Real-time contact monitoring device and method for transcranial ultrasound therapy

Abstract

The present application relates to the field of neuromodulation, and discloses a real-time contact monitoring device and method for transcranial ultrasound therapy, the device comprising a positioning cap, an external magnet array, an ultrasonic coupler, and an ultrasonic control system. The external magnet array forms a periodically changing magnetic field signal in two different directions. The ultrasonic coupler integrates an ultrasonic transducer, a three-axis pressure sensor array, and a three-axis Hall effect sensor array. Among them, the pressure sensor array is used to detect the pressure distribution of the contact surface between the ultrasonic coupler and the scalp, and the Hall effect sensor array is used to detect the magnetic field change of the external magnet array to determine the position offset of the ultrasonic coupler. The ultrasonic control system controls the working state of the ultrasonic transducer according to the pressure distribution information and the position offset information. The present application effectively solves the problem of detecting the deviation of the ultrasonic coupler from the specified position or separation from the scalp caused by external disturbances such as head movement during transcranial ultrasound stimulation.

Description

Technical Field

[0001] The present application relates to the field of neuromodulation, and in particular to a technology for real-time detection of the contact between an ultrasonic coupler and a scalp in a transcranial ultrasound stimulation scenario. Background Art

[0002] Transcranial ultrasound stimulation (TUS) technology uses low-frequency, low-intensity ultrasound waves, which are released by ultrasound transducers and penetrate the skull to reach specific areas of the brain to regulate brain nerve activity. This technology, with its high spatial resolution advantage, can achieve millimeter-level precision in the ultrasound focus area, and requires the ultrasound transducer and its structure to be precisely positioned to ensure the effect.

[0003] In the actual application of TUS, the ultrasonic transducer needs to be installed in the ultrasonic coupler for easy clamping or fixing, and the ultrasonic coupler is placed in the selected area of ​​the scalp surface and kept relatively stable. However, during the ultrasound intervention, the user may have slight head movements, which will cause the ultrasonic coupler to gradually deviate from the selected area of ​​the scalp or even detach from the scalp. The user is often unable to detect this situation in time, which leads to the ultrasonic stimulation deviation from the target and poor intervention effect. In addition, ultrasound waves are difficult to propagate in the air. If the ultrasonic coupler is detached from the scalp, it will be difficult for the ultrasound transducer to emit ultrasound waves to reach the skull, and effective transcranial ultrasound stimulation cannot be achieved.

[0004] At present, in the field of TUS, the most commonly used method to detect the relative position relationship between the ultrasonic coupler and the user's head is to use a binocular camera for spatial positioning and calibration. However, this method has problems such as long testing time, high cost of use, and large space occupation, and is not convenient for scenes with low precision requirements. In addition, the use of a binocular camera for calibration cannot directly detect the contact between the user's scalp and the ultrasonic coupler structure. The binocular camera system calculates the relative spatial position through the positioning rigid body tied to the ultrasonic coupler structure, and requires high measurement and calculation accuracy to indirectly reflect the contact between the ultrasonic coupler and the scalp, which adds difficulties to actual use.

[0005] In view of this, there is an urgent need in the art for a simple, compact and low-cost method and device to accurately detect the contact between the ultrasonic coupler and the scalp, and to solve the problem of the ultrasonic coupler deviating from the specified position or separating from the scalp due to external disturbances such as head movement during transcranial ultrasonic stimulation. This will help to significantly improve the application efficiency and therapeutic effect of transcranial ultrasonic stimulation technology. Summary of the invention

[0006] The purpose of the present application is to provide a real-time contact monitoring device and method for transcranial ultrasound therapy to solve the problems raised in the above-mentioned background technology.

[0007] The present application discloses a real-time contact monitoring device for transcranial ultrasound therapy, the device is used to detect the contact between an ultrasound coupler and a scalp, the device comprises: a positioning cap, an external magnet array, an ultrasound coupler and an ultrasound control system, wherein:

[0008] The positioning cap is provided with an opening at the ultrasonic intervention target point to accommodate the ultrasonic coupler;

[0009] The external magnet array is configured to generate a periodically varying magnetic field in at least one direction to support position monitoring and calibration;

[0010] The ultrasonic coupler comprises: an ultrasonic transducer, a three-axis pressure sensor array for detecting in real time the pressure distribution information of the contact surface between the ultrasonic coupler and the scalp, and a three-axis Hall effect sensor array for detecting the change of the magnetic field signal generated by the external magnet array to determine the position deviation of the ultrasonic coupler;

[0011] The ultrasonic control system is used to control the working state of the ultrasonic transducer according to the contact surface pressure distribution information detected by the three-axis pressure sensor array and the position offset detected by the three-axis Hall effect sensor array.

[0012] In a preferred example, the external magnet array is mounted on the positioning cap, and the external magnet array forms a periodically varying magnetic field signal in a first direction and a second direction.

[0013] In a preferred embodiment, the external magnet array is composed of two groups of orthogonal Halbach magnet arrays superimposed on each other, thereby forming a periodically varying magnetic field signal in the first direction and the second direction, and the single period pitch of the magnetic field signal in the first direction and the second direction is λ.

[0014] In a preferred embodiment, the contact surface pressure distribution information refers to the time-dependent contact deviation index Z of the contact surface between the ultrasonic coupler and the scalp. p (t), and the sliding friction index Z between the contact surface of the ultrasonic coupler and the scalp s The position offset refers to the focus offset D of the ultrasonic wave generated by the ultrasonic transducer at time t F (t).

[0015] In a preferred example, the three-axis pressure sensor array detects the contact surface pressure distribution between the ultrasonic coupler and the scalp in real time, and can judge the degree of fit of each site based on the contact surface pressure distribution; when the contact surface pressure distribution detected by the three-axis pressure sensor array deviates from a preset range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer relative to the head until the contact surface pressure distribution returns to the preset range, and the ultrasonic control system allows the ultrasonic transducer to continue the ultrasonic intervention.

[0016] In a preferred embodiment, the three-axis Hall effect sensor array is composed of three Hall effect sensor elements mounted on the outer shell of the ultrasonic coupler, and each Hall effect sensor element can simultaneously detect the magnetic field strength in three mutually perpendicular directions; wherein the spacing between the first and second Hall effect sensors, and the spacing between the first and third Hall effect sensors are both H D , and H D Satisfies: λ / 2 <H D <λ, where λ is a single periodic pitch of the magnetic field signal generated by the external magnet array in the first direction and the second direction; the three-axis Hall effect sensor array determines the position offset of the ultrasonic coupler by detecting the change in the magnetic field generated by the external magnet array, and when it is detected that the position offset of the ultrasonic coupler exceeds a preset range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer relative to the head until the position offset returns to the preset range, and the ultrasonic control system allows the ultrasonic transducer to continue the ultrasonic intervention.

[0017] In a preferred embodiment, during the calibration phase before the start of ultrasound treatment, the ultrasound coupler is accurately placed at a predetermined target position on the scalp, and at this time, the contact surface pressure distribution is initially measured by the three-axis pressure sensor array. The measurement involves the pressure components detected by each three-axis pressure sensor in three spatial directions, and the pressure components are combined into a vector sum to determine the vector sum of the three-axis pressure sensors in the calibration state.

[0018] During operation, the three-axis pressure sensor array continues to monitor the changes in the pressure distribution on the contact surface in real time, and records the pressure component of each sensor at any time t, and then calculates the vector sum of the three-axis pressure sensors at time t.

[0019] According to the vector sum of the three-axis pressure sensor in the calibration state And, the vector sum of the three-axis pressure sensor at time t Calculate the time-dependent contact deviation index Z at time t p (t):

[0020]

[0021] According to the time-dependent contact deviation index Z at time t p (t), evaluate the change of contact state, where Z p (t) When the contact surface exceeds the threshold value α0 for excessive extrusion or is lower than the threshold value α1 for non-compacting or falling off, it indicates that the contact surface is over-extruded or not compacted or falling off, and the ultrasonic control system is triggered to respond to guide the user to adjust the position of the ultrasonic coupler.

[0022] In a preferred embodiment, during the calibration phase before the start of ultrasound treatment, the ultrasound coupler is accurately placed at a predetermined target position on the scalp, and at this time, the contact surface pressure distribution is initially measured by the three-axis pressure sensor array. The measurement involves the pressure components detected by each three-axis pressure sensor in three spatial directions, and the pressure components are combined into a vector sum to determine the vector sum of the three-axis pressure sensors in the calibration state.

[0023] During operation, the three-axis pressure sensor array continues to monitor the changes in the pressure distribution on the contact surface in real time, and records the pressure component of each sensor at any time t, and then calculates the vector sum of the three-axis pressure sensors at time t.

[0024] According to the vector sum of the three-axis pressure sensor in the calibration state And, the vector sum of the three-axis pressure sensor at time t Calculate the contact surface pressure signal S(t) at time t:

[0025]

[0026] When relative sliding occurs between the object and the triaxial pressure sensor, the contact surface pressure signal will mutate. The contact surface pressure signal S(t) at time t is transformed by a single-layer discrete wavelet transform using Haar wavelet as the wavelet basis function. The high-frequency component of the discrete wavelet transform is expressed as the sliding friction index Z s .

[0027] When the sliding friction index Z s The absolute value of Z s |When the threshold value β of the sliding friction index is exceeded, it indicates that there may be sliding deviation, and the ultrasonic control system will trigger a warning and instruct the user to adjust the position of the ultrasonic coupler.

[0028] In a preferred embodiment, during the calibration process before ultrasound intervention, the device places the ultrasound coupler at a predetermined target position on the scalp and uses the external magnet array to record the coordinates x of the Hall effect sensor in the calibration state. n ,yn ,z n ;

[0029] During operation, the device continues to record in real time the coordinates X of the nth Hall effect sensor at time t during the treatment process. n (t),Y n (t),Z n (t), and based on the coordinate x of the Hall effect sensor in the calibration state n ,y n ,z n , and the coordinate X of the Hall effect sensor n (t),Y n (t),Z n (t), calculating a homogeneous transformation matrix [A], wherein the homogeneous transformation matrix [A] is used to track the position changes of the ultrasonic transducer and its treatment focus during operation;

[0030] The device applies a homogeneous transformation matrix [A] to the focal coordinate x of the ultrasonic transducer in the calibration state. F ,y F ,z F Calculate the coordinate X of the focus of the ultrasonic transducer at time t F (t),Y F (t),Z F (t), and calculate the focus offset D at time t F (t):

[0031]

[0032] And, when the focus offset D F (t) exceeds the preset threshold value δ0 of the smaller offset of the focal position and the sliding friction index Z detected by the three-axis pressure sensor array s When the preset sliding friction index threshold β is exceeded, or when the focus offset D at time t F (t) When the preset threshold value δ1 of the larger focus position offset is directly exceeded, the ultrasonic control system will suspend the ultrasonic intervention and remind the user to adjust the position of the ultrasonic transducer, where 0<δ0<δ1.

[0033] In a preferred example, the ultrasonic transducer is disposed in the ultrasonic coupler housing, the three-axis pressure sensor array is disposed at the bottom of the ultrasonic coupler housing and distributed around the ultrasonic transducer, the three-axis Hall effect sensor array is disposed on the ultrasonic coupler housing, and the ultrasonic control system is electrically connected to the ultrasonic transducer, the three-axis pressure sensor array and the three-axis Hall effect sensor array.

[0034] The present application also discloses a method for detecting the contact between an ultrasonic coupler and a scalp during transcranial ultrasound therapy, comprising:

[0035] Under the calibration state of the ultrasonic transducer, the coordinate x of the Hall effect sensor under the calibration state is obtained by measurement or simulation calculation. n ,y n ,z n During the working process, the coordinate X of the Hall effect sensor at time t is obtained in real time n (t),Y n (t),Z n (t), and according to the coordinate x of the Hall effect sensor in the calibration state n ,y n ,z n and the coordinate X of the Hall effect sensor at time t n (t),Y n (t),Z n (t), update the homogeneous transformation matrix [A], and then calculate the coordinate information X of the focus of the ultrasonic transducer at time t according to the homogeneous transformation matrix [A] F (t),Y F (t),Z F (t), then, according to the coordinate information X of the focus of the ultrasonic transducer at the time t F (t),Y F (t),Z F (t), and the expected focal position coordinate x of the ultrasonic transducer F ,y F ,z F , calculate the focus offset D F (t); and,

[0036] Under the calibration state of the ultrasonic transducer, measure the vector sum of the three-axis pressure sensor under the calibration state. During the working process, the vector sum of the three-axis pressure sensor at time t is obtained in real time. Then, according to the vector sum of the three-axis pressure sensor in the calibration state And the vector sum of the three-axis pressure sensor at time t Calculation of the time-dependent contact deviation index Z p (t) and the contact surface pressure signal S(t), and then, the sliding friction index Z is obtained according to the contact surface pressure signal S(t). s ;

[0037] According to the focus offset D F (t), time-dependent contact deviation index Z p (t), and sliding friction index Z s, determine whether the position of the ultrasonic transducer needs to be adjusted.

[0038] In a preferred embodiment, according to the coordinate x of the Hall effect sensor in the calibration state n ,y n ,z n and the coordinate X of the Hall effect sensor at time t n (t),Y n (t),Z n (t), in the step of updating the homogeneous transformation matrix [A]:

[0039]

[0040] In a preferred embodiment, the coordinate information X of the focus of the ultrasonic transducer at time t is calculated according to the homogeneous transformation matrix [A] F (t),Y F (t),Z F In step (t):

[0041]

[0042] In a preferred embodiment, according to the coordinate information X of the focus of the ultrasonic transducer at the time t, F (t),Y F (t),Z F (t), and the expected focal position coordinate x of the ultrasonic transducer F ,y F ,z F , calculate the focus offset D F In step (t):

[0043]

[0044] In a preferred embodiment, according to the vector sum of the three-axis pressure sensor in the calibration state And the vector sum of the three-axis pressure sensor at time t Calculation of the time-dependent contact deviation index Z p (t) and the contact surface pressure signal S(t):

[0045]

[0046]

[0047] In a preferred embodiment, according to the focus offset D F (t), time-dependent contact deviation index Z p (t), and sliding friction index Z s , in the step of determining whether the position of the ultrasonic transducer needs to be adjusted:

[0048] When the focus offset D F (t) exceeds the preset threshold value δ0 of the smaller offset of the focal position and the sliding friction index Z detected by the three-axis pressure sensor array s The absolute value of Z s | When the preset sliding friction index threshold β is exceeded, or when the focus offset D at time t F (t) when the preset threshold value δ1 of the focal position large offset is directly exceeded, the ultrasonic control system will suspend the ultrasonic intervention and remind the user to adjust the position of the ultrasonic transducer, wherein 0<δ0<δ1; or

[0049] When Z p (t) When the contact surface exceeds the threshold value α0 for excessive extrusion or is lower than the threshold value α1 for non-compacting or falling off, it indicates that the contact surface is over-extruded or not compacted or falling off, and the ultrasonic control system is triggered to respond to guide the user to adjust the position of the ultrasonic coupler.

[0050] In a preferred embodiment, the sliding friction index Z is obtained according to the contact surface pressure signal S(t). s The step further includes processing the contact surface pressure signal S(t) using discrete wavelet transform to extract and enhance the signal component reflecting the sliding friction characteristics between the ultrasonic coupler and the scalp contact surface, and generating a sliding friction index Z s , the sliding friction index Z s Used to evaluate the sliding of the ultrasound coupler relative to the scalp surface during treatment.

[0051] In a preferred embodiment, the method is used in a real-time contact monitoring device in transcranial ultrasound therapy as described in any one of the above.

[0052] Compared with the prior art, this application has the following beneficial effects:

[0053] (1) The real-time contact monitoring device proposed in this application uses a three-axis pressure sensor array to directly detect the pressure distribution of the contact surface between the ultrasonic coupler and the scalp, which can accurately reflect the fit status of the ultrasonic coupler and the scalp. When abnormal conditions such as excessive squeezing, lack of compaction or detachment of the contact surface are detected, the ultrasonic control system can promptly suspend the ultrasonic intervention and remind the user to adjust the position, effectively avoiding the problem of the ultrasonic focus deviating from the target and affecting the intervention effect.

[0054] (2) This application uses a three-axis Hall effect sensor array to detect the magnetic field changes generated by an external magnet array, and then determines the position offset of the ultrasonic coupler. By reasonably setting the spacing between the Hall effect sensors, accurate detection of the position offset of the ultrasonic coupler can be achieved. When it is detected that the position offset exceeds the preset range, the ultrasonic control system can suspend the ultrasonic intervention and prompt the user to correct the position, thereby ensuring that the ultrasonic transducer is always aligned with the target area.

[0055] (3) This application uses discrete wavelet transform to process the contact surface pressure signal and extracts the friction index that reflects the sliding condition of the ultrasonic coupler. Combining the focus offset, time-dependent contact deviation index and sliding friction index, the contact state between the ultrasonic coupler and the scalp can be comprehensively evaluated, triggering different levels of warnings to guide the user to adjust the position of the ultrasonic transducer in time and minimize the ultrasonic coupler from falling off or position deviation due to head movement.

[0056] (4) This application uses an external magnet array and a Hall effect sensor array to replace the binocular camera system for spatial positioning of the ultrasonic coupler, which greatly reduces the system complexity and use cost. The magnet array can be directly fixed on the positioning cap, and the Hall effect sensor array can be integrated into the ultrasonic coupler housing. The overall structure is compact and will not bring additional burden to the user. It is very suitable for use in scenarios such as homes or medical institutions.

[0057] (5) The present application realizes the synchronous monitoring of the contact state and spatial position of the ultrasonic coupler, and integrates the pressure information obtained by the three-axis pressure sensor with the position information obtained by the Hall effect sensor, which can more comprehensively and accurately reflect the relative position relationship between the ultrasonic coupler and the scalp, laying the foundation for realizing closed-loop adaptive ultrasonic intervention.

[0058] In summary, the present application is not only simple, compact and low-cost, but also can accurately detect the contact between the ultrasonic coupler and the scalp, solving the problem of the ultrasonic coupler deviating from the specified position or separating from the scalp due to external disturbances such as head movement during transcranial ultrasonic stimulation, thereby improving the convenience and efficiency of treatment, and providing patients with a better treatment experience, which will help to significantly improve the application efficiency and treatment effect of transcranial ultrasonic stimulation technology.

[0059] A large number of technical features are recorded in the specification of this application, which are distributed in various technical solutions. If all possible combinations of technical features of this application (i.e., technical solutions) are to be listed, the specification will be too long. In order to avoid this problem, the various technical features disclosed in the above-mentioned invention content of this application, the various technical features disclosed in the various embodiments and examples below, and the various technical features disclosed in the accompanying drawings can be freely combined with each other to form various new technical solutions (these technical solutions are all deemed to have been recorded in this specification), unless the combination of such technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed, and features C and D are equivalent technical means that play the same role. Technically, only one can be used, and it is impossible to use them at the same time. Feature E can be combined with feature C technically. Then, the solution of A+B+C+D should not be deemed to have been recorded because it is technically infeasible, and the solution of A+B+C+E should be deemed to have been recorded. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. It should be understood that the drawings described below are only some implementation examples of the present invention, and ordinary technicians in this field can also obtain other implementation examples based on these drawings without paying creative work.

[0061] Figure 1 is a schematic diagram of a specific usage scenario of the real-time contact monitoring device for transcranial ultrasound therapy according to the first embodiment of the present application;

[0062] Figure 2 is a schematic cross-sectional structure diagram of an ultrasonic coupler in a real-time contact monitoring device for transcranial ultrasonic therapy according to the first embodiment of the present application;

[0063] Figure 3 is a schematic diagram of the front appearance of an ultrasonic coupler of a real-time contact monitoring device for transcranial ultrasonic therapy according to the first embodiment of the present application;

[0064] Figure 4 is a schematic diagram of the bottom structure of an ultrasonic coupler of a real-time contact monitoring device for transcranial ultrasonic therapy according to the first embodiment of the present application;

[0065] Figure 5 is a schematic cross-sectional structure diagram of a plane where a three-axis Hall effect sensor array in an ultrasonic coupler of a real-time contact monitoring device for transcranial ultrasound therapy is located according to the first embodiment of the present application;

[0066] Figure 6It is a schematic diagram of the arrangement of a single group of Halbach magnet arrays and the distribution of magnetic flux lines of a real-time contact monitoring device for transcranial ultrasound therapy according to the first embodiment of the present application;

[0067] Figure 7 is a schematic diagram of the arrangement of two groups of orthogonal Halbach magnet arrays of a real-time contact monitoring device for transcranial ultrasound therapy according to the first embodiment of the present application;

[0068] Figure 8 is a schematic diagram of switching of the Hall effect sensors H1 and H2 when the three-axis Hall effect sensor of the real-time contact monitoring device for transcranial ultrasound therapy according to the first embodiment of the present application moves in the x-axis direction;

[0069] Fig. 9 is a schematic diagram of the arrangement of Hall effect sensors and magnetic field pitch when the three-axis Hall effect sensor of the real-time contact monitoring device for transcranial ultrasound therapy according to the first embodiment of the present application moves in the x-axis direction;

[0070] Fig.10 is a schematic diagram of an alarm determination flow chart of a real-time contact monitoring device for transcranial ultrasound therapy according to the first embodiment of the present application;

[0071] Fig.11 It is a flow chart of a real-time contact monitoring method for transcranial ultrasound therapy according to the second embodiment of the present application.

[0072] In each of the accompanying drawings, the symbols are as follows:

[0073] A-Ultrasonic Coupler

[0074] B-Positioning Cap

[0075] C-External Magnet Array

[0076] 1-Ultrasonic coupler upper shell

[0077] 2-Ultrasonic transducer

[0078] 3-Ultrasonic coupler lower housing cover

[0079] 4-Ultrasonic coupler lower shell

[0080] 5-Three-axis Hall Effect Sensor

[0081] 6-Triaxial Pressure Sensor Array

[0082] 7-Polymer sound-conducting substrate DETAILED DESCRIPTION

[0083] In the following description, many technical details are provided to help readers better understand the present application. However, those skilled in the art can understand that the technical solution claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0084] Description of some concepts:

[0085] Transcranial Ultrasound Stimulation (TUS) is a non-invasive neuromodulation technology that uses low-intensity, low-frequency focused ultrasound to stimulate specific nerves or functional areas in the brain to modulate brain nerve activity. Compared with other neuromodulation technologies, it has the advantages of being non-invasive, having a large stimulation depth, and having a high spatial resolution.

[0086] Ultrasound Coupler A: A device used to accommodate and fix an ultrasonic transducer 2, usually in contact with the scalp, and used to conduct ultrasonic waves into the skull.

[0087] Ultrasound Transducer 2: A device that can convert electrical signals into ultrasonic waves, or convert ultrasonic waves into electrical signals. In TUS, the ultrasonic transducer 2 is used to emit ultrasonic waves for brain stimulation.

[0088] Positioning Cap B: A head device used to fix the position of ultrasonic coupler A, usually with a reserved opening for accommodating ultrasonic coupler A.

[0089] External Magnet Array C: A magnet array C installed on the positioning cap B or other locations, used to form a specific magnetic field distribution in different directions.

[0090] Three-axis pressure sensor array 6 (Three-axis Pressure Sensor Array): An array that integrates multiple three-axis pressure sensors and is used to detect the pressure distribution on the contact surface between the ultrasonic coupler A and the scalp.

[0091] Three-axis Hall Effect Sensor Array 5: An array that integrates multiple three-axis Hall Effect sensors, used to detect the magnetic field changes generated by the external magnet array C, and then determine the position offset of the ultrasonic coupler A.

[0092] Ultrasound Control System: A system for controlling the working state of the ultrasonic transducer 2, which monitors and adjusts the ultrasonic intervention process according to the detection results of the three-axis pressure sensor array 6 and the Hall effect sensor array 5.

[0093] Contact Surface Pressure Distribution: The pressure distribution on the contact surface between ultrasonic coupler A and scalp reflects the fit between ultrasonic coupler A and scalp.

[0094] Position Offset: The offset of the ultrasonic coupler A relative to the initial position or preset position, which can be determined by detecting the magnetic field change of the external magnet array C.

[0095] The following is a brief description of some of the innovative features of this application:

[0096] The inventor of the present application has proposed a method and device for real-time detection of the contact between the ultrasonic coupler A and the scalp in the transcranial ultrasound stimulation scene through extensive and in-depth research, so as to solve the problem of the ultrasonic coupler A deviating from the specified position or separating from the scalp due to external disturbances such as head movement during the transcranial ultrasound stimulation process. The method for monitoring and adjusting the position of the ultrasonic transducer 2 in the transcranial ultrasound treatment of the present application is mainly implemented by the following steps: first, in the calibration state of the ultrasonic transducer 2, the expected coordinates of the focus are measured or calculated; secondly, during the working process, the Hall effect sensor array 5 is used to detect the magnetic field change of the external magnet array C, and the real-time coordinates of the ultrasonic transducer 2 are calculated; then, the real-time coordinates of the ultrasonic transducer 2 are compared with the expected focus coordinates, and the real-time offset of the focus is calculated; at the same time, according to the contact surface pressure distribution measured by the three-axis pressure sensor array 6, the contact deviation index and the sliding friction index are calculated; finally, the focus offset, the contact deviation index and the sliding friction index are comprehensively evaluated to determine whether the position of the ultrasonic transducer 2 needs to be adjusted.

[0097] Furthermore, the present application collects the spatial coordinate information of the ultrasonic transducer 2 and its attached Hall effect sensor in real time during operation, uses these data to update the homogeneous transformation matrix, and then calculates the actual position of the ultrasound treatment focus at a specific moment. By comparing the difference between the actual focus position and the predetermined (calibrated) focus position, the offset of the treatment focus is accurately calculated.

[0098] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0099] The first embodiment of the present application relates to a real-time contact monitoring device for transcranial ultrasound therapy, the structure of which is as follows: Figures 1 to 5 As shown, combined Figures 6 to 9 The device comprises: a positioning cap B, an external magnet array C, an ultrasonic coupler A and an ultrasonic control system (not shown in the figure), wherein:

[0100] The positioning cap B is provided with an opening at the ultrasonic intervention target point to accommodate the ultrasonic coupler A. For ease of understanding, Figure 1 Schematic diagram of the ultrasonic coupler upper housing 1 , the ultrasonic coupler lower housing 4 , and the ultrasonic coupler lower housing cover 3 are shown.

[0101] The external magnet array C is configured to generate a periodically varying magnetic field in at least one direction to support position monitoring and calibration.

[0102] The ultrasonic coupler A includes: an ultrasonic transducer 2, a three-axis pressure sensor array 6 for detecting in real time the pressure distribution information of the contact surface between the ultrasonic coupler A and the scalp, and a three-axis Hall effect sensor array 5 for detecting the change of the magnetic field signal generated by the external magnet array C to determine the position deviation of the ultrasonic coupler A.

[0103] The ultrasonic control system is used to control the working state of the ultrasonic transducer 2 according to the contact surface pressure distribution information detected by the three-axis pressure sensor array 6 and the position offset detected by the three-axis Hall effect sensor array 5.

[0104] The first embodiment of the present application proposes a device for real-time monitoring of the contact between the ultrasonic coupler A and the scalp during transcranial ultrasound therapy, wherein the positioning cap B has an opening at the ultrasonic intervention target position to accommodate the ultrasonic coupler A, so that the ultrasonic coupler A can be easily and accurately positioned to the target area of ​​the head. The external magnet array C can generate a periodically changing magnetic field in at least one direction to provide support for position monitoring and calibration. By detecting the change in the magnetic field, it can be determined whether the ultrasonic coupler A has a position shift. The ultrasonic coupler A integrates an ultrasonic transducer 2, a three-axis pressure sensor array 6, and a three-axis Hall effect sensor array 5. The three-axis pressure sensor array 6 is used to detect the contact surface pressure distribution between the ultrasonic coupler A and the scalp in real time, and the Hall effect sensor array 5 is used to detect the change in the magnetic field generated by the external magnet array C to determine whether the ultrasonic coupler A has a position shift. The ultrasonic control system controls the working state of the ultrasonic transducer 2 according to the contact surface pressure distribution information detected by the three-axis pressure sensor array 6 and the position deviation detected by the Hall effect sensor array 5. When abnormal contact surface pressure or position deviation beyond the allowable range is detected, the ultrasonic output can be suspended and the user can be prompted to adjust to ensure the safety and effectiveness of the treatment.

[0105] This device uses a comprehensive monitoring system to achieve real-time monitoring of the contact between the ultrasonic coupler A and the scalp and accurate judgment of the position deviation of the ultrasonic coupler A. In this way, when the position of the ultrasonic coupler A changes due to external disturbances such as head movement, it can quickly make adjustments and respond, ensuring the effectiveness and accuracy of the treatment, thereby improving the application efficiency and treatment effect of transcranial ultrasound therapy technology.

[0106] Optionally, the external magnet array C is mounted on the positioning cap B, and the external magnet array C forms a periodically varying magnetic field signal in a first direction and a second direction.

[0107] Specifically, the external magnet array C can be installed on the positioning cap B, which is an optional configuration. The purpose of installing on the positioning cap B is to use the positioning cap B as a fixed structure to ensure that the magnet array C and the head maintain a relatively stable positional relationship, thereby effectively generating and utilizing the magnetic field. It should be noted that in other embodiments of the present application, the external magnet array C can be set in different positions as needed, for example, it can also be set in the ultrasonic coupler A, etc.

[0108] Furthermore, the external magnet array C can form a periodically changing magnetic field signal in the first direction and the second direction. This means that the magnet array C not only generates a static magnetic field, but also the magnetic field changes periodically over time in two directions. This periodically changing magnetic field helps to improve the accuracy of positioning and monitoring. By analyzing these changing magnetic field signals, the position of the ultrasonic coupler A relative to the head can be determined more accurately, especially when making fine position adjustments.

[0109] Periodically changing magnetic field signals can provide richer information and can be used in more complex or sophisticated position monitoring and calibration algorithms compared to static magnetic fields. For example, by analyzing parameters such as the phase, frequency, and amplitude of periodically changing magnetic field signals, the position and direction of ultrasonic coupler A, as well as whether it has moved or rotated, can be more accurately inferred.

[0110] Overall, this configuration provides a flexible and effective way to utilize magnetic fields for precise position monitoring and calibration, especially in transcranial ultrasound therapy applications where high-precision positioning is required.

[0111] Optionally, the external magnet array C is formed by superimposing two groups of orthogonal Halbach magnet arrays C, so as to form a periodically varying magnetic field signal in the first direction and the second direction, and the single period pitch of the magnetic field signal in the first direction and the second direction is λ.

[0112] In this case, the external magnet array C is formed by superimposing two sets of orthogonal (i.e. perpendicular to each other) Halbach magnet arrays C. Halbach magnet array C is a specially arranged permanent magnet structure designed to enhance the magnetic field on one side of the array and weaken or almost eliminate it on the other side. By superimposing two sets of orthogonal Halbach magnet arrays C in this way, a magnetic field distribution with specific characteristics in two perpendicular directions can be created.

[0113] The configuration of the magnet array C enables the formation of periodically changing magnetic field signals in the first direction and the second direction. The "periodic change" here refers to the regular change of magnetic field intensity with position change, similar to a wave pattern, and this change is carried out independently along two perpendicular directions.

[0114] The pitch of a single cycle of the magnetic field signal in the first direction and the second direction is defined as λ. The pitch λ refers to the spatial length within a complete cycle in the periodic change pattern of the magnetic field strength. In this configuration, whether in the first direction or the second direction, the spatial distance covered by the change of the magnetic field strength from increase to decrease and then back to increase is λ, which indicates that the periodic change of the magnetic field is uniform and regular in these two directions.

[0115] The advantage of this is that it can provide a regular magnetic field variation pattern, which can be used to accurately monitor and calibrate the position of the device, especially when used in conjunction with the three-axis Hall effect sensor array 5. This special application of the Halbach magnet array C, by forming a periodically varying magnetic field in two orthogonal directions, makes it possible to achieve accurate position detection in complex spaces, greatly enhancing the system's position monitoring and calibration capabilities.

[0116] Optionally, the contact surface pressure distribution information refers to the time-dependent contact deviation index Z of the contact surface between the ultrasonic coupler A and the scalp. p (t), and the sliding friction index Z between the contact surface of the ultrasonic coupler A and the scalp s The position offset refers to the focus offset D of the ultrasonic wave generated by the ultrasonic transducer 2 at time t F (t).

[0117] Optionally, the three-axis pressure sensor array 6 detects the contact surface pressure distribution between the ultrasonic coupler A and the scalp in real time, and can judge the degree of fit of each site based on the contact surface pressure distribution; when the contact surface pressure distribution detected by the three-axis pressure sensor array 6 deviates from a preset range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer 2 relative to the head until the contact surface pressure distribution returns to the preset range, and the ultrasonic control system allows the ultrasonic transducer 2 to continue the ultrasonic intervention.

[0118] Optionally, the three-axis Hall effect sensor array 5 is composed of three Hall effect sensor elements mounted on the outer shell of the ultrasonic coupler A, each Hall effect sensor element can simultaneously detect the magnetic field strength in three mutually perpendicular directions; wherein the spacing between the first and second Hall effect sensors, and the spacing between the first and third Hall effect sensors are both H D , and H D Satisfies: λ / 2 <H D <λ, where λ is a single periodic pitch of the magnetic field signal generated by the external magnet array C in the first direction and the second direction; the three-axis Hall effect sensor array 5 determines the position offset of the ultrasonic coupler A by detecting the change of the magnetic field generated by the external magnet array C. When it is detected that the position offset of the ultrasonic coupler A exceeds the preset range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer 2 relative to the head until the position offset is restored to the preset range, and the ultrasonic control system allows the ultrasonic transducer 2 to continue the ultrasonic intervention. It is worth noting that the present application is not limited to the specific implementation of three Hall effect sensors. In other embodiments, the number and arrangement of the Hall effect sensors can be flexibly adjusted according to actual needs and application scenarios to achieve accurate detection of the position offset of the ultrasonic coupler. For example, the number of Hall effect sensors can be increased to improve the detection accuracy, or the layout of the sensors can be optimized according to the structural characteristics of the ultrasonic coupler to obtain the best detection performance. In short, those skilled in the art can make reasonable designs and improvements based on specific problems under the enlightenment of this application, which are all within the scope of protection of this application.

[0119] Optionally, in the calibration stage before the start of ultrasound treatment, the ultrasound coupler A is accurately placed at the predetermined target position of the scalp, and the contact surface pressure distribution is initially measured by the three-axis pressure sensor array 6. The measurement involves the pressure components detected by each three-axis pressure sensor in three spatial directions, and the pressure components are combined into a vector sum to determine the vector sum of the three-axis pressure sensors in the calibration state.

[0120] Furthermore, during operation, the three-axis pressure sensor array 6 continues to monitor the changes in the pressure distribution on the contact surface in real time, and records the pressure component of each sensor at any time t, and then calculates the vector sum of the three-axis pressure sensors at time t.

[0121] According to the vector sum of the three-axis pressure sensor in the calibration state And, the vector sum of the three-axis pressure sensor at time t Calculate the time-dependent contact deviation index Z at time t p(t):

[0122]

[0123] According to the time-dependent contact deviation index Z at time t p (t), evaluate the change of contact state, where Z p (t) When the contact surface exceeds the threshold value α0 for excessive extrusion or is lower than the threshold value α1 for non-compacting or falling off, it indicates that the contact surface is over-extruded or not compacted or falling off, and the ultrasonic control system is triggered to respond to guide the user to adjust the position of the ultrasonic coupler A.

[0124] More specifically, in this embodiment, the Halbach magnet array C is composed of two groups of Halbach magnets arranged orthogonally (at a 90-degree angle). Each group of magnets is arranged in such a way that the magnetic field is significantly enhanced on one side of the array, while it is weakened or even almost eliminated on the other side. Such a structure is unique in physics and engineering because it allows for more effective control of the direction and strength of the magnetic field.

[0125] Due to the special arrangement of the Halbach magnet array C, the magnetic field generated is not static, but changes periodically in two perpendicular directions as the position changes. This change pattern is similar to a waveform, in which the magnetic field strength increases and decreases regularly in space.

[0126] Furthermore, the pitch λ is defined as the spatial length required for the magnetic field intensity to undergo a complete increase and decrease cycle. This means that the distance covered by the magnetic field from a maximum value to a minimum value and then rising back to the next maximum value is λ. In this embodiment, this pitch is the same in two perpendicular directions, ensuring the uniformity and regularity of the magnetic field change.

[0127] The benefits of doing so are that, firstly, the periodic variation characteristics of the magnetic field, combined with the three-axis Hall effect sensor array 5, provide the system with a high-precision position detection mechanism. This means that by analyzing the data of the magnetic field variation, the system can accurately monitor and calibrate the position of the ultrasonic coupler A to ensure the accuracy and effectiveness of the treatment. Secondly, by generating a periodically varying magnetic field in two orthogonal directions, the position monitoring and calibration capabilities of the system are greatly enhanced, especially in transcranial ultrasound treatment scenarios that require high precision and high stability.

[0128] In summary, by utilizing the specific magnetic field characteristics generated by the Halbach magnet array C, the design of this embodiment optimizes the position monitoring and calibration process of the ultrasonic coupler A, and provides technical support for improving the accuracy and effect of transcranial ultrasound therapy.

[0129] Optionally, in the calibration stage before the start of ultrasound treatment, the ultrasound coupler A is accurately placed at the predetermined target position of the scalp, and the contact surface pressure distribution is initially measured by the three-axis pressure sensor array 6. The measurement involves the pressure components detected by each three-axis pressure sensor in three spatial directions, and the pressure components are combined into a vector sum to determine the vector sum of the three-axis pressure sensors in the calibration state.

[0130] Furthermore, during operation, the three-axis pressure sensor array 6 continues to monitor the changes in the pressure distribution on the contact surface in real time, and records the pressure component of each sensor at any time t, and then calculates the vector sum of the three-axis pressure sensors at time t.

[0131] According to the vector sum of the three-axis pressure sensor in the calibration state And, the vector sum of the three-axis pressure sensor at time t Calculate the contact surface pressure signal S(t) at time t:

[0132]

[0133] When relative sliding occurs between the object and the triaxial pressure sensor, the contact surface pressure signal will mutate. The contact surface pressure signal S(t) at time t is transformed by a single-layer discrete wavelet transform using Haar wavelet as the wavelet basis function. The high-frequency component of the discrete wavelet transform is expressed as the sliding friction index Z s . In other words, when the pressure sensor and the contact object slide relative to each other, the pressure signal on the contact surface will mutate or jump due to the change in friction. In order to detect this sudden change in the pressure signal, the wavelet transform method is optionally used. Wavelet transform is a time-frequency analysis tool that can provide time domain and frequency domain information of the signal at the same time. It is similar to a step function and is therefore suitable for detecting sudden changes in the signal. For the pressure signal S(t) collected at time t, a single-layer discrete wavelet transform is performed using the Haar wavelet. The discrete wavelet transform decomposes the signal into low-frequency components (approximate components) and high-frequency components (detail components). Since the sudden change in the pressure signal is mainly reflected in the high-frequency component, the high-frequency component of the wavelet transform is extracted as a sliding friction indicator, denoted as Z s By analyzing the sliding friction index Z s By observing the changes in the pressure, it is possible to determine whether relative sliding has occurred between the pressure sensor and the contact object, as well as information such as the sliding time and intensity.

[0134] When the sliding friction index Z s The absolute value of Z s|When the threshold value β of the sliding friction index is exceeded, it indicates that there may be sliding deviation, and the ultrasonic control system will trigger a warning and instruct the user to adjust the position of the ultrasonic coupler A.

[0135] More specifically, during the calibration phase, before the ultrasound treatment begins, the ultrasound coupler A is precisely placed at a predetermined target location on the scalp. This is to ensure the accuracy of the treatment. An initial measurement of the contact surface pressure distribution is performed using a triaxial pressure sensor array 6. Each triaxial pressure sensor detects pressure components in three spatial directions (x, y, z), and then combines these components into a vector sum to determine the pressure baseline in the calibration state.

[0136] During operation, the three-axis pressure sensor array 6 continuously monitors the changes in the pressure distribution of the contact surface in real time, records the pressure component of each sensor at any time, and calculates the vector sum at that time.

[0137] Next, the contact surface pressure signal S(t) at time t is calculated using the vector sum in the calibration state and the vector sum at any time, which is obtained by measuring the difference between the initial measurement value and the current measurement value.

[0138] As mentioned above, the contact surface pressure signal S(t) at time t is transformed by a single-layer discrete wavelet transform using Haar wavelet as the wavelet basis function. The high-frequency component of the discrete wavelet transform is expressed as the sliding friction index Z s When relative sliding occurs between the object and the triaxial pressure sensor, the sliding friction index Z s A spike will occur if the sliding friction index Z s The absolute value of exceeds the preset threshold value β, which indicates that the ultrasonic coupler A may have slipped and deviated. At this time, the ultrasound control system will issue a warning and instruct the user to adjust the position of the ultrasonic coupler A to restore the correct treatment positioning, thereby quickly correcting any possible device deviation through a real-time feedback mechanism.

[0139] Therefore, the above process ensures the accuracy and effectiveness of ultrasound treatment, and through real-time monitoring and timely adjustment, poor treatment effect caused by sliding or offset of the ultrasound coupler A can be avoided. The application of this technology increases the reliability of treatment and ensures the maximization of treatment effect.

[0140] Optionally, during the calibration process before ultrasound intervention, the device places the ultrasound coupler A at a predetermined target position on the scalp and uses the external magnet array C to record the coordinates x of the Hall effect sensor in the calibration state. n ,y n ,z n ;

[0141] During operation, the device continues to record in real time the coordinates X of the nth Hall effect sensor at time t during the treatment process. n (t),Y n (t),Z n (t), and based on the coordinate x of the Hall effect sensor in the calibration state n ,y n ,z n , and the coordinate X of the Hall effect sensor n (t),Y n (t),Z n (t), calculating a homogeneous transformation matrix [A], wherein the homogeneous transformation matrix [A] is used to track the position changes of the ultrasonic transducer 2 and its treatment focus during operation;

[0142] The device applies a homogeneous transformation matrix [A] to the focal coordinate x of the ultrasonic transducer 2 in the calibration state. F ,y F ,z F Calculate the coordinate X of the focus of ultrasonic transducer 2 at time t F (t),Y F (t),Z F (t), and calculate the focus offset D at time t F (t):

[0143]

[0144] And, when the focus offset D F (t) exceeds the preset threshold value δ0 of the smaller offset of the focus position and the sliding friction index Z detected by the three-axis pressure sensor array 6 s When the preset sliding friction index threshold β is exceeded, or when the focus offset D at time t F (t) When the preset threshold value δ1 of the larger focus position offset is directly exceeded, the ultrasonic control system will suspend the ultrasonic intervention and remind the user to adjust the position of the ultrasonic transducer 2, where 0<δ0<δ1.

[0145] More specifically, during the calibration phase, before the treatment begins, the ultrasonic coupler A is placed at a predetermined target location on the scalp. At this point, the coordinates of the Hall effect sensor in the calibration state are recorded using an external magnet array C. This step provides the basis for ensuring that ultrasound treatment can accurately target the target area. Real-time coordinate recording during operation: During treatment, the system continuously records the coordinates of the Hall effect sensor at any time. Based on the calibration coordinates and the coordinates of the Hall effect sensor during operation, the homogeneous transformation matrix [A] is calculated. This matrix is ​​used to track the position changes of the ultrasonic transducer 2 and its treatment focus during operation. By applying the homogeneous transformation matrix [A] to the focal coordinates in the calibration state, the coordinates of the focus of the ultrasonic transducer 2 at any time are calculated. Calculate the focal offset D at time t F (t). When the offset exceeds the preset smaller threshold and the sliding friction index Z s When the preset sliding friction threshold is exceeded, or when the offset directly exceeds a larger threshold, the ultrasonic control system will pause the treatment and remind the user to adjust the position of the ultrasonic transducer 2 to ensure the accuracy of the treatment.

[0146] It should be pointed out that the advantage of doing so is that the position of the ultrasonic coupler A can be accurately monitored and adjusted in real time to ensure the effectiveness of the treatment. Furthermore, by setting the thresholds (δ0, δ1, β), the system can dynamically respond to position changes to ensure the accuracy of the treatment focus and avoid affecting the treatment effect. The above technical means provide a high-precision and high-flexibility position monitoring and adjustment solution for transcranial ultrasound therapy by comprehensively utilizing the information of the Hall effect sensor and the external magnet array C, as well as advanced mathematical processing methods (such as homogeneous transformation matrices).

[0147] In summary, this embodiment takes into account various positional deviations that may occur during ultrasound treatment, and ensures the effectiveness and safety of treatment to the greatest extent through precise monitoring and timely feedback adjustment mechanisms.

[0148] Optionally, the ultrasonic transducer 2 is disposed in the housing of the ultrasonic coupler A, the three-axis pressure sensor array 6 is disposed at the bottom of the housing of the ultrasonic coupler A and is distributed around the ultrasonic transducer 2, the three-axis Hall effect sensor array 5 is disposed on the housing of the ultrasonic coupler A, and the ultrasonic control system is electrically connected to the ultrasonic transducer 2, the three-axis pressure sensor array 6 and the three-axis Hall effect sensor array 5. It should be noted that in other embodiments of the present application, the specific setting method is not limited to this and can be flexibly adjusted. For example, the position of the magnet can be replaced by installing the magnet in the ultrasonic coupler A, installing the three-axis Hall effect sensor array 5 on the positioning cap B, and so on.

[0149] In order to better understand the technical solution of the present application, a specific example is provided below for illustration. The details listed in the example are mainly for ease of understanding and are not intended to limit the scope of protection of the present application.

[0150] This example relates to a real-time contact monitoring device for transcranial ultrasound therapy, which is used to detect the contact between an ultrasonic coupler A and a scalp. The device includes an ultrasonic transducer 2, a three-axis pressure sensor array 6, a three-axis Hall effect sensor array 5, a housing of an ultrasonic coupler A, an ultrasonic control system, a positioning cap B, and an external magnet array C. The ultrasonic transducer 2, the three-axis pressure sensor array 6, and the three-axis Hall effect sensor array 5 are installed in the ultrasonic coupler A, and the three-axis pressure sensor array 6 is installed at the bottom of the housing of the ultrasonic coupler A and distributed around the ultrasonic transducer 2. The user wears the positioning cap B equipped with the external magnet array C, and the external magnet array C provides magnetic field reference information for the three-axis Hall effect sensor array 5.

[0151] Optionally, in this example, a three-axis pressure sensor is used to measure the pressure conducted on the scalp surface via the polymer sound-conducting material to detect the fit between the ultrasonic coupler A and the scalp surface, and a three-axis Hall effect sensor array 5 is used to measure the magnetic field information of the external magnet array C on the positioning cap B to detect the relative position of the ultrasonic coupler A. Finally, the contact between the ultrasonic coupler A and the scalp is comprehensively judged based on the detection information.

[0152] Specifically, optionally, in this example, the ultrasonic transducer 2 is fixed in the ultrasonic coupler A, a polymer acoustic conductive substrate 7 is installed below the ultrasonic transducer 2, and the ultrasonic coupler A is appropriately squeezed when in contact with the scalp, and the polymer acoustic conductive substrate 7 transmits the pressure to the three-axis pressure sensor array 6 installed on the shell of the ultrasonic coupler A. The three-axis pressure sensor array 6 detects the pressure magnitude and pressure distribution in the three directions of x, y, and z, and then determines the fitting state of the ultrasonic coupler A and the scalp.

[0153] Optionally, in this example, the user wears a positioning cap B equipped with an external magnet array C, and the positioning cap B has an opening at the ultrasonic intervention target position for the placement of the ultrasonic coupler A. Optionally, the external magnet array C is within 5 mm from the edge of the opening of the positioning cap B. The external magnet array C is composed of two groups of orthogonal Halbach magnet arrays C superimposed, and the external magnet array C forms a magnetic field signal with periodic changes in magnetic field intensity in the x and y directions, and the pitch of a single cycle of magnetic field intensity in the x and y directions is λ. In view of the special magnetic field shape, there are magnetic field regions that change linearly with the moving distance and magnetic field regions that change nonlinearly and appear alternately. The three-axis Hall effect sensor array 5 uses the change in magnetic field intensity of the linearly changing magnetic field region to locate the position.

[0154] Optionally, in this example, the three-axis Hall effect sensor array 5 calculates the coordinate information of the three-axis Hall effect sensor according to the periodically changing magnetic field signal generated by the external magnet array C.

[0155] Specifically, the three-axis Hall effect sensor array 5 is composed of three three-axis Hall effect sensors, each of which can simultaneously detect the magnetic field strength in three perpendicular directions. The spacing between the Hall effect sensors H1 and H2 is H D , the distance between the Hall effect sensors H1 and H3 is H D At the same time H D satisfy:

[0156] λ / 2 <H D <λ.

[0157] By setting a reasonable H D The value can ensure that when the Hall effect sensor array 5 moves in a single direction, there is always a Hall effect sensor in the linearly changing magnetic field range, and the direction of movement can be determined by the phase difference between two adjacent Hall effect sensors. For example, in the movement in the x-axis direction, when H2 leaves the linearly changing magnetic field area with the movement, H1 immediately enters the linearly changing magnetic field range and replaces H2 to detect the position information, and the same is true for other directions. Therefore, the spatial position information can be calculated by detecting the magnetic field strength.

[0158] At the same time, the displacement information detected by the three-axis Hall effect sensor array 5 is used to further calculate the ultrasonic focus position offset. When the ultrasonic focus position exceeds the specified range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer 2 relative to the head.

[0159] Optionally, in this example, a method for detecting the contact between the ultrasonic coupler A and the scalp of the real-time contact monitoring device used in the transcranial ultrasound treatment is further proposed, comprising the following steps:

[0160] Before transcranial ultrasound stimulation, the ultrasonic coupler A is placed at the scalp target point for calibration. The three-axis pressure sensor array 6 measures the pressure distribution information of the contact surface at that moment. For the nth three-axis pressure sensor, the detection signal in the calibration state includes three directional components: and Its vector sum is calculated as:

[0161]

[0162] represents the component detected by the nth triaxial pressure sensor in the x direction under calibration;

[0163] represents the component detected by the nth triaxial pressure sensor in the y direction under calibration;

[0164] represents the component detected by the nth triaxial pressure sensor in the z direction under calibration;

[0165] represents the vector sum of the nth triaxial pressure sensor in the calibration state;

[0166] by The direction marked is the calibration direction of a single three-axis pressure sensor;

[0167] Then, the measurement data of the three-axis pressure sensor array 6 is recorded in real time. The detection signal of the nth three-axis pressure sensor at time t is expressed as:

[0168]

[0169] represents the component detected by the nth triaxial pressure sensor in the x direction at time t;

[0170] represents the component detected by the nth triaxial pressure sensor in the y direction at time t;

[0171] represents the component detected by the nth triaxial pressure sensor in the z direction at time t;

[0172] represents the vector sum of the nth triaxial pressure sensor at time t;

[0173] And calculate the time-dependent contact deviation index Z at time t p (t):

[0174]

[0175] When Z p When (t) is greater than the threshold α0 of excessive extrusion of the contact surface, the position is judged to be excessively extruded. p When (t) is less than the threshold value α1 of the contact surface not being compacted or falling off, it is judged that the position is not compacted or falling off, and α0 and α1 are preset parameters selected by the system according to the characteristics of the polymer sound-conducting material.

[0176] And calculate the contact surface pressure signal S(t) at time t:

[0177]

[0178] The S(t) signal is processed using discrete wavelet transform to obtain the sliding friction index Zs , Z s It can reflect the sliding friction information between the ultrasonic coupler A and the scalp surface. s |When it is greater than the threshold value β of the sliding friction index, it is considered that the position may be offset, and further judgment needs to be made in combination with the Hall effect sensor. β is a preset parameter of the system.

[0179] At the same time, before transcranial ultrasound stimulation, the ultrasound coupler A is placed at the scalp target position for calibration, and the three-axis Hall effect sensor array 5 records the coordinate information in the calibration state according to the magnetic field information of the external magnet array C installed on the positioning cap B. After the ultrasound intervention begins, the coordinate information of the Hall effect sensor in the intervention state is recorded in real time, and the homogeneous transformation matrix during the intervention process is calculated.

[0180] The nth Hall Effect Sensor,

[0181]

[0182] x n ,y n ,z n Represents the coordinate information of the nth Hall effect sensor in the calibration state;

[0183] X n (t),Y n (t),Z n (t) represents the coordinate information of the nth Hall effect sensor at time t;

[0184] [A] represents the homogeneous transformation matrix, which can be solved by three or more sets of Hall effect sensor information to obtain [A];

[0185] The sound field and focal position of the ultrasonic transducer 2 are measured or simulated in advance, and the focal position x is calculated in the ultrasonic sound field calibration state. F ,y F ,z F ,

[0186] At the same time, the coordinate information X of the focus of the ultrasonic transducer 2 at time t is calculated according to the homogeneous transformation matrix [A] F (t),Y F (t),Z F (t):

[0187]

[0188] Calculate the focus offset D at time t F (t):

[0189]

[0190] When DF (t) is greater than the threshold value δ0 of the smaller offset of the focus position and the three-axis pressure sensor array 6 detects the sliding friction information |Z s |>β, it is considered that the position offset is too large, and the user needs to be notified to adjust the position of the ultrasonic transducer 2 relative to the head; when D F When (t) is greater than the threshold value δ1 of the larger focus position offset, it is also considered that the current position offset is too large, and the user needs to be notified to adjust the position of the ultrasonic transducer 2 relative to the head; δ0, δ1 are system preset parameters, and δ0<δ1.

[0191] The above embodiments have the following technical effects:

[0192] First, the real-time contact monitoring device of the above embodiment uses the three-axis pressure sensor array 6 to directly detect the pressure distribution of the contact surface between the ultrasonic coupler A and the scalp, which can accurately reflect the fit state between the ultrasonic coupler A and the scalp. When abnormal conditions such as excessive squeezing, lack of compaction or shedding of the contact surface are detected, the ultrasonic control system can promptly suspend the ultrasonic intervention and remind the user to adjust the position, effectively avoiding the problem of the ultrasonic focus deviating from the target point and affecting the intervention effect.

[0193] Furthermore, the above embodiment uses the three-axis Hall effect sensor array 5 to detect the magnetic field change generated by the external magnet array C, and then determines the position offset of the ultrasonic coupler A. By reasonably setting the spacing between the Hall effect sensors, accurate detection of the position offset of the ultrasonic coupler A can be achieved. When it is detected that the position offset exceeds the preset range, the ultrasonic control system can suspend the ultrasonic intervention and prompt the user to perform position correction, thereby ensuring that the ultrasonic transducer 2 is always aligned with the target area.

[0194] Furthermore, the above embodiment uses discrete wavelet transform to process the contact surface pressure signal and extracts the friction index reflecting the sliding condition of the ultrasonic coupler A. Combining the focus offset, the time-dependent contact deviation index and the sliding friction index, the contact state between the ultrasonic coupler A and the scalp can be comprehensively evaluated, and different levels of warnings can be triggered to guide the user to adjust the position of the ultrasonic transducer 2 in time, so as to minimize the fall-off or position shift of the ultrasonic coupler A caused by head movement.

[0195] Furthermore, the above embodiment uses an external magnet array C and a Hall effect sensor array 5 to replace the binocular camera system for spatial positioning of the ultrasonic coupler A, which greatly reduces the system complexity and use cost. The magnet array C can be directly fixed on the positioning cap B, and the Hall effect sensor array 5 can be integrated in the shell of the ultrasonic coupler A. The overall structure is compact and will not bring additional burden to the user, which is very suitable for use in scenarios such as homes or medical institutions.

[0196] Furthermore, the above embodiment realizes the synchronous monitoring of the contact state and spatial position of the ultrasonic coupler A, and integrates the pressure information obtained by the three-axis pressure sensor with the position information obtained by the Hall effect sensor, which can more comprehensively and accurately reflect the relative position relationship between the ultrasonic coupler A and the scalp, laying the foundation for realizing closed-loop adaptive ultrasonic intervention.

[0197] In summary, the above embodiment is not only simple, compact and low-cost, but also can accurately detect the contact between the ultrasonic coupler A and the scalp, thereby solving the problem of the ultrasonic coupler A deviating from the specified position or separating from the scalp due to external disturbances such as head movement during transcranial ultrasonic stimulation. It improves the convenience and efficiency of treatment, and provides patients with a better treatment experience, which will help to significantly improve the application efficiency and treatment effect of transcranial ultrasonic stimulation technology.

[0198] The second embodiment of the present application relates to a real-time contact monitoring method for transcranial ultrasound therapy, and its structure is as follows: Fig.10 and Fig.11 As shown, the method includes:

[0199] The present application also discloses a method for detecting the contact between an ultrasonic coupler A and a scalp during transcranial ultrasound therapy, comprising:

[0200] Step 100: Under the calibration state of the ultrasonic transducer 2, the coordinate x of the Hall effect sensor under the calibration state is obtained by measurement or simulation calculation. n ,y n ,z n ; and, measure the vector sum of the three-axis pressure sensor in the calibration state

[0201] Step 200: During the working process, the coordinate X of the Hall effect sensor at time t is obtained in real time n (t),Y n (t),Z n (t), and according to the coordinate x of the Hall effect sensor in the calibration state n ,y n ,z n and the coordinate X of the Hall effect sensor at time t n (t),Y n (t),Z n (t), update the homogeneous transformation matrix [A], and then calculate the coordinate information X of the focus of the ultrasonic transducer 2 at time t according to the homogeneous transformation matrix [A] F (t),Y F (t),Z F (t), then, according to the coordinate information X of the focus of the ultrasonic transducer 2 at the time t F (t),YF (t),Z F (t), and the expected focal position coordinate x of the ultrasonic transducer 2 F ,y F ,z F , calculate the focus offset D F (t); and, real-time acquisition of the vector sum of the three-axis pressure sensor at time t Then, according to the vector sum of the three-axis pressure sensor in the calibration state And the vector sum of the three-axis pressure sensor at time t Calculation of the time-dependent contact deviation index Z p (t) and the contact surface pressure signal S(t), and then, the sliding friction index Z is obtained according to the contact surface pressure signal S(t). s .

[0202] Step 300: According to the focus offset D F (t), time-dependent contact deviation index Z p (t), and sliding friction index Z s , determine whether the position of the ultrasonic transducer 2 needs to be adjusted.

[0203] Optional, based on the coordinate x of the Hall Effect sensor in the calibration state n ,y n ,z n and the coordinate X of the Hall effect sensor at time t n (t),Y n (t),Z n (t), in the step of updating the homogeneous transformation matrix [A]:

[0204]

[0205] Optionally, the coordinate information X of the focus of the ultrasonic transducer 2 at time t is calculated according to the homogeneous transformation matrix [A] F (t),Y F (t),Z F In step (t):

[0206]

[0207] Optionally, according to the coordinate information X of the focus of the ultrasonic transducer 2 at the time t F (t),Y F (t),Z F (t), and the expected focal position coordinate x of the ultrasonic transducer 2 F ,y F ,z F , calculate the focus offset D FIn step (t):

[0208]

[0209] Optionally, according to the vector sum of the three-axis pressure sensor in the calibration state And the vector sum of the three-axis pressure sensor at time t Calculation of the time-dependent contact deviation index Z p (t) and the contact surface pressure signal S(t):

[0210]

[0211]

[0212] Optionally, according to the focus offset D F (t), time-dependent contact deviation index Z p (t), and sliding friction index Z s , in the step of determining whether the position of the ultrasonic transducer 2 needs to be adjusted:

[0213] When the focus offset D F (t) exceeds the preset threshold value δ0 of the smaller offset of the focus position and the sliding friction index Z detected by the three-axis pressure sensor array 6 s The absolute value of Z s | When the preset sliding friction index threshold β is exceeded, or when the focus offset D at time t F (t) when the preset threshold value δ1 of the focal position large offset is directly exceeded, the ultrasonic control system will suspend the ultrasonic intervention and remind the user to adjust the position of the ultrasonic transducer 2, wherein 0<δ0<δ1; or,

[0214] When Z p (t) When the contact surface exceeds the threshold value α0 for excessive extrusion or is lower than the threshold value α1 for non-compacting or falling off, it indicates that the contact surface is over-extruded or not compacted or falling off, and the ultrasonic control system is triggered to respond to guide the user to adjust the position of the ultrasonic coupler A.

[0215] Optionally, the sliding friction index Z is obtained according to the contact surface pressure signal S(t). s The step further includes processing the contact surface pressure signal S(t) using discrete wavelet transform to extract and enhance the signal component reflecting the sliding friction characteristics between the ultrasonic coupler A and the scalp contact surface, and generating a sliding friction index Z s , the sliding friction index Z s Used to evaluate the sliding of the ultrasonic coupler A relative to the scalp surface during treatment.

[0216] Optionally, the above method can be used in the real-time contact monitoring device in the transcranial ultrasound treatment of the first embodiment.

[0217] It should be emphasized that in the embodiments of the present application, the threshold α0 for excessive contact surface compression, the threshold α1 for uncompacted or detached contact surface, the threshold δ0 for a smaller focus position offset, the threshold δ1 for a larger focus position offset, and the threshold β for the sliding friction index can all be preset according to actual application requirements and treatment goals. This preset allows the system to flexibly adjust the monitoring and response mechanisms according to different treatment situations and patient characteristics to optimize treatment effects and patient safety.

[0218] The first implementation manner is a method implementation manner corresponding to the present implementation manner. The technical details in the first implementation manner can be applied to the present implementation manner, and the technical details in the present implementation manner can also be applied to the first implementation manner.

[0219] It should be noted that in the application documents of this patent, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "including one" do not exclude the existence of other identical elements in the process, method, article or device including the elements. In the application documents of this patent, if it is mentioned that an action is performed according to an element, it means that the action is performed at least according to the element, which includes two situations: performing the action only according to the element, and performing the action according to the element and other elements. Expressions such as multiple, multiple, and multiple include 2, 2 times, 2 kinds, and more than 2, more than 2 times, and more than 2 kinds.

[0220] All documents mentioned in this application are considered to be included in the disclosure of this application as a whole, so that they can be used as the basis for modification when necessary. In addition, it should be understood that after reading the above disclosure of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope of protection claimed in this application.

Claims

1. A real-time contact monitoring device for transcranial ultrasound therapy, the device is used to detect the contact between the ultrasound coupler and the scalp, characterized in that ,The device comprises: a positioning cap, an external magnet array, an ultrasonic coupler and an ultrasonic control system, wherein: The positioning cap is provided with an opening at the ultrasonic intervention target point to accommodate the ultrasonic coupler; The external magnet array is configured to generate a periodically varying magnetic field in at least one direction to support position monitoring and calibration; The ultrasonic coupler comprises: an ultrasonic transducer, a three-axis pressure sensor array for detecting in real time the contact surface pressure distribution information between the ultrasonic coupler and the scalp, and a three-axis Hall effect sensor array for detecting the change of the magnetic field signal generated by the external magnet array to determine the position offset of the ultrasonic coupler; wherein the contact surface pressure distribution information comprises a time-dependent contact deviation index Zp(t) and a sliding friction index Zs of the contact surface between the ultrasonic coupler and the scalp, wherein the time-dependent contact deviation index Zp(t) is used to evaluate the change of the contact state between the ultrasonic coupler and the scalp, and the sliding friction index Zs is used to evaluate the sliding state of the ultrasonic coupler relative to the scalp surface during the treatment process; the position offset refers to the focus offset DF(t) of the ultrasonic wave generated by the ultrasonic transducer at time t; and, according to the vector sum of the three-axis pressure sensors in the calibration state, And, the vector sum of the three-axis pressure sensor at time t Calculate the time-dependent contact deviation index Z at time t p (t) and sliding friction index Zs; The ultrasonic control system is used to control the working state of the ultrasonic transducer according to the contact surface pressure distribution information detected by the three-axis pressure sensor array and the position offset detected by the three-axis Hall effect sensor array.

2. The device according to claim 1, characterized in that The external magnet array is mounted on the positioning cap, and the external magnet array forms a periodically changing magnetic field signal in a first direction and a second direction.

3. The device according to claim 2, characterized in that The external magnet array is formed by superimposing two groups of orthogonal Halbach magnet arrays, so as to form periodically changing magnetic field signals in the first direction and the second direction, and the single period pitch of the magnetic field signal in the first direction and the second direction is λ.

4. The device according to claim 1, characterized in that The three-axis pressure sensor array detects the contact surface pressure distribution between the ultrasonic coupler and the scalp in real time, and can judge the degree of fit of each site according to the contact surface pressure distribution; when the contact surface pressure distribution detected by the three-axis pressure sensor array deviates from a preset range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer relative to the head until the contact surface pressure distribution returns to the preset range, and the ultrasonic control system allows the ultrasonic transducer to continue the ultrasonic intervention.

5. The device according to claim 1, characterized in that The three-axis Hall effect sensor array is composed of three Hall effect sensor elements mounted on the outer shell of the ultrasonic coupler, and each Hall effect sensor element can simultaneously detect the magnetic field strength in three mutually perpendicular directions; wherein the spacing between the first and second Hall effect sensors, and the spacing between the first and third Hall effect sensors are both H D , and H D Satisfies: λ / 2 <H D <λ, where λ is a single periodic pitch of the magnetic field signal generated by the external magnet array in the first direction and the second direction; the three-axis Hall effect sensor array determines the position offset of the ultrasonic coupler by detecting the change in the magnetic field generated by the external magnet array, and when it is detected that the position offset of the ultrasonic coupler exceeds a preset range, the ultrasonic control system suspends the ultrasonic intervention and reminds the user to correct the position of the ultrasonic transducer relative to the head until the position offset returns to the preset range, and the ultrasonic control system allows the ultrasonic transducer to continue the ultrasonic intervention.

6. The device according to claim 1, characterized in that During the calibration phase before the start of ultrasound treatment, the ultrasound coupler is accurately placed at the predetermined target position of the scalp. At this time, the pressure distribution of the contact surface is initially measured by the three-axis pressure sensor array. The measurement involves the pressure components detected by each three-axis pressure sensor in three spatial directions, and they are combined into a vector sum to determine the vector sum of the three-axis pressure sensors in the calibration state. During operation, the three-axis pressure sensor array continues to monitor the changes in the pressure distribution on the contact surface in real time, and records the pressure component of each sensor at any time t, and then calculates the vector sum of the three-axis pressure sensors at time t. Time-dependent contact deviation index Z at time t p The calculation formula of (t) is: According to the time-dependent contact deviation index Z at time t p (t), evaluate the change of contact state, where Z p (t) When the contact surface exceeds the threshold value α0 for excessive extrusion or is lower than the threshold value α1 for non-compacting or falling off, it indicates that the contact surface is over-extruded or not compacted or falling off, and the ultrasonic control system is triggered to respond to guide the user to adjust the position of the ultrasonic coupler.

7. The device according to claim 1, characterized in that During the calibration phase before the start of ultrasound treatment, the ultrasound coupler is accurately placed at the predetermined target position of the scalp. At this time, the pressure distribution of the contact surface is initially measured by the three-axis pressure sensor array. The measurement involves the pressure components detected by each three-axis pressure sensor in three spatial directions, and they are combined into a vector sum to determine the vector sum of the three-axis pressure sensors in the calibration state. During operation, the three-axis pressure sensor array continues to monitor the changes in the pressure distribution on the contact surface in real time, and records the pressure component of each sensor at any time t, and then calculates the vector sum of the three-axis pressure sensors at time t. The calculation formula of the contact surface pressure signal S(t) at time t is: Furthermore, the contact surface pressure signal S(t) at time t is processed by discrete wavelet transform to obtain the sliding friction index Z s ; When the sliding friction index Z s The absolute value of Z s When the threshold value β of the sliding friction index is exceeded, indicating that there may be sliding deviation, the ultrasonic control system will trigger a warning and instruct the user to adjust the position of the ultrasonic coupler.

8. The device according to claim 7, characterized in that During the calibration process before ultrasound intervention, the device places the ultrasound coupler at a predetermined target location on the scalp and uses the external magnet array to record the coordinates x of the Hall effect sensor in the calibration state. n ,y n , z n ; During operation, the device continues to record in real time the coordinates X of the nth Hall effect sensor at time t during the treatment process. n (t), Y n (t), Z n (t), and based on the coordinate x of the Hall effect sensor in the calibration state n ,y n , z n , and the coordinate X of the Hall effect sensor n (t), Y n (t), Z n (t), calculating a homogeneous transformation matrix [A], wherein the homogeneous transformation matrix [A] is used to track the position changes of the ultrasonic transducer and its treatment focus during operation; The device applies a homogeneous transformation matrix [A] to the focal coordinate x of the ultrasonic transducer in the calibration state. F ,y F , z F Calculate the coordinate X of the focus of the ultrasonic transducer at time t F (t), Y F (t), Z F (t), and calculate the focus offset D at time t F (t): And, when the focus offset D F (t) exceeds the preset threshold value δ0 of the smaller offset of the focal position and the sliding friction index Z detected by the three-axis pressure sensor array s When the preset sliding friction index threshold β is exceeded, or when the focus offset D at time t F (t) when the preset threshold value δ1 of the focal position large offset is directly exceeded, the ultrasonic control system will suspend the ultrasonic intervention and remind the user to adjust the position of the ultrasonic transducer, where 0<δ0<δ1; Among them, the sliding friction index Z s It is used to evaluate the sliding condition of the ultrasonic coupler relative to the scalp surface during the treatment process, and the calculation method of the sliding friction index Zs is: using Haar wavelet as the wavelet basis function to perform a single-layer discrete wavelet transform on the contact surface pressure signal S(t) at the time t, and the high-frequency component of the discrete wavelet transform is expressed as the sliding friction index Z s .

9. The device according to claim 1, characterized in that The ultrasonic transducer is arranged in the ultrasonic coupler housing, the three-axis pressure sensor array is arranged at the bottom of the ultrasonic coupler housing and distributed around the ultrasonic transducer, the three-axis Hall effect sensor array is arranged on the ultrasonic coupler housing, and the ultrasonic control system is electrically connected to the ultrasonic transducer, the three-axis pressure sensor array and the three-axis Hall effect sensor array.

10. A method for detecting the contact between an ultrasonic coupler and a scalp in transcranial ultrasound therapy, characterized in that: Include: Under the calibration state of the ultrasonic transducer, the coordinate x of the Hall effect sensor under the calibration state is obtained by measurement or simulation calculation. n ,y n , z n During the working process, the coordinate X of the Hall effect sensor at time t is obtained in real time n (t), Y n (t), Z n (t), and according to the coordinate x of the Hall effect sensor in the calibration state n ,y n , z n and the coordinate X of the Hall effect sensor at time t n (t), Y n (t), Z n (t), update the homogeneous transformation matrix [A], and then calculate the coordinate information X of the focus of the ultrasonic transducer at time t according to the homogeneous transformation matrix [A] F (t), Y F (t), Z F (t), then, according to the coordinate information X of the focus of the ultrasonic transducer at the time t F (t), Y F (t), Z F (t), and the expected focal position coordinate x of the ultrasonic transducer F ,y F , z F , calculate the focus offset D F (t); and, Under the calibration state of the ultrasonic transducer, measure the vector sum of the three-axis pressure sensor under the calibration state. During the working process, the vector sum of the three-axis pressure sensor at time t is obtained in real time. Then, according to the vector sum of the three-axis pressure sensor in the calibration state And the vector sum of the three-axis pressure sensor at time t Calculation of the time-dependent contact deviation index Z p (t) and the contact surface pressure signal S(t), and then, the sliding friction index Z is obtained according to the contact surface pressure signal S(t). s ; According to the focus offset D F (t), time-dependent contact deviation index Z p (t), and sliding friction index Z s , determine whether the position of the ultrasonic transducer needs to be adjusted.

11. The method according to claim 10, characterized in that According to the coordinate x of the Hall effect sensor in the calibration state n ,y n , z n and the coordinate X of the Hall effect sensor at time t n (t), Y n (t), Z n (t), in the step of updating the homogeneous transformation matrix [A]:

12. The method according to claim 10, characterized in that According to the homogeneous transformation matrix [A], the coordinate information X of the focus of the ultrasonic transducer at time t is calculated. F (t), Y F (t), Z F In step (t):

13. The method according to claim 10, characterized in that According to the coordinate information X of the focus of the ultrasonic transducer at time t F (t), Y F (t), Z F (t), and the expected focal position coordinate x of the ultrasonic transducer F ,y F , z F , calculate the focus offset D F In step (t):

14. The method according to claim 10, characterized in that According to the vector sum of the three-axis pressure sensor in the calibration state And the vector sum of the three-axis pressure sensor at time t Calculation of the time-dependent contact deviation index Z p (t) and the contact surface pressure signal S(t):

15. The method according to claim 14, characterized in that According to the focus offset D F (t), time-dependent contact deviation index Z p (t), and sliding friction index Z s , in the step of determining whether the position of the ultrasonic transducer needs to be adjusted: When the focus offset D F (t) exceeds the preset threshold value δ0 of the smaller offset of the focal position and the sliding friction index Z detected by the three-axis pressure sensor array s The absolute value of Z s | When the preset sliding friction index threshold β is exceeded, or when the focus offset D at time t F (t) when the preset threshold value δ1 of the focal position offset is exceeded directly, the ultrasonic control system will suspend the ultrasonic intervention and remind the user to adjust the position of the ultrasonic transducer, where 0<δ0<δ1; or When Z p (t) when the contact surface exceeds the threshold value α0 of excessive extrusion or is lower than the threshold value α1 of non-compacting or falling-off of the contact surface, it indicates that the contact surface is over-extruded or non-compacted or falling-off, and the ultrasonic control system is triggered to respond to guide the user to adjust the position of the ultrasonic coupler; Among them, the sliding friction index Z s It is used to evaluate the sliding condition of the ultrasonic coupler relative to the scalp surface during the treatment process, and the calculation method of the sliding friction index Zs is: using Haar wavelet as the wavelet basis function to perform a single-layer discrete wavelet transform on the contact surface pressure signal S(t) at the time t, and the high-frequency component of the discrete wavelet transform is expressed as the sliding friction index Z s .

16. The method according to claim 10, characterized in that The method is used in the real-time contact monitoring device in transcranial ultrasound therapy as described in any one of claims 1-9.

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