inherent physical focal length of the ultrasound head but also on the coupling state between the ultrasound head and the skin. When the operator holds the handle, it is difficult to consistently apply absolutely stable pressure. Excessive pressure can cause excessive indentation of the skin surface, resulting in the ultrasound focus being deeper than the target area, potentially damaging deeper tissues such as muscles. Insufficient pressure may lead to insufficient contact between the acoustic window and the skin (incomplete adhesion), causing the ultrasound focus to float upwards, shallower than the target area, easily causing adverse events such as epidermal burns.

[0005] In other words, even if a physical focal length matching ultrasound working head is accurately selected based on ultrasound diagnosis before the operation, pressure fluctuations caused by manual operation during treatment can lead to uncontrollable deformation of the skin, which in turn causes changes in the position of the ultrasound focal point, thus affecting the treatment effect on the patient and even causing damage to the patient's skin. Summary of the Invention

[0006] The purpose of this application is to provide a subcutaneous focused ultrasound device that aims to improve the stability of the ultrasound focus during treatment in related technologies, thereby protecting the patient's skin and improving the treatment effect.

[0007] Additional aspects and advantages of this application will be set forth in part in the description which follows, and in part will be obvious from the description or may be learned by practice of this application.

[0008] According to a first aspect of this application, a subcutaneous focused ultrasound device is provided, characterized in that it comprises:

[0009] handle part;

[0010] An ultrasonic working head is disposed at the distal end of the handle portion. The ultrasonic working head is configured to adhere to the surface of human skin and emit ultrasonic pulses toward human skin in a first direction to form an ultrasonic focus in the subcutaneous tissue. The first direction is perpendicular to the surface of human skin.

[0011] A flexible connection is provided between the handle and the ultrasonic working head. The flexible connection is configured to extend or retract in the first direction in response to changes in grip pressure applied by the operator on the handle to compensate for the ultrasonic focal depth shift caused by the changes in grip pressure.

[0012] An adjustment system is configured to adjust the length variation of the flexible connection portion along the first direction;

[0013] When the gripping pressure on the handle increases, the adjustment system causes the flexible connecting part to contract along the first direction; when the gripping pressure on the handle decreases, the adjustment system causes the flexible connecting part to extend along the first direction.

[0014] In one exemplary embodiment of this application, the flexible connection portion is configured as an elastic damping buffer that can extend and retract along a first direction through deformation. One end of the elastic damping buffer is fixedly connected to the distal end of the handle portion, and the other end is fixedly connected to the ultrasonic working head.

[0015] In one exemplary embodiment of this application, an adjustment system is also included, the adjustment system comprising:

[0016] A pressure detection unit is disposed on the end face of the ultrasonic working head that is in contact with human skin. The pressure detection unit is configured to detect the pressure value between the ultrasonic working head and the surface of human skin in real time and send out a pressure signal.

[0017] The comparison unit has a preset threshold, which is determined by the focus determination module. The comparison unit is configured to receive the pressure signal and compare the pressure signal with the preset threshold. When the pressure signal is greater than the preset threshold, a first execution signal is output, and when the pressure signal is less than the preset threshold, a second execution signal is output.

[0018] A pressure actuation unit, responsive to a first actuation signal and a second actuation signal, is configured to cause the flexible connection to contract when the first actuation signal is received, and to cause the flexible connection to extend when the second actuation signal is received.

[0019] In an exemplary embodiment of this application, a sealed air pressure cavity is formed inside the flexible connection portion, and the pressure actuation unit is configured as an air pressure regulating module. The air pressure regulating module is configured to cause the flexible connection portion to extend by increasing the air pressure value inside the air pressure cavity, or to cause the flexible connection portion to contract by decreasing the air pressure value inside the air pressure cavity.

[0020] In one exemplary embodiment of this application, an air passage is further included. The air passage is disposed in the handle portion, one end of the air passage is connected to the interior of the air pressure chamber, and the other end of the air passage extends from the proximal end of the handle portion and is connected to the air pressure regulating module.

[0021] In one exemplary embodiment of this application, the flexible connection is configured as a bellows, and the pneumatic cavity is under negative or positive pressure.

[0022] In one exemplary embodiment of this application, the pressure regulating module includes a vacuum generator, which is activated in response to the first execution signal to extract gas from the pressure chamber.

[0023] In one exemplary embodiment of this application, when the pressure in the pneumatic chamber is negative, the pneumatic pressure regulating module further includes a three-way valve. The three-way valve is provided with a first port, a second port, and a third port. The first port is connected to the air passage, the second port is connected to the vacuum generator, and the third port is connected to the outside air. When the three-way valve receives a first execution signal, it controls the second port to open and the third port to close. When it receives a second execution signal, it controls the third port to open and the second port to close.

[0024] In one exemplary embodiment of this application, a flow limiter is further included, which is installed on the airway and configured to control the airflow within the airway.

[0025] In one exemplary embodiment of this application, the adjustment system further includes the focus determination module, which is configured to determine whether the ultrasound focus coincides with the subcutaneous target position. When the ultrasound focus coincides with the target position, the focus determination module sends a confirmation signal to the comparison unit. The comparison unit responds to the confirmation signal and is configured to set the pressure value corresponding to the current pressure signal to the preset threshold when it receives the confirmation signal.

[0026] The exemplary embodiments of this application may have some or all of the following beneficial effects:

[0027] 1. In the subcutaneous focused ultrasound device provided in the exemplary embodiment of this application, by introducing a flexible connecting part, dynamic real-time compensation and stable control of the ultrasound focal depth are achieved, effectively solving the defect of insufficient ultrasound focal stability caused by skin deformation due to handheld operation pressure fluctuations in traditional devices. Specifically, when the pressure applied by the operator increases, the flexible connecting part can shorten the distance between the ultrasound working head and the handle by contracting its own length, thereby suppressing the downward movement of the ultrasound focal point; when the pressure applied by the operator decreases, the flexible connecting part can increase the distance between the ultrasound working head and the handle by extending its own length, thereby preventing the ultrasound focal point from floating upward.

[0028] In summary, when the pressure applied by the operator changes, the flexible connection can adjust the relative position between the ultrasound probe and the handle by its own extension and retraction, thereby reducing the impact of pressure changes on the ultrasound working head and reducing the change in the pressure value generated by the ultrasound working head on the skin. This makes it less likely for the ultrasound focus to move, improving the stability of the ultrasound focus during treatment. In this way, it not only protects the patient's skin but also improves the treatment effect.

[0029] 2. In the subcutaneous focused ultrasound device provided in the example embodiment of this application, the pressure detection unit can detect the pressure value between the ultrasound working head and the human skin in real time. When the pressure value changes, the pressure execution unit can actively drive the length of the flexible connection to extend or contract, so as to reduce the pressure change between the ultrasound working head and the human skin, so that the flexible connection can actively adjust its length according to the pressure change of the ultrasound working head, thereby further improving the stability of the ultrasound focal position.

[0030] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0031] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0032] Figure 1 A schematic diagram of a subcutaneous focused ultrasound device according to an embodiment of this application is shown;

[0033] Figure 2 It shows Figure 1 A front view along the A-A' direction;

[0034] Figure 3 This illustration shows the state diagram of the three-way valve when the third port is open in an embodiment of this application.

[0035] Figure 4 A state diagram of the vacuum generator when it is started in an embodiment of this application is shown.

[0036] Explanation of reference numerals in the attached figures:

[0037] 1. Handle; 2. Ultrasonic working head; 21. Acoustic membrane; 3. Flexible connection; 4. Actuator; 41. Three-way valve; 42. Vacuum generator; 5. Air passage; 6. Flow restrictor; 7. Pressure detection unit; 8. Ultrasonic focus. Detailed Implementation

[0038] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore their detailed descriptions will be omitted. Furthermore, the drawings are merely illustrative of this application and are not necessarily drawn to scale.

[0039] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of an icon to another, these terms are used only for convenience, such as according to the orientation of the examples in the accompanying drawings. It is understood that if the device of the icon is flipped so that it is upside down, the component described as "upper" will become the component described as "lower." When a structure is "upper" of another structure, it may mean that the structure is integrally formed on the other structure, or that the structure is "directly" mounted on the other structure, or that the structure is "indirectly" mounted on the other structure through another structure.

[0040] The terms “a,” “one,” “the,” and “at least one” are used to indicate the existence of one or more elements / components / etc.; the terms “including” and “having” are used to indicate an open-ended inclusion and to mean that there may be other elements / components / etc. in addition to the listed elements / components / etc.; the terms “first” and “second” are used only as markers and are not a limitation on the number of objects.

[0041] Reference Figure 1 In this embodiment, a subcutaneous focused ultrasound device is provided, including a handle portion 1 and an ultrasound working head 2. The handle portion 1 has a distal end and a proximal end, and the ultrasound working head 2 is disposed below the distal end of the handle portion 1. During operation, the operator holds the proximal area of ​​the handle portion 1, so that the lower surface of the ultrasound working head 2 is in close contact with the patient's skin. The ultrasound working head 2 contains an ultrasound transducer, and the bottom of the ultrasound transducer is provided with an acoustic emission window, which can emit ultrasound pulses towards the human skin in a first direction.

[0042] Reference Figure 2 As shown, the ultrasonic working head 2 further includes a medium water cavity 21 inside for the ultrasonic transducer to emit ultrasonic pulses, and a sound-transmitting membrane 22 is provided at the bottom of the ultrasonic transducer to maintain the stability of the medium water cavity 21.

[0043] Specifically, the first direction is perpendicular to human skin.

[0044] By appropriately setting the energy parameters, this device can create an ultrasound focal point 8 under the skin, rapidly raising the temperature of the ultrasound focal point 8 and the surrounding subcutaneous tissue to 60–70°C. This alters tissue properties, activates collagen regeneration, and achieves the desired therapeutic effect. During this process, the ultrasound focal point 8 experiences the highest temperature and is also the area with the highest treatment risk.

[0045] To ensure treatment precision, the ultrasound focus 8 must be strictly controlled within the target tissue layer, such as the dermis (usually 1–2 mm below the epidermis) or the fascia (usually 4–5 mm below the epidermis). Before the procedure, the operator typically uses ultrasound diagnostics to determine the depth of the patient's specific tissue, thereby identifying the target location and selecting an ultrasound working head 2 with the corresponding depth of the ultrasound focus 8.

[0046] In practice, the stability of the ultrasound focus 8 at the target site directly determines the success of the surgery. The actual depth of the ultrasound focus 8 within the tissue is determined not only by the physical focal length of the ultrasound working head 2 itself, but also by its coupling state with the skin. When the operator holds the handle 1, it is difficult to maintain a completely stable pressure. If the pressure is too high, it will cause significant indentation on the skin surface, resulting in the actual depth of the ultrasound focus 8 exceeding the target site, and may even damage deeper tissues such as muscles. If the pressure is too low, it may cause insufficient contact and incomplete adhesion between the sound window and the skin, causing the ultrasound focus 8 to shift upwards and become shallower than the target site, which can easily lead to adverse events such as epidermal burns.

[0047] Therefore, in order to solve the above problems, the subcutaneous focused ultrasound device provided in this application also includes a flexible connecting part 3.

[0048] A flexible connecting part 3 is connected between the handle part 1 and the ultrasonic working head 2. The flexible connecting part 3 is configured to extend or retract in the first direction in response to changes in the gripping pressure applied by the operator on the handle part, so as to compensate for the depth shift of the ultrasonic focus 8 caused by the change in gripping pressure, so that the ultrasonic working head 2 is displaced relative to the handle part 1 in the first direction, thereby ensuring that the ultrasonic focus 8 can be stably located at the subcutaneous target position.

[0049] Furthermore, the flexible connection 3 can prevent or reduce the pressure transmission to the ultrasonic working head 2 through its own deformation, thereby preventing the depth of the ultrasonic focus 8 from shifting. Alternatively, if the ultrasonic focus 8 shifts, the flexible connection 3 can react in time and adjust its own length so that the ultrasonic focus 8 can quickly return to the target point.

[0050] Specifically, the flexible connection portion 3 is configured as follows:

[0051] When the external pressure on the handle portion 1 increases, the flexible connecting portion 3 contracts along the first direction;

[0052] When the external pressure on the handle portion 1 decreases, the flexible connecting portion 3 extends along the first direction.

[0053] Furthermore, the flexible connection part 3 can be adjusted passively or actively.

[0054] When the flexible connection part 3 adopts a passive adjustment method, it can be implemented using structures such as bellows, springs, medical rubber, or flexible materials. During operation, if the pressure on the hand handle part 1 increases, the flexible connection part 3 can passively contract and deform along the first direction, absorbing part or even all of the additional force, thereby reducing the pressure transmitted to the ultrasonic working head 2. This effectively reduces the risk of deformation of the skin caused by the ultrasonic working head 2, helps to improve the positional stability of the ultrasonic focus 8, and thus enhances the treatment effect on the patient.

[0055] When the flexible connection part 3 adopts an active adjustment method, it can be implemented using an airbag structure, a closed bellows structure, or the like. The subcutaneous focused ultrasound device may also include a pressure sensor for real-time monitoring of external pressure changes. The pressure sensor can be installed between the handle part 1 and the flexible connection part 3, or it can be located on the side of the ultrasound working head 2 that contacts the patient's skin, to achieve pressure change sensing and feedback control.

[0056] When a pressure sensor is installed between the handle 1 and the flexible connecting part 3, it can directly detect changes in pressure transmitted to the flexible connecting part 3 and feed this feedback to the adjustment system, which then causes the flexible connecting part 3 to extend or retract. When the pressure sensor is installed on the side of the ultrasound working head 2 that contacts the patient's skin, it can detect changes in pressure acting on the patient's skin and feed this feedback to the adjustment system, thereby adjusting the length of the flexible connecting part 3. The flexible connecting part 3 adaptively adjusts its length based on the pressure value measured by the pressure sensor: when the pressure value increases, the flexible connecting part 3 automatically contracts; when the pressure value decreases, the flexible connecting part 3 automatically extends. This structure makes it less likely for the position of the ultrasound focus 8 to shift, thus improving the effectiveness of surgical treatment for the patient.

[0057] Clearly, among the two adjustment methods mentioned above, the passive adjustment scheme has the advantages of simple structure and low manufacturing cost, which helps to improve the economic benefits of the product; while the active adjustment scheme can achieve more precise pressure feedback and position control, which can further improve the stability and treatment accuracy of the ultrasound focus 8.

[0058] In one embodiment, the flexible connection 3 is configured as an elastic damping buffer. One end of the elastic damping buffer is fixedly connected to the lower surface of the distal end of the handle 1, and the other end is fixedly connected to the top of the ultrasonic working head 2. The flexible buffer connection can buffer changes in external pressure: when the pressure on the handle 1 changes, the connection can absorb or release energy through its own deformation, thereby reducing pressure changes between the ultrasonic working head 2 and the human skin. This elastic damping buffer can passively deform under changing force and also has a damping effect, allowing the ultrasonic working head 2 to quickly return to a stable, stationary state after a change in gripping force, preventing repeated bouncing and further improving the stability of the ultrasonic focus. For example, the elastic damping buffer can be made of rubber, silicone, or a corrugated tube.

[0059] In this embodiment of the application, in order to further improve the stability of the ultrasonic focus 8, the extension and retraction of the flexible connection 3 is set to be actively adjustable.

[0060] Specifically, the subcutaneous focused ultrasound device also includes an adjustment system, which includes a pressure detection unit 7, a comparison unit, and a pressure actuation unit 4.

[0061] In this embodiment, the pressure detection unit 7 is mounted on the end face of the ultrasound working head 2 that contacts the human skin and faces the patient's skin. When the subcutaneous focused ultrasound device is in operation, the pressure detection unit 7 is in contact with the patient's skin surface, detects the pressure value between the ultrasound working head 2 and the skin in real time, and outputs a corresponding pressure signal. In this embodiment, the pressure detection unit 7 is preferably a pressure sensor, but this is not limiting.

[0062] Furthermore, the comparison unit is configured with a preset threshold, which can be set to a specific pressure value or a pressure range. When the pressure signal is greater than the preset threshold, a first execution signal is output; when the received pressure signal is higher than the preset threshold, the comparison unit outputs the first execution signal; when the pressure signal is lower than the preset threshold, a second execution signal is output. For example:

[0063] When the preset threshold is a specific pressure value, the preset threshold can be set to 10Pa. When the pressure signal is greater than 10Pa, the execution unit 4 outputs the first execution signal; when the pressure signal is less than 10Pa, the execution unit 4 outputs the second execution signal; when the pressure signal is exactly equal to 10Pa, the execution unit 4 outputs neither the first execution signal nor the second execution signal.

[0064] When the preset threshold is a certain pressure range, the preset threshold can be set to 8Pa-12Pa. When the pressure signal is greater than 12Pa, the execution unit 4 outputs the first execution signal; when the pressure signal is less than 8Pa, the execution unit 4 outputs the second execution signal; when the pressure signal is between 8Pa and 12Pa, the execution unit 4 neither outputs the first execution signal nor the second execution signal.

[0065] The above is merely an illustrative example of a preset threshold and is not restrictive.

[0066] Furthermore, the pressure actuation unit 4 responds to the first actuation signal and the second actuation signal. When the pressure actuation unit 4 receives the first actuation signal, it causes the flexible connection part 3 to contract; when it receives the second actuation signal, it causes the flexible connection part 3 to extend.

[0067] In one embodiment, the flexible connection part 3 is provided with a sealed air pressure cavity, and the pressure actuation unit 4 is set as an air pressure regulating module. The air pressure regulating module drives the flexible connection part 3 to extend or contract by adjusting the air pressure value in the air pressure cavity.

[0068] The specific structure of the flexible connection part 3 is not strictly limited in this application, and it can take the form of a corrugated pipe, an air bladder, etc. In this application, the flexible connection part 3 is preferably a corrugated pipe.

[0069] Similarly, the air pressure regulation module is not strictly limited and can adopt structures such as exhaust pump, air pump or bidirectional air pump.

[0070] Furthermore, the subcutaneous focused ultrasound device also includes an airway 5, one end of which is connected to the interior of the pneumatic cavity, and the other end of which is connected to the pneumatic pressure regulating module. The pneumatic pressure regulating module fills or discharges gas into the pneumatic cavity through the airway 5 to achieve the expansion and contraction of the flexible connection 3. Specifically, when gas is discharged through the airway 5, the pressure inside the pneumatic cavity decreases, and the flexible connection 3 (bellows) contracts; when gas is filled through the airway 5, the pressure inside the pneumatic cavity increases, and the flexible connection 3 extends.

[0071] Furthermore, the air passage 5 is located inside the handle portion 1. One end of the air passage 5 extends from the distal end of the handle portion 1 and connects to the air pressure chamber; the other end extends from the proximal end of the handle portion 1 and connects to the air pressure regulating module. This layout eliminates the need for the air passage 5 to occupy additional external operating space, thus providing convenience for the operator's daily use.

[0072] In this embodiment of the application, when the flexible connection part 3 is set as a bellows, the air pressure cavity can be in a negative pressure state or a positive pressure state.

[0073] Reference Figure 3 and Figure 4As shown, in one specific embodiment, the flexible connection part 3 adopts a bellows structure, and the air pressure chamber is in a negative pressure state. The air pressure regulating module includes a vacuum generator 42 and a three-way valve 41, which has a first port, a second port, and a third port. The first port is connected to the air passage 5, the second port is connected to the vacuum generator 42, and the third port is connected to the outside air. When the three-way valve 41 receives a first execution signal, it controls the second port to open and the third port to close; when it receives a second execution signal, it controls the third port to open and the second port to close.

[0074] Furthermore, a valve is installed at the third port, which responds to the second execution signal.

[0075] Furthermore, a pressure sensor can be added between the second port and the vacuum generator 42 to detect the pressure value in the air passage 5 when the vacuum generator 42 is working, thereby improving the control accuracy of the vacuum generator 42.

[0076] When the pressure signal detected by the pressure detection unit 7 exceeds a preset threshold, the execution unit 4 outputs a first execution signal to the vacuum generator 42. Upon receiving this signal, the vacuum generator 42 extracts gas from the pressure chamber, causing the bellows to contract and thus reducing the contact pressure between the ultrasonic working head 2 and the skin. When the pressure signal equals the preset threshold, the execution unit 4 stops outputting the first execution signal, and the vacuum generator 42 immediately stops operating.

[0077] When the pressure signal is less than the preset threshold, the actuator 4 outputs a second execution signal to the valve. The valve opens upon receiving the second execution signal. Since the pneumatic chamber is under negative pressure at this time, outside air is drawn into the chamber, causing the bellows to lengthen and thus increasing the contact pressure between the ultrasonic working head 2 and the skin. When the pressure signal equals the preset threshold, the actuator 4 stops outputting the second execution signal, and the valve closes.

[0078] In another specific embodiment, the flexible connection part 3 adopts a bellows structure, and the air pressure chamber is under positive pressure. The air pressure regulating module includes an air pump and a three-way valve 41, which has a first port, a second port, and a third port. The first port is connected to the air passage 5, the second port is connected to the air pump, which responds to a second execution signal; the third port is in communication with the outside air, and a valve is installed at the third port, which responds to the first execution signal.

[0079] When the pressure signal detected by the pressure detection unit 7 exceeds a preset threshold, the execution unit 4 outputs a first execution signal to the valve. Upon receiving the first execution signal, the valve opens. Because the pneumatic chamber is under positive pressure, the gas inside the chamber is discharged outwards through the air passage 5, causing the bellows length to contract, thereby reducing the contact pressure between the ultrasonic working head 2 and the skin. When the pressure signal equals the preset threshold, the execution unit 4 stops outputting the first execution signal, and the valve closes.

[0080] When the pressure signal is less than a preset threshold, the execution unit 4 outputs a second execution signal to the air pump. Upon receiving the second execution signal, the air pump starts and inflates the air chamber through the air passage 5, extending the length of the bellows and thus increasing the contact pressure between the ultrasonic working head 2 and the skin. When the pressure signal equals the preset threshold, the execution unit 4 stops outputting the second execution signal to the air pump, and the air pump stops working.

[0081] Furthermore, a flow limiter 6 is installed on the air passage 5. The flow limiter 6 can control the air flow rate in the air passage 5 and reduce the flow velocity of the gas in the air passage 5. On the one hand, it makes the pressure change transition smoothly and achieves the effect of slow expansion and contraction of the flexible connection 3, which improves the safety of the device. On the other hand, the lower air flow velocity also helps to improve the control accuracy of the air pressure chamber and avoid excessive expansion and contraction of the bellows due to excessive air flow.

[0082] In this embodiment of the application, the length adjustment mechanism further includes a focus determination module. The focus determination module is configured to determine whether the ultrasound focus 8 coincides with the subcutaneous target position. When the ultrasound focus 8 coincides with the target position, the focus determination module sends a confirmation signal to the comparison unit. The comparison unit responds to the confirmation signal and sets the pressure value corresponding to the current pressure signal to a preset threshold when it receives the confirmation signal.

[0083] Specifically, the focus determination module may include a detection device and a confirmation button. The detection device can be configured as medical imaging monitoring (such as ultrasound), an acoustic feedback-based algorithm (such as acoustic emission detection), or impedance matching analysis. When the operator confirms that the ultrasound focus 8 coincides with the subcutaneous target, they manually press the confirmation button, which then sends a confirmation signal to the comparison unit. Alternatively, the confirmation button can be integrated into the detection device without manual control. When the detection device detects that the ultrasound focus 8 coincides with the subcutaneous target, it automatically sends a confirmation signal to the comparison unit. Upon receiving the confirmation signal, the comparison unit sets the current pressure signal to a preset threshold.

[0084] The implementation principle of a subcutaneous focused ultrasound device according to an embodiment of this application is as follows: During patient treatment, the operator holds the proximal end of the handle 1 and places the ultrasound working head 2 against the patient's skin. The ultrasound working head 2 emits ultrasound pulses to the patient's skin through the ultrasonic transducer via the emission window, forming an ultrasound focal point 8 under the skin. In actual operation, if the pressure applied by the operator to the handle 1 increases, the flexible connecting part 3 contracts, thereby reducing the distance between the handle 1 and the ultrasound working head 2; if the pressure applied by the operator to the handle 1 decreases, the flexible connecting part 3 extends, thereby increasing the distance between the handle 1 and the ultrasound working head 2. Through the above structure, the change in the pressure value generated by the ultrasound working head 2 on the skin is effectively reduced, making the position of the ultrasound focal point 8 less prone to movement, improving the stability of the ultrasound focal point 8 during treatment, thus not only protecting the patient's skin but also improving the treatment effect.

[0085] Other embodiments of this application will readily conceive of by those skilled in the art upon consideration of the specification and practice of the embodiments thereof. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not claimed in this application. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of this application are indicated by the appended claims.

Claims

1. A subcutaneous focused ultrasound device, characterized in that, include: handle part; An ultrasonic working head is disposed at the distal end of the handle portion. The ultrasonic working head is configured to adhere to the surface of human skin and emit ultrasonic pulses toward human skin in a first direction to form an ultrasonic focus in the subcutaneous tissue. The first direction is perpendicular to the surface of human skin. A flexible connection is provided between the handle and the ultrasonic working head. The flexible connection is configured to extend or retract in the first direction in response to changes in grip pressure applied by the operator on the handle to compensate for the ultrasonic focal depth shift caused by the changes in grip pressure. An adjustment system is configured to adjust the length variation of the flexible connection portion along the first direction; When the gripping pressure on the handle increases, the adjustment system causes the flexible connecting part to retract along the first direction; When the gripping pressure on the handle decreases, the adjustment system causes the flexible connecting part to extend along the first direction; The regulating system includes: A pressure detection unit is disposed on the end face of the ultrasonic working head that is in contact with human skin. The pressure detection unit is configured to detect the pressure value between the ultrasonic working head and the surface of human skin in real time and send out a pressure signal. The comparison unit has a preset threshold, which is determined by the focus determination module. The comparison unit is configured to receive the pressure signal and compare the pressure signal with the preset threshold. When the pressure signal is greater than the preset threshold, a first execution signal is output, and when the pressure signal is less than the preset threshold, a second execution signal is output. A pressure actuation unit, responsive to a first actuation signal and a second actuation signal, is configured to cause the flexible connection to contract when the first actuation signal is received, and to cause the flexible connection to extend when the second actuation signal is received.

2. The subcutaneous focused ultrasound device according to claim 1, characterized in that, The flexible connection part is configured as an elastic damping buffer that can stretch and extend along the first direction through deformation. One end of the elastic damping buffer is fixedly connected to the distal end of the handle part, and the other end is fixedly connected to the ultrasonic working head.

3. A subcutaneous focused ultrasound device according to claim 2, characterized in that, The flexible connection portion has a sealed air pressure cavity inside. The pressure actuation unit is configured as an air pressure regulating module. The air pressure regulating module is configured to extend the flexible connection portion by increasing the air pressure value inside the air pressure cavity, or to contract the flexible connection portion by decreasing the air pressure value inside the air pressure cavity.

4. A subcutaneous focused ultrasound device according to claim 3, characterized in that, It also includes an air passage, which is disposed inside the handle portion. One end of the air passage is connected to the interior of the air pressure chamber, and the other end of the air passage extends from the proximal end of the handle portion and is connected to the air pressure regulating module.

5. A subcutaneous focused ultrasound device according to claim 4, characterized in that, The flexible connection is configured as a bellows, and the air pressure chamber is under negative or positive pressure.

6. A subcutaneous focused ultrasound device according to claim 5, characterized in that, The pressure regulation module includes a vacuum generator, which is activated in response to the first execution signal to extract gas from the pressure chamber.

7. A subcutaneous focused ultrasound device according to claim 6, characterized in that, When the pressure in the air pressure chamber is negative, the air pressure regulating module also includes a three-way valve. The three-way valve is provided with a first port, a second port, and a third port. The first port is connected to the air passage, the second port is connected to the vacuum generator, and the third port is connected to the outside air. When the three-way valve receives a first execution signal, it controls the second port to open and the third port to close. When it receives a second execution signal, it controls the third port to open and the second port to close.

8. A subcutaneous focused ultrasound device according to claim 4, characterized in that, It also includes a flow restrictor, which is installed on the airway and configured to control the airflow within the airway.

9. A subcutaneous focused ultrasound device according to claim 1, characterized in that, The adjustment system further includes a focus determination module, which is configured to determine whether the ultrasound focus coincides with the subcutaneous target position. When the ultrasound focus coincides with the target position, the focus determination module sends a confirmation signal to the comparison unit. The comparison unit responds to the confirmation signal and is configured to set the pressure value corresponding to the current pressure signal to the preset threshold when it receives the confirmation signal.

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