Blood flow disturbance device

Abstract

The present invention provides a blood flow disturbance device, which relates to the field of medical devices, including: a grid main body frame, which is cylindrical as a whole; a disturbance rod, which is arranged inside the grid main body frame and extends radially along the grid main body frame, and its first end is fixedly connected to a cross grid node of the grid main body frame, and its second end is provided with a raised limit portion; and a grid compression frame, which is arranged inside the grid main body frame, sleeved on the outside of the disturbance rod and limited to the disturbance rod by the limit portion, the grid compression frame can slide along the axial direction of the disturbance rod, and the peripheral area of ​​the grid compression frame is fixedly connected to the grid main body frame. The blood flow disturbance device provided by the present invention can be used for blood flow disturbance of the distal rupture of aortic dissection, change the direction of blood flow, prevent blood flow from entering the false lumen, and promote platelet accumulation and thrombus formation at the rupture site, and promote endothelialization at the rupture site, thereby blocking the rupture.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a blood flow disturbance device. Background Art

[0002] Aortic dissection is often accompanied by at least two ruptures, proximal and distal (the upstream in the blood flow direction is the proximal, and the downstream in the blood flow direction is the distal). During endovascular repair of aortic dissection, only the proximal rupture is blocked. If the false lumen cannot be embolized normally after surgery, blood will flow back into the false lumen from the distal rupture, causing the dissection to continue to expand until it finally ruptures.

[0003] The existing technologies for sealing the distal rupture mainly include: (1) increasing the length of the stent graft until the stent graft covers the distal rupture; (2) using an occluder to seal the distal rupture; (3) implanting a closure device such as a spring coil into the false lumen to promote embolization of the false lumen.

[0004] The existing technology mainly has the following defects:

[0005] ① If the distal rupture occurs near a branch artery, such as near or beyond the renal artery, superior mesenteric artery, lumbar artery, etc., simply extending the stent graft to cover the distal rupture will cause the branch arteries to be covered, resulting in loss of blood supply to other organs and eventual failure.

[0006] ② When using an occluder or coil to occlude the distal rupture, the guide wire needs to be inserted into the false lumen before subsequent operations can be performed. It is very difficult to insert the guide wire into the rupture. The specific location of the rupture needs to be determined by angiography and other methods, and then the guide wire is inserted into the false lumen by combining the guide wire and the catheter. If the rupture opening is too small or the rupture is difficult to visualize, the guide wire cannot be inserted. Even if the guide wire is successfully inserted, the occluder or coil delivery device cannot be inserted into the false lumen.

[0007] ③ Another drawback of using an occluder is that the size of the middle part of the occluder needs to match the size of the rupture. Multiple specifications of instruments need to be prepared before surgery, and the specifications of the occluder can be determined after measuring the size of the rupture during surgery. When using spring coils to fill the false cavity, multiple spring coils are needed to fill the false cavity, and the amount of consumables is large. Summary of the invention

[0008] The purpose of the present invention is to provide a blood flow disturbance device to alleviate the above technical problems existing in the prior art.

[0009] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions:

[0010] An embodiment of the present invention provides a blood flow disturbance device, comprising a grid main frame, a disturbance rod and a grid compression frame; specifically, the grid main frame is cylindrical as a whole; the disturbance rod is arranged inside the grid main frame and extends radially along the grid main frame, a first end of which is fixedly connected to a cross grid node of the grid main frame, and a second end of which is provided with a raised limiting portion; the grid compression frame is arranged inside the grid main frame, sleeved on the outside of the disturbance rod and limited to the disturbance rod by the limiting portion, the grid compression frame can slide axially along the disturbance rod, and the peripheral area of ​​the grid compression frame is fixedly connected to the grid main frame.

[0011] In the blood flow disturbance device provided in the embodiment of the present invention, optionally and preferably, the grid compression frame includes n sleeves and at least four support rod groups, wherein n≥2; each sleeve is slidably sleeved on the outside of the disturbance rod and blocked by the limit portion; the at least four support rod groups are evenly arranged around the disturbance rod. Each support rod group includes n+1 support rods arranged in sequence from the inside to the outside along the radial direction of the grid main frame; in each support rod group, the first end of one support rod is fixedly connected to the first end of the disturbance rod, the first ends of n support rods are fixedly connected to n sleeves one by one, the second ends of all support rods are fixedly connected together and fixedly connected to the grid main frame, and all support rods are coplanar with the four disturbance rods.

[0012] Optionally, n=2; and the number of support rod groups is four.

[0013] Optionally, a first spacing spring is provided on the disturbance rod between the first end of the disturbance rod and the sleeve closest to the first end of the disturbance rod, and the first spacing spring makes the sleeve closest to the first end of the disturbance rod always have a tendency to move away from the first end of the disturbance rod; and a second spacing spring is provided between each adjacent two sleeves on the disturbance rod, and the second spacing spring makes each adjacent two sleeves have a tendency to move away from each other.

[0014] Optionally, each support rod connected to the first end of the disturbance rod is connected to a metal mesh.

[0015] Optionally, a metal mesh is connected to each support rod connected to a sleeve closest to the disturbance rod.

[0016] In addition, in the blood flow disturbance device provided by an embodiment of the present invention, optionally, the grid main body frame includes a plurality of rhombus unit frames, and a circular connecting piece is fixed or integrally connected at the intersection of every two adjacent rhombus unit frames in the circumferential direction of the grid main body frame, and the second end of each support rod is fixedly connected to the corresponding circular connecting piece.

[0017] Optionally, an axial beam is integrally or fixedly connected between the intersections of every two adjacent diamond-shaped unit frames in the axial direction of the grid main body frame, and the first end of the disturbance rod is fixedly connected to a corresponding one of the axial beams.

[0018] Optionally, the disturbance rod is made of a memory metal material, and when the grid main body frame is in a radially compressed state, the second end of the disturbance rod bends toward one side of the disturbance rod, and when released, the disturbance rod returns to a straight shape.

[0019] Optionally, the grid main body frame and the grid compression frame are both made of memory metal material.

[0020] The beneficial effects that can be achieved by the embodiments of the present invention are as follows:

[0021] The blood flow disturbance device provided in the embodiment of the present invention can be applied to the blood flow disturbance of the distal rupture of aortic dissection. When in use, the blood flow disturbance device is released into the artery with the help of a sheath, so that it is supported around the rupture site and the grid compression frame is aligned with the rupture to change the direction of blood flow so that the blood flow does not enter the false lumen. At the same time, platelet accumulation and thrombus formation at the rupture site are promoted, and endothelialization at the rupture site is promoted, thereby blocking the rupture.

[0022] Compared with the prior art, the blood flow disturbance device provided in the embodiment of the present invention will not block the openings of other branch blood vessels, will not cause visceral ischemia, and does not require super-selection of the rupture guide wire, is not limited by the size of the rupture, and does not require multiple implantations of spring coils and other occluding parts. It is easy to operate and is conducive to improving surgical efficiency. The relevant experimental simulation analysis can be found in the specific implementation method section of this specification. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1 This is a schematic diagram of the overall structure of the blood flow disturbance device provided in Embodiment 1 of the present invention;

[0025] Figure 2 A schematic diagram of the connection structure between the grid compression frame and the disturbance rod in the blood flow disturbance device provided in the first embodiment of the present invention;

[0026] Figure 3 for Figure 2 Schematic diagram of the explosion structure;

[0027] Figure 4 A schematic diagram of the overall structure of a blood flow disturbance device provided in Embodiment 2 of the present invention;

[0028] Figure 5 A schematic diagram of an optional structure of a blood flow disturbance device provided in Embodiment 3 of the present invention;

[0029] Figure 6 A schematic diagram of another optional structure of the blood flow disturbance device provided in the third embodiment of the present invention;

[0030] Figure 7 The fluid analysis velocity cloud diagram is obtained by using ANSYS software to perform a hemodynamic analysis of the blood flow when the blood flow axis passes through the grid main frame of the blood flow disturbance device provided in the first embodiment of the present invention;

[0031] Figure 8 The fluid analysis trace diagram is obtained by using ANSYS software to perform a hemodynamic analysis on the blood flow disturbance device provided in the first embodiment of the present invention when the blood flow axis passes through the grid main frame;

[0032] Fig. 9 The fluid analysis vector diagram is obtained by using ANSYS software to perform hemodynamic analysis on the blood flow disturbance device provided in Example 1 of the present invention when the blood flow axis passes through the grid main frame.

[0033] Icon: 100 - grid main frame; 110 - circular connecting piece; 120 - axial beam; 200 - disturbance rod; 210 - limit part; 300 - grid compression frame; 31 - sleeve; 32 - support rod group; 410 - first spacing spring; 420 - second spacing spring; 500 - metal mesh. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0035] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0036] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0037] In the description of the present invention, it should be noted that:

[0038] Unless otherwise clearly specified and limited, the terms "disposed", "installed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0039] The orientation or positional relationship indicated by the terms "proximal", "distal", "axial", "radial", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or is the orientation or positional relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0040] The terms “first”, “second”, etc. are only used for distinguishing descriptions and do not indicate the total number or relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0041] In the following, some embodiments of the present invention are described in detail with reference to the accompanying drawings, with the upstream of the blood flow direction as the proximal end and the downstream of the blood flow direction as the distal end. In the absence of conflict, the features of the following embodiments and the optional embodiments in the embodiments can be combined with each other.

[0042] Embodiment 1

[0043] This embodiment provides a blood flow disturbance device, referring to Figures 1 to 3 The blood flow disturbance device comprises a grid main frame 100, a disturbance rod 200 and a grid compression frame 300; specifically:

[0044] The grid main frame 100 is cylindrical as a whole; the disturbance rod 200 is arranged inside the grid main frame 100 and extends radially along the grid main frame 100, the first end of the disturbance rod 200 is fixedly connected to a cross grid node of the grid main frame 100, and the second end of the disturbance rod 200 is provided with a raised limiting portion 210; the grid compression frame 300 is arranged inside the grid main frame 100, the grid compression frame 300 is sleeved on the outside of the disturbance rod 200 and is limited to the disturbance rod 200 by the limiting portion 210, the grid compression frame 300 can slide axially along the disturbance rod 200, and the peripheral area of ​​the grid compression frame 300 is fixedly connected to the grid main frame 100.

[0045] The blood flow disturbance device provided in this embodiment can be applied to the blood flow disturbance of the distal rupture of aortic dissection. When in use, the blood flow disturbance device is released into the artery with the help of a sheath, so that it is supported around the rupture site and the grid compression frame 300 is aligned with the rupture to change the direction of blood flow so that the blood flow does not enter the false lumen, and at the same time, platelet accumulation and thrombus formation are promoted at the rupture site, and endothelialization is promoted at the rupture site, thereby blocking the rupture.

[0046] Compared with the prior art, the blood flow disturbance device provided in the embodiment of the present invention will not block the openings of other branch blood vessels, will not cause visceral ischemia, does not require super-selection of the rupture guide wire, is not limited by the size of the rupture, does not require multiple implantations of spring coils and other occluding parts, is easy to operate, and is conducive to improving surgical efficiency.

[0047] As a specific implementation of this embodiment, Figures 1 to 3 As shown, the grid compression frame 300 includes n sleeves 31 and at least four support rod groups 32, wherein n is an integer ≥ 2; each sleeve 31 is slidably sleeved on the outside of the disturbance rod 200 and is blocked by the limit portion 210; the at least four support rod groups 32 are evenly arranged around the disturbance rod 200.

[0048] Further, each support rod group 32 includes n+1 support rods arranged in sequence from the inside to the outside along the radial direction of the grid main frame 100; in each support rod group 32, the first end of a support rod is fixedly connected to the first end of the disturbance rod 200, the first ends of n support rods are fixedly connected to n sleeves 31 one by one, the second ends of all support rods are fixedly connected together and fixedly connected to the grid main frame 100, and all support rods and the disturbance rod 200 are coplanar. For example but not limited to, Figures 1 to 3 As shown, n=2, that is, 2 sleeves are provided, and each support rod group 32 includes 3 support rods arranged in sequence from the inside to the outside along the radial direction of the grid main frame 100; the number of the support rod groups 32 is four groups uniformly arranged circumferentially around the disturbance rod 200. In other optional embodiments, other n values ​​and numbers of support rod groups 32 can also be set.

[0049] In addition, in order to improve the stability of the overall structure, in this embodiment, it is optional and preferred that Figures 1 to 3 As shown, the grid main frame 100 includes a plurality of diamond-shaped unit frames, and a circular connecting piece 110 is fixed or integrally connected at the intersection of every two adjacent diamond-shaped unit frames in the circumferential direction of the grid main frame 100 , and the second end of each support rod is fixedly connected to the corresponding circular connecting piece 110 .

[0050] Further optionally, an axial beam 120 is integrally or fixedly connected between the intersections of every two adjacent diamond-shaped unit frames in the axial direction of the grid main frame 100 , and the first end of the disturbance rod 200 is fixedly connected to a corresponding axial beam 120 .

[0051] In order to facilitate manufacturing and ensure that the blood flow disturbance device provided in this embodiment has a smaller compressed volume when being delivered to the patient's artery by means of a sheath tube, and has good resilience to support the rupture after being released, in this embodiment, preferably but not limited to, the disturbance rod 200 is made of nickel-titanium alloy or other memory metal materials, and when the grid main body frame 100 is in a radially compressed state, the second end of the disturbance rod 200 is bent toward one side of the disturbance rod 200 to reduce the volume of the blood flow disturbance device compressed inside the sheath tube, and in the released state, the disturbance rod 200 returns to a straight shape. Optionally, the grid main body frame 100 and the grid compression frame 300 are also made of memory metal materials, and slide along the disturbance rod 200 to be radially compressed during radial compression, and slide and rebound along the disturbance rod 200 after being released.

[0052] ANSYS software is used to perform hemodynamic analysis on the blood flow disturbance device provided in this embodiment when the blood flow passes through the main grid frame 100 axially. The blood flow passes through the main grid frame 100 axially. The analysis results are shown in FIG. Figures 7 to 9 , it is clear that:

[0053] like Figure 7 As shown, in the axial direction, when blood flows through the grid main frame 100, the blood flow velocity decreases sharply at the position of the grid compression frame 300 and the disturbance rod 200, and even approaches 0, and the blood flow velocity at the position close to the blood vessel wall is 0;

[0054] like Figure 8 As shown, blood flow disturbance occurs when the blood flows through the area where the grid compression frame 300 and the disturbance rod 200 are located, but the flow direction can still maintain a straight line after bypassing the area, and the blood flow is still mainly laminar flow;

[0055] like Fig. 9As shown, when the blood flows through the area where the grid compression frame 300 and the disturbance rod 200 are located, the direction changes, bypasses the disturbance rod 200 and the grid compression frame 300, converges to the far end, and finally returns to the original flow direction. During the flow, the blood flow bypasses the location where the disturbance area (the area where the grid compression frame 300 and the disturbance rod 200 are located) is connected to the blood vessel wall, and there is no blood flow along the radial direction of the blood vessel, indicating that the blood flow disturbance device provided in this embodiment can change the direction of blood flow and prevent blood from flowing out of the ruptured blood vessel. In addition, from Fig. 9 It can be seen that eddies appear in the disturbance area.

[0056] Thus, when the blood flows through the grid main frame 100 along the axial direction, it is disturbed by the combined action of the grid compression frame 300 and the disturbance rod 200, changing the original flow direction and not flowing along the direction of the rupture; and the blood flow velocity is also reduced, and no blood flows near the blood vessel wall where the rupture is located. As time goes by, under the action of the vortex blood, platelets will accumulate and form thrombi, and the vascular endothelium will grow toward the disturbance area, and finally the mixture of thrombi and tissues will block the vascular rupture.

[0057] Embodiment 2

[0058] This embodiment is based on the structure of the first embodiment, further, as follows Figure 4 As shown, a first spacing spring 410 is sleeved between the first end of the disturbance rod 200 and the sleeve 31 closest to the first end of the disturbance rod 200 on the disturbance rod 200, and the first spacing spring 410 makes the sleeve 31 closest to the first end of the disturbance rod 200 always have a movement tendency away from the first end of the disturbance rod 200; and, a second spacing spring 420 is respectively provided between every two adjacent sleeves 31 on the disturbance rod 200, and the second spacing spring 420 makes every two adjacent sleeves 31 have a movement tendency away from each other.

[0059] In this embodiment, by providing a spacing spring, radial compression of the grid compression frame 300 is not affected, and the support capacity of the grid compression frame 300 is enhanced after rebound, thereby enhancing the disturbing effect on the blood flow.

[0060] Embodiment 3

[0061] This embodiment is based on the structure of the first embodiment, further, as follows Figure 5 As shown, a metal mesh 500 is connected to each support rod connected to the first end of the disturbance rod 200. And / or, as Figure 6 As shown, a metal mesh 500 is connected to each support rod connected to a sleeve 31 closest to the disturbance rod 200. In this embodiment, "and / or" means that the structure before "and / or" and the structure after "and / or" are set simultaneously or selectively.

[0062] In this embodiment, by providing a metal mesh 500, as the blood flow is disturbed, platelets will gradually be deposited on the metal mesh 500, forming thrombi and endothelialization, thereby forming a natural coating, thereby enhancing the sealing effect of the blood flow disturbance device provided in this embodiment on blood vessel ruptures.

[0063] Finally, it should be noted that the above embodiments and their optional implementation modes in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned optional implementation modes, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

Claims

1. A blood flow disturbance device, characterized in that: include: The grid main body frame (100) is cylindrical in shape as a whole; A disturbance rod (200) is arranged inside the grid main body frame (100) and extends radially along the grid main body frame (100), a first end of which is fixedly connected to a cross grid node of the grid main body frame (100), and a second end of which is provided with a protruding limiting portion (210); and a grid compression frame (300), which is arranged inside the grid main body frame (100), sleeved outside the disturbance rod (200) and limited on the disturbance rod (200) by the limiting portion (210); the grid compression frame (300) is capable of sliding axially along the disturbance rod (200); and the peripheral area of ​​the grid compression frame (300) is fixedly connected to the grid main body frame (100); When in use, the blood flow disturbance device is released into the artery via a sheath tube, so that the blood flow disturbance device is supported around the rupture position and the grid compression frame (300) is aligned with the rupture to change the direction of blood flow and prevent the blood flow from entering the false lumen.

2. The blood flow disturbance device according to claim 1, characterized in that: The grid compression frame (300) comprises n sleeves (31) and at least four support rod groups (32), wherein n≥2; Each of the sleeves (31) is slidably sleeved outside the disturbance rod (200) and is blocked by the limiting portion (210); the at least four support rod groups (32) are evenly arranged in the circumferential direction around the disturbance rod (200); Each of the support rod groups (32) comprises n+1 support rods arranged in sequence from the inside to the outside along the radial direction of the grid main frame (100); in each of the support rod groups (32), the first end of one of the support rods is fixedly connected to the first end of the disturbance rod (200), the first ends of n of the support rods are fixedly connected to n of the sleeves (31) in a one-to-one correspondence, the second ends of all of the support rods are fixedly connected together and fixedly connected to the grid main frame (100), and all of the support rods and the disturbance rod (200) are coplanar.

3. The blood flow disturbance device according to claim 2, characterized in that: The n=2; the support rod groups (32) are provided in four groups.

4. The blood flow disturbance device according to claim 2, characterized in that: A first spacing spring (410) is sleeved on the disturbance rod (200) between the first end of the disturbance rod (200) and the sleeve (31) closest to the first end of the disturbance rod (200), and the first spacing spring (410) enables the sleeve (31) closest to the first end of the disturbance rod (200) to always have a movement tendency away from the first end of the disturbance rod (200); Furthermore, a second spacing spring (420) is provided between each two adjacent sleeves (31) on the disturbance rod (200), and the second spacing spring (420) enables each two adjacent sleeves (31) to have a tendency to move away from each other.

5. The blood flow disturbance device according to claim 2, characterized in that: A metal mesh (500) is connected to each support rod connected to the first end of the disturbance rod (200).

6. The blood flow disturbance device according to claim 2, characterized in that: A metal mesh (500) is connected to each support rod connected to a sleeve (31) closest to the disturbance rod (200).

7. The blood flow disturbance device according to claim 2, characterized in that: The grid main body frame (100) comprises a plurality of rhombus-shaped unit frames, and a circular connecting piece (110) is fixed or integrally connected at the intersection of every two adjacent rhombus-shaped unit frames in the circumferential direction of the grid main body frame (100), and the second end of each support rod is fixedly connected to the corresponding circular connecting piece (110).

8. The blood flow disturbance device according to claim 7, characterized in that: An axial beam (120) is integrally or fixedly connected between the intersections of each two adjacent rhombus unit frames in the axial direction of the grid main body frame (100), and the first end of the disturbance rod (200) is fixedly connected to a corresponding axial beam (120).

9. The blood flow disturbance device according to any one of claims 1 to 8, characterized in that: The disturbance rod (200) is made of a memory metal material; when the grid main body frame (100) is in a radially compressed state, the second end of the disturbance rod (200) bends toward one side of the disturbance rod (200); when released, the disturbance rod (200) returns to a straight shape.

10. The blood flow disturbance device according to any one of claims 1 to 8, characterized in that: The grid main body frame (100) and the grid compression frame (300) are both made of memory metal material.

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