Interventional ultrasonic treatment device and control system

Abstract

The invention provides an interventional ultrasonic treatment device and a control system, the device comprises a flexible tube body, a balloon and an ultrasonic transducer, and the balloon surrounds the ultrasonic transducer; the ultrasonic transducer is configured to be capable of outputting ultrasonic waves having different electrical parameters in response to control of an external control device to select to perform any one of the following two functional modes: a stimulus recognition mode in which the ultrasonic transducer emits ultrasonic waves of a first characteristic; an ablation therapy mode in which the ultrasound transducer emits ultrasound waves of a second characteristic. According to the interventional ultrasonic treatment device, the target nerve can be identified and ablated by configuring the same ultrasonic transducer, so that the function multiplexing on hardware is realized, the manufacturing process and the wiring structure of the catheter are simplified, the mechanical position error caused by replacing instruments or moving the catheter to find an ablation site is avoided, and the operation is simple and convenient. The accuracy of the ablation target spot is greatly improved, and the risk of accidental injury to surrounding normal tissues is reduced.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an interventional ultrasound therapy device and control system. Background Technology

[0002] Hypertension is one of the most common chronic diseases worldwide, and long-term hypertension can damage vital organs such as the heart, brain, and kidneys. For drug-resistant hypertension, renal denervation (RDN) has proven to be an effective treatment. RDN lowers blood pressure by blocking the sympathetic nerves located in the adventitia of the renal arteries, thereby reducing the activity of the renal sympathetic nerves.

[0003] Current RDN technologies mainly include radiofrequency ablation and ultrasound ablation. Radiofrequency ablation requires the catheter electrode to be in close contact with the blood vessel wall, has limited energy penetration depth, and is prone to damaging the vascular intima. In contrast, interventional ultrasound ablation utilizes the penetrability of ultrasound waves to focus energy on the adventitia of the blood vessel without damaging the vascular intima, offering advantages such as non-contact, minimal damage, and controllable treatment depth.

[0004] However, accurately locating the treatment target (i.e., the location of the renal nerve) remains a technical challenge during interventional ultrasound treatment. The renal nerve is not evenly distributed outside the renal artery and is not visible under conventional X-ray fluoroscopy. Current clinical procedures often employ an "anatomical localization method," which involves multiple blind ablation points on the main trunk or branches of the renal artery. This "blind" strategy may not only lead to incomplete treatment (missing nerves) but also prolong the procedure time due to ineffective ablation of non-nerve areas, and even increase the risk of damaging surrounding tissues. Another approach is to first identify the target nerve using other components or instruments before performing ultrasound ablation. Summary of the Invention

[0005] The purpose of this invention is to provide an interventional ultrasound therapy device and interventional ultrasound therapy control method that achieves precise positioning and effective ablation of the treatment target using a single ultrasound transducer without increasing the complexity of the catheter hardware, in order to solve the above-mentioned technical problems.

[0006] To achieve the above objectives, the present invention provides an interventional ultrasound therapy device, comprising: The catheter assembly includes a flexible tubing and an inflatable balloon; An ultrasonic transducer and a balloon are disposed in the distal region of the flexible tube, the ultrasonic transducer being configured to convert received electrical signals into ultrasonic waves, and the balloon surrounding the ultrasonic transducer. The balloon is configured to contain a fluid medium so as to change from a contracted state to an inflated state, so that the outer wall of the balloon fits against the inner wall of the target tissue. The ultrasonic transducer is configured to respond to control by an external control device and output ultrasonic waves with different electrical parameters to select either of the following two functional modes: Stimulus recognition mode, in which the ultrasonic transducer emits ultrasonic waves of a first characteristic, the ultrasonic waves of the first characteristic being configured to act on target tissue in a non-invasive manner and specifically induce target nerves to produce neurotransmitters thereby causing physiological changes. In the ablation therapy mode, the ultrasound transducer emits ultrasound waves with a second characteristic, which have a higher energy density than the first characteristic, for ablation and destruction of the target nerve.

[0007] Preferably, it also includes a signal transmission component that extends along the flexible tube, one end of which is electrically connected to the ultrasonic transducer, and the other end of which is used to connect to an external control device.

[0008] Preferably, the flexible tube is provided with a first cavity, a second cavity, and a third cavity. The first cavity is for the guide wire that guides the flexible component through the tissue to pass through. The second cavity and the third cavity are both in communication with the balloon. The second cavity is used to introduce a fluid medium into the balloon, and the third cavity is used to output the fluid medium in the balloon out of the flexible tube.

[0009] Preferably, the catheter assembly further includes a needle hub connected to the proximal end of the flexible tube, the needle hub being provided with a first interface communicating with the first cavity, a second interface communicating with the second cavity, and a third interface communicating with the third cavity.

[0010] Preferably, the system further includes a fluid supply mechanism, which includes an inlet pipe, an outlet pipe, an expansion pump, and a contraction pump. The inlet pipe is connected between the second interface and the fluid reservoir, and the outlet pipe is connected between the third interface and the fluid reservoir. The expansion pump is disposed on the inlet pipe and is used to deliver the fluid medium in the fluid reservoir into the second cavity through the second interface. The contraction pump is disposed on the outlet pipe and is used to pump the fluid medium in the third cavity into the fluid reservoir through the third interface.

[0011] Preferably, a first electrically controlled valve is provided on the liquid inlet pipe, and a second electrically controlled valve is provided on the liquid outlet pipe.

[0012] Preferably, the electrical signal corresponding to the ultrasonic wave with the first characteristic has a first duty cycle and a first amplitude; the electrical signal corresponding to the ultrasonic wave with the second characteristic has a second duty cycle and a second amplitude. Wherein, the second duty cycle is greater than the first duty cycle, and the second amplitude is greater than the first amplitude.

[0013] Preferably, the frequency corresponding to the ultrasonic wave with the first characteristic is a first frequency range, and the frequency corresponding to the ultrasonic wave with the second characteristic is a second frequency range. The second frequency range is higher than the first frequency range, and the first frequency range is configured to cover the sensitive frequency range of the target nerve.

[0014] The present invention also provides an interventional ultrasound therapy control system for controlling an interventional ultrasound therapy device, the interventional ultrasound therapy device being described above; the system includes: The mode switching module is configured to receive operation instructions and control the target working mode to be either stimulation recognition mode or ablation treatment mode according to the operation instructions. A signal generation module is configured to be electrically connected to the ultrasonic transducer and to output a first driving signal corresponding to the stimulation recognition mode or a second driving signal corresponding to the ablation treatment mode to the ultrasonic transducer according to the instruction of the mode switching module. The judgment module is configured in the stimulus recognition mode to generate a first signal or a second signal based on the received physiological change parameters. The first signal indicates that the nerve at the current position is a target nerve, and the second signal indicates that the nerve at the indicated position is a non-target nerve. The mode switching module is also configured to switch the target working mode to the ablation treatment mode based on the first signal.

[0015] Preferably, the mode switching module is further configured to: in the ablation treatment mode, when the signal generation module stops outputting, switch the target working mode to the stimulation recognition mode.

[0016] Preferably, it also includes a verification module, which, when the target operating mode switches from ablation therapy mode back to the stimulation recognition mode, is configured in situ as follows: Obtain the current physiological parameters of the target object during the re-output of the first drive signal; Calculate the change in the current physiological parameter relative to the resting state index; If the change is less than a preset effective threshold, a third signal representing the end of treatment at the current location is generated. If the change is greater than or equal to the preset effective threshold, a fourth signal is generated. The fourth signal is used to control the mode switching module to switch back to the ablation treatment mode at the current position.

[0017] Preferably, it also includes a monitoring module, which is configured to: During the process of the signal generation module outputting the second drive signal, one or more data objects among the fluid medium temperature, fluid medium filling pressure and electrical parameters of the ultrasonic transducer are monitored in real time. Determine whether the monitored data object exceeds a preset security threshold; If any of the data objects exceeds the preset safety threshold, the signal generation module is forced to stop outputting and an instruction is generated to control the balloon to contract.

[0018] Preferably, it also includes a foot pedal control interface for connecting a foot pedal switch; The signal generation module is specifically configured as follows: After the mode switching module determines the target working mode, it starts to output a first drive signal or a second drive signal in response to the closing signal of the foot switch. In response to the disconnect signal from the foot switch, the output of the corresponding first drive signal or second drive signal stops; or, In response to the closing signal of the foot switch and after maintaining it for a preset time, the first drive signal or the second drive signal is continuously output for a preset duration.

[0019] Preferably, it also includes a position adjustment module, the position adjustment module being configured to: In the stimulation recognition mode, if the judgment module generates the second signal, the balloon is contracted to allow the catheter assembly to move to a new position; After the movement is completed, the balloon is re-inflated in response to a user command, and the stimulus recognition pattern is reset.

[0020] Preferably, it also includes a temperature control module; The temperature control module is configured as follows: Receive the real-time temperature value fed back by the temperature sensor inside the balloon; Calculate the temperature deviation between the real-time temperature value and the preset target temperature; A flow regulation command is generated based on the temperature deviation. The flow rate adjustment command is used to dynamically adjust the circulation rate of the fluid medium inside the balloon.

[0021] Compared to existing technologies, the interventional ultrasound therapy device provided by the above-mentioned technical solution, by configuring a single ultrasound transducer to emit both ultrasound waves with the first characteristic used for stimulation recognition and ultrasound waves with the second characteristic used for ablation therapy, achieves functional reuse in hardware. This not only simplifies the manufacturing process and wiring structure of the catheter but also helps to reduce the outer diameter of the distal end of the catheter, making it easier to enter narrow or tortuous vascular branches for treatment. Secondly, after confirming the target point in stimulation recognition mode, it can be directly switched to ablation therapy mode without moving the catheter. This in-situ switching avoids mechanical positional errors caused by changing instruments or moving the catheter to find the ablation site, greatly improving the accuracy of the ablation target and ensuring that energy is precisely applied to the area where functional nerves are located. In addition, before releasing high energy for destructive ablation, the sympathetic nerves present in the patient's target area are detected to identify the sympathetic nerves in the target area. Then, the sympathetic nerves are ablated in all directions without blind spots, thus avoiding blind ablation. This not only improves the success rate of a single ablation, but also effectively avoids unnecessary high-energy ablation of blood vessel wall tissues without nerves, thereby reducing the risk of accidental damage to surrounding normal tissues. Attached Figure Description

[0022] Figure 1 This is a plan view of the interventional ultrasound therapy device in an embodiment of the present invention.

[0023] Figure 2 This is a schematic diagram illustrating the connection between the interventional ultrasound therapy device and the host system in an embodiment of the present invention.

[0024] Figure 3 This is a diagram showing the working state of the ultrasonic transducer in an embodiment of the present invention.

[0025] Figure 4 This is a cross-sectional view of one type of flexible tube in an embodiment of the present invention.

[0026] Figure 5 This is another cross-sectional view of the flexible tube in an embodiment of the present invention.

[0027] Figure 6 This is a schematic diagram of the fluid supply mechanism of the interventional ultrasound therapy device in an embodiment of the present invention.

[0028] Figure 7 This is a schematic diagram of the overall control principle of the interventional ultrasound therapy control system in this embodiment of the invention.

[0029] Figure 8 This is a schematic diagram of the principle structure of some functional modules of the interventional ultrasound therapy control system in an embodiment of the present invention.

[0030] Figure 9This is a flowchart illustrating the mode switching process of the mode switching module in the ablation therapy mode in an embodiment of the present invention.

[0031] Figure 10 This is a flowchart of the verification module in an embodiment of the present invention. Detailed Implementation

[0032] To illustrate the technical content, structural features, objectives, and effects of the present invention in detail, the following description is provided in conjunction with the embodiments and accompanying drawings.

[0033] This embodiment provides an interventional ultrasound therapy device, which is mainly used for interventional identification and treatment of lesions in internal organs (such as the renal artery and sympathetic nerves). Figures 1 to 3 The device mainly includes a catheter assembly and an ultrasonic transducer 1.

[0034] The catheter assembly is the carrier for the device to enter the human body, and its main part is the flexible tube 2. The flexible tube 2 is made of biocompatible materials (such as nylon, polyethylene terephthalate, thermoplastic polyurethane elastomer, etc.), and has sufficient flexibility and propulsion to facilitate passage along the body's natural cavities (such as femoral arteries, renal arteries, etc.) and reach the lesion area. An inflatable balloon 3 is placed at the distal end of the flexible tube 2 (i.e., the end that penetrates the body during treatment).

[0035] The ultrasonic transducer 1 is also located in the distal region of the flexible tube 2 and is surrounded by the balloon 3. That is, the ultrasonic transducer 1 is located inside the balloon 3. As an energy conversion component, the ultrasonic transducer 1 is configured to convert electrical signals received from the proximal end (handle or main unit end) into ultrasonic mechanical vibrations.

[0036] Specifically, such as Figure 3 As shown, the ultrasound transducer 1 is cylindrical, and this structure allows for uniform irradiation of ultrasound energy along the circumference of arteries and veins. This facilitates the full detection of sympathetic nerves in the target area, thereby optimizing and resolving the problem of widespread detection blind spots in traditional RDN medical devices.

[0037] Balloon 3 is configured to contain a fluid medium (such as physiological saline or a specific cooling fluid). During treatment, by injecting the fluid medium into balloon 3, balloon 3 can change from a contracted (folded) state when passing through a blood vessel to an inflated state. The inflated size of balloon 3 is designed to adapt to the diameter of the target blood vessel, so that the outer wall of balloon 3 can fit tightly against the inner wall of the target tissue (such as a renal artery). This fit not only fixes the catheter position, but more importantly, establishes an acoustic channel for ultrasound waves to propagate from the transducer to the target tissue, reducing the reflection attenuation of ultrasound waves at different media interfaces.

[0038] In this embodiment, the ultrasonic transducer 1 does not simply output constant energy, but is configured to respond to control commands from an external control device (such as the host system 4) and output ultrasonic waves with different electrical parameters (such as frequency, power, duty cycle, waveform, etc.) to selectively execute the stimulation recognition module or ablation treatment mode.

[0039] In stimulus recognition mode, ultrasonic transducer 1 emits ultrasonic waves with a first characteristic. The ultrasonic waves with the first characteristic are typically characterized as low-intensity, low-dose ultrasonic signals (e.g., acoustic power in the range of 0.1-5W and pulse repetition frequency in the range of 1-1000Hz).

[0040] The ultrasound waves possessing this primary characteristic are configured to act on target tissue in a "non-invasive" manner. This means that the energy level is insufficient to cause thermal damage or necrosis of the tissue, but sufficient to produce mechanical or mild thermal effects to stimulate nerves. When the ultrasound waves act on a target area rich in sympathetic nerves, they can specifically induce nerve excitation at the target site, prompting nerve endings to secrete sympathetic neurotransmitters (such as norepinephrine and angiotensin). This nerve excitation causes observable physiological changes in the patient through a physiological feedback loop, such as a significant increase in blood pressure or heart rate.

[0041] By observing whether the above physiological changes occur, the operator can determine whether there are active renal sympathetic nerves in the outer membrane of the current balloon 3 location, thereby achieving accurate identification and localization of the lesion (target nerve) and avoiding blind ablation.

[0042] For example, the preset stimulation duration or preset ablation treatment duration is 0.1-1s, or 1-5s, or 5-10s, or 10-15s, or 15-20s, or 20-60s, etc. The embodiments of the present invention can use a variety of duration ranges to perform the stimulation and ablation of the sympathetic nerves as needed, and no specific limitation is made thereto.

[0043] In ablation therapy mode, ultrasound transducer 1 emits ultrasound waves with a second characteristic. Compared to ultrasound waves with a first characteristic, ultrasound waves with a second characteristic have a higher energy density (e.g., the acoustic power is increased to 5-50W, or the duty cycle and duration are changed).

[0044] This second characteristic of ultrasound is intended for therapeutic purposes. High-energy ultrasound waves penetrate the inner wall and media of blood vessels, reaching the adventitia and surrounding areas. At the target nerve, the ultrasound energy is absorbed and converted into heat (raising the local temperature to, for example, 50-90°C), causing irreversible damage to the target nerve (such as fibrin denaturation and coagulative necrosis), thereby blocking nerve conduction and achieving the therapeutic goal (e.g., lowering blood pressure in hypertensive patients).

[0045] Therefore, for the interventional ultrasound therapy device in this embodiment, firstly, by configuring the same ultrasound transducer 1 that can emit ultrasound waves with the first characteristic for stimulation recognition and ultrasound waves with the second characteristic for ablation therapy, functional reuse in hardware is achieved. This not only simplifies the manufacturing process and wiring structure of the catheter, but also helps to reduce the outer diameter of the distal end of the catheter, making it easier to enter narrow or tortuous vascular branches for treatment.

[0046] Secondly, after identifying the target in stimulation recognition mode, the system can directly switch to ablation therapy mode without moving the catheter. This in-situ switching avoids mechanical positional errors caused by changing instruments or moving the catheter to find the ablation site, greatly improving the accuracy of the ablation target and ensuring that energy is precisely applied to the area where the functional nerve is located.

[0047] Furthermore, before releasing high energy for destructive ablation, doctors can pre-verify the presence of the target site using low-energy ultrasound stimulation. This not only improves the success rate of a single ablation session but also effectively avoids unnecessary high-energy ablation of non-nervous vascular wall tissue, thereby reducing the risk of accidental damage to surrounding normal tissue.

[0048] On the other hand, in the stimulus recognition mode, the electrical signal output by the host system 4 has a first duty cycle and a first amplitude, thereby generating an ultrasonic wave with a first characteristic on the ultrasonic transducer.

[0049] The first duty cycle is set in a low range, for example, 5% to 20%, and the first amplitude is set to a low voltage, so that the acoustic power output by the ultrasonic transducer 1 is maintained at a low level, for example, 0.1W to 5W.

[0050] This combination of low duty cycle and low amplitude primarily utilizes the mechanical effects of ultrasound to stimulate nerves and induce changes in blood pressure to identify target points, without generating enough heat to damage tissues.

[0051] When the target point is identified and the treatment mode is switched, the electrical signal output by the host system 4 is adjusted to the second duty cycle and the second amplitude, thereby generating ultrasound waves with the second characteristic on the ultrasound transducer 1.

[0052] The second duty cycle is significantly higher than the first duty cycle, for example, increasing to 30%-60%, or even 100% continuous wave. The second amplitude is also significantly higher than the first amplitude, which greatly increases the acoustic power output of the ultrasonic transducer 1, for example, from 5W to 100W.

[0053] This combination of high duty cycle and high amplitude can rapidly heat the target tissue area (e.g., to 50-90°C), thereby achieving irreversible ablation of the renal sympathetic nerves.

[0054] In addition, the frequency corresponding to the ultrasound with the first characteristic is within the first frequency range, and the frequency corresponding to the ultrasound with the second characteristic is within the second frequency range.

[0055] The second frequency range is higher than the first frequency range, and the first frequency range is configured to cover the sensitive frequency range of the target nerve. Experiments show that target nerves are most sensitive to mechanical vibrations or acoustic radiation in specific frequency bands, capable of inducing significant nerve impulses (i.e., causing instantaneous changes in blood pressure or heart rate) with minimal energy. By locking onto this sensitive frequency range, nerve locations can be precisely pinpointed with an extremely high signal-to-noise ratio.

[0056] Moreover, compared to the first frequency range, the second frequency range is higher, and higher ultrasound frequencies have a greater attenuation coefficient in biological tissues. This means that acoustic energy is more easily absorbed by local tissues and converted into heat energy, thereby rapidly heating the target area to the ablation temperature in a short time, while reducing energy penetration into deeper non-target tissues, thus improving the accuracy and safety of treatment.

[0057] Therefore, this embodiment achieves complete treatment from localization to ablation by combining "low-frequency sensitive stimulation" with "high-frequency efficient ablation".

[0058] On the other hand, in order to achieve drive control of the distal ultrasound transducer 1, the interventional ultrasound therapy device of this embodiment also includes a signal transmission component (not shown). The signal transmission component extends along the length of the flexible tube 2, and it can be disposed inside the wall of the flexible tube 2 or pass through the inner cavity of the flexible tube 2.

[0059] Specifically, one end (distal end) of the signal transmission component establishes an electrical connection with the ultrasound transducer 1 to deliver an excitation electrical signal to the transducer. The other end (proximal end) of the signal transmission component extends to the external portion of the catheter assembly for connection to an external control device (e.g., an ultrasound signal generator or host system 4). Through this signal transmission component, electrical signals with different parameters (corresponding to the aforementioned stimulation recognition mode or ablation treatment mode) emitted by the external control device can be stably transmitted to the ultrasound transducer 1, thereby driving the ultrasound transducer 1 to emit ultrasound waves with corresponding characteristics.

[0060] On the other hand, in order to meet the guidance requirements and balloon inflation circulation requirements during interventional surgery, such as Figure 4 and Figure 5 As shown, the flexible tube 2 has at least three independent cavities arranged along the axial direction inside, namely the first cavity 20, the second cavity 21 and the third cavity 22.

[0061] The first cavity 20 is the guidewire lumen, which runs through the flexible tube 2 and is used for the guidewire to pass through. During the operation, the doctor first inserts the guidewire into the blood vessel and reaches the target location. Then, the device is fitted onto the guidewire through the first cavity 20 and slid along the guidewire to guide the entire catheter assembly to the target tissue area in the body accurately and smoothly.

[0062] The second cavity 21 is the injection cavity, and the third cavity 22 is the drainage cavity. Both the second cavity 21 and the third cavity 22 are connected to the internal space of the balloon 3.

[0063] The second cavity 21 serves as a fluid inlet channel for introducing fluid media (such as cooled saline) from outside the body into the balloon 3. When the fluid media is injected through the second cavity 21, the balloon 3 expands under pressure, thereby achieving the adhesion between the outer wall of the balloon 3 and the inner wall of the blood vessel as mentioned in the previous embodiment.

[0064] The third chamber 22 serves as a fluid outlet channel, used to output the fluid medium inside the balloon 3 to the outside of the flexible tube 2 (i.e., to return it to the outside of the body).

[0065] Through the cooperation of the second chamber 21 and the third chamber 22, this device can not only control the expansion and contraction of the balloon 3, but also establish a dynamic circulation of the fluid medium. This circulation structure plays an important role in maintaining the pressure stability inside the balloon 3 and removing the working heat of the ultrasonic transducer 1.

[0066] In addition, a fourth cavity 23 is provided axially inside the flexible tube 2, which is used to pass through the wires connected to the ultrasonic transducer 1.

[0067] The conduit forming the fourth cavity 23 may be located within the third cavity 22 or may be independent of the first cavity 20, the second cavity 21, and the third cavity 22.

[0068] Furthermore, to facilitate external connections and control of the device by the operator, such as... Figure 1 The proximal end of the catheter assembly (i.e., the end located outside the patient's body) is connected to a needle hub 5. This needle hub 5 serves as a device for the operator to interact with the treatment device, and it is provided with four independent interfaces, which are respectively connected to four cavities within the flexible tube 2, namely the first interface 50, the second interface 51, the third interface 52, and the fourth interface 53.

[0069] The first interface 50 is connected to the first cavity 20. The first interface 50 is usually located at the center of the needle hub 5 and is used for the insertion, removal or fixation of the guidewire.

[0070] The second interface 51 is connected to the second cavity 21. The second interface 51 is used to connect to an external fluid delivery device (such as a syringe, infusion pump, etc.) to accurately inject fluid medium into the balloon 3 and control the inflation state of the balloon 3.

[0071] The third interface 52 is connected to the third cavity 22. The third interface 52 is used to connect to an external fluid recovery or circulation system so as to discharge or circulate the fluid medium in the balloon 3, thereby emptying the balloon 3 or refreshing the fluid medium.

[0072] The fourth interface 53 is connected to the fourth cavity 23, and the fourth interface 53 is used for electrical connection to the external host system 4.

[0073] By setting up such a needle hub 5 and a standardized interface (for example, the internationally recognized LuerLock connector can be used), this device can be easily and safely connected to various external medical devices (such as guidewires, syringes, infusion pumps, recycling bags, etc.), greatly improving the convenience and safety of operation.

[0074] On the other hand, in order to achieve precise control over the inflation state of the balloon 3 and effective circulation of the fluid medium, this embodiment further configures a fluid supply mechanism based on the above-mentioned catheter assembly.

[0075] like Figure 6 As shown, the fluid supply mechanism mainly includes a fluid reservoir 60, an inlet pipe 61, an outlet pipe 62, and a power pump set (including an expansion pump 63 and a contraction pump 64). These components work together with the interface on the aforementioned needle seat 5 to form a closed-loop or open-loop fluid control system.

[0076] The specific connection relationships and working principles are as follows: The inlet conduit 61 is connected at one end to a fluid reservoir 60 (e.g., a reservoir bag containing saline or contrast agent) and at the other end to a second interface 51 on the needle hub 5.

[0077] The liquid outlet pipe 62 is connected at one end to the third interface 52 on the needle seat 5 and at the other end to the return fluid reservoir 60.

[0078] The dilation pump 63 is installed on the inlet pipe 61. The dilation pump 63 is activated when it is necessary to dilate the balloon 3 to conform to the blood vessel wall or to block blood flow.

[0079] The expansion pump 63 pressurizes the fluid medium in the fluid reservoir 60 and injects it into the balloon 3 through the inlet pipe 61, the second interface 51, and the second cavity 21 inside the flexible tube 2.

[0080] The degree of inflation of the balloon 3 can be precisely adjusted by controlling the flow rate or pressure of the expansion pump 63.

[0081] A contraction pump 64 is installed on the fluid outlet line 62. The contraction pump 64 is activated when the catheter needs to be removed at the end of treatment or when it is necessary to accelerate fluid circulation to remove heat.

[0082] The shrink pump 64 generates negative pressure, which actively draws out the fluid medium in the balloon 3 through the third interface 52 and the third cavity 22 inside the flexible tube 2, and sends it back to the fluid storage tank 60 through the liquid outlet pipe 62.

[0083] The use of the contraction pump 64 can ensure that the balloon 3 collapses quickly and completely, facilitating the safe withdrawal of the catheter; at the same time, if the expansion pump 63 and the contraction pump 64 are turned on simultaneously during the treatment, a continuous fluid circulation can be formed, using the flowing medium to remove the heat generated by the operation of the ultrasound transducer 1, preventing tissue thermal damage.

[0084] Through this dual-pump system, the device not only achieves active control of the mechanical state (expansion / contraction) of the balloon 3, but also takes into account the thermal management needs during the treatment process.

[0085] Furthermore, in order to more precisely control the flow direction and on / off state of the fluid medium and to cooperate with the pump body to achieve rapid inflation and deflation of the balloon 3, this embodiment adds a valve control component to the fluid supply mechanism.

[0086] Specifically, the valve control assembly includes a first electrically controlled valve M1 and a second electrically controlled valve M2.

[0087] The first electrically controlled valve M1 is installed on the inlet pipe 61 (for example, between the expansion pump 63 and the second interface 51, or between the fluid reservoir 60 and the expansion pump 63). The first electrically controlled valve M1 can be a solenoid valve, which is controlled to open or close by the control circuit module of the main system 4.

[0088] The second electrically controlled valve M2 is installed on the liquid outlet pipe 62 (for example, between the third interface 52 and the shrink pump 64). This second electrically controlled valve M2 can also be a solenoid valve, which is controlled by the main system 4.

[0089] Through the coordinated operation of the first solenoid valve M1 and the second solenoid valve M2 with the pump unit, different operating modes can be switched: Expansion mode: The first solenoid valve M1 is opened and the second solenoid valve M2 is closed. At this time, the expansion pump 63 works, and the fluid is unidirectionally forced into the balloon 3. Since the fluid outlet is cut off, the pressure inside the balloon 3 is rapidly built up, achieving rapid expansion and adhesion to the wall.

[0090] Contraction mode: The first solenoid valve M1 is closed and the second solenoid valve M2 is opened. At this time, the contraction pump 64 works (or the expansion pump 63 stops at the same time), cutting off the liquid inlet. The negative pressure generated by the contraction pump 64 is used to quickly extract the liquid from the balloon 3 through the liquid outlet pipe 62, realizing the collapse and retraction of the balloon 3.

[0091] Circulating cooling mode: During treatment, the first solenoid valve M1 and the second solenoid valve M2 can be controlled to be in a specific open or adjustable state at the same time. In conjunction with the rotation speed of the expansion pump 63 and the contraction pump 64, while maintaining the inflation pressure of the balloon 3, the fluid in the balloon 3 is kept flowing and refreshed to remove the heat generated by the ultrasound transducer 1.

[0092] This dual-valve design effectively isolates the inlet and outlet circuits, prevents backflow of fluid, and improves the system's sensitivity to the pressure response of the balloon 3.

[0093] In another preferred embodiment of the present invention, an interventional ultrasound therapy control system is also disclosed, which is typically integrated into, for example, Figure 2 The host system 4 shown is used for precise control of the operation of the interventional ultrasound therapy device. This control system mainly achieves an automated or semi-automated process from nerve stimulation recognition to ablation treatment through the cooperation of software algorithms and hardware circuits.

[0094] like Figure 7 and Figure 8 The control system mainly includes a mode switching module, a signal generation module, and a judgment module.

[0095] The mode switching module is configured to receive operation commands (which can come from manual input by the operator via the touchscreen or from feedback signals from other modules within the system).

[0096] Based on the received instructions, the mode switching module locks the system's operating mode to either "stimulus recognition mode" or "ablation therapy mode".

[0097] The signal generation module, which is electrically connected to the ultrasonic transducer 1, is an execution unit and is directly controlled by the mode switching module.

[0098] When the system is in stimulus recognition mode, the signal generation module outputs a first drive signal to the ultrasonic transducer 1. This first drive signal is typically configured with a low amplitude, low duty cycle, or a specific pulse repetition frequency (e.g., 1-50 Hz) to induce a nerve reflex without generating damaging heat.

[0099] When the system switches to ablation therapy mode, the signal generation module adjusts its output to generate a second driving signal. This second driving signal has a high amplitude and duty cycle (e.g., a high-power continuous wave) designed to produce a sufficient thermal effect to ablate the nerve.

[0100] The judgment module mainly operates in stimulus recognition mode to achieve intelligent target identification.

[0101] The assessment module receives real-time physiological parameters from the patient. These parameters originate from monitoring devices connected to the system or built-in physiological indicator monitoring systems, primarily including changes in blood pressure (systolic and diastolic) and heart rate.

[0102] When the ultrasound transducer 1 emits a stimulation signal, if the judgment module detects a significant change in physiological parameters (such as a blood pressure increase exceeding a preset threshold or a significant increase in heart rate), it determines that sympathetic nerve excitation is currently present. At this time, the judgment module generates a "first signal" indicating that there is a target nerve with ablation value at the current location of the ultrasound transducer 1.

[0103] If the physiological parameters do not change significantly or the change is below the preset threshold during stimulation, the judgment module generates a "second signal" indicating that the current location is a non-target nerve area, prompting the system or doctor to adjust the catheter position.

[0104] Specifically, when the system is in stimulus recognition mode, the mode switching module monitors the signal output by the judgment module in real time. Once it receives the "first signal" indicating target confirmation, the mode switching module can automatically switch the target working mode to ablation therapy mode, or prompt the user to switch modes, thereby achieving a smooth connection in the diagnosis and treatment process.

[0105] In actual operation, the doctor first activates the stimulation mode. The signal generation module outputs a first driving signal to stimulate the nerve. The judgment module analyzes the patient's blood pressure response in real time. Once the judgment module confirms a significant increase in blood pressure (generating the first signal), this first signal is fed back to the mode switching module. The mode switching module then responds, switching the system state from "stimulation recognition" to "ablation therapy," and instructs the signal generation module to prepare to output a high-energy second driving signal, thereby completing the closed-loop control of "detection-lock-preparation for treatment."

[0106] On the other hand, the mode switching module is also configured to switch the target working mode to the stimulation recognition mode when the signal generation module stops outputting in the ablation therapy mode.

[0107] In this embodiment, the control system can automatically reset to the stimulation recognition mode after completing one ablation treatment.

[0108] Specifically, in ablation therapy mode, the signal generation module continuously outputs a second driving signal according to preset treatment parameters. The signal generation module will stop outputting when any of the following conditions are met: Time expires: The preset treatment countdown ends (e.g., ablation completes in 20 seconds); Manual intervention: The operator releases the switch; Safety Trigger: The system detects abnormal parameters (such as excessive temperature) and triggers an emergency stop.

[0109] So, if Figure 9 Once the mode switching module detects that the signal generation module has stopped outputting in the ablation treatment mode (which means that a single ablation process has ended), it will immediately or after a delay switch the system's target working mode back to "stimulus recognition mode".

[0110] Then, the system automatically calls the parameter set corresponding to the stimulus recognition pattern to prepare for the next output.

[0111] On the other hand, the control system also includes a verification module, which aims to solve the decision problem of "whether supplemental ablation is needed" after ablation, and realize the automatic determination of the treatment endpoint through quantitative data.

[0112] When the mode switching module switches the system back to "stimulation recognition mode" after ablation, the verification module is activated. At this time, the catheter assembly remains in place (i.e., the position where ablation was just performed), and the system outputs a low-energy first drive signal (stimulation signal) again.

[0113] like Figure 10 The workflow of the verification module is as follows: First, during the restimulation, the verification module collects the current physiological parameters of the target subject (patient) in real time (such as current systolic blood pressure, heart rate, etc.).

[0114] Secondly, the verification module compares the collected current physiological parameters with the "resting state index" and calculates the amount of change.

[0115] Note: The resting state index can be the baseline value measured before the start of the surgery, or the average value in the few seconds before the start of this stimulation.

[0116] For example, the change = highest systolic blood pressure under the current stimulus - resting systolic blood pressure.

[0117] Furthermore, the verification module has a preset "effective threshold" (e.g., a blood pressure increase of 5 mmHg), which is used to determine whether nerve function has been effectively blocked. The module then determines the relationship between the change and the effective threshold.

[0118] Scenario 1: Treatment successful (third signal generated).

[0119] If the calculated change is less than the preset effective threshold (for example, after restimulation, the blood pressure only increased by 2 mmHg, which is far below the threshold), it indicates that the sympathetic nerve at that location has been successfully blocked and has lost its ability to reflex to stimulation.

[0120] At this point, the verification module generates a third signal. This third signal can trigger the user interface to display a "treatment successful" or "current point completed" message, informing the doctor that the catheter can be moved to find the next target.

[0121] Scenario 2: Treatment not completed (fourth signal generated).

[0122] If the calculated change is greater than or equal to the preset effective threshold (e.g., blood pressure still increases by 10 mmHg after restimulation), it indicates that the nerve function at that location is still active, and the previous ablation may have been insufficient in energy or not fully covered.

[0123] At this point, the verification module generates a fourth signal. This fourth signal is fed back to the mode switching module, and the control system automatically or prompts the user to switch back to the "ablation treatment mode" so that supplementary ablation can be performed at the current location (e.g., an additional 20 seconds of treatment) until the verification is successful.

[0124] This embodiment transforms the doctor's experience-based judgment into a systematic quantitative analysis through the configuration of the verification module. It avoids the uncertainty of judging the ablation effect based on feelings and ensures that each target point undergoes a rigorous process of "ablation-verification-re-ablation (if necessary)," thereby significantly improving the overall success rate of renal sympathectomy (RDN).

[0125] On the other hand, the control system is also equipped with a monitoring module to ensure the safety of the procedure during ablation treatment and prevent overheating, overpressure or equipment failure from causing harm to the patient.

[0126] When the signal generation module outputs a high-energy second drive signal (i.e., when ablation treatment is performed), the monitoring module starts synchronously. It continuously collects one or more of the following key data objects: Fluid medium temperature: The temperature of the perfusion fluid used to cool the ultrasonic transducer 1 is monitored in real time by a temperature sensor installed inside or near the balloon 3.

[0127] Fluid medium filling pressure: The pressure inside balloon 3 is monitored by a pressure sensor to ensure that balloon 3 fits well against the blood vessel wall and is not over-expanded.

[0128] Electrical parameters of ultrasonic transducer 1: Monitor the electrical parameters of ultrasonic transducer 1, such as voltage, current, impedance, or phase, to determine whether the transducer is working properly.

[0129] The monitoring module also stores preset safety thresholds, such as temperature thresholds, pressure thresholds, and electrical parameter thresholds.

[0130] The monitoring module compares the real-time collected data with the aforementioned thresholds.

[0131] Once the monitoring module determines that any data object exceeds the preset safety threshold (for example, detecting a sudden rise in temperature inside balloon 3 to 65°C), the following mandatory protection measures will be immediately implemented: Action 1: Output cut-off (hard shutdown). The monitoring module has the highest priority control authority and directly forces the control signal generation module to stop outputting the second drive signal. This instantly cuts off the energy source, preventing further thermal damage.

[0132] Action 2: Balloon 3 contracts (physical withdrawal). The monitoring module generates a control command and sends it to the contraction pump 64 or the control valve of balloon 3 to control the rapid discharge of fluid from balloon 3, causing balloon 3 to contract.

[0133] The contraction of balloon 3 can cause the hot fluid to move away from the wall and carry away the heat through blood flow; at the same time, if the pressure is too high, the contraction of balloon 3 can immediately relieve the mechanical pressure on the blood vessel wall and prevent the blood vessel from rupturing.

[0134] Suppose that during the procedure, a malfunction in the fluid supply mechanism causes a decrease in flow rate, resulting in a rapid rise in temperature inside balloon 3 at the 5th second of ablation. The monitoring module immediately cuts off the ultrasound output and instructs balloon 3 to drain fluid the instant the temperature reaches 60°C. Simultaneously, a "Temperature Abnormality Alarm" pops up on the system interface, prompting the doctor to check the cooling system. This mechanism ensures that even in the event of equipment malfunction, the patient's vascular safety is maximized.

[0135] On the other hand, the control system also includes a foot control interface for connecting the foot switch 7.

[0136] During interventional procedures, doctors need to keep their hands sterile and precisely manipulate the catheter handle, making it inconvenient to operate a touchscreen or keyboard. The foot switch 7 allows doctors to control the emission and cessation of energy through foot movements.

[0137] The signal generation module supports the following two foot pedal control modes according to a preset program to adapt to different clinical needs: Mode 1: Real-time jog control.

[0138] This is typically used for "stimulus recognition mode" or short-term testing. Once the mode switching module selects the working mode, the doctor presses foot switch 7 (closing signal), and the system immediately begins to output the corresponding first driving signal (stimulation) or second driving signal (ablation).

[0139] Once the doctor releases foot switch 7 (disconnects the signal), the system immediately stops outputting.

[0140] This "step-and-stop" method provides the highest level of safety; if a doctor notices an abnormal reaction in the patient (such as a spike in blood pressure), the stimulation can be instantly interrupted simply by lifting the foot.

[0141] Mode 2: Delay-triggered automatic control.

[0142] This is typically used in standard ablation treatment modes (e.g., ablation requiring 60 or even 120 seconds). The doctor presses foot switch 7 and holds it for a preset time (e.g., 3 seconds as a confirmation signal to prevent accidental activation). Once the system recognizes this long press, it starts an automatic timing program and begins continuously outputting the second drive signal for the preset duration (e.g., 60 seconds).

[0143] During automatic output, the output will not stop even if the doctor releases the foot pedal 7, and will automatically stop after the preset time expires. This method avoids the doctor having to keep the pedal firmly pressed during a long ablation process, reducing leg fatigue and preventing body swaying caused by foot shaking, which could affect the stability of the catheter manipulation.

[0144] It should also be noted that during the operation of Mode 2 (automatic control), if the doctor steps on or double-clicks the foot switch 7 again (depending on the settings), or triggers a safety alarm, the system will immediately interrupt the automatic output process to ensure safety as the priority.

[0145] On the other hand, the control system also includes a position adjustment module designed to simplify the steps doctors take when locating nerve targets.

[0146] In stimulus recognition mode, the system outputs a first driving signal to stimulate the blood vessel wall. If the judgment module analyzes the physiological parameters and generates a second signal (i.e., determines that the current position does not cause significant changes in blood pressure / heart rate, belonging to a "non-neural distribution area" or "invalid target"), the position adjustment module is then activated.

[0147] After receiving the second signal, the position adjustment module automatically controls the fluid supply mechanism to extract the fluid from the balloon 3, causing the balloon 3 to contract.

[0148] At this point, the system interface displays "Current position invalid, please move the catheter." Under the guidance of relevant equipment (such as X-ray fluoroscopy), the doctor manually moves or rotates the catheter assembly along the vascular axis to a new potential target location (e.g., moving it 5mm distally).

[0149] Once the doctor has completed the movement and positioned the catheter in the new location, they can issue a user command via the user interface (by clicking the "In Position" button) or by using the foot switch 7.

[0150] In response to this command, the position adjustment module performs the following linked operations: Re-inflate balloon 3: Control the fluid supply mechanism to re-inflate balloon 3 and fit the new blood vessel wall position.

[0151] Reset Stimulus Recognition Mode: The system automatically switches back to the initial state of "Stimulus Recognition Mode" and prepares to transmit the first drive signal again.

[0152] Therefore, through this position adjustment module, when doctors are looking for target points, they only need to focus on the action of "moving the catheter". The system automatically completes the tedious process of "drainage - (doctor movement) - filling - switching back to stimulation mode", which greatly shortens the operation time and improves the efficiency of nerve mapping.

[0153] On the other hand, during interventional ultrasound therapy, the high-frequency vibration of the transducer generates heat. If this heat is not dissipated in time, it may damage the inner wall of the blood vessel or the transducer itself. Therefore, the control system is also equipped with a temperature control module.

[0154] In response, the temperature control module is configured as follows: Receive real-time temperature values ​​(e.g., 45°C) and calculate their deviation from a preset target temperature (e.g., 37°C); Based on the temperature deviation, a flow rate adjustment command is generated. Since the system uses dual pumps, this command is configured to simultaneously adjust the operating parameters of the expansion pump 63 and the contraction pump 64. In addition, in order to maintain the expansion size of the balloon 3 while cooling down (i.e., to keep the pressure inside the balloon 3 stable), the command requires the inlet speed of the expansion pump 63 to increase or decrease synchronously with the outlet speed of the contraction pump 64. When excessively high temperatures (large deviations) are detected, the control system instructs the expansion pump 63 to increase its speed to increase the injection of cold fluid, while simultaneously controlling the contraction pump 64 to correspondingly increase its speed to accelerate the discharge of hot fluid. At this point, the fluid's "renewal rate" within the balloon 3 is significantly improved, achieving rapid heat dissipation. When the temperature returns to the normal range, the command controls the two pumps to synchronously reduce their speed to the basic circulation flow rate in order to reduce system power consumption and mechanical noise.

[0155] Through this dual-pump coordinated regulation, the system achieves a "high-flux, low-pressure-difference" circulation mode, where the fluid flows through the balloon 3 at a very fast speed to carry away heat, but the balance between inflow and outflow prevents the balloon 3 from over-expanding or collapsing due to the increase in flow rate (maintaining stable pressure), thereby achieving efficient temperature control while ensuring that the ablation position does not shift.

[0156] In summary, as Figure 7 The control system disclosed in this invention uses a "stimulus-feedback" mechanism to screen target points and a dual-pump system to maintain the steady state of balloon 3, ensuring that energy is accurately applied to the target nerve.

[0157] It also has an intraoperative efficacy verification function, ensuring that the ablation effect of each target point meets the clinical standard and significantly reduces the postoperative recurrence rate.

[0158] Furthermore, the rapid safety response mechanism and automated auxiliary operation process not only ensure patient safety but also significantly shorten the operation time and improve the convenience of clinical use.

[0159] This technical solution provides a safe, efficient, and quantifiable new approach for renal sympathectomy in refractory hypertension through deep collaboration between software and hardware.

[0160] It should be noted that the system of the present invention is specifically used for renal artery sympathetic nerve ablation (RDN) in the treatment of hypertension. It can also be applied to nerves or tissues such as pulmonary artery sympathetic nerves, myocardial tissue at the pulmonary vein orifice, sensory nerves, dorsal root ganglia, nerve fibers, vagus nerve, pelvic nerve plexus, or sacral nerve roots.

[0161] The second characteristic of the system of the present invention is that the ultrasound generated ablates or damages the pulmonary sympathetic nerves that cause pulmonary hypertension, thereby affecting the release of neurotransmitters and the activation of pulmonary artery adrenergic receptors, thereby reducing pulmonary artery pressure.

[0162] The second characteristic of the system of the present invention is that the ultrasound generated ablates or damages the myocardial tissue at the pulmonary vein orifice, thereby achieving "pulmonary vein isolation". The tissue ablated or damaged by ultrasound acts like an "insulating wall", which can prevent abnormal electrical signals in the pulmonary vein from being transmitted to the atrium, thereby eliminating the triggering focus of atrial fibrillation and restoring the normal rhythm of the heart.

[0163] The second characteristic of the system of the present invention is the ablation or damage of sensory nerves and dorsal root ganglia within the intervertebral disc by ultrasonic waves, thereby achieving the treatment of chronic spinal arthritis and some neuropathic pain.

[0164] The second characteristic of the system of this invention is the ultrasonic ablation of these nerve fibers and vagus nerves within the bronchial wall, which can reduce the "hyperresponsiveness" and "overconstriction" capacity of the airways, thereby reducing the frequency and severity of asthma attacks. In asthma patients, excessive airway smooth muscle contraction, excessive mucus secretion, and airway inflammation are all processes that are over-regulated by the "vagus nerve afferent and efferent fibers" around the bronchi.

[0165] The second characteristic of the system of the present invention is the ablation of the pelvic nerve plexus or sacral nerve roots innervating the bladder by ultrasound, treating intractable "overactive bladder syndrome". When these nerve signals are disordered, it can lead to a series of distressing symptoms, urge incontinence, and bladder pain, such as interstitial cystitis / bladder pain syndrome.

[0166] The above-disclosed embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, any equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An interventional ultrasound treatment apparatus, characterized by, The catheter assembly comprises a flexible tube and an inflatable balloon; An ultrasonic transducer is arranged at a distal end region of the flexible tube, and is configured to convert received electrical signals into ultrasonic waves, and the balloon is arranged to surround the ultrasonic transducer; The balloon is configured to contain a fluid medium to change from a contracted state to an inflated state, so that the outer wall of the balloon is in contact with the inner wall of the target tissue; The ultrasonic transducer is configured to output ultrasonic waves with different electrical parameters in response to the control of an external control device, so as to select to execute one of the following two function modes: A stimulation identification mode, in which the ultrasonic transducer emits ultrasonic waves with a first characteristic, which is configured to act on the target tissue in a non-invasive manner and can specifically induce the target nerve to produce neurotransmitters to cause physiological changes; An ablation treatment mode, in which the ultrasonic transducer emits ultrasonic waves with a second characteristic, which has a higher energy density than the first characteristic, for ablation and destruction of the target nerve. Further comprising a signal transmission assembly extending along the flexible tube, one end of the signal transmission assembly being electrically connected with the ultrasonic transducer, and the other end being used for connecting an external control device.

2. The interventional ultrasound treatment device of claim 1, wherein, The flexible tube is provided with a first cavity for a guide wire to pass through to guide the flexible assembly to travel in the tissue, and a second cavity and a third cavity, both of which are in communication with the balloon, the second cavity being used for inputting the fluid medium into the balloon, and the third cavity being used for outputting the fluid medium in the balloon out of the flexible tube.

3. The interventional ultrasound treatment device of claim 1, wherein, The catheter assembly further comprises a needle seat connected with a proximal end of the flexible tube, the needle seat being provided with a first interface in communication with the first cavity, a second interface in communication with the second cavity, and a third interface in communication with the third cavity.

4. The interventional ultrasound treatment device of claim 3, wherein, Further comprising a fluid supply mechanism, which comprises an inlet pipeline, an outlet pipeline, an inflation pump and a contraction pump; the inlet pipeline is connected between the second interface and a fluid reservoir, and the outlet pipeline is connected between the third interface and the fluid reservoir; the inflation pump is arranged on the inlet pipeline and is used for sending the fluid medium in the fluid reservoir into the second cavity through the second interface; and the contraction pump is arranged on the outlet pipeline and is used for pumping the fluid medium in the third cavity to the fluid reservoir through the third interface.

5. The interventional ultrasound treatment device of claim 4, wherein, A first electric control valve is arranged on the inlet pipeline, and a second electric control valve is arranged on the outlet pipeline.

6. The interventional ultrasound treatment device of claim 5, wherein, The electrical signal corresponding to the ultrasonic waves with the first characteristic has a first duty cycle and a first amplitude; and the electrical signal corresponding to the ultrasonic waves with the second characteristic has a second duty cycle and a second amplitude; 7. The interventional ultrasound treatment device of claim 1, wherein, Wherein, the second duty cycle is greater than the first duty cycle, and the second amplitude is greater than the first amplitude. The frequency corresponding to the ultrasonic waves with the first characteristic is a first frequency range, and the frequency corresponding to the ultrasonic waves with the second characteristic is a second frequency range; 8. The interventional ultrasound treatment device of claim 1, wherein, ​ The second frequency range is higher than the first frequency range, and the first frequency range is configured to cover a sensitive frequency range of a target nerve.

9. An interventional ultrasound therapy control system, characterized by A system for controlling an interventional ultrasound treatment device as claimed in any one of claims 1 to 8; the system comprising: a mode switching module configured to receive an operation instruction and control a target working mode to be a stimulation identification mode or an ablation treatment mode according to the operation instruction; a signal generating module configured to be electrically connected with the ultrasound transducer, for outputting a first driving signal corresponding to the stimulation identification mode or a second driving signal corresponding to the ablation treatment mode to the ultrasound transducer according to an instruction of the mode switching module; a judging module configured to generate a first signal or a second signal according to a received physiological change parameter in the stimulation identification mode, the first signal indicating that a nerve at a current position is a target point nerve, and the second signal indicating that a nerve at the current position is a non-target point nerve; the mode switching module is further configured to switch the target working mode to the ablation treatment mode according to the first signal.

10. The interventional ultrasound therapy control system of claim 9, wherein, the mode switching module is further configured to switch the target working mode to the stimulation identification mode when the signal generating module stops outputting in the ablation treatment mode.

11. The interventional ultrasound therapy control system of claim 10, wherein, further comprising a verification module configured to: acquire a current physiological parameter of the target object during the first driving signal is outputted again; calculate a change amount of the current physiological parameter relative to a rest state indicator; generate a third signal representing that a treatment at the current position is completed if the change amount is less than a preset effective threshold; generate a fourth signal for controlling the mode switching module to switch to the ablation treatment mode again at the current position if the change amount is greater than or equal to the preset effective threshold.

12. The interventional ultrasound therapy control system of claim 9, wherein, further comprising a monitoring module configured to: monitor any one or more data objects of a fluid medium temperature, a fluid medium filling pressure in the balloon, and an electrical parameter of the ultrasound transducer in real time during the signal generating module outputs the second driving signal; determine whether the monitored data object exceeds a preset safety threshold; forcefully control the signal generating module to stop outputting and generate an instruction to control the balloon to shrink if any of the data objects exceeds the preset safety threshold.

13. The interventional ultrasound therapy control system of claim 9, wherein, further comprising a foot control interface for connecting a foot switch; the signal generating module is specifically configured to: start outputting the first driving signal or the second driving signal in response to a closing signal of the foot switch after the mode switching module determines the target working mode; stop outputting the corresponding first driving signal or second driving signal in response to an opening signal of the foot switch; or, continuously output the first driving signal or the second driving signal for a preset time duration in response to the closing signal of the foot switch and maintaining for the preset time duration.

14. The interventional ultrasound therapy control system of claim 9, wherein, further comprising a position adjusting module configured to: In the stimulation identification mode, if the judging module generates the second signal, the balloon is deflated to allow the catheter assembly to move to a new position; After the movement is completed, the balloon is re-expanded in response to a user instruction, and the stimulation identification mode is reset.

15. The interventional ultrasound therapy control system of claim 9, wherein, A temperature control adjustment module is further included; The temperature control adjustment module is configured to: receive a real-time temperature value fed back by a temperature sensor in the balloon; calculate a temperature deviation between the real-time temperature value and a preset target temperature; generate a flow adjustment instruction based on the temperature deviation; The flow adjustment instruction is used to dynamically adjust the circulating flow rate of the fluid medium in the balloon.

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