CN212699043U

CN212699043U - Asymmetric three-dimensional spiral embolectomy support

Info

Publication number: CN212699043U
Application number: CN202020681274.2U
Authority: CN
Inventors: 张晨朝; 王越; 王君毅; 时玉楠; 王国辉
Original assignee: Shanghai Xinwei Medical Technology Co ltd
Current assignee: Shanghai Xinwei Medical Technology Co ltd
Priority date: 2020-04-28
Filing date: 2020-04-28
Publication date: 2021-03-16
Anticipated expiration: 2030-04-28

Abstract

The utility model discloses an asymmetric three-dimensional spiral bolt taking support, which relates to the technical field of bolt taking supports and comprises a main body net cylinder, wherein the main body net cylinder comprises a wave-shaped unit line segment; adjacent unit line segments form a grid, and the grid is asymmetric; the side surface of the main body net barrel is in a drum shape; the side surface of the main body net barrel is not closed. The utility model discloses a get and tie support adopts asymmetric opening design for the below easily rolls up, and then easily gets into and retrieves the sheath, and forms multilayer structure on the cross-section, increases the fixed power to the thrombus when retrieving, reasonable in design, and the practicality is strong, has reduced the risk of operation.

Description

Asymmetric three-dimensional spiral embolectomy support

Technical Field

The utility model relates to a get and tie the support field, especially relate to an asymmetric three-dimensional spiral is got and is tied support.

Background

Stroke is one of the common diseases in the world at present. In patients with a viable cerebrovascular disease, about three-quarters of the patients have lost work and in severe cases even cannot be self-care. The existing treatment scheme is generally intravenous thrombolysis, such as intravenous rt-PA thrombolysis. The time window of intravenous thrombolysis is only 4 hours, the treatment time is long, the diagnosis and treatment are required to be timely, the damage to ischemic brain tissues is large, and the risk of bleeding is accompanied. In addition, the rate of thrombolysis in certain areas is very low. Based on this, a thrombus removal system is also clinically used to remove thrombus in the large intracranial blood vessel of a patient with ischemic stroke, thereby restoring blood flow.

The prior embolectomy support generally adopts a tubular structure of a single-layer hollow net. In the process of grasping thrombus, the stent with the structure is easy to fall off the thrombus. In addition, improper design of the size or the protruding part of the stent itself can cause irreversible damage to the blood vessel, which can lead to other complications such as restenosis and vascular rupture.

Therefore, those skilled in the art are devoted to develop an asymmetric three-dimensional spiral stent for thrombus removal, so that thrombus is not easy to fall off during thrombus removal, the stent is easy to be collected into a recovery sheath, the thrombus removal effect is improved, and the injury to a blood vessel passing through the stent is reduced.

SUMMERY OF THE UTILITY MODEL

In view of the above-mentioned defect of prior art, the utility model aims to solve the technical problem how reasonable design for the thrombus is difficult to drop when getting the embolus, and the sheath is retrieved in the easy income of support, improves the effect of getting the embolus, reduces the damage to passing through blood vessel.

In order to achieve the purpose, the utility model provides an asymmetric three-dimensional spiral bolt-removing bracket, which comprises a main body net cylinder, wherein the main body net cylinder comprises a wave-shaped unit line segment; adjacent unit line segments form a grid, and the grid is asymmetric; the side surface of the main body net barrel is in a drum shape; the side surface of the main body net barrel is not closed.

Further, the axial length of the mesh is greater than the transverse width.

Further, the distal end of the main body mesh cylinder has a second opening; the proximal end of the main body mesh cylinder has a first opening.

Further, the first opening has a first side and a second side on the side of the main body mesh cylinder; after the main body net cylinder is unfolded to be in a plane, the top of the first edge at the near end forms a first angle with the axis of the main body net cylinder, and the top of the second edge at the near end forms a second angle with the axis of the main body net cylinder; the first angle is different from the second angle.

Further, the first side and the second side are straight line segments.

Further, the side of the near end far away from the main body net barrel is provided with a first connecting part.

Further, still include the fixed mark of development, the fixed mark of development is connected with the side of main part net section of thick bamboo.

Further, the development fixing mark is an open-loop structure.

Further, the developing fixing mark is hung on the main body mesh cylinder.

Furthermore, at least 3 developing fixing marks are distributed at equal intervals along the middle position of the axial length direction of the main body net barrel.

Further, the material of the main body net barrel comprises a memory alloy.

Further, the memory alloy includes a nickel titanium alloy.

Further, the edge of the second opening is serrated.

Further, the second opening has a first cut away from the main body mesh cylinder.

Further, the first cutting portion is a linear protrusion; the axis of the first cutting portion is parallel to the axis of the main body net cylinder.

Further, the first connecting part is a linear type projection; the first connection portion axis is parallel to the axis of the main body net drum.

Further, the cross-sectional shape of the middle part of the main body net barrel is a spiral shape.

Further, the grid constitutes a number of grid rows parallel to each other.

Further, the main body net barrel is integrally formed.

Compared with the prior art, the utility model has the advantages of as follows:

(1) based on the asymmetric open loop design with openings, the first and second sides are subjected to different traction forces due to the different first and second angle. The edges corresponding to the large angles are subjected to larger traction force and can be rolled inwards before the opposite edges are rolled, the design ensures the formation of a multi-layer spiral structure, avoids the phenomenon that the first edge and the second edge are rolled oppositely, so that the lower part is easier to roll up and the recovery of the recovery sheath is facilitated; moreover, a multi-layer spiral structure is formed on the cross section during recovery, so that the grasping capacity and the fixing capacity of thrombus during recovery are increased, and the risk of operation is reduced;

(2) the development fixing mark is arranged, and the size of the spreading diameter of the thrombus removal support can be judged under X-ray;

(3) the suspension type developing fixing mark realizes the anti-falling in a physical mode, avoids welding, improves the production efficiency and avoids vessel damage caused by unsmooth welding spots.

The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings, so as to fully understand the objects, the features and the effects of the present invention.

Drawings

Fig. 1 is an expanded plan view of a main body net drum of a preferred embodiment of the present invention;

fig. 2 is a cross-sectional view of a main body mesh drum of a preferred embodiment of the present invention;

FIG. 3 is an enlarged view of a development fixing mark according to a preferred embodiment of the present invention;

fig. 4 is a perspective view of a main body net drum according to a preferred embodiment of the present invention.

Detailed Description

The technical contents of the preferred embodiments of the present invention will be more clearly understood and appreciated by referring to the drawings attached to the specification. The present invention may be embodied in many different forms of embodiments, and the scope of the invention is not limited to the embodiments described herein.

In the drawings, structurally identical elements are represented by like reference numerals, and structurally or functionally similar elements are represented by like reference numerals throughout the several views. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.

The utility model discloses the right each department "reel form", including but not limited to cylinder, oval cylinder, cone, oval cone, round platform, oval platform, spindle type and dumbbell type, or have cylinder, oval cylinder, cone, oval cone, round platform, oval platform, spindle type and dumbbell type of non-closed side.

For example, a roll cylinder formed after rolling up a rectangular plane; two long sides of the rectangular plane form a first side and a second side of the side surface of the drum cylinder. Said first and second edges being interconnected such that the sides of said roll cylinder are closed; the first and second edges may also be spaced such that the sides of the drum cylinder are non-closed, having an opening. The rectangular plane can also be rolled into a cylinder with a multilayer structure; for example, the first side is located inside a cylinder having a multi-layer structure, and the second side is located on the outer surface of the cylinder having a multi-layer structure, which has a spiral cross section. Similarly, in the cylinder with the multilayer structure, the second edge can be directly connected with the curved surface of the adjacent side surface, so that the cylinder with the multilayer structure is closed; or may be left unconnected, forming an open side.

Fig. 1 is a developed plan view of a main mesh cylinder of an asymmetric three-dimensional spiral thrombectomy support according to a preferred embodiment of the present invention, wherein the thrombectomy support comprises a main mesh cylinder, the main mesh cylinder comprises unit line segments, and adjacent unit line segments form an asymmetric mesh 5; the side surface of the main body net barrel is in a drum shape.

In some embodiments, the cell line segments include at least one or more of: straight line segments, broken line segments, arcs, and wavy lines. The shapes of the unit line sections are different, and the shapes of the formed grids 5 are also different, so that the radial supporting force and the flexibility of the main net barrel are different when the main net barrel is folded and unfolded. In addition, the specific shape and area size of the mesh 5 also distinguishes the immobilization ability of the captured thrombus. And the shape of the unit line segment is selected according to actual use requirements. For example, the grid 5 may be a unit line segment having a wave shape as shown in fig. 1, and the grid 5 may also be a circle, an ellipse, a triangle, or a polygon.

In some embodiments, the material of the main body net barrel is an alloy material with a memory effect; optionally, the main body net barrel is made of nickel-titanium alloy, so that the embolectomy support is rolled or released in the initial deformation mode, and meanwhile, the rolling or releasing deformation capacity is also considered. Specifically, the nitinol has a certain self-expansion capability after heat setting, and can be either crimped into a thin bundle or restored to an initial form after release.

In some embodiments, the side cross-section of the main body mesh cylinder is an open-loop structure; and at least one of the proximal end 4 and the distal end 8 of the main body mesh cylinder has an opening. The thrombus removal support has proper supporting force and certain flexibility by combining the stress characteristic of the main body mesh tube material, and can adapt to bent blood vessels with different thicknesses, such as intracranial blood vessels. The thrombus removal support has proper supporting force and flexibility, is favorable for improving the fusion of the thrombus removal support and thrombus, does not damage blood vessels, and increases the grasping capacity of the thrombus. Fig. 4 is a perspective view of the main body net barrel, and in fig. 4, both the proximal end 4 and the distal end 8 have openings.

In some embodiments, as shown in fig. 1, the cell line segments are wavy, i.e., wavy cell line segments; the adjacent wave unit line segments form a grid 5 through anchor points; the length of the grid 5 in the axial direction is greater than the width in the transverse direction; both the proximal end 4 and the distal end 8 have openings. Wherein, the axial direction refers to the axial direction of the reel-shaped main body net barrel or the direction parallel to the axial direction; the transverse direction is a direction perpendicular to the axial direction on an unfolding plane where the main net barrel is located; the length of the axial direction refers to the longest distance of the edge of the grid 5 in the axial direction; the width in the transverse direction refers to the longest distance in the transverse direction of the edge of the mesh 5.

A grid 5 with wavy edges, such that when the proximal end 4 of the main body net drum is pulled back, one side of the side with open loop structure will roll back before the other side, thereby forming a spiral-shaped structure; the cross section of the spiral-shaped structure is shown in fig. 2. It should be noted that the helical structure of the present invention refers to a structure having several inner layers, including but not limited to the inner layer coinciding with the central cross-section of the outer layer, the inner layer rising relative to the outer layer, and the inner layer falling relative to the outer layer.

In some embodiments, as shown in fig. 1, the wave unit line segment is approximately a "Z" shape with smooth turning points, and comprises two transverse short sides 10 and one axial long side 9; the proximal end 4 comprises a first edge 6 and a second edge 7, the first edge 6 and the second edge 7 being straight line segments; the first side 6 is formed by rectilinear portions of transverse short sides 10 and the second side 7 is formed by rectilinear portions of axial long sides 9. With the same material, the first edge 6 has a higher stiffness and bending resistance than the second edge 7.

Further, a first edge 6 forms a first angle 1 with the axial direction of the main net cylinder at the top of the near end 4, and a second edge 7 forms a second angle 2 with the axial direction of the main net cylinder at the top of the near end 4; the first angle 1 and the second angle 2 are different. The first and second edges 6 and 7 are subjected to different traction forces due to the difference in angles of the first and second angles 1 and 2. The large corresponding side of the angle receives more traction and is rolled inward before the opposite side. This design ensures the formation of a multi-layer helical structure, avoiding the phenomenon of the first and second sides 6, 7 curling up against each other, making the lower side easier to roll up. For example, when the second angle 2 is greater than the first angle 1, and the main mesh cylinder proximal end 4 is pulled and pulled back, the second side 7 is pulled and then rewound before the first side 6 to form a spiral structure, as shown in fig. 2. The structure with multiple layers on the cross section increases the grasping capacity and the fixing force of the main body net barrel on thrombus and enables the thrombus support to enter the recovery sheath more easily.

In some embodiments, as shown in fig. 1, the proximal end 4 has a first connection 11 on the side away from the main body mesh cylinder; the first connector 11 is a linear projection connecting the proximal end 4 and the retrieval sheath (not shown in fig. 1). Fig. 3 is a rolled up view of the main body mesh cartridge of fig. 1, with the first attachment portion 11 being linear at the proximal end 4, and the first and second edges 6, 7 being linear, to facilitate retraction of the main body mesh cartridge into a retrieval sheath or microcatheter.

Alternatively, the first edge 6 and the second edge 7 may have other shapes, such as an arc shape.

In some embodiments, the distal end 8 has a second opening with an edge having a first cutting portion connected at one end to the second opening and at the other end for insertion of a thrombus. Optionally, the first cutting portion is a linear protrusion, and the first cutting portion is parallel to the axis of the main body net cylinder.

In some embodiments, in order to confirm whether the thrombus removal stent is expanded at the bend of the blood vessel, a developing and fixing mark 3 is arranged to judge the expanded diameter of the thrombus removal stent under the matching of X-ray. Alternatively, as shown in fig. 1, the development fixing mark 3 is provided at a middle position of the axial length of the main body mesh cylinder. Further, at least three development fixing marks 3 are distributed at equal intervals along the cross section where the middle position is located, so that the size of the expanded diameter of the embolectomy support can be accurately calculated.

For example, as shown in fig. 1 and 4, three development fixing marks 3 are located at the middle position of the axial length of the main body cylinder, and are distributed at equal intervals along the circumferential direction of the middle position, and constitute three vertexes of a triangle. And (4) calculating the expanded diameter of the embolectomy stent by combining X-ray development.

In some embodiments, the development fixation mark 3 is suspended from the main body cylinder, having a free end; also, the development fixing mark 3 has an open loop structure. Fig. 3 is a partially enlarged view of the development fixing mark 3.

When the thrombus taking stent is used specifically, the thrombus taking stent is delivered to a thrombus part by a recovery sheath tube or a microcatheter and then is expanded, and is pressed and held into a bundle in the delivery process. Therefore, during the transportation, the free end of the development fixing mark 3 is lifted up, does not damage the blood vessel of the route, and cannot fall off. After the bolt taking support is conveyed in place, the bolt taking support is released, the main body net barrel is unfolded, the free end and the side face of the main body net barrel are on the same curved surface, and the split ring structure of the developing fixing mark 3 is closed and is not easy to fall off. In the recovery process, the mark 3 is fixed by developing and the recovery is in the same direction, so that the blood vessel in the route of damage is avoided.

In addition, the suspended design of the developing fixed mark 3 can avoid welding, reduce process links, improve production efficiency and reduce production cost.

The artery branch of the far-end is blocked by the free thrombus block generated by some reason in the blood vessel, and the utility model discloses the concrete process of taking thrombus is as follows:

step 1, a guide catheter is placed according to a standard interventional operation method to obtain a vascular access, and a vascular embolism position is determined by using angiography;

step 2, pushing the microcatheter to the proximal end where the vascular embolism is generated, and penetrating the thrombus to the distal end of the thrombus;

step 3, collecting the thrombus taking support into a recovery sheath, and entering the microcatheter through the recovery sheath;

step 4, pushing the thrombus taking device to enable the thrombus taking support to reach the thrombus position along the micro catheter, and withdrawing the micro catheter to enable the thrombus taking support to be released;

step 5, releasing and expanding the main body mesh cylinder of the thrombus taking bracket in a conical manner, wrapping thrombus from inside to outside, forming an inverted cone at the far end of the thrombus, protecting and carrying the captured thrombus, preventing the thrombus main body and the broken thrombus from falling off and overflowing, and ensuring that the thrombus is completely taken out;

and 6, after waiting for a certain time, combining the balloon catheter, withdrawing the microcatheter and the thrombus removal support at the same time, withdrawing the microcatheter and the thrombus removal support into the guide catheter and withdrawing the microcatheter and the thrombus removal support out of the body.

At this point, the flow within the parent vessel is restored to be patent.

The foregoing has described in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the teachings of this invention without undue experimentation. Therefore, the technical solutions that can be obtained by a person skilled in the art through logic analysis, reasoning or limited experiments based on the prior art according to the concepts of the present invention should be within the scope of protection defined by the claims.

Claims

1. An asymmetric three-dimensional spiral thrombus removal support is characterized by comprising a main body net barrel, wherein the main body net barrel comprises a wavy unit line segment; adjacent unit line segments form a grid, and the grid is asymmetric; the side surface of the main body net barrel is in a drum shape; the side surface of the main body net barrel is not closed.

2. The asymmetric three-dimensional helical embolectomy stent of claim 1 wherein the axial length of the lattice is greater than the transverse width.

3. The asymmetric three-dimensional helical embolectomy stent of claim 2 wherein the distal end of the main body mesh barrel has a second opening; the proximal end of the main body mesh cylinder has a first opening.

4. The asymmetric three-dimensional helical embolectomy support of claim 3 wherein the first opening has a first edge and a second edge on the side of the main body mesh barrel; after the main body net cylinder is unfolded to be in a plane, the top of the first edge at the near end forms a first angle with the axis of the main body net cylinder, and the top of the second edge at the near end forms a second angle with the axis of the main body net cylinder; the first angle is different from the second angle.

5. The asymmetric three-dimensional helical embolectomy stent of claim 3 wherein the proximal end has a first connector on a side distal to the main body mesh barrel.

6. The asymmetric three-dimensional helical embolectomy support of claim 1, further comprising a visualization fixation mark attached to a side surface of the main body mesh cylinder.

7. The asymmetric three-dimensional helical embolectomy stent of claim 6 wherein the visualization fixation marker is an open loop structure.

8. The asymmetric three-dimensional helical embolectomy support of claim 7 wherein the visualization fixation indicia is suspended from the main body mesh barrel.

9. The asymmetric three-dimensional spiral embolectomy support of claim 6, wherein the number of development fixing marks is at least 3, and the development fixing marks are distributed at equal intervals along the middle position of the axial length direction of the main body net barrel.

10. The asymmetric three-dimensional helical thrombectomy stent of claim 1, wherein the material selection of the main body mesh cylinder comprises nitinol.