A flow disturbing device and method of use thereof

Abstract

This invention belongs to the field of medical device technology for treating aneurysms, and particularly relates to a flow-disrupting device and its method of use. The flow-disrupting device includes: an elastic support member, the top end of which is fixedly connected to a small mesh disc at the head end via a head-end imaging ring, and the bottom end of which is fixedly connected to a large mesh disc at the aneurysm diameter via a tail-end imaging ring; a polymer support bundle is fixedly connected to the outer side of the middle part of the elastic support member, the outer diameter of which matches the outer diameter of the small mesh disc at the head end and the large mesh disc at the aneurysm diameter; one end of an electrolytic decoction wire is fixedly connected to the tail-end imaging ring, and the other end of the electrolytic decoction wire is fixedly connected to a push rod. This invention provides a flow-disrupting device that can achieve good anchoring ability, adjust its height according to the aneurysm height, and simultaneously enhance the embolization effect with the polymer bundle fixed on the middle elastic support member, so as to achieve rapid embolization and prevent blood from impacting the inner wall of the aneurysm cavity.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology for treating aneurysms, and particularly relates to a flow disturbance device and its usage method. Background Technology

[0002] Aneurysms are a very common vascular disease caused by lesions or damage to the arterial wall, resulting in localized or diffuse dilation or bulging of the arterial wall. They are characterized by an expansive, pulsating mass and can occur anywhere in the arterial system. Rupture of an aneurysm can have serious consequences. For example, rupture of an intracranial aneurysm can cause subarachnoid hemorrhage, which in severe cases can lead to vasospasm, causing extensive cerebral infarction, resulting in hemiplegia and coma. Currently, the main treatment options for aneurysms are open surgery and endovascular interventional therapy. Open surgery requires opening the body cavity surrounding the aneurysm, such as craniotomy or thoracotomy, causing significant damage to the patient and a long recovery period. Endovascular interventional therapy for aneurysms, with its minimally invasive, safe, and effective advantages, has become the preferred clinical treatment option for many medical experts.

[0003] Endovascular interventional treatment of intracranial arterial bifurcation aneurysms remains very challenging, accounting for approximately 2.9% to 7.1% of all intracranial aneurysms. The biggest challenges in endovascular treatment of bifurcation aneurysms and other aneurysms lie in the impact of coil-stabilized embolization, stent-assisted coil placement, and flow diversion devices on branch vessels, as well as aneurysm recurrence.

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

[0005] The purpose of this invention is to provide a flow disturbance device to solve the problem of how to achieve good anchoring ability, adjust the height according to the tumor height, and increase the embolization effect by fixing a polymer bundle on the elastic support in the middle, so as to achieve rapid embolization and prevent blood from impacting the inner wall of the tumor cavity.

[0006] To achieve the above objectives, the present invention provides the following solution:

[0007] A flow-disrupting device includes: an elastic support member, the top end of which is fixedly connected to a small head-end mesh disk via a head-end developing ring, and the bottom end of which is fixedly connected to a large mesh disk with a puncture diameter via a tail-end developing ring;

[0008] A polymer support bundle is fixedly connected to the outer side of the middle part of the elastic support member, and the outer diameter of the polymer support bundle matches the outer diameter of the small mesh disc at the head end and the large mesh disc at the nodule diameter.

[0009] One end of the electrolytic desorption wire is fixedly connected to the developing ring at the tail end, and the other end of the electrolytic desorption wire is fixedly connected to a push rod.

[0010] Preferably, the elastic support includes an elastic tube, the top and bottom of which are connected by at least three support rods, and at least one flexible connecting member is fixedly connected between adjacent support rods. The support rods are provided with a plurality of micropores, and the polymer support bundle is fixedly connected to the micropores.

[0011] 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 part of the support filament protrudes outward to form a support structure.

[0012] Preferably, the micropores on one of the support rods are arranged in a single row.

[0013] Preferably, the microholes on one of the support rods are arranged in a double row.

[0014] A method of using a flow-disrupting device:

[0015] S1. Prepare the turbulence device in the convergent state;

[0016] S2. Insert the head of the turbulence-disrupting device into the aneurysm using the push rod;

[0017] S3. Release the turbulence device so that the small mesh at the head end, the polymer support bundle, and the large mesh at the tumor diameter opening unfold in sequence and adhere to the inner wall of the tumor.

[0018] S4. Start the electrolytic decoupling to disconnect the connection between the push rod and the tail end developing ring, thereby fixing the turbulence device.

[0019] Preferably, the flow-disrupting device is gathered by wrapping the delivery conduit. In the step of releasing the flow-disrupting device, the small head-end mesh, the polymer support bundle, and the large mesh at the aneurysm diameter are sequentially unfolded by withdrawing the delivery conduit.

[0020] Preferably, when the turbulence device is retracted, the small head-end mesh is fitted over the outside of the large mesh at the nozzle diameter.

[0021] Preferably, step S3 includes:

[0022] S3.1. Pull out the delivery catheter to allow the small mesh at the tip to unfold and adhere tightly to the inner wall of the tumor;

[0023] S3.2 Continue to pull the delivery conduit outward to expose the polymer support bundle;

[0024] S3.3. Push the push rod to compress and deform the elastic support member, and push the polymer support bundle outward to fit tightly against the inner wall of the tumor;

[0025] S3.4 Continue to pull out the delivery conduit so that the large mesh plate at the tumor diameter opening unfolds and fits tightly against the opening side of the tumor inner wall to complete the deployment of the turbulence device.

[0026] Compared with the prior art, the present invention has the following advantages and technical effects:

[0027] In terms of anchoring capability, the small mesh disc at the head end and the large mesh disc at the tumor opening work together to adhere tightly to the inner wall deep inside the tumor and at the tumor opening, forming a stable bidirectional anchoring, effectively preventing device displacement and ensuring positional stability during treatment.

[0028] In terms of adaptability, the elastic support can flexibly adjust its overall height through compression deformation, which can adapt to aneurysms of different heights, enhance the fit between the device and the aneurysm, and solve the problem that traditional devices are difficult to adapt to aneurysms of different sizes.

[0029] The polymer bundles fixed on the intermediate support can protrude outward and adhere tightly to the inner wall of the aneurysm when the device is deployed. On the one hand, they slow down the blood flow velocity inside the aneurysm through physical turbulence, promote rapid thrombus formation, increase the embolization effect, and achieve rapid thrombus induction. On the other hand, their protruding structure can directly block the direct impact of blood on the inner wall of the aneurysm cavity, reduce the risk of aneurysm rupture, and thus comprehensively improve the safety and effectiveness of aneurysm treatment.

[0030] Therefore, the present invention provides a flow disturbance device that can achieve good anchoring capability, adjust the height according to the tumor height, and increase the embolization effect by fixing a polymer bundle on the elastic support in the middle, so as to achieve the purpose of rapid embolization and prevent blood from impacting the inner wall of the tumor cavity. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the structure of the device;

[0033] Figure 2 This is a schematic diagram of the elastic support component in this device;

[0034] Figure 3 This is a schematic diagram of the structure of the elastic support member after it has been sheared and unfolded along the axis.

[0035] Figure 4 This is a schematic diagram of the deformation of an elastic support under stress.

[0036] Figure 5 This is a top view of the polymer support bundle in Example 1;

[0037] Figure 6 This is a top view of the polymer support bundle in Example 2;

[0038] Figure 7 A schematic diagram of the structure of the small mesh disc at the head end and the large mesh disc at the tumor diameter opening;

[0039] Figure 8 This is a top view of the small mesh disc at the head end and the large mesh disc at the tumor diameter in Example 1.

[0040] Figure 9 This is a top view of the small mesh disc at the head end and the large mesh disc at the nodule diameter in Example 3.

[0041] Figure 10 This is a schematic diagram showing the device after installation.

[0042] Figure 11 This is a schematic diagram showing the initial insertion of the device;

[0043] Figure 12 This is a schematic diagram of the structure of the small mesh disk at the release head of this device;

[0044] Figure 13 This is a schematic diagram of the device after it has been fully deployed;

[0045] Figure 14 This is a schematic diagram of the device in its contracted state.

[0046] Among them, 1. Head end imaging ring; 2. Head end small mesh tray; 3. Elastic support component; 4. Polymer support bundle; 5. Tumor diameter large mesh tray; 6. Tail end imaging ring; 7. Electrolytic desiccant; 8. Push rod; 9. Delivery conduit; 31. Micropore; 32. Support rod; 33. Connecting flexible component. Detailed Implementation

[0047] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0048] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0049] Example 1

[0050] Reference Figure 1-5 7-8, 10-14, This embodiment discloses a flow disturbance device, including: an elastic support 3, the top end of the elastic support 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 3 is fixedly connected to the tubercle diameter large mesh disk 5 through the tail end developing ring 6.

[0051] The elastic support 3 is fixedly connected to a polymer support bundle 4 on the outer side of the middle part. The outer diameter of the polymer support bundle 4 matches the outer diameter of the small mesh plate 2 at the head end and the large mesh plate 5 at the nodule diameter.

[0052] One end of an electrolytic desorption wire 7 is fixedly connected to the developing ring 6 at the tail end, and the other end of the electrolytic desorption wire 7 is fixedly connected to a push rod 8.

[0053] The electrolytic de-filament 7 selected in this embodiment is a conventional technique in the field and will not be described in detail here.

[0054] When using this device, the polymer support bundle 4 can protrude outward after the elastic support member 3 is subjected to force, thereby adhering tightly to the inner wall of the aneurysm and forming a stable support. The elastic support member 3 in this device can be made of thin-walled metal tubing, laser-engraved. Because the elastic support member 3 has elasticity, it can be pushed and deformed by the push rod 8. This deformation not only enables stable control of the height of the device, but also pushes the polymer support bundle 4 outward to form a tight fit.

[0055] This device uses bidirectional anchoring via a small mesh disc 2 at the head end and a large mesh disc 5 at the aneurysm opening, ensuring stable contact with the inner wall of the aneurysm and the opening side of the aneurysm opening, effectively preventing device displacement. The elastic support 3 can deform under pressure, adjusting its height according to the aneurysm height to accommodate aneurysms of different sizes. The polymer support bundle 4, composed of support wires, protrudes outward from the center to form a support structure. After unfolding, it adheres tightly to the inner wall of the aneurysm, both slowing down the blood flow velocity within the aneurysm through turbulence to promote thrombus formation and enhance the embolization effect, and preventing blood from directly impacting the inner wall of the aneurysm cavity, reducing the risk of aneurysm rupture. Simultaneously, the delivery catheter 9 enables convergence and stepwise unfolding, combined with electrolytic detachment wire 7 for fixation. The operation is simple, the surgery is low-difficulty, and it is a minimally invasive treatment method that reduces patient trauma and facilitates postoperative recovery. It is particularly suitable for the treatment of complex aneurysms such as intracranial arterial bifurcations, improving the problems of high surgical difficulty, numerous complications, and high recurrence rates in traditional treatments.

[0056] In a further optimized design, the elastic support 3 includes an elastic tube body, with at least three support rods 32 connecting the top and bottom of the elastic tube body. At least one flexible connecting element 33 is fixedly connected between adjacent support rods 32. Several micropores 31 are provided on the support rods 32, and the polymer support bundle 4 is fixedly connected to the micropores 31.

[0057] The elastic support component, as the core skeleton of the agitation device, consists of an elastic tube, at least three support rods 32, and a connecting flexible component 33. The micropores 31 on the support rods 32 can fix the polymer support bundle 4. Adjacent support rods 32 are connected by the connecting flexible component 33 to form a deformable structure. This structure can flexibly adjust the overall height by deforming under pressure to adapt to aneurysms of different heights, enhancing the fit between the device and the aneurysm. It also provides a stable fixing base for the polymer support bundle 4, ensuring that the polymer support bundle 4 can protrude outward and closely adhere to the inner wall of the aneurysm when deployed. At the same time, by utilizing its own elastic properties in conjunction with the push rod 8, the device can be deployed in stages, ensuring the structural stability and functional effectiveness of the entire device within the aneurysm. It is a key component for achieving the adaptability, support, and operational feasibility of the device.

[0058] The scheme is further optimized so that the polymer support bundle 4 is composed of several support wires. One end of the support wire is fixedly connected to a micropore 31, and the other end of the support wire is fixedly connected to another micropore 31. The middle part of the support wire protrudes outward to form a support structure.

[0059] The polymer support bundle 4 is composed of several support wires. The two ends of the support wires are fixed to the micropores 31 of the support rod 32 of the elastic support member 3. 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 aneurysm diameter. On the one hand, when the elastic support member 3 is compressed and deformed, it can be pushed outward and closely adhere to the inner wall of the aneurysm. It can effectively turbulent the flow through physical blocking, slow down the blood flow velocity in the aneurysm, and promote thrombus formation to enhance the embolization effect. On the other hand, its protruding support structure can directly act on the inner wall of the aneurysm, prevent the blood from directly impacting the inner wall of the aneurysm cavity, reduce the risk of aneurysm rupture, and cooperate with the small mesh plate 2 at the head end and the large mesh plate 5 at the aneurysm diameter to form comprehensive support for the aneurysm, further improving the overall stability and adaptability of the device.

[0060] Further optimizing the design, the numerous micro-holes 31 on a support rod 32 are arranged in a single row, and their structural arrangement is as follows: Figure 5 As shown in the image.

[0061] A method of using a flow-disrupting device:

[0062] S1. Prepare the spoiler device in the convergence state;

[0063] S2. Insert the head of the turbulence device into the aneurysm using the push rod 8;

[0064] S3. Release the turbulence device to allow the small mesh disc 2 at the head end, the polymer support bundle 4, and the large mesh disc 5 at the tumor diameter to unfold and adhere tightly to the inner wall of the tumor in sequence.

[0065] S4. Start the electrolytic decoupling wire 7 to disconnect the connection between the push rod 8 and the tail end developing ring 6, thereby fixing the turbulence device.

[0066] Further optimization of the scheme: the turbulence device is gathered by wrapping the delivery conduit 9. In the step of releasing the turbulence device, the small mesh disk 2 at the head end, the polymer support bundle 4, and the large mesh disk 5 at the aneurysm diameter are unfolded in sequence by withdrawing the delivery conduit 9.

[0067] To further optimize the design, when the turbulence device retracts, the two small net disks at the head end are set outside the large net disk 5 at the nozzle diameter.

[0068] Further optimization of the plan, step S3 includes:

[0069] S3.1. Pull out the delivery catheter 9 to allow the small mesh disc 2 at the tip to unfold and adhere tightly to the inner wall of the tumor;

[0070] S3.2 Continue to pull out the delivery conduit 9 to expose the polymer support bundle 4;

[0071] S3.3, push the push rod 8 to compress and deform the elastic support 3, and push the polymer support bundle 4 outward to stick to the inner wall of the tumor;

[0072] S3.4 Continue to pull out the delivery conduit 9 to make the large mesh plate 5 at the tumor diameter opening unfold and fit tightly against the opening side of the tumor inner wall to complete the deployment of the turbulence device.

[0073] In Example 1, the small head-end mesh disc 2 and the large head-diameter mesh disc 5 are woven from micro nickel-titanium wires and shaped at a high temperature of 480-530℃.

[0074] Example 2

[0075] The only difference between this embodiment and embodiment 1 is that the micro-holes 31 on one of the support rods 32 are arranged in a double row, and the structural arrangement is as follows: Figure 6 As shown in the image.

[0076] Example 3

[0077] The only difference between this embodiment and Embodiment 1 is that the small mesh disc 2 at the head end and the large mesh disc 5 at the nodule diameter are laser-engraved structures, and their structural arrangement is as follows: Figure 9 As shown in the image.

[0078] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0079] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A flow-disrupting device, characterized in that, include: The elastic support (3) has its top end fixedly connected to the head end small mesh plate (2) via the head end developing ring (1), and its bottom end fixedly connected to the tumor diameter large mesh plate (5) via the tail end developing ring (6). The elastic support member (3) is fixedly connected to a polymer support bundle (4) on the outer side of the middle part. The outer diameter of the polymer support bundle (4) matches the outer diameter of the small mesh disc (2) at the head end and the large mesh disc (5) at the tumor diameter. One end of the electrolytic desorption wire (7) is fixedly connected to the tail end developing ring (6), and the other end of the electrolytic desorption wire (7) is fixedly connected to the push rod (8). The elastic support (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 flexible connecting member (33) is fixedly connected between adjacent support rods (32). Several micropores (31) are opened on the support rods (32). The polymer support bundle (4) is fixedly connected to the micropores (31).

2. The flow-disrupting device according to claim 1, characterized in that: The polymer support bundle (4) is composed of several support filaments. One end of the support filament is fixedly connected to one of the micropores (31), and the other end of the support filament is fixedly connected to another micropore (31). The middle part of the support filament protrudes outward to form a support structure.

3. The flow-disrupting device according to claim 1, characterized in that: The microholes (31) on one of the support rods (32) are arranged in a single row.

4. The flow-disrupting device according to claim 1, characterized in that: The microholes (31) on one of the support rods (32) are arranged in a double row.

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