Focused ultrasound ablation catheter and device

Abstract

Disclosed in the present invention are a focused ultrasound ablation catheter and a device. The focused ultrasound ablation catheter comprises a multi-chamber tube as a catheter body; a first ultrasound transducer, arranged at a distal end of the catheter body and electrically connected to a control part, the first ultrasound transducer being parallel to a central axis of the catheter body to be used for measuring a distance and a temperature of an inner wall of a blood vessel, thereby calculating an ablation target region and measuring a temperature of the target region for calculation of an output power of second ultrasound transducers and determination of an ablation end point; and at least two second ultrasound transducers, arranged at the distal end of the catheter body and electrically connected to the control part, the second ultrasound transducers and the central axis of the catheter body forming a set included angle, and the at least two second ultrasound transducers being symmetrical about the first ultrasound transducer for determining an ablation focus and performing focused ablation. By means of the catheter, energy transmitted by sound waves can be concentrated in a focused ablation region, and other regions are not ablated.

Description

Ultrasonic focused ablation catheter and device Technical Field

[0001] The present invention relates to an ultrasonic focusing ablation catheter and also to ultrasonic focusing ablation equipment comprising the catheter, belonging to the technical field of medical devices. Background Art

[0002] Ultrasonic ablation technology uses the ability of ultrasound to penetrate human tissue and focus on specific areas. Ultrasonic waves are emitted through the transducer inside the balloon. These ultrasonic waves act on the blood vessels and surrounding tissues after passing through physiological saline, and concentrate energy in the specific target area to achieve sufficient intensity and temperature. As the temperature gradually rises, the nerves in and around the blood vessels will be damaged, causing the target tissue to show coagulative necrosis in histopathology, achieving the purpose of treating the lesion area without affecting the tissue outside the lesion area. However, existing ultrasonic ablation devices are unable to achieve precise point ablation. The non-focused ultrasonic energy diverges in a fan shape, which can easily cause damage to the vascular endothelium and non-target areas, thereby causing vascular atrophy, stenosis and deformation, and blocking the blood vessels, leading to adverse reactions in patients and affecting the ablation effect. Summary of the Invention

[0003] The primary technical problem to be solved by the present invention is to provide an ultrasonic focusing ablation catheter.

[0004] Another technical problem to be solved by the present invention is to provide an ultrasonic focused ablation device.

[0005] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0006] According to a first aspect of an embodiment of the present invention, there is provided an ultrasound focused ablation catheter, comprising:

[0007] The catheter body is a multi-lumen tube, comprising at least a guidewire lumen for inserting a guidewire and a guidewire lumen for inserting a guidewire;

[0008] a first ultrasonic transducer disposed at the distal end of the catheter body and electrically connected to a control unit via a wire; wherein the first ultrasonic transducer is parallel to the central axis of the catheter body and is used to measure the distance to the inner wall of the blood vessel, thereby calculating the ablation target area; the first ultrasonic transducer is also used to measure the temperature of the target area for use in calculating the output power of the second ultrasonic transducer and determining the ablation endpoint;

[0009] At least two second ultrasonic transducers are arranged at the distal end of the catheter body and are used to be electrically connected to the control unit through a wire; wherein, the second ultrasonic transducers form a set angle with the central axis of the catheter body, and at least two of the second ultrasonic transducers are symmetrical with respect to the first ultrasonic transducer, so as to determine the ablation focus and perform focused ablation.

[0010] Preferably, the second ultrasonic transducer is rotatably disposed at the distal end of the catheter body to adjust the size of the set angle.

[0011] Preferably, with the first ultrasonic transducer as the center, at least two of the second ultrasonic transducers can move relatively along the central axis of the catheter body to adjust the relative distance between the at least two ultrasonic transducers.

[0012] Preferably, there are multiple first ultrasonic transducers, and the multiple first ultrasonic transducers are arranged in a circular ring around the circumferential direction of the catheter body; wherein, two inclined second ultrasonic transducers are symmetrically distributed on both sides of each first ultrasonic transducer.

[0013] Preferably, the second ultrasonic transducer is electrically connected to the controller to receive the current temperature of the ablation target area measured by the first ultrasonic transducer, and calculate the current output power;

[0014] The second ultrasonic transducer releases ultrasonic waves of corresponding intensity according to the current output power to perform focused ablation on the ablation target area.

[0015] Preferably, the ultrasound focused ablation catheter further comprises:

[0016] a tip balloon, disposed on the distal end surface of the catheter body and communicating with the internal cavity of the catheter body, for occluding a blood vessel in a filled state;

[0017] Wherein, the internal cavity includes a liquid inlet cavity for liquid inlet and a liquid outlet cavity for liquid outlet.

[0018] Preferably, a flexible electrode is installed on the outside of the tip balloon, and a pressure sensor is installed on the inside of the tip balloon. Both the flexible electrode and the pressure sensor are electrically connected to a control unit for detecting impedance and water pressure.

[0019] According to a second aspect of an embodiment of the present invention, there is provided an ultrasound focused ablation device, comprising:

[0020] A control unit, used for automatic control of ultrasonic ablation;

[0021] an operating handle connected to the control unit;

[0022] The ultrasonic focusing ablation catheter mentioned above, wherein the proximal end of the ultrasonic focusing ablation catheter is mounted on the operating handle and electrically connected to the control unit;

[0023] The control unit continuously adjusts the output power of the second ultrasonic transducer according to the measured temperature of the first ultrasonic transducer until the ablation end point is reached; the control unit is also used to determine whether the ablation end point is reached according to the judgment logic.

[0024] Preferably, the judgment logic specifically includes:

[0025] When the current temperature of the ablation target area measured by the first ultrasonic transducer reaches a set value and stabilizes for a preset time, and when the distance to the inner wall of the blood vessel measured by the first ultrasonic transducer reaches a theoretical value, it is determined that the ablation endpoint has been reached.

[0026] Preferably, the control unit at least includes:

[0027] The main control module is used to process signals and data and control automated ablation;

[0028] a signal generator, connected to the main control module, for receiving and sending ultrasonic signals;

[0029] a power amplifier connected to the signal generator for amplifying the ultrasonic signal;

[0030] A gating module, connected to the power amplifier, for selecting the number of signal channels;

[0031] A phase voltage and current module, connected to the main control module, for detecting parameters and outputting a matching ultrasonic frequency;

[0032] The impedance matching module is connected to the main control module and is used to detect the matching impedance and output an ultrasonic signal with matching power.

[0033] Compared with the prior art, the present invention has the following technical effects:

[0034] 1. The horizontally set first ultrasonic transducer measures the distance to the inner wall of the blood vessel, calculates the ablation target area, and measures the target area temperature. In addition, the tilted second ultrasonic transducer is used to focus the energy transmitted by the sound wave to the focal ablation area, without ablating other areas, thereby effectively protecting the vascular endothelium.

[0035] 2. The second ultrasonic transducer is rotatable, thereby enabling adjustment of different focal lengths, and thus enabling adaptive adjustment according to different ablation positions of the blood vessels, thereby improving the applicability of the ultrasonic focused ablation catheter.

[0036] 3. The second ultrasonic transducer is movable, thereby enabling adjustment of the size of the focused ablation area, and thus enabling adaptive adjustment according to different ablation positions of the blood vessels, thereby improving the applicability of the ultrasonic focused ablation catheter.

[0037] 4. Multiple first ultrasonic transducers and multiple second ultrasonic transducers can form multiple ablation groups, and any one or several ablation groups can be controlled by the control unit to enter the working state, thereby achieving all-round ablation within 360° without rotating the catheter body, which not only improves the ablation efficiency but also improves the convenience of the ablation operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] FIG1 is a schematic structural diagram of an ultrasound focused ablation catheter provided by a first embodiment of the present invention;

[0039] FIG2 is a cross-sectional view of the catheter body in the first embodiment of the present invention;

[0040] FIG3 is a schematic diagram of focused ablation in the first embodiment of the present invention;

[0041] FIG4A is a schematic structural diagram of an ultrasound focused ablation catheter provided by a second embodiment of the present invention;

[0042] FIG4B is a schematic structural diagram of an ultrasound focused ablation catheter provided by a third embodiment of the present invention;

[0043] FIG5 is a schematic structural diagram of an ultrasound focused ablation catheter provided by a fourth embodiment of the present invention;

[0044] FIG6 is a schematic structural diagram of an ultrasonic focused ablation catheter provided by a fifth embodiment of the present invention;

[0045] FIG7 is a schematic structural diagram of an ultrasonic focused ablation device provided by a sixth embodiment of the present invention;

[0046] FIG8 is a schematic structural diagram of a control unit in a sixth embodiment of the present invention. DETAILED DESCRIPTION

[0047] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0048] First embodiment

[0049] As shown in FIG1 , an ultrasonic focusing ablation catheter provided by the first embodiment of the present invention includes a catheter body 1, a first ultrasonic transducer 2, at least two second ultrasonic transducers 3, and a tip balloon 4. The catheter body 1 is a multi-lumen tube, and each lumen has a different function, such as a guidewire lumen for threading a guidewire, a guidewire lumen for threading a guidewire, a liquid inlet lumen and a liquid outlet lumen for liquid circulation, etc. In addition, as shown in FIG1 , the first ultrasonic transducer 2 is horizontally arranged to measure the distance and temperature of the inner wall of the blood vessel, thereby calculating the ablation target area and measuring the current temperature of the ablation target area. At least two ultrasonic transducers 3 are tilted to determine the ablation focus and perform focused ablation. The tip balloon 4 is arranged at the distal end of the catheter body 1 to block the blood vessel in a filled state.

[0050] In this embodiment, the proximal end of the catheter body 1 is used to connect to the control unit 100 (see Figure 7), and the distal end of the catheter body 1 is used to extend into the blood vessel. As shown in Figure 2, the catheter body 1 is a multi-lumen tube, comprising at least a guidewire lumen 11, a guidewire lumen 12, a liquid inlet lumen 13, and a liquid outlet lumen 14. A guidewire 10 is inserted into the guidewire lumen 11 to control the bending direction of the catheter body 1 through the guidewire 10, thereby driving the catheter body 1 into different vascular tissues. A guidewire 20 is inserted into the guidewire lumen 12, and the first ultrasonic transducer 2 and at least two second ultrasonic transducers 3 can be electrically connected to the control unit by the guidewire 20, so that the first ultrasonic transducer 2 and at least two second ultrasonic transducers 3 can be controlled by the control unit for ablation. The liquid inlet lumen 13 and the liquid outlet lumen 14 are respectively connected to the liquid inlet and liquid outlet of the external water supply device for liquid circulation, so that the tip balloon 4 can switch between the filled state and the released state. It is understandable that the catheter body 1 may also be provided with other lumens as required, which is not specifically limited here.

[0051] As shown in Figure 1, the first ultrasonic transducer 2 is disposed at the distal end of the catheter body 1 and is electrically connected to the control unit via a wire 20. Specifically, referring to the orientation shown in Figure 1, the first ultrasonic transducer 2 is parallel to the central axis O of the catheter body 1, thereby converting the pulsed electrical signal into a mechanical signal under the control of the control unit and generating a single ultrasonic wave to calculate tissue morphological changes and temperature changes by analyzing the echo signal. That is, the first ultrasonic transducer 2 can operate in a measurement mode under the control of the control unit. Thus, the first ultrasonic transducer 2 can be used to measure the distance to the inner wall of the blood vessel, thereby calculating the ablation target area. In addition, the first ultrasonic transducer 2 can also measure the current temperature of the ablation target area.

[0052] Furthermore, in another embodiment, an infrared measuring device may be used in place of the first ultrasonic transducer 2 to achieve temperature and distance measurement using infrared rays. It is understood that temperature and distance measurement using infrared rays is a prior art technique and will not be elaborated upon herein. The specific type of infrared measuring device may be adaptively selected as needed to meet the requirements of different measurement scenarios.

[0053] As shown in Figure 1, at least two second ultrasonic transducers 3 are provided at the distal end of the catheter body 1, and are used to be electrically connected to the control unit through a wire 20. In this embodiment, the second ultrasonic transducers 3 are used as an example for explanation. Specifically, the second ultrasonic transducer 3 forms a set angle α with the central axis 0 of the catheter body 1, and the two second ultrasonic transducers 3 are symmetrical with each other about the first ultrasonic transducer 2, so as to determine the ablation focus and perform focused ablation (as shown in Figure 3). Among them, under the control of the control unit, the second ultrasonic transducer 3 converts the electrical signal into mechanical vibration to continuously generate ultrasonic waves and heat the ablation target area within the energy focus range of the sound wave transmission, that is, the second ultrasonic transducer 3 can work in the ablation mode under the control of the control unit. In addition, in this embodiment, the catheter body 1 can be rotated so that the first ultrasonic transducer 2 and the second ultrasonic transducer 3 correspond to different positions of the blood vessel to achieve 360° all-round ablation.

[0054] It is understandable that as the second ultrasonic transducer 3 continues to ablate, the temperature of the ablation target area will gradually increase. During this process, the first ultrasonic transducer 2 will continuously detect the current temperature of the ablation target area and feed it back to the control unit. Correspondingly, the control unit will calculate the current output power of the second ultrasonic transducer 3 based on the preset algorithm based on the current temperature of the ablation target area. It can be seen that in the actual ablation process, as the second ultrasonic transducer 3 continues to ablate, the ablation power of the second ultrasonic transducer 3 is constantly changing until the final control unit determines that the ablation end point has been reached (how to determine the ablation end point is explained below). In this way, automated focused ablation can be achieved, ablation efficiency can be improved, and the method of manually judging the ablation state is replaced by automated control, which is conducive to reducing the error rate of manually judging the ablation state and ensuring the consistency of the ablation effect.

[0055] As shown in Figure 1, the tip balloon 4 is arranged at the distal end of the catheter body 1 and is connected to the liquid inlet cavity 13 and the liquid outlet cavity 14. Thus, liquid can be introduced into the tip balloon 4 through an external liquid supply device, so that the tip balloon 4 is continuously filled until it hits the blood vessel wall. In addition, in this embodiment, preferably, a flexible electrode is installed on the outside of the tip balloon 4, and a pressure sensor is installed on the inside of the tip balloon 4. The flexible electrode and the pressure sensor are both electrically connected to the control unit for detecting impedance and water pressure. Thus, in the process of continuous filling of the tip balloon 4, the control unit 1 can determine whether the tip balloon 4 is completely adhered to the wall by receiving impedance and water pressure to ensure the wall adhesion of the tip balloon 4. Preferably, the tip balloon 4 is made of silicone and the flexible electrode is a flexible printed circuit board (FPC).

[0056] Furthermore, it is understood that during the ablation process, the external liquid supply device maintains the current pressure and continuously feeds liquid through the catheter body 1, ensuring that the tip balloon 4 maintains the desired size while also cooling the interior of the tip balloon 4. The liquid enters the tip balloon 4 through the liquid inlet lumen 13 of the catheter body 2 and is then discharged from the liquid outlet lumen 14 to the storage device for recycling.

[0057] Second embodiment

[0058] As shown in FIG4A , a second embodiment of the present invention provides an ultrasonic focused ablation catheter, comprising a catheter body 1, a first ultrasonic transducer 2, at least two second ultrasonic transducers 3, and a tip balloon 4. Compared to the first embodiment, this embodiment differs in that the second ultrasonic transducer 3 is rotatable.

[0059] In this embodiment, the second ultrasonic transducer 3 is rotatably disposed at the distal end of the catheter body 1 to adjust the size of the set angle α. Specifically, an additional guidewire (not shown in the figure) can be disposed in the guidewire cavity 12 and connected to the second ultrasonic transducer 3, so that the second ultrasonic transducer 3 can be rotated by pulling the guidewire, so that the set angle α can be freely adjusted within a certain angle range (for example, 30 to 60 degrees). It is understandable that when the angle α changes, the focal point and focal area of ​​the two second ultrasonic transducers 3 will change accordingly, so that adaptive adjustment can be made according to different ablation positions of the blood vessels to improve the applicability of the ultrasonic focused ablation catheter.

[0060] In addition, in this embodiment, the rotation adjustment of the second ultrasonic transducer 3 by setting a guide wire is only one of the implementation methods. In other embodiments, it can be adaptively replaced with other adjustment structures as needed to adjust the size of the set angle α, which is not specifically limited here.

[0061] Except for the above differences, the remaining structural features of this embodiment are the same as those of the first embodiment and will not be described again here.

[0062] Third embodiment

[0063] As shown in FIG4B , a third embodiment of the present invention provides an ultrasound focused ablation catheter, comprising a catheter body 1, a first ultrasound transducer 2, at least two second ultrasound transducers 3, and a tip balloon 4. Compared to the first embodiment, this embodiment differs in that the second ultrasound transducer 3 is movable.

[0064] In this embodiment, with the first ultrasonic transducer 2 as the center, the two second ultrasonic transducers 3 can move relative to each other along the central axis of the catheter body 1 to adjust the relative distance between the two second ultrasonic transducers 3. Specifically, an additional guide wire (not shown in the figure) can be set in the guide wire cavity 12 and connected to the second ultrasonic transducer 3, so that the central axis of the catheter body of the second ultrasonic transducer 3 can be moved by pulling the guide wire, so that the two second ultrasonic transducers 3 are moved closer to or away from each other, thereby adjusting the distance between the two. It can be understood that when the distance between the two second ultrasonic transducers 3 changes, the size of the ablation target area determined by the two will also change accordingly, so that it can be adaptively adjusted according to different ablation positions of the blood vessels to improve the applicability of the ultrasonic focused ablation catheter.

[0065] In addition, in this embodiment, adjusting the movement of the second ultrasonic transducer 3 by setting a guide wire is only one of the implementation methods. In other embodiments, other adjustment structures can be adaptively replaced as needed to adjust the distance between the two second ultrasonic transducers 3, which is not specifically limited here.

[0066] Except for the above differences, the remaining structural features of this embodiment are the same as those of the first embodiment and will not be described again here.

[0067] Fourth embodiment

[0068] As shown in FIG5 , a fourth embodiment of the present invention provides an ultrasonic focused ablation catheter, comprising a catheter body 1, multiple first ultrasonic transducers 2, multiple second ultrasonic transducers 3, and a tip balloon 4. Compared to the first embodiment, this embodiment differs in the number of first ultrasonic transducers 2 and second ultrasonic transducers 3.

[0069] Specifically, in this embodiment, there are multiple first ultrasonic transducers 2, and the multiple first ultrasonic transducers 2 are evenly distributed around the circumference of the catheter body 1, thereby forming a circular ring. Accordingly, two second ultrasonic transducers 3 are symmetrically distributed on both sides of each first ultrasonic transducer 2, each inclined at a set angle α.

[0070] Thus, one ultrasonic transducer 2 and its two corresponding ultrasonic transducers 3 can be considered an ablation group, with multiple ablation groups formed circumferentially on the catheter body 1. During use, the control unit can control any one or more ablation groups to enter an operational state, enabling 360° omnidirectional ablation without rotating the catheter body 1. This improves ablation efficiency and the convenience of the ablation procedure.

[0071] It is understood that in another embodiment, the plurality of second ultrasonic transducers 2 may also be distributed in a spiral arrangement along the axial direction of the catheter body 1 to form a spiral structure, thereby enabling the plurality of ablation groups to be spaced apart along the length of the catheter body 1. This, on the one hand, improves the convenience of installing the ablation groups, and on the other hand, enables the ultrasound focused ablation catheter to correspond to a larger ablation area, thereby reducing the number and distance of movement of the catheter body 1 within the blood vessel.

[0072] Except for the above differences, the remaining structural features of this embodiment are the same as those of the first embodiment and will not be described again here.

[0073] Fifth embodiment

[0074] As shown in FIG6 , the fifth embodiment of the present invention provides an ultrasound focused ablation catheter, comprising a catheter body 1, a plurality of first ultrasound transducers 2, a plurality of second ultrasound transducers 3, and a tip balloon 4. Compared with the first embodiment, this embodiment differs in that it further comprises an external balloon 5.

[0075] Specifically, in this embodiment, the outer balloon 5 is sheathed at the distal end of the catheter body 1 to simultaneously enclose the multiple first ultrasonic transducers 2, the multiple second ultrasonic transducers 3, and the tip balloon 4. A water circulation device (not shown) can be added to the outer balloon 5 to cool the first ultrasonic transducers 2 and the second ultrasonic transducers 3 to ensure the working efficiency of the ultrasonic transducers.

[0076] Furthermore, because the outer balloon 5 can enclose the first ultrasonic transducer 2, the second ultrasonic transducer 3, and the tip balloon 4, a vacuum isolation is formed when the ultrasound focused ablation catheter enters a human blood vessel, thereby preventing contamination of the ultrasonic transducers and improving their operating efficiency. Furthermore, it is understood that after the outer balloon 5 is installed, the tip balloon 4 can be removed, and the outer balloon 5 can be used to perform impedance and water pressure detection.

[0077] Except for the above differences, the remaining structural features of this embodiment are the same as those of the first embodiment and will not be described again here.

[0078] Sixth embodiment

[0079] As shown in FIG7 , a sixth embodiment of the present invention provides an ultrasonic focusing ablation device, comprising a control unit 100 , an operating handle 200 , and the ultrasonic focusing ablation catheter 300 described in any one of the first to third embodiments.

[0080] In this embodiment, the control unit 100 is used for automatic control of ultrasonic ablation. Specifically, as shown in Figure 8, the control unit 100 includes a main control module 101, a signal generator 102, a power amplifier 103, a gating module 104, a phase voltage and current module 105, and an impedance matching module 106. The main control module 101 is used to process signals and data and control automated ablation. The signal generator 102 is connected to the main control module 101 to receive and transmit ultrasonic signals. The power amplifier 103 is connected to the signal generator 102 to amplify the ultrasonic signals. The gating module 104 is connected to the power amplifier 103 to select the number of signal channels. The phase voltage and current module 105 is connected to the main control module 101 to detect parameters and output a matching ultrasonic frequency. The impedance matching module 106 is connected to the main control module 101 to detect matching impedance and output an ultrasonic signal with matching power. The operating handle 200 is connected to the control unit 100 to allow the doctor to perform the ablation procedure. The proximal end of the ultrasound focused ablation catheter 300 is mounted on the operating handle 200 and is electrically connected to the control unit 100 so as to perform ultrasound focused ablation under the control of the control unit 100 .

[0081] The control unit 100 continuously adjusts the output power of the second ultrasonic transducer 3 according to the measured temperature of the first ultrasonic transducer 2 until the ablation endpoint is reached. The control unit 100 is also used to determine whether the ablation endpoint has been reached based on judgment logic.

[0082] In this embodiment, the judgment logic specifically includes: when the first ultrasonic transducer 2 measures that the current temperature of the ablation target area reaches the set value and stabilizes for a preset time, and the first ultrasonic transducer 2 measures that the distance to the inner wall of the blood vessel reaches the theoretical value, it is determined that the ablation end point has been reached.

[0083] The following describes the specific working steps of the ultrasound focused ablation device in detail:

[0084] S1: The device performs self-test and sends the self-test data to the main control module 11 and visualizes it through the display.

[0085] S2: The doctor inserts the catheter body 1 into the patient's designated tissue, manually starts ablation, and uses an external liquid supply device to inject liquid into the tip balloon 4. At the beginning of liquid injection, a 3-5 second exhaust procedure is performed. After the exhaust procedure is completed, the main control module 11 closes the drainage hole and maintains the liquid injection hole for continuous injection.

[0086] During this process, a pressure sensor detects changes in water pressure, and a flexible electrode 5 detects changes in impedance. These changes are transmitted in real time to the main control module 101, which then determines whether the tip balloon 4 is fully adherent to the vessel wall. When the tip balloon 4 is fully adherent to the vessel wall, ultrasonic ablation begins, and the main control module 101 opens the drainage holes and maintains the appropriate water pressure, ensuring that the tip balloon 4 remains adherent to the vessel wall while the liquid inside the balloon continuously circulates, thereby cooling the tip balloon 4.

[0087] S3: When the tip balloon 4 is completely attached to the wall, the main control module 101 sends an ultrasonic signal through the signal generator 102, and the signal is amplified by the power amplifier 103. At the same time, the phase voltage and current module 105 starts working and feeds back parameters to the main control module 101 in real time for phase detection. The main control module 101 adjusts the parameters of the signal generator 102 to complete phase matching.

[0088] S4: The phase-matched signal is sent to the first ultrasonic transducer 2 and the second ultrasonic transducer 3 via a suitable number of channels selected by the gating module 104 .

[0089] S5: The first ultrasonic transducer 2 begins to measure the distance to the inner wall of the blood vessel and the current temperature of the ablation target area, and transmits the temperature and distance data to the main control module 101. Correspondingly, the second ultrasonic transducer 3 releases ultrasonic waves of corresponding intensity according to the current output power sent by the main control module 101 to perform focused ablation on the ablation target area.

[0090] S6: During the entire ablation process, the real-time monitored temperature, pressure, and impedance data are fed back to the main control module 101. The main control module 101 processes the data and determines whether the ablation endpoint has been reached based on the judgment logic, thereby completing the ablation procedure.

[0091] On the basis of the above embodiment, an embodiment of the present invention further provides an ultrasonic ablation system, which includes the above ultrasonic focused ablation device.

[0092] In summary, the ultrasonic focused ablation catheter and device provided by the embodiments of the present invention have the following beneficial effects:

[0093] 1. The distance to the inner wall of the blood vessel is measured by the horizontally set first ultrasonic transducer 2, and the ablation target area and the current temperature of the ablation target area are calculated; and the second ultrasonic transducer 3 is set at an angle to focus the energy transmitted by the sound wave to the focal ablation area, without ablating other areas, thereby effectively protecting the vascular endothelium.

[0094] 2. The second ultrasonic transducer 3 is rotatable, thereby enabling adjustment of different focal lengths, thereby enabling adaptive adjustment according to different ablation positions of the blood vessels, thereby improving the applicability of the ultrasonic focused ablation catheter.

[0095] 3. The second ultrasonic transducer is movable, thereby enabling adjustment of the size of the focused ablation area, and thus enabling adaptive adjustment according to different ablation positions of the blood vessels, thereby improving the applicability of the ultrasonic focused ablation catheter.

[0096] 4. Multiple first ultrasonic transducers 2 and multiple second ultrasonic transducers 3 can form multiple ablation groups, and any one or several ablation groups can be controlled by the control unit to enter the working state, thereby achieving all-round ablation within 360° without rotating the catheter body 1, which not only improves the ablation efficiency but also improves the convenience of the ablation operation.

[0097] 5. The ultrasound focused ablation device monitors the water pressure and impedance of the surgical process and surgical environment in real time to ensure that the tip balloon 4 is completely adhered to the wall, improves the wall adhesion, and ensures the ablation effect.

[0098] 6. The main control module 11 controls the output power of the second ultrasonic transducer 3 to continuously change, realizes automatic ablation, and automatically determines the ablation endpoint during the ablation process, shortens the operation time, and reduces the adverse reactions of the patient during the operation.

[0099] It should be noted that the above embodiments are merely examples, and the technical solutions of the various embodiments may be combined and are all within the scope of protection of the present invention.

[0100] It should be understood that the terms "upper", "lower", "horizontal", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0101] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0102] The ultrasound focused ablation catheter and apparatus provided by the present invention are described in detail above. For those skilled in the art, any obvious modification made thereto without departing from the essence of the present invention will constitute an infringement of the patent rights of the present invention and will result in corresponding legal liability.

Claims

1. An ultrasonic focused ablation catheter, characterized in that Comprising: A catheter body, which is a multi-lumen tube and at least includes a guide wire lumen for threading a guide wire and a wire lumen for threading a wire; A first ultrasonic transducer, disposed at the distal end of the catheter body, for being electrically connected to a control unit through a wire; wherein, the first ultrasonic transducer is parallel to the central axis of the catheter body for measuring the distance to the inner wall of a blood vessel so as to calculate an ablation target area; the first ultrasonic transducer is further used for measuring the temperature of the target area for calculating the output power of a second ultrasonic transducer and judging an ablation end point; At least two second ultrasonic transducers, disposed at the distal end of the catheter body, for being electrically connected to the control unit through a wire; wherein, the second ultrasonic transducers form a set included angle with the central axis of the catheter body, and at least two of the second ultrasonic transducers are symmetrical with respect to the first ultrasonic transducer for determining an ablation focus and performing focused ablation.

2. The ultrasonic focused ablation catheter according to claim 1, wherein: The second ultrasonic transducer is rotatably disposed at the distal end of the catheter body to adjust the size of the set included angle.

3. The ultrasonic focused ablation catheter according to claim 1, wherein: Centered on the first ultrasonic transducer, at least two of the second ultrasonic transducers are relatively movable along the central axis of the catheter body to adjust the relative distance between at least two of the ultrasonic transducers.

4. The ultrasonic focused ablation catheter according to claim 1, wherein: There are a plurality of the first ultrasonic transducers, and the plurality of the first ultrasonic transducers are arranged in a circular ring around the circumferential direction of the catheter body; wherein, two inclined second ultrasonic transducers are symmetrically distributed on both sides of each of the first ultrasonic transducers.

5. The ultrasonic focused ablation catheter according to claim 1, wherein: The second ultrasonic transducer is electrically connected to the controller to receive the current temperature of the ablation target area measured by the controller based on the first ultrasonic transducer and calculate the current output power; The second ultrasonic transducer releases ultrasonic waves with a corresponding intensity according to the current output power to perform focused ablation on the ablation target area.

6. The ultrasonic focused ablation catheter according to claim 1, wherein Further comprising: A tip balloon, disposed on the end surface of the distal end of the catheter body and communicating with the internal cavity of the catheter body for blocking a blood vessel in a filled state; Wherein, the internal cavity includes a liquid inlet cavity for liquid inlet and a liquid outlet cavity for liquid outlet.

7. The ultrasonic focused ablation catheter according to claim 6, wherein: A flexible electrode is installed on the outer side of the tip balloon, and a pressure sensor is installed on the inner side of the tip balloon. The flexible electrode and the pressure sensor are both electrically connected to the control unit for detecting impedance and water pressure.

8. An ultrasonic focused ablation device, characterized in that Comprising: A control unit for automatic control of ultrasonic ablation; An operation handle, connected to the control unit; The ultrasonic focused ablation catheter according to any one of claims 1 to 7, the proximal end of the ultrasonic focused ablation catheter is installed on the operation handle and is electrically connected to the control unit; Wherein, the control unit continuously adjusts the output power of the second ultrasonic transducer according to the measured temperature of the first ultrasonic transducer until the ablation end point is reached; the control unit is further configured to judge whether the ablation end point is reached according to a judgment logic.

9. The ultrasonic focused ablation device according to claim 8, wherein The judgment logic specifically includes: When the current temperature of the ablation target area measured by the first ultrasonic transducer reaches a set value and is stable for a preset duration, and the distance measured by the first ultrasonic transducer to reach the inner wall of the blood vessel reaches a theoretical value, it is determined that the ablation end point is reached.

10. The ultrasonic focused ablation device according to claim 8, wherein The control unit at least includes: A main control module, configured to process signals and data and control automated ablation; A signal generator, connected to the main control module for receiving and transmitting ultrasonic signals; A power amplifier, connected to the signal generator for amplifying ultrasonic signals; A gating module, connected to the power amplifier for selecting the number of signal channels; A phase voltage current module, connected to the main control module for detecting parameters and outputting a matching ultrasonic frequency; An impedance matching module, connected to the main control module for detecting the matching impedance and outputting an ultrasonic signal with a matching power.

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