Ultrasonic ablation catheter, ultrasonic ablation system and control method of ultrasonic ablation catheter

Abstract

The ultrasonic ablation catheter comprises a supporting part and an energy carrier, and the energy carrier is configured to emit ultrasonic waves to target tissue in different ultrasonic wave emission modes; the ultrasonic transmitting modes are various, the duration of each ultrasonic transmitting mode forms a working stage, the working stages comprise a plurality of working stages, and the working stages are continuously switched; the working stage comprises an ablation stage and a continuation stage, and the ablation stage is located before the continuation stage. In the ultrasonic ablation catheter, the ultrasonic ablation system and the control method of the ultrasonic ablation catheter, an energy carrier can emit ultrasonic waves to a target tissue in different ultrasonic wave emission modes at different working stages which are continuously switched; therefore, the energy accumulation and / or energy conduction deposition condition of the target tissue and the surrounding tissue thereof can be more flexibly controlled through different ultrasonic wave emission modes, so that the damage to the surrounding tissue is reduced while the target tissue is ablated.

Description

Technical Field

[0001] This application relates to the field of ultrasonic ablation, and more particularly to an ultrasonic ablation catheter, an ultrasonic ablation system, and a method for controlling the ultrasonic ablation catheter. Background Technology

[0002] This application relates to the field of ultrasonic ablation, and more particularly to an ultrasonic ablation catheter, an ultrasonic ablation system, and a method for controlling the ultrasonic ablation catheter. Summary of the Invention

[0003] At least one embodiment of this application provides an ultrasonic ablation catheter, an ultrasonic ablation system, and a control method for the ultrasonic ablation catheter. In at least one embodiment, the ultrasonic ablation catheter can continuously emit energy of different sound intensities towards the target tissue, possibly based on the time difference between the temperature rise and fall at the focal point and the heat dissipation within different tissues. This facilitates more precise control of the temperature within the target tissue, resulting in better tissue damage to the target tissue while reducing unnecessary damage to other tissues outside the target tissue, such as reducing damage to the vessel wall near or adjacent to the ultrasonic ablation catheter. In at least one embodiment, a first aspect of this application provides an ultrasonic ablation catheter, including a support component and an energy carrier. The energy carrier is disposed on the support component and configured to emit ultrasonic waves towards the target tissue in different ultrasonic wave emission modes. Multiple ultrasonic wave emission modes are available, and the duration of each mode constitutes a working phase, with each working phase continuously switching between them. Each working phase includes an ablation phase and a continuation phase, with the ablation phase preceding the continuation phase.

[0004] The energy carrier can emit ultrasound waves to the target tissue in different ultrasound emission modes during different working stages that are continuously switched. This allows for flexible control of energy accumulation, diffusion, and / or energy conduction deposition in the target tissue and its surrounding tissues through different ultrasound emission modes. This helps to ablate the target tissue while reducing damage to surrounding tissues (such as blood vessel walls and other tissues adjacent to blood vessel walls).

[0005] In some embodiments, the total number of working stages is 2-N, where N≤20. By setting the number of working stages, the number of working stages and the switching order can be flexibly selected according to the target organization and the ablation target of the target organization.

[0006] In some embodiments, the ultrasonic emission mode is defined by ultrasonic intensity parameters, and the ultrasonic intensity parameters at each working stage are adjusted by peak acoustic power parameters and / or duty cycle parameters. The ultrasonic emission mode is defined by ultrasonic intensity parameters, allowing for different ultrasonic emission mode settings regardless of the operating mode of the energy carrier, thus expanding the application scenarios of ultrasonic ablation catheters.

[0007] In some embodiments, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasound ablation catheter during each operational phase. This mode of operation helps to further enhance the difference between energy accumulation and / or energy conduction deposition in the target tissue and its surrounding tissue, thereby contributing to improved precision in the regulation of energy accumulation and / or energy conduction deposition in the target tissue and its surrounding tissue, and reducing the risk of damage to surrounding tissues.

[0008] In some embodiments, the ultrasonic emission mode is defined by at least one of an ultrasonic intensity parameter and a rotation parameter, wherein the rotation parameter includes a rotation rate parameter and a number of rotations parameter. The ultrasonic emission mode can be defined by the ultrasonic intensity parameter, by the rotation parameter, or by both. Defining the ultrasonic emission mode by the rotation parameter allows for relatively precise adjustment of energy accumulation and diffusion and / or energy conduction deposition in the target tissue and its surrounding tissue, thereby helping to further reduce the risk of damage to surrounding tissues.

[0009] In some embodiments, the total number of working stages is 2-3, including an ablation stage and a continuation stage, with the continuation stage following the ablation stage. The ultrasonic emission mode uses ultrasonic intensity parameters as necessary parameters, with the ultrasonic intensity parameters in the ablation stage being greater than those in the continuation stage. The coordination between the ablation and continuation stages helps reduce the risk of damage to surrounding tissues.

[0010] In some embodiments, an ablation phase and a continuation phase are included, with the ablation phase preceding the continuation phase; the energy carrier is configured to rotate relative to a support member about the axis of the ultrasonic ablation catheter in each working phase, the ultrasonic emission mode being defined by at least one of an ultrasonic intensity parameter and a rotation parameter; the ultrasonic intensity parameter of the ablation phase is greater than that of the continuation phase, and / or the rotation parameter includes a rotation rate parameter, with the rotation rate parameter of the ablation phase being less than that of the continuation phase.

[0011] In some embodiments, the ultrasonic intensity parameters during the ablation phase are changed by at least one set of operational information, each set of operational information including any value of the peak acoustic power range and any value of the duty cycle range, wherein the peak acoustic power range is 5W-50W (or a smaller range such as 8W-25W, 5W-36W, 10W-35W, 10W-40W, 5W-25W, 5W-35W, 5W-55W, or 10W-50W), and the duty cycle range is 10%-80% (or a smaller range such as 30%-80%, 35%-70%, 20%-65%, 20%-80%, or 10%-70%); and / or, during the ablation phase, the energy carrier is configured to pre- The rotational speed is set to rotate relative to the support component about the axis of the ultrasonic ablation catheter. The rotational speed is at least one value in the range of 20︒ / s-160︒ / s (or a smaller range such as 20︒ / s-140︒ / s, 30︒ / s-120︒ / s, 45︒ / s-150︒ / s, 25︒ / s-160︒ / s, or 50︒ / s-160︒ / s). The energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset number of rotations. The number of rotations is at least one value in the range of 3 to 30 rotations (or a smaller range such as 3 to 18 rotations, 5 to 16 rotations, 3 to 25 rotations, 7 to 22 rotations, or 8 to 18 rotations). Each rotational speed corresponds to one number of rotations.

[0012] Limiting one or more of the operating parameters, such as rotation rate, peak acoustic power, duty cycle, and number of rotations, during the ablation phase is beneficial for the energy conduction, accumulation, and diffusion of ultrasonic energy during the ablation phase, thereby achieving better tissue damage.

[0013] In some embodiments, the ultrasonic intensity parameters during the continuation phase are changed by at least one set of operational information, each set of operational information including any value of the peak acoustic power range and any value of the duty cycle range. The peak acoustic power range is 3W-40W (or a smaller range such as 3W-28W, 5W-20W, 6W-29W, 15W-30W, 20W-30W, 3W-30W, 10W-35W, or 10W-40W), and the duty cycle range is 20%-90% (or a smaller range such as 40%-90%, 25%-70%, 20%-60%, 20%-80%, or 50%-90%). And / or, during the continuation phase, the energy carrier is configured to rotate around the ultrasonic wave at a preset rotation rate. The axis of the ultrasonic ablation catheter rotates relative to the supporting component at a speed of at least one value within the range of 40° / s to 240° / s (or within a smaller range such as 35° / s to 210° / s, 60° / s to 150° / s, 70° / s to 200° / s, 50° / s to 190° / s, 45° / s to 170° / s, or 80° / s to 240° / s). The energy carrier is configured to rotate relative to the supporting component about the axis of the ultrasonic ablation catheter at a preset number of rotations, with the number of rotations ranging from 1 to 25 (or within a smaller range such as 1 to 20, 2 to 25, 5 to 20, 10 to 20, or 10 to 25). Each rotation speed corresponds to one number of rotations.

[0014] During the extended phase, limiting one or more of the operating parameters, such as rotation rate, peak acoustic power, duty cycle, and number of rotations, helps to maintain or slow down the rapid increase in energy within the tissue area to be ablated (a continued rapid increase in energy may lead to an undesirable expansion of the ablation range). This helps to reduce or even avoid damage to the blood vessel wall caused by the rapidly accumulating energy during the ablation process, achieving both protective ablation of the blood vessel wall and sufficient tissue damage to the tissue area to be ablated.

[0015] In some embodiments, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset rotation rate and a preset number of rotations during the current working phase, and to enter the next working phase when at least one of the rotation rate and number of rotations in the current working phase reaches a corresponding preset value. Controlling the switching between working phases according to the preset rotation rate and / or number of rotations helps reduce control difficulty and improves the efficiency and accuracy of ultrasonic ablation.

[0016] In some embodiments, the ultrasonic ablation catheter includes a temperature sensor disposed in at least one of a support component and an energy carrier. The temperature sensor is used to sense the temperature of at least one of the energy carrier and the target tissue. The energy carrier is configured to enter the next working stage when the temperature sensed by the temperature sensor reaches a preset temperature. The placement of the temperature sensor allows for the acquisition of the temperature of the target tissue, thereby facilitating rapid or precise control of the switching between working stages.

[0017] In some embodiments, the ultrasonic ablation catheter includes a temperature sensor disposed in at least one of a support component and an energy carrier. The temperature sensor is used to sense the temperature of the target tissue. The energy carrier is configured to switch from an ablation phase to a continuation phase when the temperature sensed by the temperature sensor reaches a preset second switching temperature, wherein the second switching temperature is any value within the range of 60°C to 80°C. Controlling the switching between working phases based on the detected temperature of the target tissue allows the ultrasonic ablation catheter to more accurately control the change points of the working phases, thereby achieving better ablation results.

[0018] In some embodiments, the energy carrier includes a base and at least one ultrasonic emitting element disposed on one side of the base, the base being configured to rotate about the axial direction of the ultrasonic ablation catheter relative to a support member to drive the ultrasonic emitting element to rotate.

[0019] In some embodiments, the ultrasonic emitting element is located on one side of the base. When the base rotates, the emission direction of the ultrasonic emitting element changes accordingly. Therefore, the acoustic intensity emitted by the ultrasonic emitting element towards the target tissue can be adjusted by rotating the base. For example, during the rotation of the energy carrier, the direction of the emission surface of the ultrasonic emitting element changes with the rotation direction of the energy carrier. Consequently, the energy in the tissue area to be ablated will slow down and continue to rise rapidly. Continued rapid energy rise may lead to an undesirable expansion of the ablation range. If the emission surface of the ultrasonic emitting element rotates from facing other areas to facing the tissue area to be ablated, the temperature of the tissue area to be ablated will rise. Therefore, by utilizing the instantaneous rise and slow fall of the temperature in the tissue area to be ablated during rotation, and by controlling the rate, the time difference between the temperature rise and fall at the focal point, as well as the heat dissipation in different tissues, can be used to more precisely control the energy accumulation and diffusion and / or energy conduction deposition within the damaged area, resulting in better tissue damage. This may also reduce unnecessary tissue damage and protect vascular tissues (such as blood vessel walls) near the energy carrier.

[0020] In some embodiments, the number of ultrasonic emitting elements is multiple, and the multiple ultrasonic emitting elements are distributed circumferentially along the ultrasonic ablation catheter; and / or the ultrasonic emitting elements include multiple array elements distributed in an array to adjust the focal position; and / or the ultrasonic emitting elements are configured as sheet-like structures to emit ultrasonic waves with a fixed focal depth; and / or the ultrasonic emitting elements are formed as curved surfaces on the radial side of the ultrasonic ablation catheter away from the base to emit ultrasonic waves with a fixed focal depth.

[0021] In different embodiments, different sizes of tissues to be ablated (such as renal arteries) can be ablated by varying the number of ultrasonic emitting elements, the array distribution, and the shape of the ultrasonic emitting elements, thus expanding the application scenarios of ultrasonic ablation catheters.

[0022] In some embodiments, along the proximal to distal direction, the support member includes a support body segment, a sound-permeable membrane, and a support head segment that are fixedly connected in sequence, with the two ends of the sound-permeable membrane fixedly connected to the support body segment and the support head segment, respectively. The acoustic membrane has a receiving cavity, and the energy carrier is located inside the receiving cavity of the acoustic membrane; Along the direction from the near end to the far end, the two ends of the energy carrier are respectively located at the main support section and the head support section.

[0023] In some embodiments, a second aspect of this application provides a control method for an ultrasonic ablation catheter, the ultrasonic ablation catheter including a support component and an energy carrier disposed on the support component; the control method includes: receiving multiple target working stage information, each target working stage information corresponding to a working stage, the start time of the latter working stage being the end time of the former working stage in two adjacent working stages; each target working stage information includes an ultrasonic wave emission mode, at least two of the multiple target working stage information including different ultrasonic wave emission modes; based on the ultrasonic wave emission mode included in each target working stage information, emitting ultrasonic waves to a target tissue through the energy carrier; the working stage includes an ablation stage and a continuation stage, the ablation stage being located before the continuation stage.

[0024] The energy carrier can emit ultrasound waves to the target tissue in different ultrasound emission modes during different working stages that are continuously switched. This allows for flexible control of energy accumulation, diffusion, and / or energy conduction deposition in the target tissue and its surrounding tissues through different ultrasound emission modes. This helps to ablate the target tissue while reducing damage to surrounding tissues (such as blood vessel walls and other tissues adjacent to blood vessel walls).

[0025] In some embodiments, a third aspect of this application provides a method for controlling an ultrasonic ablation catheter. The ultrasonic ablation catheter includes a support component and an energy carrier disposed on the support component. The control method includes: acquiring multiple working stage information, each working stage information corresponding to a working stage; selecting multiple target working stage information from the multiple working stage information, each working stage information including an ultrasonic wave emission mode, wherein at least two of the multiple target working stage information include different ultrasonic wave emission modes; transmitting the multiple target working stage information, and emitting ultrasonic waves to a target tissue through the energy carrier based on the ultrasonic wave emission mode included in each target working stage information; in the working stages corresponding to the multiple target working stage information, the start time of the latter working stage in two adjacent working stages is the end time of the former working stage; the working stage includes an ablation stage and a continuation stage, wherein the ablation stage precedes the continuation stage.

[0026] By controlling the energy carrier to emit ultrasound waves to the target tissue in different ultrasound emission modes during different working stages that are continuously switched, the energy accumulation, diffusion and / or energy conduction deposition of the target tissue and its surrounding tissues can be flexibly controlled through different ultrasound emission modes. This helps to ablate the target tissue while reducing damage to surrounding tissues (such as blood vessel walls and other tissues adjacent to blood vessel walls).

[0027] In some embodiments, the ultrasonic emission mode is defined by ultrasonic intensity parameters, which are determined by peak acoustic power parameters and duty cycle parameters.

[0028] In some embodiments, the ultrasound emission mode is defined by at least one of an ultrasound intensity parameter and a rotation parameter. The rotation parameter includes a rotation rate parameter and a number of rotations parameter. The rotation rate parameter indicates the rate at which the energy carrier rotates relative to the support component about the axis of the ultrasound ablation catheter, and the number of rotations parameter indicates the number of rotations the energy carrier makes relative to the support component about the axis of the ultrasound ablation catheter. The ultrasound emission mode can be defined by the ultrasound intensity parameter, by the rotation parameter, or by both to reduce the risk of damage to surrounding tissues.

[0029] In some embodiments, the ultrasonic emission mode is defined by rotation parameters, including rotation rate parameters and rotation number parameters. The method further includes: acquiring the real-time rotation rate and real-time rotation parameters of the energy carrier in the current working stage; and causing the energy carrier to enter the next working stage in response to at least one of the real-time rotation rate and real-time rotation number of the energy carrier in the current working stage reaching the corresponding value in the rotation parameters.

[0030] According to the preset settings, the system will enter the next working stage when at least one of the rotation speed and number of rotations in the current working stage reaches the corresponding preset value, thereby facilitating more accurate and efficient switching between different working stages.

[0031] Regarding the rotation rate parameter, when entering a working stage, the rotation rate of the energy carrier begins to change after entering that working stage, until it reaches the preset rotation rate, and then enters the next working stage; if the energy carrier has a rotation rate at the end of the previous working stage, and changes from that rotation rate after entering the next working stage until it reaches the preset rotation rate, then ablation can end or continue to enter another working stage.

[0032] Regarding the rotation count parameter, after entering a working stage, the rotation count of the energy carrier begins to accumulate until it reaches the preset rotation count, at which point it enters the next working stage. In the next working stage, the rotation count can start to accumulate again or be accumulated by subtraction (i.e., subtracting the number of parameters from the previous working stage).

[0033] In some embodiments, the control method further includes: acquiring at least one of the current temperature of the target tissue and the current temperature of the energy carrier; and controlling the energy carrier to enter the next working stage when the current temperature of the target tissue reaches a first preset temperature or the current temperature of the energy carrier reaches a second preset temperature. Controlling the switching between working stages according to a preset rotation rate and / or number of rotations helps reduce control difficulty and improve the efficiency and accuracy of ultrasonic ablation.

[0034] In some embodiments, the control method further includes: acquiring the current temperature of the target tissue; and when the current temperature of the target tissue reaches a second switching temperature, controlling the energy carrier to move from the ablation phase to the continuation phase, wherein the second switching temperature is any value within the range of 60°C to 80°C. Controlling the switching between working phases based on the detected temperature of the target tissue allows the ultrasonic ablation catheter to more accurately control the changing points of the working phases, thereby achieving better ablation results.

[0035] In some embodiments, a fourth aspect of this application provides an ultrasonic ablation system, comprising: an ultrasonic ablation catheter; and a control unit communicatively connected to the ultrasonic ablation catheter, wherein the ultrasonic ablation catheter is the ultrasonic ablation catheter of the first aspect, the control unit is used to control the ultrasonic intensity of an energy carrier to continuously act on a target tissue for multiple working stages; and / or, the control unit is used to implement the control method of the ultrasonic ablation catheter of any of the third aspects.

[0036] It should be noted that the technical solutions formed by any combination of the above-described embodiments (or examples) are all within the scope of protection of this application. It is understood that "any" refers to any single embodiment or implementation method, as well as multiple embodiments or combinations thereof. Attached Figure Description

[0037] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiments below. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 This is a schematic diagram of the structure of an ultrasonic ablation system provided in some embodiments of this application; Figure 2 Schematic diagrams of the ultrasonic ablation catheter provided for some embodiments of this application; Figure 3 A perspective view of the ultrasonic ablation catheter provided in some embodiments of this application; Figure 4 Schematic diagrams of the structure of ultrasonic ablation catheters provided for other embodiments of this application; Figure 5 A perspective view of the ultrasonic ablation catheter provided in some other embodiments of this application; Figure 6 This is a schematic diagram of the structure of an energy carrier provided in some embodiments of this application; Figure 7 A schematic cross-sectional view of an energy carrier within a blood vessel, provided in some embodiments of this application; Figure 8 Schematic diagrams of the structure of the energy carrier provided in other embodiments of this application; Figure 9 Schematic diagrams of ultrasonic transmitting elements provided in some embodiments of this application; Figure 10 This application provides structural schematic diagrams of energy carriers in some embodiments; Figure 11 This is a schematic diagram of the structure of the energy carrier provided in some embodiments of this application; Figure 12 This is a schematic diagram of the structure of an ultrasonic transmitting element provided in some embodiments of this application; Figure 13 This application also provides structural schematic diagrams of energy carriers in some embodiments; Figure 14 Schematic diagram of cross-sectional structure of energy carrier located in blood vessel for other embodiments of this application; Figure 15A block diagram illustrating a method for controlling an ultrasonic ablation catheter provided in some embodiments of this application; Figure 16-1 This is a schematic diagram illustrating the temperature changes of ex vivo tissue when the ultrasonic ablation catheter control method provided in some embodiments of this application is used to manipulate ex vivo tissue. Figure 16-2 Show Figure 16-1 A schematic diagram of organizational changes under the model; Figure 17 This is a schematic diagram illustrating the damage caused by using the ultrasonic ablation catheter control method provided in some embodiments of this application during ex vivo tissue manipulation. Figure 18 The images show the tissue damage effects obtained from animal experiments using the ultrasonic ablation catheter control method described in some embodiments of this application.

[0038] Explanation of reference numerals in the attached figures: 1. Ultrasonic ablation system; 10. Ultrasonic ablation catheter; 11. Support component; 111. Support body section; 112. Acoustic membrane; 1121. Receiving cavity; 113. Support head section; 12. Energy carrier; 121. Base; 122. Ultrasonic emitting element; 1221. Emitting surface; 13. Handle; 131. Drive device; 14. Torque transmission tube; B. Blood vessel wall; X. Radial; Y. Axial; S. Cross section of single injury area. Detailed Implementation

[0039] It should be understood that the examples and illustrations in this application are for illustrative purposes, and deviations and variations can be constructed and deployed based on the teachings of this application without departing from the scope of this application. Before detailing at least one embodiment of this application, it should be understood that this application is not necessarily limited to the detailed configuration and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or embodiments. This application can have other embodiments or can be practiced or implemented in different ways.

[0040] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. While similar or equivalent methods and materials to those described in this application may be used to practice or test embodiments of this application, exemplary methods and / or materials are described below. In the event of any conflict, the specification (including definitions) of this application shall prevail. Furthermore, these materials, methods, and embodiments are illustrative only and are not intended to impose necessary limitations.

[0041] In the description of this application, unless otherwise expressly specified and limited, the terms "set at," "contained in," "alongside," "connected," "fixed," "fixed to," and "fixed connection," etc., should be interpreted broadly. For example, they can refer to a non-removable fixed connection, a detachable fixed connection, or an integral part, except where there is a specific emphasis, such as a non-removable fixed connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances. Furthermore, the terms "first," "second," etc., are used merely for descriptive distinction and have no special meaning.

[0042] In this application, the distal end refers to the end of the ultrasonic ablation catheter and at least some of the components constituting the ultrasonic ablation catheter that is exemplarily far from the operator during use (or, the distal end refers to the end of the ultrasonic ablation catheter and at least some of the components constituting the ultrasonic ablation catheter that exemplarily first contacts or intervenes in the tissue of the organism when used on a living organism), and the proximal end refers to the end of the ultrasonic ablation catheter and at least some of the components constituting the ultrasonic ablation catheter that is exemplarily close to the operator during operation (or, the proximal end refers to the end of the ultrasonic ablation catheter and at least some of the components constituting the ultrasonic ablation catheter that is exemplarily farther from the tissue of the organism than the distal end when used on a living organism).

[0043] Interventional ultrasound neuroablation technology involves placing an ultrasound ablation catheter (with an ultrasound transducer at the distal end) into the renal artery to emit ultrasound waves. This causes biological effects such as increased tissue temperature, localized high-intensity pressure or temperature changes, and tissue damage, leading to tissue heating, protein denaturation, cell membrane fusion, and even coagulative necrosis, thus achieving the goal of nerve ablation. The ultrasound waves emitted by the transducer penetrate the blood vessel wall and focus on the nerve tissue outside the blood vessel to damage the target nerve tissue and achieve the ablation effect.

[0044] As the inventors know, during ultrasound ablation, ultrasound energy begins to accumulate from the focal point outside the blood vessel wall. As the energy increases and accumulates, it diffuses towards the transducer (i.e., towards the blood vessel wall or inner wall), which may cause unnecessary damage to the tissue near the transducer during ultrasound ablation. If the blood vessel wall is thin, the possibility of undesirable damage to the blood vessel wall or inner wall is even higher.

[0045] To reduce or even avoid unwanted tissue damage (such as tissue near the transducer), this application provides, in at least one embodiment, an ultrasonic ablation catheter, an ultrasonic ablation system, and a method for controlling the ultrasonic ablation catheter. The ultrasonic ablation catheter includes a support component and an energy carrier. The energy carrier is disposed on the support component and configured to emit ultrasonic waves to the target tissue in different ultrasonic wave emission modes. Multiple ultrasonic wave emission modes are available, and the duration of each mode constitutes a working phase, with continuous switching between working phases.

[0046] In some implementations, the energy carrier can emit ultrasound waves to the target tissue in different ultrasound emission modes during different working phases that are switched continuously. This allows for flexible control of the energy accumulation (total integral from the starting point to the current moment) and diffusion and / or energy conduction deposition (energy deposition rate at an instant / location) of the target tissue and its surrounding tissues through different ultrasound emission modes. This helps to ablate the target tissue while reducing damage to surrounding tissues (e.g., tissues near the ultrasound emission element of the energy carrier, blood vessel walls, or other tissues adjacent to blood vessel walls).

[0047] During ultrasound ablation, ultrasound energy accumulates and diffuses in the tissue over time. When the accumulated energy in the tissue reaches a level that causes tissue ablation (one manifestation of this is when the tissue temperature rises to the ablation temperature, such as when the temperature of renal nerve tissue rises above 45°C), the tissue will be ablated.

[0048] In some implementations, the ultrasonic emission mode is defined by at least one operating parameter, which includes any parameter capable of altering the energy accumulation in the target tissue.

[0049] When an ultrasound ablation catheter is configured to emit ultrasound energy to the target tissue, ultrasound energy accumulates in both the target tissue and surrounding tissues (tissues not intended to be ablated, such as the vessel wall near the energy carrier and other tissues adjacent to the vessel wall). Due to differences in heat dissipation efficiency among different tissues, and differences in heat dissipation and energy accumulation efficiency among vessel walls of different thicknesses, there are certain differences in energy accumulation at different tissue locations. Different ultrasound emission modes in different working stages further amplify the differences in energy accumulation in the target tissue and its surrounding tissues. By utilizing this difference and rationally setting the ultrasound emission mode in each working stage, it is possible to control the energy accumulation in the target tissue and its surrounding tissues more quickly or precisely, which helps to achieve ablation of the target tissue while the surrounding tissues are basically not ablated, reducing damage to non-target tissues during the ablation process.

[0050] Exemplarily, the energy carrier remains stationary relative to the supporting component during each working phase. The energy carrier can be configured to emit ultrasonic waves toward one radial side of the ultrasonic ablation catheter, thereby ablating the target tissue in the direction of ultrasonic wave emission. This operation is referred to as point ablation in this application. The energy carrier can also be configured to continuously emit ultrasonic waves in a ring along the circumferential annular region (e.g., a 360° annular region) of the ultrasonic ablation catheter, thereby causing annular ablation of the annular target tissue around the ultrasonic ablation catheter. This operation is referred to as continuous annular ablation in this application.

[0051] For example, the energy carrier rotates relative to the supporting component around the axis of the ultrasonic ablation catheter during each working stage, thereby enabling the emission of ultrasonic waves to the circumferential annular region (e.g., a 360° annular region) of the ultrasonic ablation catheter. The energy carrier is configured to generate ultrasonic waves only in one or several directions around the circumference of the ultrasonic ablation catheter to form a fan-shaped ablation, and relies on rotation to generate ultrasonic waves to the annular region. Therefore, in the actual ablation process, the tissue in the annular region is not always able to receive ultrasonic waves. This operation mode is referred to in this application as discontinuous annular ablation.

[0052] In some embodiments, the ultrasonic emission mode is defined by ultrasonic intensity parameters; in other words, at least the ultrasonic intensity parameters are different in different ultrasonic emission modes. Here, the ultrasonic intensity parameter specifically refers to the sound wave energy passing through a certain area per unit time. Regardless of the operating method of the energy carrier (such as a combination of different working stages), different ultrasonic emission modes can be set, which facilitates expanding the application scenarios of ultrasonic ablation catheters.

[0053] In some embodiments, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter during each working phase. During one rotation cycle of the energy carrier (e.g., during one complete rotation), the target tissue and its surrounding tissues experience periods of receiving ultrasonic energy and periods of not receiving ultrasonic energy. During periods of receiving ultrasonic energy, energy accumulation increases over time; during periods of not receiving ultrasonic energy, energy accumulation decreases over time. In other words, the energy accumulation in the target tissue and its surrounding tissues does not continuously increase. As mentioned above, different tissues have different heat dissipation efficiencies. Therefore, this operating method helps to further enhance the difference in energy accumulation between the target tissue and its surrounding tissues, thereby improving the precision of energy accumulation control and reducing the risk of damage to surrounding tissues.

[0054] In some embodiments, the ultrasonic emission mode can be defined by at least one of an ultrasonic intensity parameter and a rotation parameter. Here, the rotation parameter includes a rotation rate parameter and a number of rotations parameter.

[0055] In some embodiments, the ultrasonic emission mode can be defined by ultrasonic intensity parameters, rotation parameters, or both. Defining the ultrasonic emission mode by rotation parameters allows for relatively precise adjustment of energy accumulation in the target tissue and its surrounding tissues, thereby helping to further reduce the risk of damage to surrounding tissues. Defining the ultrasonic emission mode by rotation rate facilitates uniform and gentle heating of the target tissue to the desired temperature, while defining the ultrasonic emission mode by the number of rotations helps to increase the uniformity of energy distribution at different locations within the target tissue.

[0056] The ultrasonic ablation catheter, ultrasonic ablation system, and control method of the ultrasonic ablation catheter will be described below with reference to the accompanying drawings.

[0057] In some embodiments, the ultrasonic ablation catheter of this application can be used in an ultrasonic ablation system, such as... Figure 1 As shown, the ultrasonic ablation system 1 includes a host (not shown) and an ultrasonic ablation catheter 10. The ultrasonic ablation catheter 10 is communicatively connected to the host, which may include a control unit (not shown).

[0058] like Figure 2 and Figure 3 As shown, the ultrasonic ablation catheter 10 includes a support component 11, an energy carrier 12, and a handle 13. The support component 11 is disposed on the handle 13, and the energy carrier 12 is disposed on the support component 11. Along the proximal to distal direction of the ultrasonic ablation catheter 10, the support component 11 includes a support main body segment 111, an acoustic membrane 112, and a support head segment 113 connected in sequence. The proximal and distal ends of the acoustic membrane 112 are connected to the support main body segment 111 and the support head segment 113, respectively. The acoustic membrane 112 closes around the axial direction Y to form a receiving cavity 1121, and the energy carrier 12 is disposed within the receiving cavity 1121 of the acoustic membrane 112. Along the proximal to distal direction of the ultrasonic ablation catheter 10, both ends of the energy carrier 12 are connected to the support main body segment 111 and the support head segment 113, respectively (as in a rotatable connection). The cavity formed by the support main body segment 111 and the receiving cavity 1121 are in communication. The cavity 1121 can be filled with a medium for cooling the energy carrier 12.

[0059] In some embodiments, the support member 11 may be integral, that is, the support body segment 111, the sound-permeable membrane 112 and the support head segment 113 may be non-detachably connected as one unit; or, the support body segment 111, the sound-permeable membrane 112 and the support head segment 113 may be detachably connected.

[0060] The energy carrier 12 includes a base 121 and an ultrasonic emitting element 122. The ultrasonic emitting element 122 is disposed on the side of the base 121 along the radial direction X, and the emitting surface 1221 of the ultrasonic emitting element 122 faces the acoustic membrane 112. The base 121 is rotatable about the axial direction Y to drive the ultrasonic emitting element 122 to rotate about the axial direction Y. Thus, the ultrasonic emitting element 122 can emit ultrasonic waves around the outer periphery of the ultrasonic ablation catheter 10 about the axial direction Y during rotation.

[0061] In some embodiments, the base 121 may be made of metal, such as a metal material with high thermal conductivity. The ultrasonic ablation catheter 10 also includes a torque transmission tube 14, which is located in the cavity formed by the support body section 111; the base 121 is fixedly connected to the distal end of the torque transmission tube 14, and the energy carrier 12 can rotate in the bent state of the catheter by rotating the torque transmission tube 14.

[0062] In some embodiments, the diameter of the base 121 along the radial direction X ranges from approximately 1.8 to 2.5 mm. Exemplarily, the diameter of the base 121 is any value such as approximately 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm.

[0063] In some embodiments, the length of the base 121 along the axial direction Y ranges from approximately 10 to 15 millimeters. Exemplarily, the length of the base 121 is any value such as approximately 10 millimeters, 10.1 millimeters, 12.5 millimeters, 14.9 millimeters, or 15 millimeters.

[0064] In some embodiments, the ultrasonic ablation catheter 10 further includes a temperature sensor (not shown in the figure), which is disposed on the energy carrier 12 (e.g., on the base 121 or the ultrasonic emitting element 122) to sense the temperature of the ultrasonic emitting element 122 or the base 121. The temperature sensor and the ultrasonic emitting element 122 may be disposed on the same side of the base 121 or on different sides, which is not specifically limited in this application.

[0065] In some embodiments, a temperature sensor is connected to a host unit (such as a control unit). The temperature sensor transmits the sensed temperature to the control unit, which then determines the temperature of the ultrasonic emitting element 122 and performs corresponding operations. For example, if the control unit determines that the temperature is too high, it prompts the operator to adjust parameters or the position of the ablation catheter. Monitoring the temperature rise of the energy carrier using a temperature sensor improves the reliability of the ablation operation performed by the ultrasonic ablation system 1.

[0066] In some embodiments, the ultrasonic emitting element 122 may be bonded to the base 121 with adhesive. However, this application is not limited to this, and in some embodiments, the ultrasonic emitting element 122 may also be connected to the base 121 by welding, snap-fitting, threading, or other means.

[0067] In some embodiments, the distance between the ultrasonic transmitting element 122 and the base 121 along the radial direction X is in the range of approximately 0.02-1.5 mm (e.g., 0.05 mm). This facilitates enhanced mounting connection strength between the ultrasonic transmitting element 122 and the base 121, reduces ultrasonic energy attenuation, and ensures good thermal conduction between the ultrasonic transmitting element 122 and the base 121 for heat dissipation of the ultrasonic transmitting element 122.

[0068] In some embodiments, the ultrasonic emitting element 122 emits ultrasonic waves toward the tissue region to be ablated, and the ultrasonic waves emitted by the ultrasonic emitting element 122 are adjustable. For example, the direction of the sound beam or the focal position can be changed by controlling the phase or delay of the excitation signal of the ultrasonic emitting element 122. In other words, the energy carrier 12 can incorporate adjustments to ultrasonic parameters, i.e., by controlling the focal point or ablation distance, to achieve acoustic field modulation and tissue damage range adjustment, thereby helping to reduce unwanted tissue damage.

[0069] In some embodiments, the ultrasonic emitting element 122 may be a piezoelectric element. The piezoelectric element comprises a piezoelectric ceramic material. Exemplarily, the ceramic material in the piezoelectric ceramic material is a high-performance piezoelectric ceramic material. High-performance piezoelectric ceramic materials have high electromechanical conversion coefficients or electroacoustic conversion efficiencies, thereby facilitating increased output acoustic power and reduced heat generation in the energy carrier 12 (i.e., the ultrasonic emitting element 122). Exemplarily, the piezoelectric element comprises lead zirconate titanate type 5 material (PZT-5) and lead zirconate titanate type 8 material (PZT-8).

[0070] For example, the ultrasonic transmitting element 122 can also be a microelectromechanical component, and the energy carrier 12 containing the microelectromechanical component is called a piezoelectric micromachined ultrasonic transducer (PMUT).

[0071] For example, the ultrasonic transmitting element 122 can also be a capacitive micromechanical element, and the energy carrier 12 containing the capacitive micromechanical element is called a capacitive micromachined ultrasonic transducer (CMUT).

[0072] In some embodiments, the number of ultrasonic emitting elements 122 can be one or more, and the multiple ultrasonic emitting elements are distributed circumferentially or axially along the ultrasonic ablation catheter 10. When multiple ultrasonic emitting elements 122 are included, the multiple ultrasonic emitting elements 122 can be identical, for example, all can be piezoelectric elements, microelectromechanical elements, or capacitive micromechanical elements. Exemplarily, the multiple ultrasonic emitting elements 122 can be different; for example, the multiple ultrasonic emitting elements 122 can include at least two of piezoelectric elements, microelectromechanical elements, and capacitive micromechanical elements. Exemplarily, through the piezoelectric element with adjustable ultrasonic energy, when the ultrasonic ablation catheter 10 is located at the ablation site of a smaller branch (possibly with a thinner vessel wall) or the distal end of the renal artery trunk, the ultrasonic energy can be modulated to create a sufficient area of ​​damage during the ablation process, minimizing damage to adjacent tissues that are not the ablation target.

[0073] like Figure 1 As shown, the handle 13 is equipped with a drive device 131, which is a motor. The motor can drive the torque transmission tube 14 to rotate, thereby causing the base 121 to rotate around the Y-axis. The rotation of the base 121 causes the ultrasonic emitting element 122 to rotate. It should be noted that this application is not limited to this. In some embodiments, the base 121 may not rotate, but instead directly drive the ultrasonic emitting element 122 to rotate.

[0074] The drive device 131 can drive the base 121 to rotate, for example, it can drive the base 121 to rotate continuously about the axis Y in the same direction (e.g., clockwise or counterclockwise), so that the ultrasonic emitting element 122 can rotate continuously in the same direction.

[0075] For example, the drive device 131 can also drive the base 121 to reciprocate around the axis Y. For instance, the drive device 131 can drive the base 121 to rotate one or more times clockwise around the axis Y, and then one or more times counterclockwise. Alternatively, the drive device 131 can drive the base 121 to rotate one or more times counterclockwise around the axis Y, and then one or more times clockwise.

[0076] For example, the drive device 131 can drive the base 121 to rotate at different speeds.

[0077] The rotation speed and direction of the drive base 121 driven by the drive device 131 can be determined based on the desired effect on the tissue area to be treated during the treatment operation. For example, it can be determined based on the ablation area and ablation depth of the tissue area to be treated.

[0078] During the rotation of the energy carrier 12, the orientation of the emitting surface 1221 of the ultrasound emitting element 122 changes with the rotation of the energy carrier 12. Therefore, the energy accumulation in the tissue area to be ablated will slow down or even stop, and then continue to accumulate energy at a faster rate, causing a change in the temperature of the tissue area to be ablated. The increased energy accumulation in the tissue area to be ablated due to the rotation of the emitting surface 1221 of the ultrasound emitting element 122 leads to an increase in the temperature of the tissue area to be ablated. Therefore, by utilizing the instantaneous rise and slow fall of the temperature in the tissue area to be ablated during rotation, and by controlling the rate, the energy distribution within the lesion area can be more precisely controlled by taking advantage of the time difference between the temperature rise and fall at the focal point and the heat dissipation in different tissues. This results in better tissue damage while reducing unnecessary tissue damage and protecting the blood vessel wall tissue near the energy carrier 12.

[0079] In some embodiments, the control unit controls the drive base 121 of the drive device 131 to rotate. The control unit also controls the output rate of the drive device 131 and the number of rotations of the base 121 driven by the drive device 131 according to different stages of the ablation operation. The different working stages of the ablation operation will be described in detail in subsequent embodiments.

[0080] In some embodiments, the control unit may also control the intensity of ultrasonic waves emitted by the energy carrier 12.

[0081] In some embodiments, such as Figure 2 and Figure 3 As shown, along the radial direction X, the outer diameter of the acoustic membrane 112 is larger than the outer diameter of the supporting body segment 111. The shape of such an acoustic membrane 112 can be formed as a spherical shape; the acoustic membrane 112 can switch between an expanded structure and a compressed structure.

[0082] In some embodiments, such as Figure 4 and Figure 5 As shown, along the radial direction X, the outer diameter of the acoustic membrane 112 is equal to the outer diameter of the supporting body segment 111. Such an acoustic membrane 112 can be formed into a shape similar to a thin-walled tube.

[0083] The outer diameter of the supporting main body segment 111 is less than or equal to the outer diameter of the sound-permeable membrane 112, which helps to reduce the damage of the supporting main body segment 111 to blood vessels.

[0084] In some embodiments, the outer diameter of the acoustic membrane 112 along the radial direction X ranges from 2 mm to 3 mm. Exemplarily, the outer diameter of the acoustic membrane 112 is approximately 2 mm, 2.9 mm, or 3 mm. Of course, this application is not limited to this, and in some embodiments the outer diameter of the acoustic membrane 112 is also less than 2 mm.

[0085] The outer diameter of the acoustic membrane 112 is set to 2 to 3 millimeters, allowing the ultrasound ablation catheter 10 to be used not only in the main aorta (such as the main renal artery) but also inside branch vessels (such as renal artery branches). Multiple branch vessels can be included, and the inner diameter of these vessels (such as renal artery branches) is typically around 3 millimeters. The acoustic membrane 112 can thus enter at least one branch vessel (such as a renal artery branch) for ablation.

[0086] The diameter of the main aorta is often greater than 4 mm at the distal end (or the end furthest from the abdominal aorta), and can even reach 9 to 10 mm at the proximal end (or the end closest to the abdominal aorta). Therefore, the acoustic membrane 112, which can enter the renal artery branches, can also enter the main aorta. This helps reduce the number of catheter exchanges within the vessel and minimizes damage to the vessel during the exchange process.

[0087] In some embodiments, the outer diameter of the acoustic membrane 112 along the radial direction X ranges from 2 mm to 8 mm.

[0088] The outer diameter of the acoustic membrane 112 ranges from 2 mm to 8 mm, making the ultrasonic ablation catheter 10 suitable for operation within the main aortic trunk. Exemplarily, the outer diameter of the acoustic membrane 112 is approximately 2 mm, 2.1 mm, 3.4 mm, 5.3 mm, 6 mm, 7.9 mm, or 8 mm. However, this application is not limited to these, and in some embodiments, the outer diameter of the acoustic membrane 112 is also less than 2 mm.

[0089] In some embodiments, the thickness of the acoustic membrane 112 ranges from 0.01 mm to 0.15 mm. Exemplarily, the thickness of the acoustic membrane 112 is approximately 0.01 mm, 0.02 mm, 0.1 mm, 0.11 mm, 0.14 mm, or 0.15 mm. It should be noted that the thickness of the acoustic membrane 112 refers to the thickness of one side of the acoustic membrane 112.

[0090] The thickness of the acoustic membrane 112 ranges from 0.01 mm to 0.15 mm, which helps to reduce the sound attenuation and sound reflection of the acoustic membrane 112, and is beneficial to improving the propagation of ultrasonic power and the sound transmission effect.

[0091] In some embodiments, the acoustic membrane 112 can be made of a high-temperature resistant polymer material and formed into a thin-walled tube or a balloon shape. Using a high-temperature resistant material to make the acoustic membrane 112 helps to reduce the influence of the acoustic membrane 112 on the ultrasonic energy.

[0092] For example, the so-called polymer material can be PET (Polyethylene Terephthalate, abbreviated as polyester), PTFE (Polytetrafluoroethylene), PI (Polyimide), or a combination of multiple materials.

[0093] In some embodiments, the energy carrier 12 may include only one ultrasonic emitting element 122, which is referred to as a single ultrasonic emitting element 122 for easy distinction.

[0094] like Figure 6 and Figure 7 As shown, taking the ultrasonic emitting element 122 as an example of a piezoelectric element, the ultrasonic emitting element 122 can be a planar sheet structure. For example... Figure 7 As shown, the ultrasonic emitting element 122 emits ultrasonic waves toward the tissue area to be ablated. Figure 7 The figure shows a cross-section S of a single damaged area formed by the ultrasonic transmitting element 122 emitting a single ultrasonic wave toward the tissue area to be ablated; it can be understood that the damaged area in the figure appears to be separated from the vessel wall B by a gap but is not limited thereto. The damaged area may be on the outer surface of the vessel wall B (such as the renal sympathetic nerve on the renal artery), or the damaged area may be on a portion of the radial thickness of the vessel wall B.

[0095] In some embodiments, the width of a single sheet-like piezoelectric element along the radial direction X can range from approximately 1.8 to 2.5 mm. Exemplarily, the width of a single sheet-like piezoelectric element can be approximately 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm.

[0096] In some embodiments, the length of a single sheet-like piezoelectric element along the axial direction Y can range from approximately 5 to 10 millimeters. Exemplarily, the length of a single sheet-like piezoelectric element can be approximately 5 millimeters, 5.1 millimeters, 5.2 millimeters, 8.2 millimeters, 8.3 millimeters, 9 millimeters, 9.8 millimeters, 9.9 millimeters, or 10 millimeters.

[0097] like Figure 8 and Figure 9 As shown, taking the ultrasonic emitting element 122 as a piezoelectric element as an example, the ultrasonic emitting element 122 can be a rectangular curved sheet structure; the ultrasonic emitting element 122 is formed as a curved surface on the side of the ultrasonic ablation catheter 10 facing away from the base 121 along the radial X. Figure 8 and Figure 9 The piezoelectric element shown in the figure is shaped like a portion of a cylinder, and for easy distinction, it is called a rectangular piezoelectric element.

[0098] In some embodiments, the width of a single rectangular piezoelectric element along the radial direction X can range from approximately 1.8 to 2.5 mm. Exemplarily, the width of a single rectangular piezoelectric element can be approximately 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm.

[0099] In some embodiments, the length of a single rectangular piezoelectric element along the axial direction Y can range from approximately 5 to 10 millimeters. Exemplarily, the length of a single rectangular piezoelectric element can be approximately 5 millimeters, 6.6 millimeters, 6.7 millimeters, 8 millimeters, 8.1 millimeters, 9 millimeters, 9.9 millimeters, or 10 millimeters.

[0100] In some embodiments, such as Figure 10 As shown, taking the ultrasonic emitting element 122 as a piezoelectric element as an example, the ultrasonic emitting element 122 can be an arc-shaped curved sheet structure; the ultrasonic emitting element 122 is formed as a curved surface on the side of the ultrasonic ablation catheter 10 facing away from the base 121 along the radial X. Figure 10 The piezoelectric element shown in the image resembles a portion of a sphere and is referred to as a curved piezoelectric element for easy distinction.

[0101] In some embodiments, the radius of a single arcuate piezoelectric element along the radial direction X ranges from approximately 6 to 15 millimeters. Exemplarily, the radius of a single arcuate piezoelectric element may be approximately 6 millimeters, 7.7 millimeters, 11 millimeters, 12.7 millimeters, 14.9 millimeters, or 15 millimeters.

[0102] In some embodiments, such as Figure 11 and Figure 12 The ultrasonic emitting element 122 shown, which has a curved surface (which may be a rectangular curved surface, an arc curved surface or other irregular curved surface) formed on the side of the ultrasonic ablation catheter 10 facing away from the base 121, may include multiple array elements distributed in an array, thereby allowing the position of the focal point to be adjusted. Figure 11 and Figure 12 An embodiment of multiple array elements arranged along the Y-axis is shown, but this application is not limited thereto. In some embodiments, the multiple array elements can be arranged in an array of any form, such as a circumferential array arrangement.

[0103] In some embodiments, such as Figure 13 and Figure 14 The ultrasonic emitting element 122 with a planar sheet structure shown may include multiple array elements distributed in an array. Figure 13 and Figure 14 An embodiment is shown in which multiple array elements are arranged along the Y-axis, but this application is not limited thereto. In some embodiments, the multiple array elements can be arranged in an array of any form.

[0104] In some embodiments, the size of the array composed of multiple array elements may be the same as or similar to the size of a single piezoelectric element in the foregoing embodiments, which will not be elaborated here.

[0105] In some embodiments, the energy carrier 12 is configured to emit ultrasonic waves to the target tissue in different ultrasonic emission modes; there are multiple ultrasonic emission modes, the duration of each ultrasonic emission mode constitutes a working phase, and the working phases are switched continuously.

[0106] For example, the number of work stages is 2 to N, where N ≤ 20. Each work stage is continuous in the time dimension, that is, the start time of the latter work stage is the end time of the former work stage in two adjacent work stages.

[0107] In some embodiments, the ultrasonic emission mode is defined by an ultrasonic intensity parameter; in other words, the energy carrier 12 emits ultrasonic energy using at least different ultrasonic intensities in different ultrasonic emission modes. The ultrasonic intensity can be specifically adjusted by peak acoustic power and / or duty cycle.

[0108] Peak power refers to the maximum instantaneous power of the energy carrier 12 per unit time. It can be understood that the higher the peak acoustic power, the higher the ultrasonic intensity.

[0109] Duty cycle specifically refers to the percentage of time that the energy carrier 12 emits ultrasonic waves per unit time. It can be understood that the higher the duty cycle, the higher the ultrasonic intensity.

[0110] In this embodiment, the ultrasonic emission mode is defined by the ultrasonic intensity parameter. Regardless of the operating mode of the energy carrier 12, different ultrasonic emission modes can be set, which is beneficial to expanding the application scenarios of the ultrasonic ablation catheter 10.

[0111] In some embodiments, the energy carrier 12 is configured to rotate relative to the support member 11 about the axial direction of the ultrasonic ablation catheter during each working phase. The ultrasonic emission mode is defined by at least one of the ultrasonic intensity parameter and the rotation parameter, which includes at least the rotation rate and the number of rotations.

[0112] The ultrasonic emission mode can be defined by ultrasonic intensity parameters, rotational parameters, or both. Defining the ultrasonic emission mode by rotational parameters allows for relatively precise adjustment of energy accumulation in the target tissue and its surrounding tissues, thereby helping to further reduce the risk of damage to surrounding tissues.

[0113] Defining the ultrasonic emission mode by rotation rate is beneficial for heating the target tissue to the expected temperature uniformly and gently. Defining the ultrasonic emission mode by the number of rotations is beneficial for reducing the coverage dead zone of ultrasonic energy through multiple rotations of ultrasonic energy coverage, and for making the energy accumulation at different locations of the target tissue more uniform.

[0114] In some embodiments, the working phase includes an ablation phase and a continuation phase, with the continuation phase following the ablation phase.

[0115] In embodiments where the energy carrier 12 remains stationary relative to the supporting component 11 during each working phase (i.e., the energy carrier 12 does not rotate), the ultrasonic emission mode is defined by the ultrasonic intensity, with the ultrasonic intensity during the ablation phase being greater than that during the continuation phase.

[0116] In an embodiment where the energy carrier 12 rotates relative to the support member 11 about the axis of the ultrasonic ablation catheter 10 during each working phase, the ultrasonic emission mode is defined by at least one of the ultrasonic intensity parameter and the rotation parameter. In such an embodiment, the ultrasonic intensity during the ablation phase may be greater than that during the continuation phase, or the rotation rate during the ablation phase may be less than that during the continuation phase. Alternatively, the ultrasonic intensity during the ablation phase may be greater than that during the continuation phase, and the rotation rate during the ablation phase may be less than that during the continuation phase.

[0117] In terms of time, the continuation phase follows the ablation phase. In other words, the ablation phase begins first, followed by the continuation phase.

[0118] During the ablation phase, the energy carrier 12 emits ultrasonic waves with a relatively high ultrasonic intensity and / or a relatively low rotational speed, such that the energy accumulation of the target tissue in the corresponding ultrasonic emission mode during the ablation phase is sufficient to cause the target tissue to ablate; including at least at some point during the conditioning phase, the energy accumulation of the target tissue is sufficient to cause the target tissue to ablate.

[0119] It is understandable that when the energy carrier 12 emits ultrasound with a relatively high ultrasonic intensity, the target tissue receives a high amount of energy per unit time, causing the energy in the target tissue to accumulate relatively quickly and reach the ablation temperature, with the energy accumulation rapidly increasing. When the energy carrier 12 emits ultrasound with a lower rotational rate, the target tissue receives ultrasonic energy for a longer time in a single rotation cycle, resulting in a higher energy peak in a single rotation cycle, thus causing the energy in the target tissue to accumulate quickly to the ablation temperature. In the continuation phase, the energy carrier 12 emits ultrasound with a relatively low ultrasonic intensity and / or a higher rotational rate. It is understood that in the continuation phase, after the ablation phase, the energy accumulation of the target tissue in the ablation phase has reached a level sufficient to ablate the target tissue. Therefore, in the continuation phase, it is only necessary to maintain the target tissue at approximately the ablation energy (including a slight increase or decrease in energy accumulation), without further rapidly increasing the energy accumulation of the target tissue. This helps to reduce the energy accumulation of surrounding tissues in this phase while achieving a better ablation effect, thereby further reducing the risk of damage to surrounding tissues.

[0120] To the inventors' knowledge, one related technology focuses on ablation depth (e.g., in locations far from the renal artery wall), aiming to increase the absolute depth of ultrasound ablation. This is achieved, for example, by increasing the intensity of ultrasound waves. One purpose is to reduce or even avoid incomplete ablation of deep nerve tissue, which could potentially damage the vessel wall. However, the inventors have found that pursuing ablation depth is not suitable in all situations. For instance, near the distal end of the renal artery (the end furthest from the abdominal aorta) where branches originate, some patients may have other organs or tissues adjacent to the distal end of the renal artery. Furthermore, the renal nerves at the distal end of the renal artery are relatively closer to the outer wall of the renal artery. Pursuing ablation depth in such cases could damage nearby organs and tissues, and could also spread to and damage the vessel wall. This application employs a multi-stage approach to achieve both superficial ablation (distance from the emitting surface of the catheter, such as the energy carrier 12). First, in the ablation stage, energy accumulation begins at the ultrasound focal point, causing coagulative necrosis of the target tissue to achieve ablation. At this stage, the tissue ablated first forms a certain acoustic barrier, with at least some ultrasound waves reflecting or scattering towards the surface tissue of the target tissue (the side closer to the catheter). This allows energy accumulation to diffuse towards the surface tissue of the target tissue, reducing or even preventing energy accumulation into deeper tissues and thus avoiding damage to other adjacent tissues and organs (the side farther from the catheter). Finally, a continuation stage follows, where the ultrasound intensity decreases, slowing or maintaining the energy of the ablation stage to ablate the surface tissue of the target tissue. This slows or even prevents excessive energy from continuing to diffuse and accumulate towards the vessel wall (the side closer to the catheter), thereby reducing the risk of damage to the vessel wall.

[0121] It is understandable that "taking into account shallow ablation" means that both shallow ablation and deep ablation can be performed.

[0122] In some embodiments, the ultrasonic intensity during the ablation phase is changed by at least one set of operational information, each set of operational information including any value of the peak acoustic power range and any value of the duty cycle range.

[0123] Here, the ultrasonic intensity during the ablation phase can be changed by only one piece of operational information; in other words, the peak acoustic power and duty cycle of the energy carrier 12 remain constant throughout the ablation phase, which helps reduce control difficulty. Alternatively, the ultrasonic intensity during the ablation phase can be changed by multiple pieces of operational information; in other words, the peak acoustic power and / or duty cycle of the energy carrier 12 may change during the ablation phase.

[0124] In some embodiments, during the ablation phase, the peak acoustic power of the energy carrier 12 ranges from 5W to 50W. For example, the peak acoustic power of the energy carrier 12 during the ablation phase can be any value such as 5W, 6W, 7W, 8W, 9W, 10W, 11W, 12W, 13W, 14W, 15W, 16W, 17W, 18W, 19W, 20W, 21W, 22W, 23W, 24W, 25W, 26W, 27W, 28W, 29W, 30W, 31W, 32W, 33W, 34W, 35W, 36W, 37W, 38W, 39W, 40W, 41W, 42W, 43W, 44W, 45W, 46W, 47W, 48W, 49W, or 50W, or fall within the range of any two values.

[0125] In some embodiments, during the ablation phase, the duty cycle of the energy carrier 12 ranges from 10% to 80%. For example, the duty cycle of the energy carrier 12 during the ablation phase is any value such as approximately 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, or 75%, or falls within a range of any two values.

[0126] In some embodiments, during the ablation phase, the energy carrier 12 is configured to rotate relative to the support member 11 about the axis of the ultrasonic ablation catheter 10 at a preset rotational speed, the rotational speed being at least one value in the range of 20︒ / s to 160︒ / s. For example, during the ablation phase, the rotational speed of the energy carrier 12 is 20︒ / s, 25︒ / s, 30︒ / s, 35︒ / s, 40︒ / s, 45︒ / s, 50︒ / s, 55︒ / s, or 60︒ / s. The value can be any value, such as 65° / s, 70° / s, 75° / s, 80° / s, 85° / s, 90° / s, 95° / s, 100° / s, 105° / s, 110° / s, 115° / s, 120° / s, 125° / s, 130° / s, 135° / s, 140° / s, 145° / s, 150° / s, 155° / s, or 160° / s, or fall within the range of any two values. Furthermore, the energy carrier 12 is configured to rotate relative to the support component 11 about the axis of the ultrasonic ablation catheter 10 at a preset number of rotations. The number of rotations is at least one value ranging from 3 to 30 rotations. For example, the number of rotations of the energy carrier 12 during the ablation phase can be any value such as 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27.5, 28, 29, or 30 rotations, or fall within the range of any two values. Each rotation rate corresponds to one number of rotations.

[0127] Here, the energy carrier 12 can rotate at the same rotation rate for a set number of revolutions during the ablation phase, or it can rotate at different rotation rates for the corresponding number of revolutions.

[0128] In some embodiments, the ultrasonic intensity during the sustained phase is changed by at least one operational information, each operational information including any value of the peak acoustic power range and any value of the duty cycle range.

[0129] Here, the ultrasonic intensity during the continuation phase can be changed by only one piece of operating information; in other words, the peak acoustic power and duty cycle of the energy carrier 12 remain constant throughout the entire continuation phase, which helps reduce control difficulty. Alternatively, the ultrasonic intensity during the continuation phase can be changed by multiple pieces of operating information; in other words, the peak acoustic power and / or duty cycle of the energy carrier 12 may change during the continuation phase.

[0130] In some embodiments, during the sustaining phase, the peak acoustic power of the energy carrier 12 ranges from 3W to 40W. For example, the peak acoustic power of the energy carrier 12 during the sustaining phase can be any value such as 3W, 4W, 5W, 6W, 7W, 8W, 9W, 10W, 11W, 12W, 13W, 14W, 15W, 16W, 17W, 18W, 19W, 20W, 21W, 22W, 23W, 24W, 25W, 26W, 27W, 28W, 29W, 30W, 31W, 32W, 33W, 34W, 35W, 36W, 37W, 38W, 39W, or 40W, or fall within the range of any two values.

[0131] In some embodiments, during the continuation phase, the duty cycle of the energy carrier 12 ranges from 20% to 90%. For example, the duty cycle of the energy carrier 12 during the continuation phase is approximately any value such as 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90%, or falls within a range of any two values.

[0132] In some embodiments, during the continuation phase, the energy carrier 12 is configured to rotate relative to the support member 11 about the axis of the ultrasonic ablation catheter 10 at a preset rotational speed, wherein the rotational speed is at least one value in the range of 40° / s to 240° / s. For example, during the continuation phase, the rotational speed of the energy carrier 12 is 40° / s, 50° / s, 60° / s, 70° / s, 80° / s, etc. Any value such as 90︒ / s, 100︒ / s, 110︒ / s, 120︒ / s, 130︒ / s, 140︒ / s, 150︒ / s, 160︒ / s, 170︒ / s, 180︒ / s, 190︒ / s, 200︒ / s, 210︒ / s, 220︒ / s, 230︒ / s, or 240︒ / s, or within the range of any two values. Furthermore, the energy carrier 12 is configured to rotate relative to the support component 11 about the axis of the ultrasonic ablation catheter at a preset number of rotations. The number of rotations is at least one value ranging from 1 to 30 rotations. For example, the number of rotations of the energy carrier 12 during the continuation phase can be any value such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11.6, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 rotations, or fall within the range of any two values. Each rotation rate corresponds to one number of rotations.

[0133] Here, the energy carrier 12 can rotate at the same rotation rate for a set number of revolutions during the continuation phase, or it can rotate at different rotation rates for the corresponding number of revolutions in sequence.

[0134] In some embodiments, the energy carrier 12 is configured to rotate relative to the support member 11 about the axis of the ultrasonic ablation catheter 10 at a preset rotation speed and a preset number of rotations in the current working phase, and to enter the next working phase when at least one of the rotation speed and the number of rotations in the current working phase reaches a corresponding preset value. That is, whether the energy carrier 12 enters the next working phase is determined based on whether the number of rotations or the rotation speed of the energy carrier 12 reaches the corresponding preset value; that is, the energy carrier 12 is configured to enter the next working phase in response to at least one of the rotation speed and the number of rotations in the current working phase reaching the corresponding preset value.

[0135] According to the preset settings, the system will enter the next working stage when at least one of the rotation speed and number of rotations in the current working stage reaches the corresponding preset value, thereby facilitating more accurate and efficient switching between different working stages.

[0136] Taking the rotation rate reaching the corresponding preset value to enter the next working stage as an example, when entering a working stage, the rotation rate of the energy carrier 12 begins to change until it reaches the corresponding preset value, then the next working stage is entered; if the energy carrier 12 has a rotation rate at the end of the previous working stage, and changes from that rotation rate until it reaches the corresponding preset value after entering the next working stage, then the ablation ends or the next working stage continues.

[0137] Taking the number of rotations reaching a preset value as an example, after entering the first working stage, the number of rotations of the energy carrier 12 begins to accumulate until it reaches the preset value, at which point it enters the next working stage; in the next working stage, the number of rotations begins to accumulate again.

[0138] Taking the entry into the next working stage as an example where both the rotation rate and rotation parameters reach the corresponding preset values, after entering the first working stage, if the rotation rate of the energy carrier 12 reaches and maintains the corresponding preset value, the number of rotations begins to accumulate until the number of rotations reaches the corresponding preset value, then the next working stage is entered.

[0139] For example, in practical applications, the energy accumulation required to reach the corresponding working stage is obtained by testing isolated tissues, thereby determining the required rotation rate and / or number of rotations.

[0140] In this embodiment, the switching between each working stage is controlled according to a preset rotation rate and / or number of rotations, which helps to reduce the difficulty of control and improve the efficiency of ultrasonic ablation.

[0141] In some embodiments, the ultrasonic ablation catheter 10 includes a temperature sensor disposed in at least one of the support member 11 and the energy carrier 12, and configured to sense the temperature of the target tissue. Based on the temperature of the target tissue sensed by the temperature sensor, the current energy accumulated in the target tissue (i.e., the current energy accumulation in the target tissue) can be determined, thus determining the current degree of tissue damage. For example, if the temperature sensed by the temperature sensor has reached or exceeded the set temperature for the ablation stage, it can be considered that the degree of tissue damage has met the conditions for transitioning from the ablation stage to the prolongation stage, thereby allowing the energy carrier 12 to enter the ablation stage. The presence of the temperature sensor allows for the acquisition of the target tissue temperature, thereby enabling more precise control over changes in the working stage. In some embodiments, the temperature sensor is a thermocouple.

[0142] In some embodiments, it can be preset that when the temperature sensed by the temperature sensor reaches any value within the range of 60°C to 80°C, the energy carrier 12 can move from the ablation phase to the continuation phase.

[0143] In this embodiment, the switching between each working stage is controlled based on the detected temperature of the target tissue, which helps to more accurately control the change nodes of the working stage, thereby facilitating a better ablation effect.

[0144] In some embodiments, the ultrasound ablation catheter 10 may include an imaging sensor configured to acquire images of the target tissue. The imaging sensor can provide the acquired images of the target tissue to an operator (doctor) or a control unit, who can then determine whether to maintain the current working phase or proceed to the next phase based on changes in the tissue's morphology.

[0145] In some embodiments, it can be preset that when the tissue morphology changes from the ablation stage to the continuation stage or to a transitional morphology between the ablation stage and the continuation stage, the energy carrier 12 is controlled to enter the continuation stage from the ablation stage.

[0146] In some embodiments, the morphological changes of three-dimensional tissues at different working stages can be obtained by testing isolated tissues. Based on a certain number of test results, the morphological changes of tissues in two adjacent working stages in the time dimension are determined, and these changes are stored as preset changes in the control unit for comparison and judgment by operators or corresponding working modules of the control unit. The energy concentrated in the target tissue varies in different working stages, leading to different morphological changes. Therefore, changes in tissue morphology can also be considered as changes in the energy concentrated in the tissue.

[0147] In this embodiment, controlling the switching between each working stage based on the detected morphology of the target tissue is beneficial for more accurate control of the change nodes of the working stage, thereby facilitating a better ablation effect.

[0148] Based on a similar concept, some embodiments of this application also provide a control method for an ultrasonic ablation catheter. Exemplarily, the control method for the ultrasonic ablation catheter in this embodiment is executed by the energy carrier of the ultrasonic ablation catheter. The control method for the ultrasonic ablation catheter 10 includes the following operations: S11: Receive multiple target work stage information, each target work stage information corresponds to one work stage, and the start time of the latter work stage in two adjacent work stages is the end time of the former work stage.

[0149] Each target working stage information includes an ultrasonic emission mode, and at least two of the target working stage information include different ultrasonic emission modes.

[0150] S12: Based on the ultrasonic emission mode included in the information of each target working stage, ultrasonic waves are emitted to the target tissue through the energy carrier.

[0151] Based on the received target working stage information, the energy carrier 12 emits ultrasound waves to the target tissue in different ultrasound emission modes over time. By varying the parameters of the ultrasound emission modes, the energy accumulation in the target tissue is controlled, thereby achieving ablation of the target tissue while minimizing damage to the blood vessel walls and other adjacent tissues.

[0152] Based on a similar concept, some embodiments of this application also provide a method for controlling an ultrasonic ablation catheter 10, the method of which includes the following operations: S21: Obtain information on multiple work stages, with each work stage corresponding to one work stage.

[0153] S22: Select multiple target working stage information from multiple working stage information, each working stage information includes an ultrasonic emission mode, and at least two of the multiple target working stage information include different ultrasonic emission modes.

[0154] S23: Send multiple target working stage information, and based on the ultrasonic emission mode included in each target working stage information, emit ultrasonic waves to the target tissue through an energy carrier.

[0155] S24: Among the work stages corresponding to multiple target work stage information, the start time of the latter work stage is the end time of the former work stage in two adjacent work stages.

[0156] The control unit of the ultrasound ablation system 1 controls the energy carrier 12 to continuously emit ultrasound waves at different ultrasound emission modes over time to the target tissue based on the acquired information of the working stage. By varying the parameters of the ultrasound emission modes, the energy accumulation in the target tissue is controlled, thereby achieving ablation of the target tissue while minimizing damage to the blood vessel wall and other tissues adjacent to the blood vessel wall. The main unit of the ultrasound ablation system 1 includes the control unit.

[0157] In some embodiments, the method for controlling the ultrasonic ablation catheter 10 includes the following operations: S31: Receive multiple target work stage information, each target work stage information corresponds to one work stage, and the start time of the latter work stage in two adjacent work stages is the end time of the former work stage.

[0158] S32: Each target working stage information includes an ultrasonic emission mode, and at least two of the target working stage information include different ultrasonic emission modes.

[0159] S33: Based on the ultrasonic emission mode included in the information of each target working stage, ultrasonic waves are emitted to the target tissue through an energy carrier.

[0160] S34: Obtain the real-time rotation rate and real-time rotation parameters of the energy carrier during the current working stage.

[0161] S35: In response to at least one of the real-time rotation rate and the real-time number of rotations of the energy carrier in the current working phase reaching the corresponding value in the rotation parameters, the energy carrier enters the next working phase.

[0162] In some embodiments, the method for controlling the ultrasonic ablation catheter 10 includes the following operations: S41: Receive multiple target work stage information, each target work stage information corresponds to one work stage, and the start time of the latter work stage in two adjacent work stages is the end time of the former work stage.

[0163] S42: Each target working stage information includes an ultrasonic emission mode, and at least two of the target working stage information include different ultrasonic emission modes.

[0164] S43: Based on the ultrasonic emission mode included in the information of each target working stage, ultrasonic waves are emitted to the target tissue through an energy carrier.

[0165] S44: Obtain the real-time rotation rate and real-time rotation parameters of the energy carrier during the current working phase.

[0166] S45: In response to at least one of the real-time rotation rate and the real-time number of rotations of the energy carrier in the current working phase reaching the corresponding value in the rotation parameters, the energy carrier enters the next working phase.

[0167] In some embodiments, the method for controlling the ultrasonic ablation catheter 10 includes the following operations: S51: Receive multiple target working stage information, each target working stage information corresponds to a working stage, and the start time of the latter working stage in two adjacent working stages is the end time of the former working stage.

[0168] S52: Each target working stage information includes an ultrasonic emission mode, and at least two of the target working stage information include different ultrasonic emission modes.

[0169] S53: Based on the ultrasonic emission mode included in the information of each target working stage, ultrasonic waves are emitted to the target tissue through an energy carrier.

[0170] S54: Obtain at least one of the current temperature of the target tissue and the current temperature of the energy carrier.

[0171] S55: When the current temperature of the target tissue reaches the first preset temperature or the current temperature of the energy carrier reaches the second preset temperature, control the energy carrier to enter the next working stage.

[0172] In some embodiments, the method for controlling the ultrasonic ablation catheter 10 includes the following operations: S61: Receive multiple target working stage information, each target working stage information corresponds to a working stage, and the start time of the latter working stage in two adjacent working stages is the end time of the former working stage.

[0173] S62: Each target working stage information includes an ultrasonic emission mode, and at least two of the target working stage information include different ultrasonic emission modes.

[0174] S63: Based on the ultrasonic emission mode included in the information of each target working stage, ultrasonic waves are emitted to the target tissue through an energy carrier.

[0175] S64:: Get the current temperature of the target tissue.

[0176] S65: When the temperature sensed by the temperature sensor reaches the preset second switching temperature, the energy carrier is controlled to enter the continuation stage from the ablation stage. The second switching temperature is any value in the range of 60℃-80℃.

[0177] Based on a similar concept, this application also provides an ultrasonic ablation system, including: an ultrasonic ablation catheter; and a control unit, which is communicatively connected to the ultrasonic ablation catheter, wherein the ultrasonic ablation catheter is the ultrasonic ablation catheter of the aforementioned embodiment, the control unit is used to control the ultrasonic intensity of the energy carrier to continuously act on the target tissue in multiple working stages; and / or, the control unit is used to implement the control method of the ultrasonic ablation catheter of any of the aforementioned embodiments.

[0178] In a specific embodiment, such as Figure 15 As shown, the control unit controls the ultrasonic ablation catheter 10 to operate in the following manner: S101: Enables the energy carrier to emit ultrasonic energy at the operating parameters of the ablation phase.

[0179] S102: When the working phase of the energy carrier changes from the ablation phase to the continuation phase, the ultrasonic energy emitted by the energy carrier is reduced to the ultrasonic energy of the continuation phase.

[0180] The operating parameters for both the ablation and continuation phases include peak acoustic power, duty cycle, rotational speed, and number of rotations.

[0181] For example, during the ablation phase, the peak acoustic power of the energy carrier 12 ranges from 5W to 25W, the duty cycle ranges from 30% to 70%, the rotation speed ranges from 20° / s to 130° / s, and the number of rotations ranges from 5 to 20. During the continuation phase, the peak acoustic power of the energy carrier 12 ranges from 2W to 20W, the duty cycle ranges from 40% to 85%, the rotation speed ranges from 50° / s to 200° / s, and the number of rotations ranges from 2 to 20.

[0182] For example, during the ablation phase, the peak acoustic power of the energy carrier 12 ranges from 10W to 28W, the duty cycle ranges from 20% to 60%, the rotation speed ranges from 40° / s to 145° / s, and the number of rotations ranges from 4 to 20. During the continuation phase, the peak acoustic power of the energy carrier 12 ranges from 5W to 23W, the duty cycle ranges from 40% to 80%, the rotation speed ranges from 50° / s to 200° / s, and the number of rotations ranges from 1 to 20.

[0183] For example, during the ablation phase, the peak acoustic power of the energy carrier 12 ranges from 20W to 35W, the duty cycle ranges from 20% to 50%, the rotational speed ranges from 80° / s to 145° / s, and the number of rotations ranges from 4 to 20. During the continuation phase, the peak acoustic power of the energy carrier 12 ranges from 10W to 25W, the duty cycle ranges from 40% to 60%, the rotational speed ranges from 50° / s to 180° / s, and the number of rotations ranges from 1 to 20.

[0184] Again, exemplarily speaking, during the ablation phase, the peak acoustic power of the energy carrier 12 ranges from 14W to 32W, the duty cycle ranges from 10% to 55%, the rotational speed ranges from 50° / s to 150° / s, and the number of rotations ranges from 3 to 20. During the continuation phase, the peak acoustic power of the energy carrier 12 ranges from 11W to 28W, the duty cycle ranges from 20% to 50%, the rotational speed ranges from 70° / s to 240° / s, and the number of rotations ranges from 1 to 22.

[0185] Again, exemplarily speaking, during the ablation phase, the peak acoustic power of the energy carrier 12 ranges from 25W to 50W, the duty cycle ranges from 10% to 35%, the rotational speed ranges from 120° / s to 160° / s, and the number of rotations ranges from 3 to 20. During the continuation phase, the peak acoustic power of the energy carrier 12 ranges from 3W to 22W, the duty cycle ranges from 20% to 60%, the rotational speed ranges from 70° / s to 200° / s, and the number of rotations ranges from 1 to 22.

[0186] For details regarding the setting of operating parameters, control of the energy carrier, and changes in the operating stage, please refer to the aforementioned embodiments; further details will not be provided here.

[0187] Figure 16-1 The diagram illustrates the temperature changes in ex vivo tissue under conditions where the ablation phase is performed first, followed by the continuation phase (using values ​​within the range of the working parameters for the two phases). Figure 16-2 Show Figure 16-1 A schematic diagram of organizational changes under the given pattern. Figure 16-1 In the figure, the vertical axis represents voltage (in volts) and the horizontal axis represents time (in seconds); thermocouples and oscilloscopes are used to detect the temperature of ex vivo tissues, and the voltage and temperature of the oscilloscopes are positively correlated.

[0188] Where A represents the temperature of the ultrasound emitting surface near the energy carrier 12 in the tissue injury (near the focal point), B represents the temperature of the ultrasound emitting surface away from the energy carrier 12 in the tissue injury (near the focal point), i.e., the side away from the epidermis in the diagram, i.e., the side near the epidermis in the diagram, C represents the surface of the sound-transmitting membrane (such as a balloon), i.e., the epidermal temperature in the diagram (which can correspond to the target blood vessel wall), and D represents the temperature of the outer side of the target blood vessel (e.g., the outer surface of the blood vessel wall). Figure 16-1 As shown in curves A and B, when the energy emitting surface of the energy carrier 12 (corresponding to the ultrasound emitting element 122) faces the detection position, the temperature at the focal point rises instantaneously. As the energy carrier 12 rotates, the temperature at this position first drops rapidly and then slowly, with the rate of temperature decrease being much slower than the rate of temperature increase, eventually showing a trend of temperature increase. Then, by increasing the rotation rate to reduce energy accumulation, it can be seen that the temperature at the focal point still shows a trend of first rising instantaneously and then slowly decreasing, but eventually the temperature reaches equilibrium. Therefore, by first using a larger energy for ablation and then using a lower energy for output, the tissue temperature rise caused by the instantaneous heat generated by the energy output of the energy carrier 12 can be balanced with the temperature drop caused by heat dissipation within the tissue, maintaining the tissue temperature. Simultaneously, the temperature accumulated during the treatment process is insufficient to cause a rapid increase in energy accumulation in the surrounding tissues near the energy carrier 12, thus minimizing damage to the blood vessel wall. This achieves both protective ablation of the blood vessel wall and sufficient tissue damage at the focal point.

[0189] like Figure 16-2 The diagram of the ex vivo tissue shows that the area inside the ellipse represents tissue damage caused by ultrasonic energy, while the area outside the ellipse represents normal ex vivo tissue. The arrow points to the epidermis of the ex vivo tissue, corresponding to the placement position of the distal end of the ultrasonic ablation catheter (i.e., the energy carrier 12). It can be observed that no obvious damage was found in the epidermal tissue, while significant tissue damage was observed in the deeper epidermal tissue (i.e., the area inside the ellipse). Therefore, the method of controlling the ultrasonic ablation catheter 10 according to this application, which ensures that the ultrasonic energy emitted by the energy carrier 12 during the ablation phase is higher than that during the continuation phase, is reliable for ablation.

[0190] Figure 17 This is a schematic diagram of damage in an in vitro tissue experiment. Figure 17 The light-colored area (the area inside the dashed ellipse) represents tissue damage caused by ultrasound energy, while the dark-colored area (the area outside the dashed ellipse) represents normal ex vivo tissue. The arrow indicates the placement position of the distal end of the ultrasound ablation catheter (i.e., the energy carrier 12). Figure 17In the diagram, Part A shows the ring-shaped lesion formed by ablation only during the ablation phase (as a control group). Part B shows the lesion formed by first performing high-intensity ablation with a certain amount of ultrasound energy (corresponding to the ablation phase), and then maintaining the temperature or slowing down the rapid increase in energy with a certain amount of ultrasound energy (corresponding to the continuation phase). This demonstrates that by outputting ultrasound energy through a multi-stage operation, ring-shaped lesions can be formed. Furthermore, through multiple stages of ultrasound output, deeper tissue damage can be created while simultaneously protecting the vessel wall B.

[0191] In some embodiments, Figure 18 This image illustrates the tissue damage effects of an animal renal artery nerve ablation experiment performed using the control method of the ultrasonic ablation catheter 10 according to some embodiments of this application [HE staining (Hematoxylin and Eosin staining), a conventional method]. Part A shows a section of vascular tissue at the ablation site, Part A1 is a magnified view of the damaged nerve tissue at the location marked with a black box in Part A, the area inside the dashed ellipse represents the vessel wall B, and the arrow indicates the placement position of the distal end of the ultrasonic ablation catheter (i.e., the energy carrier 12). By controlling the output of energy using the ultrasonic ablation catheter 10 of this application, a ring-shaped injury can be formed within the tissue while protecting the vessel wall B. According to... Figure 18 As can be seen, after ablation surgery using the ultrasound ablation catheter 10 described in the above embodiment, the ultrasound energy of the ultrasound ablation catheter 10 did not cause significant damage to the renal artery tissue. No complications such as renal artery rupture, dissection, hemorrhage, or thrombosis occurred. The vascular tissue structure was normal, the lumen shape was visible, the internal elastic lamina were regularly arranged, and there were no obvious breaks. The elastic lamina of the media were regularly arranged, and there was circular smooth muscle between the elastic lamina. The adventitia was normal, with no obvious inflammatory cell infiltration or fibrosis. No damage was caused to the vascular tissue. However, for the nerve tissue surrounding the vascular tissue, numerous pathological changes such as nuclear condensation and disappearance, vacuolation, etc., were observed, along with adventitia hyperplasia, indicating significant damage to the nerve tissue. The above conclusions may reveal that the ultrasound ablation catheter 10 can cause damage to the nerve tissue surrounding the renal artery while protecting the renal artery.

[0192] It should be noted that the technical solutions formed by any combination of the above-described embodiments (or examples) are all within the scope of protection of this application. It is understood that "any" refers to any single embodiment or implementation method, as well as multiple embodiments or combinations thereof.

[0193] Whenever a range of values ​​is indicated in this application, it refers to any of the listed values ​​(fractions and integers) that fall within the indicated range. The phrases “range between the first indicated value and the second indicated value” and “range from the first indicated value to the second indicated value” are used interchangeably in this application and refer to the values ​​indicated by the first and second indications, as well as all fractional and integer values ​​in between.

[0194] As used herein, when used in conjunction with numerical values ​​and / or ranges, the terms “about” and / or “approximately” generally refer to numerical values ​​and / or ranges that are close to the given value and / or range. In some cases, the terms “about” and “approximately” may mean within ±10% of the value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., 90 to 110). The terms “about” and “approximately” are used interchangeably.

[0195] As used in this application, the singular forms “an,” “a,” and “the” include the plural forms unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include a variety of compounds, including mixtures thereof.

[0196] The implementation of the methods and / or systems of this application may include performing or fully performing selected tasks manually, automatically, or in a combination thereof. Furthermore, the actual instruments and equipment used in the implementation of the methods and / or systems of this application, using an operating system, may implement several selected tasks via hardware, software, firmware, or a combination thereof.

[0197] For example, the hardware used to perform the selected task according to embodiments of this application can be implemented in the form of a chip or circuit. As software, the task selected according to embodiments of this application can be implemented as multiple software instructions executable by a computer using any suitable operating system. In exemplary embodiments of this application, one or more tasks of exemplary embodiments of the method and / or system according to this application are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. A display and / or user input devices such as a keyboard or mouse are also optionally provided.

[0198] It should be understood that certain features of this application described in the context of a single implementation for clarity can also be provided in combination in a single implementation. Conversely, multiple features of this application described in the context of a single implementation for brevity can also be provided individually or in any suitable sub-combination or, as appropriate, in any other implementation of this application. Certain features described in the context of multiple implementations should not be considered essential features of those implementations unless the implementation does not function without these elements.

[0199] Although this application has been described in conjunction with its specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations are possible. Therefore, it is intended to include all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

Claims

1. An ultrasonic ablation catheter, characterized in that, include: Support components; Energy carrier, the energy carrier is located in the supporting component; The energy carrier is configured to emit ultrasound waves toward the target tissue in different ultrasound emission modes; There are multiple ultrasonic emission modes, and the duration of each ultrasonic emission mode constitutes a working phase, with each working phase switching continuously; Each work phase includes an ablation phase and a continuation phase, with the ablation phase preceding the continuation phase.

2. The ultrasonic ablation catheter according to claim 1, characterized in that, The ultrasonic emission mode is defined by ultrasonic intensity parameters, and the ultrasonic intensity parameters for each working stage are adjusted by at least one of the peak acoustic power parameters and the duty cycle parameters.

3. The ultrasonic ablation catheter according to claim 1, characterized in that, The energy carrier is configured to rotate relative to the support components about the axis of the ultrasonic ablation catheter during each working phase.

4. The ultrasonic ablation catheter according to claim 3, characterized in that, The ultrasonic emission mode is defined by at least one of the ultrasonic intensity parameter and the rotation parameter, wherein the rotation parameter includes the rotation rate parameter and the number of rotations parameter.

5. The ultrasonic ablation catheter according to claim 1, characterized in that, The ultrasonic emission mode is defined by ultrasonic intensity parameters, with the ultrasonic intensity parameters in the ablation phase being greater than those in the continuation phase.

6. The ultrasonic ablation catheter according to claim 1, characterized in that, It includes an ablation phase and a continuation phase, with the ablation phase preceding the continuation phase; The energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter during each working phase, and the ultrasonic emission mode is defined by at least one of the ultrasonic intensity parameter and the rotation parameter, which includes the rotation rate parameter. The ultrasonic intensity parameters during the ablation phase are greater than those during the continuation phase, and / or The rotation rate parameter during the ablation phase is lower than that during the continuation phase.

7. The ultrasonic ablation catheter according to claim 5 or 6, characterized in that, The target tissue in the ablation phase and the continuation phase can be ablated in the corresponding ultrasonic emission mode.

8. The ultrasonic ablation catheter according to claim 5 or 6, characterized in that, The ultrasonic intensity parameters during the ablation phase are changed by at least one set of operational information, each set of operational information including any value in the peak acoustic power range and any value in the duty cycle range, wherein the peak acoustic power range is 5W-50W and the duty cycle range is 10%-80%; and / or, during the ablation phase, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset rotational speed, wherein the rotational speed is at least one value in the range of 20︒ / s-160︒ / s, and the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset number of rotations, wherein the number of rotations is at least one value in the range of 3 to 30 rotations, wherein each rotational speed corresponds to one number of rotations.

9. The ultrasonic ablation catheter according to claim 5 or 6, characterized in that, During the continuation phase, the ultrasonic intensity parameters are changed through at least one set of operational information, each set of operational information including any value within the peak acoustic power range and any value within the duty cycle range, wherein the peak acoustic power range is 3W-40W and the duty cycle range is 20%-90%; and / or, during the continuation phase, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset rotational speed, wherein the rotational speed is at least one value within the range of 40︒ / s-240︒ / s, and the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset number of rotations, wherein the number of rotations is at least one value within the range of 1 to 25 rotations, wherein each rotational speed corresponds to one number of rotations.

10. The ultrasonic ablation catheter according to claim 5 or 6, characterized in that, The ultrasonic ablation catheter includes a temperature sensor, which is located in at least one of the support component and the energy carrier; the temperature sensor is used to sense the temperature of the target tissue. The energy carrier is configured as follows: When the temperature sensed by the temperature sensor reaches the preset second switching temperature, the process switches from the ablation stage to the continuation stage. The second switching temperature is any value in the range of 60℃-80℃.

11. The ultrasonic ablation catheter according to claim 1, characterized in that, The energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset rotation rate and a preset number of rotations during the current working phase, and to enter the next working phase when at least one of the rotation rate and number of rotations during the current working phase reaches the corresponding preset value.

12. The ultrasonic ablation catheter according to claim 1, characterized in that, The ultrasonic ablation catheter includes a temperature sensor, which is located in at least one of the support component and the energy carrier. The temperature sensor is used to sense the temperature of at least one of the energy carrier and the target tissue. The energy carrier is configured to enter the next working stage when the temperature sensed by the temperature sensor reaches a preset temperature.

13. The ultrasonic ablation catheter according to claim 1, characterized in that, The energy carrier includes a base and at least one ultrasonic emitting element, the ultrasonic emitting element being disposed on one side of the base, the base being configured to rotate relative to a support member about the axis of the ultrasonic ablation catheter to drive the ultrasonic emitting element to rotate.

14. The ultrasonic ablation catheter according to claim 13, characterized in that, The ultrasonic emitting elements are multiple, and these multiple ultrasonic emitting elements are distributed at intervals along the circumference of the ultrasonic ablation catheter; and / or The ultrasonic emitting element comprises multiple array elements distributed in an array; and / or The ultrasonic transmitting element is configured as a sheet-like structure, thereby emitting ultrasonic waves with a fixed focusing depth; and / or The ultrasonic emitting element is formed as a curved surface on the side of the ultrasonic ablation catheter facing away from the base, thereby emitting ultrasonic waves with a fixed focusing depth.

15. The ultrasonic ablation catheter according to any one of claims 1-6 or any one of claims 11-14, characterized in that, Along the proximal to distal direction, the support component includes a support body section, a sound-permeable membrane, and a support head section that are fixedly connected in sequence, with the two ends of the sound-permeable membrane fixedly connected to the support body section and the support head section, respectively; The acoustic membrane has a receiving cavity, and the energy carrier is located inside the receiving cavity of the acoustic membrane; Along the direction from the near end to the far end, the two ends of the energy carrier are respectively located at the main support section and the head support section.

16. A method for controlling an ultrasonic ablation catheter, characterized in that, The ultrasonic ablation catheter includes a support component and an energy carrier located on the support component; The control method includes: It receives information on multiple target working stages, each target working stage corresponding to one working stage. The start time of the latter working stage is the end time of the former working stage in two adjacent working stages. Each target working stage information includes an ultrasonic transmission mode, and the ultrasonic transmission modes included in each target working stage information are different. Based on the ultrasonic emission mode included in the information of each target working stage, ultrasonic waves are emitted to the target tissue through an energy carrier; The process involves multiple phases, including an ablation phase and a continuation phase; the continuation phase follows the ablation phase.

17. A method for controlling an ultrasonic ablation catheter, characterized in that, The ultrasonic ablation catheter includes a support component and an energy carrier located on the support component; The control method includes: Obtain information on multiple work stages, with each piece of information corresponding to one work stage; Multiple target working stage information are selected from the multiple working stage information. Each target working stage information includes an ultrasonic emission mode, and the ultrasonic emission modes included in each target working stage information are different. Send the multiple target working stage information, and based on the ultrasonic emission mode included in each target working stage information, emit ultrasonic waves to the target tissue through an energy carrier; Among the multiple target work stage information corresponding to the work stages, the start time of the latter work stage in two adjacent work stages is the end time of the former work stage. The process involves multiple phases, including an ablation phase and a continuation phase; the continuation phase follows the ablation phase.

18. The method for controlling the ultrasonic ablation catheter according to claim 17, characterized in that, The ultrasonic emission mode uses ultrasonic intensity parameters as necessary parameters, which are determined by peak acoustic power parameters and duty cycle parameters.

19. The method for controlling the ultrasonic ablation catheter according to claim 17, characterized in that, The ultrasonic emission mode is defined by at least one of the ultrasonic intensity parameter and the rotation parameter. The rotation parameter includes the rotation rate parameter and the number of rotations parameter. The rotation rate parameter is used to indicate the rate at which the energy carrier rotates relative to the support component about the axis of the ultrasonic ablation catheter. The number of rotations parameter is used to indicate the number of rotations of the energy carrier relative to the support component about the axis of the ultrasonic ablation catheter.

20. The method for controlling the ultrasonic ablation catheter according to claim 17, characterized in that, The ultrasonic emission mode uses ultrasonic intensity parameters as necessary parameters, and the ultrasonic intensity parameters in the ablation phase are greater than those in the continuation phase.

21. The method for controlling the ultrasonic ablation catheter according to claim 17, characterized in that, The ultrasonic emission mode is defined by at least one of the ultrasonic intensity parameter and the rotation parameter, wherein the rotation parameter includes the rotation rate parameter. The ultrasonic intensity parameters during the ablation phase are greater than those during the continuation phase, and / or The rotation rate parameter during the ablation phase is lower than that during the continuation phase.

22. The method for controlling the ultrasonic ablation catheter according to claim 20 or 21, characterized in that, The ablation phase and the continuation phase can respectively cause the target tissue to ablate.

23. The method for controlling the ultrasonic ablation catheter according to claim 20 or 21, characterized in that, The ultrasonic intensity parameters during the ablation phase are changed by at least one set of operational information, each set of operational information including any value in the peak acoustic power range and any value in the duty cycle range, wherein the peak acoustic power range is 5W-50W and the duty cycle range is 10%-80%; and / or, during the ablation phase, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset rotational speed, wherein the rotational speed is at least one value in the range of 20︒ / s-160︒ / s, and the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset number of rotations, wherein the number of rotations is at least one value in the range of 3 to 30 rotations, wherein each rotational speed corresponds to one number of rotations.

24. The method for controlling the ultrasonic ablation catheter according to claim 20 or 21, characterized in that, During the continuation phase, the ultrasonic intensity parameters are changed through at least one set of operational information, each set of operational information including any value within the peak acoustic power range and any value within the duty cycle range, wherein the peak acoustic power range is 3W-40W and the duty cycle range is 20%-90%; and / or, during the continuation phase, the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset rotational speed, wherein the rotational speed is at least one value within the range of 40︒ / s-240︒ / s, and the energy carrier is configured to rotate relative to the support component about the axis of the ultrasonic ablation catheter at a preset number of rotations, wherein the number of rotations is at least one value within the range of 1 to 25 rotations, wherein each rotational speed corresponds to one number of rotations.

25. The method for controlling the ultrasonic ablation catheter according to claim 17, characterized in that, The ultrasonic emission mode is defined by rotation parameters, including rotation rate parameters and number of rotations parameters. The method further includes: Obtain the real-time rotation rate and real-time rotation parameters of the energy carrier during the current working stage; The energy carrier enters the next working stage in response to at least one of its real-time rotation rate and real-time number of rotations in the current working stage reaching the corresponding value in the rotation parameters.

26. The method for controlling the ultrasonic ablation catheter according to claim 17, characterized in that, Control methods also include: Obtain at least one of the current temperature of the target tissue and the current temperature of the energy carrier; When the current temperature of the target tissue reaches the first preset temperature or the current temperature of the energy carrier reaches the second preset temperature, the energy carrier is controlled to enter the next working stage.

27. The method for controlling the ultrasonic ablation catheter according to claim 20 or 21, characterized in that, Control methods also include: Obtain the current temperature of the target tissue; When the current temperature of the target tissue reaches the second switching temperature, the energy carrier is controlled to move from the ablation phase to the continuation phase. The second switching temperature is any value in the range of 60 ℃ to 80 ℃.

28. An ultrasonic ablation system, characterized in that, include: Ultrasonic ablation catheter; as well as The control unit is in communication with the ultrasonic ablation catheter; Wherein, the ultrasonic ablation catheter is the ultrasonic ablation catheter of any one of claims 1-15, the control unit is used to control the ultrasonic intensity of the energy carrier to continuously act on the target tissue in multiple working stages; and / or, the control unit is used to implement the control method of the ultrasonic ablation catheter of any one of claims 16-27.

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