Thrombus removing device

Abstract

The invention relates to a medical instrument, and particularly discloses a thrombus removing device which comprises a sheath tube, a thrombus suction catheter is arranged in the sheath tube, the front end of the thrombus suction catheter is connected with a tip head outside the sheath tube, at least one thrombus suction hole is formed in the tube wall of the front section of the thrombus suction catheter, and the tip head is connected with the thrombus suction catheter. The front section of the thrombus suction catheter is further provided with a thrombus capturing net which can be unfolded or folded into the sheath tube, the thrombus capturing net is located on the periphery of the thrombus suction hole, the rear section of the sheath tube is provided with a flushing opening, and the flushing opening is connected with a flushing pipeline through a valve. The device has the functions of trapping, thrombus breaking and suction, is simpler in structure, easy to produce and manufacture and low in cost, thoroughly solves the blockage problem in the thrombus extraction process, does not need in-vitro maintenance, and can continuously perform thrombus extraction operation.

Description

Technical Field

[0001] The invention relates to clinical medical instruments, in particular to a thrombus removal device. Background Art

[0002] In recent years, the research and clinical application of thrombus removal devices have become a hot topic in the field of vascular interventional treatment, especially in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Currently, the mechanical thrombectomy devices on the market often have a single function, some of which only have the function of crushing and capturing thrombi, and some of which only have the function of suction. To a certain extent, they have solved some of the thrombus removal problems, but they still face the problems of incomplete thrombus removal, large blood loss during surgery, and complex operation.

[0003] In order to solve the above technical problems, researchers have made many attempts. For example, CN116458964A discloses a thrombus removal device with cutting and suction functions, including a cutting segment, a braiding segment and a suction component, wherein the suction component includes a suction catheter and a rotating head, and the head end of the suction catheter passes through the cutting segment and is fixed to the braiding segment; a rotating wire is arranged inside the suction catheter, a suction port is arranged on the suction catheter, and the rotating head is located at the suction port and connected to the rotating wire. The technical solution has the following problems: 1) The capture net in the technical solution is a single-layer mesh structure including a woven section and a cutting section, involving different woven structures and materials. Although it also has the function of capturing and cutting thrombi, this integrated structure will lead to a significant increase in manufacturing difficulty and cost, and poor applicability; 2) A rotating head is set at the suction port to cut thrombi, but in fact, the rotating head is only effective for a small local area around the suction port, and multiple coagulated thrombi may still bridge near the suction port, causing blockage; and the rotating wire set inside the suction catheter will also occupy the effective space in the suction catheter, and even increase the possibility of thrombi hanging on the wall, reducing the suction efficiency, and is not easy to repair and maintain. 3) For thrombi deposited in the capture net far away from the suction port, or when encountering serious blockage, it is still necessary to recover the capture net, remove the thrombus removal device, and perform in vitro flushing and maintenance before intubation again for thrombus removal. There may be multiple intubation and thrombus removal operations, which increases the difficulty and time of the operation. Summary of the invention

[0004] The purpose of the present invention is to solve the technical problems existing in the background technology and to provide a thrombus removal device that has the functions of capturing, crushing and aspirating, has a simpler structure, is easy to produce and manufacture, has low cost, and completely solves the blockage problem in the thrombus removal process, does not require in vitro maintenance, and can perform thrombus removal operations continuously.

[0005] The technical solution includes a sheath tube, wherein a thrombus suction catheter is arranged inside the sheath tube, the front end of the thrombus suction catheter is connected to the tip head outside the sheath tube, at least one thrombus suction hole is opened on the tube wall of the front section of the thrombus suction catheter, the front section of the thrombus suction catheter is also provided with a thrombus capture net that can be expanded or retracted into the sheath tube, the thrombus capture net is located on the outer periphery of the thrombus suction hole, and the rear section of the sheath tube is provided with a flushing port, and the flushing port is connected to the flushing pipeline through a valve.

[0006] A cutting net is also provided between the thrombus suction hole and the thrombus catching net.

[0007] The cutting net is composed of a plurality of arc-shaped cutting wires which are evenly and spirally arranged, and the two ends of the cutting wires are fixed on the pipe wall around the suction bolt hole.

[0008] The cross section of the cutting wire is a triangle.

[0009] The cutting wire is made of metal material.

[0010] The embolus suction catheter is provided with a guidewire channel, an embolus suction channel and a traction wire channel for a capture net; the guidewire channel is provided with a guidewire, and the front end of the guidewire passes through a tip head; the front end of the embolus suction channel is connected to the embolus suction hole, and the rear end is connected to a negative pressure pipe; the traction wire channel for the capture net is provided with multiple traction wires, and the front end of the traction wire is connected to the opening end of the thrombus capture net, and the rear end is connected to the capture net driving mechanism.

[0011] The rear end of the thrombus suction channel is connected to the negative pressure pipeline and the thrombolysis pipeline respectively through a three-way valve.

[0012] The mesh diameter of the thrombus capturing net is 1.0-1.8 mm.

[0013] In view of the problems existing in the background technology, the inventor has made the following improvements:

[0014] 1) On the basis of the existing sheath, thrombus suction catheter and tip head, a conventional thrombus capture net is used to capture thrombi. Although it has a single function, it does not have a complex weaving structure, has a simple manufacturing process, low cost, and is easy to produce. At the same time, in order to solve the problem of thrombus crushing, a cutting net is set between the thrombus suction hole and the thrombus capture net. The cutting net is composed of a plurality of arc-shaped cutting wires arranged evenly in a spiral. The two ends of the cutting wires are fixed on the tube wall around the thrombus suction hole. The thrombus cutting and crushing process is passive cutting under pressure. The structure is extremely simple, not connected to the driving mechanism, and there is no possibility of direct contact with the blood vessel wall. Instead, it cooperates with the thrombus capture net and the thrombus suction catheter. When the thrombus capture net captures the thrombus, on the one hand, the volume of the thrombus capture net is contracted by the traction wire to squeeze the thrombus. On the other hand, under the action of negative pressure, the thrombus moves toward the thrombus suction hole. When passing through the cutting wire, the thrombus is shredded, reducing the volume of the thrombus, which is more conducive to the thrombus being sucked by the thrombus suction catheter. The above structure can improve the efficiency of thrombus suction and better control the pressure, avoid damage to the blood vessel wall and reduce blood loss.

[0015] By adopting the above structure, the functions of thrombus capture, crushing and suction are realized simultaneously, and the local structure is simple, easy to manufacture, reliable, and efficient in thrombus suction. It does not require excessive negative pressure to effectively solve the problem of blockage during thrombus suction, and there will be no problem of thrombus bridging around the thrombus suction hole. Preferably, the cross-section of the cutting wire is triangular, and the apex angle of the triangle can better crush the thrombus, and the two sides of the apex angle can further squeeze the thrombus to improve the crushing and suction efficiency. The thrombus capture net here can be made of medical metal materials with certain flexibility and excellent shape retention properties, such as platinum-iridium alloy; and the cutting net is made of medical metal materials with better toughness, such as nickel-titanium alloy; technical personnel in this field can also make reasonable choices in medical materials according to needs and in combination with existing technologies to meet the thrombus capture and cutting functions, which will not be described in detail here.

[0016] 2) In order to completely solve the problem of thrombus blockage during suction, the applicant changed the usual way of thinking and considered setting a flushing port at the rear section of the sheath, and the flushing port was connected to the flushing pipeline through a valve. This structure seems simple, but it is actually ingenious. When the thrombus in the thrombus capture net cannot be completely suctioned out, or the thrombus suction port and the extreme thrombus catheter are blocked and cannot be cleared, the thrombus suction catheter can be pulled back to recycle the thrombus capture net and the cutting net into the sheath, and the tip head is used to block the front end opening of the sheath. At this time, the sheath is not connected to the blood vessel, and the pressure change in the sheath will not affect the blood vessel. The flushing fluid is introduced into the flushing port for pressurized perfusion, and negative pressure suction is started at the same time to form a single circulation pathway in the sheath. The flushing fluid flushes the sheath and the thrombus capture net and cutting net inside it in turn, and then passes through the thrombus suction hole to the thrombus suction catheter, and is finally discharged through the negative pressure suction device, thereby achieving comprehensive cleaning of the entire thrombus removal pathway. The pressure is adjustable, and there is no need to consider the impact on the blood vessel, thereby effectively solving the problem of thrombus suction catheter blockage. Moreover, the above-mentioned unblocking process does not require the sheath to be pulled out from the body. After the blockage is cleared, the tip head can be opened again to release the thrombus capture net, cutting net and the front section of the embolic catheter to continue the thrombus clearing operation, which greatly simplifies the operation, improves efficiency and reduces the patient's pain.

[0017] The present invention has the functions of capturing, crushing and aspirating, has high thrombus aspiration efficiency, simpler structure, easy production and manufacturing, low cost, and completely solves the blockage problem in the thrombus removal process. It does not require in vitro maintenance and can perform thrombus removal operations continuously, and has practical and broad market application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic diagram of the structure of the present invention.

[0019] Figure 2 Schematic diagram of the installation of the thrombus capture net.

[0020] Figure 3 This is a schematic diagram of the installation of the cutting net.

[0021] Figure 4 This is a cross-sectional view of the cutting wire.

[0022] Figure 5 This is a cross-sectional view of the embolus aspiration catheter.

[0023] Among them, 1-sheath, 2-valve, 3-thrombus capture net, 4-capturing net driving mechanism, 5-cutting net, 6-thrombus suction catheter, 7-catheter driving component, 8-thrombus suction hole, 9-traction wire, 10-control handle, 11-tip head, 12-guide wire, 13-thrombus suction channel, 14-guide wire channel, 15-capturing net traction wire channel, 16-cutting wire, 17-flushing port, 18-three-way valve. DETAILED DESCRIPTION

[0024] The present invention will be further explained below in conjunction with the accompanying drawings:

[0025] Example 1: See Figure 1 and Figure 2 The sheath tube 1 is provided with an embolus suction catheter 6, the front end of which is connected to a tip head 11. The tip head 11 is preferably conical and can correspond to the front end opening of the sheath tube 1 when the embolus suction catheter 6 is recovered.

[0026] At least one thrombus suction hole 8 is formed on the wall of the front section of the thrombus suction catheter 6. The front section of the thrombus suction catheter 6 is also provided with a thrombus capture net 3 that can be expanded or retracted into the sheath 1. The thrombus capture net 3 is located at the periphery of the thrombus suction hole 8. A cutting net 5 is also provided between the thrombus suction hole 8 and the thrombus capture net 3. The rear section of the sheath 1 is provided with a flushing port 17, and the flushing port 17 is connected to a flushing pipeline via a valve 2 (not shown in the figure).

[0027] See also Figure 3 The cutting net 5 is composed of a plurality of arc-shaped cutting wires 16 arranged evenly and spirally. The two ends of the cutting wires 16 are fixed on the tube wall around the embolus suction hole 8. Under the action of external force, the thrombus before entering the embolus suction hole 8 is passively cut and broken. Preferably, see Figure 4 The cross-section of the cutting wire 16 can be a hollow or solid triangle, which can better cut thrombi coming from different directions. Preferably, the maximum outer diameter of the cutting net 5 is smaller than the inner diameter of the sheath 1, so as to facilitate its collection into the sheath 1. In this embodiment, the thrombus capture net 3 can be woven with, for example, a platinum-iridium alloy material (or other medical materials that meet the performance requirements). It has both the flexibility of a capture net and the shape-keeping property. After being freed from the restraint of the sheath 1, it can be quickly opened to maintain the capture state. Its open end is connected to the traction wire 9, and the mesh diameter and mesh volume of the thrombus capture net 3 can be flexibly controlled by driving the traction wire 9. Since venous thrombi are relatively soft and fragile, larger meshes can easily generate excessive shear force on the thrombus during the capture process, causing the thrombus to be cut or fragmented. In order to better wrap the thrombus, reduce the risk of thrombus fragmentation and escape during the capture process, and ensure the smoothness of local blood flow, the mesh diameter is preferably 1.0-1.8mm. The cutting wire can be made of, for example, nickel-titanium alloy material (or other medical materials that meet the performance requirements), has good toughness, can maintain its shape to effectively cut the thrombus, and can be retracted into the sheath 1 along with the thrombus suction catheter 6. The spacing of the cutting wire 16 can be reasonably designed based on factors such as the size of the negative pressure during thrombus suction, the size of the thrombus suction hole, and the mesh size of the thrombus capture net, so that the cut thrombus can be smoothly sucked into the thrombus suction hole 8 and discharged from the body.

[0028] See also Figure 5 The embolus suction catheter 6 is provided with an embolus suction channel 13 , a capture net traction wire channel 15 and a guide wire channel 14 .

[0029] A guide wire 12 is arranged in the guide wire channel 14, and the front end of the guide wire 12 passes through the tip head 11 to guide the device to reach the lesion site.

[0030] The front end of the embolus suction channel 13 is connected to the embolus suction hole 8, and the rear end passes through the tube sheath 1 and is connected to the negative pressure pipeline and the thrombolysis pipeline (not shown in the figure) through the three-way valve 18. When the negative pressure pipeline is connected, the broken thrombus drawn out of the embolus suction hole 8 is led out of the body through the embolus suction channel 13 under the action of negative pressure. When the thrombolysis pipeline is connected, the thrombolytic drug can be directionally injected into the blood vessel through the thrombolysis pipeline through the embolus suction channel 13.

[0031] A plurality of traction wires 9 (three traction wires 19 in this embodiment) are arranged in the traction wire channel 15 of the capture net, the front end of the traction wire is connected to the open end of the thrombus capture net 3, and the rear end is connected to the capture net driving mechanism 4. The capture net driving mechanism 4 controls the net opening diameter and net volume of the thrombus capture net 3 by driving the traction wire 19 to extend or pull back, thereby achieving the capture of thrombi of different sizes.

[0032] Furthermore, those skilled in the art can also refer to the prior art to design an adjustable curvature of the front section (i.e., the bendable section) of the embolism suction catheter to adapt to blood vessels of different directions. The specific structure can be reasonably selected in the prior art, such as the bendable section is composed of multiple independent small sections, which are connected between sections by hinges or bellows, so that they can be deformed under the traction of the pull wire; the pull wire is usually arranged along the length direction of the embolism suction catheter 6, and its front end is connected to different positions of the bendable section of the embolism suction catheter 6. Different pull wires will correspond to different bending directions. Usually, at least two pull wires can control the bending and straightening of the front section of the embolism suction catheter 6. The design of the bendable section makes the bending angle of the front section of the embolism suction catheter adjustable within a certain range, and restores to a straight line after the operation is completed; the rear end of the pull wire is connected to the catheter drive mechanism 7, and the catheter drive mechanism 7 and the capture net drive mechanism 4 can be centrally arranged in the control handle 10. The specific selection and structure of the catheter drive mechanism 7 and the capture net drive mechanism 4 can be reasonably selected by those skilled in the art as needed. This is the prior art and will not be described in detail.

[0033] The following is an example of a patient with iliofemoral vein thrombosis to illustrate the operation of the device of the present invention:

[0034] For patients with iliofemoral vein thrombosis, the guide wire 12 is controlled to reach the thrombus site, the sheath 1 is withdrawn, the tip head 11 is loosened, the thrombus capture net 3 is released, and the thrombus is captured by the thrombus capture net driving mechanism 4 through the traction wire 9. The three-way valve 18 is connected to the negative pressure pipeline to connect to the external negative pressure equipment, and the thrombus captured in the net is sucked out through the thrombus suction catheter 6. Under the action of negative pressure, the thrombus in the thrombus capture net 3 passes through the cutting wire 16 of the cutting net 5 and enters the thrombus suction catheter 6 through the thrombus suction hole 8, and finally enters the negative pressure pipeline through the three-way valve 18 and is sucked out of the body. If the volume of the thrombus in the net is large, the traction wire 9 is controlled by the capture net driving mechanism 4 on the control handle 10 to reduce the volume of the thrombus capture net 3, thereby squeezing the thrombus. At the same time, under the action of the negative pressure from the thrombus suction hole 8, the thrombus under the external pressure of the thrombus capture net 3 is pressed toward the cutting net 5, and is cut into smaller pieces of thrombus by the cutting net 5 when passing through the cutting net 5. The thrombus is more easily sucked into the thrombus suction hole 8 and enters the thrombus suction pipe 6, and is finally discharged from the body.

[0035] If the thrombus load is heavy or the blood vessel diameter is large, the curvature of the front section of the thrombus suction catheter 6 can be adjusted through the catheter driving component 7, so that the spatial range of the thrombus suction catheter 6 is larger and can better adapt to target diseased blood vessels of different diameters and tortuous blood vessels.

[0036] If the thrombus in the thrombus capture net 3 cannot be completely aspirated, or the thrombus aspiration hole 8 or thrombus aspiration catheter 6 is blocked, there is no need to pull out the sheath 1. The device of the present invention can be removed from the body. The thrombus aspiration catheter 6 can be partially withdrawn, and the thrombus capture net 3 and the thrombus cutting net 5 are recovered into the sheath 1 along with the thrombus aspiration catheter 6. At the same time, the TIP head 11 blocks the front end of the sheath 1 and seals it, closing the passage to the blood vessel. Open the valve 2, and use physiological saline to inject it into the sheath 1 through the flushing pipe and the valve 2 from the flushing port 17 to perform liquid pressurized perfusion. At the same time, start the negative pressure device. After the physiological saline is flushed through the sheath 1 and the thrombus capture net 3 and the thrombus cutting net 5 inside, it passes through the thrombus aspiration hole 8 to flush the thrombus aspiration catheter 6, and is finally discharged through the negative pressure pipe under the action of negative pressure. Since the passage to the blood vessel is temporarily closed, the suction pressure can be freely adjusted to ensure the dredging effect. This single-circulation passage can effectively solve the blockage problem of the thrombus aspiration hole 8 or the thrombus aspiration catheter 6.

[0037] After flushing is completed, the sheath 1 can be withdrawn again, the tip head 11 can be loosened, the thrombus capture net 3 and the thrombus cutting net 5 can be released at a fixed point again, and the thrombus suction operation can be continued.

[0038] As another embodiment, as needed, the rear end of the thrombus suction channel 13 can also be connected to a negative pressure pipeline and a thrombolytic pipeline respectively through a three-way valve 18; before thrombus suction, the thrombolytic pipeline can be connected through the three-way valve 18, and a thrombolytic agent, such as urokinase thrombolytic agent, can be injected into the thrombus suction channel 13, and the thrombolytic agent can be infused into the target diseased blood vessel segment through the thrombus suction catheter 6 to dissolve the thrombus and loosen part of the thrombus; then the three-way valve 18 is used to connect the negative pressure pipeline to perform thrombus suction operation, thereby improving the efficiency of thrombus removal and further enhancing the treatment effect.

Claims

1. A thrombus removal device, comprising a sheath tube, wherein a thrombus suction catheter is arranged inside the sheath tube, the front end of the thrombus suction catheter is connected to a tip head outside the sheath tube, and at least one thrombus suction hole is opened on the front wall of the thrombus suction catheter, characterized in that: The front section of the embolus suction catheter is also provided with a thrombus capture net that can be expanded or retracted into the sheath, and the thrombus capture net is located at the periphery of the embolus suction hole. The rear section of the sheath is provided with a flushing port, and the flushing port is connected to a flushing pipeline via a valve.

2. The thrombus removal device according to claim 1, characterized in that: A cutting net is also provided between the thrombus suction hole and the thrombus catching net.

3. The thrombus removal device according to claim 2, characterized in that: The cutting net is composed of a plurality of arc-shaped cutting wires which are evenly spirally arranged, and the two ends of the cutting wires are fixed on the pipe wall around the suction bolt hole.

4. The thrombus removal device according to claim 3, characterized in that: The cross section of the cutting wire is triangular.

5. The thrombus removal device according to claim 3, characterized in that: The cutting wire is made of metal material.

6. The thrombus removal device according to any one of claims 1 to 5, characterized in that: The embolus suction catheter is provided with a guidewire channel, an embolus suction channel and a traction wire channel for a capture net; the guidewire channel is provided with a guidewire, and the front end of the guidewire passes through a tip head; the front end of the embolus suction channel is connected to the embolus suction hole, and the rear end is connected to a negative pressure pipe; the traction wire channel for the capture net is provided with multiple traction wires, and the front end of the traction wire is connected to the opening end of the thrombus capture net, and the rear end is connected to the capture net driving mechanism.

7. The thrombus removal device according to claim 6, characterized in that: The rear end of the thrombus suction channel is connected to the negative pressure pipeline and the thrombolysis pipeline respectively through a three-way valve.

8. The thrombus removal device according to claim 1, characterized in that: The mesh diameter of the thrombus capturing net is 1.0-1.8 mm.

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