Intraoperative brain protection device

Abstract

The application discloses an intraoperative brain protection device, which comprises an elastic support and a filter screen; the elastic support can be self-inflated on the inner wall of a blood vessel of an aortic arch and is attached to the inner wall of the blood vessel of the aortic arch, the elastic support is a ring-like structure surrounded by an elastic metal material, the distal end and the proximal end of the ring-like structure are upwardly curved to fix the intraoperative brain protection device in the aortic arch; the filter screen is located in the area surrounded by the elastic support, and the two ends of the filter screen are connected with the distal end and the proximal end of the ring-like structure respectively to block the thrombus generated in the operation from entering the head artery. The protection device adopts a left subclavian artery approach, compared with a traditional femoral artery protection device, the influence of other femoral artery access instruments on the femoral artery is reduced, the operation effect is guaranteed, and the application of the intraoperative brain protection device in the medical instrument technical field is facilitated.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an intraoperative brain protection device. BACKGROUND

[0002] With the wide clinical and development of cardiovascular intervention surgery in the world, such as transcatheter aortic valve replacement and transcatheter mitral valve replacement, etc. In the process of surgery, calcified plaques, blood clots and other structures are broken and fall off, enter the cerebral blood vessels or other important organs along the direction of blood flow, and cause serious complications such as cerebral stroke.

[0003] There is a kind of thrombus protection device for femoral artery intervention in the prior art. This kind of device occupies part of the space of femoral artery during TAVI or transcatheter mitral valve replacement surgery, etc., resulting in the use of other devices which are more likely to cause damage to blood vessels. For example, the technical solution disclosed in the Chinese invention "Thrombus protection device" (application number: CN108309505A) needs to enter through the femoral artery, occupies the limited space of the femoral artery, limits the use of other devices, is not conducive to intraoperative operation, and is difficult to guarantee the postoperative effect. Therefore, it is necessary to make new design to overcome the above-mentioned shortcomings. SUMMARY

[0004] In order to overcome the defects in the prior art, the purpose of the present application is to provide an intraoperative brain protection device. The protection device is accessed through the left subclavian artery, compared with the traditional femoral artery protection device, which reduces the influence of other femoral artery access devices on the femoral artery, guarantees the surgical effect, and is conducive to the promotion and application of the above-mentioned intraoperative brain protection device in the technical field of medical devices.

[0005] In order to achieve the above-mentioned purpose of the application, the following technical scheme is adopted: an intraoperative brain protection device, comprising an elastic support and a filter screen; the elastic support can be self-inflated on the inner wall of the aortic arch blood vessel and is in close contact with the inner wall of the aortic arch blood vessel, the elastic support is a ring-like structure surrounded by elastic metal material, the distal end and the proximal end of the ring-like structure are upwardly tilted to fix the intraoperative brain protection device in the aortic arch; the filter screen is located in the area surrounded by the elastic support, and the two ends of the filter screen are connected with the distal end and the proximal end of the ring-like structure respectively to block the thrombus generated during the operation from entering the head artery.

[0006] As a preferred scheme of the present application, the filter screen covers one third or more of the inner wall of the aortic arch cross section.

[0007] As a preferred scheme of the present application, the angle of the distal end of the elastic support upwardly tilted is 90°-150°, and the angle of the proximal end of the elastic support upwardly tilted is 20°-90°.

[0008] As a preferred scheme of the present application, the distal end of the elastic stent is provided with an outward expansion structure for increasing the contact area between the intraoperative brain protection device and the inner wall of the aortic arch blood vessel in the direction perpendicular to the axial direction.

[0009] As a preferred scheme of the present application, the elastic stent is further provided with a smooth transition zone for connecting the distal end and the proximal end of the elastic stent, the transition zone is outwardly convex to form a support section for supporting the aortic arch blood vessel away from the brain artery.

[0010] As a preferred scheme of the present application, the proximal end of the elastic stent is further provided with a second filter screen, the mesh density of the second filter screen is greater than that of the filter screen, the second filter screen can be contracted to a folded state conforming to the proximal end of the elastic stent, and the second filter screen can be expanded to an expanded state conforming to the inner wall of the aortic arch blood vessel.

[0011] As a preferred scheme of the present application, the outer edge of the filter screen is connected with part or all of the inner edge of the elastic stent.

[0012] As a preferred scheme of the present application, the elastic stent has a connecting part in the form of a threaded rod or a threaded hole structure for connecting with an external delivery device, the connecting part is arranged near the converging end of the elastic stent, and the connecting part is located at or inside the left subclavian artery opening.

[0013] As a preferred scheme of the present application, the proximal end of the elastic stent is further provided with a proximal end sealing member, the connecting part is located on the proximal end sealing member, and the proximal end sealing member conforms to the left subclavian artery opening or the inner wall thereof.

[0014] As a preferred scheme of the present application, the proximal end sealing member surrounds the left subclavian artery opening; the intraoperative brain protection device is delivered to the inner wall of the aortic arch blood vessel through the left subclavian artery by the delivery device, the elastic stent is fixed to the inner wall of the aortic arch blood vessel, the filter screen is unfolded in the fixed range of the elastic stent, and after unfolding, emboli or plaques are adsorbed on the filter screen under the action of blood and enter the proximal end sealing member through the filter screen.

[0015] Compared with the prior art, the present application has the following beneficial effects:

[0016] The intraoperative brain protection device in the present application adopts the left subclavian artery approach, and compared with the traditional femoral artery protection device, the influence of other femoral artery access instruments on the femoral artery is reduced.

[0017] Further, the elastic stent in the present application adopts a double-curvature support structure, which can better conform to the aortic arch blood vessel and provide higher conformability and protection capability.

[0018] Further, the present application is provided with a mesh structure at the subclavian artery opening, which can effectively collect the filtered thrombus into the mesh along the blood flow, reducing the amount of flow to the femoral artery.

[0019] Further, the present application is provided with a mesh structure at the subclavian artery opening, which can effectively collect the filtered thrombus into the mesh along the blood flow, reducing the amount of flow to the femoral artery.

[0020] Further, the present application is not only limited to the protection of the aortic arch, but also can be used for the protection of blood vessels at other positions. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 is a structure diagram of an intraoperative brain protection device in embodiment one of the present application;

[0022] Figure 2 is a structure diagram of an intraoperative brain protection device in embodiment one of the present application;

[0023] Figure 3 is a structure diagram of an intraoperative brain protection device in embodiment one of the present application;

[0024] Figure 4 is Figure 3 is an enlarged structure diagram of A in

[0025] Figure 5 is a structure diagram of an intraoperative brain protection device in embodiment two of the present application;

[0026] Figure 6 is a structure diagram of an intraoperative brain protection device in embodiment two of the present application;

[0027] Figure 7 is a structure diagram of an intraoperative brain protection device in embodiment three of the present application;

[0028] Figure 8 is a structure diagram of an intraoperative brain protection device in embodiment three of the present application;

[0029] Figure 9 is a structure diagram of an intraoperative brain protection device in embodiment three of the present application;

[0030] Figure 10 is a structure diagram of an intraoperative brain protection device in embodiment four of the present application;

[0031] Figure 11 is a structure diagram of an intraoperative brain protection device in embodiment four of the present application;

[0032] Figure 12is a sectional view of an intraoperative brain protection device in embodiment four of the present application;

[0033] Figure 13 is a structural view of an intraoperative brain protection device in embodiment five of the present application;

[0034] Figure 14 is a structural view of an intraoperative brain protection device in embodiment five of the present application;

[0035] Figure 15 is a sectional view of an intraoperative brain protection device in embodiment five of the present application;

[0036] Figure 16 is a structural view of an intraoperative brain protection device in embodiment five of the present application;

[0037] Figure 17 is a use state view of an intraoperative brain protection device in embodiment five of the present application;

[0038] Figure 18 is a structural view of an intraoperative brain protection device in embodiment five of the present application.

[0039] The figure mark: 1, elastic support; 2, filter screen; 3, proximal sealing element; 4, connecting part; 5, left subclavian artery; 6, left common carotid artery; 7, brachiocephalic trunk; 8, through hole; 9, guide wire; 10, delivery device; 11, aortic arch; 12, second filter screen; 13, outward expansion structure; 14, transition zone. DETAILED DESCRIPTION

[0040] In order to make the above objectives, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application are described in detail below. In the following description, a large number of specific details are set forth in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the scope of the present application, therefore the present application is not limited by the specific embodiments disclosed below.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0042] In the field of interventional medical devices, the "distal end" is defined as the end far away from the operator during the operation, and the "proximal end" is defined as the end close to the operator during the operation. The "axial direction" refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device, and the "radial direction" refers to the direction perpendicular to the above-mentioned axial direction.

[0043] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0044] Example 1: As Figures 1 to 4 As shown, an intraoperative brain protection device includes an elastic stent 1 and a filter 2. The elastic stent 1 is in a contracted state before entering the inner wall of the aortic arch 11. Once it enters the inner wall of the aortic arch 11, the elastic stent 1 expands to fit against the inner wall of the aortic arch 11. Figure 3 As shown, to avoid injury to the patient from the edges of the elastic stent 1, the elastic stent 1 is a ring-like structure made of elastic metal material. This ring-like structure effectively avoids the formation of sharp edges, providing support while ensuring safety during the procedure. The ring-like elastic stent 1 has its distal and proximal ends angled upwards along its own axis to fix the intraoperative brain protection device within the aortic arch 11. The filter 2 is located within the area enclosed by the elastic stent 1, and its two ends are connected to the distal and proximal ends of the ring-like structure, respectively, to prevent intraoperative thrombi from entering the cerebral arteries.

[0045] In order to facilitate the flow of thrombus or embolus to the filter screen 2 and to ensure the stability of the elastic stent 1 during use, the distal end of the elastic stent 1 is tilted upward at an angle of 90° to 150°, preferably 120° to 140°; the proximal end of the elastic stent 1 is tilted upward at an angle of 20° to 90°, preferably 30° to 60°.

[0046] The distal end of the elastic stent 1 has an outward expansion structure 13 in the direction perpendicular to the axial direction. The outward expansion structure 13 is mainly used to increase the contact area between the above-mentioned intraoperative brain protection device and the inner wall of the aortic arch 11, thereby playing an effective protective role.

[0047] The elastic stent 1 is also provided with a smooth transition region 14 to connect the distal end and proximal end of the elastic stent 1. The transition region 14 protrudes outward to form a support segment, which is used to support the aortic arch 11 vessels away from the cerebral arteries.

[0048] The elastic support 1 has a connecting part 4 connected with the external delivery device 10. The connecting part 4 can be provided as a simple threaded structure, a screw rod structure or a screw hole structure, so as to be detachable with the external delivery device 10, thereby reducing the operation difficulty. In order to facilitate the operation, the connecting part 4 is arranged at the converging end of the elastic support 1 and close to the converging end. In order to ensure the use effect of the filter screen 2, the elastic support 1 adopts a double curvature structure to support the blood vessel position of one third or more than one third. Compared with the traditional entry from the aortic arch 11, the brain protection device in the embodiment is delivered into the blood vessel inner wall of the aortic arch 11 through the left subclavian artery 5. The entry through the left subclavian artery 5 is mainly to prevent the thrombus and other substances generated by the mitral valve replacement from flowing into the left (right) common carotid artery 6 and the left subclavian artery 5 through the aortic arch 11, thereby reducing the influence of the common femoral artery on the entry of the device.

[0049] The cut-off line of the elastic support 1 is consistent with the cut-off line of the filter screen 2 or the cut-off line of the filter screen 2 is arranged to exceed the cut-off line of the elastic support 1 to support the blood vessel position of one third or more than one third, thereby ensuring the use performance of the device in the use process.

[0050] In order to ensure the connection strength and reduce the probability of the filter screen 2 falling off, the outer edge of the filter screen 2 is connected with part or all of the inner edge of the elastic support 1.

[0051] The specifications of the existing technology mitral valve replacement implantation catheter and the brain protection device are both 10F, which may cause the blood vessel to rupture. In order to solve the above technical problem, the brain protection device in the embodiment can be accommodated in a 7F sheath tube. Compared with the existing technology, the volume is reduced, which can effectively reduce the probability of blood vessel rupture and protect the safety of the aortic blood vessel.

[0052] In order to ensure the structural strength of the connection part of the elastic support 1 and the filter screen 2 and reduce the probability of the filter screen 2 falling off, the filter screen 2 is connected on the elastic support 1 by one or more of weaving, wrapping and welding.

[0053] In order to facilitate the adsorption of thrombus and the protection of the blood vessel inner wall, the filter screen 2 can be coated on the surface.

[0054] The elastic support 1 is in a streamline arc structure as a whole, which can fully fit the blood vessel inner wall, provide support for the whole filter screen 2 and converge when the device is recovered, thereby reducing the influence on the blood vessel inner wall.

[0055] The material of the elastic support 1 is any one or a combination of more than one of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy.

[0056] The elastic support 1 is made by any one or a combination of more than one of laser cutting and welding process.

[0057] The material of the filter screen 2 is any one or more of nickel titanium wire, platinum iridium wire, and polyurethane polymer.

[0058] To reduce the probability of embolus or plaque exposure, the pore size of the filter screen 2 is between 60 and 200 um.

[0059] To ensure the quality of the filter screen 2, the filter screen 2 is made into a mesh shape by weaving or chemical process.

[0060] Embodiment Two: As shown in the figure, the difference between this embodiment and Embodiment One is that the intraoperative brain protection device in this embodiment includes an elastic stent 1 and a filter screen 2, and a second filter screen 12 is further provided on the outside of the proximal end of the elastic stent 1. The second filter screen 12 is arranged on the extension line of the filter screen 2, that is, the filter screen 2 extends to the left subclavian artery 5 direction until the second filter screen 12 can completely cover the left subclavian artery 5, avoiding embolus or plaque entering the left subclavian artery 5. Figures 5 to 6 To facilitate storage and deployment, and for safety, the mesh density of the second filter screen 12 is greater than that of the filter screen 2. The second filter screen 12 can be contracted to a folded state that fits the proximal end of the elastic stent 1, and can be expanded to an expanded state that fits the inner wall of the aortic arch 11 blood vessel.

[0061] Embodiment Three: As shown in the figure, the difference between this embodiment and Embodiment One is that the intraoperative brain protection device in this embodiment includes an elastic stent 1 and a filter screen 2. The proximal end of the elastic stent 1 is arranged obliquely upward. A proximal end seal 3 for collecting embolus or plaque is formed by the filter screen 2 near the converging end of the elastic stent 1. The proximal end of the elastic stent 1 is also provided with a proximal end seal 3, and the connection part 4 is located on the proximal end seal 3. The proximal end seal 3 fits the opening of the left subclavian artery 5 or its inner wall.

[0062] Figures 7 to 9 The proximal end seal 3 surrounds the opening of the left subclavian artery 5. The intraoperative brain protection device is delivered by the delivery device 10 through the left subclavian artery 5 to the inner wall of the aortic arch 11 blood vessel. The elastic stent 1 is fixed to the inner wall of the aortic arch 11 blood vessel. The filter screen 2 is deployed within the fixed range of the elastic stent 1. After deployment, embolus or plaque is adsorbed on the filter screen 2 under the action of blood and enters the proximal end seal 3 through the filter screen 2.

[0063] The proximal end seal 3 surrounds the opening of the left subclavian artery 5. The intraoperative brain protection device is delivered by the delivery device 10 through the left subclavian artery 5 to the inner wall of the aortic arch 11 blood vessel. The elastic stent 1 is fixed to the inner wall of the aortic arch 11 blood vessel. The filter screen 2 is deployed within the fixed range of the elastic stent 1. After deployment, embolus or plaque is adsorbed on the filter screen 2 under the action of blood and enters the proximal end seal 3 through the filter screen 2.

[0064] ​The aforementioned brain protection device is delivered to the inner wall of the aortic arch 11 via the left subclavian artery 5 through the aforementioned delivery device 10. The aforementioned elastic stent 1 is fixed to the inner wall of the aortic arch 11. The aforementioned filter 2 is deployed within the fixed range of the aforementioned elastic stent 1. After deployment, emboli or plaques are adsorbed onto the aforementioned filter 2 under the action of blood and enter the aforementioned proximal seal 3 through the aortic arch 11.

[0065] In this embodiment, two filter screens 2 are configured, and the two filter screens 2 are bundled together to form a shape as shown. Figure 8 The closed type shown has one side that precisely blocks the left common carotid artery 6 and the brachiocephalic trunk 7, completely preventing emboli or plaques from affecting them.

[0066] Example 4: Figures 10 to 12 As shown, the difference between this embodiment and embodiment four is that the intraoperative brain protection device in this embodiment includes an elastic support 1 and a filter 2. The end of the filter 2 in this embodiment, i.e., the proximal seal 3, is a closed woven mesh structure. The middle of the proximal seal 3 is provided with a through hole 8 for the heart valve repair device to pass through. The through hole 8 is the delivery channel of the mitral valve replacement delivery device 10, so that the proximal seal 3 can be contracted by pulling the delivery device 10, thereby collecting emboli or plaques.

[0067] Example 5: Figures 13 to 18 As shown, the difference between this embodiment and Embodiment Four lies in the following: the intraoperative brain protection device in this embodiment includes an elastic support 1 and a filter 2. The filter 2 has a semi-open structure in the middle, which facilitates compression of the woven mesh during advancement, reducing the space occupied by the device within the blood vessel. Simultaneously, the overall center of gravity of the elastic support 1 and the filter 2 is moved towards the connecting part 4, forming a fully enclosed net bag, and a fully enclosed net bag channel is formed within the elastic support 1. The device is then operated via a guide wire 9, reducing operational difficulty and facilitating the retrieval and release of the filter 2.

[0068] The mesh of the filter 2 described above can be enlarged to collect emboli or plaques at the location of the femoral artery.

[0069] The intraoperative brain protection device in the above embodiments adopts a left subclavian artery approach, which reduces the impact of other femoral artery access devices occupying the femoral artery compared with traditional femoral artery protection devices. The elastic stent 1 adopts a hyperboloid support structure, which can better fit the aortic arch vessels and provide higher fit and protection capabilities. At the opening of the subclavian artery, a mesh structure is provided, which can effectively collect the filtered thrombus along the blood flow into the mesh, reducing the amount flowing into the femoral artery. By setting a mesh-shaped filter, the present invention can significantly reduce thrombus leakage and reduce surgical risks when the device collects thrombus and then recovers it.

[0070] The device is not limited to use for protection at the aortic arch, but can also be used for protection of blood vessels at other locations.

[0071] The foregoing description of the disclosed embodiments enables a person skilled in the art to carry out or use the present application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other embodiments without departing from the spirit or scope of the application; therefore, the present application is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0072] Although the terms: 1, elastic stent; 2, filter screen; 3, proximal sealing member; 4, connecting portion; 5, left subclavian artery; 6, left common carotid artery; 7, brachiocephalic trunk; 8, through hole; 9, guide wire; 10, delivery device; 11, aortic arch; 12, second filter screen; 13, outwardly expanding structure; 14, transition zone, etc. are used more frequently herein, the possibility of using other terms is not excluded. The use of these terms is merely for the convenience of describing and explaining the nature of the present application; any interpretation of them as being any kind of additional limitation is contrary to the spirit of the present application.

Claims

1. An intraoperative brain protection device, characterized in that: The device includes an elastic stent (1) and a filter (2); the elastic stent (1) can expand to fit the inner wall of the aortic arch (11) and adhere to the inner wall of the aortic arch (11); the elastic stent (1) is a ring-like structure made of elastic metal material; the distal and proximal ends of the elastic stent (1) are both tilted upwards along the axial direction to fix the intraoperative brain protection device inside the aortic arch (11); the angle at which the distal end of the elastic stent (1) tilts upwards is 90° to 150°, and the angle at which the proximal end of the elastic stent (1) tilts upwards is 20° to 90°; the distal end of the elastic stent (1) has an outward expansion structure (13) in the direction perpendicular to the axial direction to increase the contact area between the intraoperative brain protection device and the inner wall of the aortic arch (11); the elastic stent (1) also has a flat A smooth transition zone (14) connects the distal and proximal ends of the elastic stent. The transition zone (14) protrudes outward to form a support segment, which supports the aortic arch (11) vessels away from the cerebral arteries. The filter (2) is located within the area enclosed by the elastic stent (1). The two ends of the filter (2) are respectively connected to the distal and proximal ends of the ring-like structure to prevent thrombi generated during the operation from entering the cerebrovascular arteries. The filter (2) covers more than one-third of the inner wall of the aortic arch (11) vessels. The elastic stent (1) has a connecting part (4) with a threaded rod or threaded hole structure that connects to the external delivery device (10). The connecting part (4) is located near the constriction end of the elastic stent (1) and is located at or inside the orifice of the left subclavian artery (5). The elastic stent (1) is further provided with a second filter (12) on the proximal exterior. The mesh density of the second filter (12) is greater than that of the filter (2). The second filter (12) can shrink to fit the folded state of the proximal elastic stent (1) and can expand to fit the expanded state of the inner wall of the aortic arch (11).

2. The intraoperative brain protection device according to claim 1, characterized in that: The outer edge of the filter (2) is connected to part or all of the inner edge of the elastic support (1).

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