Ablation catheter and ablation device

Abstract

Provided in embodiments of the present application are an ablation catheter and an ablation device, which belong to the field of ablation technologies. The ablation catheter comprises a catheter, a balloon, and an ultrasonic ablation assembly, wherein the catheter is provided with a fluid cavity; the balloon is arranged at the distal end of the catheter, and the balloon is capable of receiving a medium in the fluid cavity to switch between a contraction state and an expansion state; the ultrasonic ablation assembly is arranged at the distal end of the catheter and located in the balloon, and the ultrasonic ablation assembly is electrically connected to a control part and used for performing ultrasonic ablation on an ablation region. A constraining wire is arranged between the catheter and the distal end of the balloon, and the constraining wire is located on an outer peripheral side of the balloon. When the balloon is in the expansion state, the balloon expands outward, and the constraining wire comes into contact with the outer surface of the balloon and provides a constraint force to the balloon, so as to extrude the outer surface of the balloon to form a groove. According to this ablation catheter, during ultrasonic ablation, the balloon may not block the flow of liquid in the lumen, such as blood within a blood vessel, thereby reducing the risk of damage to the tissue of the posterior organ and improving the ablation efficiency.

Description

ablation catheters and ablation devices

[0001] Cross-references to related applications

[0002] This application claims priority to Chinese Patent Application No. 202510110821.9, filed on January 23, 2025, entitled “Ablation Catheter and Ablation Device”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of ablation technology, and more specifically, to an ablation catheter and ablation device. Background Technology

[0004] Currently, ultrasound ablation technology utilizes the ability of ultrasound waves to pass through human tissue and focus on a specific target area. By concentrating energy to a sufficient intensity, the focal area reaches an instantaneous high temperature, destroying the target tissue. Histopathologically, this manifests as coagulative necrosis, thus achieving the goal of destroying the lesion area while leaving surrounding tissue undamaged. Most ultrasound ablation catheters use metal or polymer balloons as the tip component. Metal tips are relatively rigid and cannot adapt to the natural cavities of the body, easily causing scratches. Existing balloons, when fully inflated, completely block cavities. If the ablation process is prolonged, this can cause organs and tissues downstream to be in a state of obstruction for extended periods, preventing sufficient oxygen and nutrient supply and potentially causing irreversible damage in severe cases. Summary of the Invention

[0005] This application provides an ablation catheter and ablation device. During ultrasound ablation, the balloon does not block the flow of fluid in the cavity, such as blood in blood vessels, reducing the risk of damage to downstream organs and tissues and improving ablation efficiency.

[0006] In a first aspect, embodiments of this application provide an ablation catheter, which includes a catheter, a balloon, and an ultrasonic ablation assembly. The catheter has a fluid cavity; the balloon is disposed at the distal end of the catheter and is capable of receiving media within the fluid cavity to switch between a contracted state and an inflated state; the ultrasonic ablation assembly is disposed at the distal end of the catheter and located within the balloon, and is electrically connected to a control unit for performing ultrasonic ablation on the ablation area; wherein a constraint wire is disposed between the distal ends of the catheter and the balloon, and the constraint wire is located on the outer periphery of the balloon; when the balloon is in an inflated state, the balloon expands outward, and the constraint wire contacts the outer surface of the balloon and provides a constraint force to the balloon, thereby compressing and forming a groove on the outer surface of the balloon.

[0007] In this design, a fluid cavity is provided within the catheter, which communicates with the interior of the balloon. The fluid cavity allows media to enter and exit the balloon, enabling the balloon to switch between inflated and contracted states. During the actual ablation process, the ablation catheter is inserted into a natural body cavity, such as the ablation area of ​​a blood vessel. Media enters the balloon, and under continuous pressure from the media, the balloon gradually inflates, switching from a contracted to an inflated state. The balloon then contacts the inner wall of the blood vessel. The ultrasound ablation component is located inside the balloon. This component uses sound waves to focus on the corresponding ablation area of ​​the blood vessel, which could be, for example, nerves surrounding the blood vessel. The ultrasound energy penetrates the vessel wall and reaches the nerve, achieving ultrasound ablation. By placing a constraint wire on the outer periphery of the balloon, during inflation, the constraint area where the balloon contacts the constraint wire is restricted, while the non-constraint area expands naturally. This creates grooves in the constraint area under the compression of the constraint wire. The non-constraint area of ​​the balloon adheres normally to the inner wall of the blood vessel, while the area enclosed between the groove and the inner wall of the blood vessel forms a channel for blood flow, maintaining smooth blood flow without blocking it and minimizing adverse effects on tissues and organs at the rear of the balloon. Simultaneously, the duration of a single ultrasound ablation session in the ablation area can be freely controlled, offering high controllability and higher ablation efficiency. The ablation time is not limited by balloon-induced blood blockage, preventing short single ablation sessions or repeated ablation of the same area. Furthermore, during ultrasound ablation, the grooves on the balloon allow normal blood flow, which carries away some heat from the ablation area, increasing the cooling rate and reducing the risk of temperature runaway due to excessively rapid local heating.

[0008] In some embodiments, the number of constraint wires is multiple, and the multiple constraint wires are distributed at intervals along the circumference of the balloon.

[0009] In the above technical solution, by setting the number of constraint wires to multiple, when the balloon is inflated, the multiple constraint wires will act on different positions in the circumferential direction of the balloon, and form multiple grooves with intervals in the circumferential direction of the balloon. The formation of multiple grooves can ensure a larger blood flow area and a larger flow area, and the balloon has less impact on blood blockage.

[0010] In some embodiments, the ablation catheter further includes a tip, which is disposed at the distal end of the balloon, and the end of the restraint wire away from the catheter is connected to the tip; a contrast agent is disposed on the tip.

[0011] In the above technical solution, a tip is provided at the distal end of the balloon, the distal end of the restraint wire is connected to the tip, and the proximal end is connected to the catheter. The restraint wire has a good fixation effect, and it can restrain the balloon after inflation. By providing a imaging component on the tip, the imaging component can achieve clear imaging of the distal end of the catheter under medical imaging equipment, so that doctors can accurately grasp the position and status of the catheter in the body.

[0012] In some embodiments, the balloon includes a body and two connecting portions located at both axial ends of the body, the two connecting portions being connected to a catheter and a tip, respectively; when the balloon is inflated, the cross-sectional shape of the body is petal-shaped.

[0013] In the above technical solution, when the balloon is inflated, the cross-sectional shape of the balloon is petal-shaped. Compared with a spherical balloon, the petal-shaped balloon has a larger contact area with the inner wall of the blood vessel along the axial direction of the balloon, providing better support for the blood vessel and facilitating the ultrasonic ablation of the ultrasonic ablation component.

[0014] In some embodiments, the ablation catheter further includes a central wire, the proximal end of which passes through the catheter and is connected to the handle, and the distal end of which is connected to the tip. The central wire is used for mounting the ultrasound ablation assembly and is coaxial with the central axis of the balloon.

[0015] In the above technical solution, the central wire is used to install the ultrasound ablation component inside the balloon, and the central wire is coaxial with the central axis of the balloon. The ultrasound ablation component is located on the central line of the balloon. When the balloon is inflated and adheres to the inner wall of the blood vessel, the ultrasound ablation component is always located in the center of the blood vessel. By rotating the central wire or rotating the tip, the ultrasound ablation component can be oriented towards different positions in the circumferential direction of the inner wall of the blood vessel, and the focal point of the ultrasound ablation component always corresponds to the ablation area of ​​the blood vessel, so as to achieve 360° all-round ablation.

[0016] In some embodiments, the ultrasonic ablation assembly includes a substrate and two ultrasonic transducers, the substrate being connected to a central wire; the two ultrasonic transducers are spaced apart on the substrate along the axial direction of the central wire, the angles formed by the two ultrasonic transducers and the central axis of the central wire are equal, and the two ultrasonic transducers are facing each other toward the side away from the central wire.

[0017] In the above technical solution, two pairs of ultrasonic transducers are arranged symmetrically facing each other about the cross-section of the balloon, and the ultrasonic transducers form an angle with the central axis of the catheter and the angles are equal. The two ultrasonic transducers cooperate with each other, and the focal point of the energy transmitted by the two ultrasonic transducers corresponds to the ablation area of ​​the blood vessel. They do not ablate other areas outside the ablation area of ​​the blood vessel, thus realizing ultrasonic ablation of the ablation area of ​​the blood vessel.

[0018] In some embodiments, the ablation catheter further includes a monitoring component disposed on the outer surface of the balloon, the monitoring component being used to monitor the balloon's wall pressure and / or temperature information.

[0019] In the above technical solution, a monitoring component is provided on the outer surface of the balloon. The monitoring component can monitor the wall-attaching pressure of the balloon and determine whether the balloon has completed wall-attaching; and / or, the monitoring component can monitor the temperature of the ablation area and transmit the data to the control unit to complete the real-time monitoring of the temperature of the ablation area.

[0020] In some embodiments, the monitoring component includes, from the outside to the inside, a first insulating layer, a temperature-sensitive resistor layer, a second insulating layer, a first electrode sheet layer, a sensitive elastomer layer, a second electrode sheet layer, and a substrate layer stacked sequentially; the temperature-sensitive resistor layer is electrically connected to the control unit via a first wire to monitor the temperature information of the ablation area; the first electrode sheet layer and the second electrode sheet layer are electrically connected to the control unit via a second wire to monitor the pressure information of the balloon adhering to the wall.

[0021] In the above technical solution, the monitoring component includes a first insulating layer, a temperature-sensitive resistor layer, a second insulating layer, a first electrode layer, a sensitive elastomer layer, a second electrode layer, and a base layer. That is, the monitoring component is a laminated monitoring component integrating pressure and temperature monitoring functions. The first insulating layer is the outermost layer that contacts the inner wall of the blood vessel, serving to insulate it from the inner wall and protect the blood vessel. The second insulating layer isolates the temperature-sensitive resistor layer, ensuring its accuracy. The temperature-sensitive resistor layer is electrically connected to the handle via a first wire. During the ablation process, when a temperature change is detected, the resistance of the temperature-sensitive resistor layer changes, and this change is transmitted to the handle via a current signal, thus enabling temperature monitoring of the ablation area. The first and second electrode layers work together to form a capacitive sensor, which monitors the adhesion force of the balloon to the wall. The sensitive elastomer layer is positioned between the first and second electrode layers, providing support and allowing for deformation.

[0022] In some embodiments, the monitoring components are disposed on the outer surface of the balloon and located between two adjacent constraint wires. Multiple monitoring components are provided, and these components are spaced apart along the circumferential and / or axial direction of the balloon.

[0023] In the above technical solution, the monitoring component is placed in the area between two adjacent constraint wires on the balloon. This way, when the balloon is inflated, the monitoring component is located on the outer surface of the unconstrained area of ​​the balloon, making it easier to contact the inner wall of the blood vessel, thus achieving monitoring of balloon adhesion and temperature in the ablation area. By using multiple monitoring components distributed along the circumference and / or axial direction of the balloon, pressure and temperature can be measured at different points along the circumference and / or axial direction, effectively monitoring balloon adhesion and temperature in all directions, making balloon adhesion monitoring more accurate and reliable.

[0024] Secondly, this application also provides an ablation device, which includes a control unit and an ablation catheter of any of the foregoing embodiments, and the ultrasonic ablation component is electrically connected to the control unit via a wire.

[0025] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 is a schematic diagram of the structure of the ablation catheter provided in some embodiments of this application;

[0028] Figure 2 is a schematic diagram of the distal end of the catheter in Figure 1;

[0029] Figure 3 is a schematic diagram of the structure of the balloon in the ablation catheter provided in some embodiments of this application, in which the balloon is engaged with the constraint wire in the inflated state;

[0030] Figure 4 is a side view of the ablation catheter provided in some embodiments of this application;

[0031] Figure 5 is a schematic diagram of the structure of the ultrasonic ablation component in the ablation catheter provided in some embodiments of this application;

[0032] Figure 6 is a cross-sectional view of the monitoring component in an ablation catheter provided in some embodiments of this application;

[0033] Figure 7 is a cross-sectional view of the catheter in the ablation catheter provided in some embodiments of this application.

[0034] Icons: 100-Ablation catheter; 10-Catheter; 11-Fluid cavity; 111-Inlet cavity; 112-Outlet cavity; 20-Balloon; 21-Body; 22-Connector; 23-Groove; 30-Tip; 40-Constraint wire; 50-Ultrasonic ablation assembly; 51-Substrate; 52-Ultrasonic transducer; 60-Imaging component; 70-Center wire; 80-Monitoring component; 81-First insulating layer; 82-Temperature-sensitive resistor layer; 83-Second insulating layer; 84-First electrode sheet; 85-Sensitive elastomer layer; 86-Second electrode sheet; 87-Base layer; 90-Handle. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, 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. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0036] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0037] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0038] In the description of the embodiments of this application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on this application. In addition, the terms "first," "second," "third," etc. are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0039] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up" and "connected" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0040] When a balloon stent is placed in the ablation area of ​​a natural body cavity, the balloon, upon full inflation, contacts the inner wall of the cavity, completely sealing it. However, if the ablation process is prolonged, it can cause organs and tissues downstream of the patient to remain blocked for an extended period, preventing adequate oxygen and nutrient supply and potentially leading to irreversible damage in severe cases.

[0041] In view of this, this application provides an ablation catheter. Referring to Figures 1 to 7, the ablation catheter 100 includes a catheter 10, a balloon 20, and an ultrasonic ablation assembly 50. The catheter 10 has a fluid cavity 11. The balloon 20 is disposed at the distal end of the catheter 10 and can receive the medium in the fluid cavity 11 to switch between a contracted state and an expanded state. The ultrasonic ablation assembly 50 is disposed at the distal end of the catheter 10 and located inside the balloon 20. The ultrasonic ablation assembly 50 is electrically connected to a control unit and is used to perform ultrasonic ablation on the ablation area. A constraint wire 40 is disposed between the distal end of the catheter 10 and the balloon 20 and is located on the outer periphery of the balloon 20. When the balloon 20 is in the expanded state, the balloon 20 expands outward, and the constraint wire 40 contacts the outer surface of the balloon 20 and provides a constraint force to the balloon 20 to compress and form a groove 23 on the outer surface of the balloon 20.

[0042] In this design, a fluid cavity 11 is provided within the catheter 10, which communicates with the interior of the balloon 20. The fluid cavity 11 allows the medium to enter and exit the balloon 20, enabling the balloon 20 to switch between an inflated and a contracted state. During the actual ablation process, the ablation catheter 100 is inserted into a natural body cavity, such as the ablation area of ​​a blood vessel. The medium enters the balloon 20, and under continuous pressure from the medium, the balloon 20 gradually inflates, switching from a contracted to an inflated state. The balloon 20 contacts the inner wall of the blood vessel. The ultrasound ablation component 50 is located within the balloon 20. The ultrasound ablation component 50 uses sound waves to focus on the corresponding ablation area of ​​the blood vessel, which may be, for example, the nerve surrounding the blood vessel. The ultrasound energy penetrates the blood vessel wall and reaches the nerve, achieving ultrasound ablation. By placing a constraint wire 40 on the outer periphery of the balloon 20, during inflation, the constraint area of ​​the balloon 20 in contact with the constraint wire 40 is restricted by the constraint wire 40, while the non-constraint area of ​​the balloon 20 not in contact with the constraint wire 40 expands naturally. This causes the constraint area of ​​the balloon 20 in contact with the constraint wire 40 to form a groove 23 under the compression of the constraint wire 40. The non-constraint area of ​​the balloon 20 normally adheres to the inner wall of the blood vessel, while the area enclosed between the groove 23 and the inner wall of the blood vessel forms a channel for blood flow, maintaining smooth blood flow without blocking blood flow and minimizing adverse effects on the tissues and organs at the rear end of the balloon 20. Simultaneously, the time for a single ultrasound ablation of the ablation area can be freely controlled, offering strong controllability and higher ablation efficiency. The ablation time is not limited by the balloon 20 blocking blood flow, resulting in a short single ablation time or multiple repeated ablations of the same ablation area. Furthermore, during ultrasound ablation, the grooves 23 on the balloon 20 allow for normal blood flow. The flow of blood can carry away some of the heat from the ablation area of ​​the blood vessel, increasing the cooling rate of the ablation area and reducing the risk of temperature runaway due to excessively rapid local heating in the ablation area.

[0043] The body's natural cavities can be bronchi, bile ducts, esophagus, gastrointestinal tract, urinary and reproductive tracts, or blood vessels. Taking blood vessels as an example, refractory hypertension can be treated by ablation of the renal sympathetic nerves or the external carotid nerves; type 2 diabetes can be treated by ablation of nerves near the liver; and the function of metabolic organs can be affected by ablation of the sympathetic nerves that innervate internal organs such as the liver, pancreas, and gastrointestinal tract. In addition, pain can be relieved by ablation of nerves outside peripheral blood vessels.

[0044] The cavities in the following embodiments all use blood vessels as an example, and the application scenario is the ablation of renal sympathetic nerves to treat refractory hypertension. This is only to facilitate the understanding of the technology by those skilled in the art, and is 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 type of scenario, and those skilled in the art can directly apply it to multiple treatment scenarios under the instructions of the specification. Applying the technical solution of this application to multiple similar scenarios is within the protection scope and implementation method of this application.

[0045] The balloon 20 can have various shapes, such as spherical or cylindrical. The balloon 20 can be made of materials such as polyester fiber, polyamide fabric, polyurethane, silicone, or nylon.

[0046] In this embodiment, the balloon 20 is made of nylon. Nylon is one of the commonly used materials for making airbags. It has high tensile strength and can withstand greater pressure when the balloon 20 is inflated, ensuring that the balloon 20 plays a protective role at critical moments.

[0047] The medium can be of various types, but it is generally a fluid. The pressure inside the balloon 20 is easier to control compared to a gas. In this embodiment, the medium is physiological saline.

[0048] Referring to Figure 7, the fluid chamber 11 of the catheter 10 may include an inlet chamber 111 and an outlet chamber 112, with the balloon 20 communicating with both. The inlet chamber 111 and outlet chamber 112 are respectively connected to the inlet and outlet of an external water supply device for fluid circulation, allowing the balloon 20 to switch between inflated and contracted states. Fluid can be introduced into the balloon 20 through the external fluid supply device, causing the balloon 20 to continuously inflate until it reaches the inner wall of the blood vessel. During ultrasound ablation, the external fluid supply device maintains the current pressure and continuously supplies fluid through the inlet chamber of the catheter 10, ensuring the balloon 20 maintains the required size while also cooling the inside of the balloon 20. After entering the balloon 20 through the inlet chamber 111 of the catheter 10, the fluid is discharged through the outlet chamber 112 to a storage device (not shown) for recycling. It is understood that the catheter 10 can also be configured with other cavities as needed, which are not specifically limited here.

[0049] The ultrasonic ablation component 50 refers to a mechanism capable of performing ultrasonic ablation on ablation areas of natural cavities in the human body. Figure 2 illustrates the relationship between the ultrasonic ablation component 50 and the balloon 20. Figure 2 is a perspective view of the distal end of the catheter. The dotted line in Figure 2 indicates that the ultrasonic ablation component 50 is located inside the balloon 20. The working principle of the ultrasonic ablation component 50 is that the energy of the ultrasonic waves is focused on the ablation area of ​​the cavity, causing the ablation area of ​​the cavity to heat up, thereby achieving ultrasonic ablation.

[0050] The restraint wire 40 refers to the restraint component disposed between the proximal and distal ends of the balloon 20, extending along both the proximal and distal directions of the balloon 20. During balloon 20 inflation, the restraint wire 40 contacts the outer surface of the balloon 20, providing restraint and compression to prevent inflation in the area where the restraint wire 40 contacts the balloon 20, thereby forming a groove 23 on the outer surface of the balloon 20. This groove 23 forms a channel for blood flow between itself and the inner wall of the blood vessel, maintaining normal blood circulation.

[0051] The number of constraint wires 40 can be one or more, and the specific number of constraint wires 40 can be determined according to the actual situation. When there is only one constraint wire 40, when the balloon 20 is inflated, the constraint wire 40 can form a groove 23 on the outer surface of the balloon 20. When there are multiple constraint wires 40, the multiple constraint wires 40 can be distributed circumferentially around the balloon 20, and the multiple constraint wires 40 form multiple grooves 23 on the outer surface of the balloon 20, and the cross-sectional shape of the balloon 20 is approximately petal-shaped.

[0052] The control unit refers to the control component that can control the ultrasonic ablation assembly 50 to perform ultrasonic ablation. The ultrasonic ablation assembly 50 receives the corresponding output power from the control unit and releases ultrasonic waves of corresponding intensity, and heats up the ablation area within the energy focal range of the sound wave transmission.

[0053] In some embodiments, there are multiple constraint wires 40, which are distributed at intervals along the circumference of the balloon 20. By setting the number of constraint wires 40 to multiple, when the balloon 20 is inflated, the multiple constraint wires 40 will act on different positions in the circumference of the balloon 20, forming multiple spaced grooves 23 in the circumference of the balloon 20. The formation of multiple grooves 23 can ensure a larger blood flow area and a larger flow zone, and the balloon 20 has a smaller impact on blood flow obstruction.

[0054] The multiple constraint wires 40 are distributed at intervals along the circumference of the balloon 20, meaning that the multiple constraint wires 40 can be distributed at equal intervals or at unequal intervals along the circumference of the balloon 20.

[0055] When multiple constraint wires 40 are evenly distributed along the circumference of the balloon 20, the distribution of the action area of ​​the multiple constraint wires 40 on the balloon 20 is more uniform, the stress uniformity of the balloon 20 is better, the phenomenon of local stress concentration is less likely to occur, and the stability of the balloon 20 is better. As shown in Figures 3 and 4, in this embodiment, the number of constraint wires 40 is six, and the six constraint wires 40 are evenly distributed along the circumference of the balloon 20.

[0056] In some embodiments, the material of the constraint wire 40 includes at least one of nickel-titanium or polyethylene fiber.

[0057] In some embodiments, referring to Figures 1 and 2, the ablation catheter 100 further includes a tip 30, which is disposed at the distal end of the balloon 20. The end of the restraint wire 40 furthest from the catheter 10 is connected to the tip 30. A contrast-enhancing component 60 is disposed on the tip 30. By disposing the tip 30 at the distal end of the balloon 20, and connecting the distal end of the restraint wire 40 to the tip 30 and the proximal end to the catheter 10, the restraint wire 40 provides good fixation, effectively restraining the balloon 20 after inflation. The contrast-enhancing component 60 on the tip 30 enables clear visualization of the distal end of the catheter 10 under medical imaging equipment, allowing physicians to accurately determine the position and status of the catheter 10 within the body.

[0058] The tip 30 refers to the distal end of the ablation catheter 100. The tip 30 is used for the distal connection and fixation of the balloon 20. The balloon 20 is positioned between the distal end of the catheter 10 and the tip 30, and both axial ends of the balloon 20 are fixedly connected to the distal end of the catheter 10 and the tip 30, respectively. One end of the restraint wire 40 is fixedly connected to the tip 30, and the other end of the restraint wire 40 is fixedly connected to the catheter 10.

[0059] The imaging component 60 is made of a special material that can generate unique signals in the imaging mode, or can absorb imaging equipment to emit specific energy waves, etc. The imaging component 60 is a commonly used technology in interventional catheter 10 technology, so we will not go into too much detail about the imaging component 60 here.

[0060] In some embodiments, referring to Figures 2 and 3, the balloon 20 includes a body 21 and two connecting portions 22 located at both axial ends of the body 21. The two connecting portions 22 are respectively connected to the catheter 10 and the tip 30. When the balloon 20 is inflated, the cross-sectional shape of the body 21 is petal-shaped. When the balloon 20 is inflated, the petal-shaped cross-sectional shape of the balloon 20, compared to a spherical balloon 20, provides a larger contact area with the inner wall of the blood vessel along the axial direction of the balloon 20, providing better support for the blood vessel and facilitating ultrasonic ablation of the ultrasonic ablation component.

[0061] The connecting part 22 is tapered and is integrally formed with the body 21. The connecting part 22 has a large end and a small end in the axial direction. The large end of the connecting part 22 is connected to the body 21, and the small end of the connecting part 22 is connected to the end or the distal end of the conduit 10.

[0062] In some embodiments, referring to Figure 2, the ablation catheter 100 further includes a central wire 70. The proximal end of the central wire 70 passes through the catheter 10 and is connected to the handle 90, while the distal end of the central wire 70 is connected to the tip 30. The central wire 70 is used for mounting the ultrasound ablation component 50, and the central wire 70 is coaxially arranged with the central axis of the balloon 20. The central wire 70 allows the ultrasound ablation component 50 to be mounted inside the balloon 20, and the central wire 70 is coaxially arranged with the central axis of the balloon 20. The ultrasound ablation component 50 is located on the central line of the balloon 20. When the balloon 20 is inflated and adheres to the inner wall of the blood vessel, the ultrasound ablation component 50 is always located in the center of the blood vessel. By rotating the central wire 70 or rotating the tip 30, the ultrasound ablation component 50 can be oriented towards different positions in the circumferential direction of the inner wall of the blood vessel, and the focal point of the ultrasound ablation component 50 always corresponds to the ablation area of ​​the blood vessel, so as to achieve 360° all-round ablation.

[0063] However, this is not the only option. The center wire 70 and the balloon 20 can also be set off from the same axis. The specific position of the center wire 70 can be determined according to the actual situation.

[0064] In some embodiments, referring to Figures 2 and 5, the ultrasonic ablation assembly 50 includes a substrate 51 and two ultrasonic transducers 52. The substrate 51 is connected to a central wire 70. The two ultrasonic transducers 52 are spaced apart on the substrate 51 along the axial direction of the central wire 70. The angles formed by the two ultrasonic transducers 52 and the central axis of the central wire 70 are equal, and the two ultrasonic transducers 52 are arranged facing each other towards the side away from the central wire 70. The paired ultrasonic transducers 52 are symmetrically arranged facing each other with respect to the cross-section of the balloon 20, and the angles formed by the ultrasonic transducers 52 and the central axis of the catheter 10 are equal. The two ultrasonic transducers 52 cooperate with each other, and the focal point of the concentrated energy transmitted by the two ultrasonic transducers 52 corresponds to the ablation area of ​​the blood vessel, without ablating other areas outside the ablation area of ​​the blood vessel, thus realizing ultrasonic ablation of the ablation area of ​​the blood vessel. The ultrasonic transducer 52 is a device that converts electromagnetic energy into mechanical energy (acoustic energy). The two ultrasonic transducers 52 are electrically connected to the control unit through wires. It should be noted that the paired ultrasonic transducers 52 form an angle with the central axis of the catheter 10. The angles formed by the two ultrasonic transducers 52 and the central axis of the catheter 10 may be equal or unequal.

[0065] The angle α formed by the ultrasonic transducer 52 and the central axis of the central wire 70 can be 0° to 60°. Preferably, the angle α formed by the ultrasonic transducer 52 and the central axis of the central wire 70 is 30° to 60°.

[0066] Of course, in addition to being fixedly mounted on the substrate 51, the ultrasonic transducer 52 can also be rotatably mounted on the substrate 51 to adjust the set angle α in order to improve its applicability. Specifically, an additional guidewire (not shown in the figure) can be placed in the lumen of the catheter 10 and connected to the ultrasonic transducer 52. By pulling the guidewire, the ultrasonic transducer 52 can be rotated relative to the substrate 51, so that the set angle α can be freely adjusted within a certain angle range (e.g., 30-60°). It is understood that when the angle α changes, the focal point and focal area of ​​the two ultrasonic transducers 52 will change accordingly, thereby enabling adaptive adjustment according to different ablation locations of blood vessels to improve the applicability of the ablation catheter 100.

[0067] Furthermore, in this embodiment, adjusting the rotation of the ultrasonic transducer 52 by setting a guide wire is only one implementation method. In other embodiments, other adjustment structures can be adapted as needed to adjust the size of the set angle α, which is not specifically limited here.

[0068] Furthermore, the ultrasonic transducer 52 is movably disposed on the base plate 51 along the central axis of the catheter 10 to adjust the relative distance between the two ultrasonic transducers 52. Specifically, the ultrasonic transducer 52 is slidably disposed on the base plate 51. By placing an additional guidewire (not shown in the figure) within the lumen of the catheter 10 and connecting the guidewire to the ultrasonic transducer 52, the ultrasonic transducer 52 can be moved along the central axis of the catheter 10 by pulling the guidewire, thereby bringing the two ultrasonic transducers 52 closer to or further apart from each other, thus adjusting the distance between them. It is understood that when the distance between the two ultrasonic transducers 52 changes, the size of the ablation target area determined by them will also change accordingly, thus enabling adaptive adjustment according to different ablation locations of the blood vessel to improve the applicability of the ablation catheter 100.

[0069] Furthermore, the method of adjusting the movement of the ultrasonic transducer 52 by setting a guide wire in this embodiment is only one implementation method. In other embodiments, other adjustment structures can be adapted as needed to adjust the distance between the two ultrasonic transducers 52, which is not specifically limited here.

[0070] In some embodiments, the number of ultrasonic ablation components 50 is set to multiple, and the multiple ultrasonic ablation components 50 are distributed at intervals along the extension direction of the central wire 70. By setting the number of ultrasonic ablation components 50 to multiple, the multiple ultrasonic ablation components 50 can cooperate to ablate simultaneously or selectively, which can realize ultrasonic ablation of multiple ablation areas of the blood vessel in one go, and the ablation efficiency is higher.

[0071] When the number of ultrasonic ablation components 50 is set to multiple, each ultrasonic ablation component 50 is electrically connected to the control unit and is controlled independently. The control unit can control multiple ultrasonic ablation components 50 to work simultaneously, or it can control one or more of the multiple ultrasonic ablation components 50 to work, depending on the actual situation.

[0072] In some embodiments, referring to FIG2, the ablation catheter 100 further includes a monitoring component 80 disposed on the outer surface of the balloon 20. The monitoring component 80 is used to monitor the wall adhesion pressure and / or temperature information of the balloon 20. By providing the monitoring component 80 on the outer surface of the balloon 20, the monitoring component 80 can monitor the wall adhesion pressure of the balloon 20 to determine whether the balloon 20 has completed wall adhesion; and / or, the monitoring component 80 can monitor the temperature of the ablation area and transmit the data to the control unit to complete real-time monitoring of the temperature of the ablation area.

[0073] The monitoring component 80 can be a separate pressure monitoring component 80 or a temperature monitoring component 80. Of course, the monitoring component 80 can also be an integrated unit that combines pressure and temperature monitoring functions.

[0074] In some embodiments, referring to FIG6, the monitoring component 80 includes, from the outside to the inside, a first insulating layer 81, a temperature-sensitive resistor layer 82, a second insulating layer 83, a first electrode sheet layer 84, a sensitive elastomer layer 85, a second electrode sheet layer 86, and a base layer 87, which are stacked sequentially. The temperature-sensitive resistor layer 82 is electrically connected to the control unit through a first wire to monitor the temperature information of the ablation area. The first electrode sheet layer 84 and the second electrode sheet layer are electrically connected to the control unit through a second wire to monitor the pressure information of the balloon 20 adhering to the wall. The monitoring component 80 includes a first insulating layer 81, a temperature-sensitive resistor layer 82, a second insulating layer 83, a first electrode sheet layer 84, a sensitive elastomer layer 85, a second electrode sheet layer 86, and a base layer 87. That is, the monitoring component 80 is a laminated monitoring component 80 that integrates pressure and temperature monitoring functions. The first insulating layer 81 is the outermost layer of the monitoring component 80 that contacts the inner wall of the blood vessel. The first insulating layer 81 serves to insulate the monitoring component 80 from the inner wall of the blood vessel and protect the blood vessel. The second insulating layer 83 isolates the temperature-sensitive resistor layer 82, ensuring its accuracy. The temperature-sensitive resistor layer 82 is electrically connected to the handle 90 via a first wire. During ablation, when a temperature change is detected, the resistance of the temperature-sensitive resistor layer 82 changes, and this change is transmitted to the handle 90 via a current signal, thus enabling temperature monitoring of the ablation area of ​​the blood vessel. The first electrode layer 84 and the second electrode layer work together to form a capacitive sensor, which monitors the adhesion force of the balloon 20 to the wall. The sensitive elastomer layer 85 is disposed between the first electrode layer 84 and the second electrode layer 86, providing support and allowing for deformation.

[0075] Specifically, the working principle of the monitoring component 80 in monitoring pressure is as follows: the first electrode layer 84 and the second electrode layer work together to form a capacitive sensor. When no pressure is applied, the capacitance between the two electrode layers is C0. As the balloon 20 expands, the monitoring component 80 gradually adheres to the inner wall of the blood vessel, generating pressure. This pressure is transmitted to the first electrode layer 84 through the upper medium, causing displacement of the first electrode layer 84 and reducing the distance between the two electrode layers. This results in a change in capacitance from C0 to Cx. The capacitance Cx is used to express the pressure P value monitored by the monitoring component 80. The first electrode layer 84 and the second electrode layer are electrically connected to the handle 90, transmitting electrical signals to the handle 90. The sensitive elastomer layer 85 is located between the first electrode layer 84 and the second electrode layer, providing support and allowing for deformation.

[0076] The base layer 87 can be a flexible polymer material layer, which provides a base for the above layers. The first insulating layer 81, the temperature-sensitive resistor layer 82, the second insulating layer 83, the first electrode sheet layer 84, the sensitive elastomer layer 85, and the second electrode sheet layer 86 are all stacked on the base layer 87. Since the base layer 87 is a flexible material, it can change along with the expansion of the balloon 20.

[0077] The handle 90 is located at the proximal end of the conduit 10 and is electrically connected to the control unit.

[0078] In some embodiments, referring to Figure 2, the monitoring component 80 is disposed on the outer surface of the balloon 20 and located between two adjacent constraint wires 40. By disposing the monitoring component 80 in the area between two adjacent constraint wires 40 on the balloon 20, when the balloon 20 is inflated, the monitoring component 80 is located on the outer surface of the unconstrained area of ​​the balloon 20, making it easier to contact the inner wall of the blood vessel, thereby realizing the wall-adhesion monitoring of the balloon 20 and the temperature monitoring of the ablation area.

[0079] Along the axial direction of the balloon 20, the monitoring component 80 is disposed on the outer surface of the balloon 20 and located in the middle region between two adjacent constraint wires 40.

[0080] In some embodiments, the number of monitoring components 80 is set to multiple, and the multiple monitoring components 80 are distributed at intervals along the circumference and / or axial direction of the balloon 20. By setting the number of monitoring components 80 to multiple, and distributing the multiple monitoring components 80 along the circumference and / or axial direction of the balloon 20, the pressure and temperature at different points along the circumference and / or axial direction of the balloon 20 can be measured, and the wall adhesion and temperature of the balloon 20 in all directions can be effectively monitored, making the wall adhesion monitoring of the balloon 20 more accurate and reliable.

[0081] The distribution of multiple monitoring components 80 along the circumferential and / or axial direction of the balloon 20 means that the multiple monitoring components 80 can be distributed circumferentially, axially, or both, depending on the specific circumstances. In this embodiment, the multiple monitoring components 80 are distributed circumferentially and axially.

[0082] This application also provides an ablation device, which includes a control unit and an ablation catheter 100 of any of the foregoing embodiments, and an ultrasonic ablation component 50 is electrically connected to the control unit via a wire.

[0083] The control unit may include a main control module, a signal generator, a power amplifier, and a gating module. The main control module is used to process signals and data and control automated ablation; the signal generator is connected to the main control module and is used to receive and transmit ultrasound signals; the power amplifier is connected to the signal generator and is used to amplify the ultrasound signals; the gating module is connected to the power amplifier and is used to select the number of signal channels.

[0084] Of course, the control unit also includes a phase voltage and current module and an impedance matching module. The phase voltage and current module is connected to the main control module to detect parameters and output a matched ultrasonic frequency. The impedance matching module is connected to the main control module and is used to detect the matching impedance and output a matched power ultrasonic signal.

[0085] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0086] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An ablation catheter, characterized in that, include: A catheter with a fluid cavity; A balloon, disposed at the distal end of the catheter, is capable of receiving media within the fluid cavity to switch between a contracted state and an inflated state; An ultrasonic ablation component is disposed at the distal end of the catheter and located inside the balloon. The ultrasonic ablation component is electrically connected to the control unit and is used to perform ultrasonic ablation on the ablation area. A constraint wire is provided between the catheter and the distal end of the balloon, and the constraint wire is located on the outer periphery of the balloon. When the balloon is in the inflated state, the balloon expands outward, and the constraint wire contacts the outer surface of the balloon and provides a constraint force to the balloon, so as to compress and form a groove on the outer surface of the balloon.

2. The ablation catheter according to claim 1, characterized in that, The number of constraint wires is multiple, and the multiple constraint wires are distributed at intervals along the circumference of the balloon.

3. The ablation catheter according to claim 1, characterized in that, The ablation catheter also includes: The head end is located at the distal end of the balloon, and the end of the constraint wire away from the catheter is connected to the head end; a radiopaque component is provided on the head end.

4. The ablation catheter according to claim 3, characterized in that, The balloon includes a body and two connecting portions located at both axial ends of the body, the two connecting portions being connected to the catheter and the tip, respectively; When the balloon is in the inflated state, the cross-sectional shape of the body is petal-shaped.

5. The ablation catheter according to claim 3, characterized in that, The ablation catheter also includes: A central wire, the proximal end of which passes through the catheter and is connected to the handle, and the distal end of which is connected to the head end, is used for mounting the ultrasonic ablation assembly; the central wire is coaxial with the central axis of the balloon.

6. The ablation catheter according to claim 5, characterized in that, The ultrasonic ablation component includes: The substrate is connected to the central wire; Two ultrasonic transducers are spaced apart on the substrate along the axial direction of the central filament. The angles formed by the two ultrasonic transducers and the central axis of the central filament are equal, and the two ultrasonic transducers are arranged facing each other towards the side away from the central filament.

7. The ablation catheter according to claim 1, characterized in that, The ablation catheter also includes: A monitoring component is disposed on the outer surface of the balloon, and the monitoring component is used to monitor the wall pressure and / or temperature information of the balloon.

8. The ablation catheter according to claim 7, characterized in that, The monitoring component comprises, from the outside to the inside, a first insulating layer, a temperature-sensitive resistor layer, a second insulating layer, a first electrode sheet layer, a sensitive elastomer layer, a second electrode sheet layer, and a substrate layer, which are stacked sequentially. The temperature-sensitive resistor layer is electrically connected to the control unit via a first wire to monitor the temperature information of the ablation area; the first electrode layer and the second electrode layer are electrically connected to the control unit via a second wire to monitor the pressure information of the balloon adhering to the wall.

9. The ablation catheter according to claim 8, characterized in that, The monitoring component is disposed on the outer surface of the balloon and located between two adjacent constraint wires; the number of monitoring components is set to multiple, and the multiple monitoring components are distributed at intervals along the circumference of the balloon.

10. An ablation device, characterized in that, It includes a control unit and an ablation catheter according to any one of claims 1-9, wherein the ultrasonic ablation assembly is electrically connected to the control unit via a wire.

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