CN108938039A - Novel encephalic aneurysm plugging device and preparation method thereof - Google Patents

Abstract

The present invention relates to a novel intracranial aneurysm occlusion device and a manufacturing method thereof. The occlusion device includes a occlusion device body, a development mark, a delivery guide wire, a separation point, a delivery tube, and a separator. The development marks are respectively It is fixed on 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 nickel-titanium memory alloy wires; Developing marks, and the developing marks bundle and fix the nitinol wire at the distal end and the proximal end of the occlusion device respectively; the delivery guide wire is located in the delivery tube; A separation point is provided; the proximal end of the delivery guide wire is connected with a separator; the manufacturing method of the blocking device is shaped by a mold of the blocking device. In the case of no craniotomy, for intracranial narrow upper and lower wide, giant aneurysm type, bifurcation type aneurysm, by implanting the body of the occlusion device, the structure of the occlusion device is stable, and the aneurysm can be quickly and densely packed after deployment cavity, so as to slow down the flow of blood in the aneurysm cavity, reduce the impact pressure of blood on the aneurysm cavity, strengthen the repair ability, and achieve the purpose of treating aneurysm.

Description

Novel intracranial aneurysm occlusion device and manufacturing method thereof

technical field

The patent of the present invention relates to a minimally invasive interventional therapy device, which belongs to the technical field of medical devices, and in particular to a device for sealing intracranial aneurysms through minimally invasive interventional means and a manufacturing method thereof.

Background technique

According to the guidelines for the prevention and treatment of cerebrovascular diseases in China, with the rapid development of my country's national economy in recent years, people's material living standards have also been greatly improved, seriously affecting the regularity of diet and life, and accompanied by the rapid aging of the population, At present, cerebrovascular-related diseases have become one of the main diseases that affect the health of middle-aged and elderly people in my country and threaten their lives.

There are about 2 million new stroke patients (including hemorrhagic stroke and ischemic stroke) in the country every year; about 1.5 million patients die from cerebrovascular-related diseases every year; the number of surviving patients (including disabled patients and cured patients) 6 to 7 million. Cerebrovascular-related diseases lead to a high proportion of patients with disabilities. According to statistics, about three-quarters of the surviving patients with cerebrovascular-related diseases lose their ability to work or take care of themselves to varying degrees, and about 40% of them The patient is severely disabled due to cerebrovascular disease. At present, the national annual medical expenses for the treatment of cerebrovascular diseases are estimated to be more than 10 billion yuan, plus various indirect economic losses, it is estimated that the total annual expenditure due to cerebrovascular diseases is close to 20 billion yuan, which is a contribution to the country and many A heavy financial burden on the patient's family.

In cerebrovascular diseases, the incidence of intracranial aneurysm is next to that of cerebral thrombosis, and its occurrence is related to hypertension, cerebral arteriosclerosis, infection, trauma, etc., and it is more likely to occur in middle-aged and elderly people aged 40-60. Subarachnoid hemorrhage following rupture of an intracranial aneurysm is a disease with a high incidence of mortality.

Traditional intracranial aneurysm treatment methods include 1) surgical treatment such as: aneurysm neck clipping, aneurysm neck ligation, incision and suture of giant aneurysm, etc.; 2) medical treatment, traditional medical treatment usually uses For unruptured stable aneurysms, the main purpose is to control those potential risk factors that can induce aneurysm rupture through drugs, such as controlling the patient's blood pressure; Aneurysm cavity, and stent-assisted packing, etc.

Hemodynamic factors affecting intracranial blood vessels play an important role in the occurrence of intracranial aneurysms. Studies have shown that: When blood flows in a blood vessel, it produces several different forces on the blood vessel wall, mainly including shear stress, pulsating force and pressure. The continuous force of blood is likely to cause damage to the elastic layer at the bifurcation of the cerebral artery, and it is often accompanied by the expansion of the middle layer defect of the blood vessel. Under the pressure of the flow, a local swelling protrusion is produced, and finally an aneurysm is gradually formed.

The microscopic injury at the top of the intracranial arterial bifurcation caused by the impact of blood flow has a certain correlation with the formation of aneurysm. Since blood is a viscous liquid, the normal blood viscosity is 5.45-6.35mpa/second, which is a comprehensive expression of the flow deformation and aggregation ability of the main blood components (platelets, red blood cells, white blood cells and plasma, etc.). Viscous blood flow can continue to generate axial shear stress on the vessel wall at the bifurcation site, and the faster the blood flow velocity, the greater the shear stress on the site. When the shear stress increases to a certain extent, it will cause An aneurysm develops as the lining of an artery becomes damaged or torn. The distal bulge of the bifurcation of the arteries is often the main point of action of blood flow impact. Therefore, intracranial aneurysms are most likely to occur at the bulge of the bifurcation arteries; The greater the impact on the vessel wall, the more likely it is to form an aneurysm. Once an aneurysm occurs, the shape of the arterial vessel will also change (protrusion, local expansion, etc.), which will lead to a corresponding change in the hemodynamics of the intracranial vessel.

After the formation of an intracranial aneurysm, the blood flow of the arterial vessel first enters the distal part of the aneurysm neck through a thinner inflow channel 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 through the outer wall of the distal end 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 end of the aneurysm neck.

Based on the principle of hemodynamics, China Invention Patent Application No. 201210278884.8 discloses a cerebral aneurysm stent system and its preparation method. The aneurysm is isolated by the covered stent and the inner support stent, thereby preventing the aneurysm from rupture and reducing the size of the parent artery. occlusion. However, because this technology isolates intracranial aneurysms by covering the surface of the stent with a polymer film, the requirements for the release of the stent are relatively high in actual clinical use. Due to inaccurate positioning, the stent may cover the branch vessels, which may cause surgical complications. Posterior stroke complications; at the same time, due to the double stent technology of covered stent and inner support stent, the delivery system is not flexible enough, and the ability to pass through intracranial tortuous vascular lesions is limited, thus limiting its use.

Also based on the principle of hemodynamics, China Invention Patent Application No. 200810202854.2 discloses a vascular stent for diseased blood vessel repair, which is designed with a nickel-titanium memory alloy braided mesh with a mesh porosity of 55% to 75%. The stent is implanted into the diseased blood vessel, and after the stent is released at the neck of the aneurysm, the high-density metal mesh forms a blocking effect at the neck of the aneurysm, slowing down the blood flow in the aneurysm, thereby realizing the repair and reconstruction of the blood vessel. The high-density vascular stent design can play a role in the treatment of aneurysms, but because the braided metal wire is placed in the normal parent artery and covers part of the normal blood vessels, patients often need to take anticoagulation for life In order to avoid thrombosis in normal blood vessels, the dense mesh stent system of this invention needs a stable and normal blood vessel as the fixed section of the stent at the lesion site of the aneurysm in order to maintain the stability of the stent in the blood vessel, which limits the product. Clinical application.

To sum up, there is currently no suitable treatment for intracranial aneurysms that are narrow at the top and wide at the bottom, giant aneurysms, and aneurysms in bifurcated vessels. A new type of minimally invasive interventional therapy for aneurysms is urgently needed clinically. The product, the occlusion device has a stable structure, and can quickly and densely fill the aneurysm cavity after deployment, thereby slowing down the flow of blood in the aneurysm cavity, reducing the impact pressure of blood on the aneurysm cavity, strengthening the repair ability, and achieving the purpose of treating aneurysms.

Contents of the invention

The present invention proposes a novel intracranial aneurysm occluder and a manufacturing method thereof,

The purpose of the present invention is to provide a new type of minimally invasive interventional treatment of aneurysms that can quickly and densely fill the aneurysm cavity for intracranial aneurysms that are narrow at the top and wide at the bottom, huge, and bifurcated vessels. The occlusion device has a stable structure and can quickly and densely fill the aneurysm cavity after deployment, thereby slowing down the flow of blood in the aneurysm cavity, reducing the impact pressure of blood on the aneurysm cavity, strengthening the repair ability, and achieving the purpose of treating the aneurysm.

The occlusion device includes a occlusion device body, a development mark, a delivery guide wire, a separation point, a delivery tube, and a separator; the occlusion device is woven into a net shape by 24-72 strands of nickel-titanium memory alloy wire; the occlusion device After the occlusion device is fully opened, the distal end and the proximal end are respectively provided with development marks, and the development marks respectively bind and fix the nickel-titanium memory alloy wires at the distal end and the proximal end of the occlusion device; the delivery guide wire is located in the delivery tube; A separation point is set between the development mark 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 a separator; the manufacturing method of the occlusion device is shaped by the mold of the occlusion device.

The occlusion device is separated from the delivery guidewire by a separation point.

The blocking device breaks off the separation point through the separator.

The blocking device is "cylindrical" and the upper and lower surfaces are concave "conical".

The built-in height of the developing marks at the proximal end and the distal end of the main body of the blocking device must not exceed the upper and lower sides of the main body.

The occlusion device determines the position of the occlusion device in the parent artery through the development marks on the proximal end and the distal end of the occlusion device body.

In the manufacturing method, three kinds of molds are used to shape the nickel-titanium memory alloy wire.

For intracranial narrow upper and lower wide types, giant aneurysm type, and bifurcated aneurysms, the occlusion device can quickly and densely fill the aneurysm cavity after being deployed, thereby slowing down the flow of blood in the aneurysm cavity. The flow of blood reduces the impact pressure of blood on the aneurysm cavity, strengthens the repair ability, and achieves the purpose of treating aneurysms.

After the occlusion device is placed in the aneurysm, it will be stretched out in an "elliptical shape" and attached to the vessel wall to generate support, and the aneurysm cavity will be filled with high-density uniform mesh nickel-titanium memory alloy wire, which will slow down the blood flow rate, accelerate thrombus coagulation, and promote vascular Patching heals.

Description of drawings

Accompanying drawing 1 is a structural schematic diagram of a novel intracranial aneurysm occlusion device of the present invention.

Accompanying drawing 2 is a structural schematic view of a novel intracranial aneurysm occlusion device of the present invention placed in a giant aneurysm.

Accompanying drawing 3 is the manufacturing method of a kind of novel intracranial aneurysm sealing device of the present invention.

Accompanying drawing 4 and 5 (preferably) are a kind of novel intracranial aneurysm occluding device of the present invention and its structure schematic diagram placed in giant aneurysm.

Accompanying drawing 6 and 7 (preferably) are a kind of novel intracranial aneurysm occlusion device of the present invention and its placement in lower wide upper narrow type aneurysm structure schematic diagram.

Accompanying drawing 8 and 9 (preferably) are a kind of novel intracranial aneurysm occlusion device of the present invention and its structure schematic diagram placed in bifurcation type aneurysm.

Detailed ways

Embodiments of the present invention are described in detail with reference to accompanying drawings 1-9.

The reference signs and components involved in the accompanying drawings are as follows:

1. Occlusion device 2. Visualization mark on the distal end of the occlusion device

3. Visible marking on the proximal end of the closure device 4. Separation point

5. Delivery guide wire 6. Delivery tube

7. Separator 8. Aneurysm

9. Parent artery 10. Mold (1)

11. Mold (2) 12. Mold (3)

13. Development mark on fixed wing 14 Fixed wing

15. Connecting line

Accompanying drawing 1 is a structural schematic diagram of a novel intracranial aneurysm occlusion device of the present invention. The occlusion device includes a occlusion device body 1, a development mark 2 at the distal end of the occlusion device, a development mark 3 at the proximal end of the occlusion device, a delivery guide wire 5, a separation point 4, a delivery tube 6, and a separator 7; The plugging device 1 is woven into a net shape by 24-72 strands of nickel-titanium memory alloy wires; the device is a net-like structure, the overall shape is "cylindrical", the upper and lower sides are "conical", and the proximal and distal ends are both convergent and fixed. In the distal development mark 2 and the proximal development mark 3 of the occlusion device; the occlusion device 1 is folded into the delivery tube 6 during delivery; the occlusion device 1 is expanded from the delivery tube 6 to the outside by the delivery guide wire 5 A thrust is generated; a separation point 4 is provided between the development mark 3 at the proximal end of the occlusion device and the distal end of the delivery guide wire 5 ; a separator 7 is provided at the proximal end of the delivery guide wire 5 for disconnecting the separation point 4 .

Accompanying drawing 2 is a structural schematic view of a novel intracranial aneurysm occlusion device of the present invention placed in a giant aneurysm. The occlusion device 1 is placed in the giant aneurysm 8; the occlusion device 1 is "elliptical" due to the extrusion of the inner wall of the aneurysm, and the upper and lower sides are concave "conical"; the occlusion device 1 The part of the mesh-shaped nickel-titanium memory alloy wire on the side wall is closely attached to the tumor wall; the occlusion device 1 is delivered by the delivery tube 6 entering the parent artery 9; the delivery tube 6 has a delivery guide wire 5 inside.

Accompanying drawing 3 is the manufacturing method of a kind of novel intracranial aneurysm sealing device of the present invention. The manufacturing method is composed of two molds (1) 10, two molds (2) 11 and one mold (3) 12 spliced together.

Accompanying drawing 4 and 5 (preferably) are a kind of novel intracranial aneurysm occluding device of the present invention and its structure schematic diagram placed in giant aneurysm. The blocking device is one of the extended preferred solutions of the present invention. Accompanying drawing 4 is the front view and sectional view of this optimal new device; This device adds fixed wing 14 at the near end of blocking device 1; Fixed wing 14 is mesh structure, and both sides are " wing shape "; Fold and fix on the developing mark 13 on the fixed wing; the proximal end of the connection line 15 is connected with the developing mark 13 on the fixed wing, and the distal end is connected with the developing mark 3; the accompanying drawing 5 is a front view of the optimal new device placed in a giant aneurysm As shown in the sectional view; the fixed wing 14 is connected to the occlusion device 1 through the connection line 15; the fixed wing 14 is placed at the opening of the aneurysm 8; the two wings of the fixed wing 14 are respectively attached to the blood vessel walls on both sides of the parent artery 9. The preferred new device is characterized in that: fixed wings 14 are added to the original occlusion device 1, and the two wings of the fixed wings 14 are close to the blood vessel walls on both sides of the parent artery 9, so that the blood flow in the blood vessels will not be slowed down, and the thrombus can be prevented and can be prevented. Fixed occlusion device 1; the acute angle wall formed by the aneurysm 8 and the vessel wall of the parent artery 9 conforms to the width of the gap between the occlusion device 1 and the fixed wing 14, that is, the acute angle formed by the aneurysm 8 and the vessel wall of the parent artery 9 The wall is inserted into the gap between the blocking device 1 and the fixed wing 14, which also forms a fixing method, so that the blocking device 1 is not easy to fall off.

Accompanying drawing 6 and 7 (preferably) are a kind of novel intracranial aneurysm occlusion device of the present invention and its placement in lower wide upper narrow type aneurysm structure schematic diagram. The blocking device is one of the extended preferred solutions of the present invention. Accompanying drawing 6 is the front view and cross-sectional view of this preferred new device; the device is a mesh structure, in the form of "a narrow top and a wide bottom"; the device adds a fixed wing 14 at the proximal end of the blocking device 1; the fixed wing 14 is Mesh structure, both sides are "wing-shaped"; the fixed wing 14 is folded and fixed on the developing mark 13 on the fixed wing; the proximal end of the connecting line 15 is connected with the developing mark 13 on the fixed wing, and the far end is connected with the developing mark 3; attached drawing 7 For this optimization, the new device is placed in the upper narrow and lower wide-shaped aneurysm. The front view and cross-sectional view; the fixed wing 14 is connected to the occlusion device 1 through the connecting line 15; the fixed wing 14 is placed at the distal end of the opening of the aneurysm 8; the fixed wing The two wings of 14 are respectively close to the two sides of parent artery 9 . The preferred new device is characterized in that: fixed wings 14 are added to the original occlusion device 1, and the two wings of the fixed wings 14 are close to both sides of the parent artery 9, so that the blood flow rate will not be slowed down, and the occlusion device 1 can be fixed while preventing thrombus. The two wings of the fixed wing 14 are close to both sides of the parent artery 9, and the fixed wing 14 is connected with the occlusion device 1 through the connection line 15 to generate a supporting force, so that the occlusion device 1 plays a role of fixing in the aneurysm 8.

Accompanying drawing 8 and 9 (preferably) are a kind of novel intracranial aneurysm occlusion device of the present invention and its structure schematic diagram placed in bifurcation type aneurysm. The blocking device is one of the extended preferred solutions of the present invention. Accompanying drawing 8 is the structural schematic diagram of this optimal new device; This device is mesh structure, is " spherical "; This device adds fixed wing 14 at the proximal end of blocking device 1; Fixed wing 14 is net structure, and overall is " "bowl-shaped"; the fixed wing 14 is folded and fixed on the developing mark 13 on the fixed wing; the proximal end of the connecting line 15 is connected with the developing mark 13 on the fixed wing, and the far end is connected with the developing mark 3; the accompanying drawing 8 is the bifurcated type of the new device Schematic diagram of the structure inside the aneurysm; the fixed wing 14 is connected to the occluding device 1 through the connecting wire 15; the outer diameter of the fixed wing 14 is larger than that of the occluding device 1; the fixed wing 14 and the occluding device 1 are placed in the aneurysm 8 together. Its characteristic of this optimal new device is: add fixed wing 14 on original blocking device 1; Blocking device 1 and fixed wing 14 are all placed in the aneurysm 8; Because fixed wing 14 outer diameter is greater than blocking device 1, when sealing After the distal end of the occluding device 1 is attached to the inner wall of the aneurysm 8, the fixed wing 14 is attached to the inner vessel wall of the aneurysm 8 opening to generate support force and fix the occluding device 1; and because the aneurysm 8 is a cross aneurysm, blood flow The direction is directly opposite to the aneurysm 8, which causes a great burden on the aneurysm 8, so the fixed wing 14 can slow down the blood flow velocity in addition to the fixing effect, and when the slowed down flow velocity of the blood passes through the blocking device 1, it is slowed down again, greatly reducing the pressure on the aneurysm 8. the pressure of the aneurysm8.

During interventional treatment, the location of the intracranial aneurysm 8 is first determined by angiography, the occlusion device 1 is placed in the delivery tube 6, and then the device is introduced into the blood vessel from the femoral artery or brachial artery, and the delivery tube 6 is pushed to the parent artery 9 The position of the occlusion device 1 is determined by the development mark 2. When the distal end of the delivery tube 6 is confirmed to pass through the opening of the aneurysm 8, gently push the delivery guide wire 5 to release the occlusion device 1, and the nickel-titanium memory wire leaves the delivery tube. After 6, memory deformation occurs, and the occlusion device 1 is fully opened to fit the blood vessel wall in the tumor, and then the separation point 4 is disconnected, and the delivery guide wire 5 and delivery tube 6 are retracted.

The present invention is a new type of intracranial aneurysm occlusion device. Without craniotomy, by inserting the occlusion device 1, the aneurysm cavity can be quickly and densely packed, thereby slowing down the flow of blood in the aneurysm 8 cavities, achieving Purpose of treating aneurysms 8 . The present invention extends three kinds of optimal new occlusion devices, and makes different device schemes for intracranial narrow upper and lower wide, huge, and bifurcated aneurysms 8, and adds fixed wings 14 to the original basic occlusion device 1 , the fixed wing 14 plays a great role in different schemes. In the upper narrow and lower wide aneurysm 8, the fixed wing 14 plays a great supporting role to prevent the occluding device from falling off; in the huge aneurysm 8 , the fixed wing 14 has played a great role in fixing, preventing the occluding device from falling off; in the bifurcated aneurysm 8, the fixed wing 14 has played a great role in fixing, and greatly reduces the flow velocity of blood, playing a very good role. protective effect. The occlusion device has a stable structure and can quickly and densely fill the aneurysm cavity after deployment, thereby slowing down the flow of blood in the aneurysm cavity, reducing the impact pressure of blood on the aneurysm cavity, strengthening the repair ability, and achieving the purpose of treating aneurysms.

The above is a preferred embodiment of the present invention. Those skilled in the art can also make equivalent modifications or replacements without violating the spirit of the present invention. These equivalent modifications or replacements are all included in the claims of the application. In the range.

Claims (10)

1. The present invention relates to a novel intracranial aneurysm occlusion device and a manufacturing method thereof. The occlusion device includes a occlusion device body, a development mark, a delivery guide wire, a separation point, a delivery tube, and a separator. The development Markers are respectively fixed on the distal end and the proximal end of the occlusion device body; the occlusion device is woven into a net shape from 24-72 strands of nickel-titanium memory alloy wire; the delivery guide wire is located in the delivery tube; the occlusion device is near A separation point is set between the terminal development mark and the distal end of the delivery guide wire; the proximal end of the delivery guide wire is connected to a separator; the manufacturing method of the occlusion device includes shaping the device through a mold of the occlusion device. 2. The tumor occlusion device according to claim 1, characterized in that, 24-72 strands of nickel-titanium memory alloy wires are woven into a net shape; the distal bundle is fixed on the distal development mark, and the proximal bundle is fixed on the proximal The proximal end of the device is connected to the detachment point and the delivery guidewire, and is moved by the delivery guidewire. 3. The tumor occlusion device according to claim 1, wherein the body of the occlusion device can be a uniform cylinder, or a spherical shape with a bulge in the middle, or a mushroom shape with fixed wings connected to the proximal end. 4. The tumor occlusion device according to claim 1, characterized in that the occlusion device and the delivery guide wire are separated by a separation point. 5. The aneurysm occlusion device according to claim 1, characterized in that the separation point is disconnected by a separator. 6. The tumor occlusion device according to claim 2, wherein the height of the developed marks at the proximal end and the distal end of the device body does not exceed the upper and lower sides of the device body. 7. The manufacturing method according to claim 1, characterized in that, the nickel-titanium memory alloy wire is shaped by the mold 1, the mold 2, and the mold 3. 8. The manufacturing method as claimed in claim 1, characterized in that the mold 1 is in the shape of a "disc" with a concave "cylindrical" in the middle. 9. The manufacturing method according to claim 1, characterized in that the lower part of the mold 2 is "cylindrical" and the upper part is "conical". 10. The manufacturing method according to claim 1, characterized in that the mold 3 is "cylindrical" and the upper and lower sides are "conical".