Double-frequency collaborative puncture type tissue damage system

Abstract

The invention relates to a double-frequency collaborative puncture type tissue damage system. The ultrasonic probe unit and the inertial cavitation driving unit are adaptively and electrically connected with the cooperative control unit, and the cooperative control unit can drive the ultrasonic probe unit to emit an activation pulse signal capable of inducing the phase-change nano liquid drops to generate sound-induced evaporation to a target organization structure; enabling the phase-change nano liquid drops in the target tissue structure to form microbubble cloud under the high-frequency activation pulse signal; and the cooperative control unit sends a low-frequency inertial cavitation driving signal to the inertial cavitation driving unit, and configures and drives the inertial cavitation driving unit to be in an inertial cavitation driving state so as to excite the micro-bubble cloud to generate violent inertial cavitation until the micro-bubble cloud expands and then imploses. According to the method, an extremely low energy threshold value is achieved through exogenous cavitation, meanwhile, the activation and damage range of cavitation can be accurately controlled, and safe, efficient and controllable tissue damage is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to a tissue damage system, in particular a dual-frequency collaborative puncture type tissue damage system. BACKGROUND

[0002] Ultrasound Histotripsy is a new non-thermal ablation technology, which uses high-intensity ultrasound pulses to induce mechanical cavitation effects in the target area, that is, the phenomenon of micro-bubble generation, oscillation and collapse occurs in the target area. During this process, the shock waves and mechanical forces such as micro-jets produced can mechanically pulverize the biological tissue in the target area to subcellular structures, while causing minimal thermal damage to the surrounding tissue. This technology has shown application potential in the field of tumor ablation.

[0003] To achieve the cavitation effect required for tissue damage, the prior art mainly adopts two approaches, specifically: The first is extracorporeal "intrinsic threshold" Histotripsy. This scheme uses an extracorporeal high-power ultrasound transducer to focus high energy (high peak negative pressure) to the lesion in the body, forcibly "pulls" out micro-bubbles (cavitation nuclei) in the tissue fluid, and drives them to collapse, thereby producing mechanical damage. However, the energy threshold of this approach is extremely high, usually requiring peak negative pressure of tens of megapascals, which poses a high technical challenge to the ultrasound equipment (especially the transducer and power source). In addition, high-energy pulses can cause cumulative damage when penetrating the pre-focus tissue. At the same time, this approach is limited by the acoustic window, and ultrasound waves cannot effectively penetrate bones (such as ribs) or gas-containing organs (such as the lungs and intestines), limiting its application scenarios.

[0004] The second is "nanodroplet-mediated" Histotripsy (Nanodroplet meditated histotripsy, NMH). To reduce the high energy threshold required by the first approach, this scheme introduces exogenous cavitation nuclei. Its specific implementation is as follows: first, phase-change nanodroplets are injected into the body through intravenous injection or percutaneous puncture, etc. These droplets reach the lesion area, and the extracorporeal high-frequency imaging ultrasound transducer emits a first group of "activation" pulses to cause them to undergo liquid-gas phase change and form micro-sized bubbles. Subsequently, the extracorporeal low-frequency treatment transducer emits a second group of "treatment" pulses to excite these micro-bubbles to produce inertial cavitation, achieving the purpose of tissue damage.

[0005] Although the introduction of nanodroplets can reduce the energy threshold, the damage range may be out of control due to the random flow and diffusion of nanodroplets, causing "misactivation" of droplets on the pre-focus or extra-focus path when activated by extracorporeal ultrasound. In addition, the micro-bubble cloud formed at the focus point will produce a strong "acoustic shielding" effect, blocking the subsequent ultrasound energy from reaching the deep lesion, resulting in uneven damage. SUMMARY

[0006] The purpose of the present application is to overcome the deficiencies in the prior art, and provide a dual-frequency collaborative puncture type tissue damage system which utilizes exogenous cavitation to achieve an extremely low energy threshold, and can also accurately control the activation and damage range of cavitation, to achieve safe, efficient and controllable tissue damage.

[0007] According to the technical scheme provided by the present application, a dual-frequency collaborative puncture type tissue damage system, the tissue damage system comprises a collaborative control unit, and an ultrasonic probe unit and an inertial cavitation driving unit which are electrically connected to the collaborative control unit, wherein, The collaborative control unit can drive the ultrasonic probe unit to emit an activation pulse signal which can induce phase change nanodroplet to undergo acoustic evaporation to the target tissue structure, so that the phase change nanodroplets located in the target tissue structure form a microbubble cloud under the high-frequency activation pulse signal; The inertial cavitation driving unit extends into the target tissue structure, and after the microbubble cloud is formed in the target tissue structure, the microbubble cloud wraps the part of the inertial cavitation driving unit extending into the target tissue structure; The collaborative control unit sends a low-frequency inertial cavitation driving signal to the inertial cavitation driving unit, and configures the inertial cavitation driving unit to be in an inertial cavitation driving state to excite the microbubble cloud to undergo violent inertial cavitation, until the microbubble cloud explodes after swelling.

[0008] The inertial cavitation driving unit at least comprises a puncture needle body and a needle body motion driving mechanism for driving the mechanical motion of the puncture needle body, wherein, The puncture needle body at least punctures into the target tissue structure before the microbubble cloud is formed by the phase change nanofluid, and after the microbubble cloud is formed by the phase change nanofluid, the needle tip part of the puncture needle body is located in the microbubble cloud; The needle body motion driving mechanism is electrically connected to the collaborative control unit, the collaborative control unit loads the low-frequency inertial cavitation driving signal to the needle body motion driving mechanism, and the needle body motion driving mechanism at least drives the needle tip of the puncture needle body to reciprocate in a low-frequency high-amplitude state in the microbubble cloud, so that the inertial cavitation driving unit is in the inertial cavitation driving state.

[0009] The reciprocating motion direction of the puncture needle body driven by the needle body motion driving mechanism is consistent with the axial direction of the puncture needle body, and the reciprocating motion of the needle tip of the puncture needle body is utilized to excite the microbubble cloud to undergo violent inertial cavitation.

[0010] Under the low-frequency inertial cavitation driving signal, the puncture needle body is in a mechanical resonance state driven by the vibration of the needle body motion driving mechanism, and the needle tip of the puncture needle body is located at the displacement antinode of the longitudinal vibration, so that the puncture needle body can move along the axial direction of the puncture needle body; The displacement amplitude of the tip of the puncture needle body in the axial direction is 30 μm to 120 μm.

[0011] The puncture needle body further comprises a plurality of injection channels for injecting phase change nanodroplets into the target tissue structure. When the puncture needle body has the injection channels, the puncture needle body is guided to puncture into the target tissue structure, and then the phase change nanodroplets in the injection channels are injected into the target tissue structure through the tip of the puncture needle body. After the phase change nanodroplets are injected into the target tissue structure, the tip of the puncture needle body remains in the target tissue structure.

[0012] The puncture needle body adopts an acoustic waveguide mode, and the length of the puncture needle body is:

[0013] Wherein, L is the length of the puncture needle body, n is an integer, λ is the wavelength corresponding to the vibration frequency of the needle movement driving mechanism.

[0014] The needle movement driving mechanism comprises a low-frequency transducer as a vibration source and an acoustic horn connected with the low-frequency transducer, wherein, The low-frequency transducer is fixedly connected with the tail of the puncture needle body through the acoustic horn; The low-frequency transducer vibrates under the action of a low-frequency inertial cavitation driving signal, and drives the puncture needle body to vibrate through the acoustic horn, so that the puncture needle body and the low-frequency transducer are in mechanical resonance.

[0015] The cross-sectional profile of the acoustic horn is exponential or catenary.

[0016] The low-frequency transducer comprises a transducer cover and a piezoelectric ceramic unit in the transducer cover, wherein, The piezoelectric ceramic unit comprises a plurality of piezoelectric ceramic rings, The acoustic horn is fixedly connected with the transducer cover, The low-frequency inertial cavitation driving signal is loaded to the piezoelectric ceramic unit to make the piezoelectric ceramic unit vibrate, and the vibration is conducted to the puncture needle body through the acoustic horn.

[0017] The cooperative control unit can also drive the ultrasonic probe unit to emit imaging pulse signals to the target tissue structure, so as to use the imaging pulse echo signals to perform ultrasonic imaging on the target tissue structure, wherein, Based on the ultrasonic imaging of the imaging pulse echo signals, at least the inertial cavitation driving unit is guided to extend into the target tissue structure, the state of forming microbubble cloud in the target tissue structure and / or the tissue damage state of the target tissue structure are determined.

[0018] The advantage of the present application: when the tissue is damaged, the ultrasonic probe unit acts as a high-frequency activation source, the phase change nanodroplet is activated and the microbubble cloud is generated by the ultrasonic probe unit emitting an activation pulse signal; the inertial cavitation driving unit acts as a low-frequency driving source to activate the microbubble cloud to occur violent inertial cavitation until the implosion occurs.

[0019] The high-frequency activation source and the low-frequency driving source of the present application are separately arranged, the puncture needle body in the inertial cavitation driving unit contacts the microbubble cloud and activates the microbubble cloud to occur inertial cavitation through reciprocating motion, the output power of the puncture needle body activating the microbubble cloud to occur inertial cavitation is also reduced, that is, the energy threshold required for activating the microbubble cloud is reduced, so that the tissue can be efficiently damaged while unnecessary thermal damage is avoided, and the device can be more minimally invasive and safer.

[0020] The imaging pulse signal and the activation pulse signal emitted by the ultrasonic probe unit can realize sub-millimeter level precise control of tissue damage space, specifically, the injected phase change nanodroplet covers the specified lesion area, the microbubble cloud formed by the activation pulse signal controllably covers the specified lesion area, and the puncture needle body can effectively contact the microbubble cloud formed, so that the damage occurs only when these conditions are met, so that the range and boundary of the damage are firmly limited within the preset of the operator, realizing precise control that cannot be compared with other technologies, and completely eliminating the risk of out-of-focus activation and out-of-control cavitation cloud.

[0021] In addition, the tissue damage of the present application can also eliminate the "acoustic shielding" effect, which refers to the reflection and absorption of subsequent treatment energy by the microbubble cloud after the in-vitro acoustic beam generates a microbubble cloud at the focal point, resulting in the inability of the treatment acoustic beam to reach the deep lesion, causing uneven damage and low efficiency. The present application directly contacts the microbubble cloud with the puncture needle body, and the vibration energy is transmitted from the inside to the outside, there is no physical path for self-shielding, ensuring that the damage around the needle tip is uniform and sufficient, that is, the "acoustic shielding" effect is eliminated. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 It is a system block diagram of an embodiment of the dual-frequency cooperative puncture type tissue destruction system of the present application.

[0023] Figure 2 It is a schematic diagram of an embodiment of the inertial cavitation driving unit of the present application.

[0024] Reference numerals: 100-injection device, 101-puncture needle body, 102-injection connector, 103-low frequency transducer, 104-microbubble cloud, 105-target tissue structure, 106-acoustic amplitude rod, 107-front cover plate, 108-piezoelectric ceramic ring, 109-back cover plate, 200-ultrasound probe unit, 300-synergistic control unit. DETAILED DESCRIPTION

[0025] The application will be further described below in conjunction with specific drawings and examples.

[0026] In order to achieve a low energy threshold by using exogenous cavitation, to achieve safe, efficient and controllable tissue damage, the application provides a dual-frequency synergistic puncture type tissue damage system, specifically, the tissue damage system comprises a synergistic control unit 300, and an ultrasound probe unit 200 and an inertial cavitation driving unit adapted and electrically connected to the synergistic control unit 300, wherein, The synergistic control unit 300 can drive the ultrasound probe unit 200 to emit an activation pulse signal that can induce phase change nanodroplet to occur acoustic-induced evaporation to the target tissue structure 105, so that the phase change nanodroplets located in the target tissue structure 105 form a microbubble cloud 104 under the high-frequency activation pulse signal; The inertial cavitation driving unit extends into the target tissue structure 105, and after the microbubble cloud 104 is formed in the target tissue structure 105, the microbubble cloud 104 wraps the part of the inertial cavitation driving unit extending into the target tissue structure 105; The synergistic control unit 300 sends a low-frequency inertial cavitation driving signal to the inertial cavitation driving unit, and configures the inertial cavitation driving unit to be in an inertial cavitation driving state to excite the microbubble cloud 104 to occur violent inertial cavitation, until the microbubble cloud 104 explodes after swelling.

[0027] Figure 1 An embodiment of the tissue damage system is shown in the figure, as can be seen from the figure, the tissue damage system of the application should comprise a synergistic control unit 300, an ultrasound probe unit 200 and an inertial cavitation driving unit, the synergistic control unit 300 is electrically connected to the ultrasound probe unit 200 and the inertial cavitation driving unit, and the synergistic control unit 300 is used to synergistically control the corresponding working states of the ultrasound probe unit 200 and the inertial cavitation driving unit, it should be understood that the main purpose of synergistically controlling the working states of the ultrasound probe unit 200 and the inertial cavitation driving unit is to effectively complete the tissue damage under a low energy threshold. The synergistic control unit 300 can adopt existing common forms, such as the synergistic control unit 300 can adopt a computer terminal device, the type of the synergistic control unit 300 can be selected according to needs, and the selection should meet the needs of synergistic control.

[0028] As the same as the existing tissue damage, when the tissue damage is performed, the target tissue structure 105 needs to be determined, the target tissue structure 105 is at least the region where the tissue damage is performed, Figure 1 As shown in the middle of the figure, one embodiment of the target tissue structure 105 is the liver, and it can be understood that when there is a lesion in the liver, the lesion in the liver should be damaged, that is, the damaged tissue of the present application should be the lesion in the target tissue structure 105; when the target tissue structure 105 is other organs, please refer to the corresponding description here.

[0029] As can be known from the above description, when the tissue damage is performed, the microbubble cloud 104 should be formed in the target tissue structure 105, and it should be understood that the microbubble cloud 104 should at least cover the region where the lesion is located in the target tissue structure 105, or according to the requirement of the required tissue damage by using the microbubble cloud 104. The mechanism of using the formed microbubble cloud to damage the lesion is consistent with the existing one.

[0030] In order to form the microbubble cloud 104, the phase change nanodroplet should be injected into the target tissue structure 105, and then the cooperative control unit 300 configures the ultrasonic probe unit 300 to emit an activation pulse signal to induce the phase change nanodroplet in the target tissue structure 105 to undergo acoustic evaporation by using the activation pulse signal, and then the microbubble cloud 104 can be formed in the target tissue structure 105. The way of using the activation pulse signal to guide the phase change nanodroplet to undergo acoustic evaporation can be consistent with the prior art, therefore, the ultrasonic probe unit 200 of the present application should be able to at least emit the activation pulse signal, and the phase change nanodroplet undergoes acoustic evaporation and forms the microbubble cloud 104 by the activation pulse signal. The ultrasonic probe unit 200 can adopt the existing common form, and the specific emission of the required activation pulse signal is subject to the required activation pulse signal.

[0031] It should be understood that the cooperative control is driven by the cooperative control unit 300 to drive the ultrasonic probe unit 200 to emit the activation pulse signal to the target tissue structure 105; as the same as the prior art, the activation pulse signal is a high-frequency pulse, and the characteristics of emitting the activation pulse signal can be: the signal frequency is 2-5MHz, the pulse length of the activation pulse signal is 2-5 cycles, the pulse repetition frequency is 20-50Hz, the acoustic peak negative pressure is 2-5Mpa, and the duration is 2-5 seconds. It can be understood that the energy of the activation pulse signal should be lower than the tissue damage threshold of the target tissue structure 105, at this time, the target tissue structure 105 will not be damaged. In the specific implementation, the cooperative control unit 300 drives the ultrasonic probe unit 200 to emit the activation pulse signal, and the configuration of the signal characteristics of the activation pulse signal can be consistent with the prior art, which will not be described here.

[0032] Different from the existing tissue damage, when the microbubble cloud 104 is activated to generate inertial cavitation, the present application can utilize exogenous cavitation and achieve a low energy threshold. That is, different from the existing ultrasonic probe unit 200 re-emitting a second group of "treatment" pulses to stimulate the microbubble cloud 104 to generate inertial cavitation, when the microbubble cloud 104 is activated to generate inertial cavitation, the present application no longer utilizes the ultrasonic probe unit 200 to emit a second group of treatment pulses, but utilizes an inertial cavitation driving unit. At this time, compared with the ultrasonic probe unit 200, the inertial cavitation driving unit serves as an exogenous cavitation.

[0033] In order to activate the inertial cavitation of the microbubble cloud 104, in an embodiment of the present application, the inertial cavitation driving unit should be inserted into the target tissue structure 105. For example, the inertial cavitation driving unit can be inserted into the target tissue structure 105 through puncture. After the microbubble cloud 104 is formed in the target tissue structure 105, the microbubble cloud 104 should wrap the part of the inertial cavitation driving unit inserted into the target tissue structure 105, that is, the inertial cavitation driving unit should form physical contact with the microbubble cloud 104.

[0034] In order to achieve low-energy threshold tissue damage, the cooperative control unit 300 should send a low-frequency inertial cavitation driving signal to the inertial cavitation driving unit, so that the inertial cavitation driving unit is configured to be in an inertial cavitation driving state under the low-frequency inertial cavitation driving signal. It can be understood that the inertial cavitation driving unit in the inertial cavitation driving state specifically means that the microbubble cloud 104 can be stimulated to generate violent inertial cavitation, until the microbubble cloud 104 is inflated and implodes. When the microbubble cloud 104 implodes, the microbubble cloud 104 can be used to damage the corresponding lesion in the target tissue structure 105. The principle of tissue damage can be consistent with the prior art. The corresponding lesion specifically refers to the lesion corresponding to the microbubble cloud 104.

[0035] In specific implementation, when the inertial cavitation driving unit contacts the microbubble cloud 104 and stimulates the microbubble cloud 104 to generate inertial cavitation, the driving is mainly based on the low-frequency inertial cavitation driving signal. Since the low-frequency inertial cavitation driving signal is a low-frequency signal, the energy of the inertial cavitation driving signal driving the inertial cavitation driving unit to stimulate the microbubble cloud 104 to generate inertial cavitation will be much lower than the energy of the ultrasonic treatment pulse in the prior art to stimulate inertial cavitation. Therefore, when damaging the lesion tissue, unnecessary thermal damage can be avoided, and the damage is safer.

[0036] The inertial cavitation driving unit and the way and process of stimulating the microbubble cloud 104 to generate inertial cavitation and make the microbubble cloud 104 inflate and implode will be described below.

[0037] In an embodiment of the present application, the inertial cavitation driving unit comprises at least a puncture needle body 101 and a needle body motion driving mechanism for driving the puncture needle body 101 to move, wherein, The puncture needle body 101 punctures into the target tissue structure 105 at least before the microbubble cloud 104 formed by the phase change nanofluid, and after the microbubble cloud 104 formed by the phase change nanofluid, the needle tip of the puncture needle body 101 is located in the microbubble cloud 104; The needle body motion driving mechanism is electrically connected with the cooperative control unit 300, the cooperative control unit 300 loads the low-frequency inertial cavitation driving signal to the needle body motion driving mechanism, and the needle body motion driving mechanism drives the needle tip of the puncture needle body 101 to reciprocate in the microbubble cloud 104 in a low-frequency high-amplitude state, so that the inertial cavitation driving unit is in an inertial cavitation driving state.

[0038] Figure 1 An embodiment of the inertial cavitation driving unit is shown in FIG. 1. As shown in the figure, the inertial cavitation driving unit comprises a puncture needle body 101, which can be a cylindrical needle with a sharp tip. The puncture needle body 101 can be used for puncture to place the puncture needle body 101 into a corresponding position in the target tissue structure 105. Therefore, the inertial cavitation driving unit extends into the target tissue structure 105, specifically, the needle tip of the puncture needle body 101 punctures into the target tissue structure 105. In addition, when the microbubble cloud 104 is formed, the microbubble cloud 104 will wrap the needle tip of the puncture needle body 101, that is, the needle tip of the puncture needle body 101 will be located in the microbubble cloud 104.

[0039] In order to excite the microbubble cloud 104 to generate intense inertial cavitation, in an embodiment of the present application, the needle tip of the puncture needle body 101 can be configured to move relative to the microbubble cloud 104. In order to drive the motion of the puncture needle body 101, the inertial cavitation driving unit should also comprise a needle body motion driving mechanism, which can drive the needle tip of the puncture needle body 101 to reciprocate in the microbubble cloud 104 in a low-frequency high-amplitude state. In an embodiment of the present application, the direction of the reciprocating motion of the puncture needle body 101 driven by the needle body motion driving mechanism is consistent with the axial direction of the puncture needle body 101. Since the puncture needle body 101 is generally a long cylindrical shape, the direction of the reciprocating motion of the puncture needle body 101 driven by the needle body motion driving mechanism is consistent with the length direction of the puncture needle body 101.

[0040] It can be understood that the cooperative control unit 300 sends a low-frequency inertial cavitation driving signal to the inertial cavitation driving unit, specifically, the cooperative control unit 300 loads the low-frequency inertial cavitation driving signal to the needle body motion driving mechanism. In an embodiment of the present application, under the low-frequency inertial cavitation driving signal, the vibration of the needle body motion driving mechanism drives the puncture needle body 101 to be in a mechanical resonance state, and the needle tip of the puncture needle body 101 is located at the displacement antinode of the longitudinal vibration, so that the puncture needle body 101 can move along the axis direction of the puncture needle body 101. The displacement amplitude of the needle tip of the puncture needle body 101 in the axis direction is 30 μm to 120 μm.

[0041] In a specific implementation, when the needle tip of the puncture needle body 101 reciprocates in the microbubble cloud 104, in an embodiment of the present application, the vibration of the needle body motion driving mechanism can drive the puncture needle body 101 to be in a mechanical resonance state, and the needle tip of the puncture needle body 101 is located at the displacement antinode of the longitudinal vibration. When the microbubble cloud 104 is excited to generate inertial cavitation, the displacement amplitude of the needle tip can be 30 μm to 120 μm. When the displacement amplitude of the needle tip is 30 μm to 120 μm, it can be ensured that the needle tip can produce negative pressure lower than the saturated vapor pressure of the liquid in an instant during the retraction stroke, thereby effectively exciting the microbubble cloud 104 to generate intense inertial cavitation. That is, the way to excite the microbubble cloud 104 to generate intense inertial cavitation mainly relies on the reciprocating motion of the needle tip in the microbubble cloud 104.

[0042] In an embodiment of the present application, the needle body motion driving mechanism includes a low-frequency transducer 103 as a vibration source and an acoustic horn 106 adaptively connected with the low-frequency transducer 103. The low-frequency transducer 103 is fixedly connected with the tail of the puncture needle body 101 through the acoustic horn 106. The low-frequency transducer 103 vibrates under the action of the low-frequency inertial cavitation driving signal, and drives the puncture needle body 101 to vibrate through the acoustic horn 106, and makes the puncture needle body 101 and the low-frequency transducer 103 in a mechanical resonance state.

[0043] Figure 1 An embodiment of the needle body motion driving mechanism is shown in FIG. 5. As shown in the figure, the needle body motion driving mechanism can include a low-frequency transducer 103, wherein the low-frequency transducer 103 mainly serves as a vibration source, and an acoustic horn 106 is arranged on the low-frequency transducer 103. The acoustic horn 106 mainly serves as a speed transformer, amplifies the small amplitude of the low-frequency transducer 103, and efficiently transmits it to the puncture needle body 101, so that the puncture needle body 101 can be configured to be in the above-mentioned mechanical resonance state.

[0044] In specific implementation, the cross-sectional profile of the acoustic horn 106 is exponential or catenary, and the shape of the cross-sectional profile of the acoustic horn 106 can be selected as required to efficiently transmit the small amplitude of the low-frequency transducer 103 to the puncture needle body 101, and the cross-sectional profile is not listed here.

[0045] In an embodiment of the present application, the puncture needle body 101 adopts the form of an acoustic waveguide, and the length of the puncture needle body 101 is:

[0046] wherein, is the length of the puncture needle body 101, is an integer, is the wavelength corresponding to the vibration frequency of the needle movement driving mechanism.

[0047] In order to form the mechanical resonance described above and to make the needle tip located at the displacement antinode of the longitudinal vibration, the length of the puncture needle body 101 should be configured, specifically, based on the characteristics of mechanical resonance, the length of the puncture needle body 101 is related to the vibration frequency of the low-frequency transducer 101, wherein the vibration frequency of the needle movement driving mechanism is the vibration frequency of the low-frequency transducer 103 under the low-frequency inertial cavitation driving signal, and it should be understood that the vibration frequency of the low-frequency transducer 103 is in a low-frequency state. The integer n can generally be selected as required, such as being selected according to different tissue damage scenarios, and the length of the puncture needle body 101 is in mm. In addition, the unit of the wavelength corresponding to the vibration frequency is also mm.

[0048] In specific implementation, for the vibration generated by the low-frequency transducer 103, the primary amplification is first performed by the acoustic horn 106 and conducted to the puncture needle body 101, and at the same time, the puncture needle body 101 adopts the form of an acoustic waveguide, which can realize the re-amplification of the amplitude, that is, the double amplification of the vibration generated by the low-frequency transducer 103, so as to make the displacement of the needle tip obtain a very high mechanical gain, and the energy of the movement of the needle tip acts on the microbubble cloud 104. Since the low-frequency frequency is very easy to drive the microbubble cloud 104 to generate inertial cavitation, the displacement amplitude of the needle tip is sufficient to overcome the cavitation threshold of the microbubble cloud 104, thereby realizing efficient inertial cavitation with very low power (<3W, the power here is the power of the low-frequency inertial cavitation driving signal), reducing the energy requirement for inertial cavitation of the microbubble cloud 104 in the prior art; when the microbubble cloud 104 is subjected to violent expansion and implosion, it releases strong mechanical force (shock wave, microjet) to purely mechanically damage the lesion tissue.

[0049] In addition, when the low frequency transducer 103 and the acoustic horn 106 are used as the needle body motion driving mechanism, the connection between the puncture needle body 101 and the acoustic horn 106 and the assembly mode of the low frequency transducer 103 should ensure that the puncture needle body 101 can realize the reciprocating motion as described above.

[0050] In an embodiment of the present application, the low frequency transducer 103 comprises a transducer cover and a piezoelectric ceramic unit in the transducer cover, wherein, The piezoelectric ceramic unit comprises a plurality of piezoelectric ceramic rings 108, The acoustic horn 106 is fixedly connected with the transducer cover, The low frequency inertial cavitation driving signal is loaded to the piezoelectric ceramic unit to make the piezoelectric ceramic unit vibrate, and the vibration is conducted to the puncture needle body 101 through the acoustic horn 106.

[0051] Figure 2 An embodiment of the low frequency transducer 103 is shown in FIG. 4, wherein the transducer cover can comprise a front cover plate 107 and a rear cover plate 109, and the piezoelectric ceramic unit is between the front cover plate 107 and the rear cover plate 109. The piezoelectric ceramic unit can be assembled between the front cover plate 107 and the rear cover plate 109 in a conventional manner. The piezoelectric ceramic unit can comprise a plurality of piezoelectric ceramic rings 108, Figure 2 An embodiment of the piezoelectric ceramic unit comprising two stacked piezoelectric ceramic rings 108 is shown in FIG. 5. The number of piezoelectric ceramic rings 108 in the piezoelectric ceramic unit can be selected according to the need to generate the required vibration.

[0052] It can be understood that when the low frequency transducer 103 is used as a vibration source, the low frequency inertial cavitation driving signal is loaded to the low frequency transducer 103, specifically, the low frequency inertial cavitation driving signal is loaded to the piezoelectric ceramic unit to make the piezoelectric ceramic unit vibrate, and the vibration is conducted to the puncture needle body 101 through the acoustic horn 106. Therefore, the low frequency inertial cavitation driving signal should be able to drive the piezoelectric ceramic unit to generate vibration, and in a specific implementation, the signal frequency of the low frequency inertial cavitation driving signal can be 20-200 kHz. In addition, the piezoelectric ceramic unit is assembled in the transducer cover, which should ensure that the low frequency transducer 103 is used as a vibration source, and the specific assembly mode will not be described here.

[0053] In a specific implementation, after the low frequency transducer 103 is determined, the frequency at which the piezoelectric ceramic unit generates vibration can be determined according to the characteristics of the low frequency transducer 103 and the signal frequency of the low frequency inertial cavitation driving signal, and then the wavelength corresponding to the vibration frequency of the needle body motion driving mechanism can be determined. Therefore, the length of the puncture needle body 101 can be designed.

[0054] As can be seen from the above description, when the micro-bubble cloud 104 is formed, phase-change nano-droplets should be injected into the target tissue structure, and the phase-change nano-droplets injected and the injection method of the phase-change nano-droplets can be consistent with the prior art. It can be understood that the position of the phase-change nano-droplets injected should correspond to the position of the micro-bubble cloud 104 formed and the position of the lesion to be destroyed.

[0055] In order to further simplify the operation of tissue destruction and improve the efficiency of tissue destruction, in an embodiment of the present application, the puncture needle body 101 further comprises a plurality of liquid injection channels capable of injecting phase-change nano-droplets into the target tissue structure 105, wherein, When the puncture needle body 101 has the liquid injection channel, the puncture needle body 101 is guided to first puncture into the target tissue structure 105, and then the phase-change nano-droplets in the liquid injection channel are injected into the target tissue structure 105 through the needle tip of the puncture needle body 101; After the phase-change nano-droplets are injected into the target tissue structure 105, the needle tip of the puncture needle body 101 is left in the target tissue structure 105.

[0056] It can be understood that when the puncture needle body 101 is provided with the liquid injection channel, the phase-change nano-droplets can be injected into the target tissue structure 105 at the required position through the liquid injection channel of the puncture needle body 101. Of course, before the phase-change nano-droplets are injected, the puncture needle body 101 should be guided to puncture into the target tissue structure 105, and the phase-change nano-droplets in the liquid injection channel can be injected into the target tissue structure 105 at the required position through the needle tip of the puncture needle body 101.

[0057] In specific implementation, the number of liquid injection channels in the puncture needle body 101 can be selected as required, such as being selected and determined according to the inner diameter of the puncture needle body 101, and the liquid injection channels are generally distributed along the length direction of the puncture needle body 101. Figure 1 As shown in FIG. 1, the injection connector 102 is arranged at the tail end of the puncture needle body 101, and the injection connector 102 can be connected with the injection device 100. Then, the phase-change nano-droplets can be injected into one or more liquid injection channels through the injection device 100, and the injection device 100 can provide the driving force for the phase-change nano-droplets to be delivered into the target tissue structure 105 at the required position. The injection device 100 can be a common syringe or an injection pump, and the type of the injection device 100 can be selected as required, so as to inject the phase-change nano-droplets into the target tissue structure at the required position.

[0058] In one embodiment of the present application, after the phase change nano-droplet is sent into the target tissue structure 105, the puncture needle body 101 can be left in place so as to activate the inertial cavitation of the subsequent micro-bubble cloud 104 by the puncture needle body 101. It can be understood that, since the phase change nano-droplet is sent into the target tissue structure 105 by the needle tip of the puncture needle body 101, the phase change nano-droplet will surround the needle tip of the puncture needle body 101, and after the micro-bubble cloud 104 is formed by the activation pulse signal, the needle tip of the puncture needle body 101 will be in the micro-bubble cloud 104.

[0059] It should be understood that, when the phase change nano-droplet is not sent into the target tissue structure 105 by the puncture needle body 101, the phase change nano-droplet should be first sent into the target tissue structure 105 by the nano-droplet injection device, and then the nano-droplet injection device is withdrawn from the target tissue structure 105, and the puncture needle body 101 is punctured into the target tissue structure 105. The needle tip of the puncture needle body 101 should enter the phase change nano-droplet in the target tissue structure 105, and then the phase change nano-droplet is activated by the activation pulse signal to form the micro-bubble cloud 104, and the needle tip of the puncture needle body 101 is located in the formed micro-bubble cloud 104. The nano-droplet injection device can be in the form of a commonly used syringe, and the specific selection can be made according to the needs.

[0060] In one embodiment of the present application, the cooperative control unit 300 can also drive the ultrasonic probe unit 200 to emit an imaging pulse signal to the target tissue structure 105, so as to perform ultrasonic imaging on the target tissue structure 105 by the imaging pulse echo signal, wherein, Based on the ultrasonic imaging of the imaging pulse echo signal, at least the inertial cavitation driving unit is guided to extend into the target tissue structure 105, the state of forming the micro-bubble cloud 104 in the target tissue structure 105 is determined, and / or the tissue damage state of the target tissue structure 105 is determined.

[0061] In specific implementation, the ultrasonic probe unit 300 can also emit an imaging pulse signal, and when the cooperative control unit 300 drives the ultrasonic probe unit 200 to emit the imaging pulse signal and receives the corresponding imaging pulse echo signal, ultrasonic imaging can be realized. The mode and principle of ultrasonic imaging can be consistent with the prior art, that is, the mode in which the cooperative control unit 300 configures the ultrasonic probe unit 200 to emit the imaging pulse signal and configures the ultrasonic probe unit 200 to receive the imaging pulse echo signal and perform imaging can be consistent with the prior art, and details are not described herein.

[0062] The timing of the ultrasonic imaging by the ultrasonic probe unit 200 can be selected as required, for example, before the phase-change nanodroplets are injected into the target tissue structure 105, the ultrasonic imaging can be performed to determine the position of the lesion to be destroyed in the target tissue structure 105, and then, according to the image of the ultrasonic imaging, the puncture needle body or the nanodroplet injection device can be guided to puncture through the skin so as to accurately send the phase-change nanodroplets to the desired position in the target tissue structure 105, that is, the inertial cavitation driving unit can be at least guided to extend into the target tissue structure 105. Of course, during the injection of the phase-change nanodroplets, the ultrasonic imaging can still be performed by the ultrasonic probe unit 200 to monitor the process of the injection of the phase-change nanodroplets.

[0063] After the phase-change nanodroplets are injected and the puncture needle body 101 punctures into the target tissue structure 105, the ultrasonic probe unit 200 can be configured to emit an activation pulse signal, and then the ultrasonic imaging can be performed again by the ultrasonic probe unit 200 to observe the formation of the microbubble cloud 104, for example, the echo intensity of the region can be observed to be significantly enhanced on the image, and the effective coverage range of the microbubble cloud 104 can be immediately confirmed. The way of observing the formation of the microbubble cloud 104 by the ultrasonic imaging can be consistent with the prior art.

[0064] When the microbubble cloud 104 implodes, the ultrasonic imaging can be performed again by the ultrasonic probe unit 200 to observe the state of the tissue after being destroyed by using the ultrasonic imaging, that is, the tissue destruction state of the target tissue structure 105 can be observed and determined, for example, whether the lesion is completely and effectively destroyed and whether the lesion boundary is exceeded or not, so as to observe the realization of the tissue destruction and improve the controllability of the tissue destruction operation.

[0065] As can be known from the above description, in the tissue destruction, the ultrasonic probe unit 200 serves as a high-frequency activation source, the ultrasonic probe unit 200 emits an activation pulse signal to activate the phase-change nanodroplets and generate the microbubble cloud 104; the inertial cavitation driving unit serves as a low-frequency driving source to activate the microbubble cloud 104 to have intense inertial cavitation until the inflation implosion occurs.

[0066] The high-frequency activation source and the low-frequency driving source of the present application are separately arranged, the puncture needle body 101 in the inertial cavitation driving unit contacts the microbubble cloud 104 and activates the microbubble cloud 104 to have inertial cavitation through the reciprocating motion, the output power of the puncture needle body 101 activating the microbubble cloud 104 to have inertial cavitation is reduced, that is, the energy threshold required for activating the microbubble cloud 104 is reduced, so that the tissue can be efficiently destroyed, and unnecessary thermal damage can be avoided, and the instrument can be more minimally invasive and safer.

[0067] The imaging pulse signal and the activation pulse signal emitted by the ultrasonic probe unit 200 can achieve sub-millimeter spatial precision control of tissue damage, specifically, the injected phase change nanodroplet covers the designated lesion area, and the microbubble cloud 104 formed by the activation pulse signal controllably covers the designated lesion area, and can make the puncture needle body 101 effectively contact the microbubble cloud 104 formed, and only when these conditions are met will tissue damage occur, so that the range and boundary of the damage are firmly limited within the preset of the operator, achieving precision control that other technologies cannot match, and completely eliminating the risk of out-of-focus activation and uncontrolled cavitation cloud.

[0068] In addition, the tissue damage of the present application can also eliminate the "acoustic shielding" effect, which refers to the reflection and absorption of subsequent treatment energy by the microbubble cloud 104 after the in-vitro acoustic beam generates the microbubble cloud 104 at the focal point, resulting in the inability of the treatment acoustic beam to reach the deep lesion, causing uneven damage and low efficiency. The present application directly contacts the puncture needle body 104 with the microbubble cloud 104, and the vibration energy is transmitted from the inside to the outside, and there is no physical path for self-shielding, ensuring that the damage around the needle tip is uniform and sufficient, i.e. eliminating the "acoustic shielding" effect.

[0069] The cooperative control unit 300 controls the ultrasonic probe unit 200 and the inertial cavitation driving unit to work cooperatively, and completes the whole steps of "guiding-injection-activation-damage-evaluation" in one go, with the functions of diagnostic imaging, puncture guidance, consumable delivery (phase change nanodroplet injection), energy activation, treatment driving and real-time monitoring and evaluation. This closed-loop treatment process greatly simplifies the operation, shortens the operation time, and allows the operator to dynamically adjust the treatment according to real-time feedback, ensuring the sufficiency and safety of the treatment.

[0070] The above is only a preferred embodiment of the present application, and is not intended to limit the scope of protection of the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

Claims

1. A dual frequency synergistic puncture tissue damaging system, characterized in that, The tissue damage system comprises a cooperative control unit and an ultrasonic probe unit and an inertial cavitation driving unit electrically connected to the cooperative control unit, wherein The cooperative control unit can drive the ultrasonic probe unit to emit an activation pulse signal to the target tissue structure to induce phase change nanodroplet to generate acoustic evaporation, so that the phase change nanodroplet in the target tissue structure forms a microbubble cloud under the high-frequency activation pulse signal; The inertial cavitation driving unit extends into the target tissue structure, and after the microbubble cloud is formed in the target tissue structure, the microbubble cloud wraps the part of the inertial cavitation driving unit extending into the target tissue structure; The cooperative control unit sends a low-frequency inertial cavitation driving signal to the inertial cavitation driving unit to configure the inertial cavitation driving unit to be in an inertial cavitation driving state to excite the microbubble cloud to generate intense inertial cavitation until the microbubble cloud explodes after swelling.

2. The dual frequency synergistic tissue damaging system of claim 1, wherein: The inertial cavitation driving unit at least comprises a puncture needle body and a needle body motion driving mechanism for driving the puncture needle body to move mechanically, wherein The puncture needle body at least punctures into the target tissue structure before the microbubble cloud is formed by the phase change nanofluid, and after the microbubble cloud is formed by the phase change nanofluid, the needle tip of the puncture needle body is located in the microbubble cloud; The needle body motion driving mechanism is electrically connected to the cooperative control unit, the cooperative control unit loads a low-frequency inertial cavitation driving signal to the needle body motion driving mechanism, and the needle body motion driving mechanism at least drives the needle tip of the puncture needle body to reciprocate in a low-frequency high-amplitude state in the microbubble cloud, so that the inertial cavitation driving unit is in an inertial cavitation driving state.

3. The dual frequency synergistic tissue damaging system of claim 2, wherein: The reciprocating direction of the puncture needle body driven by the needle body motion driving mechanism is consistent with the axial direction of the puncture needle body, and the reciprocating motion of the needle tip of the puncture needle body is used to excite the microbubble cloud to generate intense inertial cavitation.

4. The dual frequency synergistic tissue damaging system of claim 3 wherein the first and second electrodes are configured to be positioned on the skin of the patient in a first and second electrode configuration, respectively, and wherein the first and second electrode configurations are different. Under the low-frequency inertial cavitation driving signal, the puncture needle body is in a mechanical resonance state driven by the vibration of the needle body motion driving mechanism, and the needle tip of the puncture needle body is located at the displacement antinode of the longitudinal vibration, so that the puncture needle body can move along the axial direction of the puncture needle body; The displacement amplitude of the needle tip of the puncture needle body in the axial direction is 30μm to 120μm.

5. The dual-frequency synergistic puncture-type tissue destruction system according to claim 2, characterized in that: in The puncture needle body further comprises a plurality of liquid injection channels capable of injecting phase change nanodroplets into the target tissue structure, wherein When the puncture needle body has the liquid injection channel, the puncture needle body is guided to first puncture into the target tissue structure, and then the phase change nanodroplets in the liquid injection channel are injected into the target tissue structure through the needle tip of the puncture needle body; After the phase change nanofluid is injected into the target tissue structure, the needle tip of the puncture needle body is left in the target tissue structure.

6. The dual frequency synergistic tissue damaging system of claim 4, wherein: The puncture needle body adopts an acoustic guide wave form, and the length of the puncture needle body is: wherein is the length of the piercing needle body, is an integer, is the wavelength corresponding to the vibration frequency of the needle body movement drive mechanism.

7. The dual frequency synergistic tissue lesion system according to any of claims 4 to 6, characterized in that: The needle body motion driving mechanism comprises a low-frequency transducer as a vibration source and an acoustic horn connected to the low-frequency transducer, wherein The low-frequency transducer is fixedly connected to the tail of the puncture needle body through the acoustic horn; The low-frequency transducer vibrates under the action of the low-frequency inertial cavitation driving signal, and drives the puncture needle body to vibrate through the acoustic horn, and the puncture needle body and the low-frequency transducer are in a mechanical resonance state.

8. The dual frequency synergistic tissue damaging system of claim 7, wherein: The cross-sectional profile of the acoustic horn is exponential or catenary.

9. The dual frequency synergistic tissue damaging system of claim 7, wherein: The low-frequency transducer comprises a transducer cover and a piezoceramic unit in the transducer cover, wherein, The piezoceramic unit comprises a plurality of piezoceramic rings, The acoustic horn is fixedly connected with the transducer cover, The low-frequency inertial cavitation driving signal is loaded to the piezoceramic unit to make the piezoceramic unit vibrate, and the vibration is conducted to the puncture needle body through the acoustic horn.

10. The dual frequency synergistic dissection system of any of claims 1-6, wherein: The cooperative control unit can also drive the ultrasonic probe unit to emit imaging pulse signals to the target tissue structure, so that the target tissue structure can be ultrasonically imaged by using the imaging pulse echo signals, wherein, Based on the ultrasonic imaging of the imaging pulse echo signals, at least the inertial cavitation driving unit is guided to extend into the target tissue structure, the state of forming the micro-bubble cloud in the target tissue structure and / or the tissue damage state of the target tissue structure are determined.

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