A cerebral protection filter assembly

Abstract

The application relates to the technical field of medical devices, in particular to a brain protection filter assembly, which comprises a first frame body and a second frame body connected with the first frame body, and an anchoring part is arranged on the second frame body and used for connecting and positioning when the brain protection filter assembly is recovered; in the application, the above-mentioned brain protection filter assembly is used, the covering positions of the first frame body and the second frame body are matched, foreign matters in the head-arm trunk artery, the left common carotid artery and the left subclavian artery can be filtered at the same time, the aortic arch is comprehensively covered, the anchoring part arranged on the second frame body is used for connecting and positioning when the brain protection filter assembly is recovered, the brain protection filter assembly can be freely recovered in the patient's body after operation, the foreign matter capturing time is prolonged, and the efficiency of preventing stroke is improved.

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 the operation, and 80% of TAVR-related strokes occur within a week after the operation. 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 completed. 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, implant head and arm trunk and left common carotid artery, so that the left subclavian artery (branch containing vertebral artery) accounting for about 10% of cerebral perfusion is not protected;

[0006] 2. The device is not stable 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 device cannot be stored in the body for a certain period of time to effectively recover postoperative thrombus. SUMMARY

[0009] In view of the shortcomings of the prior art, the present application provides a brain protection filter assembly which has a comprehensive protection range and can store a certain period of time in the body to perform long-term recovery of thrombus.

[0010] To achieve the above object, the present application is realized by the following technical scheme.

[0011] The present application provides a brain protection filter assembly, comprising a first frame body for covering the head and arm trunk artery, the left common carotid artery, or covering the left common carotid artery and the left subclavian artery at the same time, and a second frame body connected with the first frame body and capable of being placed in the head and arm trunk artery or the left subclavian artery and used for covering the artery at the placement position.

[0012] Wherein, the second frame body is provided with an anchoring part for connecting and positioning when recovering the brain protection filter assembly.

[0013] Further limitation, the above-mentioned brain protection filter assembly, wherein the first frame body comprises a circumferentially closed annular support and a filter unit located in the inner region of the annular support and connected with the annular support.

[0014] Further limitation, the above-mentioned brain protection filter assembly, wherein the annular support is made of one or more combinations of alloy, medical stainless steel and high polymer material.

[0015] Further limitation, the above-mentioned brain protection filter assembly, wherein the filter unit is a filter membrane covering the annular support, and the filter membrane has first filter holes for blood flow.

[0016] Further limitation, the above-mentioned brain protection filter assembly, wherein the filter membrane is made of one or more combinations of polyester or polyether ether ketone.

[0017] Further limitation, the above-mentioned brain protection filter assembly, wherein the filter unit is a filter screen with a periphery connected with the annular support, and the annular support and the filter screen are integrally formed.

[0018] Further, the brain protection filter assembly, wherein the annular frame is elliptical.

[0019] Further, the brain protection filter assembly, wherein the second frame has a closed end and an open end, and the second frame is provided with second filter holes.

[0020] Further, the brain protection filter assembly, wherein the second frame is covered with a filter membrane.

[0021] Further, the brain protection filter assembly, wherein the second frame is cylindrical, and the second frame is provided with a plurality of second filter holes on the wall of the second frame, and the wall of the second frame is further provided with nodes between the second filter holes, and the nodes are provided with a folding freedom towards the closed end of the second frame.

[0022] Further, the brain protection filter assembly, wherein the anchor part comprises a hook body fixedly arranged on the second frame.

[0023] Further, the brain protection filter assembly, wherein the hook body comprises a frame connecting part fixedly connected with the second frame, and a hook body part extended from the frame connecting part.

[0024] Further, the brain protection filter assembly, wherein the frame connecting part is provided with a receiving cavity, and the second frame is provided with a plurality of connecting members extended into the receiving cavity and fixedly connected with the frame connecting part.

[0025] Further, the brain protection filter assembly, wherein the hook body part comprises a hook body wall and a channel formed by the hook body wall, and the channel is through the receiving cavity.

[0026] Further, the brain protection filter assembly, wherein the second frame and the first frame are connected through a connecting wire.

[0027] The application further provides a brain protection filter system, which is characterized by comprising a brain protection filter assembly, and a delivery system capable of accommodating and releasing the brain protection filter assembly and capable of driving the brain protection filter assembly to displace.

[0028] Compared with the prior art, the application has at least the following beneficial effects:

[0029] 1. By matching the covering positions of the first frame body and the second frame body, the foreign matter can be filtered from the brachiocephalic artery, the left common carotid artery and the left subclavian artery at the same time, so as to realize the comprehensive coverage of the aortic arch, and the anchor part provided on the second frame body is used to realize the connection and positioning during the recovery of the brain protection filter assembly, so as to realize the free recovery of the brain protection filter assembly in the patient's body after the operation, thereby prolonging the foreign matter capturing time and improving the efficiency of preventing stroke;

[0030] 2. By the filtering unit and the second filter hole, the foreign matters such as calcified tissue, valve tissue, natural collagen and thrombus tissue can be effectively deflected and captured, the patency of the brain circulation is maintained, and the risk of new stroke after the operation is reduced;

[0031] 2. The first frame body can be released and recovered by the second frame body, and the stability of the placement position of the first frame body is improved by the second frame body, so as to ensure the long-term stable storage of the brain protection filter assembly in the patient's body after the operation. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 It is a specific structure diagram of the brain protection filter assembly in the embodiment 1 of the present application;

[0033] Figure 2 It is a structure front view of the brain protection filter assembly in the embodiment 1 of the present application;

[0034] Figure 3 It is an enlarged structure diagram of the "anchor part 21" of the brain protection filter assembly in the embodiment 1 of the present application;

[0035] Figure 4 It is a structure top view of the brain protection filter assembly in the embodiment 1 of the present application;

[0036] Figure 5 It is a specific structure diagram of the brain protection filter assembly in the embodiment 2 of the present application;

[0037] Figure 6 It is a specific structure diagram of the brain protection filter assembly in the embodiment 3 of the present application;

[0038] Figure 7 It is a specific structure diagram of the brain protection filter assembly in the embodiment 4 of the present application;

[0039] Figure 8 It is an installation diagram of the brain protection filter assembly in the embodiment of the present application;

[0040] Figure 9 It is an installation diagram of the brain protection filter assembly in the embodiment of the present application.

[0041] REFERENCE NUMERALS

[0042] First frame body-10, annular support-101, filter screen-102, filter membrane-11, first filter hole-12, second frame body-20, anchoring part-21, accommodation cavity-211, channel-212, second filter hole-22, connecting wire-30, connecting body-31, ascending aorta-40, brachiocephalic artery-41, left common carotid artery-42, left subclavian artery-43, descending aorta-44, aortic arch-45. DETAILED DESCRIPTION

[0043] 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 those of ordinary skill in the art belong to the scope of protection of the present application.

[0044] 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 an "or" relationship.

[0045] The brain protection filter assembly provided by the embodiments of the present application will be described in detail below in combination with the drawings, through specific embodiments and application scenarios.

[0046] Embodiment 1:

[0047] As Figures 1-4As shown, the embodiment of the present application provides a brain protection filter assembly, which comprises a first frame body 10 in a sheet shape and used to cover the brachiocephalic trunk 41, the left common carotid artery 42 or the left common carotid artery 42 and the left subclavian artery 43 at the same time, and a second frame body 20 connected with the first frame body 10 and capable of being placed in the brachiocephalic trunk 41 or the left subclavian artery 43 and used to cover the artery at the placement position, the first frame body 10 is provided with first filter holes 12, the second frame body 20 is provided with an anchoring part 21 and second filter holes 22, the second frame body 20 is in a cylindrical shape and has an open end and a closed end, the second filter holes 22 are provided in plurality on the wall of the second frame body 20, the wall of the second frame body 20 also has nodes between two adjacent second filter holes 22, and the nodes have a folding freedom to the side of the closed end of the second frame body 20, that is, the open end of the second frame body 20 can be folded outward to the side of the closed end thereof, the anchoring part 21 is fixedly arranged at the closed end of the second frame body 20, one side of the open end of the second frame body 20 extends away from the closed end of the second frame body 20 and is fixedly connected with the edge of the first frame body 10, the connection form can be point connection, line connection or surface connection, and the connection method can be welding, bonding or binding, etc., the first frame body 10 comprises a circumferentially closed annular support 101 formed by two support rods connected and welded at the tail ends and a filter unit located in the internal region of the annular support 101 and connected with the annular support 101, the material of the support rods can be alloy, medical stainless steel, high polymer or the like, and the shape of the annular support 101 can be oval, quadrilateral, hexagon or the like, wherein the oval shape can make the welding process of the two support rods simpler and make the first frame body 10 have good radial support force and larger coverage area, and the filter unit comprises a filter membrane 11 arranged on the annular support 101, the filter membrane 11 is made of one or more combinations of polyester or polyether ether ketone or the like, and the first filter holes 12 are arranged on the filter membrane 11.

[0048] The pore diameter of the first filter holes 12 and the second filter holes 22 is 50-500 μm, which can ensure the interception of foreign matters in the flowing blood and guarantee the blood flow, and the first filter holes 12 and the second filter holes 22 can be arranged in polygonal shape, circular shape or the like, wherein the quadrilateral shape of the first filter holes 12 and the second filter holes 22 not only facilitates processing, but also enables the first frame body 10 and the second frame body 20 to have better stretching performance.

[0049] The anchor part 21 includes a frame connecting part fixedly arranged on the closed end of the second frame body 20 and a hook body part extended from the frame connecting part, the frame connecting part has a receiving cavity 211, the second frame body has a plurality of connecting pieces extended into the receiving cavity 211 and fixedly connected with the frame connecting part, the hook body part includes a hook body wall and a channel 212 formed by the hook body wall, the channel 212 extends in a spiral shape towards the side close to the second frame body 20 and penetrates the receiving cavity 211, when the brain protection filter assembly is released and recovered, a nut is welded in the receiving cavity 211, the nut is connected with a conveying system matched with the brain protection filter assembly, and the conveying system is used to release and recover the brain protection filter assembly.

[0050] The second frame body 20 is made of braided wires, the second filter hole 22 is surrounded by the braided wires for making the second frame body 20, and the material of the braided wires can be a nickel-titanium alloy or a cobalt-chromium alloy. The memory alloy has good biocompatibility and good corrosion resistance in various physiological solutions or media. When an artificial device made of the memory alloy is implanted into a human body, no rejection reaction or inflammation occurs, the artificial device has no cytotoxicity, no sensitization, no carcinogenicity, and a hemolysis of 0.13%, and has good corrosion resistance, high fatigue resistance, no influence on nuclear magnetic resonance, super-elasticity, and an elastic modulus close to that of human bones. Therefore, the memory alloy is an ideal bioengineering material.

[0051] In the embodiment, the brain protection filter assembly is used to filter foreign matters in blood flowing through the first frame body 10 and the second frame body 20 through the first filter hole 12 and the second filter hole 22. The sheet structure of the first frame body 10 can expand the filtering range, has a large contact area with the inner wall of a blood vessel when released, has strong anchoring force when blood flow impacts, is not easy to deflect, and has high stability. The second frame body can release and recover the first frame body 10, improves the stability of the placement position of the first frame body 10, realizes long-time storage and free recovery of the brain protection filter assembly in the patient after surgery, prolongs the foreign matter capturing time, and improves the efficiency of preventing stroke.

[0052] Embodiment 2

[0053] As shown in Figure 5 The embodiment provides a brain protection filter assembly, one side of the open end of the second frame body 20 extends away from the closed end of the second frame body 20 and is fixedly provided with a connecting body 31, a connecting wire 30 is welded on the connecting body 31, and the other end of the connecting wire 30 is welded with the edge of the first frame body 10. The connecting wire 30 can be a nickel-titanium wire or a cobalt-chromium wire, and the connecting body 31 can improve the welding stability of the connecting wire 30 and the second frame body 20.

[0054] Example 3:

[0055] like Figure 6 As shown, this application embodiment provides a brain protection filter assembly. The first frame 10 and the second frame 20 are both made by cutting a substrate. The substrate can be made of materials such as alloy, medical stainless steel, or polymer. The filter unit is a filter screen connected to the annular support 101 around its periphery. The annular support 101 and the filter screen are integrally formed. The first filter hole 12 is disposed on the filter screen. That is, the first frame 10 and the first filter hole 12 are integrally formed by cutting a substrate. The second frame 20 and the first filter hole 22 are integrally formed by cutting a substrate. The second frame 20 is covered with a polymer material filter membrane.

[0056] Of course, it is understandable that the first frame 10 and the second frame 20 can be manufactured in various ways. For example, the first frame 10 can also be made of braided yarn, in which case the first filter hole 12 is surrounded by the braided yarn constituting the first frame 10. Similarly, when the first frame 10 is made by cutting a substrate, the second frame 20 can be made of braided yarn. That is, the function of the first frame 10 and the second frame 20 depends more on the structure. The manufacturing method can affect its performance to a certain extent, but the overall function will not be greatly affected.

[0057] Example 4:

[0058] like Figure 7 As shown, this application embodiment provides a brain protection filter assembly. The first frame 10 and the second frame 20 are both integrally cut or integrally woven. In this case, the first frame 10 and the first filter hole 12 are integrally formed, and the edge of the opening end of the second frame 20 extends toward the surface of the first frame 10 and connects with the first frame 10. That is, the first frame 10 is formed by the opening end of the second frame 20.

[0059] With this connection method between the first frame 10 and the second frame 20, the first frame 10 and the second frame 20 are no longer separate parts. When the first frame 10 is released, the anchoring force between it and the inner wall of the blood vessel will have a greater impact on the placement stability of the second frame 20, thereby making the overall integrity of the first frame 10 and the second frame 20 stronger. At the same time, the position of the second frame 20 relative to the first frame 10 can be customized according to needs, thereby achieving targeted structural optimization for different release and retrieval conditions of the brain protection filter component.

[0060] Example 5:

[0061] This application provides a brain protection filter system, including a brain protection filter component as described in any of the preceding claims, and a delivery system capable of accommodating and releasing the brain protection filter component and capable of displacing the brain protection filter component.

[0062] Embodiment 6:

[0063] As Figure 8 shown, the embodiment of the present application provides a method for installing and recovering a brain protection filter assembly, which adopts the brain protection filter system as described above, specifically:

[0064] 1. Before performing a transcatheter aortic valve replacement (TAVR) operation, a brain protection filter assembly is delivered through a sheath delivery system via left radial artery puncture to enter and deliver the brain protection filter assembly, and the first frame body 10 of the brain protection filter assembly enters the inside of the aorta through the left subclavian artery 43 to open and fix at the positions of the two branches of the aortic arch 45, i.e., the brachiocephalic artery 41 and the left common carotid artery 42 of the patient;

[0065] 2. The second frame body 20 is partially released in the left subclavian artery 43 to achieve comprehensive coverage of the brain circulation, and the anchor part 21 is placed in a positive hanging manner, i.e., the anchor part 21 far from the side end of the second frame body 20 is directed away from the side of the first frame body 10;

[0066] 3. 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 anchor part 21 is captured through the radial artery or brachial artery to reach the left subclavian artery 43 to capture the anchor part 21 and recover the brain protection filter assembly.

[0067] In this embodiment, since the above method is adopted, the first frame body 10 fully expands to provide full coverage protection for the brachiocephalic artery 41 and the left common carotid artery 42, and at this time, the second frame body 20 is positioned and released at the position of the left subclavian artery 43 to effectively protect the left subclavian artery 43, which not only meets the hemodynamic index and does not affect the circulation of blood flow, but also has the effect of deflecting thrombus flow to the recovered thrombus.

[0068] Embodiment 7:

[0069] The embodiment of the present application provides a method for installing and recovering a brain protection filter assembly, which adopts the brain protection filter system as described in any one of the above, specifically:

[0070] 1. Before performing a transcatheter aortic valve replacement (TAVR) operation, a brain protection filter assembly is delivered through a sheath delivery system via femoral artery or radial artery puncture to enter and deliver the brain protection filter assembly, and the first frame body 10 of the brain protection filter assembly enters the inside of the aorta through the descending aorta 44 or the left subclavian artery 43 to open and fix at the positions of the two branches of the aortic arch 45, i.e., the left common carotid artery 42 and the left subclavian artery 43 of the patient;

[0071] 2、Second frame body 20 is partially released in the head and arm trunk artery 41, and the anchor part 21 is placed in an inverted manner, that is, the anchor part 21 is away from the side end of the second frame body 20 and faces the side close to the first frame body 10;

[0072] 3、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 brain protection filter assembly is retrieved through the capture device into the head and arm trunk artery 41 at the anchor part 21 of the ascending aorta 40 or the femoral artery.

[0073] Embodiment 8:

[0074] The embodiment of the present application provides a method for installing and retrieving a brain protection filter assembly, which adopts any one of the brain protection filter systems described above, and specifically comprises the following steps:

[0075] 1、Before performing the transcatheter aortic valve replacement (TAVR) operation, the brain protection filter assembly is delivered through the left radial artery puncture and the sheath delivery system, and the first frame body 10 of the brain protection filter assembly enters the inside of the aorta through the left subclavian artery 43 and is opened and fixed at the positions of the two branches of the aortic arch 45, that is, the head and arm trunk artery 41 and the left common carotid artery 42 of the patient.

[0076] 2、The second frame body 20 is partially released in the left subclavian artery 43 to achieve comprehensive coverage of the cerebral circulation, and the anchor part 21 is placed in a normal manner, that is, the anchor part 21 is away from the side end of the second frame body 20 and faces away from the side of the first frame body 10;

[0077] 3、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 brain protection filter assembly is retrieved through the capture device into the left subclavian artery 43 at the anchor part 21.

[0078] In the embodiment, since the above method is adopted, it can be known that the brain protection filter assembly not only can effectively cover the three main arteries to prevent the entry of thrombus, but also has good operating flexibility, can flexibly change the release and retrieval process according to the use requirement, and has stronger operability.

[0079] It should be noted that, in the present document, the terms "comprises", "comprising", or any other variations 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 include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises... a" does not, without more constraints, exclude the presence of additional identical elements in the process, method, article, or apparatus that comprises the element. Furthermore, it is to be understood that the method and apparatus of the present application can be carried out by someone other than the person named in the independent claims, and that the scope of the independent claims is not limited to the person named in the independent claims. In addition, it should be noted that the scope of the method and apparatus of the present application is not limited to performing the functions in the order shown or discussed, but can also include performing the functions in a substantially simultaneous manner or in a reverse order, for example, the described method can be performed in an order different from that described, and various steps can be added, omitted, or combined. In addition, features described with reference to certain examples can be combined in other examples.

[0080] The embodiments of the present application are described above with reference to the accompanying drawings, but the present application is not limited to the specific embodiments described above, which are merely illustrative and not restrictive, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the purpose of the present application and the scope protected by the claims.

Claims

1. A cerebral protection filter assembly comprising: The first frame body is a closed annular stent formed by two branch rods, and a filter unit is arranged in the annular stent; the second frame body is a cylindrical woven structure, one end of which is a closed end and is provided with an anchoring part for connecting and positioning when the brain protection filter assembly is recovered, and the other end is an open end connected with the edge of the first frame body through a connecting wire; a plurality of second filter holes are arranged on the cylinder wall of the second frame body, and the nodes between adjacent second filter holes have a folding freedom outward to the side of the closed end. The annular stent is made of one or more of alloy, medical stainless steel and high polymer material. The annular stent is elliptical.

2. A cerebral protection filter assembly according to claim 1, wherein, The second frame body is covered with a filter membrane.

3. A cerebral protection filter assembly according to claim 1, wherein, The anchoring part comprises a hook body fixedly arranged on the second frame body.

4. A cerebral protection filter assembly according to claim 1, wherein, The hook body comprises a frame body connecting part fixedly connected with the second frame body and a hook body part extended from the frame body connecting part.

5. A cerebral protection filter assembly according to any one of claims 1 to 4, wherein, The frame body connecting part has a receiving cavity, and the second frame body has a plurality of connecting pieces extended into the receiving cavity and fixedly connected with the frame body connecting part.

6. A cerebral protection filter assembly according to claim 5, wherein, The hook body part comprises a hook body wall and a channel formed by the hook body wall, and the channel is through the receiving cavity.

7. A cerebral protection filter assembly according to claim 6, wherein, ​ 8. A cerebral protection filter assembly according to claim 7, wherein, ​

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