Dual-frequency integrated ultrasonic diagnosis and treatment probe

Abstract

The application discloses a kind of dual-frequency integrated ultrasonic diagnosis and treatment probe, including the zooming warehouse of one side opening, flexible substrate is set in zooming warehouse and has spherical arc surface, low-frequency focusing module and high-frequency imaging module are connected on flexible substrate, and with the electric connection of low-frequency focusing module and high-frequency imaging module intelligent identification system;Low-frequency focusing module is fixed in the inside of flexible substrate;Zooming warehouse center is slidably provided with focusing handle, and the end of focusing handle into zooming warehouse is connected with flexible substrate and high-frequency imaging module, and one end of focusing handle is suitable for moving in zooming warehouse along axis line.According to the detection information of high-frequency imaging module, the spherical surface curvature of flexible substrate and the relative distance between flexible substrate and tissue are adjusted by moving focusing handle, the focusing depth and focal region size of low-frequency focusing module can be adjusted, and real-time imaging can be carried out by cooperating with high-frequency imaging module, so that the ablation position can be adjusted in real time, and the lesion tissue can be accurately focused.

Description

Technical Field

[0001] This invention relates to the field of ultrasound probe technology, specifically to a dual-frequency integrated ultrasound diagnostic and therapeutic probe. Background Technology

[0002] Ultrasound probes are the core components of medical ultrasound diagnostic and therapeutic auxiliary equipment. Currently, in clinical practice, ultrasound is used for applications such as neuromodulation, targeted drug delivery, blood-brain barrier opening, cell screening and culture, and ablation of diseased tissues, utilizing its mechanical, thermal, and physicochemical effects.

[0003] Currently, single-element arc-shaped ultrasound transducers are commonly used both domestically and internationally for neuromodulation and ablation of lesions. This technology is relatively easy to implement in terms of manufacturing and emission control. However, these single-element transducers have limitations in focusing performance after ultrasound penetrates the skull. For complex brain regions involving multiple different targets, including the peripheral nervous system, spinal nerve roots, central nervous system, superficial areas such as the primary motor cortex and fronto-ocular region, and deep structures such as the hippocampus, amygdala, and thalamus, these intricate neural circuits and functional networks require comprehensive, individualized, and precise modulation. Traditional single-element focused ultrasound stimulation devices cannot meet the needs of this multi-target modulation. Compared to single-element systems, phased-array focused ultrasound stimulation systems have many advantages, including improved efficiency, targeting, and flexibility in low-intensity focused ultrasound penetration of the skull. However, phased-array focusing probes require extremely high uniformity in the consistency and spatial arrangement of elements, and the depth adjustment range through phased-array focusing is limited, failing to meet the comprehensive, individualized, and precise applications of neuromodulation and lesion ablation. Summary of the Invention

[0004] Therefore, the present invention aims to solve the problem that existing ultrasound imaging probes cannot meet the requirements of comprehensive, individualized and precise control of neural modulation and ablation of lesions, thereby providing a dual-frequency integrated ultrasound diagnostic and therapeutic probe.

[0005] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0006] A dual-frequency integrated ultrasound diagnostic probe includes a zoom chamber with an opening on one side, a flexible substrate disposed within the zoom chamber, a low-frequency focusing module connected to the flexible substrate, a high-frequency imaging module passing through the center of the flexible substrate, and an intelligent recognition system electrically connected to the low-frequency focusing module and the high-frequency imaging module. The flexible substrate has a spherical arc surface recessed on the side opposite to the opening, and the low-frequency focusing module is fixed within the spherical arc surface of the flexible substrate. A focusing handle is slidably disposed at the center of the side of the zoom chamber away from its opening. One end of the focusing handle entering the zoom chamber is connected to the flexible substrate and the high-frequency imaging module, and the other end of the focusing handle is adapted to move along an axis within the zoom chamber.

[0007] Furthermore, the zoom chamber is provided with a movable chamber fixedly connected to the distal end of the focusing handle, the flexible substrate is disposed in the movable chamber, and the focusing handle is adapted to drive the low-frequency focusing module and the high-frequency imaging module to move within the zoom chamber.

[0008] Furthermore, the zoom chamber is suitable for containing an ultrasonic coupling agent, the distal end of the zoom chamber is detachably provided with a sealing cover, the inner peripheral wall of the proximal end of the zoom chamber is provided with an anti-overflow chamber, the anti-overflow chamber is provided with a negative pressure piston that can slide along its depth direction, and the proximal end of the anti-overflow chamber is provided with a through hole communicating with the outside.

[0009] Furthermore, the zoom chamber has a cylindrical structure, and a frustum-shaped focusing chamber connected to the sealing cover is provided on the zoom chamber. The inner diameter of the focusing chamber gradually decreases from the proximal end to the distal end. The interior of the zoom chamber is conical, and a focusing hole is opened at the tip of the zoom chamber.

[0010] Furthermore, both the outer side of the zoom chamber and the outer side of the focusing chamber are provided with flexible structures.

[0011] Furthermore, the focusing chamber is detachably connected to the variable focus chamber via threads or snaps.

[0012] Furthermore, the inner wall material of the focusing chamber is smooth stainless steel or acrylic.

[0013] Furthermore, the movable compartment is spaced in the middle of the anti-overflow compartment, and the focusing handle is adapted to drive the movable compartment and the high-frequency imaging module to move within the interval between the movable compartment and the anti-overflow compartment.

[0014] Furthermore, the high-frequency imaging module includes a plurality of imaging transducers located at the center of the flexible substrate, and the low-frequency focusing module includes a plurality of diagnostic and therapeutic transducers fixed in a ring array at intervals on the flexible substrate, with the plurality of diagnostic and therapeutic transducers uniformly surrounding the outer periphery of the imaging transducer.

[0015] Furthermore, the distal end of the focusing handle is provided with a straight rod that passes sequentially through the proximal center of the moving chamber and the center of the flexible substrate, and a plurality of the imaging transducers are disposed at the distal end of the straight rod.

[0016] Furthermore, the outer peripheral wall of the focusing handle is provided with scale values.

[0017] Furthermore, it also includes a frequency modulation module electrically connected to the intelligent identification system, the frequency modulation module being electrically connected to the low-frequency focusing module, and the frequency modulation module being adapted to tune the ultrasonic frequency of the low-frequency focusing module to a fundamental frequency of 0.5MHz-3MHz or a third harmonic of 1.5MHz-15MHz.

[0018] Furthermore, a driving structure is provided at the end of the focusing handle away from the flexible substrate, and the driving structure is electrically connected to the intelligent recognition system.

[0019] Furthermore, an adaptive electrical impedance matching network is provided on the side of the flexible substrate away from the diagnostic transducer, and the adaptive electrical impedance matching network is electrically connected to the diagnostic transducer and the imaging transducer.

[0020] Furthermore, the focusing depth of the diagnostic transducer is adjustable from 3cm to 10cm, the target tissue positioning accuracy of the diagnostic transducer is ≥0.5mm, and the output acoustic power is greater than or equal to 3W.

[0021] Furthermore, the distance that one end of the focusing handle moves within the zoom chamber is 0-5cm.

[0022] The technical solution of this invention has the following advantages:

[0023] 1. The dual-frequency integrated ultrasound diagnostic probe provided by this invention performs ultrasound imaging of target tissue through a high-frequency imaging module. Combined with an intelligent recognition system, it can identify the spatial location and pathological state of the target tissue obtained by the high-frequency imaging module. By moving the focusing handle, the spherical curvature of the flexible substrate can be adjusted, thereby adjusting the focusing depth and focal area size of the low-frequency focusing module. Simultaneously, the target depth and target area size of the high-frequency imaging module can be adjusted, achieving real-time imaging of the ablation area. Based on the detection information from the high-frequency imaging module, the focusing depth and focal area size of the low-frequency focusing module can be adjusted, thereby achieving precise focusing on the lesion tissue. Combined with the real-time imaging of the high-frequency imaging module, the focal area can be adjusted in real time, thus allowing for real-time adjustment of the ablation position.

[0024] 2. The dual-frequency integrated ultrasound diagnostic probe provided by this invention includes a movable chamber within a zoom chamber that is fixedly connected to the distal end of the focusing handle. The flexible substrate is disposed within the movable chamber, and the focusing handle is adapted to drive the low-frequency focusing module and the high-frequency imaging module to move within the zoom chamber. This configuration allows the flexible substrate to extend and retract as a whole, changing the position of the center of the arc-shaped flexible substrate, thereby altering the distance between the low-frequency focusing module and the tissue, and thus changing the focusing distance of the low-frequency focusing module.

[0025] 3. The dual-frequency integrated ultrasound diagnostic probe provided by this invention has a zoom chamber suitable for containing ultrasound coupling agent. A detachable sealing cap is provided at the distal end of the zoom chamber, and an anti-overflow chamber is provided on the inner peripheral wall of the proximal end of the zoom chamber. A negative pressure piston that can slide along its depth direction is provided within the anti-overflow chamber, and a through hole communicating with the outside is opened at the proximal end of the anti-overflow chamber. This configuration, with the sealing cap, prevents the ultrasound coupling agent from overflowing; the detachable sealing cap facilitates replacement of the ultrasound coupling agent; and with the anti-overflow chamber and negative pressure piston, when the moving chamber moves within the zoom chamber, the space inside the zoom chamber decreases, and the ultrasound coupling agent in the zoom chamber is forced into the anti-overflow chamber by squeezing the negative pressure piston. This ensures that the zoom chamber is filled with ultrasound coupling agent while also ensuring smooth movement of the focusing handle and the moving chamber within the zoom chamber.

[0026] 4. The dual-frequency integrated ultrasound diagnostic probe provided by this invention features a cylindrical focusing chamber. The focusing chamber is cylindrical, and a frustum-shaped focusing chamber connected to the sealing cover is provided on the focusing chamber. The inner diameter of the focusing chamber gradually decreases from the proximal end to the distal end. The interior of the focusing chamber is conical, and a focusing aperture is formed at the tip of the focusing chamber. This design allows the focusing chamber to reflect sound waves within its space, thereby concentrating the sound waves emitted by the low-frequency focusing module at the tip of the focusing chamber before emitting them through the focusing aperture. This effectively enhances the focusing effect, further improving the probe's long-distance focusing capability, reducing the far-field divergence effect of the probe's acoustic energy, and increasing the intensity of the focused acoustic energy.

[0027] 5. The dual-frequency integrated ultrasound diagnostic probe provided by this invention has a flexible structure on the outer surface of the focusing chamber away from the focusing handle. This design allows the ultrasound probe to better conform to the human body structure and adapt to the irregular surface structure of the human body, thereby achieving close contact with the human body during use and improving the ultrasound detection effect.

[0028] 6. The dual-frequency integrated ultrasound diagnostic probe provided by this invention has a focusing chamber that is detachably connected to the variable focusing chamber via threads or snap-fit. This design facilitates the installation and use of the focusing chamber as needed.

[0029] 7. The dual-frequency integrated ultrasound diagnostic probe provided by the present invention has a movable chamber spaced in the middle of the anti-overflow chamber, and the focusing handle is adapted to drive the movable chamber and the high-frequency imaging module to move within the interval between the movable chamber and the anti-overflow chamber. This configuration allows adjustment of the positions of the low-frequency focusing module and the high-frequency imaging module within the zoom chamber, thereby adjusting the focusing position of the low-frequency focusing module and the imaging area of ​​the high-frequency imaging module.

[0030] 8. The dual-frequency integrated ultrasound diagnostic and therapeutic probe provided by this invention includes a high-frequency imaging module comprising several imaging transducers located at the center of the flexible substrate, and a low-frequency focusing module comprising several diagnostic and therapeutic transducers fixed in a ring array at intervals on the flexible substrate, with the diagnostic and therapeutic transducers uniformly surrounding the outer periphery of the imaging transducers. This configuration enables real-time imaging monitoring of the ablation area through the centrally located imaging transducer, providing real-time images of the ablation area to the diagnostic and therapeutic transducer during ablation-assisted treatment. If the target position shifts during treatment, the diagnostic and therapeutic transducer can immediately adjust its focusing position when the imaging transducer changes position, thereby ensuring that energy is always concentrated on the target point. This integrated imaging and ablation mode can significantly reduce the risk of damage and is crucial in focused tissue ablation-assisted treatment.

[0031] 9. The dual-frequency integrated ultrasound diagnostic probe provided by the present invention has a straight rod at the distal end of the focusing handle that passes sequentially through the proximal center of the movable chamber and the center of the flexible substrate. A plurality of imaging transducers are disposed at the distal end of the straight rod. This arrangement, with the imaging transducers mounted at the distal end of the straight rod passing through the center of the flexible substrate, causes the imaging transducers to protrude beyond at least a portion of the diagnostic transducers, thereby reducing the detection distance of the imaging transducers and improving imaging accuracy.

[0032] 10. The dual-frequency integrated ultrasound diagnostic probe provided by this invention has a scale value set on the outer peripheral wall of the focusing handle. This setting allows for a more intuitive view of the adjusted value through the scale value when adjusting the extension and retraction of the focusing handle, thereby enabling better control over the focal length adjustment of the low-frequency focusing module and the high-frequency imaging module, and effectively improving the focusing accuracy control.

[0033] 11. The dual-frequency integrated ultrasound diagnostic probe provided by the present invention further includes a frequency modulation module electrically connected to the intelligent identification system. The frequency modulation module is electrically connected to the low-frequency focusing module, and the frequency modulation module is adapted to adjust the ultrasound frequency of the low-frequency focusing module to a fundamental frequency of 0.5-3MHz or a third harmonic of 8-50MHz. With this configuration, by adjusting the ultrasound frequency of the low-frequency focusing module to a fundamental frequency of 2MHz, the transducer's working efficiency, absolute total sound pressure level, and focusing area can be improved, adapting to high-energy diagnostic and treatment needs and large-area treatment areas. By adjusting the ultrasound frequency of the low-frequency focusing module to a third harmonic of 8MHz, the transducer's focusing area can be smaller, and the absolute sound pressure level can be reduced, making it suitable for precise control applications in small-area treatment areas.

[0034] 12. The dual-frequency integrated ultrasound diagnostic probe provided by the present invention has a driving structure at the end of the focusing handle away from the flexible substrate, and the driving structure is electrically connected to the intelligent recognition system. This configuration allows for electric focusing via the driving structure; the electrical connection between the driving structure and the intelligent recognition system enables the intelligent recognition system to control the driving structure to adjust the focusing handle when it receives information on the target tissue location and histopathological state from the high-frequency imaging module, thereby controlling the low-frequency focusing module to achieve precise focusing and thus realizing automatic focusing.

[0035] 13. The dual-frequency integrated ultrasound diagnostic and therapeutic probe provided by the present invention has an adaptive electrical impedance matching network disposed on the side of the flexible substrate away from the diagnostic and therapeutic transducer. The adaptive electrical impedance matching network is electrically connected to the diagnostic and therapeutic transducer and the imaging transducer. With this configuration, the adaptive electrical impedance matching network intelligently matches the corresponding electrical impedance circuit structure according to the transducer's operating frequency and operating state, thereby achieving the optimal electro-acoustic conversion efficiency of the transducer array elements. Attached Figure Description

[0036] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0037] Figure 1 This is a cross-sectional view of the dual-frequency integrated ultrasound diagnostic probe provided in an embodiment of the present invention;

[0038] Figure 2 This is a three-dimensional structural diagram of the dual-frequency integrated ultrasound diagnostic and therapeutic probe provided in an embodiment of the present invention;

[0039] Figure 3This is a top view of the dual-frequency integrated ultrasound diagnostic probe provided in an embodiment of the present invention;

[0040] Figure 4 This is a three-dimensional structural diagram of the focusing chamber in an embodiment of the present invention;

[0041] Figure 5 This is a schematic diagram of the simulation results of the focused absolute sound pressure distribution at a fundamental frequency of 2MHz for a diagnostic transducer provided in an embodiment of the present invention;

[0042] Figure 6 This is a schematic diagram of the simulation results of the absolute sound pressure distribution of the third harmonic 8MHz focused transducer provided in an embodiment of the present invention;

[0043] Explanation of reference numerals in the attached diagram: 1. Zoom chamber; 2. Focus chamber; 3. Moving chamber; 4. Anti-overflow chamber; 5. Flexible substrate; 6. Circuit board; 7. Focusing handle; 8. Imaging transducer; 9. Diagnostic transducer; 10. Focusing aperture; 11. Scale value; 12. Through hole; 13. Straight rod; 14. Negative pressure piston. Detailed Implementation

[0044] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] In the description of this invention, it should be noted that the term "far end" refers to the end furthest from the operator, and "proximal end" refers to the end closest to the operator. Terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. These are used solely for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0046] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0047] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0048] like Figures 1-6 The dual-frequency integrated ultrasound diagnostic probe shown includes a zoom chamber 1 with an opening on one side, a flexible substrate 5 disposed within the zoom chamber 1, a low-frequency focusing module connected to the flexible substrate 5, a high-frequency imaging module passing through the center of the flexible substrate 5, and an intelligent recognition system electrically connected to the low-frequency focusing module and the high-frequency imaging module. The flexible substrate 5 has a concave spherical arc surface on the side opposite to the opening, and the low-frequency focusing module is fixed within the spherical arc surface of the flexible substrate 5. A focusing handle 7 is slidably disposed at the center of the side of the zoom chamber 1 away from its opening. One end of the focusing handle 7 that enters the zoom chamber 1 is connected to the flexible substrate 5 and the high-frequency imaging module, and one end of the focusing handle 7 is adapted to move along the axis within the zoom chamber 1.

[0049] This dual-frequency integrated ultrasound diagnostic probe uses a high-frequency imaging module to perform ultrasound imaging on the target tissue. Combined with an intelligent recognition system, it can identify the spatial location and pathological state of the target tissue obtained by the high-frequency imaging module. By moving the focusing handle 7, the spherical curvature of the flexible substrate 5 can be adjusted, thereby regulating the focusing depth and focal area size of the low-frequency focusing module. Simultaneously, it can adjust the target depth and target area size of the high-frequency imaging module, achieving real-time imaging of the ablation area. Based on the detection information from the high-frequency imaging module, the focusing depth and focal area size of the low-frequency focusing module can be adjusted, thus achieving precise focusing on the lesion tissue. Combined with the real-time imaging of the high-frequency imaging module, the focal area can be adjusted in real time, allowing for real-time adjustment of the ablation position.

[0050] The zoom chamber 1 contains a movable chamber 3 fixedly connected to the distal end of the focusing handle 7. The flexible substrate 5 is disposed within the movable chamber 3. The focusing handle 7 is adapted to drive the low-frequency focusing module and the high-frequency imaging module to move within the zoom chamber 1. This configuration allows the flexible substrate 5 to extend and retract as a whole, changing the position of the center of the curved flexible substrate 5. This alters the distance between the low-frequency focusing module and the tissue, thereby changing the focusing distance of the low-frequency focusing module. Specifically, the moving distance of one end of the focusing handle 7 within the zoom chamber 1 is 0-5 cm. By adjusting the relative distance between the low-frequency ultrasound module and the target tissue using the focusing handle 7, the focusing depth of the low-frequency ultrasound module within the tissue is adjusted.

[0051] In this embodiment, a sealing cover is detachably provided at the distal end of the zoom chamber 1, and an anti-overflow chamber 4 is provided on the inner peripheral wall of the proximal end of the zoom chamber 1. A negative pressure piston 14, which can slide along its depth direction, is provided inside the anti-overflow chamber 4, and a through hole 12 communicating with the outside is opened at the proximal end of the anti-overflow chamber 4. This configuration, by providing a sealing cover, prevents the ultrasonic coupling agent from overflowing; the detachable sealing cover facilitates the replacement of the ultrasonic coupling agent; by providing the anti-overflow chamber 4 and the negative pressure piston 14, when the moving chamber 3 moves within the zoom chamber 1, the space inside the zoom chamber 1 decreases, and the ultrasonic coupling agent in the zoom chamber 1 enters the anti-overflow chamber 4 by squeezing the negative pressure piston 14. This ensures that the zoom chamber 1 is filled with ultrasonic coupling agent while also ensuring smooth movement of the focusing handle 7 and the moving chamber 3 within the zoom chamber 1. In an alternative embodiment, several anti-overflow chambers 4 can be arranged at intervals along the inner peripheral wall of the zoom chamber 1, each anti-overflow chamber 4 is provided with a negative pressure piston 14, and the bottom of each anti-overflow chamber 4 communicates with the outside.

[0052] In this embodiment, the zoom chamber 1 has a cylindrical structure, and a frustum-shaped focusing chamber 2 connected to the sealing cover is provided on the zoom chamber 1. The inner diameter of the focusing chamber 2 gradually decreases from the proximal end to the distal end. The interior of the zoom chamber 1 is conical, and a focusing hole 10 is opened at the tip of the zoom chamber 1. Preferably, the slope of the inner wall of the conical focusing chamber 2 is 15°-60°. With this configuration, the sound waves in its space can be reflected by the focusing chamber 2, thereby focusing the sound waves emitted by the low-frequency focusing module at the tip of the focusing chamber 2 and then emitting them out through the focusing hole 10, thereby effectively enhancing the focusing effect, further improving the long-distance focusing capability of the probe, reducing the far-field divergence effect of the probe's acoustic energy, and increasing the intensity of the focused acoustic energy.

[0053] Specifically, the focusing chamber 2 is detachably connected to the variable focusing chamber 1 via threads or snap-fit. This design facilitates the installation and use of the focusing chamber 2 as needed. Specifically, the inner wall of the focusing chamber 2 is smooth and made of stainless steel or acrylic material, exhibiting either total acoustic emission or strong reflection characteristics. Specifically, the depth of the focusing chamber 2 is 3cm-5cm. When sound waves propagate into the tissue through the focusing hole 10 of the focusing chamber 2, the intensity and depth of the focused ultrasound propagating into the tissue can be altered.

[0054] In this embodiment, a flexible water bladder structure is provided on the outer surface of the zoom chamber 1 away from the focusing handle 7. This design allows the ultrasonic probe to better conform to the human body structure and adapt to the irregular surface structure of the human body, thereby achieving a close fit with the human body during use and improving the ultrasonic detection effect.

[0055] In this embodiment, the movable chamber 3 is spaced apart in the middle of the anti-overflow chamber 4, and the focusing handle 7 is adapted to drive the movable chamber 3 and the high-frequency imaging module to move within the interval between the movable chamber 3 and the anti-overflow chamber 4. This arrangement allows adjustment of the positions of the low-frequency focusing module and the high-frequency imaging module within the zoom chamber 1, thereby adjusting the focusing position of the low-frequency focusing module and the imaging area of ​​the high-frequency imaging module.

[0056] In this embodiment, a straight rod 13 is provided at the distal end of the focusing handle 7, passing sequentially through the proximal center of the movable chamber 3 and the center of the flexible substrate 5. A plurality of imaging transducers 8 are disposed at the distal end of the straight rod 13. This arrangement, with the imaging transducers 8 mounted at the distal end of the straight rod 13 passing through the center of the flexible substrate 5, causes the imaging transducers 8 to protrude beyond at least a portion of the diagnostic transducers 9, thereby reducing the detection distance of the imaging transducers 8 and improving imaging accuracy.

[0057] In this embodiment, a scale value 11 is provided on the outer peripheral wall of the focusing handle 7. This design allows the adjusted value to be more intuitively seen through the scale value 11 when adjusting the extension and retraction of the focusing handle 7, thereby enabling better control over the focal length adjustment of the low-frequency focusing module and the high-frequency imaging module, and effectively improving the focusing accuracy control.

[0058] In this embodiment, the high-frequency imaging module includes several imaging transducers 8 located at the center of the flexible substrate 5, and the low-frequency focusing module includes several therapeutic transducers 9 fixed in a ring array at intervals on the flexible substrate 5, with the therapeutic transducers 9 uniformly surrounding the outer periphery of the imaging transducers 8. This configuration allows for real-time imaging monitoring of the ablation area via the centrally located imaging transducer 8, providing real-time images of the ablation area to the therapeutic transducers 9 during ablation-assisted treatment. If the target position shifts during treatment, the therapeutic transducers 9 can immediately adjust their focusing position when the imaging transducers 8 change position, ensuring that energy remains concentrated on the target point. This integrated imaging and ablation mode significantly reduces the risk of damage and is crucial in targeted tissue ablation-assisted treatment. The therapeutic transducers 9 are electrically connected via a circuit board 6. Specifically, the circuit board 6 is located between the bottom of the zoom chamber 1 and the flexible substrate 5.

[0059] In this embodiment, a frequency modulation module electrically connected to the intelligent identification system is also included. This frequency modulation module is electrically connected to the low-frequency focusing module, and is adapted to tune the ultrasonic frequency of the low-frequency focusing module to a fundamental frequency of 3MHz or a third harmonic of 8MHz. This configuration, by tuning the ultrasonic frequency of the low-frequency focusing module to a fundamental frequency of 2MHz, improves transducer efficiency, increases total sound pressure level, and enlarges the focusing area, thus adapting to high-energy diagnostic and treatment needs and large treatment areas. Conversely, by tuning the ultrasonic frequency of the low-frequency focusing module to a third harmonic of 8MHz, the transducer focusing area is smaller, reducing the absolute sound pressure level, making it suitable for precise control applications in small treatment areas. Specifically, the focusing energy is adjusted according to the tissue size; larger tissues require larger focusing ranges and energy, while smaller tissues require smaller focusing ranges and energy.

[0060] In this embodiment, a drive structure is provided at the end of the focusing handle 7 furthest from the flexible substrate 5, and the drive structure is electrically connected to the intelligent recognition system. This configuration allows for motorized focusing via the drive structure. Furthermore, the electrical connection between the drive structure and the intelligent recognition system enables the intelligent recognition system to control the drive structure to adjust the focusing handle 7 when it receives information about the target tissue location and pathological state from the high-frequency imaging module. This allows the intelligent recognition system to control the low-frequency focusing module to achieve precise focusing, thus realizing automatic focusing. Specifically, the drive structure is a high-precision displacement mechanism suitable for driving the focusing handle 7 to move along the X-axis, Y-axis, and Z-axis respectively.

[0061] In this embodiment, an adaptive electrical impedance matching network is provided on the side of the flexible substrate 5 away from the diagnostic transducer 9. The adaptive electrical impedance matching network is electrically connected to the diagnostic transducer 9 and the imaging transducer 8. With this configuration, the adaptive electrical impedance matching network intelligently matches the corresponding electrical impedance circuit structure according to the operating frequency and operating state of the transducer, thereby achieving the optimal electro-acoustic conversion efficiency of the transducer array elements.

[0062] In this embodiment, an adaptive electrical impedance matching network is disposed on the side of the flexible substrate 5 away from the diagnostic transducer 9. This network is electrically connected to both the diagnostic transducer 9 and the imaging transducer 8. This configuration allows the adaptive electrical impedance matching network to intelligently match the corresponding electrical impedance circuit structure based on the transducer's operating frequency and state, achieving optimal electro-acoustic conversion efficiency for the transducer array elements. Specifically, based on the operating frequency and state of the diagnostic transducer 9, the adaptive electrical impedance matching network can intelligently match the corresponding electrical impedance circuit structure to achieve optimal electro-acoustic conversion efficiency for the array elements of the diagnostic transducer 9. The diagnostic transducer 9 has relatively large geometric dimensions and relatively low impedance, resulting in a significant imbalance with the system's electrical transmission impedance. Therefore, the adaptive electrical impedance matching network is needed to achieve bidirectional matching between the diagnostic transducer 9 and the electrical system, reducing electrical reflections and improving the electro-acoustic conversion efficiency of the diagnostic transducer 9. The adaptive electrical impedance matching network employs the Smith chart, used in electronic engineering for impedance matching circuit calculations, to add a bidirectional passive impedance matching network for both transmitting and receiving components between the diagnostic transducer 9 and its connected circuitry. Based on electrical transmission line theory, the transducer's equivalent circuit model uses a six-terminal electromechanical equivalent circuit. Adding a bidirectional passive impedance matching network between the diagnostic transducer 9 and its connected circuitry enables impedance matching between the transducer's input and output.

[0063] In this embodiment, both the diagnostic transducer 9 and the imaging transducer 8 include, from the outside to the inside, a matching layer, an upper electrode layer, a piezoelectric layer, a lower electrode layer, and a backing layer, with multiple matching layers. This arrangement allows for efficient transmission and reception of ultrasound waves through the synergistic effects of acoustic impedance matching, piezoelectric effect conversion, electrical signal transmission, and aftershock absorption, meeting the needs of auxiliary treatment or neuromodulation of lesions at different depths. Specifically, the sound waves generated by the high-frequency vibration of the piezoelectric layer pass through the transducer matching layer, through the flexible water bladder structure, and then reach the biological tissue. The acoustic impedance undergoes multiple conversions. To achieve effective transmission of sound waves into the biological tissue, a multi-layer matching structure is designed for the transducer based on the KLM model and multi-mode filter theory. Each layer is made of a material with corresponding acoustic impedance characteristics, meeting the needs of auxiliary treatment or neuromodulation of lesions at different depths. The diagnostic transducer 9 needs to have adjustable sound energy focusing depth, width, and intensity.

[0064] In this embodiment, the focusing depth of the diagnostic transducer 9 is adjustable from 3cm to 10cm, the target tissue positioning accuracy of the diagnostic transducer 9 is ≥0.5mm, and the output acoustic power is greater than or equal to 3W.

[0065] In this embodiment, a motion control system, an excitation adjustment system, and a host computer are also included, all electrically connected to the intelligent recognition system. The intelligent recognition system includes an artificial intelligence image algorithm unit. The motion control system is electrically connected to the high-precision displacement mechanism, and the excitation adjustment system is electrically connected to the low-frequency focusing module and the high-frequency imaging module. With this configuration, the motion control system primarily controls the motor to move the high-precision mechanism in various dimensions, thereby driving the low-frequency focusing module and the high-frequency imaging module within the probe to move electrically. By adjusting the excitation signal parameters of the excitation adjustment system, the intensity and frequency of the radiated sound field of the low-frequency focusing module and the high-frequency imaging module can be controlled. It can also specifically control the excitation and non-excitation of the diagnostic transducers 9 at certain locations, achieving precise control of the focal zone energy and spatial position.

[0066] In this embodiment, the operation steps of this dual-frequency integrated ultrasound diagnostic probe are as follows:

[0067] S1: The excitation adjustment system sends a high-frequency electrical excitation signal to the high-frequency imaging module, and the imaging transducer 8 is used to accurately locate the target tissue and collect pathological data.

[0068] S2: By displaying ultrasound data images from the device, combined with the artificial intelligence image algorithm unit-assisted diagnostic system, it provides doctors with spatial location and pathological grading information of the lesion tissue, and gives corresponding ultrasound ablation-assisted treatment plans;

[0069] S3: After the doctor determines the ultrasound ablation-assisted treatment plan, the doctor uses image guidance to control the high-precision focus adjustment mechanism to move the diagnostic transducer 9 in the low-frequency focusing module to focus on the target tissue.

[0070] S4: After confirmation by the doctor, ultrasound ablation-assisted treatment is performed through the diagnostic transducer 9. The excitation adjustment system provides an electrical excitation signal of corresponding intensity, and the diagnostic transducer 9 emits corresponding ablation ultrasound energy to irradiate the target tissue with ultrasound.

[0071] S5: During or after ultrasound irradiation-assisted therapy, the cavitation signal of the target area tissue is monitored and the target area tissue is imaged by the imaging transducer 8, and the feedback is sent to the artificial intelligence image algorithm unit.

[0072] S6: By combining images and data information reflecting physiological state, such as clinical MRI / CT / ECG, the AI-assisted diagnosis and treatment system provides further auxiliary treatment suggestions, ultimately achieving the goal of precision diagnosis and treatment.

[0073] In summary, this dual-frequency integrated ultrasound diagnostic probe uses a high-frequency imaging module to perform ultrasound imaging on the target tissue. Combined with an intelligent recognition system, it can identify the spatial location and pathological state of the target tissue obtained by the high-frequency imaging module. By moving the focusing handle 7, the spherical curvature of the flexible substrate 5 can be adjusted, thereby regulating the focusing depth and focal area size of the low-frequency focusing module. Simultaneously, the target depth and target area size of the high-frequency imaging module can be adjusted, enabling real-time imaging of the ablation area. Based on the detection information from the high-frequency imaging module, the focusing depth and focal area size of the low-frequency focusing module can be adjusted, achieving precise focusing on the lesion tissue. Combined with the real-time imaging of the high-frequency imaging module, the focal area can be adjusted in real time, allowing for real-time adjustment of the ablation position.

[0074] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A dual-frequency integrated ultrasound diagnostic probe, characterized in that, The system includes a zoom chamber (1) with an opening on one side, a flexible substrate (5) disposed within the zoom chamber (1), a low-frequency focusing module connected to the flexible substrate (5), a high-frequency imaging module passing through the center of the flexible substrate (5), and an intelligent recognition system electrically connected to the low-frequency focusing module and the high-frequency imaging module; the flexible substrate (5) has a spherical arc surface recessed on the side opposite to the opening, and the low-frequency focusing module is fixed within the spherical arc surface of the flexible substrate (5); a focusing handle (7) is slidably disposed at the center of the side of the zoom chamber (1) away from its opening, and one end of the focusing handle (7) entering the zoom chamber (1) is connected to the flexible substrate (5) and the high-frequency imaging module, and the focusing handle... One end of the handle (7) is adapted to move along the axis within the zoom chamber (1); a movable chamber (3) is provided within the zoom chamber (1) and fixedly connected to the distal end of the focusing handle (7); the flexible substrate (5) is disposed within the movable chamber (3); the focusing handle (7) is adapted to drive the low-frequency focusing module and the high-frequency imaging module to move within the zoom chamber (1); the zoom chamber (1) is adapted to contain an ultrasonic coupling agent; a sealing cover is detachably provided at the distal end of the zoom chamber (1); an anti-overflow chamber (4) is provided on the inner peripheral wall of the proximal end of the zoom chamber (1); a negative pressure piston (14) that can slide along its depth direction is provided within the anti-overflow chamber (4); and a through hole (12) communicating with the outside is opened at the proximal end of the anti-overflow chamber (4).

2. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, The zoom chamber (1) has a cylindrical structure. A frustum-shaped focusing chamber (2) connected to the sealing cover is provided on the zoom chamber (1). The inner diameter of the focusing chamber (2) gradually decreases from the proximal end to the distal end. The interior of the zoom chamber (1) is conical. A focusing hole (10) is opened at the tip of the zoom chamber (1).

3. The dual-frequency integrated ultrasound diagnostic probe according to claim 2, characterized in that, Flexible structures are provided on the outside of both the variable focus chamber (1) and the focusing chamber (2).

4. The dual-frequency integrated ultrasound diagnostic probe according to claim 2, characterized in that, The focusing chamber (2) is detachably connected to the variable focus chamber (1) by threads or snaps.

5. The dual-frequency integrated ultrasound diagnostic probe according to claim 2, characterized in that, The inner wall material of the focusing chamber (2) is smooth stainless steel or acrylic.

6. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, The movable compartment (3) is spaced in the middle of the anti-overflow compartment (4), and the focusing handle (7) is adapted to drive the movable compartment (3) and the high-frequency imaging module to move within the interval between the movable compartment (3) and the anti-overflow compartment (4).

7. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, The high-frequency imaging module includes several imaging transducers (8) located at the center of the flexible substrate (5), and the low-frequency focusing module includes several diagnostic and therapeutic transducers (9) fixed in a ring array on the flexible substrate (5), with the diagnostic and therapeutic transducers (9) uniformly surrounding the outer periphery of the imaging transducer (8).

8. The dual-frequency integrated ultrasound diagnostic probe according to claim 7, characterized in that, The focusing handle (7) has a straight rod (13) that passes through the center of the near end of the moving chamber (3) and the center of the flexible substrate (5) in sequence. Several imaging transducers (8) are all located at the end of the straight rod (13).

9. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, The focusing handle (7) has a scale value (11) on its outer peripheral wall.

10. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, It also includes a frequency modulation module electrically connected to the intelligent identification system, the frequency modulation module being electrically connected to the low-frequency focusing module, and the frequency modulation module being adapted to tune the ultrasonic frequency of the low-frequency focusing module to a fundamental frequency of 0.5MHz-5MHz or a third harmonic of 1.5MHz-15MHz.

11. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, The focusing handle (7) has a driving structure at one end away from the flexible substrate (5), and the driving structure is electrically connected to the intelligent recognition system.

12. The dual-frequency integrated ultrasound diagnostic probe according to claim 7, characterized in that, An adaptive electrical impedance matching network is provided on the side of the flexible substrate (5) away from the diagnostic transducer (9), and the adaptive electrical impedance matching network is electrically connected to the diagnostic transducer (9) and the imaging transducer (8).

13. The dual-frequency integrated ultrasound diagnostic probe according to claim 7, characterized in that, The focusing depth of the diagnostic transducer (9) is adjustable from 3cm to 10cm, the target tissue positioning accuracy of the diagnostic transducer (9) is ≥0.5mm, and the output acoustic power is greater than or equal to 3W.

14. The dual-frequency integrated ultrasound diagnostic probe according to claim 1, characterized in that, The distance that one end of the focusing handle (7) moves within the zoom chamber (1) is 0-5cm.

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