Turbulent flow device and using method thereof

Abstract

The invention belongs to the technical field of medical instruments for treating aneurysm, and particularly relates to a turbulent flow device and a using method thereof.The turbulent flow device comprises an elastic supporting piece, the top end of the elastic supporting piece is fixedly connected with a head end small net disc through a head end developing ring, and the bottom end of the elastic supporting piece is fixedly connected with a tumor diameter opening large net disc through a tail end developing ring; the outer side of the middle of the elastic supporting piece is fixedly connected with a macromolecule supporting bundle, and the outer diameter of the macromolecule supporting bundle is matched with the outer diameter of the head end small net disc and the outer diameter of the tumor diameter opening large net disc. The tail end developing ring is fixedly connected with one end of an electrolysis wire, and the other end of the electrolysis wire is fixedly connected with a push rod. According to the turbulent flow device, good anchoring capacity can be achieved, the height of the turbulent flow device can be adjusted according to the tumor height, and the polymer bundles fixed to the middle elastic supporting piece improve the embolism effect at the same time, so that the purposes of rapidly embolism and preventing blood from impacting the inner wall of a tumor cavity are achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices for treating aneurysms, and in particular relates to a flow disturbing device and a method for using the same. Background Art

[0002] Aneurysms are a very common vascular disease. They are caused by disease or damage to the arterial wall, resulting in localized or diffuse dilation or bulging of the arterial wall. They primarily manifest as an expansive, pulsating mass and can occur anywhere in the arterial system. Once an aneurysm ruptures, it can have serious consequences. For example, rupture of an intracranial aneurysm can cause subarachnoid hemorrhage. In severe cases, vascular spasm can trigger widespread cerebral infarction, leading to hemiplegia and coma. Currently, the main treatment options for aneurysms include open surgery and endovascular interventional therapy. Open surgery requires opening the body cavity surrounding the aneurysm, such as through craniotomy or thoracotomy, causing significant damage to the patient and requiring a long recovery period. However, endovascular interventional therapy for aneurysms, due to its minimally invasive, safe, and effective nature, has become the preferred clinical treatment option for many medical experts.

[0003] Endovascular interventional treatment of intracranial bifurcation aneurysms remains difficult, accounting for approximately 2.9% to 7.1% of all intracranial aneurysms. The greatest challenges in endovascular treatment of bifurcation aneurysms and other aneurysms are the stable packing of coils, the impact of stent-assisted coils and flow-diverting devices on branch vessels, and aneurysm recurrence.

[0004] For bifurcated aneurysms, single-stent embolization is difficult. Multiple stents are typically used to treat bifurcated aneurysms. Complex stent-assisted techniques include "Y"-shaped, "X"-shaped, and "T"-shaped stents. However, these complex techniques still have the disadvantages of high surgical difficulty, numerous complications, and a high recurrence rate. Summary of the Invention

[0005] The purpose of the present invention is to provide a flow-disturbing device to solve the problem of how to achieve better anchoring ability, adjust the height according to the tumor height, and increase the embolization effect of the polymer bundle fixed on the middle elastic support member at the same time, so as to achieve the purpose of rapid thrombosis and prevent blood from impacting the inner wall of the tumor cavity.

[0006] To achieve the above object, the present invention provides the following solutions: A spoiler device comprises: an elastic support member, wherein the top end of the elastic support member is fixedly connected to a small mesh disk at the head end through a head end developing ring, and the bottom end of the elastic support member is fixedly connected to a mesh disk with a large diameter through a tail end developing ring; A polymer support bundle is fixedly connected to the outer side of the middle portion of the elastic support member, and the outer diameter of the polymer support bundle matches the outer diameters of the small mesh disk at the head end and the mesh disk with a large tumor diameter; One end of the electrolytic wire release is fixedly connected to the tail end developing ring, and the other end of the electrolytic wire release is fixedly connected to a pushing rod.

[0007] Preferably, the elastic support member includes an elastic tube body, the top and bottom of the elastic tube body are connected by at least three support rods, at least one connecting flexible member is fixedly connected between adjacent support rods, a plurality of micropores are opened on the support rod, and the polymer support bundle is fixedly connected to the micropores.

[0008] Preferably, the polymer support bundle is composed of a plurality of support filaments, one end of the support filament is fixedly connected to one of the micropores, the other end of the support filament is fixedly connected to another micropore, and the middle portion of the support filament protrudes outward to form a support structure.

[0009] Preferably, the plurality of microholes on one support rod are arranged in a single row.

[0010] Preferably, the plurality of microholes on one support rod are arranged in double rows.

[0011] A method for using a spoiler device: S1, the spoiler is ready in a converged state; S2, extending the head of the flow-disturbing device into the aneurysm through the pushing rod; S3, releasing the flow-disturbing device, so that the small mesh disk at the head end, the polymer support bundle, and the mesh disk with a large tumor diameter are sequentially unfolded and adhered to the inner wall of the tumor; S4, starting the electrolytic wire-removing to disconnect the connection between the pushing rod and the tail end developing ring, thereby fixing the spoiler.

[0012] Preferably, the flow-disturbing device is converged by wrapping the delivery catheter, and in the step of releasing the flow-disturbing device, the small mesh disk at the head end, the polymer support bundle, and the large mesh disk at the tumor diameter are sequentially unfolded by withdrawing the delivery catheter.

[0013] Preferably, when the spoiler device is converged, the small mesh disk at the head end is sleeved on the outside of the large mesh disk at the tumor diameter.

[0014] Preferably, the step S3 includes: S3.1. Pull out the delivery catheter, allowing the small mesh plate at the tip to unfold and adhere closely to the inner wall of the tumor; S3.2. Continue to withdraw the delivery catheter to expose the polymer support bundle; S3.3. Push the push rod, causing the elastic support member to deform under pressure, pushing the polymer support bundle outward and closely against the inner wall of the tumor; S3.4. Continue to pull out the delivery catheter, so that the large-diameter mesh plate of the tumor is unfolded and close to the opening side of the tumor inner wall to complete the deployment of the flow-disturbing device.

[0015] Compared with the prior art, the present invention has the following advantages and technical effects: In terms of anchoring ability, the cooperation between the small mesh plate at the head end and the large mesh plate at the tumor opening can respectively stick to the inner wall deep inside the tumor and at the tumor opening, forming a stable two-way anchoring, effectively preventing the device from shifting and ensuring a stable position during treatment.

[0016] In terms of height adaptability, the elastic support can flexibly adjust the overall height through compression deformation, which can adapt to aneurysms of different heights, enhance the fit between the device and the tumor, and solve the problem that traditional devices are difficult to adapt to tumors of different sizes.

[0017] The polymer bundles fixed on the middle support can protrude outward and stick to the inner wall of the aneurysm when the device is deployed. On the one hand, it slows down the blood flow rate in the aneurysm through physical turbulence, promotes rapid thrombus formation, increases the embolization effect, and achieves rapid thrombosis; on the other hand, its protruding structure can directly block the direct impact of blood on the inner wall of the aneurysm cavity, reducing the risk of aneurysm rupture, thereby comprehensively improving the safety and effectiveness of aneurysm treatment.

[0018] Therefore, the present invention provides a flow-disturbing device that can achieve better anchoring ability, can adjust the height according to the tumor height, and fix the polymer bundles on the middle elastic support member to increase the embolization effect, so as to achieve the purpose of quickly causing thrombosis and preventing blood from impacting the inner wall of the tumor cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. Those skilled in the art can also derive other drawings based on these drawings without inventive work. Figure 1 Schematic diagram of the structure of the device; Figure 2 Schematic diagram of the structure of the elastic support member in the device; Figure 3 This is a schematic diagram of the structure of the elastic support member after shearing and unfolding along the axis; Figure 4 Schematic diagram of the deformation of the elastic support member under stress; Figure 5 A top view of the polymer support bundle of Example 1; Figure 6 A top view of the polymer support bundle of Example 2; Figure 7 This is a schematic diagram of the structure of the small mesh disk at the head end and the large mesh disk at the tumor diameter; Figure 8 This is a schematic diagram of the top structure of the small mesh disk at the head end and the mesh disk with a large diameter at the tumor mouth in Example 1; Figure 9 This is a schematic diagram of the top view of the small mesh disk at the head end and the mesh disk with a large diameter at the tumor mouth in Example 3; Figure 10 This is a schematic diagram of the device after installation; Figure 11 This is a schematic diagram of the device when it is initially inserted; Figure 12 This is a schematic diagram of the structure of the small network disk at the head end of the device; Figure 13 This is a schematic diagram of the structure of the device after it is fully expanded; Figure 14 This is a structural diagram of the device in the convergence state.

[0020] Among them, 1. Head end developing ring; 2. Head end small mesh disk; 3. Elastic support part; 4. Polymer support bundle; 5. Large mesh disk with tumor diameter; 6. Tail end developing ring; 7. Electrolytic wire removal; 8. Push rod; 9. Delivery catheter; 31. Micropore; 32. Support rod; 33. Connecting flexible part. DETAILED DESCRIPTION

[0021] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0022] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0023] Example 1

[0024] Reference Figure 1-5 , 7-8, 10-14, this embodiment discloses a spoiler device, comprising: an elastic support member 3, the top end of the elastic support member 3 is fixedly connected to the head end small mesh disk 2 through the head end developing ring 1, and the bottom end of the elastic support member 3 is fixedly connected to the tumor diameter large mesh disk 5 through the tail end developing ring 6; A polymer support bundle 4 is fixedly connected to the outer side of the middle of the elastic support member 3. The outer diameter of the polymer support bundle 4 matches the outer diameters of the small mesh disk 2 at the head end and the large mesh disk 5 at the tumor opening. One end of the electrolytic release wire 7 is fixedly connected to the tail end developing ring 6 , and the other end of the electrolytic release wire 7 is fixedly connected to a pushing rod 8 .

[0025] The electrolytic wire removal 7 selected in this embodiment is a conventional technical means in this field and will not be described in detail here.

[0026] During use, the polymer support bundles 4 within the device are able to protrude outward after being stressed by the elastic support members 3, thereby clinging to the inner wall of the aneurysm and providing stable support. The elastic support members 3 can be made of a thin-walled metal tube, shaped by laser engraving. Due to their elasticity, the elastic support members 3 can be pushed and deformed by the push rod 8. This deformation not only ensures stable control of the device's height but also pushes the polymer support bundles 4 outward, creating a close fit.

[0027] Through the bidirectional anchoring of the small mesh plate 2 at the head end and the large mesh plate 5 at the tumor diameter, this device can stably fit the inner wall of the tumor and the opening side of the tumor diameter, effectively preventing the device from shifting; the elastic support member 3 can be deformed under pressure, and can adjust the height according to the tumor height to adapt to aneurysms of different sizes; the polymer support bundle 4 is composed of supporting wires, and the middle part protrudes outward to form a supporting structure. After unfolding, it is close to the inner wall of the tumor, which can not only slow down the blood flow speed in the tumor through the turbulent effect to promote thrombosis and enhance the embolization effect, but also prevent blood from directly impacting the inner wall of the tumor cavity, reducing the risk of aneurysm rupture; at the same time, with the help of the delivery catheter 9, the convergence and step-by-step unfolding are achieved, and the fixation is completed in combination with the electrolytic release wire 7. It is easy to operate and has low surgical difficulty. It is a minimally invasive treatment method, which can reduce patient trauma and is conducive to postoperative recovery. It is especially suitable for the treatment of complex aneurysms such as intracranial artery bifurcations, and can improve the problems of high surgical difficulty, many complications and high recurrence rate in traditional treatments.

[0028] A further optimized solution is that the elastic support member 3 includes an elastic tube body, the top and bottom of the elastic tube body are connected by at least three support rods 32, at least one connecting flexible member 33 is fixedly connected between adjacent support rods 32, a plurality of micropores 31 are opened on the support rod 32, and the polymer support bundle 4 is fixedly connected to the micropores 31.

[0029] The elastic support member serves as the core skeleton of the flow-disturbing device, and is composed of an elastic tube body, at least three support rods 32 and a connecting flexible member 33. The micropores 31 on the support rods 32 can fix the polymer support bundle 4, and the adjacent support rods 32 are connected by the connecting flexible member 33 to form a deformable structure. It can flexibly adjust the overall height through compression deformation to adapt to aneurysms of different "tumor heights" and enhance the fit between the device and the tumor body. It can also provide a stable fixing foundation for the polymer support bundle 4, ensuring that the polymer support bundle 4 can protrude outward and tightly adhere to the inner wall of the tumor when deployed. At the same time, with the help of its own elastic properties, the push rod 8 is operated to realize the step-by-step deployment of the device, thereby ensuring the structural stability and functional effectiveness of the entire device in the aneurysm. It is a key component for achieving the adaptability, support and operational feasibility of the device.

[0030] According to a further optimized solution, the polymer support bundle 4 is composed of a plurality of support wires, one end of the support wire is fixedly connected to a micropore 31, the other end of the support wire is fixedly connected to another micropore 31, and the middle part of the support wire protrudes outward to form a support structure.

[0031] The polymer support bundle 4 is composed of several support wires, the two ends of which are respectively fixed to the micropores 31 of the support rod 32 of the elastic support member 3, and the middle part protrudes outward to form a support structure. Its outer diameter matches the outer diameter of the small mesh plate 2 at the head end and the large mesh plate 5 at the tumor diameter. On the one hand, when the elastic support member 3 is compressed and deformed, it can be pushed to protrude outward and tightly adhere to the inner wall of the tumor, effectively disturbing the flow through physical blocking, slowing down the blood flow rate in the tumor, promoting thrombosis to enhance the embolization effect; on the other hand, its protruding support structure can directly act on the inner wall of the tumor, preventing blood from directly impacting the inner wall of the tumor cavity, reducing the risk of aneurysm rupture, and at the same time cooperating with the small mesh plate 2 at the head end and the large mesh plate 5 at the tumor diameter to form a comprehensive support for the tumor body, further improving the overall stability and adaptability of the device.

[0032] Further optimization scheme, a plurality of micro holes 31 on a support rod 32 are arranged in a single row, and its structural arrangement is as follows Figure 5 As shown in .

[0033] A method for using a spoiler device: S1, prepare the spoiler in the convergent state; S2, inserting the head of the flow-disturbing device into the aneurysm through the pushing rod 8; S3, releasing the flow disturbance device, so that the small mesh plate 2 at the head end, the polymer support bundle 4, and the large mesh plate 5 at the tumor diameter are sequentially unfolded and adhered to the inner wall of the tumor; S4, start the electrolytic wire 7 to disconnect the connection between the push rod 8 and the tail end developing ring 6, so as to fix the spoiler.

[0034] To further optimize the solution, the flow-disturbing device is converged by wrapping the delivery catheter 9. In the step of releasing the flow-disturbing device, the delivery catheter 9 is withdrawn to realize the sequential deployment of the small mesh disk 2 at the head end, the polymer support bundle 4, and the large mesh disk 5 at the tumor diameter.

[0035] To further optimize the solution, when the spoiler device is converged, the small mesh plate 2 at the head end is installed on the outside of the large mesh plate 5 at the tumor diameter.

[0036] To further optimize the solution, step S3 includes: S3.1. Pull out the delivery catheter 9, allowing the small mesh plate 2 at the tip to unfold and adhere closely to the inner wall of the tumor; S3.2. Continue to pull out the delivery catheter 9 to expose the polymer support bundle 4; S3.3. Push the push rod 8, causing the elastic support member 3 to deform under pressure, pushing the polymer support bundle 4 outward to cling to the inner wall of the tumor; S3.4. Continue to pull out the delivery catheter 9, so that the large-diameter mesh plate 5 is unfolded and close to the opening side of the tumor inner wall to complete the deployment of the flow-turbulating device.

[0037] The mesh plates of the small mesh plate 2 at the head end and the large mesh plate 5 at the tumor opening in Example 1 are woven with micro nickel-titanium wires and are shaped at a high temperature of 480-530°C.

[0038] Example 2

[0039] The only difference between this embodiment and embodiment 1 is that the plurality of microholes 31 on one support rod 32 are arranged in double rows. Figure 6 As shown in .

[0040] Example 3

[0041] The only difference between this embodiment and embodiment 1 is that the small mesh disk 2 at the head end and the large mesh disk 5 at the tumor diameter are laser engraved structures. Figure 9 As shown in .

[0042] In the description of the present invention, it should be understood that the terms "longitudinal", "transverse", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0043] The embodiments described above are merely descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Without departing from the spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by persons skilled in the art should fall within the scope of protection defined by the claims of the present invention.

Claims

1. A spoiler device, characterized in that: include: An elastic support member (3), wherein the top end of the elastic support member (3) is fixedly connected to the head end small mesh disk (2) via the head end developing ring (1), and the bottom end of the elastic support member (3) is fixedly connected to the tumor diameter large mesh disk (5) via the tail end developing ring (6); A polymer support bundle (4) is fixedly connected to the outer side of the middle portion of the elastic support member (3), and the outer diameter of the polymer support bundle (4) matches the outer diameters of the head end small mesh disk (2) and the tumor-diameter large mesh disk (5); One end of the electrolytic wire release (7) is fixedly connected to the tail end developing ring (6), and the other end of the electrolytic wire release (7) is fixedly connected to a pushing rod (8).

2. A spoiler device according to claim 1, characterized in that: The elastic support member (3) comprises an elastic tube body, the top and bottom of the elastic tube body are connected by at least three support rods (32), at least one connecting flexible member (33) is fixedly connected between adjacent support rods (32), a plurality of micropores (31) are formed on the support rods (32), and the polymer support bundle (4) is fixedly connected to the micropores (31).

3. A spoiler device according to claim 2, characterized in that: The polymer support bundle (4) is composed of a plurality of support filaments, one end of the support filament is fixedly connected to one of the micropores (31), the other end of the support filament is fixedly connected to another micropore (31), and the middle portion of the support filament protrudes outward to form a support structure.

4. A spoiler device according to claim 1, characterized in that: The plurality of microholes (31) on one support rod (32) are arranged in a single row.

5. The spoiler device according to claim 1, characterized in that: The plurality of microholes (31) on one support rod (32) are arranged in double rows.

6. A method for using the spoiler according to any one of claims 1 to 5, characterized in that: S1, the spoiler is ready in a converged state; S2, extending the head of the flow-disturbing device into the aneurysm through the pushing rod (8); S3, releasing the flow-disturbing device, so that the small mesh plate (2) at the head end, the polymer support bundle (4), and the large mesh plate (5) at the tumor diameter are sequentially unfolded and closely attached to the inner wall of the tumor; S4, starting the electrolytic wire release (7) to disconnect the connection between the push rod (8) and the tail end developing ring (6), thereby achieving the fixation of the spoiler.

7. The method for using the spoiler according to claim 6, characterized in that: The flow-disturbing device is converged by wrapping the delivery catheter (9), and in the step of releasing the flow-disturbing device, the small mesh disk (2) at the head end, the polymer support bundle (4), and the large mesh disk (5) at the tumor diameter are sequentially deployed by withdrawing the delivery catheter (9).

8. The method for using a spoiler according to claim 6, characterized in that: When the flow-turbulating device is closed, the small mesh plate (2) at the head end is sleeved on the outside of the large mesh plate (5) with a tumor diameter.

9. The method for using a spoiler according to claim 7, characterized in that: The step S3 includes: S3.

1. Pull out the delivery catheter (9) to expand the small mesh plate (2) at the head end and adhere to the inner wall of the tumor; S3.2, continue to pull out the delivery catheter (9) to expose the polymer support bundle (4); S3.3, pushing the push rod (8), so that the elastic support member (3) is compressed and deformed, pushing the polymer support bundle (4) to protrude outward and adhere closely to the inner wall of the tumor; S3.4, continue to pull out the delivery catheter (9), so that the large-diameter mesh plate (5) of the tumor is unfolded and close to the opening side of the tumor inner wall to complete the deployment of the flow-disturbing device.

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