Aneurysm embolization device and preparation method thereof

Abstract

The invention provides an aneurysm embolism device and a preparation method thereof.The aneurysm embolism device comprises an implant, the implant is provided with an implant body and a spiral coil at least arranged at the near end of the implant body, and the implant body has a conveying state used for being conveyed and an implantation state used for blocking aneurysm; when the implant main body is in a conveying state, the implant main body is in a long filament shape, and the spiral coil is arranged on the implant main body in a sleeving manner; when the implant main body is in an implanted state, the implant main body is in a three-dimensional shape formed by spirally winding along the length direction of the implant main body, at least the near end of the implant is in a closed shape, and the spiral coil forms a closed barrier layer; the device has the advantages of simplicity, convenience and time saving in operation, small pushing resistance, high blocking rate and high safety.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to an aneurysm embolization device and a preparation method thereof. Background Art

[0002] Intracranial aneurysm is an abnormal bulge formed by the gradual expansion of intracranial arterial vessels due to local damage to the blood vessel wall caused by congenital or acquired injuries and other factors under the influence of hemodynamic load and other factors.

[0003] The main treatment methods for aneurysms are craniotomy, clipping and endovascular intervention. Among them, endovascular intervention has become the main method for treating aneurysms because of its advantages such as minimally invasive, safe and effective.

[0004] The interventional treatment techniques for aneurysms mainly include simple coil embolization technology, balloon-assisted or stent-assisted coil embolization technology, blood flow guidance device, and dense mesh embolization device. For coil embolization technology, for medium and large aneurysms, the surgeon needs to perform multiple operations to fill the aneurysm with a basket ring, a filling ring, and a finishing ring. The operation is complicated and time-consuming. The stent-assisted coil embolization technology has high finished product costs and complex operations. The blood flow guidance device also has the problems of high cost and complex operation, and the use of this method will delay the rupture of the aneurysm. The dense mesh embolization device usually uses a braided structure to block the neck of the aneurysm. However, the diameter of the braided structure in a compressed state is large, and the inner diameter of the microcatheter that needs to be matched is also large. At the same time, the braided structure has a large push resistance and is not easy to push. Even if the proximal and distal central parts of the braided structure are densely braided, there will be tiny gaps between the braided wires, and blood will still flow into the aneurysm through these gaps, resulting in a low occlusion rate. Summary of the invention

[0005] The object of the present invention is to provide an aneurysm embolization device and a preparation method thereof.

[0006] To achieve the above-mentioned purpose of the invention, the present invention provides an aneurysm embolization device, including an implant, wherein the implant has an implant body and a spiral coil at least arranged at the proximal end of the implant body, the implant body has a delivery state for being delivered and an implantation state for blocking an aneurysm, when the implant body is in the delivery state, the implant body is in the shape of a long filament, and the spiral coil is sleeved on the implant body; when the implant body is in the implantation state, the implant body is in a three-dimensional shape spirally wound along the length direction of the implant body, at least the proximal end of the implant is in a closed shape, and the spiral coil forms a closed barrier layer.

[0007] As a further improvement of the present invention, the implant body is nickel-titanium wire; and / or the diameter of the metal wire forming the implant body is 0.005 mm to 0.5 mm.

[0008] As a further improvement of the present invention, the material of the spiral coil is platinum-tungsten alloy.

[0009] As a further improvement of the present invention, the spiral coil is a secondary spiral coil wound from a primary spiral coil, the diameter of the primary spiral coil is 0.1 mm to 0.5 mm; the diameter of the secondary spiral coil is 0.2 mm to 6 mm.

[0010] As a further improvement of the present invention, when the implant body is in an implanted state, the implant body includes a main body portion, and closing portions arranged at the proximal and distal ends of the main body portion, and the closing portion at at least one end is recessed in the corresponding end portion of the main body portion; the spiral coil is at least located at the closing portion.

[0011] As a further improvement of the present invention, the pitch of the spiral coil is consistent, and the pitch of the spiral coil is 0.1mm~0.25mm; or the pitch of the spiral coil located at the closing part is smaller than the pitch of the spiral coil located at the main body, wherein the pitch of the spiral coil located at the closing part is 0.05mm~0.15mm, and the pitch of the spiral coil located at the main body is 0.3mm~0.4mm.

[0012] As a further improvement of the present invention, the closing portion includes a first end continuous with the main body portion and a second end located inside the main body portion, and the closing portion gradually converges from the first end to the second end; when the implant body is in the implanted state, from the proximal end to the distal end, the outer diameter of the main body portion first gradually increases and then gradually decreases, or the main body portion has a columnar structure; wherein the ratio of the diameter of the first end to the maximum outer diameter of the main body portion is 0.1 to 0.9.

[0013] As a further improvement of the present invention, when the implant body is in the implanted state, the distal end of the main body has a distal closing portion; the ratio of the diameter of the first end of the distal closing portion to the maximum outer diameter of the main body is 0.1 to 0.5.

[0014] As a further improvement of the present invention, when the implant body is in the implanted state, the proximal end of the main body has a proximal closing portion, and the distal end of the main body has a distal closing portion; the ratio of the sum of the recess depths of the proximal closing portion and the distal closing portion to the height of the main body is 0.1 to 0.6.

[0015] As a further improvement of the present invention, the spiral coil includes a first spiral coil sleeved on the proximal section of the implant body and a second spiral coil sleeved on the distal section of the implant body; the ratio of the length of the first spiral coil to the length of the second spiral coil is 0.5-2.

[0016] As a further improvement of the present invention, the spiral coil includes a first spiral coil sleeved on the proximal segment of the implant body and a second spiral coil sleeved on the distal segment of the implant body; when the implant body is in a conveying state, the ratio of the length of the first spiral coil to the length of the implant body is 0.05 to 0.3, and the ratio of the length of the second spiral coil to the length of the implant body is 0.05 to 0.3.

[0017] As a further improvement of the present invention, the distal end of the implant has a molten ball.

[0018] In order to achieve the above-mentioned object of the invention, the present invention also provides a method for preparing the above-mentioned aneurysm embolization device, comprising the following steps:

[0019] shaping the metal wire with shape memory function to form an implant body in an implanted state;

[0020] pulling the shaped implant body into a filament shape;

[0021] A spiral coil is sleeved and fixed on a filament-shaped implant body, wherein the spiral coil is at least located at the proximal end of the implant body; when the implant body is in an implanted state, the spiral coil forms a closed barrier layer;

[0022] connecting the proximal end of the implant body to the distal end of the delivery guidewire;

[0023] The shaped implant body is pulled into a filament to form an implant body in a delivery state, and is placed in a guide sheath. At this time, the proximal end of the delivery guide wire extends to the outside of the guide sheath.

[0024] The beneficial effects of the present invention are as follows: the aneurysm embolization device of the present invention, when the implant body is in the delivery state, the implant body is in the shape of a long filament, has smaller pushing resistance, and can be delivered using a microcatheter with a smaller inner diameter, which is convenient for achieving high positioning and reducing complications during surgical operations; when the implant body is in the implanted state, the implant body is in a three-dimensional shape spirally wound along the length direction of the implant body, and the aneurysm can be blocked by one release, which is easy to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a schematic structural diagram of an implant in a specific embodiment of the present invention when it is in a delivery state;

[0026] Figure 2 is a schematic structural diagram of an implant in a specific embodiment of the present invention when it is in an implanted state;

[0027] Figure 3 yes Figure 2 A schematic diagram of the structure from another angle;

[0028] Figure 4 yes Figure 2 A schematic structural diagram of an implant body in an implanted state;

[0029] Figure 5 yes Figure 2 The schematic diagram of the structure of the implant after being implanted into the aneurysm;

[0030] Figure 6 is a structural schematic diagram of an implant body of an implant in another specific embodiment of the present invention when it is in an implanted state;

[0031] Figure 7 is a structural schematic diagram of an implant body of an implant in another specific embodiment of the present invention when it is in an implanted state;

[0032] Figure 8 is a schematic structural diagram of the aneurysm embolization device of the present invention in a delivery state (the guide sheath is omitted);

[0033] Fig. 9 for Figure 8 The enlarged view of point A in the middle;

[0034] Fig.10 The figure is a schematic diagram of the manufacturing process of the aneurysm embolization device of the present invention. DETAILED DESCRIPTION

[0035] The present invention will be described in detail below in conjunction with the various embodiments shown in the accompanying drawings. Figures 1 to 10 It is shown as a preferred embodiment of the present invention. However, it should be noted that these embodiments are not limitations of the present invention, and any equivalent transformation or replacement of functions, methods, or structures made by ordinary technicians in the field according to these embodiments shall fall within the protection scope of the present invention.

[0036] The words expressing position and direction described in the present invention are all based on the instrument operator as a reference, the end close to the instrument operator is the proximal end, and the end away from the instrument operator is the distal end; the axial direction in the present invention refers to the length direction of the component. In addition, the terms first, second, etc. in the present invention are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features.

[0037] Combination Figures 1 to 9As shown, the present invention provides an aneurysm embolization device 10, comprising an implant 1 for occluding an aneurysm 20. Figure 5 As shown, the aneurysm 20 protrudes outward from the side wall of the patient's blood vessel. When the aneurysm embolization device 10 is used to treat the patient's aneurysm 20, the implant 1 is implanted inside the aneurysm 20. At this time, the distal end of the implant 1 is close to the top of the aneurysm, and the proximal end is close to the neck of the aneurysm to block the aneurysm 20.

[0038] The aneurysm embolization device 10 also includes a guide sheath, a delivery guidewire 3 connected to the proximal end of the implant 1, and a release area 31 is provided at the distal end of the delivery guidewire 3 near the implant 1. Before use, the implant 1 and part of the delivery guidewire 3 are located inside the guide sheath, and the proximal end of the delivery guidewire 3 is located outside the guide sheath. When in use, the distal end of the guide sheath is first connected to the proximal end of the microcatheter with the distal end in place, and then the delivery guidewire 3 is pushed, and the implant 1 is pushed from the guide sheath into the microcatheter. After the implant 1 is detached from the microcatheter from the distal end of the microcatheter, the implant 1 is implanted into the aneurysm 20 to block the aneurysm 20, and after the release area 31 is released, the delivery guidewire 3 and the microcatheter can be withdrawn.

[0039] Specifically, the release area 31 is exposed to the outside. During release, the proximal end of the delivery guide wire 3 is connected to the positive pole of the release device, and the human body is connected to the negative pole of the release device. After power is turned on, the delivery guide wire 3 and the human body form a loop, and the release area 31 undergoes electrolytic separation under the action of anodic oxidation to achieve release.

[0040] It should be noted that the above-mentioned distal end being in place means that the distal end of the microcatheter reaches the neck of the aneurysm 20. At the same time, the delivery guide wire 3 in the aneurysm embolization device 10 of the present invention can use the delivery guide wire 3 in the prior art. In addition, except for the size, the structure and material of the guide sheath in the present invention can also use the structure and material of the guide sheath in the prior art, which will not be repeated here.

[0041] The implant 1 has an implant body 11, and the implant body 11 has a delivery state for being delivered and an implant state for occluding an aneurysm 20. Figure 1 As shown, when the implant body 11 is in the delivery state, the implant body 11 is in the shape of a long filament. Figure 2 As shown, when the implant body 11 is in the implanted state, the implant body 11 is in a three-dimensional shape spirally wound along the length direction of the implant body 11. At this time, at least the proximal end of the implant 1 is in a closed shape.

[0042] Specifically, combined Figure 1As shown, when the implant 1 is located in the guide sheath and the microcatheter, the implant body 11 is subject to radial limiting force, and the implant body 11 is in the delivery state. Compared with the existing implant 1 with a braided structure, the implant 1 in the present invention is in the form of a long filament when in the delivery state. On the one hand, the diameter can be made smaller, and a microcatheter with a smaller inner diameter can be used for delivery, such as a 0.017in microcatheter. The microcatheter with a smaller diameter has a smaller surface area in contact with the blood, and can reach a farther position in the blood vessel, which is convenient for achieving high placement. At the same time, the distal end of the microcatheter with a smaller diameter is softer and will not puncture the blood vessel, causing the risk of thrombosis, thereby reducing complications during the surgical operation. On the other hand, the implant body 11 is in a straightened and elongated state, and compared with the existing stents, braided structures, blood flow guide devices, etc., the push resistance is smaller and it is easy to operate.

[0043] In a specific embodiment, the diameter of the metal wire forming the implant body 11 is 0.005 mm to 0.5 mm, which can be adapted to a 0.017-inch microcatheter. Of course, this is not limited to this.

[0044] Combination Figure 2 As shown, after the implant 1 is detached from the microcatheter from the distal end of the microcatheter, the implant body 11 is not restricted by the microcatheter, and is spirally wound into a three-dimensional shape with at least the proximal end closed, and the implant body 11 is in the implanted state. At this time, the proximal end of the implant 1 is located at the neck of the aneurysm, and the closed proximal end can block the aneurysm 20 and prevent blood from flowing into the aneurysm 20; at the same time, the implant body 11 in the implanted state is three-dimensional, so that the implant 1 can fit the inner wall of the aneurysm 20 more fully, avoiding displacement of the implant 1 after release, and playing a role in fully blocking the aneurysm 20. The aneurysm 20 can be blocked by one release, which is easy to operate.

[0045] It should be noted that the above-mentioned closed state means that the occlusion rate of the proximal end of the implant 1 in the implanted state is not less than 95%, which can achieve a good blocking effect on the aneurysm 20.

[0046] Specifically, the three-dimensional shape of the implant body 11 in the implanted state can be pre-set according to the shape of the aneurysm 20. Figure 2 to Figure 4 As shown, in a specific embodiment, the implant body 11 in the implanted state is spherical. At this time, from the proximal end to the distal end, the outer diameter of the implant body 11 gradually increases and then gradually decreases. The implant 1 is suitable for implanting the spherical aneurysm 20; Figure 6As shown, in another specific embodiment, the implant body 11a in the implanted state is configured as a columnar structure, which is suitable for implanting the columnar aneurysm 20. That is, the specific shape of the implant body 11 in the implanted state can be adapted to the shape of the aneurysm 20 to be implanted, and no further examples are given here.

[0047] Specifically, the maximum outer diameter Dmax of the implant body 11 in the implanted state is 2 mm to 26 mm, such as 2 mm, 6 mm, 10 mm, 15 mm, 26 mm, etc., which can meet the size requirements of various aneurysms 20 and improve the versatility of the aneurysm embolization device 10.

[0048] It should be noted that, with the arrangement direction of the proximal end and the distal end as the length direction, the outer diameter of the implant body 11 in the present invention refers to the diameter of the implant body 11 in a direction perpendicular to the length direction.

[0049] In a specific embodiment, the implant body 11 is a nickel-titanium wire. When the implant body 11 is in a conveying state, the implant body 11 is a long strip of nickel-titanium wire; when the implant body 11 is in an implanted state, the implant body 11 is in the shape of a nickel-titanium spiral coil. It is known that the shape of the implant body 11 in the implanted state is the initial shape of the implant body 11, and the implant body 11 in the conveying state is formed by stretching and straightening the implant body 11 in the initial shape. The nickel-titanium alloy material forming the nickel-titanium wire has superelasticity and shape memory functions. After being separated from the microcatheter, the implant body 11 can automatically return to its initial shape, thereby forming the implant body 11 in the implanted state; at the same time, the nickel-titanium alloy material is also a biocompatible material and is relatively safe. Of course, this is not limited to the above, and the material of the implant body 11 can also be other materials with shape memory function and biocompatibility.

[0050] Specifically, in this embodiment, the implant body 11 is a nickel-titanium wire with a diameter of 0.005 mm to 0.5 mm, and the pitch of the implant body 11 in the implanted state is 0.01 mm to 0.5 mm.

[0051] Please refer to Figure 1 to Figure 3As shown, the implant 1 also includes a spiral coil 12 at least arranged at the proximal end of the implant body 11. When the implant body 11 is in a conveying state, the spiral coil 12 is sleeved on the implant body 11, and when the implant body 11 is in an implanted state, the spiral coil 12 is wound with the implant body 11 to form a closed barrier layer. In this embodiment, at least the proximal end of the implant body 11 is encrypted by the spiral coil 12 to improve the sealing effect of the implant 1 in the implanted state and block the blood from flowing into the aneurysm 20. Of course, it is not limited to this. In other embodiments, the sealing effect of the implant 1 in the implanted state can also be improved by at least increasing the density of the nickel-titanium spiral coil 12 at the proximal end of the implant body 11 in the implanted state, such as reducing the pitch of the nickel-titanium spiral coil 12 at the proximal end to 0.005mm~0.01mm.

[0052] Specifically, the spiral coil 12 is made of platinum-tungsten alloy, which is soft enough to be fixed to the implant body 11 in the implanted state, and will not affect the deformation of the implant body 11, and the spiral coil 12 has almost no effect on the pushing force of the implant 1 in the guide sheath and the microcatheter; at the same time, platinum-tungsten alloy is a biocompatible material, and can quickly produce thrombus and is easy to shape when in contact with blood flow, and can form a dense and closed barrier layer to prevent blood from flowing into the aneurysm 20; in addition, the platinum-tungsten alloy itself has the characteristic of developing under the DSA device, so that the position of the implant 1 can be directly located by the development of the platinum-tungsten alloy, without the need to set a developing element on the implant 1, the structure is simple, and the cost is reduced.

[0053] Furthermore, the spiral coil 12 is a secondary spiral coil wound from a primary spiral coil, the diameter of the primary spiral coil is 0.1 mm to 0.5 mm, and the diameter of the secondary spiral coil is 0.2 mm to 6 mm. Improving the encryption effect of the spiral coil 12 on the implant body 11 in the implanted state can improve the blocking effect of the implant 1 on the aneurysm 20 and block the blood from flowing into the aneurysm 20.

[0054] Furthermore, when the implant body 11 is in the implanted state, the implant body 11 includes a main body 111 and a closing portion 112 provided at the proximal and distal ends of the main body 111. Specifically, the closing portion 112 includes a proximal closing portion located at the proximal end of the main body 111 and a distal closing portion located at the distal end of the main body 111, and the proximal closing portion corresponds to the neck opening of the aneurysm 20.

[0055] The spiral coil 12 is at least located at the closing portion 112. The spiral coil 12 located at the proximal closing portion can densify the proximal end of the implant 1 to form a first barrier layer, which can block the neck of the aneurysm 20 and prevent blood from entering the aneurysm 20. The spiral coil 12 located at the distal closing portion can densify the distal end of the implant 1 to form a second barrier layer, which can prevent a small amount of blood that enters the inner cavity of the implant 1 through the proximal end of the implant 1 from flowing out, further improving the blocking effect of the implant 1.

[0056] Specifically, the spiral coil 12 includes a first spiral coil sleeved on the proximal end section of the implant body 11 and a second spiral coil sleeved on the distal end section of the implant body 11. When the implant body 11 is in the implanted state, the first spiral coil forms a first barrier layer at the proximal end of the implant 1, and the first spiral coil is at least located at the proximal end closing portion, and the second spiral coil forms a second barrier layer at the distal end of the implant 1, and the second spiral coil is at least located at the distal end closing portion.

[0057] Furthermore, the ratio of the length of the first spiral coil to the length of the second spiral coil is 0.5 to 2. Generally, when the implant 1 is used to implant an aneurysm 20 with a ruptured dome or a narrow-necked aneurysm 20, the ratio of the length of the first spiral coil 12 to the length of the second spiral coil 12 is 0.5 to 1, that is, the second spiral coil 12 can be set longer to prevent blood from flowing out. When the implant 1 is used to implant a wide-necked aneurysm 20, the ratio of the length of the first spiral coil 12 to the length of the second spiral coil 12 is 1 to 2, that is, the first spiral coil 12 can be set longer to match the wider aneurysm neck. Of course, this is not limited to this, and the lengths of the first spiral coil 12 and the second spiral coil 12 can be adjusted according to specific needs.

[0058] The wide-necked aneurysm 20 mentioned above satisfies that the ratio of the diameter of the aneurysm neck opening to the maximum diameter of the aneurysm body is not less than 1 / 2, or the diameter of the aneurysm neck opening is greater than 4 mm. Correspondingly, the narrow-necked aneurysm 20 satisfies that the ratio of the diameter of the aneurysm neck opening to the maximum diameter of the aneurysm body is not greater than 1 / 2.

[0059] Specifically, when the implant body 11 is in the delivery state, the ratio of the length of the first spiral coil 12 to the length of the implant body 11 is 0.05-0.3, and the ratio of the length of the second spiral coil 12 to the length of the implant body 11 is 0.05-0.3.

[0060] In a specific embodiment, when the length of the implant body 11 is between 8 mm and 200 mm, the lengths of the first spiral coil and the second spiral coil are between 2 mm and 60 mm.

[0061] Furthermore, the spiral coil 12 is located on the closing portion 112 and the portion of the main body 111 near the closing portion 112 to densify the closing portion 112 and the main body 111 near the closing portion 112, thereby preventing the blood in the current-carrying artery from entering the aneurysm 20 from the edge of the closing portion 112.

[0062] For a narrow-necked aneurysm 20, the neck opening of the aneurysm is relatively narrow, and generally the closing portion 112 can completely cover the neck opening of the aneurysm. Therefore, setting the pitch of the spiral coil 12 located at the closing portion 112 of the implant 1 for implantation in the narrow-necked aneurysm 20 to be smaller than the pitch of the spiral coil 12 located at the main body 111 can reduce the usage of the spiral coil 12 and reduce costs.

[0063] Specifically, the pitch of the spiral coil 12 located at the closing portion 112 is 0.05 mm to 0.15 mm, and the pitch of the spiral coil 12 located at the main body 111 is 0.3 mm to 0.4 mm.

[0064] For a wide-necked aneurysm 20, the neck of the aneurysm is relatively wide, and blood can easily enter the aneurysm 20 from the edge of the closing portion 112. Therefore, the spiral coil 12 in the implant 1 for implantation in the wide-necked aneurysm 20 is tightly wound, and the pitch is set to be consistent, for example, the pitch of the spiral coil 12 is 0.1 mm to 0.25 mm.

[0065] Furthermore, the closing portion 112 at at least one end is recessed in the corresponding end of the main body 111. In a specific embodiment, the proximal closing portion is recessed in the proximal end of the main body 111 to prevent the proximal end of the implant 1 from protruding into the tumor-bearing artery 30, so that the implant 1 will not affect the blood flow in the tumor-bearing artery 30, and will not form a thrombus, and will not cause the risk of blocking the blood vessel. The distal closing portion is recessed in the distal end of the main body 111 to prevent the distal end of the implant 1 from touching the aneurysm 20 and puncturing the aneurysm 20, so as to protect the aneurysm 20 and prevent the aneurysm 20 from rupturing. Of course, this is not limited to this. In other embodiments, only the proximal closing portion can be recessed in the proximal end of the main body 111, or only the distal closing portion can be recessed in the distal end of the main body 111 according to needs.

[0066] Specifically, the closing portion 112 includes a first end continuous with the main body 111 and a second end located inside the main body 111, and the closing portion 112 gradually converges from the first end to the second end, that is, the closing portion 112 is trumpet-shaped. The ratio of the diameter D1 of the first end to the maximum outer diameter Dmax of the main body 111 is 0.1 to 0.9. The ratio of the diameter D1 of the first end of the closing portion 112 to the maximum outer diameter Dmax of the main body 111 is greater than 0.1, which can make the closing portion 112 concave. The ratio of the diameter D1 of the first end of the closing portion 112 to the maximum outer diameter Dmax of the main body 111 is less than 0.9, which can prevent the implant 1 from shifting after release.

[0067] Further, the ratio of the diameter D1 of the first end of the proximal closing portion to the maximum outer diameter Dmax of the main body 111 is 0.1 to 0.9. The ratio Dmax of the diameter D1 of the first end of the proximal closing portion to the maximum outer diameter of the main body 111 is greater than 0.1, which can make the proximal closing portion concave and prevent the proximal end of the implant 1 from protruding into the tumor-bearing artery 30. The ratio of the diameter D1 of the first end of the proximal closing portion to the maximum outer diameter Dmax of the main body 111 is less than 0.9, which can prevent the implant 1 from shifting after release.

[0068] Specifically, the ratio of the diameter D1 of the first end of the proximal closing portion to the maximum outer diameter Dmax of the main body 111 can be determined according to the ratio of the diameter at the neck of the aneurysm to the diameter of the aneurysm 20. The larger the ratio of the diameter at the neck of the aneurysm 20 to be implanted is, the larger the ratio of the diameter of the first end of the proximal closing portion to the maximum outer diameter of the main body 111 is, such as Figure 7 The implant body 11b in another specific embodiment is shown. Correspondingly, the smaller the ratio of the diameter of the neck of the aneurysm 20 to the diameter of the aneurysm 20 to be implanted is, the smaller the ratio of the diameter of the first end of the proximal closing portion to the maximum outer diameter of the main body 111 is.

[0069] Furthermore, the ratio of the diameter D1 of the first end of the distal end closing portion to the maximum outer diameter Dmax of the main body 111 is 0.1 to 0.5. When the length of the implant 1 in the delivery state is constant, the height of the implant 1 in the implant state can be increased to provide a recessed space for the recessed closing portion 112.

[0070] Furthermore, the ratio of the sum of the concave depths of the proximal closing portion and the distal closing portion to the height H of the main body 111 is 0.1 to 0.6. When the length of the implant 1 in the delivery state is constant, the height of the implant 1 in the implant state can be increased, so that the implant 1 can be more fully attached to the inner wall of the aneurysm 20, avoiding displacement of the implant 1 after release, and playing the role of fully blocking the aneurysm 20.

[0071] In a specific embodiment, the height H of the main body 111 is 0.8Dmax, the concave depth Hnear concave of the proximal end closing portion is 0.1Dmax, and the concave depth Hfar concave of the distal end closing portion is 0.1Dmax, wherein Dmax is the maximum outer diameter of the main body 111. Of course, this is not limited thereto.

[0072] Furthermore, the distal end of the implant 1 is a molten ball 13, which can prevent the implant 1 from getting stuck when pushed inside the guide sheath and the microcatheter, and prevent the distal end of the implant 1 from puncturing the blood vessel wall after the implant 1 is pushed out of the microcatheter.

[0073] Furthermore, combined with Figure 8-Figure 9 As shown, the aneurysm embolization device 10 further includes a support ring 4 sleeved on the delivery guide wire 3 and close to the proximal end of the release area 31, and a developing ring 5 located at the proximal end of the support ring 4. The support ring 4 can support the distal end of the delivery guide wire 3 to prevent the distal end of the delivery guide wire 3 from being folded or bent. The developing ring 5 is used to realize the development of the delivery guide wire 3, so that the operator can know the specific position of the delivery guide wire 3.

[0074] Specifically, the support ring 4 is a stainless steel support ring 4. The length of the support ring 4 is 20 mm to 35 mm, the outer diameter of the support ring 4 is 0.18 mm to 0.25 mm, and the diameter of the stainless steel wire forming the support ring 4 is 0.02 mm to 0.08 mm.

[0075] The developing ring 5 is a platinum-tungsten developing ring 5. The length of the developing ring 5 is 260 mm to 500 mm, the outer diameter of the supporting developing ring 5 is 0.24 mm to 0.35 mm, and the diameter of the platinum-tungsten wire forming the developing ring 5 is 0.01 mm to 0.06 mm.

[0076] Furthermore, a PTFE heat shrink tube 6 is sleeved on the outer side of the support ring 4 and the developing ring 5, which can fix the support ring 4 and the developing ring 5 on the delivery guide wire 3 and prevent the support ring 4 and the developing ring 5 from contacting and puncturing the blood vessel wall. At the same time, the delivery guide wire 3 can be insulated from the blood to avoid separation during release.

[0077] Furthermore, the distal end of the delivery guide wire 3 is also sheathed with a PET heat shrink tube 7 connected to the PTFE heat shrink tube 6, and the release area 31 is exposed outward from the PET heat shrink tube 7. The PET-wrapped distal end of the delivery guide wire 3 has an insulating effect, which can prevent the distal end of the delivery guide wire 3 from being released together when released.

[0078] Specifically, the PET heat shrink tube 7 is softer than the PTFE heat shrink tube 6 , and the distal end of the delivery guide wire 3 is sleeved with the PET tube, which can avoid the distal end of the delivery guide wire 3 being too hard, and is conducive to the delivery guide wire 3 being in place.

[0079] Furthermore, combined with Fig.10 As shown, the present invention also provides a method for preparing an aneurysm embolization device 10, comprising the following steps:

[0080] S1: shaping the metal wire with shape memory function to form an implant body 11 in an implanted state;

[0081] S2: pulling the shaped implant body 11 into a filament shape;

[0082] S3: sleeve and fix the spiral coil 12 on the filament-shaped implant body 11, wherein the spiral coil 12 is at least located at the proximal end of the implant body 11; when the implant body 11 is in the implanted state, the spiral coil 12 forms a closed barrier layer;

[0083] S4: Connecting the proximal end of the implant body 11 to the distal end of the delivery guide wire 3;

[0084] S5: The shaped implant body 11 is pulled into a filament to form the implant body 11 in a delivery state, and is placed in the guide sheath. At this time, the proximal end of the delivery guide wire 3 extends to the outside of the guide sheath.

[0085] In a specific embodiment, the metal wire with shape memory function is a nickel-titanium wire. Of course, it is not limited to this.

[0086] Specifically, step S1 includes the following steps:

[0087] S11: Turn on the circulating box furnace, set the temperature to 400-700℃, keep warm for 20-90min, and prepare a bucket of cooling water next to the box furnace;

[0088] S12: Winding the nickel-titanium wire onto the preliminary shaping mold, placing the nickel-titanium wire into the circulating box furnace for heating, and taking out the product after a preset time and cooling it in cooling water;

[0089] S13: Winding the nickel-titanium wire onto the final shaping mold, putting them together into the circulating box furnace for heating, taking out the product after the preset time is reached and cooling it in cooling water to form the implant body 11 in the implantation state.

[0090] It can be known that the shape of the implant body 11 in the implanted state can be configured to match the aneurysm 20 to be implanted, for example, it can be spherical, or it can be a columnar structure, a fusiform structure, etc.

[0092] Specifically, in step S3, the spiral coil 12 can be fixed to the implant body 11 by glue.

[0093] When the spiral coil 12 includes a first spiral coil 12 sleeved on the proximal end section of the implant body 11 and a second spiral coil 12 sleeved on the distal end section of the implant body 11, the step S3 of “sleeving and fixing the spiral coil 12 on the filamentous implant body 11” specifically includes the following steps:

[0094] Insert the formed first spiral coil 12 and second spiral coil 12 into the implant body 11 from the distal end in sequence, pull open 2 to 10 turns of the proximal end of the first spiral coil 12, pull open 2 to 10 turns of the distal end of the second spiral coil 12, and then position the implant body 11 so that the distal end of the second spiral coil 12 is exposed by 0.2mm to 1mm, and the proximal end of the implant body 11 is exposed by 0.5mm to 2mm of the first spiral coil 12, and then apply glue to the opened part of the first spiral coil 12 and the opened part of the second spiral coil 12; after applying glue, put the glued product into an electric heated blast constant temperature drying oven for heating and insulation, the temperature is set to 10 to 200°C, and the time is set to 10 to 100min, so as to fix the spiral coil 12 to the implant body 11.

[0095] Furthermore, the method for preparing the spiral coil 12 comprises the following steps:

[0096] First, the platinum tungsten wire is wound into a primary spiral coil;

[0097] Pull the two ends of the formed primary spiral coil apart by 3 to 8 mm, manually wind the primary spiral coil onto the mold, use the scrapped spring coil wire to straighten it and then wind it around the tail of the wound primary spiral coil and tie a knot to secure it;

[0098] Put it into the muffle furnace and heat it at 500-700℃ for 20-200 minutes.

[0099] The finished spiral coil 12 is removed from the mold to form a secondary spiral coil, that is, the spiral coil 12 is formed.

[0100] The diameter of the primary spiral coil is 0.1 mm to 0.5 mm, and the diameter of the secondary spiral coil is 0.2 mm to 6 mm. Of course, this is not limited to the above.

[0101] Furthermore, step S4 specifically includes the following steps:

[0102] Place the proximal end of the implant 1 close to the distal end of the delivery guide wire 3, keep the distance between the two at 0.1-0.2 mm, and use instant glue to fix the proximal end of the implant 1 and the distal end of the delivery guide wire 3;

[0103] Pull the proximal end of the first spiral coil 12 apart by 2 to 10 turns, apply instant glue to 1 to 2 turns of the proximal end of the first spiral coil 12 under a microscope, then apply glue to the farthest end of the stretched first spiral coil 12, leave it for 10 to 30 minutes, put epoxy glue on the un-glueized part of the stretched part of the first spiral coil 12, and then heat it on a heating table to achieve the connection between the implant 1 and the delivery guide wire 3.

[0104] Furthermore, before step S4, the method for preparing the aneurysm embolization device 10 further includes the step of preparing the delivery guide wire 3:

[0105] A PTFE heat shrink tube 6 is sleeved on the conveying guide wire 3, and one end of the PTFE heat shrink tube 6 is heat-shrunk, wherein the parameters of the heat shrink PTFE heat shrink tube 6 are: air 3 to 9 liters / minute, heating 4 to 8 liters / minute;

[0106] Insert the developing ring 5 and the supporting ring 4 from the distal end of the conveying guide wire 3 in sequence, and adjust the developing ring 5 and the supporting ring 4 to the preset positions;

[0107] Fix the distal end of the primary support ring 4 at the joint between the developing ring 5 and the support ring 4 with glue;

[0108] Insert the distal end of the delivery guide wire 3 into the PET heat shrink tube 7 until the proximal end of the PET heat shrink tube 7 reaches the distal end of the support ring 4;

[0109] Turn on the heater and heat shrink the PET heat shrink tube 7. Heat shrink the PET heat shrink tube 7 parameters: air 3-8 liters / minute, heating 3-9 liters / minute;

[0110] Turn on the heater to heat shrink the PTFE heat shrink tube 6 until the PTFE heat shrink tube 6 covers the proximal end of the PET heat shrink tube 7, and cool in the air;

[0111] Cut the heat shrink tube to expose the release area 31: Under a microscope, confirm that the cutting starting point is 1 to 3 mm away from the farthest end of the delivery guide wire 3, and use a blade to cut the PET heat shrink tube 7 to expose the delivery guide wire 3, with a cutting length of 0.1 to 0.2 mm.

[0112] Furthermore, step S5 is specifically as follows:

[0113] The proximal end of the delivery guide wire 3 is inserted into the guide sheath from the distal end of the guide sheath, until the nickel-titanium wire and the spiral coil 12 at the distal end of the implant body 11 in the delivery state are exposed to the distal end of the guide sheath by about 2 mm;

[0114] The nickel-titanium wire at the distal end of the implant 1 and the spiral coil 12 are formed into a molten ball 13 using a laser welding machine.

[0115] In summary, the aneurysm embolization device 10 of the present invention, when the implant body 11 is in the delivery state, the implant body 11 is in the shape of a long filament, has a smaller pushing resistance, and can be delivered using a microcatheter with a smaller inner diameter, which is convenient for achieving high positioning and reducing complications during surgical operations; when the implant body 11 is in the implanted state, the implant body 11 is in a three-dimensional shape spirally wound along the length direction of the implant body 11, and the aneurysm 20 can be blocked by one release, which is easy to operate.

[0116] It should be understood that although this specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each implementation mode may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

[0117] The series of detailed descriptions listed above are only specific descriptions of feasible implementation methods of the present invention and are not intended to limit the scope of protection of the present invention. All equivalent implementation methods or changes that do not deviate from the technical spirit of the present invention should be included in the scope of protection of the present invention.

Claims

1. An aneurysm embolization device, comprising an implant, characterized in that: The implant comprises an implant body and a spiral coil at least arranged at the proximal end of the implant body. The implant body has a delivery state for being delivered and an implantation state for blocking an aneurysm. When the implant body is in the delivery state, the implant body is in a filament shape, and the spiral coil is sleeved on the implant body; when the implant body is in the implantation state, the implant body is in a three-dimensional shape spirally wound along the length direction of the implant body, and at least the proximal end of the implant is in a closed shape, and the spiral coil forms a closed barrier layer.

2. The aneurysm embolization device according to claim 1, characterized in that: The implant body is nickel-titanium wire; and / or the diameter of the metal wire forming the implant body is 0.005 mm to 0.5 mm.

3. The aneurysm embolization device according to claim 1, characterized in that: The material of the spiral coil is platinum-tungsten alloy.

4. The aneurysm embolization device according to claim 1, characterized in that: The spiral coil is a secondary spiral coil wound from a primary spiral coil, the diameter of the primary spiral coil is 0.1 mm to 0.5 mm; the diameter of the secondary spiral coil is 0.2 mm to 6 mm.

5. The aneurysm embolization device according to claim 1, characterized in that: When the implant body is in an implanted state, the implant body includes a main body, and closing parts arranged at the proximal and distal ends of the main body, and at least one end of the closing part is recessed in the corresponding end of the main body; the spiral coil is at least located at the closing part.

6. The aneurysm embolization device according to claim 5, characterized in that: The pitch of the spiral coils is consistent, and the pitch of the spiral coils is 0.1mm to 0.25mm; or the pitch of the spiral coils located at the closing portion is smaller than the pitch of the spiral coils located at the main body, wherein the pitch of the spiral coils located at the closing portion is 0.05mm to 0.15mm, and the pitch of the spiral coils located at the main body is 0.3mm to 0.4mm.

7. The aneurysm embolization device according to claim 5, characterized in that: The closing portion includes a first end continuous with the main body and a second end located inside the main body, and the closing portion gradually converges from the first end to the second end; when the implant body is in an implanted state, from the proximal end to the distal end, the outer diameter of the main body first gradually increases and then gradually decreases, or the main body presents a columnar structure; wherein the ratio of the diameter of the first end to the maximum outer diameter of the main body is 0.1 to 0.

9.

8. The aneurysm embolization device according to claim 7, characterized in that: When the implant body is in an implanted state, the distal end of the main body has a distal closing portion; the ratio of the diameter of the first end of the distal closing portion to the maximum outer diameter of the main body is 0.1 to 0.

5.

9. The aneurysm embolization device according to claim 7, characterized in that: When the implant body is in an implanted state, the proximal end of the main body has a proximal closing portion, and the distal end of the main body has a distal closing portion; the ratio of the sum of the recessed depths of the proximal closing portion and the distal closing portion to the height of the main body is 0.1 to 0.

6.

10. The aneurysm embolization device according to claim 1, characterized in that: The spiral coil comprises a first spiral coil sleeved on the proximal end section of the implant body and a second spiral coil sleeved on the distal end section of the implant body; the ratio of the length of the first spiral coil to the length of the second spiral coil is 0.5-2.

11. The aneurysm embolization device according to claim 1, characterized in that: The spiral coil includes a first spiral coil sleeved on the proximal section of the implant body and a second spiral coil sleeved on the distal section of the implant body; when the implant body is in a conveying state, the ratio of the length of the first spiral coil to the length of the implant body is 0.05 to 0.3, and the ratio of the length of the second spiral coil to the length of the implant body is 0.05 to 0.

3.

12. The aneurysm embolization device according to claim 1, characterized in that: The distal end of the implant has a molten ball.

13. A method for preparing the aneurysm embolization device according to any one of claims 1 to 12, characterized in that: The steps include: shaping the metal wire with shape memory function to form an implant body in an implanted state; pulling the shaped implant body into a filament shape; A spiral coil is sleeved and fixed on a filament-shaped implant body, wherein the spiral coil is at least located at the proximal end of the implant body; when the implant body is in an implanted state, the spiral coil forms a closed barrier layer; connecting the proximal end of the implant body to the distal end of the delivery guidewire; The shaped implant body is pulled into a filament to form an implant body in a delivery state, and is placed in a guide sheath. At this time, the proximal end of the delivery guide wire extends to the outside of the guide sheath.

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