Embolic protection device and embolic protection system

Abstract

The present application provides an embolic protection device, comprising a support frame and at least one filter screen coated on the support frame, the support frame comprising at least two adjacent frames arranged along the axial direction of the support frame from proximal to distal, the surface formed by the support frame being an arc surface, and at least one waist structure being formed between the two adjacent frames on at least one side surface of the support frame. The embolic protection device of the present application can increase the fixation stability and the compliance in the radial direction of the embolic protection device, thereby effectively filtering the microparticles or particles such as thrombus in the blood flow, and reducing the possibility of leakage of the edges of the support frame.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an embolization protection device and embolization protection system. Background Technology

[0002] Cerebral embolism occurs when various emboli (such as mural thrombi in the heart, atherosclerotic plaques, fat, tumor cells, fibrocartilage, or air) travel through the bloodstream into narrow, tortuous cerebral arteries and obstruct the blood flow. When collateral circulation cannot compensate, it causes ischemic necrosis of brain tissue in the area supplied by that artery, resulting in focal neurological deficits. Cerebral embolism commonly occurs in the internal carotid artery system, and is relatively rare in the vertebrobasilar artery system. Cerebral embolism accounts for approximately 15% to 20% of ischemic strokes. About 75% of cardiac emboli embolisms occur in the brain. Common cardiac diseases causing cerebral embolism include atrial fibrillation, valvular heart disease, infective endocarditis, and cardiac myxoma. With advancements in medical technology, an increasing number of cardiac and vascular surgical problems can be addressed through endovascular surgery. Stent implantation and valve replacement are among the rapidly developing endovascular procedures in recent years. Valve replacement surgery primarily involves transcatheter aortic valve implantation (TAVI). A catheter is inserted through the femoral artery to deliver an artificial heart valve to the aortic valve area, where it is opened to complete the implantation and restore valve function. The procedure does not require open-chest surgery, resulting in minimal trauma and rapid recovery. When used in conjunction with anti-embolism devices, valve replacement surgery effectively prevents emboli from entering the brain and causing blockage, further reducing risks.

[0003] Currently, clinical research suggests that effective embolism filtering is necessary for all three branches of the aortic arch to minimize the risk of stroke. Most existing anti-embolism devices use a nickel-titanium alloy frame with a filter membrane to block the three branches of the aortic arch. In this type of device, the nickel-titanium alloy frame is a single, regular closed loop. In clinical applications, after implantation, the different areas of the frame, despite varying stress levels, still influence each other. This prevents adaptive adjustment to ensure both stability and conformity for better fit within the aortic arch, thus avoiding leakage at the frame edges. Summary of the Invention

[0004] Therefore, it is necessary to provide a new embolism protection device and system to address the problem that the support frame of existing embolism protection devices cannot simultaneously ensure stability and prevent edge leakage.

[0005] On one hand, an embolism protection device is proposed, comprising a support frame and at least one filter screen covered on the support frame, the support frame comprising at least two adjacent side frames arranged along its axial direction from near to far, the surface formed by the support frame being an arcuate surface, and at least one waist-recessed structure formed between the two adjacent side frames on at least one side portion of the support frame.

[0006] On the other hand, an embolism protection system is proposed, including the embolism protection device as described above and a delivery device, the delivery device being used to compress and deliver the embolism protection device.

[0007] In the aforementioned embolization protection device, at least one waist-recessed structure is formed between two adjacent frame sides on at least one side portion of the support frame; that is, a portion of at least one side portion of the support frame is recessed towards the interior of the support frame. Taking implantation within the aortic arch as an example, during the process of the embolization protection device being implanted at the appropriate position in the three branch vessels within the aortic arch and being released and deployed, the two adjacent frame sides cooperate with each other to fix the embolization protection device within the aortic arch, increasing the stability of the fixation. At the same time, the filter screen is supported upwards by its pre-shaped arcuate surface, so that each part of the filter screen fits against the inner wall of the three branch vessels within the aortic arch. Furthermore, the waist-cinching structure transforms the support frame from a single, regular closed loop into a segmented support framework. The sides of the waist-cinching structure can be adjusted relatively flexibly to increase the compliance of the embolization protection device. This allows the support frame to adapt to the structure and size of the aortic arch in different areas, ensuring that the support frame is more securely fixed within the aortic arch and fits more tightly against the inner wall. This enables the embolization protection device to more effectively filter thrombi and other microparticles or particles in the blood flow to the three branch vessels, and also reduces the possibility of leakage at the edges of the support frame. Attached Figure Description

[0008] Figure 1 This is a schematic diagram of the overall structure of the embolism protection device in Example 1;

[0009] Figure 2 for Figure 1 A schematic diagram of the structure of the embolism protection device when the filter screen is not covered;

[0010] Figure 3 This is a schematic diagram of the embolization protection device of Example 1 being implanted in the aortic arch;

[0011] Figure 4 This is another structural schematic diagram of the embolism protection device in Example 1 when the filter screen is not covered;

[0012] Figure 5 This is another structural schematic diagram of the embolism protection device in Example 1 when the filter screen is not covered;

[0013] Figure 6 for Figure 2 The support frame of the structure shown is placed in a side view on a horizontal plane;

[0014] Figure 7 for Figure 2 The support frame of the structure shown is placed in a top view on a horizontal plane;

[0015] Figure 8 This is a schematic diagram of the overall structure of the embolism protection device in Example 2;

[0016] Figure 9 for Figure 8 A schematic diagram of the structure of the embolism protection device when the filter screen is not covered;

[0017] Figure 10 for Figure 8 The diagram shows the embolization protection device implanted in the aortic arch.

[0018] Figure 11 for Figure 10 Another structural diagram of the embolism protection device;

[0019] Figure 12 This is another structural schematic diagram of the embolism protection device in Example 2 when the filter screen is not covered;

[0020] Figure 13 This is a schematic diagram of the embolism protection device in Example 3 when the filter screen is not covered;

[0021] Figure 14 for Figure 13 Enlarged view of point C in the middle;

[0022] Figure 15 This is a schematic diagram of the embolism protection device in Example 4 when the filter screen is not covered;

[0023] Figure 16 for Figure 15 Enlarged view at point D;

[0024] Figure 17 This is a schematic diagram of the embolism protection device in Example 5 when the filter screen is not covered. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0026] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0027] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0028] Example 1

[0029] Example 1 presents an embolism protection device 10, used in valve replacement surgery as an example. It is used to block thrombi or lumps in the bloodstream from flowing into the brain through any of the three branches of the aortic arch, thus preventing cerebral embolism. Furthermore, it can be used in open-chest surgery to filter blood, or implanted into blood vessels to filter thrombi or calcifications. Please refer to [reference needed]. Figure 1 The embolism protection device 10 includes a support frame 11 and a filter screen 12 covering the support frame 11, as well as a connector 13 disposed near the proximal end of the support frame 11 for connection to the distal end of the sheath core. Figure 1-2 As shown, the support frame 11 includes a first frame 111 and a second frame 112 arranged adjacent to each other along its axial direction from near to far. The surface formed by the support frame 11 is an arc-shaped surface, which can conform to the shape of the aortic arch and fit well against the inner wall of the three branch vessels of the aortic arch.

[0030] The filter 12 is a membrane made of polymer materials such as PTFE (Polytetrafluoroethylene), TPU (Thermoplastic polyurethanes), or PET (Polyethylene terephthalate). It can also be a woven mesh with multiple holes, made of woven yarns with shape memory properties. In this embodiment, the filter 12 is made of PTFE membrane, and there is only one filter. The edge portion of the filter 12 is fixedly connected to the corresponding portion of the first frame 111 and the second frame 112. The other portion of the filter 12 covers the entire outer surface of the support frame 11 and is supported upwards by the arc-shaped structure of the support frame 11 to better conform to the inner wall of the three branch vessels of the aortic arch. In other implementations, the filter 12 may include two or more independently configured sub-nets that cooperate with each other to cover the entire support frame 11 and are each fixedly connected to a suitable position on the first frame 111 or the second frame 112. For example, the filter 12 may include two sub-nets, one of which covers the first frame 111 and the edge portion of the sub-net is fixed to a suitable position on the first frame 111, and the other sub-net covers the second frame 112 and the edge portion of the sub-net is fixed to a suitable position on the second frame 112.

[0031] The thickness of the filter screen 12 ranges from 10 micrometers to 55 micrometers. The membrane has numerous small pores for filtration, with pore diameters ranging from 25 micrometers to 300 micrometers. The shape and size of the filter screen 12 are similar to or match the shape and size of the support frame 11, provided that the filter screen 12 completely covers the support frame 11 and its edges are securely attached to the first frame 111 and the second frame 112 at appropriate positions. The edges of the filter screen 12 can be secured to the first frame 111 and the second frame 112 using processes such as glue, high-frequency welding, laser welding, or sewing. The filter screen 12 can filter large particles such as blood clots or lumps, as well as small particles such as blood clots or lumps.

[0032] In other implementations, the support frame 11 may be covered with two or more filter screens 12. These filter screens 12 may be completely or partially overlapped, or they may be connected along the axial direction of the plug protection device 10, as long as they can cover the entire structure of the support frame 11. The size and number of holes in the multiple filter screens 12 may be the same or different, as long as effective filtration can be achieved.

[0033] like Figure 1-2As shown, the first border 111 is located at the near end of the support frame 11, and the second border 112 is located at the far end of the support frame 11. The shape of the first border 111 can be the shape of an ellipse or a rectangle after removing a small portion, or other similar shapes or variations, and is not limited here. The second border 112 can also be the shape of an ellipse or a rectangle after removing a small portion, such as... Figure 2 , Figure 4 and Figure 5 As shown, other similar shapes or variations are also possible and are not limited here. In this embodiment, the first border 111 is shaped by removing a portion of a straight line segment from one side of an ellipse, and the second border 112 is a shape that is mirror-symmetrical to the first border 111. This shape has smooth edges to avoid scratching the inner wall tissue of the aortic arch. For other shapes, various damage prevention methods in the prior art can be used to avoid scratching, which will not be elaborated here.

[0034] like Figure 2As shown, the first border 111 includes a first end 1111 and a second end 1112, and the second border 112 includes a third end 1121 and a fourth end 1122. The first end 1111 is connected to the third end 1121, and the second end 1112 is connected to the fourth end 1122. The distance between the first end 1111 and the second end 1112 is less than the maximum width of the first border 111, and the distance between the third end 1121 and the fourth end 1122 is less than the maximum width of the second border 112. Therefore, at the connecting part A connecting the first end 1111 and the third end 1121 of the support frame 11, and at the connecting part B connecting the second end 1112 and the fourth end 1122, a waist-recessed structure is formed on both sides of the support frame 11 axially relative to the other parts of the support frame 11. That is, the connecting parts A and B at these two connections are recessed towards the interior of the support frame 11. At this time, the first end 1111 and the third end 1121 are closer to the central axis of the support frame 11 than the side portion of the support frame 11, and the second end 1112 and the fourth end 1122 are closer to the central axis of the support frame 11 than the side portion of the support frame 11. Thus, a relatively independent swinging wing portion is formed on each of the two side portions of the first frame 111, and a relatively independent swinging wing portion is also formed on each of the two side portions of the second frame 112. Therefore, during the process of the embolization protection device 10 being implanted into the appropriate position at the three branch vessels in the aortic arch and being released and deployed, the first frame 111 and the second frame 112 cooperate to fix the embolization protection device 10 in the aortic arch, increasing the stability of the fixation. At the same time, the filter 12 is supported upward by its pre-shaped arc structure so that each part of the filter 12 fits against the inner wall of the three branch vessels in the aortic arch. Furthermore, since there is at least one waist-tightening structure between the first frame 111 and the second frame 112, there is at least one wing portion in the first frame 111 and at least one wing portion in the second frame 112. The two adjacent wing portions exert less influence on each other under the action of the aortic arch, so they can be adjusted freely according to the shape of the blood vessel wall, thereby adapting to the structure and size of the aortic arch in different regions. This ensures that the support frame 11 fits the aortic arch better and has better radial compliance, fitting the inner wall more tightly. This makes the embolism protection device 10 more effective in filtering thrombi and other particles or particles in the blood flow to the three branch vessels, and also reduces the possibility of leakage at the edge of the support frame 11.

[0035] The first frame 111 can be made of alloys or polymers with shape memory properties, such as nickel-titanium alloys, cobalt-chromium alloys, TPU, PTFE, PE (polyethylene), etc. The second frame 112 can also be made of alloys or polymers with shape memory properties, such as nickel-titanium alloys, cobalt-chromium alloys, TPU, PTFE, PE, etc.

[0036] The embolism protection device 10 also includes a connecting part, such as Figure 2 As shown, in this embodiment, the connecting part is the connecting part A between the first end 1111 and the third end 1121, and the connecting part B between the second end 1112 and the fourth end 1122. The connecting part connects at least the first frame 111 and the second frame 112 in series along the axial direction of the plug protection device 10. In other embodiments, the connecting part may also be a connecting rod or a rotating component.

[0037] In this implementation, two tapering structures are formed between the first border 111 and the second border 112. In other implementations, a tapering structure may be provided only on one side of the embolization protection device 10, such as... Figure 4-5 As shown, the connecting portion A of the first end 1111 and the third end 1121 is recessed toward the interior of the support frame 11 to form a waist-tight structure, while the second end 1112 and the fourth end 1122 are connected together, but the part at the connection point extends axially and is connected together without being recessed toward the interior of the support frame 11.

[0038] In this implementation, the first end 1111 and the second end 1112 are spaced apart, as are the third end 1121 and the fourth end 1122. This allows the ends of the first frame 111 and the second frame 112 on the same side to be directly connected, reducing the possibility of leakage due to gaps between adjacent frames. Simultaneously, the resulting tapered structure gives the embolism protection device greater freedom and flexibility, increasing its radial compliance and enabling it to better adapt to different structures and sizes of the aortic arch. It also allows for adjustment of the height of the support screen 12 as needed. In other implementations, the first end 1111 and the second end 1112 can be directly or indirectly connected, and / or the third end 1121 and the fourth end 1122 can be directly or indirectly connected.

[0039] The proximal section of connector 13 is hollow and tubular, while the distal section is rod-shaped. The distal ends of the proximal sections are directly connected to the proximal ends of the distal sections. The proximal section of connector 13 allows the distal end of the sheath core to enter and exit from its proximal end, after which the sheath core extends distally for a certain distance until the distal end of the sheath core is closer to the distal end of the embolization protection device 10. Figure 3 As shown. After implantation into the aortic arch, the distal segment can rest against the sheath core. In clinical applications, the embolization protection device 10 can be fixedly connected to the distal end of the sheath core via the proximal segment of the connector 13. In other implementations, the embolization protection device 10 can also be fixedly connected to the sheath core via a fixing wire provided on the second frame 112.

[0040] like Figure 6-7 As shown, Figure 1 When the embolism protection device 10 shown is placed on a horizontal plane M, the vertical distance H from the highest point of the embolism protection device 10 to the horizontal plane M is greater than or equal to 0 mm and less than or equal to 100 mm. Preferably, 20 mm ≤ H ≤ 80 mm; for example, H can be 50 mm. The length L of the support frame 11 is in the range of 60 mm ≤ L ≤ 200 mm.

[0041] The width W of the support frame 11 ranges from 30mm ≤ W ≤ 100mm. When the embolism protection device is placed on the horizontal plane M, at least two ends are in contact with the horizontal plane M, while the middle part of the support frame 11 arches upward, meaning the support frame 11 is curved relative to the horizontal plane M, and the curvature d of the curvature ranges from R20 to R60. This allows the curved support frame 11 to better conform the filter to the inner wall of the aortic arch after the embolism protection device 10 is released. The embolism protection device 10 with the above-described structure, manufactured using these parameters, can cover the three branch vessels of the aortic arch, covering most of the anatomical structures, thus achieving effective embolism prevention.

[0042] To facilitate observation of the surgical procedure using DSA (Digital Subtraction Angiography) equipment, at least two contrast-enhancing elements can be installed on the embolization protection device 10. These contrast-enhancing elements can be made of materials that are visible under DSA, such as gold, platinum, platinum-iridium alloy, or other materials with strong contrast properties. The specific structure or shape of the contrast-enhancing elements is not limited, as long as they can be fixed in a suitable position on the embolization protection device 10. Specifically, for example... Figure 1-2 As shown, a first contrast agent 113 can be provided at the distal end of the support frame 11, and a second contrast agent 114 can be provided at the proximal end of the support frame 11. In other implementations, other contrast agents can also be provided at other locations of the embolism protection device 10, such as on the first end 1111 or its constricted portion, to assist in determining whether the filter 12 on the embolism protection device 10 effectively adheres to the inner wall of the aortic arch.

[0043] This embodiment also proposes an embolism protection system 100 including the aforementioned embolism protection device 10 and a sheath core. The embolism protection system 100 further includes a conveying device 90 for compressing and conveying the aforementioned embolism protection device 10. The conveying device 90 includes a sheath core 18 and a sheath tube (not shown in the figure), such as... Figure 3As shown. The aforementioned embolization protection device 10 possesses superelasticity and shape memory properties. After being fixed to the distal end of the sheath core 18, the embolization protection device 10 is pulled into the sheath tube (not shown in the figure) by the sheath core 18, and is in a compressed state within the space between the sheath tube and the sheath core 18. This facilitates the delivery of the embolization protection device 10 to a predetermined position in the body via the sheath tube, and then releases and unfolds to fit the aortic arch. When the embolization protection device 10 extends from the sheath tube, the positions of the embolization protection device 10 and the sheath core 18 relative to the three branch vessels of the aortic arch are as follows. Figure 3 As shown, the embolism protection device 10 can expand and unfold under the action of shape memory characteristics, forming a shape like... Figure 1 The deployed state is shown. The embolism protection device 10, after deployment at the aortic arch, is in the same shape as shown. Figure 1 The deployed state shown is generally consistent in its natural state, but may vary slightly depending on the specific implantation location in the aortic arch. Unless otherwise specified, the above description of the embolization protection device 10 refers to its characteristics in the deployed state.

[0044] Before the procedure, one end of the embolization protection device 10 needs to be fixed at a suitable position at the distal end of the sheath core 18. This can be done by fixing the proximal end of the embolization protection device 10 to the sheath core 18 while leaving the distal end unfixed, or by fixing the distal end of the embolization protection device 10 to the sheath core 18 while leaving the proximal end unfixed. The following will describe the process in detail using the example of fixing the proximal end of the embolization protection device 10 to the sheath core. The proximal end of the sheath core is inserted into the distal end of the sheath tube and then exits through the lumen of the sheath tube until the embolization protection device 10 is pulled into the distal lumen of the sheath tube. This causes the embolization protection device 10 to be radially compressed and axially elongated, thus being housed within the distal end of the sheath tube in a compressed state.

[0045] During the procedure, a puncture is made in the femoral artery on one side of the human or animal body, and a guidewire is then inserted to establish an intra-body delivery channel. Once the guidewire reaches the predetermined position, the sheath containing the embolization protection device 10 is delivered along the guidewire channel to the area where the aortic arch is located. At this point, using a DSA device, the relative positions of the embolization protection device 10 and the three branch vessels of the aortic arch are determined based on the positions of the multiple contrasting elements on the embolization protection device 10. When the DSA device shows that the first contrasting element 113 and the second contrasting element 114 on the embolization protection device 10 are respectively located at both ends of the three branch vessel areas of the aortic arch, the sheath core is kept still, and then the sheath is slowly withdrawn to gradually release the embolization protection device 10 from the sheath until the entire embolization protection device 10 extends completely from the distal end of the sheath and expands to cover the openings of the three branch vessels of the aortic arch. Afterwards, a pigtail catheter is used... After entering through the femoral artery on the affected side and passing through the aortic arch, angiography is performed at the location of the calcified aortic valve. The aortic valve replacement sheath is then inserted into the body through puncture of the femoral artery on the opposite side until it reaches the aortic valve for valve replacement. During the replacement, detached calcified tissue, emboli, and other particles or microparticles will move towards the aortic arch with the blood flow. Because the embolization protection device 10 has formed a tight filtering mechanism at the openings of the three branch vessels of the aortic arch, emboli, calcified tissue, and other floating objects are deflected by the embolization protection device 10 to the descending aorta, thereby preventing these floating objects from flowing to the brain through the three branch vessels. After the aortic valve replacement is completed, the aortic valve replacement sheath is withdrawn. Then, the sheath of the embolization protection system is pushed distally to compress the embolization protection device 10 and house it within the distal end of the sheath. Finally, the embolization protection device 10 is withdrawn from the body along with the sheath, thus completing the surgery.

[0046] Example 2

[0047] Example 2 presents another embolism protection device and its embolism protection system. The features of the embolism protection device 20 in Example 2 that are the same as or can be reused from the embolism protection device 10 in Example 1 will not be described again here. The main difference is that, in the embolism protection device 20 of Example 2, such as... Figure 8-12 As shown, the support frame 21 also includes at least one third frame 213 located along its axial direction between the first frame 211 and the second frame 212, the first frame 211 and the second frame 212 being connected by one or more third frames 213.

[0048] In one implementation, such as Figure 8-11As shown, the support frame 21 includes a first frame 211, a third frame 213, and a second frame 212 arranged sequentially from near to far along its axial direction. The third frame 213 includes a fifth end 2131 and a sixth end 2132 located at its near end and correspondingly arranged, and a seventh end 2133 and an eighth end 2134 located at its far end and correspondingly arranged. The first end 2111 is connected to the fifth end 2131, the second end 2112 is connected to the sixth end 2132, the third end 2121 is connected to the seventh end 2133, and the fourth end 2122 is connected to the eighth end 2134. The distance between the fifth end 2131 and the sixth end 2132 is less than the maximum width of the third frame 213, and the distance between the seventh end 2133 and the eighth end 2134 is less than the maximum width of the third frame 213. Thus, one or two waist-cinching structures can be formed between the first frame 211 and the third frame 213, and one or two waist-cinching structures can be formed between the third frame 213 and the second frame 212. Specifically, as Figure 9 As shown, when both the fifth end 2131 and the sixth end 2132 are closer to the central axis of the support frame 21 than the side portion of their corresponding support frame 21, two waist-cinching structures can be formed between the first frame 211 and the third frame 213; when only one of the fifth end 2131 and the sixth end 2132 is closer to the central axis of the support frame 21 than the side portion of its corresponding support frame 21, one waist-cinching structure is formed between the first frame 211 and the third frame 213. Similarly, when both the seventh end 2133 and the eighth end 2134 are closer to the central axis of the support frame 21 than the side portion of their corresponding support frame 21, two waist-cinching structures can be formed between the second frame 212 and the third frame 213; when only one of the seventh end 2133 and the eighth end 2134 is closer to the central axis of the support frame 21 than the side portion of its corresponding support frame 21, one waist-cinching structure is formed between the second frame 212 and the third frame 213. Taking the first frame 211 and the third frame 213 as examples, forming two waist-cinching structures between them, compared to forming a single waist-cinching structure, allows each of the two side portions to adapt more flexibly to the structure and compression degree of the aortic arch. This makes the support frame 21 more firmly fixed at the aortic arch. In addition, the force exerted by the aortic arch on the two side portions can be transmitted to the waist-cinching structures, thereby promoting the cooperation of the two opposing waist-cinching structures to lift the filter 22 upward, enhancing the tight fit between the filter 22 and the inner wall of the three branch vessels of the aortic arch, and increasing the stability of the fixation. The effect of the two waist-cinching structures formed between the second frame 212 and the third frame 213 is the same, and will not be described again here.

[0049] In other implementations, the distance between the fifth end 2131 and the sixth end 2132 may be less than the maximum width of the third frame 213, thereby forming one or two waist-tightening structures between the first frame 211 and the third frame 213. Similarly, in another implementation, the distance between the seventh end 2133 and the eighth end 2134 may be less than the maximum width of the third frame 213, thereby forming one or two waist-tightening structures between the third frame 213 and the second frame 212. These different implementations also enhance the adaptability and stability of the embolization protection device 20 after implantation into the aortic arch or other blood vessels.

[0050] In this implementation, such as Figure 9 As shown, the first end 2111 and the second end 2112 are spaced apart, as are the fifth end 2131 and the sixth end 2132. This "spaced apart" means that the two ends are not directly connected, but rather disconnected or have gaps. The third end 2121 and the fourth end 2122 are also spaced apart, as are the seventh end 2133 and the eighth end 2134. The adjacent ends of the first frame 211, the second frame 212, and the third frame 213 are directly connected on the same side, reducing the possibility of leakage due to gaps between adjacent frames. Simultaneously, the resulting tapered structure gives the first frame 211, the second frame 212, and the third frame 213 greater freedom and flexibility, increasing the radial compliance of the embolism protection device. This allows for better adaptation to different structures and sizes of the aortic arch, and also allows for adjustment of the height of the support screen 22 as needed. In other implementations, the first end 2111 and the second end 2112 can be directly or indirectly connected together, the fifth end 2131 and the sixth end 2132 can be directly or indirectly connected together, the third end 2121 and the fourth end 2122 can be directly or indirectly connected together, and the seventh end 2133 and the eighth end 2134 can be directly or indirectly connected together. In other implementations, the relatively arranged first end 2111 and the second end 2112, the third end 2121 and the fourth end 2122, etc., can be spaced apart or connected as needed.

[0051] In another implementation, such as Figure 12As shown, the support frame 21 includes a first frame 211, a proximal third frame 213a, a distal third frame 213b, and a second frame 212 arranged sequentially from near to far along its axial direction. That is, the support frame 21 includes two third frames 213 connected in series along its axial direction. The proximal third frame 213a includes a fifth end 2131 and a sixth end 2132 located at its proximal end and correspondingly arranged, and a seventh end 2133 and an eighth end 2134 located at its distal end and correspondingly arranged. The distal third frame 213b includes a ninth end 2135 and a tenth end 2136 located at its proximal end and correspondingly arranged, and an eleventh end 2137 and a twelfth end 2138 located at its distal end and correspondingly arranged. The first end 2111 is connected to the fifth end 2131, the second end 2112 is connected to the sixth end 2132, the seventh end 2133 is connected to the ninth end 2135, the eighth end 2134 is connected to the tenth end 2136, the eleventh end 2137 is connected to the third end 2121, and the twelfth end 2138 is connected to the fourth end 2122. The distance between the fifth end 2131 and the sixth end 2132 is less than the maximum width of the near-end third border 213a, the distance between the ninth end 2135 and the tenth end 2136 is less than the maximum width of the far-end third border 213b, the distance between the seventh end 2133 and the eighth end 2134 is less than the maximum width of the near-end third border 213a, and the distance between the eleventh end 2137 and the twelfth end 2138 is less than the maximum width of the far-end third border 213b. Therefore, one or two waist-slimming structures can be formed between the first border 211 and the near-end third border 213a, between the near-end third border 213a and the far-end third border 213b, and between the far-end third border 213b and the second border 212.

[0052] In other implementations, when the support frame 21 includes two or more third frame borders 213, all the third frame borders 213 are connected in pairs along the axial direction of the embolism protection device 20, so as to adapt to the curvature of different parts of the aortic arch and achieve better fit and fixation. The different third frame borders 213 have the same or similar shapes, and their sizes may be the same or different. The waist-tightening between two adjacent third frame borders 213 is similar to that in the aforementioned implementations and will not be described again here.

[0053] The third frame 213 can be made of alloys or polymers with shape memory properties, such as nickel-titanium alloys, cobalt-chromium alloys, TPU, PTFE, PE, etc.

[0054] Example 3

[0055] Example 3 presents another embolism protection device and its embolism protection system. The features that are the same as or can be reused in the embolism protection device of Example 2 will not be repeated here. The main difference is that in the embolism protection device of Example 3, each frame is a closed-loop structure, and adjacent frames are directly or indirectly connected together. Furthermore, one side of each adjacent frame has an arc-shaped transition so that the two sides of the support frame are recessed inward, thus forming a waist-shaped structure. Figure 13-14 As shown. In addition, the support frame 31 also includes at least one support member, disposed within the first frame 311 or the second frame 312, for supporting a portion of at least one filter screen (not shown). The support member is preferably a closed-loop structure and can be connected to the corresponding frame via one or more support rods 36. The at least one support member is capable of adaptive deformation to conform to the inner wall of the tissue, allowing the filter screen to better fit the inner wall of the tissue, thereby ensuring effective filtration of microparticles or particles such as thrombi.

[0056] Furthermore, such as Figure 13-14 As shown, the embolism protection device also includes a connecting rod 34. The connecting rod 34 connects the first frame 311, the third frame 313, and the second frame 312 in series along the axial direction of the embolism protection device 30. The connecting rod 34 serves as the connection point, connecting each frame together axially to form a support frame 31. This makes the support frame 31 a segmented structure, which is more likely to adapt to the inner wall of the body tissue and deform accordingly, allowing the filter to better fit the inner wall of the body tissue, thereby ensuring effective filtration of thrombi and other microparticles or particles. Preferably, the connecting rod 34 is located on the central axis of the support frame 31.

[0057] Specifically, such as Figure 13 As shown, the embolization protection device includes a first frame 311, a third frame 313, and a second frame 312. At least one waist structure is provided between the first frame 311 and the third frame 313, and at least one waist structure may also be provided between the second frame 312 and the third frame 313, thereby forming relatively free wing parts that can be adjusted freely and flexibly, increasing the radial compliance of the embolization protection device. The waist structure allows the embolization protection device to adapt to the structure and size of the aortic arch in different regions, ensuring that the support frame is more firmly fixed in the aortic arch and fits the inner wall more tightly. This makes the embolization protection device more effective in filtering thrombi and other particles or particles in the blood flow to the three branch vessels, and also reduces the possibility of leakage at the edge of the support frame.

[0058] A first support member 351 is provided inside the first frame 311, a second support member 352 is provided inside the second frame 312, and a third support member 353 is provided inside the third frame 313. The provision of the support members improves the support strength of the support frame 31 for the filter screen. The first support member 351, the second support member 352, and the third support member 353 are all annular or other closed-loop structures to avoid sharp points that could puncture internal tissues or damage the filter screen. The first support member 351, the second support member 352, and the third support member 353 are each axially connected to their respective frame via two support rods 36.

[0059] When the embolization protection device is deployed within the aortic arch or other blood vessels, the first support member 351 inside the first frame 311 supports a sub-filter or a portion of a single integral filter upwards to conform to the local tissue wall or at least cover the opening of one branch of the aortic arch; the second support member 352 inside the second frame 312 supports another sub-filter or another portion of the single integral filter upwards to conform to another local tissue wall or at least cover the opening of another branch of the aortic arch; the third support member 353 inside the third frame 313 supports another sub-filter or another portion of the single integral filter upwards to conform to another local tissue wall or at least cover the opening of another branch of the aortic arch.

[0060] The support component can be made of the same material as the first frame 311 or the second frame 312. The support component can be made separately and then fixed to the corresponding frame, or it can be made of the same sheet material as the frame, cut and then heat-set.

[0061] The central axis of the first support member 351 coincides with the central axis of the support frame 31, the central axis of the second support member 352 coincides with the central axis of the support frame 31, and the central axis of the third support member 353 coincides with the central axis of the support frame 31. This not only promotes greater radial support force and anchoring stability of the support frame 31, but also maximizes the adhesion of the filter to the inner wall of tissues such as the aortic arch. In other implementations, the central axis of the first support member 351 may not coincide with the central axis of the support frame 31. Similarly, the central axis of the second support member 352 may not coincide with the central axis of the support frame 31, and / or the central axis of the third support member 353 may not coincide with the central axis of the support frame 31. This also increases the radial support force and anchoring stability of the support frame 31 and promotes the adhesion of the filter to the inner wall of tissues such as the aortic arch.

[0062] Taking the first support member 351 as an example, such as Figure 13As shown, the first support member 351 is a ring-shaped structure symmetrical about both ends of the central axis of the support frame 31. The proximal connection point on the central axis of the first support member 351 is connected to the proximal end of the first frame 311 via a proximal support rod 36, and the distal connection point on the central axis of the first support member 351 is connected to the distal end of the first frame 311 via a distal support rod. Both the left and right portions of the first support member 351 are suspended, thus allowing them to adaptively adjust their shape under external force to fit tightly against the inner wall of the tissue. The surface formed by the first support member 351 is also arc-shaped, so that at least a portion of the filter covering it gradually rises upwards from its left and right ends toward its central axis, allowing this portion of the filter to fit more tightly against the inner wall of the aortic arch and other tissues without the need for a sheath core.

[0063] In this implementation, the filter screen only covers the various support members and support rods without being fixedly connected to them. In other implementations, at least one support member or a portion of the support rod can be partially fixed to the filter screen by means of adhesive bonding or suture stitching. The at least one support member can adaptively deform to conform to the inner wall of the tissue, allowing the filter screen to fit more tightly against the aortic arch wall, thereby ensuring effective filtration of thrombi and other microparticles or particles.

[0064] Example 4

[0065] Example 4 presents another embolism protection device and its embolism protection system. The features that are the same as or can be reused in the embolism protection device of Example 4 and Example 3 will not be described again here. The main difference is that whether or not the embolism protection device of Example 4 includes a support member is not limited. Figure 15-16As shown, the first frame 411 and the third frame 413, as well as the second frame 412 and the third frame 413, are connected by a rotating member 44 arranged axially along the support frame 41. The rotating member 44 connects the first frame 411, the second frame 412, and the third frame 413 in series along the axial direction of the embolization protection device. The rotating member 44 includes an insert 441 respectively disposed on one frame, a recess 442 on the other frame, and a rotating shaft 443. The insert 441 and the recess 442 are shaped to fit each other, and the insert 441 and the recess 442 are provided with through holes in the radial direction for the rotating shaft 443 to pass through, so that the first frame 411 can rotate relative to the third frame 413 along the rotating shaft 443. The rotating member 44 allows the first frame 411 to rotate relative to the third frame 413 about the rotating shaft 443, so that the embolization protection device 40 has a higher degree of freedom and flexibility, and can better adapt to different structures and sizes of the aortic arch or other blood vessels. Furthermore, the third frame 413 is rotatable relative to the second frame 412, which also gives the embolism protection device 40 greater freedom and flexibility, enabling it to better adapt to different structures and sizes of the aortic arch or other blood vessels.

[0066] In this embodiment, the rotating member 44 is arranged along the axial direction of the plug protection device 40 on the central axis of the support frame 41, connecting the first frame 411 and the second frame 412 in series, as shown below. Figure 15 As shown. In other implementations, adjacent frames are directly connected via ends on the same side, and the rotating member 44 can also be located at the connection between the end of the first frame and the end of the second frame.

[0067] In this implementation, the various frames of the support frame 41 are connected by rotating parts 44. Therefore, the first frame 411 and the second frame 412 can rotate relative to the third frame 413 under the pressure of the blood vessel wall structure, so that the embolization protection device adapts to the structure of the aortic arch, which increases the axial compliance of the embolization protection device and allows each frame to deform independently to adapt to the aortic arch wall and fit more tightly.

[0068] Example 5

[0069] Example 5 presents another embolism protection device and its embolism protection system. The features of the embolism protection device of Example 5 that are the same as or can be reused from the embolism protection device 10 of Example 1 will not be described again here. The main difference is that, in the embolism protection device of Example 5, such as... Figure 17 As shown, the first frame 511 and the second frame 512 of the support frame 51 partially overlap to form an overlapping area 57. The setting of the overlapping area 57 can better control the shape and size of the waist-cinching structure to reduce edge leakage in the area where the waist-cinching structure is located.

[0070] This invention provides an embolism protection device with at least one waist-recessed structure formed between two adjacent frame sides. That is, a portion of at least one side of the support frame is recessed towards the interior of the support frame, so that the support frame is no longer a single, regular closed-loop frame. Therefore, the sides of the adjacent frame sides along the axial direction can be adjusted relatively flexibly and freely, thereby regionally adapting to the structure and size of the aortic arch, resulting in higher compliance. This ensures that the support frame is more firmly fixed within the aortic arch and fits more tightly against the inner wall, making the embolism protection device more effective in filtering thrombi and other particles or microparticles in the blood flow to the three branch vessels, and also reducing the possibility of leakage at the edge of the support frame.

[0071] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0072] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An embolism protection device, comprising a support frame and at least one filter screen covered on the support frame, characterized in that, The support frame includes at least two adjacent side frames arranged along its axial direction from near to far. The surface formed by the support frame is an arc-shaped surface. Both adjacent side frames are closed-loop structures. One side of the adjacent side frame has an arc transition so that the two sides of the support frame are recessed inward to form a waist-shaped structure. The waist-shaped structure makes the support frame no longer a whole regular closed-loop frame, but a regional support frame formed by the waist-shaped structure. The side of the side frame forming the waist-shaped structure can be adjusted relatively flexibly, so that at least one side portion of the two adjacent side frames respectively forms a wing portion that can swing relatively independently.

2. The embolism protection device according to claim 1, characterized in that, One of the borders includes a first end and a second end, and the other border includes a third end and a fourth end, the first end being connected to the second end, the third end being connected to the fourth end, the distance between the first end and the second end being less than the maximum width of the corresponding border, and the distance between the third end and the fourth end being less than the maximum width of the corresponding border.

3. The embolism protection device according to claim 1, characterized in that, The support frame includes at least three adjacent frame sides.

4. The embolism protection device according to claim 1, characterized in that, The embolism protection device further includes a connecting part that connects at least two adjacent frame edges in series along the axial direction of the embolism protection device.

5. The embolism protection device according to claim 1, characterized in that, The support frame further includes at least one support member, which is disposed within at least one of the frame members for supporting a portion of the at least one filter screen.

6. The embolism protection device according to claim 1, characterized in that, The two adjacent frame sides are connected by a rotating component.

7. The embolism protection device according to claim 6, characterized in that, The rotating component includes an insert in one of the frame sides, a recess in the other frame side, and a pivot that passes through the insert and the recess in a radial direction.

8. An embolism protection system, characterized in that, It includes the embolism protection device as described in any one of claims 1-7 and a delivery device, the delivery device being used to compress and deliver the embolism protection device.

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