An ultrasonic thrombus fragmentation catheter and an ultrasonic thrombus fragmentation device

Abstract

The present invention provides an ultrasonic thrombus fragmentation catheter and an ultrasonic thrombus fragmentation device, which relate to the technical field of thrombus fragmentation medical devices. The device includes a catheter assembly, a positioning stent, and a thrombus fragmentation stent. The catheter assembly axially movably penetrates through an outer tube. The proximal end of the catheter assembly is used to connect an ultrasonic transducer, and a guiding head is provided at the distal end. The positioning stent is coaxially arranged on the catheter assembly and is located on the proximal side of the guiding head. The positioning stent has a compression and reset function. The thrombus fragmentation stent is coaxially arranged on the catheter assembly, and the thrombus fragmentation stent is located on the proximal side of the positioning stent. The thrombus fragmentation stent has a compression and reset function. The thrombus fragmentation position of the present invention is accurate, and the thrombus fragmentation efficiency is high, and it can remove old and stubborn plaques.

Description

Technical Field

[0001] The present invention relates to the technical field of thrombus-breaking medical devices, and particularly to an ultrasonic thrombus-breaking catheter and an ultrasonic thrombus-breaking device. Background Art

[0002] Deep venous thrombosis (DVT) of the lower extremities is a venous return disorder disease caused by abnormal coagulation of blood in the deep veins of the lower extremities, often resulting in lower extremity swelling and pain. In severe cases, pulmonary embolism may occur, endangering life. At present, the treatment methods for DVT mainly include anticoagulant therapy, thrombolytic therapy, and interventional therapy. Among them, interventional therapy has the advantages of less trauma and definite curative effect, and has become one of the important means for the treatment of DVT.

[0003] Ultrasonic thrombus-breaking technology is a new type of interventional therapy developed in recent years. Its principle is to use the cavitation effect and mechanical effect of ultrasonic waves to break thrombus into tiny particles, so as to dissolve thrombus and restore blood flow. Compared with traditional thrombolytic drugs, ultrasonic thrombus-breaking technology has the following advantages: 1. Fast thrombolytic speed and significant curative effect; 2. Little damage to vascular endothelium and low bleeding risk; 3. No need to use thrombolytic drugs, avoiding drug-related side effects. However, the existing ultrasonic thrombus-breaking catheters still have some deficiencies: it is difficult for the catheter tip to accurately reach the thrombus site, the thrombus-breaking position is inaccurate, and when the catheter tip acts on the blood vessel wall, it is easy to cause damage to the blood vessel wall; moreover, it is difficult to completely break old thrombus. Summary of the Invention

[0004] The purpose of the present invention is to provide an ultrasonic thrombus-breaking catheter and an ultrasonic thrombus-breaking device to solve the problems existing in the above-mentioned prior art, with accurate thrombus-breaking position, high thrombus-breaking efficiency, and the ability to remove old and stubborn plaques.

[0005] To achieve the above purpose, the present invention provides the following solutions:

[0006] An ultrasonic thrombus-breaking catheter comprises a catheter assembly, a positioning bracket and a thrombus-breaking bracket, wherein the catheter assembly is used to be movably arranged in an outer tube along the axial direction, the proximal end of the catheter assembly is used to connect an ultrasonic transducer to transmit ultrasonic energy, and the distal end of the catheter assembly is provided with a guide head, which is used to drill a channel on the thrombus; the positioning bracket is coaxially arranged on the catheter assembly, located on the proximal side of the guide head and close to the guide head; the positioning bracket has a compression and reset function, can be contracted into the outer tube under the compression action of the outer tube, and can be extended from the outer tube to expand and support the blood vessel wall; the thrombus-breaking bracket is coaxially arranged on the catheter assembly, and the thrombus-breaking bracket is located on the proximal side of the positioning bracket; the thrombus-breaking bracket has a compression and reset function, can be contracted into the outer tube under the compression action of the outer tube, and can be extended from the outer tube to expand.

[0007] As one embodiment, the thrombus-breaking bracket is located on the proximal side of the positioning bracket; the positioning bracket is a spherical structure, the catheter assembly axially limits the distal end of the spherical structure, and the proximal end of the spherical structure is movably arranged with the catheter assembly; a filter membrane is arranged on the spherical wall surface of the spherical structure, and the filter membrane is provided with filter holes capable of filtering thrombus fragments; after the spherical structure is expanded and unfolded, the filter membrane is bowl-shaped, and the bowl-shaped opening faces the thrombus-breaking bracket.

[0008] As one embodiment, the spherical structure includes a first distal ring, a first proximal ring and a first connecting rod. The catheter assembly axially limits the first distal ring, and the first proximal ring is movably arranged on the catheter assembly; a plurality of first connecting rods are arranged at circumferential intervals along the catheter assembly, and the two ends of the first connecting rod are respectively fixed on the first distal ring and the first proximal ring; the first connecting rod is made of a memory alloy, and the filter membrane is fixed on the first connecting rod.

[0009] As one embodiment, the catheter assembly includes a catheter body and a traction wire inserted into the catheter body, the distal end of the traction wire passes through the distal end of the catheter body and is connected to the positioning bracket and the guide head; the distal end of the thrombus-breaking bracket is fixedly connected to the traction wire, and the proximal end of the thrombus-breaking bracket is fixedly connected to the distal end of the catheter body; the proximal end of the catheter body and the proximal end of the traction wire are detachably connected, and the proximal end of the catheter body and the proximal end of the traction wire are both used to connect to the ultrasonic transducer.

[0010] As one embodiment, the thrombus-breaking stent includes a second distal ring, a second proximal ring and a second connecting rod, the second distal ring is fixedly connected to the traction wire, the second proximal ring is fixedly connected to the catheter body, a plurality of second connecting rods are arranged at circumferential intervals along the traction wire, the distal end and proximal end of the second connecting rod are fixedly connected to the second distal ring and the second proximal ring respectively; the second connecting rod is made of memory alloy.

[0011] As an implementation manner, the second connecting rod is bent, and the radial cross-sectional area of ​​the bolt-breaking bracket gradually decreases from the middle to both ends.

[0012] As one embodiment, a connecting seat is provided at the proximal end of the catheter body, an external thread is provided on the outer wall of the connecting seat, a connecting head is fixed to the proximal end of the traction wire, an internal thread is provided on the inner wall of the connecting head, the connecting head is sleeved on the outside of the connecting seat and fixed by a threaded connection; the connecting head is used to connect the ultrasonic transducer.

[0013] As an embodiment, discontinuous spiral slits are provided on the outer wall of the catheter body.

[0014] As an implementation manner, the guide head is wound by a spring, and a distal end of the guide head has a pointed tip.

[0015] The present invention also provides an ultrasonic thrombus fragmentation device, comprising the ultrasonic thrombus fragmentation catheter, an outer tube and an outer tube seat as described above, wherein the catheter assembly in the ultrasonic thrombus fragmentation catheter is axially movably arranged in the outer tube, the outer tube seat is fixed to the distal end of the outer tube, the cavity of the outer tube seat is connected to the tube cavity of the outer tube; and a drug injection port is provided on the outer tube seat.

[0016] Compared with the prior art, the present invention has the following technical effects:

[0017] 1. The guide head in the present invention can break up the thrombus and drill a hole to form a channel. After the thrombus-breaking stent is placed in the channel inside the thrombus, it is more conducive to the thrombus-breaking stent to expand and break up the thrombus from the inside of the thrombus, and the thrombus-breaking efficiency is higher. Moreover, the cross-sectional area of ​​the thrombus-breaking stent after expansion is larger, and its outer wall is closer to the blood vessel wall, which can perform strong and large-area mechanical crushing on stubborn plaques and complete the removal of stubborn plaques.

[0018] 2. The positioning stent in the present invention can abut against the blood vessel wall to form a positioning support, so that the part of the catheter assembly near the positioning stent is basically located on the axis of the blood vessel, ensuring the stability of the position of the guide head and the thrombus-breaking stent during the thrombus-breaking process, and avoiding the problem of incomplete thrombus-breaking or damage to the blood vessel due to the unstable position of the thrombus-breaking stent.

[0019] 3. In the present invention, the seeker, the positioning bracket, and the thrombus-breaking bracket are distributed in sequence from far to near. When the seeker breaks the thrombus to open the channel, the thrombus-breaking bracket can be in a compressed state in the outer tube and will not expand and deploy, avoiding the problem that during the thrombus-breaking process by the seeker, the thrombus-breaking bracket also expands and contacts the blood vessel wall, causing damage to the blood vessel wall.

[0020] The following are the technical effects of other technical solutions of the present invention compared with the prior art:

[0021] By dividing the catheter assembly into a catheter body and a traction wire, the present invention can use the traction wire to pull the thrombus-breaking bracket, change the expansion degree of the thrombus-breaking bracket or change the abutting force between the thrombus-breaking bracket and the thrombus, thereby improving the thrombus-breaking effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0023] Figure 1 Schematic diagram of the structure in which the thrombus-breaking bracket and the positioning bracket in the ultrasonic thrombus-breaking device according to an embodiment of the present invention are both contracted in the outer tube;

[0024] Figure 2 Schematic diagram of the structure in which the positioning bracket in the ultrasonic thrombus-breaking device according to an embodiment of the present invention is exposed outside the outer tube and expands and deploys;

[0025] Figure 3 Schematic diagram of the structure in which the thrombus-breaking bracket and the positioning bracket in the ultrasonic thrombus-breaking device according to an embodiment of the present invention are both exposed outside the outer tube and expand and deploy;

[0026] Figure 4 Schematic diagram of the structure of the positioning bracket and the filter membrane in the ultrasonic thrombus-breaking catheter according to an embodiment of the present invention;

[0027] Figure 5 Schematic diagram of the cooperation structure of the positioning bracket and the traction wire in the ultrasonic thrombus-breaking catheter according to an embodiment of the present invention;

[0028] Figure 6 Schematic diagram of the structure of the seeker in the ultrasonic thrombus-breaking catheter according to an embodiment of the present invention;

[0029] Figure 7 Schematic diagram of the catheter body and the connection seat in the ultrasonic thrombus-breaking catheter according to an embodiment of the present invention;

[0030] Figure 8Schematic diagram of the matching structure between the outer tube and the outer tube seat in an ultrasonic thrombus fragmentation device according to an embodiment of the present invention;

[0031] Figure 9 Schematic diagram of the structure of the ultrasonic main unit in an ultrasonic thrombus fragmentation device according to an embodiment of the present invention;

[0032] Figure 10 Schematic diagram of the structure of an ultrasonic thrombus fragmentation device placed at the position of a blood vessel thrombus according to an embodiment of the present invention;

[0033] Figure 11 Schematic diagram of the structure of a guiding head crushing a thrombus to form a channel in an ultrasonic thrombus fragmentation device according to an embodiment of the present invention;

[0034] Figure 12 Schematic diagram of the thrombus fragmentation process of a thrombus fragmentation stent in an ultrasonic thrombus fragmentation device according to an embodiment of the present invention.

[0035] Description of reference numerals:

[0036] 1. Outer tube;

[0037] 2. Catheter assembly; 21. Catheter body; 22. Traction wire; 23. Connection seat; 24. Connector;

[0038] 3. Positioning stent; 31. First distal ring; 32. First proximal ring; 33. First connecting rod;

[0039] 4. Thrombus fragmentation stent; 41. Second distal ring; 42. Second proximal ring; 43. Second connecting rod;

[0040] 5. Guiding head;

[0041] 6. Filter membrane;

[0042] 7. Thrombus;

[0043] 8. Blood vessel wall;

[0044] 9. Outer tube seat; 91. Drug injection port;

[0045] 10. Ultrasonic main unit. Detailed implementation manners

[0046] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0047] The purpose of the present invention is to provide an ultrasonic thrombus fragmentation catheter and an ultrasonic thrombus fragmentation device to solve the problems existing in the prior art, with accurate thrombus fragmentation position and high thrombus fragmentation efficiency, and the ability to remove old and stubborn plaques.

[0048] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0049] Embodiment 1:

[0050] like Figures 1 to 12 As shown, this embodiment provides an ultrasonic thrombus-breaking catheter, which needs to be used in conjunction with an outer tube 1. The ultrasonic thrombus-breaking catheter includes a catheter assembly 2, a positioning bracket 3 and a thrombus-breaking bracket 4, wherein the catheter assembly 2 is axially movable and penetrates the outer tube 1, and the proximal end of the catheter assembly 2 is used to connect an ultrasonic transducer to transmit ultrasonic energy. Specifically, the catheter assembly 2 is made of metal material, which can reduce the attenuation of ultrasonic energy. A guide head 5 is provided at the distal end of the catheter assembly 2, and the guide head 5 is used to drill a channel on the thrombus 7; the positioning bracket 3 is coaxially arranged on the catheter assembly 2, located on the proximal side of the guide head 5, and close to the guide head 5; the positioning bracket 3 has a compression and reset function, and can be retracted into the outer tube 1 under the compression of the outer tube 1. When the outer tube 1 loses the compression and restraint effect on the positioning bracket 3, the positioning bracket 3 can be extended from the outer tube 1 and expanded, and abut against the blood vessel wall 8 for support. The embolismic stent 4 is coaxially arranged on the catheter assembly 2, and is located on the proximal side of the positioning stent 3; the embolismic stent 4 has a compression and reset function, and can be retracted into the outer tube 1 under the compression of the outer tube 1. When the outer tube 1 loses its compression and restraining effect on the embolismic stent 4, the embolismic stent 4 can extend from the outer tube 1 and expand.

[0051] The proximal end in this embodiment refers to the end close to the operator, and the distal end refers to the end far away from the operator, that is, the end close to the patient.

[0052] When in use, the proximal end of the catheter assembly 2 is connected to the ultrasonic transducer on the ultrasound machine, and then the catheter assembly 2 is inserted into the outer tube 1, and the positioning bracket 3 and the thrombus-breaking bracket 4 are both located in the outer tube 1. Under the restraining effect of the outer tube 1, the positioning bracket 3 and the thrombus-breaking bracket 4 remain in a contracted state; then the outer tube 1 and the catheter assembly 2 are placed into the affected part of the human blood vessel. At this time, the catheter assembly 2 and the outer tube 1 are located at the upstream position of the thrombus 7, as shown in FIG. Figure 10As shown in the figure; place the guide head 5 at the distal end of the catheter assembly 2 into the thrombus 7 (if the guide head 5 is inside the outer tube 1, move the outer tube 1 a certain distance proximally or move the catheter assembly 2 a certain distance distally to expose the guide head 5 outside the outer tube 1), start the ultrasonic transducer, and begin thrombus fragmentation treatment. At the beginning, the ultrasonic energy generated by the ultrasonic transducer is transmitted through the catheter assembly 2 to the guide head 5. The guide head 5 vibrates under the action of the ultrasonic energy to pre-fragment and perforate the target thrombus 7 position. If the guide head 5 is significantly skewed in the blood vessel, move the outer tube 1 a certain distance proximally to expose the positioning stent 3 outside the outer tube 1. After the positioning stent 3 is exposed, it expands and unfolds under its own restoring force. The outer wall of the positioning stent 3 fits against the blood vessel wall 8 to support and position the catheter assembly 2, preventing the guide head 5 from acting on the blood vessel wall 8 with excessive skew, as Figure 11 shown in the figure. During the process of fragmenting and drilling the thrombus 7 by the guide head 5, the thrombus fragmentation stent 4 is inside the outer tube 1 and in a compressed state. When the channel in the thrombus 7 is established, the positioning stent 3 and the guide head 5 are retracted into the outer tube 1, and the outer tube 1 and the blood vessel assembly are transported downstream of the calcified site. Move the outer tube 1 proximally to expose both the positioning stent 3 and the thrombus fragmentation stent 4. The positioning stent 3 expands and returns to its original position, and its outer wall fits against the blood vessel wall 8 to support and position the catheter assembly 2. The thrombus fragmentation stent 4 is exactly located in the channel in the thrombus 7. Initially, due to the restriction of the thrombus 7 plaque, the thrombus fragmentation stent 4 cannot fully expand and unfold. The positioning stent 3 gradually breaks the thrombus 7 during vibration, resulting in a gradually increasing diameter of the channel in the thrombus 7, and the thrombus fragmentation stent 4 also gradually expands. Eventually, the thrombus fragmentation stent 4 fully unfolds to complete the thrombus fragmentation operation (the maximum diameter of the thrombus fragmentation stent 4 after full expansion is slightly smaller than the blood vessel diameter), as Figure 12 shown in the figure. After thrombus fragmentation is completed, pull the catheter assembly 2 proximally or push the outer tube 1 distally to retract the thrombus fragmentation stent 4 and the positioning stent 3 back into the outer tube 1, and then remove the outer tube 1 and the catheter assembly 2.

[0053] Thus, the guide head 5 in this embodiment can fragment and drill the thrombus 7 to form a channel. After placing the thrombus fragmentation stent 4 into the channel inside the thrombus 7, it is more conducive to the thrombus fragmentation stent 4 to fragment the thrombus while expanding from inside the thrombus 7, and the thrombus fragmentation efficiency is relatively high. Moreover, the cross-sectional area of the thrombus fragmentation stent 4 after expansion in this embodiment is relatively large, and its outer wall is closer to the blood vessel wall 8, which can mechanically fragment stubborn plaques with strong force over a large area to complete the removal of stubborn plaques. The positioning stent 3 in this embodiment can abut against the blood vessel wall 8 to form positioning support, so that the part of the catheter assembly 2 near the positioning stent 3 is basically located on the blood vessel axis position, ensuring the stable positions of the guide head 5 and the thrombus fragmentation stent 4 during thrombus fragmentation, and avoiding the problems of incomplete thrombus fragmentation or damage to the blood vessel caused by the unstable position of the thrombus fragmentation stent 4.

[0054] In addition, in this embodiment, the seeker 5, the positioning bracket 3, and the thrombus fragmentation bracket 4 are distributed in sequence from far to near. When the seeker 5 fragments the thrombus to open a channel, the thrombus fragmentation bracket 4 can be in a compressed state in the outer tube 1 and will not expand. This avoids the problem that during the thrombus fragmentation process by the seeker 5, the thrombus fragmentation bracket 4 also expands and contacts the blood vessel wall 8, causing damage to the blood vessel wall 8.

[0055] As Figure 4 shown, in this embodiment, the positioning bracket 3 is a spherical structure, which can be a spherical shape or an ellipsoidal shape. The catheter assembly 2 axially limits the distal end of the spherical structure, so that the distal end of the spherical structure cannot move axially on the catheter assembly 2. However, in some connection methods, the distal end of the spherical structure can rotate on the catheter assembly 2. For example, two spaced protrusions are provided on the catheter assembly 2, and the two protrusions are distributed on both sides of the distal end of the spherical structure. The proximal end of the spherical structure is movably arranged on the catheter assembly 2, that is, the proximal end of the spherical structure can move axially on the catheter assembly 2 and can also rotate around the axis of the catheter assembly 2. When the outer tube 1 is pushed distally to squeeze the positioning bracket 3, the proximal end of the positioning bracket 3 moves proximally along the axis, and the wall surface of the spherical structure gradually approaches the catheter assembly 2 and is finally compressed into the outer tube 1.

[0056] As Figure 4 shown, in this embodiment, a filter membrane 6 is provided on the spherical wall surface of the spherical structure, and filter holes capable of filtering thrombus 7 fragments are provided on the filter membrane 6; after the spherical structure expands and unfolds, the filter membrane 6 is in a bowl shape, and the bowl-shaped opening faces the thrombus fragmentation bracket 4. During the thrombus fragmentation process, the thrombus 7 fragments are collected by the filter net, avoiding the thrombus 7 fragments from causing distal blood vessel embolism as they flow with the blood. The filter membrane 6 is made of TPU (polyurethane), and is a transparent film formed by shaping and demolding a TPU solution and covering it on the spherical structure.

[0057] In this embodiment, the spherical structure includes a first distal ring 31, a first proximal ring 32, and a first connecting rod 33. The first distal ring 31 is axially restricted on the catheter assembly 2, and the first proximal ring 32 is movably arranged on the catheter assembly 2 and can rotate and move axially; a plurality of first connecting rods 33 are circumferentially spaced along the catheter assembly 2, and both ends of the first connecting rod 33 are respectively fixed to the first distal ring 31 and the first proximal ring 32, and the connection method is welding; the first connecting rod 33 is made of shape memory alloy, specifically nickel-titanium alloy, and the filter membrane 6 is fixed to the first connecting rod 33.

[0058] As Figure 5 、 Figure 7As shown in the figure, in this embodiment, the catheter assembly 2 includes a catheter body and a guide wire 22 threaded through the catheter body. The distal end of the guide wire 22 extends out of the distal end of the catheter body and is connected to the positioning stent 3 and the guiding head 5. The guiding head 5 is fully welded to the distal end of the guide wire 22 to ensure that the ultrasonic energy can be fully transmitted to the guiding head 5 through the guide wire 22. The distal end of the thrombus fragmentation stent 4 is fixedly connected to the guide wire 22, and the proximal end of the thrombus fragmentation stent 4 is fixedly connected to the distal end of the catheter body; the proximal end of the catheter body and the proximal end of the guide wire 22 are detachably connected, and both the proximal end of the catheter body and the proximal end of the guide wire 22 are used to connect to the ultrasonic transducer. After the thrombus fragmentation stent 4 naturally expands to full reset, its maximum diameter will not be greater than the inner diameter of the blood vessel, reducing the possibility of contact between the thrombus fragmentation stent 4 and the blood vessel wall 8 during the thrombus fragmentation process, thereby reducing the possibility of blood vessel injury. In this way, in some cases, it may not be possible to completely remove the thrombus 7 plaque. For example, the thrombus 7 outside the thrombus fragmentation stent 4 is unevenly distributed and there are old and stubborn thrombus 7 plaques. In this embodiment, when the guide wire 22 is pulled in the catheter body, it can drive the positioning stent 3 and the guiding head 5 to move axially, and can drive the distal end of the thrombus fragmentation stent 4 to move axially. Since the proximal end of the thrombus fragmentation stent 4 is fixedly connected to the distal end of the catheter body, when the distal end of the thrombus fragmentation stent 4 moves towards the proximal end, the thrombus fragmentation stent 4 is axially compressed, the axial dimension becomes smaller, and the radial dimension becomes larger, and the overall shape is flattened. The distance between the side wall of the thrombus fragmentation stent 4 and the blood vessel wall 8 decreases, the distance from the thrombus 7 plaque decreases, and the contact area increases, which can improve the thrombus fragmentation effect. If there are stubborn thrombus 7 plaques outside the thrombus fragmentation stent 4, when the guide wire 22 is pulled, even if the radial dimension of the thrombus fragmentation stent 4 does not increase under the limiting action of the plaque, the abutting force between the thrombus fragmentation stent 4 and the plaque will increase, thereby improving the thrombus fragmentation effect of the stubborn thrombus fragmentation stent 4. Therefore, in this embodiment, by dividing the catheter assembly 2 into a catheter body and a guide wire 22, the guide wire 22 can be used to pull the thrombus fragmentation stent 4, changing the expansion degree of the thrombus fragmentation stent 4 or changing the abutting force between the thrombus fragmentation stent 4 and the thrombus 7, improving the thrombus fragmentation effect.

[0059] As Figure 5 shown, in this embodiment, the thrombus fragmentation stent 4 includes a second distal ring 41, a second proximal ring 42, and a second connecting rod 43. The second distal ring 41 is fixedly connected to the guide wire 22, and the fixed connection method is full welding. The second proximal ring 42 is fixedly connected to the catheter body. A plurality of second connecting rods 43 are arranged at intervals along the circumference of the guide wire 22. The distal end and the proximal end of the second connecting rod 43 are respectively fixedly connected to the second distal ring 41 and the second proximal ring 42, and the connection method is welding; the second connecting rod 43 is made of a shape memory alloy, specifically it can be a nickel-titanium alloy. In this embodiment, the second connecting rod 43 is bent, and the radial cross-sectional area of the thrombus fragmentation stent 4 gradually decreases from the middle to both ends, so that the overall shape of the thrombus fragmentation stent 4 is a shape formed by rotating a rhombus around one of its diagonals.

[0060] When the second link 43 is subjected to the compressive force of the outer tube 1, it can retract into the outer tube 1; through the existing process settings, when the second link 43 retracts into the outer tube 1, it retracts in a spiral manner, and when expanding, multiple second links 43 expand spirally. This process setting is the prior art and will not be elaborated in this embodiment.

[0061] In this embodiment, a connection seat 23 is provided at the proximal end of the catheter body. An external thread is provided on the outer wall of the connection seat 23. A connection head 24 is fixed to the proximal end of the traction wire 22. An internal thread is provided on the inner wall of the connection head 24. The connection head 24 is sleeved outside the connection seat 23 and is fixed by threaded connection; the connection head 24 is used to connect the ultrasonic transducer. For example, the inner wall of the connection head 24 is sleeved outside the output end of the ultrasonic transducer. The ultrasonic energy emitted by the ultrasonic transducer can be transmitted to the thrombus fragmentation stent 4 and the guiding head 5 through the catheter body and the traction wire 22, so that the thrombus fragmentation stent 4 and the guiding head 5 perform thrombus fragmentation. When it is necessary to pull the traction wire 22 to change the expansion size of the thrombus fragmentation stent 4, the connection head 24 can be rotated. When the connection head 24 rotates, it moves axially relative to the connection seat 23, and then pulls the traction wire 22; the traction wire 22 will rotate synchronously with the connection head 24, and then drive the guiding head 5 to rotate. However, the positioning stent 3 will abut against the blood vessel wall 8 in the expanded state and is not convenient to rotate; therefore, both ends of the positioning stent 3 (i.e., the first distal ring 31 and the first proximal ring 32) are rotatably connected to the traction wire 22, and the proximal end (the first proximal ring 32) of the positioning stent 3 can also slide axially relative to the traction wire 22.

[0062] If the connection head 24 and the connection seat 23 are not connected by threaded connection, but by clamping or other means, when pulling the traction wire 22, the connection head 24 does not need to rotate, and only when moving axially, the distal end (i.e., the first distal ring 31) of the positioning stent 3 can be completely fixed to the traction wire 22, such as by welded connection.

[0063] As Figure 7 shown, in this embodiment, intermittent spiral cuttings are provided on the outer wall of the catheter body to improve the flexibility of the catheter body, make it easy to bend in the blood vessel, and improve the passing ability. The intermittent spiral cuttings can be understood as that some points of the continuous spiral cuttings are filled with entities, making the continuous spiral cuttings intermittent.

[0064] As Figure 6As shown, in this embodiment, the guide head 5 is formed by winding a spring, and the distal end of the guide head 5 has a tip. This tip only means that the distal end of the spring is thinner than the proximal end and is easy to penetrate into the thrombus 7, and does not limit its distal end to have a sharp endpoint. Specifically, the guide head 5 is made of a shape memory alloy core wire, a platinum-iridium alloy spring with good imaging effect, and soldering tin, and has good flexibility and elasticity, can adapt to the bending direction of blood vessels and can be imaged under X-rays. The distal end of the guide head 5 has a hemispherical end. The special structure of the spring can grind the thrombus 7, making the broken thrombus fragments smaller. Even if the thrombus fragments generated when the guide head 5 does not open the thrombus 7 channel are not captured, these thrombus fragments will not cause distal vascular embolism.

[0065] In this embodiment, the traction wire 22 is a metal structure, and a section of spring can also be arranged at its distal part, and the positioning bracket 3 is arranged on the spring.

[0066] Embodiment 2:

[0067] As Figures 1 to 12 shown, this embodiment also provides an ultrasonic thrombus fragmentation device, including the ultrasonic thrombus fragmentation catheter, the outer tube 1 and the outer tube seat 9 in Embodiment 1. The catheter assembly 2 in the ultrasonic thrombus fragmentation catheter axially movably penetrates through the outer tube 1. The outer tube seat 9 is fixed at the distal end of the outer tube 1, and the cavity of the outer tube seat 9 communicates with the lumen of the outer tube 1; a drug injection port 91 is arranged on the outer tube seat 9. The outer tube 1 is made of a polymer flexible material, and the outer tube seat 9 has a locking valve to avoid blood overflow.

[0068] The ultrasonic thrombus fragmentation device further includes an ultrasonic main unit 10, which is composed of a main unit, a controller, a transducer, and a power supply. It can generate ultrasonic waves, and under the action of the controller and the transducer, it can control the energy size of the ultrasonic waves to adapt to different situations. The ultrasonic main unit 10 is an intelligent main unit, which can receive ultrasonic feedback and output suitable energy according to the feedback result. The transducer is equipped with an inductive self-locking device, which will self-lock and clamp the proximal end of the catheter body 21 when it detects the connection of the catheter body, preventing the catheter body from falling off.

[0069] The ultrasonic main unit 10 is a common device in this field, and those skilled in the art are familiar with its structure and usage method. Therefore, this embodiment does not elaborate on the working principle of the ultrasonic main unit 10.

[0070] The adaptive changes made according to actual needs are all within the protection scope of the present invention.

[0071] In the present invention, specific examples are used to illustrate the principle and implementation manner of the present invention. The description of the above embodiments is only used to help understand the method and its core idea of the present invention; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manner and application scope. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. An ultrasonic thrombus fragmentation catheter, characterized in that, include: A catheter assembly, the catheter assembly is used to be movably arranged in the outer tube along the axial direction, the proximal end of the catheter assembly is used to connect an ultrasonic transducer to transmit ultrasonic energy, and the distal end of the catheter assembly is provided with a guide head, and the guide head is used to drill a channel on the thrombus; A positioning stent, the positioning stent is coaxially arranged on the catheter assembly, located at the proximal side of the guide head and close to the guide head; the positioning stent has a compression and reset function, can be contracted into the outer tube under the compression of the outer tube, and can be extended from the outer tube to expand and support the blood vessel wall; and a thrombus-breaking stent, which is coaxially arranged on the catheter assembly and is located at the proximal end of the positioning stent; the thrombus-breaking stent has a compression and reset function, and can be contracted into the outer tube under the compression of the outer tube, and can be extended from the outer tube and then expanded; The catheter assembly includes a catheter body and a traction wire inserted into the catheter body, the distal end of the traction wire passes through the distal end of the catheter body and is connected to the positioning bracket and the guide head; the distal end of the thrombus-breaking bracket is fixedly connected to the traction wire, and the proximal end of the thrombus-breaking bracket is fixedly connected to the distal end of the catheter body; the proximal end of the catheter body and the proximal end of the traction wire are detachably connected, and the proximal end of the catheter body and the proximal end of the traction wire are both used to connect to the ultrasonic transducer.

2. The ultrasonic thrombus fragmentation catheter according to claim 1, wherein The thrombus-breaking bracket is located on the proximal side of the positioning bracket; the positioning bracket is a spherical structure, the catheter assembly axially limits the distal end of the spherical structure, and the proximal end of the spherical structure is movably arranged with the catheter assembly; a filter membrane is arranged on the spherical wall surface of the spherical structure, and filter holes capable of filtering thrombus fragments are arranged on the filter membrane; after the spherical structure is expanded and unfolded, the filter membrane is bowl-shaped, and the bowl-shaped opening faces the thrombus-breaking bracket.

3. The ultrasonic thrombus fragmentation catheter according to claim 2, wherein The spherical structure includes a first distal ring, a first proximal ring and a first connecting rod. The catheter assembly axially limits the first distal ring, and the first proximal ring is movably arranged on the catheter assembly; a plurality of first connecting rods are arranged at intervals along the circumference of the catheter assembly, and the two ends of the first connecting rod are respectively fixed on the first distal ring and the first proximal ring; the first connecting rod is made of a memory alloy, and the filter membrane is fixed on the first connecting rod.

4. The ultrasonic thrombus fragmentation catheter according to claim 1, wherein The thrombus-breaking stent includes a second distal ring, a second proximal ring and a second connecting rod. The second distal ring is fixedly connected to the traction wire, the second proximal ring is fixedly connected to the catheter body, a plurality of second connecting rods are arranged at circumferential intervals along the traction wire, and the distal end and proximal end of the second connecting rod are fixedly connected to the second distal ring and the second proximal ring respectively; the second connecting rod is made of memory alloy.

5. The ultrasonic thrombus fragmentation catheter according to claim 4, characterized in that, The second connecting rod is bent, and the radial cross-sectional area of ​​the bolt-breaking bracket gradually decreases from the middle to both ends.

6. The ultrasonic thrombus fragmentation catheter according to claim 1, wherein A connector base is provided at the proximal end of the catheter body. External threads are provided on the outer wall of the connector base. A connection head is fixed to the proximal end of the traction wire. Internal threads are provided on the inner wall of the connection head. The connection head is sleeved outside the connector base and is fixed by threaded connection. The connection head is used to connect the ultrasonic transducer.

7. The ultrasonic thrombus fragmentation catheter according to claim 1, characterized in that, Intermittent spiral slits are provided on the outer wall of the catheter body.

8. The ultrasonic thrombus fragmentation catheter according to claim 1, wherein The guiding head is formed by winding a wire spring, and the distal end of the guiding head has a tip.

9. An ultrasonic thrombus fragmentation device, characterized in that, It includes the ultrasonic thrombus fragmentation catheter, outer tube and outer tube base according to any one of claims 1 to 8. The catheter assembly in the ultrasonic thrombus fragmentation catheter is axially movably inserted in the outer tube. The outer tube base is fixed to the distal end of the outer tube. The cavity of the outer tube base communicates with the lumen of the outer tube. A drug injection port is provided on the outer tube base.

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