Dual frequency synergistic piercing tissue damaging system

Abstract

The present application relates to a kind of dual-frequency collaborative puncture type tissue damage system.It includes collaborative control unit and the ultrasonic probe unit and inertial cavitation drive unit of collaborative control unit adaptation electric connection, wherein, collaborative control unit can drive ultrasonic probe unit to emit the activation pulse signal of inducible phase change nanodroplet sound-induced evaporation to target tissue structure, so that the phase change nanodroplet in target tissue structure is formed under the high-frequency activation pulse signal microbubble cloud;Collaborative control unit sends low-frequency inertial cavitation drive signal to inertial cavitation drive unit, configuration drive inertial cavitation drive unit is in inertial cavitation drive state, to excite microbubble cloud to occur violent inertial cavitation, until microbubble cloud occurs swelling after implosion.The present application utilizes exogenous cavitation to realize extremely low energy threshold, while also can accurately control the activation and damage range of cavitation, to realize safe, efficient, controllable tissue damage.

Description

Technical Field

[0001] This invention relates to a tissue destruction system, and more particularly to a dual-frequency synergistic puncture tissue destruction system. Background Technology

[0002] Ultrasonic histotripsy is an emerging non-thermodynamic ablation technique that uses high-intensity ultrasound pulses to induce mechanical cavitation in the target area. This involves the generation, oscillation, and collapse of microbubbles in the target area. During this process, the generated shock waves and microjets can mechanically pulverize the biological tissue in the target area down to the subcellular structure with minimal thermal damage to surrounding tissues. This technique has shown potential for application in fields such as tumor ablation.

[0003] To achieve the cavitation effect required for tissue destruction, existing technologies mainly employ two approaches, specifically: The first approach is the in vitro "intrinsic threshold" Histotripsy. This method uses a high-power ultrasound transducer to focus high energy (peak negative pressure) onto the lesion inside the body, forcibly "pulling" out microbubbles (cavitation nuclei) in the tissue fluid and driving them to collapse, thereby causing mechanical damage. However, this approach has an extremely high energy threshold, typically requiring a peak negative pressure of tens of megapascals. This poses a significant technical challenge to ultrasound equipment (especially transducers and power sources), and the high-energy pulses may cause cumulative damage when penetrating prefocal tissue. Furthermore, this approach is limited by the acoustic window, preventing ultrasound waves from effectively penetrating bones (such as ribs) or air-containing organs (such as the lungs and intestines), thus limiting its application scenarios.

[0004] The second method employs "nanodroplet-mediated histotripsy" (NHM). To reduce the high energy threshold required by the first approach, this method introduces exogenous cavitation nuclei. The specific implementation is as follows: First, phase-change nanodroplets are applied into the body via intravenous injection or percutaneous puncture. After these droplets reach the lesion area, an in vitro high-frequency imaging ultrasound transducer emits the first set of "activation" pulses to induce a liquid-gas phase change, forming micron-sized bubbles. Subsequently, an in vitro low-frequency therapeutic transducer emits the second set of "therapeutic" pulses to excite these microbubbles to generate inertial cavitation, thereby achieving the purpose of tissue destruction.

[0005] While introducing nanodroplets can lower the energy threshold, the extent of damage may be affected by the random flow and diffusion of the nanodroplets. During in vitro ultrasound activation, droplets may be "misactivated" in the prefocal or out-of-focal path, leading to uncontrolled cavitation. Furthermore, the microbubble cloud formed at the focal point can generate a strong "acoustic shielding" effect, blocking subsequent ultrasound energy from reaching the depths of the lesion and causing uneven damage. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a dual-frequency synergistic puncture-type tissue destruction system, which utilizes exogenous cavitation to achieve an extremely low energy threshold, while also precisely controlling the activation and destruction range of cavitation, so as to achieve safe, efficient and controllable tissue destruction.

[0007] According to the technical solution provided by this invention, a dual-frequency coordinated puncture-type tissue destruction system is provided. The tissue destruction system includes a coordinated control unit and an ultrasonic probe unit and an inertial cavitation drive unit electrically connected to the coordinated control unit. The collaborative control unit can drive the ultrasonic probe unit to emit activation pulse signals that can induce sono-evaporation of phase change nanodroplets towards the target tissue structure, so that the phase change nanodroplets located in the target tissue structure can form microbubble clouds under the high-frequency activation pulse signals. The inertial cavitation drive unit extends into the target tissue structure and forms a microbubble cloud within the target tissue structure, after which the microbubble cloud envelops the portion of the inertial cavitation drive unit that extends into the target tissue structure. The collaborative control unit sends a low-frequency inertial cavitation drive signal to the inertial cavitation drive unit, configuring the inertial cavitation drive unit to be in an inertial cavitation drive state, so as to stimulate the microbubble cloud to undergo violent inertial cavitation until the microbubble cloud expands and then implodes.

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

[0009] The needle motion drive mechanism drives the reciprocating motion of the puncture needle in the same direction as the axis of the puncture needle, and uses the reciprocating motion of the needle tip to induce violent inertial cavitation in the microbubble cloud.

[0010] Under the low-frequency inertial cavitation drive signal, the vibration of the needle body motion drive mechanism drives the puncture needle body to be in a mechanical resonance state, 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 along the axial direction is 30μm to 120μm.

[0011] The puncture needle also includes several injection channels capable of injecting phase-change nanodroplets into the target tissue structure, wherein... When the puncture needle has an injection channel, the puncture needle is guided to puncture the target tissue structure first. Then, the phase change nanodroplets in the injection channel are injected into the target tissue structure through the tip of the puncture needle. After the phase change nanofluid is injected into the target tissue structure, the tip of the puncture needle remains inside the target tissue structure.

[0012] The puncture needle body adopts an acoustic wave guide design, and its length is:

[0013] in, The length of the puncture needle body. It is an integer. The wavelength corresponding to the vibration frequency of the needle motion drive mechanism.

[0014] The needle motion drive mechanism includes a low-frequency transducer as a vibration source and an acoustic amplitude transformer adapted and connected to the low-frequency transducer, wherein... The low-frequency transducer is fixedly connected to the tail of the puncture needle via an acoustic amplitude transformer. The low-frequency transducer vibrates under the action of the low-frequency inertial cavitation drive signal, and drives the puncture needle body to vibrate through the acoustic amplitude transformer, so that the puncture needle body and the low-frequency transducer are in a state of mechanical resonance.

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

[0016] The low-frequency transducer includes a transducer cover and a piezoelectric ceramic unit located within the transducer cover, wherein, The piezoelectric ceramic unit comprises multiple piezoelectric ceramic rings. The acoustic amplitude transformer is fixedly connected to the transducer cover. A low-frequency inertial cavitation drive signal is applied to the piezoelectric ceramic unit to cause the piezoelectric ceramic unit to vibrate, and the vibration is transmitted to the puncture needle body through the acoustic amplitude transformer.

[0017] The collaborative control unit can also drive the ultrasound probe unit to transmit imaging pulse signals towards the target tissue structure, so as to use the imaging pulse echo signal to perform ultrasound imaging of the target tissue structure. Ultrasonic imaging based on imaging pulse echo signals can at least guide an inertial cavitation drive unit into the target tissue structure to determine the state of microbubble clouds formed within the target tissue structure and / or the state of tissue damage in the target tissue structure.

[0018] Advantages of the present invention: When tissue is damaged, the ultrasonic probe unit acts as a high-frequency activation source, which emits activation pulse signals to activate phase change nanodroplets and generate microbubble clouds; the inertial cavitation drive unit acts as a low-frequency drive source to activate the microbubble clouds to undergo violent inertial cavitation until expansion and implosion occur.

[0019] In this invention, the high-frequency activation source and the low-frequency driving source are set separately. The puncture needle in the inertial cavitation driving unit contacts the microbubble cloud and activates the microbubble cloud to produce inertial cavitation through reciprocating motion. The output power of the puncture needle to activate the microbubble cloud to produce inertial cavitation is reduced, which can reduce the energy threshold required to activate the microbubble cloud. Thus, while efficiently destroying tissue, unnecessary thermal damage can be avoided, making the instrument more minimally invasive and safer.

[0020] By using imaging pulse signals and activation pulse signals emitted by the ultrasound probe unit, precise control of tissue damage space at the sub-millimeter level can be achieved. Specifically, the injected phase change nanodroplets cover the designated lesion area, and the microbubble cloud formed by the activation pulse signal can controllably cover the designated lesion area, allowing the puncture needle to effectively contact the formed microbubble cloud. Tissue damage will only occur when these conditions are met, so that the scope and boundary of the damage are firmly limited within the operator's preset range, achieving a level of precision control that other technologies cannot match, and completely eliminating the risk of out-of-focus activation and uncontrolled cavitation cloud.

[0021] Furthermore, the tissue destruction method of this invention eliminates the "acoustic shielding" effect. Acoustic shielding refers to the phenomenon where, after an external sound beam generates a microbubble cloud at the focal point, the microbubble cloud reflects and absorbs subsequent treatment energy, preventing the treatment sound beam from reaching the deep lesion, resulting in uneven destruction and low efficiency. In this invention, the puncture needle directly contacts the microbubble cloud, and the vibrational energy is transmitted from the inside out, eliminating any self-shielding physical path. This ensures that the destruction around the needle tip is uniform and sufficient, thus eliminating the "acoustic shielding" effect. Attached Figure Description

[0022] Figure 1 This is a system block diagram of one embodiment of the dual-frequency collaborative puncture-type tissue destruction system of the present invention.

[0023] Figure 2 This is a schematic diagram of one embodiment of the inertial cavitation drive unit of the present invention.

[0024] Explanation of reference numerals in the attached drawings: 100-Injection device, 101-Puncture needle body, 102-Injection connector, 103-Low-frequency transducer, 104-Microbubble cloud, 105-Target tissue structure, 106-Acoustic amplitude transformer, 107-Front cover plate, 108-Piezoelectric ceramic ring, 109-Rear cover plate, 200-Ultrasonic probe unit, 300-Coordination control unit. Detailed Implementation

[0025] The present invention will be further described below with reference to specific accompanying drawings and embodiments.

[0026] To achieve a low energy threshold through exogenous cavitation, thus enabling safe, efficient, and controllable tissue destruction, this invention provides a dual-frequency synergistic puncture-type tissue destruction system. Specifically, the tissue destruction system includes a synergistic control unit 300 and an ultrasonic probe unit 200 and an inertial cavitation drive unit electrically connected to the synergistic control unit 300. The collaborative control unit 300 can drive the ultrasonic probe unit 200 to emit an activation pulse signal that can induce sono-evaporation of phase change nanodroplets towards 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. After the inertial cavitation drive unit extends into the target tissue structure 105 and forms a microbubble cloud 104 within the target tissue structure 105, the microbubble cloud 104 encloses the portion of the inertial cavitation drive unit that extends into the target tissue structure 105. The cooperative control unit 300 sends a low-frequency inertial cavitation drive signal to the inertial cavitation drive unit, configuring the inertial cavitation drive unit to be in an inertial cavitation drive state, so as to stimulate the microbubble cloud 104 to undergo violent inertial cavitation until the microbubble cloud 104 expands and then implodes.

[0027] Figure 1 An embodiment of a tissue destruction system is illustrated. As shown in the figure, the tissue destruction system of the present invention includes a collaborative control unit 300, an ultrasonic probe unit 200, and an inertial cavitation drive unit. The collaborative control unit 300 is electrically connected to the ultrasonic probe unit 200 and the inertial cavitation drive unit. The collaborative control unit 300 is used to collaboratively control the corresponding working states of the ultrasonic probe unit 200 and the inertial cavitation drive unit. It should be understood that the main purpose of collaboratively controlling the operation of the ultrasonic probe unit 200 and the inertial cavitation drive unit is to effectively complete tissue destruction at low energy thresholds. The collaborative control unit 300 can adopt existing common forms, such as a computer terminal device. The type of collaborative control unit 300 can be selected as needed to meet the requirements of collaborative control.

[0028] Similar to existing organizational destruction, when carrying out organizational destruction, it is necessary to identify the target organizational structure 105, which must be at least the area where the organizational destruction will take place. Figure 1 The illustration shows an embodiment where the target tissue structure 105 is the liver. It is understood that when there are lesions in the liver, the lesions in the liver should be destroyed. That is, the tissue destroyed by the present invention should be the lesions in the target tissue structure 105. When the target tissue structure 105 is other organs, the corresponding description can be referred to here.

[0029] As explained above, when performing tissue destruction, a microbubble cloud 104 should be formed within the target tissue structure 105. It should be understood that the microbubble cloud 104 should at least cover the area where the lesion is located within the target tissue structure 105, or, as required, enable the necessary tissue destruction using the microbubble cloud 104. The mechanism of using the formed microbubble cloud to destroy the lesion is consistent with existing methods.

[0030] To form the microbubble cloud 104, phase change nanodroplets should be injected into the target tissue structure 105. Subsequently, the co-control unit 300, configured with an ultrasonic probe unit 300, emits an activation pulse signal to induce acoustic evaporation of the phase change nanodroplets within the target tissue structure 105. This allows the formation of the microbubble cloud 104 within the target tissue structure 105. The method of using the activation pulse signal to guide the acoustic evaporation of the phase change nanodroplets is consistent with existing technologies. Therefore, the ultrasonic probe unit 200 of this invention should be able to emit at least an activation pulse signal and induce acoustic evaporation of the phase change nanodroplets to form the microbubble cloud 104. The ultrasonic probe unit 200 can adopt a commonly used form, specifically designed to emit the required activation pulse signal.

[0031] It should be understood that during coordinated control, the coordinated control unit 300 drives the ultrasonic probe unit 200 to emit an activation pulse signal towards the target tissue structure 105. Similar to existing technologies, the activation pulse signal is a high-frequency pulse. The characteristics of the emitted activation pulse signal can be: a signal frequency of 2-5 MHz, a pulse length of 2-5 cycles, a pulse repetition frequency of 20-50 Hz, an acoustic peak negative pressure of 2-5 MPa, and a duration of 2-5 seconds. It is 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 point, it will not cause damage to the target tissue structure 105. In specific implementation, the coordinated control unit 300 drives the ultrasonic probe unit 200 to emit the activation pulse signal, and the method for configuring the signal characteristics of the activation pulse signal can be consistent with existing technologies, and will not be elaborated here.

[0032] Unlike existing methods of tissue damage, when the microbubble cloud 104 is activated to generate inertial cavitation, the present invention can achieve a low energy threshold by means of exogenous cavitation. That is, unlike the existing method where the ultrasound probe unit 200 emits a second set of "treatment" pulses to excite the microbubble cloud 104 to generate inertial cavitation, the present invention does not use the ultrasound probe unit 200 to emit a second set of treatment pulses when activating the microbubble cloud 104 to generate inertial cavitation. Instead, it uses an inertial cavitation driving unit. At this time, compared with the ultrasound probe unit 200, the inertial cavitation driving unit acts as an exogenous cavitation.

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

[0034] To achieve tissue destruction at a low energy threshold, the coordinating control unit 300 should send a low-frequency inertial cavitation drive signal to the inertial cavitation drive unit. This low-frequency inertial cavitation drive signal configures the inertial cavitation drive unit to be in an inertial cavitation drive state. Specifically, being in an inertial cavitation drive state means that the microbubble cloud 104 can be excited to undergo violent inertial cavitation until it expands and implodes. After the microbubble cloud 104 implodes, the microbubble cloud 104 can be used to destroy corresponding lesions within the target tissue structure 105. The principle of tissue destruction is consistent with existing technologies, where the corresponding lesion specifically refers to the lesion directly corresponding to the microbubble cloud 104.

[0035] In practice, when the inertial cavitation driving unit contacts the microbubble cloud 104 and excites the microbubble cloud 104 to undergo inertial cavitation, it is mainly driven by a 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 excite the microbubble cloud 104 to undergo inertial cavitation is much lower than the energy of inertial cavitation excited by ultrasound treatment pulses in the prior art. Therefore, unnecessary thermal damage can be avoided when destroying lesion tissue, making the destruction safer.

[0036] The following section provides a detailed explanation of the inertial cavitation drive unit and the method and process by which the microbubble cloud 104 is excited by the inertial cavitation drive unit, and then expands and implodes within the microbubble cloud 104.

[0037] In one embodiment of the present invention, the inertial cavitation drive unit includes at least a puncture needle body 101 and a needle body motion drive mechanism for driving the mechanical movement of the puncture needle body 101, wherein, The puncture needle body 101 punctures into the target tissue structure 105 at least before the microbubble cloud 104 is formed by the phase change nanoliquid, and after the microbubble cloud 104 is formed by the phase change nanoliquid, the tip of the puncture needle body 101 is located within the microbubble cloud 104. The needle body motion drive mechanism is electrically connected to the collaborative control unit 300. The collaborative control unit 300 loads a low-frequency inertial cavitation drive signal to the needle body motion drive mechanism, which drives at least the tip of the puncture needle body 101 to reciprocate in a low-frequency, high-amplitude state within the microbubble cloud 104, so that the inertial cavitation drive unit is in an inertial cavitation drive state.

[0038] Figure 1 The figure illustrates one embodiment of an inertial cavitation drive unit. As shown in the figure, the inertial cavitation drive unit includes a puncture needle body 101, which may be cylindrical and have a pointed needle tip. The needle tip of the puncture needle body 101 can be used to puncture and place the puncture needle body 101 into the target tissue structure 105 at the corresponding position. Therefore, the inertial cavitation drive unit extends into the target tissue structure 105, specifically meaning that the needle tip of the puncture needle body 101 punctures into the target tissue structure 105. In addition, when a microbubble cloud 104 is formed, the microbubble cloud 104 will surround the needle tip of the puncture needle body 101, that is, the needle tip of the puncture needle body 101 will be located within the microbubble cloud 104.

[0039] In order to induce intense inertial cavitation in the microbubble cloud 104, in one embodiment of the present invention, the tip of the puncture needle body 101 may be configured to move relative to the microbubble cloud 104. To drive the movement of the puncture needle body 101, the inertial cavitation drive unit should also include a needle body motion drive mechanism, which drives the tip of the puncture needle body 101 to reciprocate in a low-frequency, high-amplitude state within the microbubble cloud 104. In one embodiment of the present invention, the direction of the reciprocating motion of the puncture needle body 101 driven by the needle body motion drive 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 drive mechanism is consistent with the length direction of the puncture needle tip 101.

[0040] It is understood that the cooperative control unit 300 sends a low-frequency inertial cavitation drive signal to the inertial cavitation drive unit, specifically meaning that the cooperative control unit 300 loads the low-frequency inertial cavitation drive signal onto the needle body motion drive mechanism. In one embodiment of the present invention, under the low-frequency inertial cavitation drive signal, the vibration of the needle body motion drive mechanism drives the puncture needle body 101 to 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 axial direction of the puncture needle body 101; The displacement amplitude of the tip of the puncture needle body 101 along the axial direction is 30μm to 120μm.

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

[0042] In one embodiment of the present invention, the needle motion driving mechanism includes a low-frequency transducer 103 as a vibration source and an acoustic amplitude transformer 106 adapted to and connected to the low-frequency transducer 103, wherein, The low-frequency transducer 103 is fixedly connected to the tail of the puncture needle body 101 via the acoustic amplitude transformer 106; The low-frequency transducer 103 vibrates under the action of the low-frequency inertial cavitation drive signal, and drives the puncture needle body 101 to vibrate through the acoustic amplitude transformer 106, so that the puncture needle body 101 and the low-frequency transducer 103 are in a mechanical resonance state.

[0043] Figure 1 The figure shows an embodiment of the needle motion drive mechanism. As can be seen from the figure, the needle motion drive mechanism may include a low-frequency transducer 103, wherein the low-frequency transducer 103 mainly serves as a vibration source. An acoustic amplitude transformer 106 is provided on the low-frequency transducer 103. The acoustic amplitude transformer 106 mainly serves as a speed transformer, which amplifies the small amplitude of the low-frequency transducer 103 and transmits it to the puncture needle 101 efficiently, thereby configuring the puncture needle 101 to be in the mechanical resonance state described above.

[0044] In specific implementation, the cross-sectional profile of the acoustic amplitude transformer 106 is exponential or catenary. The shape of the cross-sectional profile of the acoustic amplitude transformer 106 can be selected as needed to ensure that the small amplitude of the low-frequency transducer 103 is efficiently transmitted to the puncture needle body 101. The specific cross-sectional profiles will not be listed here.

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

[0046] in, The length of the puncture needle body 101, It is an integer. The wavelength corresponding to the vibration frequency of the needle motion drive mechanism.

[0047] To achieve the aforementioned mechanical resonance and ensure the needle tip is positioned at the antinode of the longitudinal vibration wave, the length of the puncture needle body 101 should be configured accordingly. 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. The vibration frequency of the needle motion drive mechanism is the same as the vibration frequency of the low-frequency transducer 103 under a low-frequency inertial cavitation drive signal. It should be understood that the vibration frequency of the low-frequency transducer 103 is a low-frequency state. The integer n can generally be selected as needed, such as according to different tissue damage scenarios. The unit of the length of the puncture needle body 101 is mm. Furthermore, the unit of the wavelength corresponding to the vibration frequency is also mm.

[0048] In specific implementation, the vibration generated by the low-frequency transducer 103 is first amplified by the acoustic amplitude transformer 106 and transmitted to the puncture needle body 101. At the same time, the puncture needle body 101 adopts the form of an acoustic waveguide, which can further amplify the amplitude, thus achieving a double amplification of the vibration generated by the low-frequency transducer 103. This allows the displacement of the needle tip to obtain extremely high mechanical gain. The energy of the needle tip movement acts on the microbubble cloud 104. Since the low frequency easily drives 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. This enables efficient inertial cavitation to be achieved with extremely low power (<3W, where the power is the power of the low-frequency inertial cavitation driving signal), reducing the energy requirements for inertial cavitation of the microbubble cloud 104 in the prior art. When the microbubble cloud 104 undergoes violent expansion and implosion, the powerful mechanical force (shock wave, microjets) it releases performs pure mechanical destruction on the lesion tissue.

[0049] Furthermore, when the needle motion drive mechanism adopts the combination of low-frequency transducer 103 and acoustic amplitude transformer 106, the connection between the puncture needle 101 and the acoustic amplitude transformer 106, as well as the assembly method of the low-frequency transducer 103, should ensure that the puncture needle 101 can achieve the above-mentioned reciprocating motion.

[0050] In one embodiment of the present invention, the low-frequency transducer 103 includes a transducer cover and a piezoelectric ceramic unit located within the transducer cover, wherein, The piezoelectric ceramic unit includes multiple piezoelectric ceramic rings 108. The acoustic amplitude transformer 106 is fixedly connected to the transducer cover. A low-frequency inertial cavitation drive signal is applied to the piezoelectric ceramic unit to cause the piezoelectric ceramic unit to vibrate. The vibration is transmitted to the puncture needle body 101 via the acoustic amplitude transformer 106.

[0051] Figure 2 The figure illustrates one embodiment of a low-frequency transducer 103. The transducer cover may include a front cover plate 107 and a rear cover plate 109. A piezoelectric ceramic unit is located 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 using conventional methods. The piezoelectric ceramic unit may include multiple piezoelectric ceramic rings 108. Figure 2 The illustration shows an embodiment of a piezoelectric ceramic unit comprising two stacked piezoelectric ceramic rings 108. The number of piezoelectric ceramic rings 108 within the piezoelectric ceramic unit can be selected as needed to generate the required vibrations.

[0052] It is understandable that when the low-frequency transducer 103 serves as a vibration source, a low-frequency inertial cavitation drive signal is applied to the low-frequency transducer 103. Specifically, this means that the low-frequency inertial cavitation drive signal is applied to the piezoelectric ceramic unit, causing the piezoelectric ceramic unit to vibrate. The resulting vibration is transmitted to the puncture needle body 101 via the acoustic amplitude transformer 106. Therefore, the low-frequency inertial cavitation drive signal should be sufficient to drive the piezoelectric ceramic unit to vibrate. In practice, the signal frequency of the low-frequency inertial cavitation drive signal can be 20-200kHz. Furthermore, the piezoelectric ceramic unit is assembled within the transducer cover to ensure that the low-frequency transducer 103 serves as a vibration source. Specific assembly methods will not be illustrated here.

[0053] In practical implementation, after determining the low-frequency transducer 103, the frequency of vibration generated by the piezoelectric ceramic unit can be determined based on the characteristics of the low-frequency transducer 103 and the signal frequency of the low-frequency inertial cavitation drive signal. Furthermore, the wavelength corresponding to the vibration frequency of the needle motion drive mechanism can be determined. Therefore, the length of the puncture needle body 101 can be designed.

[0054] As explained above, when forming the microbubble cloud 104, phase change nanodroplets should be injected into the target tissue structure. Both the injected phase change nanodroplets and the injection method are consistent with existing technologies. It is understood that the injection location of the phase change nanodroplets should correspond precisely to the location of the microbubble cloud 104 formation and the location of the corresponding damaged lesion.

[0055] To further simplify the tissue destruction procedure and improve its efficiency, in one embodiment of the present invention, the puncture needle body 101 further includes several injection channels capable of injecting phase change nanodroplets into the target tissue structure 105. When the puncture needle body 101 has an injection channel, the puncture needle body 101 is guided to first puncture into the target tissue structure 105. After that, the phase change nanodroplets in the injection channel are injected into the target tissue structure 105 through the needle tip of the puncture needle body 101. After the phase change nanofluid is injected into the target tissue structure 105, the tip of the puncture needle body 101 remains inside the target tissue structure 105.

[0056] Understandably, when an injection channel is provided inside the puncture needle body 101, phase change nanodroplets can be injected into the desired location within the target tissue structure 105 through the injection channel of the puncture needle body 101. Of course, before injecting the phase change nanodroplets, the puncture needle body 101 should be guided to puncture into the target tissue structure 105. The puncturist can then inject the phase change nanodroplets that have entered the injection channel into the desired location within the target tissue structure 105 through the needle tip of the puncture needle body 101.

[0057] In practice, the number of injection channels inside the puncture needle body 101 can be selected as needed, such as based on the inner diameter of the puncture needle body 101. The injection channels are generally distributed along the length of the puncture needle body 101. Figure 1 The diagram shows an injection connector 102 at the tail end of the puncture needle body 101. The injection connector 102 can be adapted to connect with an injection device 100. Subsequently, the injection device 100 can inject phase change nanodroplets into one or more injection channels and provide propulsion for delivering the phase change nanodroplets to the desired location within the target tissue structure 105. The injection device 100 can be a commonly used syringe or injection pump; the type of injection device 100 can be selected as needed to inject the phase change nanodroplets into the desired location within the target tissue structure.

[0058] In one embodiment of the present invention, after the phase change nanodroplets are delivered into the target tissue structure 105, the puncture needle 101 can be left in place to activate the inertial cavitation of the subsequent microbubble cloud 104. It is understood that since the nano-phase change droplets are delivered into the target tissue structure 105 by the tip of the puncture needle 101, the nano-phase change droplets will surround the tip of the puncture needle 101. After the microbubble cloud 104 is formed using the activation pulse signal, the tip of the puncture needle 101 will be within the microbubble cloud 104.

[0059] It should be understood that when the phase change nanodroplets are not delivered into the target tissue structure 105 via the puncture needle 101, a nanodroplet injection device should be used to first deliver the phase change nanodroplets into the target tissue structure 105. Afterward, the nanodroplet injection device should be withdrawn from the target tissue structure 105, and then the puncture needle 101 should be inserted into the target tissue structure 105. The tip of the puncture needle 101 should enter the phase change nanodroplet within the target tissue structure 105. Subsequently, an activation pulse signal is used to activate the phase change nanodroplets, forming a microbubble cloud 104, with the tip of the puncture needle 101 located within the formed microbubble cloud 104. The nanodroplet injection device can be any commonly used syringe or similar device, and the specific choice can be made according to requirements.

[0060] In one embodiment of the present invention, the collaborative control unit 300 can also drive the ultrasound probe unit 200 to transmit imaging pulse signals toward the target tissue structure 105, so as to use the imaging pulse echo signal to perform ultrasound imaging on the target tissue structure 105, wherein... Ultrasonic imaging based on imaging pulse echo signals at least guides the inertial cavitation drive unit to extend into the target tissue structure 105, determines the state of the formation of microbubble cloud 104 within the target tissue structure 105, and / or the tissue damage state of the target tissue structure 105.

[0061] In specific implementation, the ultrasonic probe unit 300 can also emit imaging pulse signals. When the cooperating control unit 300 drives the ultrasonic probe unit 200 to emit imaging pulse signals and receives the corresponding imaging pulse echo signals, ultrasonic imaging can be realized. The method and principle of ultrasonic imaging can be consistent with the existing technology. That is, the method of configuring the ultrasonic probe unit 200 to emit imaging pulse signals and the method of configuring the ultrasonic probe unit 200 to receive imaging pulse echo signals and form images can be consistent with the existing technology, and will not be elaborated here.

[0062] The timing of ultrasound imaging by the ultrasonic probe unit 200 in the collaborative control unit 300 can be selected as needed. For example, ultrasound imaging can be performed before injecting phase change nanodroplets into the target tissue structure 105 to determine the location of the lesion to be destroyed within the target tissue structure 105. Subsequently, based on the ultrasound imaging images, the puncture needle or nanodroplet injection device can be guided for percutaneous puncture so that the phase change nanodroplets can be accurately delivered into the required location within the target tissue structure 105, which can at least guide the inertial cavitation drive unit to extend into the target tissue structure 105. Of course, during the injection of phase change nanodroplets, ultrasound imaging can still be performed through the ultrasonic probe unit 200 to monitor the injection process.

[0063] After the phase change nanodroplet injection is completed and the puncture needle 101 has punctured into the target tissue structure 105, the ultrasound probe unit 200 can be configured to emit an activation pulse signal. Subsequently, ultrasound imaging can be performed through the ultrasound probe unit 200 to observe the state of the formed microbubble cloud 104. If a significant increase in echo intensity can be observed in the image, the effective coverage area of ​​the microbubble cloud 104 can be immediately confirmed. The method of observing the state of the formed microbubble cloud 104 through ultrasound imaging is consistent with the existing technology.

[0064] After the microbubble cloud 104 implodes, ultrasound imaging can be performed again using the ultrasound probe unit 200. Ultrasound imaging can be used to observe the state of tissue damage, that is, to observe / determine the state of tissue damage of the target tissue structure 105, such as whether the lesion has been completely and effectively destroyed and whether it has exceeded the lesion boundary, thereby observing the tissue damage and improving the controllability of tissue damage operation.

[0065] As can be seen from the above description, when tissue is damaged, the ultrasonic probe unit 200 acts as a high-frequency activation source, emitting an activation pulse signal to activate phase change nanodroplets and generate microbubble cloud 104; the inertial cavitation drive unit acts as a low-frequency drive source to activate the microbubble cloud 104 to undergo violent inertial cavitation until expansion and implosion occur.

[0066] In this invention, the high-frequency activation source and the low-frequency driving source are set separately. The puncture needle 101 in the inertial cavitation driving unit contacts the microbubble cloud 104 and activates the microbubble cloud 104 to produce inertial cavitation through reciprocating motion. The output power of the puncture needle 101 to activate the microbubble cloud 104 to produce inertial cavitation is reduced, which can reduce the energy threshold required to activate the microbubble cloud 104. Thus, while efficiently destroying tissue, unnecessary thermal damage can be avoided, making the instrument more minimally invasive and safer.

[0067] By using imaging pulse signals and activation pulse signals emitted by the ultrasound probe unit 200, precise control of tissue damage space at the sub-millimeter level can be achieved. Specifically, the injected phase change nanodroplets cover the designated lesion area, and the microbubble cloud 104 formed by the activation pulse signal can controllably cover the designated lesion area, and can effectively contact the puncture needle body 101 with the formed microbubble cloud 104. Tissue damage will only occur when these conditions are met, so that the scope and boundary of the damage are firmly limited within the operator's preset range, achieving precise control that other technologies cannot match, and completely eliminating the risk of out-of-focus activation and uncontrolled cavitation cloud.

[0068] Furthermore, the tissue destruction method of this invention also eliminates the "acoustic shielding" effect. Acoustic shielding refers to the phenomenon where, after an external sound beam generates a microbubble cloud 104 at the focal point, the microbubble cloud 104 reflects and absorbs subsequent treatment energy, preventing the treatment sound beam from reaching the deep lesion, resulting in uneven destruction and low efficiency. In this invention, the puncture needle 104 directly contacts the microbubble cloud 104, and the vibration energy is transmitted from the inside out, without any self-shielding physical path. This ensures that the destruction around the needle tip is uniform and sufficient, thus eliminating the "acoustic shielding" effect.

[0069] This invention utilizes a collaborative control unit 300 to coordinate the operation of the ultrasound probe unit 200 and the inertial cavitation drive unit, seamlessly integrating diagnostic imaging, puncture guidance, consumable delivery (phase change nanodroplet injection), energy activation, treatment drive, and real-time monitoring and evaluation functions into a single process encompassing "guidance-injection-activation-destruction-evaluation." This closed-loop treatment process significantly simplifies the procedure, shortens surgical time, and allows the operator to dynamically adjust the treatment based on real-time feedback, ensuring both adequacy and safety of the treatment.

[0070] The above description is merely a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A dual-frequency synergistic puncture-type tissue destruction system, characterized in that, The tissue destruction system includes a collaborative control unit and an ultrasonic probe unit and an inertial cavitation drive unit that are electrically connected to the collaborative control unit. The collaborative control unit can drive the ultrasonic probe unit to emit activation pulse signals that can induce sono-evaporation of phase change nanodroplets towards the target tissue structure, so that the phase change nanodroplets located in the target tissue structure can form microbubble clouds under the high-frequency activation pulse signals. The inertial cavitation drive unit extends into the target tissue structure and forms a microbubble cloud within the target tissue structure, after which the microbubble cloud envelops the portion of the inertial cavitation drive unit that extends into the target tissue structure. The collaborative control unit sends a low-frequency inertial cavitation drive signal to the inertial cavitation drive unit, configuring the inertial cavitation drive unit to be in an inertial cavitation drive state, so as to stimulate the microbubble cloud to undergo violent inertial cavitation until the microbubble cloud expands and then implodes. The inertial cavitation drive unit includes at least a puncture needle body and a needle body motion drive mechanism for driving the mechanical movement of the puncture needle body, wherein... The puncture needle body penetrates the target tissue structure at least before the microbubble cloud is formed by the phase change nanoliquid, and after the microbubble cloud is formed by the phase change nanoliquid, the tip of the puncture needle body is located within the microbubble cloud; The needle body motion drive mechanism is electrically connected to the collaborative control unit. The collaborative control unit loads a low-frequency inertial cavitation drive signal to the needle body motion drive mechanism, which drives at least the tip of the puncture needle body to reciprocate in a low-frequency, high-amplitude state within the microbubble cloud, so that the inertial cavitation drive unit is in an inertial cavitation drive state. Under the low-frequency inertial cavitation drive signal, the vibration of the needle body motion drive mechanism drives the puncture needle body to be in a mechanical resonance state, 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 along the axial direction is 30μm to 120μm; The puncture needle also includes several injection channels capable of injecting phase-change nanodroplets into the target tissue structure, wherein... When the puncture needle has an injection channel, the puncture needle is guided to puncture the target tissue structure first. Then, the phase change nanodroplets in the injection channel are injected into the target tissue structure through the tip of the puncture needle. After the phase change nanofluid is injected into the target tissue structure, the tip of the puncture needle remains inside the target tissue structure.

2. The dual-frequency synergistic puncture-type tissue destruction system according to claim 1, characterized in that: The needle motion drive mechanism drives the reciprocating motion of the puncture needle in the same direction as the axis of the puncture needle, and uses the reciprocating motion of the needle tip to induce violent inertial cavitation in the microbubble cloud.

3. The dual-frequency synergistic puncture-type tissue destruction system according to claim 1, characterized in that: The puncture needle body adopts an acoustic wave guide design, and its length is: in, The length of the puncture needle body. It is an integer. The wavelength corresponding to the vibration frequency of the needle motion drive mechanism.

4. The dual-frequency synergistic puncture-type tissue lesioning system according to any one of claims 1 to 3, characterized in that: The needle motion drive mechanism includes a low-frequency transducer as a vibration source and an acoustic amplitude transformer adapted and connected to the low-frequency transducer, wherein... The low-frequency transducer is fixedly connected to the tail of the puncture needle via an acoustic amplitude transformer. The low-frequency transducer vibrates under the action of a low-frequency inertial cavitation drive signal, and drives the puncture needle body to vibrate through the acoustic amplitude transformer, so that the puncture needle body and the low-frequency transducer are in a state of mechanical resonance.

5. The dual-frequency synergistic puncture-type tissue destruction system according to claim 4, characterized in that: The cross-sectional profile of the acoustic amplitude transformer is exponential or catenary.

6. The dual-frequency synergistic puncture-type tissue destruction system according to claim 4, characterized in that: The low-frequency transducer includes a transducer cover and a piezoelectric ceramic unit located within the transducer cover, wherein... The piezoelectric ceramic unit comprises multiple piezoelectric ceramic rings. The acoustic amplitude transformer is fixedly connected to the transducer cover. A low-frequency inertial cavitation drive signal is applied to the piezoelectric ceramic unit to cause the piezoelectric ceramic unit to vibrate, and the vibration is transmitted to the puncture needle body through the acoustic amplitude transformer.

7. The dual-frequency synergistic puncture-type tissue lesioning system according to any one of claims 1 to 3, characterized in that: The collaborative control unit can also drive the ultrasound probe unit to transmit imaging pulse signals towards the target tissue structure, so as to use the imaging pulse echo signal to perform ultrasound imaging of the target tissue structure. Ultrasonic imaging based on imaging pulse echo signals can at least guide an inertial cavitation drive unit into the target tissue structure to determine the state of microbubble clouds formed within the target tissue structure and / or the state of tissue damage in the target tissue structure.

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