A cerebral protection filter assembly

Abstract

The present application relates to the technical field of medical devices, in particular to a brain protection filter assembly, comprising a first frame body and a second frame body connected with the first frame body, the second frame body is provided with a first connecting body for connecting and positioning when the brain protection filter assembly is recovered, the present application has the beneficial effects that the first frame body and the second frame body can simultaneously cover the brachiocephalic trunk artery, the left common carotid artery and the left subclavian artery, ensuring the comprehensiveness of the protection range, in addition, the first connecting body provided on the second frame body can realize the free recovery of the brain protection filter assembly after long-time storage in the patient's body after operation, prolong the foreign body capture time, and improve the efficiency of preventing stroke.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a cerebral protection filter assembly. BACKGROUND

[0002] With the gradual advancement of the development process of TAVR surgery and the continuous increase in the number of surgeries, some postoperative complications have gradually emerged, including the problem of new-onset stroke after TAVR. Previous studies have shown that the incidence of symptomatic new-onset stroke after TAVR is 2% to 5%, but most of the data in previous statistics are for brain strokes with larger infarction areas or severe fatal brain strokes. After monitoring and statistics by head magnetic resonance imaging, it was found that the incidence of new-onset ischemic brain injury of all types after TAVR is higher, which can reach 80% to 90%. Although TAVR technology is continuously developing and surgical experience is continuously improving, the problem of new-onset stroke after TAVR has not been effectively solved.

[0003] New-onset stroke after TAVR can be related to the shedding of calcified substances on the aortic valve during catheter or guidewire operation. During TAVR, any operation that causes debris, emboli, tissue, or foreign matter to fall from a certain part of the vascular access (femoral artery to aortic valve or even to the left ventricle) can lead to new-onset stroke after surgery. Therefore, to reduce the risk of new-onset stroke after TAVR, it is necessary to operate gently and maximize the degree of precision and effectiveness of each step of the operation during TAVR, and to avoid repeated operations during the operation. Through research, it is known that 68% of TAVR-related strokes occur within the first 3 days after surgery, and 80% of TAVR-related strokes occur within a week after surgery. During transcatheter aortic valve replacement (TAVR), the stenotic material around the valve can fall off during the implantation of the artificial valve. In addition, atherosclerosis along the aorta and aortic arch and atherosclerosis in the aorta and aortic arch can fall off when the TAVR catheter is advanced towards the diseased aortic valve and then withdrawn after implantation is complete. In addition, fragments of the catheter itself can be stripped off during delivery and implantation. These various forms of vascular debris, whether native or foreign, can travel into one or more cerebral arteries to form emboli or cause stroke, multiple strokes, or neurocognitive disorders.

[0004] In the treatment of stroke caused by TAVR surgery, some inventors prepare filters or deflector or combined progressive systems to intercept these debris before they enter any cerebral artery, however, most of the existing filters or deflectors or combined progressive systems have the following problems:

[0005] 1. Unable to completely cover the aortic arch, implanting the brachiocephalic trunk and the left common carotid artery, so that the left subclavian artery (branch containing the vertebral artery) accounting for about 10% of cerebral perfusion is not protected;

[0006] 2. The device is unstable in the aorta and can be easily offset by blood flow impact;

[0007] 3. Cannot effectively protect the plaque on the aortic wall from falling off;

[0008] 4. The operation in the artery can promote vascular injury, leading to peeling, arterial thrombosis or embolism;

[0009] 5. Unable to effectively contain thrombus;

[0010] 6. Postoperative thrombosis may occur after the operation, and the device cannot be effectively retrieved after a certain period of time in the body. SUMMARY

[0011] In view of the shortcomings of the prior art, the present application provides a brain protection filter assembly which has comprehensive protection range, stable fixation effect and convenient recovery.

[0012] To achieve the above object, the present application is realized by the following technical scheme.

[0013] The present application provides a brain protection filter assembly, a first frame body arranged in the aortic arch for covering the brachiocephalic trunk or simultaneously covering the brachiocephalic trunk, the left common carotid artery, or simultaneously covering the left common carotid artery, the left subclavian artery, or covering the aortic arch upstream of the brachiocephalic trunk blood flow;

[0014] A second frame body is connected to the first frame body and arranged in one of the brachiocephalic trunk, the left common carotid artery and the left subclavian artery which is not covered by the first frame body and used to cover the artery at the installation position.

[0015] The second frame body is provided with a first connecting body for connecting and positioning when the brain protection filter assembly is recovered.

[0016] Further limited, the above-mentioned brain protection filter assembly, wherein the second frame body comprises a support frame, the support frame has an open end and a closed end, and the support frame is provided with a filter hole.

[0017] Further limited, the above-mentioned brain protection filter assembly, wherein the support frame is covered with a first filter membrane.

[0018] Further limited, the above-mentioned brain protection filter assembly, wherein the support frame is cylindrical and the filter holes are provided on the support frame cylinder wall, the support frame cylinder wall also has nodes between the filter holes, and the support frame has a folding freedom at the nodes to the side of the support frame closed end.

[0019] Further limit, one of the above brain protection filter assembly, wherein the first connector is a hook structure.

[0020] Further limit, one of the above brain protection filter assembly, wherein the first connector is provided in the support frame body closing end.

[0021] Further limit, one of the above brain protection filter assembly, wherein the second frame further comprises:

[0022] Second connector, provided on the support frame;

[0023] The connecting wire, one end is connected with the second connector, the other end is connected with the first frame.

[0024] Further limit, one of the above brain protection filter assembly, wherein the first frame comprises:

[0025] Cylinder, the wall is mesh and inside through the filter cavity is equipped;

[0026] Conical filter body, at least one is provided in the cylinder, its divergent end is connected with the filter cavity inner wall and the convergent end is located at the filter cavity center axis position;

[0027] Wherein, the conical filter body is provided with filter gap.

[0028] Further limit, one of the above brain protection filter assembly, wherein the cylinder wall on the mesh aperture is 50-500 μm.

[0029] Further limit, one of the above brain protection filter assembly, wherein the cylinder, conical filter body is covered with second filter membrane.

[0030] Compared with the prior art, the beneficial effects of the present application at least include:

[0031] 1, the first frame and the second frame are connected, based on the first frame and the second frame setting position can realize the head arm trunk artery, left common carotid artery, left subclavian artery at the same time cover, so as to ensure the comprehensiveness of the protection range, in addition, through the first connector provided on the second frame, the brain protection filter assembly can be recycled after long time storage in the patient's body, so as to prolong the foreign body capture time and improve the efficiency of preventing stroke.

[0032] 2、The first frame body adopts a cylindrical body with a mesh structure and cooperates with a conical filter body located in the cylindrical body. The cylindrical body ensures that the plaque on the inner wall of the blood vessel does not fall off and simultaneously captures foreign matters such as calcified tissue, valve tissue, natural collagen, and thrombus tissue. The conical filter body filters and collects the captured foreign matters, thereby maintaining the patency of the cerebral circulation to reduce the risk of postoperative new-onset stroke.

[0033] 3、The first connecting body is provided at the closing end of the support frame body and has a hook-shaped structure. The opening end of the support frame can be folded outward to the closing end side, so that the installation form of the second frame body has multiple forms, thereby enabling the installation and recovery process of the brain protection filter assembly to select a wider channel and improving the controllability of the surgical operation. BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 It is a specific structure diagram of the brain protection filter mechanism of the embodiment of the present application.

[0035] Figure 2 It is a specific structure diagram of the brain protection filter assembly of the embodiment of the present application.

[0036] Figure 3 It is a specific structure diagram of the brain protection filter assembly of the embodiment of the present application.

[0037] Figure 4 It is a specific structure diagram of the brain protection filter assembly of the embodiment of the present application.

[0038] Figure 5 It is a structure diagram of the "cylindrical body 110" part of the brain protection filter assembly of the embodiment of the present application.

[0039] Figure 6 It is a structure diagram of the "cylindrical body 110" part of the brain protection filter assembly of the embodiment of the present application.

[0040] Figure 7 It is a structure diagram of the "first connecting body" part of the brain protection filter assembly of the embodiment of the present application.

[0041] Figure 8 It is a structure diagram of the "first connecting body" part of the brain protection filter assembly of the embodiment of the present application.

[0042] Figure 9 It is an implementation diagram of the installation and recovery method of the embodiment of the present application.

[0043] Figure 10 It is an implementation diagram of the installation and recovery method of the embodiment of the present application.

[0044] Figure 11 It is an implementation diagram of the installation and recovery method of the embodiment of the present application.

[0045] Reference signs

[0046] Cylinder-110, conical filter-120, anchoring hook-210, support frame-220, connecting part-230, connecting wire-240, base column-250, magnetic buckle-260, anchoring cylinder-270, threaded hole-280, ascending aorta-310, descending aorta-320, aortic arch-330, left subclavian artery-340, left common carotid artery-350, head and arm trunk artery-360. DETAILED DESCRIPTION

[0047] The technical solutions in the embodiments of the present application will be clearly described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art belong to the scope of protection of the present application.

[0048] The terms "first", "second", and the like in the specification and claims of the present application are used to distinguish similar objects, and are not used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged under appropriate circumstances, so that the embodiments of the present application can be implemented in an order other than those illustrated or described herein, and the objects distinguished by "first", "second", etc. are generally a category and do not limit the number of objects, for example, the first object can be one or more. In addition, "and / or" in the specification and claims indicates at least one of the connected objects, and the character " / ", generally indicates that the front and rear associated objects are in a "or" relationship.

[0049] The brain protection filter assembly provided by the embodiments of the present application will be described in detail below in combination with the drawings and specific embodiments and application scenarios.

[0050] Embodiment 1:

[0051] As shown in the drawings, Figures 1-3 The present application provides a brain protection filter assembly, which comprises a cylinder 110 with a mesh structure and a filter cavity inside, the cylinder 110 is used to support the blood vessel at the implantation site, the first cylinder 110 can be made of a plurality of interlaced and overlapped woven wires, or can be made of a plurality of interlaced and overlapped woven wires, the woven wire material constituting the cylinder 110 can be, but is not limited to, nickel-titanium alloy, PLA-PCL, magnesium alloy, cobalt-chromium alloy or medical stainless steel, etc., the mesh on the cylinder 110 is surrounded by the woven wire constituting the cylinder 110, which has a quadrilateral structure and an aperture range of 50-500 μm when opened.

[0052] The filter cavity of the cylinder 110 is provided with a conical filter 120 for capturing impurities in the blood flowing through the cylinder 110. The conical filter 120 is a conical structure formed by a plurality of support wires, and a filter gap is provided between adjacent two support wires. One end of the support wire constituting the conical filter 120 is connected to one end of the cylinder 110, and the other end protrudes into the inside of the cylinder 110 and gradually converges to the central axis of the cylinder 110.

[0053] In the embodiment of the present application, the above-mentioned brain protection filter assembly is adopted. The cylinder 110 with the mesh structure captures thrombus while the conical filter 120 filters and collects thrombus under the condition of meeting the hemodynamic standard, effectively protecting the detachment of plaques and capturing fragment particles, thereby reducing the risk of stroke.

[0054] Embodiment 2:

[0055] As shown in Figure 4 , the embodiment of the present application provides a brain protection filter assembly. The cylinder 110 and the conical filter 120 are cut from a base material and covered with a high molecular material filter film on the surface. The base material can be, but is not limited to, nickel-titanium alloy, PLA-PCL, magnesium alloy, cobalt-chromium alloy or medical stainless steel, etc. The mesh on the cylinder 110 is formed by cutting the base material, which has a quadrilateral structure and an aperture range of 50-500 μm when opened.

[0056] Embodiment 3:

[0057] As shown in Figure 5 , the embodiment of the present application provides a brain protection filter assembly. Two conical filters 120 are provided in the cylinder 110. The divergent ends of the two conical filters 120 are respectively connected to the two ends of the cylinder 110, and the converging ends are directed to the central position inside the filter cavity of the cylinder 110. The two conical filters 120 can enhance the ability of the brain protection filter assembly to capture thrombus.

[0058] Embodiment 4:

[0059] As shown in Figure 6 , the embodiment of the present application provides a brain protection filter assembly. Two conical filters 120 are provided in the cylinder 110. The divergent ends of the two conical filters 120 are respectively connected to the inner wall of the filter cavity of the cylinder 110, and the converging ends of the two conical filters 120 are directed to the same direction. Among them, the two conical filters 120 do not protrude out of the filter cavity of the cylinder 110.

[0060] Embodiment 5:

[0061] As shown in Figures 2-4As shown, this application embodiment provides a brain protection filter assembly, which also includes a support frame 220 made of braided yarn. The support frame 220 has filter holes and has a constricted end and an open end. The support frame 220 is cylindrical and has multiple filter holes on its cylindrical wall. The cylindrical wall of the support frame 220 also has nodes, which are the intersections of two adjacent filter holes. The support frame 220 has a degree of freedom to bend towards its constricted end at the nodes, that is, the open end of the support frame 220 can bend outward towards its constricted end. The support frame 220 is provided with a first connector, which is specifically fixed to the side of the constricted end of the support frame 220 away from the open end and is hook-shaped. The anchoring hook 210 has its hook opening facing the support frame 220. When the brain protection filter assembly is retrieved, the retrieval device that works with the brain protection filter assembly can remove the support frame 220 by hooking the anchoring hook 210. The support frame 220 is provided with a second connector, which is specifically a connecting part 230 fixed to the open end of the support frame 220. Two connecting wires 240 are fixed on the connecting part 230. The connecting part 230 and the connecting wires 240 can be connected by, but not limited to, welding, polymerization, hot melting, etc. The ends of the two connecting wires 240 away from the connecting part 230 are fixedly set on the cylindrical body 110 or the conical filter body 120.

[0062] Among them, the support frame 220, anchor hook 210, connecting part 230, and connecting wire 240 can be made of materials such as alloy, medical stainless steel, and polymer.

[0063] In this embodiment, due to the above-described structure, after the brain protection filter assembly is implanted, the support frame 220 can capture thrombi through the filter holes. At the same time, when the brain protection filter assembly is retrieved, the support frame 220 can be removed from the human body by the hook-shaped anchoring hook 210. Since the support frame 220 and the cylindrical body 110 are connected by the connecting wire 240, the cylindrical body 110 can be removed together, thus providing a basis for the long-term storage of the brain protection filter assembly in the human body, enabling the brain protection filter assembly to capture thrombi for a long time to prevent stroke.

[0064] Example 6:

[0065] like Figure 4 As shown, this application provides a brain protection filter assembly. The support frame 220 is cut from a substrate and its surface is covered with a filter membrane of polymer material. The substrate can be made of materials such as nickel-titanium alloy, PLA-PCL, magnesium alloy, cobalt-chromium alloy or medical stainless steel. The filter holes on the support frame 220 are formed by cutting the substrate.

[0066] Example 7:

[0067] like Figure 7As shown, this application embodiment provides a brain protection filter assembly. The first connector is specifically a base post 250 and a magnetic buckle 260. The base post 250 is fixedly disposed on the side of the support frame 220 away from the opening end at the closing end. The magnetic buckle 260 is fixedly disposed on the side of the base post 250 away from the support frame 220. The side of the magnetic buckle 260 away from the base post 250 is a magnetic protrusion. The grasping device that cooperates with the brain protection filter assembly is provided with a groove that can be attracted to the magnetic protrusion of the magnetic buckle 260. When the brain protection filter assembly is retracted, the grasping device that cooperates with the brain protection filter assembly can remove the support frame 220 by attracting the magnetic protrusion on the magnetic buckle 260.

[0068] Example 8:

[0069] like Figure 8 As shown, this application embodiment provides a brain protection filter assembly. The first connecting body specifically consists of an anchoring cylinder 270 and a threaded hole 280. The anchoring cylinder 270 is fixedly disposed on the side of the support frame 220 away from the opening end at the closed end. The threaded hole 280 is disposed inside the anchoring cylinder 270 and its opening faces away from the support frame 220. The capture device that cooperates with the brain protection filter assembly is provided with a bolt that can be threadedly connected to the threaded hole 280. When the brain protection filter assembly is retracted, the capture device that cooperates with the brain protection filter assembly can remove the support frame 220 through the threaded connection to the anchoring cylinder 270.

[0070] Example 9:

[0071] like Figure 9 As shown, this application provides an installation and recycling method, employing a brain protection filter assembly as described in any of the preceding claims, specifically:

[0072] Before performing transcatheter aortic valve replacement (TAVR) surgery, the brain protection filter component is delivered via a sheath delivery system through a puncture of the left radial artery. The cylindrical part 110 enters the aorta through the left subclavian artery 340 and opens and fixes itself at the position of the aortic arch 330 of the patient's aortic arch 330, at the positions of the two branches of the aortic arch 330, the brachiocephalic trunk 360 and the left common carotid artery 350, to achieve full coverage of cerebral circulation.

[0073] The support frame 220 is partially released into the left subclavian artery 340 and performs secondary filtration on the blood flowing through that location. The first connector is placed in a positive hanging manner. If the first connector adopts the anchor hook 210 structure, the hook part of the anchor hook 210 faces the side closer to the cylindrical body 110.

[0074] After the transcatheter aortic valve replacement (TAVR) procedure is completed and the brain protection filter component is observed in the patient for a certain period of time without any abnormalities, the first connector is captured and retrieved by a capture device through the left radial region to the left subclavian artery at position 340.

[0075] In the embodiment, the cerebral protection filter assembly achieves full coverage of the aortic arch 330, protects the plaque from falling off, and can be freely recovered after the operation, thereby effectively improving the thrombus capture efficiency.

[0076] Embodiment 10:

[0077] As shown in the Figure 10 The embodiment of the present application provides an installation and recovery method, which adopts the cerebral protection filter assembly according to any one of the above, and specifically comprises the following steps:

[0078] Before performing a transcatheter aortic valve replacement (TAVR) operation, the cerebral protection filter assembly is delivered through a sheath delivery system by puncturing the femoral artery, and the cylindrical body 110 is partially inserted into the aortic arch 330 through the descending aorta 320 to open and fix the cerebral protection filter assembly at the position of the brachiocephalic trunk 360 of the patient's aortic arch 330.

[0079] The support frame 220 is partially released in the left common carotid artery 350, the first connecting body is elongated and placed in an inverted manner, at this time, the opening end of the support frame 220 is folded outward to the side of the closing end, and if the first connecting body adopts the structure of the anchoring hook 210, the hook part of the anchoring hook 210 is directed away from the cylindrical body 110.

[0080] After the transcatheter aortic valve replacement (TAVR) operation is completed and the cerebral protection filter assembly is retained in the patient's body for a certain period of time without any abnormalities, the cerebral protection filter assembly is recovered by the grabbing device through the femoral artery to reach the aortic arch 330 to grab the first connecting body at the left common carotid artery 350.

[0081] In the embodiment, the puncture and recovery of the cerebral protection filter assembly are performed from the femoral artery, and the artery has a wider channel to the aortic arch 330, thereby improving the controllability of the operation.

[0082] Embodiment 11:

[0083] As shown in the Figure 11 The embodiment of the present application provides an installation and recovery method, which adopts the cerebral protection filter assembly according to any one of the above, and specifically comprises the following steps:

[0084] Before performing a transcatheter aortic valve replacement (TAVR) operation, the cerebral protection filter assembly is delivered through a sheath delivery system by puncturing the femoral artery or radial artery, and the cylindrical body 110 is inserted into the aortic arch 330 through the descending aorta 320 or the left subclavian artery 340 to open and fix the cerebral protection filter assembly at the position of the brachiocephalic trunk 360 of the patient's aortic arch 330.

[0085] The support frame 220 is partially released in the head and arm trunk artery 360, the first connecting body is elongated and placed in an inverted manner, at this time the opening end of the support frame 220 is folded to the side of the closing end along the outside, if the first connecting body adopts the structure of the anchoring hook 210, the hook part of the anchoring hook 210 is directed away from the side of the cylinder body 110;

[0086] After the transcatheter aortic valve replacement (TAVR) operation is completed and the brain protection filter assembly is retained in the patient's body for a certain period of time without any abnormalities, the first connecting body is captured by the grabbing device through the femoral artery to reach the head and arm trunk artery 360 of the aortic arch 330 to capture the brain protection filter assembly.

[0087] It should be noted that in this document, the terms "comprising", "including", or any other variant thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not only include those elements, but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without more limitations, the element defined by the statement "comprising a" does not exclude the presence of additional identical elements in the process, method, article, or apparatus that includes the element. In addition, it should be pointed out that the scope of the methods and apparatus in the embodiments of the present application is not limited to performing functions in the order shown or discussed, but can also include performing functions in a substantially simultaneous manner or in reverse order, for example, the described method can be performed in an order different from that described, and various steps can also be added, omitted, or combined. In addition, the features described with reference to certain examples can be combined in other examples.

[0088] The embodiments of the present application are described above in combination with the drawings, but the present application is not limited to the above-described specific embodiments, which are only illustrative and not limiting, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the scope of the present application and the scope protected by the claims.

Claims

1. A cerebral protection filter assembly comprising: The application relates to a cerebral protection filter assembly. The first frame is arranged in the aortic arch and used for covering the arteria brachiocephalic trunk or simultaneously covering the arteria brachiocephalic trunk, the left common carotid artery, the left subclavian artery or covering the aortic arch upstream of the arteria brachiocephalic trunk blood flow; the second frame is connected with the first frame and arranged in one of the arteria brachiocephalic trunk, the left common carotid artery and the left subclavian artery which is not covered by the first frame and used for covering the artery at the installation position; the second frame comprises a support frame which has an open end and a closed end and is provided with filter holes; the support frame is in a cylindrical shape and the filter holes are arranged on the cylindrical wall of the support frame; the cylindrical wall of the support frame is further provided with nodes between the filter holes; the support frame has the freedom of being bent to one side of the closed end of the support frame at the nodes. The second frame is provided with a first connecting body for connecting and positioning when the cerebral protection filter assembly is recovered; the first connecting body is an anchor hook which is fixed on the closed end of the support frame and in a hook shape; the hook opening of the anchor hook faces the support frame; when the cerebral protection filter assembly is recovered, the recovery device matched with the cerebral protection filter assembly can take out the support frame by hooking the anchor hook. The support frame is covered with a first filter membrane.

2. The cerebral protection filter assembly of claim 1, wherein, The first connecting body is arranged on the closed end of the support frame.

3. The cerebral protection filter assembly of claim 1, wherein, The second frame further comprises:

4. The cerebral protection filter assembly of claim 1, wherein, A second connecting body arranged on the support frame; A connecting wire connected with one end of the second connecting body and the other end of the first frame. The first frame comprises:

5. The cerebral protection filter assembly of claim 1, wherein, A cylindrical body with a mesh-shaped cylindrical wall and a filter cavity arranged in the cylindrical body; A conical filter body arranged in the cylindrical body and having a diverging end connected with the inner wall of the filter cavity and a converging end located at the central axis position of the filter cavity; The conical filter body is provided with filter gaps. The mesh diameter of the cylindrical wall of the cylindrical body is 50-500 mu m.

6. The cerebral protection filter assembly of claim 5, wherein, The cylindrical body and the conical filter body are covered with a second filter membrane.

7. The cerebral protection filter assembly of claim 5, wherein, ​

Images