Foam emboli and methods of making same

By designing deformable foam vascular plugs and utilizing the differences in cross-sectional area and incompressible porous material channels, the problems of nickel ion risk and adaptability to tortuous blood vessels of metal vascular plugs were solved, achieving efficient embolization and rapid recovery, and reducing the risk of MRI artifacts.

CN119908792BActive Publication Date: 2026-05-29SHANGHAI SHAPE MEMORY ALLOY

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHANGHAI SHAPE MEMORY ALLOY
Filing Date
2024-12-31
Publication Date
2026-05-29

AI Technical Summary

Technical Problem

Existing metal vascular plugs pose risks of nickel ion allergy, long-term risks due to high density, and MRI artifacts. Furthermore, traditional embolization products have poor mobility within blood vessels and are difficult to adapt to tortuous vessels.

Method used

Design a foam vascular plug made of deformable foam material, consisting of first and second parts with different cross-sectional areas, and incompressible porous material channels that allow the plug to recover its shape through blood and water to achieve embolism.

Benefits of technology

It improves the sheathing performance and expansion rate of vascular plugs, adapts to tortuous blood vessels, reduces nickel ion risk, shortens embolization time, and reduces MRI artifacts.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure provides a foam vascular plug, comprising a first part and a second part connected to each other, and the cross-sectional area of the first part in a cross section perpendicular to the axial direction is greater than the cross-sectional area of the second part in a cross section perpendicular to the axial direction, wherein the first part is made of a deformable foam material, and the second part is made of a deformable foam material. The foam vascular plug in an embodiment of the present disclosure, by setting the first part and the second part with different cross-sectional areas, the first part with a larger cross-sectional area can block the blood vessels at a specific position when it is not compressed, and the second part with a smaller cross-sectional area can facilitate the movement of the foam vascular plug in the blood vessels when it is compressed. Therefore, the foam vascular plug of the present disclosure has strong sheathability, high expansion rate and short expansion time, which helps to treat patients.
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Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a foam vascular plug and its preparation method. Background Technology

[0002] Interventional therapy is the mainstream treatment for vascular diseases. Vascular intervention is divided into three main areas: coronary intervention, neurointervention, and peripheral intervention. Peripheral intervention mainly involves the blood vessels of the trunk and limbs, excluding the aorta in the human circulatory system. Peripheral vessels are divided into peripheral arteries and veins, and peripheral vascular diseases are also divided into peripheral artery diseases and peripheral venous diseases.

[0003] Transcatheter arterial embolization (TAE) is a technique that, under X-ray fluoroscopy, involves injecting or delivering embolic material through a catheter into a target blood vessel to block the vessel and treat disease. It achieves its therapeutic goal by obstructing blood flow to the affected area or a specific part of the body.

[0004] To date, various vascular embolization devices have been introduced to the market. However, the permanent residue of the aforementioned metallic materials after implantation can lead to a series of long-term risks, such as nickel ion allergy. The high density of metallic materials requires a larger mass for filling, further exacerbating these risks. Furthermore, the implanted metal can produce artifacts during subsequent MRI examinations, affecting the diagnostic results. These devices are used in the treatment of various clinical diseases. Currently available peripheral vascular embolization products are mostly made of NiTi alloy braided mesh or coils. Summary of the Invention

[0005] In order to overcome at least one of the defects described in the prior art, the purpose of this application is to provide a foam vascular plug and a method for preparing the same, so as to solve the problems of existing metal vascular plugs.

[0006] In a first aspect, this disclosure provides a foam vascular plug, comprising a first part and a second part connected to each other, wherein the cross-sectional area of ​​the first part in a cross section perpendicular to the axial direction is greater than the cross-sectional area of ​​the second part in a cross section perpendicular to the axial direction, wherein the first part is made of a deformable foam material and the second part is made of a deformable foam material.

[0007] Optionally, a first channel is formed in the first portion; the first channel communicates with the outside and / or the first channel extends into the second portion.

[0008] Optionally, the first channel is provided with the incompressible porous material.

[0009] Optionally, the first part is made of a biodegradable and deformable foam material, the second part is made of a biodegradable and deformable foam material, and the first channel is provided with the incompressible biodegradable porous material.

[0010] Optionally, the incompressible porous material is fixed in the first channel using medical bio-adhesive.

[0011] Optionally, the first part forms multiple first channels, and the first channels are straight, the size of the first channels is greater than 1000 micrometers, and the pore size of the foam material is 50~3000 micrometers.

[0012] Optionally, the foam vascular plug includes a first portion and a second portion that are alternately arranged along the axial direction.

[0013] Optionally, the foam vascular plug further includes a third part, which is connected to the first part through the second part, and the third part is made of deformable foam material, and a second channel is formed in the third part; the second channel is connected to the outside and / or the second channel extends into the second part.

[0014] Optionally, the foam material is a porous material to allow liquid to pass through, and the foam material is a shape memory foam.

[0015] In a second aspect, this disclosure provides a method for preparing a foam vascular plug for use in preparing the foam vascular plug described in any embodiment of the first aspect, comprising:

[0016] The raw materials are foamed;

[0017] The foamed raw material is molded to obtain a molded foam vascular plug.

[0018] Optionally, bio-adhesive is applied / sprayed onto the incompressible porous material, and then the incompressible porous material is placed into the first channel.

[0019] In one embodiment of this disclosure, a foam vascular plug is provided with two portions, a first portion and a second portion, with different cross-sectional areas. The larger first portion, when uncompressed, can block a blood vessel at a specific location, while the smaller second portion facilitates the movement of the foam vascular plug within the blood vessel when compressed. Therefore, the foam vascular plug of this disclosure exhibits strong sheath-passing performance, a high expansion rate, and a short expansion time, thus aiding in patient treatment. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the structure of a foam vascular plug before compression in one embodiment of this disclosure.

[0021] Figure 2 This is a schematic diagram of the structure of a foam vascular plug after compression in one embodiment of this disclosure.

[0022] Figure 3 This is a schematic diagram of the structure of a foam vascular plug after it is inserted into a blood vessel in one embodiment of this disclosure.

[0023] Figure 4 This is a schematic diagram of the structure of the foam vascular plug in Embodiment 1 of this disclosure.

[0024] Figure 5 This is a schematic diagram of the structure of the foam vascular plug in Embodiment 2 of this disclosure.

[0025] Figure 6 This is a schematic diagram of the structure of a foam vascular plug before compression in another embodiment of this disclosure.

[0026] Figure 7 This is a schematic diagram of the structure of the foam vascular plug in Embodiment 3 of this disclosure.

[0027] Figure 8 This is a schematic diagram of the structure of the foam vascular plug before compression in another embodiment of this disclosure.

[0028] Figure 9 This is a schematic diagram of the structure of the foam vascular plug in Embodiment 4 of this disclosure.

[0029] Figure 10 This is a schematic diagram of the structure of the foam vascular plug in Embodiment 5 of this disclosure.

[0030] Figure 11 This is a schematic diagram of the structure of the foam vascular plug before compression in another embodiment of the present disclosure.

[0031] The diagram is labeled as follows: 100, Part 1; 110, First Channel; 200, Part 2; 300, Part 3; 400, Part 4; 310, Second Channel; Z, Axial. Detailed Implementation

[0032] To better understand and implement this application, the technical solutions in this application will be clearly and completely described below with reference to the accompanying drawings.

[0033] In the description of this application, it should be noted that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "far", "near", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0035] First, this disclosure provides a foam vascular plug, including a first portion 100 and a second portion 200 connected to each other, wherein the cross-sectional area of ​​the first portion 100 in a cross section perpendicular to the axial direction Z is greater than the cross-sectional area of ​​the second portion 200 in a cross section perpendicular to the axial direction Z, wherein the first portion 100 is made of deformable foam material, the second portion 200 is made of deformable foam material, and a first channel 110 is formed in the first portion 100; the first channel 110 communicates with the outside and / or the first channel 110 extends into the second portion 200.

[0036] like Figure 1 As shown, the vascular plug is composed of a first part 100 and a second part 200 alternately arranged along the Z-axis. The first part 100 has a near-cylindrical structure, and the second part 200 has a near-cylindrical structure. The diameter of the cross-section of the first part 100 is 2-6 times the diameter of the cross-section of the second part 200, so that the cross-sectional area of ​​the first part 100 perpendicular to the Z-axis is greater than the cross-sectional area of ​​the second part 200 perpendicular to the Z-axis. Specifically, the cross-sectional dimension of the second part 200 is approximately smaller than the blood vessel to be inserted, but the cross-sectional dimension of the first part 100 is larger than the blood vessel to be inserted.

[0037] When inserting a vascular plug to the intended position, the blood vessel may be tortuous and difficult to pass through. Therefore, this disclosure uses a foam vascular plug made of foam material, which allows medical personnel to compress the foam vascular plug for insertion into the blood vessel. As the foam vascular plug of this disclosure meanders through the blood vessel, because the second part 200 is smaller than or close to the blood vessel to be passed through, its degree of compression after entering the blood vessel is low. Therefore, when the foam vascular plug passes through the blood vessel, there is still a certain gap between the foam vascular plug and the blood vessel, making it easier for the foam vascular plug to pass through the tortuous blood vessel and reach the intended position.

[0038] For ease of understanding, this disclosure provides schematic diagrams of the foam vascular plug before and after compression. For example... Figure 1 As shown, before the foam vascular plug is compressed, its shape is as follows: Figure 1 As shown. When compressed, the foam vascular plug becomes Figure 2 As shown. At this point, the first part 100 is significantly compressed, while the second part 200 is not compressed, or only slightly compressed. Therefore, the second part 200 of the compressed foam vascular plug still retains some deformation space, allowing it to deform relatively easily. Consequently, under external force, it can move along potentially meandering blood vessels. For details, please refer to... Figure 3 .

[0039] Upon reaching the predetermined location, since this disclosure uses a foam vascular plug, with both the first part 100 and the second part 200 being made of foam material, water in the blood can diffuse into the foam components of the foam vascular plug, causing the foam vascular plug to return to its initial shape and complete the embolization of the blood vessel.

[0040] It should be noted that both the first part 100 and the second part 200 are deformable foam materials. The foam material in the first part 100 has a porous structure, allowing liquid to pass through its channels under normal circumstances. However, when the first part 100 is compressed, some of the originally unobstructed channels may close, or the flow rate may become extremely low, thus affecting the recovery of the first part 100 and preventing it from returning to its original size for a long time, thus impacting treatment. Therefore, a first channel 110 is formed in the first part 100, which communicates with the outside and / or extends into the second part 200, as detailed below. Figures 9-11 As shown.

[0041] Specifically, when the first channel 110 is connected to the outside, fluid from the blood can enter the first part 100 through the first channel 110, and then reach various locations within the first part 100 through its porous structure, thereby allowing the first part 100 to expand and recover, achieving the effect of vascular obstruction. It should be noted that the first channel 110 should be connected to the pores of the porous structure of the first part 100, allowing fluid from the blood to enter and exit the pores of the porous structure, thus enabling the first part 100 to recover.

[0042] When the first channel 110 is connected to the second part 200, external moisture can enter the first channel 110 through the porous structure of the second part 200, and then enter the porous structure of the first part 100 through the first channel 110, thereby allowing the first part 100 to expand and recover. It should be noted that since the second part 200 has not been compressed or has only undergone minor compression deformation, most of the porous structure channels of the second part 200 are not closed, so external moisture can also easily enter the second part 200.

[0043] When the first portion 100 is compressed, the first channel 110 of the first portion 100 may also partially close, preventing liquid flow and thus affecting the recovery of the first portion 100. Therefore, in some embodiments, an incompressible porous material, such as incompressible PLA (Polylactic Acid) porous filler, is provided in the first channel 110 so that the first channel 110 will not be compressed when the first portion 100 is compressed. This ensures that the liquid can flow from the pores of the incompressible porous material to all locations of the first portion 100 as much as possible, allowing each location of the first portion 100 to contact and absorb the liquid and recover its original shape as soon as possible.

[0044] Furthermore, to prevent the incompressible porous material from leaving the first channel 110, it can be fixed within the first channel 110 using bio-adhesive. It should be noted that when using bio-adhesive for fixation, it can be simply distributed onto a localized surface of the incompressible porous material by spraying or using a tool. It should also be noted that in some embodiments, the foam vascular plug is inserted into a specific location on the blood vessel via a sheath; therefore, the incompressible material is less likely to flow out under the influence of the sheath. Therefore, in some optional embodiments, the size of the first channel and the size of the incompressible porous material can be set such that the size of the incompressible porous material is slightly larger than the first channel, allowing it to be inserted into the first channel.

[0045] Optionally, the first part 100 is made of a biodegradable and deformable foam material, the second part 200 is made of a biodegradable and deformable foam material, and the first channel 110 is provided with an incompressible biodegradable porous material. Specifically, the materials of the first part 100 and the second part 200 are one or more of polyurethane foam, polycaprolactone foam, polylactide foam, polytrimethylene carbonate foam, polydodecylglycerol foam, and poly(ω-pentadecanolactone) foam. Furthermore, the foam material disclosed herein is a shape memory foam, meaning that the compressed foam material can restore its shape after absorbing liquid.

[0046] Optionally, the first part 100 forms multiple first channels 110, and the first channels 110 are straight. The size of the first channels 110 is greater than 1000 micrometers, and the pore size of the foam material is 50-3000 micrometers. It should be noted that the shape of each channel in a single foam material is not uniform, but rather varies. For example, in all the channels of a certain foam material, most channels have a pore size of only 100 micrometers, while a small portion of the channels have a pore size of 3000 micrometers. However, the uneven distribution of large-diameter channels may not meet the requirements. Therefore, this disclosure provides first channels 110 to penetrate into the interior of the first part 100, so as to provide more stable moisture to each region of the first part 100.

[0047] In addition, the first channel 110 can also be a branched type, that is, it has multiple branch channels.

[0048] Optionally, when uncompressed, the span of the first part 100 in the cross-section is 2-5 times the span of the second part 200 in the cross-section. Specifically, to avoid excessive compression of the first part 100, which would result in extremely slow recovery, in some optional embodiments, the height of the first part 100 is compressed or the compression ratio does not exceed 5 times. That is, if the span of the first part 100 in the cross-section was originally 10mm, then after compression, it should preferably not be less than 2mm.

[0049] Optionally, the foam vascular plug includes a first portion 100 and a second portion 200 alternately arranged along the Z-axis, or the foam vascular plug further includes a third portion 300, which is connected to the first portion 100 via the second portion 200, and the third portion 300 is made of deformable foam material, and a second channel 310 is formed in the third portion 300; the second channel 310 communicates with the outside and / or the second channel 310 extends into the second portion 200. The foam vascular plug can have various shapes, which will be described in conjunction with specific drawings.

[0050] like Figure 1 As shown, in some embodiments, the foam vascular plug can be formed by alternating first portions 100 and second portions 200 along the Z-axis. Specifically, the foam vascular plug includes four semi-cylindrical first portions 100 and three semi-cylindrical second portions 200, with the first portions 100 and second portions 200 alternating. The diameter of the first portion 100 is 15 mm, the diameter of the second portion 200 is 5 mm, and the total length of the foam vascular plug along the Z-axis is 25 mm. Specifically, the length of each first portion 100 along the Z-axis is 4 mm, and the length of each second portion 200 along the Z-axis is 3 mm.

[0051] like Figure 4As shown, in some embodiments, the foam vascular plug is formed by sequentially connecting the third portion 300 on the left, the first second portion 200, the first first portion 100, the second second portion 200, the second first portion 100, the third second portion 200, and the third portion 300 on the right along the axial direction Z. The diameter of the first portion 100 is 15 mm, the diameter of the third portion 300 is 7 mm, the diameter of the second portion 200 is 5 mm, the length of each first portion 100 along the axial direction Z is 5 mm, the length of each second portion 200 along the axial direction Z is 3 mm, and the length of each third portion 300 along the axial direction Z is 3 mm.

[0052] like Figure 5 As shown, in some embodiments, the foam vascular plug is composed of a first portion 100 on the left, a first second portion 200, a first third portion 300, a second second portion 200, a second third portion 300, a third second portion 200, and a first portion 100 on the right. The diameter of the first portion 100 is 15 mm, the diameter of the third portion 300 is 7 mm, the diameter of the second portion 200 is 5 mm, the length of each first portion 100 along the Z-axis is 5 mm, the length of each second portion 200 along the Z-axis is 3 mm, and the length of each third portion 300 along the Z-axis is 3 mm.

[0053] Furthermore, in some embodiments, such as Figure 6 As shown, the foam vascular plug consists of a third part 300 on the left, a first second part 200, a first first part 100, a second second part 200, a second third part 300, a third second part 200, and a first part 100 on the right. The diameter of the first part 100 is 15 mm, the diameter of the third part 300 is 7 mm, the diameter of the second part 200 is 5 mm, and the total length of the foam vascular plug along the Z-axis is 25 mm. Each first part 100 has a length of 5 mm along the Z-axis, each second part 200 has a length of 3 mm along the Z-axis, and each third part 300 has a length of 3 mm along the Z-axis.

[0054] Furthermore, in some embodiments, such as Figure 7As shown, the foam vascular plug may further include a fourth part 400. Specifically, the first part 100 is located in the middle, and the third part 300 and the fourth part 400 are located on both sides. Specifically, two fourth parts are located on the left and right sides respectively, and two third parts 300 are located between the first part 100 and the left fourth part 400, and between the first part 100 and the right fourth part 400, respectively. The outer diameters of the first part 100, the third part 300, and the fourth part 400 gradually decrease. Multiple second parts 200 are located between the first part 100 and the third part 300, and between the third part 300 and the fourth part 400, respectively. The maximum diameter of the first part 100 is 15 mm, the maximum diameter of the third part 300 is 12 mm, the maximum diameter of the fourth part 400 is 10 mm, the maximum diameter of the fourth part 400 is 5 mm, and the length of the entire foam vascular plug along the Z-axis is 25 mm. Each first part 100 has a length of 5mm along the Z-axis, each second part 200 has a length of 1mm along the Z-axis, each third part 300 has a length of 4mm along the Z-axis, and each fourth part 400 has a length of 4mm along the Z-axis.

[0055] In some embodiments, such as Figure 8 As shown, the foam vascular plug includes two first portions 100 and a second portion 200 located between the two first portions 100. The first portion 100 has a semi-circular structure, and the cross-sections of the two first portions 100 are arranged opposite each other, with the two cross-sections connected by the second portion 200. Each first portion 100 has a length of 10 mm along the Z-axis, and each second portion 200 has a length of 5 mm along the Z-axis.

[0056] To further test the effectiveness of the foam vascular plug, this disclosure also conducts tests on different embodiments. Specifically, the foam vascular plug is compressed to match the cross-section of the second part 200, that is, its cross-section is compressed to approximately a circle with a diameter of 5 mm, ensuring that the compressed volume is approximately the same. Then, it is immersed in water to test the time required for it to fully expand (i.e., return to its original shape).

[0057]

[0058] Meanwhile, this disclosure also provides a control group, which uses cylindrical polyurethane foam with a diameter of 15 mm and a length of 25 mm. Testing revealed that its complete expansion time was 23.3 ± 2.1 min (23.3 mm is the average value of the embodiments, and ± 2.1 min is determined by the value with the largest difference from the average value in the experimental data), significantly longer than the embodiments described above. Specifically, firstly, since this application includes a second part 200, which is not compressed or only minimally compressed when entering the blood vessel, the porous structure of the second part 200 is not blocked by compression. Therefore, water in the blood vessel can quickly enter the second part 200. Furthermore, since the second part 200 is connected to the first part 100, water in the second part 200 can also gradually enter the first part 100 through the area connected to it, allowing the foam vascular plug of this disclosure to recover its original shape more quickly.

[0059] It should be noted that, due to the limited contact area between the second part 200 and the first part 100, the area of ​​the first part 100 closer to the second part 200 recovers quickly, while the area of ​​the first part 100 farther from the second part 200 may recover slowly. Therefore, a first channel 110 can be provided in the first part 100 to facilitate the absorption of external blood. Specifically, the first channel 110 can be provided on the side of the first part 100 away from the second part 200 to accelerate contact with external blood.

[0060] In addition, it should also be noted that medical staff may choose to use foam vascular plugs with a first channel 110 or foam vascular plugs without a first channel 110, depending on the situation.

[0061] Furthermore, this disclosure also provides a method for preparing a foam vascular plug, used to prepare the vascular plug in any of the above embodiments, wherein the method includes:

[0062] Step S1. Foam the raw materials;

[0063] Step S2. The foamed raw material is molded to obtain the molded foam vascular plug.

[0064] The raw materials disclosed herein are diverse. Taking the preparation of polyurethane foam as an example, the core raw materials are isocyanate and polyether polyol. Halogenated olefins can also be added as foaming agents, and dibutyltin dilaurate can be used as a catalyst to catalyze the process, ultimately yielding polyurethane foam.

[0065] When preparing polycaprolactone foam, polylactide foam, polytrimethylene carbonate foam, polydodecaneglyceride foam, and poly(ω-pentadecanolactone) foam, polymers are used as the main raw materials, and inorganic salts (NaCl / KCl) are used as pore-forming agents. The foam is prepared by solvent dissolution / heating and melting.

[0066] Taking the preparation of lactide foam as an example: using polylactide as the core raw material, substances that modify PLA are added, such as multifunctional epoxy chain extenders (BASF SE's Joncryl is the most commonly used commercial product), peroxides (lauroyl peroxide, dicumyl peroxide), maleic anhydride, oxazoline, etc.

[0067] Finally, the foamed material, such as polyurethane foam, can be laser-formed to obtain a foam vascular plug. It should be noted that there are various methods for forming the foamed material. In some alternative embodiments, the foamed material can be placed into a mold for shaping to obtain the molded foam vascular plug.

[0068] Optionally, a bio-adhesive (e.g., methyl α-cyanoacrylate, fibrin glue) is applied / sprayed onto an incompressible porous material (e.g., PLA porous material) before placing the incompressible porous material into the first channel 110. During the application process, the user can simply use a tool to spray the bio-adhesive onto a portion of the outer surface of the incompressible porous material to avoid immersing the incompressible porous material in the bio-adhesive.

[0069] In using the foam vascular plug of this disclosure, medical personnel can compress the foam vascular plug before inserting it into the blood vessel. Then, with the aid of tools, the medical personnel can push the foam vascular plug along the blood vessel until it reaches the predetermined position. Finally, after reaching the predetermined position, the foam vascular plug expands upon contact with blood, causing the first portion 100 and / or the third portion 300 to return to their original size, thereby blocking the specific location for treatment.

[0070] This invention designs a shape-memory porous foam vascular plug. The main component of the vascular plug is shape-memory foam. This foam vascular plug can be compressed into a rod-shaped material in vitro. Due to the extremely high porosity of the foam, its volume compression ratio is extremely high. The compressed vascular plug can reach the lesion site through a thin delivery sheath, avoiding damage to tissues during delivery. After reaching the lesion site, water in the blood diffuses into the foam component of the vascular plug, enabling the foam to return to its initial shape and complete the embolization of the blood vessel.

[0071] First, the compressed foam vascular plug has an alternating distribution of soft segments (i.e., the second part 200) and hard segments (i.e., the compressed first part 100), which gives the vascular plug good bending performance. It can reach the lesion site at the distal end through tortuous blood vessels, significantly expanding the application range of foam vascular plugs.

[0072] Secondly, the main component of foam vascular plugs (biodegradable foam) has an extremely high compression ratio. However, the high compression ratio will make the surface of the compressed foam have a dense structure, which will prevent water molecules in the blood from diffusing into the foam. This will result in a longer foam expansion time and a risk of the vascular plug being displaced by blood flow.

[0073] Secondly, the compressed foam vascular plug disclosed herein contains an uncompressed porous foam portion (i.e., the second portion 200), through which water molecules can rapidly diffuse into the interior of the foam vascular plug, accelerating the shape recovery of the vascular plug, achieving rapid and immediate embolization, avoiding the problem of vascular plug displacement, reducing clinical risks, and shortening operation time.

[0074] Furthermore, the expansion time of the product can be adjusted by controlling the ratio and distribution of different diameters in the foam vascular plug to adapt to vascular embolism under various hemodynamic conditions.

[0075] Furthermore, by designing a first channel 110 on the foam, this disclosure further regulates the diffusion rate of water, and can effectively prepare vascular plugs suitable for various application scenarios.

[0076] To more clearly illustrate the technical solutions disclosed herein, the technical means of this application are not limited to those disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be noted that those skilled in the art can make several improvements and modifications without departing from the principles of this application, and these improvements and modifications are also considered within the scope of protection of this application.

Claims

1. A foam vascular plug, characterized in that, It includes a first part and a second part that are connected to each other, and the cross-sectional area of ​​the first part in a cross section perpendicular to the axial direction is greater than the cross-sectional area of ​​the second part in a cross section perpendicular to the axial direction, wherein the material of the first part is a deformable foam material and the material of the second part is a deformable foam material. A first channel is formed in the first part; the first channel communicates with the outside and / or the first channel extends into the second part; The first channel is provided with an incompressible porous material.

2. The foam vascular plug according to claim 1, characterized in that, The first part is made of a biodegradable and deformable foam material, the second part is made of a biodegradable and deformable foam material, and the first channel is provided with the biodegradable incompressible porous material.

3. The foam vascular plug according to claim 1, characterized in that, The incompressible porous material is fixed in the first channel using medical bio-adhesive.

4. The foam vascular plug according to claim 1, characterized in that, The first part forms multiple first channels, and the first channels are straight. The size of the first channels is greater than 1000 micrometers, and the pore size of the foam material is 50~3000 micrometers.

5. The foam vascular plug according to claim 1, characterized in that, The foam vascular plug includes a first portion and a second portion alternately arranged along the axial direction; or The foam vascular plug further includes a third part, which is connected to the first part through the second part, and the third part is made of deformable foam material. A second channel is formed in the third part; the second channel is connected to the outside and / or the second channel extends into the second part.

6. The foam vascular plug according to any one of claims 1-5, characterized in that, The foam material is a porous material to allow liquid to pass through, and the foam material is a shape memory foam.

7. A method for preparing a foam vascular plug, for use in preparing the foam vascular plug according to any one of claims 1-6, characterized in that, include: The raw materials are foamed; The foamed raw material is molded to obtain a molded foam vascular plug.

8. The method for preparing foam vascular plugs according to claim 7, characterized in that, Bio-adhesive is applied / sprayed onto the incompressible porous material, and then the incompressible porous material is placed into the first channel.