Intra-tumor turbulent flow device

Abstract

The device comprises an umbrella-shaped elastic net disc, a pushing rod, a releasing section and a micro catheter, the umbrella-shaped elastic net disc is of a double-layer structure woven by metal wires, points at the maximum diameter of a disc opening of the umbrella-shaped elastic net disc are located on the same plane, and anchoring devices are distributed around the two sides of the skirt edge of the umbrella-shaped elastic net disc; the umbrella-shaped elastic net disc is used for strengthening fixation of the umbrella-shaped elastic net disc and a tumor wall, so that the umbrella-shaped elastic net disc can be better attached to the inner wall of a tumor cavity and is not prone to displacement in the tumor cavity, the umbrella-shaped elastic net disc is provided with a blocking area, the middle position of the blocking area right faces an aneurysm neck opening, and a coating for promoting growth of vascular endothelial cells is arranged in the middle position of the blocking area of the umbrella-shaped elastic net disc. The coating can accelerate endothelialization of the neck of the aneurysm, so that reconstruction of the aneurysm-carrying artery is also realized, and the risk of recurrence and recanalization of the aneurysm is reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to an intra-tumor flow disturbance device. Background Art

[0002] Intracranial aneurysms are pathological protrusions of the intracranial artery wall, with an incidence of 5%-10%. MRA studies have shown that the incidence of unruptured aneurysms in adults aged 35-75 in my country is about 7.0%. Although subarachnoid hemorrhage caused by ruptured intracranial aneurysms accounts for about 2%-7% of strokes, the mortality rate of the first rupture is 25%-35%, and the mortality rate of re-rupture is as high as 60%. Traditional treatment methods cause great trauma to patients, have a long recovery period, and high surgical risks. With the continuous maturity of neurointerventional technology in recent years, interventional treatment has gradually replaced traditional surgical operations and plays an irreplaceable role in the treatment of intracranial aneurysms.

[0003] Coils and blood flow diversion devices are two typical devices for neurointerventional treatment of intracranial aneurysms. Wide-necked aneurysms located at the bifurcation of the artery are a more difficult type of intracranial aneurysm to treat intravascularly. Due to their inherent anatomical characteristics, it is difficult to stabilize them in the aneurysm cavity using only coils, and multiple stents or balloons are often required. Since multiple device treatments occupy more space in the parent artery and are prone to cause ischemic complications, and antiplatelet aggregation drugs are required during the perioperative period, ruptured intracranial aneurysms are sometimes not effectively treated. Therefore, on this basis, a new type of device, intratumoral flow diversion devices, has been developed in recent years. The main features of this type of device are: first, it has the advantage of not requiring antiplatelet therapy after surgery; second, it is more suitable for wide-necked aneurysms, especially bifurcation aneurysms, and is an important supplement to the treatment of aneurysms with blood flow diversion devices.

[0004] However, when the anatomical structure of the intracranial aneurysm is complex, the existing intratumoral flow spoiling devices may have problems such as poor wall adhesion, easy collapse of the device, easy displacement or dislocation after release, and slow endothelialization at the neck of the aneurysm, which may lead to poor prognosis. Therefore, it is urgent to design an intratumoral flow spoiling device with good wall adhesion, not easy to be displaced or dislocated, and high safety. Summary of the invention

[0005] The purpose of the present invention is to overcome the deficiencies in the prior art and provide an intra-tumor flow spoiler device, which can improve the stability of the intra-tumor flow spoiler device when placed in an aneurysm, effectively prevent the flow spoiler device from being displaced or misplaced, and improve the radial supporting force of the intra-tumor flow spoiler device so that it can better fit the inner wall of the aneurysm cavity; a coating containing extracellular matrix protein is provided at the occlusion area of ​​the intra-tumor flow spoiler device, and this coating can accelerate the endothelialization of the neck of the aneurysm and accelerate the formation of thrombus in the tumor.

[0006] To achieve the above-mentioned purpose, the present invention proposes an intra-tumor disturbance device, comprising an umbrella-shaped elastic mesh disk, a push rod, a release section, and a microcatheter; the umbrella-shaped elastic mesh disk is a double-layer structure woven with metal wires; anchoring devices are distributed around the skirt of the umbrella-shaped elastic mesh disk on both sides to strengthen the fixation of the umbrella-shaped elastic mesh disk and the tumor wall; the center of the umbrella-shaped elastic mesh disk has a developing mark; the metal wire in the middle of the umbrella-shaped elastic mesh disk is fixed in the developing mark; the center of the umbrella-shaped elastic mesh disk protrudes upward, and the developing mark is not lower than the nearest end of the umbrella-shaped elastic mesh disk; the umbrella-shaped elastic mesh disk has a blocking area, the middle position of which is directly opposite to the neck of the aneurysm, and a coating that promotes the growth of vascular endothelial cells is arranged in the middle position of the blocking area of ​​the umbrella-shaped elastic mesh disk, and this coating can accelerate the endothelialization of the neck of the aneurysm.

[0007] Furthermore, the pushing rod is connected to the umbrella-shaped elastic net disk through the release section and is used for pushing the umbrella-shaped elastic net disk.

[0008] Furthermore, the development mark is connected and fixed to the center of the umbrella-shaped elastic mesh disk occluding area, and the development mark is used to connect with the release section; the center of the umbrella-shaped elastic mesh disk occluding area protrudes upward toward the tumor cavity of the occluding area, and the development mark does not exceed the lowest point of the umbrella-shaped elastic mesh disk occluding area.

[0009] Furthermore, the microcatheter is used to deliver an umbrella-shaped elastic mesh disk; the pushing rod folds the umbrella-shaped elastic mesh disk reversely along the microcatheter, compresses it into a bundle-shaped spoiler mesh disk, and pushes it into the aneurysm cavity of the aneurysm. The umbrella-shaped mesh disk is reversely folded to form a disc-shaped state, and the spoiler mesh disk is reversely folded and unfolded in the aneurysm cavity and adheres to the inner wall of the aneurysm cavity. The release section is broken by electrolysis or electrothermal release, and the center of the spoiler mesh disk bulges upward, pulling the development mark into the aneurysm cavity opening.

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

[0011] Furthermore, the anchoring device is convex on the outer side of the skirt of the umbrella-shaped elastic mesh disk, the skirt of the umbrella-shaped elastic mesh disk is formed by bending and extending the umbrella-shaped elastic mesh disk, and the blocking area is formed by enclosing the mesh disk skirt.

[0012] Furthermore, the anchoring device is a multi-layer structure of an upper and lower structure, and each layer is woven from 4 points, 6 points, 8 points, 12 points, 16 points or 20 metal protrusions and formed by heat treatment.

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

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

[0015] Furthermore, the material of the metal wire of the braided umbrella-shaped elastic mesh disk is 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 disk are developable metal wires.

[0017] Furthermore, a coating for promoting the growth of vascular endothelial cells is arranged in the middle of the occluding area of ​​the umbrella-shaped elastic mesh disc, and the coating is a coating containing extracellular matrix proteins.

[0018] Further, the development mark is a solid ring made of gold, tantalum, platinum-iridium alloy or platinum-tungsten alloy.

[0019] Furthermore, the height of the outer edge of the spoiler umbrella-shaped net disk is not higher than the height of the folded portion of the central area of ​​the umbrella-shaped elastic net disk.

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

[0021] Compared with the prior art, the technical solution of the present invention has the following beneficial effects: (1) The points at the maximum diameter of the opening of the umbrella-shaped elastic mesh disk of the present invention are all on the same plane, and an anchoring device can be arranged around the skirt of the outer layer of the umbrella-shaped elastic mesh disk. Such an arrangement can improve the radial support force of the umbrella-shaped elastic mesh disk, so that it can better fit the inner wall of the tumor cavity and is not easy to shift in the tumor cavity. (2) A coating containing extracellular matrix protein is arranged in the middle position of the occlusion area of ​​the umbrella-shaped elastic mesh disk. Such an arrangement can accelerate the endothelialization and neointimal growth of the neck of the aneurysm, thereby achieving the reconstruction of the tumor-bearing artery and reducing the risk of aneurysm recurrence and recanalization. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0023] Figure 1 It is a schematic structural diagram of the umbrella-shaped elastic net disk of the intra-tumor flow disturbance device of the present invention in an unfolded state; Figure 2 It is a schematic diagram of the intratumoral flow disturbance device of the present invention being delivered in a microcatheter; Figure 3 A schematic diagram of the intratumoral flow disturbance device of the present invention being released and separated from a microcatheter; Figure 4 It is a schematic diagram of the intratumoral flow disturbance device of the present invention completely releasing the elastic mesh disk from the microcatheter, folding back and separating; Figure 5 A schematic diagram of the intra-tumor flow disturbance device of the present invention applied to an aneurysm and a partial schematic diagram of the anchoring device; Figure 6It is a schematic diagram of the one-pressing-one-weaving method of the umbrella-shaped elastic mesh disk of the present invention; Figure 7 It is a schematic diagram of the two-pressing-two-weaving method of the umbrella-shaped elastic mesh disk of the present invention.

[0024] In the attached drawings: 1 is an umbrella-shaped elastic mesh disk, 2 is a developing mark, 3 is a microcatheter, 4 is a release section, 5 is a pushing rod, 6 is an anchoring device, 7 is an occluding area, and 8 is a skirt of the umbrella-shaped elastic mesh disk. DETAILED DESCRIPTION

[0025] In order to make the above-mentioned objects, features and advantages of the present invention more clearly understood, the specific implementation methods of the present invention are described in detail below in conjunction with the accompanying drawings. When describing the embodiments of the present invention in detail, for the sake of convenience, the schematic diagrams are not partially enlarged according to the general proportion, and this should not be used as a limitation of the present invention.

[0026] The "proximal end" involved in the patent of this invention refers to the end closer to the operator of the intratumor flow disturbance device, and the "distal end" refers to the end farther from the operator of the intratumor flow disturbance device.

[0027] Figure 1 The present invention is a schematic diagram of the structure of an umbrella-shaped elastic mesh disk of the intratumoral flow disturbance device in the unfolded state. The umbrella-shaped elastic mesh disk 1 includes a woven umbrella-shaped elastic mesh disk body and a development mark 2. The umbrella-shaped elastic mesh disk 1 is a double-layer umbrella-shaped elastic mesh disk structure woven by metal wires. The metal wires at the center of the umbrella-shaped elastic mesh disk 1 are fixed in the development mark 2 at the center point of the umbrella-shaped elastic mesh disk 1. In the unfolded state, the bottom end of the development mark 2 does not exceed the bottom end 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 the diameter of the umbrella-shaped elastic mesh disk 1. The development mark 2 is a solid ring made of gold, tantalum, platinum-iridium alloy or platinum-tungsten alloy. The development mark 2 is used to indicate the release position mark of the intratumoral flow disturbance device during surgery, and is also the position mark for withdrawing the intratumoral flow disturbance device.

[0028] In one embodiment, the umbrella-shaped elastic mesh disk 1 is woven from metal wires, and the material of the metal wires can be nickel-titanium alloy wires, 10-40% platinum core nickel-titanium wires, or 35NLT alloy wires. The metal wires can also be development metal wires, which can achieve full development function during surgery. The number of metal wires can be 36, 48, 64, 72, 96, or 128. In the process of using metal wires to weave the umbrella-shaped elastic mesh disk 1, the metal wires are cross-woven and can slide relative to each other, and the center of the woven umbrella-shaped elastic mesh disk 1 is bound in the development mark 2.

[0029] In another embodiment, the umbrella-shaped elastic mesh disk 1 is formed by weaving metal wires with alloy wires of different wire diameters, and thickened alloy wires are added during weaving. Each layer consists of 4, 6, 8, 12, 16 or 20 alloy wires. This weaving method can increase the radial supporting force of the intra-tumor spoiler device and prevent the umbrella-shaped elastic mesh disk from shifting in the tumor cavity.

[0030] The cross section of the woven umbrella-shaped elastic mesh disk 1 is circular, the wire diameter of the metal wire is 0.01 mm to 0.04 mm, the weaving density is PPi80-PPi150 per layer per inch, and a 1:1 cross pattern of warp and weft is adopted, such as Figure 6 As shown, the clockwise and counterclockwise threads are woven in a one-press-one mode in which the sinusoidal curves intersect each other. In other embodiments, umbrella-shaped elastic mesh disks of other strengths and specifications can be selected as required, and the weaving density and pattern can also be adjusted, for example, according to Figure 7 When the clockwise thread and the counterclockwise thread cross each other, the two-on-two pattern is used for weaving, where the clockwise thread exchanges positions with the counterclockwise thread at every two crossing points.

[0031] like Figure 2-4 As shown, the microcatheter 3 is used to establish a delivery channel for the umbrella-shaped elastic mesh disc 1 during surgery. The umbrella-shaped elastic mesh disc 1 can be compressed into a bundle in the microcatheter 3 for easy pushing. The push rod 5 is used to push the umbrella-shaped elastic mesh disc 1 in the delivery channel. The push rod 5 is connected to the umbrella-shaped elastic mesh disc 1 through the release section 4. The umbrella-shaped elastic mesh disc 1 is compressed into a bundle in the microcatheter 3. The push rod 5 pushes the umbrella-shaped elastic mesh disc 1 into the aneurysm cavity and unfolds it. The umbrella-shaped elastic mesh disc 1 is folded back and unfolded and fits on the inner wall of the aneurysm cavity to achieve the occlusion of the aneurysm neck, hinder the blood flow from entering the aneurysm cavity, and achieve the embolization treatment of the aneurysm. The release section 4 is broken under the action of the electrolytic separator or the electrothermal separator. At this time, the umbrella-shaped elastic mesh disc 1 will be retained in the aneurysm cavity, and the central part of the umbrella-shaped elastic mesh disc 1 will return to a convex state, and the development mark will be pulled into the aneurysm neck, so as to prevent the development mark from causing embolism in the blood vessel cavity.

[0032] like Figure 5 The diagram shows the schematic diagram of the intra-tumor spoiler device applied in the aneurysm and the partial schematic diagram of the anchor device. The anchor device 6 can be arranged on the umbrella-shaped elastic mesh plate 1. The anchor device 6 is woven from metal wires. The anchor device 6 can be distributed in multiple layers on the outer surface of the umbrella-shaped elastic mesh plate 1. Each layer consists of 4 points, 6 points, 8 points, 12 points, 16 points or 20 metal convex points, which are formed by heat treatment. The anchor device is arranged on the outer surface of the umbrella-shaped elastic mesh plate to fix the spoiler device to prevent it from shifting in the aneurysm cavity and causing danger.

[0033] like Figure 5As shown, the blocking area 7 of the intratumoral flow spoiler device is located at the neck of the aneurysm, and can be sprayed with a coating or other surface treatments to promote vascular endothelialization and better achieve occlusion of the neck of the aneurysm. The sprayed material can be an extracellular matrix protein, such as an ECM protein. By adding a coating to the blocking area 7 of the intratumoral flow spoiler device, the endothelialization of the neck of the aneurysm can be accelerated, which can effectively enhance the blocking effect.

[0034] The above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. An intratumoral flow disturbance device, comprising an umbrella-shaped elastic mesh disk, a release section, a push rod, and a microcatheter; the umbrella-shaped elastic mesh disk is a double-layer structure woven with metal wires; the center of the umbrella-shaped elastic mesh disk has a developing mark, characterized in that: The points at the maximum diameter of the disk opening of the umbrella-shaped elastic net disk are all on the same plane.

2. The intratumor flow disturbance device according to claim 1, characterized in that: The umbrella-shaped elastic mesh disk 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 disk and the tumor wall.

3. The intratumor flow disturbance device according to claim 2, characterized in that: The anchoring device is convex on the outer side of the skirt.

4. The intratumor flow disturbance device according to claim 2, characterized in that: The umbrella-shaped elastic net disk has a blocking area, and the blocking area is formed by the skirt.

5. The intra-tumor flow disturbance device according to claim 1, characterized in that: The metal wire in the middle of the umbrella-shaped elastic net disk is fixed in the development mark; the center of the umbrella-shaped elastic net disk protrudes upward; and the development mark is not lower than the nearest end of the umbrella-shaped elastic net disk.

6. The intratumoral flow disturbance device according to claim 4, characterized in that: The middle position of the occluding area is opposite to the neck of the aneurysm, and a coating promoting the growth of vascular endothelial cells is arranged in the middle position of the occluding area.

7. The intratumor flow disturbance device according to claim 2, characterized in that: The anchoring device is woven from metal wires; the anchoring device is a multi-layer structure of an upper and lower structure, each layer is woven from 4 points, 6 points, 8 points, 12 points, 16 points or 20 metal protrusions, and is formed by heat treatment.

8. The intra-tumor flow disturbance device according to claim 1, characterized in that: The material of the metal wire is nickel-titanium alloy wire, platinum-core nickel-titanium wire or 35NLT alloy; the number of the metal wires is 36, 48, 64, 72, 96 or 128; the wire diameter of the metal wire is 0.01 mm to 0.04 mm.

9. The intra-tumor flow disturbance device according to claim 1, characterized in that: The metal wire is a developing metal wire.

10. The intra-tumor flow disturbance device according to claim 1, characterized in that: The umbrella-shaped elastic mesh disk is formed by weaving metal wires mixed with alloy wires of different wire diameters, and thickened alloy wires are added during weaving. Each layer consists of 4, 6, 8, 12, 16 or 20 alloy wires.

Images