Novel Intracranial Aneurysm Occlusion Device and Its Manufacturing Method

Abstract

The present invention relates to a novel intracranial aneurysm occlusion device and a manufacturing method thereof. The occlusion device includes an occlusion device body, a radiopaque marker, a delivery guide wire, a separation point, a delivery tube, and a separator. The radiopaque markers are respectively fixed to the distal end and the proximal end of the occlusion device body. The occlusion device is woven into a net shape by 24 - 72 strands of nitinol shape memory alloy wire. After the occlusion device is fully expanded, radiopaque markers are provided at both the distal end and the proximal end, and the radiopaque markers respectively bundle and fix the nitinol shape memory alloy wires at the distal end and the proximal end of the occlusion device. The delivery guide wire is located inside the delivery tube. A separation point is provided between the radiopaque marker at the proximal end of the occlusion device and the distal end of the delivery guide wire. The proximal end of the delivery guide wire is connected to the separator. The manufacturing method of the occlusion device is shaped by an occlusion device mold. Without craniotomy, for intracranial aneurysms with a narrow upper part and a wide lower part, giant aneurysms, and bifurcation aneurysms, by implanting the occlusion device body, the occlusion device has a stable structure, can quickly and densely fill the aneurysm cavity after deployment, thereby slowing down the blood flow in the aneurysm cavity, reducing the impact pressure of the blood on the aneurysm cavity, enhancing the repair ability, and achieving the purpose of treating aneurysms.

Description

Technical Field

[0001] This invention patent relates to a minimally invasive interventional treatment device, belonging to the technical field of medical devices, and particularly to a device for occluding intracranial aneurysms by minimally invasive interventional means and its manufacturing method. Background Art

[0002] According to the Guidelines for the Prevention and Treatment of Cerebrovascular Diseases in China, in recent years, with the rapid development of the national economy, the material living standards of people have been greatly improved, seriously affecting the regularity of diet and life. At the same time, with the rapid arrival of the aging population process, cerebrovascular-related diseases have now become one of the main diseases affecting the physical health and threatening the life safety of middle-aged and elderly people in China.

[0003] The number of newly diagnosed stroke patients (including hemorrhagic stroke and ischemic stroke) in the country each year is about 2 million; the number of patients who die from cerebrovascular-related diseases each year is about 1.5 million; the number of surviving patients (including disabled patients and those who have recovered) is 6 million to 7 million. The disability rate caused by cerebrovascular-related diseases is very high. According to statistics, among the surviving cerebrovascular-related disease patients, about three-quarters of the patients have lost their labor ability or self-care ability to varying degrees, and about 40% of the patients are severely disabled due to cerebrovascular diseases. Currently, the estimated annual medical expenses for the treatment of cerebrovascular diseases in the country exceed 10 billion yuan. Coupled with various indirect economic losses, the total annual expenditure due to cerebrovascular diseases is estimated to be close to 20 billion yuan, causing a heavy economic burden on the country and many patient families.

[0004] Among cerebrovascular diseases, the incidence of intracranial aneurysms ranks second only to cerebral thrombosis. Its occurrence is related to hypertension, cerebral arteriosclerosis, infection, trauma, etc., and it is prone to occur in middle-aged and elderly people aged 40 - 60. Subarachnoid hemorrhage caused by the rupture of intracranial aneurysms is a disease with a high mortality rate.

[0005] Traditional intracranial aneurysm treatment methods include: 1) Surgical treatment such as aneurysm neck clipping, aneurysm neck ligation, incision and suture of giant aneurysms, etc.; 2) Medical drug treatment. Traditional medical drug treatment is usually used for unruptured stable aneurysms, and the main purpose is to control potential risk factors that can induce aneurysm rupture through drugs, such as controlling the patient's blood pressure, etc.; 3) Minimally invasive interventional treatment such as coil embolization of the aneurysm cavity, liquid glue embolization of the aneurysm cavity, and stent-assisted embolization, etc.

[0006] Hemodynamic factors affecting intracranial blood vessels play an important role in the occurrence of intracranial aneurysms. Research shows that when blood flows in blood vessels, several different forces act on the vessel wall, mainly shear stress, pulsatile force, and pressure. The continuous action of blood is likely to cause damage to the internal elastic lamina at the bifurcation of cerebral arteries, and is often accompanied by an enlarged defect in the middle layer of the blood vessel. Therefore, the intracranial blood vessels are continuously impacted by blood flow at the bifurcation site, prone to intimal damage of the blood vessel and local bulging under the blood flow pressure, and finally gradually form aneurysms.

[0007] There is a certain correlation between the minute damage at the apex of the bifurcation of intracranial artery blood vessels caused by blood flow impact and the formation of aneurysms. Since blood is a viscous liquid, the normal blood viscosity is 5.45 - 6.35 mPa / s, which is a comprehensive manifestation of the flow deformation and aggregation ability of the main components of blood (platelets, red blood cells, white blood cells, plasma, etc.). The viscous blood flow can continuously generate axial shear stress on the blood vessel wall at the bifurcation site, and the faster the blood flow velocity, the greater the shear stress at this site. When the shear stress increases to a certain extent, it causes damage or tearing of the arterial intima and gradually forms an aneurysm. The distal bulge of the arterial bifurcation is often the main point of action of blood flow impact. Therefore, intracranial aneurysms are most likely to occur at the bulge of the bifurcated artery; and the larger the bifurcation angle, the greater the impact force on the distal blood vessel wall at the bifurcation, making it more likely to form an aneurysm. Once an aneurysm occurs, the morphology of the arterial blood vessel also changes (protrusion, local swelling, etc.), resulting in corresponding changes in the hemodynamics of the intracranial blood vessels.

[0008] After the formation of an intracranial aneurysm, the blood flow in the arterial blood vessel first enters the distal part of the aneurysm neck through a relatively thin inflow tract when passing through the aneurysm, causing a direct impact on the distal outer wall of the aneurysm, and at the same time the blood flow velocity slows down; then, the blood flow passing through the distal outer wall of the aneurysm flows along the inner wall of the aneurysm at a slower speed, gradually forming a vortex; finally, the blood flow of the formed vortex flows out through the proximal part of the aneurysm neck.

[0009] Based on the hemodynamic principle, Chinese Patent Application No. 201210278884.8 discloses a cerebral aneurysm stent system and its preparation method, which isolates the aneurysm through a covered stent and an inner support stent, thereby preventing the aneurysm from rupturing and reducing the occlusion of the parent artery. However, since this technology isolates intracranial aneurysms by covering the surface of the stent with a polymer film, it has relatively high requirements for stent release in actual clinical use. Due to inaccurate positioning, it may lead to the situation where the stent covers the branch blood vessels, thereby causing postoperative stroke complications; at the same time, due to the use of a double-stent technology of a covered stent and an inner support stent, the flexibility of the delivery system is insufficient, and the ability to pass through intracranial tortuous vascular lesions is limited, thus restricting its use.

[0010] Based on the same hemodynamic principle, Chinese Patent Application No. 200810202854.2 discloses a vascular stent for repairing diseased blood vessels. It is designed with a nickel-titanium shape memory alloy braided mesh with a mesh porosity of 55% - 75%. After implanting this vascular stent into the diseased blood vessel and releasing the stent at the aneurysm neck, due to the blocking effect formed by the high-density metal mesh at the aneurysm neck, the blood flow in the aneurysm is slowed down, thus achieving the repair and reconstruction of the blood vessel. This high-density vascular stent design can play a role in treating aneurysms. However, since the wire materials of the braided structure are placed in the normal parent artery and cover part of the normal blood vessel, patients often need to take anticoagulant drugs for life to avoid thrombus formation in the normal blood vessel. In order to maintain the stability of the stent in the blood vessel, the dense mesh stent system of this invention requires a section of stable normal blood vessel as the fixed section of the stent at the aneurysm lesion site, which limits the clinical application of this product.

[0011] In summary, at present, there is no suitable method to deal with intracranial aneurysms with a narrow upper part and wide lower part, giant aneurysms, and aneurysms at the bifurcation of blood vessels. Clinically, there is an urgent need for a new minimally invasive interventional product for treating aneurysms. The occlusion device of the present invention has a stable structure and can quickly and densely fill the aneurysm cavity after deployment, thereby slowing down the blood flow in the aneurysm cavity, reducing the impact pressure of the blood on the aneurysm cavity, enhancing the repair ability, and achieving the purpose of treating aneurysms. Summary of the Invention

[0012] The present invention provides a new type of intracranial aneurysm occluder and its manufacturing method.

[0013] The purpose of the present invention is to provide a new minimally invasive interventional product for treating aneurysms that can quickly and densely fill the aneurysm cavity for intracranial aneurysms with a narrow upper part and wide lower part, giant aneurysms, and aneurysms at the bifurcation of blood vessels. The occlusion device has a stable structure and can quickly and densely fill the aneurysm cavity after deployment, thereby slowing down the blood flow in the aneurysm cavity, reducing the impact pressure of the blood on the aneurysm cavity, enhancing the repair ability, and achieving the purpose of treating aneurysms.

[0014] The occlusion device includes an occlusion device body, visualization markers, a delivery guide wire, a separation point, a delivery tube, and a separator. The occlusion device is braided into a mesh shape by 24 - 72 strands of nickel-titanium shape memory alloy wire. After the occlusion device is fully opened, visualization markers are provided at both the distal end and the proximal end, and the visualization markers respectively bundle and fix the nickel-titanium shape memory alloy wires at the distal end and the proximal end of the occlusion device. The delivery guide wire is located inside the delivery tube. A separation point is provided between the visualization marker at the proximal end of the occlusion device and the distal end of the delivery guide wire. The proximal end of the delivery guide wire is connected to the separator. The manufacturing method of the occlusion device is shaped by an occlusion device mold.

[0015] The occlusion device is separated from the delivery guide wire through the separation point.

[0016] The plugging device disconnects the separation point through a separator.

[0017] The plugging device is "cylindrical" in shape, with its upper and lower surfaces being concave "conical".

[0018] The built-in height of the imaging markers at the proximal and distal ends within the main body device of the plugging device shall not exceed the upper and lower surfaces of the main body device.

[0019] The position of the plugging device within the parent artery is determined by the imaging markers at the proximal and distal ends of the main body device of the plugging device.

[0020] The manufacturing method shapes the nitinol memory alloy wire using three molds.

[0021] For intracranial aneurysms with a narrow upper part and a wide lower part, giant aneurysms, and bifurcation aneurysms, the plugging device can quickly and densely fill the aneurysm cavity after the main body device of the plugging device is implanted, thereby slowing down the blood flow within the aneurysm cavity, reducing the impact pressure of the blood on the aneurysm cavity, enhancing the repair ability, and achieving the purpose of treating aneurysms.

[0022] After the plugging device is placed into the aneurysm, it expands into an "elliptical" shape and tightly adheres to the blood vessel wall to generate a supporting force. The aneurysm cavity is filled with a high-density and uniform network of nitinol memory alloy wires, which slows down the blood flow rate, accelerates thrombus aggregation, and promotes blood vessel repair and healing. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG. Figure 1 is a schematic structural diagram of a novel intracranial aneurysm plugging device of the present invention.

[0024] FIG. Figure 2 is a schematic structural diagram of a novel intracranial aneurysm plugging device of the present invention placed within a giant aneurysm.

[0025] FIG. Figure 3 is a manufacturing method of a novel intracranial aneurysm plugging device of the present invention.

[0026] FIG. Figure 4 and 5 (Preferably) is a schematic structural diagram of a novel intracranial aneurysm plugging device of the present invention and its placement within a giant aneurysm.

[0027] FIG. Figure 6 and 7 (Preferably) is a schematic structural diagram of a novel intracranial aneurysm plugging device of the present invention and its placement within an aneurysm with a wide lower part and a narrow upper part.

[0028] FIG. Figure 8 and 9 (Preferably) is a schematic structural diagram of a novel intracranial aneurysm plugging device of the present invention and its placement within a bifurcation aneurysm. DETAILED DESCRIPTION OF THE INVENTION

[0029] Refer to the attached Figure 1-9 Embodiments of the present invention are described in detail.

[0030] The reference numerals and components in the drawings are as follows:

[0031] 1. Occlusion device 2. Distal imaging marker of the occlusion device

[0032] 3. Visual marking of the proximal end of the occlusion device 4. Separation point

[0033] 5. Delivery guide wire 6. Delivery tube

[0034] 7. Separator 8. Aneurysm

[0035] 9. Parent artery 10. Mold (1)

[0036] 11. Mould (2) 12. Mould (3)

[0037] 13.Development mark on fixed wing 14 fixed wing

[0038] 15. Connecting wire

[0039] Attachment Figure 1 This is a schematic diagram of the structure of a novel intracranial aneurysm occlusion device according to the present invention. The occlusion device comprises a occlusion device body 1, a distal imaging marker 2, a proximal imaging marker 3, a delivery guidewire 5, a separation point 4, a delivery tube 6, and a separator 7. The occlusion device 1 is woven into a mesh of 24-72 strands of nickel-titanium memory alloy wire. The device is a mesh structure, cylindrical in shape, with a conical top and bottom, with both the proximal and distal ends converged and fixed within the distal imaging marker 2 and proximal imaging marker 3 of the occlusion device. The occlusion device 1 is retracted into the delivery tube 6 during delivery. The occlusion device 1 expands outward from the delivery tube 6, with the delivery guidewire 5 generating a thrust. A separation point 4 is provided between the proximal imaging marker 3 of the occlusion device and the distal end of the delivery guidewire 5. A separator 7 is provided at the proximal end of the delivery guidewire 5 for disconnecting the separation point 4.

[0040] Attachment Figure 2 This is a schematic diagram of the structure of a novel intracranial aneurysm occlusion device according to the present invention, placed within a giant aneurysm. The occlusion device 1 is placed within a giant aneurysm 8. Due to compression from the aneurysm's inner wall, the occlusion device 1 assumes an "elliptical" shape, with the upper and lower surfaces forming an inwardly concave "conical" shape. The meshed nickel-titanium memory alloy wires on the sidewalls of the occlusion device 1 adhere closely to the aneurysm wall. The occlusion device 1 is delivered via a delivery tube 6 that enters the parent artery 9. A delivery guidewire 5 is located within the delivery tube 6.

[0041] Attachment Figure 3The invention discloses a method for manufacturing a novel intracranial aneurysm occlusion device, which comprises splicing two molds (1) 10, two molds (2) 11, and one mold (3) 12.

[0042] Attachment Figure 4 and 5 (Preferred) is a novel intracranial aneurysm occlusion device of the present invention and a schematic diagram of its structure when placed in a giant aneurysm. The occlusion device is one of the preferred extended solutions of the present invention. Figure 4 The front view and cross-sectional view of the preferred new device; the device adds a fixed wing 14 at the proximal end of the occluding device 1; the fixed wing 14 has a mesh structure, and both sides are "wing-shaped"; the distal end of the fixed wing 14 is folded and fixed to the imaging mark 13 on the fixed wing; the proximal end of the connecting line 15 is connected to the imaging mark 13 on the fixed wing, and the distal end is connected to the imaging mark 3; Figure 5 This is a front view and a cross-sectional view of the preferred new device placed in a giant aneurysm; the fixing wing 14 is connected to the occluding device 1 by a connecting line 15; the fixing wing 14 is placed at the opening of the aneurysm 8; the two wings of the fixing wing 14 are respectively in close contact with the vascular walls on both sides of the parent artery 9. The characteristics of the preferred new device are: the fixing wing 14 is added to the original occluding device 1, and the two wings of the fixing wing 14 are in close contact with the vascular walls on both sides of the parent artery 9, which will not slow down the blood flow rate in the blood vessel, prevent the formation of thrombus, and can fix the occluding device 1; the acute angle wall formed by the aneurysm 8 and the vascular wall of the parent artery 9 conforms to the width of the gap where the occluding device 1 and the fixing wing 14 are connected, that is, the acute angle wall formed by the aneurysm 8 and the vascular wall of the parent artery 9 is inserted into the gap where the occluding device 1 and the fixing wing 14 are connected, which also forms a fixing method, so that the occluding device 1 is not easy to fall off.

[0043] Attachment Figure 6 and 7 (Preferred) is a novel intracranial aneurysm occlusion device of the present invention and a schematic diagram of its structure when placed in a lower wide and upper narrow aneurysm. The occlusion device is one of the extended preferred solutions of the present invention. Figure 6 The front view and cross-sectional view of the preferred new device are shown; the device is a mesh structure, which is "narrow at the top and wide at the bottom"; the device adds a fixed wing 14 at the proximal end of the occluding device 1; the fixed wing 14 is a mesh structure, with "wing-shaped" on both sides; the fixed wing 14 is folded and fixed to the imaging mark 13 on the fixed wing; the proximal end of the connecting line 15 is connected to the imaging mark 13 on the fixed wing, and the distal end is connected to the imaging mark 3; Figure 7This is a front view and cross-sectional view of the preferred new device placed within an aneurysm that is narrow at the top and wide at the bottom; the fixing wings 14 are connected to the occlusion device 1 via a connecting line 15; the fixing wings 14 are placed distal to the opening of the aneurysm 8; the two wings of the fixing wings 14 are in close contact with the sides of the parent artery 9. This preferred new device is characterized by the addition of fixing wings 14 to the existing occlusion device 1. The two wings of the fixing wings 14 are in close contact with the sides of the parent artery 9, which does not slow blood flow, prevents thrombosis, and stabilizes the occlusion device 1. The two wings of the fixing wings 14 are in close contact with the sides of the parent artery 9, and the fixing wings 14 are connected to the occlusion device 1 via a connecting line 15, generating a supporting force that secures the occlusion device 1 within the aneurysm 8.

[0044] Attachment Figure 8 and 9 (Preferred) is a novel intracranial aneurysm occlusion device of the present invention and a schematic diagram of its structure when placed in a bifurcated aneurysm. The occlusion device is one of the preferred extended solutions of the present invention. Figure 8 Schematic diagram of the structure of the preferred new device; the device is a mesh structure, in the shape of a "sphere"; the device adds a fixed wing 14 at the proximal end of the occluding device 1; the fixed wing 14 is a mesh structure, in the shape of a "bowl" as a whole; the fixed wing 14 is retracted and fixed to the imaging mark 13 on the fixed wing; the proximal end of the connecting line 15 is connected to the imaging mark 13 on the fixed wing, and the distal end is connected to the imaging mark 3; Figure 8 This is a schematic diagram of the structure of the novel aneurysm occlusion device placed within a bifurcated aneurysm; the fixing wings 14 are connected to the occlusion device 1 via a connecting line 15; the outer diameter of the fixing wings 14 is larger than that of the occlusion device 1; and the fixing wings 14 and the occlusion device 1 are placed within the aneurysm 8. The preferred new device is characterized in that: fixing wings 14 are added to the original occlusion device 1; the occlusion device 1 and the fixing wings 14 are both placed within the aneurysm 8; because the outer diameter of the fixing wings 14 is larger than that of the occlusion device 1, when the distal end of the occlusion device 1 is attached to the inner wall of the aneurysm 8, the fixing wings 14 are attached to the inner wall of the aneurysm 8, generating a supporting force to fix the occlusion device 1; and because this aneurysm 8 is a giant aneurysm at a bifurcated location, the direction of blood flow is directly opposite to the aneurysm 8, causing a great blood flow impact burden on the aneurysm 8. Therefore, in addition to its fixing function, the fixing wings 14 can slow down the blood flow rate. When the blood with slowed flow rate passes through the occlusion device 1, it is slowed down again, greatly reducing the pressure on the aneurysm 8.

[0045] During interventional treatment, first, the position of the intracranial aneurysm 8 is determined through angiography. The occlusion device 1 is placed inside the delivery tube 6. Then, the device is introduced into the blood vessel from the femoral artery or brachial artery. The delivery tube 6 is pushed to the parent artery 9. The position of the occlusion device 1 is determined through the imaging marker 2. When it is confirmed that the distal end of the delivery tube 6 has passed through the opening position of the aneurysm 8, the delivery guide wire 5 is gently pushed to release the occlusion device 1. After the nitinol memory wire leaves the delivery tube 6, it undergoes memory deformation. The occlusion device 1 fully expands and fits against the blood vessel wall inside the aneurysm. Then, the separation point 4 is disconnected, and the delivery guide wire 5 and the delivery tube 6 are withdrawn.

[0046] The present invention is a novel intracranial aneurysm occlusion device. Without craniotomy, by implanting the occlusion device 1, it can quickly and densely fill the aneurysm cavity, thereby slowing down the blood flow in the aneurysm 8 cavity and achieving the purpose of treating the aneurysm 8. The present invention extends to three preferred new occlusion devices, and different device solutions are made for the intracranial aneurysms 8 with a narrow upper part and a wide lower part, giant aneurysms, and bifurcated aneurysms. The fixed wing 14 is added to the original occlusion device 1 in the solutions. The fixed wing 14 plays a great role in different solutions. In the aneurysm 8 with a narrow upper part and a wide lower part, the fixed wing 14 plays a great supporting role to prevent the occlusion device from falling off; in the giant aneurysm 8, the fixed wing 14 plays a great fixing role to prevent the occlusion device from falling off; in the bifurcated aneurysm 8, the fixed wing 14 plays a great fixing role and greatly reduces the blood flow rate, playing a good protective role. The occlusion device has a stable structure. After deployment, it can quickly and densely fill the aneurysm cavity, thereby slowing down the blood flow in the aneurysm cavity, reducing the impact pressure of the blood on the aneurysm cavity, enhancing the repair ability, and achieving the purpose of treating the aneurysm.

[0047] The above is the preferred embodiment of the present invention. Those skilled in the art can make equivalent deformations or substitutions without departing from the spirit of the present invention, and these equivalent variations or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A plugging device, characterized in that, It includes a plugging device body, a proximal imaging marker of the plugging device, a distal imaging marker of the plugging device, a delivery guide wire, a separation point, and a delivery tube. The delivery guide wire is located inside the delivery tube; a separation point is provided between the proximal imaging marker of the plugging device and the distal end of the delivery guide wire; the plugging device body is woven into a net by 24-72 strands of nitinol shape memory alloy wire, the distal end is bundled and fixed on the distal imaging marker of the plugging device, and the proximal end is bundled and fixed on the proximal imaging marker of the plugging device. The plugging device further includes fixing wings and connecting lines. The fixing wings are connected to the plugging device body through the connecting lines, and the outer diameter of the fixing wings is greater than the outer diameter of the plugging device body. The fixing wings are placed at the distal end of the aneurysm opening. The two sides of the fixing wings are wing-shaped and respectively closely adhere to both sides of the parent artery. The plugging device is in an open state. Alternatively, the fixing wings are placed inside the aneurysm. The fixing wings are bowl-shaped and fit along the circumferential side to the blood vessel wall inside the aneurysm opening.

2. The plugging device according to claim 1, wherein, The overall shape of the plugging device is cylindrical, and the upper and lower surfaces are conical.

3. The plugging device according to claim 1, characterized in that, The built-in height of the proximal imaging marker of the plugging device and the distal imaging marker of the plugging device does not exceed the upper and lower surfaces of the plugging device body.

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