An ultrasonic ablation transducer structure, ultrasonic ablation catheter, and apparatus

Abstract

This invention provides an ultrasonic ablation transducer structure, an ultrasonic ablation catheter, and a device, relating to the field of ultrasonic ablation instrument technology. It includes a transducer base and a transducer, wherein the transducer comprises a ring-shaped piezoelectric ceramic, which is sleeved and fixed to the transducer base. Both the transducer base and the piezoelectric ceramic are used for communication connection with the ultrasonic ablation host. The piezoelectric ceramic in this invention is ring-shaped and can emit ultrasonic energy in a 360° circumferential manner, uniformly ablating the renal artery sympathetic nerve. Therefore, 360° circumferential ablation of the renal artery sympathetic nerve can be achieved without rotating the transducer structure, greatly improving the uniformity of ablation and reducing the difficulty of surgical operation.

Description

Technical Field

[0001] This invention relates to the field of ultrasonic ablation device technology, and in particular to an ultrasonic ablation transducer structure, an ultrasonic ablation catheter, and a device. Background Technology

[0002] Hypertension is a leading cause of all-cause mortality worldwide, closely associated with cardiovascular disease morbidity and global mortality. Currently, over one billion people worldwide suffer from hypertension, and the prevalence and mortality rates are increasing annually, seriously impacting human health and life. Although various antihypertensive drugs are available, hypertension remains uncontrolled in a significant number of patients due to lifestyle modifications and poor medication adherence. Studies indicate that even with strict adherence to regular antihypertensive medication, approximately 15%–18% of hypertensive patients still experience poor blood pressure control, eventually developing into refractory hypertension (RH). Refractory hypertension refers to a condition where, despite lifestyle modifications and the simultaneous use of three or more appropriate doses of different antihypertensive drugs (including a diuretic), blood pressure remains above target levels. Because hypertension is difficult to control, the prognosis for these patients is often poor, and they may experience damage to target organs such as the heart, brain, and kidneys. Therefore, effectively controlling blood pressure in patients with refractory hypertension is an urgent problem to be solved.

[0003] Among the technologies known to the inventors, the pathophysiological changes caused by excessive activation of the sympathetic nervous system play a crucial role in the development and progression of hypertension. Currently, it is believed that increased renin secretion and increased sodium retention due to renal tubular sodium reabsorption caused by excessive sympathetic nerve activation are essential for the occurrence and maintenance of hypertension. As early as the mid-20th century, some scholars used surgical methods to remove sympathetic nerves to control hypertension. Although this method had some effectiveness, it was not widely adopted due to its high mortality rate and serious complications. With the development of electrophysiological technology, catheter-based renal sympathetic nerve ablation (RDN) emerged. This technique destroys the sympathetic nerves around the renal artery using radiofrequency or ultrasound energy, reducing systemic sympathetic nerve activity to some extent. It can be used to treat refractory hypertension and other diseases related to excessive sympathetic nerve activation, such as heart failure, obstructive sleep apnea, and chronic kidney disease. Percutaneous renal artery radiofrequency ablation via catheter for hypertension selectively severs the renal sympathetic nerves through radiofrequency ablation, thereby achieving a good antihypertensive effect.

[0004] Renal artery ultrasound ablation is a minimally invasive interventional treatment for refractory hypertension. It involves using an ultrasound ablation catheter to deliver high-energy ultrasound waves. These waves can penetrate the arterial wall and reach the sympathetic nerve endings outside the renal artery, causing irreversible damage and functional inhibition. This ablation process does not affect the intima or vessel wall structure of the renal artery; its goal is to destroy the nerve fibers that transmit sympathetic nerve signals.

[0005] The inventors understand that the transducer in a renal artery ultrasound ablation system is sheet-shaped and arranged in a triangular prism configuration. The ultrasonic energy emitted by this structure is not distributed in a 360° circumferential pattern. Theoretically, 360° circumferential ablation of the renal artery sympathetic nerves can only be achieved through multiple ablation cycles by rotating the catheter. However, in actual surgery, due to the influence of vascular path, blood flow velocity, and catheter support method (non-balloon, stent-like support structure), the surgeon may experience repeated ablation of the same area while rotating the catheter proximally, and some areas may remain unablated. Summary of the Invention

[0006] The purpose of this invention is to provide an ultrasonic ablation transducer structure, ultrasonic ablation catheter, and device to solve the problems existing in the prior art. It can emit ultrasonic energy in a 360° circumferential manner to uniformly ablate the renal artery sympathetic nerve, thereby achieving 360° circumferential ablation of the renal artery sympathetic nerve without rotating the transducer structure, which greatly improves the uniformity of ablation and reduces the difficulty of surgical operation.

[0007] To achieve the above objectives, the present invention provides the following solution:

[0008] An ultrasonic ablation transducer structure includes a transducer base and a transducer. The transducer includes an annular piezoelectric ceramic, which is sleeved and fixed to the transducer base. Both the transducer base and the piezoelectric ceramic are used for communication connection with the ultrasonic ablation host.

[0009] As one embodiment, the transducer includes a plurality of piezoelectric ceramics nested together.

[0010] As one embodiment, multiple transducer bases are provided, and each transducer base is fixed with a transducer. The multiple transducers are connected in series and / or in parallel.

[0011] In one embodiment, the piezoelectric ceramic is bonded and fixed to the transducer base with conductive adhesive.

[0012] This invention provides an ultrasonic ablation catheter, comprising an ultrasonic ablation transducer structure as described above, an inner tube, an outer tube, a tip component, and a balloon. The transducer base in the ultrasonic ablation transducer structure is fixed on the inner tube; the outer tube is sleeved outside the inner tube; the tip component is fixedly connected to the front end of the inner tube; the balloon is sleeved outside the transducer, and both ends of the balloon are fixedly connected to the tip component and the outer tube, respectively.

[0013] In one embodiment, the outer tube includes a perforation cavity, an inlet cavity, and an outlet cavity, and the inner tube is inserted into the perforation cavity. Both the inlet cavity and the outlet cavity are connected to the internal cavity of the balloon.

[0014] In one embodiment, the transducer base and the transducer are communicatively connected to the ultrasonic ablation host via wires, and the wires are disposed inside the water inlet cavity.

[0015] As one embodiment, the transducer base is annular in shape, and a groove is provided on the inner surface of the transducer base. In the axial direction parallel to the transducer base, the two ends of the groove communicate with the internal cavity of the balloon.

[0016] In one embodiment, the transducer base and the inner tube are fixed together by epoxy resin bonding.

[0017] This invention provides an ultrasonic ablation device, including an ultrasonic ablation catheter and an ultrasonic ablation host as described above; the ultrasonic ablation host includes a housing, and a main control board, a power amplifier board, and a power supply that are interconnected within the housing. The housing also includes a display screen, buttons, and an interface. The display screen and the buttons are both interconnected with the main control board, and the interface is interconnected with the power amplifier board; the transducer base and piezoelectric ceramic in the ultrasonic ablation catheter are both interconnected with the interface.

[0018] The present invention has the following technical advantages over the prior art:

[0019] The piezoelectric ceramic in this invention is ring-shaped and can emit ultrasonic energy in a 360° circumference to uniformly ablate the renal artery sympathetic nerve. Therefore, it can achieve 360° circumferential ablation of the renal artery sympathetic nerve without the need for a rotating transducer structure, which greatly improves the uniformity of ablation and reduces the difficulty of surgical operation.

[0020] Other technical solutions of the present invention also have the following technical effects:

[0021] The transducer in this invention includes multiple piezoelectric ceramics nested together, forming a series structure. During ablation, the multiple annular piezoelectric ceramics vibrate simultaneously, and the vibration effects are superimposed, which greatly improves the electroacoustic conversion efficiency and generates higher ultrasonic energy. This allows for good ablation results in a shorter ablation time, shortening the treatment time and improving surgical efficiency.

[0022] This invention, by setting an inlet and outlet water chamber in the outer tube, can use water cooling to cool the transducer structure and wires, ensuring that the transducer structure can work continuously and stably. Attached Figure Description

[0023] 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.

[0024] Figure 1 This is a schematic diagram of the mating structure between the transducer and the transducer base in one embodiment of the present invention;

[0025] Figure 2 This is a schematic diagram of the radial cross-sectional structure of the transducer in one embodiment of the present invention;

[0026] Figure 3 This is a schematic diagram of the radial cross-sectional structure of the transducer base in one embodiment of the present invention;

[0027] Figure 4 This is a schematic diagram of the cooperative structure of multiple transducers in one embodiment of the present invention;

[0028] Figure 5 This is a schematic diagram of the structure of an ultrasonic ablation catheter in one embodiment of the present invention;

[0029] Figure 6 This is a schematic diagram of the radial cross-sectional structure of the outer tube in one embodiment of the present invention;

[0030] Figure 7 This is a schematic diagram of a structure in which three transducers are used in series in one embodiment of the present invention;

[0031] Figure 8 This is a schematic diagram of a structure in which three transducers are used in parallel in one embodiment of the present invention;

[0032] Figure 9 This is a schematic diagram of a structure in one embodiment of the present invention, in which two transducers are connected in series and one transducer is connected in parallel.

[0033] Figure 10 This is a schematic diagram of a structure in one embodiment of the present invention, in which two transducers are connected in parallel and in series with one transducer;

[0034] Figure 11 This is a schematic diagram of the structure of an ultrasonic ablation host in one embodiment of the present invention;

[0035] Figure 12 This is a schematic diagram of the connection structure between the ultrasonic ablation catheter and the ultrasonic ablation host in one embodiment of the present invention;

[0036] Figure 13 This is a schematic diagram of the internal connection structure of the ultrasonic ablation host in one embodiment of the present invention.

[0037] Explanation of reference numerals in the attached figures:

[0038] 1. Transducer base; 11. Groove; 2. Transducer; 21. Piezoelectric ceramic; 3. Inner tube; 4. Outer tube; 41. Through-tube cavity; 42. Water inlet cavity; 43. Water outlet cavity; 5. Tip component; 6. Balloon; 7. Wire; 8. Outer shell; 9. Display screen; 10. Button; 11. Interface. Detailed Implementation

[0039] 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.

[0040] The purpose of this invention is to provide an ultrasonic ablation transducer structure, ultrasonic ablation catheter, and device to solve the problems existing in the prior art. It can emit ultrasonic energy in a 360° circumferential manner to uniformly ablate the renal artery sympathetic nerve, thereby achieving 360° circumferential ablation of the renal artery sympathetic nerve without rotating the transducer structure, which greatly improves the uniformity of ablation and reduces the difficulty of surgical operation.

[0041] 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.

[0042] Example 1:

[0043] like Figures 1-10As shown, this embodiment provides an ultrasonic ablation transducer structure, including a transducer base 1 and a transducer 2. The transducer base 1 is typically fixedly installed. The transducer 2 includes a ring-shaped piezoelectric ceramic 21, which is sleeved and fixed to the transducer base 1. Both the transducer base 1 and the piezoelectric ceramic 21 are used for communication connection with the ultrasonic ablation host. The communication connection can be made by connecting wires 7. After the wires 7 are connected, a closed loop is formed between the transducer 2, the transducer base 1, and the ultrasonic ablation host. In use, the ultrasonic ablation host provides an electrical signal, and the piezoelectric ceramic 21 vibrates under the drive of the electrical signal. Since the piezoelectric ceramic 21 in this embodiment is ring-shaped, it can emit ultrasonic energy in a 360° circumferential manner, uniformly ablating the renal artery sympathetic nerve. Therefore, it is not necessary to rotate the transducer structure to achieve 360° circumferential ablation of the renal artery sympathetic nerve, which greatly improves the uniformity of ablation and reduces the difficulty of surgical operation.

[0044] like Figure 1 , Figure 2 , Figure 4 As shown, in this embodiment, the transducer 2 includes multiple piezoelectric ceramics 21 nested together. Adjacent piezoelectric ceramics 21 are bonded and fixed together with conductive adhesive. The inner and outer surfaces of the piezoelectric ceramics 21 have the same polarity, and the multiple piezoelectric ceramics 21 form a series structure. During ablation, the multiple annular piezoelectric ceramics 21 vibrate simultaneously, and the vibration effects are superimposed, greatly improving the electroacoustic conversion efficiency and generating higher ultrasonic energy. This allows for achieving good ablation results in a shorter ablation time, shortening the treatment time and improving surgical efficiency.

[0045] In this embodiment, the diameter of a single piezoelectric ceramic 21 is 1mm to 3mm, the length is 5mm to 10mm, and the frequency is 5MHz to 10MHz. Those skilled in the art can adjust the number and thickness of the piezoelectric ceramics 21 according to actual conditions, thereby adjusting the generated ultrasonic energy, changing the propagation distance of the ultrasonic waves, and achieving the purpose of adjusting the ablation area. Furthermore, since renal artery vessel sizes vary, the balloon 6 with the transducer structure also needs to have different diameters to accommodate them. In this embodiment, by adjusting the thickness of a single annular piezoelectric ceramic 21 (for example, adjusting the thickness of the outermost piezoelectric ceramic 21), the transducer structure can be matched with balloons 6 of different diameters, adjusting the distance between the transducer 2 and the renal artery sympathetic nerve, thereby eliminating the influence of ultrasonic wave propagation distance on the ablation effect.

[0046] like Figure 4As shown, in this embodiment, multiple transducer bases 1 are provided, and each transducer base 1 is fixed with a transducer 2. The multiple transducers 2 are connected in series and / or in parallel. The term "multiple transducers 2 connected in series and / or in parallel" refers to all transducers 2 being connected in series, or all transducers 2 being connected in parallel, or some transducers 2 being connected in series and then in parallel with the remaining transducers 2. For example, in this embodiment, three transducers 2 are provided, and the three transducers 2 can be connected in series (e.g., ...). Figure 7 As shown), they can be connected in parallel (e.g. Figure 8 As shown), two can be connected in series with another one in parallel (e.g. Figure 9 As shown), two can be connected in parallel with another in series (as shown). Figure 10 (As shown). By adjusting the connection method of multiple transducers 2, ideal voltage, current and impedance matching can be obtained, thereby achieving fine adjustment of the ablation zone.

[0047] In one embodiment, the piezoelectric ceramics 21 are bonded and fixed together with each other and with the transducer base 1 using conductive adhesive.

[0048] Example 2:

[0049] like Figures 1-10 As shown, this embodiment provides an ultrasound ablation catheter, including the ultrasound ablation transducer structure of Embodiment 1, an inner tube 3, an outer tube 4, a tip component 5, and a balloon 6. The transducer base 1 in the ultrasound ablation transducer structure is fixed to the inner tube 3; the outer tube 4 is sleeved outside the inner tube 3; the tip component 5 is fixedly connected to the front end of the inner tube 3 (in this embodiment, the front end refers to the end furthest from the ultrasound ablation host); the balloon 6 is sleeved outside the transducer 2, and both ends of the balloon 6 are fixedly connected to the tip component 5 and the outer tube 4, respectively. The front end of the tip component 5 typically has a rounded chamfer to facilitate movement within the blood vessel and avoid scratching the inner wall of the blood vessel.

[0050] Balloon 3 can be classified as compliant, semi-compliant, or non-compliant. If it is a non-compliant balloon, the diameter of balloon 3 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 several different specifications. If it is a compliant balloon, it can be of one size, and the diameter of balloon 3 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 balloon 3 can be adjusted, but the adjustment range is smaller than that of a compliant balloon.

[0051] like Figure 6As shown, in this embodiment, the outer tube 4 is provided with a partition wall, which divides the lumen of the outer tube 4 into a perforation lumen 41, a water inlet lumen 42, and a water outlet lumen 43. Both the water inlet lumen 42 and the water outlet lumen 43 are connected to the internal cavity of the balloon 6. The inner tube 3 is inserted into the perforation lumen 41, and the inner tube 3 is press-fitted with the perforation lumen 41 to prevent water in the balloon 6 from flowing out of the perforation lumen 41. In use, the water inlet lumen 42 is connected to a cold water source, and the water outlet lumen 43 is connected to a container for storing cold water. Cold water enters the balloon 6 from the water inlet lumen 42, causing the balloon 6 to expand and support the blood vessel wall. When the cold water is discharged from the water outlet lumen 43, it carries away the heat generated by the transducer 2, cooling the transducer 2. Simultaneously, the cold water also lowers the temperature of the tissue in contact with the surface of the balloon 6 (the renal artery intima side), thereby protecting the renal artery intima and preventing thermal damage to the renal artery intima.

[0052] In this embodiment, the transducer base 1 is an annular structure, and at least one groove 11 is provided on the inner surface of the annular structure. The extension direction of the groove 11 is parallel to the axial direction of the annular structure. Furthermore, the groove 11 is a through groove, and its two ends are connected to the inner cavity of the balloon 6, so that cold water can fill the groove 11, increasing the contact area between the transducer base 1 and the cold water, and improving the heat exchange effect on the transducer structure.

[0053] In this embodiment, the transducer base 1 and the transducer 2 are communicatively connected to the ultrasonic ablation host via a wire 7, which is located inside the water inlet chamber 42. During the cold water circulation process, heat exchange can occur between the cold water and the wire 7, preventing the wire 7 from overheating. Furthermore, the temperature of the cold water in the water inlet chamber 42 is lower than that of the cold water in the water outlet chamber 43. The placement of the wire 7 inside the water inlet chamber 42 can improve the heat exchange efficiency between the cold water and the wire 7, ensuring a cooling effect on the wire 7.

[0054] In one embodiment, the transducer base 1 and the inner tube 3 are bonded and fixed together with epoxy resin adhesive.

[0055] Example 3:

[0056] like Figures 1 to 13As shown, this embodiment provides an ultrasonic ablation device, including the ultrasonic ablation catheter and ultrasonic ablation host as in Embodiment 2. The ultrasonic ablation host includes a housing 8, inside which a main control board, a power amplifier board, and a power supply are interconnected. The housing 8 also has a display screen 9, buttons 10, and an interface 11. The display screen 9 and buttons 10 are both connected to the main control board, and the interface 11 is connected to the power amplifier board. The outer tube 4 in the ultrasonic ablation catheter forms a connector at its rear end. The transducer base 1 and the piezoelectric ceramic 21 are both connected to the connector via wires 7. The connector is plugged into the interface 11 to achieve communication. Before ablation, the operator sets the ablation parameters through the display screen 9 of the ultrasonic ablation host. During ablation, an electrical signal is generated by the main control board and transmitted sequentially through the power amplifier board and the interface 11 to the transducer structure in the ultrasonic ablation catheter, causing the piezoelectric ceramic 21 to vibrate under the drive of the electrical signal and emit ultrasonic energy in a 360° circumferential direction.

[0057] In order to dissipate heat from the ultrasonic ablation host, an exhaust port is provided on the back of the outer casing 8 (the side where the display screen 9 is located is the front). A fan is installed at the exhaust port to exhaust air and dissipate heat, so as to prevent the components inside the outer casing 8 from getting too hot.

[0058] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0059] 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 transducer structure, characterized in that, include: Transducer base; The transducer includes an annular piezoelectric ceramic, which is sleeved and fixed to the transducer base; both the transducer base and the piezoelectric ceramic are used for communication connection with the ultrasonic ablation host.

2. The ultrasonic ablation transducer structure according to claim 1, characterized in that, The transducer comprises a plurality of piezoelectric ceramics nested together.

3. The ultrasonic ablation transducer structure according to claim 1 or 2, characterized in that, Multiple transducer bases are provided, and each transducer base is fixed with a transducer. The multiple transducers are connected in series and / or in parallel.

4. The ultrasonic ablation transducer structure according to claim 3, characterized in that, The piezoelectric ceramic is bonded and fixed to the transducer base with conductive adhesive.

5. An ultrasonic ablation catheter, characterized in that, include: The ultrasonic ablation transducer structure as described in any one of claims 1 to 4; The transducer base in the ultrasonic ablation transducer structure is fixed on the inner tube; The outer tube is sleeved outside the inner tube; A pointed component, which is fixedly connected to the front end of the inner tube; And a balloon, which is sleeved outside the transducer, with its two ends fixedly connected to the tip member and the outer tube, respectively.

6. The ultrasonic ablation catheter according to claim 5, characterized in that, The outer tube includes a through-tube cavity, an inlet cavity, and an outlet cavity. The inner tube is inserted into the through-tube cavity. Both the inlet cavity and the outlet cavity are connected to the internal cavity of the balloon.

7. The ultrasonic ablation catheter according to claim 6, characterized in that, The transducer base and the transducer are connected to the ultrasonic ablation host via wires, which are located inside the water inlet cavity.

8. The ultrasonic ablation catheter according to claim 5, characterized in that, The transducer base is annular in shape, and a groove is provided on the inner surface of the transducer base. In the axial direction parallel to the transducer base, the two ends of the groove are connected to the internal cavity of the balloon.

9. The ultrasonic ablation catheter according to claim 5, characterized in that, The transducer base and the inner tube are fixed together by epoxy resin bonding.

10. An ultrasonic ablation device, characterized in that, The device includes the ultrasonic ablation catheter and the ultrasonic ablation host as described in any one of claims 6 to 9; the ultrasonic ablation host includes a housing, in which a main control board, a power amplifier board, and a power supply are disposed and communicate with each other; the housing is also provided with a display screen, buttons, and an interface; the display screen and the buttons are communicatively connected to the main control board, and the interface is communicatively connected to the power amplifier board; the transducer base and the piezoelectric ceramic in the ultrasonic ablation catheter are communicatively connected to the interface.

Images