Embolic protection device

Abstract

An embolic protection device (100) comprises a frame (110), a side filter screen (120) and a plurality of support rods (130) arranged at intervals, the support rods (130) comprising a first end (131), a second end (131) and at least one distal head end (132), the first end (131) and the second end (131) being connected to opposite sides of the frame (110) respectively, the first end (131), the second end (131) and the head end (132) forming a first line segment (V1), a second line segment (V2) and a third line segment (V3) respectively, the first line segment (V1) extending from the first end (131) to the head end (132) and gradually away from the frame (110), the second line segment (V2) extending from the second end (131) to the head end (132) and gradually away from the frame (110), so that the plurality of support rods (130) props up the side filter screen (120) on the plurality of support rods (130) in a direction away from the frame (110). The device can fit the side filter screen to the three branches of the aortic arch without the aid of a sheath core, and in actual application, the frame and the support rods interact and promote each other, enabling the frame to be stably fixed at the aortic arch, and also enabling each support rod to give the filter screen greater upward support, thereby enabling the side filter screen to better fit the aortic arch.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an embolization protection device. 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 filtration at all three branches of the aortic arch is necessary 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. With this type of device, the filter membrane typically needs to be supported by a bent sheath core at the arch to achieve thrombus filtration at the three branches. Another type of embolism protection device usually uses a pre-bent, cut support mesh that adheres to the inner wall of the three branches for filtration. However, in clinical application, these devices often fail to adhere well to the aortic arch wall at the three branches, allowing some emboli to still enter the aortic arch branches, posing a safety hazard. Summary of the Invention

[0004] Therefore, it is necessary to provide a new embolism protection device to address the problem that the filter membrane or filter screen of existing embolism protection devices cannot fit well into the three branches of the aortic arch.

[0005] An embolism protection device is proposed, comprising a frame and a filter screen covering the frame. The embolism protection device further includes a plurality of support rods spaced apart along its axial direction. Each support rod includes a first end, a second end, and at least one distal end. The first end and the second end are respectively connected to opposite sides of the frame. A first line segment is formed between the first end and the distal end, and a second line segment is formed between the second end and the distal end. The first line segment extends from the first end toward the distal end and gradually moves away from the frame, and the second line segment extends from the second end toward the distal end and gradually moves away from the frame, thereby causing the plurality of support rods to support the filter screen covering the plurality of support rods in a direction away from the frame.

[0006] In one embodiment, when the embolism protection device is placed on a horizontal plane, the vertical distance from the highest point of the support rod to the horizontal plane is greater than or equal to 3 mm and less than or equal to 30 mm.

[0007] In one embodiment, the vertical distance between the vertical projection point of the head end to the horizontal plane and the vertical projection points of the first end and the second end to the horizontal plane is greater than or equal to 20 mm and less than or equal to 120 mm.

[0008] In one embodiment, the shortest distance between the first end and the second end ranges from 20 mm to 100 mm.

[0009] In one embodiment, at least one of the head ends bends and extends toward the far end and toward the border.

[0010] In one embodiment, at least one of the head ends is provided with a damage protection element.

[0011] In one embodiment, the embolism protection device is provided with at least one sliding constraint ring.

[0012] In one embodiment, the sliding constraint ring is disposed on the frame of the embolism protection device, or on at least one head end of at least one support rod.

[0013] In one embodiment, the proximal and / or distal end of the embolism protection device is provided with at least one imaging element.

[0014] An embolism protection system is also proposed, comprising an elongated sheath core and any of the aforementioned embolism protection devices.

[0015] In one embodiment, the embolism protection device is provided with at least one sliding constraint ring, one end of the embolism protection device is fixed to the sheath core, and the other end can move axially along the sheath core through the sliding constraint ring.

[0016] In the aforementioned embolism protection device and its embolism protection system, the embolism protection device includes multiple support rods spaced apart along its axial direction. Since the first and second ends of the support rods are respectively connected to opposite sides of the frame, and the first line segment formed from the first end to the head end and the second line segment formed from the second end to the head end on the support rods extend from their corresponding ends toward the head end and gradually away from the frame, this structural design allows the support rods to extend upwards toward the distal end and away from the frame, with the head end of the support rods suspended. This allows the filter covering these support rods to be supported upwards away from the frame. Therefore, the filter can be attached to the three branches of the aortic arch without the aid of a sheath. In practical applications, the frame and support rods can interact and promote each other, not only making the frame more securely fixed at the aortic arch but also enabling each support rod to provide greater upward support to the filter, thereby promoting better adhesion of the filter to the upper wall tissue of the aortic arch. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of the embolism protection device in Example 1;

[0018] Figure 2 for Figure 1 A schematic diagram of the structure of the embolism protection device when the filter screen is not covered;

[0019] Figure 3 for Figure 2 Top view of the structure shown;

[0020] Figure 4 This is another structural schematic diagram of the embolism protection device of Example 1 when the filter screen is not covered;

[0021] Figure 5 for Figure 4 Top view of the structure shown;

[0022] Figure 6 This is another structural schematic diagram of the embolism protection device of Example 1 when the filter screen is not covered;

[0023] Figure 7 for Figure 2 A schematic diagram of the structure shown when it is placed on a horizontal plane;

[0024] Figure 8 for Figure 1 A schematic diagram of an embolization protection device implanted in the aortic arch;

[0025] Figure 9 This is a schematic diagram of the overall structure of the embolism protection device in Example 2;

[0026] Figure 10 for Figure 9 A schematic diagram of the structure of the embolism protection device when the filter screen is not covered;

[0027] Figure 11 This is another structural schematic diagram of the embolism protection device of Example 2;

[0028] Figure 12 for Figure 9 A schematic diagram of the structure of the embolization protection device housed inside the sheath;

[0029] Figure 13 for Figure 9 A schematic diagram of an embolization protection device implanted in the aortic arch. Detailed Implementation

[0030] 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.

[0031] 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.

[0032] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0033] Example 1

[0034] Example 1 presents an embolism protection device, exemplified in valve replacement surgery. It blocks thrombi or lumps from flowing through any of the three branches of the aortic arch into the brain, 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 and Figure 2The embolism protection device 100 includes a frame 110 and a filter screen 120 covering the frame 110, and also includes four support rods 130 spaced apart along the axial direction of the embolism protection device 100. Each support rod 130 is V-shaped and includes a first end 131, a second end 131, and a head end 132 facing the distal end. The first end 131 and the second end 131 are respectively fixedly connected to opposite sides of the frame 110. A virtual first line segment V1 is formed between the first end 131 and the head end 132, and a virtual second line segment V2 is formed between the second end 131 and the head end 132. The first line segment V1 extends from the first end 131 toward the head end 132 and gradually moves away from the frame 110, and the second line segment V2 extends from the second end 131 toward the head end 132 and gradually moves away from the frame 110. That is, at least a portion of each support rod 130 extends from its corresponding first end 131 and second end 131 toward its corresponding head end 132 and gradually moves away from the frame 110, so as to support the filter screen 120 covering the four support rods 130 upward in a direction away from the frame 110. In some embodiments, a portion of the support rods 130 may be selected for supporting the filter screen 120 upward in a direction away from the frame 110, while the other portion of the support rods 130 may have other shapes and other functions.

[0035] The frame 110 is a closed ring within the embolism protection device 100. The frame 110 may be elliptical in shape or hollow, leaf-shaped. The frame 110 can be made of alloys or polymers with shape memory properties, such as nickel-titanium alloys, cobalt-chromium alloys, TPU (Thermoplastic polyurethanes), PTFE (Polytetrafluoroethylene), or PE (polyethylene). The surface enclosed by the frame 110 can be parallel to a horizontal plane or an arc-shaped surface that conforms to the shape of the aortic arch.

[0036] The filter 120 is a membrane made of polymer materials such as PTFE, TPU, or PET (Polyethylene terephthalate), or it can be made of woven yarns with shape memory properties. The thickness of the filter 120 ranges from 10 micrometers to 55 micrometers, and the membrane has many small pores 121 for filtration, with pore diameters ranging from 25 micrometers to 300 micrometers. The shape and size of the filter 120 are similar to or match the shape and size of the frame 110, as long as the filter 120 can completely cover the frame 110 and the edges of the filter 120 can be fixedly connected to the frame 110. The edges of the filter 120 are fixedly connected to the frame 110 using processes such as glue, high-frequency welding, laser welding, or sewing. The filter 120 can filter large particles such as blood clots or lumps, as well as small particles such as blood clots or lumps.

[0037] The support rod 130 can be made of the same material as the frame 110. The support rod 130 can be manufactured separately and then fixed to the frame 110, or it can be made from the same sheet material as the frame 110, cut and then heat-set. Along the axial direction of the embolism protection device 100, the minimum distance between the head ends 132 of two adjacent support rods 130 ranges from 5 mm to 100 mm. The first and second ends 131 on the same support rod 130 can be symmetrical along the central axis of the frame 110, which can both increase the radial support force and anchoring stability of the frame 110 and maximize the fit of the filter 120 to the upper wall of the aortic arch. In other implementations, the first and second ends 131 of the same support rod 130 can also be asymmetrical along the central axis of the frame 110. The head end 132 of the support rod 130 is away from the frame 110 and suspended. The first portion of the support rod 130 from its first end 131 to its head end 132 and the second portion from its second end 131 to its head end 132 gradually lift the filter screen 120 covering the support rod 130 upwards in a direction away from the frame 110, so that this portion of the filter screen 120 can stably conform to the upper wall of the aortic arch without the need for support by the sheath core. In other implementations, the number of support rods 130 can also be 3 or 5, etc., and an appropriate number of support rods 130 can be set as needed.

[0038] like Figure 3As shown, the included angle α between the two support rods 133 constituting a V-shaped rod 130 ranges from 10 degrees to 145 degrees. When this included angle α is less than 10 degrees, the support rod 130 cannot provide sufficient opening force to the frame 110 when the embolization protection device 100 is deployed, which may prevent the frame 110 from being properly anchored to the inner wall of the aortic arch. When this included angle α is greater than 145 degrees, the embolization protection device 100 has weak radial flexibility, which may damage blood vessels. In this embodiment, the included angle α between the two support rods 133 of the support rod 130 is 135 degrees.

[0039] In other implementations, the support rod 130 can also be a U-shaped rod; or, the support rod 130 can be composed of two or more V-shaped rods and / or U-shaped rods connected in series, for example... Figure 4 and Figure 5 The W-shaped rod 130 shown, composed of two V-shaped rods, can also be a zigzag rod composed of two or more V-shaped rods, or a wavy rod composed of two or more U-shaped rods. In this case, the support rod 130 has two or more head ends 132. Such a support rod 130 can fit the filter 120 to the upper wall of the aortic arch at multiple angles, and the support rod 130 has better unfolding strength, enabling the frame 110 to be better anchored within the aortic arch. For a support rod 130 with two or more head ends 132, the first line segment V1 can be a virtual line segment formed between the first end 131 of the support rod 130 and any one of the head ends 132 on the support rod 130, and the second line segment V2 can be another virtual line segment formed between the second end 131 of the support rod 130 and any one of the head ends 132 on the support rod 130.

[0040] Figure 1 The four support rods 130 in the device have different lengths, specifically, they gradually increase in length from the proximal end to the distal end of the embolization protection device 100. All four support rods 130 have a certain degree of curvature towards the distal end, and the degree of curvature can also vary, as long as they cooperate to ensure that the supported filter 120 fully conforms to the upper wall of the three branches of the aortic arch. As one implementation method, such as... Figure 2 As shown, the minimum included angle b between the support rod 130 and the frame 110 is greater than or equal to 10 degrees and less than or equal to 80 degrees.

[0041] In this embodiment, the four tips 132 on the embolization protection device 100 are all curved downwards towards the distal end and slightly towards the frame 110, thereby preventing the distal ends of the tips 132 from puncturing the filter screen 120 when entering or exiting the sheath 400, or from puncturing the upper wall tissue of the aortic arch when unfolded. To further avoid this problem, the tips 132 of each support rod 130 can be passivated. In other implementations, at least one tip 132 is provided with a damage-preventing component, such as a ball head formed by heat fusion of the tip 132, or silicone covering the tip 132, which can prevent the tip 132 from puncturing the filter screen 120. In other implementations, the tips 132 on the support rod 130 can also extend distally while extending slightly upwards away from the frame 110. In this case, the tips 132 can be passivated as described above or provided with the aforementioned damage-preventing component, and the tip 132 is the highest point on the support rod 130 on which it is located. In other implementations, such as Figure 6 As shown, all the head ends 132 extend downwards a short distance towards the far end and towards the frame 110. The curvature c of the downward bend of the head ends 132 ranges from R2 to R30, so that the portion of the support rod 130 in contact with the filter screen 120 has no sharp point, and the support rod 130 and the filter screen 120 make smooth contact, thereby preventing the head ends 132 from puncturing the filter screen 120. In embodiments where the support rod 130 includes two or more head ends 132, one or more head ends 132 of the support rod 130 can adopt the above-described method of preventing the head ends 132 from puncturing the filter screen 120, which will not be repeated here.

[0042] like Figure 7 As shown, Figure 2 When the embolism protection device 100 shown is placed on the horizontal plane M, the frame 110 is in contact with the horizontal plane M. Taking one of the support rods 130 as an example, the vertical distance H from the highest point of the support rod 130 to the horizontal plane M is greater than or equal to 3 mm and less than or equal to 30 mm. For example, H can be 20 mm. In this embodiment, since the head end 132 is slightly bent downwards, the head end 132 is not the highest point of the support rod 130. If the vertical distance H from the highest point of the support rod 130 to the horizontal plane M is greater than 30 mm, the height difference between the first end 131 or the second end 131 of the support rod 130 and the head end 132 will be too large, which is not conducive to the overall fit between the support rod 130 and the filter screen 120, thereby affecting the sealing performance of the filter screen 120 for the three branches. If the vertical distance H from the highest point of the support rod 130 to the horizontal plane M is less than 3 mm, the support height of the support rod 130 is limited, which is not conducive to the fit between the filter 120 and the upper wall of the aortic arch. Assuming... Figure 7 Point A on the middle support rod 130 is the highest point, and the vertical distance from point A to the horizontal plane M is H.

[0043] The vertical distance L1 between the head end 132 of the support rod 130 and its vertical projection point B on the horizontal plane M, and between the first end 131 of the support rod 130 and its vertical projection point C on the horizontal plane M, and the second end 131 and its vertical projection point D on the horizontal plane M, is greater than or equal to 20 mm and less than or equal to 120 mm; for example, L1 can be 30 mm. The shortest distance between the first end 131 and the second end 131 of the support rod 130, i.e., the length of the straight line CD, is between 20 mm and 100 mm; for example, the shortest distance between the first end 131 and the second end 131 can be 50 mm.

[0044] like Figure 8 As shown, after such an embolization protection device 100 is implanted into the aortic arch 200, its multiple support rods 130 cooperate with each other to not only fully fit the filter 120 at the three branches 210 of the aortic arch 200, but also interact with the frame 110 which is compressed by the inner wall of the aortic arch 200. On the one hand, after being compressed, the frame 110 transmits a part of the force to each support rod 130, so that each support rod 130 further supports the filter 120 upward, thereby making the filter 120 fit more closely to the upper wall of the three branches 210 of the aortic arch 200. On the other hand, each support rod 130 reacts to the frame 110, pushing the two sides of the frame 110 connected to each support rod 130 outward, so that the frame 110 can be stably anchored to the inner wall of the aortic arch 200.

[0045] In this embodiment, when the embolism protection device 100 is placed on the horizontal plane M, the frame 110 is substantially completely flush with the horizontal plane M. In another implementation, such as Figure 6 As shown, when the embolism protection device 100 is placed on the horizontal plane M, only the distal part of the frame 110 contacts the horizontal plane M, while the middle part of the frame 110 arches upward, that is, the frame 110 is curved relative to the horizontal plane M, and the curvature d of the curvature ranges from R20 to R200. Thus, after the embolism protection device 100 is released, the curved frame 110 can cause the support rod 130 and the filter screen 120 to better fit the upper wall of the aortic arch 200.

[0046] When the embolism protection device 100 is placed on the horizontal plane M, such as Figure 3 As shown, the axial length L2 of the frame 110 ranges from 50 mm to 150 mm; along the axial direction of the frame 110, the width of different areas of the frame 110 can be different, and the maximum width W ranges from 30 mm to 100 mm, thus covering the three branches 210 of the aortic arch 200 of most anatomical structures, achieving effective embolism prevention.

[0047] In this embodiment, the filter screen 120 only covers each support rod 130 without being fixedly connected to it. In other implementations, a portion of the support rod 130 may be partially fixed to the filter screen 120 by means of adhesive bonding or stitching. When a support rod 130 includes two or more head ends 132, hinged engagement of the head ends 132 during sheath insertion can also be avoided.

[0048] like Figure 1 As shown, the proximal end of the frame 110 is provided with a connector 140 that connects to the distal end of the sheath core 300. The proximal segment 141 of the connector 140 is a hollow tube, and the distal segment 142 is a rod. The distal end of the proximal segment 141 is directly connected to the proximal end of the distal segment 142. The proximal segment 141 of the connector 140 is used to allow the distal end of the sheath core 300 to enter and exit from its proximal end, and then the sheath core 300 extends distally for a certain distance until the distal end of the sheath core 300 is closer to the distal end of the embolization protection device 100. After implantation into the aortic arch 200, the distal segment 142 can rest against the sheath core 300. In clinical applications, the embolization protection device 100 can be fixedly connected to the distal end of the sheath core 300 via the proximal segment 141 of the connector 140. In other implementations, the embolism protection device 100 can also be fixedly connected to the sheath core 300 via the frame 110 or the support rod 130.

[0049] To facilitate observation of the surgical procedure using DSA (Digital Subtraction Angiography) equipment, such as Figure 1 As shown, at least two imaging elements 150 can be provided on the embolism protection device 100. The imaging elements 150 can be made of materials that are visible under DSA equipment, such as gold, platinum, platinum-iridium alloy, or other materials with strong imaging properties. The specific structure or shape of the imaging elements 150 is not limited, as long as they can be fixed in a suitable position on the embolism protection device 100. Specifically, a first imaging element 151 can be provided at the distal end of the embolism protection device 100, and a second imaging element 152 can be provided at the proximal end of the embolism protection device 100. In other embodiments, other imaging elements 150 can also be provided at other positions on the embolism protection device 100, for example, an imaging element 150 can be provided on the head end 132 of the support rod 130 in the middle region of the embolism protection device 100, to assist in determining whether the filter screen 120 on the embolism protection device 100 effectively adheres to the upper wall of the aortic arch 200.

[0050] This embodiment also proposes an embolism protection system including the aforementioned embolism protection device 100 and sheath core 300. The embolism protection system further includes a sheath tube 400 for compressing and delivering the aforementioned embolism protection device 100. The aforementioned embolism protection device 100 has superelasticity and shape memory properties. After being fixed to the distal end of the sheath core 300, the embolism protection device 100 is pulled into the sheath tube 400 by the sheath core 300 and is in a compressed state, so as to facilitate the delivery of the embolism protection device 100 into the body by means of the sheath tube 400. When the embolism protection device 100 extends out of the sheath tube 400, it can expand and unfold under the action of shape memory properties, forming a shape like... Figure 1 The deployed state is shown. The embolism protection device 100, after deployment at the aortic arch 200, has the same shape as... Figure 1 The deployed state shown is generally consistent in its natural state, but may vary slightly depending on the specific implantation into the aortic arch 200. Unless otherwise specified, the above description of the embolism protection device 100 refers to its characteristics in the deployed state.

[0051] Before the procedure, one end of the embolization protection device 100 needs to be fixed at a suitable position at the distal end of the sheath core 300. This can be done by fixing the proximal end of the embolization protection device 100 to the sheath core 300 while leaving the distal end unfixed, or by fixing the distal end of the embolization protection device 100 to the sheath core 300 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 100 to the sheath core 300. The proximal end of the sheath core 300 is inserted into the distal end of the sheath tube 400 and then exits through the lumen of the sheath tube 400 until the embolization protection device 100 is pulled into the distal lumen of the sheath tube 400. This causes the embolization protection device 100 to be radially compressed and axially elongated, thus being housed within the distal end of the sheath tube 400 in a compressed state.

[0052] 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 400 containing the embolization protection device 100 is delivered along the guidewire channel to the area where the aortic arch 200 is located. At this point, using a DSA device, the relative positions of the embolization protection device 100 and the three branches 210 of the aortic arch 200 are determined based on the positions of the multiple contrasting elements 150 on the embolization protection device 100. When the DSA device observes that the first contrasting element 151 and the second contrasting element 152 on the embolization protection device 100 are respectively located at both ends of the area of ​​the three branches 210 of the aortic arch 200, the sheath core 300 is kept stationary, and then the sheath 400 is slowly withdrawn to gradually release the embolization protection device 100 from the sheath 400 until the entire embolization protection device 100 extends completely from the distal end of the sheath 400 and expands to cover the three branches 210 of the aortic arch 200. Afterwards... Using a pigtail catheter, angiography is performed after entering the femoral artery on the affected side and passing through the aortic arch 200 to reach the calcified aortic valve. The aortic valve replacement sheath 400 is then inserted into the body through puncture of the contralateral femoral artery until it reaches the aortic valve for valve replacement. During the replacement process, detached calcified tissue, emboli, and other particles or microparticles will move with the blood flow towards the aortic arch 200. Since the embolism protection device 100 is already at the openings of the three branches 210 of the aortic arch 200... A tight filtration mechanism is formed, deflecting emboli, calcified tissue, and other floating objects to the descending aorta by the embolization protection device 100, thereby preventing these floating objects from flowing to the brain through the three branches 210. After the aortic valve replacement is completed, the aortic valve replacement sheath 400 is withdrawn. Then, the sheath 400 is pushed distally to compress the embolization protection device 100 and contain it in the distal end of the sheath 400. Finally, the embolization protection device 100 is withdrawn from the body along with the sheath 400, thus completing the surgery.

[0053] Example 2

[0054] Example 2 presents another embolization protection device and its embolization protection system. The embolization protection device 500 of Example 2 is generally similar to the embolization protection device 100 of Example 1. The definitions and characteristics of the virtual first segment V1 and the virtual second segment V2 are also the same, and the surgical procedure is also generally the same. The main difference between the two is that the embolization protection device 500 of Embodiment 2 is provided with at least one sliding constraint ring 160, which can be set on the frame 110 or on at least one head end 132 of the support rod 130. In the embolization protection system of Embodiment 2, the distal end of the sheath core 300 passes through one or more sliding constraint rings 160 on the embolization protection device 500. Thus, when the embolization protection device 500 is squeezed by the aortic arch 200, the sliding constraint ring 160 can move axially along the sheath core 300, thereby causing the entire embolization protection device 500 to adaptively bend and deform to better fit the upper wall of the aortic arch 200, achieving a more effective anti-embolization effect. At the same time, it can also prevent the embolization protection device 500 from shifting relative to the sheath core 300, which would lead to ineffective thrombus filtering.

[0055] A sliding constraint ring 160 may be provided on at least one end 132 of one or more support rods 130 of the embolism protection device 500, and the number of sliding constraint rings 160 on each end 132 may be set as needed. Figure 9 and Figure 10 As shown, a sliding constraint ring 160 is provided on the tip 132 of the distal support rod 130 of the embolization protection device 500. This not only prevents the distal end of the embolization protection device 500 from shifting relative to the sheath core 300, thus preventing a poor seal, but also allows the sheath core 300 to conform to the curvature of the aortic arch 200, promoting better support of the filter screen 120 by the support rod 130. This results in a tighter fit and more comprehensive filtration of the filter screen 130 at the three branches 210. Furthermore, it prevents the tip 132 of the support rod 130 from poking into the filter screen 120 or the inner wall of the aortic arch 200. In other implementations, such as... Figure 11 As shown, a sliding constraint ring 160 may be provided at the distal or proximal end of the frame 110 of the embolism protection device 500. In other implementations, at least one sliding constraint ring 160 may be provided at the distal end of the frame 110 of the embolism protection device 500 and at least one head end 132 of at least one support rod 130. Figure 12 As shown, the proximal end of the embolism protection device 500 is fixed to the distal end of the sheath core 300. The distal end is relatively fixed to the sheath core 300 by a sliding constraint ring 160 on the frame 110. Both the embolism protection device 500 and the distal end of the sheath core 300 are housed in the distal end of the sheath tube 400, thus presenting a compressed state. The state of the embolism protection device 100 housed in the sheath tube 400 in Embodiment 1 is similar to... Figure 12 resemblance.

[0056] Before the operation, one end of the embolization protection device 500 needs to be fixed at a suitable position at the distal end of the sheath core 300. The proximal end of the embolization protection device 500 can be fixed to the sheath core 300, and the distal end can be relatively fixed by passing through the distal end of the sheath core 300 through the provided sliding constraint ring 160. Alternatively, the distal end of the embolization protection device 500 can be fixed to the sheath core 300, and the proximal end can be relatively fixed by passing through the distal end of the sheath core 300 through the provided sliding constraint ring 160. Figure 13 The example described is that the proximal end of the embolization protection device 500 is fixed to the distal end of the sheath core 300, and the distal end is relatively fixed by a sliding constraint ring 160 located on the frame 110 passing through the distal end of the sheath core 300. The surgical procedure is largely the same as that in Example 1, and will not be described again here.

[0057] The sliding constraint ring 160 on the embolization protection device 500 ensures that the embolization protection device 500 always slides along the axial direction of the sheath core 300 during the release, deployment and retraction process, which can well conform to the curvature of the aortic arch 200, thereby further reducing the risk of excessive torsion or deflection of the embolization protection device 500.

[0058] 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.

[0059] 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 embolic protection device comprising a frame and a filter mesh covering the frame, characterized in that, The embolic protection device further comprises a plurality of support rods arranged along the axial direction of the device, each of the support rods comprising a first end, a second end, and at least one distal head, the heads of adjacent two of the support rods being arranged at a distance and being suspended, at least one of the heads being curved and extending towards the frame, the first end and the second end being connected to opposite sides of the frame, respectively, a first line segment being formed between the first end and the head, and a second line segment being formed between the second end and the head, the first line segment extending from the first end towards the head and gradually away from the frame, and the second line segment extending from the second end towards the head and gradually away from the frame, so that the plurality of support rods supports the filter screen on the plurality of support rods and raises the filter screen away from the frame.

2. The embolic protection device according to claim 1, wherein, When the embolic protection device is placed on a horizontal plane, the vertical distance from the highest point on the support rods to the horizontal plane is greater than or equal to 3 mm and less than or equal to 30 mm.

3. The embolic protection device according to claim 2, wherein the distal end of the filter is configured to be positioned within the aortic arch. The vertical distance between the vertical projection of the head on the horizontal plane and the vertical projection of the first end and the second end on the horizontal plane is greater than or equal to 20 mm and less than or equal to 120 mm.

4. The embolic protection device according to claim 3, wherein the distal end of the filter is configured to be positioned within the aortic arch. The shortest distance between the first end and the second end is 20 mm to 100 mm.

5. The embolic protection device according to claim 1, wherein, At least one of the heads is provided with an anti-injury member.

6. The embolic protection device according to claim 1, wherein, The embolic protection device is provided with at least one sliding constraint ring.

7. The embolic protection device according to claim 6, wherein the distal end of the filter is configured to be positioned within the aortic arch. The sliding constraint ring is arranged on the frame of the embolic protection device or at least one of the heads of at least one of the support rods.

8. The embolic protection device according to claim 1, wherein, The proximal end and / or the distal end of the embolic protection device is provided with at least one developing member.

9. An embolic protection system comprising: The embolic protection device comprises an elongated sheath core and the embolic protection device according to any one of claims 1 to 8.

10. The embolic protection system of claim 9, wherein the filter is configured to be positioned in the aortic arch. The embolic protection device is provided with at least one sliding constraint ring, one end of the embolic protection device is fixed on the sheath core, and the other end can move axially along the sheath core through the sliding constraint ring.

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