Double-layer filter anti-embolism distal protection device

Abstract

The present invention belongs to the technical field of medical devices and relates to a double-layer filter anti-embolism distal protection device, comprising an elastic base, a first filter, and a second filter. The two ends of the first filter are a first open end and a first closed end, respectively. The distance between the first closed end and the elastic base is greater than the distance between the first open end and the elastic base, and the first open end is connected to the elastic base. A plurality of first filter holes are distributed on the first filter. A plurality of second filter holes are distributed on the second filter. The second filter is connected to the elastic base, and the second filter is mounted outside the elastic base and the first filter, so that during use of the double-layer filter anti-embolism distal protection device, blood passes through the elastic base, the first open end, the first filter hole, and the second filter hole in sequence and flows to the downstream of the blood vessel. By providing the first filter and the second filter, and the second filter being mounted outside the first filter, a double-layer filtration can be formed, which can effectively filter thrombi or plaques and prevent thrombi or plaques from flowing to the downstream of the blood vessel.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a double-layer filter anti-embolism distal protection device. Background Art

[0002] With the improvement of living standards, life expectancy in my country has increased significantly, the aging population has intensified, and the incidence of ischemic stroke has become increasingly high, becoming one of the major diseases that endanger the lives of middle-aged and elderly people in my country. Among them, atherosclerotic carotid artery stenosis accounts for approximately 20%-30% of ischemic stroke cases.

[0003] Interventional treatment for carotid artery stenosis is an important measure for preventing ischemic stroke. Conventional surgical procedures for carotid artery stenosis include intracranial carotid artery dissection, balloon angioplasty, thrombectomy, and carotid artery stenting. These procedures have gradually become the mainstay of treatment for carotid artery stenosis due to their minimal surgical trauma, low anesthetic risk, and few contraindications and complications. However, during these procedures, thrombi or plaques often break off. These detached thrombi or plaques can migrate downstream with the bloodstream, causing intracranial cerebral embolism and leading to acute ischemic stroke.

[0004] Currently, a single-layer filter structure is generally used to filter thrombi or plaques to prevent the thrombi or plaques from flowing downstream. However, once there are too many thrombi or plaques or large thrombi or plaques appear, blood flow is easily blocked. Summary of the Invention

[0005] The object of the present invention is to provide a double-layer filter anti-embolism distal protection device, which can improve the effect of filtering thrombus or plaque.

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] A double-layer filter anti-embolism distal protection device, comprising:

[0008] elastic base frame;

[0009] a first filter screen, wherein the first filter screen has a first open end and a first closed end at two ends, the first closed end is farther away from the elastic base than the first open end, and the first open end is connected to the elastic base, and a plurality of first filter holes are distributed on the first filter screen;

[0010] A second filter screen, with a plurality of second filter holes distributed on the second filter screen; the second filter screen is connected to the elastic base frame, and the second filter screen is mounted outside the elastic base frame and the first filter screen, so that during use of the double-layer filter screen anti-embolism distal protection device, blood passes through the elastic base frame, the first open end, the first filter hole and the second filter hole in sequence and flows to the downstream of the blood vessel.

[0011] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the second filter is spaced apart from the first filter.

[0012] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the hole area of ​​the first filter hole decreases successively in the direction from the first open end to the first closed end.

[0013] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the first filter is a conical structure, and the diameter of the first filter gradually decreases in the direction from the first open end to the first closed end.

[0014] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the hole area of ​​the second filter hole is smaller than the hole area of ​​the first filter hole.

[0015] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the second filter includes a filter segment, the second filter holes are distributed in the filter segment, the filter segment is a conical structure, and the diameter of the filter segment gradually decreases in the direction away from the elastic base.

[0016] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the filter segment is sleeved on the first filter, and the opening of the filter segment is flush with the first open end.

[0017] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the second filter includes a connected filtering section and a mounting section, the mounting section is a cylindrical structure, and the mounting section is fitted on and connected to the outer surface of the elastic base.

[0018] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the elastic base frame includes an abutment portion, the outer wall of the abutment portion bulges toward the inner wall of the blood vessel, and the mounting section is sleeved on the periphery of the abutment portion and fits together with the abutment portion.

[0019] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the double-layer filter anti-embolism distal protection device further comprises a guide wire, and the guide wire is connected to one end of the elastic base.

[0020] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the first filter is a metal filter and / or the second filter is a polymer filter.

[0021] Preferably, in the above-mentioned double-layer filter anti-embolism distal protection device, the first filter is a nickel-titanium alloy filter, a cobalt-chromium alloy filter, or a stainless steel filter.

[0022] The beneficial effect of the double-layer filter anti-embolism distal protection device of the present invention is that by setting a first filter and a second filter, and the second filter is mounted outside the first filter, a double-layer filtration can be formed, which can effectively filter thrombi or plaques and prevent thrombi or plaques from flowing downstream of the blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Schematic diagram of a double-layer filter anti-embolism distal protection device according to an embodiment of the present invention;

[0024] Figure 2 Schematic diagram of the double-layer filter anti-embolism distal protection device in use according to an embodiment of the present invention;

[0025] Figure 3 Schematic diagram of the connection between the elastic base frame and the first filter of the double-layer filter anti-embolism distal protection device according to an embodiment of the present invention;

[0026] Figure 4 Schematic diagram of the structure of the second filter of the double-layer filter anti-embolism distal protection device according to an embodiment of the present invention.

[0027] The names and numbers of the components in the figure are as follows:

[0028] Double-layer filter anti-embolism distal protection device 100, elastic base frame 10, abutment portion 11, gathering end 12, first filter 20, first open end 21, first closed end 22, second filter 30, second open end 31, second closed end 32, filter section 33, installation section 34, large thrombus or plaque 51, small thrombus or plaque 52. DETAILED DESCRIPTION

[0029] The present invention will be further described in detail below with reference to the accompanying drawings and examples. It will be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions relevant to the present invention, not all structures.

[0030] In the description of the present invention, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific circumstances.

[0031] In the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0032] In the description of this embodiment, the terms "upper," "lower," "right," and other orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely for ease of description and simplified operation. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meanings.

[0033] For the convenience of description, in this embodiment, upstream and downstream are defined based on the flow direction of blood in a blood vessel, where blood flows from upstream to downstream.

[0034] Figure 1 Schematic diagram of a double-layer filter anti-embolism distal protection device 100 according to an embodiment of the present invention. Figure 2 FIG. 1 is a schematic diagram of the double-layer filter anti-embolism distal protection device 100 in use according to an embodiment of the present invention. Figure 1 and Figure 2 As shown, this embodiment discloses a double-layer filter anti-embolism distal protection device 100. The double-layer filter anti-embolism distal protection device 100 includes an elastic base 10, a first filter 20, and a second filter 30. The elastic base 10 can be formed by a plurality of elastic rods interlaced and hingedly connected to each other, allowing for expansion and contraction. One end of the elastic base 10, facing upstream, forms a converged end 12, and the other end, after the elastic base 10 is expanded, forms an open end. The elastic base 10 expands and contracts with the converged end 12 as the base point.

[0035] After the double-layer filter anti-embolism distal protection device 100 reaches the predetermined target position through insertion, it is released. The elastic base 10 expands due to its own elasticity to fit and anchor to the inner wall of the blood vessel. A radial support force is generated between the blood vessel and the elastic base 10, thereby limiting the elastic base 10 to the blood vessel and positioning it at a predetermined position upstream of the blood vessel. The diameter of the blood vessel released by the elastic base 10 is slightly smaller than its own diameter in a natural state without external constraints. Therefore, the elastic base 10's rebound force on the blood vessel wall is limited, meeting the required anchoring force without damaging the blood vessel.

[0036] The first filter screen 20 has a first open end 21 and a first closed end 22 at its ends. The first closed end 22 is located farther from the elastic base 10 than the first open end 21, and the first open end 21 is connected to the elastic base 10. A plurality of first filter holes are distributed on the first filter screen 20. A plurality of second filter holes are distributed on the second filter screen 30. The second filter screen 30 is connected to the elastic base 10 and is mounted outside the elastic base 10 and the first filter screen 20. During use of the double-layer filter screen anti-embolism distal protection device 100, blood flows sequentially through the elastic base 10, the first open end 21, the first filter holes, and the second filter holes, toward the downstream blood vessel.

[0037] The double-layer filter anti-embolism distal protection device 100 of this embodiment is configured with a first filter 20 and a second filter 30, and the second filter 30 is mounted outside the first filter 20, thereby forming a double-layer filtration, which can effectively filter thrombi or plaques and prevent thrombi or plaques from flowing downstream of the blood vessels.

[0038] Specifically, the first filter screen 20 and the second filter screen 30 of this embodiment can be connected to the elastic base frame 10 respectively by bonding, hot melting, welding or sewing.

[0039] The first filter screen 20 of this embodiment can be a polymer mesh structure. The first filter screen 20 has a certain rigidity, and its shape and mesh size are not easily changed during the blood flow and under the influence of thrombus or plaque. The diameter of the first filter hole of the first filter screen 20 is 500μm to 1200μm, preferably 500μm to 600μm. For example, the diameter of the first filter hole is 500μm or 600μm or 1200μm. The first filter screen 20 of this embodiment can also be woven into a mesh structure by elastic metal wire or polymer wire.

[0040] The diameter of the second filter pores of the second filter screen 30 is 70 μm to 150 μm, preferably 80 μm to 120 μm. For example, the diameter of the second filter pores is 70 μm, 80 μm, 120 μm, or 150 μm. Similarly, the second filter screen 30 has a certain degree of rigidity, and its shape and mesh size are not easily changed during blood flow and under the influence of thrombus or plaque. The second filter screen 30 can be woven into a mesh structure with elastic metal wire or polymer wire.

[0041] The elastic base 10 has a suitable elastic force. When the double-layer filter anti-embolism distal protection device 100 is retrieved, the elastic base 10 can shrink, and with it the first filter 20 and the second filter 30. That is, the diameter of the elastic base 10 is reduced and compressed, and the first filter 20 and the second filter 30 attached to the elastic base 10 shrink along with it. During use, the double-layer filter anti-embolism distal protection device 100 is compressed to its minimum diameter. After entering the blood vessel and reaching the predetermined position, it is released and then expanded, causing the diameter of the elastic base 10 to rebound to a diameter equivalent to that of the blood vessel, thereby achieving adhesion to the blood vessel wall.

[0042] The first and second filter screens 20 and 30 of the present application also expand during the expansion of the elastic base 10 to filter blood clots or plaque. The apertures of the first and second filter holes mentioned below refer to the expanded apertures. The structures of the elastic base 10, first and second filter screens 20 and 30 of the present application refer to the expanded structures.

[0043] Preferably, the second filter 30 is spaced apart from the first filter 20. After the first and second filters 20 and 30 are opened, they are spaced apart and do not contact each other. In this embodiment, the first and second filters 20 and 30 are spaced apart at least where filtering actually occurs. This embodiment employs a double-layer, spaced filter, with the filter pores of the two layers having different pore sizes, to filter thrombi or plaques of different sizes. This allows thrombi or plaques to be distributed axially along the double-layer filter anti-embolism distal protection device 100, preventing accumulation. This helps ensure normal blood flow and reduces the risk of blood obstruction, perfusion, or turbulence. It also facilitates the final recovery of the double-layer filter anti-embolism distal protection device 100. If a large thrombus or plaque particle is captured by the first filter 20, the impact of blood flow can cut the large thrombus or plaque into smaller pieces, which are then captured by the second filter 30.

[0044] With a single-layer filter, captured thrombi or plaque accumulate on that single layer. This can easily lead to thrombus or plaque accumulation during surgery, disrupting normal blood circulation. Furthermore, thrombi or plaque accumulation on a single filter can cause localized radial diameter enlargement, making it difficult to retrieve the double-layer filter anti-embolism distal protection device 100 after surgery. Therefore, this embodiment employs two layers of spaced filters, dispersing thrombi or plaque along the course of the blood vessel. This prevents localized radial diameter enlargement and facilitates the retrieval of the double-layer filter anti-embolism distal protection device 100.

[0045] Figure 3 FIG. 1 is a schematic diagram showing the connection between the elastic base frame 10 and the first filter 20 of the double-layer filter anti-embolism distal protection device 100 according to an embodiment of the present invention. Figure 1 and Figure 3 As shown, preferably, the pore area of ​​the first filter holes decreases in sequence from the first open end 21 to the first closed end 22, which is beneficial to improving the effect of the first filter screen 20 in filtering thrombi or plaques.

[0046] Preferably, the first filter 20 is a conical structure, and the diameter of the first filter 20 gradually decreases from the first open end 21 to the first closed end 22, which is beneficial to improving the effect of the first filter 20 in filtering thrombi or plaques.

[0047] Preferably, the second filter holes have a smaller area than the first filter holes. In this embodiment, large thrombi or plaques 51 are first filtered through the first filter 20. Small thrombi or plaques 52 then pass through the first filter holes and enter the space between the first and second filter 30. They are then filtered by the second filter holes of the second filter 30 and remain in the space between the first and second filter 30. This embodiment sequentially filters thrombi or plaques in layers, resulting in excellent filtration results.

[0048] Figure 4 FIG. 1 is a schematic structural diagram of the second filter 30 of the double-layer filter anti-embolism distal protection device 100 according to an embodiment of the present invention. Figure 1 and Figure 4 As shown, preferably, the second filter screen 30 includes a filter section 33, the second filter holes are distributed in the filter section 33, the filter section 33 is a conical structure, and the diameter of the filter section 33 gradually decreases in the direction away from the elastic base frame 10, which is beneficial to improve the effect of the second filter screen 30 in filtering thrombi or plaques.

[0049] Preferably, the filter segment 33 is mounted on the first filter screen 20, with the opening of the filter segment 33 flush with the first open end 21. This allows the first filter screen 20 and the second filter screen 30 of this embodiment to filter simultaneously, with the first filter screen 20 filtering large thrombi or plaques 51 and the second filter screen 30 filtering small thrombi or plaques 52, resulting in more complete filtration. The opening of the filter segment 33 here refers to the opening at the upstream end of the filter segment 33. The other end of the filter segment 33, opposite this opening, forms the second closed end 32 of the entire second filter screen 30.

[0050] like Figure 2 and Figure 4 As shown, the second filter screen 30 preferably includes a connected filtering section 33 and a mounting section 34. The mounting section 34 is a cylindrical structure that fits over and is connected to the outer surface of the elastic base 10. The structure of the mounting section 34 in this embodiment facilitates the connection between the second filter screen 30 and the elastic base 10 and allows the second filter screen 30 to be easily mounted outside the first filter screen 20. The upstream end of the mounting section 34 forms the second open end 31 of the entire second filter screen 30.

[0051] like Figure 1 、 Figure 2 and Figure 4 As shown, preferably, the elastic base 10 includes an abutment portion 11, the outer wall of which rises toward the inner wall of the blood vessel, and the mounting section 34 is sleeved around the periphery of the abutment portion 11 and fits closely to the abutment portion 11. The mounting section 34 is provided between the abutment portion 11 of the elastic base 10 of this embodiment and the inner wall of the blood vessel. The outer surface of the mounting section 34 is closer to the local structure of the blood vessel, thereby further facilitating blood vessel protection. The mounting section 34 of this embodiment also has a certain degree of elasticity. The abutment portion 11 combined with the mounting section 34 can better abut the blood vessel, positioning it at a predetermined position and preventing it from moving during surgery.

[0052] Preferably, the double-layer filter anti-embolism distal protection device 100 further includes a guide wire 40 , which is connected to one end of the elastic base 10 . Specifically, the guide wire 40 is connected to the gathering end 12 .

[0053] The guidewire 40 is used to deliver the double-layer filter anti-embolism distal protection device 100 to a predetermined vascular location, for example, to the target lesion site, and serves as a guidewire, catheter, angiography catheter, balloon, thrombectomy device, aspiration catheter, stent delivery device, and retrieval catheter for subsequent interventional procedures. The guidewire 40 can be made of a biocompatible metal or polymer, such as nickel-titanium alloy, stainless steel, or cobalt-chromium alloy, or a polymer such as nylon, PI, or PET. The outer diameter of the guidewire 40 is generally between 0.010 inches and 0.038 inches, preferably 0.014 inches.

[0054] During the process of recovering the double-layer filter anti-embolism distal protection device 100, the elastic base frame 10, the first filter 20 and the second filter 30 will be deformed due to contraction, causing turbulent, swirling or turbulent blood flow. The structure of the first filter 20 and the second filter 30 of this embodiment makes it difficult for the captured thrombus or plaque to escape from the double-layer filter anti-embolism distal protection device 100 during the process of recovering the double-layer filter anti-embolism distal protection device 100.

[0055] In other embodiments, the first filter screen 20 and the second filter screen 30 may also be in the shape of a windsock.

[0056] Preferably, when the first filter screen 20 is a metal filter screen, for example, the first filter screen 20 is a nickel-titanium alloy filter screen or a cobalt-chromium alloy filter screen or a stainless steel filter screen, it is convenient to connect with the elastic base frame 10 made of metal material, for example, it can be integrally formed with the elastic base frame 10.

[0057] Obviously, the above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention and are not intended to limit the embodiments of the present invention. A person skilled in the art would be able to make various obvious changes, readjustments, and substitutions without departing from the scope of protection of the present invention. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. A double-layer filter anti-embolism distal protection device, characterized in that: include: An elastic base frame (10), wherein two ends of the elastic base frame (10) are respectively a gathered end (12) and an open end; a first filter screen (20), wherein the two ends of the first filter screen (20) are respectively a first open end (21) and a first closed end (22), the distance between the first closed end (22) and the elastic base (10) is greater than the distance between the first open end (21) and the elastic base (10), and the first open end (21) is connected to the elastic base (10), and a plurality of first filter holes are distributed on the first filter screen (20); a second filter screen (30), wherein a plurality of second filter holes are distributed on the second filter screen (30); the second filter screen (30) is connected to the elastic base frame (10), and the second filter screen (30) is sleeved outside the elastic base frame (10) and the first filter screen (20), so that during use of the double-layer filter screen anti-embolism distal protection device, blood sequentially passes through the elastic base frame (10), the first open end (21), the first filter holes and the second filter holes, and flows to the downstream of the blood vessel; The second filter screen (30) comprises a connected filtering section (33) and a mounting section (34); the mounting section (34) is a cylindrical structure; the mounting section (34) is fitted onto and connected to the outer surface of the elastic base frame (10).

2. The double-layer filter anti-embolism distal protection device according to claim 1, characterized in that: The second filter screen (30) is spaced apart from the first filter screen (20).

3. The double-layer filter anti-embolism distal protection device according to claim 1, characterized in that: In the direction from the first open end (21) to the first closed end (22), the pore areas of the first filter pores decrease sequentially.

4. The double-layer filter anti-embolism distal protection device according to claim 3, characterized in that: The first filter screen (20) is a conical structure, and the diameter of the first filter screen (20) gradually decreases in the direction from the first open end (21) to the first closed end (22).

5. The double-layer filter anti-embolism distal protection device according to any one of claims 1 to 4, characterized in that: The pore area of ​​the second filter pores is smaller than the pore area of ​​the first filter pores.

6. The double-layer filter anti-embolism distal protection device according to claim 5, characterized in that: The second filter holes are distributed in the filter section (33), the filter section (33) is a conical structure, and the diameter of the filter section (33) gradually decreases in a direction away from the elastic base frame (10).

7. The double-layer filter anti-embolism distal protection device according to claim 6, characterized in that: The filter section (33) is sleeved on the first filter screen (20), and the opening of the filter section (33) is flush with the first open end (21).

8. The double-layer filter anti-embolism distal protection device according to claim 1, characterized in that: The elastic base frame (10) includes an abutment portion (11), the outer wall of which bulges toward the inner wall of the blood vessel, and the mounting section (34) is sleeved on the periphery of the abutment portion (11) and fits together with the abutment portion (11).

9. The double-layer filter anti-embolism distal protection device according to claim 1, characterized in that: The double-layer filter anti-embolism distal protection device further comprises a guide wire (40), and the guide wire (40) is connected to one end of the elastic base frame (10).

10. The double-layer filter anti-embolism distal protection device according to claim 1, characterized in that: The first filter screen (20) is a metal filter screen and / or the second filter screen (30) is a polymer filter screen.

11. The double-layer filter anti-embolism distal protection device according to claim 10, characterized in that: The first filter screen (20) is a nickel-titanium alloy filter screen, a cobalt-chromium alloy filter screen, or a stainless steel filter screen.

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