An ultrasonic ablation balloon, an ultrasonic ablation catheter, and an ultrasonic ablation system

Abstract

This invention discloses an ultrasonic ablation balloon, an ultrasonic ablation catheter, and an ultrasonic ablation system, belonging to the field of medical device technology. The ultrasonic ablation balloon includes a balloon wall, an ultrasonic transducer, and a protective colloid. The balloon wall encloses the balloon to form an ablation cavity. The ultrasonic transducer is located within the ablation cavity, and cooling water is filled around the transducer, forming a first protective layer. The protective colloid is disposed around the first protective layer, forming a second protective layer. The protective colloid of the second protective layer has a certain thermal resistance and, combined with the cooling water of the first protective layer, forms a double protective barrier, effectively protecting the blood vessel wall and preventing damage during ultrasonic ablation. The protective colloid of the second protective layer also has a certain acoustic impedance, which helps to adjust the focusing depth and control the coagulation thickness, thereby adjusting the ultrasonic focusing depth and protecting the tissues and muscles surrounding the renal artery.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an ultrasonic ablation balloon, an ultrasonic ablation catheter, and an ultrasonic ablation system. Background Technology

[0002] Hypertension, a prevalent cardiovascular disease worldwide, poses a significant threat to human health and safety due to its high incidence and serious complications. It is defined as a resting systolic blood pressure (SBP) of 140 mmHg or higher and a diastolic blood pressure (DBP) of 90 mmHg or higher in adults without the use of antihypertensive medication. Hypertension is not only a leading cause of all-cause mortality globally, but its control is also increasingly challenging and complex.

[0003] Despite significant advancements in antihypertensive drug development in modern medicine, offering patients a variety of options, the control of hypertension remains a serious concern. Lifestyle changes and poor medication adherence are key reasons for ineffective hypertension control. Even more challenging is that a considerable proportion (approximately 15%–18%) of hypertensive patients fail to achieve effective blood pressure control, developing refractory hypertension (RH). Patients with refractory hypertension often have poor prognoses and frequently experience damage to vital target organs such as the heart, brain, and kidneys, further exacerbating the harmful effects of hypertension.

[0004] In recent years, the role of the sympathetic nervous system in the pathogenesis of hypertension has received increasing attention. Studies have shown that excessive activation of the sympathetic nervous system not only promotes renin secretion but also enhances renal tubular reabsorption of sodium, leading to sodium retention, which is one of the key factors in the occurrence and maintenance of hypertension. In order to explore more effective treatment methods, scholars have attempted to directly remove the sympathetic nerves through surgery, but this method has not been widely used due to high mortality and serious complications.

[0005] With the rapid development of electrophysiological technology, catheter-based renal sympathetic nerve ablation (RDN) has emerged as an innovative treatment method. This technique selectively destroys the sympathetic nerves around the renal artery using radiofrequency or ultrasound energy, thereby reducing systemic sympathetic nerve activity and achieving effective treatment for refractory hypertension. Among these techniques, percutaneous renal artery radiofrequency ablation has attracted much attention due to its simplicity and significant antihypertensive effect.

[0006] However, existing renal artery ablation techniques still have certain limitations. In particular, when the transducer is used for ablation within the renal artery, the ultrasound energy used may damage the vessel wall, which undoubtedly increases the risk of surgery and the incidence of complications. Therefore, addressing the shortcomings of current techniques and reducing vascular damage is a technical problem that needs to be solved. Summary of the Invention

[0007] The purpose of this invention is to provide an ultrasonic ablation balloon, an ultrasonic ablation catheter, and an ultrasonic ablation system to solve the problems existing in the prior art. Cooling water filling the area around the ultrasonic transducer forms a first protective layer, and a protective colloid disposed around the first protective layer forms a second protective layer. The protective colloid of the second protective layer has a certain thermal resistance and combines with the cooling water of the first protective layer to form a double protective barrier, which can effectively protect the blood vessel wall and avoid damage to the blood vessel wall during ultrasonic ablation.

[0008] To achieve the above objectives, the present invention provides the following solution:

[0009] The present invention provides an ultrasonic ablation balloon, comprising a balloon wall, an ultrasonic transducer, and a protective colloid. The balloon wall encloses the balloon to form an ablation cavity. The ultrasonic transducer is located inside the ablation cavity, and cooling water is filled around the ultrasonic transducer to form a first protective layer. The protective colloid is disposed around the first protective layer to form a second protective layer.

[0010] In one embodiment, the protective colloid is polyethylene glycol, polyvinyl alcohol, or polyvinylpyrrolidone.

[0011] In one embodiment, a first receiving cavity is formed between the balloon wall and the blood vessel wall at the location of the balloon wall, and the first receiving cavity is used to fill the protective colloid.

[0012] In one embodiment, the balloon wall includes an inner balloon wall and an outer balloon wall, and a second receiving cavity is formed between the inner balloon wall and the outer balloon wall, the second receiving cavity being used to fill the protective colloid.

[0013] In one embodiment, the inner wall of the balloon is not elastic or the elasticity of the inner wall of the balloon is less than that of the outer wall of the balloon.

[0014] This invention provides an ultrasonic ablation catheter, comprising a catheter, a tip tube, and a balloon as described above. The catheter includes an inner tube and an outer tube, the distal end of the inner tube extending out of the outer tube. The interior of the inner tube is a guidewire lumen, and a water channel is formed between the inner tube and the outer tube. The tip tube has an internal channel, and the guidewire lumen communicates with the internal channel. The balloon is disposed on the outer diameter side of the portion of the inner tube extending out of the outer tube. An ultrasonic transducer is sleeved on the inner tube. The distal end of the balloon is connected to the wall of the tip tube, and the proximal end of the balloon is connected to the wall of the outer tube. The water channel communicates with the ablation chamber.

[0015] In one embodiment, the water channel is divided into an inlet channel and an outlet channel by a partition, and the inlet channel is provided with a wire for connecting the ultrasonic transducer.

[0016] In one embodiment, the device further includes a conduit seat connected to the proximal end of the conduit. The conduit seat includes an inlet port, an outlet port, and a plug. The inlet port is connected to the inlet channel, the outlet port is connected to the outlet channel, and the plug is connected to the wire.

[0017] In one embodiment, the water inlet is a male connector and the water outlet is a female connector.

[0018] The present invention provides an ultrasonic ablation system, including a microcatheter, an ultrasonic ablation catheter as described above, and a device host. The microcatheter is used to inject the protective colloid. The device host includes an ultrasonic controller and a circulating water pump. The ultrasonic controller is used to connect to the ultrasonic transducer, and the circulating water pump is used to connect to the water channel.

[0019] The present invention achieves the following technical effects compared to the prior art:

[0020] In this invention, the ultrasonic transducer is positioned within the ablation cavity enclosed by the balloon wall. Cooling water surrounding the transducer forms a first protective layer, and a protective colloid surrounding the first protective layer forms a second protective layer. This second protective colloid possesses a certain thermal resistance and, combined with the cooling water in the first protective layer, forms a double protective barrier, effectively protecting the blood vessel wall and preventing damage during ultrasonic ablation. Furthermore, the protective colloid in the second protective layer has a certain acoustic impedance, which helps adjust the focusing depth and control the coagulation thickness, thereby regulating the ultrasonic focusing depth and protecting the tissues and muscles surrounding the renal artery. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the ultrasonic ablation catheter in an embodiment of the present invention;

[0023] Figure 2 for Figure 1 Cross-sectional view of the middle conduit;

[0024] Figure 3 This is a schematic diagram of the protective colloid on the outer wall of the balloon in an embodiment of the present invention;

[0025] Figure 4 This is a schematic diagram of the protective colloid between the inner wall and the outer wall of the balloon in an embodiment of the present invention;

[0026] Figure 5 This is a schematic diagram of the ultrasonic ablation system in an embodiment of the present invention;

[0027] Figure 6 This is a schematic diagram illustrating the usage instructions for injecting the protective colloid in an embodiment of the present invention;

[0028] The components include: 1. Main unit of the device; 2. Ultrasonic ablation catheter; 3. Handle; 4. Double row of tubing; 5. Infusion tubing; 6. Water bag; 7. Syringe; 8. Injection bottle; 9. Microcatheter; 10. Puncture cup; 20. Blood vessel wall;

[0029] 21. Tip tube; 22. Ultrasonic ablation balloon; 23. Ultrasonic transducer; 24. Catheter; 25. Stress protection sleeve; 26. Catheter seat; 27. Plug; 28. Water inlet; 29. ​​Water outlet;

[0030] 221. Balloon wall; 2211. Outer wall of the balloon; 2212. Inner wall of the balloon; 222. Protective colloid;

[0031] 231. Wire;

[0032] 241. Inner tube; 242. Outer tube; 243. Guide wire cavity; 244. Water inlet channel; 245. Water outlet channel; 246. Baffle. Detailed Implementation

[0033] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] The purpose of this invention is to provide an ultrasonic ablation balloon, an ultrasonic ablation catheter, and an ultrasonic ablation system to solve the problems existing in the prior art. Cooling water filling around the ultrasonic transducer forms a first protective layer, and a protective colloid disposed around the first protective layer forms a second protective layer. The protective colloid of the second protective layer has a certain thermal resistance and combines with the cooling water of the first protective layer to form a double protective barrier, which can effectively protect the blood vessel wall and avoid damage to the blood vessel wall during ultrasonic ablation.

[0035] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0036] In this invention, the distal end refers to the end furthest from the surgeon, and the proximal end refers to the end closest to the surgeon.

[0037] like Figures 1-6As shown, this invention provides an ultrasonic ablation balloon, including a balloon wall 221, an ultrasonic transducer 23, and a protective colloid 222. The balloon wall 221 encloses and forms an ablation cavity. Depending on whether the balloon wall 221 is elastic and the degree of elasticity, the ultrasonic ablation balloon 22 can be classified as a compliant balloon, a semi-compliant balloon, or a non-compliant balloon. If it is a non-compliant balloon, the diameter of the ultrasonic ablation balloon 22 can be 3mm to 8mm, and the effective length can be 8mm to 20mm, depending on the size distribution of the renal artery, and it has multiple different specifications. If it is a compliant balloon, it can be of one specification, and the diameter of the ultrasonic ablation balloon 22 can be adjusted by adjusting the pressure to meet different renal artery structures. If it is a semi-compliant balloon, it is between a compliant balloon and a non-compliant balloon, that is, the diameter of the ultrasonic ablation balloon 22 can be adjusted, but the adjustment range is smaller than that of a compliant balloon. The ultrasound transducer 23 is located within the ablation chamber, surrounded by cooling water. The cooling water within the ablation chamber completely submerges the ultrasound transducer 23, facilitating its isolation and cooling. This cooling water protection mechanism keeps the temperature of the vessel wall 20 in contact with the balloon wall 221 low, protecting it from damage. Thus, the cooling water forms a first protective layer. A protective colloid 222 is disposed around the first protective layer. It can be attached to the outside of the balloon wall 221 or placed within the balloon wall 221's own interlayer. The protective colloid 222 forms a protective barrier of a certain thickness, ranging from 0.5mm to 2mm. The protective colloid 222 has a certain thermal resistance, effectively protecting the vessel wall 20 from damage. Therefore, the protective colloid 222 forms a second protective layer.

[0038] In this invention, the ultrasonic transducer 23 is disposed within the ablation cavity enclosed by the balloon wall 221. Cooling water filling the area around the ultrasonic transducer 23 forms a first protective layer. A protective colloid 222 disposed around the first protective layer forms a second protective layer. The protective colloid 222 of the second protective layer has a certain thermal resistance and combines with the cooling water of the first protective layer to form a double protective barrier, which can effectively protect the blood vessel wall 20 and prevent damage to the blood vessel wall 20 during ultrasonic ablation.

[0039] In one embodiment, the protective colloid 222 is made of polyethylene glycol, polyvinyl alcohol, or polyvinylpyrrolidone, etc.

[0040] In one embodiment, adjusting the thickness of the protective colloid 222 can adjust the acoustic impedance and thus the focusing depth. The principle is similar to adjusting the focal point by adjusting the thickness of a convex lens. By controlling the injection amount of the protective colloid 222, the coagulation thickness can be controlled, thereby adjusting the ultrasound focusing depth. This can prevent ultrasound from focusing at a long distance and protect the tissues and muscles around the renal artery.

[0041] In one implementation, such as Figure 3 and Figure 6As shown, a first receiving cavity is formed between the balloon wall 221 and the blood vessel wall 20 at the location of the balloon wall 221. The first receiving cavity is used to fill the protective colloid 222. Before filling the protective colloid 222, the microcatheter 9 needs to be inserted from the femoral artery into the renal artery through the guiding tube. When filling the protective colloid 222, the puncture cup 10 is first installed on the injection bottle 8. The protective colloid 222 in the injection bottle 8 is drawn into the syringe 7 through the puncture cup 10. Then, the syringe 7 is connected to the microcatheter 9, and a small amount of protective colloid 222 is injected into the area around the ultrasound ablation balloon 22 through the thinner microcatheter 9. Before the ultrasound ablation balloon 22 is fully inflated (inflated to a relatively low pressure, between 60% and 90% inflation), a certain gap exists between the balloon wall 221 and the vessel wall 20. Protective colloid 222 is injected proximally into the ultrasound ablation balloon 22 through the microcatheter 9. Under capillary action, the protective colloid 222 rapidly flows to the vicinity of the ultrasound ablation balloon 22 and distributes evenly. At this point, the distal end of the microcatheter 9 is located proximally to the ultrasound ablation balloon 22, 1mm to 5mm from the effective segment of the balloon. The injected protective colloid 222, upon contact with the vessel wall 20 and balloon wall 221, will briefly adhere to the vessel wall 20. Then, the protective colloid 222 will distribute evenly around the ultrasound ablation balloon 22 and rapidly coagulate. This coagulation does not generate heat. Post-procedure, the protective colloid 222 hydrolyzes and is eliminated from the body.

[0042] In one implementation, such as Figure 3 and Figure 6 As shown, the balloon wall 221 includes an inner balloon wall 2212 and an outer balloon wall 2211. A double-layered gap between the inner balloon wall 2212 and the outer balloon wall 2211 forms a second receiving cavity, which is used to fill the protective colloid 222. When filling the protective colloid 222, firstly, cooling water is filled into the ultrasonic ablation balloon 22 to inflate it. When the balloon is partially inflated (i.e., before it is completely inflated), the protective colloid 222 is injected proximally into the ultrasonic ablation balloon 22 using a microcatheter 9 until the second receiving cavity between the inner balloon wall 2212 and the outer balloon wall 2211 is filled. After the procedure, the protective colloid 222 can be withdrawn from the body using negative pressure from the microcatheter 9.

[0043] In one embodiment, when cooling water is injected into the ultrasonic ablation balloon 22, the internal pressure of the ultrasonic ablation balloon 22 tends to increase as the cooling water flow rate increases. As the pressure increases, the ultrasonic ablation balloon 22 is at risk of rupture. By controlling the internal pressure of the ultrasonic ablation balloon 22 to maintain within a suitable range, the risk of rupture of the ultrasonic ablation balloon 22 can be reduced.

[0044] In one implementation, such as Figure 3As shown, the inner wall 2212 and outer wall 2211 of the balloon wall 221 may both be inelastic, or one of them may be elastic. For example, if the inner wall 2212 is inelastic, it can limit the maximum inflation size after full inflation, thus allowing the protective colloid 222 to be smoothly filled between the inner wall 2212 and the outer wall 2211, ensuring that the protective colloid 222 fills all positions of the second receiving cavity. Alternatively, if the elasticity of the inner wall 2212 is less than that of the outer wall 2211, its expansion capacity is weaker due to the lower elasticity of the inner wall 2212. Therefore, when filling with the protective colloid 222, the outer wall 2211 can expand due to elastic deformation, ensuring the fluidity of the protective colloid 222 and allowing it to be fully filled into the second receiving cavity.

[0045] like Figures 1-6As shown, this invention provides an ultrasonic ablation catheter, including a catheter 24, a tip tube 21, an ultrasonic ablation balloon 22, and an ultrasonic transducer 23. The catheter 24 includes an inner tube 241 and an outer tube 242, with the inner tube 241 sleeved between the outer tube 242 and a supporting structure providing a gap between them. The distal end of the inner tube 241 extends out of the outer tube 242. The interior of the inner tube 241 is a guidewire lumen 243, which is used to pass through the guidewire. The guidewire lumen 243 is located in the middle position. Compared with the four-lumen structure where the guidewire lumen 243 is not in the center and requires guidewire "climbing" treatment, this invention has better guidewire passage. A water channel is formed between the inner tube 241 and the outer tube 242, which is used for flowing cooling water to achieve isolation and cooling effects. The tip tube 21 has an internal channel, and the guidewire lumen 243 communicates with the internal channel to allow the guidewire to pass through the tip tube 21, facilitating the movement of the catheter 24 along the guidewire. An ultrasonic ablation balloon 22 is positioned on the outer diameter side of the portion of the inner tube 241 extending into the outer tube 242, forming an ablation cavity between the ultrasonic ablation balloon 22 and the inner tube 241. The distal end of the ultrasonic ablation balloon 22 is connected to the wall of the tip tube 21, achieving sealing of the distal end of the ablation cavity. The proximal end of the ultrasonic ablation balloon 22 is connected to the wall of the outer tube 242, connecting the water channel to the ablation cavity, meaning that the cooling water flowing through the water channel can enter the ablation cavity inside the ultrasonic ablation balloon 22. An ultrasonic transducer 23 is located inside the ablation cavity, fitted onto the outer diameter side of the inner tube 241, and protected by cooling water, forming a first protective layer. Furthermore, a protective colloid 222 is positioned around the first protective layer, serving as a second protective layer. The protective colloid 222 of the second protective layer has a certain thermal resistance, combining with the cooling water of the first protective layer to form a double protective barrier, effectively protecting the vessel wall 20 and preventing damage to the vessel wall 20 during ultrasonic ablation. The vibration of the ultrasonic transducer 23 and the wire 231 will generate heat. The inner tube 241 supports the ultrasonic transducer 23 so that it does not directly contact the outer tube 242. At this time, the ultrasonic transducer 23 adopts a ring-shaped, circumferential ablation radiation. It can transmit ultrasonic energy over a long distance without direct contact with the renal artery intima, so as to achieve direct ablation of the sympathetic nerves of the renal artery adventitia, thereby protecting the vascular intima and potentially reducing the risk of renal artery stenosis after surgery.

[0046] This invention places an ultrasonic transducer 23 inside the ablation chamber of an ultrasonic ablation balloon 22, using ultrasonic energy to ablate the renal artery. The ablation chamber is connected to a water channel, which isolates the ultrasonic transducer 23 from the blood vessel wall 20 by water, thereby protecting the blood vessel wall 20 in contact with the ultrasonic ablation balloon 22. Combined with the protection of the protective colloid 222, a double barrier is formed. This invention not only has the characteristics of simple structure and convenient operation, but also achieves efficient and uniform ablation effect, providing a new technical means for the treatment of refractory hypertension.

[0047] In one embodiment, the ultrasonic transducer 23 can be made of piezoelectric ceramic, with a diameter of 1mm to 2mm and a length of 5mm to 10mm, and has a cylindrical structure. It can be fitted onto the outer diameter side of the inner tube 241. The frequency of the ultrasonic transducer 23 can be designed to be 7MHz to 10MHz. The ultrasonic transducer 23 can emit in a 360° circumferential manner, which can uniformly ablate the renal artery sympathetic nerves.

[0048] In one embodiment, the water channel is divided into an inlet channel 244 and an outlet channel 245 by a partition 246, and the conduit 24 forms a three-cavity structure, namely having three cavities: an inlet channel 244, an outlet channel 245, and a guide wire cavity 243, with a cross-section as shown in Figure 245. Figure 2 As shown, compared to the four-chamber structure, the cooling water pipe has a larger area under the same conduit cross-section, allowing for greater cooling water flow regulation. This enables higher excitation energy therapy, thus shortening the operation time and improving treatment efficacy. A wire 231 is installed within the water inlet channel 244. One end of the wire 231 is welded to the ultrasonic transducer 23, and the other end is welded to a plug 27. The plug 27 connects to the main unit 1 and is used to provide energy and control to the ultrasonic transducer 23. The cooling water temperature within the water inlet channel 244 is relatively lower than that within the water outlet channel 245. The wire 231, located within the water inlet channel 244, directly carries away the heat generated during operation, effectively reducing the heat generated by the wire 231 and achieving efficient cooling. This is safer and prevents treatment failure due to the wire 231 melting at high temperatures.

[0049] In one embodiment, a conduit seat 26 is also included. The conduit seat 26 is connected to the proximal end of the conduit 24. The conduit seat 26 includes a water inlet 28, a water outlet 29, and a plug 27. The water inlet 28 is connected to the water inlet channel 244 for introducing cooling water into the water inlet channel 244. The water outlet 29 is connected to the water outlet channel 245 for discharging cooling water from the water outlet channel 245. The plug 27 is connected to a wire 231 for connecting the ultrasonic transducer 23 to the ultrasonic controller.

[0050] In one embodiment, the water inlet 28 is a male connector used to connect to the water inlet pipe, and the water outlet 29 is a female connector used to connect to the water outlet pipe. The male and female connectors may have a foolproof design; for example, the male connector may be a Luer connector with an inner conical shape, while the female connector may be a Luer connector with an outer conical shape, allowing direct differentiation between the water inlet 28 and the water outlet 29. This prevents errors caused by operator oversight or forgetfulness when connecting the water inlet and outlet pipes.

[0051] In one embodiment, a stress protection sleeve 25 is provided at the connection between the conduit 24 and the conduit seat 26. The stress protection sleeve 25 protects the connection between the conduit 24 and the conduit seat 26 and prevents bending damage.

[0052] like Figures 1-6 As shown, this invention provides an ultrasonic ablation system, including a microcatheter 9, an ultrasonic ablation catheter 2 as described above, and a device host 1. The microcatheter 9 is used to inject protective colloid 222 into a first or second receiving cavity. The device host 1 includes an ultrasonic controller and a circulating water pump, and is equipped with corresponding control circuits, etc. The ultrasonic controller is used to connect to an ultrasonic transducer 23, control parameters such as the amplitude and frequency of ultrasonic waves, and excite the ultrasonic transducer 23 in a frequency-tracking manner to emit ultrasonic waves to ablate the renal artery. The circulating water pump is used to connect to a water channel to provide cooling water at a set pressure and flow rate as needed. The ultrasonic ablation system may also include a handle 3, a consumable box, and connecting cables, etc. The handle 3 is convenient for hand operation, controlling opening, closing, or adjusting parameters, etc. The consumable box is used to hold surgical consumables, and the connecting cables are used to connect various devices. The main unit 1 also includes a casing, display screen, main control board, power amplifier board, switching power supply, cooling fan, stepper motor, filter, internal connecting wires, etc. The display screen is used to display relevant parameters and other information, and the cooling fan is used to dissipate heat from the main unit 1 and the cooling water. The other devices are standard settings to achieve the corresponding functions, and will not be described in detail here.

[0053] In one embodiment, a pressure sensor is also included. The pressure sensor is installed inside the device host 1 and connected to a water channel. The pressure sensor is used to monitor the internal pressure of the ultrasonic ablation balloon 22, realize the algorithm to dynamically adjust the cooling water flow rate, and provide real-time feedback on the integrity of the ultrasonic ablation balloon 22 during the operation.

[0054] In one embodiment, the system further includes a double-row pipe 4, an infusion pipe 5, and a water bag 6. The water channel includes an inlet channel 244 and an outlet channel 245. The double-row pipe 4 has a first pipe and a second pipe arranged in parallel. The two ends of the first pipe are respectively connected to the inlet channel 244 and the outlet of the circulating water pump, and the two ends of the second pipe are respectively connected to the outlet channel 245 and the inlet of the circulating water pump. Under the action of the circulating water pump, the cooling water circulates in the cooling circulation system formed by the circulating water pump, the inlet channel 244, the ultrasonic ablation balloon 22, and the outlet channel 245. The water bag 6 is connected to the inlet of the circulating water pump to provide or replenish cooling water. The cooling water is preferably sterile water to avoid introducing bacteria into the human body.

[0055] In one embodiment, the present invention provides the following ultrasonic ablation principle and working process:

[0056] Ultrasound refers to mechanical waves with a frequency >20000Hz. When it propagates through tissues, its mechanical energy is absorbed by the body and converted into heat energy. It primarily utilizes the thermal effect of ultrasound to deliver ultrasound energy directly to the adventitia of the renal artery and the surrounding tissues. The thermal effect of ultrasound generates heat around the adventitia, thus ablating the renal sympathetic nerves.

[0057] In this procedure, the femoral artery is punctured using the Seldinger technique (percutaneous puncture). An angiography catheter is inserted into the arterial sheath and advanced under the guidance of a super-slippery guidewire to perform renal artery angiography. Subsequently, the ultrasound ablation catheter 2 is positioned at the opening of the renal artery. Based on the dimensional data of the distal, mid, and proximal ends of the artery revealed by the renal angiography, an appropriate size ultrasound ablation catheter 2 is selected. Under guidewire guidance, the ultrasound ablation catheter 2 is advanced to the renal aorta near its distal branch. A microcatheter 9 is inserted near the ultrasound ablation balloon 22 through the arterial sheath, and a protective colloid 222 is injected proximally into the ultrasound ablation balloon 22 through the microcatheter 9. The main unit 1 is then connected to begin inflating the ultrasound ablation balloon 22 until the internal pressure is maintained at 1 atm to 3 atm. The ultrasound transducer 23 is then positioned at the center of the ultrasound ablation balloon 22, i.e., the vascular center. At this point, ultrasound ablation treatment begins via the main unit 1. Ultrasonic energy is transmitted in a 360° radius, targeting a depth of 1mm to 8mm. 80% of the sympathetic nerves are concentrated in this area, achieving highly efficient nerve damage. Simultaneously, cooling water (sterile water can be used) and protective colloid 222 are applied to protect the vessel wall 20 in contact with the ultrasound ablation balloon 22, while also removing heat generated by the ultrasound transducer 23 and leads 231. Each treatment session lasts 5-20 seconds. After treatment, pressure is released, and the device gradually moves towards the renal artery opening. The next ablation location is determined based on the length of the renal artery trunk. This treatment process is repeated until both renal arteries are ablated. Generally, each renal artery can undergo 2-3 ablation treatments to interrupt the renal sympathetic nerves.

[0058] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. An ultrasonic ablation balloon, characterized by, include: The balloon wall, which encloses and forms an ablation cavity; An ultrasonic transducer is located inside the ablation cavity, and the ultrasonic transducer is surrounded by cooling water, which forms a first protective layer. And a protective colloid, which is disposed on the periphery of the first protective layer, forming a second protective layer.

2. The ultrasonic ablation balloon of claim 1, wherein: The protective colloid is made of polyethylene glycol, polyvinyl alcohol, or polyvinylpyrrolidone.

3. The ultrasonic ablation balloon of claim 1, wherein: A first receiving cavity is formed between the balloon wall and the blood vessel wall at the location of the balloon wall, and the first receiving cavity is used to fill the protective colloid.

4. The ultrasonic ablation balloon of any of claims 1-3, wherein: The balloon wall includes an inner balloon wall and an outer balloon wall, and a second receiving cavity is formed between the inner balloon wall and the outer balloon wall, the second receiving cavity being used to fill the protective colloid.

5. The ultrasonic ablation balloon of claim 4, wherein: The inner wall of the balloon is not elastic or the elasticity of the inner wall of the balloon is less than that of the outer wall of the balloon.

6. An ultrasonic ablation catheter characterized by, include: The catheter includes an inner tube and an outer tube, the distal end of the inner tube extending out of the outer tube, the interior of the inner tube being a guidewire lumen, and a water channel between the inner tube and the outer tube; A tip tube having an internal channel, the guidewire cavity communicating with the internal channel; And the balloon as described in any one of claims 1-5, wherein the balloon is disposed on the outer diameter side of the portion of the inner tube extending out of the outer tube, the ultrasonic transducer is sleeved on the inner tube, the distal end of the balloon is connected to the wall of the tip tube, the proximal end of the balloon is connected to the wall of the outer tube, and the water channel communicates with the ablation chamber.

7. The ultrasonic ablation catheter of claim 6, wherein: The water channel is divided into an inlet channel and an outlet channel by a partition, and the inlet channel is provided with a wire for connecting the ultrasonic transducer.

8. The ultrasonic ablation catheter of claim 7, wherein: It also includes a conduit seat, which is connected to the proximal end of the conduit. The conduit seat includes an inlet port, an outlet port, and a plug. The inlet port is connected to the inlet channel, the outlet port is connected to the outlet channel, and the plug is connected to the wire.

9. The ultrasonic ablation catheter of claim 8, wherein: The water inlet uses a male connector, and the water outlet uses a female connector.

10. An ultrasonic ablation system, characterized in that, include: Microcatheter for injecting the protective colloid; The ultrasonic ablation catheter as described in any one of claims 6-9; The device host includes an ultrasonic controller and a circulating water pump. The ultrasonic controller is used to connect to the ultrasonic transducer, and the circulating water pump is used to connect to the water channel.

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