An ultrasonic ablation transducer structure and an ultrasonic ablation device

Abstract

The application provides an ultrasonic ablation transducer structure and an ultrasonic ablation device, relates to the technical field of ultrasonic ablation devices, and comprises a transducer base, a transducer and a separation ring. The transducer is a cylindrical structure, the transducer is fixedly sleeved with the transducer base, the separation ring is fixedly sleeved with the transducer base, the axial two sides of the transducer are provided with the separation ring, the outer diameter of the separation ring is greater than the outer diameter of the transducer, the separation ring with the outer diameter greater than the transducer is arranged at the axial two ends of the transducer, the transmission of side lobe energy is blocked by the separation ring, the ultrasonic energy emitted by the transducer is emitted in the direction vertical or approximately vertical to the outer surface of the transducer, the directivity of the ultrasonic wave is improved, the ultrasonic wave accurately acts on the target region tissue, and the purpose of ablation of the target tissue while protecting the surrounding tissue is achieved.

Description

Technical Field

[0001] This invention relates to the field of ultrasonic ablation device technology, and in particular to an ultrasonic ablation transducer structure and an ultrasonic ablation 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 uses an ultrasound ablation device to release 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 are aware that some renal artery ultrasound ablation systems can damage adjacent tissues during the ultrasound ablation process. Therefore, it is necessary to develop a novel ultrasound ablation structure to address this technical problem. Summary of the Invention

[0006] The purpose of this invention is to provide an ultrasonic ablation transducer structure and an ultrasonic ablation device to solve the problems existing in the prior art, improve the directivity of ultrasonic waves, enable ultrasonic waves to act precisely on the target area tissue, and achieve the purpose of protecting the surrounding tissue while ablating the target tissue.

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

[0008] An ultrasonic ablation transducer structure includes a transducer base, a transducer, and a separator ring. The transducer has a cylindrical structure and is sleeved and fixed to the transducer base. The separator ring is sleeved and fixed to the transducer base. The separator ring is provided on both axial sides of the transducer. The separator ring is located near the end of the transducer, or the separator ring abuts against the end of the transducer. The outer diameter of the separator ring is larger than the outer diameter of the transducer.

[0009] In one embodiment, the outer end of the separator ring has an axially extending extension in the radial direction, the extension being located outside the end of the transducer adjacent to it.

[0010] As one embodiment, a plurality of transducers are provided on the transducer base, and a separation ring is provided between adjacent transducers.

[0011] In one embodiment, the transducer and the transducer base are bonded and fixed together by conductive adhesive.

[0012] The present invention also discloses an ultrasonic ablation device, comprising the aforementioned ultrasonic ablation transducer structure, an inner tube, an outer tube, a tip component, and a balloon; the proximal end of the transducer base in the ultrasonic ablation transducer structure is fixedly connected to the distal end of the inner tube; the outer tube is sleeved outside the inner tube; the balloon is sleeved outside the transducer, the distal end of the balloon is connected to the tip component, and the proximal end of the balloon is fixedly connected to the distal end of the outer tube.

[0013] In one embodiment, the transducer base of the ultrasonic ablation transducer structure has an axial cavity, the distal end of which is connected to the internal cavity of the balloon; the lumen of the inner tube includes a guidewire lumen and an inlet and an outlet lumen, both of which are connected to the proximal end of the cavity, the distal end of the sidewall of the guidewire lumen is sealed to the inner wall of the tip member, and the guidewire lumen is connected to the guidewire hole provided on the tip member.

[0014] In one embodiment, the transducer base and the transducer are communicatively connected to the ultrasonic ablation host via wires. The lumen of the inner tube also includes a wire cavity, in which the wire is disposed. After the wire is inserted, the distal end of the wire cavity is sealed.

[0015] As one embodiment, it also includes a guide tube seat, which is provided with a guide tube interface, a water inlet, a water outlet, a guide wire interface, and a wire interface. The proximal ends of the outer tube and the inner tube are both fixedly connected to the guide tube interface. The water inlet, the water outlet, the guide wire interface, and the wire interface are respectively connected to the water inlet cavity, the water outlet cavity, the guide wire cavity, and the wire cavity.

[0016] In one embodiment, the guidewire interface is coaxially arranged with the guidewire cavity; a sealing part for sealing the gap between the inner tube and the outer tube is provided.

[0017] As one embodiment, a stress sleeve is also connected to the catheter interface and fitted onto the outer wall of the catheter interface, with both the inner tube and the outer tube inserted into the stress sleeve.

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

[0019] This invention, by setting separator rings with an outer diameter larger than that of the transducer at both ends of the transducer along the axial direction, can block the transmission of sidelobe energy through the separator rings, so that the ultrasonic energy emitted by the transducer is emitted perpendicularly or approximately perpendicularly to the outer surface of the transducer, thereby improving the directivity of the ultrasonic waves and enabling the ultrasonic waves to act precisely on the target area tissue, achieving the purpose of ablating the target tissue while protecting the surrounding tissue.

[0020] Other technical effects of the present invention are described in the specific embodiments. 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 a transducer structure in one embodiment of the present invention;

[0023] Figure 2 This is a schematic diagram of the transducer structure in another embodiment of the present invention;

[0024] Figure 3 This is a schematic diagram of the ultrasonic ablation device in one embodiment of the present invention;

[0025] Figure 4 for Figure 3 A schematic diagram of the side section structure;

[0026] Figure 5 for Figure 4 A magnified view of a portion of region A in the middle;

[0027] Figure 6 This is a schematic diagram of the inner tube in one embodiment of the present invention;

[0028] Figure 7 This is a schematic diagram of the structure of the catheter seat in one embodiment of the present invention;

[0029] Figure 8 This is a schematic diagram showing the sound field range emitted by a single transducer when the separator ring does not have an extension portion in this invention.

[0030] Figure 9 This is a schematic diagram showing the sound field range emitted by multiple transducers when the separator ring does not have an extension portion in this invention.

[0031] Figure 10 This is a schematic diagram showing the sound field range emitted by a single transducer when the separator ring has an extension portion in this invention;

[0032] Figure 11 This is a schematic diagram showing the sound field range emitted by multiple transducers when the separator ring has an extension portion in this invention.

[0033] Explanation of reference numerals in the attached figures:

[0034] 1. Tip component; 2. Balloon; 3. Transducer structure; 31. Transducer base; 32. Transducer; 33. Separator ring; 4. Inner tube; 41. Central tube; 42. Separator wall; 43. Guide wire cavity; 44. Inlet cavity; 45. Outlet cavity; 46. Wire cavity; 5. Outer tube; 6. Stress sleeve; 7. Guide tube seat; 71. Guide tube interface; 72. Inlet; 73. Outlet; 74. Wire interface; 75. Guide wire interface. Detailed Implementation

[0035] 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.

[0036] The purpose of this invention is to provide an ultrasonic ablation transducer structure and an ultrasonic ablation device to solve the problems existing in the prior art, improve the directivity of ultrasonic waves, enable ultrasonic waves to act precisely on the target area tissue, and achieve the purpose of protecting the surrounding tissue while ablating the target tissue.

[0037] 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.

[0038] Example 1:

[0039] like Figures 1-3 As shown, this embodiment discloses an ultrasonic ablation transducer structure 3, including a transducer base 31, a transducer 32, and a separator ring 33. The transducer 32 is a cylindrical structure with a circular radial cross-section. The transducer 32 is sleeved and fixed to the transducer base 31. The separator ring 33 is sleeved and fixed to the transducer base 31. Separator rings 33 are distributed on both axial sides of the transducer 32, and the separator rings 33 are located near the end of the transducer 32, or the separator rings 33 abut against the end of the transducer 32. The outer diameter of the separator ring 33 is larger than the outer diameter of the transducer 32, meaning that in the radial direction, the end of the separator ring 33 is located outside the end of the transducer 32.

[0040] During operation, both the transducer base 31 and the transducer 32 are communicatively connected to the ultrasonic ablation host. This connection can be made via a wire, forming a closed loop between the transducer 32, the transducer base 31, and the ultrasonic ablation host. The cylindrical transducer 32 converts alternating current signals into ultrasonic energy and emits it outwards in a 360° circular pattern. When the ultrasonic waves propagate through tissue, their mechanical energy is absorbed by the tissue and converted into heat energy, thus achieving tissue ablation. When the ultrasonic waves are emitted outwards, the sound field is radially distributed. The largest radiating beam is usually called the main lobe, and the smaller beams beside the main lobe are usually called side lobes. The direction of the main lobe is generally perpendicular or approximately perpendicular to the surface of the transducer 32, while the direction of the side lobes is generally not perpendicular to the surface of the transducer 32, but rather forms a certain angle with it. When the transducer 32 is working, the main lobe is typically required to be aligned with the target tissue area, as the energy from the side lobes can cause damage to adjacent tissue areas.

[0041] In this embodiment, by setting a separator ring 33 with an outer diameter larger than that of the transducer 32 at both ends of the transducer 32 along the axial direction, the transmission of sidelobe energy can be blocked by the separator ring 33, so that the ultrasonic energy emitted by the transducer 32 is emitted perpendicularly or approximately perpendicularly to the outer surface of the transducer 32, thereby improving the directivity of the ultrasonic wave and enabling the ultrasonic wave to act precisely on the target area tissue, so as to achieve the purpose of protecting the surrounding tissue while ablating the target tissue.

[0042] In this embodiment, "the partition ring 33 is located near the end of the transducer 32" means that the partition ring 33 is located in a region that can block the energy transmission of the side lobes.

[0043] In this embodiment, the transducer 32 is made of PZT (lead zirconate titanate), or in other words, the transducer 32 is a piezoelectric ceramic. The outer diameter of the transducer 32 can be 1mm to 2mm, the axial length of the transducer 32 can be 3mm to 6mm, and its frequency can be designed to be 7MHz to 10MHz. The separator ring 33 is used to block the propagation of sound waves and can be a thin circular ring made of metal or non-metal. If the separator ring 33 is made of metal, it can be SUS304 (304 stainless steel). The thickness of the separator ring 33 is 0.2mm to 0.5mm, and the outer diameter of the separator ring 33 needs to be larger than the outer diameter of the cylindrical transducer 32. For example, if the diameter of the cylindrical transducer 32 is 1.5mm, the corresponding diameter of the separator ring 33 is 2mm to 2.5mm.

[0044] In order to improve the range of ultrasonic waves, multiple transducers 32 are provided on the transducer base 31 in this embodiment, and a partition ring 33 is provided between adjacent transducers 32.

[0045] As one structural form, the cross-sectional shape of the partition ring 33 in this embodiment can be rectangular. As another structural form, in the radial direction, the outer end of the partition ring 33 has an axially extending extension, located outside the end of the adjacent transducer 32. When transducers 32 are provided on both sides of the partition ring 33, and the outer end of the partition ring 33 extends axially to both sides to form an extension, the cross-sectional shape of the partition ring 33 is T-shaped. When a transducer 32 is provided on one side of the partition ring 33, and the outer end of the partition ring 33 extends axially to the side where the transducer 32 is located to form an extension, the cross-sectional shape of the partition ring 33 is L-shaped. When multiple transducers 32 are provided, partition rings 33 with both T-shaped and L-shaped cross-sectional shapes can coexist.

[0046] In this embodiment, the transducer 32 and the transducer base 31 are bonded and fixed with conductive adhesive.

[0047] Example 2:

[0048] like Figures 1 to 7As shown, this embodiment discloses an ultrasound ablation device, including the ultrasound ablation transducer structure 3, inner tube 4, outer tube 5, tip component 1, and balloon 2 as in Embodiment 1; the proximal end of the transducer base 31 in the ultrasound ablation transducer structure 3 is fixedly connected to the distal end of the inner tube 4; the outer tube 5 is sleeved outside the inner tube 4; the balloon 2 is sleeved outside the transducer 32 and is used to support the blood vessel after expansion. The distal end of the balloon 2 is connected to the tip component 1, and the proximal end of the balloon 2 is fixedly connected to the distal end of the outer tube 5. The tip of the tip component 1 usually has a rounded chamfer to facilitate movement within the blood vessel and avoid scratching the inner wall of the blood vessel.

[0049] In this embodiment, the proximal end refers to the end closer to the surgeon, and the distal end refers to the end farther away from the surgeon.

[0050] In this embodiment, the balloon 2 is a non-compliant balloon 2. The diameter of the balloon 2 can be 3mm to 8mm, and the effective length can be 8mm to 20mm, with multiple different specifications.

[0051] In this embodiment, the transducer base 31 of the ultrasonic ablation transducer structure 3 is a tubular structure with an axially opened cavity. The distal end of the cavity is connected to the internal cavity of the balloon 2. A central tube 41 is disposed in the cavity of the inner tube 4, and a partition wall 42 is disposed between the central tube 41 and the inner wall of the inner tube 4. The cavity of the central tube 41 is a guidewire cavity 43. The distal end of the central tube 41 is fixedly connected to the inner wall of the tip member 1, and the guidewire cavity 43 is connected to the guidewire hole opened on the tip member 1 for inserting the guidewire. The partition wall 42 divides the area between the outer wall of the central tube 41 and the inner wall of the inner tube 4 into a water inlet cavity 44, a water outlet cavity 45, and a guide wire cavity 46. The water inlet cavity 44 and the water outlet cavity 45 are both connected to the cavity, while the guidewire cavity 43 is not connected to the cavity. The lead wire cavity 46 is used to lead out the wires connecting the transducer 32 and the transducer base 31. After the wires are distributed in the lead wire cavity 46, the distal end of the guide cavity is sealed with sealing material to prevent cold water from flowing into the lead wire cavity 46 after water is introduced. In use, the inlet cavity 44 is connected to the cold water supply device, and the outlet cavity 45 is connected to the cold water collection device. Cold water flows into the balloon 2 from the inlet cavity 44 and the cavity, causing the balloon 2 to expand and support the inner wall of the blood vessel, maintaining the pressure inside the balloon 2 at 1 atm to 3 atm. Cold water is continuously introduced, and after heat exchange with the transducer 32, the cold water flows out from the outlet cavity 45. This not only prevents the transducer 32 from overheating and ensures that the transducer 32 can work stably for a long time, but also prevents the renal artery intima from being damaged by the overheating of the balloon 2.

[0052] In this embodiment, the cross-sectional area of ​​both the inlet chamber 44 and the outlet chamber 45 should be no less than 0.2 mm². 2 The recommended value is 0.5mm. 2 The recommended overall length of the ultrasonic ablation device is 100cm to 120cm.

[0053] In this embodiment, the outer pipe 5 is sleeved outside the inner pipe 4. After water is supplied, water will enter the gap between the inner pipe 4 and the outer pipe 5. To prevent water from flowing out of the gap between the inner pipe 4 and the outer pipe 5, a sealing part must be installed in this gap.

[0054] To facilitate the implementation of steps such as water flow, water outlet, and guide wire insertion, this embodiment also includes a guide tube seat 7. The guide tube seat 7 is provided with a guide tube interface 71, a water inlet 72, a water outlet 73, a guide wire interface 75, and a wire interface 74. The guide wire interface 75 is coaxially arranged with the guide wire hole on the tip member 1 and the guide wire cavity 43 in the inner tube 4. The proximal ends of the outer tube 5 and the inner tube 4 are fixedly connected to the guide tube interface 71. The water inlet 72, water outlet 73, guide wire interface 75, and wire interface 74 are respectively connected to the water inlet cavity 44, the water outlet cavity 45, the guide wire cavity 43, and the wire cavity 46.

[0055] In one embodiment, a stress sleeve 6 is also connected to the conduit interface 71 and fitted onto the outer wall of the conduit interface 71. Both the inner tube 4 and the outer tube 5 are inserted into the stress sleeve 6. The stress sleeve 6 serves to prevent the outer tube 5 and the inner tube 4 from bending at the conduit interface 71.

[0056] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0057] 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; A transducer, wherein the transducer has a cylindrical structure and is sleeved and fixed to the transducer base; The transducer includes a separator ring, which is sleeved and fixed to the transducer base. The separator rings are provided on both axial sides of the transducer. The separator rings are located near the end of the transducer or abut against the end of the transducer. The outer diameter of the separator ring is larger than the outer diameter of the transducer.

2. The ultrasonic ablation transducer structure according to claim 1, characterized in that, In the radial direction, the outer end of the separator ring has an axially extending extension located outside the end of the adjacent transducer.

3. The ultrasonic ablation transducer structure according to claim 1 or 2, characterized in that, The transducer base is provided with a plurality of transducers, and the separator rings are provided between adjacent transducers.

4. The ultrasonic ablation transducer structure according to claim 3, characterized in that, The transducer is fixed to the transducer base by adhesive bonding.

5. An ultrasonic ablation device, characterized in that, include: The ultrasonic ablation transducer structure as described in any one of claims 1 to 4; The inner tube is fixedly connected to the proximal end of the transducer base in the ultrasonic ablation transducer structure. The outer tube is sleeved outside the inner tube; Tipped components; And a balloon, the balloon being fitted over the transducer, the distal end of the balloon being connected to the tip member, and the proximal end of the balloon being fixedly connected to the distal end of the outer tube.

6. The ultrasonic ablation device according to claim 5, characterized in that, The transducer base of the ultrasonic ablation transducer structure has an axial cavity, the distal end of which is connected to the internal cavity of the balloon; the lumen of the inner tube includes a guidewire lumen and an inlet and an outlet lumen, both of which are connected to the proximal end of the cavity; the distal end of the sidewall of the guidewire lumen is sealed to the inner wall of the tip member, and the guidewire lumen is connected to the guidewire hole provided on the tip member.

7. The ultrasonic ablation device according to claim 6, characterized in that, The transducer base and the transducer are connected to the ultrasonic ablation host via wires. The inner tube also includes a wire cavity, in which the wire is placed. After the wire is inserted, the distal end of the wire cavity is sealed.

8. The ultrasonic ablation device according to claim 7, characterized in that, It also includes a guide tube seat, which is provided with a guide tube interface, a water inlet, a water outlet, a guide wire interface, and a wire interface. The proximal ends of the outer tube and the inner tube are both fixedly connected to the guide tube interface. The water inlet, the water outlet, the guide wire interface, and the wire interface are respectively connected to the water inlet cavity, the water outlet cavity, the guide wire cavity, and the wire cavity.

9. The ultrasonic ablation device according to claim 8, characterized in that, The guide wire interface is coaxially arranged with the guide wire cavity; the inner tube and the outer tube have a sealing part for sealing the gap between them.

10. The ultrasonic ablation device according to claim 8, characterized in that, The catheter interface is also connected to a stress sleeve that is fitted onto the outer wall of the catheter interface, and both the inner tube and the outer tube are inserted into the stress sleeve.

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