Intratumoral turbulence device

Abstract

The utility model relates to medical instrument technical field, specifically disclose a kind of intratumoral turbulence device, comprising: a kind of intratumoral turbulence device, comprising: the first turbulence net of proximal end, the second turbulence net of distal end and fixed ring;Fixed ring is set between the first turbulence net and the second turbulence net, for binding connection both;The first turbulence net and the second turbulence net are both bowl type structure of double-layer sheet-like woven net composition, the diameter of second turbulence net is not less than the diameter of first turbulence net;Device releases after in tumor, the first turbulence net and the second turbulence net are overlapped, form the composite structure of bottom concave inwards.This design utilizes distal end low-density woven net to promote intratumoral blood flow stasis and the synergistic mechanism of proximal high-density woven net to block blood flow impact, significantly optimize hemodynamic environment;Its concave composite structure closely conforms irregular tumor cavity morphology, combined with the mechanical constraint of fixed ring, greatly improve the anchoring stability of device and effectively inhibit displacement risk.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an intratumoral turbulence device. Background Technology

[0002] An aneurysm is a localized dilation or bulging of an artery wall caused by congenital abnormalities or acquired injury, resulting in decreased function and elasticity, under hemodynamic load and other triggering factors. Intracranial aneurysms are the leading cause of subarachnoid hemorrhage; rupture can lead to disability or even death. Current main treatment options for intracranial aneurysms include traditional open craniotomy clipping and endovascular interventional therapy.

[0003] Traditional craniotomy clipping requires opening the skull and separating brain tissue to clip the aneurysm neck, resulting in significant surgical trauma and a long recovery period for patients. In contrast, endovascular interventional therapy, with its advantages of being minimally invasive, allowing for rapid postoperative recovery, and having a lower complication rate, is gradually replacing craniotomy and becoming the mainstream clinical treatment choice. Devices used in endovascular interventional therapy primarily focus on intra-aneurysmal embolization, and can be divided into two main categories: total intra-aneurysmal embolization devices and aneurysm neck occlusion devices.

[0004] However, existing technologies have significant limitations. Intra-aneurysmal total embolization devices aim to completely fill the aneurysm cavity, but they suffer from poor conformity to the aneurysm's morphology. If the device fails to precisely align with the aneurysm neck, not only will effective treatment be difficult, but the risk of subsequent aneurysm rupture may also increase, a problem particularly prominent in the treatment of lateral wall aneurysms. Furthermore, the proximal end of the device tends to protrude into the parent vessel of the aneurysm, further increasing the risk of vascular stenosis. While aneurysm neck occlusion devices are relatively simple in terms of instrument selection, their potential risk of displacement within the body is relatively higher. Utility Model Content

[0005] To achieve the purpose of this utility model, this application provides an intratumoral turbulence device, comprising: a first turbulence net at the proximal end, a second turbulence net at the distal end, and a fixing ring; the fixing ring is disposed between the first turbulence net and the second turbulence net for binding and connecting the two; both the first turbulence net and the second turbulence net are bowl-shaped structures composed of double-layer sheet-like woven mesh, and the diameter of the second turbulence net is not less than the diameter of the first turbulence net; after the device is released inside the tumor, the first turbulence net and the second turbulence net adhere and overlap to form a composite structure with a concave bottom.

[0006] Furthermore, the diameter of the first turbulence mesh is 1 / 2 to the same diameter as the second turbulence mesh.

[0007] Furthermore, the first and second turbulence nets are woven together as a single unit, and the fixing rings bind and gather the woven threads to form a connecting structure.

[0008] Furthermore, the first and second spoiler nets are separate woven structures connected by a fixing ring.

[0009] Furthermore, the weaving density of the second turbulence mesh is no greater than the weaving density of the first turbulence mesh.

[0010] Furthermore, the retaining ring is made of platinum-iridium alloy, platinum-tungsten alloy, or stainless steel; the height of the retaining ring is 0.5mm to 2.5mm.

[0011] Furthermore, the braiding filament material is selected from cobalt-chromium alloy, nickel-titanium alloy, platinum-tungsten alloy, or nickel-titanium-non-transparent core-spun composite filament; the diameter of the braiding filament is 0.01mm to 0.20mm, and the number is 6 to 96.

[0012] Furthermore, the bowl-shaped woven mesh forms a continuous, smooth, concave surface after release, with a radius of curvature adapted to the anatomical shape of the aneurysm cavity.

[0013] The beneficial effects of the above technical solution are as follows:

[0014] This device employs a double-layered, bowl-shaped composite structure formed by connecting a small-diameter proximal bleed-off mesh and a large-diameter distal bleed-off mesh via a fixing ring. Upon release, this structure automatically conforms to form a concave bottom. This design utilizes a synergistic mechanism of the distal low-density woven mesh promoting blood flow stagnation within the tumor and the proximal high-density woven mesh blocking blood flow impact, significantly optimizing the hemodynamic environment. Its concave composite structure closely conforms to the irregular tumor cavity shape, and combined with the mechanical constraint of the fixing ring, greatly improves the device's anchoring stability and effectively suppresses the risk of displacement. Simultaneously, the miniaturized proximal design significantly reduces the size of the device protruding into the tumor-bearing vessel, minimizing the risk of vascular stenosis and thrombosis. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Fig. 1 This is a schematic diagram of the intratumoral turbulence device of this utility model;

[0017] Fig. 2 This is a schematic diagram of the intratumoral disturbance device of this utility model after it is released within the lateral wall aneurysm;

[0018] Fig. 3 This is a schematic diagram of the intratumoral turbulence device of this utility model after it is released within the bifurcation aneurysm.

[0019] Among them, 1. Second turbulence network; 2. First turbulence network; 3. Fixing ring; 4. Aneurysm; 5. Artery. Detailed Implementation

[0020] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments.

[0021] Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar symbols denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0022] This utility model embodiment provides an intratumoral turbulence disturbance device, such as Figs. 1 to 3 As shown, the device includes: a first baffle net 2 at the proximal end, a second baffle net 1 at the distal end, and a fixing ring 3. The fixing ring 3 is positioned between the first baffle net 2 and the second baffle net 1 to bind and connect them. Both the first baffle net 2 and the second baffle net 1 are bowl-shaped structures composed of double-layered sheet-like woven meshes, and the diameter of the second baffle net 1 is not less than the diameter of the first baffle net 2. After the device is released within the aneurysm, the first baffle net 2 and the second baffle net 1 adhere and overlap, forming a composite structure with a concave bottom. The first baffle net 2 (proximal end) closely adheres to the neck of the aneurysm 4 and slightly protrudes into the lumen of the aneurysm-bearing vessel, with its bowl-shaped edge forming a circumferential seal with the periphery of the aneurysm neck. The second baffle net 1 (distal end) is completely located within the aneurysm lumen, with its bowl-shaped curved surface fully conforming to the bottom and sidewalls of the aneurysm lumen, covering the largest cross-sectional area of ​​the aneurysm lumen. It can be seen that the double-layered bowl-shaped composite structure formed by the connection of the small-diameter baffle net at the proximal end and the large-diameter baffle net at the distal end via the fixing ring 3 automatically adheres to form a concave bottom shape after release. This design utilizes a synergistic mechanism of distal low-density braided mesh promoting intratumoral blood flow stagnation and proximal high-density braided mesh blocking blood flow impact, significantly optimizing the hemodynamic environment. Its concave composite structure closely conforms to the irregular tumor cavity morphology, and combined with the mechanical constraint of the fixing ring 3, greatly improves the device's anchoring stability and effectively suppresses the risk of displacement. Simultaneously, the proximal miniaturization design significantly reduces the size of the device protruding into the tumor-bearing vessel, minimizing the risk of vascular stenosis and thrombosis. This device can adapt to sidewall types (such as...). Fig. 2 (as shown) and branched (such as) Fig. 3 Aneurysms with diverse anatomical structures (as shown in the image) provide a solution for minimally invasive interventional treatment that is both highly efficient and universally applicable.

[0023] In a specific embodiment of this invention, the diameter of the first baffle net 2 is limited to 1 / 2 to the same diameter as the second baffle net 1. This proportional design allows the second baffle net 1 to fully conform to the bottom of the aneurysm cavity, while the first baffle net 2 precisely adapts to the size of the aneurysm neck: in wide-necked bifurcated aneurysms 4, the large-diameter second baffle net 1 spans the aneurysm neck to form three-way support; in lateral wall aneurysms 4 with narrow necks, the equal-diameter double nets form a symmetrically overlapping concave surface to achieve full coverage. Its mechanical optimization enables the device to generate an anchoring force towards the bottom of the aneurysm cavity under the impact of blood flow, avoiding the risk of compression of the carrier vessel. This size combination allows a single device to adapt to various aneurysm neck conditions, and the aneurysm neck occlusion and blood flow remodeling can be completed simultaneously without changing the device during interventional procedures, significantly improving surgical efficiency and reducing the risk of displacement.

[0024] In a specific embodiment of this invention, the first bleeder net 2 and the second bleeder net 1 are integrally woven together with braided filaments, and the filaments are bound together by a fixing ring 3 to form a connecting node. This seamless woven structure eliminates the welding or mechanical connection points of traditional split-type devices, making the stress transmission path between the two nets continuous and uniformly distributed. When the device undergoes micro-deformation under the impact of blood flow, the braided filament network disperses the local load through the elastic expansion and contraction of the overall structure, avoiding the risk of metal fatigue fracture caused by stress concentration; at the same time, the constraint of the fixing ring 3 on the gathering point of the braided filaments forms a controllable deformation fulcrum, ensuring that the two nets always maintain a precise spacing of 0.2-0.5mm in the dynamic blood flow environment, maintaining the stability of the concave shape and providing growth space for thrombi in the aneurysm cavity. This design reduces the device breakage rate to near zero through material continuity, and its integrally molded biocompatible surface completely eliminates thrombosis or inflammatory reactions caused by metal debris shedding, providing a structural basis for long-term implantation safety.

[0025] In the split-type embodiment of this utility model, the first bleeder net 2 and the second bleeder net 1 are independently woven and then connected by a fixing ring 3 to form a modular combination structure. This design breaks through the limitations of integrated weaving and achieves differentiated customization of the two nets: the first bleeder net 2 can strengthen the blood flow barrier of the aneurysm neck, and the second bleeder net 1 independently optimizes the morphological compliance of the aneurysm cavity; the fixing ring 3 precisely controls the spacing between the two nets to eliminate filling dead zones. The split structure not only meets the rigid support requirements of giant aneurysms, but also allows for flexible intraoperative replacement of multiple lesions. Its independent folding characteristics ensure complete morphological restoration after microcatheter delivery, while eliminating stress concentration points and enhancing long-term fit reliability.

[0026] In a specific embodiment of this invention, the weaving density of the second turbulence mesh 1 is designed to be no greater than that of the first turbulence mesh 2, forming a gradient density distribution from the distal to the proximal end. This structural characteristic allows some blood flow to penetrate to the bottom of the aneurysm cavity after implantation, reducing flow velocity while inducing the aggregation of red blood cells and platelets, accelerating the progressive formation of intratumoral thrombi; while the high-density weaving of the proximal first turbulence mesh 2 forms a dense barrier, effectively blocking the continuous impact of the main artery 5 blood flow on the aneurysm neck, increasing the blood flow stagnation rate in the aneurysm neck region to above the critical threshold.

[0027] In a specific embodiment of this invention, the fixation ring 3 is made of platinum-iridium alloy, platinum-tungsten alloy, or stainless steel, with its height controlled within the range of 0.5-2.5 mm. The inert surface of the platinum-iridium alloy inhibits thrombus and intimal hyperplasia, the platinum-tungsten alloy provides high-strength support against blood flow impact, and the stainless steel balances mechanical performance and manufacturing cost. The 0.5 mm ultra-thin design improves the permeability of microcatheter delivery, and the 2.5 mm ring height gives the dual-network adaptive deformation freedom of the bifurcation vessel angle. Surface micro-arc oxidation promotes endothelial cell adhesion, and combined with the inherent radiopaqueness of the platinum-based alloy, achieves precise intraoperative positioning. This design makes the fixation ring 3 the core hub coordinating the functions of the dual networks, ensuring the complete unfolding of the giant aneurysm 4 while maintaining the precise spacing during tandem implantation, optimizing device performance from three dimensions: biocompatibility, mechanical stability, and operational controllability.

[0028] In specific embodiments of this invention, the braided filaments are selected from cobalt-chromium alloy, nickel-titanium alloy, platinum-tungsten alloy, or nickel-titanium core-coated composite filaments, with a diameter of 0.01-0.20 mm and a quantity of 6-96 filaments. The cobalt-chromium alloy provides rigid support against blood flow erosion, while the nickel-titanium alloy ensures precise restoration of the pre-set bowl-shaped structure after compression and delivery. The platinum-tungsten alloy enhances intraoperative imaging, and the nickel-titanium core-coated composite filaments simultaneously achieve morphological adaptation and zero-artifact imaging. The ultra-fine filament diameter forms a micron-level mesh, selectively permeating plasma proteins to promote thrombus formation while blocking red blood cell penetration. The high quantity of braids significantly improves the efficiency of blood flow obstruction at the aneurysm neck. Optimized material surface treatment enhances biocompatibility, enabling the device to maintain structural integrity under long-term blood flow load, covering the treatment needs of aneurysms ranging from small to giant.

[0029] In a specific embodiment of this invention, the bowl-shaped woven mesh, after release, forms a continuous and smooth concave curved surface, the radius of curvature of which dynamically adapts to the anatomical morphology of the aneurysm 4 cavity. This curved surface design achieves stress-free adhesion to the aneurysm wall, adaptively wrapping the bifurcation ridge of the vessel in the bifurcation aneurysm 4, and forming uniform support throughout the lateral wall aneurysm; it also significantly attenuates the inflow velocity of blood into the aneurysm through tangential flow guidance, inhibiting turbulence formation and promoting fibrin deposition around the aneurysm neck; simultaneously, the negative pressure adsorption effect generated by the concave structure synergistically enhances the wall-adhesion stability, effectively resisting the impact of blood flow pulsation. This curvature adaptive mechanism transforms the device from a rigid geometric constraint into an anatomically responsive instrument, simultaneously optimizing anatomical matching, blood flow regulation, and long-term anchoring reliability.

[0030] In the description of this specification, the references to terms such as "an embodiment," "some embodiments," "example," "specific example," "a specific embodiment," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, illustrative expressions of terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0031] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. An intratumoral flow disturbance device, characterized in that, include: The device consists of a first turbulence mesh (2) at the proximal end, a second turbulence mesh (1) at the distal end, and a fixing ring (3). The fixing ring (3) is positioned between the first turbulence mesh (2) and the second turbulence mesh (1) to bind and connect the two. Both the first turbulence mesh (2) and the second turbulence mesh (1) are bowl-shaped structures made of double-layer sheet-like woven mesh. The diameter of the second turbulence mesh (1) is not less than the diameter of the first turbulence mesh. After the device is released inside the tumor, the first turbulence mesh (2) and the second turbulence mesh (1) adhere and overlap to form a composite structure with a concave bottom.

2. The intratumoral turbulence device according to claim 1, characterized in that, The diameter of the first turbulence mesh (2) is 1 / 2 to the same diameter as the diameter of the second turbulence mesh (1).

3. The intratumoral turbulence device according to claim 1, characterized in that, The first turbulence mesh (2) and the second turbulence mesh (1) are woven together by braiding filaments, and the fixing ring (3) binds and gathers the braiding filaments to form a connecting structure.

4. The intratumoral turbulence device according to claim 1, characterized in that, The first bleed net (2) and the second bleed net (1) are separate woven structures and are connected by the fixing ring (3).

5. The intratumoral turbulence device according to any one of claims 1-4, characterized in that, The weaving density of the second turbulence mesh (1) is not greater than the weaving density of the first turbulence mesh (2).

6. The intratumoral turbulence device according to claim 1, characterized in that, The material of the fixing ring (3) is selected from platinum-iridium alloy, platinum-tungsten alloy or stainless steel; the height of the fixing ring (3) is 0.5mm to 2.5mm.

7. The intratumoral turbulence device according to claim 1, characterized in that, The braiding wire is made of cobalt-chromium alloy, nickel-titanium alloy, platinum-tungsten alloy or nickel-titanium-non-transparent core-spun composite wire; the diameter of the braiding wire is 0.01mm to 0.20mm and the number is 6 to 96.

8. The intratumoral turbulence device according to claim 1, characterized in that, The bowl-shaped woven mesh forms a continuous, smooth, concave surface after release, with a radius of curvature adapted to the anatomical shape of the aneurysm cavity.

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