Intravascular calcified plaque impact fracture device

Abstract

The present invention provides an intravascular calcified plaque impact fracture device, the device comprises a balloon catheter, an ultrasonic transducer and a balloon arranged on the balloon catheter, the ultrasonic transducer comprises a first conductive lead, a second conductive lead and an annular body arranged inside the balloon and sleeved on the balloon catheter; the annular body comprises a first annular electrode layer, a piezoelectric effect layer and a second annular electrode layer, the first annular electrode layer is located radially inside, the second annular electrode layer is located radially outside, the piezoelectric effect layer is located between the first annular electrode layer and the second annular electrode layer, the piezoelectric effect layer comprises a plurality of piezoelectric ceramic parts and a plurality of polymer parts without piezoelectricity, and the polymer parts and the piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body. The intravascular calcified plaque impact fracture device of the present invention can better achieve the intravascular calcified plaque impact fracture effect, break the stress ring on the calcified plate, and facilitate balloon angioplasty and stent implantation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a device for impact-fracture of intravascular calcified plaques. Background Art

[0002] Vascular calcification is a common pathological manifestation of atherosclerosis, hypertension, diabetic vascular disease, vascular damage, chronic kidney disease and aging.

[0003] For the treatment of vascular calcification, the prior art provides a method of using an ultrasonic balloon to treat calcification, and the specific method is as follows: an ultrasonic balloon coated with a pre-set air microbubble coating on the outer surface is delivered to the lesion site and then expanded to make the balloon contact the lesion tissue, and then ultrasonic waves are applied through the ultrasonic transducer in the balloon, and the sulfur hexafluoride air bubbles in the pre-set air microbubble coating produce a cavitation effect under the action of the ultrasonic transducer, and the cavitation effect causes the air bubbles to explode and break up the calcified plaques on the inner wall of the blood vessel. Obviously, the treatment effect of this prior art needs to rely on the pre-set air microbubble coating on the outer surface of the balloon. Summary of the invention

[0004] Based on the above situation, the main purpose of the present invention is to provide a device for impact fracture of intravascular calcified plaques, which can better achieve the impact fracture effect of intravascular calcified plaques.

[0005] To achieve the above-mentioned purpose, the technical solution of the present invention provides an intravascular calcified plaque impact fracture device, comprising a balloon catheter, an ultrasonic transducer and a balloon arranged on the balloon catheter, wherein the ultrasonic transducer comprises a first conductive lead, a second conductive lead and an annular body arranged inside the balloon and sleeved on the balloon catheter;

[0006] The annular body comprises a first annular electrode layer, a piezoelectric effect layer and a second annular electrode layer, the first annular electrode layer is located radially inward, the second annular electrode layer is located radially outward, the piezoelectric effect layer is located between the first annular electrode layer and the second annular electrode layer, the piezoelectric effect layer comprises a plurality of piezoelectric ceramic parts and a plurality of polymer parts without piezoelectricity, and the polymer parts and the piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body, so that the plurality of piezoelectric ceramic parts are separated in the circumferential direction of the annular body;

[0007] The first conductive lead is electrically connected to the first annular electrode layer, the second conductive lead is electrically connected to the second annular electrode layer, and the first conductive lead and the second conductive lead are used to apply voltage between the first annular electrode layer and the second annular electrode layer so that the annular body generates ultrasonic waves in the radial direction of the balloon catheter.

[0008] Further, the first conductive lead and / or the second conductive lead are arranged along the balloon catheter and are located on the surface of the balloon catheter;

[0009] The annular body is also provided with a first terminal electrically connected to the first annular electrode layer, the first terminal being arranged at a position close to the polymer portion and extending along the axial direction of the balloon catheter, and the first conductive lead being electrically connected to the first annular electrode layer through the second terminal;

[0010] The annular body is also provided with a second terminal electrically connected to the second annular electrode layer. The second terminal is arranged at a position close to the polymer portion and extends along the radial direction of the balloon catheter. The second conductive lead is electrically connected to the second annular electrode layer through the second terminal.

[0011] Furthermore, on the annular end surface of the piezoelectric effect layer, the area of ​​the plurality of piezoelectric ceramic parts is 40% to 90% of the total area of ​​the annular end surface.

[0012] Furthermore, the balloon comprises a middle portion which is cylindrical after expansion and an end portion which is conical after expansion, and the annular body is located in the middle portion.

[0013] Furthermore, the piezoelectric effect layer is squeezed by the first annular electrode layer and the second annular electrode layer, the first annular electrode layer is formed on the inner side of the piezoelectric effect layer by cooling and pressing, and the second annular electrode layer is formed on the outer side of the piezoelectric effect layer by hot pressing.

[0014] Furthermore, the material of the polymer part includes at least one of polytetrafluoroethylene and epoxy resin, the material of the piezoelectric ceramic part includes at least one of PZT 4, PZT 5, and PZT8, and the material of the first annular electrode layer and the second annular electrode layer includes at least one of steel, copper, and aluminum.

[0015] Furthermore, the balloon catheter includes an inner tube and an outer tube, the outer tube is sleeved on the outer circumference of the inner tube, and there is an annular cavity between the inner tube and the outer tube for transporting the developer to the interior of the balloon, the opening position of the balloon is sealed on the outer tube, and there is a missing area of ​​the outer tube on the outer circumference of the inner tube located in the balloon, so that the annular cavity is connected with the interior of the balloon, and the annular body is sleeved on the inner tube located in the missing area.

[0016] Furthermore, the balloon catheter includes an inner tube, the opening position of the balloon is sealed on the inner tube, and there is a through hole on the inner tube inside the balloon so that the inner tube is connected with the interior of the balloon, and the annular body is sleeved on the inner tube inside the balloon.

[0017] Furthermore, the device is used for human coronary arteries, and comprises two annular bodies distributed along the axial direction of the balloon catheter.

[0018] Furthermore, the device is used for a peripheral artery of a human body, and comprises three annular bodies distributed along the axial direction of the balloon catheter.

[0019] The intravascular calcified plaque impact fracture device provided by the present invention comprises an ultrasonic transducer arranged inside a balloon, comprising an annular body sleeved on a balloon catheter, comprising a first annular electrode layer, a piezoelectric effect layer, and a second annular electrode layer, which can emit ultrasonic waves in different radial directions. When the balloon is delivered to the lesion site, the annular body of the ultrasonic transducer can generate ultrasonic waves to plaques at different positions on its periphery, and the piezoelectric effect layer of the ultrasonic transducer comprises a plurality of polymer parts and a plurality of piezoelectric ceramic parts, the polymer parts and the piezoelectric ceramic parts are spaced apart in the circumferential direction of the annular body. By means of such a piezoelectric composite design, the lateral coupling of the piezoelectric ceramics in the piezoelectric effect layer can be reduced, and the piezoelectric effect layer on the annular body can be increased. The electromechanical conversion efficiency in the radial direction is improved, that is, it is beneficial to reduce the energy loss caused by axial vibration and increase the ultrasonic energy in the radial direction. At the same time, the polymer part can reduce the overall acoustic resistance of the annular body, so that more ultrasonic energy can be transmitted to the developer in the balloon and act on the calcified plaque. The calcified plaque can be broken up under the joint action of cavitation bubbles generated by the ultrasonic cavitation effect, thereby better achieving the impact fracture effect of the calcified plaque in the blood vessel, breaking the stress ring on the calcified plate, facilitating balloon angioplasty and stent implantation, and helping to reduce the dependence on the special coating on the outer surface of the balloon (such as the air microbubble coating in the prior art), and it may even be unnecessary to add such a special coating on the outer surface of the balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The preferred embodiments according to the present invention will be described below with reference to the accompanying drawings.

[0021] Figure 1 A schematic diagram of the intravascular calcified plaque impact rupture device provided by the embodiment of the present invention being delivered into a blood vessel;

[0022] Figure 2 A schematic diagram of an explosion of a device for impacting and rupturing intravascular calcified plaques provided in an embodiment of the present invention;

[0023] Figure 3 A schematic diagram of a ring-shaped body of an ultrasonic transducer provided in an embodiment of the present invention;

[0024] Figure 4 for Figure 3 A schematic diagram of a piezoelectric effect layer in a ring-shaped body is shown;

[0025] Figure 5 for Figure 3 A schematic diagram of a first annular electrode layer in the annular body shown;

[0026] Figure 6 for Figure 3 A schematic diagram of a second annular electrode layer in the annular body shown;

[0027] Figure 7 A schematic diagram of the operation of an ultrasonic transducer provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0028] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid confusing the essence of the present invention, known methods, processes, procedures, and components are not described in detail.

[0029] In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

[0030] Unless the context clearly requires otherwise, throughout the specification and claims, the words "include", "comprising" and similar words should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to".

[0031] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0032] See also Figure 1 and Figure 2 The intravascular calcified plaque impact fracture device provided by the embodiment of the present invention comprises a balloon catheter 20, a balloon 30 arranged on the balloon catheter 20, and an ultrasonic transducer, wherein the ultrasonic transducer is a piezoelectric transducer, which comprises a first conductive lead, a second conductive lead, and an annular body 50 arranged inside the balloon 30 and sleeved on the balloon catheter 20, for example, the annular body is specifically in the shape of a circular ring;

[0033] See also Figure 3-Figure 6The annular body 50 includes a first annular electrode layer 51, a piezoelectric effect layer 52 and a second annular electrode layer 53, wherein the first annular electrode layer 51 is located radially inside the annular body 50, the second annular electrode layer 53 is located radially outside the annular body 50, the piezoelectric effect layer 52 is located between the first annular electrode layer 51 and the second annular electrode layer 53, the piezoelectric effect layer 53 is also correspondingly annular, and includes a plurality of piezoelectric ceramic parts 52a and a plurality of polymer parts 52b that do not have piezoelectricity, and the polymer parts 52b and the piezoelectric ceramic parts 52a are spaced apart in the circumferential direction of the annular body 50, so that the plurality of piezoelectric ceramic parts 52a are spaced apart in the circumferential direction of the annular body 50;

[0034] For example, the piezoelectric effect layer 53 may include four polymer parts 52b of the same shape and size and four piezoelectric ceramic parts 52a of the same shape and size, and the polymer parts 52b and the piezoelectric ceramic parts 52a are spaced apart to form a circular ring structure;

[0035] The first conductive lead is electrically connected to the first annular electrode layer 51, and the second conductive lead is electrically connected to the second annular electrode layer 53. The first conductive lead and the second conductive lead are used to apply voltage between the first annular electrode layer and the second annular electrode layer so that the annular body generates ultrasonic waves in the radial direction of the balloon catheter 20.

[0036] The intravascular calcified plaque impact fracture device provided by the embodiment of the present invention comprises an ultrasonic transducer arranged inside the balloon, comprising an annular body sleeved on the balloon catheter, comprising a first annular electrode layer, a piezoelectric effect layer, and a second annular electrode layer, which can emit ultrasonic waves in different radial directions. When the balloon is delivered to the lesion site, the annular body of the ultrasonic transducer can emit ultrasonic waves to the plaques at different positions on its periphery, and the piezoelectric effect layer of the ultrasonic transducer comprises a plurality of polymer parts and a plurality of piezoelectric ceramic parts, the polymer parts and the piezoelectric ceramic parts are spaced apart in the circumferential direction of the annular body. By adopting such a piezoelectric composite design method, the lateral coupling of the piezoelectric ceramics in the piezoelectric effect layer can be reduced, and the piezoelectric effect layer in the annular body can be increased. The electromechanical conversion efficiency in the radial direction of the body is improved, that is, it is beneficial to reduce the energy loss caused by axial vibration and increase the ultrasonic energy in the radial direction. At the same time, the polymer part can reduce the overall acoustic resistance of the annular body, so that more ultrasonic energy can be transmitted to the developer in the balloon and act on the calcified plaque, and the calcified plaque can be broken under the joint action of cavitation bubbles generated by the ultrasonic cavitation effect, thereby better achieving the impact fracture effect of the calcified plaque in the blood vessel, breaking the stress ring on the calcified plate, facilitating balloon angioplasty and stent implantation, and helping to reduce the dependence on the special coating on the outer surface of the balloon (such as the air microbubble coating in the prior art), and it may even be unnecessary to add such a special coating on the outer surface of the balloon.

[0037] The intravascular calcified plaque impact fracture device provided by the embodiment of the present invention has the following advantages: first, the ultrasonic transducer can transmit ultrasonic energy to the calcified plaque through radial vibration, so as to cause cracks in the plaque and destroy the stress ring inside it, thereby increasing the flexibility of the blood vessel at the plaque to facilitate the expansion of the stent; second, during the vibration of the ultrasonic transducer, cavitation bubbles will be generated in the developer around it, and the cavitation bubbles will expand at a high speed under the action of the internal and external pressure difference, and finally rupture, thereby driving the surrounding liquid to form microjets, and the microjets can perform secondary crushing on the surface of the plaque, generate a large number of microcracks, and release the local stress of the plaque; third, the annular body of the ultrasonic transducer is located inside the balloon, which can prevent the toxic substances in these annular bodies (such as lead and other toxic substances in piezoelectric ceramics) from harming the human body.

[0038] In the present invention, the first conductive lead and the second conductive lead can be connected to an external ultrasonic power supply. For example, after the annular body 50 is delivered to the diseased part of the human body, the ultrasonic power supply located outside the human body outputs a high-frequency voltage signal between the first annular electrode layer and the second annular electrode layer through the first conductive lead and the second conductive lead, so that the piezoelectric effect layer 52 located between the first annular electrode layer 51 and the second annular electrode layer 53 generates mechanical vibration in the radial direction, thereby generating ultrasonic waves. In one embodiment of the present invention, the first conductive lead and / or the second conductive lead are arranged along the balloon catheter and are located on the surface of the balloon catheter.

[0039] In one embodiment of the present invention, the annular body 50 is further provided with a first wiring terminal 54 electrically connected to the first annular electrode layer 51, the first wiring terminal 54 is arranged at a position close to a polymer portion 52b and extends along the axial direction of the balloon catheter 20, and the first conductive lead is electrically connected to the first annular electrode layer 51 through the second wiring terminal 54;

[0040] The annular body 50 is also provided with a second terminal 55 electrically connected to the second annular electrode layer 53. The second terminal 55 is arranged at a position close to a polymer portion 52b and extends along the radial direction of the balloon catheter 20. The second conductive lead is electrically connected to the second annular electrode 53 through the second terminal 55. For example, the second terminal 55 can cover the position of the polymer portion on the annular end face of the annular body 50.

[0041] By arranging the first connecting terminal and the second connecting terminal at a position close to the polymer part, that is, away from the piezoelectric ceramic, since the polymer part is not conductive, the influence on the piezoelectric ceramic can be reduced.

[0042] In the present invention, the number, size and distribution of the polymer parts will affect the performance of the ultrasonic transducer. The proportion of piezoelectric ceramics in the entire piezoelectric effect layer is different, and the overall acoustic impedance and energy density of the piezoelectric effect layer are also different. It can be understood that the larger the proportion of piezoelectric ceramics, the greater the acoustic impedance and energy density.

[0043] For example, in one embodiment, on the annular end face of the piezoelectric effect layer, the area occupied by the multiple piezoelectric ceramic parts is 40% to 90% of the total area of ​​the annular end face, for example, it can be 60%, 80%, etc.; for example, the polymer part 52b and the piezoelectric ceramic part 52a are both columnar with the side faces perpendicular to the bottom face, so that the volume of the multiple piezoelectric ceramic parts is 40% to 90% of the total volume of the piezoelectric effect layer, which can take into account the overall acoustic impedance and energy density of the piezoelectric effect layer, and can enable more ultrasonic energy to act on the calcified plaque.

[0044] In addition, the intravascular calcified plaque impact fracture device of the present invention may further include a developing member 40 disposed inside the balloon 30. For example, the developing member 40 may also be correspondingly annular and sleeved on the balloon catheter 30. The position of the balloon can be observed through the developing member 40, and it can be positioned in the target treatment area. Then, a developer is transported to the inside of the balloon 30 through the balloon catheter 20. The developer can inflate the balloon, and at least a portion of the inflated balloon can be in close contact with the heart valve or blood vessel with calcified lesions. In addition, the expansion and expansion of the balloon can also be observed through the developer. Preferably, in one embodiment of the present invention, the balloon 30 includes a cylindrical middle portion after expansion and a conical end portion after expansion, wherein the annular body 50 is located in the middle portion, and the developing member 40 can be located at the end portion. When the balloon 30 is inflated, its cylindrical middle portion is in close contact with the calcified plaque in the target treatment area, so that the ultrasonic energy generated by the annular body and the microjet formed by the cavitation bubble can better act on the calcified plaque.

[0045] For example, see Figure 7 When the balloon 30 is delivered to the target treatment area in the human blood vessel 10 and filled with the developer, the outer surface of the balloon 30 is closely attached to the calcified plaque 11 in the blood vessel, and the annular body 50 of the ultrasonic transducer is connected to the external ultrasonic power supply through the first wire lead and the second conductive lead on the surface of the balloon catheter 20, generating ultrasonic vibration, and the vibration energy is transmitted to the calcified plaque 11 through the developer in the balloon 30, thereby generating a large number of microcracks on the plaque. At the same time, high-frequency piezoelectric ultrasound will generate cavitation bubbles 60 in the interface between the annular body 50 and the developer, and the bubbles will expand at a high speed under the action of the internal and external pressure difference, and finally burst, driving the surrounding liquid to form microjets, further crushing the calcified plaque 11.

[0046] The ultrasound generated by the annular body 50 will be refracted and reflected when propagating on the interface between the piezoelectric ceramic and the developer. Due to the large difference in acoustic impedance between the piezoelectric ceramic and the developer, most of the energy is reflected back by the interface, and only a small amount of energy enters the developer and finally acts on the calcified plaque. The present invention uses a piezoelectric composite material with piezoelectric ceramics and polymers spaced apart to reduce the energy loss caused by axial vibration on the one hand; on the other hand, it can reduce the overall acoustic impedance of the piezoelectric effect layer, so that more energy is transmitted to the developer and acts on the calcified plaque.

[0047] In the present invention, the polymer part 52b does not have piezoelectricity and can be made of a polymer material that does not have piezoelectricity. For example, the material of the polymer part 52b in the embodiment of the present invention can include at least one of polytetrafluoroethylene and epoxy resin.

[0048] The material of the piezoelectric ceramic portion 52 a may include at least one of PZT 4, PZT 5, and PZT 8, and the material of the first annular electrode layer and the second annular electrode layer may include at least one of steel, copper, and aluminum.

[0049] Preferably, in an embodiment of the present invention, in order to further improve the energy density of the ultrasonic transducer, in the annular body 50, the piezoelectric effect layer is squeezed by the first annular electrode layer and the second annular electrode layer, the first annular electrode layer is formed on the inner side of the piezoelectric effect layer by cooling and pressing, and the second annular electrode layer is formed on the outer side of the piezoelectric effect layer by hot pressing.

[0050] For example, the first annular electrode layer and the second annular electrode layer are both thin-walled stainless steel rings, wherein the outer steel ring serving as the second annular electrode layer is inserted into the outer side of the annular piezoelectric effect layer by hot pressing, and the inner steel ring serving as the first annular electrode layer is pressed into the inner side of the annular piezoelectric effect layer by cooling, and both the inner and outer steel rings generate extrusion pressure on the annular piezoelectric effect layer, thereby increasing the energy density of the piezoelectric ceramic, and the inner and outer steel rings also act as electrodes.

[0051] In the present invention, the balloon catheter 20 is used to transport the developer to the interior of the balloon 30. For example, in one embodiment, the balloon catheter 20 may include an inner tube and an outer tube. The outer tube is sleeved on the outer circumference of the inner tube and there is an annular cavity between the inner tube and the outer tube for transporting the developer to the interior of the balloon. The opening position of the balloon is sealed on the outer tube, and there is a missing area of ​​the outer tube on the outer circumference of the inner tube located in the balloon, so that the annular cavity is connected to the interior of the balloon, and the annular body is sleeved on the inner tube located in the missing area.

[0052] For example, in another embodiment, the balloon catheter 20 may include only an inner tube, the opening position of the balloon 30 is sealed on the inner tube, and there is a through hole on the inner tube located inside the balloon so that the inner tube is connected to the interior of the balloon, and the annular body is sleeved on the inner tube located inside the balloon.

[0053] The intravascular calcified plaque impact fracture device of the embodiment of the present invention is an interventional device that utilizes the ultrasonic energy generated by the piezoelectric effect of piezoelectric ceramics to break up the calcified plaque in the blood vessel, thereby promoting balloon expansion and stent implantation. During the balloon angioplasty procedure, the stress ring of the calcified plaque can be destroyed, allowing the balloon to expand smoothly, thereby improving the success rate and quality.

[0054] In the embodiment of the present invention, the specific size and number of the annular body in the intravascular calcified plaque impact fracture device can be determined according to the part of the human body to be treated;

[0055] For example, in one embodiment of the present invention, the above-mentioned intravascular calcified plaque impact rupture device is used for human coronary arteries, and may include two annular bodies distributed along the axial direction of the balloon catheter.

[0056] For example, in another embodiment of the present invention, the above-mentioned intravascular calcified plaque impact rupture device is used for peripheral arteries of the human body, and may include three annular bodies distributed along the axial direction of the balloon catheter.

[0057] Those skilled in the art will appreciate that, without conflict, the above-mentioned preferred solutions can be freely combined and superimposed.

[0058] It should be understood that the above-mentioned embodiments are merely illustrative and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that can be made by those skilled in the art to the above-mentioned details will be included in the scope of the claims of the present invention.

Claims

1. A device for impact rupture of intravascular calcified plaques, comprising a balloon catheter (20), an ultrasonic transducer, and a balloon (30) arranged on the balloon catheter (20), characterized in that: The ultrasonic transducer comprises a first conductive lead, a second conductive lead, and an annular body (50) disposed inside the balloon (30) and sleeved on the balloon catheter (20); The annular body (50) comprises a first annular electrode layer (51), a piezoelectric effect layer (52) and a second annular electrode layer (53); the first annular electrode layer (51) is located radially inward, the second annular electrode layer (53) is located radially outward, the piezoelectric effect layer (52) is located between the first annular electrode layer (51) and the second annular electrode layer (53); the piezoelectric effect layer (52) comprises a plurality of piezoelectric ceramic parts (52a) and a plurality of polymer parts (52b) that are not piezoelectric, and the polymer parts (52b) and the piezoelectric ceramic parts (52a) are spaced apart in the circumferential direction of the annular body (50), so that the plurality of piezoelectric ceramic parts (52a) are spaced apart in the circumferential direction of the annular body (50); The first conductive lead is electrically connected to the first annular electrode layer (51), the second conductive lead is electrically connected to the second annular electrode layer (53), and the first conductive lead and the second conductive lead are used to apply a voltage between the first annular electrode layer (51) and the second annular electrode layer (53), so that the annular body (50) generates ultrasonic waves in the radial direction of the balloon catheter (20); When the balloon (30) is filled with developer, the ultrasonic vibration energy is transmitted to the calcified plaque through the developer in the balloon (30), thereby generating microcracks on the plaque; the ultrasound generates cavitation bubbles (60) in the interface between the annular body (50) and the developer, and the cavitation bubbles (60) expand at a high speed until they burst under the action of the internal and external pressure difference, driving the surrounding liquid to form microjets, thereby further breaking up the calcified plaque.

2. The device according to claim 1, characterized in that The first conductive lead and / or the second conductive lead are arranged along the balloon catheter (20) and are located on the surface of the balloon catheter (20); The annular body (50) is also provided with a first wiring terminal (54) electrically connected to the first annular electrode layer (51); the first wiring terminal (54) is arranged at a position close to the polymer portion (52b) and extends along the axial direction of the balloon catheter (20); the first conductive lead is electrically connected to the first annular electrode layer (51) via a second wiring terminal (55); The annular body (50) is also provided with a second terminal (55) electrically connected to the second annular electrode layer (53); the second terminal (55) is arranged at a position close to the polymer portion (52b) and extends along the radial direction of the balloon catheter (20); the second conductive lead is electrically connected to the second annular electrode layer (53) via the second terminal (55).

3. The device according to claim 1, characterized in that On the annular end surface of the piezoelectric effect layer (52), the area of ​​the plurality of piezoelectric ceramic parts (52a) is 40% to 90% of the total area of ​​the annular end surface.

4. The device according to claim 1, characterized in that The balloon comprises a middle portion which is cylindrical after expansion and an end portion which is conical after expansion, and the annular body (50) is located in the middle portion.

5. The device according to claim 1, characterized in that The piezoelectric effect layer (52) is squeezed by the first annular electrode layer (51) and the second annular electrode layer (53); the first annular electrode layer (51) is formed on the inner side of the piezoelectric effect layer (52) by cooling and pressing, and the second annular electrode layer (53) is formed on the outer side of the piezoelectric effect layer (52) by hot pressing.

6. The device according to claim 1, characterized in that The material of the polymer part (52b) includes at least one of polytetrafluoroethylene and epoxy resin, the material of the piezoelectric ceramic part (52a) includes at least one of PZT4, PZT5, and PZT8, and the material of the first annular electrode layer (51) and the second annular electrode layer (53) includes at least one of steel, copper, and aluminum.

7. The device according to claim 1, characterized in that The balloon catheter (20) comprises an inner tube and an outer tube, wherein the outer tube is sleeved on the outer circumference of the inner tube, and an annular cavity for conveying a developing solution to the interior of the balloon exists between the inner tube and the outer tube, the opening position of the balloon is sealed on the outer tube, and there is a missing area of ​​the outer tube on the outer circumference of the inner tube located in the balloon, so that the annular cavity is connected with the interior of the balloon, and the annular body (50) is sleeved on the inner tube located in the missing area.

8. The device according to claim 1, characterized in that The balloon catheter (20) comprises an inner tube, the opening position of the balloon is sealed on the inner tube, and a through hole is provided on the inner tube inside the balloon so that the inner tube is connected with the interior of the balloon, and the annular body (50) is sleeved on the inner tube inside the balloon.

9. The device according to any one of claims 1 to 8, characterized in that: The device is used for human coronary arteries, and comprises two annular bodies (50) distributed along the axial direction of the balloon catheter (20).

10. The device according to any one of claims 1 to 8, characterized in that: The device is used for peripheral arteries of the human body, and comprises three annular bodies (50) distributed along the axial direction of the balloon catheter (20).

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