Interventional treatment system and ultrasonic catheter for interventional treatment

Abstract

The present disclosure relates to the field of interventional treatment technology, and in particular, to an interventional treatment system and an ultrasonic catheter for interventional treatment. The ultrasonic catheter for interventional treatment comprises: a dual-cavity micro-catheter, comprising a first guide cavity and a first core part cavity; a sound transmission section, comprising a second core part cavity and a second guide cavity, wherein the second guide cavity is provided with a guide wire outlet, and the first core part cavity and the second core part cavity both extend in a pushing direction and are arranged in parallel; a core part, wherein a distal end of the core part is provided with an ultrasonic transducer, the core part is arranged in the second core part cavity and the first core part cavity, and the ultrasonic transducer is arranged in the second core part cavity; and a rapid exchange section, connected to a distal end of the sound transmission section, wherein a leading guide wire passes through the rapid exchange section from a distal end to a proximal end. The device has the functions of ultrasonic imaging for intravascular diagnosis and guide wire intervention. The guide wire puncture can be guided in real time under the guidance of intravascular ultrasound (IVUS), so as to build a channel entering the real lumen of a blood vessel at a distal end of an occluded section, thus improving the operation success rate.

Description

An interventional therapy system and an ultrasonic catheter used for interventional therapy

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on January 18, 2024, with application number 202410074720.6 and invention name “An interventional therapy system and an ultrasound catheter for interventional therapy thereof”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of interventional therapy, and more particularly, to an ultrasonic catheter for interventional therapy and an interventional therapy system comprising the ultrasonic catheter for interventional therapy. Background Art

[0003] Conventional ultrasound catheters are single-lumen structures used solely for ultrasound transducer imaging. They have a single function and cannot directly achieve therapeutic effects. For devices that combine ultrasound for interventional therapy, various interventional instruments must be serially connected to the same primary guidewire to reach the target location. This results in a larger overall radial dimension and greater limitations in usage scenarios. It is difficult to synchronize ultrasound imaging with interventional instruments. In particular, if an interventional instrument enters another branch, the ultrasound image cannot continue to provide real-time image guidance. For complex procedures, multiple instruments must be serially connected to a single primary guidewire, requiring a rigorous and careful sequence design. Otherwise, multiple instruments must be withdrawn and rearranged, resulting in complex procedures, poor ultrasound imaging quality, and difficulty ensuring the continuity of ultrasound guidance. This results in long and challenging procedures. For example, in the case of completely occluded vascular lesions, the lack of real-time image guidance makes it difficult to determine the direction and occluded segment of the vascular intima, making it impossible to effectively steer the guidewire through the intima back to the true lumen or locate the occluded entrance.

[0004] In summary, how to make the catheter have both the functions of image guidance and interventional treatment, reduce the operation time and difficulty, and improve the success rate of the operation is an urgent problem to be solved by those skilled in the art.

[0005] Summary of the Invention

[0006] In light of this, the present invention aims to provide an ultrasound catheter for interventional therapy that combines the capabilities of intravascular ultrasound (IVUS) imaging and guidewire therapy. Under IVUS guidance, it can provide real-time guidewire puncture, creating access to the true lumen of the vessel distal to the occluded segment, effectively reducing surgical time and difficulty and improving surgical success rates. Another object of the present invention is to provide an interventional therapy system that includes the aforementioned ultrasound catheter for interventional therapy.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] An ultrasonic catheter for interventional treatment, comprising:

[0009] A double-lumen microcatheter comprises a first guide lumen and a first core lumen; a sound-transmitting section comprising a second core lumen communicating with the distal end of the first core lumen and a second guide lumen communicating with the distal end of the first guide lumen, the second guide lumen being provided with a guidewire outlet, the second core lumen and the second guide lumen both extending distally and being arranged side by side with each other; a core having an ultrasonic transducer provided at its distal end, the core being arranged in the second core lumen and the first core lumen, the ultrasonic transducer being arranged in the second core lumen; a quick-exchange section, the quick-exchange section being connected to the distal end of the sound-transmitting section, the distal end of the quick-exchange section being used for the insertion of a guide wire, and the proximal end of the quick-exchange section being used for the exit of a guide wire; and further comprising a Y-shaped connector and a joint; the Y-shaped connector comprising a third core lumen communicating with the proximal end of the first core lumen and a third guide lumen communicating with the proximal end of the first guide lumen; and the joint comprising a flushing interface and a core interface, both of which are communicated with the third core lumen.

[0010] In one embodiment, the ultrasonic transducer is used to select a target position and to obtain images along the radial direction of the second core cavity. The ultrasonic catheter can be twisted so that the guidewire outlet and the target position are arranged on the same side of the ultrasonic transducer.

[0011] In one embodiment, the sound-transmitting section is made of a material that is easily sound-transmitting; the cross-sectional profile of the sound-transmitting section is circular, or the cross-sectional profile of the sound-transmitting section transitions from circular to elliptical as it extends toward the distal end.

[0012] In one embodiment, the cross-sectional profile of the sound-transmitting section is elliptical; and the ratio of the short axis to the long axis of the elliptical sound-transmitting section is 1:1.7 to 1:2.3, and / or the ratio of the minimum wall thickness to the maximum wall thickness of the elliptical sound-transmitting section is 1:4 to 1:6.

[0013] In one embodiment, the first core cavity and the second core cavity are both cylindrical cavities, and the core can move forward or backward relative to the first core cavity and the second core cavity; and the ultrasonic transducer has an initial position that is basically flush with the guide wire outlet, and the ultrasonic transducer has a detection position that moves relative to the guide wire outlet.

[0014] In one embodiment, the length of the rapid exchange section is L1, the length from the distal end of the ultrasonic catheter to the proximal end of the acoustically transparent section is (L1+Lt), and the ratio of L1 to (L1+Lt) is between 1 / 5 and 1 / 7.

[0015] In one embodiment, the sound-transparent section is provided with an arc-shaped profile at the guidewire outlet, and the radial dimension of the sound-transparent section gradually decreases as it extends toward the distal end; and / or, the rapid exchange section is provided with an arc-shaped hole for the guidewire to bend through.

[0016] In one embodiment, a double-lumen microcatheter includes, from the inside to the outside, a polymer inner layer, an intermediate reinforcement layer, and a resin outer layer; the polymer inner layer is made of a polymer material with a low friction coefficient, and the polymer inner layer forms a first guide cavity and a first core cavity; the intermediate reinforcement layer is formed by weaving, winding, or sleeved on the polymer inner layer; the resin outer layer is made of at least two materials with different hardness, and the hardness of the resin outer layer gradually decreases from the proximal end to the distal end; the polymer inner layer, the intermediate reinforcement layer, and the resin outer layer are formed into an ultrasonic catheter by co-extrusion technology or heat shrink tube technology.

[0017] An interventional treatment system comprises a plurality of guidewires and any of the above-mentioned ultrasound catheters for interventional treatment; the guidewires comprise an interventional guidewire extending from a guidewire outlet and a guide guidewire passed through a rapid exchange segment; the guide guidewire is used to guide the ultrasound catheter to a desired position, and the interventional guidewire is used to deliver the ultrasound catheter to a targeted target position under the image guidance of the ultrasound catheter; the guidewire can switch between a state of extending from the guidewire outlet and a state of passing through the rapid exchange segment, thereby enabling the guidewire to switch between the guide guidewire and the interventional guidewire.

[0018] In one embodiment, an interventional medical device is also included, which includes at least one of a working guide wire, a balloon, a stent, a rotational grinding device, and a suction device; the interventional medical device is used to be delivered to the targeted target position along the guide wire, or the interventional medical device is used to be directly extended from the guide wire outlet under the image guidance of the ultrasound catheter and delivered to the targeted target position.

[0019] In one embodiment, the interventional treatment system is used for interventional occlusion treatment; the guidewire also includes an interventional treatment guidewire, the distal end of the interventional treatment guidewire is arranged at the distal end of the vascular occlusion segment, the proximal end of the interventional treatment guidewire is arranged at the proximal end of the vascular occlusion segment, and the middle section of the interventional treatment guidewire bypasses the vascular occlusion segment through the interlayer between the intima and the media of the vascular segment where the vascular occlusion segment is located under the imaging guidance of the ultrasound catheter.

[0020] In summary, the interventional treatment system and the ultrasonic catheter for interventional treatment provided by the present invention have the functions of intravascular diagnostic ultrasound (IVUS) imaging and interventional treatment. Under the guidance of IVUS, an interventional treatment path can be established or treatment can be performed directly. Since the ultrasonic catheter is an integrated structure, the accuracy of image guidance can be better guaranteed, and the ultrasonic imaging effect is better. And when performing interventional treatment, there is no need to share the guide path with other instruments. It can independently play the function of guiding to the target position and the function of treating the targeted target position, so the overall outer diameter can be reduced to broaden the scope of application. In addition, since the catheter can allow the guide wire to switch to a guide guide wire or an interventional guide wire at different stages, the ultrasonic transducer of the catheter can provide continuous image guidance at each stage, which can effectively reduce the operation time and difficulty and improve the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0022] FIG1 is a schematic structural diagram of the distal end of an ultrasound catheter for interventional therapy provided by the present invention;

[0023] FIG2 is a schematic structural diagram of the proximal end of an ultrasound catheter used for interventional therapy;

[0024] FIG3 is a schematic structural diagram of a double-lumen microcatheter;

[0025] FIG4 is a schematic diagram of the end portion of the sound-transmitting section;

[0026] FIG5 is a schematic structural diagram of the sound-transmitting section;

[0027] FIG6 is a schematic structural diagram of a rapid exchange section;

[0028] FIG7 is a schematic structural diagram of a Y-shaped connector;

[0029] Figure 8 is a schematic structural diagram of a joint;

[0030] FIG9 is a schematic structural diagram of the core;

[0031] FIG10 is a schematic structural diagram of the second guide wire and the first guide wire;

[0032] FIG11 is a schematic diagram of the structure of a dual-lumen ultrasound catheter entering the vascular intima;

[0033] FIG12 is a schematic diagram of the structure of a dual-lumen ultrasound catheter entering a branch vessel of an occluded stump;

[0034] FIG13 is another schematic structural diagram of a double-lumen microcatheter;

[0035] FIG14 is a schematic diagram showing the length of the rapid exchange section;

[0036] FIG15 is a schematic diagram showing the length of the rapid exchange section;

[0037] FIG16 is a schematic diagram of the structure when the sound-transmitting section has an elliptical outline;

[0038] FIG17 is an ultrasound image displayed by the acoustically transparent segment of FIG16 ;

[0039] FIG18 is a schematic diagram of the structure when the sound-transmitting section has a circular outline;

[0040] FIG. 19 is an ultrasound image displayed by the acoustically transparent segment of FIG. 18 .

[0041] In Figures 1 to 19:

[0042] 1 is a double-lumen microcatheter, 11 is the first guide cavity, 12 is the first core cavity, 2 is the sound-transparent section, 21 is the second core cavity, 22 is the second guide cavity, 23 is the water outlet, 24 is the guide wire outlet, 3 is the rapid exchange section, 31 is the distal tube, 32 is the TIP, 33 is the developing ring, 4 is the Y-shaped connector, 41 is the third guide cavity, 42 is the third core cavity, 5 is the joint, 51 is the flushing interface, 52 is the core interface, 6 is the core, 61 is the ultrasonic transducer, 62 is the transducer base, 63 is the torque spring, 64 is the core joint, 7 is the second guide wire, 8 is the first guide wire, 9 is the third guide wire, 02 is the circular contour, and 03 is the RX rapid exchange section. DETAILED DESCRIPTION

[0043] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0044] The core of this invention is to provide an ultrasound catheter for interventional therapy that combines the functions of intravascular ultrasound (IVUS) imaging and guidewire intervention. Under IVUS guidance, it can provide real-time guidance for interventional therapy and create access to the true lumen of the vessel distal to the occluded segment, effectively reducing surgical time and difficulty and improving surgical success rates. Another core of this invention is to provide an interventional therapy system that includes this ultrasound catheter for interventional therapy.

[0045] Please refer to Figures 1 to 19. The present application provides an interventional treatment system and an ultrasound catheter used for interventional treatment.

[0046] The present application provides an ultrasound catheter for interventional treatment, comprising: a double-lumen microcatheter 1, which includes a first guide cavity 11 and a first core cavity 12; a sound-transmitting section 2, which is made of a material with good sound-transmitting performance, and includes a second core cavity 21 connected to the distal end of the first core cavity 12 and a second guide cavity 22 connected to the distal end of the first guide cavity 11, the second core cavity 21 is used to place the ultrasonic transducer 61 at the distal end of the core 6, the second guide cavity 22 is provided with a guide wire outlet 24, the second guide cavity 22 is a cavity for an interventional guide wire (such as the second guide wire 7 in Figure 10) or an interventional treatment (such as a working guide wire, a balloon, a stent, a thoracotomy device, a suction device, etc.) to pass through, the second core cavity 21 and the second guide cavity 22 both extend distally and They are arranged side by side with each other; a quick exchange section 3, which includes a distal outer tube 31 connected to the distal end of the sound-transmitting section 2, a TIP end 32 (i.e., the softer end of the distal end of the catheter) provided at the distal end of the distal outer tube 31, and a developing ring 33 sleeved on the outer periphery of the distal outer tube 31, the quick exchange section 3 is connected to the distal end of the sound-transmitting section 2, the distal end of the quick exchange section 3 is used for the guide wire (such as the first guide wire 8 in Figure 10) to pass through, and the proximal end of the quick exchange section 3 is used for the guide wire to pass out; a core 6, a distal end of which is provided with an ultrasonic transducer 61, the ultrasonic transducer 61 has an ultrasonic imaging function, the core 6 is arranged in the second core cavity 21 and the first core cavity 12, and the ultrasonic transducer 61 is arranged in the second core cavity 21.

[0047] In some embodiments of the present application, as shown in FIG7 and FIG8 , the ultrasonic catheter further includes:

[0048] A Y-shaped connector 4 comprising a third core cavity 42 communicating with the proximal end of the first core cavity 12 and a third guide cavity 41 communicating with the proximal end of the first guide cavity 11;

[0049] The connector 5 includes a flushing interface 51 and a core interface 52 . Both the flushing interface 51 and the core interface 52 are communicated with the third core cavity 42 .

[0050] The core 6 passes through the core interface 52, passes through the third core cavity 42, and the second core cavity 21 to reach the first core cavity 12;

[0051] The proximal end of the dual-lumen microcatheter 1 is connected to the distal end of the Y-shaped connector 4. The third guide lumen 41 and third core lumen 42 of the Y-shaped connector 4 are respectively connected to the first guide lumen 11 and first core lumen 12 of the dual-lumen microcatheter 1. The Y-shaped connector 4 is connected to the connector 5 through the third core lumen 42 and communicates with the flushing port 51 and the core port 52.

[0052] During actual use, the shape, structure, size, material, position, etc. of the double-lumen microcatheter 1, the sound-transparent section 2, the rapid exchange section 3, the Y-shaped connector 4, the connector 5, the core 6, the second guide wire 7 and the first guide wire 8 can be determined according to actual conditions and actual needs.

[0053] In addition to the above-mentioned ultrasound catheter for interventional treatment, the present application also provides an interventional treatment system including the above-mentioned ultrasound catheter for interventional treatment. The interventional treatment system includes several guidewires and the above-mentioned ultrasound catheter for interventional treatment. The guidewires include an interventional guidewire extending from the guidewire outlet 24 and a guide guidewire passing through the rapid exchange section 3; the guide guidewire is used to guide the ultrasound catheter to the expected position, and the interventional guidewire is used to deliver to the targeted target position under the image guidance of the ultrasound catheter; the guidewire can switch between a state of extending from the guidewire outlet 24 and a state of passing through the rapid exchange section 3, so that the guidewire can switch between a guide guidewire and an interventional guidewire.

[0054] Compared to existing technologies, conventional ultrasound catheters have a single lumen structure that is only used for ultrasound transducer imaging and has a single function, and cannot directly achieve therapeutic functions. This application provides a dual-lumen ultrasound catheter, which utilizes the characteristics of dual-lumen catheters that can carry ultrasound imaging and interventional treatment functions, and can meet various treatment purposes using ultrasound imaging guidance as a platform.

[0055] Compared with the existing instruments that combine ultrasound function for interventional treatment, the dual-cavity structure has a smaller radial size, a wider range of applications, and is more convenient and flexible to enter multiple types of blood vessels for interventional treatment. Because there is no need to connect various types of interventional treatment instruments in series on the same first guidewire in order to reach the target position, the synchronization of ultrasound imaging and interventional treatment instruments can be conveniently achieved. In particular, if the interventional treatment instrument enters another branch, the ultrasound image cannot continue to follow for real-time image guidance. Especially for surgeries with complex operating steps, multiple instruments are operated in series on a first guidewire, which requires a strict design sequence. Otherwise, it is necessary to withdraw unnecessary instruments and rearrange each instrument multiple times, which is complicated to operate and has great restrictions on application scenarios. It is also difficult to ensure the continuity of ultrasound image guidance. The dual-cavity structure can conveniently synchronize the core 6 with the interventional treatment instrument in another cavity, without the need for a serial connection design on the guidewire, which greatly simplifies the operating steps and reduces the difficulty of the operation, and can help improve the success rate of the operation.

[0056] In the following multiple embodiments, an interventional treatment device equipped with ultrasound function is used for occlusion interventional treatment as an example. It should be understood that the protection scope of this application includes this embodiment but is not limited to this embodiment.

[0057] In the treatment of occlusive lesions, such as CTO (chronic total occlusion) lesions, effectively clearing the occluded segment or establishing a path through the occluded segment is the key to a successful operation. In clinical practice, due to the hard fiber cap at the occlusion site, the guidewire is usually unable to identify the occlusion entrance suitable for intervention, or the guidewire direction cannot be controlled and mistakenly enters the interlayer between the endothelium and the media to form a false lumen. The existing technology lacks the function of real-time image guidance, making it difficult to determine the direction of the endothelium and the occlusion segment, and cannot effectively control the guidewire to pass through the endothelium and return to the true lumen or find the occluded entrance of the blood vessel. Due to the possibility of "blind penetration", multi-position angiography comparison is required, which will extend the operation time and reduce the success rate of the operation. In addition, the surgical instruments are expensive, which imposes an economic burden on patients.

[0058] It should be noted that the present application does not limit a guidewire to be fixed only as an interventional guidewire or a guidewire, but rather a guidewire that is used as an interventional guidewire or a guidewire in a certain implementation stage, and can play another function in the next stage by adjusting the connection relationship between the guidewire and the ultrasound catheter. Therefore, the guidewire can switch between an interventional guidewire and a guidewire. For example, in the treatment of occlusive lesions, after the ultrasound catheter reaches the intimal true lumen proximal to the occluded segment along the first guidewire 8, the second guidewire 7 is punctured into the subintimal cavity under the guidance of the ultrasound catheter, and then the ultrasound catheter and the first guidewire 8 are withdrawn, and the second guidewire 7 is used as a guide to penetrate the rapid exchange section 3 of the ultrasound catheter, and the ultrasound catheter is pushed along the second guidewire 7 to the subintimal cavity, and the third guidewire 9 is sent into the first guide lumen 11 and the second guide lumen 22. The third guidewire 9 passes through the intimal cavity and returns to the intimal true lumen under the guidance of the ultrasound catheter image, reaching the vascular true lumen distal to the occluded segment.

[0059] From the above, it can be seen that the guiding guidewire can include the first guidewire 8 and the second guidewire 7, and the interventional guidewire can include the second guidewire 7 and the third guidewire 9. It can be seen that the second guidewire 7 can belong to the guiding guidewire or the interventional guidewire according to different implementation stages. As long as it plays a guiding role in the current implementation stage, it is the guiding guidewire of the current stage. As long as it plays an intervention (puncture, inspection, etc.) role in the current implementation stage, it is the interventional guidewire. The role played by the guidewire in the current stage is not necessarily related to the role played in the next stage, but can be flexibly changed due to the purpose of implementation. The above description is only an example from the perspective of ease of understanding. In specific implementation, there can be multiple implementation methods according to actual needs. For example, each time the vascular endothelium is punctured, the same guidewire with a harder hardness is used. After the puncture is completed, it is withdrawn and replaced with a softer guidewire to enter the false cavity and return to the true cavity along the puncture port. They will no longer be listed one by one.

[0060] In addition, the target position mentioned in this application is not a constant position, but a preferred intervention position that can be selected by the ultrasound catheter according to ultrasound images at different stages.

[0061] In a preferred case, the operator can introduce the first guidewire 8 into the patient's body, pass through the occluded segment through the first guidewire 8 and reach the true cavity at the distal end of the occluded segment. The first guidewire 8 provides a pushing path for interventional treatment devices (such as working guidewires, balloons, stents, grinding devices, suction devices, etc.), so that the interventional treatment devices can work near the occluded segment, thereby creating a pathway for the interventional treatment devices to open the occluded segment, such as by expanding the balloon to make the structure of the blocking material in the occluded segment looser, by using the grinding device to grind the blocking material in the occluded segment along the first guidewire 8, etc. to create a pathway. Other interventional treatment devices can be used adaptively as needed and will not be elaborated one by one.

[0062] Generally speaking, it is difficult for an operator to directly find and penetrate the occlusion entrance by blindly inserting a guidewire. In some embodiments, as shown in FIG12 , when the first guidewire 8 enters the branch vessel of the occluded vessel stump, an ultrasound catheter is inserted along the first guidewire 8. Then, the second guidewire 7 is inserted through the third guide lumen 41 and the first guide lumen 11. The second guidewire 7 exits from the guidewire outlet 24 of the second guide lumen 22. Under the real-time guidance of the IVUS function, the occlusion entrance can be found and reach the distal end of the occlusion segment. This means that the ultrasound function of the core 6 can be activated to observe the relative positions of the second guidewire 7 and the occlusion entrance in real time. When it is determined that the artifact of the second guidewire 7 is on the same side as the occlusion entrance, the second guidewire 7 is operated to enter the occlusion segment and, through continuous delivery, the distal end of the second guidewire 7 reaches the true lumen of the vessel at the distal end of the occlusion segment.

[0063] From the above content, it can be seen that the present application saves operation time for finding the occlusion entrance through the IVUS function of the ultrasound catheter. At the same time, the operator can adjust the first guide wire 8 with a more appropriate hardness according to the image requirements of the occlusion segment seen by the ultrasound catheter. The ultrasound catheter of the present application can effectively reduce the operation time and difficulty, and improve the success rate of the operation.

[0064] The occluded segment of a vessel is typically a calcified fibrous cap. When the occluded segment is dense and lacks an occluded entrance, or when an occluded entrance exists but a guidewire cannot be delivered to the true lumen distal to the occluded segment, it is necessary to bypass the occluded segment to reach the true lumen distal to the occluded segment. In this case, how to penetrate from the true lumen proximal to the occluded segment into the subintimal false lumen, and how to return to the true lumen distal to the occlusion after entering the subintimal false lumen, are challenges that require improvement and overcoming.

[0065] In some embodiments, the ultrasound catheter of the present application can reach the proximal end of the occluded segment of the blood vessel with the help of the first guide wire 8, and the imaging function of the ultrasound catheter can guide the second guide wire 7 to penetrate from the true lumen of the blood vessel into the false lumen under the endothelium. Since the occlusion shape of the occluded segment of the blood vessel is mostly irregular, the real-time guidance of the image can identify the puncture point that is easier to puncture into the subendothelium, and use this puncture point as the target position to make the distal end of the second guide wire 7 enter the subendothelium.

[0066] Then, the ultrasonic catheter and the first guide wire 8 are withdrawn, and with the second guide wire 7 as a guide, the second guide wire 7 is inserted into the rapid exchange section 3 of the ultrasonic catheter, and the ultrasonic catheter is pushed to the subintima along the second guide wire 7, and the third guide wire 9 is sent into the first guide cavity 11 and the second guide cavity 22. As shown in Figure 11, under the real-time guidance of the IVUS function, the puncture point that is easier to puncture and return to the true cavity can be identified through real-time guidance of the image. The guide wire outlet 24 of the second guide cavity 22 is for the third guide wire 9 to extend, and the third guide wire 9 passes through the vascular intima and returns to the vascular true cavity. The distal end of the third guide wire 9 can pass back to the targeted target position at the distal end of the occluded segment, so that the third guide wire 9 realizes a path across the occluded segment from the vascular true cavity at the proximal end of the occluded segment to the vascular true cavity pair at the distal end of the occluded segment.

[0067] In addition, if the distal end of first guidewire 8 accidentally enters the subintimal false lumen (not shown), the ultrasound catheter can be further advanced along first guidewire 8 into the false lumen and then traversed back to the distal end of the occluded segment according to the aforementioned embodiment, which will not be repeated here. Third guidewire 9 is the interventional treatment guidewire, which ultimately crosses the stenosis to establish a treatment channel for the occluded lesion.

[0068] In the present application, the ultrasonic function of the core 6 is activated, and the relative position of the second guide wire 7 and the true lumen of the blood vessel is observed in real time. When it is determined that the artifact of the second guide wire 7 is on the same side as the true lumen of the blood vessel, it indicates that the puncture direction is correct, and the second guide wire 7 is operated to pass through the endothelium and enter the true lumen of the blood vessel at the distal end of the occluded segment; if the artifact of the second guide wire 7 is not on the same side as the true lumen of the blood vessel, it is necessary to twist the ultrasonic catheter to rotate the guide wire outlet 24 of the second guide lumen 22 to a position on the same side as the true lumen of the blood vessel, and then push and puncture the second guide wire 7, and then withdraw the first guide wire 8 and the ultrasonic catheter, leaving only the second guide wire 7 in the patient's body to provide a push path for the interventional treatment device.

[0069] The implementation principle of the above-mentioned ultrasound catheter using the ultrasound function to guide the second guide wire 7 to directional puncture into the subintimal false lumen is the same as the implementation principle of the aforementioned ultrasound function to guide the second guide wire 7 to directionally pass back into the true lumen of the blood vessel. The implementation methods are similar and belong to the implementation content that can be understood by technical personnel in this field based on Figure 11, and will not be further described.

[0070] As can be seen from the above, the present application uses the IVUS function of the ultrasound catheter to select a suitable puncture point for entering the false lumen and returning to the true lumen, effectively creating a path around the occluded segment of the blood vessel. It can also remedy the situation where the first guidewire accidentally enters the false lumen of the blood vessel, replacing the first guidewire 8 that has entered the false lumen with the second guidewire 7 that enters the true lumen. Through the ultrasound catheter of the present application, the ADR (Advanced Subintimal Reentry to the True Lumen) technology is simplified, improving the success rate of the operation.

[0071] It should be noted that the second guide wire 7 and the third guide wire 9 can be replaced with softer guide wires. The above only uses the form of direct puncture to establish a channel as an example. For example, to prevent the second guide wire 7 with a higher hardness from puncturing the vascular membrane or causing hematoma after entering the subintima, the second guide wire 7 can be withdrawn after forming a puncture in the vascular intima, and replaced with a softer working guide wire (i.e., the third guide wire 9) to enter or exit the subintima through the puncture.

[0072] Alternatively, the second guide wire 7 can also be directly replaced with an interventional treatment device, such as a balloon, which is delivered through the first guide lumen 11 and the second guide lumen 22 and enters the target location or performs balloon dilation at the target location under the guidance of the ultrasonic transducer 61. This application does not impose any restrictions on this, and the operator or those skilled in the art can select or combine multiple implementations according to actual needs, which all fall within the scope of protection of this application.

[0073] In addition to being able to establish a path from the true lumen at the proximal end of the occluded segment to the true lumen at the distal end of the occluded segment, the above-mentioned embodiment can also be used to establish a vascular pathway next to the occluded segment, using the interlayer between the intima and the media of the vascular segment where the vascular occluded segment is located as a new blood flow path, and connecting the new blood flow channel with the proximal and distal ends of the vascular occluded segment to form a blood flow channel that bypasses the vascular occluded segment.

[0074] To improve the single-lumen ultrasound catheter to the dual-lumen ultrasound catheter of the present application, the second guide lumen 22 is sandwiched and arranged approximately parallel to the second core lumen 21. The outer contour of the acoustically transparent section 2 is elliptical or circular. Alternatively, the outer contour of the distal end of the acoustically transparent section 2 is elliptical, the outer contour of the proximal end is circular, and the outer contour of the middle section of the acoustically transparent section 2 transitions from circular to elliptical. The aforementioned elliptical shape can be a regular ellipse or an irregular ellipse, such as a pebble-shaped ellipse. Whether the elliptical contour is regular or irregular depends primarily on the ratio of the radial dimensions of the second guide lumen 22 to the second core lumen 21, as shown in FIG4 .

[0075] Since the second guide wire 7 is inserted into the endometrium or returned to the true lumen under the guidance of ultrasound imaging, the second guide lumen 22 is clamped between the second core lumen 21 and the target position (a puncture position suitable for puncturing into the subendocardium or a puncture position suitable for puncturing back to the true lumen), the ultrasonic transducer 61 in the second core lumen 21 needs to obtain the dynamic relative position between the second guide wire 7 extending from the guide wire outlet 24 of the second guide lumen 22 and the target position in real time.

[0076] In some embodiments, to ensure that ultrasound imaging is not compromised, the acoustically transparent segment 2 is preferably configured with a regular or irregular elliptical profile. This significantly reduces the thickness of the acoustically transparent material surrounding the ultrasonic transducer 61. The ratio of the minor axis to the major axis of the elliptical profile is 1:1.7 to 1:2.3, and the ratio of the minimum wall thickness to the maximum wall thickness of the elliptical profile is 1:4 to 1:6. The maximum wall thickness T1 of the elliptical profile is approximately 1 / 4 to 1 / 2 of the maximum wall thickness T2 of the circular profile, as shown in Figures 16 and 17. The ratio of the minimum wall thickness to the maximum wall thickness of the circular outer profile is 1:8 to 1:24, as shown in Figures 18 and 19.

[0077] Compared with the sound-transmitting segment 2 with a circular profile 02, the present application adopts a sound-transmitting segment 2 with an elliptical profile. The wall thickness of the sound-transmitting segment 2 is reduced to improve the ultrasonic penetration, thereby obtaining better clarity and detection depth, a wider field of view, and imaging in a hexagonal phantom. A complete hexagonal image can be obtained, as shown in Figure 17, while the circular sound-transmitting segment displays an image with lines that are not straight and clear enough, as shown in Figure 19.

[0078] In some embodiments, the first core cavity 12 and the second core cavity 21 are both cylindrical cavities, and the core 6 can move forward or backward relative to the first core cavity 12 and the second core cavity 21; and the ultrasonic transducer 61 has an initial position that is basically flush with the guidewire outlet 24, and the ultrasonic transducer 61 has a detection position that moves relative to the guidewire outlet 24.

[0079] In some embodiments, the core 6 reaches the second core cavity 21 by the first core cavity 12, and the first core cavity 12 and the second core cavity 21 are both cylindrical cavities, so that the core 6 rotates forward or backward. Since the first core cavity 12 and the second core cavity 21 of the present device are both cylindrical cavities, when the core 6 rotates forward or backward, the first core cavity 12 and the second core cavity 21 will not hinder the movement of the core 6, which facilitates the smooth advancement and withdrawal operation of the core 6, and can better achieve the alignment and guidance of the ultrasonic transducer 61 and the guide wire outlet 24. Moreover, the detection position here can be any other position except the initial position during the withdrawal process.

[0080] In some embodiments, the core 6 has a retraction function. During surgery, the IVUS function is activated to observe the structural condition of the diseased blood vessel. In the initial state, the distal end of the core (the location of the ultrasonic transducer 61) is approximately flush with the exit position of the second guidewire 7. The core 6 is then retracted, and the vascular segment corresponding to the retraction distance includes both the unobstructed segment and the obstructed segment as much as possible, thereby ensuring that the initial position of the distal end of the core 7 is in the unobstructed segment and at a relatively suitable distance from the occluded segment, so that a more suitable puncture point can be selected for the second guidewire 7. The use of a rotatable forward or backward ultrasonic transducer 61 can achieve both a retraction function and a reduced size compared to other types of transducers such as multi-element or circular arrays, making the diameter of the ultrasonic catheter thinner.

[0081] In order to reduce the degree of tearing under the intima and alleviate hematoma, the rapid exchange segment 3 is arranged at the distal end of the acoustically transparent segment 2 to avoid excessive and undesirable separation of the vascular intima and vascular media in the area outside the field of view of the ultrasonic transducer 61.

[0082] In some embodiments, the length L1 of the rapid exchange segment 3 is 1 / 5 to 1 / 7 of the length (L1 + Lt) from the distal end of the ultrasound catheter to the proximal end of the acoustically transparent segment. The rapid exchange length L1 of the rapid exchange segment 3 is 1 / 4 to 1 / 2 of the length L2 of the RX rapid exchange segment 03 of the commercially available IVUS product. In other words, shortening the length of the rapid exchange segment 3 can reduce blind spots, resulting in smaller vascular dissections. When located subintimally, the resulting vascular delamination is minimized, helping to reduce hematomas and improve the operator's puncture success rate. In addition to the aforementioned benefits, shortening the size of the rapid exchange segment 3 also facilitates the transmission of torsional forces, preventing kinking of the ultrasound catheter.

[0083] As previously shown, the ultrasonic catheter can penetrate the subintimal cavity and return to the true lumen. Specifically, the entire ultrasonic catheter can reside partially in the subintimal false lumen and partially in the true lumen, a state that spans the vascular intima. As previously mentioned, if the guidewire exit 24 and the target location are not on the same side, the ultrasonic catheter needs to be twisted to align them. Shortening the size of the rapid exchange segment 3 will increase the twisting force, improving the compliance and torque transmission from the proximal end of the ultrasonic catheter to the rapid exchange segment 3, and preventing kinking.

[0084] In some embodiments, the acoustically transparent segment 2 is configured with an arcuate profile at the guidewire outlet 24, so that the radial dimension of the acoustically transparent segment 2 gradually decreases as it extends distally. This prevents sudden changes in the radial dimension of the acoustically transparent segment 2, better transmits torsional forces, and responds to the torsional forces of the ultrasonic catheter without kinking. Furthermore, the arcuate profile at the guidewire outlet 24 allows for a larger bending angle for the second guidewire 7 or interventional medical device extending from the guidewire outlet 24.

[0085] In some embodiments, an arcuate hole can be provided in the distal outer tube 31 of the rapid exchange section 3. When the ultrasound catheter needs to be pushed along the first guidewire 8, the first guidewire 8 enters through the distal end of the TIP 32, moves along the arcuate hole in the distal outer tube 31, and finally exits from the proximal end of the distal outer tube 31. The arcuate hole ensures that the first guidewire 8 has a larger contact area within the rapid exchange section 3, making the pushing operation smoother.

[0086] In summary, the ultrasonic catheter for interventional treatment instruments or guidewires provided by the present invention combines the functions of intravascular diagnostic ultrasound (IVUS) imaging and guidewire treatment. Under the guidance of IVUS, it can guide intervention in real time, improve the success rate of interventional targeting positions, effectively reduce operation time and difficulty, and improve the success rate of surgery.

[0087] In one embodiment, the sound-transmitting section 2 includes a water outlet 23 and a guide wire outlet 24 . The water outlet 23 is located on the opposite side of the second guide cavity 22 , and the guide wire outlet 24 is located at the distal end of the second guide cavity 22 .

[0088] It should be noted that the second core cavity 21 and the second guide cavity 22 of the sound-transmitting section 2 contain water to improve the development effect of the device and have less impact on ultrasound. By setting a water outlet 23 on the opposite side (opposite side) of the second guide cavity 22, it is beneficial to discharge the water.

[0089] A guide wire outlet 24 is provided at the distal end of the second guide lumen 22. In some embodiments, the distal end of the second guide lumen 22 is parallel to the second core lumen, and the curvature of the second guide wire 7 itself can be utilized to provide the second guide wire 7 with a certain curvature after puncturing. Alternatively, the distal end of the second guide lumen 22 can be configured as an elbow-shaped structure to provide the second guide wire 7 with a certain curvature after puncturing the distal end of the second guide lumen 22.

[0090] In one embodiment, as shown in FIG9 , the core 6 includes a transducer base 62, an ultrasonic transducer 61 disposed on the transducer base 62, a torque spring 63, and a core connector 64. The transducer base 62 is connected to one end of the torque spring 63, and the other end of the torque spring 63 is connected to the core connector 64. The core 6 passes through the core interface 52 of the connector 5, passes through the third core cavity 42 of the Y-shaped connector 4, and enters the second core cavity 21 of the sound-transmitting section 2. Furthermore, the ultrasonic transducer 61 can reach the distal end of the second core cavity 21 of the sound-transmitting section 2, i.e., the position of the ultrasonic transducer 61 is aligned with the guidewire outlet 24 of the sound-transmitting section 2.

[0091] In one embodiment, the distal end of the dual-lumen microcatheter 1 is welded to the proximal end of the acoustically transparent section 2. Specifically, the acoustically transparent section 2 and the dual-lumen microcatheter 1 are welded together. The second core lumen 21 and second guide lumen 22 of the acoustically transparent section 2 are respectively connected to the first core lumen 12 and first guide lumen 11 of the dual-lumen microcatheter 1. The distal end of the acoustically transparent section 2 is welded to the proximal end of the rapid exchange section 3. Specifically, the acoustically transparent section 2 and the rapid exchange section 3 are connected together by thermal welding.

[0092] In one embodiment, the outer layer of the double-lumen microcatheter 1 is a polymer material whose hardness gradually decreases from the proximal end to the distal end, and the polymer material is one or more of PEBAX, TPU or PE; the middle layer of the double-lumen microcatheter 1 is a metal braid and / or spring, and the middle layer is one or more of stainless steel, nickel titanium, platinum iridium, liquid crystal polymer or polymer material.

[0093] It should be noted that when the dual-lumen microcatheter 1 is formed by a multi-layer Reflow composite, the inner layer of the dual-lumen microcatheter 1 is made of one or more of PEBAX, PTFE, HDPE, or TPU. The middle layer of the dual-lumen microcatheter 1 is a braided and / or spring structure, made of one or more metals or polymers such as stainless steel, nickel-titanium, platinum-iridium, and LCP. The outer layer of the dual-lumen microcatheter 1 is made of one or more of PEBAX, TPU, or PE.

[0094] One manufacturing process involves inserting an ultrathin PTFE tube onto each of the two core shafts, which is then inserted into a metal braided mesh tube. Two sections of PEBAX single-lumen tubing are then inserted onto the outer layer of the metal braided mesh tube, with the hardness of the single-lumen tubing gradually decreasing from proximal to distal, to 72D and 55D, respectively. Finally, the outermost layer is covered with FEP heat shrink tubing, which is then heat-welded into a single piece. After this process is complete, the FEP heat shrink tubing is removed, and the two core shafts are removed to obtain the product. This means that the double-lumen microcatheter 1 can be formed by integral overmolding or by heat-compounding an inner polymer double-lumen tube, an intermediate spring / braided layer, and an outer resin layer. The outer resin layer is welded in multiple sections, with the hardness gradually decreasing from proximal to distal. The structure is shown in Figure 13, with the two sections of the double-lumen microcatheter 1 having different hardnesses.

[0095] In one embodiment, the inner layers of the first guide cavity 11 and the first core cavity 12 are each made of one or more of PEBAX, PTFE, HDPE, or TPU. That is, the first guide cavity 11 and the first core cavity 12 are made of a polymer material with a low coefficient of friction. The inner walls of the first guide cavity 11 and the first core cavity 12 are each provided with a PTFE super-slip layer. Furthermore, the inner walls of the first core cavity 12 and the second guide cavity 22 of the sound-permeable section 2 are not provided with a PTFE super-slip layer.

[0096] In one embodiment, the sound-transmitting section 2 is made of PE or Pebax to ensure good sound transmission effect of the sound-transmitting section 2 .

[0097] In one embodiment, distal outer tube 31 is made of Pebax or PA; TIP 32 is made of Pebax or PU; and imaging ring 33 is made of platinum-iridium, tantalum, or gold. Furthermore, the proximal end of distal outer tube 31 can be welded to the distal end of acoustically transparent section 2, with distal outer tube 31 positioned on the opposite side of second guide lumen 22.

[0098] In some embodiments, the invention further comprises an interventional medical device, wherein the interventional medical device comprises at least one of a working guide wire, a balloon, a stent, a rotational atherectomy device, and a suction device;

[0099] The interventional medical device is used to be delivered to the targeted target position along the second guide wire 7 , or the interventional medical device is used to be directly extended from the guide wire outlet 24 and delivered to the targeted target position.

[0100] In some embodiments, the interventional therapy system is used for interventional occlusion treatment; the guidewire further includes a third guidewire 9 for interventional therapy. The distal end of third guidewire 9 is positioned distally of the occluded segment of the blood vessel, the proximal end of third guidewire 9 is positioned proximally of the occluded segment of the blood vessel, and the middle section of third guidewire 9 bypasses the occluded segment of the blood vessel under the guidance of ultrasound catheter imaging, via the interlayer between the intima and media of the blood vessel segment where the occluded segment is located. Third guidewire 9 is an interventional therapy guidewire, i.e., the guidewire that ultimately crosses the stenosis to establish a treatment channel for the occluded lesion.

[0101] It should be noted that the first guide lumen 11, second guide lumen 22, and guidewire outlet 24 of the ultrasonic catheter can sequentially pass through a guidewire, and the rapid exchange section 3 of the ultrasonic catheter can pass through a guidewire; the guidewires are the second guidewire 7, first guidewire 8, and third guidewire 9 described in the previous embodiment. That is, the first guidewire 8, second guidewire 7, and third guidewire 9 can have the specific features of any of the above embodiments. The first guide lumen 11, second guide lumen 22, and third guide lumen 41 are used to pass through the second guidewire 7 or the third guidewire 9, and the rapid exchange section 3 can pass through the first guidewire 8 or the second guidewire 7. In some embodiments, the second guidewire 7 or the third guidewire 9 can sequentially pass through the third guide lumen 41 of the Y-shaped connector 4, the first guide lumen 11 of the dual-lumen microcatheter 1, and the second guide lumen 22 of the sound-transparent section 2, and finally exit through the guidewire outlet 24 of the sound-transparent section 2.

[0102] In some embodiments, the first guide wire 8 or the second guide wire 7 is passed through the distal end of TIP32 and out of the proximal end of the distal outer tube 31. The first guide wire 8 and the second guide wire 7 can create a pushing path for the ultrasonic catheter and allow the ultrasonic catheter to be pushed to the target position along the first guide wire 8 and the second guide wire 7.

[0103] It should be noted that in all the aforementioned specific embodiments, the end closer to the operator (e.g., medical staff) is defined as the proximal end, and the end for inserting into the patient's body is defined as the distal end. For a single component, the end closer to the operator is defined as the proximal end, and the end farther from the operator is defined as the distal end.

[0104] For example, in actual use, although the distal tube is arranged as a whole in the patient's body, the proximal end of the distal tube represents the end or side closer to the operator along the path of catheter push intervention. In the embodiment shown in Figure 1 or Figure 6, the push intervention direction of the catheter is from the right side of the figure to the left side of the figure, and the proximal end of the distal tube is near the connection between the distal tube and the sound-transparent section 2, that is, the proximal end of the distal tube is on the right side of the distal tube in the figure. The distinction between the distal and proximal ends of other components is similar to the above description unless explicitly excluded.

[0105] In addition, the first guide cavity 11, the second guide cavity 22, the third guide cavity 41, the first core cavity 12, the second core cavity 21, the third core cavity 42, the first guide wire 8, the second guide wire 7, and the third guide wire 9 mentioned in the present invention, among which "first", "second" and "third" are only used to distinguish the different positions, and there is no order of precedence.

[0106] Furthermore, it should be noted that the directions or positional relationships indicated by "far" and other indicators in the present invention are based on the directions or positional relationships shown in the accompanying drawings and are intended solely to simplify description and facilitate understanding. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. For ease of description, only the portions relevant to the invention are shown in the accompanying drawings.

[0107] In the absence of conflict, the embodiments of the present invention and the features therein can be combined with each other. As used in the present invention, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements can be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, or the two elements can be connected through energy or signal response, but cannot be understood as indicating or implying a spatial position relationship or direct contact relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0108] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other. Any combination of all the embodiments provided by the present invention is within the scope of protection of this invention and will not be described in detail here.

[0109] The above describes in detail the interventional therapy system and its ultrasonic catheter for interventional therapy provided by the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is intended only to facilitate understanding of the method and core concepts of the present invention. It should be noted that those skilled in the art may make various improvements and modifications to the present invention without departing from the principles of the present invention, and such improvements and modifications fall within the scope of protection of the claims of the present invention.

Claims

1. An ultrasonic catheter for interventional therapy, characterized in that, Comprising: A double-lumen microcatheter, which includes a first guiding lumen and a first core lumen; An acoustic transmission section, which includes a second core lumen communicating with the distal end of the first core lumen and a second guiding lumen communicating with the distal end of the first guiding lumen. The second guiding lumen is provided with a guide wire outlet, and both the second core lumen and the second guiding lumen extend distally and are arranged side by side; A core, the distal end of which is provided with an ultrasonic transducer. The core is arranged in the second core lumen and the first core lumen, and the ultrasonic transducer is arranged in the second core lumen; A rapid exchange section, which is connected to the distal end of the acoustic transmission section. The distal end of the rapid exchange section is for a guiding guide wire to penetrate, and the proximal end of the rapid exchange section is for the guiding guide wire to penetrate out; It further includes a Y-shaped connector and a connector; The Y-shaped connector includes a third core lumen communicating with the proximal end of the first core lumen and a third guiding lumen communicating with the proximal end of the first guiding lumen; The connector includes a flushing interface and a core interface, and both the flushing interface and the core interface communicate with the third core lumen.

2. The ultrasonic catheter for interventional therapy according to claim 1, wherein The ultrasonic transducer is used to select a target position, and the ultrasonic transducer is used to obtain an image along the radial direction of the second core lumen. The ultrasonic catheter can be twisted so that the guide wire outlet and the target position are arranged on the same side of the ultrasonic transducer.

3. The ultrasonic catheter for interventional therapy according to claim 1, wherein The acoustic transmission section is made of a material that is easy to transmit sound; The cross-sectional profile of the acoustic transmission section is circular, or the cross-sectional profile of the acoustic transmission section transitions from circular to elliptical as it extends distally.

4. The ultrasonic catheter for interventional therapy according to claim 1, wherein, The cross-sectional profile of the acoustic transmission section is elliptical; and The ratio of the minor axis to the major axis of the elliptical acoustic transmission section is 1:1.7 to 1:2.3, and / or the ratio of the minimum wall thickness to the maximum wall thickness of the elliptical acoustic transmission section is 1:4 to 1:

6.

5. The ultrasonic catheter for interventional therapy according to any one of claims 1 to 4, characterized in that, Both the first core lumen and the second core lumen are cylindrical cavities, and the core can move forward or backward relative to the first core lumen and the second core lumen; And The ultrasonic transducer has an initial position that is basically flush with the guide wire outlet, and the ultrasonic transducer has a detection position that moves relative to the guide wire outlet.

6. The ultrasonic catheter for interventional therapy according to any one of claims 1 to 4, characterized in that, The length of the rapid exchange section is L1, the length from the distal end of the ultrasonic catheter to the proximal end of the acoustic transmission section is (L1 + Lt), and the ratio of L1 to (L1 + Lt) is between 1 / 5 and 1 / 7.

7. The ultrasonic catheter for interventional therapy according to any one of claims 1 to 4, characterized in that, The acoustic transmission section is provided with an arc-shaped profile at the guide wire outlet, and the radial dimension of the acoustic transmission section gradually decreases as it extends distally; and / or The rapid exchange section is provided with an arc-shaped hole for the guiding guide wire to bend through.

8. The ultrasound catheter for interventional therapy according to any one of claims 1 to 4, characterized in that, The double-lumen microcatheter sequentially includes a polymer inner layer, an intermediate reinforcing layer, and a resin outer layer from the inside to the outside; The polymer inner layer is made of a polymer material with a small friction coefficient, and the polymer inner layer forms the first guiding lumen and the first core lumen; The intermediate reinforcing layer is formed by weaving, winding, or sleeving on the polymer inner layer; The resin outer layer is made of at least two materials with different hardnesses, and the hardness of the resin outer layer gradually decreases from the proximal end to the distal end; The polymer inner layer, the intermediate reinforcing layer, and the resin outer layer form the ultrasonic catheter through co-extrusion technology or heat shrinkable tube technology.

9. An ultrasonic catheter for interventional therapy, characterized in that, Comprising: A dual-lumen microcatheter, which includes a first guiding lumen and a first core lumen; An acoustic transmission section, which includes a second core lumen communicating with the distal end of the first core lumen and a second guiding lumen communicating with the distal end of the first guiding lumen. The second guiding lumen is provided with a guide wire outlet. The second core lumen and the second guiding lumen both extend distally and are arranged side by side; A core, the distal end of which is provided with an ultrasonic transducer. The core is arranged in the second core lumen and the first core lumen, and the ultrasonic transducer is arranged in the second core lumen; A rapid exchange section, which is connected to the distal end of the acoustic transmission section. The distal end of the rapid exchange section is used for a guiding guide wire to penetrate, and the proximal end of the rapid exchange section is used for the guiding guide wire to penetrate out. The proximal end of the ultrasonic catheter can be penetrated by intervention guide wires with different hardnesses and the intervention guide wires are sequentially passed through the first guiding lumen of the dual-lumen microcatheter and the second guiding lumen of the acoustic transmission section, so that the intervention guide wires with different hardnesses extend out of the guide wire outlet; 10. The ultrasonic catheter for interventional therapy according to claim 9, characterized in that, The ultrasonic catheter can withdraw from the true lumen relative to a guide wire and then enter the subintima with the guide wire as a guide, so as to switch the guide wire from the intervention guide wire to the guiding guide wire. The ultrasonic transducer is used to select a targeted target position, and the ultrasonic transducer is used to obtain an image along the radial direction of the second core lumen. The ultrasonic catheter can be twisted so that the guide wire outlet and the targeted target position are arranged on the same side of the ultrasonic transducer.

11. The ultrasonic catheter for interventional therapy according to claim 9, characterized in that, The acoustic transmission section is made of a material that is easy to transmit sound; 12. The ultrasonic catheter for interventional therapy according to claim 9, characterized in that, The cross-sectional profile of the acoustic transmission section is circular, or the cross-sectional profile of the acoustic transmission section transitions from circular to elliptical as it extends distally. The cross-sectional profile of the acoustic transmission section is elliptical; and 13. The ultrasonic catheter for interventional therapy according to claim 9, wherein, The ratio of the minor axis to the major axis of the elliptical acoustic transmission section is 1:1.7 to 1:2.3, and / or the ratio of the minimum wall thickness to the maximum wall thickness of the elliptical acoustic transmission section is 1:4 to 1:

6. Both the first core lumen and the second core lumen are cylindrical cavities, and the core can move forward or backward relative to the first core lumen and the second core lumen; and 14. The ultrasonic catheter for interventional therapy according to any one of claims 9 to 13, characterized in that, The ultrasonic transducer has an initial position that is basically flush with the guide wire outlet, and the ultrasonic transducer has a detection position that moves relative to the guide wire outlet. The length of the rapid exchange section is L1, and the length from the distal end of the ultrasonic catheter to the proximal end of the acoustic transmission section is (L1 + Lt). The ratio of L1 to (L1 + Lt) is between 1 / 5 and 1 / 7.

15. The ultrasonic catheter for interventional therapy according to any one of claims 9 to 13, characterized in that, The acoustic transmission section is provided with an arc-shaped profile at the guide wire outlet, and the radial dimension of the acoustic transmission section gradually decreases as it extends distally; and / or 16. The ultrasonic catheter for interventional therapy according to any one of claims 9 to 13, characterized in that, The rapid exchange section is provided with an arc-shaped hole for the guiding guide wire to bend through. The dual-lumen microcatheter sequentially includes a polymer inner layer, an intermediate reinforcing layer, and a resin outer layer from the inside to the outside; 17. The ultrasonic catheter for interventional therapy according to any one of claims 9 to 13, characterized in that, The polymer inner layer is made of a polymer material with a small coefficient of friction, and the polymer inner layer forms the first guiding lumen and the first core lumen; ​ The middle reinforcing layer is formed by weaving, winding or sleeving on the polymer inner layer; The resin outer layer is made of at least two materials with different hardnesses, and the hardness of the resin outer layer gradually decreases from the proximal end to the distal end; The polymer inner layer, the middle reinforcing layer and the resin outer layer form the ultrasonic catheter through a co-extrusion technique or a heat-shrinkable tube technique.

18. An interventional therapy system, characterized in that, It includes a plurality of guide wires and an ultrasonic catheter, and the ultrasonic catheter is the ultrasonic catheter for interventional therapy described in any one of claims 1-8 or claims 9-17 above; The guide wire includes an interventional guide wire extending from the guide wire outlet and a guiding guide wire passing through the rapid exchange section; The guiding guide wire is used to guide the ultrasonic catheter to the expected position, and the interventional guide wire is used to deliver to the target position under the image guidance of the ultrasonic catheter; The guide wire can be switched between the state of extending from the guide wire outlet and the state of passing through the rapid exchange section, so that the guide wire can be switched between the guiding guide wire and the interventional guide wire.

19. The interventional treatment system according to claim 18, characterized in that, It further includes an interventional medical device, and the interventional medical device includes at least one of a working guide wire, a balloon, a stent, a rotational atherectomy device and a suction device; The interventional medical device is used to deliver along the guide wire to the target position, or the interventional medical device is used to directly extend from the guide wire outlet under the image guidance of the ultrasonic catheter and deliver to the target position.

20. The interventional treatment system according to claim 18, wherein The interventional therapy system is used for interventional occlusion treatment; The guide wire further includes an interventional therapy guide wire, the distal end of the interventional therapy guide wire is arranged at the distal end of the vascular occlusion segment, the proximal end of the interventional therapy guide wire is arranged at the proximal end of the vascular occlusion segment, and the middle section of the interventional therapy guide wire bypasses the vascular occlusion segment through the dissection between the intima and the media of the blood vessel segment where the vascular occlusion segment is located under the image guidance of the ultrasonic catheter.

21. The interventional treatment system according to claim 18, wherein The ultrasonic catheter further includes a Y-shaped connector and a connector; The Y-shaped connector includes a third core cavity communicating with the proximal end of the first core cavity and a third guide cavity communicating with the proximal end of the first guide cavity. The interventional guide wire sequentially passes through the third guide cavity of the Y-shaped connector, the first guide cavity of the double-lumen microcatheter and the second guide cavity of the sound-transmitting section and extends out from the guide wire outlet; the connector includes a flushing interface and a core interface, and both the flushing interface and the core interface communicate with the third core cavity.

Images