Thrombus separator

Abstract

The invention discloses a thrombus separator, and relates to the technical field of medical instruments, the thrombus separator comprises an inner-layer stent, an outer-layer stent and a conveying guide wire, the outer-layer stent is fixedly connected to one end of the conveying guide wire, and the outer-layer stent is used for chopping thrombus; the inner-layer stent is arranged on the inner side of the outer-layer stent, the inner-layer stent is used for recycling chopped thrombus, and the inner-layer stent and the outer-layer stent are both made of elastic metal materials. According to the invention, calcified stubborn thrombus can be effectively cut up through the outer-layer stent in a specific shape, and can be effectively laid under the action of matching with the negative pressure suction of the suction catheter by virtue of the arranged inner-layer stent, so that the thrombus treatment efficiency is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a thrombus separator. Background Technology

[0002] In the field of interventional therapy, especially in the treatment of critical illnesses such as acute myocardial infarction, stroke, and peripheral artery embolism, the rapid and thorough removal of pathological substances such as thrombi and atherosclerotic plaques that block blood vessels is key to restoring blood flow and saving ischemic tissues.

[0003] Current techniques primarily rely on aspiration catheters as the core interventional device for thrombus removal. During the procedure, the doctor guides the catheter to the lesion site, applies negative pressure proximally, and draws thrombi and other substances into the catheter lumen through the distal aspiration opening and removes them from the body.

[0004] However, existing aspiration catheters are primarily suitable for aspirating newly formed, flexible, acute thrombi. For subacute thrombi that have been formed for a longer period, or even stubborn thrombi that have become severely calcified, aspiration catheters alone cannot effectively dislodge and remove the thrombus, thus significantly impacting aspiration efficiency. Furthermore, during the use of aspiration catheters, there is a possibility of catheter blockage due to excessively large thrombi in some patients. In such cases, clinicians need to remove the catheter for cleaning or replace it with a new one, which not only affects surgical efficiency but also increases the risk of secondary injury to the patient. Therefore, current techniques for treating thrombi using aspiration catheters are not effective enough and are inefficient, necessitating the development of a thrombectomy device to address these problems. Summary of the Invention

[0005] The purpose of this invention is to provide a thrombus separator to solve the technical problems of existing technologies that rely on aspiration catheters to effectively treat some stubborn thrombi, and that the treatment efficiency is low and the catheter is prone to blockage.

[0006] The technical problem to be solved by this invention can be achieved through the following technical solution: A thrombus separator includes an inner stent, an outer stent, and a delivery guidewire. The outer stent is fixedly connected to one end of the delivery guidewire and is used to break up thrombi. The inner stent is disposed inside the outer stent and is used to collect the broken up thrombi. Both the inner and outer stents are made of elastic metal material.

[0007] Preferably, the outer support includes a head section, an outer body section, and a tail section, with the outer body section connected between the head section and the tail section.

[0008] Preferably, the head section has a conical pointed structure.

[0009] Preferably, the outer main body segment includes segment groups, and multiple groups of segment groups are distributed circumferentially around the inner support; each group of segment groups includes multiple segment units connected laterally in sequence, and the segment units of adjacent segment groups are aligned and connected.

[0010] Preferably, the segment unit has a first mesh and a second mesh. The first mesh is located on the side of the segment unit away from the conveying guide wire, and there are two second meshes, which are radially distributed on the side of the first mesh closer to the conveying guide wire.

[0011] Preferably, the segment unit has a tapered tip on the side near the guide wire, and there are two tapered tips, which are respectively located on the outer side of the second mesh; the edge of the segment unit has an arc-shaped rounded corner.

[0012] Preferably, the tail segment includes multiple sets of triangular mesh cells, which are connected to the segment group, and each set of triangular mesh cells is uniformly provided with multiple auxiliary third meshes.

[0013] Preferably, the tail section further includes multiple tail-gathering skeletons, one end of each tail-gathering skeleton is connected to a triangular mesh cell, and the other end converges towards the location of the inner support.

[0014] Preferably, the inner stent includes an inner main body segment, the outer surface of which is wavy and has alternating protrusions and depressions, and multiple perforated mesh holes are evenly distributed on the inner main body segment.

[0015] Preferably, the inner support further includes a front connecting tube and a rear connecting tube, the inner main body segment is fixedly connected between the front connecting tube and the rear connecting tube, one end of the outer support is fixedly connected to a front fixing ring, and the other end is fixedly connected to a rear fixing ring, the front connecting tube is fixedly connected to the front fixing ring, and the rear connecting tube is fixedly connected to the rear fixing ring; the rear connecting tube is also fixedly connected to the delivery guide wire.

[0016] The beneficial effects of this invention are: 1. This invention can effectively break up calcified stubborn thrombi through a specially shaped outer stent, and effectively spread them out under the negative pressure suction of the aspiration catheter by the inner stent, thereby improving the efficiency of thrombus treatment.

[0017] 2. After the outer stent of the present invention is deployed in the blood vessel, it is in the shape of a fishbone. When it is squeezed and contacts the inner wall of the blood vessel, the outer stent moves back and forth and rotates, thereby effectively cutting and breaking the thrombus by means of the distributed first and second meshes. At the same time, it is easy for the fragmented thrombus to pass through the outer stent. During the movement of the outer stent, the set conical tip further breaks the thrombus in multiple directions, effectively breaking large thrombi into smaller pieces. The fragmented thrombus enters the inner stent area on the inside. Under the negative pressure suction of the aspiration catheter, the inner stent can effectively capture the thrombus by means of the blood-permeable mesh, preventing the fragmented thrombus from escaping.

[0018] 3. The outer support of the present invention is fishbone shaped, and its front part is a conical tip, which can clear any thrombus blockage that may exist in the aspiration catheter, avoiding medical staff from removing the catheter for cleaning or replacing the aspiration catheter, thereby avoiding affecting the efficiency of the operation. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the outer support structure in this invention; Figure 3 This is a schematic diagram of the segmental unit in this invention; Figure 4 This is a schematic diagram of the triangular mesh cell structure in this invention; Figure 5 This is a schematic diagram of the left-side structure of the outer support in this invention; Figure 6 This is a schematic diagram of the inner support structure in this invention; Figure 7 This is a schematic diagram of the structure of the outer support being compressed and assembled inside the suction catheter in this invention; Figure 8 This is a schematic diagram of the developing fiber structure in this invention; Figure 9 This is a schematic diagram of the guide wire delivery structure in this invention.

[0020] Explanation of reference numerals in the attached figures: 1. Imaging wire; 2. Inner support; 21. Front connecting tube; 22. Inner main body segment; 221. Protruding position; 222. Recessed position; 223. Blood-penetrating mesh; 23. Rear connecting tube; 3. Outer support; 31. Front fixing ring; 32. Head segment; 33. Outer main body segment; 331. Segmental unit; 3311. Conical tip; 3312. Rounded corner; 3313. First mesh; 3314. Second mesh; 34. Tail segment; 341. Triangular mesh cell; 3411. Third mesh; 342. Closing tail skeleton; 35. Rear fixing ring; 4. Transport guidewire; 41. Working section; 42. Transition section; 43. Manipulation section; 5. Aspiration catheter. Detailed Implementation

[0021] The specific embodiments of the present invention will be described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0022] like Figures 1-9 As shown, a thrombus separator is used to clean subacute thrombi or severely calcified thrombi that have been formed for a long time in blood vessels. The separator includes an inner stent 2, an outer stent 3, and a delivery guidewire 4. The outer stent 3 is fixedly connected to one end of the delivery guidewire 4 and is used to break up the thrombus. The delivery guidewire 4 can operate the outer stent 3 to move forward, backward, or rotate. The inner stent 2 is located inside the outer stent 3 and is used to retrieve the broken up thrombi. Both the inner stent 2 and the outer stent 3 are made of elastic metal material, specifically nickel-titanium alloy, and are integrally laser-cut and then heat-set to facilitate deformation and contraction. It is used in conjunction with an aspiration catheter 5 for easy release or storage in blood vessels.

[0023] In addition, the maximum outer diameter of the outer support 3 can be set between 2mm and 10mm, and is larger than the inner diameter of the suction catheter 5. It is in a compressed state in the suction catheter 5 and can be released and unfolded when extended.

[0024] Example 1

[0025] refer to Figure 2 As shown, the outer stent 3 is shaped like a fishbone and includes a head segment 32, an outer body segment 33, and a tail segment 34. The outer body segment 33 is connected between the head segment 32 and the tail segment 34, and the tail segment 34 is positioned close to the delivery guidewire 4. The head segment 32 facilitates the advancement of the entire outer stent 3 to penetrate the calcified thrombus at the corresponding position. The outer body segment 33 relies on rotation and reciprocating motion to break up the thrombus. The tail segment 34 is used to further assist in breaking up the thrombus.

[0026] In some specific embodiments of this example, the head segment 32 is a conical pointed structure, similar to a fish head. Because it is pointed, it is easy to pass through calcified thrombi in the direction of travel.

[0027] In some specific implementations of this embodiment, combined with Figure 2 and Figure 3 As shown, the outer main body segment 33 includes segment groups, and multiple groups of segment groups are distributed circumferentially around the inner stent 2; each segment group includes multiple segment units 331 connected laterally in sequence, and the segment units 331 of adjacent segment groups are aligned and connected; the segment units 331 function as units that specifically cut up thrombi.

[0028] The segment unit 331 has a first mesh 3313 and a second mesh 3314. The first mesh 3313 is located on the side of the segment unit 331 away from the conveying guide wire 4. There are two second meshes 3314, radially distributed on the side of the first mesh 3313 closer to the conveying guide wire 4. Both the first mesh 3313 and the second mesh 3314 are quadrilaterals, and the two second meshes 3314 are in contact with each other through one end corner. Each of the two second meshes 3314 is in line contact with the first mesh 3313. The first mesh 3313 of segment unit 331 is formed at the position of the first mesh 3313 and is connected to the position between the two second meshes 3314 of the adjacent segment unit 331. The presence of the first mesh 3313 and the second mesh 3314 facilitates the flexible deformation of segment unit 331 in curved blood vessels, facilitates contact with the blood vessel wall, and when squeezing the thrombus, the linear metal edge between the holes also helps to squeeze and cut the thrombus, making it easier for the thrombus to fall into the mesh and promote the thrombus to be dislodged during the movement of the entire outer stent 3.

[0029] It should be noted that the actual number of segmental units 331 can be increased or decreased according to actual needs, that is, the outer stent 3 of the corresponding size and specifications can be prepared according to the length of the thrombus.

[0030] In addition, a tapered tip 3311 is provided on the side of the segment unit 331 near the delivery guide wire 4. There are two tapered tips 3311, which are respectively located on the outside of the second mesh 3314. When the delivery guide wire 4 is reciprocated and rotated, the distributed tapered tips 3311 can effectively penetrate and break up the calcified thrombus.

[0031] Furthermore, the edge of segmental unit 331 is rounded with arcs 3312, especially on the outward side. The presence of rounded arcs 3312 can prevent damage to the inner wall of the blood vessel during operation.

[0032] In some specific implementation schemes of this embodiment, combined with Figure 2 and Figure 4As shown, the tail segment 34 is roughly fish-tail shaped and includes multiple sets of triangular mesh cells 341. The triangular mesh cells 341 are connected to the segment groups. Each set of triangular mesh cells 341 has multiple auxiliary third meshes 3411 evenly distributed on it. Specifically, it can be set as: 1 third mesh 3411 in the front section, 2 third meshes 3411 in the middle section, and 3 third meshes 3411 in the tail section. It should be noted that the actual number of third meshes 3411 can also be arranged according to actual needs.

[0033] The tail segment 34 uses triangular mesh cells 341 to facilitate the compliant transition from the dense segmental units 331 of the outer main body segment 33 to the end, making it easier for the entire stent to advance along the blood vessel. At the same time, the provided third mesh 3411 also helps to further scavenge and collect thrombi.

[0034] In a further specific implementation of this embodiment, the tail section 34 also includes multiple retractable tail skeletons 342. One end of each retractable tail skeleton 342 is connected to a triangular mesh cell 341, and the other end converges toward the location of the inner stent 2. The whole structure is concave toward the inner stent 2 and is distributed in an arc. The retractable tail skeleton facilitates the release or retraction of the entire outer stent 3 from the corresponding medical catheter device, and avoids the tail from protruding, which could easily damage the inner wall of the blood vessel.

[0035] Example 2

[0036] refer to Figure 6 As shown, the inner stent 2 includes an inner main body segment 22. The outer surface of the inner main body segment 22 is wavy and has alternating protrusions 221 and depressions 222, which can radially constrain the inner stent, reduce the torsion amplitude of the inner stent in the blood vessel, and reduce the shear stress from the blood. Multiple blood permeable meshes 223 are evenly distributed on the inner main body segment 22. The maximum outer diameter of the blood permeable meshes 223 is set to be smaller than the maximum outer diameter of the thrombus, which allows blood to pass through while blocking larger thrombus fragments. With the negative pressure suction of the aspiration catheter 5, the thrombus is effectively captured.

[0037] Example 3

[0038] Based on Embodiment 2, the inner support 2 further includes a front connecting pipe 21 and a rear connecting pipe 23. The inner main body section 22 is fixedly connected between the front connecting pipe 21 and the rear connecting pipe 23. One end of the outer support 3 is fixedly connected to a front fixing ring 31, and the other end is fixedly connected to a rear fixing ring 35. The front connecting pipe 21 is fixedly connected to the front fixing ring 31, and the rear connecting pipe 23 is fixedly connected to the rear fixing ring 35. The rear connecting pipe 23 is also fixedly connected to the conveying guide wire 4. The above-mentioned fixed connection method can be welding or adhesive fixing. In addition, the retractable tail frame 342 of the outer support 3 is fixedly connected to the rear fixing ring 35, thereby realizing the fixed connection between the outer support 3 and the inner support 2, effectively ensuring the stable use of the whole.

[0039] Example 4

[0040] Based on Example 3, and referring to Figure 9 As shown, the guide wire 4 includes a working section 41, a transition section 42, and an operating section 43. The working section 41 has a diameter slightly smaller than the operating section 43 and is used to fix the outer support 3 and the inner support 2. The transition section 42 is located between the working section 41 and the operating section 43. The guide wire 4 is preferably made of 304V stainless steel or nickel-titanium alloy and can be manufactured by grinding.

[0041] Example 5

[0042] The separator also includes a radiopaque wire 1, which is located at the end of the outer support 3 away from the delivery guide wire 4. The radiopaque wire 1 is preferably made of a metal material that has good radiopaque effect under X-rays, such as a platinum-iridium alloy material, which is made by spiral winding to facilitate positioning of the separator in the blood vessel with medical imaging equipment.

[0043] To facilitate understanding of the embodiments of this solution by those skilled in the art, the working principle of this solution will now be briefly explained in conjunction with specific application scenarios: First, based on the relevant procedures of interventional surgery, the aspiration catheter 5 is delivered to the thrombus location. Then, the entire thrombus separator is compressed and enters the aspiration catheter 5 through the guide sheath. If there is a thrombus blocking the aspiration catheter 5, the thrombus separator can be repeatedly pulled back and forth and stirred to cut and unclog the thrombus in the catheter. After the thrombus separator passes through the aspiration catheter 5, it unfolds and takes the shape of a fishbone. Then, by repeatedly pulling and rotating the guide wire 4, the thrombus separator is agitated and moved back and forth. This allows the conical tip 32 of the outer stent 3 to advance and penetrate the calcified thrombus at the corresponding position. The first mesh 3313 and the second mesh 3314 on the outer stent 3 can effectively contact the blood vessel wall and squeeze the thrombus, breaking it up. This makes it easier for the thrombus to fall into the mesh and promotes the thrombus to detach during the movement of the outer stent 3. At the same time, the conical tip 3311 distributed on the segment unit 331 can further effectively penetrate and break the calcified thrombus. During the movement of the outer stent 3, the arc-shaped rounded corner 3312 on the outer edge can effectively avoid damage to the blood vessel. Furthermore, during the movement of the outer stent 3, the tail segment 34 is designed with triangular mesh cells 341 to facilitate the compliant transition from the dense segmental units 331 of the outer main body segment 33 to the end, making it easier for the entire stent to move along the blood vessel. At the same time, the provided third mesh 3411 is also helpful to further assist in cutting and stripping the thrombus. The thrombus fragmented by the outer stent 3 can pass through the first mesh 3313, the second mesh 3314 and the third mesh 3411 at the corresponding positions and enter the inner side of the outer stent 3, so as to effectively remove the calcified thrombus. Furthermore, due to the blood permeable mesh 223 distributed in the inner stent 2, blood can pass through while blocking larger thrombus fragments. With the aspiration action of the aspiration catheter 5, the thrombus can be attached to the inner stent 2, effectively preventing the escape of the fragmented thrombus.

[0044] The above-disclosed embodiments are merely a few specific examples of the present invention. However, the embodiments of the present invention are not limited thereto, and any variations that can be conceived by those skilled in the art should fall within the protection scope of the present invention.

Claims

1. A thrombus separator, characterized in that, It includes an inner support (2), an outer support (3), and a delivery guide wire (4); The outer stent (3) is fixedly connected to one end of the delivery guide wire (4), and the outer stent (3) is used to cut up the thrombus; the inner stent (2) is disposed inside the outer stent (3), and the inner stent (2) is used to recover the cut up thrombus, and both the inner stent (2) and the outer stent (3) are made of elastic metal material.

2. The thrombus separator according to claim 1, characterized in that, The outer support (3) includes a head section (32), an outer body section (33) and a tail section (34), with the outer body section (33) connected between the head section (32) and the tail section (34).

3. A thrombus separator according to claim 2, characterized in that, The head section (32) is a conical pointed structure.

4. A thrombus separator according to claim 2, characterized in that, The outer main body segment (33) includes segment groups, and multiple segments are distributed circumferentially around the inner support (2); each segment group includes multiple laterally connected segment units (331), and the segment units (331) of adjacent segment groups are aligned and connected.

5. A thrombus separator according to claim 4, characterized in that, The segment unit (331) is provided with a first mesh (3313) and a second mesh (3314). The first mesh (3313) is located on the side of the segment unit (331) away from the conveying guide wire (4). There are two second meshes (3314), which are radially distributed on the side of the first mesh (3313) close to the conveying guide wire (4).

6. A thrombus separator according to claim 5, characterized in that, The segment unit (331) is provided with a tapered tip (3311) on the side near the guide wire (4). There are two tapered tips (3311), which are respectively located on the outside of the second mesh (3314). The edge of the segment unit (331) is an arc-shaped rounded corner (3312).

7. A thrombus separator according to claim 4, characterized in that, The tail segment (34) includes multiple sets of triangular mesh cells (341), which are connected to the segment group. Each set of triangular mesh cells (341) is evenly provided with multiple auxiliary third meshes (3411).

8. A thrombus separator according to claim 7, characterized in that, The tail section (34) also includes multiple tail-gathering skeletons (342), one end of each tail-gathering skeleton (342) is connected to a triangular mesh cell (341), and the other end converges towards the location of the inner support (2).

9. A thrombus separator according to claim 1, characterized in that, The inner stent (2) includes an inner main body section (22). The outer surface of the inner main body section (22) is wavy and has alternating protrusions (221) and depressions (222). Multiple blood-permeable mesh holes (223) are evenly provided on the inner main body section (22).

10. A thrombus separator according to claim 9, characterized in that, The inner support (2) also includes a front connecting tube (21) and a rear connecting tube (23). The inner main body section (22) is fixedly connected between the front connecting tube (21) and the rear connecting tube (23). One end of the outer support (3) is fixedly connected to a front fixing ring (31), and the other end is fixedly connected to a rear fixing ring (35). The front connecting tube (21) is fixedly connected to the front fixing ring (31), and the rear connecting tube (23) is fixedly connected to the rear fixing ring (35). The rear connecting tube (23) is also fixedly connected to the conveying guide wire (4).

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