Double-layer embolism protection device and embolism protection system

Abstract

The invention provides a double-layer embolism protection device and an embolism protection system.The double-layer embolism protection device comprises a wall-attached support, a conveying guide wire, a first intercepting filter screen and a second intercepting filter screen, and the wall-attached support is provided with a deformable containing space; the conveying guide wire is arranged in the wall-attached support in a penetrating mode, and the wall-attached support is connected with the conveying guide wire. First filter holes are formed in the first intercepting filter screen, the first intercepting filter screen is arranged around the conveying guide wire, the near end of the first intercepting filter screen is connected to the far end of the wall-attached support, and the far end of the first intercepting filter screen is slidably connected to the conveying guide wire; second filter holes are formed in the second intercepting filter screen, the second intercepting filter screen is arranged around the conveying guide wire and arranged on the outer side of the first intercepting filter screen in a sleeving mode, the near end of the second intercepting filter screen is connected to the far end of the wall-attached support, and the far end of the second intercepting filter screen is connected to the conveying guide wire in a sliding mode. The thrombus or plaque filtering device can effectively filter thrombus or plaque and prevent thrombus or plaque from flowing to the downstream of the blood vessel.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a double-layer embolic protection device and an embolic protection system. Background Art

[0002] Embolic protection devices, also known as distal embolic protectors or umbrellas, are generally used more in carotid and coronary artery interventions. They are used to capture and remove embolic materials (such as thrombi and plaques) during vascular interventional procedures to provide protection against distal vascular embolism.

[0003] Embolic protection devices are generally divided into two types, one is a balloon-type embolic protection device, and the other is a filter-type protection device. The former cannot be used for a long time, otherwise it will cause ischemia risk, and it is impossible to effectively remove all plaques, so the latter is used more. However, for the existing filter-type protection device, it still has the following problems: First, the existing filter-type protection device uses a single filter structure to filter thrombi (or plaques), and the thrombus (or plaque) interception effect is poor, and some thrombi (or plaques) will still flow to the downstream of the blood vessel; second, when encountering too many or large thrombi (or plaques), it is easy to block bleeding; second, due to the poor flexibility and wall adhesion performance of the existing embolic protection device, it is interfered by subsequent treatment equipment during use, and it is easy to have problems such as poor wall adhesion and displacement, which leads to some unfiltered blood flowing from the gap between the elastic filter membrane and the blood vessel wall to the distal end of the blood vessel, and the probability of embolus escape is high, blocking the distal blood vessel and causing distal tissue necrosis.

[0004] Therefore, it is necessary to at least provide a double-layer embolic protection device that can effectively filter thrombi or plaques, and to provide an embolic protection system having the double-layer embolic protection device. Summary of the invention

[0005] The first object of the present invention is to provide a double-layer embolic protection device that can effectively filter thrombi or plaques.

[0006] A second object of the present invention is to provide an embolic protection system having a double-layer embolic protection device that can effectively filter thrombi or plaques.

[0007] To achieve the above-mentioned first purpose, the present invention provides a double-layer embolic protection device, including a wall-attached stent, a delivery guidewire, a first interception filter and a second interception filter, the wall-attached stent having a deformable accommodating space; the delivery guidewire is inserted into the wall-attached stent, and the wall-attached stent is connected to the delivery guidewire; the first interception filter is provided with a plurality of first filter holes connected to the accommodating space, the first interception filter is arranged around the delivery guidewire, and the proximal end of the first interception filter is connected to the distal end of the wall-attached stent along the circumferential direction of the distal end of the wall-attached stent, and the distal end of the first interception filter is slidably connected to the delivery guidewire; the second interception filter is provided with a plurality of second filter holes, the second interception filter is arranged around the delivery guidewire and is sleeved on the outer side of the first interception filter, and the proximal end of the second interception filter is connected to the distal end of the wall-attached stent along the circumferential direction of the distal end of the wall-attached stent, and the distal end of the second interception filter is slidably connected to the delivery guidewire.

[0008] Compared with the prior art, the double-layer embolic protection device of the present invention respectively sets a first interception filter and a second interception filter at the distal end of the wall-attached stent, and the second interception filter is arranged on the outside of the wall-attached stent. During use, blood passes through the accommodating space of the wall-attached stent, the first filter hole of the first interception filter and the second filter hole of the second interception filter in sequence, and thus flows to the downstream of the blood vessel, thereby achieving the purpose of double interception and filtration of thrombi or plaques in the blood, achieving the effect of effectively filtering thrombi or plaques, and preventing thrombi or plaques from flowing to the downstream of the blood vessel.

[0009] Preferably, a gathering piece is provided at the proximal end of the wall-attached stent, and the delivery guide wire is connected to the gathering piece.

[0010] Preferably, the wall-attached bracket includes a wall-attached bracket body and a plurality of connecting rods, the proximal end of each connecting rod is respectively connected to the gathering piece, the distal end of each connecting rod is respectively connected to the proximal end of the wall-attached bracket body, and the wall-attached bracket body and the connecting rods surround the accommodating space; the proximal end of the first intercepting filter net and the proximal end of the second intercepting filter net are respectively connected to the distal end of the wall-attached bracket body.

[0011] Preferably, the wall-attached bracket body includes a first support unit and a second support unit, the first support unit and the second support unit are both annular wavy structures, a plurality of the first support units and the second support units are alternately arranged along the axial direction, and there are a plurality of adjacent wave peaks between adjacent first support units and second support units, and the adjacent wave peaks between the first support unit and the second support unit are connected to form a first connecting portion.

[0012] Preferably, the first connecting portions in two adjacent annular directions of the wall-adherent stent body are staggered.

[0013] Preferably, the wave peaks between the first support unit and the second support unit located at the proximal end and adjacent to each other correspond one-to-one and are connected to form a second connection portion; or / and, the wave peaks between the first support unit and the second support unit located at the distal end and adjacent to each other correspond one-to-one and are connected to form a third connection portion.

[0014] Preferably, the outer surface of the adherent stent is provided with a biocompatible film.

[0015] Preferably, the distal end of the delivery guide wire is provided with an elastic end portion.

[0016] Preferably, there is a filtering gap between the first intercepting filter screen and the second intercepting filter screen.

[0017] Preferably, the first intercepting filter has at least one of the following characteristics: (1) the proximal end of the first intercepting filter is an open structure, and the distal end of the first intercepting filter is a closed structure; (2) the area of ​​each of the first filter holes gradually decreases from the proximal end to the distal end of the first intercepting filter.

[0018] Preferably, the second intercepting filter has at least one of the following characteristics: (1) the proximal end of the second intercepting filter is an open structure, and the distal end of the second intercepting filter is a closed structure; (2) the area of ​​each of the second filter holes gradually decreases from the proximal end to the distal end of the second intercepting filter.

[0019] Preferably, the area of ​​the second filter hole is smaller than the area of ​​the first filter hole.

[0020] Preferably, the surfaces of the first interception filter and the second interception filter are provided with a porcine intestinal mucosal heparin coating or a water-soluble antispasmodic drug coating.

[0021] To achieve the above-mentioned second purpose, the present invention provides an embolic protection system, including a delivery catheter and the above-mentioned double-layer embolic protection device, wherein a delivery channel is provided in the delivery catheter, the double-layer embolic protection device can be slidably disposed in the delivery channel, and the inner wall of the delivery channel can squeeze the wall-attached bracket.

[0022] Compared with the prior art, the embolic protection system of the present invention has a double-layer embolic protection device, which is provided with a first interception filter and a second interception filter at the distal end of the wall-attached stent, and the second interception filter is arranged on the outside of the wall-attached stent. During use, the double-layer embolic protection device is released through the delivery channel of the delivery catheter, so that the double-layer embolic protection device filters blood at a designated position; wherein the wall-attached stent can abut against the inner wall of the blood vessel, thereby being anchored at a targeted position on the inner wall of the blood vessel, and the radial support force formed between the wall-attached stent and the inner wall of the blood vessel can ensure The wall-attached stent is firmly positioned on the inner wall of the blood vessel without damaging the blood vessel, thereby preventing thrombus or plaque from flowing from the gap between the wall-attached stent and the inner wall of the blood vessel to the distal end of the blood vessel. Therefore, the probability of thrombus 301 or plaque escape is very low; the blood passes through the accommodating space of the wall-attached stent, the first filter hole of the first interception filter net, and the second filter hole of the second interception filter net in sequence, thereby flowing to the downstream of the blood vessel, achieving the purpose of double interception and filtration of thrombus or plaque in the blood, reducing the phenomenon of blocked bleeding, achieving the effect of effectively filtering thrombus or plaque, and preventing thrombus or plaque from flowing to the downstream of the blood vessel.

[0023] Preferably, it further comprises a retrieval catheter, wherein a retrieval channel is provided in the retrieval catheter, the double-layer embolic protection device is selectively slidably disposed in one of the retrieval channel and the delivery channel, and the distal end of the retrieval catheter has an enlarged opening.

[0024] Preferably, the delivery catheter is connected to the recovery catheter in an integral manner or in a separate manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 1 is a structural diagram of the double-layer embolic protection device of the present invention.

[0026] Figure 2 It is a structural diagram of the connection between the first interception filter and the delivery guide wire of the double-layer embolic protection device of the present invention.

[0027] Figure 3 It is a structural diagram of the connection between the second interception filter and the delivery guide wire of the double-layer embolic protection device of the present invention.

[0028] Figure 4 It is a structural diagram of the connection between the second intercepting filter screen and the delivery guide wire of another embodiment of the double-layer embolic protection device of the present invention.

[0029] Figure 5 It is a structural diagram of the wall-attached stent of the double-layer embolic protection device of the present invention.

[0030] Figure 6 yes Figure 5 The structural diagram of the wall-attached stent after unfolding is shown.

[0031] Figure 7 yes Figure 6 Enlarged view of point A in the middle.

[0032] Figure 8 It is a structural diagram of the embolic protection system of the present invention when a double-layer embolic protection device is delivered in a blood vessel through a delivery catheter.

[0033] Fig. 9 It is a structural diagram of the delivery catheter of the embolic protection system of the present invention after releasing the double-layer embolic protection device.

[0034] Fig.10 It is a structural diagram of the connection between the delivery catheter and the recovery catheter of the embolic protection system of the present invention.

[0035] Fig.11 It is a structural diagram of the double-layer embolic protection device of the embolic protection system of the present invention when it is retracted into the delivery catheter.

[0036] Fig.12 It is a structural diagram of the retrieval catheter of the embolic protection system of the present invention when retrieving the double-layer embolic protection device. DETAILED DESCRIPTION

[0037] In order to explain the technical content and structural features of the present invention in detail, further description will be given below in combination with the implementation modes and the accompanying drawings.

[0038] See also Figures 1 to 3 The present invention provides a double-layer embolic protection device 100, which includes a wall-attached bracket 1, a delivery guide wire 2, a first interception filter 3 and a second interception filter 4, the wall-attached bracket 1 has a deformable accommodating space 11; the delivery guide wire 2 is inserted into the wall-attached bracket 1, and the wall-attached bracket 1 is connected to the delivery guide wire 2; the first interception filter 3 is provided with a plurality of first filter holes 31 connected to the accommodating space 11, the first interception filter 3 is arranged around the delivery guide wire 2, and the proximal end of the first interception filter 3 is connected to the distal end of the wall-attached bracket 1 along the circumferential direction of the distal end of the wall-attached bracket 1, and the distal end of the first interception filter 3 is slidably connected to the delivery guide wire 2; the second interception filter 4 is provided with a plurality of second filter holes 41, the second interception filter 4 is arranged around the delivery guide wire 2 and is sleeved on the outside of the first interception filter 3, and the proximal end of the second interception filter 4 is connected to the distal end of the wall-attached bracket 1 along the circumferential direction of the distal end of the wall-attached bracket 1, and the distal end of the second interception filter 4 is slidably connected to the delivery guide wire 2.

[0039] Among them, the wall-attached stent 1 adopts an elastically deformable structure, so that the wall-attached stent 1 can be squeezed and shrunk or released and expanded and opened, and the accommodating space 11 of the wall-attached stent 1 becomes larger or smaller with the deformation. When the wall-attached stent 1 is expanded and opened, the wall-attached stent 1 can abut against the inner wall of the blood vessel 300, so as to be anchored at the target position of the inner wall of the blood vessel 300. The radial support force formed between the wall-attached stent 1 and the inner wall of the blood vessel 300 can ensure that the wall-attached stent 1 is firmly positioned on the inner wall of the blood vessel 300, and at the same time will not damage the blood vessel 300, and prevent the thrombus 301 or plaque from flowing from the gap between the wall-attached stent 1 and the inner wall of the blood vessel 300 to the distal end of the blood vessel 300, so that the probability of thrombus 301 or plaque escape is very low. Since the first interception filter 3 and the second interception filter 4 are respectively arranged at the distal end of the wall-attached stent 1, and the second interception filter 4 is arranged outside the wall-attached stent 1, during use, the blood sequentially passes through the accommodating space 11 of the wall-attached stent 1, the first filter hole 31 of the first interception filter 3 and the second filter hole 41 of the second interception filter 4, and then flows to the downstream of the blood vessel 300, achieving the purpose of double interception and filtration of the thrombus 301 or plaque in the blood. Figure 1 In one embodiment, a gathering piece 12 is provided at the proximal end of the wall-adherent stent 1, and the delivery guide wire 2 is connected to the gathering piece 12. The wall-adherent stent 1 can be squeezed and shrunk or released and expanded and opened with the gathering piece 12 as a fixed point.

[0040] See also Figure 1 In one embodiment, a first developing member is provided on the gathering member 12. The first developing member can be used as a key developing mark for surgical reference, which is convenient for doctors to observe and understand the proximal position of the wall-attached stent 1, so as to determine the release and recovery position of the double-layer embolic protection device 100 of the present invention, thereby improving surgical efficiency and surgical safety.

[0041] See also Figure 1 In one embodiment, the wall-attached bracket 1 includes a wall-attached bracket body 13 and a plurality of connecting rods 14, the proximal ends of the connecting rods 14 are respectively connected to the gathering piece 12, and the distal ends of the connecting rods 14 are respectively connected to the proximal ends of the wall-attached bracket body 13, and the wall-attached bracket body 13 and the connecting rods 14 are surrounded by a accommodating space 11; the proximal ends of the first intercepting filter net 3 and the proximal ends of the second intercepting filter net 4 are respectively connected to the distal ends of the wall-attached bracket body 13.

[0042] See also Figures 5 to 7In one embodiment, the wall-attached bracket body 13 includes a first support unit 131 and a second support unit 132. The first support unit 131 and the second support unit 132 are both annular wave-shaped structures. A plurality of first support units 131 and second support units 132 are alternately arranged along the axial direction, and there are a plurality of adjacent wave crests between adjacent first support units 131 and second support units 132. The adjacent wave crests between the first support unit 131 and the second support unit 132 are connected to form a first connecting portion 133. Figure 7 As shown, the wave crest 131 a of the first supporting unit 131 and the wave crest 132 a of the second supporting unit 132 are adjacent to each other and connected to form a first connecting portion 133 .

[0043] Among them, the annular wavy structure of the first support unit 131 and the second support unit 132 can adopt multiple V-shaped components arranged in sequence along the circumferential direction, the opening directions of two adjacent V-shaped components are the same, and multiple V-shaped structural parts are connected end to end in sequence, but not limited to this. For example, multiple U-shaped components or other shapes can also be used.

[0044] The number of first connection parts 133 formed between adjacent first support units 131 and second support units 132 can be one, two, three, etc. The more the number of first connection parts 133 is, the stronger the support performance of the wall-attached bracket 1 is, but the compliance performance is reduced. The number of first connection parts 133 between adjacent first support units 131 and second support units 132 is determined according to the design requirements of the support performance and compliance performance of the wall-attached bracket 1.

[0045] Through the above arrangement, the flexibility and fatigue resistance of the wall-adhering stent 1 are improved. Under the premise of low stimulation to the blood vessel 300, the wall-adhering effect of the wall-adhering stent 1 is enhanced to adapt to the requirements of the curved blood vessel 300 and the active blood vessel 300 for the wall-adhering stent 1.

[0046] In one embodiment, the first connection parts 133 in two adjacent annular directions of the wall-attached bracket body 13 are staggered. In the two adjacent annular directions of the wall-attached bracket body 13, there are two rows of first connection parts 133, and the first connection parts 133 in the two rows are staggered. In the same row, the distance between two adjacent first connection parts 133 is equal, but this is not limited to this. For example, in other embodiments, the distance between two adjacent first connection parts 133 may also be unequal.

[0047] In one embodiment, the wave crests between the first support unit 131 and the second support unit 132 located at the proximal end and adjacent to each other correspond to each other and are connected to form a second connection portion 134, so that the proximal end of the wall-attached stent body 13 is a closed loop structure. The second connection portion 134 is a strip-shaped structure, and the second connection portion 134 extends along the axial direction, but is not limited thereto. For example, in other embodiments, the second connection portion 134 may also form a certain angle with the axial direction.

[0048] In one embodiment, the wave crests between the first support unit 131 and the second support unit 132 located at the distal end and adjacent to each other correspond to each other and are connected to form a third connection portion 135, so that the distal end of the wall-attached stent body 13 is a closed loop structure. The third connection portion 135 is a strip-shaped structure, and the third connection portion 135 extends along the axial direction, but is not limited thereto. For example, in other embodiments, the third connection portion 135 may also form a certain angle with the axial direction.

[0049] In one embodiment, the material of the wall-attached stent 1 can be nickel-titanium alloy. The nickel-titanium alloy stent has a shape memory effect and can maintain elastic deformation under large deformation. The wall-attached stent 1 made of nickel-titanium alloy is compressed and transported to the blood vessel 300. When the wall-attached stent 1 reaches the phase change temperature, the shape memory effect of the stent is induced, causing it to automatically expand and deform to the release size. After being implanted, the wall-attached stent 1 is also affected by the contraction pulsation of the inner wall of the blood vessel 300. Therefore, under the interaction force between the wall-attached stent 1 and the inner wall of the blood vessel 300, the wall-attached stent 1 can be firmly anchored on the inner wall of the blood vessel 300.

[0050] In one embodiment, a second developing member 136 is provided on the wall-attached stent body 13. The second developing member 136 is arranged on at least one of the proximal end, the middle side position and the distal end of the wall-attached stent body 13. Specifically, by arranging the second developing member 136 at the middle side position of the wall-attached stent body 13, which middle side position can be on the outer common edge of the wall-attached stent body 13, the developing area of ​​the wall-attached stent body 13 can be as large as possible, so as to improve the accuracy of the release or recovery position of the wall-attached stent body 13, thereby improving the surgical efficiency and increasing the safety of the surgery. In order to further improve the developing property of the wall-attached stent body 13, the second developing member 136 can also be arranged on the proximal end and the distal end of the wall-attached stent body 13.

[0051] In one embodiment, a biocompatible film is provided on the outer surface of the wall-attached stent 1. The outer surface of the biocompatible film is closer to the local structure of the blood vessel 300, which is more conducive to protecting the blood vessel 300. In this embodiment, the biocompatible film also has a certain elasticity, so that the wall-attached stent 1 combined with the biocompatible film can better abut against the blood vessel 300 to anchor in a designated position, avoiding the problem of movement of the wall-attached stent 1 during surgery. In addition, the provision of the biocompatible film closes the gap between the wall-attached stent 1 and the inner wall of the blood vessel 300, further reducing the chance of thrombus 301 escaping from the gap between the wall-attached stent 1 and the inner wall of the blood vessel 300.

[0052] See also Figures 1 to 4 In one embodiment, the distal end of the delivery guide wire 2 is provided with an elastic end 21. The elastic end 21 is a soft structure, so that the delivery guide wire 2 reduces the damage to the blood vessel 300 when it moves in the blood vessel 300. Further, the elastic end 21 can be a developing spring, and the developing spring can be wound with one or more of platinum iridium wire, platinum tungsten wire, and tungsten gold wire materials, so as to facilitate the display of the real-time position of the delivery guide wire 2, but it is not limited to this. For example, the elastic end 21 can also be made of other materials with good biocompatibility, certain elasticity or softness.

[0053] See also Figures 1 to 3 In one embodiment, there is a filtering gap 5 between the first intercepting filter 3 and the second intercepting filter 4. After the wall-attached support 1 expands and opens and drives the first intercepting filter 3 and the second intercepting filter 4 to open, the first intercepting filter 3 and the second intercepting filter 4 are spaced apart and form a filtering gap 5, so that when the blood passing through the first intercepting filter 3 is filtered by the second intercepting filter 4, the thrombus 301 or plaque still existing in the blood can be intercepted and retained in the filtering gap 5, which is conducive to ensuring the normal passage of blood and is not prone to blood blockage, perfusion or turbulence. In addition, if there are large thrombi 301 or plaques, after being captured by the first interception filter 3, the first interception filter 3 can cut the large thrombi 301 or plaques into small pieces under the action of blood flow impact power, and the small thrombi 301 or plaques are finally intercepted by the second interception filter 4. In this way, the thrombi 301 are intercepted in layers, which also reduces the interception burden of the first interception filter 3 or the second interception filter 4, and is less likely to cause the problem of blocking bleeding, thereby improving the effect of the first interception filter 3 and the second interception filter 4 in filtering thrombi 301 or plaques. Please refer to Figures 1 to 4In one embodiment, the proximal end of the first interception filter 3 is an open structure, and the distal end of the first interception filter 3 is a closed structure. Specifically, the second interception filter 4 is a conical structure, and the diameter of the second interception filter 4 gradually decreases from the proximal end to the distal end. The conical design allows the inclined filter structure used to reduce the impact strength of the blood flow containing the thrombus 301 during the interception process, and the filtered thrombus 301 with a larger particle size will accumulate around the second interception filter 4, which can effectively avoid the blockage of the second interception filter 4, which is conducive to improving the effect of the first interception filter 3 filtering the thrombus 301 or plaque.

[0054] In one embodiment, the area of ​​each first filter hole 31 gradually decreases from the proximal end to the distal end of the first interception filter 3, which is beneficial to improving the effect of the first interception filter 3 in filtering thrombus 301 or plaque.

[0055] In one embodiment, the proximal end of the second intercepting filter 4 is an open structure, and the distal end of the second intercepting filter 4 is a closed structure. In order to facilitate the development of the distal position of the second intercepting filter 4 during surgery, a third developing member 42 is provided at the closed structure. By providing the third developing member 42, the distal position of the second intercepting filter 4 can be developed during surgery, so that the doctor can observe and understand the distal position of the second intercepting filter 4. Specifically, the second intercepting filter 4 is a conical structure, and the diameter of the second intercepting filter 4 gradually decreases from the proximal end to the distal end, which is conducive to improving the effect of the second intercepting filter 4 in filtering thrombi 301 or plaques.

[0056] In one embodiment, the area of ​​each second filter hole 41 gradually decreases from the proximal end to the distal end of the second interception filter 4, which is beneficial to improving the effect of the second interception filter 4 in filtering thrombus 301 or plaque.

[0057] In one embodiment, the area of ​​the second filter hole 41 is smaller than that of the first filter hole 31. The large thrombus 301 or plaque is first filtered through the first interception filter 3, and the small thrombus 301 or plaque passes through the first filter hole 31 and enters the filter gap 5 between the first interception filter 3 and the second interception filter 4. The small thrombus 301 or plaque can be filtered by the second filter hole 41 and stay in the filter gap 5 between the first interception filter 3 and the second interception filter 4. By filtering the thrombus 301 or plaque in layers, the filtering effect is improved, and the interception pressure of the first interception filter 3 and the second interception filter 4 can also be reduced, thereby reducing the phenomenon of blocking bleeding.

[0058] See also Figure 1 In one embodiment, the proximal end of the second intercepting filter net 4 is flush with the proximal end of the first intercepting filter net 3 .

[0059] See also Figures 1 to 4In one embodiment, the first interception filter 3 is a polymer filter, and the second interception filter 4 is a metal filter or a combination filter of a metal skeleton 43 and a polymer filter membrane 44. The first interception filter 3 located in the inner layer is a polymer filter. Compared with metal weaving, under the same pore size, the diameter of the polymer filter after folding is smaller, and the expansion force on the blood vessel 300 after opening is smaller. The second interception filter 4 located in the outer layer has a certain mechanical strength by using a combination filter of a metal filter or a metal skeleton 43 and a polymer filter membrane 44. When the second interception filter 4 in the outer layer is expanded and opened, it can drive the first interception filter 3 in the inner layer to expand and open.

[0060] In one embodiment, the metal material of the second intercepting filter 4 is nickel-titanium alloy, cobalt-chromium alloy or stainless steel, so as to improve the convenience of connection with the metal wall-attached bracket 1. In other embodiments, the second intercepting filter 4 can also be integrally formed with the wall-attached bracket 1.

[0061] In one embodiment, the surfaces of the first interception filter 3 and the second interception filter 4 are provided with a porcine intestinal mucosal heparin coating. By providing the porcine intestinal mucosal heparin coating on the surfaces of the first interception filter 3 and the second interception filter 4, it is ensured that the first interception filter 3 and the second interception filter 4 remain in an open state during deployment, and the fitting area between the second interception filter 4 and the wall of the blood vessel 300 is increased, so that emboli with a larger diameter can be captured, and it is also helpful to maintain the patency of the first interception filter 3 and the second interception filter 4, avoid the first interception filter 3 and the second interception filter 4 from being blocked, and improve the efficiency of capturing thrombi 301 or plaques in the blood vessel 300.

[0062] In one embodiment, the surfaces of the first interception filter 3 and the second interception filter 4 are provided with a water-soluble antispasmodic drug coating, which can reduce the risk of intraoperative spasm of the carotid artery 300. The water-soluble antispasmodic drug coating can be a coating such as atropine, papaverine hydrochloride, heparin, etc.

[0063] In one embodiment, the outer surface of the delivery guidewire 2 is provided with a polytetrafluoroethylene coating, thereby increasing the lubricity of the delivery guidewire 2, improving the smoothness of the delivery guidewire 2 when pushed in the delivery catheter, and reducing the damage caused by the delivery guidewire 2 to the blood vessel.

[0064] In one embodiment, a scale line is provided at the proximal end of the delivery guide wire 2 to facilitate the doctor to understand the length of the delivery guide wire 2 pushed.

[0065] See also Figure 8 and Fig. 9The present invention also provides an embolic protection system 200, which includes a delivery catheter 201 and the above-mentioned double-layer embolic protection device 100. A delivery channel 201a is provided in the delivery catheter 201. The double-layer embolic protection device 100 can be slidably disposed in the delivery channel 201a, and the inner wall of the delivery channel 201a can accommodate the wall-attached stent 1. Since the wall-attached stent 1 is connected to the delivery guide wire 2 through the gathering member 12, the flexibility of the wall-attached stent 1 and the distal ends of the first interception filter 3 and the second interception filter 4 are slidably connected to the delivery guide wire 2. When the delivery catheter 201 compresses the double-layer embolic protection device 100, the wall-attached stent 1 will be gathered toward the center of the delivery guide wire, and the distal ends of the first interception filter 3 and the second interception filter 4 will extend and gather toward the distal end of the delivery guide wire. When the delivery catheter is separated from the double-layer embolic protection device 100, the wall-attached stent 1 automatically expands and deforms to a release size due to its shape memory effect, and the wall-attached stent 1 is released and opens, driving the first interception filter 3 and the second interception filter 4 to open.

[0066] See also Figures 10 to 12 In one embodiment, the embolic protection system 200 further includes a retrieval catheter 202, in which a retrieval channel 202a is provided, and the double-layer embolic protection device 100 is selectively slidably disposed in one of the retrieval channel 202a and the delivery channel 201a.

[0067] See also Figures 10 to 12 In one embodiment, the distal end of the recovery catheter 202 has an enlarged opening 202a1 to facilitate guiding the double-layer embolic protection device 100 during recovery and to squeeze the wall-adherent stent 1, so that the double-layer embolic protection device 100 can be quickly and effectively recovered into the recovery channel 202a of the recovery catheter 202. In addition, when there are too many thrombi 301 or plaques intercepted by the first interception filter 3 and the second interception filter 4, only the wall-adherent stent 1 can enter the recovery catheter 202, so as to avoid leakage of thrombi 301 or plaques due to forced recovery of the double-layer embolic protection device 100.

[0068] Please continue reading Figures 10 to 12The delivery catheter 201 is connected to the recovery catheter 202 in an integral manner or in a split manner. When one end of the delivery catheter 201 is connected to one end of the recovery catheter 202, the connection between the delivery catheter 201 and the recovery catheter 202 forms an intermediate connection section 203. The delivery catheter 201 is provided with a delivery hole 201b near the intermediate connection section 203. The delivery hole 201b provides a delivery entrance for the double-layer embolic protection device 100. The delivery catheter 201 is provided with a guide wire exchange port 201c at a position away from the intermediate connection section 203. The guide wire exchange port 201c is used for the guide wire 400 to pass. The recovery catheter 202 is provided with a recovery hole 202b near the intermediate connection section 203. The recovery hole 202b is used for the recovery of the double-layer embolic protection device 100.

[0069] See also Figures 8 to 12 The specific working principle of the embolic protection system 200 of the present invention is as follows:

[0070] Delivery steps: First, insert the rear end of the delivery guide wire 2 into the delivery catheter 201 from the front end of the delivery catheter 201 and pass through the delivery hole 201b of the delivery catheter 201. Hold the delivery catheter 201 and pull the rear end of the delivery guide wire 2 until the double-layer embolic protection device 100 is completely pulled into the delivery catheter 201, and the distal end of the double-layer embolic protection device 100 is located at the rear side of the guide wire exchange port 201c; then insert the guide wire 400 from the guide wire exchange port 201c into the interior of the delivery catheter 201, and the front end of the guide wire 400 passes through the front end of the delivery catheter 201; then slowly push the delivery catheter 201 and the guide wire into the human body. 400, ensure that the guide wire 400 delivers the delivery catheter 201 to the distal end of the affected area. After reaching the distal end of the affected area, withdraw the guide wire 400, hold the delivery guide wire 2, and withdraw the delivery catheter 201, thereby releasing the double-layer embolic protection device 100, and the wall-attached stent 1 is released and opened, and drives the first interception filter 3 and the second interception filter 4 to open. At this time, the delivery guide wire 2 can be used to place a stent or catheter to treat the affected area. During the treatment, the double-layer embolic protection device 100 in the open state intercepts and filters the thrombus 301 or plaque in the blood to prevent the thrombus 301 or plaque from entering the downstream blood vessel 300 and causing downstream tissue necrosis.

[0071] Recovering step: After the treatment of the affected area is completed and the related treatment accessories are withdrawn, the rear end of the delivery guide wire 2 is inserted into the recovery catheter 202 from the front end of the recovery catheter 202, and the rear end of the delivery guide wire 2 is passed out from the recovery hole 202b, and the recovery catheter 202 is slowly pushed forward, so that the double-layer embolic protection device 100 intercepted with the thrombus 301 or plaque is gradually compressed and covered in the recovery catheter 202, and then the delivery guide wire 2 and the recovery catheter 202 are withdrawn from the blood vessel 300 together, thereby achieving the purpose of recovering the double-layer embolic protection device 100.

[0072] In summary, the embolic protection system 200 of the present invention has a double-layer embolic protection device 100. The double-layer embolic protection device 100 is provided with a first interception filter 3 and a second interception filter 4 at the distal end of the wall-attached stent 1, and the second interception filter 4 is arranged on the outside of the wall-attached stent 1. During use, the double-layer embolic protection device 100 is released through the delivery channel 201a of the delivery catheter 201, and the wall-attached stent 1 of the double-layer embolic protection device 100 can be expanded and opened, and drive the first interception filter 3 and the second interception filter 4 to open, so that the double-layer embolic protection device 100 filters the blood at a designated position; wherein, the wall-attached stent 1 can abut against the inner wall of the blood vessel 300, thereby being anchored at a targeted position on the inner wall of the blood vessel 300, and the wall-attached stent 1 and the blood vessel The radial supporting force formed between the inner walls of 300 can ensure that the wall-attached stent 1 is firmly positioned on the inner wall of the blood vessel 300 without damaging the blood vessel 300, thereby preventing the thrombus 301 or plaque from flowing from the gap between the wall-attached stent 1 and the inner wall of the blood vessel 300 to the distal end of the blood vessel 300. Therefore, the probability of thrombus 301 or plaque escape is very low; the blood passes through the accommodating space 11 of the wall-attached stent 1, the first filter hole 31 of the first interception filter net 3 and the second filter hole 41 of the second interception filter net 4 in sequence, and thus flows to the downstream of the blood vessel 300, thereby achieving the purpose of double interception and filtration of the thrombus 301 or plaque in the blood, reducing the phenomenon of blocking bleeding, achieving the effect of effectively filtering the thrombus 301 or plaque, and preventing the thrombus 301 or plaque from flowing to the downstream of the blood vessel 300.

[0073] The above disclosure is only a preferred embodiment of the present invention, which cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are all within the scope of the present invention.

Claims

1. A double-layer embolic protection device, characterized in that: include: A wall-attached bracket, wherein the wall-attached bracket has a deformable accommodation space; A delivery guide wire, the delivery guide wire is inserted into the wall-adherent stent, and the wall-adherent stent is connected to the delivery guide wire; A first interception filter net, wherein the first interception filter net is provided with a plurality of first filter holes communicating with the accommodating space, the first interception filter net is arranged around the delivery guide wire, and the proximal end of the first interception filter net is connected to the distal end of the wall-attached stent along the circumferential direction of the distal end of the wall-attached stent, and the distal end of the first interception filter net is slidably connected to the delivery guide wire; A second intercepting filter net, wherein a plurality of second filter holes are provided on the second intercepting filter net, the second intercepting filter net is arranged around the conveying guide wire and is sleeved on the outer side of the first intercepting filter net, and the proximal end of the second intercepting filter net is connected to the distal end of the wall-attached bracket along the distal circumferential direction of the wall-attached bracket, and the distal end of the second intercepting filter net is slidably connected to the conveying guide wire.

2. The double-layer embolic protection device according to claim 1, characterized in that: A gathering piece is provided at the proximal end of the wall-adherent stent, and the delivery guide wire is connected to the gathering piece.

3. The double-layer embolic protection device according to claim 2, characterized in that: The wall-attached bracket comprises a wall-attached bracket body and a plurality of connecting rods, the proximal end of each connecting rod is respectively connected to the gathering member, the distal end of each connecting rod is respectively connected to the proximal end of the wall-attached bracket body, and the wall-attached bracket body and the connecting rods are surrounded by the accommodating space; The proximal end of the first interception filter net and the proximal end of the second interception filter net are respectively connected to the distal end of the wall-attached bracket body.

4. The double-layer embolic protection device according to claim 3, characterized in that: The wall-attached bracket body includes a first support unit and a second support unit, the first support unit and the second support unit both have an annular wavy structure, a plurality of the first support units and the second support units are alternately arranged along the axial direction, and there are a plurality of adjacent wave peaks between adjacent first support units and second support units, and the adjacent wave peaks between the first support unit and the second support unit are connected to form a first connecting portion.

5. The double-layer embolic protection device according to claim 4, characterized in that: The first connection portions in two adjacent annular directions of the wall-adherent stent body are staggered.

6. The double-layer embolic protection device according to claim 4, characterized in that: The wave crests between the first support unit and the second support unit located at the proximal end and adjacent to each other correspond one-to-one and are connected to form a second connection portion; or / and, the wave crests between the first support unit and the second support unit located at the distal end and adjacent to each other correspond one-to-one and are connected to form a third connection portion.

7. The double-layer embolic protection device according to claim 1, characterized in that: The outer surface of the wall-adherent stent is provided with a biocompatible film.

8. The double-layer embolic protection device according to claim 1, characterized in that: The distal end of the delivery guide wire is provided with an elastic end portion.

9. The double-layer embolic protection device according to claim 1, characterized in that: A filtering gap is provided between the first intercepting filter screen and the second intercepting filter screen.

10. The double-layer embolic protection device according to claim 1, characterized in that: The first interception filter has at least one of the following characteristics: (1) The proximal end of the first intercepting filter is an open structure, and the distal end of the first intercepting filter is a closed structure; (2) The area of ​​each of the first filter holes gradually decreases from the proximal end to the distal end of the first intercepting filter net.

11. The double-layer embolic protection device according to claim 1, characterized in that: The second interception filter has at least one of the following characteristics: (1) The proximal end of the second intercepting filter is an open structure, and the distal end of the second intercepting filter is a closed structure; (2) The area of ​​each of the second filter holes gradually decreases from the proximal end to the distal end of the second intercepting filter.

12. The double-layer embolic protection device according to claim 1, characterized in that: The area of ​​the second filter hole is smaller than the area of ​​the first filter hole.

13. The double-layer embolic protection device according to claim 1, characterized in that: The surfaces of the first interception filter net and the second interception filter net are provided with a porcine intestinal mucosal heparin coating or a water-soluble antispasmodic drug coating.

14. An embolic protection system, characterized in that: It comprises a delivery catheter and a double-layer embolic protection device as described in any one of claims 1 to 13, wherein a delivery channel is provided in the delivery catheter, the double-layer embolic protection device can be slidably disposed in the delivery channel, and the inner wall of the delivery channel can squeeze the wall-attached bracket.

15. The embolic protection system according to claim 14, characterized in that: It also includes a retrieval catheter, in which a retrieval channel is provided. The double-layer embolic protection device is selectively slidably disposed in one of the retrieval channel and the delivery channel. The distal end of the retrieval catheter has an enlarged opening.

16. The embolic protection system according to claim 15, characterized in that: The delivery catheter is connected to the recovery catheter in an integral manner or in a separate manner.

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