Antithrombotic protection device and medical instrument

Abstract

The application provides an anti-embolism protection device and medical equipment, which comprises a guide wire, a coarse mesh framework and a dense mesh braided layer; wherein the coarse mesh framework is a self-expanding braided umbrella structure with a proximal end opening, which is sleeved on the guide wire; the dense mesh braided layer covers at least a distal end part of the coarse mesh framework in the circumferential direction of the coarse mesh framework, and at least the proximal end opening of the dense mesh braided layer is contracted and opened to the proximal end opening of the coarse mesh framework. The anti-embolism protection device and medical equipment provided by the application can meet the requirements of the wall-adhesion performance and the thrombus capture performance, and can effectively reduce the risk of thrombus escape; when the dense mesh braided layer is fixed to the coarse mesh framework, braiding is not needed, so that the process difficulty is reduced and the processing efficiency is improved.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and in particular to an antithrombotic protective device and medical instrument. Background Technology

[0002] The incidence of vascular diseases is rising, with vascular stenosis accounting for a large proportion of cases. Vascular stenosis can occur in the heart, coronary arteries, cerebral vessels, or peripheral vessels.

[0003] Currently, for diseases involving vascular stenosis, medication, surgery, or endovascular interventional therapy can be used. Endovascular interventional therapy also offers a variety of procedures for removing thrombi and clearing blood vessels, such as stent thrombectomy, intravascular aspiration, or plaque excision. In some cases, stents are also placed after thrombus removal to ensure long-term blood flow after the procedure.

[0004] During thrombus removal and stent placement, some emboli may detach from their original location and escape distally with the blood flow. This escape can lead to embolism in other blood vessels, resulting in adverse consequences. Therefore, during the procedure, distal embolization protection devices must be used to mitigate or prevent this phenomenon.

[0005] Currently, distal protection devices for embolism are typically distal protective umbrellas. The manufacturing processes used for these umbrellas generally include two types: membrane coating and dense mesh weaving. Membrane coating is usually implemented on a coarse mesh framework after the tubing has been cut, resulting in high processing costs and a difficult coating process with unstable membrane conditions. Dense mesh weaving requires manual stitching of the beveled openings, leading to high labor costs due to manual intervention. Furthermore, the woven umbrella body and push rod are eccentrically distributed, resulting in poor adhesion to the vessel wall and a risk of thrombus escape to the distal end. Summary of the Invention

[0006] The purpose of this invention is to provide an anti-embolism protection device and medical device to solve one or more problems of existing anti-embolism protection devices.

[0007] To solve the above-mentioned technical problems, the present invention provides an anti-embolism protection device, comprising: a guidewire, a coarse mesh skeleton, and a dense mesh braided layer; wherein,

[0008] The coarse mesh skeleton is a self-expanding woven umbrella structure with a near-end opening, and is fitted onto the guide wire.

[0009] The dense mesh layer covers at least the distal portion of the coarse mesh skeleton along its circumference, and the degree to which the dense mesh layer closes and opens at its proximal opening is approximately the same as that of the coarse mesh skeleton.

[0010] Optionally, in the aforementioned anti-embolism protection device, the proximal portion of the coarse mesh skeleton includes a bevel structure, the crest of which constitutes the proximal end point of the coarse mesh skeleton.

[0011] Optionally, in the aforementioned anti-embolism protection device, the bevel structure includes at least two bevels evenly distributed circumferentially.

[0012] Optionally, in the aforementioned anti-embolism protection device, the axial dimension of the bevel structure is not greater than the distance between the maximum outer diameter of the coarse mesh skeleton and the proximal end point of the coarse mesh skeleton.

[0013] Optionally, in the aforementioned anti-embolism protection device, the portion of the coarse mesh skeleton other than the bevel structure is formed by interlacing braided threads, and each bevel side of the bevel structure includes multiple braided threads.

[0014] Optionally, in the aforementioned anti-embolism protection device, the anti-embolism protection device further includes two connectors, which are movably sleeved on the guide wire. The guide wire has a protrusion located between the two connectors. When the guide wire moves to the point where the protrusion abuts against one of the connectors, the guide wire drives the abutting connector to move in the direction of the guide wire's movement. The two ends of the coarse mesh skeleton are respectively fixed to one of the connectors and move with the movement of the connector.

[0015] Optionally, in the aforementioned anti-embolism protection device, the anti-embolism protection device further includes a connector. The guidewire includes a first segment and a second segment connected in sequence. The second segment has a protrusion. The connector is movably sleeved on the second segment at the proximal end of the protrusion. The distal portion of the second segment is movably connected to the first segment along the axial direction of the first segment. When the second segment moves to abut against the proximal end face of the first segment, it drives the first segment to move. When the second segment moves to abut against the connector at the protrusion, it drives the connector to move.

[0016] The proximal end of the coarse mesh skeleton is fixed to the connector and moves with the movement of the connector, while the distal end of the coarse mesh skeleton is fixed to the guide wire.

[0017] Optionally, in the anti-embolism protection device, the distal end of the second segment is divided into a cavity structure with an enlarged radius relative to the other parts of the second segment. The cavity structure constitutes the protrusion. The second segment is sleeved on the first segment through the cavity structure and moves along the axial direction of the first segment. When the second segment moves to the point where the first segment abuts against the proximal end of the cavity structure, it drives the first segment to move.

[0018] Optionally, in the aforementioned anti-embolism protection device, all connecting parts are radiopaque rings, and the protrusions are made of radiopaque material.

[0019] Optionally, in the aforementioned anti-embolism protection device, several of the braided filaments of the coarse mesh skeleton are developing filaments, and the developing structure composed of several developing filaments outlines the shape of the coarse mesh skeleton.

[0020] Optionally, in the aforementioned anti-embolism protection device, the mesh area of ​​the densely woven layer is in the range of 100 μm. 2 ~4mm 2 .

[0021] Optionally, in the aforementioned anti-embolism protection device, the dense mesh woven layer covers the inner surface of the coarse mesh skeleton.

[0022] The present invention also provides a medical device, characterized in that it comprises:

[0023] The anti-embolism protection device as described in any of the preceding items; and,

[0024] The catheter, wherein the guidewire is used to retract the coarse mesh skeleton into the catheter or to extend the coarse mesh skeleton out of the catheter; when the coarse mesh skeleton is retracted into the catheter, the coarse mesh skeleton is in a retracted state, and when the coarse mesh skeleton is extended out of the outer sheath, the coarse mesh skeleton is in an open state.

[0025] In summary, the anti-embolism protection device and medical device provided by the present invention include: a guidewire, a coarse mesh skeleton, and a dense mesh braided layer; wherein, the coarse mesh skeleton is a self-expanding braided umbrella structure with a proximal opening, fitted over the guidewire; the dense mesh braided layer covers at least the distal portion of the coarse mesh skeleton along its circumference, and the degree of contraction and opening at the proximal opening of the dense mesh braided layer is approximately consistent with that of the coarse mesh skeleton. Compared with the prior art, the anti-embolism protection device and medical device provided by the present invention have the following beneficial effects:

[0026] (1) The anti-thrombotic protection device provided by the present invention adopts a double-layer capture structure. The radial tension of the coarse mesh skeleton makes the overall wall adhesion good, which can prevent thrombi from escaping from the gap between the coarse mesh skeleton and the blood vessel wall. At least the dense mesh braided layer surrounding the far end of the coarse mesh skeleton can effectively capture thrombi and prevent thrombi from escaping to the far end. Therefore, the anti-thrombotic protection device provided by the present invention takes into account both the requirements for wall adhesion performance and thrombus capture performance, and can effectively reduce the risk of thrombus escape.

[0027] (2) The anti-embolism protection device provided by the present invention can fix the far end of the dense mesh woven layer to the far end of the coarse mesh skeleton after the coarse mesh skeleton is formed, without the need for further weaving, thus reducing the difficulty of the process and improving the processing efficiency.

[0028] (3) Furthermore, in the anti-embolism protection device provided by the present invention, the proximal portion of the coarse mesh skeleton adopts a bevel structure, so that the coarse mesh skeleton can be retracted into the catheter.

[0029] (4) Furthermore, the inclined bevel structure includes at least two inclined bevels evenly distributed along the circumference, so that the coarse mesh skeleton is kept coaxial and non-eccentric with the guide wire, thereby the coarse mesh skeleton has good wall adhesion throughout the entire circumference, which can prevent thrombi from escaping from the gap between the antithrombotic protection device and the blood vessel wall in multiple directions, and the capture effect is better. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the structure of an anti-embolism protection device provided in an embodiment of the present invention;

[0031] Figures 2a-2c This is a schematic diagram of the coarse mesh skeleton described in an embodiment of the present invention;

[0032] Figure 3 This is a weaving structure diagram of the middle part of the coarse mesh skeleton in an embodiment of the present invention;

[0033] Figure 4 This is a schematic diagram of the beveled structure of the coarse mesh skeleton in an embodiment of the present invention, showing the wires branching towards the middle.

[0034] Figures 5a-5c This is a schematic diagram of the structure of the dense mesh woven layer in an embodiment of the present invention;

[0035] Figure 6 This is a schematic diagram of the anti-embolism protection device provided in Embodiment 1 of the present invention moving toward the distal end;

[0036] Figure 7 This is a schematic diagram of the anti-embolism protection device provided in Embodiment 1 of the present invention moving towards the proximal end;

[0037] Figure 8 This is a schematic diagram of a guidewire structure according to an example of Embodiment 1 of the present invention;

[0038] Figure 9 This is a schematic diagram of another anti-embolism protection device provided in an embodiment of the present invention;

[0039] Figure 10 This is a schematic diagram of the imaging portion of the anti-embolism protection device provided in an embodiment of the present invention;

[0040] Figure 11 This is a schematic diagram showing the anti-embolism protection device provided in an embodiment of the present invention in a blood vessel;

[0041] The labels in the attached figures are explained as follows:

[0042] 11-Coarse mesh skeleton; 12-Dense mesh woven layer; 13-Connector;

[0043] 2-Guidewire; 3-Catheter; 4-Coil;

[0044] 121-Sloping bevel structure

[0045] 100 - Protrusion; 101 - Guide section; 102 - Arc head; 103 - Groove;

[0046] 200-Developable structure;

[0047] 21 - First paragraph; 22 - Second paragraph. Detailed Implementation

[0048] The anti-embolism protection device and medical device proposed in this invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of this invention will become clearer from the following description. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, only for the purpose of conveniently and clearly illustrating the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structure. In particular, different proportions may be used in different drawings to show different emphases. It should also be understood that, unless specifically stated or indicated, the terms "first," "second," "third," etc., in the specification are only used to distinguish the various components, elements, steps, etc., in the specification, and are not used to indicate the logical or sequential relationships between the various components, elements, steps, etc.

[0049] In this application, "proximal" and "distal" refer to the relative orientation, position, and direction of the components or movements relative to each other from the perspective of the physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is closer to the physician during normal operation, while "distal" usually refers to the end that first enters the patient's body.

[0050] like Figure 1 As shown, an embodiment of the present invention provides an anti-embolism protection device, comprising: a guidewire 2, a coarse mesh skeleton 11, and a dense mesh braided layer 12; wherein,

[0051] The coarse mesh frame 11 is a self-expanding woven umbrella structure with a near-end opening, and is fitted onto the guide wire 2;

[0052] The dense mesh woven layer 12 covers at least the distal portion of the coarse mesh skeleton 11 along its circumference, and the degree to which the dense mesh woven layer closes and opens is approximately the same as that of the coarse mesh skeleton 11 at least at its proximal opening.

[0053] The antithrombotic protection device provided in this embodiment of the invention adopts a double-layer capture structure. The radial tension of the coarse mesh skeleton 11 ensures good overall wall adhesion, preventing thrombi from escaping from the gap between the antithrombotic protection device and the blood vessel wall. At least the dense mesh braided layer 12 surrounding the distal end of the coarse mesh skeleton 11 can effectively capture thrombi and prevent them from escaping distally. Therefore, the antithrombotic protection device provided by this invention simultaneously meets the requirements for both wall adhesion performance and thrombus capture performance, effectively reducing the risk of thrombus escape.

[0054] Specifically, the coarse mesh skeleton 11 can be formed by coarse filament weaving, and the dense mesh layer 12 can be formed by fine filament weaving. The smaller the diameter of the weaving yarn used, the smaller the mesh area of ​​the structure that can be formed. The mesh area of ​​the coarse mesh skeleton 11 is not specifically limited, as long as sufficient radial tension is ensured. The mesh area of ​​the dense mesh layer 12 can be as small as possible. Preferably, the mesh area of ​​the dense mesh layer 12 is within the range of 100 μm. 2 ~4mm 2 .

[0055] The anti-embolism protection device provided in this embodiment can be configured such that after the coarse mesh skeleton 11 is formed, the dense mesh woven layer 12 is fixed to the far end of the coarse mesh skeleton 11. For example, the far end of the dense mesh woven layer 12 is fixed to the connector 13 located at the far end of the coarse mesh skeleton 11. Alternatively, the dense mesh woven layer 12 can be directly fixed to the far end of the coarse mesh skeleton 11, for example, by binding, integral weaving, or other methods.

[0056] like Figures 2a-2c As shown, in this embodiment, the distal portion of the coarse mesh frame 11 is umbrella-shaped when open, with the top of the umbrella being the distal end of the coarse mesh frame 11. The proximal portion of the coarse mesh frame 11 includes a bevel structure 121, the top of which forms the proximal end of the coarse mesh frame 11. Thus, the coarse mesh frame 11 resembles a fishing net or a drawstring bag; by pulling the braided thread at the proximal end of the coarse mesh frame 11 to gather it, the coarse mesh frame 11 can be dragged into the guide tube 3.

[0057] Preferably, the bevel structure 121 includes at least two bevels evenly distributed circumferentially, such as two, three, four, or five. Specifically, as shown below... Figure 2a As shown, when the number of bevels in the bevel structure 121 is two, the bevel structure 121 includes two inclined sides, such as... Figure 2b As shown, when the number of bevels in the bevel structure 121 is three, the bevel structure 121 includes three inclined sides evenly distributed in the circumferential direction, such as... Figure 2cAs shown, when the number of bevels in the bevel structure 121 is four, the bevel structure 121 includes four bevels evenly distributed in the circumferential direction, and so on. When at least two bevels of the bevel structure 121 are evenly distributed in the circumferential direction, the coarse mesh skeleton 11 can be coaxially and non-eccentrically distributed with the guidewire 2 when it is fitted onto the guidewire 2. Therefore, it has good wall adhesion throughout the entire circumferential direction, which can prevent thrombi from escaping through the gap between the antithrombotic protection device and the blood vessel wall in multiple directions.

[0058] In a preferred embodiment, the portion of the coarse mesh skeleton 11 other than the bevel structure 121 is formed by interlacing braided threads, and each bevel of the bevel structure 121 includes multiple braided threads. The braided threads on each bevel can branch out in different directions or at different positions, and by interlacing the braided threads from different directions, the portion of the coarse mesh skeleton 11 other than the bevel structure 121 can be formed as a plain weave or a variation of a plain weave, for example, as... Figure 3 As shown, it forms structures such as 1-press-1, 1-press-2, 1-press-3, 2-press-2, 2-press-3, or twisted structures.

[0059] like Figure 4 As exemplified, for one of the inclined sides A of the bevel structure 121, at point a, two braided threads branch out toward the adjacent inclined side B, and then at point b, two more braided threads branch out toward inclined side B. Similarly, the same branching method is used from inclined side B toward inclined side A, thereby forming a 2-over-2 braided structure in the middle part of the coarse mesh skeleton 11.

[0060] Because the mesh size of the bevel structure 121 is relatively large, in this embodiment, preferably, the axial dimension of the bevel structure 121 is not greater than the distance between the maximum outer diameter of the coarse mesh skeleton 11 and the proximal end point of the coarse mesh skeleton 11. That is, the bevel structure 121 is located on the proximal side of the maximum outer diameter of the coarse mesh skeleton 11. Thus, when the coarse mesh skeleton 11 captures a thrombus, the thrombus will not escape from the bevel structure 121, thereby achieving a better capture effect.

[0061] As previously described, in the anti-embolism protection device provided in this embodiment, the densely woven layer 12 covers at least the distal portion of the coarse mesh skeleton 11 along its circumference. Specifically, the densely woven layer 12 may cover the outer and / or inner surfaces of the coarse mesh skeleton 11 and match the contour of the distal portion of the coarse mesh skeleton 11.

[0062] For example, such as Figure 5a As shown, the densely woven layer 12 is conical in shape, or, as... Figure 5bAs shown, the distal portion of the dense mesh woven layer 12 is conical. When the dense mesh woven layer 12 adopts this structural design, the distal end of the dense mesh woven layer 12 can be fixed to the connector 13 located at the distal end of the coarse mesh frame 11, and the proximal end of the dense mesh woven layer 12 can be directly fixed to the coarse mesh frame 11. Alternatively, when the dense mesh woven layer 12 covers the inner surface of the coarse mesh frame 11, only the distal end of the dense mesh woven layer 12 needs to be fixed. During use, the dense mesh woven layer 12 naturally opens and adheres to the inner wall of the coarse mesh frame 11 due to blood flow impact.

[0063] In other embodiments, the densely woven layer 12 may also employ other structural designs, for example, such as... Figure 5c As shown, the dense mesh braided layer 12 adopts a tubular structure with a radius that gradually increases from the distal end to the proximal end. When the dense mesh braided layer 12 adopts this structural design, it can be directly fixed to the coarse mesh skeleton 11, for example, by binding or other means. During use, because the coarse mesh skeleton 11 remains in a closed state, its distal end is umbrella-shaped, resulting in a smaller aperture. The proximal end itself can effectively capture thrombi. The tubular structure of the dense mesh braided layer 12, with its radius gradually increasing from the distal end to the proximal end, does not cover the distal end of the coarse mesh skeleton 11. This prevents the coarse mesh skeleton 11 from stacking at the distal end due to its closed state, thus avoiding excessive radial force at the edge and the resulting vasospasm.

[0064] As can be seen from the above description, in the anti-embolism protection device provided by the embodiments of the present invention, after the coarse mesh skeleton 11 is formed, the dense mesh woven layer 12 can be mechanically fixed to the far end of the coarse mesh skeleton 11 without further weaving, thus reducing the difficulty of the process and improving the processing efficiency.

[0065] In this embodiment, preferably, the guide wire 2 can bidirectionally control the movement of the coarse mesh skeleton 11. In a specific embodiment, such as Figure 1 As shown, the anti-embolism protection device also includes two connectors 13, which are movably sleeved on the guide wire 2. The guide wire 2 has a protrusion 100 located between the two connectors 13. When the guide wire 2 moves to the point where the protrusion 100 abuts against one of the connectors 13, the guide wire 2 drives the abutting connector 13 to move in the direction of the guide wire 2. The two ends of the coarse mesh skeleton 11 are respectively fixed to one of the connectors 13 and move with the movement of the connectors 13.

[0066] Specifically, such as Figure 6As shown, when the guidewire 2 moves from the proximal end to the distal end (i.e., the first direction shown in the figure) within the catheter 3 until the protrusion 100 abuts against the connector 13 located at the distal end of the coarse mesh skeleton 11, the guidewire 2 is pushed to move along the first direction. Figure 7 As shown, when the guidewire 2 moves from the distal end to the proximal end of the catheter 3 (i.e., the second direction shown in the figure) until the protrusion 100 abuts against the connector 13 located near the proximal end of the coarse mesh skeleton 11, the guidewire 2 moves along the second direction. Therefore, the anti-embolism protection device provided in this embodiment, through the combined design of the protrusion 100 and the connector 13, allows for bidirectional control of the movement of the coarse mesh skeleton 11. That is, the coarse mesh skeleton 11 can be advanced forward or retracted into the sheath without relying on a dedicated sheath, and can be used with other various access devices.

[0067] In this implementation, specifically, such as Figure 1 As shown, the two ends of the coarse mesh frame 11 can be fixed to the outer periphery of the connector 13 by coils 4. Figure 1 As shown in the diagram, although only the distal end of the coarse mesh skeleton 11 is illustrated to be fixed to the outer periphery of the connector 13 located at the distal end via coil 4, it should be understood that the proximal end of the coarse mesh skeleton 11 can also be fixed to the outer periphery of the connector 13 located at the proximal end via coil 4. In some other embodiments, the coarse mesh skeleton 11 can also be fixed to the outer periphery of the connector 13 via heat shrink tubing, which will not be described further here.

[0068] Furthermore, it is preferable that both of the connecting members 13 are developing rings, and the protrusion 100 is made of developing material. This allows for timely tracking of the relative position of the protrusion 100 and the two connecting members 13, avoiding misoperation. For example, when there is no need to push or pull the coarse mesh skeleton 11 out, the movement of the guide wire 2 may cause the coarse mesh skeleton 11 to be accidentally pushed out or pulled back.

[0069] In this embodiment, the guidewire 2 can be a mandrel that tapers from proximal to distal, or a mandrel with a uniform diameter. The guidewire 2 serves as both the push rod during the delivery of the coarse mesh skeleton 11 and the exchange guidewire 2 for other rapid exchange devices. The protrusion 100 can be a convex ring fitted onto the guidewire body, with the proximal portion of the convex ring being the guiding portion 101 of the guidewire 2, having a diameter of, for example, 0.014 inches, compatible with various balloon and stent delivery systems on the market.

[0070] In another specific implementation, such as Figure 9As shown, the anti-embolism protection device further includes a connector 13. The guidewire 2 includes a first segment 21 and a second segment 22 connected in sequence. The second segment 22 has a protrusion 100. The connector 13 is movably sleeved on the second segment 22 at the proximal end of the protrusion 100. The distal end of the second segment 22 is movably connected to the first segment 21 along the axial direction of the first segment 21. When the second segment 22 moves to abut against the proximal end face of the first segment 21, it drives the first segment 21 to move. When the second segment 22 moves to abut against the protrusion 100 and the connector 13, it drives the connector 13 to move. The coarse mesh frame 11 is a self-expanding woven umbrella structure with a proximal opening. The proximal end of the coarse mesh frame 11 is fixed to the connector 13 and moves with the movement of the connector 13. The distal end of the coarse mesh frame 11 is fixed to the guidewire 2.

[0071] That is, unlike the previous specific embodiment, in this example, the guidewire 2 adopts a segmented structure, and the coarse mesh skeleton 11 is only sleeved on the guidewire 2 at its proximal end through the connector 13, moving with the movement of the connector 13, while its distal end is fixed to the guidewire 2, maintaining relative fixation with the guidewire 2. The guidewire 2 adopts a segmented design, and the distal end of the coarse mesh skeleton 11 is relatively fixed to the guidewire 2 with no gap or a small gap, thereby preventing thrombus from escaping from the gap between the connector 13 and the guidewire 2 when they slide relative to each other. Furthermore, the distal end of the second segment 22 is divided into a cavity structure with an enlarged radius relative to the other parts of the second segment 22. The cavity structure constitutes the protrusion 100. The second segment 22 is sleeved on the first segment 21 through the cavity structure and moves along the axial direction of the first segment 21. When the second segment 22 moves to the point where the first segment 21 abuts against the proximal end of the cavity structure, it drives the first segment 21 to move. When the distal portion of the second segment 22 is provided with a cavity and fitted onto the first segment 21, the second segment 22 and the first segment 21 can be coaxially arranged, thereby the guide wire 2 has good compliance during operation and the radial dimension of the guide wire 2 is minimized.

[0072] In this embodiment, the distal ends of the coarse mesh skeleton 11 and the dense mesh braided layer 12 can be directly fixed to the guide wire 2 by coils 4 made of developing material, or the distal end of the coarse mesh skeleton 11 can be directly fixed to the guide wire 2 by coils 4 made of developing material, while the dense mesh braided layer 12 is disposed on the coarse mesh skeleton 11 in the manner described in Embodiment 1. In this embodiment, the outer contour of the connector 13 is not specifically limited; for example, the outer contour of the connector 13 can be circular or square. However, in specific implementation, for convenience, the outer contour of the connector 13 can be designed to be circular, so that when the coarse mesh skeleton 11 is fixed to the connector 13, it can be distributed along the circumference of the connector 13, thereby maintaining coaxiality with the guide wire 2. In addition, as Figure 8 As shown, the distal end of the guidewire 2 can adopt an arc-shaped head 102, and the distal part of the guidewire 2 has multiple grooves 103. The multiple grooves 103 are arranged sequentially along the axial direction of the guidewire 2, thereby avoiding the guidewire 2 from scratching or puncturing blood vessels during movement.

[0073] In this embodiment, no specific limitation is made on the outer contour of the connector 13. For example, the outer contour of the connector 13 can be circular or square. However, in specific implementation, for convenience, the outer contour of the connector 13 can be designed to be circular, so that when the coarse mesh skeleton 11 is fixed to the connector 13, it can be distributed along the circumference of the connector 13, thereby maintaining coaxiality with the guide wire 2.

[0074] Please see Figure 10 In a further preferred embodiment, several of the braided filaments of the coarse mesh skeleton 11 are radiopaque filaments, and the radiopaque structure 200 formed by these radiopaque filaments outlines the shape of the coarse mesh skeleton 11. This allows for timely observation of the positional and morphological changes of the coarse mesh skeleton 11 within the blood vessel, facilitating intraoperative judgment and manipulation by the surgeon. For example... Figure 11 As shown, in the blood vessel, the doctor can clearly observe the state of the coarse mesh skeleton 11 and the connector 13. The coarse mesh skeleton 11 is held in place by its own supporting force against the wall.

[0075] This embodiment also provides a medical device, including:

[0076] As described in this embodiment, the anti-embolism protection device; and,

[0077] The catheter 3, the guidewire 2 is used to retract the coarse mesh skeleton 11 into the catheter 3 or to push the coarse mesh skeleton 11 out of the catheter 3; when the coarse mesh skeleton 11 is retracted into the catheter 3, the coarse mesh skeleton 11 is in a retracted state, and when the coarse mesh skeleton 11 is pushed out of the outer sheath, the coarse mesh skeleton 11 is in an open state.

[0078] Specifically, during delivery, the coarse mesh skeleton 11 of the anti-embolism protection device is retracted within the catheter 3. When the coarse mesh skeleton 11 reaches the target position, such as the aortic arch, the guidewire 2 pushes the coarse mesh skeleton 11 out of the catheter 3, causing it to expand and open into an umbrella shape. After the procedure is completed, the guidewire 2 is withdrawn, and the coarse mesh skeleton 11 is retracted back into the catheter 3, thus being withdrawn.

[0079] In summary, the anti-embolism protection device and medical device provided by the present invention include: a guidewire, a coarse mesh skeleton, and a dense mesh braided layer; wherein, the coarse mesh skeleton is a self-expanding braided umbrella structure with a proximal opening, sleeved on the guidewire; the dense mesh braided layer covers at least the distal portion of the coarse mesh skeleton along its circumference, and the degree of contraction and opening at the proximal opening of the dense mesh braided layer is approximately consistent with that of the coarse mesh skeleton. The anti-embolism protection device and medical device provided by the present invention simultaneously meet the requirements for wall adhesion performance and thrombus capture performance, effectively reducing the risk of thrombus escape; the dense mesh braided layer does not require further weaving when fixed to the coarse mesh skeleton, thus reducing the manufacturing difficulty and improving processing efficiency. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the scope of protection of the claims.

Claims

1. An anti-embolism protection device, characterized in that, include: Guide wire, coarse mesh skeleton and dense mesh braided layer; among which, The coarse mesh skeleton is a self-expanding woven umbrella structure with a near-end opening, and is fitted onto the guide wire. The dense mesh woven layer covers at least the distal portion of the coarse mesh skeleton along the circumference of the coarse mesh skeleton, and the degree to which the dense mesh woven layer closes and opens at least at the proximal opening is approximately the same as that of the coarse mesh skeleton. The anti-embolism protection device further includes a connector. The guidewire includes a first segment and a second segment connected in sequence. The second segment has a protrusion. The connector is movably sleeved on the second segment at the proximal end of the protrusion. The distal portion of the second segment is movably connected to the first segment along the axial direction of the first segment. When the second segment moves to abut against the proximal end face of the first segment, it drives the first segment to move. When the second segment moves to abut against the connector at the protrusion, it drives the connector to move. The proximal end of the coarse mesh skeleton is fixed to the connector and moves with the movement of the connector, while the distal end of the coarse mesh skeleton is fixed to the guide wire.

2. The anti-embolism protection device as described in claim 1, characterized in that, The near-end portion of the coarse mesh skeleton includes a bevel structure, and the top of the bevel structure forms the near-end point of the coarse mesh skeleton.

3. The anti-embolism protection device as described in claim 2, characterized in that, The bevel structure includes at least two bevels evenly distributed circumferentially.

4. The anti-embolism protection device as described in claim 2, characterized in that, The axial dimension of the bevel structure is not greater than the distance between the maximum outer diameter of the coarse mesh skeleton and the near end point of the coarse mesh skeleton.

5. The anti-embolism protection device as described in claim 3, characterized in that, The coarse mesh skeleton, excluding the bevel structure, is formed by interweaving braided threads, and each bevel structure includes multiple braided threads on each side.

6. The anti-embolism protection device as described in claim 1, characterized in that, The distal end of the second segment is divided into a cavity structure with an enlarged radius relative to the other parts of the second segment. The cavity structure constitutes the protrusion. The second segment is fitted onto the first segment through the cavity structure and moves along the axial direction of the first segment. When the second segment moves to the point where the first segment abuts against the proximal end of the cavity structure, it drives the first segment to move.

7. The anti-embolism protection device as described in claim 1, characterized in that, All connectors are developing rings, and the protrusions are made of developing material.

8. The anti-embolism protection device as described in claim 1, characterized in that, Several of the braided filaments in the coarse mesh skeleton are developing filaments, and the developing structure composed of several developing filaments outlines the shape of the coarse mesh skeleton.

9. The anti-embolism protection device as described in claim 1, characterized in that, The mesh area of ​​the densely woven layer ranges from 100 μm. 2 ~4mm 2 .

10. The anti-embolism protection device as described in claim 1, characterized in that, The dense mesh woven layer covers the inner surface of the coarse mesh skeleton.

11. A medical device, characterized in that, include: The anti-embolism protection device as described in any one of claims 1 to 10; as well as, The catheter, wherein the guidewire is used to retract the coarse mesh skeleton into the catheter or to extend the coarse mesh skeleton out of the catheter; when the coarse mesh skeleton is retracted into the catheter, the coarse mesh skeleton is in a retracted state, and when the coarse mesh skeleton is extended out of the catheter, the coarse mesh skeleton is in an open state.

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