A blood vessel occlusion device

Abstract

This utility model relates to a blood vessel occlusion device, which includes a support body, a membrane covering the support body and forming a hollow cavity with closed ends together with the support body, multiple isolation membranes arranged axially at intervals in the hollow cavity and dividing the hollow cavity into several independent chambers, and expansion particles filling each chamber. The membrane has several through holes that connect the hollow cavity to the external environment and allow water molecules to pass through. Water in the blood enters the hollow cavity through the through holes. The expansion particles inside absorb water in the blood and expand, thereby forming a stable and reliable support for the support body, making the device fit more closely to the blood vessel, effectively enhancing the anchoring performance of the device, and significantly reducing the risk of device displacement caused by blood flow impact. The isolation membranes divide the hollow cavity into several chambers, which can prevent the expansion particles from being unevenly distributed in the cavity.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a blood vessel occlusion device. Background Technology

[0002] In the medical field, blood vessels play a vital role in maintaining the normal physiological functions of human tissues, primarily transporting oxygen and nutrients to surrounding tissues via the bloodstream. However, when tissues become cancerous, tumor growth becomes highly dependent on the nutrients and oxygen supplied by blood vessels. Therefore, blocking the blood supply to tumors has become an important treatment strategy; that is, by sealing off the blood vessels supplying the tumor, the tumor tissue dies due to ischemia and hypoxia, thereby inhibiting or eliminating the tumor. Furthermore, when blood vessels rupture and bleed due to trauma, disease, or other factors, especially large vessel bleeding, rapidly blocking the blood flow proximal to the heart is a key means of controlling the bleeding.

[0003] Currently, commonly used vascular occlusion devices in clinical practice mainly fall into two categories: microspheres and coils. However, these devices still have significant drawbacks. Microspheres, due to their small size and high mobility, are prone to displacement under the impact of blood flow, leading to ectopic embolism in non-target vessels and causing serious complications such as ischemia of normal tissues or organ dysfunction. While coils offer some support, their front end has poor basket-like structure, making it difficult to form a stable anchoring structure within the vessel. They are also prone to displacement or detachment due to blood flow impact, posing a similar risk of ectopic embolism, affecting treatment efficacy and increasing clinical risks. Utility Model Content

[0004] The purpose of this invention is to provide a novel vascular occlusion device that improves vascular occlusion ability and prevents ectopic embolism caused by displacement due to vascular flushing.

[0005] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0006] This utility model provides a blood vessel occlusion device, which includes:

[0007] A support having a tubular structure extending along the axial direction;

[0008] A membrane is used to cover the support and together with the support, form a hollow cavity with closed ends. The membrane has several through holes that connect the hollow cavity to the external environment and allow water molecules to pass through.

[0009] A plurality of isolation diaphragms, having a plurality of axially spaced diaphragms arranged in the hollow cavity, the plurality of isolation diaphragms dividing the hollow cavity into several independent chambers; and

[0010] Expanding particles are filled in each of the chambers and configured to expand after absorbing water. The particle size of the expanding particles in the initial state is larger than the pore size of the through holes, and each of the chambers has a number of through holes in the corresponding coating area.

[0011] In some embodiments, the tubular structure includes a plurality of annular supports arranged axially. The annular supports provide better radial support.

[0012] In some embodiments, the annular support member is composed of a plurality of periodically arranged support rods, with adjacent support rods connected and forming an angle between them, and alternating peaks and troughs in the circumferential direction. At least a portion of the annular support member is a first annular support member, and some or all of the peaks of the first annular support member are supporting peaks, which are bent inward and connected to the isolation diaphragm; and / or, some or all of the troughs of the first annular support member are supporting troughs, which are bent inward and connected to the isolation diaphragm. The isolation diaphragm can be connected in accordance with existing technologies. For example, it can be fixed by hot melt welding, ultrasonic welding, biocompatible adhesive fixation, suture fixation, etc.

[0013] The present invention has the following advantages in setting support crests / valvees: First, as mechanical nodes of the annular support, the support crests / valvees have the best structural strength. Connecting the isolation diaphragm to these nodes can form a stable radial support frame, preventing the isolation diaphragm from rupturing during device release and the chamber from collapsing or shifting under the impact of blood. Second, the inwardly bent support crests / valvees can actively conform to the isolation diaphragm, reducing stress concentration on the diaphragm and extending its service life.

[0014] Furthermore, the angles at which the supporting peaks and supporting troughs bend inward are independently 5° to 80°, preferably 25° to 50°.

[0015] In some specific embodiments, when the crests of the first annular support member are only partially support crests, the support crests are distributed uniformly or non-uniformly along the circumference. Preferably, the support crests are distributed uniformly along the circumference.

[0016] In some specific embodiments, when the troughs of the first annular support are only partially support troughs, the support troughs are distributed uniformly or non-uniformly along the circumference. Preferably, the support troughs are distributed uniformly along the circumference.

[0017] In some specific embodiments, when only some of the annular supports are first annular supports and the rest are second annular supports, the first annular supports and the second annular supports are arranged alternately or in a manner that is at least one second annular support is spaced apart.

[0018] In some embodiments, some of the wave crests on the annular support are connected to the wave troughs of its adjacent annular support, and / or some of the wave troughs on the annular support are connected to the wave crests of its adjacent annular support.

[0019] In some embodiments, the tubular structure is formed from a mesh woven from metal wires.

[0020] In some embodiments, the support body further has end rods disposed at the proximal and distal ends of the tubular structure, with a plurality of end rods respectively connected to the proximal or distal end of the tubular structure, and the outer ends of the plurality of end rods converging and connecting together.

[0021] In some embodiments, the film covers the outer surface of the support.

[0022] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art:

[0023] After the vascular occlusion device of this invention is implanted into a human blood vessel, the through holes on its membrane allow water in the blood to enter the hollow cavity. The expansion particles in the hollow cavity expand after absorbing water in the blood, thereby forming a stable and reliable support for the support body, making the device fit more closely to the blood vessel, effectively enhancing the anchoring performance of the device, and significantly reducing the risk of device displacement caused by blood flow impact.

[0024] Furthermore, this invention also divides the hollow cavity into several chambers by setting an isolation membrane inside the hollow cavity. This not only prevents the expansion particles from being unevenly distributed within the cavity and avoids the problem of insufficient local support, but also allows for precise control of the radial support force in different areas of the same device by setting the number of expansion particles differently in different chambers. This meets the personalized adaptation requirements of different vascular anatomy structures and clinical needs. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of a blood vessel occlusion device provided in Example 1;

[0026] Figure 2 for Figure 1 A cross-sectional view of plane AA;

[0027] Figure 3 for Figure 1 Enlarged schematic diagram of part B in the middle;

[0028] Figure 4 A simplified structural diagram of the supporting peak and the insulating diaphragm provided in Example 1;

[0029] Wherein: 1. Support body; 11. Tubular structure; 111. Annular support; 1111. First annular support; 1112. Second annular support; 1113. Support rod; 1114. Crest; 1115. Trough; 1116. Support crest; 12. End rod;

[0030] 2. Coating; 3. Separating membrane; 4. Expanding particles; a. Angle. Detailed Implementation

[0031] The present invention will be further described below with reference to the embodiments shown in the accompanying drawings.

[0032] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the present invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0033] In the description of this application, it should be understood that "distal end" refers to the end of the instrument or component away from the operator, and "proximal end" refers to the end of the instrument or component closer to the operator; "axial direction" refers to the direction parallel to the line connecting the centers of the distal and proximal ends of the instrument or component; "inner" and "outer" are positions defined by distance relative to the center of the instrument or component, where "inner" is the position closer to the center of the instrument or component, and "outer" is the position away from the center of the instrument or component. The above description of directional terms is only for the convenience of describing the embodiments of the present invention and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of this utility model.

[0034] In the description of the embodiments of this utility model, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of this utility model, "multiple" means two or more, unless otherwise explicitly specified.

[0035] In this embodiment of the invention, unless otherwise expressly specified and limited, the first feature "on" or "under" the second feature may include direct contact between the first and second features, or contact between the first and second features not in direct contact but through another feature between them.

[0036] The following disclosure provides many different implementations or examples for different structures of the embodiments of the present invention. To simplify the disclosure of the embodiments of the present invention, specific examples of components and arrangements are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. Furthermore, reference numerals and / or reference letters may be repeated in different examples of the embodiments of the present invention; such repetition is for simplification and clarity and does not in itself indicate a relationship between the various implementations and / or arrangements discussed.

[0037] Example 1

[0038] A blood vessel occlusion device, such as Figures 1 to 4 As shown, it includes a support 1, a membrane 2, a separating membrane 3, and expanding particles 4. The support 1 has an axially extending tubular structure 11 adapted to a blood vessel. The membrane 2 covers the support 1 and together with the support 1 forms a hollow cavity closed at both ends. The membrane 2 has several through-holes (not shown in the figure) that connect the hollow cavity to the external environment and allow water molecules to pass through. Multiple separating membranes 3 are arranged axially at intervals within the hollow cavity, dividing the hollow cavity into several independent chambers. Expanding particles 4 fill each chamber and are configured to expand upon absorbing water. The particle size of the expanding particles 4 in the initial state is larger than the pore size of the through-holes to prevent leakage. Each chamber has several through-holes corresponding to the membrane 2 area.

[0039] After implantation, water from the blood enters the hollow cavity through the through-hole. The expanding particles 4 within the hollow cavity absorb water and expand, allowing the device to fit more tightly against the blood vessel, thus preventing displacement due to blood flow impact. However, due to blood flow impact, the expanding particles 4 are prone to displacement and aggregation during expansion, leading to uneven occlusion. Axially distributed isolation membranes 3 divide the hollow cavity into multiple independent chambers, each containing only a limited number of expanding particles 4. This physically blocks the possibility of long-distance migration of particles with the blood flow, avoiding insufficient local support. Furthermore, by varying the number of expanding particles 4 in different chambers, precise control of radial support in different areas of the same device can be achieved, thus meeting personalized adaptation requirements for different vascular anatomy and clinical needs. In this embodiment, the number of expanding particles 4 in several independent chambers is equal or substantially equal. "Substantially equal" means that the difference in mass or volume of expanding particles 4 between chambers should be ≤10% (based on the average content of a single chamber). In some other embodiments, the number of expanding particles 4 in several independent chambers is set to be unequal. The material of the expanding particles 4 can refer to the prior art; for example, it is a superabsorbent polymer, such as polyacrylic acid or polyvinyl alcohol.

[0040] The tubular structure 11 can be formed by multiple annular supports 111 arranged axially, or by a mesh woven from metal wires. In this embodiment, the tubular structure 11 includes multiple annular supports 111 arranged axially. Compared to a mesh woven from metal wires, the annular supports 111 have stronger radial support force and can better conform to blood vessels. The following detailed discussion uses one of the annular supports 111 as an example.

[0041] The annular support 111 is composed of a plurality of periodically arranged support rods 1113, with adjacent support rods 1113 connected and forming an included angle α, and alternating peaks 1114 and troughs 1115 in the circumferential direction. The support rods 1113 are preferably metal support rods 1113, such as nickel-titanium alloy rods. At least a portion of the annular support 111 is a first annular support 1111, and some or all of the peaks 1114 of the first annular support 1111 are supporting peaks 1116, which are bent inward and connected to an isolation diaphragm 3; and / or, some or all of the troughs 1115 of the first annular support 1111 are supporting troughs, which are bent inward and connected to an isolation diaphragm 3. The isolation diaphragm 3 can be connected in a manner consistent with existing technology; for example, it can be fixed by hot-melt welding, ultrasonic welding, biocompatible adhesive fixation, suture fixation, etc.

[0042] In this embodiment, some of the annular support members 111 are first annular support members 1111, and the rest are second annular support members 1112, with the first annular support members 1111 and the second annular support members 1112 arranged alternately. Some of the wave crests 1114 of the first annular support member 1111 are support wave crests 1116. The support wave crests 1116 are bent inwards and connected to the isolation diaphragm 3, and the support wave crests 1116 are evenly spaced circumferentially. The support wave crests 1116, as mechanical nodes of the annular support member 111, have optimal structural strength. Connecting the isolation diaphragm 3 to these crests forms a stable radial support frame, preventing the isolation diaphragm 3 from rupturing during device release and preventing the chamber from collapsing or shifting under the impact of blood. Furthermore, the inwardly bent support wave crests 1116 actively conform to the isolation diaphragm 3, reducing stress concentration on the diaphragm and extending its service life. In some other embodiments, the first annular support 1111 may not have a support peak 1116, but instead have a portion of the valleys 1115 as support valleys, with the support valleys bent inwards and connected to the isolation diaphragm 3. Alternatively, the first annular support 1111 may have both a support peak 1116 and a support valley.

[0043] Furthermore, the inward bending angle of the support crest 1116 is 5° to 80°, preferably 25° to 50°. A portion of the crest 1114 on the annular support 111 is connected to the trough 1115 of its adjacent annular support 111, and a portion of the trough 1115 on the annular support 111 is connected to the crest 1114 of its adjacent annular support 111. This improves the connection stability of the tubular structure 11.

[0044] The support 1 also has end rods 12 disposed at the proximal and distal ends of the tubular structure 11. Multiple end rods 12 are connected to the proximal or distal end of the tubular structure 11, and the outer ends of these multiple end rods 12 converge and connect together. Preferably, a membrane 2 covers the outer surface of the support 1, and the covering method refers to existing technologies, including but not limited to adhesive fixation, heat pressing fixation, or sew fixation. The material of the membrane 2 can also refer to existing technologies. For example, it can be a synthetic polymer material, such as expanded polytetrafluoroethylene, polyurethane, or polyester fiber; it can also be a natural biological material, such as decellularized matrix or silk fibroin; or it can be a composite material. The material of the isolation membrane 3 may be the same as or different from that of the membrane 2, depending on actual needs.

[0045] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A vascular occlusion device, comprising: include: Support (1), which has a tubular structure (11) extending along the axial direction; A membrane (2) is wrapped around the support (1) and together with the support (1) forms a hollow cavity with closed ends. The membrane (2) has several through holes that connect the hollow cavity to the external environment and allow water molecules to pass through. A plurality of isolation diaphragms (3) are arranged axially at intervals in the hollow cavity, the plurality of isolation diaphragms (3) dividing the hollow cavity into several independent chambers; and, Expanding particles (4) are filled in each of the chambers and configured to expand after absorbing water. The particle size of the expanding particles (4) in the initial state is larger than the pore size of the through holes, and each of the chambers has a number of through holes in the membrane (2) area.

2. The blood vessel occlusion device according to claim 1, characterized in that, The tubular structure (11) includes a plurality of annular support members (111) arranged along the axial direction.

3. The blood vessel occlusion device according to claim 2, characterized in that, The annular support (111) is composed of a plurality of periodically arranged support rods (1113), with adjacent support rods (1113) connected and forming an angle between them, and alternating peaks (1114) and troughs (1115) in the circumferential direction. At least part of the annular support (111) is a first annular support (1111). Some or all of the peaks (1114) of the first annular support member (1111) are support peaks (1116), the support peaks (1116) are bent inward and connected to the isolation diaphragm (3); and / or, some or all of the troughs (1115) of the first annular support member (1111) are support troughs, the support troughs are bent inward and connected to the isolation diaphragm (3).

4. The blood vessel occlusion device according to claim 3, characterized in that, When the crest (1114) of the first annular support (1111) is only partially a support crest (1116), the support crest (1116) is evenly or non-uniformly distributed along the circumferential direction. And / or, when the troughs (1115) of the first annular support (1111) are only partially support troughs, the support troughs are distributed uniformly or non-uniformly along the circumferential direction; And / or, when only some of the annular supports (111) are first annular supports (1111), and the rest are second annular supports (1112), the first annular supports (1111) and the second annular supports (1112) are arranged alternately, or arranged in a manner that is at least one second annular support (1112) apart.

5. The blood vessel occlusion device according to claim 3, characterized in that, The angles at which the supporting peaks (1116) and supporting troughs bend inward are independently 5° to 80°.

6. The blood vessel occlusion device according to claim 5, characterized in that, The angles at which the supporting peaks (1116) and supporting troughs bend inward are independently 25° to 50°.

7. The blood vessel occlusion device according to claim 3, characterized in that, A portion of the wave crests (1114) on the annular support (111) are connected to the wave troughs (1115) of the adjacent annular support (111), and / or a portion of the wave troughs (1115) on the annular support (111) are connected to the wave crests (1114) of the adjacent annular support (111).

8. The blood vessel occlusion device according to claim 1, characterized in that, The tubular structure (11) is formed by a mesh woven from metal wires.

9. The blood vessel occlusion device according to claim 1, characterized in that, The support (1) also has end rods (12) disposed at the proximal and distal ends of the tubular structure (11), and the proximal or distal end of the tubular structure (11) is connected to a plurality of the end rods (12), and the outer ends of the plurality of end rods (12) converge and connect together.

10. The blood vessel occlusion device according to claim 1, characterized in that, The film (2) covers the outer side of the support (1).

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