Intratumoral turbulence device

Abstract

The application discloses an intratumoral turbulence device, which comprises an umbrella-shaped elastic net disc, a pushing rod, a release section and a microcatheter. The umbrella-shaped elastic net disc is a double-layer structure woven by metal wires, and the points at the maximum diameter of the disc opening are all on a plane. Anchor devices are distributed around the two sides of the skirt edge of the umbrella-shaped elastic net disc, which are used for strengthening the fixation of the umbrella-shaped elastic net disc and the tumor wall, so that the umbrella-shaped elastic net disc can better adhere to the inner wall of the tumor cavity and is not easy to be displaced in the tumor cavity. The umbrella-shaped elastic net disc has a blocking area, and the middle position of the blocking area is opposite to the aneurysm neck. A coating for promoting the growth of vascular endothelial cells is arranged at the middle position of the blocking area of the umbrella-shaped elastic net disc. The coating can accelerate the endothelialization of the aneurysm neck position, so that the reconstruction of the aneurysm-carrying artery is realized, and the risk of aneurysm recurrence and recanalization is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates to an intratumoral flow disturbance device. Background Technology

[0002] Intracranial aneurysms are pathological protrusions in the walls of intracranial arteries, with an incidence rate of 5%-10%. MRA studies show that the incidence of unruptured aneurysms in adults aged 35-75 in my country is approximately 7.0%. Although subarachnoid hemorrhage caused by ruptured intracranial aneurysms accounts for about 2%-7% of strokes, the mortality rate for first-time rupture is 25%-35%, and the mortality rate for re-rupture is as high as 60%. Traditional treatment methods are highly invasive, have long recovery periods, and carry high surgical risks. With the continuous maturation of neurointerventional techniques in recent years, interventional therapy has gradually replaced traditional surgery and plays an irreplaceable role in the treatment of intracranial aneurysms.

[0003] Coils and flow diverters are two typical instruments used in neurointerventional treatment of intracranial aneurysms. Wide-necked aneurysms located at arterial bifurcation points are a particularly challenging type of intracranial aneurysm to treat endovascularly. Due to their inherent anatomical characteristics, coils alone are insufficient to stabilize them within the aneurysm sac, often requiring the use of multiple stents or balloons. Because multiple devices occupy a significant portion of the aneurysm-bearing artery, they are prone to ischemic complications, necessitating perioperative antiplatelet therapy. Therefore, they sometimes cannot effectively treat ruptured intracranial aneurysms. In recent years, a new type of device—the intra-aneurysmal flow diversion device—has been developed. The main advantages of this device are: firstly, it eliminates the need for postoperative antiplatelet therapy; and secondly, it is more suitable for wide-necked aneurysms, especially bifurcation aneurysms, serving as an important supplement to flow diverters in aneurysm treatment.

[0004] However, existing intraaneural flow disruptors suffer from problems such as poor adherence to the aneurysm wall, easy device collapse, easy displacement or misalignment after release, and slow endothelialization at the aneurysm neck when the anatomical structure of the intracranial aneurysm is complex, leading to poor prognosis. Therefore, there is an urgent need to design an intraaneural flow disruptor with good adherence to the aneurysm wall, low displacement or misalignment, and high safety. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide an intra-aneurysmal flow disturbance device that can improve the stability of the device within the aneurysm, effectively prevent displacement or misalignment, and increase the radial support force of the device to better fit the inner wall of the aneurysm cavity. A coating containing extracellular matrix proteins is provided at the blocking area of ​​the intra-aneurysmal flow disturbance device. This coating can accelerate endothelialization at the neck of the aneurysm and accelerate thrombus formation within the aneurysm.

[0006] To achieve the above objectives, this invention proposes an intra-aneurysmal flow disturbance device, comprising an umbrella-shaped elastic mesh, a push rod, a release section, and a microcatheter; the umbrella-shaped elastic mesh is a double-layer structure woven from metal wires; anchoring devices are distributed around both sides of the skirt of the umbrella-shaped elastic mesh to enhance the fixation between the umbrella-shaped elastic mesh and the aneurysm wall; the center of the umbrella-shaped elastic mesh has a contrast marker; the metal wire in the middle of the umbrella-shaped elastic mesh is fixed within the contrast marker; the center of the umbrella-shaped elastic mesh bulges upward, and the contrast marker is not lower than the nearest end of the umbrella-shaped elastic mesh; the umbrella-shaped elastic mesh has a occlusion area, the middle position of which is directly opposite the neck of the aneurysm, and a coating that promotes the growth of vascular endothelial cells is provided in the middle position of the occlusion area of ​​the umbrella-shaped elastic mesh, which can accelerate the endothelialization of the neck of the aneurysm.

[0007] Furthermore, the push rod is connected to the umbrella-shaped elastic mesh disk via a release section, and is used to push the umbrella-shaped elastic mesh disk.

[0008] Furthermore, the imaging marker is fixedly connected to the center of the umbrella-shaped elastic mesh occlusion area, and the imaging marker is used to connect with the release segment; the center of the umbrella-shaped elastic mesh occlusion area protrudes upward toward the aneurysm cavity of the occlusion area, and the imaging marker does not exceed the lowest point of the umbrella-shaped elastic mesh occlusion area.

[0009] Furthermore, the microcatheter is used to deliver an umbrella-shaped elastic mesh; the pusher rod folds the umbrella-shaped elastic mesh in the opposite direction along the microcatheter, compresses it into a bundle-shaped turbulence mesh, and pushes it into the aneurysm cavity. The umbrella-shaped mesh is folded in the opposite direction to form a disc shape. The turbulence mesh unfolds in the opposite direction within the aneurysm cavity and adheres to the inner wall of the aneurysm cavity. The release segment breaks through electrolysis or electrothermal release, and the center of the turbulence mesh bulges upward, pulling the imaging marker into the aneurysm cavity opening.

[0010] Furthermore, all points at the maximum diameter of the umbrella-shaped elastic mesh disk are on the same plane.

[0011] Furthermore, the anchoring device protrudes on the outer side of the umbrella-shaped elastic mesh panel skirt, which is formed by bending and extending the umbrella-shaped elastic mesh panel, and the sealing area is formed by the mesh panel skirt.

[0012] Furthermore, the anchoring device is a multi-layered structure with an upper and lower layer. Each layer is woven from 4, 6, 8, 12, 16, or 20 metal protrusions and heat-treated to form the structure.

[0013] Furthermore, the number of metal wires in the woven umbrella-shaped elastic mesh is 36, 48, 64, 72, 96, or 128.

[0014] Furthermore, the diameter of the metal wires used to weave the umbrella-shaped elastic mesh is 0.01mm-0.04mm.

[0015] Furthermore, the metal wires used to weave the umbrella-shaped elastic mesh are made of nickel-titanium alloy wire, platinum-core nickel-titanium wire, or 35NLT alloy.

[0016] Furthermore, the metal wires used to weave the umbrella-shaped elastic mesh are developable metal wires.

[0017] Furthermore, a coating that promotes the growth of vascular endothelial cells is provided in the middle of the umbrella-shaped elastic mesh occlusion area. This coating contains extracellular matrix proteins.

[0018] Furthermore, the developing markers are solid rings made of gold, tantalum, platinum-iridium alloy, or platinum-tungsten alloy.

[0019] Furthermore, the height of the outer edge of the turbulence-inducing umbrella-shaped mesh disk is not higher than the height of the fold at the center of the umbrella-shaped elastic mesh disk.

[0020] Furthermore, the height of the turbulence-inducing umbrella-shaped mesh disk is between 10% and 40% of the diameter of the turbulence-inducing umbrella-shaped mesh disk.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) In the intratumoral disturbance device of the present invention, the points at the maximum diameter of the umbrella-shaped elastic mesh are all on the same plane, and an anchoring device can be provided around the skirt of the outer layer of the umbrella-shaped elastic mesh. This arrangement can improve the radial support force of the umbrella-shaped elastic mesh, making it better fit the inner wall of the aneurysm cavity, and it is not easy to shift within the aneurysm cavity. (2) A coating containing extracellular matrix protein is provided in the middle of the occlusion area of ​​the umbrella-shaped elastic mesh. This arrangement can accelerate the endothelialization and new intimal growth at the neck of the aneurysm, thereby realizing the reconstruction of the aneurysm-bearing artery and reducing the risk of aneurysm recurrence and recanalization. Attached Figure Description

[0022] The features and advantages of the present invention will become apparent from the following detailed description of embodiments of the invention with reference to the accompanying drawings.

[0023] Figure 1 This is a schematic diagram of the structure of the umbrella-shaped elastic mesh disk of the intratumoral turbulence device of the present invention in its unfolded state;

[0024] Figure 2 This is a schematic diagram of the delivery of the intratumoral turbulence device of the present invention in a microcatheter;

[0025] Figure 3 This is a schematic diagram showing the release and separation of the intratumoral turbulence device of the present invention from the microcatheter;

[0026] Figure 4 This is a schematic diagram showing the complete release of the elastic mesh disk from the microcatheter and its reverse folding and separation by the intratumoral turbulence device of the present invention;

[0027] Figure 5This is a schematic diagram of the intraneural flow disturbance device of the present invention applied to an aneurysm and a partial schematic diagram of the anchoring device;

[0028] Figure 6 This is a schematic diagram of the one-press-one-weave method of the umbrella-shaped elastic mesh disc of the present invention;

[0029] Figure 7 This is a schematic diagram of the two-press, two-weave method of the umbrella-shaped elastic mesh disc of the present invention.

[0030] In the attached diagram: 1 is an umbrella-shaped elastic mesh, 2 is a contrast marker, 3 is a microcatheter, 4 is a release segment, 5 is a push rod, 6 is an anchoring device, 7 is a sealing area, and 8 is the skirt of the umbrella-shaped elastic mesh. Detailed Implementation

[0031] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the detailed description of the embodiments of the present invention, for ease of explanation, the schematic diagrams are not partially enlarged to scale and should not be construed as limiting the present invention.

[0032] In this invention patent, "proximal end" refers to the end closer to the operator of the intratumoral flow disturbance device, and "distal end" refers to the end farther from the operator of the intratumoral flow disturbance device.

[0033] Figure 1 This is a schematic diagram of the umbrella-shaped elastic mesh disk of the intratumoral flow disturbance device of the present invention in its deployed state. The umbrella-shaped elastic mesh disk 1 includes a woven umbrella-shaped elastic mesh disk body and a highlighting mark 2. The umbrella-shaped elastic mesh disk 1 is a double-layered umbrella-shaped elastic mesh disk structure woven from metal wires. The metal wire at the center of the umbrella-shaped elastic mesh disk 1 is fixed within the highlighting mark 2 at the center point of the umbrella-shaped elastic mesh disk 1. In the deployed state, the bottom of the highlighting mark 2 does not exceed the bottom of the umbrella-shaped elastic mesh disk 1. The height of the skirt of the umbrella-shaped elastic mesh disk 1 is lower than the height of the central protrusion of the umbrella-shaped elastic mesh disk 1. The height of the umbrella-shaped elastic mesh disk 1 is between 10% and 40% of its diameter. The highlighting mark 2 is a solid ring made of gold, tantalum, platinum-iridium alloy, or platinum-tungsten alloy. The highlighting mark 2 is used to indicate the release position of the intratumoral flow disturbance device during surgery, and also serves as a position mark for retracting the intratumoral flow disturbance device.

[0034] In one embodiment, the umbrella-shaped elastic mesh 1 is woven from metal wires. The metal wires can be made of nickel-titanium alloy wire, 10-40% platinum-core nickel-titanium wire, or 35NLT alloy wire. The metal wires can also be radiopaque metal wires, enabling full radiopaqueness during surgery. The number of metal wires can be 36, 48, 64, 72, 96, or 128. During the weaving of the umbrella-shaped elastic mesh 1, the metal wires are interwoven and can slide relative to each other. The center of the woven umbrella-shaped elastic mesh 1 is bound within the radiopaque marker 2.

[0035] In another embodiment, the umbrella-shaped elastic mesh 1 is made of metal wires woven with alloy wires of different diameters. Thickened alloy wires are added during weaving. Each layer consists of 4, 6, 8, 12, 16 or 20 alloy wires. This weaving method can improve the radial support force of the intratumoral turbulence device and prevent the umbrella-shaped elastic mesh from shifting in the tumor cavity.

[0036] The woven umbrella-shaped elastic mesh disc 1 has a circular cross-section, with wire diameters ranging from 0.01mm to 0.04mm and a weaving density of 80-150 PPi per layer per inch. It employs a 1:1 warp and weft cross pattern. Figure 6 As shown, clockwise and counterclockwise threads are woven in a one-over-one pattern, intersecting with each other in a sine curve. In other embodiments, umbrella-shaped elastic mesh of other strengths and specifications can be selected as needed, and the weaving density and pattern can also be adjusted, for example, according to... Figure 7 The clockwise and counterclockwise threads are intersected, and the clockwise thread is woven in a two-over-two pattern, where the clockwise thread and the counterclockwise thread exchange positions at every two intersection points.

[0037] like Figure 2-4 As shown, the microcatheter 3 is used to establish a delivery channel for the umbrella-shaped elastic mesh 1 during surgery. The umbrella-shaped elastic mesh 1 can be compressed into a bundle within the microcatheter 3 for easy pushing. The push rod 5 is used to push the umbrella-shaped elastic mesh 1 within the delivery channel. The push rod 5 is connected to the umbrella-shaped elastic mesh 1 via a release section 4. Within the microcatheter 3, the umbrella-shaped elastic mesh 1 is compressed into a bundle, and the push rod 5 pushes the umbrella-shaped elastic mesh 1 into the aneurysm cavity and unfolds it. After unfolding, the umbrella-shaped elastic mesh 1 folds back and adheres to the inner wall of the aneurysm cavity, achieving occlusion of the aneurysm neck and preventing blood flow into the aneurysm cavity, thus achieving embolization treatment of the aneurysm. The release section 4 breaks under the action of an electrolytic separator or an electrothermal separator. At this time, the umbrella-shaped elastic mesh 1 will remain in the aneurysm cavity, and the central part of the umbrella-shaped elastic mesh 1 will return to a convex state, pulling the contrast marker into the aneurysm neck opening. This can prevent the contrast marker from causing embolism in the vascular cavity.

[0038] like Figure 5The diagram shows a schematic of the intra-aneurysmal flow disturbance device applied within an aneurysm and a partial schematic of the anchoring device. Anchoring devices 6, made of woven metal wire, can be installed on the umbrella-shaped elastic mesh 1. These anchoring devices 6 can be distributed in multiple layers on the outer surface of the umbrella-shaped elastic mesh 1, with each layer consisting of 4, 6, 8, 12, 16, or 20 metal protrusions, heat-treated to form the structure. The anchoring devices on the outer surface of the umbrella-shaped elastic mesh 1 are used to fix the flow disturbance device, preventing it from shifting within the aneurysm cavity and causing danger.

[0039] like Figure 5 As shown, the occlusion zone 7 of the intra-aneurysmal flow disturbance device is located at the neck of the aneurysm. Applying a coating or other surface treatment can promote endothelialization and better achieve occlusion of the aneurysm neck. The coating material can be an extracellular matrix protein, such as ECM protein. By adding a coating to the occlusion zone 7 of the intra-aneurysmal flow disturbance device, endothelialization of the aneurysm neck can be accelerated, effectively enhancing the occlusion effect.

[0040] The above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An intratumoral flow disturbance device, comprising an umbrella-shaped elastic mesh disk, a release section, a push rod, and a microcatheter; wherein the umbrella-shaped elastic mesh disk has a double-layer structure woven from metal wires; and wherein the center of the umbrella-shaped elastic mesh disk has a radiopaque marker, characterized in that: The points at the maximum diameter of the umbrella-shaped elastic mesh disc are all on a single plane; the umbrella-shaped elastic mesh disc is bent and extended to form a skirt; anchoring devices are distributed around both sides of the skirt, and the anchoring devices are used to strengthen the fixation of the umbrella-shaped elastic mesh disc to the nodule wall; the anchoring devices are protruding on the outer side of the skirt; the anchoring devices are woven from metal wires; the anchoring devices are multi-layered with an upper and lower structure, each layer consisting of 4, 6, 8, 12, 16, or 20 metal protrusions woven together and heat-treated.

2. The intratumoral turbulence device according to claim 1, characterized in that: The umbrella-shaped elastic mesh has a blocking area, which is formed by the skirt surrounding it.

3. The intratumoral turbulence device according to claim 1, characterized in that: The metal wire in the middle of the umbrella-shaped elastic screen is fixed inside the developing mark; the center of the umbrella-shaped elastic screen protrudes upward; the developing mark is not lower than the nearest end of the umbrella-shaped elastic screen.

4. The intratumoral turbulence device according to claim 2, characterized in that, The center of the occlusion zone is directly opposite the neck of the aneurysm, and a coating that promotes the growth of vascular endothelial cells is provided in the center of the occlusion zone.

5. The intratumoral turbulence device according to claim 1, characterized in that: The metal wire is made of nickel-titanium alloy wire, platinum-core nickel-titanium wire, or 35NLT alloy; the number of metal wires is 36, 48, 64, 72, 96, or 128; the diameter of the metal wire is 0.01mm to 0.04mm.

6. The intratumoral turbulence device according to claim 1, characterized in that: The metal wire is a developing metal wire.

7. The intratumoral turbulence device according to claim 1, characterized in that: The umbrella-shaped elastic mesh is made of metal wires woven with alloy wires of different diameters. Thickened alloy wires are added during the weaving process, and each layer has 4, 6, 8, 12, 16 or 20 alloy wires.

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