Embolism assembly and embolism system for treating hemangioma

Abstract

The invention relates to an embolism assembly and an embolism system for treating hemangioma, the embolism assembly is provided with a far end and a near end which are opposite, the embolism assembly comprises an embolism part, the embolism part is made of shape memory polymer foam, and a threading channel is formed in the embolism part; the near end of the delivery shaft is an operating end, the far end of the delivery shaft is provided with a connecting section, the connecting section is detachably inserted into the threading channel, the connecting section is clamped when the embolism part is intervened and delivered after being loaded, and the connecting section is clamped when the embolism part is released. The connecting section is moved out of the threading channel, and the threading channel is sealed by the plug piece; the blocking net is fixed to the delivery shaft, the blocking net has a compressed state suitable for interventional delivery and a relative unfolded state, the blocking net is located on the near end side of the connecting section in the compressed state, and the blocking net is used for blocking the embolism piece in the unfolded state. Through the structural improvement of the plug part and the mutual cooperation of the plug part and the blocking net, a better positioning effect can be achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of vascular intervention treatment, in particular to an embolization assembly and system for treating hemangioma. BACKGROUND

[0002] Vascular occlusion devices made of high polymer materials have been applied in clinical intervention of various vascular diseases. Abnormal blood flow along a specific vascular path can easily cause pain, tissue necrosis, and even life-threatening thrombus or hemorrhagic complications. High polymer vascular occlusion devices can block the blood flow channel of the target blood vessel through minimally invasive means, and guide the blood to flow to a safe path, thereby achieving the treatment purpose. Currently, shape memory polymer (SMP) based minimally invasive vascular occlusion devices have become the core direction of research and application in this field. They have the characteristics of being delivered through a catheter and self-expanding in the body, which can significantly reduce the treatment trauma and reduce the incidence of postoperative complications. The shape memory performance and vascular occlusion performance of such foams are mainly achieved by monomer combination design and preparation process control. Typical polyurethane SMP foams are synthesized from N,N,N',N'-tetra (2-hydroxypropyl) ethylenediamine (HPED), triethanolamine (TEA) and hexamethylene diisocyanate (HDI) as basic raw materials. Some technical solutions also introduce trimethylhexamethylene diisocyanate (TMHDI) to adjust the hydrophobicity of the material, thereby adapting to the expansion requirements in different in vivo environments. However, such devices still have obvious technical limitations in clinical practice, which restricts the treatment effect and application safety. For example, the complete expansion period of polyurethane SMP foam is usually 2-10 minutes, which cannot fill the vascular lumen immediately after the catheter is released. During the expansion delay stage, the continuous blood flow impact is easy to push the incompletely fixed device away from the preset implantation position. When the hemangioma lumen volume is large or the opening size is wide, the incompletely fixed embolization piece is easy to be pushed away from the blood vessel wall under the continuous impact of blood flow, thereby causing serious safety risks. SUMMARY

[0003] The present application provides a vascular embolization system for treating hemangioma, which is more convenient to position and release the embolization piece, so as to overcome the position deviation problem of the embolization piece in the initial release stage.

[0004] The present application provides an embolization assembly for treating hemangioma, which has opposite distal and proximal ends, and comprises: An embolization piece made of shape memory polymer foam, a through channel is formed in the embolization piece; a delivery shaft, a proximal end of the delivery shaft being an operation end, a distal end of the delivery shaft having a connecting segment, the connecting segment being detachably inserted into the through channel, the plug member clamping the connecting segment when the plug member is loaded and is being intervened and delivered, the connecting segment being moved out of the through channel after the plug member is released, and the through channel being closed by the plug member itself; a barrier net fixed to the delivery shaft, the barrier net having a compressed state suitable for intervention and delivery and an opposite expanded state, the compressed state being located at a proximal end side of the connecting segment, and the expanded state being used to block the plug member.

[0005] The following also provides several optional modes, but not as an additional limitation to the above general scheme, just a further supplement or preferred, without technical or logical contradiction, each optional mode can be combined alone for the above general scheme, but also can be combined between multiple optional modes.

[0006] In one embodiment, the closure is sequentially composed of a compressed loading state, a limited expansion implantation state, and a fully expanded preset state according to the relative volume from small to large; The through channel penetrates the plug member in the axial direction, or is cut off inside the plug member, and the plug member clamps the connecting segment in the loading state; In the preset state, the through channel is completely closed or at least partially open, and the open part is closed by the plug member itself under the extrusion of the surrounding tissue in the implantation state.

[0007] In one embodiment, the connecting segment has one or multiple radially expanded outer convex parts; In the loading state, at least one of the outer convex parts is located at the proximal end side of the plug member; In the preset state, the outer convex part is in interference fit with the through channel.

[0008] In one embodiment, the outer convex part includes: A first outer convex part located at the proximal end side of the plug member; A second outer convex part located inside the through channel; Both the first outer convex part and the second outer convex part have a radiographic marker.

[0009] In one embodiment, the barrier net includes multiple unit arms radially distributed around the delivery shaft, the number of unit arms being three to eight.

[0010] In one embodiment, in the axial view of the delivery shaft, the unit arm is in a straight rod shape, an S shape, or is annular by itself in the expanded state.

[0011] In one embodiment, each of the unit arms does not overlap with each other in the expanded state along the axial view of the delivery shaft.

[0012] In one embodiment, each of the unit arms is independently configured, and the end of at least one of the unit arms is provided with a visualization marker.

[0013] In one embodiment, one end of the unit arm is fixed to the delivery shaft, and the other end of the unit arm extends to the distal side and the extension length is adapted to the embolic member in the compressed state and the loaded state; or One end of the unit arm is fixed to the delivery shaft, and the fixed part is adapted to the embolic member in the loaded state, and the other end of the unit arm extends to the proximal side.

[0014] The application also provides an embolization system for treating hemangioma, comprising an interventional catheter and an embolic assembly as described in the application, wherein the embolic assembly is loaded in the interventional catheter.

[0015] The application also provides a method for loading an embolic member, comprising: providing an embolization system as described in the application; extending the connecting section of the delivery shaft into the lead-through passage of the embolic member; compressing the embolic member and folding the barrier net to the compressed state; loading the delivery shaft together with the embolic member and the barrier net into the interventional catheter.

[0016] In the application, through the structural improvement of the embolic member and the cooperation with the barrier net, the positioning of the embolic member can be realized in the initial release stage through the cooperation of the delivery shaft and the barrier net, the deviation of the expected posture or implantation position under the action of blood flow is avoided, the safety hidden danger is further reduced, and the treatment effect is ensured. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without creative labor.

[0018] Figure 1 It is a schematic diagram of the position deviation of the embolic member in the hemangioma in the prior art; Figure 2 It is a schematic diagram of another position deviation of the embolic member in the hemangioma in the prior art; Figure 3 It is a schematic diagram of an embolization system in one embodiment of the application; Figure 4 Structural comparison of the embolization member in different states in an embodiment of the present application; Figure 5 Structural comparison of the embolization member in different states in another embodiment of the present application; Figure 6 Schematic diagram of the embolization assembly in another embodiment of the present application; Figure 7 Schematic diagram of the embolization assembly in another embodiment of the present application; Figure 8 Schematic diagram of the barrier net in an embodiment of the present application; Figure 9 Schematic diagram of the barrier net in another embodiment of the present application; Figure 10 Schematic diagram of the barrier net in an embodiment of the present application; Figure 11 Schematic diagram of the barrier net in another embodiment of the present application; Figure 12 Schematic diagram of the embolization system in an embodiment of the present application for interventional delivery; Figure 13 Schematic diagram of the embolization member in Figure 12 after being pushed and starting to be exposed to the interventional catheter; Figure 14 Schematic diagram of the embolization member in Figure 13 after being completely exposed and positioned by the delivery shaft; Figure 15 Schematic diagram of the barrier net in Figure 14 after being released; Figure 16 Schematic diagram of the embolization member in Figure 15 after being completely released; Figure 17 Schematic diagram of the interventional catheter, the delivery shaft and the barrier net in Figure 16 after being withdrawn; Figure 18 Schematic diagram of the embolization system in another embodiment of the present application; Figure 19 Schematic diagram of the embolization member in Figure 18 during the release process; Figure 20 Schematic diagram of the embolization member in Figure 18 after being fitted with a sheath.

[0019] The component reference numbers are as follows: 100, blood vessel; 110, hemangioma; 111, lumen; 112, opening; 200, embolization member; 210, lead-through passage; 300, interventional catheter; 310, first imaging marker; 400, delivery shaft; 410, connecting section; 420, second developing mark; 430, outer convex portion; 440, collar; 441, step structure; 500, blocking net; 510, unit arm; 511, third developing mark; 600, sheath. DETAILED DESCRIPTION

[0020] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, a lot of specific details are set forth in order to fully understand the present application. However, the present application can be implemented in many different ways other than those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0021] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there can be a middle component. When a component is referred to as being "connected to" another component, it can be directly connected to the other component or there can be a middle component. The terms "vertical", "horizontal", "up", "down", "left", "right", and similar expressions used in the description of the present application are for the purpose of illustration only and do not indicate the only implementation.

[0022] In addition, the terms "first", "second", etc. are used only for the purpose of description and should not be understood as indicating or implying relative importance or implying the number of the indicated technical features. Therefore, the features defined as "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically limited.

[0023] Unless otherwise defined, all technical and scientific terms used in the specification of the present application have the same meaning as understood by those skilled in the art to which the present application belongs. The terms used in the specification of the present application are only for the purpose of describing the specific embodiments and are not intended to limit the present application. The term "and / or" used in the specification of the present application includes any and all combinations of one or more related listed items.

[0024] Reference is made to Figure 1 , Figure 2For the treatment of hemangioma 110, polyurethane SMP foam can be used as embolic member 200, which is generally pre-compressed and loaded in interventional catheter 300, and delivered in vivo through interventional catheter 300, delivery shaft 400 can generally be in the form of a guide wire capable of bearing axial pushing force, delivery shaft 400 extends in interventional catheter 300 and its distal end is adjacent to embolic member 200, after reaching the predetermined implantation position, interventional catheter 300 is kept at the current position, and delivery shaft 400 is pushed distally, and then embolic member 200 is pushed out of the distal end of interventional catheter 300 and exposed in the lumen 111 of hemangioma 110, but embolic member 200 will not immediately expand to block and anchor in lumen 111, and may be pushed out of opening 112 by the action of blood flow, deviating from the predetermined implantation position and causing safety hazards, or turning over and not meeting the expected spatial attitude, making it difficult to ensure the blocking effect. The dashed line in the figure is the initial position or attitude of embolic member 200 in lumen 111, which slightly expands to the solid line filling area after being released from interventional catheter 300 and the position or attitude deviates.

[0025] To solve the positioning problem of embolic member at the initial release stage, an embodiment of the present application provides an embolic assembly and an embolic system for treating hemangioma, which has opposite distal and proximal ends, the proximal end generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the opposite side, along the interventional path, each component has opposite distal and proximal ends; when the proximal and distal ends are in a straight line, the axial direction is also determined, and the radial direction perpendicular to the axial direction and the circumferential direction around the axial direction are also determined; when used to refer to a structure, "end" in the text represents the end point of the structure or a certain point or area in that direction or a specific structure connected to the point or area.

[0026] Referring to Figures 3-5 The embolic assembly of the embodiment includes embolic member 200, delivery shaft 400 and blocking net 500, based on the embolic member 200 itself, it can be understood that the present application also provides an embolic member 200 for vascular occlusion, further combined with interventional catheter 300, it can be understood that the present application also provides an embolic system, in the following method description, it can be understood that the present application also provides a method for loading embolic member 200.

[0027] The embolus 200 itself can adopt a shape memory polymer foam, and its material and preparation can be implemented in combination with the prior art, such as polyurethane memory foam, etc. At a relatively low temperature, such as around 0 degrees Celsius, it can maintain the current shape of being molded, and it can expand to the preset state when it encounters water and / or the body temperature in the body. For example, the polyurethane shape memory foam disclosed in Chinese Patent Document CN120550217A can be combined to prepare a polyurethane acrylate prepolymer using a macromolecular polyol, a diisocyanate, a chain extender containing a disulfide bond, other small molecule chain extenders, and an acrylate end-capping agent. Then, the polyurethane acrylate prepolymer, an acrylate monomer diluent, a foaming agent, a foaming aid, a photoinitiator, and a high-boiling-point solvent are uniformly mixed to form a first foaming liquid. The first foaming liquid is then subjected to light curing and foaming in sequence to obtain a solid foam, and the expansion rate of the solid foam can be 100-150 times.

[0028] In some embodiments, the embolus 200 is degradable, further highlighting biocompatibility and safety. The embolus 200 is block-shaped, but its overall shape is not strictly limited, and it can be adaptively processed according to the physiological structure of the site to be plugged, such as being cylindrical, circular truncated cone, spherical, ellipsoidal, or even various special shapes after complete expansion. When referring to the outer diameter, it can be understood as an example of a cylindrical shape, and when the cross-section is of another shape, it can be converted to the diameter corresponding to the circle of equal area.

[0029] The interventional catheter 300 is used to accommodate the embolus 200 in the loaded state. The interventional catheter 300 can be made of existing materials and is suitable for interventional delivery. The inner wall of the interventional catheter 300 can have a lubricating layer. An operating handle can be provided at the proximal end of the interventional catheter 300 as needed. The interventional catheter 300 can also be configured with a bending mechanism to adapt to a complex and winding access path. The direction of the distal end of the interventional catheter 300 can be changed by a corresponding driving mechanism on the operating handle. The distal end of the interventional catheter 300 can be provided with a ring-shaped first imaging marker 310.

[0030] The interior of the embolus 200 is a porous structure, so its volume can be changed by compression to adapt to loading and delivery through a catheter. In the body, it can expand and occupy the space of the implantation site to achieve the plugging effect. During use, the relative volume generally increases in the following order according to the common state: a compressed loading state, for example Figure 3 being accommodated in the interventional catheter 300 for interventional delivery; a restricted expansion implantation state, for example Figure 4 In the case of a blood vessel 100, the restriction can be understood as being slightly compressed under the action of the blood vessel wall. Since it has a tendency to further expand, there is an interaction force between it and the blood vessel wall, and it is tensioned and maintained at the implantation site; The preset state is the fully expanded state, which can be understood as the maximum volume of the embolus 200 that can be expanded without being squeezed by the surrounding.

[0031] The preset state can be 50-100 times the volume of the loaded state, and in some cases, the axial length of the embolus in the preset state and the loaded state is substantially unchanged, only the radial outer expansion, the outer diameter can be expanded by about 10 times.

[0032] The embolus 200 in the embodiment is provided with a through channel 210 for the delivery shaft 400 to extend into. After loading, the delivery shaft 400 extends in the interventional catheter 300, the proximal end of the delivery shaft 400 is the operation end, which can extend out of the proximal end of the interventional catheter 300, for example, the control end can be independently operated, or can be connected and controlled by the operation handle. The distal end of the delivery shaft 400 has a connecting section 410, which extends into the through channel 210 and is clamped by the embolus 200 in the loaded state. Unlike the distal end position of the delivery shaft 400 in the prior art (on the proximal end side of the embolus 200), the connecting section 410 of the delivery shaft 400 in the embodiment extends into the embolus 200 and is clamped by the embolus 200 after loading.

[0033] When the embolus 200 is released, the connecting section 410 and the embolus 200 extend out of the interventional catheter 300 and are positioned at the implantation site. After the embolus 200 is expanded to the implantation state and positioned at the implantation site, the connecting section 410 moves proximally out of the through channel 210, and the through channel 210 is squeezed and closed by the deformation of the embolus 200 itself.

[0034] In the preset state, the cross-sectional shape of the through channel 210 is strip-shaped, Y-shaped, U-shaped, cross-shaped, H-shaped, polygonal, circular or elliptical.

[0035] For example Figure 4 In some embodiments, the cross-sectional shape of the through channel 210 is approximately cross-shaped, Figure 5 In some embodiments, the cross-sectional shape of the through channel 210 is approximately elliptical, and the implantation state is further squeezed and deformed relative to the preset state. Therefore, the through channel 210 in the preset state can be partially open, which is more convenient for the connecting section 410 to extend in during loading, and the open part is squeezed by the surrounding tissue, such as the blood vessel 100, in the implantation state, and is closed by the embolus 200 itself to ensure the blocking effect. Further, after the release is completed, it is convenient to withdraw the delivery shaft 400 from the through channel, avoiding unintended displacement of the embolus 200. The through channel 210 in the preset state can also be completely closed.

[0036] In combination with Figure 4In one embodiment, one part of the plug 200 is taken as a reference part and has an outer diameter D1 of 3-15 mm in the implanted state. The reference part in the preset state has an outer diameter D2, and D2:D1=1.1-1.5:1. The appropriate ratio can make the plug 200 in the implanted state obtain a suitable friction in the blood vessel 100 to anchor its position, and also take into account the force between the delivery shaft 400.

[0037] The lead-through channel 210 penetrates the plug 200 in the axial direction, or stops at the inside of the plug 200, for example, at the middle region of the plug 200 in the axial direction, or at the position adjacent to the distal end of the plug 200, i.e. the lead-through channel 210 can be a blind hole penetrating or not penetrating in the axial direction. In the loaded state, the inner wall of the lead-through channel 210 can clasp the connecting section 410.

[0038] The lead-through channel 210 can have different extension trends or cross-sectional shape change trends, for example, in the preset state, the lead-through channel 210 extends linearly in the axial direction, or the cross-sectional shape has a change trend, in which at least one section of the lead-through channel 210 is further reduced in cross section relative to the adjacent part. For example, the cross-sectional area periodically changes in the axial direction. The lead-through channel 210 can also have a spiral extension trend or a middle wave undulation extension trend, which can better hold the delivery shaft 400 during the release process, i.e. when the plug 200 has not yet anchored itself.

[0039] In some embodiments, different parts of the connecting section 410 can be provided with corresponding second imaging markers 420, for example Figure 3 The connecting section 410 in the above embodiment is provided with three second imaging markers 420, for example, the distal end of the connecting section 410, between the plug 200 and the barrier net 500, and the proximal side of the barrier net are provided with the second imaging markers 420. The distal end of the connecting section 410 can extend out of the plug 200, or be approximately aligned with the distal end of the plug 200, or be inside the plug 200.

[0040] Referring to Figure 6 In another embodiment, in order to improve the binding force of the connecting section 410 and the plug 200 during the release process, the connecting section 410 is provided with a radially expanded outer convex part 430, which is one or multiple spaced-apart parts. For example, the outer convex part 430 is spherical, ellipsoidal or double-conical, etc.

[0041] For example, the outer diameter of the connection section 410 (non-outer convex portion) is 0.1-0.5 mm, and the outer diameter of the outer convex portion 430 is 0.6-1.0 mm. For example, in the preset state, the cross section of the threading channel 210 is circular, and the circular diameter is 0.5-0.8 mm. The outer diameter of the outer convex portion 430 is slightly larger than the cross section diameter of the threading channel 210, for example, the ratio of the outer diameter of the outer convex portion 430 to the cross section diameter of the threading channel 210 is 1.2-2:1. In the preset state, the outer convex portion 430 and the threading channel 210 are in interference fit.

[0042] The outer convex portion 430 itself can serve as a developing mark or the second developing mark 420 is arranged on the outer convex portion 430, which facilitates the identification of the current position of the connection section 410 in combination with the imaging device, so as to better guide the surgical process.

[0043] The plug member 200 is compressed in the radial gap between the interventional catheter 300 and the delivery shaft 400 in the loaded state, and at least one outer convex portion 430 is located on the proximal side of the plug member 200. When the plug member 200 is pushed to the distal end and released, the outer convex portion 430 facilitates force application on the proximal side of the plug member 200.

[0044] Referring to Figure 7 In another embodiment, compared with the embodiment of Figure 6 , the threading channel and the delivery shaft 400 do not pass through the plug member 200, and the distal end of the delivery shaft 400 is located at the middle of the plug member 200, which can reduce the length of the connection section 410 and avoid the safety risk of the distal end of the connection section 410 pricking the tissue.

[0045] In the prior art, polyurethane foam as a plug member is used in combination with metal components to implement anchoring or support, etc., but the degradation performance of the polyurethane foam and the metal components is difficult to be synchronized, which has a security risk. The plug member 200 in an embodiment of the present application is only composed of a shape memory polymer foam, i.e., does not contain metal components, which can solve the risk of degradation difference with the metal components in the prior art.

[0046] Referring to Figures 8-11 , the blocking net 500 can adopt a memory metal material, for example, a nickel-titanium alloy wire, which is pre-treated to obtain a shape corresponding to the expanded state, and tends to the expanded state after being released in the body. The blocking net 500 includes a plurality of unit arms 510 radially distributed on the outer periphery of the delivery shaft 400. In different embodiments, the number of unit arms 510 is three to eight, and the unit arms 510 can also be configured in different shapes.

[0047] In terms of each unit arm 510 itself, independent configuration is adopted, which can avoid mutual interference during loading and releasing, and is more widely applicable.

[0048] Figure 8In some embodiments, the unit arms 510 are straight rods in the expanded state, each with a third marker 511 at the end.

[0049] Figure 9 In some embodiments, the unit arms 510 are S-shaped in the expanded state.

[0050] Figure 10 In some embodiments, the unit arms 510 are annular in the expanded state, and are three-lobed in whole.

[0051] Figure 11 In some embodiments, the unit arms 510 are annular in the expanded state, and are five-lobed in whole.

[0052] In the above embodiments, the unit arms 510 do not overlap each other in the expanded state, avoiding occupying too much radial space in the compressed state. If viewed from the radial direction of the delivery shaft 400, the unit arms 510 can be expanded radially outward or curved to the distal end in an arc shape, or curved to the proximal end in an arc shape. One end of the unit arm 510 is fixed to the delivery shaft 400, for example, directly fixed, or fixed to the delivery shaft 400 through an annular hoop. The other end of the unit arm 510 extends to the distal end in the loaded state, and the extended end portion (with the third marker 511) is connected to the embolic device in the loaded state, which can make full use of the axial space. The extended end portion can also abut the embolic device in the loaded state, providing a distal pushing force when the embolic device is released.

[0053] Further referring to Figures 12-17 In an embodiment of the present application, the embolization system implements the following intervention delivery process: Figure 12 In some embodiments, the intervention catheter 300 carries the delivery shaft 400 and the embolic device 200 in the loaded state for delivery in the blood vessel 100, wherein the blocking net 500 is on the proximal side of the embolic device 200, the delivery shaft 400 extends into the through channel and extends to the middle of the embolic device 200. The distal end of the intervention catheter 300, the end of each unit arm, and the delivery shaft 400 can be provided with a marker, wherein three second markers 420 are provided on the delivery shaft 400 on the proximal side of the blocking net 500, the distal side of the embolic device 200, and between the blocking net 500 and the embolic device 200, and the delivery shaft 400 is clamped in the through channel 210 of the embolic device 200.

[0054] When the distal end of the intervention catheter 300 travels to the opening site of the angioma 110, the pointing direction can be changed by adjusting the bending to further extend into the angioma 110 along the direction of the arrow in Figure 12

[0055] Figure 13 ​In the embodiment, the distal end of the embolization member 200 is pushed to expose the distal end of the interventional catheter 300, and at this time, the distal end of the interventional catheter 300 is located in the middle region of the aneurysm 110.

[0056] Figure 14 In the embodiment, the embolization member 200 is separated from the interventional catheter 300 and located in the intended implantation position, and at this time, the blocking net has not been released, and although the volume of the embolization member 200 has not been expanded to the preset state, the embolization member 200 can be prevented from being dislocated under the action of the blood flow due to the fact that the embolization member 200 is still clamped on the outer periphery of the delivery shaft 400, that is, the embolization member 200 is positioned in the implantation position by the binding force of the delivery shaft 400.

[0057] In the process of changing from the loading state to the implantation state of the embolization member 200, the material in the peripheral region expands faster, and the expansion amplitude of the central region is relatively small, so that the binding force of the embolization member 200 to the delivery shaft 400 can be maintained through the central region in the initial stage of the release and expansion process of the embolization member 200, and the embolization member 200 can be prevented from being dislocated by the blood flow.

[0058] Figure 15 In the embodiment, the embolization member 200 is further expanded, and the binding force of the embolization member 200 to the delivery shaft 400 is further reduced, and in this process, the interventional catheter 300 is withdrawn proximally relative to the delivery shaft 400, so that the blocking net 500 is exposed and covers the opening of the aneurysm 110 in the expanded state, and the embolization member 200 can be prevented from slipping outwards, and since the delivery shaft 400 is still located in the guide channel, the spatial posture of the embolization member 200 can be prevented from being changed unexpectedly.

[0059] Figure 16 In the embodiment, the embolization member 200 is expanded to the implantation state and is positioned by friction against the inner wall of the aneurysm 110, and at this time, the binding force of the embolization member 200 to the delivery shaft 400 is further weakened, so that the delivery shaft 400 can be withdrawn to separate from the guide channel.

[0060] Figure 17 In the embodiment, the embolization member 200 is in the implantation state and the delivery shaft 400 has been moved out of the guide channel 210, and the embolization member 200 is maintained in the implantation state by the surrounding tissue and seals the guide channel 210 by itself. After the delivery shaft 400 and the blocking net 500 are withdrawn into the interventional catheter 300 and the interventional catheter 300 is withdrawn to the outside of the body, only the embolization member 200 remains in the implantation position.

[0061] Referring to Figure 18 In another embodiment of the present application, an embolization system is also provided, which is different from the above-mentioned embodiments in that one end of the unit arm 510 of the blocking net 500 is fixed to the delivery shaft 400 and the fixed position is adjacent to or connected to the embolization member 200 in the loading state, and the other end of the unit arm 510 extends to the proximal side.

[0062] Figure 18The two ends of the connecting section 410 matched with the plug 200 in the delivery shaft 400 are respectively provided with outer convex parts 430, and the two outer convex parts 430 and the part therebetween are developed as a whole, that is, as a development mark, which can be made of metal or high polymer material.

[0063] In addition, the delivery shaft 400 in the embodiment has a step structure 441 on the distal end side of the barrier net 500, and when the plug 200 is released, the step structure 441 can provide a distal end side abutting force to the plug 200. The part of the delivery shaft 400 on the proximal end side of the connecting section can have an overall outer diameter greater than that of the connecting section, and the variable diameter part where the two are connected forms the step structure 441. Alternatively, the delivery shaft 400 can be radially convex only on the distal end side of the barrier net 500, for example, a collar 440 is fixed thereon, and the distal end side of the collar 440 provides the step structure 441. Meanwhile, the unit arms 510 of the barrier net 500 can be fixedly connected to the collar 440, which is convenient for overall assembly to the delivery shaft 400. The collar 440 can be fixed to the delivery shaft 400 by welding or interference fit.

[0064] Referring to Figure 19 Since the fixed part of the barrier net 500 is close to the plug 200 in the delivery shaft 400, the barrier net 500 tends to be inside the hemangioma 110 after being released, further ensuring the interception effect. After the barrier net 500 is withdrawn, the part of the plug 200 interfered is further inflated to completely fill the inside of the hemangioma 110.

[0065] Referring to Figure 20 Before the plug 200 and the barrier net 500 are accommodated in the interventional catheter, in order to keep the plug 200 in the loading state and facilitate subsequent operation, a sheath 600 can be wrapped around the outer periphery of the plug 200. The sheath 600 also wraps the barrier net 500 and keeps it in a compressed state. The sheath 600 can be provided with a low-strength tear line or a tear guide opening. When in use, the sheath 600 is torn open, and the plug 200 and the barrier net 500 are transferred to the interventional catheter together with the delivery shaft 400 in time. Since the plug 200 and the barrier net 500 can maintain the current shape at a lower temperature, the sheath 600 can be released in ice water and loaded into the interventional catheter together with the delivery shaft 400 during operation. In this way, the interventional catheter and other components can be stored and transported separately, and the matching mode of different types of equipment is more flexible.

[0066] The technical features of the above-described embodiments can be combined in any manner. In order to make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope disclosed in the specification. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of each embodiment involved.

[0067] The above-described embodiments are merely illustrative of several embodiments of the present application, which are described in more detail and in a more specific and detailed manner, but should not be construed as limiting the scope of the patent application. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the patent protection scope of the present application should be subject to the appended claims.

Claims

1. An embolization assembly for treating a hemangioma having opposite distal and proximal ends, characterized by, The embolization assembly comprises: an embolus made of shape memory polymer foam, the embolus having a through channel formed therein; a delivery shaft, the proximal end of the delivery shaft being an operation end, the distal end of the delivery shaft having a connecting segment, the connecting segment being detachably inserted into the through channel, the embolus clamping the connecting segment when the embolus is loaded and is being intervened and delivered, the connecting segment being moved out of the through channel after the embolus is released, and the through channel being closed by the embolus itself; a barrier net fixed to the delivery shaft, the barrier net having a compressed state suitable for intervention and delivery and an opposite expanded state, the barrier net in the compressed state being located on the proximal side of the connecting segment, and the barrier net in the expanded state being used to block the embolus.

2. The embolization assembly of claim 1, wherein, The occlusion according to the relative volume sequentially comprises a compressed loading state, a limited expansion implantation state, and a fully expanded preset state from small to large; The through channel penetrates the embolus in the axial direction, or is cut off at the inside of the embolus, and the embolus clamps the connecting segment in the loading state; In the preset state, the through channel is completely closed or at least partially open, and the open part is extruded by the surrounding tissue and closed by the embolus itself in the implantation state.

3. The embolization assembly of claim 2, wherein, The connecting segment has one or multiple radially expanded outer convex parts; In the loading state, at least one of the outer convex parts is located on the proximal side of the embolus; In the preset state, the outer convex part is in interference fit with the through channel.

4. The embolization assembly of claim 3, wherein, The outer convex part comprises: a first outer convex part located on the proximal side of the embolus; a second outer convex part located inside the through channel; Both the first outer convex part and the second outer convex part have a radiographic marker.

5. The embolization assembly of claim 1, wherein, The barrier net comprises multiple unit arms radially distributed around the delivery shaft, and the number of the unit arms is three to eight.

6. The embolization assembly of claim 5, wherein, In the axial view of the delivery shaft, the unit arms in the expanded state are straight, S-shaped, or annular.

7. The embolization assembly of claim 5, wherein, In the axial view of the delivery shaft, the unit arms in the expanded state do not overlap with each other.

8. The embolization assembly of claim 5, wherein, Each of the unit arms is independently configured, and at least one of the unit arms has a radiographic marker at the end thereof.

9. The embolization assembly of claim 5, wherein, One end of the unit arm is fixed to the delivery shaft, and the other end of the unit arm extends to the distal side and the extension length thereof is adapted to the embolus in the compressed state and the loading state; or One end of the unit arm is fixed to the delivery shaft and the fixed part thereof is adapted to the embolus in the loading state, and the other end of the unit arm extends to the proximal side.

10. An embolization system for treating hemangioma, comprising an intervention catheter and an embolization assembly according to any one of claims 1-9, the embolization assembly being loaded in the intervention catheter.

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