CN115715692A - Flow-disturbing device in aneurysm - Google Patents

Abstract

The invention discloses an intratumoral turbulent flow device which comprises an elastic net disk, wherein the elastic net disk comprises a net disk bottom and net disk side parts, the net disk side parts are formed by bending and extending the periphery of the net disk bottom, the net disk side parts and the net disk bottom enclose to form a plugging cavity, and the ratio of the height of the elastic net disk to the width of the elastic net disk is between 20 and 40 percent; when the intratumoral turbulent flow device is arranged in an aneurysm cavity, the peripheral part of the bottom of the net disk is attached to the inner wall of the aneurysm cavity, and the side part of the net disk is positioned in the aneurysm. The technical scheme of the invention can improve the position stability of the intratumoral turbulent flow device in the aneurysm, reduce the risk of bursting the aneurysm, improve the blood flow plugging efficiency and facilitate the thrombosis of the aneurysm.

Description

Flow-disturbing device in aneurysm

Technical Field

The invention relates to the field of medical instruments, in particular to an intra-aneurysm turbulent flow device.

Background

Intracranial aneurysm refers to an abnormal enlargement of the wall of an intracranial artery, resulting in a neoplastic protrusion of the artery wall. Intracranial aneurysm formation is the first cause of subarachnoid hemorrhage, which is mainly caused by congenital defect of cerebral artery wall local or cystic bulging caused by increased pressure in cranial cavity. Surgical craniotomy and minimally invasive intervention are two main modes of intracranial aneurysm treatment at present. Although surgery has the advantage of low recurrence rate, it is highly traumatic to patients, has a long recovery period, and is not suitable for some complicated positions of aneurysms and patients with poor physical conditions; the minimally invasive interventional therapy is a preferred treatment scheme of many hospitals due to the advantages of small wound, high safety, quick healing after operation and the like, the mode of clinically interventional therapy for intracranial aneurysm is basically an intracranial embolic coil, however, coil products approved to be on the market at home and abroad are proved in the clinical use process, and the adoption of the embolic coil mode in the clinical use for treating intracranial aneurysm diseases still has many problems which cannot be solved, such as poor adhesion of the embolic coil to the inner wall of arterial blood vessels, incomplete filling and secondary congestion and expansion in the aneurysm; excessive tamponade leads to problems such as rupture of the aneurysm or protrusion of the coil out of the aneurysm neck. Resulting in low postoperative total occlusion rate and high long-term recurrence rate of patients.

In recent years, a new type of aneurysm treatment device, called "intratumoral turbulent flow device", has emerged, the main advantages of which are: a. no antiplatelet therapy is needed after operation; b. compared with a spring ring device, the device is more suitable for wide-neck aneurysms; c. the treatment success rate for bifurcation lesion is higher at present.

For example, a chinese patent application with publication number CN113274087A and publication date of 2021, 08 and 20 discloses an intratumoral turbulent flow device, which includes: the spoiler disc is of a double-layer metal wire weaving structure; the bottom of the center of the spoiler disc is provided with a developing mark, and the metal wire at the center of the spoiler disc is fixed in the developing mark; the center of the spoiler disc is upwards raised, and the bottom of the developing mark does not exceed the lowest end of the spoiler disc. In this patent, though the vortex net dish is expanded and is pasted closely tumour intracavity wall in the tumour chamber, hinders blood flow and goes into and out the tumour chamber to draw the development mark of near-end into the tumour neck in tumour chamber, prevent to initiate endovascular embolism. However, the contact area between the edge of the spoiler disc and the tumor cavity is small, so that the position of the spoiler disc in the tumor cavity is not fixed firmly enough.

Disclosure of Invention

The invention provides an intratumoral turbulent flow device which improves the turbulent flow effect in an aneurysm, improves the side wall attachment stability and is beneficial to thrombosis in the aneurysm, and the intratumoral turbulent flow device is realized by the following technical scheme:

an intra-aneurysm turbulent flow device comprises an elastic net disk, wherein the elastic net disk comprises a net disk bottom and net disk side portions, the net disk side portions are formed by bending and extending the periphery of the net disk bottom, the net disk side portions and the net disk bottom enclose to form a plugging cavity, and the ratio of the height of the elastic net disk to the width of the elastic net disk is between 20% and 40%; when the turbulence device is arranged in the aneurysm cavity, part of the outer surface of the bottom of the net disk is attached to the inner wall of the aneurysm cavity, and the side part of the net disk is located in the plugging cavity.

The design has the following advantages:

after the intratumoral turbulent flow device is placed in an aneurysm, because the neck of the aneurysm is covered by the elastic net disk, blood is directly prevented from flowing into the aneurysm cavity from a parent artery, the flow velocity of the blood in the aneurysm is greatly reduced, and the risk of aneurysm rupture is reduced;

the elastic net disk and the side wall of the aneurysm have sufficient contact area, and simultaneously, the intratumoral turbulent flow device has memory and can quickly rebound under the action of blood flow impact force, so that the intratumoral turbulent flow device and the intratumoral turbulent flow device can be stably arranged in the aneurysm by combining the elastic net disk and the intratumoral turbulent flow device, and the possibility of displacement during and after operation is avoided;

because the ratio of the height to the width of the elastic net disk in a free state is between 20 and 40 percent, when the elastic net disk is placed in an aneurysm in an operation, the ratio of the height to the width can be effectively reserved, so that the height part of the elastic net disk in the air is not attached to the side wall of the aneurysm and is suspended in the cavity of the aneurysm. The structure can change the hemodynamics in the aneurysm cavity, further reduce the blood flow speed and accelerate the thrombosis in the aneurysm.

The flow disturbing device is loaded with two coatings, the middle position of the bottom of the elastic net disk is right opposite to the neck opening of the aneurysm, and the position is loaded with a coating for promoting the growth of endothelial cells; the peripheral part and the lateral part of the bottom of the elastic net disk are opposite to the inner wall of the aneurysm and in the aneurysm, and the position is loaded with a coating for promoting thrombosis. The two coatings play different functions at different positions, and finally achieve the purposes of accelerating endothelialization of the neck part of the aneurysm and accelerating thrombosis in the aneurysm.

Drawings

FIG. 1 is a schematic view of the overall structure of an intratumoral turbulent flow device according to an embodiment of the present invention;

FIG. 2 is a top view of the intratumoral turbulence device of FIG. 1;

FIG. 3 is a front view of the intratumoral turbulence device of FIG. 1;

FIG. 4 is an enlarged partial view of the intratumoral turbulence device of FIG. 1 at the visualization marker;

FIG. 5 is a simplified structural schematic of the intratumoral turbulence device of FIG. 1;

FIG. 6 is a schematic view of the intratumoral turbulence device of FIG. 1 connected to a delivery device;

FIG. 7 is a schematic view of the intratumoral turbulence device of FIG. 1 positioned within a delivery device and moved to an aneurysm;

FIG. 8 is a schematic view of the intratumoral turbulent flow device of FIG. 1 being advanced into an aneurysm by a delivery device;

FIG. 9 is a schematic view of the intratumoral turbulent flow device of FIG. 1 fully advanced into the aneurysm through the delivery device;

FIG. 10 is a schematic view of the intratumoral turbulent flow device of FIG. 1 positioned within an aneurysm separate from the delivery device.

FIG. 11 is a schematic structural view of the intratumoral turbulent flow device of FIG. 1 with the first material and the second material disposed in different locations, respectively;

fig. 12 is a schematic view of the intratumoral turbulent flow device of fig. 1 configured with a first material and a second material and positioned within an aneurysm.

The reference numerals in the drawings mean: 1. an elastic net disk; 11. the bottom of the net plate; 12. a side of the net disc; 2. developing the mark; 21. a proximal end; 22. a distal end; 3. plugging the cavity; 4. a conveying device; 41. a microcatheter; 42. a guidewire.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and detailed description.

Referring to fig. 1 to 3, the intratumoral turbulent flow device provided in this embodiment includes an elastic mesh disk 1, where the elastic mesh disk 1 includes a mesh disk bottom 11 and a mesh disk side 12. As shown in fig. 5, the mesh plate side portion 12 is formed by bending and extending the periphery of the mesh plate bottom portion 11, and the mesh plate side portion 12 and the mesh plate bottom portion 11 enclose to form the blocking cavity 3, that is, the intratumoral turbulent flow device is integrally in a bowl-shaped structure.

Moreover, the ratio of the height of the elastic mesh disk 1 (as shown in H in fig. 5, i.e. the distance between the lowest point and the highest point of the elastic mesh disk 1) to the width of the elastic mesh disk 1 (as shown in W in fig. 5, i.e. the maximum diameter of the outer edge of the circumference of the elastic mesh disk 1) is between 20% and 40%, by adopting the ratio, after the intratumoral turbulent flow device is placed in an aneurysm, the radial support of the intratumoral turbulent flow device is under the action of the tumor wall, the side portions 12 of the mesh disk are in an inward bent shape and do not directly contact with the top end of the aneurysm, so that the risk that the intratumoral turbulent flow device breaks the aneurysm under the action of blood flow is better reduced, and meanwhile, the inward bent side portions 12 of the mesh disk can play a certain role of buffering the blood in the aneurysm, further reduce the flow speed of the blood in the aneurysm cavity, and accelerate thrombosis.

Further, referring to fig. 1 to 3, the intratumoral turbulent flow device further comprises a visualization marker 2, wherein the visualization marker 2 has a proximal end 21 and a distal end 22, the proximal end 21 of the visualization marker 2 is used for connecting with the conveying device 4 (as shown in fig. 6), and the distal end 22 of the visualization marker 2 is connected with the center of the mesh disc bottom 11; the center of the mesh bottom 11 is recessed toward the inside of the closed off cavity 3 so that the proximal end 21 of the development mark 2 does not go beyond the lowest point of the mesh bottom 11 (as shown in fig. 4). Because the bottom of the intratumoral turbulent flow device is inwards sunken, the development mark 2 cannot protrude out of the bottom of the elastic net disk 1, and after the intratumoral turbulent flow device is placed in an aneurysm cavity, the blood flow of nearby blood vessels cannot be obstructed. Meanwhile, the developing mark 2 is positioned outside the bottom 11 of the screen disc by the invagination structure of the bottom 11 of the screen disc, and can be directly connected with the conveying device 4.

Referring to fig. 6, 7 and 9, the intratumoral turbulent flow device comprises a compressed state placed inside a microcatheter 41 (as shown in fig. 7), an expanded state placed in air (as shown in fig. 6) and an operative state placed inside an aneurysm (as shown in fig. 9).

Wherein the ratio of the length of the intratumoral turbulent flow device in the compressed state (as shown by L in FIG. 7, the distance between the proximal end 21 of the visualization mark 2 and the top end of the mesh side 12 of the elastic mesh disk 1) to the height of the intratumoral turbulent flow device in the expanded state (which is equivalent to the height H of the elastic mesh disk 1) is between 2 and 3. The diameter of the completely expanded intratumoral turbulent flow device needs to be larger than the diameter of the aneurysm at the pathological change part, and after the intratumoral turbulent flow device is unfolded and fixed in an aneurysm cavity (as shown in figure 10), the elastic net disk 1 is attached to the neck of the aneurysm after self-expansion release, so that the rapid thrombosis in the cavity of the aneurysm can be realized, the repair of the neck of the aneurysm is promoted, and the rupture of the aneurysm is prevented.

The delivery device 4 for delivering the intratumoral turbulent flow device comprises a micro catheter 41 and a guide wire 42, wherein the guide wire 42 is positioned in the micro catheter 41, and one end of the guide wire 42 is connected with the developing mark 2 of the intratumoral turbulent flow device. In the operation process, the microcatheter 41 is put in place, the elastic mesh disc is placed at the proximal end of the microcatheter, the guide wire 42 is pushed to move along the microcatheter 41, the elastic mesh disc 1 is compressed into a strip bundle shape, the microcatheter 41 provides a conveying channel for the elastic mesh disc 1, and finally the elastic mesh disc 1 is pushed to the opening part at the distal end of the microcatheter 41. In this manner, the intratumoral turbulent device can be moved to the neck of the aneurysm by means of the delivery device 4 (as shown in fig. 7). The elastic mesh disk 1 is pushed out of the microcatheter 41 by continuing to push the guide wire 42 and comes into contact with the inner wall of the aneurysm cavity by its own expansion (as shown in fig. 8). Finally, the guide wire 42 is disconnected from the development mark 2 through electrolytic detachment or mechanical detachment, the elastic net disk 1 is left in the aneurysm, the elastic net disk 1 is completely unfolded under the elastic action of the elastic net disk 1 and is tightly attached to the inner wall of the aneurysm cavity through part of the outer surface of the net disk bottom 11, and blood flowing into the aneurysm cavity is disturbed. The side part 12 of the net disk is positioned in the aneurysm cavity and is not contacted with the top end and the inner wall of the aneurysm, so that the risk of bursting the aneurysm is reduced, the flowing speed of blood in the aneurysm cavity is further reduced, and the thrombosis is accelerated. Meanwhile, the bottom of the elastic net disk 1 returns to be concave, and the developing mark 2 is pulled into the neck of the aneurysm cavity, so that the blood flow in the nearby blood vessel is prevented from being blocked (as shown in fig. 9).

After the intratumoral turbulent flow device is placed in an aneurysm (as shown in figure 10), by means of the elasticity of the intratumoral turbulent flow device, the elastic net disk 1 is tightly attached to the inner wall of an aneurysm cavity through the partial outer surface of the bottom 11 of the net disk, the elastic net disk 1 and the inner wall of the aneurysm cavity have a larger contact area, the stability of the intratumoral turbulent flow device in the aneurysm can be improved, and the fixing effect of the intratumoral turbulent flow device in the aneurysm is improved. Specifically, the area of apposition to the inner wall of the aneurysm accounts for more than about 60% of the total area of the inner wall of the aneurysm after placement of the intratumoral turbulent flow device within the aneurysm.

When the intratumoral turbulent flow device is placed in an aneurysm cavity, the formation of thrombus in the aneurysm is accelerated in three ways: 1. the elastic net disk 1 is positioned at the neck of the aneurysm, and the double-layer net disk can directly block blood flow, so that the blood flow into the aneurysm can be reduced by more than 50%; 2. the mesh side 12 is in a fixed shape in the aneurysm cavity, which further disturbs the flow velocity of blood in the aneurysm and provides a physical carrier for platelets to accelerate their adhesion and aggregation; 3. the peripheral part and the side part of the bottom of the aneurysm are loaded with the blood coagulation promoting medicine, which can accelerate the formation of thrombus in the aneurysm. The three modes mutually promote and mutually accelerate, and finally the complete thrombosis time is reduced.

In one embodiment, the ratio of the height of the elastic mesh disc 1 to the width of the elastic mesh disc 1 is between 20% and 30%; further, the ratio of the height of the elastic net disk 1 to the width of the elastic net disk 1 is between 25% and 30%. So, can make elastic mesh dish 1 and aneurysm cavity inside have great contact area, can improve the stability of the interior turbulent flow device of tumour in the aneurysm, promote the fixed action of the interior turbulent flow device of tumour in the aneurysm.

In one embodiment, the ratio of the height of the depression of the center of the bottom 11 of the mesh disc towards the plugging chamber 3 (as shown by H1 in fig. 5, i.e. the distance between the most top point of the depression of the bottom 11 of the mesh disc and the lowest point of the bottom 11 of the mesh disc) to the height of the elastic mesh disc 1 is between 30% and 50%; further, the ratio of the height of the depression of the center of the bottom 11 of the net disk towards the plugging chamber 3 to the height of the elastic net disk 1 is 1/3. Therefore, after the intratumoral turbulent flow device is placed in an aneurysm cavity, the blood flow of nearby blood vessels cannot be obstructed.

Referring to fig. 11 to 12, as a preferred embodiment, the middle portion of the bottom portion 11 of the mesh tray at the position of the aneurysm neck (as the portion circled by the dashed line a in fig. 11 and 12) may be coated or otherwise surface-treated with a first material for promoting endothelialization of blood vessels, which can promote endothelialization of blood vessels, and better achieve occlusion of the aneurysm neck. The part of the periphery of the bottom 11 of the net disk, which is attached to the inner wall of the aneurysm cavity, and the side 12 of the net disk (as the part encircled by the dotted line b in fig. 11 and fig. 12) may be coated or otherwise surface-treated with a second material for promoting thrombus formation, so as to accelerate thrombus formation of blood flowing into the aneurysm, further enhance the occlusion effect on blood flow, and the second material for promoting thrombus formation may be a material of polysaccharide, such as alginate; may also be an extracellular matrix protein, such as an ECM protein. Different coatings are added to different parts of the intratumoral turbulent flow device, so that the same device can accelerate the formation of thrombus in a tumor cavity and the endothelialization of a tumor neck, and the plugging effect and the blocking effect can be effectively enhanced.

As an embodiment, the elastic mesh plate 1 is a double-layer mesh structure formed by weaving a plurality of memory alloy wires and performing a heat treatment setting process. The development mark 2 is a collar structure.

The intratumoral turbulent flow device adopts a unique self-expansion structural design, and the soft and hyperelastic memory alloy wire can be tightly attached to the inner wall of a tumor body, so that the support property to the wall of the aneurysm is improved; meanwhile, thrombosis in the aneurysm is accelerated through three modes, and the effect of rapid plugging is achieved. Furthermore, the intratumoral turbulence device is a tubular braided body braided by 64 to 288 wires, and the wires comprise nickel-titanium alloy wires, cobalt-chromium alloy wires, platinum wires, polymer wires, composite wires and the like which are commonly used in the field of implantation. The tubular knitted body is of a double-layer dense-mesh structure by means of inward recessing of one end, the diameter range of the silk threads is between 0.01 mm and 0.05 mm, and a fine and dense double-layer silk mesh can be formed.

The above detailed description is specific to possible embodiments of the present invention, and the embodiments are not intended to limit the scope of the present invention, and all equivalent implementations or modifications that do not depart from the scope of the present invention are intended to be included within the scope of the present invention.

Claims (10)

1. An intra-aneurysm flow-disturbing device comprising an elastic mesh disc (1), characterized in that: the elastic net disk (1) comprises a net disk bottom (11) and net disk side parts (12), the net disk side parts (12) are formed by bending and extending the periphery of the net disk bottom (11), the net disk side parts (12) and the net disk bottom (11) enclose to form a blocking cavity (3), and the ratio of the height of the elastic net disk (1) to the width of the elastic net disk (1) is between 20% and 40%; when the flow disturbing device in the aneurysm is arranged in the aneurysm cavity, part of the outer surface of the bottom (11) of the net disk is attached to the inner wall of the aneurysm cavity, and the side part (12) of the net disk bends towards the inside of the plugging cavity (3).

2. The intra-aneurysm flow-disrupting device of claim 1, wherein: the intra-aneurysm flow disturbing device further comprises a visualization marker (2), the visualization marker (2) is provided with a proximal end (21) and a distal end (22), the proximal end (21) of the visualization marker (2) is used for being connected with a conveying device (4), and the distal end (22) of the visualization marker (2) is connected with the center of the mesh disc bottom (11); the center of the bottom (11) of the net disk is sunken towards the inner side of the blocking cavity (3), so that the proximal end (21) of the developing mark (2) does not exceed the lowest point of the bottom (11) of the net disk.

3. The intra-aneurysm flow-disrupting device of claim 1, wherein: the ratio of the height of the elastic net disk (1) to the width of the elastic net disk (1) is between 20% and 30%; or the ratio of the height of the elastic net disk (1) to the width of the elastic net disk (1) is between 25% and 30%.

4. The intra-aneurysm flow-disrupting device of claim 2, wherein: the ratio of the height of the center of the bottom (11) of the net disc sunken towards the plugging cavity (3) to the height of the elastic net disc (1) is 30-50%; or the ratio of the height of the center of the bottom (11) of the net disk sunken towards the plugging cavity (3) to the height of the elastic net disk (1) is 1/3.

5. The intra-aneurysm flow-disrupting device of claim 1, wherein: the intra-aneurysm flow-disrupting device comprises a compressed state disposed within a microcatheter (41) and an expanded state disposed in air; the ratio of the length of the flow-disturbing device in the aneurysm in the compressed state to the height of the flow-disturbing device in the aneurysm in the expanded state is between 2 and 3.

6. The intra-aneurysm flow-disrupting device of claim 1, wherein: the parts, which are not attached to the inner wall of the aneurysm cavity, of the bottom (11) of the net disk are loaded with a first material, and the first material is mainly a substance for promoting the growth of endothelial cells; the net disk bottom (11) and the portion of aneurysm intracavity wall laminating and net disk lateral part (12) load and have the second material, the second material is mainly for promoting the material of thrombus formation, including procoagulant medicine, polysaccharide or extracellular matrix protein etc..

7. The intra-aneurysm flow-disrupting device of claim 1, wherein: the elastic net plate (1) is a double-layer wire net structure which is formed by weaving a plurality of memory alloy wires and performing a heat treatment shaping process.

8. The intra-aneurysm flow-disrupting device of claim 7, wherein: each layer of the double-layer silk screen structure is formed by weaving 64 to 288 silk yarns, and the silk yarns comprise nickel-titanium alloy wires, cobalt-chromium alloy wires, platinum wires, polymer wires, composite wires and the like which are commonly used in the field of implantation.

9. The intra-aneurysm flow-disrupting device of claim 8, wherein: the diameter range of the silk threads is between 0.01 mm and 0.05 mm.

10. The intra-aneurysm flow-disrupting device of claim 2, wherein: the developing mark (2) is of a lantern ring structure, and the center of the bottom (11) of the net disc is converged in the lantern ring.

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