Ultrasonic catheter, ultrasonic thrombolytic device and method for preparing ultrasonic catheter

Abstract

The present invention provides an ultrasonic catheter, an ultrasonic thrombolysis device and a method for preparing an ultrasonic catheter. The ultrasonic catheter comprises: an ultrasonic core component, which is used to emit ultrasonic waves to form a sound field; the ultrasonic core component comprises a negative plate and an ultrasonic element arranged on the negative plate; a support tube, which is used to accommodate and support the ultrasonic core component to guide the movement of the ultrasonic core component; an insulating sealing layer, which is arranged between the ultrasonic core component and the support tube, and packages the ultrasonic core component and the support tube as a whole; wherein the negative plate is in the shape of a long strip, and there are a plurality of ultrasonic elements, and the plurality of ultrasonic elements are arranged at intervals along the length direction of the negative plate, and the ultrasonic elements are coated with an insulating film. The present invention improves the structure of the ultrasonic element, controls the emission phase angle of the ultrasonic element, controls the position of ultrasonic focusing to be the thrombolysis position, reduces damage to the blood vessel wall, and improves the safety of thrombolytic therapy.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an ultrasonic catheter, an ultrasonic thrombolytic device and a method for preparing the ultrasonic catheter. Background Art

[0002] Thrombosis is one of the common diseases in clinic. The formation of thrombus often causes peripheral vascular occlusion, and in severe cases, it can cause dangerous diseases such as ischemic stroke, myocardial infarction, pulmonary embolism, etc., which seriously endangers human life and health. Existing thrombus removal methods such as drug thrombolysis, balloon interventional angioplasty or surgical thrombectomy have obvious defects. For example, surgical thrombectomy causes great damage to patients, and drug thrombolysis often causes complications such as nerve damage and intra-tissue bleeding due to excessive use of thrombolytic agents.

[0003] Studies have shown that applying ultrasound on the basis of catheter-directed thrombolysis (CDT) can enhance the thrombolytic effect of drugs, and use the mechanical effect and cavitation effect of ultrasound to increase the penetration of drugs into the thrombus, increase the contact area between the drug and the thrombus, and accelerate the dissolution of thrombus. Ultrasonic thrombolysis technology has the characteristics of high thrombolytic efficiency and good safety, and can significantly reduce the dosage of thrombolytic drugs, greatly reducing the risk of complications such as intra-tissue bleeding and neurological damage.

[0004] Ultrasonic thrombolysis also has certain disadvantages. For example, in addition to its therapeutic effect on the thrombus site, ultrasonic thrombolysis will also cause certain damage to the blood vessel wall. When a blood vessel is damaged, it is precisely because of the formation of a thrombus that bleeding can be stopped quickly. If the thrombus at the blood vessel wall is destroyed during the ultrasonic thrombolysis treatment, it will cause bleeding symptoms. Therefore, there is an urgent need for an ultrasonic thrombolysis device that can selectively treat the thrombus site and cause less damage to the blood vessel wall to enhance the safety of thrombolysis treatment. Summary of the invention

[0005] The embodiments of the present invention provide an ultrasonic catheter, an ultrasonic thrombolytic device, and a method for preparing an ultrasonic catheter, which improves the structure of an ultrasonic element, controls the emission phase angle of the ultrasonic element, controls the position of ultrasonic focusing to be the thrombolytic position, reduces damage to the blood vessel wall, and improves the safety of thrombolytic therapy.

[0006] An ultrasonic catheter provided by an embodiment of the present invention comprises:

[0007] An ultrasonic core component, used for emitting ultrasonic waves to form a sound field; the ultrasonic core component comprises a negative plate and an ultrasonic element arranged on the negative plate;

[0008] A support tube, used for accommodating and supporting the ultrasonic core component to guide the movement of the ultrasonic core component;

[0009] An insulating sealing layer is provided between the ultrasonic core component and the support tube to package the ultrasonic core component and the support tube as a whole;

[0010] The negative electrode plate is in the shape of a long strip, and there are a plurality of ultrasonic elements, which are arranged at intervals along the length direction of the negative electrode plate, and the ultrasonic elements are coated with an insulating film.

[0011] Optionally, the ultrasonic element comprises a plurality of ultrasonic units, and the ultrasonic element is formed by arranging the plurality of ultrasonic units in an array.

[0012] Optionally, the ultrasonic unit is in the form of a thin sheet, and a plurality of the ultrasonic units are arranged in parallel and at intervals along the width direction of the negative electrode plate to form the ultrasonic element.

[0013] Optionally, the material of the ultrasonic element is piezoelectric ceramic, the material of the insulating film is polyimide, and the material of the support tube is polyimide, polyurethane, thermoplastic elastomer or braided polyimide.

[0014] Based on the same inventive concept, the present invention also provides an ultrasonic thrombolytic device, comprising: the ultrasonic catheter mentioned above;

[0015] An ultrasound host connected to the ultrasound catheter and used to drive the ultrasound catheter to emit ultrasound waves;

[0016] a thrombolytic agent catheter, used to accommodate the ultrasonic catheter and introduce the thrombolytic agent,

[0017] The thrombolytic agent catheter comprises a shell, the shell comprises a first cavity and a second cavity which are axially connected, the first cavity and the second cavity are not connected to each other, the first cavity accommodates the ultrasonic catheter, and the outer wall of the second cavity is provided with an outlet connected to the second cavity; the proximal end of the thrombolytic agent catheter is provided with a first inlet and a second inlet, the first inlet is connected to the first cavity, and the first inlet is used to inject coolant; the second inlet is connected to the second cavity, and the second inlet is used to inject thrombolytic agent, and the thrombolytic agent flows out through the outlet.

[0018] Optionally, the first cavity is arranged at the center of the shell, and the second cavity is a plurality of circumferentially spaced apart and arranged outside the first cavity.

[0019] Optionally, the shell and the first cavity are both cylindrical, the outer diameter of the shell is 2.5mm-3.5mm, and the diameter of the first cavity is 2mm-3mm.

[0020] Optionally, the number of the second cavities is four, the circumferential length of the second cavity is 1 mm-2 mm, the radial width is 0.05-0.2 mm, and the diameter of the outlet is 0.02 mm-0.1 mm.

[0021] Optionally, the inner wall of the first cavity is provided with a boss for supporting the ultrasonic catheter, and a gap is formed between the ultrasonic catheter and the inner wall of the first cavity to form a channel for the coolant to flow through.

[0022] Optionally, the shell is made of polytetrafluoroethylene, polyethylene or polyamide.

[0023] Based on the same inventive concept, the present invention also provides a method for preparing the above-mentioned ultrasonic catheter, wherein the ultrasonic catheter comprises an ultrasonic core component, the ultrasonic core component comprises a negative electrode plate and an ultrasonic element arranged on the negative electrode plate, the ultrasonic element comprises a plurality of ultrasonic units, and the ultrasonic element is formed by arranging the plurality of ultrasonic units in an array, and is characterized in that the method comprises the following steps:

[0024] Weaving piezoelectric ceramics as the ultrasonic unit so that a plurality of the ultrasonic units are arranged in an array to form the ultrasonic element;

[0025] Using an FPC circuit board as the negative electrode plate, and sequentially soldering the plurality of ultrasonic elements to the FPC circuit board at intervals along the length direction of the FPC circuit board;

[0026] Welding and connecting the positive wires of the plurality of ultrasonic elements;

[0027] The polyimide tube is used as an insulating film to cover the outside of the ultrasonic element, and the ultrasonic elements are covered one by one;

[0028] A heat shrink tube is sleeved as a support tube outside the ultrasonic core component, and the heat shrink tube is heated to shrink the heat shrink tube until it is completely attached to the insulating film and covers the ultrasonic core component;

[0029] Pour UV potting glue into the heat shrink tube to fill the gap between the insulating film and the ultrasonic element and the gap between the ultrasonic elements, and then cure the UV potting glue through ultraviolet equipment.

[0030] Compared with the prior art, the technical solution of the present invention has beneficial effects.

[0031] For example, multiple ultrasonic elements of an ultrasonic catheter are arranged at intervals so that each ultrasonic element can have a different emission phase angle, and the ultrasonic waves emitted by the multiple ultrasonic elements can form a focusing center at a set position; by controlling different phase angle focusing methods, the ultrasonic focusing center can be controlled at different azimuths and different distances from the sound wave emission center; during the treatment process, the ultrasonic focusing center is located at the thrombolysis center and away from the blood vessel wall to avoid excessive damage to the blood vessel wall; an insulating film is provided outside the ultrasonic element to improve the insulation performance.

[0032] For another example, the ultrasonic unit is formed into an ultrasonic element by means of braiding, which ensures the assembly accuracy of the ultrasonic unit and is beneficial to the control of the emission phase angle of the ultrasonic element.

[0033] For another example, the support tube uses a heat shrink tube to fasten the insulating film and the ultrasonic element into a whole through heat shrinkage; and after the heat shrink tube is shrunk, the glue is poured to force the potting glue to pass through the gap between the insulating film and the ultrasonic element, thereby avoiding the formation of bubbles between the insulating film and the ultrasonic element, which affects the ultrasonic performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a schematic diagram of the structure of an ultrasonic catheter in an embodiment of the present invention;

[0035] Figure 2 2 is a schematic diagram of the structure of an ultrasonic core component in an embodiment of the present invention;

[0036] Figure 3 1 is a schematic diagram of the structure of the ultrasonic core component after the insulating film is removed in the embodiment of the present invention;

[0037] Figure 4 is a schematic structural diagram of an ultrasonic thrombolysis device according to an embodiment of the present invention;

[0038] Figure 5 is a schematic cross-sectional assembly diagram of an ultrasound catheter and a thrombolytic agent catheter in an embodiment of the present invention;

[0039] Figure 6 2 is a schematic diagram of the structure of the thrombolytic agent catheter housing in an embodiment of the present invention;

[0040] Figure 7 It is a flow chart of the method for preparing an ultrasonic catheter in an embodiment of the present invention.

[0041] Description of reference numerals:

[0042] 10. thrombolytic agent catheter; 11. housing; 12. second cavity; 13. first cavity; 111. boss; 121. outlet;

[0043] 20. Ultrasonic catheter; 21. Ultrasonic core component; 22. Support tube; 23. Insulation sealing layer; 211. Ultrasonic element; 212. Negative plate; 213. Insulation film; 2111. Ultrasonic unit;

[0044] 30. Ultrasonic host;

[0045] 40. Second entrance;

[0046] 50. First entrance. DETAILED DESCRIPTION

[0047] In order to make the purpose, features and beneficial effects of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. It can be understood that the specific embodiments described below are only used to explain the present invention, rather than to limit the present invention. In addition, the same or similar reference numerals may be used in the figures to refer to the same or similar elements in different embodiments, and the descriptions of the same or similar elements in different embodiments and the descriptions of the prior art elements, features, effects, etc. may be omitted. In the description of the present invention, the "proximal end" represents the end close to the operator, and the "distal end" represents the end away from the operator; "axial", "radial" and "circumferential" all represent the "axial", "radial" and "circumferential" of the ultrasonic catheter 20.

[0048] Reference Figures 1 to 7 , an embodiment of the present invention provides an ultrasonic catheter 20.

[0049] Specifically, the ultrasonic catheter 20 includes:

[0050] The ultrasonic core 21 is used to emit ultrasonic waves to form a sound field; the ultrasonic core 21 includes a negative plate 212 and an ultrasonic element 211 disposed on the negative plate 212;

[0051] The support tube 22 is used to accommodate and support the ultrasonic core member 21 to guide the movement of the ultrasonic core member 21;

[0052] The insulating sealing layer 23 is disposed between the ultrasonic core component 21 and the support tube 22 to encapsulate the ultrasonic core component 21 and the support tube 22 as a whole; it is also the insulating layer of the ultrasonic core component 21 and the propagation medium of the ultrasonic wave;

[0053] The negative electrode plate 212 is in a long strip shape, and there are a plurality of ultrasonic elements 211 . The plurality of ultrasonic elements 211 are arranged at intervals along the length direction of the negative electrode plate 212 . The ultrasonic elements 211 are coated with an insulating film 213 .

[0054] Since the plurality of ultrasonic elements 211 are arranged at intervals, the ultrasonic host 30 can be used to control each ultrasonic element 211 to have a different emission phase angle, so that the ultrasonic wave emitted by the ultrasonic element 211 is focused at a certain point in space, thereby forming a focused sound field. The sound intensity is the largest at the focus center of the focused sound field, and the farther from the focus center, the smaller the sound intensity. By controlling different emission phase angle focusing methods, the ultrasonic focusing center can be controlled at different azimuths and different distances from the sound emission center. During the treatment process, after confirming the diameter of the blood vessel and the distance between the ultrasonic element 211 and the blood vessel wall, the driving scheme of the ultrasonic element 211 can be determined to keep the ultrasonic focusing center away from the blood vessel wall to avoid excessive damage to the blood vessel wall.

[0055] In some embodiments, the ultrasonic element 211 includes a plurality of ultrasonic units 2111 , and the ultrasonic element 211 is composed of the plurality of ultrasonic units 2111 arranged in an array.

[0056] In some embodiments, the ultrasonic unit 2111 is in the form of a thin sheet, and a plurality of ultrasonic units 2111 are arranged in parallel and spaced apart along the width direction of the negative electrode plate 212 to form the ultrasonic element 211. The ultrasonic unit 2111 preferably has a size of 0.3 mm*2 mm*0.6 mm.

[0057] In a specific implementation, the ultrasonic unit 2111 can be any shape, such as a cylinder, a sheet, a triangle, etc. The ultrasonic unit 2111 can also be an array composed of smaller ultrasonic units 2111 .

[0058] In some embodiments, the material of the ultrasonic element 211 is piezoelectric ceramic, preferably piezoelectric ceramic P-81 material, which has better stability under high power state; the material of the insulating film 213 is polyimide, which enhances the insulation performance of the ultrasonic element 211.

[0059] In some embodiments, the insulating potting layer 23 is made of UV (Ultra-Violet Ray) potting glue.

[0060] In some embodiments, the ultrasonic catheter 20 is disposed in the thrombolytic catheter 10, and the support tube 22 needs to provide sufficient structural support so that the ultrasonic catheter 20 can move freely in the thrombolytic catheter 10 and has the ability to transmit torque. The material of the support tube 22 is preferably polyimide, polyurethane, thermoplastic elastomer and braided polyimide. The size of the support tube 22 is preferably 2.5 mm in outer diameter and 2.4 mm in inner diameter.

[0061] See also Figure 4 , based on the same inventive concept, the present invention also provides an ultrasonic thrombolytic device, comprising: the ultrasonic catheter 20 mentioned above;

[0062] An ultrasound host 30, which is connected to the ultrasound catheter 20 and is used to drive the ultrasound catheter 20 to emit ultrasound waves;

[0063] The thrombolytic agent catheter 10 is used to accommodate the ultrasonic catheter 20 and introduce the thrombolytic agent.

[0064] The thrombolytic agent catheter 10 includes a shell 11, which includes a first cavity 13 and a second cavity 12 which are axially connected. The first cavity 13 and the second cavity 12 are not connected to each other. The first cavity 13 accommodates the ultrasonic catheter 20, and the outer wall of the second cavity 12 is provided with an outlet 121 connected to the second cavity 12; the proximal end of the thrombolytic agent catheter 10 is provided with a first inlet 50 and a second inlet 40, the first inlet 50 is connected to the first cavity 13, and the first inlet 50 is used to inject coolant; the second inlet 40 is connected to the second cavity 12, and the second inlet 40 is used to inject thrombolytic agent, and the thrombolytic agent flows out through the outlet 121.

[0065] The ultrasonic host 30 is used to drive and control the ultrasonic core 21 in real time. The frequency control module and the power amplifier module in the ultrasonic host 30 are used to drive the ultrasonic core 21 to emit ultrasonic waves of a certain frequency and power. The software module in the ultrasonic host 30 realizes the power adaptive output of the ultrasonic core 21 to achieve safe ultrasonic thrombolytic therapy. The ultrasonic energy of a certain intensity emitted by the ultrasonic core 21 promotes the penetration of the thrombolytic agent. The second inlet 40 controls the thrombolytic agent to be delivered to the thrombolytic agent catheter 10 at a certain flow rate, and the first inlet 50 controls the coolant to cool the ultrasonic catheter 20 at a certain flow rate, thereby achieving stable ultrasonic thrombolytic therapy.

[0066] Preferably, the shell 11 is made of polytetrafluoroethylene, polyethylene or polyamide, which is a material with sufficient flexibility, kink resistance and rigidity, and has a structural strength that can support pushing the tube body to the treatment site.

[0067] In some embodiments, the first cavity 13 is disposed at the center of the housing 11 , and a plurality of second cavities 12 are circumferentially spaced and disposed outside the first cavity 13 .

[0068] In some embodiments, the shell 11 and the first cavity 13 are both cylindrical, the outer diameter of the shell 11 is 2.5 mm-3.5 mm, preferably 3 mm; the diameter of the first cavity 13 is 2 mm-3 mm, preferably 2.5 mm.

[0069] In some embodiments, the number of the second cavities 12 is four, the circumferential length of the second cavity 12 is 1 mm-2 mm, preferably 1.5 mm, the radial width is 0.05-0.2 mm, preferably 0.1 mm, and the outlet 121 is a circular hole with a diameter of 0.02 mm-0.1 mm. The function of the second cavity 12 is to ensure that the thrombolytic agent flows into the blood vessel at a uniform speed, and the outlet 121 is used to control the flow rate of the thrombolytic agent. The aperture of the outlet 121 that varies with the depth of the catheter can be selected according to the different pressures at different positions of the thrombolytic catheter 10.

[0070] In some embodiments, the inner wall of the first cavity 13 is provided with a boss 111 for supporting the ultrasonic catheter 20, and a gap is formed between the ultrasonic catheter 20 and the inner wall of the first cavity 13 to form a channel for the coolant to flow through. The coolant is uniformly introduced into the gap through the first inlet 50 to cool the ultrasonic catheter 20, thereby achieving constant temperature operation throughout the entire process of ultrasonic thrombolytic therapy.

[0071] In order to better understand the technical solution provided by the embodiment of the present invention, the following further describes the process of intravascular thrombolysis using the ultrasonic thrombolysis device proposed by the present invention, taking old thrombus as the thrombolysis object. The specific steps are as follows:

[0072] S100: inserting a guidewire through the blood vessel to allow the guidewire to reach the thrombus position; guiding and inserting the thrombolytic agent catheter 10 through the guidewire; and then removing the guidewire;

[0073] S101: Sending the ultrasonic catheter 20 along the first cavity 13 of the thrombolytic agent catheter 10 to the distal end of the thrombolytic agent catheter 10;

[0074] S102 : injecting the thrombolytic agent into the second cavity 12 of the thrombolytic agent catheter 10 from the second inlet 40 at a constant flow rate, and injecting the coolant into the first cavity 13 of the thrombolytic agent catheter 10 from the first inlet 50 at a constant flow rate.

[0075] S103: Turn on the power of the ultrasound host 30, drive the ultrasound core component 21 to emit ultrasound at a certain power, and the circuit system in the ultrasound host 30 controls the ultrasound core component 21 to circulate the sound field focusing center around the ultrasound core component 21, and controls the sound field focusing center to have a certain distance from the blood vessel wall, so that the ultrasound energy is evenly transmitted to the surroundings.

[0076] By using the ultrasonic thrombolysis device provided in the embodiment of the present invention to perform ultrasonic thrombolysis operations, various types of thrombi can be effectively treated; the damage to blood vessels is minimal, and the risks of complications such as tissue bleeding and nerve damage are greatly reduced.

[0077] See also Figure 7Based on the same inventive concept, the present invention also provides a method for preparing the ultrasonic catheter 20. The ultrasonic catheter 20 includes an ultrasonic core 21. The ultrasonic core 21 includes a negative electrode plate 212 and an ultrasonic element 211 disposed on the negative electrode plate 212. The ultrasonic element 211 includes a plurality of ultrasonic units 2111. The ultrasonic element 211 is formed by the plurality of ultrasonic units 2111 being arranged in an array. The preparation method includes the following steps:

[0078] S1: braiding piezoelectric ceramics as ultrasonic units 2111 so that multiple ultrasonic units 2111 are arranged in an array to form an ultrasonic element 211;

[0079] S2: Using an FPC (Flexible Printed Circuit) circuit board as the negative electrode plate 212, and soldering a plurality of ultrasonic elements 211 to the FPC circuit board in sequence and at intervals along the length direction of the FPC circuit board;

[0080] S3: welding and connecting the positive wires of the plurality of ultrasonic elements 211;

[0081] S4: The polyimide tube is used as an insulating film 213 and is sleeved on the outside of the ultrasonic element 211 to cover the ultrasonic elements 211 one by one;

[0082] S5: The heat shrinkable tube is used as a support tube 22 and is sleeved on the outside of the ultrasonic core component 21 , and the heat shrinkable tube is heated to shrink the heat shrinkable tube until it is completely attached to the insulating film 213 and covers the ultrasonic core component 21 ;

[0083] S6: Pour UV potting glue into the heat shrink tube to fill the gap between the insulating film 213 and the ultrasonic element 211 and the gap between the ultrasonic elements 211, and then cure the UV potting glue by ultraviolet equipment.

[0084] The support tube 22 adopts a heat shrink tube, which fastens the insulating film 213 and the ultrasonic element 211 into a whole by heat shrinkage; and after the heat shrink tube is shrunk, glue is poured, forcing the UV potting glue to pass through the gap between the insulating film 213 and the ultrasonic element 211, thereby avoiding the generation of bubbles between the insulating film 213 and the ultrasonic element 211, which affects the ultrasonic performance.

[0085] In summary, the multiple ultrasonic elements 211 of the ultrasonic catheter 20 of the present invention are arranged at intervals, so that each ultrasonic element 211 can have a different emission phase angle, and the ultrasonic waves emitted by the multiple ultrasonic elements 211 can form a focusing center at a set position; by controlling different phase angle focusing methods, the ultrasonic focusing center can be controlled at different azimuths and different distances from the sound wave emission center; during the treatment process, the ultrasonic focusing center is located at the thrombolysis center and away from the blood vessel wall to avoid excessive damage to the blood vessel wall; an insulating film 213 is provided outside the ultrasonic element 211 to improve the insulation performance.

[0086] Furthermore, the ultrasonic unit 2111 of the present invention is formed into an ultrasonic element 211 by means of braiding, which ensures the assembly accuracy of the ultrasonic unit 2111 and is beneficial to the control of the emission phase angle of the ultrasonic element 211.

[0087] Furthermore, the support tube 22 of the present invention adopts a heat shrink tube, and the insulating film 213 and the ultrasonic element 211 are fastened into a whole by heat shrinkage; and after the heat shrink tube is shrunk, the glue is poured, forcing the pouring glue to pass through the gap between the insulating film 213 and the ultrasonic element 211, thereby avoiding the generation of bubbles between the insulating film 213 and the ultrasonic element 211, which affects the ultrasonic performance.

[0088] Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the present disclosure, even when only a single embodiment is described with respect to specific features. The feature examples provided in the present disclosure are intended to be illustrative rather than limiting, unless otherwise stated. In specific implementations, the technical features of one or more dependent claims may be combined with the technical features of the independent claims, based on actual needs and where technically feasible, and the technical features from the corresponding independent claims may be combined in any appropriate manner rather than just by the specific combinations listed in the claims.

[0089] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. An ultrasonic catheter, characterized in that: include: An ultrasonic core component, used for emitting ultrasonic waves to form a sound field; the ultrasonic core component comprises a negative plate and an ultrasonic element arranged on the negative plate; The support tube is used to accommodate and support the ultrasonic core component to guide the movement of the ultrasonic core component; the insulating sealing layer is arranged between the ultrasonic core component and the support tube to package the ultrasonic core component and the support tube into one body; The negative electrode plate is in the shape of a long strip, the ultrasonic element is multiple, the multiple ultrasonic elements are arranged at intervals along the length direction of the negative electrode plate, and the ultrasonic element is covered with an insulating film; the ultrasonic element includes multiple ultrasonic units, and the ultrasonic element is composed of multiple ultrasonic units arranged in an array; the ultrasonic unit is in the shape of a thin sheet, and multiple ultrasonic units are arranged in parallel and at intervals along the width direction of the negative electrode plate to form the ultrasonic element; The method for preparing the ultrasonic catheter comprises the following steps: Weaving piezoelectric ceramics as the ultrasonic unit so that a plurality of the ultrasonic units are arranged in an array to form the ultrasonic element; Using an FPC circuit board as the negative electrode plate, and sequentially soldering the plurality of ultrasonic elements to the FPC circuit board at intervals along the length direction of the FPC circuit board; Welding and connecting the positive wires of the plurality of ultrasonic elements; The polyimide tube is used as an insulating film to cover the outside of the ultrasonic element, and the ultrasonic elements are covered one by one; A heat shrink tube is sleeved as a support tube outside the ultrasonic core component, and the heat shrink tube is heated to shrink the heat shrink tube until it is completely attached to the insulating film and covers the ultrasonic core component; Pour UV potting glue into the heat shrink tube to fill the gap between the insulating film and the ultrasonic element and the gap between the ultrasonic elements, and then cure the UV potting glue through ultraviolet equipment.

2. The ultrasonic catheter according to claim 1, characterized in that The material of the ultrasonic element is piezoelectric ceramics, the material of the insulating film is polyimide, and the material of the support tube is polyimide, polyurethane, thermoplastic elastomer or braided polyimide.

3. An ultrasonic thrombolytic device, characterized in that: include: The ultrasonic catheter according to claim 1 or 2; An ultrasound host connected to the ultrasound catheter and used to drive the ultrasound catheter to emit ultrasound waves; a thrombolytic agent catheter, used to accommodate the ultrasonic catheter and introduce the thrombolytic agent, The thrombolytic agent catheter comprises a shell, the shell comprises a first cavity and a second cavity which are axially connected, the first cavity and the second cavity are not connected to each other, the first cavity accommodates the ultrasonic catheter, and the outer wall of the second cavity is provided with an outlet connected to the second cavity; the proximal end of the thrombolytic agent catheter is provided with a first inlet and a second inlet, the first inlet is connected to the first cavity, and the first inlet is used to inject coolant; the second inlet is connected to the second cavity, and the second inlet is used to inject thrombolytic agent, and the thrombolytic agent flows out through the outlet.

4. The ultrasonic catheter according to claim 3, characterized in that: The first cavity is arranged at the center of the shell, and the second cavity is a plurality of circumferentially spaced apart and arranged outside the first cavity.

5. The ultrasonic catheter according to claim 4, characterized in that: The shell and the first cavity are both cylindrical, the outer diameter of the shell is 2.5mm-3.5mm, and the diameter of the first cavity is 2mm-3mm.

6. The ultrasonic catheter according to claim 5, characterized in that The number of the second cavities is four, the circumferential length of the second cavity is 1 mm-2 mm, the radial width is 0.05-0.2 mm, and the diameter of the outlet is 0.02 mm-0.1 mm.

7. The ultrasonic catheter according to claim 3, characterized in that: The inner wall of the first cavity is provided with a boss for supporting the ultrasonic catheter, and a gap is formed between the ultrasonic catheter and the inner wall of the first cavity to form a channel for the coolant to flow through.

8. The ultrasonic catheter according to claim 3, characterized in that: The shell is made of polytetrafluoroethylene, polyethylene or polyamide.

9. A method for preparing an ultrasonic catheter according to claim 1 or 2, wherein the ultrasonic catheter comprises an ultrasonic core component, the ultrasonic core component comprises a negative electrode plate and an ultrasonic element disposed on the negative electrode plate, the ultrasonic element comprises a plurality of ultrasonic units, and the ultrasonic element is formed by arranging the plurality of ultrasonic units in an array, wherein: The steps include: Weaving piezoelectric ceramics as the ultrasonic unit so that a plurality of the ultrasonic units are arranged in an array to form the ultrasonic element; Using an FPC circuit board as the negative electrode plate, and sequentially soldering the plurality of ultrasonic elements to the FPC circuit board at intervals along the length direction of the FPC circuit board; Welding and connecting the positive wires of the plurality of ultrasonic elements; The polyimide tube is used as an insulating film to cover the outside of the ultrasonic element, and the ultrasonic elements are covered one by one; A heat shrink tube is sleeved as a support tube outside the ultrasonic core component, and the heat shrink tube is heated to shrink the heat shrink tube until it is completely attached to the insulating film and covers the ultrasonic core component; Pour UV potting glue into the heat shrink tube to fill the gap between the insulating film and the ultrasonic element and the gap between the ultrasonic elements, and then cure the UV potting glue through ultraviolet equipment.

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