Ablation catheter and ablation equipment

Abstract

The embodiment of the invention provides an ablation catheter and ablation equipment, and belongs to the technical field of ablation. The ablation catheter comprises a catheter body, a balloon and an ultrasonic ablation assembly. The catheter body is provided with a fluid cavity. The balloon is arranged at the far end of the catheter, and the balloon can receive a medium in the fluid cavity so as to be switched between a contraction state and an expansion state; the ultrasonic ablation assembly is arranged at the far end of the catheter and located in the balloon, and the ultrasonic ablation assembly is electrically connected with the control part and used for conducting ultrasonic ablation on the ablation area; a restraining wire is arranged between the catheter and the far end of the balloon and located on the peripheral side of the balloon. When the balloon is in an expansion state, the balloon expands outwards, the restraint wire makes contact with the outer surface of the balloon and provides restraint force for the balloon, and therefore the outer surface of the balloon is extruded to form a groove. According to the ablation catheter, during ultrasonic ablation, the balloon cannot block flowing of liquid in a cavity such as blood in a blood vessel, the risk of damage to organ tissue at the rear end is reduced, and the ablation efficiency is improved.

Description

Technical Field

[0001] The present application relates to the field of ablation technology, and in particular, to an ablation catheter and an ablation device. Background Art

[0002] At present, ultrasonic ablation technology refers to the use of the characteristics of ultrasonic waves that can pass through human tissues and focus on specific target areas, concentrating energy to a sufficient intensity, causing the focal area to reach an instantaneous high temperature, destroying the target area tissue, and manifesting as coagulative necrosis in tissue pathology, thereby achieving the purpose of destroying the lesion area, while the tissue outside the lesion area is not damaged. The stent at the head end of the ablation catheter of most ultrasonic ablation technologies is usually made of metal materials, or a balloon made of polymer materials is used as the head end component. The metal material used at the head end is relatively hard, and the rigidity cannot meet the requirements of adaptability to the natural cavity morphology of the human body, and it is easy to scratch the natural cavity of the human body. The existing balloon will completely block the cavity when fully inflated. Once the ablation process is long, the organs and tissues at the rear end will be blocked for a long time, and sufficient oxygen and nutrient supply cannot be guaranteed. In severe cases, it may even cause irreversible damage to the organs. Summary of the invention

[0003] The embodiments of the present application provide an ablation catheter and an ablation device. During ultrasonic ablation, the balloon will not block the flow of liquid in the cavity, such as blood in the blood vessels, thereby reducing the risk of damage to the rear organ tissues and improving the ablation efficiency.

[0004] In a first aspect, an embodiment of the present application provides an ablation catheter, which includes a catheter, a balloon and an ultrasonic ablation component, wherein the catheter has a fluid cavity; the balloon is disposed at the distal end of the catheter, and the balloon can receive a medium in the fluid cavity to switch between a contracted state and an expanded state; the ultrasonic ablation component is disposed at the distal end of the catheter and is located inside the balloon, and the ultrasonic ablation component is electrically connected to a control unit for ultrasonically ablating the ablation area; wherein a constraint wire is disposed between the distal end of the catheter and the balloon, and the constraint wire is located on the outer peripheral side of the balloon; when the balloon is in an expanded state, the balloon expands outward, and the constraint wire contacts the outer surface of the balloon and provides a constraint force to the balloon to squeeze and form a groove on the outer surface of the balloon.

[0005] In this solution, a fluid cavity is provided in the catheter, and the fluid cavity is connected to the inside of the balloon. The fluid cavity can allow the medium to enter and exit the balloon, so that the balloon can switch between the expanded state and the contracted state. In the actual ablation process, after the ablation catheter is placed in the natural cavity of the human body, such as the ablation area of ​​the blood vessel, the medium enters the balloon, and under the continuous pressure of the medium, the balloon gradually expands, so that the balloon switches from the contracted state to the expanded state, and the balloon contacts the inner wall of the blood vessel. The ultrasonic ablation component is located in the balloon, and the ultrasonic ablation component uses sound waves to focus on the corresponding ablation area of ​​the blood vessel. The ablation area can be, for example, the nerves around the blood vessel. The ultrasonic energy penetrates the blood vessel wall and reaches the nerves to achieve ultrasonic ablation. By arranging a constraint wire on the outer peripheral side of the balloon, during the expansion process of the balloon, the constraint area where the balloon contacts the constraint wire is restricted by the constraint wire, and the non-constraint area of ​​the balloon that does not contact the constraint wire expands naturally, so that the constraint area where the balloon contacts the constraint wire forms a groove under the extrusion of the constraint wire, and the non-constraint area of ​​the balloon is normally fitted with the inner wall of the blood vessel, and the area enclosed between the groove and the inner wall of the blood vessel can form a channel for blood circulation, maintain the smooth circulation of blood, will not block the blood flow, and is not easy to cause adverse effects on the tissues and organs at the rear end of the balloon. At the same time, the time of a single ultrasonic ablation in the ablation area can be freely controlled, with strong controllability and higher ablation efficiency. The ablation time will not be limited by the phenomenon of a single ablation time being short due to the balloon blocking the blood or repeated ablation in the same ablation area. In addition, during the ultrasonic ablation process, the grooves on the balloon allow blood to circulate normally, and the circulation of blood can take away part of the heat in the ablation area of ​​the blood vessel, thereby increasing the cooling rate of the ablation area and reducing the risk of temperature runaway due to excessive local heating in the ablation area.

[0006] In some embodiments, there are multiple constraining wires, and the multiple constraining wires are spaced apart along the circumference of the balloon.

[0007] In the above technical solution, by setting the number of constraint wires to multiple, when the balloon is in an expanded state, the multiple constraint wires will respectively act on different positions of the balloon in the circumferential direction, and form a plurality of spaced grooves in the circumferential direction of the balloon. The formation of multiple grooves can ensure a larger blood circulation area, a larger circulation area, and a smaller impact of the balloon on blood blockage.

[0008] In some embodiments, the ablation catheter further comprises a head end, which is arranged at the distal end of the balloon, and one end of the constraint wire away from the catheter is connected to the head end; a developing component is arranged on the head end.

[0009] In the above technical solution, by arranging a head end at the distal end of the balloon, the distal end of the constraint wire is connected to the head end, and the proximal end is connected to the catheter, the constraint wire has a good fixing effect, and the constraint wire can play a restraining role on the balloon after the balloon is expanded. By arranging a developing component on the head end, the developing component can realize clear development of the distal end of the catheter under medical imaging equipment, so that the doctor can accurately grasp the position and state of the catheter in the body.

[0010] In some embodiments, the balloon includes a body and two connecting parts located at two axial ends of the body, and the two connecting parts are respectively connected to the catheter and the head end; when the balloon is in an expanded state, the cross-sectional shape of the body is petal-shaped.

[0011] In the above technical solution, when the balloon is in an expanded state, 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, provides better support for the blood vessel, and is more conducive to ultrasonic ablation of the ultrasonic ablation component.

[0012] In some embodiments, the ablation catheter also includes a center wire, the proximal end of the center wire is passed through the catheter and connected to the handle, the distal end of the center wire is connected to the head end, the center wire is used for installation of the ultrasonic ablation component, and the center wire is coaxially arranged with the central axis of the balloon.

[0013] In the above technical solution, the center wire can be used for the ultrasonic ablation component to be installed in the balloon, and the center wire is coaxially arranged with the central axis of the balloon. The ultrasonic ablation component is located on the center line of the balloon. When the balloon is expanded and adheres to the inner wall of the blood vessel, the ultrasonic ablation component is always located in the center of the blood vessel. By rotating the center wire or rotating the head end, the ultrasonic ablation component can be directed to different positions on the circumference of the inner wall of the blood vessel, and the focus of the ultrasonic ablation component always corresponds to the ablation area of ​​the blood vessel to achieve 360° all-round ablation.

[0014] In some embodiments, the ultrasonic ablation component includes a substrate and two ultrasonic transducers, wherein the substrate is connected to the center wire; the two ultrasonic transducers are arranged on the substrate at intervals along the axial direction of the center wire, the angles formed by the two ultrasonic transducers and the central axis of the center wire are equal, and the two ultrasonic transducers are arranged facing each other on the side away from the center wire.

[0015] 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 focus of the energy transmitted by the two ultrasonic transducers after concentration corresponds to the ablation area of ​​the blood vessel, and other areas outside the ablation area of ​​the blood vessel are not ablated, thereby realizing ultrasonic ablation of the ablation area of ​​the blood vessel.

[0016] In some embodiments, the ablation catheter further includes a monitoring component, which is disposed on the outer surface of the balloon and is used to monitor the wall pressure and / or temperature information of the balloon.

[0017] In the above technical solution, a monitoring component is provided on the outer surface of the balloon, which can monitor the wall pressure of the balloon and determine whether the balloon has completed wall adhesion; and / or, the monitoring component 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.

[0018] 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 layer, a sensitive elastomer layer, a second electrode layer and a base layer stacked in sequence; the temperature-sensitive resistor layer is electrically connected to the control unit through 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 through a second wire to monitor the pressure information of the balloon adhering to the wall.

[0019] 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 of the monitoring component in contact with the inner wall of the blood vessel. The first insulating layer plays the role of insulating the inner wall of the blood vessel and protecting the blood vessel. The second insulating layer isolates the temperature-sensitive resistor layer, thereby ensuring the accuracy of the temperature-sensitive resistor layer. The temperature-sensitive resistor layer is electrically connected to the handle by means of a first wire electrical connection. When the temperature change is detected during the ablation process, the resistance value of the temperature-sensitive resistor layer changes, and is transmitted to the handle through the current signal, thereby realizing the function of monitoring the temperature of the ablation area. The first electrode layer and the second electrode layer are used together to form a capacitive sensor, which plays the role of monitoring the wall adhesion force of the balloon. The sensitive elastomer layer is arranged between the first electrode layer and the second electrode layer, which plays the role of supporting and providing deformation.

[0020] In some embodiments, the monitoring component is disposed on the outer surface of the balloon and between two adjacent restraining wires. The number of the monitoring components is set to be multiple, and the multiple monitoring components are distributed at intervals along the circumference and / or axial direction of the balloon.

[0021] In the above technical solution, the monitoring component is arranged in the area between two adjacent restraining wires on the balloon, so that when the balloon is in an expanded state, the monitoring component is located on the outer surface of the non-constrained area of ​​the balloon, which is easier to contact with the inner wall of the blood vessel, so as to realize the wall adhesion monitoring of the balloon and the temperature monitoring of the ablation area. By setting the number of monitoring components to multiple, and distributing the multiple monitoring components in the circumference and / or axial direction of the balloon, the pressure and temperature at different points in the circumference and / or axial direction of the balloon can be measured, and the wall adhesion and temperature of the balloon in all directions can be effectively monitored, and the wall adhesion monitoring of the balloon is more accurate and reliable.

[0022] In a second aspect, an embodiment of the present application further provides an ablation device, which includes a control unit and an ablation catheter of any of the aforementioned embodiments, and an ultrasonic ablation component is electrically connected to the control unit via a wire.

[0023] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 A schematic diagram of the structure of an ablation catheter provided in some embodiments of the present application;

[0026] Figure 2 for Figure 1 Schematic diagram of the structure of the distal end of the middle catheter;

[0027] Figure 3 A schematic diagram of the structure of the balloon in the ablation catheter provided in some embodiments of the present application cooperating with the restraining wire in the expanded state;

[0028] Figure 4 A side view of an ablation catheter provided in some embodiments of the present application;

[0029] Figure 5 A schematic diagram of the structure of an ultrasonic ablation component in an ablation catheter provided in some embodiments of the present application;

[0030] Figure 6 A cross-sectional view of a monitoring component in an ablation catheter provided in some embodiments of the present application;

[0031] Figure 7 A cross-sectional view of a catheter in an ablation catheter provided in some embodiments of the present application.

[0032] Icons: 100-ablation catheter; 10-catheter; 11-fluid cavity; 111-liquid inlet cavity; 112-liquid outlet cavity; 20-balloon; 21-body; 22-connecting part; 23-groove; 30-head end; 40-restraint wire; 50-ultrasonic ablation component; 51-substrate; 52-ultrasonic transducer; 60-developing part; 70-center wire; 80-monitoring part; 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 DESCRIPTION

[0033] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0034] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0035] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0036] In the description of the embodiments of the present 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 the application is usually placed when in use, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0037] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be fixedly connected, detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0038] After the existing balloon stent is placed in the ablation area of ​​the natural cavity of the human body, the balloon contacts the inner wall of the cavity when it is fully expanded, and the balloon will completely block the cavity. If the ablation process is long, the patient's posterior organs and tissues will be blocked for a long time, and sufficient oxygen and nutrients cannot be guaranteed. In severe cases, it may even cause irreversible damage to the organs.

[0039] In view of this, the present application embodiment provides an ablation catheter, please refer to Figures 1 to 7 The ablation catheter 100 includes a catheter 10, a balloon 20 and an ultrasonic ablation component 50. The catheter 10 has a fluid cavity 11. The balloon 20 is arranged at the distal end of the catheter 10, and the balloon 20 can receive the medium in the fluid cavity 11 to switch between a contracted state and an expanded state. The ultrasonic ablation component 50 is arranged at the distal end of the catheter 10 and is located in the balloon 20. The ultrasonic ablation component 50 is electrically connected to the control unit and is used to perform ultrasonic ablation on the ablation area. A restraint wire 40 is arranged between the distal end of the catheter 10 and the balloon 20, and the restraint wire 40 is located on the outer peripheral side of the balloon 20. When the balloon 20 is in an expanded state, the balloon 20 expands outward, and the restraint wire 40 contacts the outer surface of the balloon 20 and provides a restraint force to the balloon 20, so as to squeeze the outer surface of the balloon 20 to form a groove 23.

[0040] In this solution, a fluid cavity 11 is provided in the catheter 10, and the fluid cavity 11 is connected to the interior of the balloon 20. The fluid cavity 11 can allow the medium to enter and exit the balloon 20, so that the balloon 20 can switch between the expansion state and the contraction state. In the actual ablation process, after the ablation catheter 100 is placed in the natural cavity of the human body, such as the ablation area of ​​the blood vessel, the medium enters the balloon 20. Under the continuous pressurization of the medium, the balloon 20 gradually expands, so that the balloon 20 switches from the contraction state to the expansion state. The balloon 20 contacts the inner wall of the blood vessel, and the ultrasonic ablation component 50 is located in the balloon 20. The ultrasonic ablation component 50 uses sound waves to focus on the corresponding ablation area of ​​the blood vessel. The ablation area can be, for example, the nerves around the blood vessel. The ultrasonic energy penetrates the blood vessel wall and reaches the nerves to achieve ultrasonic ablation. By arranging the restraining wire 40 on the outer peripheral side of the balloon 20, during the expansion process of the balloon 20, the restraining area where the balloon 20 contacts the restraining wire 40 is restricted by the restraining wire 40, and the non-restraining area of ​​the balloon 20 that does not contact the restraining wire 40 expands naturally, so that the restraining area where the balloon 20 contacts the restraining wire 40 forms a groove 23 under the squeezing action of the restraining wire 40, and the non-restraining area of ​​the balloon 20 fits normally with the inner wall of the blood vessel, and the area enclosed by the groove 23 and the inner wall of the blood vessel can form a channel for blood circulation, maintain the smooth circulation of blood, will not block the blood flow, and is not likely to cause adverse effects on the tissues and organs at the rear end of the balloon 20. At the same time, the time of a single ultrasonic ablation in the ablation area can be freely controlled, with strong controllability and higher ablation efficiency. The ablation time will not be limited by the phenomenon of a short single ablation time or repeated ablation in the same ablation area due to the blocking of blood by the balloon 20. Moreover, during ultrasonic ablation, the grooves 23 on the balloon 20 allow normal blood circulation. The blood flow can take away part of the heat in the ablation area of ​​the blood vessel, thereby increasing the cooling rate of the ablation area and reducing the risk of temperature runaway in the ablation area due to rapid local heating.

[0041] The natural cavities of the human body can be bronchi, bile ducts, esophagus, gastrointestinal tract, urogenital tract or blood vessels. Taking blood vessels as an example, for example, refractory hypertension can be treated by ablation of renal sympathetic nerves or external carotid nerves, type 2 diabetes can be treated by ablation of nerves near the liver, and metabolic organ functions can be affected by ablation of sympathetic nerves that control visceral organs such as the liver, pancreas, and gastrointestinal tract. In addition, pain can be relieved by ablation of nerves outside peripheral blood vessels.

[0042] The cavities in the following embodiments all take blood vessels as an example, and ablation of renal sympathetic nerves for the treatment of refractory hypertension is used as the application scenario. This is only to facilitate the understanding of the technology by those skilled in the art, and does not exclude the application of the technical solution of this application to other scenarios. It should be understood that each implementation method of this application can be applied to one type of scenario, and those skilled in the art can directly apply it to a variety of treatment scenarios under the instructions of the specification. The application of the technical solution of this application in a variety of similar scenarios falls within the protection scope and implementation methods of this application.

[0043] The shape of the balloon 20 can be various, such as spherical or cylindrical, etc. The balloon 20 is made of polyester fiber, polyamide fabric, polyurethane, silica gel or nylon, etc.

[0044] In this embodiment, the material of the balloon 20 is nylon. Nylon is one of the common materials for making airbags, has high tensile strength, and can withstand high pressure when the balloon 20 is filled, ensuring that the balloon 20 plays a protective role at a critical moment.

[0045] The medium may be of various types, and the medium is generally a fluid, and the pressure in the balloon 20 is easier to control than that in a gas. In this embodiment, the medium is physiological saline.

[0046] Please refer to Figure 7 The fluid cavity 11 of the catheter 10 may include a liquid inlet cavity 111 and a liquid outlet cavity 112, and the balloon 20 is connected to the liquid inlet cavity 111 and the liquid outlet cavity 112. The liquid inlet cavity 111 and the liquid outlet cavity 112 are respectively connected to the liquid inlet and the liquid outlet of the external water supply device to circulate the liquid, so that the balloon 20 can switch between the expansion state and the contraction state. The liquid can be introduced into the balloon 20 through the external liquid supply device, so that the balloon 20 is continuously filled and expanded until it is against the inner wall of the blood vessel. During the ultrasonic ablation process, the external liquid supply device maintains the current pressure and continuously inputs liquid through the liquid inlet cavity of the catheter 10, ensuring that the balloon 20 maintains the required size while also cooling the inside of the balloon 20. After the liquid enters the balloon 20 through the liquid inlet cavity 111 of the catheter 10, it is discharged from the liquid outlet cavity 112 to a storage device (not shown) for recycling. It can be understood that the catheter 10 can also be provided with other cavities as needed, which are not specifically limited here.

[0047] The ultrasonic ablation component 50 refers to a mechanism capable of performing ultrasonic ablation on the ablation area of ​​a natural cavity of a human body. Figure 2 The relationship between the ultrasonic ablation component 50 and the balloon 20 is shown. Figure 2 is a perspective view of the distal end of the catheter. Figure 2 The dotted line in the figure indicates that the ultrasonic ablation component 50 is located inside the balloon 20. The working principle of the ultrasonic ablation component 50 is to focus the energy transmitted by the ultrasonic wave on the ablation area of ​​the cavity, so that the ablation area of ​​the cavity is heated up, thereby achieving ultrasonic ablation.

[0048] The restraining wire 40 refers to a restraining component disposed between the proximal end and the distal end of the balloon 20, and the restraining wire 40 extends along the proximal and distal directions of the balloon 20. During the expansion of the balloon 20, the restraining wire 40 contacts the outer surface of the balloon 20, and provides restraint and squeezing effects on the balloon 20, preventing the area where the restraining wire 40 contacts the balloon 20 from expanding, thereby forming a groove 23 on the outer surface of the balloon 20. A channel for blood circulation is formed between the groove 23 and the inner wall of the blood vessel, which can maintain normal blood circulation.

[0049] The number of the constraint wires 40 may be one or more, and the specific number of the constraint wires 40 may be determined according to actual conditions. When the number of the constraint wires 40 is one, when the balloon 20 is in an expanded state, the constraint wire 40 may form a groove 23 on the outer surface of the balloon 20. When the number of the constraint wires 40 is multiple, the multiple constraint wires 40 may be distributed at intervals along the circumference of the balloon 20, and the multiple constraint wires 40 may 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.

[0050] The control unit refers to a control component that can control the ultrasonic ablation component 50 to perform ultrasonic ablation. The ultrasonic ablation component 50 receives the corresponding output power of the control unit and releases ultrasonic waves of corresponding intensity, and heats the ablation area within the energy focus range of the sound wave transmission.

[0051] In some embodiments, there are multiple restraining wires 40, and the multiple restraining wires 40 are spaced apart along the circumference of the balloon 20. By setting the number of restraining wires 40 to be multiple, when the balloon 20 is in an expanded state, the multiple restraining wires 40 will act on different positions of the circumference of the balloon 20 respectively, and form multiple spaced apart grooves 23 on the circumference of the balloon 20. The formation of multiple grooves 23 can ensure a larger blood circulation area, a larger circulation area, and a smaller impact of the balloon 20 on blood blockage.

[0052] The multiple constraint wires 40 are distributed at intervals along the circumference of the balloon 20, which means that the multiple constraint wires 40 can be distributed at equal intervals or at unequal intervals along the circumference of the balloon 20.

[0053] When the plurality of restraining wires 40 are evenly spaced along the circumference of the balloon 20, the plurality of restraining wires 40 have a more even distribution of the areas of action on the balloon 20, the force 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. Figure 3 and Figure 4 As shown, in this embodiment, the number of the restraining wires 40 is six, and the six restraining wires 40 are evenly spaced along the circumference of the balloon 20 .

[0054] In some embodiments, the material of the restraint wire 40 includes at least one of nickel titanium or polyethylene fiber.

[0055] In some embodiments, please refer to Figure 1 and Figure 2 The ablation catheter 100 further includes a head end 30, which is disposed at the distal end of the balloon 20, and the end of the constraint wire 40 away from the catheter 10 is connected to the head end 30; a developing component 60 is disposed on the head end 30. By disposing the head end 30 at the distal end of the balloon 20, the distal end of the constraint wire 40 is connected to the head end 30, and the proximal end is connected to the catheter 10, the fixing effect of the constraint wire 40 is good, and the constraint wire 40 can play a restraining role on the balloon 20 after the balloon 20 is expanded. By disposing the developing component 60 on the head end 30, the developing component 60 realizes clear development of the distal end of the catheter 10 under medical imaging equipment, so that the doctor can accurately grasp the position and state of the catheter 10 in the body.

[0056] The tip 30 refers to the most distal component of the ablation catheter 100, and the tip 30 can be connected and fixed to the distal end of the balloon 20, and the balloon 20 is arranged between the distal end of the catheter 10 and the tip 30, and the axial ends of the balloon 20 are respectively fixedly connected to the distal end of the catheter 10 and the tip 30. 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.

[0057] The developing component 60 is made of special materials that can generate unique signals in imaging mode, or can absorb specific energy waves emitted by imaging equipment. The developing component 60 is a commonly used technology in interventional catheter 10 technology, and will not be described in detail here.

[0058] In some embodiments, please refer to Figure 2 and Figure 3 The balloon 20 includes a body 21 and two connecting parts 22 located at the axial ends of the body 21, and the two connecting parts 22 are respectively connected to the catheter 10 and the head end 30; when the balloon 20 is in an expanded state, the cross-sectional shape of the body 21 is petal-shaped. When the balloon 20 is in an expanded state, the cross-sectional shape of the balloon 20 is petal-shaped. Compared with a spherical balloon 20, along the axial direction of the balloon 20, the petal-shaped balloon 20 has a larger contact area with the inner wall of the blood vessel, better supports the blood vessel, and is more conducive to ultrasonic ablation of the ultrasonic ablation assembly.

[0059] The connection part 22 is conical in shape and is integrally formed with the body 21. The connection part 22 has a large end and a small end in the axial direction, the large end of the connection part 22 is connected to the body 21, and the small end of the connection part 22 is connected to the end or the distal end of the catheter 10.

[0060] In some embodiments, please refer to Figure 2The ablation catheter 100 further includes a center wire 70, the proximal end of which is passed through the catheter 10 and connected to the handle 90, and the distal end of which is connected to the head end 30. The center wire 70 is used for installing the ultrasonic ablation component 50, and the center wire 70 is coaxially arranged with the central axis of the balloon 20. The center wire 70 can be installed in the balloon 20 for the ultrasonic ablation component 50, and the center wire 70 is coaxially arranged with the central axis of the balloon 20. The ultrasonic ablation component 50 is located on the center line of the balloon 20. When the balloon 20 is expanded and attached to the inner wall of the blood vessel, the ultrasonic ablation component 50 is always located at the center of the blood vessel. The ultrasonic ablation component 50 can be directed to different positions on the inner wall of the blood vessel in the circumferential direction by rotating the center wire 70 or rotating the head end 30, and the focus of the ultrasonic ablation component 50 always corresponds to the ablation area of ​​the blood vessel, so as to achieve 360° all-round ablation.

[0061] However, the present invention is not limited thereto. The central wire 70 and the balloon 20 may also be coaxially arranged, and the specific position of the central wire 70 may be determined according to actual conditions.

[0062] In some embodiments, please combine Figure 2 and Figure 5 The ultrasonic ablation assembly 50 includes a substrate 51 and two ultrasonic transducers 52. The substrate 51 is connected to the center wire 70. The two ultrasonic transducers 52 are arranged on the substrate 51 at intervals along the axial direction of the center wire 70. The angles formed by the two ultrasonic transducers 52 and the central axis of the center wire 70 are equal, and the two ultrasonic transducers 52 are arranged facing each other and away from the center wire 70. The two paired ultrasonic transducers 52 are arranged symmetrically facing each other with respect to the cross section of the balloon 20, and the ultrasonic transducers 52 and the central axis of the catheter 10 form an angle and the angles are equal. The two ultrasonic transducers 52 cooperate with each other. The two ultrasonic transducers 52 use the focus of the concentrated energy transmitted by the ultrasonic wave to correspond to the ablation area of ​​the blood vessel, and do not ablate other areas outside the ablation area of ​​the blood vessel, so as to realize 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 a wire. It should be noted that the paired ultrasonic transducers 52 form an angle with the central axis of the catheter 10 , and the angles formed by the two ultrasonic transducers 52 and the central axis of the catheter 10 may be equal or unequal.

[0063] The angle α formed by the ultrasonic transducer 52 and the central axis of the central wire 70 may 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°.

[0064] Of course, in addition to being fixedly disposed on the substrate 51, in order to improve the scope of application of the ultrasonic transducer 52, the ultrasonic transducer 52 can be rotatably disposed on the substrate 51 to adjust the size of the set angle α. Specifically, an additional guide wire (not shown in the figure) can be disposed in the guide wire cavity of the catheter 10, and the guide wire can be connected to the ultrasonic transducer 52, so that the ultrasonic transducer 52 can be driven to rotate relative to the substrate 51 by pulling the guide wire, so that the set angle α can be freely adjusted within a certain angle range (for example: 30 to 60°). It can be understood that when the angle α changes, the focal point and focal area of ​​the two ultrasonic transducers 52 will change accordingly, so that it can be adaptively adjusted according to different ablation positions of the blood vessels to improve the applicability of the ablation catheter 100.

[0065] In addition, in this embodiment, the rotation adjustment of the ultrasonic transducer 52 by setting a guide wire is only one implementation method. In other embodiments, it can be adaptively replaced with other adjustment structures as needed to adjust the size of the set angle α, which is not specifically limited here.

[0066] In addition, the ultrasonic transducer 52 is movably disposed on the substrate 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 substrate 51, and an additional guide wire (not shown in the figure) is disposed in the guide wire cavity of the catheter 10, and the guide wire is connected to the ultrasonic transducer 52, so that the ultrasonic transducer 52 can be driven to move along the central axis of the catheter 10 by pulling the guide wire, so that the two ultrasonic transducers 52 are close to each other or away from each other, thereby adjusting the distance between the two. It can be understood that when the distance between the two ultrasonic transducers 52 changes, the size of the ablation target area determined by the two will also change accordingly, so that it can be adaptively adjusted according to different ablation positions of the blood vessels to improve the applicability of the ablation catheter 100.

[0067] In addition, in this embodiment, adjusting the movement of the ultrasonic transducer 52 by setting a guide wire is only one implementation method. In other embodiments, it can be adaptively replaced with other adjustment structures as needed to adjust the distance between the two ultrasonic transducers 52, which is not specifically limited here.

[0068] In some embodiments, the number of ultrasonic ablation components 50 is set to be multiple, and the multiple ultrasonic ablation components 50 are spaced apart along the extension direction of the central wire 70. The number of ultrasonic ablation components 50 is set to be multiple, and the multiple ultrasonic ablation components 50 can cooperate with ablation simultaneously or selectively, so that ultrasonic ablation of multiple ablation areas of a blood vessel can be achieved at one time, and the ablation efficiency is higher.

[0069] When there are multiple ultrasonic ablation components 50, each ultrasonic ablation component 50 is electrically connected to the control unit and is independently controlled. The control unit can control multiple ultrasonic ablation components 50 to work simultaneously, or control one or more of the multiple ultrasonic ablation components 50 to work, depending on the actual situation.

[0070] In some embodiments, please refer to Figure 2 The ablation catheter 100 further includes a monitoring component 80, which is disposed on the outer surface of the balloon 20 and is used to monitor the wall pressure and / or temperature information of the balloon 20. By disposing the monitoring component 80 on the outer surface of the balloon 20, the monitoring component 80 can monitor the wall pressure of the balloon 20 and determine whether the balloon 20 has completed the 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 the real-time monitoring of the temperature of the ablation area.

[0071] The monitoring component 80 may be an independent pressure monitoring component 80 or a temperature monitoring component 80. Of course, the monitoring component 80 may also integrate the pressure and temperature monitoring functions.

[0072] In some embodiments, please refer to Figure 6 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 layer 84, a sensitive elastic layer 85, a second electrode layer 86 and a base layer 87, which are stacked in sequence; 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 layer 84 and the second electrode 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 the first insulating layer 81, the temperature-sensitive resistor layer 82, the second insulating layer 83, the first electrode layer 84, the sensitive elastic layer 85, the second electrode layer 86 and the base layer 87, that is, the monitoring component 80 is a laminated monitoring component 80 integrating pressure and temperature monitoring functions, the first insulating layer 81 is the outermost side of the monitoring component 80 in contact with the inner wall of the blood vessel, and the first insulating layer 81 plays the role of insulating from the inner wall of the blood vessel and protecting the blood vessel. The second insulating layer 83 isolates the temperature sensitive resistor layer 82, ensuring the accuracy of the temperature sensitive resistor layer 82. The temperature sensitive resistor layer 82 is electrically connected to the handle 90 by means of a first wire electrical connection. When the temperature change is detected during the ablation process, the resistance value of the temperature sensitive resistor layer 82 changes, and the current signal is transmitted to the handle 90 to realize the function of monitoring the temperature of the ablation area of ​​the blood vessel. The first electrode layer 84 and the second electrode layer are used together to form a capacitive sensor, which plays a role in monitoring the wall force of the balloon 20. The sensitive elastomer layer 85 is arranged between the first electrode layer 84 and the second electrode layer 86, which plays a role in supporting and providing deformation.

[0073] Specifically, the working principle of the monitoring component 80 for monitoring pressure is as follows: the first electrode layer 84 and the second electrode layer are used together to form a capacitive sensor. When not under pressure, the capacitance between the two layers of electrode sheets is C0. As the balloon 20 expands, the monitoring component 80 gradually fits the inner wall of the blood vessel and generates pressure. The pressure is transmitted to the first electrode layer 84 through the upper medium. The first electrode layer 84 is displaced, which reduces the distance between the two layers of electrode sheets, resulting in a change in capacitance from C0 to Cx. The capacitance Cx is used to express the value of the pressure P monitored by the monitoring component 80. The first electrode layer 84 and the second electrode layer are connected to the handle 90 by electrical connection, and the electrical signal is transmitted to the handle 90; the sensitive elastic layer 85 is located between the first electrode layer 84 and the second electrode layer, and plays a role in supporting and providing deformation.

[0074] The base layer 87 can be a flexible polymer material layer. The base layer 87 provides a base for the above-mentioned layers. The first insulating layer 81, the temperature-sensitive resistor layer 82, the second insulating layer 83, the first electrode layer 84, the sensitive elastomer layer 85, and the second electrode layer 86 are all stacked on the base layer 87. Since the base layer 87 is made of a flexible material, it can change with the expansion of the balloon 20.

[0075] The handle 90 is disposed at the proximal end of the catheter 10 , and the handle 90 is electrically connected to the control unit.

[0076] In some embodiments, please refer to Figure 2 The monitoring component 80 is arranged on the outer surface of the balloon 20 and between two adjacent restraining wires 40. The monitoring component 80 is arranged in the area between two adjacent restraining wires 40 on the balloon 20, so that when the balloon 20 is in an expanded state, the monitoring component 80 is located on the outer surface of the non-restrained area of ​​the balloon 20, which is easier to contact with 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.

[0077] Along the axial direction of the balloon 20 , the monitoring component 80 is disposed on the outer surface of the balloon 20 and is located in the middle area between two adjacent restraining wires 40 .

[0078] In some embodiments, the number of monitoring components 80 is set to be 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 be multiple, and the multiple monitoring components 80 are distributed in the circumference and / or axial direction of the balloon 20, it is possible to measure the pressure and temperature of different points in the circumference and / or axial direction of the balloon 20, and the wall adhesion and temperature of the balloon 20 in all directions can be effectively monitored, and the wall adhesion monitoring of the balloon 20 is more accurate and reliable.

[0079] Multiple monitoring components 80 are distributed at intervals along the circumference and / or axial direction of the balloon 20, which means that multiple monitoring components 80 can be distributed at intervals along the circumference of the balloon 20, or distributed at intervals along the axial direction of the balloon 20, or multiple monitoring components 80 can be distributed at intervals along the circumference and axial direction of the balloon 20 at the same time, depending on the actual situation. In this embodiment, multiple monitoring components 80 are distributed at intervals along the circumference and axial direction of the balloon 20.

[0080] The embodiment of the present application further provides an ablation device, which includes a control unit and the ablation catheter 100 of any of the aforementioned embodiments, and the ultrasonic ablation component 50 is electrically connected to the control unit through a wire.

[0081] 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 the signal generator is used to receive and send ultrasonic signals; the power amplifier is connected to the signal generator, and the power amplifier is used to amplify ultrasonic signals; the gating module is connected to the power amplifier, and the power amplifier is used to select the number of signal channels.

[0082] 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 matching ultrasonic frequencies; the impedance matching module is connected to the main control module, and the impedance matching module is used to detect matching impedance and output matching power ultrasonic signals.

[0083] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0084] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An ablation catheter, characterized in that: include: a catheter having a fluid lumen; a balloon, disposed at the distal end of the catheter, the balloon being capable of receiving a medium in the fluid chamber to switch between a contracted state and an expanded state; An ultrasonic ablation component is arranged at the distal end of the catheter and located in the balloon, the ultrasonic ablation component is electrically connected to the control unit and is used to perform ultrasonic ablation on the ablation area; Wherein, a constraint wire is arranged between the catheter and the distal end of the balloon, and the constraint wire is located on the peripheral side of the balloon; when the balloon is in the expanded state, the balloon expands outward, the constraint wire contacts the outer surface of the balloon and provides a constraint force to the balloon, so as to squeeze the outer surface of the balloon to form a groove.

2. The ablation catheter according to claim 1, characterized in that: There are multiple restraining wires, and the multiple restraining 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 further comprises: The head end is arranged at the distal end of the balloon, and the end of the constraint wire away from the catheter is connected to the head end; the head end is provided with a developing component.

4. The ablation catheter according to claim 3, characterized in that: The balloon comprises a body and two connecting parts located at two axial ends of the body, and the two connecting parts are respectively connected to the catheter and the head end; When the balloon is in the expanded 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 further comprises: A center wire, the proximal end of which is passed through the catheter and connected to the handle, the distal end of which is connected to the head end, and the center wire is used for installation of the ultrasonic ablation component; the center wire is coaxially arranged with the central axis of the balloon.

6. The ablation catheter according to claim 5, characterized in that: The ultrasonic ablation component comprises: a substrate connected to the central wire; Two ultrasonic transducers are arranged on the substrate at intervals 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 arranged facing each other and away from the central wire.

7. The ablation catheter according to claim 1, characterized in that: The ablation catheter further comprises: A monitoring component is arranged on the outer surface of the balloon, and 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 elastic layer, a second electrode sheet layer and a base layer which are stacked in sequence; 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 arranged on the outer surface of the balloon and is located between two adjacent restraining wires; the number of the monitoring components is set to be multiple, and the multiple monitoring components are distributed at intervals along the circumference of the balloon.

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

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