Balloon ultrasonic ablation catheter, cooling system and ultrasonic ablation system

Abstract

According to the balloon ultrasonic ablation catheter, the cooling system and the ultrasonic ablation system, cooling liquid can be independently introduced into each layer of structure of the balloon of the balloon ultrasonic ablation catheter so as to meet the requirements of different blood vessel sizes, the problem that the catheter needs to be frequently replaced due to different blood vessel sizes in the using process of the balloon ultrasonic ablation catheter is solved, and the service life of the balloon ultrasonic ablation catheter is prolonged. Meanwhile, the double-layer cooling liquid improves the cooling effect to a certain extent, the operation efficiency and safety are improved, in addition, the balloon ultrasonic ablation catheter balloon can cool the transducer, meanwhile, the transducer can be fixed and centered in different blood vessel diameters, and ultrasonic ablation with the stable depth is achieved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and in particular to a balloon ultrasonic ablation catheter, a cooling system and an ultrasonic ablation system. Background Art

[0002] Hypertensive patients usually have persistently high blood pressure due to the abundant sympathetic nerves around the renal artery. At present, interventional surgery can be performed through ultrasonic ablation catheters to effectively ablate the nerves, thereby reducing the patient's blood pressure. Ultrasonic ablation catheters can generally release ultrasonic energy through the ultrasonic transducer in the distal balloon to act on the sympathetic nerves outside the renal artery, increase tissue temperature and cause nerve necrosis, thereby achieving the effect of lowering blood pressure.

[0003] Ultrasonic catheters need to be passed through the balloon with circulating coolant to reduce the heat generated by the ultrasonic transducer itself when working, and at the same time limit the transducer to the center of the blood vessel to prevent the difference in ablation depth caused by angle tilt or being too close to the blood vessel wall on one side and too far from the other side, thus losing effective control over the depth of the ablation lesion. Therefore, it is necessary to confirm the blood vessel size of the treatment site based on the patient's preoperative angiography results to select an ultrasonic ablation catheter with a balloon of the appropriate size. However, the distal blood vessel size of the primary or secondary branches of the renal artery is often smaller (2-4mm); while the blood vessel size of the main trunk and proximal end of the renal artery and the abdominal aorta is often larger (4-6mm); under normal circumstances, a single-size balloon can only meet the needs of matching blood vessel size within a small range (1-2mm range to adapt to changes). At present, for this situation, it is often necessary to frequently replace catheters with different balloon sizes during surgery, which greatly increases the difficulty and risk of surgery. Utility Model Content

[0004] The purpose of the utility model is to provide a balloon ultrasonic ablation catheter and an ultrasonic ablation system to solve one or more problems existing in the prior art.

[0005] In order to solve the above problems, the utility model provides a balloon ultrasonic ablation catheter, comprising: a catheter body, the catheter body comprising an inner tube, a distal single-lumen tube and a proximal single-lumen tube, the distal single-lumen tube and the proximal single-lumen tube are arranged at intervals in the axial direction, and the inner tube is sequentially passed through the proximal single-lumen tube and the distal single-lumen tube from the proximal end to the distal end;

[0006] an ultrasonic transducer fixed on the inner tube between the proximal single-lumen tube and the distal single-lumen tube;

[0007] a balloon, which is a double-layer or multi-layer structure, fixed between the proximal single-lumen tube and the distal single-lumen tube and arranged around the inner tube; and,

[0008] The cooling liquid delivery unit has a delivery passage, and the delivery passage is used to independently introduce cooling liquid into each layer structure of the balloon.

[0009] Optionally, in the balloon ultrasonic ablation catheter, the side wall of the proximal single-lumen tube or the distal single-lumen tube has a first through hole;

[0010] The balloon comprises an inner balloon and an outer balloon covering the inner balloon;

[0011] The delivery pathway includes a first delivery pathway and a second delivery pathway of the balloon ultrasonic ablation catheter. The first delivery pathway is arranged in the inner tube, or between the inner tube and the proximal single-lumen tube, and is used to deliver cooling liquid into the inner balloon. The second delivery pathway is arranged between the inner tube and the proximal single-lumen tube, and is used to deliver cooling liquid into the outer balloon through the first through hole.

[0012] Optionally, in the balloon ultrasonic ablation catheter, the first delivery passage is disposed between the proximal single-lumen tube and the inner tube, and the liquid inlet of the first delivery passage extends into the inner balloon; or,

[0013] The first delivery passage is located in the inner cavity of the inner tube, and the side wall of the inner tube has a second through hole, and the first delivery passage is connected with the inner cavity of the inner balloon through the second through hole.

[0014] Optionally, in the balloon ultrasonic ablation catheter, the minimum distance between the liquid inlet of the first delivery passage and the ultrasonic transducer is no more than 1 / 2 of the length of the ultrasonic transducer.

[0015] Optionally, in the balloon ultrasonic ablation catheter, the first delivery pathway and the second delivery pathway respectively include two delivery tubes passing through the proximal single-lumen tube and the inner tube, one of the two delivery tubes is used to introduce cooling liquid, and the other is used to discharge cooling liquid, and the distal ends of all the delivery tubes are located on the proximal side of the ultrasonic transducer, wherein the distal ends of the two delivery tubes constituting the first delivery pathway extend into the inner balloon, and the distal ends of the two delivery tubes constituting the second delivery pathway do not extend beyond the distal end of the proximal single-lumen tube.

[0016] Optionally, in the balloon ultrasonic ablation catheter, the distal end of the delivery tube constituting the first delivery pathway extends 1 to 10 cm beyond the distal end of the delivery tube constituting the second delivery pathway.

[0017] Optionally, in the balloon ultrasonic ablation catheter, the ultrasonic transducer is a single-chip crystal ultrasonic transducer or an array transducer, and the ultrasonic transducer is embedded in the outer wall of the inner tube through an insulating structural member.

[0018] The utility model also provides a cooling system, the cooling system comprising: a processor, a driving module, a control module and a data processing module; the processor is electrically connected to the driving module, the control module and the data processing module respectively to control the driving module, the control module and the data processing module to perform corresponding operations respectively;

[0019] The driving module is used to deliver cooling liquid into the inner balloon and the outer balloon of the balloon ultrasonic ablation catheter;

[0020] The control module is used to control the flow rate and pressure of the coolant in the inner balloon and the outer balloon respectively, so as to control the outer diameter of the inner balloon and the outer balloon respectively;

[0021] The data processing module is used to display in real time the flow rate and pressure of the cooling liquid in the inner balloon and the outer balloon, the outer diameter of the inner balloon and the outer balloon, and the temperature of the ultrasonic transducer, and to feed back the displayed results to the processor and the ablation device in real time.

[0022] Optionally, in the cooling system, the control module includes an internal cooling module and an external cooling module, the internal cooling module is used to control the flow rate and pressure of the cooling liquid in the inner balloon to control the outer diameter of the inner balloon, and the external cooling module is used to control the flow rate and pressure of the cooling liquid in the outer balloon to control the outer diameter of the outer balloon.

[0023] The utility model also provides an ultrasonic ablation system, characterized in that it comprises:

[0024] The balloon ultrasound ablation catheter as described in any one of the above items;

[0025] A cooling system as described in any one of the above items; and

[0026] An ablation device is used to adjust the output power of the ultrasonic transducer in real time according to feedback from the cooling system.

[0027] In summary, the utility model provides a balloon ultrasonic ablation catheter, a cooling system and an ultrasonic ablation system. Each layer structure of the balloon ultrasonic ablation catheter balloon can be independently supplied with cooling liquid to adapt to different blood vessel size requirements, thereby solving the problem of frequent replacement of the ultrasonic ablation catheter due to different blood vessel sizes during use. At the same time, the double-layer cooling liquid improves the cooling effect to a certain extent, thereby improving the efficiency and safety of the operation. In addition, the balloon ultrasonic ablation catheter balloon can not only realize transducer cooling, but also fix the transducer in the center in different blood vessel diameters, thereby realizing ultrasonic ablation of stable depth. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention, wherein:

[0029] Figure 1 A schematic diagram of the structural anatomy of a balloon ultrasonic ablation catheter provided in an embodiment of the utility model;

[0030] Figure 2 A schematic diagram of the structure of the balloon ultrasonic ablation catheter provided by an embodiment of the utility model after the balloon is removed;

[0031] Figure 3 A schematic diagram of the overall structure of a balloon ultrasonic ablation catheter provided in an embodiment of the utility model;

[0032] Figure 4 A schematic diagram of the composition of an ultrasonic ablation catheter provided in an embodiment of the utility model;

[0033] Figures 5 to 7 A schematic diagram of the structure of a balloon ultrasonic ablation catheter provided by an embodiment of the utility model in different application scenarios;

[0034] The descriptions of the reference numerals are as follows:

[0035] 1-balloon ultrasonic ablation catheter; 2-ablation device; 3-cooling liquid passage; 4-handle; 5-main tube; 6-single-lumen tube; 7-double-layer balloon; 8-electrical signal passage; 9-cooling system; 10-excitation system; 11-processor; 12-driving module; 13-control module; 14-data processing module; 15-internal cooling module; 16-external cooling module;

[0036] 17-distal single-lumen tube; 18-first through hole; 19-proximal single-lumen tube; 21-first delivery pathway; 22-second delivery pathway; 23-inner tube; 24-ultrasonic transducer; 25-inner balloon; 26-outer balloon. DETAILED DESCRIPTION

[0037] The utility model is further described in detail below in conjunction with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the utility model will be clearer. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the utility model. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different proportions are used. It should also be understood that, unless otherwise specified or pointed out, the terms "first", "second", "third" and the like in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, rather than to represent the logical relationship or sequential relationship between the various components, elements, steps, etc., and thus, the features defined as "first", "second", and "third" can explicitly or implicitly include one or at least two of the features.

[0038] In this application document, "proximal" and "distal" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is close to the doctor during normal operation, and "distal" generally refers to the end that first enters the patient's body.

[0039] See also Figure 4 Combined with Figures 1 to 3 An embodiment of the utility model provides a balloon ultrasonic ablation catheter 1, which includes: a catheter body, an ultrasonic transducer 24, a double-layer balloon 7 and a cooling liquid delivery unit, and the catheter body includes an inner tube 23 and a single-lumen tube 6.

[0040] Specific as Figures 1 to 3As shown in , the single-lumen tube 6 includes a distal single-lumen tube 17 and a proximal single-lumen tube 19, the distal single-lumen tube 17 and the proximal single-lumen tube 19 are spaced apart in the axial direction, the inner tube 23 is sequentially penetrated through the proximal single-lumen tube 19 and the distal single-lumen tube 17 from the proximal end to the distal end, and the side wall of the proximal single-lumen tube 19 or the distal single-lumen tube 17 has a first through hole 18. The ultrasonic transducer 24 is fixed on the inner tube 23 between the proximal single-lumen tube 19 and the distal single-lumen tube 17. The double-layer balloon 7 is fixed between the proximal single-lumen tube 19 and the distal single-lumen tube 17, and is arranged around the inner tube 23. The double-layer balloon 7 includes an inner balloon 25 and an outer balloon 26; the coolant delivery unit has a first delivery passage 21 and a second delivery passage 22. The first delivery passage 21 is arranged in the inner tube 23, or between the inner tube 23 and the proximal single-lumen tube 19, and is used to deliver coolant to the inner balloon 25. The second delivery passage 22 is arranged between the inner tube 23 and the proximal single-lumen tube 19, and is used to deliver coolant to the outer balloon 26 through the first through hole 18.

[0041] like Figure 4 As shown in the figure, when the balloon ultrasonic ablation catheter 1 is used in conjunction with the cooling system 9 and the ablation device 2, the ablation device 2 is electrically connected to the ultrasonic transducer 24, and the output power of the ultrasonic transducer 24 is adjusted in real time to achieve different ablation depths. The cooling liquid passage 3 of the cooling system 9 is connected to the first delivery passage 21 and the second delivery passage 22, and cooling liquid is pumped into the double-layer balloon 7 at the distal end of the catheter, and the cooling liquid at the end of the cycle can also be received and stored.

[0042] For further information, see Figure 4 The proximal end of the balloon ultrasonic ablation catheter 1 may be provided with a handle 4, and the handle 4 is provided with an electrical interface and a coolant passage interface, so as to facilitate the electrical connection between the ultrasonic transducer 24 and the ablation device 2, and the communication between the first delivery passage 21 and the second delivery passage 22 and the coolant passage 3 of the cooling system 9. In addition to the inner tube 23, the distal single-lumen tube 17, and the proximal single-lumen tube 19, the catheter body may also include a main body tube 5, the handle 4 is provided at the proximal end of the main body tube 5, and the distal end of the main body tube 5 is transitionally connected to the proximal single-lumen tube 19.

[0043] For better, see Figure 2 The liquid inlet of the first delivery passage 21 is as close to the ultrasonic transducer 24 as possible in terms of distance to improve the cooling efficiency, but cannot be completely close to the ultrasonic transducer 24 to prevent affecting the transmission of ultrasonic energy. In specific configuration, the minimum distance between the liquid inlet of the first delivery passage 21 and the ultrasonic transducer 24 is not greater than 1 / 2 of the length of the ultrasonic transducer 24.

[0044] Optionally, the first delivery passage 21 is arranged between the proximal single-lumen tube 19 and the inner tube 23, and the liquid inlet of the first delivery passage 21 extends into the inner balloon 25, or the first delivery passage 21 is located in the inner tube 23. For example, the inner cavity of the inner tube 23 constitutes the first delivery passage 21, and the side wall of the inner tube 23 has a second through hole (not shown), and the first delivery passage 21 is connected with the inner cavity of the inner balloon 25 through the second through hole. In this way, the cooling liquid delivered from the first delivery passage 21 can flow into the inner balloon 25 through the second through hole.

[0045] In addition, optionally, the first delivery passage 21 is also used to discharge the coolant in the inner balloon 25; the second delivery passage 22 is also used to discharge the coolant in the outer balloon 26. That is, the first delivery passage 21 and the second delivery passage 22 have a liquid outlet in addition to a liquid inlet. Optionally, the liquid inlets of the first delivery passage 21 and the second delivery passage 22 can be located at the distal side of the ultrasonic transducer 24, or at the proximal side of the ultrasonic transducer 24. In order to have a good coolant circulation effect, preferably, the liquid discharge ports of the first delivery passage 21 and the second delivery passage 22 are located at the proximal side of the ultrasonic transducer 24. When the liquid inlets of the first delivery passage 21 and the second delivery passage 22 are located at the distal side of the ultrasonic transducer, a "far in and near out" coolant circulation passage can be formed, further improving the coolant circulation effect. However, since the specific setting of the first delivery passage 21 and the second delivery passage 22 involves the arrangement of the internal structure of the catheter, for example, if the liquid outlets of the first delivery passage 21 and the second delivery passage 22 are set on the distal side of the ultrasonic transducer 24, how to pass the cooling liquid to the corresponding liquid outlets without interfering with the setting or operation of the ultrasonic transducer 24 is the key.

[0046] Based on the above considerations, in this embodiment, preferably, the first delivery passage 21 and the second delivery passage 22 may include two delivery tubes respectively inserted between the proximal single-lumen tube 19 and the inner tube 23, one of the two delivery tubes is used to pass the cooling liquid, and the other is used to discharge the cooling liquid, and the distal ends of all the delivery tubes are located on the proximal side of the ultrasonic transducer 24, wherein the distal ends of the two delivery tubes constituting the first delivery passage 21 extend into the inner balloon 25, and the distal ends of the two delivery tubes constituting the second delivery passage 22 do not extend beyond the distal end of the proximal single-lumen tube 19. In some specific embodiments, the distal end of the delivery tube constituting the second delivery passage 22 extends 1 to 10 cm beyond the distal end of the delivery tube constituting the first delivery passage 21.

[0047] Optionally, the two conveying tubes of the first conveying passage 21 / the second conveying passage 22 have the same axial extension length and are symmetrically distributed about the axis of the inner tube 23; or, the two conveying tubes of the first conveying passage 21 / the second conveying passage 22 have different axial extension lengths, and the conveying tube with the larger axial extension length is used to convey the coolant, and the conveying tube with the smaller axial extension length is used to discharge the coolant.

[0048] For the convenience of description, the two delivery tubes of the first delivery passage 21 are distinguished as the first delivery tube and the second delivery tube, and the two delivery tubes of the second delivery passage 22 are distinguished as the third delivery tube and the fourth delivery tube. The first delivery tube, the second delivery tube, the third delivery tube and the fourth delivery tube are all inserted between the proximal single-lumen tube 19 and the inner tube 23. The difference is that the distal ends of the first delivery tube and the second delivery tube extend out of the proximal single-lumen tube 19 and extend into the inner balloon 25, approaching the ultrasonic transducer 24 on the proximal side of the ultrasonic transducer 24, but do not affect the ultrasonic energy transmission of the ultrasonic transducer 24, and the distal ends of the third delivery tube and the fourth delivery tube remain in the proximal single-lumen tube 19 and do not extend into the inner balloon 25. Therefore, the first delivery tube and the second delivery tube have a larger axial length than the third delivery tube and the fourth delivery tube, and the difference in length is the above-mentioned 1 to 10 cm.

[0049] In some other embodiments, the cooling liquid in the inner balloon 25 and the outer balloon 26 may also be directly discharged into the body without being recycled.

[0050] Optionally, the ultrasonic transducer 24 is a single crystal ultrasonic transducer or an array transducer. The ultrasonic transducer 24 can be embedded in the side wall of the inner tube 23 through an insulating structural member, and the insulating structural member can be made of a polymer material such as high-density polyethylene. The ultrasonic transducer 24 wire can be set inside the inner tube 23 for signal energy transmission, and is electrically connected to the ablation device 2 through the electrical interface on the handle 4.

[0051] In this embodiment, the inner tube 23 can be made of a single-layer / double-layer multi-strand braided spring tube, which has good mechanical properties and torque conductivity. The distal single-lumen tube 17 and the proximal single-lumen tube 19 can be composed of a mesh braided wire structure without an inner layer of nickel-titanium wire or stainless steel wire, and are only softer single-lumen tubes made of Pebax (polyamide) materials to reduce the overall hardness of the distal end of the catheter and improve the placement of the catheter. The main tube 5 is a slender tube body, which has a supporting tube body to prevent deformation and has the function of transmitting the catheter torque in proportion.

[0052] In addition, the balloon in this embodiment can be a free combination of compliant, semi-compliant and non-compliant balloons, such as: the inner balloon 25 is compliant, the outer balloon 26 is non-compliant; the inner and outer balloons 26 are both semi-compliant or compliant, etc. Compliance refers to the expansion amplitude with the increase of pressure. The non-compliant balloon is rigidly expanded and the radial expansion is only 2%-10%; the semi-compliant balloon can expand radially by 10%-30%; the compliant balloon can expand radially by 30%-300%. The balloon material can be Pebax, polyamide, PET, polyurethane, etc. The balloon can contain a braided wire structure made of, for example, stainless steel to increase the bursting pressure while maintaining flexibility and low profile.

[0053] See also Figure 4 The embodiment of the utility model also provides a cooling system 9, which includes: a processor 11, a driving module 12, a control module 13 and a data processing module 14; the processor 11 is electrically connected to the driving module 12, the control module 13 and the data processing module 14 respectively, so as to control the driving module 12, the control module 13 and the data processing module 14 to perform corresponding operations respectively; the driving module 12 is used to transport and recover cooling liquid into the inner balloon 25 and the outer balloon 26; the control module 13 is used to control the flow rate and pressure of the cooling liquid in the inner balloon 25 and the outer balloon 26 respectively, so as to control the outer diameter of the inner balloon 25 and the outer balloon 26 respectively; the data processing module 14 is used to display the flow rate and pressure of the cooling liquid in the inner balloon 25 and the outer balloon 26, the outer diameter of the inner balloon 25 and the outer balloon 26, and the temperature of the ultrasonic transducer 24 in real time, and feed back the displayed results to the processor 11 and the ablation device 2 in real time.

[0054] It should be noted here that the cooling system 9 provided in this embodiment can be used in conjunction with the balloon ultrasonic ablation catheter 1 provided in this embodiment, and can also be used in conjunction with other double-layer balloons, as long as the pressures of the inner and outer balloons of the double-layer balloon can be controlled separately.

[0055] Furthermore, the control module 13 may include an internal cooling module 15 and an external cooling module 16. The internal cooling module 15 is used to control the flow rate and pressure of the coolant in the inner balloon 25 to control the outer diameter of the inner balloon 25, and the external cooling module 16 is used to control the flow rate and pressure of the coolant in the outer balloon 26 to control the outer diameter of the outer balloon 26.

[0056] It can be understood that the functional modules of the cooling system 9 can be combined in one device, or any one of the modules can be split into multiple sub-modules, or at least part of the functions of one or more modules can be combined with at least part of the functions of other modules and implemented in one functional module.

[0057] The present invention also provides an ultrasonic ablation system, comprising:

[0058] The balloon ultrasound ablation catheter 1 as described in this embodiment;

[0059] A cooling system 9 as described in this embodiment; and

[0060] The ablation device 2 is used to adjust the output power of the ultrasonic transducer 24 in real time according to the feedback of the cooling system 9. The ablation device 2 includes an excitation system, which can adjust the output power of the ultrasonic transducer 24 in real time to achieve different ablation depths, and can set and display the ablation power and ablation time accordingly.

[0061] Optionally, the cooling system 9 and the ablation device 2 are provided separately, or the cooling system 9 and the ablation device 2 are integrated into one. For example, various functional modules of the cooling system 9 may be integrated into the ablation device 2 .

[0062] Figures 5 to 7 The schematic diagram of the structure of the balloon ultrasonic ablation catheter 1 provided by the embodiment of the utility model in different application scenarios; wherein, Figure 5 It is a schematic diagram of the distal end of the catheter and the balloon structure when the catheter is in the delivery state. The delivery state includes the state when it initially enters the body and when it changes position after ablation. At this time, there is no cooling liquid in the inner balloon 25 and the outer balloon 26, and the ultrasonic transducer 24 is in a non-working state. At this time, the inner balloon 25 and the outer balloon 26 are both tightly attached to the ultrasonic transducer 24 and the inner tube 23. The overall diameter of the balloon is similar to the diameter of the single-lumen tube 6, which can maintain the compliance of the catheter and facilitate smooth movement in the blood vessel. Figure 6The inner balloon 25 at the distal end of the catheter is filled with cooling liquid, and the outer balloon 26 is in a state without cooling liquid. At this time, the catheter is at the distal end of the primary branch or the secondary branch of the renal artery, and the blood vessel diameter is 2-4mm. At this time, the inner balloon 25 can be selected for cooling through the cooling system 9 operation interface, and the flow rate and pressure of the inner balloon 25 can be adjusted. After completion, the cooling system 9 delivers the cooling circulating liquid to the inner balloon 25 at the distal end of the catheter through the cooling liquid passage 3 and the first delivery passage 21 through the driving module 12. The inner balloon 25 is inflated to a suitable size (matching the blood vessel size, which can be slightly larger than the blood vessel size) due to the hydraulic pressure. At this time, the outer balloon 26 is also closely attached to the inner balloon 25 due to the indirect effect of the hydraulic pressure. The cooling liquid can be returned to the cooling system 9 through the first delivery passage 21 for storage, realizing uninterrupted circulation of the cooling liquid, so as to reduce the working temperature of the transducer in real time and avoid the occurrence of safety events such as thrombosis caused by excessive transducer temperature. When the inner balloon 25 is inflated and the cooling liquid circulation is stabilized, the ultrasonic energy is delivered through the excitation system 10. After ablation of this point is completed, the cooling liquid in the balloon should be recovered and the distal end of the catheter should be changed to the delivery state ( Figure 5 state) and then perform ultrasonic ablation at the next site. Figure 6 The balloon 25 in the catheter is filled with cooling liquid, and the space between the outer balloon 26 and the inner balloon 25 is also filled with cooling liquid. At this time, the catheter should be in the main renal artery, or the bifurcation between the renal artery and the abdominal aorta, and the blood vessel diameter is 4-6mm. The operation steps are as follows: first, through the cooling system 9 operation interface, select the cooling of the inner balloon 25, adjust the flow rate and pressure of the cooling liquid in the inner balloon 25, and the cooling system 9 delivers the cooling circulating liquid through the cooling liquid passage 3 and the first delivery passage 21 to the inner balloon 25 at the distal end of the catheter through the driving module 12 and the inner cooling module. The inner balloon 25 is inflated to a suitable size (less than or equal to the rated bursting pressure RB) due to hydraulic pressure. P), at this time, through the cooling system 9 operation interface, select the cooling of the outer balloon 26, adjust the flow rate and pressure of the coolant in the outer balloon 26, and the cooling system 9 can transport the cooling circulating liquid through the coolant passage 3 and the outer balloon 26 coolant pipeline through the first through hole 18 to the distal outer balloon 26 through the driving module 12 and the external cooling module. At this time, since there is a certain hydraulic pressure in the inner balloon 25, the outer balloon 26 will expand and fill outward, and the outer balloon 26 will expand as a whole to a suitable size (matching the blood vessel size, which can be slightly larger than the blood vessel size). At this time, the corresponding ultrasonic ablation can be performed at this position by controlling the excitation system 10 of the ablation device 2.

[0063] To summarize, the balloon ultrasonic ablation catheter, cooling system and ultrasonic ablation system provided by the embodiments of the utility model, each layer structure of the balloon ultrasonic ablation catheter balloon can be independently supplied with cooling liquid to adapt to different blood vessel size requirements, thereby solving the problem of frequent replacement of the ultrasonic ablation catheter due to different blood vessel sizes during use. At the same time, the double-layer cooling liquid improves the cooling effect to a certain extent, thereby improving the efficiency and safety of the operation. In addition, the balloon ultrasonic ablation catheter balloon can not only realize transducer cooling, but also fix the transducer in the center in different blood vessel diameters, thereby realizing ultrasonic ablation at a stable depth.

[0064] The above description is only a description of the preferred embodiment of the utility model, and is not any limitation on the scope of the utility model. Any changes and modifications made by ordinary technicians in the field of the utility model based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A balloon ultrasonic ablation catheter, characterized in that: include: A catheter body, the catheter body comprising an inner tube, a distal single-lumen tube and a proximal single-lumen tube, the distal single-lumen tube and the proximal single-lumen tube are spaced apart in the axial direction, and the inner tube is sequentially passed through the proximal single-lumen tube and the distal single-lumen tube from the proximal end to the distal end; an ultrasonic transducer fixed on the inner tube between the proximal single-lumen tube and the distal single-lumen tube; a balloon, which is a double-layer or multi-layer structure, fixed between the proximal single-lumen tube and the distal single-lumen tube and arranged around the inner tube; and, The cooling liquid delivery unit has a delivery passage, and the delivery passage is used to independently introduce cooling liquid into each layer structure of the balloon.

2. The balloon ultrasonic ablation catheter according to claim 1, characterized in that: The side wall of the proximal single-lumen tube or the distal single-lumen tube has a first through hole; The balloon comprises an inner balloon and an outer balloon covering the inner balloon; The delivery pathway includes a first delivery pathway and a second delivery pathway of the balloon ultrasonic ablation catheter. The first delivery pathway is arranged in the inner tube, or between the inner tube and the proximal single-lumen tube, and is used to deliver cooling liquid into the inner balloon. The second delivery pathway is arranged between the inner tube and the proximal single-lumen tube, and is used to deliver cooling liquid into the outer balloon through the first through hole.

3. The balloon ultrasonic ablation catheter according to claim 2, characterized in that: The first delivery passage is disposed between the proximal single-lumen tube and the inner tube, and the liquid inlet of the first delivery passage extends into the inner balloon; or, The first delivery passage is located in the inner cavity of the inner tube, and the side wall of the inner tube has a second through hole, and the first delivery passage is connected with the inner cavity of the inner balloon through the second through hole.

4. The balloon ultrasonic ablation catheter according to claim 2, characterized in that: The minimum distance between the liquid inlet of the first delivery passage and the ultrasonic transducer is no more than 1 / 2 of the length of the ultrasonic transducer.

5. The balloon ultrasonic ablation catheter according to claim 2, characterized in that: The first delivery pathway and the second delivery pathway respectively include two delivery tubes passing through the proximal single-lumen tube and the inner tube, one of the two delivery tubes is used for introducing cooling liquid, and the other is used for discharging cooling liquid, and the distal ends of all the delivery tubes are located on the proximal side of the ultrasonic transducer, wherein the distal ends of the two delivery tubes constituting the first delivery pathway extend into the inner balloon, and the distal ends of the two delivery tubes constituting the second delivery pathway do not extend beyond the distal end of the proximal single-lumen tube.

6. The balloon ultrasonic ablation catheter according to claim 5, characterized in that: The distal end of the delivery tube constituting the first delivery passage extends beyond the distal end of the delivery tube constituting the second delivery passage by 1 to 10 cm.

7. The balloon ultrasonic ablation catheter according to claim 1, characterized in that: The ultrasonic transducer is a single crystal ultrasonic transducer or an array transducer, and the ultrasonic transducer is embedded in the outer wall of the inner tube through an insulating structural member.

8. A cooling system, characterized in that: The cooling system includes: a processor, a driving module, a control module and a data processing module; the processor is electrically connected to the driving module, the control module and the data processing module respectively to control the driving module, the control module and the data processing module to perform corresponding operations respectively; The driving module is used to deliver cooling liquid into the inner balloon and the outer balloon of the balloon ultrasonic ablation catheter; The control module is used to control the flow rate and pressure of the coolant in the inner balloon and the outer balloon respectively, so as to control the outer diameter of the inner balloon and the outer balloon respectively; The data processing module is used to display in real time the flow rate and pressure of the cooling liquid in the inner balloon and the outer balloon, the outer diameters of the inner balloon and the outer balloon, and the temperature of the ultrasonic transducer of the balloon ultrasonic ablation catheter set in the inner balloon, and to feed back the displayed results to the processor and ablation device in real time.

9. The cooling system according to claim 8, characterized in that The control module includes an inner cooling module and an outer cooling module. The inner cooling module is used to control the flow rate and pressure of the cooling liquid in the inner balloon to control the outer diameter of the inner balloon. The outer cooling module is used to control the flow rate and pressure of the cooling liquid in the outer balloon to control the outer diameter of the outer balloon.

10. An ultrasonic ablation system, characterized in that: include: The balloon ultrasonic ablation catheter according to any one of claims 1 to 7; A cooling system as claimed in claim 8 or 9; and An ablation device is used to adjust the output power of the ultrasonic transducer in real time according to feedback from the cooling system.

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