Ultrasonic balloon recanalization guide catheter and catheter system

Abstract

The utility model provides an ultrasonic balloon recanalization guiding catheter and a catheter system. The catheter system comprises an ultrasonic generator and the ultrasonic balloon recanalization guiding catheter. The ultrasonic balloon recanalization guide catheter comprises a balloon guide catheter, an ultrasonic catheter and a connecting seat. The balloon guiding catheter comprises an inner tube, a first outer tube and a first balloon, the near end of the first balloon is connected with the far end of the first outer tube, the far end of the first balloon is connected with the inner tube, and the near end of the inner tube and the near end of the first outer tube are both connected with the connecting base. The ultrasonic catheter is movably arranged in the inner tube in a penetrating mode. An ultrasonic transducer is arranged at the far end of the ultrasonic catheter, the ultrasonic generator is electrically connected with the ultrasonic transducer, and the ultrasonic transducer is used for releasing ultrasonic waves to target tissue. The expanded first balloon can be anchored in a target pipeline so as to limit the movement amplitude of the ultrasonic catheter in the radial direction of the first balloon. According to the ultrasonic balloon recanalization guide catheter, the catheter head end can be prevented from entering a blood vessel false cavity, thrombus is prevented from escaping, and then the safety and reliability of an operation can be improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and particularly relates to an ultrasonic balloon recanalization guiding catheter and a catheter system. Background Art

[0002] Vascular calcification is a vascular stenosis and sclerosis disease caused by the accumulation of calcified plaques in human blood vessels. Among them, the calcified plaque is composed of fibrous tissue, fat, and calcium elements. The accumulated calcified plaques in the blood vessels hinder the normal flow of blood, resulting in insufficient supply of oxygen and nutrients in the body. If vascular calcification occurs in peripheral blood vessels, it can cause lower limb arteriosclerosis, which can cause mild symptoms such as coldness, numbness, and intermittent claudication in the lower limbs, and severe cases can lead to weakened or disappeared pulsation of the lower limb arteries, especially the dorsalis pedis artery, and even require amputation treatment. If vascular calcification occurs in the coronary arteries, the clinical manifestations are coronary atherosclerotic heart disease, myocardial ischemia, angina pectoris, or myocardial infarction and other diseases.

[0003] Currently, in the interventional treatment of chronic total occlusion (CTO) lesions of blood vessels, the clinical method used is the wire passing technique. Specifically, when constructing a passage through the wire, since the wire cannot directly penetrate the hard calcified lesion, during the operation of opening a completely occluded blood vessel, the wire needs to penetrate the intima of the blood vessel wall and enter the media of the blood vessel wall to advance, and then a blood flow passage under the intima false lumen of the blood vessel wall is constructed by means of balloon dilation and stent implantation to bypass the calcified plaques in the intima of the blood vessel. This operation causes greater damage to the blood vessel wall at the lesion site and has a higher surgical failure rate.

[0004] To overcome the above problems, a new ultrasonic catheter recanalization technology has been developed clinically recently. The ultrasonic catheter recanalization technology acts directly in the true lumen of the blood vessel. Specifically, the ultrasonic transducer converts electrical energy into mechanical energy, and then the mechanical vibration energy is transmitted to the distal end of the catheter through the ultrasonic transmission member in the catheter. The distal end of the catheter can directly remove calcified tissue in the form of ultrasonic pulses to achieve the opening of the blood vessel. This technology can remove calcified tissue in the true lumen of the blood vessel to re - conduct the blood vessel. However, currently, during the working process of the ultrasonic recanalization catheter, the distal end of the catheter may accidentally enter the false lumen of the blood vessel, and since the blood flow is not blocked during the operation, there is a risk of thrombus escape and the formation of acute thrombus in the blood vessel during the operation, resulting in a longer operation time and reduced surgical safety. Content of the Utility Model

[0005] The purpose of the utility model is to provide an ultrasonic balloon recanalization guiding catheter and a catheter system. The balloon guiding catheter of the ultrasonic balloon recanalization guiding catheter can limit the radial movement of the ultrasonic catheter, so as to avoid the distal end of the ultrasonic catheter from entering the false lumen of the blood vessel, and can also prevent thrombus escape, thereby improving the safety and reliability of the operation.

[0006] To achieve the above object, the present utility model provides an ultrasonic balloon recanalization guiding catheter, which comprises a balloon guiding catheter, an ultrasonic catheter and a connector; the balloon guiding catheter comprises an inner tube, a first outer tube and a first balloon, the proximal end of the first balloon is connected to the distal end of the first outer tube, the distal end of the first balloon is connected to the inner tube, and the proximal ends of the inner tube and the first outer tube are both connected to the connector; the ultrasonic catheter is movably disposed in the inner tube;

[0007] An ultrasonic transducer is disposed at the distal end of the ultrasonic catheter, and the ultrasonic transducer is used to release ultrasonic waves to the target tissue; the first balloon can expand or contract, and after expansion, the first balloon can be anchored in the target pipeline to limit the radial movement amplitude of the ultrasonic catheter.

[0008] Optionally, the ultrasonic catheter comprises a metal head end, a delivery tube and a first buffer sleeve connected in sequence from the distal end to the proximal end, the proximal end of the first buffer sleeve is connected to the connector, and at least part of the section of the first buffer sleeve can be telescoped axially to enable the delivery tube to move relative to the inner tube; the ultrasonic transducer is fixed at the distal end of the metal head end.

[0009] Optionally, a through hole axially penetrating along the delivery tube is provided on the metal head end, and the delivery tube is communicated with the through hole; a first connection port is provided on the connector, the proximal end of the first buffer sleeve is communicated with the first connection port, and the first connection port is used to sequentially deliver conductive liquid to the distal end of the metal head end through the first buffer sleeve, the delivery tube and the through hole.

[0010] Optionally, the ultrasonic catheter further comprises a first wire, the first wire is movably disposed in the delivery tube and at least part of the first buffer sleeve, the distal end of the first wire is connected to the ultrasonic transducer; a second connection port is provided on the connector, and the proximal end of the first wire extends out of the first buffer sleeve and extends out of the connector through the second connection port.

[0011] Optionally, the inner tube has a first chamber and a second chamber, the first chamber is used to accommodate the ultrasonic catheter, and the axis of the first chamber coincides with the axis of the inner tube; the second chamber is used to accommodate a guide wire.

[0012] Optionally, the connector further comprises a third connection port and a fourth connection port, the third connection port is communicated with the first outer tube and is used to inject or extract a filling medium into or from the first balloon; the fourth connection port is communicated with the inner tube and is used to allow the guide wire to pass through.

[0013] Optionally, the connection seat includes a first connection seat and a second connection seat, and the proximal end of the first connection seat is connected to the distal end of the second connection seat; both the inner tube and the first outer tube are fixed on the first connection seat; the first buffer sleeve is placed in the second connection seat, the proximal end of the delivery tube passes through the first connection seat and extends into the second connection seat to communicate with the distal end of the first buffer sleeve; the first connection port and the second connection port are arranged on the second connection seat, and the third connection port and the fourth connection port are arranged on the first connection seat.

[0014] Optionally, the ultrasonic catheter further includes a second balloon, a second outer tube, a second buffer sleeve and an ultrasonic generating component. The metal head end, the second balloon, the second outer tube and the second buffer sleeve are sequentially connected in the direction from the distal end to the proximal end, and the proximal end of the second buffer sleeve is connected to the connection seat; the delivery tube movably penetrates through the second outer tube and at least part of the second buffer sleeve; the ultrasonic generating component is fixed on the delivery tube and corresponds to the position of the second balloon; the ultrasonic generating component is used to release ultrasonic waves to the target tissue on the inner wall of the target pipeline through the second balloon.

[0015] Optionally, a fifth connection port is further arranged on the connection seat. The fifth connection port communicates with the second buffer sleeve and is used for injecting or extracting a filling medium into or from the second balloon.

[0016] Optionally, the ultrasonic catheter further includes a second wire. The distal end of the second wire is connected to the ultrasonic generating component; a second connection port is arranged on the connection seat, and the proximal end of the second wire passes through the cavity between the second outer tube and the delivery tube and extends out of the connection seat from the second connection port.

[0017] Optionally, a first operating member is arranged on the connection seat, and a cooperating member is arranged on the outer wall of the proximal end of the delivery tube. The first operating member is used to cooperate with the cooperating member on the delivery tube to drive the delivery tube to move relative to the inner tube.

[0018] Optionally, a second operating member is further arranged on the connection seat, and a wire storage disc is arranged in the connection seat. The wire storage disc is connected to the second operating member; the wire of the ultrasonic catheter can be wound around the wire storage disc and extend out of the connection seat, and the wire storage disc is used to recycle or release the wire under the drive of the second operating member.

[0019] To achieve the above object, the present invention further provides a catheter system, which includes an ultrasonic generator and any one of the ultrasonic balloon recanalization guiding catheters, and the ultrasonic generator is electrically connected to the ultrasonic transducer.

[0020] Optionally, the ultrasonic balloon recanalization guiding catheter further includes a pressure sensor, which is arranged at the distal end of the ultrasonic catheter and is used to detect the pressure signal when the distal end of the ultrasonic catheter contacts the target tissue; the pressure sensor is electrically connected to the ultrasonic generator, and the ultrasonic generator is used to selectively turn on or off according to the pressure signal sent by the pressure sensor.

[0021] The utility model provides an ultrasonic balloon recanalization guiding catheter and a catheter system. By arranging a balloon guiding catheter outside the ultrasonic catheter, on the one hand, the first balloon can limit the radial movement amplitude of the ultrasonic catheter when the ultrasonic catheter interacts with the target tissue, so as to position the ultrasonic catheter through the first balloon, thereby avoiding excessive vibration amplitude of the ultrasonic catheter and damaging the blood vessel wall. Moreover, by simultaneously arranging the balloon guiding catheter and the ultrasonic catheter in the ultrasonic balloon recanalization guiding catheter, compared with separately arranging the two catheters, the production cost can be reduced, the operation time can be shortened, and the operation safety can be improved.

[0022] On the other hand, after the first balloon expands and abuts against the blood vessel wall, the expanded first balloon can block the blood flow during the operation, thereby preventing thrombus escape and avoiding the formation of acute thrombus during the operation, improving the safety and reliability of the operation. In addition, since the ultrasonic catheter can flexibly stretch in the balloon guiding catheter, the ultrasonic catheter can treat blood vessels with different lesion lengths after reaching the lesion position, and then can completely eliminate the calcified plaque of the blood vessel through the axial movement of the ultrasonic catheter, successfully realizing the dredging of the blood vessel and improving the treatment effect of the operation. Description of the Drawings

[0023] Figure 1 It is a schematic cross-sectional structure diagram of the catheter system in the first preferred embodiment of the utility model;

[0024] Figure 2 It is a schematic cross-sectional structure diagram of the catheter system in the second preferred embodiment of the utility model;

[0025] Figure 3 is Figure 1 a partial enlarged view of;

[0026] Figure 4 is Figure 2 a partial enlarged view of;

[0027] Figure 5 It is a schematic cross-sectional structure diagram of the catheter system in the third preferred embodiment of the utility model;

[0028] Figure 6 is Figure 5 a partial enlarged view of;

[0029] Figure 7This is the control schematic diagram of the catheter system in a preferred embodiment of the present utility model.

[0030] In the figure:

[0031] Balloon guiding catheter 1; inner tube 11; first chamber 111; second chamber 112; first outer tube 12; first balloon 13;

[0032] Ultrasound catheter 2; ultrasound transducer 21; metal tip 22; through hole 221; delivery tube 23; thread 231; first buffer sleeve 24; quick connection port 241; first wire 25; second balloon 261; second outer tube 262; second buffer sleeve 263; ultrasound generating component 264; second wire 27;

[0033] Connection seat 3; first knob 311; roller 312; second knob 321; wire storage tray 322; first connection port 31; second connection port 32; third connection port 33; fourth connection port 34; first connection seat 351; second connection seat 352; connecting tube 353; third connection seat 36; first proximal region 361; first distal region 362; fourth connection seat 37; second proximal region 371; second distal region 372; fifth connection port 38;

[0034] Ultrasound generator 4; pressure sensor 5; control unit 6; display component 7. Detailed implementation manners

[0035] The following further elaborates on the present utility model in conjunction with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the present utility model will be clearer. It should be noted that the accompanying drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the purpose of the embodiments of the present utility model.

[0036] The orientation or positional relationship indicated by terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the indicated mechanism or element must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present utility model.

[0037] In the present utility model, unless otherwise clearly defined and limited, terms such as "installation", "connection", "fixation", etc. shall be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection, an electrical connection, or communication with each other; it can be directly connected, or connected through an intermediate medium, and can be the communication inside two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0038] In this article, the "distal end" generally refers to the end of the balloon guide catheter or the ultrasonic catheter that is far from the operator; the term "proximal end" is opposite to the "distal end" and generally refers to the end of the balloon guide catheter or the ultrasonic catheter that is close to the operator; the term "axial direction" refers to the direction of the central axis of the first outer tube or the inner tube; the term "radial direction" refers to the direction perpendicular to the central axis of the first outer tube or the inner tube; the term "circumferential direction" refers to the direction around the central axis of the first outer tube or the inner tube.

[0039] The following will describe the present utility model in detail with reference to the accompanying drawings and preferred embodiments. Without conflict, the following embodiments and the features in the embodiments can be mutually supplemented or combined.

[0040] Refer to Figures 1 to 4 As shown, a preferred embodiment of the present utility model provides an ultrasonic balloon recanalization guide catheter, which includes a balloon guide catheter 1, an ultrasonic catheter 2, and a connection seat 3. The balloon guide catheter 1 includes an inner tube 11, a first outer tube 12, and a first balloon 13. The proximal end of the first balloon 13 is connected to the distal end of the first outer tube 12, the distal end of the first balloon 13 is connected to the inner tube 11, and the proximal ends of the inner tube 11 and the first outer tube 12 are both connected to the connection seat 3. The ultrasonic catheter 2 is movably disposed in the inner tube 11.

[0041] Refer to Figure 1 and Figure 3 As shown, an ultrasonic transducer 21 is disposed at the distal end of the ultrasonic catheter 2, and the ultrasonic transducer 21 is used to release ultrasonic waves to the target tissue. The ultrasonic transducer 21 preferably adopts a micro piezoelectric transducer and has good insulation. The first balloon 13 can expand or contract, and after expansion, the first balloon 13 can be anchored in the target pipeline (i.e., blood vessel) to limit the movement amplitude of the ultrasonic catheter 2 in its own radial direction, so as to avoid excessive movement amplitude of the ultrasonic catheter 2 in its own radial direction during operation and damage the inner wall of the blood vessel. It should be known that the target tissue generally refers to calcified tissue (i.e., calcified plaque) in the blood vessel.

[0042] During actual implantation, after the balloon guiding catheter 1 is delivered to the lesion site, the first balloon 13 is expanded and anchored in the inner wall of the blood vessel. Then, the ultrasonic catheter 2 is extended from the distal end of the inner tube 11 and moved to a position adjacent to the target tissue. Subsequently, ultrasonic waves are released to the calcified plaque through the ultrasonic transducer 21 until the calcified plaque is broken up.

[0043] It should be understood that the lesion site delivered by the balloon guiding catheter 1 refers to the delivery position of the balloon guiding catheter 1 when the ultrasonic catheter 2 can be adjacent to the calcified tissue after extending out of the balloon guiding catheter 1. The lesion site usually refers to the inner wall of the blood vessel at the lesion site, that is, the inner wall of the blood vessel covering the calcified plaque in the blood vessel where the ultrasonic balloon recanalization guiding catheter is implanted, such as the inner wall of the coronary artery. The calcified tissue refers to the calcified lesion in the blood vessel, which may specifically include fibrosis or calcified spots.

[0044] In this application, a balloon guiding catheter 1 is arranged outside the ultrasonic catheter 2. On the one hand, the first balloon 13 can limit the radial movement amplitude of the ultrasonic catheter 2 when the ultrasonic catheter 2 interacts with the target tissue, so as to position the ultrasonic catheter 2 through the first balloon 13, thereby avoiding excessive vibration amplitude of the ultrasonic catheter 2 and damaging the blood vessel wall. Moreover, by arranging both the balloon guiding catheter 1 and the ultrasonic catheter 2 in the ultrasonic balloon recanalization guiding catheter at the same time, compared with arranging the two types of catheters separately, the production cost can be reduced, the operation time can be shortened, and the operation safety can be improved.

[0045] On the other hand, after the first balloon 13 is expanded and anchored on the blood vessel wall, the expanded first balloon 13 can block the blood flow during the operation, and thus has the effect of preventing thrombus escape, so as to avoid the formation of acute thrombus due to thrombus escape during the operation and improve the safety and reliability of the operation.

[0046] In addition, since the ultrasonic catheter 2 can flexibly stretch and contract within the balloon guiding catheter 1, the ultrasonic catheter 2 can treat blood vessels with different lesion lengths after reaching the lesion site, and thus the calcified plaque in the blood vessel can be completely removed through the axial movement of the ultrasonic catheter 2, successfully achieving the dredging of the blood vessel and improving the treatment effect of the operation.

[0047] This application does not limit the connection manner between the first balloon 13 and the inner tube 11, as well as between the first balloon 13 and the first outer tube 12. The proximal end of the first balloon 13 and the inner tube 11 can be connected by methods such as dispensing, laser welding, and hot air welding. At the same time, the distal end of the first balloon 13 and the first outer tube 12 can also be connected by methods such as dispensing, laser welding, and hot air welding, but not limited thereto.

[0048] Preferably, for the convenience of delivering the balloon guiding catheter 1, the first balloon 13 can be set as a compliant balloon. Among them, the material of the first balloon 13 can be one or a combination of silicone, PU, PVC, or PE.

[0049] It should be understood that since the inner tube 11 needs to be penetrated by the ultrasonic catheter 2, and the distal end of the inner tube 11 needs to have flexibility to facilitate transportation in blood vessels. The distal end of the inner tube 11 can be set to a specific shape (including but not limited to straight shape, primary bend, secondary bend, and tertiary bend). Such a setting can enable the inner tube 11 to smoothly pass through complex lesion positions. At the same time, the head end of the inner tube 11 is preferably also designed to be conical. At this time, the head end of the inner tube 11 is relatively soft and fine, which can help the inner tube 11 to be transported to a farther position.

[0050] This application does not limit the preparation material of the inner tube 11. The material of the inner tube 11 includes but is not limited to Pebax or nylon. The inner tube 11 preferably has a three-layer tube structure. Among them, the inner layer of the inner tube 11 can be prepared from HDPE material, the middle layer can be prepared from LDPE material, and the outer layer can be prepared from Pebax or PA material.

[0051] This application also does not limit the preparation material of the first outer tube 12. As the cavity for the inflation of the first balloon 13, the first outer tube 12 needs to have good sealing performance and support performance. The first outer tube 12 preferably uses a three-layer tube structure. Among them, the inner layer of the first outer tube 12 can be prepared from nylon material with a PTFE coating to reduce internal friction and lower the risk of thrombus formation. The middle layer of the first outer tube 12 can be made of a braided tube woven with stainless steel wire or nitinol wire to facilitate improving the support performance of the balloon guide catheter 1. The outer layer of the first outer tube 12 can be prepared from materials with good flexibility and good sealing performance such as nylon and Pebax to improve the transportation performance.

[0052] Refer to Figures 1 to 4 shown, and in combination with Figure 7 In a preferred embodiment of the present invention, a catheter system is further provided, including an ultrasonic generator 4 and an ultrasonic balloon recanalization guide catheter. The ultrasonic generator 4 is electrically connected to the ultrasonic transducer 21. The ultrasonic generator 4 is used to provide a high-frequency alternating current signal to the ultrasonic transducer 21. After receiving the high-frequency alternating current signal, the ultrasonic transducer 21 releases ultrasonic waves.

[0053] Refer to Figure 1 shown, the ultrasonic catheter 2 includes a metal head end 22, a delivery tube 23, and a first buffer sleeve 24 connected in sequence from the distal end to the proximal end. The proximal end of the first buffer sleeve 24 is connected to the connection seat 3. At least part of the section of the first buffer sleeve 24 can be telescoped in its own axial direction so that the delivery tube 23 can move relative to the inner tube 11. The ultrasonic transducer 21 can be fixed to the distal end of the metal head end 22 by means of dispensing, welding, or other methods. The metal head end 22 is used to move along its own axial direction under the drive of the delivery tube 23 until it abuts against the target tissue. Then, the ultrasonic transducer 21 is turned on and releases mechanical energy to the target tissue through ultrasonic waves, thereby crushing the calcified tissue.

[0054] Reference Figure 1 and Figure 3 As shown, a through hole 221 axially penetrating the metal head end 22 is provided on the metal head end 22, and the delivery tube 23 communicates with the through hole 221. The ultrasonic transducer 21 preferably has a waterproof function, and the ultrasonic transducer 21 is preferably installed in the vicinity of the through hole 221. In one embodiment, the distal end of the delivery tube 23 extends into the through hole 221 to realize the connection between the delivery tube 23 and the through hole 221. At this time, the delivery tube 23 and the through hole 221 are coaxially connected.

[0055] Continuing to refer Figure 1 As shown, a first connection port 31 is provided on the connection base 3. The proximal end of the first buffer sleeve 24 communicates with the first connection port 31. The first connection port 31 is used to sequentially deliver a conductive liquid (such as saline) to the distal end of the metal head end 22 through the first buffer sleeve 24, the delivery tube 23 and the through hole 221. At this time, the inner cavity of the delivery tube 23 can be used as a channel for the conductive liquid to flow through. The ultrasonic transducer 21 can interact with the conductive liquid and then shatter the target tissue.

[0056] More specifically, when the ultrasonic waves generated by the ultrasonic transducer 21 propagate in the conductive liquid, cavitation bubbles can be continuously formed in the conductive liquid under the action of the ultrasonic waves until they burst. When the cavitation bubbles burst, an instantaneous high pressure can impact the surface of the calcified tissue, so that the calcified tissue is decomposed and ruptured under the action of the bursting impact force of the cavitation bubbles, and then the blood vessel blocked by the calcified tissue is successfully dredged.

[0057] Furthermore, since the metal head end 22 needs to break the calcified plaque through ultrasonic vibration, the metal head end 22 usually requires a relatively high hardness. At this time, the preparation material of the metal head end 22 can be selected from one or more of stainless steel, nitinol alloy or tungsten steel.

[0058] At the same time, since the delivery tube 23 needs to maintain the flexibility, passability and supportability of the distal end of the ultrasonic catheter 2. Therefore, the delivery tube 23 is preferably designed as a metal stepped tube, and the outer diameter of the distal end of the metal stepped tube is smaller than the outer diameter of the proximal end of the metal stepped tube. The thin end (i.e., the distal end) of the metal stepped tube and the metal head end 22 can be connected by resistance welding or laser welding and other connection methods. In addition, since the metal stepped tube should also have good sealing and insulation properties, an insulating coating can be coated on both the inner surface and the outer surface of the metal stepped tube. The insulating coating includes but is not limited to PTFE, parylene or PI coating.

[0059] This application does not limit the fixing method of the delivery tube 23 with the first buffer sleeve 24 and the first connection port 31. For example, the proximal end of the delivery tube 23 and the distal end of the first buffer sleeve 24 can be connected by laser welding, dispensing or hot air welding and other methods, and the proximal end of the first buffer sleeve 24 and the first connection port 31 can be connected by dispensing.

[0060] Further, continuing to refer to Figure 1 and Figure 3 , the ultrasonic catheter 2 further includes a first wire 25, the first wire 25 is movably threaded through the delivery tube 23 and at least part of the first buffer sleeve 24, and the distal end of the first wire 25 is connected to the ultrasonic transducer 21. The proximal end of the first wire 25 extends out of the first buffer sleeve 24, and extends out of the connection base 3 through the second connection port 32, and then is connected to the ultrasonic generator 4.

[0061] In one solution, the first wire 25 and the conductive liquid share the lumen of the delivery tube 23. At this time, the insulating skin outside the first wire 25 can prevent the first wire 25 from directly contacting the conductive liquid. In another solution, two independent lumens can also be provided in the delivery tube 23. At this time, the first wire 25 and the conductive liquid can be respectively placed in different lumens.

[0062] Continuing to refer to Figure 1 , in a specific example, the distal end of the first wire 25 extends out of the delivery tube 23 and enters the through hole 221 to be connected to the ultrasonic transducer 21. A quick connection port 241 is opened on the side wall of the first buffer sleeve 24, and the proximal end of the first wire 25 extends out of the first buffer sleeve 24 from the quick connection port 241.

[0063] It should be explained that since the first buffer sleeve 24 needs to adaptively expand and contract as the metal head end 22 and the delivery tube 23 move, and at the same time, it also needs to have the functions of protecting the first wire 25 and sealing the conductive liquid lumen, the first buffer sleeve 24 should be made of a material with a relatively soft texture and good elasticity. The preparation materials of the first buffer sleeve 24 include but are not limited to PVC, PE, PA, etc.

[0064] Referring to Figure 1 and Figure 2 as shown, in a preferred embodiment, the inner tube 11 is a double-lumen tube, specifically including a first chamber 111 and a second chamber 112. The first chamber 111 of the inner tube 11 is used to accommodate the ultrasonic catheter 2, that is, the ultrasonic catheter 2 is movably arranged in the first chamber 111. The axis of the first chamber 111 preferably coincides with the axis of the inner tube 11. At this time, the first chamber 111 is located at the central position of the inner tube 11. With such a configuration, after the first balloon 13 expands and anchors on the blood vessel wall, the ultrasonic catheter 2 is located at the central position of the blood vessel, which can improve the treatment effect of the ultrasonic catheter 2 on calcified tissues and is also convenient for the subsequent placement of the stent. The second chamber 112 is used to accommodate a guide wire (not shown). During actual implantation, the operator first delivers the guide wire to the lesion site, and then can move the balloon guide catheter 1 along the guide wire, and then move the balloon guide catheter 1 to the lesion site.

[0065] Preferably, the connection base 3 further includes a third connection port 33 and a fourth connection port 34 (refer toFigure 1 and Figure 2 ), the third connection port 33 communicates with the first outer tube 12 and is used to inject or extract a filling medium (such as saline) into or from the first balloon 13, so as to expand or contract the first balloon 13. The fourth connection port 34 communicates with the inner tube 11, specifically with the second chamber 112, and the fourth connection port 34 is used for a guide wire to pass through.

[0066] This application does not limit the fixing method of the inner tube 11 and the fourth connection port 34, nor the fixing method of the first outer tube 12 and the third connection port 33. The inner tube 11 and the fourth connection port 34 can be fixedly connected by gluing, and at the same time, the first outer tube 12 and the third connection port 33 can also be fixedly connected by gluing, but not limited to this.

[0067] As a preferred embodiment, a first operating member is provided on the connection seat 3, and a cooperating member is provided on the proximal outer wall of the delivery tube 23. The first operating member is used to cooperate with the cooperating member on the delivery tube 23 to drive the delivery tube 23 to move relative to the inner tube 11.

[0068] As Figure 1 and Figure 2 shown, in a specific embodiment, the first operating member can be set as the first knob 311, the cooperating member can be set as the thread 231 on the proximal outer wall of the delivery tube 23, a roller 312 is arranged inside the connection seat 3, and the roller 312 is coaxially connected with the first knob 311. The roller 312 is used to cooperate with the thread 231 on the delivery tube 23 and is used to drive the delivery tube 23 to move relative to the inner tube 11 under the drive of the first knob 311.

[0069] In this embodiment, the first knob 311 is arranged on the outer wall of the connection seat 3, the roller 312 is arranged inside the connection seat 3, and the first knob 311 extends into the connection seat 3 and is fixedly connected with the roller 312.

[0070] Specifically, after the balloon guide catheter 1 is delivered to the lesion site, the operator can drive the roller 312 to rotate by rotating the first knob 311. After the roller 312 rotates, it can drive the delivery tube 23 with the thread 231 to move axially on its own, so that the metal head end 22 extends out of the inner tube 11 and abuts against the calcified tissue.

[0071] In another specific embodiment, the first operating member can also be set as a pushing member, the pushing member can match the cooperating member on the delivery tube 23, and when the pushing member moves, it can drive the delivery tube 23 to move relative to the inner tube 11 through the cooperating member, so as to drive the distal end of the ultrasonic catheter 2 to extend out of or retract into the balloon guide catheter 1.

[0072] As a preferred embodiment, a second operating member is further provided on the connecting seat 3, and a wire storage disc 322 is further provided in the connecting seat 3. The wire of the ultrasonic catheter 2 can be wound around the wire storage disc 322 and extend out of the connecting seat 3. The wire storage disc 322 is used to recover or release the wire under the drive of the second operating member.

[0073] Continue to refer to Figure 1 and Figure 2 In a preferred embodiment, the second operating member is provided as a second knob 321. The wire storage disc 322 is coaxially connected to the second knob 321. The first wire 25 extending out from the quick connection port 241 can be wound around the wire storage disc 322 and extend out of the connecting seat 3. The wire storage disc 322 is used to recover or release the first wire 25 under the drive of the second knob 321, that is, the wire storage disc 322 can be used to store the redundant first wire 25.

[0074] In an example, the second knob 321 is provided on the outer wall of the connecting seat 3, the wire storage disc 322 is provided inside the connecting seat 3, and the second knob 321 extends into the connecting seat 3 and is fixedly connected to the wire storage disc 322.

[0075] Specifically, after the balloon guide catheter 1 is delivered to the lesion site, the operator can first drive the wire storage disc 322 to rotate by rotating the second knob 321, thereby releasing the first wire 25 so that the first wire 25 is redundant in the delivery tube 23. Then the operator can drive the roller 312 to rotate by rotating the first knob 311, so that the distal ends of the metal tip 22 and the first wire 25 move synchronously relative to the inner tube 11 until the metal tip 22 abuts against the calcified tissue. When the ultrasonic transducer 21 on the metal tip 22 shatters the calcified tissue, the operator can first rotate the first knob 311 to retract the metal tip 22 into the inner tube 11. Then the operator can rotate the second knob 321 to recover the first wire 25, that is, to wind the first wire 25 around the wire storage disc 322 again.

[0076] Continue to refer to Figures 1 to 4 The ultrasonic balloon recanalization guide catheter further includes a pressure sensor 5. The pressure sensor 5 is provided at the distal end of the ultrasonic catheter 2, specifically, it can be provided at the distal end of the metal tip 22. The pressure sensor 5 is preferably provided near the ultrasonic transducer 21. The pressure sensor 5 is used to detect the pressure signal when the distal end of the ultrasonic catheter 2 (i.e., the metal tip 22) contacts the target tissue (i.e., the calcified tissue). The pressure sensor 5 is electrically connected to the ultrasonic generator 4, and the ultrasonic generator 4 is used to selectively turn on or off according to the pressure signal sent by the pressure sensor 5.

[0077] Refer to Figure 7As shown, the pressure sensor 5 is electrically connected to the control unit 6 within the ultrasonic generator 4. The pressure sensor 5 is used to transmit the real-time pressure signal when the metal tip 22 contacts the calcified tissue to the control unit 6. That is, the pressure sensor 5 can detect the pressure change of the metal tip 22 during the treatment of calcified lesions, and then send it to the control unit 6 of the ultrasonic generator 4 through an electrical signal. The control unit 6 can control the turning on or off of the ultrasonic generator 4 according to the pressure signal.

[0078] More specifically, the control unit 6 can compare the real-time pressure signal with a predetermined pressure value. When the real-time pressure signal is greater than or equal to the predetermined pressure value, it indicates that both the pressure sensor 5 and the ultrasonic transducer 21 are in contact with the calcified tissue. At this time, the control unit 6 turns on the ultrasonic generator 4, and the ultrasonic transducer 21 starts to release ultrasonic waves to the calcified tissue. When the real-time pressure signal is less than the preset pressure value, it indicates that both the pressure sensor 5 and the ultrasonic transducer 21 are separated from the calcified tissue, and the calcified tissue may have been decomposed or shattered. At this time, the control unit 6 turns off the ultrasonic generator 4, and the ultrasonic transducer 21 stops releasing ultrasonic waves. After the ultrasonic catheter 2 shatters the adjacent calcified tissue, the ultrasonic catheter 2 can continue to move distally and repeat the above steps until all the calcified tissue is shattered within the movable stroke range of the ultrasonic catheter 2.

[0079] Continue to refer to Figure 7 , the catheter system further includes a display component 7. The display component 7 is communicatively connected to the control unit 6 and is used to display the real-time pressure signal detected by the pressure sensor 5.

[0080] In a non-limiting embodiment, the implantation process of the catheter system is as follows:

[0081] First, the balloon guide catheter 1 can be delivered to the lesion site through the guide wire, and then a filling medium is injected into the third connection port 33 to make the first balloon 13 closely adhere to the blood vessel wall.

[0082] Then rotate the second knob 321 to release the first wire 25, and at the same time rotate the first knob 311 to drive the conveying tube 23 to move distally by the roller 312 until the ultrasonic transducer 21 of the metal tip 22 extends out of the inner tube 11 and adheres to the calcified plaque (i.e., the calcified lesion site). During this process, the first buffer sleeve 24 is in a stretched state under the pulling of the conveying tube 23.

[0083] After the ultrasonic transducer 21 adheres to the calcified plaque, the pressure sensor 5 of the metal tip 22 receives a sharply increased pressure signal and transmits the pressure signal to the control unit 6 within the ultrasonic generator 4. The control unit 6 turns on the ultrasonic generator 4.

[0084] Then, conductive liquid is manually or automatically injected into the first connection port 31. At this time, the ultrasonic transducer 21 on the metal head end 22 starts to vibrate and emit ultrasonic waves, and at the same time, the conductive liquid on the metal head end 22 flushes the ultrasonic transducer 21. The ultrasonic transducer 21 breaks up calcified plaques through ultrasonic vibration and the cavitation effect of the conductive liquid.

[0085] During the treatment process, after the ultrasonic transducer 21 of the ultrasonic catheter 2 breaks up the nearby calcified plaques, the second knob 321 and the first knob 311 can be continuously rotated, and then the first wire 25 is further released and the ultrasonic catheter 2 is pushed distally, so that the ultrasonic transducer 21 of the ultrasonic catheter 2 abuts against and breaks up the calcified plaques at other positions in the blood vessel until the diseased calcified plaques in the blood vessel are completely eliminated, and at this time, the blood vessel passage is re-opened.

[0086] It should be understood that when the ultrasonic catheter 2 moves to the most distal position, the roller 312 moves to the edge of the thread 231 of the delivery tube 23, and the first buffer sleeve 24 is in a fully stretched state.

[0087] After the ultrasonic catheter 2 eliminates the calcified plaques, the pressure sensor 5 on the metal head end 22 receives a sharply decreased pressure signal and transmits the pressure signal to the control unit 6 of the ultrasonic generator 4, and the control unit 6 turns off the ultrasonic generator 4. Then, the injection of the conductive liquid into the first connection port 31 and the injection of the filling medium into the third connection port 32 are stopped. Then, the first knob 311 and the second knob 321 are rotated in reverse in sequence, so that the ultrasonic catheter 2 retracts into the inner tube 11, and at the same time, the first wire 25 is retracted into the wire storage disc 322 until the metal head end 22 is completely retracted into the inner tube 11. Subsequently, the entire balloon guide catheter 1 is retracted, and then the entire surgical process is ended.

[0088] <Example 1>

[0089] Refer to Figure 1 and Figure 3 As shown in

[0090] Refer to Figure 1, in one example, the connection base 3 further includes a connecting pipe 353. The proximal end of the first connection base 351 is connected to the distal end of the second connection base 352 through the connecting pipe 353. The proximal end of the delivery pipe 23 extends out of the first connection base 351, and after passing through the connecting pipe 353, it extends into the second connection base 352. The distal end and the proximal end of the connecting pipe 353 can be respectively connected to the first connection base 351 and the second connection base 352 by means of dispensing glue.

[0091] Further, the threaded section 231 of the delivery pipe 23, the roller 312, as well as the second knob 321 and the wire storage disc 322 are all disposed within the second connection base 352. The first connection port 31 and the second connection port 32 are both provided on the second connection base 352. The proximal end of the first buffer sleeve 24 is connected to the first connection port 31. After the first wire 25 is wound around the wire storage disc 322, it extends out of the second connection base 352 from the second connection port 32 and is connected to the ultrasonic generator 4.

[0092] <Example Two>

[0093] Refer to Figure 2 and Figure 4 As shown in [relevant figures], the connection base 3 includes a third connection base 36. The third connection base 36 includes a first proximal region 361 and a first distal region 362. The distal end of the first proximal region 361 is respectively connected to the proximal end of the inner tube 11 and the proximal end of the first outer tube 12. The proximal end of the first proximal region 361 is connected to the distal end of the first distal region 362. The first buffer sleeve 24 is disposed within the first distal region 362. The proximal end of the delivery pipe 23 passes through the first proximal region 361 and communicates with the distal end of the first buffer sleeve 24. The third connection port 33 and the fourth connection port 34 are provided on the first proximal region 361.

[0094] Further, the threaded section 231 of the delivery pipe 23, the roller 312, as well as the second knob 321 and the wire storage disc 322 are all disposed within the first distal region 362. The first connection port 31 and the second connection port 32 are provided on the first distal region 362. The proximal end of the first buffer sleeve 24 is connected to the first connection port 31. After the first wire 25 is wound around the wire storage disc 322, it extends out of the second connection base 352 from the second connection port 32 and is connected to the ultrasonic generator 24.

[0095] <Example Three>

[0096] Refer to Figure 5 and Figure 6As shown, the ultrasonic catheter 2 further includes a second balloon 261, a second outer tube 262, a second buffer sleeve 263, and an ultrasonic generating component 264. The metal tip 22, the second balloon 261, the second outer tube 262, and the second buffer sleeve 263 are connected in sequence in the direction from the distal end to the proximal end. The second balloon 261 is preferably sleeved on the distal end of the metal tip 22, and the proximal end of the second buffer sleeve 263 is connected to the connection seat 3. At least part of the second buffer sleeve 263 can be telescoped in its own axial direction, so that the proximal ends of the second outer tube 262 and the second buffer sleeve 263 can follow the movement of the metal tip 22.

[0097] Further, the delivery tube 23 movably penetrates through the second outer tube 262 and at least part of the second buffer sleeve 263. The ultrasonic generating component 264 is fixed on the delivery tube 23 and corresponds to the position of the second balloon 261, that is, the ultrasonic generating component 264 is fixed inside the second balloon 261. The ultrasonic generating component 264 is electrically connected to the ultrasonic generator 4 and is used to release ultrasonic waves to the target tissue on the inner wall of the target pipeline (i.e., blood vessel) through the second balloon 261.

[0098] It should be noted that since the second balloon 261 needs to break the calcified tissue on the blood vessel wall under the action of ultrasonic waves, the second balloon 261 is required to have good wall attachment. Therefore, the second balloon 261 is preferably a semi-compliant balloon, and the material of the second balloon 261 includes but is not limited to one or more of materials such as Pebax and nylon.

[0099] Refer to Figure 5 and Figure 6 As shown, the second balloon 261 can expand or contract. After the second balloon 261 expands, it can be anchored on the blood vessel wall and can break the calcified plaque on the inner wall of the blood vessel under the action of the ultrasonic generating component 264.

[0100] This application does not limit the connection methods between the distal end of the second balloon 261 and the metal tip 22, and between the proximal end of the second balloon 261 and the distal end of the second outer tube 262. The distal end of the second balloon 261 and the metal tip 22 can be connected by methods such as dispensing, laser welding, and hot air welding, and the proximal end of the second balloon 261 and the distal end of the second outer tube 262 can also be connected by methods such as dispensing, laser welding, and hot air welding, but not limited thereto.

[0101] In a specific example, the ultrasonic generating component 264 can be set as an electrode assembly.

[0102] During actual implantation, after the balloon guide catheter 1 reaches the lesion site, a filling medium can be injected into or withdrawn from the second balloon 261 to achieve the expansion or contraction of the second balloon 261. After the second balloon 261 expands and adheres to the inner wall of the blood vessel, the ultrasonic generating component 264 can generate ultrasonic waves in the second balloon 261 after receiving electrical energy from the ultrasonic generator 4. The ultrasonic waves cause the filling medium closer to the ultrasonic generating component 264 in the second balloon 261 to generate bubbles. The impact force generated when the bubbles expand and burst acts on the adjacent filling medium to push the filling medium in the second balloon 261 to generate ultrasonic waves moving towards the inner wall of the second balloon 261. After the outer wall of the second balloon 261 receives the ultrasonic waves, it impacts the calcified tissue in the blood vessel wall to crack and break the calcified lesion, restore the elasticity of the blood vessel and reshape the diseased blood vessel, and at the same time avoid damage to the inner wall or intima of the blood vessel.

[0103] Continue to refer to Figure 5 , the connector 3 includes a fourth connector 37. A fifth connection port 38 is provided on the fourth connector 37. The fifth connection port 38 communicates with the proximal end of the second buffer sleeve 264 and is used to inject or withdraw a filling medium into or from the second balloon 261 to achieve the expansion or contraction of the second balloon 261.

[0104] In this embodiment, the ultrasonic generating component 264 can be fixed on the delivery tube 23 by dispensing or other means. The proximal end of the second outer tube 262 and the distal end of the second buffer sleeve 263, as well as the proximal end of the second buffer sleeve 263 and the fifth connection port 38, can be connected by dispensing or other suitable means.

[0105] Refer to Figure 5 As shown, in a preferred example, the fourth connector 37 includes a second proximal region 371 and a second distal region 372. The distal end of the second proximal region 371 is respectively connected to the proximal ends of the inner tube 11 and the first outer tube 12. The proximal end of the second proximal region 371 is connected to the distal end of the second distal region 372. The first buffer sleeve 24 is placed in the second distal region 372. The proximal end of the delivery tube 23 passes through the second proximal region 371 and communicates with the distal end of the first buffer sleeve 24. The third connection port 33, the fourth connection port 34, and the fifth connection port 38 are all provided on the second proximal region 371.

[0106] Continue to refer to Figure 5 and Figure 6 , the ultrasonic catheter 2 preferably further includes a second wire 27. The distal end of the second wire 27 is connected to the ultrasonic generating component 264. A second connection port 32 is provided on the connector 3. The proximal end of the second wire 27 passes through the cavity between the second outer tube 262 and the delivery tube 23 and extends out of the connector 3 from the second connection port 32 to be connected to the ultrasonic generator 4.

[0107] Furthermore, the second wire 27 can be wound around the wire storage reel 322 and extend out from the second connection port 32. The wire storage reel 322 is used to recycle or release the second wire 27 under the drive of the second knob 321.

[0108] In a non-limiting embodiment, the implantation process of the ultrasonic balloon recanalization guiding catheter further includes:

[0109] After the metal tip 22 is delivered in place and abuts against the calcified tissue, the control unit 6 of the ultrasonic generator 4 receives the pressure information sent by the pressure sensor 5 and turns on the ultrasonic generator 4. The ultrasonic transducer 21 on the metal tip 22 starts to vibrate and release ultrasonic waves. Then, the operator can manually or automatically inject the filling medium into the fifth connection port 38 until the second balloon 261 expands and abuts against the blood vessel wall.

[0110] Subsequently, the ultrasonic generator 4 supplies electric energy to the ultrasonic generating component 264, and the ultrasonic generating component 264 releases ultrasonic waves to the calcified tissue on the blood vessel wall through the second balloon 261, thereby breaking up the calcified tissue on the blood vessel wall.

[0111] After the ultrasonic catheter 2 breaks up the calcified tissue in the nearby area, the ultrasonic catheter 2 can be further pushed distally until the calcified tissue in the blood vessel channel and on the blood vessel wall is completely removed. After the calcified tissue in the blood vessel is completely removed, the control unit 6 in the ultrasonic generator 4 receives a sharply decreased pressure signal and turns off the ultrasonic generator 4. Subsequently, the operator stops injecting the filling medium into the third connection port 33 and the fifth connection port 38, and by rotating the first knob 311 and the second knob 321, the ultrasonic catheter 2 is gradually retracted into the balloon guiding catheter 1. Finally, the entire balloon guiding catheter 1 is withdrawn from the body, thus ending the entire surgical procedure.

[0112] In summary, the present utility model provides an ultrasonic balloon recanalization guiding catheter and a catheter system. By arranging the balloon guiding catheter 1 outside the ultrasonic catheter 2, on the one hand, the first balloon 13 can limit the radial movement range of the ultrasonic catheter 2 when the ultrasonic catheter 2 interacts with the target tissue, so as to position the ultrasonic catheter 2 through the first balloon 13, thereby avoiding excessive vibration amplitude of the ultrasonic catheter 2 and damaging the blood vessel wall. Moreover, by simultaneously arranging the balloon guiding catheter 1 and the ultrasonic catheter 2 in the ultrasonic balloon recanalization guiding catheter, compared with separately arranging the two types of catheters, the production cost can be reduced, the surgical time can be shortened, and the surgical safety can be improved.

[0113] On the other hand, after the first balloon 13 is expanded and abuts against the blood vessel wall, the expanded first balloon 13 can block blood flow during the operation, thereby preventing thrombus escape, avoiding the formation of acute thrombus during the operation, and improving the safety and reliability of the operation. In addition, since the ultrasonic catheter 2 can flexibly stretch in the balloon guiding catheter 1, after the ultrasonic catheter 2 reaches the lesion location, it can treat blood vessels with complete occlusion of different lesion lengths. Furthermore, the calcified plaque of the blood vessel can be completely removed by the axial movement of the ultrasonic catheter 2, successfully achieving the dredging of the blood vessel and improving the treatment effect of the operation.

[0114] The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. An ultrasonic balloon recanalization guiding catheter, characterized in that, It includes a balloon guiding catheter, an ultrasonic catheter and a connecting seat; the balloon guiding catheter includes an inner tube, a first outer tube and a first balloon, the proximal end of the first balloon is connected to the distal end of the first outer tube, the distal end of the first balloon is connected to the inner tube, and the proximal ends of the inner tube and the first outer tube are both connected to the connecting seat; the ultrasonic catheter is movably disposed in the inner tube; The distal end of the ultrasonic catheter is provided with an ultrasonic transducer for releasing ultrasonic waves to the target tissue; the first balloon can be expanded or contracted, and after expansion, the first balloon can be anchored in the target pipeline to limit the movement range of the ultrasonic catheter in its own radial direction.

2. The ultrasonic balloon recanalization guiding catheter according to claim 1, wherein The ultrasonic catheter includes a metal head end, a delivery tube and a first buffer sleeve connected in sequence from the distal end to the proximal end. The proximal end of the first buffer sleeve is connected to the connecting seat, and at least part of the section of the first buffer sleeve can be telescoped in its own axial direction so that the delivery tube can move relative to the inner tube; the ultrasonic transducer is fixed to the distal end of the metal head end.

3. The ultrasonic balloon recanalization guiding catheter according to claim 2, characterized in that, A through hole axially penetrating along the delivery tube is provided on the metal head end, and the delivery tube communicates with the through hole; a first connection port is provided on the connecting seat, the proximal end of the first buffer sleeve communicates with the first connection port, and the first connection port is used to sequentially deliver a conductive liquid to the distal end of the metal head end through the first buffer sleeve, the delivery tube and the through hole.

4. The ultrasonic balloon recanalization guiding catheter according to claim 2, wherein, The ultrasonic catheter further includes a first wire movably disposed in the delivery tube and at least part of the first buffer sleeve, and the distal end of the first wire is connected to the ultrasonic transducer; a second connection port is provided on the connecting seat, and the proximal end of the first wire extends out of the first buffer sleeve and extends out of the connecting seat through the second connection port.

5. The ultrasonic balloon recanalization guiding catheter according to claim 2, characterized in that, The inner tube has a first chamber and a second chamber. The first chamber is used to accommodate the ultrasonic catheter, and the axis of the first chamber coincides with the axis of the inner tube; the second chamber is used to accommodate a guide wire.

6. The ultrasonic balloon recanalization guiding catheter according to claim 2, wherein, The connecting seat further includes a third connection port and a fourth connection port. The third connection port communicates with the first outer tube and is used to inject or extract a filling medium into the first balloon; the fourth connection port communicates with the inner tube and is used to allow the guide wire to pass through.

7. The ultrasonic balloon recanalization guiding catheter according to claim 6, characterized in that, The connecting seat includes a first connecting seat and a second connecting seat. The proximal end of the first connecting seat is connected to the distal end of the second connecting seat; the inner tube and the first outer tube are both fixed on the first connecting seat; the first buffer sleeve is placed in the second connecting seat, and the proximal end of the delivery tube passes through the first connecting seat and extends into the second connecting seat to communicate with the distal end of the first buffer sleeve; the first connection port and the second connection port are provided on the second connecting seat, and the third connection port and the fourth connection port are provided on the first connecting seat.

8. The ultrasonic balloon recanalization guiding catheter according to claim 6, characterized in that, The ultrasonic catheter further includes a second balloon, a second outer tube, a second buffer sleeve, and an ultrasonic generating component. The metal tip, the second balloon, the second outer tube, and the second buffer sleeve are sequentially connected in the direction from the distal end to the proximal end. The proximal end of the second buffer sleeve is connected to the connection seat. The delivery tube movably passes through the second outer tube and at least part of the second buffer sleeve. The ultrasonic generating component is fixed on the delivery tube and corresponds to the position of the second balloon. The ultrasonic generating component is configured to release ultrasonic waves to the target tissue on the inner wall of the target pipeline through the second balloon.

9. The ultrasonic balloon recanalization guiding catheter according to claim 8, characterized in that, A fifth connection port is further provided on the connection seat. The fifth connection port communicates with the second buffer sleeve and is configured to inject or extract a filling medium into the second balloon.

10. The ultrasonic balloon recanalization guiding catheter according to claim 8, wherein, The ultrasonic catheter further includes a second wire. The distal end of the second wire is connected to the ultrasonic generating component. A second connection port is provided on the connection seat. The proximal end of the second wire passes through the cavity between the second outer tube and the delivery tube and extends out of the connection seat from the second connection port.

11. The ultrasonic balloon recanalization guiding catheter according to any one of claims 2-10, characterized in that, A first operating member is provided on the connection seat. A mating member is provided on the outer wall of the proximal end of the delivery tube. The first operating member is configured to cooperate with the mating member on the delivery tube to drive the delivery tube to move relative to the inner tube.

12. The ultrasonic balloon recanalization guiding catheter according to claim 2, wherein, A second operating member is further provided on the connection seat. A wire storage reel is further provided in the connection seat. The wire storage reel is connected to the second operating member. The wire of the ultrasonic catheter can be wound around the wire storage reel and extend out of the connection seat. The wire storage reel is configured to retract or release the wire under the drive of the second operating member.

13. A catheter system, characterized in that, It includes an ultrasonic generator and the ultrasonic balloon recanalization guiding catheter according to any one of claims 1-12. The ultrasonic generator is electrically connected to the ultrasonic transducer.

14. The catheter system according to claim 13, wherein The ultrasonic balloon recanalization guiding catheter further includes a pressure sensor. The pressure sensor is provided at the distal end of the ultrasonic catheter and is configured to detect a pressure signal when the distal end of the ultrasonic catheter contacts the target tissue. The pressure sensor is electrically connected to the ultrasonic generator. The ultrasonic generator is configured to selectively turn on or off according to the pressure signal sent by the pressure sensor.

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