Intracranial aneurysm plugging device and use method thereof

Abstract

The invention relates to the technical field of aneurysm treatment equipment, in particular to an intracranial aneurysm plugging device and a use method thereof. The plugging device comprises a support rod body, the support rod body is of a cylindrical structure, and at least one of the two ends of the support rod body is of a flaring structure; the local film covering part is located in the middle area of the stent rod body, and a covering film is arranged on the portion, where the local film covering part is located, of the stent rod body. In the plugging device, the local film covering part is only arranged in the middle area of the stent rod body, so that the local film covering part can accurately plug the aneurysm, hemodynamics can be changed, the aneurysm and blood circulation can be isolated to prevent rupture, and the space occupying effect caused by filling materials in the aneurysm sac can be thoroughly avoided; and the risk of pressing surrounding brain tissues is avoided.

Description

Technical Field

[0001] This application relates to the field of aneurysm treatment equipment technology, and in particular to an intracranial aneurysm occlusion device and its usage method. Background Technology

[0002] Intracranial aneurysms are aneurysmal protrusions formed by abnormal local blood vessels and are a major cause of subarachnoid hemorrhage. Rupture and hemorrhage of intracranial aneurysms are characterized by rapid onset, severe symptoms, high mortality, and high disability rates. With the development of minimally invasive techniques, endovascular interventional therapy has become the preferred method for treating intracranial aneurysms.

[0003] Endovascular interventional treatment for aneurysms mainly involves intra-aneurysmal embolization and reconstruction of the parent artery. Intra-aneurysmal embolization involves using a stent to support the parent vessel and filling the aneurysm cavity with coils or embolic agents. This slows or stops blood flow within the aneurysm cavity, leading to thrombus formation and ultimately sealing the aneurysm cavity. However, it's important to note that neither coils nor embolic agents are absorbed by the body, posing a space-occupying effect and increasing the risk of inflammation.

[0004] Reconstruction of the parent artery of an aneurysm primarily utilizes a dense mesh stent. By altering the hemodynamics of the lesion area, it obstructs blood flow into the aneurysm sac, thereby reducing the blood flow velocity within the aneurysm. The high metal coverage of the stent acts as a "scaffold," promoting stent endothelialization and ultimately achieving the goal of reconstructing the parent artery. Although dense mesh stents possess the structural characteristics of high metal coverage and low porosity, they present challenges during the procedure, such as difficulties in delivery and high resistance during advancement. Postoperative complications may also include delayed aneurysm rupture, thrombosis of the parent artery, and occlusion of paravascular vessels.

[0005] Covered stents, as a treatment for aneurysms, possess the characteristic of a biophysical barrier function. They can isolate the aneurysm from the normal blood supply while maintaining unobstructed blood flow in the parent artery, promoting the natural formation of thrombi within the aneurysm and ultimately achieving the goal of curing the lesion. However, because the covered stent is covered with a membrane material, it often cannot adapt to the tortuous anatomical morphology of intracranial vessels. This can lead to problems such as poor antegrade alignment and poor stent-vessel apposition, resulting in proximal arteriovenous fistulas. Furthermore, it can easily cause vessel wall tears or traction damage to the associated branch arteries, leading to fatal hemorrhage. This not only increases the risk of surgical procedures but can also induce fatal complications in severe cases, presenting several clinical challenges.

[0006] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0007] The purpose of this application is to provide an intracranial aneurysm occlusion device and its method of use, so as to solve or alleviate the problems existing in the prior art.

[0008] To achieve the above objectives, this application provides the following technical solution: An intracranial aneurysm occlusion device, the occlusion device comprising: The support rod is a cylindrical structure, and at least one of its two ends is a flared structure; A partial film-coated section is located in the middle region of the support rod, and a film is provided on the support rod where the partial film-coated section is located.

[0009] In the intracranial aneurysm occlusion device described above, preferably, the local covering portion occupies 20% to 90% of the diameter of the stent rod in the radial direction.

[0010] In the intracranial aneurysm occlusion device described above, preferably, the local covering portion accounts for 30% to 90% of the axial length of the stent rod.

[0011] In the intracranial aneurysm occlusion device described above, preferably, a coating imaging point is provided on the proximal end of the local coating portion of the stent rod.

[0012] In the intracranial aneurysm occlusion device described above, preferably, a coating imaging point is provided on the distal end of the local coating portion of the stent rod.

[0013] In the intracranial aneurysm occlusion device described above, preferably, stent imaging points are provided at both ends of the stent rod.

[0014] In the intracranial aneurysm occlusion device described above, preferably, the solid stent of the stent rod covers 3% to 15% of the volume of the stent rod after it is deployed.

[0015] In the intracranial aneurysm occlusion device described above, preferably, the stent rod is made of metal or polymer material.

[0016] In the intracranial aneurysm occlusion device described above, preferably, the membrane is made of expanded polytetrafluoroethylene and / or polyurethane.

[0017] This application also provides a method of using an intracranial aneurysm closure device, the method of using the above-mentioned intracranial aneurysm closure device, the method of using the device includes the following steps: Step 1: Establish a pathway using a microguidewire and an intermediate catheter, and deliver the microcatheter to the distal end of the aneurysm neck. Step 2: Retract the microguidewire, and deliver the occlusion device and push rod into place along the microcatheter. The occlusion device is pressed onto the push rod, and the stent is used for positioning during this process. Step 3: Slowly retract the microcatheter and slowly release the stent rod. During the release process, adjust the covering imaging point to align with the aneurysm location by rotating the push rod, so that the local covering part can completely cover the aneurysm diameter. Step 4: Retract the microcatheter and push rod to fully release the aneurysm closure device and complete the angiography.

[0018] Compared with the closest prior art, the technical solution of this application has the following beneficial effects: In this occlusion device, a localized covering portion is provided only in the middle region of the stent rod, which allows the localized covering portion to precisely occlude the aneurysm. This not only changes hemodynamics and isolates the aneurysm from blood flow to prevent rupture, but also completely avoids the space-occupying effect caused by the filling material in the aneurysm sac, thus avoiding the risk of compression on the surrounding brain tissue.

[0019] The other non-covered parts of the stent retain the original pores of the stent. Because the stent has a non-dense mesh structure, it ensures the patency of the parent artery and para-branch vessels after the stent is deployed, fundamentally eliminating the possibility of para-branch vessel blockage. Furthermore, the stent with only the middle covered part is not only suitable for lateral wall aneurysms, but can also fully meet the treatment needs of bifurcation aneurysms.

[0020] Because the support rod has a non-dense mesh structure and a partial membrane is provided in the middle area of ​​the support rod, the structure of the support rod itself is extremely simplified. As a result, the compressed size of the support rod is very small, which is more conducive to the transportation of the support rod and can ensure that the support rod has better smoothness. Attached Figure Description

[0021] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments and descriptions of this application are used to explain this application and do not constitute an undue limitation of this application. Wherein: Figure 1 This is a schematic diagram of the sealing device provided according to some embodiments of this application; Figure 2 This is a schematic diagram of a sealing device provided according to some embodiments of this application; Figure 3 A schematic diagram illustrating the establishment of a blocking device pathway according to some embodiments of this application; Figure 4 This is a schematic diagram of the conveying of the sealing device according to some embodiments of this application; Figure 5 This is a schematic diagram illustrating the release of the blocking device according to some embodiments of this application; Figure 6 This is a schematic diagram of the sealing device after it has been fully released according to some embodiments of this application.

[0022] Explanation of reference numerals in the attached figures: 1. Stent rod; 2. Localized covered portion; 3. Covered imaging point; 4. Stent imaging point; 5. Microguidewire; 6. Microcatheter; 7. Intermediate catheter; 8. Aneurysm. Detailed Implementation

[0023] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0024] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0025] The present application will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in the embodiments of the present application can be combined with each other.

[0026] According to specific embodiments of this application, such as Figure 1-6 As shown, this application provides an intracranial aneurysm occlusion device, the occlusion device comprising: The support rod 1 is a cylindrical structure, and at least one of its two ends is a flared structure.

[0027] Partially coated section 2 is located in the middle region of the support rod 1, and a coating is provided on the support rod 1 where the partially coated section 2 is located.

[0028] In this occlusion device, the stent rod 1 is a self-expanding stent. The stent rod 1 is configured as a cylindrical structure, and at least one end of the stent rod 1 is configured as a flared structure, so that after the stent rod 1 is released into the tumor-bearing vessel, the stent rod 1 can automatically expand to form a stable support.

[0029] Based on this, the occlusion device provides an occlusion solution that does not require filling the aneurysm sac. Specifically, in this occlusion device, a local covering part 2 is provided only in the middle region of the stent rod 1, so that the local covering part 2 can accurately block the aneurysm 8. This can not only change hemodynamics and isolate the aneurysm 8 from blood flow to prevent rupture, but also completely avoid the space-occupying effect caused by the filling material in the aneurysm sac, and avoid the risk of compression on the surrounding brain tissue.

[0030] The other non-covered parts of the stent rod 1 retain the original pores of the stent rod 1. Because the stent rod 1 has a non-dense mesh structure, it ensures the patency of the parent artery and parabranch vessels after the stent rod 1 is deployed, fundamentally eliminating the possibility of parabranch vessel blockage. Furthermore, the stent rod 1 with only the middle covered part is not only suitable for lateral wall aneurysms 8, but also fully meets the treatment needs of bifurcation aneurysms 8.

[0031] Because the support rod 1 has a non-dense mesh structure and a partial membrane is provided in the middle area of ​​the support rod 1, the structure of the support rod 1 itself is extremely simplified, which makes the compressed volume of the support rod 1 extremely small, which is more conducive to the transportation of the support rod 1 and can ensure that the support rod 1 has better smoothness.

[0032] The partially coated portion 2 occupies 20% to 90% of the diameter of the support rod 1 in the radial direction. In this embodiment, the partially coated portion 2 occupies 20% to 90% of the radial direction of the support rod 1, that is, 20% to 90% of the diameter of the support rod, so that there is a part of the non-coated area in the radial direction of the support rod 1, thereby ensuring that the partially coated portion 2 does not completely close the support rod 1 in the radial direction.

[0033] The localized covering portion 2 occupies 30% to 90% of the axial length of the stent stem 1. In this embodiment, the localized covering portion 2 occupies 30% to 90% of the axial length of the stent stem 1. This arrangement ensures that the localized covering portion 2 occupies as much as possible of the axial length of the stent stem 1, so as to ensure that the localized covering portion 2 has sufficient area to cover the aneurysm neck of the aneurysm 8. At the same time, it also ensures that there are some non-covered areas at both ends of the stent stem 1 in the axial direction, thereby ensuring that the localized covering portion 2 does not completely close the stent stem 1 in the axial direction.

[0034] A coating development point 3 is provided on the support rod 1 at the proximal end of the local coating part 2.

[0035] A coating development point 3 is provided on the far end of the local coating section 2 on the support rod 1.

[0036] In this embodiment, on the stent rod 1, both the proximal and distal ends of the local covering portion 2 are provided with covering imaging points 3, which facilitates clearer observation of the position of the local covering portion 2 and makes it easier to accurately cover the aneurysm neck of the aneurysm 8 with the local covering portion 2.

[0037] Both ends of the stent rod 1 are provided with stent imaging points 4. In this embodiment, stent imaging points 4 are provided at both ends of the stent rod 1, which facilitates clearer observation of the position of the stent rod 1 and makes it easier to accurately deliver the stent rod 1 to the blood vessel where the aneurysm 8 is located.

[0038] In this embodiment, the coating developing point 3 and the support developing point 4 are made of one or more materials such as platinum-iridium alloy, platinum-tungsten alloy, gold, and tantalum alloy. The developing points can be fixed to the support rod 1 by means of wire wrapping, bonding, welding, sleeve connection, or pressing.

[0039] The solid stent of the stent rod 1 occupies 3% to 15% of the unfolded volume of the stent rod 1. In this embodiment, when the stent rod 1 is made of metal, that is, the metal coverage of the stent rod 1, the coverage range is only 3% to 15%. In other words, the solid material of the stent rod 1 occupies a relatively low overall coverage of the unfolded volume. This also indicates that the stent rod 1 in this application is not a dense mesh stent, which makes the stent rod 1 smaller in volume after compression, making it easier for the compressed occlusion device to pass through tortuous blood vessels, thus improving the pass rate of the occlusion device.

[0040] The stent rod 1 is made of metal or polymer material. In this embodiment, metal materials include nickel-titanium alloy, cobalt-chromium alloy, magnesium alloy, platinum alloy, tantalum alloy, stainless steel, etc., and polymer materials include polytetrafluoroethylene, polylactic acid, polycaprolactone, etc.; all of the above-mentioned metal or polymer materials have good biocompatibility and can be used as materials for manufacturing the stent rod 1. The cylindrical stent rod 1 can be in an open-loop or closed-loop form, and the stent rod 1 can be either self-expanding or ball-expanding.

[0041] The coating material is expanded polytetrafluoroethylene (e-PTFE) and / or polyurethane. In this embodiment, the coating has good biological and chemical stability, is resistant to body fluid corrosion, and has a thickness ranging from 20 micrometers to 100 micrometers. Furthermore, as a barrier coating, it has low porosity and small pore size, effectively preventing blood leakage.

[0042] This application also provides a method of using the intracranial aneurysm occlusion device, the method of using the above-mentioned intracranial aneurysm occlusion device includes the following steps: Step 1: Establish a pathway through the microguidewire 5 and the intermediate catheter 7, and deliver the microcatheter 6 to the distal end of the neck of the aneurysm 8; Step 2: Retract the microguidewire 5, and deliver the occlusion device and push rod into place along the microcatheter 6. The occlusion device is pressed onto the push rod, and the stent imaging point 4 is used for positioning during this process. In this embodiment, if the release position is not ideal, the entire occlusion device can be retracted back into the microcatheter 6 and released again.

[0043] Step 3: Slowly retract the microcatheter 6 and slowly release the stent rod 1. During the release of the stent rod 1, the overlapping imaging point 3 is adjusted to align with the position of the aneurysm 8 by rotating the push rod, so that the local covering part 2 can completely cover the aneurysm diameter opening of the aneurysm 8. Among them, due to the shape recovery performance of the self-expanding stent rod 1, the local covering part 2 can be tightly combined with the aneurysm neck opening, preventing blood flow into the aneurysm sac and playing the role of sealing the aneurysm neck opening of the aneurysm 8.

[0044] Step 4: Retract the microcatheter 6 and push rod to completely release the aneurysm 8 occlusion device and complete the angiography.

[0045] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An intracranial aneurysm occlusion device, characterized in that, The sealing device includes: The support rod is a cylindrical structure, and at least one of its two ends is a flared structure; A partial film-coated section is located in the middle region of the support rod, and a film is provided on the support rod where the partial film-coated section is located.

2. The intracranial aneurysm occlusion device according to claim 1, characterized in that, The partially coated portion occupies 20% to 90% of the diameter of the support rod in the radial direction.

3. The intracranial aneurysm occlusion device according to claim 2, characterized in that, The partially covered portion accounts for 30% to 90% of the axial length of the support rod.

4. The intracranial aneurysm occlusion device according to claim 3, characterized in that, The support rod has a coating development point located near the proximal end of the local coating portion.

5. The intracranial aneurysm occlusion device according to claim 4, characterized in that, The support rod has a coating development point at the distal end of the local coating section.

6. The intracranial aneurysm occlusion device according to claim 5, characterized in that, Both ends of the support rod are equipped with support development points.

7. The intracranial aneurysm occlusion device according to claim 6, characterized in that, The solid support of the support rod covers 3% to 15% of the volume of the support rod after it is unfolded.

8. The intracranial aneurysm occlusion device according to any one of claims 1-7, characterized in that, The support rod is made of metal or polymer material.

9. The intracranial aneurysm occlusion device according to any one of claims 1-7, characterized in that, The coating material is expanded polytetrafluoroethylene and / or polyurethane.

10. A method of using an intracranial aneurysm occlusion device, characterized in that, The method of use employs the intracranial aneurysm occlusion device according to claim 7, and the method of use includes the following steps: Step 1: Establish a pathway using a microguidewire and an intermediate catheter, and deliver the microcatheter to the distal end of the aneurysm neck. Step 2: Retract the microguidewire, and deliver the occlusion device and push rod into place along the microcatheter. The occlusion device is pressed onto the push rod, and the stent is used for positioning during this process. Step 3: Slowly retract the microcatheter and slowly release the stent rod. During the release process, adjust the covering imaging point to align with the aneurysm location by rotating the push rod, so that the local covering part can completely cover the aneurysm diameter. Step 4: Retract the microcatheter and push rod to fully release the aneurysm closure device and complete the angiography.

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