Targeted ablation device

Abstract

The utility model discloses a targeted ablation device, and relates to the technical field of medical instruments, the targeted ablation device comprises: a catheter body, which comprises an outer tube and a rotatable inner tube, and the outer tube is arranged outside the inner tube; the imaging element is provided with a working surface arranged in the radial direction of the catheter body, and the working surface is used for transmitting and receiving signals; the ablation element comprises a plurality of array elements which can be addressed and controlled independently, and the array elements can be excited to send energy to a target area; the imaging element and the ablation element are axially and separately connected to the far end of the inner tube, the ablation element further comprises a blocking piece connected to the inner tube, and a plurality of array elements are connected to the blocking piece and uniformly distributed in the circumferential direction of the inner tube; the imaging element can receive the torque transmitted by the inner tube to rotate and obtain image information of a target area, and the blocking piece isolates the torque transmitted by the inner tube to the array elements so that the array elements can be kept still relative to the target area. According to the scheme, the corresponding array elements are pertinently excited to send energy for ablation, and the diameter size of the catheter of the ablation device is reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to targeted ablation devices. Background Technology

[0002] Interventional surgery delivers energy to the target anatomical location of the patient to inhibit the activity of the target tissue, and is a treatment method for diseases such as pain, diabetes and hypertension.

[0003] Hypertension is one of the most common chronic cardiovascular diseases, and its awareness and control rates remain low worldwide. Studies have found that the kidneys play a feedback and regulatory role in human blood circulation. Early research showed that renal sympathetic nerve flow is active in patients with refractory hypertension. Renal denervation (RDN) is a technique that reduces blood pressure by destroying sympathetic nerve fibers on the renal artery wall through intervention.

[0004] Current ablation devices, whether using radiofrequency ablation or ultrasound ablation, lack guidance from nerve position monitoring or positioning devices. The energy emitting elements they use generally have a ring-shaped emitting surface, causing energy to radiate circumferentially towards the renal artery, which can easily damage other non-target tissues. This inevitably leads to blind ablation and makes precise targeted ablation treatment impossible.

[0005] In summary, how to provide an ablation device that can perform ablation therapy with precision, while ensuring a small catheter size, simple operation, high control accuracy and ablation efficiency, is a problem that urgently needs to be solved by those skilled in the art. Utility Model Content

[0006] In view of this, the purpose of this application is to provide a targeted ablation device to solve at least one technical problem in the prior art. The specific solution is as follows:

[0007] In a first aspect, this application discloses a targeted ablation device, comprising:

[0008] The catheter body includes an outer tube and a rotatable inner tube, the outer tube being disposed outside the inner tube;

[0009] An imaging element has a working surface arranged radially toward the catheter body, the working surface being used to transmit and receive signals;

[0010] The ablation element comprises multiple independently addressable and controllable array elements, which can be excited to send energy to the target area;

[0011] The imaging element and the ablation element are axially separated and connected to the distal end of the inner tube. The ablation element also includes a barrier connected to the inner tube. A plurality of the array elements are connected to the barrier and are evenly distributed along the circumference of the inner tube.

[0012] The imaging element can receive the torque transmitted by the inner tube to rotate and acquire image information of the target area, and the barrier isolates the torque transmitted by the inner tube to the array element so that each array element remains stationary relative to the target area.

[0013] Optionally, one of the plurality of array elements is configured to have an angle consistent with the initial angle of the imaging element.

[0014] Optionally, a control unit is also included, connected to the proximal end of the catheter body. The control unit includes a recording module for storing initial angle information of the imaging element and / or array element information whose angles are consistent with the initial angle of the imaging element.

[0015] Optionally, the recording module includes a code disk connected to the proximal end of the inner tube, the code disk being capable of recording the initial angle information of the imaging element.

[0016] Optionally, the recording module is also used to store the angle information of each array element and / or the number information of the array elements.

[0017] Optionally, when the array element remains stationary relative to the target region, the imaging element rotates relative to the target region by an angle of N*360° as the inner tube rotates, where N represents an integer greater than or equal to 1.

[0018] Optionally, the outer surface of the inner tube has a groove arranged circumferentially around its axis, the barrier includes a seat and a rolling component disposed in the groove, the rolling component is used to reduce the coefficient of friction and / or contact area between the inner tube and the barrier, and the array element is connected to the seat.

[0019] The barrier transmits the axial movement of the inner tube to the array element and isolates the torque transmission from the inner tube to the array element.

[0020] Optionally, the inner surface of the seat of the barrier is provided with a plurality of recesses, and the rolling component is placed in the gap between the recesses and the groove, and the rolling component rolls in the gap as the inner tube rotates.

[0021] Optionally, it also includes a balloon disposed around the distal end of the catheter body, wherein the gap between the inner tube and the outer tube and the inner lumen of the inner tube are in communication with the inner lumen of the balloon to allow the flow of liquid medium, and the inner lumen of the balloon can switch to a contracted state or an inflated state as the volume of the liquid medium changes.

[0022] Optionally, in the targeted ablation device, the inner tube includes a cable cavity with a preset cable hole, the cable cavity being used to lay a first communication cable, the first communication cable connecting the host and the imaging element;

[0023] The outer tube is provided with an arc-shaped notch that matches the number of array elements. The arc-shaped notch forms a cable laying area, and each cable laying area is used to lay a second communication cable between the array element and the host.

[0024] Optionally, it also includes a display screen that presents image information of the target area acquired by the imaging element, and the display screen is also used to display target point capture markers and / or target point information.

[0025] Beneficial effects: The targeted ablation device of this application includes an imaging element and an ablation element. The ablation element comprises multiple independently addressable and controllable array elements, enabling the ablation element to purposefully and specifically stimulate the corresponding array elements to send energy for ablation under the guidance of the imaging element, avoiding damage to non-target tissues and achieving high control precision and ablation efficiency. Furthermore, the imaging element and the ablation element are axially separated and connected to the distal end of the inner tube. The imaging element can receive torque transmitted from the inner tube to rotate and acquire image information of the target area. A blocking element isolates the torque transmitted from the inner tube to the array elements, keeping each array element stationary relative to the target area. That is, the imaging element and the ablation element are coaxially connected to the inner tube. Considering that the ablation element has multiple array elements and is therefore relatively large, this application sets the ablation element to rotate independently of the imaging element via a blocking element, eliminating the need to consider the space required for the rotation of multiple array elements and their cables, resulting in a compact spatial structure. This allows for both imaging guidance and ablation device size without increasing the overall size, simplifying the structure for easier operation. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of a targeted ablation device disclosed in this application.

[0028] Figure 2 This is a schematic diagram of a specific barrier element disclosed in this application;

[0029] Figure 3 This is a schematic diagram of a specific balloon arrangement disclosed in this application;

[0030] Figure 4 This is a cross-sectional schematic diagram of the first specific targeted ablation device disclosed in this application;

[0031] Figure 5 This is a schematic diagram of a specific balloon inflation state disclosed in this application;

[0032] Figure 6 This is a cross-sectional schematic diagram of the second specific targeted ablation device disclosed in this application;

[0033] Figure 7 This is a schematic diagram of a specific imaging element arrangement disclosed in this application;

[0034] Figure 8 This is a cross-sectional schematic diagram of the third specific targeted ablation device disclosed in this application;

[0035] Figure 9 This is a schematic diagram of a specific array element communication cable layout disclosed in this application;

[0036] Figure 10 This is a flowchart of a control method based on a targeted ablation device disclosed in this application;

[0037] Figure 11 This is a schematic diagram of a specific working element incentive disclosed in this application;

[0038] Figure 12 This is a structural diagram of an electronic device disclosed in this application.

[0039] The following labels are shown in the attached diagram:

[0040] 1. Outer tube; 2. Inner tube; 3. Imaging element; 4. Array element; 5. Barrier component; 6. Balloon; 7. Blood vessel; 8. Blood vessel wall; 9. Target nerve tissue; 10. Gap between inner and outer tubes; 11. Inner cavity; 12. Cable cavity; 13. First communication cable; 14. Second communication cable; 15. Main unit; 41. Working array element; 51. Base; 52. Rolling component; 20. Electronic equipment; 21. Processor; 22. Memory; 23. Power supply; 24. Communication interface; 25. Input / output interface; 26. Communication bus; 221. Operating system; 222. Computer program and data; 223. Detailed Implementation

[0041] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0042] The technical solution of this application can be applied to various scenarios where energy is emitted from inside blood vessels to outside tissues for tissue ablation. For example, it can be used to treat refractory hypertension by ablating the renal sympathetic nerve or the external carotid nerve; to treat type 2 diabetes by ablating nerves near the liver; and to affect the function of metabolic organs by ablating the sympathetic nerves that innervate internal organs such as the liver, pancreas, and gastrointestinal tract. Additionally, it can alleviate pain by ablating nerves outside peripheral blood vessels. The following embodiments use the treatment of refractory hypertension by ablating the renal sympathetic nerve as an example, and are only intended to facilitate understanding of the technology by those skilled in the art, not to exclude the application of the technical solution of this application to other scenarios. It should be understood that each embodiment of this application can be applied to a class of scenarios, and those skilled in the art can directly apply it to multiple treatment scenarios under the guidance of the specification. Applying the technical solution of this application to multiple similar scenarios is within the protection scope and implementation methods of this application. The kidneys play a feedback and regulatory role in the human blood circulation. Early studies have shown that the renal sympathetic nerve flow is active in patients with refractory hypertension. Transcatheter renal sympathectomy is a technique that reduces blood pressure by destroying the sympathetic nerve fibers in the renal artery wall through intervention. Human RDN can be performed using a single-electrode linear radiofrequency catheter. The catheter is positioned at the distal renal artery and performs multiple radiofrequency ablations on the inner surface of the lumen in a circular motion during the retraction process.

[0043] Currently, ablation devices typically perform circumferential ablation of the target tissue surrounding the target blood vessel wall, resulting in a large ablation area. This is essentially blind ablation of the renal artery, lacking targeted treatment and potentially affecting surgical outcomes. In contrast, if the imaging and ablation elements are coaxially positioned and rotate synchronously, multiple in vivo positioning and ablation of nerves will be required, especially for densely distributed nerve areas. This necessitates complex algorithm design or cumbersome operational procedures. Alternatively, if the ablation and imaging elements are positioned off-axis within the catheter—requiring two inner tubes to house the ablation and imaging elements respectively—the ablation element can rotate asynchronously with the imaging element. However, this off-axis configuration results in a larger catheter diameter, further restricting the already limited space available for the ablation device.

[0044] Therefore, this application provides a targeted ablation scheme, which provides an ablation device that can accurately perform ablation treatment, while maintaining a small catheter size, simple operation, high control precision and ablation efficiency as much as possible.

[0045] See Figure 1 As shown in the figure, this application discloses a targeted ablation device, including:

[0046] The catheter body includes an outer tube 1 and a rotatable inner tube 2, wherein the outer tube 1 is disposed outside the inner tube 2;

[0047] Imaging element 3 has a working surface arranged radially toward the catheter body, the working surface being used to transmit and receive signals;

[0048] The ablation element includes multiple independently addressable and controllable array elements 4, which can be excited to send energy to the target area;

[0049] The imaging element 3 and the ablation element 4 are axially separated and connected to the distal end of the inner tube 2. The ablation element also includes a barrier 5 connected to the inner tube 2. A plurality of the array elements 4 are connected to the barrier 5 and are evenly distributed along the circumference of the inner tube 2.

[0050] The imaging element 3 can receive the torque transmitted by the inner tube 2 to rotate and acquire image information of the target area. The blocking member 5 isolates the torque transmitted by the inner tube 2 to the array element 4 so that each array element 4 remains stationary relative to the target area.

[0051] First, the targeted ablation device of this application includes a catheter body, an imaging element, and an ablation element. The imaging element can receive the torque transmitted by the rotatable inner tube of the catheter body to rotate and acquire image information of the target area. The blocking element of the ablation element isolates the torque transmitted from the inner tube to the array elements so that each array element remains stationary relative to the target area. In this way, although the imaging element and the ablation element are axially separated and connected to the distal end of the inner tube, that is, the imaging element and the ablation element are coaxially arranged on the inner tube, the purpose of asynchronous rotation of the imaging element and the ablation element is still achieved, thereby reducing the diameter of the catheter body. Furthermore, the ablation element includes multiple independently addressable and controllable components. The array elements are uniformly distributed along the circumference of the inner tube. The corresponding array elements can be excited according to the image information of the target area acquired by the imaging element, so that the excited array elements send energy to the target area and avoid sending energy to non-target areas, thereby reducing ablation damage to non-target tissues. In some cases, multiple array elements can be controlled to ablate target points in different directions of the target area at the same time. Compared with the existing ablation methods, this application has both monitoring and ablation functions, the ablation is more targeted, and the array elements can be excited at different angles at the same time. Therefore, the operation is simpler and the ablation time required is shorter, and the ablation efficiency is improved.

[0052] The distal end of the catheter body is positioned within the blood vessel of the target area. The end closer to the operator (e.g., a healthcare professional) is defined as the proximal end, and the end used to insert into the patient's body is defined as the distal end. For a single component, the end closer to the operator is the proximal end, and the end further away from the operator is the distal end.

[0053] In some embodiments, the catheter body includes an outer tube 1 and an inner tube 2. The outer tube 1 is disposed outside the inner tube 2, and the inner tube 2 is rotatable. The imaging element 3 has a working surface arranged radially toward the catheter body. The working surface is used to transmit and receive signals. The imaging element 3 can receive the torque transmitted by the inner tube 2 to rotate and acquire image information of the target area. Specifically, imaging can be performed by optical coherence tomography (OCT) or ultrasound. In ultrasound imaging, the imaging element can specifically be an IVUS (Intravenous Ultrasound) transducer. The working surface is used to transmit and receive signals to form tissue imaging around the target area.

[0054] The imaging element 3 and the ablation element are axially separated and connected to the far end of the inner tube 2. The axial relative position between the imaging element 3 and the ablation element is fixed at δ mm. The ablation element also includes a barrier 5 connected to the inner tube 2. Multiple array elements 4 are connected to the barrier 5 and are evenly distributed along the circumference of the inner tube 2. Different array elements correspond to different orientations and can ablate target areas in different orientations. The barrier 5 can isolate the torque transmitted from the inner tube 2 to the array elements 4 so that each array element 4 remains stationary relative to the target area. That is, the imaging element 3 can rotate and move with the inner tube 2, etc. The array elements 4 will not rotate with the inner tube 2 but can move axially with the inner tube 2. In other words, while imaging a target area, the ablation element will not rotate synchronously. However, this does not mean that the synchronous motion state of the two in other states is excluded. For example, after the imaging element 3 rotates and acquires image information of a target area, the catheter body needs to be moved so that the target area is within the ablation range of the ablation element. The ablation range generally includes the radial range of the ablation element. Then, the ablation element is excited to release energy at a selected location in the target area for ablation. During this process, the imaging element 3 and the ablation element move synchronously when the catheter body is moved. Furthermore, during the movement from the current target area to another target area, the movements (movement, rotation, and torsion, etc.) of the outer tube 1 and inner tube 2 due to the patient's physiological curvature or operator-driven actions are selectively transmitted to the array element 4. That is, the movement of the distal end of the catheter body from the current target area to another target area can drive the synchronous movement of the imaging element 3 and the ablation element. It is also understood that the movement from the current target area to another target area can be independent and / or continuous. The independent movement process has been described above and will not be repeated here. The continuous movement can include at least two scenarios. For example, in one scenario, after the imaging element 3 rotates and acquires image information of the current target area, the catheter body needs to be moved so that the target area is ablated within the ablation range of the ablation element. At the same time, the imaging element 3 is moved to the next target area and can rotate with the drive shaft to acquire image information of the next target area. In another scenario, the inner tube 2 rotates so that the imaging element 3 acquires image information of a continuous segment of area, which includes several target areas. By analyzing the image information of a segment of area and recording the corresponding sites of the corresponding areas, the process is then traced back to ensure that the recorded corresponding areas are within the radial range of the ablation element for ablation.

[0055] In some embodiments, one of the plurality of array elements 4 is configured with an angle consistent with the initial angle of the imaging element 3. Configuring the angle of one of the array elements 4 to be consistent with the initial angle of the imaging element 3 means aligning the imaging element 3 with a certain array element of the ablation element. In this way, when the imaging element 3 moves to the target area and rotates to acquire image information, the array element aligned with the imaging element 3 can be used as a reference array element to match the angle correspondence between the image information and each array element, thus finding the array element in the target area image information that corresponds to the target point orientation.

[0056] More specifically, the targeted ablation device also includes a control unit connected to the proximal end of the catheter body. The control unit includes a recording module for storing the initial angle information of the imaging element 3, and / or the array element information whose angle matches the initial angle of the imaging element 3 (as reference array element information). A control unit is also connected to the proximal end of the catheter body. This control unit includes a recording module for storing the initial angle information of the imaging element 3 and / or the array element information whose angle matches the initial angle of the imaging element 3. When the imaging element 3 rotates with the inner tube 2 and acquires image information, it can select the array element corresponding to the target point's azimuth angle in the image information from all array elements 4 as the working array element based on the array element information (i.e., reference array element information) and the image information, and excite the working array element to send energy to the target point in the target area. If the initial angle information of an array element is bound to the imaging element 3 during factory settings, i.e., a reference array element is bound, the imaging element 3 will start circumferential scanning from that initial angle and transmit image information. The operator selects a target point in the image information or identifies a target point in the image information using software algorithms. The angle difference between the target point angle and the initial angle determines the array element at a certain angle from the reference array element as the working array element. For example, if the image information shows a target point at a 60° angle, then the array element at a 60° angle from the reference array element is activated as the working array element and emits energy to the target point. Alternatively, array elements at 50°-90° angles from the reference array element can be activated as working array elements as needed. Furthermore, in some embodiments, the reference array element may not be bound as a fixed array element at the factory settings. Instead, during operation, the initial angle of the imaging element 3 is obtained, and an array element with an angle consistent with that angle is selected as the reference array element. The other methods for selecting working array elements are the same as described above. It should be noted that the initial angle of the imaging element 3 is not the initial angle at which the catheter body begins to enter the human body, but rather the initial angle of the imaging element 3 when it begins to image a certain target area.

[0057] In some embodiments, the recording module includes a code disk connected to the proximal end of the inner tube, the code disk being capable of recording the initial angle information of the imaging element. The code disk is a digital encoder for measuring angular displacement, possessing advantages such as high resolution, high measurement accuracy, and reliable operation. Specifically, the code disk can be an absolute encoder or an incremental encoder, capable of recording the initial angle information of the imaging element 3.

[0058] In some embodiments, the recording module is further configured to store the angle information of each array element and / or the quantity information of the array elements. Specifically, the recording module may record and store the initial angle information of the imaging element 3, and / or the array element information whose angle is consistent with the initial angle of the imaging element 3, the angle information of each array element, and / or the quantity information of the array elements. In this way, after acquiring image information, the angle information of the target point can be determined based on the image information. Thus, the working array element can be determined from each array element based on the angle information and quantity information recorded by the recording module. It can be understood that the working angle of the working array element is oriented towards the target area to achieve targeted ablation.

[0059] In some embodiments, when the array element remains stationary relative to the target region, the imaging element rotates relative to the target region by an angle of N*360° as the inner tube rotates, where N represents an integer greater than or equal to 1. The imaging element completes one or more full circular rotations relative to the target region, allowing for multiple captures of image information from different angles, resulting in more accurate and comprehensive image information. If an apparatus for imaging and ablation modes is used in a manner other than that described in this application, such that the imaging element and the ablation element are coaxial and rotate synchronously, it is necessary to ablate each current target point one by one and then rotate to the next position for image recognition and ablation. This is because the circumferential scanning imaging transducer usually rotates at least once to obtain an image before recognizing the corresponding target point, and then rotates to the corresponding position according to the target point position. This relies heavily on the continuous synchronous rotation of the imaging and ablation functions. That is, if the imaging element in the coaxial synchronous rotation implementation recognizes a target point at a position of 60°, it needs to rotate another 60° after already rotating 360° to obtain an image in order for the ablation element to release energy toward the target point for ablation. Especially for tissues with dense target points, it is necessary to frequently drive the synchronous rotation of the imaging element and the ablation element to move back and forth for alignment and positioning, which is a rather cumbersome operation and results in low ablation efficiency. This implementation reduces the dependence of the ablation element on the rotation angle of the imaging element. Ideally, the imaging element only needs to rotate one full circle or an integer multiple of circles in the current target area to obtain image information. There is no need for the ablation element to follow the imaging element in rotating and aligning multiple target points one by one for ablation. Instead, it can directly ablate multiple target points in the target area simultaneously, making the operation simpler and improving ablation efficiency. Furthermore, since the rotation of the imaging element is an integer multiple of circles, the reference array element corresponding to the initial position of the imaging element does not need to be reselected, resulting in higher accuracy in identifying and ablating target points.

[0060] In some embodiments, the outer surface of the inner tube has a groove circumferentially arranged with its axis as the center. The barrier includes a seat and a rolling member disposed in the groove. The rolling member is used to reduce the coefficient of friction and / or contact area between the inner tube and the barrier. The array element is connected to the seat. The barrier transmits the axial movement of the inner tube to the array element and isolates the torque transmission from the inner tube to the array element. The barrier includes a base and a rolling component. The base is the foundation of the ablation element, and the array element is connected to the base. The outer surface of the inner tube has a groove circumferentially arranged around its axis. This groove is the rolling path of the rolling component. The base is made of a rigid material with a higher density than the inner tube, such as W18Cr4V or chromium steel. The inner tube is a conduit made of a material that meets the preset bending performance requirements, such as stainless steel or nickel-titanium alloy. Therefore, the rolling component can reduce the coefficient of friction and / or contact area between the inner tube and the barrier, such as ball bearings, needle rollers, or rollers. The barrier transmits the axial movement of the inner tube to the array element and isolates the torque transmission from the inner tube to the array element. That is, when the inner tube moves axially, the barrier can transmit the axial movement to the array element. However, when the inner tube rotates, because the rolling component reduces the coefficient of friction and / or contact area between the inner tube and the barrier, the barrier isolates the torque transmitted from the inner tube to the array element so that each array element remains stationary relative to the target area.

[0061] In some embodiments, the inner surface of the seat 51 of the barrier 5 has multiple recesses, and the rolling member 52 is placed in the gap between the recesses and the groove. The rolling member 52 rolls within the gap as the inner tube 2 rotates. Further, the inner surface of the seat 51 may have multiple recesses, and the rolling member 52 is placed in the gap between the recesses and the groove. More specifically, the gap between the recesses and the groove can be used as the rolling space for the rolling member 52. The rolling member 52 rolls within the gap as the inner tube 2 rotates, but the rolling of the rolling member 52 is insufficient to rotate the seat 51, thus preventing the seat 51 from rotating and keeping it stationary relative to the target area. Specifically, the rolling member 52 is a ball, needle, or roller, for example... Figure 2 The diagram shown is a specific type of barrier. Figure 2 The rolling component 52 is specifically a ball in the gap between the seat 51 and the inner tube 2.

[0062] The targeted ablation device also includes a balloon 6, disposed around the distal end of the catheter body. The gap between the inner and outer tubes, as well as the inner lumen of the inner tube, are connected to the inner lumen of the balloon to allow for the flow of liquid medium. The inner lumen of the balloon can switch between a contracted state and an inflated state according to the volume change of the liquid medium. For example... Figure 3The diagram shows a specific balloon arrangement. The targeted ablation device also includes a balloon 6, which surrounds the distal end of the catheter body. The balloon 6 contains an imaging element 3, an ablation element, and an inner tube 2. The outer tube 1 terminates at the proximal interface of the balloon. For example... Figure 4 The schematic diagram of a cross-section of the first specific targeted ablation device shows that the gap 10 between the inner tube 2 and the outer tube 1, as well as the inner cavity 11 of the inner tube 2, are connected to the inner cavity of the balloon 6 to allow the flow of liquid medium. The inner cavity 11 of the inner tube 2 is the liquid inflow cavity, and the gap 10 between the inner tube 2 and the outer tube 1 is the liquid outflow cavity. That is, the liquid flows into the balloon 6 through the inner cavity 11 of the inner tube 1, and the liquid in the balloon is then discharged from the balloon 6 through the gap 10 between the inner tube 2 and the outer tube 1. The above embodiment is only one presentation, and it can be understood that the liquid inflow and outflow paths are reversed. In this way, controlling the inflow and outflow of liquid from balloon 6 allows the inner cavity of balloon 6 to switch between a contracted and inflated state according to the volume change of the liquid medium. Furthermore, the liquid medium flowing within balloon 6 carries away heat from the blood vessels in contact with the balloon, reducing damage to the vascular tissue at the contact point. Thus, the temperature when liquid flows into balloon 6 is lower than the temperature when liquid exits balloon 6, reducing the heat generated by ablation on non-target tissues and minimizing ablation damage to non-target tissues. Specifically, the balloon can be made of rubber, giving it good extensibility and flexibility, for example... Figure 5 The diagram shows a specific balloon inflation state. The targeted ablation device reaches the designated position inside the blood vessel 7. After reaching the designated ablation position, the balloon 6 is expanded by liquid or gas to be slightly larger than the inner diameter of the blood vessel and abuts against the blood vessel wall 8. The imaging element 3 can acquire image information of the target area, which is the area corresponding to the target nerve tissue 9.

[0063] In some embodiments, the inner tube includes a cable cavity with a preset cable hole for laying a first communication cable, which connects the host computer and the imaging element. The outer tube has arc-shaped notches corresponding to the number of array elements, forming cable laying areas. Each cable laying area is used to lay a second communication cable between the array element and the host computer. The arc-shaped notches facilitate the laying of the second communication cable while also helping to suppress the rotation of the array elements fixedly connected to the second communication cable.

[0064] For example Figure 6 The diagram shows a cross-sectional view of the second specific targeted ablation device. This diagram represents the cross-section of the outer tube 1. The inner tube 2 may include a cable cavity 12 with a pre-set cable hole. The cable cavity 12 is used to lay a first communication cable, which connects the host computer and the imaging element 3, enabling the imaging element 3 to receive signals sent by the host computer and perform imaging. For example... Figure 7The diagram shows a specific arrangement of imaging elements. The cable cavity 12 of the inner tube extends to the tip of the balloon. The non-cable cavity portion of the inner tube 2 of the balloon needs to be recessed and sunken at the distal end to accommodate the imaging element 3. The first communication cable 13 passes through a pre-set cable hole to connect with the imaging element 3. For example... Figure 8 The diagram shows a cross-sectional view of the third specific targeted ablation device. The diagram is a cross-section of the outer tube 1. The inner tube 2 contains both a cable cavity 12 and an inner cavity 11. The cable cavity 12 is used to lay the first communication cable, and the inner cavity 11 is a liquid inflow cavity.

[0065] The outer tube has arc-shaped notches corresponding to the number of array elements. These notches form a cable routing area for laying the second communication cable between the array elements and the host. Specifically, the second communication cable connects the array elements and the host through these arc-shaped notches. For example... Figure 9 The diagram shows a specific array element communication cable layout. The second communication cable 14 of the array element is connected to the host 15 to realize communication between the array element 4 and the host 15, and to add the power output by the host 15 to the array element 4 so that the array element 4 can work.

[0066] The pre-drilled cable holes in the cable cavity, the connection between the first communication cable and the imaging element, the connection between the second communication cable and the array element, the outer surface of the first communication cable, and the outer surface of the second communication cable are all coated with an insulating material layer. In other words, the solder joints and exposed metal wires in the targeted ablation device are insulated with UV glue, and the drilled holes are also filled with UV glue to prevent liquid from flowing into the cable cavity. Furthermore, the second communication cable is fixed at the arc-shaped notch with an adhesive layer to prevent the second communication cable from tangling or knotting during use.

[0067] The ablation element consists of a ceramic transducer with an inner piezoelectric ceramic material layer and an outer matching layer. The inner layer has an inner electrode electrically connected to the shielding layer of the second communication cable, and the outer layer has an outer electrode electrically connected to the signal layer of the second communication cable. The ablation element comprises multiple ceramic transducers. The inner layer of the ceramic sheet is made of piezoelectric material, and the outer layer is a matching layer. The ceramic sheets are arranged circumferentially, and both the inner and outer surfaces of the ceramic sheets have electrodes, called the inner and outer electrodes, which are electrically connected to the shielding layer and signal layer of the cable, respectively. The host excites the corresponding ceramic transducer to ablate the target area. The host circuit provides tens of watts of electrical power to each ceramic transducer, which converts the electrical signal into ultrasonic waves that are absorbed by the tissue, raising the temperature of the surrounding nerve tissue and causing nerve cell necrosis. Each array element is connected to the host circuit via a second communication cable. Array elements can be independent of each other, and array elements can be independently addressed and controlled. Multiple array elements can also be connected together, and all array elements can be grounded. The array element gating circuit controls whether the plate transducer array element is excited or turned off.

[0068] The targeted ablation device also includes a display screen that presents image information of the target area acquired by the imaging element. The display screen is also used to display target point capture markers and / or target point information. In addition to displaying image information of the target area, the display screen may also display one or more target point capture markers. These markers are typically visual aids used to help users identify, locate, or select specific points or regions in the image. Besides the target point capture markers, the display screen may also display target point information related to the target point. This information may include data about the target point's coordinates, size, color, or other attributes, or other important information associated with the target point, such as identification results, analysis results, or user notes.

[0069] On the other hand, this application also includes a control method based on a targeted ablation device.

[0070] See Figure 10 As shown in the figure, this application discloses a control method based on a targeted ablation device, wherein the targeted ablation device is the aforementioned targeted ablation device, and the control method includes:

[0071] Step S11: The distal end of the catheter body is pushed to the target area.

[0072] In a specific targeted ablation scenario, the targeted ablation device includes a catheter body, an imaging element, and an ablation element. The catheter includes an outer tube and a rotatable inner tube. The outer tube is located outside the inner tube. The imaging element and the ablation element are axially separated and connected to the distal end of the inner tube. The ablation element includes a blocking element and multiple array elements. The blocking element is connected to the inner tube, and the multiple array elements are connected to the blocking element and are evenly distributed along the circumference of the inner tube. That is, different array elements correspond to different working angles to ablate target points at different angles. The catheter body is pushed in the balloon in a contracted state, so that the distal end of the catheter body is pushed to the target area, such as to the target location of the target blood vessel, such as entering the renal artery to ablate the sympathetic nerves on the renal artery.

[0073] Step S12: The imaging element receives the torque transmitted by the inner tube and rotates synchronously to acquire image information of the target area. At the same time, the blocking member isolates the torque transmitted by the inner tube to the array element so that the array element remains stationary relative to the target area.

[0074] The imaging element can receive the torque transmitted by the inner tube and rotate synchronously. That is, the imaging element rotates with the inner tube to obtain image information of the target area. The outer surface of the inner tube has a groove arranged circumferentially with its axis as the center. The blocking component includes a seat and a rolling component disposed in the groove. The rolling component is used to reduce the coefficient of friction and / or contact area between the inner tube and the blocking component. The array element is connected to the seat, so the array element does not rotate with the inner tube. That is, the blocking component isolates the torque transmitted from the inner tube to the array element so that the array element remains stationary relative to the target area. It is important to note that the imaging element and the array elements will move along the axial direction of the inner tube. For example, for a certain target area, after the imaging element rotates and acquires the image information of the target area, the catheter body needs to be moved so that the target area is within the radial range of the ablation element. During this process, the imaging element and the ablation element move synchronously when the catheter body is moved. In addition, during the process of moving from the current target area to another target area, the movements (movement, rotation, and torsion, etc.) of the outer and inner tubes due to the patient's physiological curvature or the operator's drive are selectively transmitted to the array elements. That is, the movement of the distal end of the entire catheter body from the current target area to another target area can drive the synchronous movement of the imaging element and the ablation element.

[0075] In some embodiments, the outer surface of the inner tube is machined with a number of arc-shaped grooves, which cooperate with the arc-shaped grooves on the inner surface of the seat to place the rolling component. The inner tube transmits torque to the rotation of the rolling component. The seat should be made of a rigid material with high density, such as W18Cr4V, chromium steel and other metal materials. The inner tube is made of a material with good bending performance, such as stainless steel, nickel-titanium alloy and other materials. The material density of the seat is greater than that of the inner tube of the balloon, so as to ensure that the seat should provide a radial force to the inner tube to press the rolling component.

[0076] In some embodiments, before the imaging element receives the torque transmitted by the inner tube and rotates synchronously, the method further includes: selecting an array element whose angle matches the initial angle of the imaging element from among the plurality of array elements as a reference array element, and determining the array element number and deflection angle of each array element based on the reference array element. The initial angle of the imaging element is not the initial angle at which the catheter body begins to enter the human body, but rather the initial angle of the imaging element when imaging begins for a target area. Selecting an array element whose angle matches the initial angle of the imaging element from among the plurality of array elements as a reference array element, and determining the array element number and deflection angle of each array element based on the reference array element, for example, the array element number and deflection angle of the reference array element are (1, 0°), and then determining the array element number and deflection angle of each array element clockwise or counterclockwise from the reference array element, respectively (2, 360 / N°)...(N, 360*(N-1) / N), where N represents the total number of array elements. In this way, the array element number and deflection angle of each array element are determined.

[0077] Step S13: Obtain the orientation information of the target point based on the image information, select the corresponding array element as the working array element from the multiple array elements of the ablation element, and send an excitation signal to the working array element to control the working array element to emit energy towards the target point to achieve targeted ablation.

[0078] In this embodiment, selecting a corresponding array element as a working array element from multiple array elements of the ablation element includes: obtaining target point orientation information based on the image information; wherein, the target point orientation information includes the target point deflection angle; selecting the deflection angle close to the target point deflection angle from the deflection angles of each array element as the target deflection angle, and determining the array element corresponding to the target deflection angle among the multiple array elements as the working array element.

[0079] The target orientation information is obtained based on the image information. The target orientation information includes the target deflection angle. The target deflection angle can characterize the angle by which the imaging element rotates from the initial angle until it reaches the working angle corresponding to the tissue to be ablated. The deflection angle that is close to the target deflection angle is selected from the deflection angles of each array element as the target deflection angle, and the array element that corresponds to the target deflection angle among multiple array elements is determined as the working array element. The deflection angle that is close to the target deflection angle can be one or multiple, which can be set according to the specific scenario.

[0080] For example, if the target deflection angle is 36°, and the deflection angle of element number 4 is 30° and the deflection angle of element number 5 is 40°, it can be understood that because the working angles of elements numbered 4 and 5 are close to the target deflection angle of 36°, both 30° and 40° can be identified as the target deflection angles, and elements numbered 4 and 5 are considered working elements. Similarly, if the target deflection angle is 70°, and the deflection angle of element number 8 is 70°, it can be understood that because the working angle of element number 8 corresponds to the target deflection angle of 70°, both 70° can be identified as the target deflection angles, and element number 8 is considered a working element.

[0081] For example Figure 11 The diagram shows a specific working element excitation schematic. The targeted ablation device is located inside the corresponding blood vessel wall 8. The imaging element emits ultrasound waves to image the surrounding tissue outside the blood vessel, identifies dense sympathetic nerves, and selects the working element 41 in that direction to excite the nerve tissue 9 according to the position of the nerve tissue 9 in the circumferential direction when the balloon 6 is inflated, thereby achieving targeted excitation of the nerve tissue 9.

[0082] In some embodiments, sending an excitation signal to the working array element includes: pushing the catheter body in the axial direction according to the axial distance between the imaging element and the ablation element, so that the current ablation element is coplanar with the target region, and then sending an excitation signal to the working array element on the ablation element. The imaging element and the ablation element are axially separated and connected to the distal end of the inner tube, for example, the axial distance between the imaging element and the ablation element is δ mm. When sending the excitation signal to the working array element, the catheter body is first pushed δ mm in the axial direction so that the target region is within the ablation range of the ablation element. The ablation range generally includes the radial range of the ablation element, so that the ablation element is aligned with the target region. Then, an excitation signal is sent to the working array element on the ablation element. In this way, the working array element is not only aligned with the target region in orientation, but also minimizes the distance to the target region, reduces energy loss, and facilitates targeted ablation.

[0083] In some embodiments, to better protect non-target tissues, especially the vessel wall, from damage, the targeted ablation device further includes a balloon. The balloon surrounds the distal end of the catheter body, and the gap between the inner and outer tubes, as well as the lumen of the inner tube, communicate with the lumen of the balloon to allow for the flow of liquid medium. The lumen of the balloon can switch between a contracted state and an inflated state according to the volume change of the liquid medium. After the distal end of the catheter body is pushed to the target area, liquid is then injected into the lumen of the balloon through the lumen of the inner tube and circulated, causing the balloon to inflate and adhere to the vessel wall. The circulation of liquid lowers the temperature of the vessel wall, preventing thermal necrosis of the vessel wall tissue.

[0084] To achieve both a contracted and inflated balloon state, a liquid inflow chamber and a liquid outflow chamber are required. The inner lumen of the inner tube serves as the liquid inflow chamber, allowing liquid to flow into the inner lumen of the balloon. The gap between the inner and outer tubes acts as the liquid outflow chamber, enabling liquid to drain from the balloon. This achieves liquid flow within the balloon. The aforementioned embodiment is merely one example; it is understood that the liquid inflow and outflow paths are reversed. Furthermore, the temperature of liquid flowing into the balloon is typically lower than the temperature of liquid exiting the balloon, thereby reducing the heat generated by ablation on non-target areas and minimizing ablation damage to non-target tissues.

[0085] Furthermore, embodiments of this application also provide an electronic device. Figure 12 This is a structural diagram of an electronic device 20 according to an exemplary embodiment. The content of the diagram should not be construed as limiting the scope of this application.

[0086] Figure 12This is a schematic diagram of the structure of an electronic device provided in an embodiment of this application. Specifically, it may include: at least one processor 21, at least one memory 22, a power supply 23, a communication interface 24, an input / output interface 25, and a communication bus 26. The memory 22 stores a computer program, which is loaded and executed by the processor 21 to implement the relevant steps in the control method based on a targeted ablation device performed by the electronic device disclosed in any of the foregoing embodiments.

[0087] In this embodiment, the power supply 23 is used to provide operating voltage for various hardware devices on the electronic device; the communication interface 24 can create a data transmission channel between the electronic device and external devices, and the communication protocol it follows can be any communication protocol applicable to the technical solution of this application, and is not specifically limited here; the input / output interface 25 is used to acquire external input data or output data to the outside world, and its specific interface type can be selected according to specific application needs, and is not specifically limited here.

[0088] The processor 21 may include one or more processing cores, such as a quad-core processor or an octa-core processor. The processor 21 may be implemented using at least one hardware form selected from DSP (Digital Signal Processing), FPGA (Field-Programmable Gate Array), and PLA (Programmable Logic Array). The processor 21 may also include a main processor and a coprocessor. The main processor, also known as a CPU (Central Processing Unit), is used to process data in the wake-up state; the coprocessor is a low-power processor used to process data in the standby state. In some embodiments, the processor 21 may integrate a GPU (Graphics Processing Unit), which is responsible for rendering and drawing the content to be displayed on the screen. In some embodiments, the processor 21 may also include an AI (Artificial Intelligence) processor, which is used to handle computational operations related to machine learning.

[0089] In addition, the memory 22, as a carrier for resource storage, can be a read-only memory, random access memory, disk or optical disk, etc. The resources stored on it include operating system 221, computer program 222 and data 223, etc., and the storage method can be temporary storage or permanent storage.

[0090] The operating system 221 manages and controls the various hardware devices and computer programs 222 on the electronic device to enable the processor 21 to perform calculations and processing on the massive amounts of data 223 in the memory 22. The operating system can be Windows, Unix, Linux, etc. The computer program 222, in addition to including a computer program capable of performing the control method based on the targeted ablation device executed by the electronic device as disclosed in any of the foregoing embodiments, may further include computer programs capable of performing other specific tasks. The data 223 may include data received by the electronic device from external devices, as well as data collected by its own input / output interface 25.

[0091] Furthermore, this application also discloses a computer-readable storage medium for storing a computer program; wherein, when the computer program is executed by a processor, it implements the aforementioned control method based on a targeted ablation device. Specific steps of this method can be found in the corresponding content disclosed in the foregoing embodiments, and will not be repeated here.

[0092] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the apparatus disclosed in the embodiments, since it corresponds to the method disclosed in the embodiments, the description is relatively simple; relevant parts can be referred to in the method section.

[0093] Those skilled in the art will further recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, computer software, or a combination of both. To clearly illustrate the interchangeability of hardware and software, the components and steps of the various examples have been generally described in terms of functionality in the foregoing description. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application. The steps of the methods or algorithms described in conjunction with the embodiments disclosed herein can be implemented directly in hardware, software modules executed by a processor, or a combination of both. The software module may be located in random access memory (RAM), memory, read-only memory (ROM), electrically programmable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), register, hard disk, removable disk, CD-ROM (Compact Disc Read-Only Memory), or any other form of storage medium known in the art.

[0094] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0095] The control method, apparatus, device, and medium based on a targeted ablation device provided in this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A targeted ablation device, characterized by, The application relates to a targeted ablation device, comprising: a catheter body, comprising an outer tube and a rotatable inner tube, the outer tube being arranged outside the inner tube; an imaging element, having a working surface arranged radially towards the catheter body, the working surface being used for emitting and receiving signals; an ablation element, comprising a plurality of independently addressable and controllable array elements, the array elements being capable of being excited to send energy to a target area; the imaging element and the ablation element being connected axially separately at the distal end of the inner tube, the ablation element further comprising a barrier connected to the inner tube, the plurality of array elements being connected to the barrier and being uniformly distributed along the circumference of the inner tube; the imaging element being capable of receiving torque transmitted by the inner tube to rotate and acquire image information of the target area, the barrier isolating the torque transmitted by the inner tube to the array elements to keep each array element stationary relative to the target area.

2. The targeted ablation device of claim 1, wherein, One of the plurality of array elements is configured to have an angle consistent with the initial angle of the imaging element.

3. The targeted ablation device of claim 1, wherein, Further comprising a control unit connected to the proximal end of the catheter body, the control unit comprising a recording module for storing initial angle information of the imaging element and / or information of the array element having an angle consistent with the initial angle of the imaging element.

4. The targeted ablation device of claim 3, wherein, The recording module comprises a code disc connected to the proximal end of the inner tube, the code disc being capable of recording the initial angle information of the imaging element.

5. The targeted ablation device of claim 3, wherein, The recording module is further used for storing angle information of each array element and / or quantity information of the array elements.

6. The targeted ablation device of claim 1, wherein, When the array elements are kept stationary relative to the target area, the rotation angle of the imaging element relative to the target area is N*360 degrees as the inner tube rotates, wherein N represents an integer greater than or equal to 1.

7. The targeted ablation device of claim 1, wherein, The outer surface of the inner tube has a groove arranged circumferentially around the axis thereof, the barrier comprises a seat body and a rolling component arranged in the groove, the rolling component being used for reducing the friction coefficient and / or contact area between the inner tube and the barrier, the array elements being connected to the seat body; The barrier transmits the axial movement of the inner tube to the array elements and isolates the torque transmission of the inner tube to the array elements.

8. The targeted ablation device of claim 7, wherein, The inner surface of the seat body of the barrier is provided with a plurality of recesses, the rolling component being placed in the gap between the recesses and the groove, the rolling component rolling in the gap as the inner tube rotates.

9. The targeted ablation device of any of claims 1-8, wherein, Further comprising a balloon arranged around the distal end of the catheter body, the gap between the inner tube and the outer tube and the inner cavity of the inner tube being in communication with the inner cavity of the balloon for liquid medium to flow, the inner cavity of the balloon being capable of switching to a contracted state or an expanded state as the volume of the liquid medium changes.

10. The targeted ablation device according to any one of claims 1-8, wherein: the inner tube comprises a cable cavity provided with a preset cable hole, the cable cavity being used for arranging a first communication cable, the first communication cable being connected between a host and the imaging element; the outer tube is provided with a plurality of arc-shaped notches consistent with the number of the array elements, the arc-shaped notches constituting cable arrangement zones, each cable arrangement zone being used for arranging a second communication cable between the array elements and the host.

11. The targeted ablation device of any of claims 1-8, wherein, The display screen is further configured to display a target point capture mark and / or target point information.

Images