Hemangioma occlusion device, hemangioma occlusion treatment device and hemangioma occlusion system

Abstract

The present invention relates to a hemangioma occlusion device, a hemangioma occlusion treatment device and a hemangioma occlusion system. Among them, the hemangioma occlusion device includes an expansion structure and a guiding structure. The expansion structure is a three-dimensional mesh. The expansion structure has an expanded state wound in a spiral shape from the distal end to the proximal end and a compressed state for delivery from the blood vessel into the hemangioma; the guiding structure is arranged at the distal end of the expansion structure; the proximal end of the guiding structure is connected to the distal end of the expansion structure; the guiding structure has an expanded state wound in a spiral shape from the distal end to the proximal end and a compressed state for delivery from the blood vessel into the hemangioma. The present invention has the advantages of achieving stable and compliant packing, preventing hemangioma rupture, preventing blood vessel embolism, improving the coverage rate of the tumor neck opening, promoting the formation of thrombus in the tumor, and accelerating hemangioma embolism, etc.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a hemangioma occlusion device, a hemangioma occlusion treatment device, and a hemangioma occlusion system. Background Art

[0002] An intracranial aneurysm is a pathological protrusion of the intracranial artery wall, with an incidence rate of 5% - 10%. MRA research shows that the incidence rate of unruptured aneurysms in Chinese adults aged 35 - 75 is approximately 7.0%. Although subarachnoid hemorrhage caused by the rupture of intracranial aneurysms accounts for about 5% of strokes, the mortality rate of the first rupture is 20% - 30%, and the mortality rate of the second rupture is as high as 60%. The fundamental way to treat aneurysms is to completely isolate the aneurysm from blood circulation through treatment means. Currently, the main treatment means include craniotomy clipping and endovascular interventional treatment. Among them, the endovascular interventional treatment method can avoid the brain tissue and directly reach the lesion, and its minimally invasive characteristics make it the mainstream of current intracranial aneurysm treatment. Currently, the main endovascular interventional treatments are as follows:

[0003] (1) Embolization coils in the aneurysm cavity are currently the main method for treating aneurysms. Its treatment principle is to change local hemodynamic factors, promote thrombus formation, and then achieve the occlusion and treatment of aneurysms. However, the shapes of aneurysms are diverse. Incomplete packing of coils may lead to recanalization of aneurysms, while over-packing may cause intraoperative rupture of aneurysms, which requires high skills and experience of doctors. Moreover, coil packing needs to be repeated multiple times with low embolization efficiency, and in some cases, stents, balloons, and catheters are also required for assistance, making the operation complex. In addition, for wide-diameter aneurysms, coils are prone to herniating into the parent artery, affecting blood flow, and may even cause vascular stenosis in severe cases.

[0004] (2) As a major breakthrough in the endovascular treatment of intracranial aneurysms, the flow diversion device has brought a new method for the treatment of complex aneurysms. Its treatment principle is to place a dense mesh stent in the parent artery. After reconstructing the lumen of the diseased blood vessel, the inner surface of the blood vessel lumen is reshaped through the neointima on the surface of the aneurysm neck. The application of the flow diversion device has significantly improved the long-term efficacy of large and giant aneurysms and significantly reduced the use of coils. And according to computer hemodynamic simulation analysis, when the metal coverage rate reaches 30% - 50%, it can significantly reduce the blood flow in the aneurysm cavity and has a high cure rate. However, the application of the flow diversion device makes patients rely on dual antiplatelet therapy for a long time, and there is a risk of hemorrhagic complications after surgery. In addition, there is a certain risk of delayed rupture after treating some large aneurysms.

[0005] (3) There are currently some new types of primary embolization devices, which are usually made of shape memory materials and shaped into spherical, cylindrical or disc shapes. They are delivered through a catheter, pushed out of the sheath at a specific position, and self-expand to return to a spherical shape, thereby achieving the purpose of occluding the aneurysm. For example, a first embolization device is provided, which is a spherical or cylindrical dense mesh device with rivet points at both ends. The entire device expands in the aneurysm cavity, and the aneurysm is treated by covering the aneurysm neck with the proximal dense mesh. Another second embolization device is provided, which consists of a radiopaque wire and a peripherally self-expanding memory alloy to form a three-dimensional mesh structure. It can be released and retrieved through a catheter like a coil, and can be spherical when filling the aneurysm, thereby playing a flow disturbance role. A third embolization device is also provided, which is woven from double-layer nickel-titanium alloy. A fourth embolization device is also provided, which is woven from double-layer memory alloy. It is disc-shaped without restriction and will be tulip-shaped due to the restriction of the aneurysm wall when released in the aneurysm body. It can be stabilized at the lower part of the aneurysm body and cover the aneurysm neck, thereby playing a role in reconstructing hemodynamics. However, the rivet point design at the proximal end of the first embolization device makes the device a symmetric structure, resulting in an orientation in covering the aneurysm neck. It is mainly used for treating wide-neck bifurcated aneurysms and is particularly suitable for regular aneurysms. Moreover, the rivet point design at the distal end of the first embolization device has an impact on the aneurysm wall, easily causing the aneurysm wall to rupture and aneurysm bleeding. And in some cases, the proximal rivet point of the first embolization device will be herniated into the parent artery by the compression of the aneurysm wall, affecting the endothelialization process of the aneurysm neck. In addition, the first embolization device is usually a single spherical or cylindrical shape. Although the contact area is large, the supporting force is insufficient, and its long-term stability in the aneurysm cavity is poor, and the device is prone to displacement. The second embolization device is formed by shaping multiple sheet-like meshes into a three-dimensional mesh structure, similar to a spherical shape. Due to the large friction force between the three-dimensional mesh structures and between them and the aneurysm wall, the forming stability of the device in the aneurysm is poor, and it is not easy to restore to the predetermined shape, affecting the filling effect. Moreover, it needs to be used in cooperation with a coil, and the operation is complex. The working principle of the third embolization device is basically similar to that of the first embolization device, so it also has the same problems. And the proximal rivet point of the fourth embolization device is also easily herniated into the parent artery by the compression of the aneurysm wall. It is suitable for apical aneurysms, and the position of the device needs to be adjusted repeatedly. Otherwise, it will affect the stability of the device in the aneurysm. Therefore, the efficiency is low. Summary of the Invention

[0006] In order to solve the above technical problems, the object of the present invention is to provide a hemangioma occlusion device, a hemangioma occlusion treatment device and a hemangioma occlusion system for realizing the occlusion treatment of hemangiomas. The hemangioma occlusion device has more stable shaping in the aneurysm, is easier to restore the prefabricated shape, has less damage to the aneurysm wall, avoids the risk of hemangioma rupture, and can be compressed smaller, so as to be transported in a catheter with a small inner diameter and reach more lesion sites or narrower blood vessels.

[0007] To achieve the above objectives, the present invention provides a hemangioma occlusion device, comprising an expansion structure and a guide structure; the expansion structure is a three-dimensional mesh, and the expansion structure has an expanded state in which it is wound into a spiral shape from the distal end to the proximal end, and a compressed state for delivery to the hemangioma from within a blood vessel;

[0008] The guide structure is arranged at the distal end of the expansion structure; the proximal end of the guide structure is connected to the distal end of the expansion structure; the guide structure has an expanded state in which it is spirally wound from the distal end to the proximal end and a compressed state for delivery to the hemangioma from within the blood vessel.

[0009] Optionally, the guiding structure is a three-dimensional spiral formed by winding a linear body from the distal end to the proximal end.

[0010] Optionally, the spiral direction of the guide structure is the same as the spiral direction of the expansion structure.

[0011] Optionally, the rotation axis of the guide structure when it is helical coincides with the rotation axis of the expansion structure when it is helical.

[0012] Optionally, the distal end of the guide structure is fixedly connected to a distal developing ring, and / or the proximal end of the expansion structure is fixedly connected to a proximal developing ring.

[0013] Optionally, the cross-sectional area of the expansion structure first increases and then decreases from the proximal end to the distal end.

[0014] Optionally, the expansion structure comprises a proximal portion, a middle portion and a distal portion that are axially connected in sequence;

[0015] The cross-sectional area of the proximal portion increases sequentially from the proximal end to the distal end, and / or the cross-sectional area of the distal portion increases sequentially from the distal end to the proximal end.

[0016] Optionally, the cross-sectional area of the expansion structure increases and then decreases repeatedly from the proximal end to the distal end.

[0017] Optionally, in the expanded state, the maximum outer diameter of the expansion structure is not less than 1 / 4 of the maximum spiral outer diameter of the expansion structure.

[0018] Optionally, in the expanded state, the maximum outer diameter of the expansion structure is 1 / 3 to 1 / 2 of the maximum spiral outer diameter of the expansion structure.

[0019] Optionally, the maximum outer diameter of the expansion structure is 2.0 mm to 8.0 mm, and the maximum spiral outer diameter of the expansion structure is 3.0 mm to 25 mm.

[0020] Optionally, the expansion structure is woven from braided wires made of a shape memory material, the diameter of the braided wires is 0.0005 in to 0.002 in, and the total number of the braided wires is 48 to 144.

[0021] Optionally, the expansion structure is woven from developable braided wires, or the expansion structure is woven from a combination of developable braided wires and non-developable braided wires.

[0022] Optionally, the number of turns of the spiral shape of the expansion structure in the deployed state is one turn or more;

[0023] When the number of turns is more than one, the outer diameter of the first spiral of the expansion structure near the distal end is smaller than the outer diameters of the remaining spirals of the expansion structure.

[0024] Optionally, when the number of turns of the spiral shape of the expansion structure in the deployed state is more than one, the outer diameter of the first spiral is not less than 2 / 3 of the outer diameters of the remaining spirals.

[0025] Optionally, when the number of turns of the spiral shape of the expansion structure in the deployed state is more than one, the outer diameters of the remaining spirals of the expansion structure except the first spiral are the same.

[0026] Optionally, the number of turns of the spiral shape of the guiding structure in the deployed state is one turn or more;

[0027] When the number of turns of the guiding structure is more than one, the outer diameter of the first spiral of the guiding structure near the distal end is smaller than the outer diameters of the remaining spirals of the guiding structure.

[0028] Optionally, when the number of turns of the spiral shape of the guiding structure in the deployed state is more than one, the outer diameters of the remaining spirals of the guiding structure except the first spiral do not exceed the outer diameter of the first spiral of the expansion structure near the distal end.

[0029] Optionally, when the number of turns of the spiral shape of the guiding structure in the deployed state is more than one, the outer diameter of the first spiral of the guiding structure near the distal end is not less than 2 / 3 of the outer diameters of the remaining spirals of the guiding structure.

[0030] Optionally, when the number of turns of the spiral shape of the guiding structure in the deployed state is more than one, the outer diameters of the remaining spirals of the guiding structure except the first spiral are the same.

[0031] Optionally, when the number of turns of the spiral of the guiding structure in the unfolded state is multiple turns, the outer diameter of the remaining spirals of the guiding structure except the first spiral is not less than 2 / 3 of the outer diameter of the first spiral near the distal end of the expanding structure.

[0032] Optionally, the expanding structure and the guiding structure are integrally braided and formed.

[0033] To achieve the above object, a hemangioma occlusion treatment device provided by the present invention is used to deliver any one of the hemangioma occlusion devices, and the hemangioma occlusion treatment device includes a push rod connected to the proximal end of the expanding structure.

[0034] Optionally, the push rod extends along the tangent direction of the spiral line of the spiral shape of the expanding structure in the unfolded state.

[0035] To achieve the above object, a hemangioma occlusion system provided by the present invention includes any one of the hemangioma occlusion devices and a catheter. The expanding structure is compressed in the catheter and can still return to the unfolded state of the spiral shape after being separated from the catheter.

[0036] Optionally, the inner diameter of the catheter is 0.017 inches, 0.021 inches or 0.027 inches.

[0037] To achieve the above object, the present invention also provides a method for treating hemangioma, wherein the neck of the hemangioma leads to a blood vessel, and the method includes:

[0038] Placing the hemangioma occlusion device in the hemangioma;

[0039] First, releasing the guiding structure in the hemangioma to make the guiding structure rotate and form in the hemangioma along a predetermined shape;

[0040] Then, releasing the expanding structure in the hemangioma to make the expanding structure continue to rotate and form in the hemangioma under the guidance of the guiding structure, and making the outer side surface of the expanding structure straddle the neck of the hemangioma.

[0041] Optionally, the method further includes:

[0042] The proximal end of the expanding structure is located between the tumor wall of the hemangioma and the outer side surface, and the proximal end of the expanding structure is parallel to the tumor wall of the hemangioma and does not herniate into the blood vessel.

[0043] In the above-mentioned hemangioma occlusion device, the expansion structure is a three-dimensional mesh. The expansion structure has an expanded state wound in a spiral shape from the distal end to the proximal end and a compressed state for delivery from the blood vessel into the hemangioma. Such a structure is configured such that the frictional force received by the expansion structure when released in the hemangioma cavity is small, making the shaping of the expansion structure in the hemangioma more stable, more easily achieving the restoration of the predetermined shape, and more easily achieving the occlusion of the neck of the tumor. On the other hand, based on the spiral shape, the distal end of the device is wrapped inside or does not face the tumor wall, and the proximal end of the device is pressed between the outer side surface of the three-dimensional mesh and the tumor wall, parallel to (including tangent to) the tumor wall. In this way, the distal end and the proximal end of the device will not impact the tumor wall, avoiding the risk of hemangioma rupture. On the other hand, the outer side surface of the largest spiral after the expansion structure is deployed in the hemangioma covers and occludes the neck of the hemangioma, with a high coverage rate of the neck of the tumor, more easily causing embolization in the tumor, and also being able to prevent the proximal rivet point of the expansion structure from being located in the middle of the neck of the tumor or protruding into the parent vessel, thereby accelerating the endothelialization of the neck of the tumor and also avoiding the risk of vascular stenosis.

[0044] In the above-mentioned hemangioma occlusion device, since a guiding structure in a spiral shape is provided at the distal end of the expansion structure, it is convenient to guide the expansion structure through the guiding structure, making the shaping of the expansion structure in the hemangioma more stable, more easily achieving the restoration of the predetermined shape, and more easily achieving the occlusion of the neck of the tumor. On the other hand, due to the guiding structure being relatively slender and flexible, the pushing resistance is reduced, making the pushing of the entire device easier, and it can also buffer the release tension, reducing the impact on the tumor wall and further reducing the risk of hemangioma rupture. In addition, during the delivery process, that is, during the process of delivering from the blood vessel into the hemangioma, both the expansion structure and the guiding structure can be in a linear shape and loaded in the catheter for delivery. The delivery size of the device is small, facilitating delivery in a catheter with a small inner diameter, so as to reach more lesion sites or narrower blood vessels, and the treatment is more extensive. In particular, the three-dimensional spiral structure has no orientation problem, can be applied to regular or irregular hemangiomas, and can also conform to the shape of the hemangioma, making it easier to achieve the occlusion of the hemangioma. In addition, only one embolization is required, that is, there is no need to pack multiple embolization devices, the embolization efficiency is high, and the operation is also simple, which can reduce the dependence on the doctor's experience during the operation, reduce the operation difficulty, and reduce the operation time. In addition, the outer side surface of the largest spiral of the expansion structure occludes the neck of the tumor. The outer diameter of the largest spiral matches the inner diameter of the hemangioma, with a large contact area and high support strength, enabling the stable occlusion of the hemangioma occlusion device and not easily shifting. In particular, the expansion structure is a three-dimensional mesh, with a large contact area with the tumor wall, making the hemangioma occlusion device more stable in the tumor and less likely to shift, and at the same time further reducing the risk of the proximal end of the expansion structure herniating into the parent vessel.

[0045] In the above-mentioned hemangioma occlusion device, the guiding structure is preferably a three-dimensional helix, and more preferably the helix direction of the guiding structure is the same as that of the expanding structure. With such a configuration, the shaping of the expanding structure is more stable, it is easier to achieve the restoration of the predetermined shape, and it is easier to occlude the aneurysm neck. Moreover, the cross-sectional area of the expanding structure preferably first increases and then decreases from the proximal end to the distal end, or the cross-sectional area of the expanding structure first increases and then decreases repetitively from the proximal end to the distal end. With such a setting, it is convenient to construct the expanding structure into a spindle shape, that is, small at both ends and large in the middle. This not only facilitates compression to a smaller size, but also improves the flexibility of the device, further reduces the pushing resistance, and reduces the impact on the aneurysm wall. The distal end of the above-mentioned guiding structure is preferably fixedly connected with a distal imaging ring. Especially in the case where there is no guiding structure, it can make the distal end of the expanding structure smooth, further reducing the damage to the aneurysm wall.

[0046] In the above-mentioned hemangioma occlusion device, the expanding structure is formed by braiding braided wires into a mesh, and the diameter of the braided wires is 0.0005 in to 0.002 in, and the number of the braided wires is 48 to 144. In this way, dense mesh holes can be constructed, which is more likely to cause embolism in the tumor, and the force on the aneurysm wall is more uniform, further reducing the risk of hemangioma rupture.

[0047] In the above-mentioned hemangioma occlusion treatment device, the proximal end of the expanding structure is connected to a pushing rod, and the pushing rod preferably extends along the tangent direction of the spiral line of the spiral shape in the unfolded state of the expanding structure. With such a design, it is convenient to use the pushing rod to cover the aneurysm neck opening with the outer side surface of the maximum helix of the expanding structure, making the surgical operation more accurate and the covering effect better. Description of the Drawings

[0048] Figure 1 is a schematic structural diagram of the hemangioma occlusion device provided by a preferred embodiment of the present invention, in which the number of spiral turns of the guiding structure in the unfolded spiral shape is 1.5 turns, the number of spiral turns of the expanding structure in the unfolded spiral shape is 1 turn, and the spiral direction of the guiding structure is opposite to the spiral direction of the expanding structure;

[0049] Figure 2 is a schematic structural diagram of the hemangioma occlusion device provided by a preferred embodiment of the present invention, in which the number of spiral turns of the guiding structure in the unfolded spiral shape is 2 turns, the number of spiral turns of the expanding structure in the unfolded spiral shape is 1 turn, and the spiral direction of the guiding structure is the same as the spiral direction of the expanding structure;

[0050] Figure 3It is a schematic structural diagram of a hemangioma occlusion device provided by a preferred embodiment of the present invention. Among them, the number of turns of the spiral of the guiding structure in the unfolded state is 1 turn, the number of turns of the spiral of the expanding structure in the unfolded state is 1 turn, and the spiral direction of the guiding structure is opposite to that of the expanding structure;

[0051] Figure 4 It is a state diagram of the hemangioma occlusion device provided by a preferred embodiment of the present invention when the guiding structure is first released in the tumor;

[0052] Figure 5 It is a state diagram of the hemangioma occlusion device provided by a preferred embodiment of the present invention when it is completely released in the tumor;

[0053] Figure 6 It is a partial enlarged view of the hemangioma occlusion device provided by a preferred embodiment of the present invention covering the tumor neck opening.

[0054] In the drawings, the same reference numerals are used to represent the same or similar components. Detailed Description of the Invention

[0055] To make the objectives, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the objectives of the embodiments of the present invention.

[0056] As used in this specification, the singular forms "a", "an" and "the" include plural objects unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or" unless the context clearly indicates otherwise. The term "plural" is generally used in the sense of including two or more unless the context clearly indicates otherwise. The term "several" is generally used in the sense of including an indefinite quantity unless the context clearly indicates otherwise. The term "proximal" generally refers to the end close to the operator of the medical device, and the term "distal" generally refers to the end where the instrument first enters the human body unless the context clearly indicates otherwise.

[0057] Refer to Figure 1, in an embodiment of the present invention, a hemangioma occlusion device 10 is provided. The hemangioma occlusion device 10 can be used for the occlusion treatment of hemangiomas, where the hemangiomas include but are not limited to intracranial aneurysms. The hemangioma occlusion device 10 specifically includes an expansion structure 11 and a guiding structure 12. The expansion structure 11 is a wound three-dimensional spiral mesh. In some embodiments, the spiral of the three-dimensional spiral mesh is not wound on a single horizontal plane. The expansion structure 11 of the three-dimensional spiral mesh can be more firmly supported in the tumor, has strong anchoring force, and is not prone to displacement. The guiding structure 12 is disposed outside the expansion structure 11 and at the distal end of the expansion structure 11. The proximal end 121 of the guiding structure 12 is connected to the distal end 111 of the expansion structure 11, and the outer wound spiral shape of the guiding structure 12 is, for example, a three-dimensional spiral body or a planar spiral body.

[0058] In this embodiment, the guiding structure 12 is preferably a three-dimensional spiral body wound from a linear body from the distal end to the proximal end. In other embodiments, the guiding structure 12 can also be a planar spiral body wound from a linear body from the distal end to the proximal end. Further, the spiral direction of the guiding structure 12 and the spiral direction of the expansion structure 11 can be the same or different. Preferably, the spiral direction of the guiding structure 12 is the same as the spiral direction of the expansion structure 11, which has a good guiding effect and can avoid the problem of the spiral at the distal end 122 of the guiding structure 12 being bent during the pushing process, affecting the shape recovery of the expansion structure 11 in the tumor. Further, the rotation axis of the guiding structure 12 during the spiral and the rotation axis of the expansion structure 11 during the spiral can coincide or not coincide. Preferably, the rotation axis of the guiding structure 12 during the spiral coincides with the rotation axis of the expansion structure 11 during the spiral.

[0059] In actual application, the expansion structure 11 has a compressed state and an expanded state; when the expansion structure 11 is in the expanded state, the expansion structure 11 has a spiral shape wound from the distal end to the proximal end; when the expansion structure 11 is in the compressed state, it is convenient to deliver the expansion structure 11 from the blood vessel to the hemangioma. More specifically, when the expansion structure 11 is in a catheter 40 (i.e., an external mechanism, refer to Figure 4)Sometimes it has a compressed state inside. In the compressed state, the expansion structure 11 can be compressed into a straight shape to minimize its radial dimension, facilitating transportation within a catheter 40 with a small inner diameter. And when the expansion structure 11 is detached from the catheter 40, it expands using its own elasticity and is in an unfolded state. In the unfolded state, the expansion structure 11 resumes its three-dimensional helical shape. Similarly, the guiding structure 12 also has a compressed state and an unfolded state. When the guiding structure 12 is in the unfolded state, the guiding structure 12 has a helical shape wound from the distal end to the proximal end, such as a three-dimensional helical shape or a planar helical shape. When the guiding structure 12 is in the compressed state, it is also convenient to deliver the guiding structure 12 from the blood vessel into the hemangioma. More specifically, sometimes the guiding structure 12 has a compressed state inside the catheter 40. In the compressed state, the guiding structure 12 can be compressed into a straight shape for transportation within the catheter 40. And when the guiding structure 12 is detached from the catheter 40, it expands using its own elasticity and has an unfolded state. In the unfolded state, the guiding structure 12 resumes its helical shape.

[0060] Return to refer Figure 1 , The embodiment of the present invention also provides a hemangioma occlusion treatment device, including a push rod 20 for transporting the hemangioma occlusion device 10. The proximal end 112 of the expansion structure 11 is used for detachably connecting with the push rod 20. The main function of the push rod 20 is to push the hemangioma occlusion device 10 out of the catheter 40 to realize the release of the hemangioma occlusion device 10 within the hemangioma 30. Optionally, a connecting member (not shown) is additionally provided at the proximal end 112 of the expansion structure 11 for detachably connecting with the push rod 20. Further, the push rod 20 preferably extends along the tangent direction of the helical line of the helical shape of the expansion structure 11 in the unfolded state. This design facilitates covering the outer side of the largest helix of the expansion structure 11 on the neck opening 31 of the tumor (refer to Figure 6 ), that is, the outer side of the three-dimensional mesh crosses the neck of the hemangioma, thereby increasing the coverage rate of the neck opening 31 of the tumor and avoiding the proximal end 112 of the expansion structure 11 being located in the middle of the neck opening 31 and avoiding the proximal end 112 herniating into the parent vessel, so as to avoid affecting the healing of the tumor neck while preventing vascular embolism. The detachment method of the push rod 20 and the proximal end 112 of the expansion structure 11 can adopt existing technologies such as thermal detachment, electrolytic detachment, mechanical detachment, or hydrolytic detachment, etc., and is not limited thereto.

[0061] The guiding structure 12 is preferably in an elongated structure (i.e., a linear body) after deployment, and its outer diameter is much smaller than the outer diameter of the three-dimensional mesh of the expanding structure 11. Therefore, the guiding structure 12 is more slender and flexible relative to the expanding structure 11. Its main function is to guide the expanding structure 11 through its own helix, making it easier for the expanding structure 11 to resume its three-dimensional helical shape within the hemangioma. Moreover, it is also used to buffer the release tension of the expanding structure 11, reduce the impact on the tumor wall, and can also reduce the pushing resistance, making the pushing easier. In particular, the guiding structure 12 is relatively slender and compliant, causing less damage to the tumor wall and avoiding damage to the tumor wall.

[0062] Next, in combination with Figures 4 to 6 , the usage mode of the hemangioma occlusion device 10 of the present invention will be further described. However, the following usage mode is not a limitation of the present invention, but is only explained as a preferred operation mode.

[0063] First, the hemangioma occlusion device 10 is loaded into a catheter 40 for delivery. Before delivery, the hemangioma occlusion device 10 is first loaded into the catheter 40. After loading, the hemangioma occlusion device 10 is compressed. At this time, the expanding structure 11 and the guiding structure 12 are stretched and preferably in a straight shape, making the radial dimension of the whole device smaller and enabling it to be delivered within the catheter 40 with a small inner diameter. Optionally, the inner diameter of the catheter 40 is 0.017 inches, 0.021 inches or 0.027 inches. After that, as Figure 4 shown, when the distal end of the catheter 40 is positioned near the hemangioma 30, the hemangioma occlusion device 10 can be released. During the release process, the guiding structure 12 can be pushed distally by means of the push rod 20 or the catheter 40 can be retracted proximally, so that the guiding structure 12 is first released within the hemangioma 30, and the guiding structure 12 rotates and forms a shape within the tumor along a predetermined shape. Since the guiding structure 12 is a slender and flexible helical structure, the frictional force within the tumor is relatively small and it is easy to resume its helical shape, thus rotating and forming a shape within the tumor. Then, as the hemangioma occlusion device 10 is further pushed, the expanding structure 11 begins to be released within the hemangioma 30, and under the guidance of the guiding structure 12, the expanding structure 11 continues to rotate and form a shape, with the outer diameter of the helix continuously increasing until the expanding structure 12 is fully deployed, obtaining Figure 5 the tamponade state shown. At this time, the outer surface of the largest helix of the hemangioma occlusion device 10 covers the inner side of the tumor neck, and the whole device is stably coiled within the hemangioma 30, forming a stable and compliant tamponade. Finally, after confirming that the tamponade is correct, the push rod 20 can be electrolytically detached from the expanding structure 11, and the catheter 40 and the push rod 20 can be withdrawn to complete the embolization of the hemangioma 30.

[0064] Continue to refer to Figure 5, after embolization, the distal end of the hemangioma occlusion device 10 (i.e., the distal end of the guiding structure 12) is wrapped inside the helix of the expanding structure 11, having no impact on the tumor wall. Moreover, the proximal end 112 of the expanding structure 11 is constrained between the outer side of the largest helix of the expanding structure 11 and the tumor wall and is parallel to the tumor wall, also having little impact on the tumor wall. At the same time, the parts in contact with the tumor wall are all closely woven meshes, which can make the force on the tumor wall more uniform and cause less damage to the tumor wall. In particular, the three-dimensional helix of the expanding structure 11 is composed of multiple inner and outer helices, forming multiple layers of barriers inside the tumor, having a better blood flow blocking effect, being more likely to form thrombus, and accelerating the embolization of the hemangioma. Another reference is Figure 6 , the outer side of the largest helix of the expanding structure 11 occludes the tumor neck opening 31. The occlusion is achieved by matching the outer side of the largest helix with the inner wall of the hemangioma 30. The device has good stability, and at the same time, the proximal end of the device is not easily herniated into the parent vessel 50 (refer to Figure 5 ), which will not affect the endothelialization of the tumor neck, can accelerate the healing of the tumor neck opening, and has a good embolization effect.

[0065] Alternatively, the guiding structure 12 can also be cancelled, and only the expanding structure 11 is provided, and the occlusion of the hemangioma 30 can also be achieved. Preferably, a guiding structure 12 is provided at the distal end of the expanding structure 11. The advantage of this is that through the guidance of the guiding structure 12, the expanding structure 11 is more likely to restore to a predetermined shape inside the tumor and is more likely to achieve the occlusion of the tumor neck.

[0066] Furthermore, the guiding structure 12 is preferably capable of being imaged. For example, it can be entirely made of an imaging material. The imaging material for preparing the guiding structure 12 is not limited. For example, platinum (Pt), platinum-iridium alloy (Pt-Ir), Au (gold), platinum-tungsten alloy, etc. can be selected. Alternatively, the material of the guiding structure 12 can also be a non-imaging material, such as nitinol or stainless steel, etc. In one embodiment, a slender linear body can be obtained by winding a metal wire around a metal mandrel to form a first-level coil, where the coil is wound tightly, and then the wound first-level coil (which can be called a coil) is shaped, and the guiding structure 12 in a helical shape in the deployed state can be obtained. In another embodiment, a flexible hollow tube can be first obtained by cutting a metal tube, and then the flexible hollow tube is stretched into a slender shape and then shaped to obtain the helical guiding structure 12. In yet another embodiment, a woven tube can be pre-woven, and then the woven tube is stretched into a slender shape and then shaped, and the helical guiding structure 12 can also be obtained. In other embodiments, the stretching process may not be performed, and a slender linear body can be directly obtained, and then the linear body is shaped into a helical structure. It should also be understood that the expanding structure 11 and the guiding structure 12 can be integrally woven and formed.

[0067] Furthermore, the distal end 122 of the guiding structure 12 is preferably smooth. For example, a hemispherical structure formed by photocuring glue can be provided at the distal end 122 to form a smooth head and reduce the damage to the aneurysm wall. Further, a distal end developing ring 123 can be provided at the distal end 122 of the guiding structure 12. On the one hand, it can be developed under X-ray to confirm the position of the distal end 122 of the guiding structure 12. On the other hand, the distal end 122 of the guiding structure 12 can be constrained and fixed within the distal end developing ring 123 to further reduce the damage to the aneurysm wall. Alternatively, the distal end 122 of the guiding structure 12 can also be fixed by glue bonding to reduce the damage to the aneurysm wall. Moreover, while using glue to bond the distal end 122 of the guiding structure 12, the distal end developing ring 123 can also be used to achieve a double protection effect.

[0068] The expansion structure 11 is preferably formed by helically winding a braided tube. Preferably, the diameter of the braided wire forming the braided tube is 0.0005 in to 0.002 in, and the total number of braided wires is 48 to 144. In this way, a dense mesh with a large grid density can be constructed to effectively block the blood flow in the aneurysm cavity, promote the formation of thrombus in the aneurysm, and while increasing the coverage rate of the aneurysm neck, make the force on the aneurysm wall more uniform and further reduce the risk of aneurysm rupture. The material of the braided wire includes shape memory materials, and the shape memory materials can be metallic materials with shape memory functions, such as nickel-titanium (Ni-Ti) alloy, nickel-titanium-cobalt alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti@Pt), etc. The material of the braided wire can also be a sub-polymer material with a certain shape recovery ability, such as polydioxanone (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), poly(norbornene) amorphous polymer, etc., or a combination of these materials. Here, the braided wire is made of a shape memory metal material or a polymer material with a certain shape recovery ability, so that the grid has a shape memory function to restore its original shape. Preferably, the expansion structure 11 is woven from developable braided wires, or the expansion structure 11 is woven from a mixture of developable braided wires and non-developable braided wires. Such a design can not only make the expansion structure 11 itself developable under X-ray, but also ensure the elasticity of the expansion structure 11, so that the expansion structure 11 has a strong shape recovery ability and the ability to maintain its original shape, and can also improve the flexibility of the expansion structure 11 while eliminating additional developing components. The present invention does not particularly limit the developing material of the developable braided wire. For example, platinum (Pt), platinum-iridium (Pt-Ir), Au (gold), platinum-tungsten alloy, etc. can be selected.

[0069] The number of turns of the spiral of the guiding structure 12 may be one turn or multiple turns, preferably 1 to 6 turns, more preferably 1 to 3 turns. Further considering that an excessively large outer diameter of the spiral of the guiding structure 12 is likely to affect the pushing of the expanding structure 11 or the expansion of the expanding structure 11, therefore, in the deployed state, the maximum outer diameter of the spiral of the guiding structure 12 is defined as not exceeding the outer diameter of the first spiral of the expanding structure 11 near the distal end. For example, when the number of turns of the spiral of the guiding structure 12 is multiple turns, at this time, the outer diameter of the first spiral of the guiding structure 12 near the distal end is preferably smaller than the outer diameters of the remaining spirals of the guiding structure 12. Further, the outer diameters of the remaining spirals of the guiding structure 12 except the first spiral do not exceed the outer diameter of the first spiral of the expanding structure 11 near the distal end. Further, the outer diameters of the remaining spirals of the guiding structure 12 except the first spiral may be the same or different, preferably the same. Furthermore, the outer diameter of the first spiral of the guiding structure 12 near the distal end is not less than 2 / 3 of the outer diameters of the remaining spirals of the guiding structure 12. Further, the outer diameters of the remaining spirals of the guiding structure 12 except the first spiral are more preferably not less than 2 / 3 of the outer diameter of the first spiral of the expanding structure 11 near the distal end. The advantage of such a design is that during the process of the release and shaping of the expanding structure 11, space is provided for the stuffing of the expanding structure 11, so that the spirals of the guiding structure 12 do not occupy extra space, thereby avoiding affecting the release and shaping of the expanding structure 11 in the tumor. It should be understood that the first spiral of the guiding structure 12 refers to the first spiral wound starting from the most distal end of the guiding structure 12.

[0070] In addition, the number of turns of the spiral of the expansion structure 11 is mainly set according to the size of the hemangioma to be treated actually. When the number of turns of the spiral of the expansion structure 11 is small, it is suitable for the treatment of small hemangiomas. As the number of turns of the spiral increases, hemangiomas with larger sizes can be treated. In this embodiment, the number of turns of the spiral of the expansion structure 11 in the unfolded spiral shape may be one turn or multiple turns, and may be selected from 1 to 3 turns. Further, considering that when the number of turns of the spiral exceeds 3 turns, the pushing resistance of the hemangioma occlusion device 10 will increase, and the frictional force during in-vessel molding is also greater, and it is not easy to restore the expansion structure 11 to the spiral shape. For this reason, the number of turns of the spiral of the expansion structure 11 in the unfolded spiral shape is preferably not more than 3 turns, and more preferably 1 to 3 turns. In this embodiment, when the number of turns of the spiral of the expansion structure 11 in the unfolded spiral shape is multiple turns, the outer diameter of the first spiral near the distal end of the expansion structure 11 is preferably smaller than the outer diameters of the other spirals of the expansion structure 11, and the outer diameters of the other spirals of the expansion structure 11 except the first spiral are preferably the same. The advantage of such a design is to minimize the molding resistance of the spiral of the expansion structure 11 to make it better molded. At the same time, it can also provide sufficient supporting force to make the hemangioma occlusion device 10 more stable and provide space for the final stuffing to obtain a denser stuffing effect. Preferably, the outer diameter of the first spiral near the distal end of the expansion structure 11 is not less than 2 / 3 of the outer diameters of the other spirals of the expansion structure 11. It should be understood that the first spiral of the expansion structure 11 refers to the first spiral wound starting from the most distal end of the expansion structure 11.

[0071] Further, in one embodiment, as Figure 1As shown, when not implanted in the body and in the deployed state, the guiding structure 12 is a wound three-dimensional helix or a planar helix. The number of turns of the guiding structure 12 is 1.5 turns. At the same time, the expanding structure 11 is a wound three-dimensional helical mesh, and the number of turns of the expanding structure 11 is 1 turn. At this time, the proximal end 112 and the distal end 111 of the expanding structure 11 are preferably at the same radial position (i.e., the line connecting the proximal end 112 and the distal end 111 is parallel to the rotation axis) and on the same side of the rotation axis of the helix. In addition, the helical direction of the expanding structure 11 is opposite to that of the guiding structure 12, and the outer diameter of the first helix of the guiding structure 12 near the distal end is slightly smaller than that of the second helix, preferably not less than 2 / 3 of the outer diameter of the second helix, and the outer diameter of the second helix of the guiding structure 12 does not exceed the outer diameter of the first helix of the expanding structure 11 near the distal end. Preferably, the outer diameter of the second helix of the guiding structure 12 is not less than 2 / 3 of the outer diameter of the first helix of the expanding structure 11 near the distal end. In addition, in the deployed state, the maximum outer diameter D1 of the expanding structure 11 is preferably not less than 1 / 4 of its maximum helical outer diameter D2, such as 1 / 3 to 1 / 2. In this embodiment, the guiding structure 12 can guide the three-dimensional helical expanding structure 11 to rotate and form in the tumor through a three-dimensional or planar helix, and at the same time, the damage to the tumor wall by the distal end of the expanding structure 11 is reduced through the guiding structure 12.

[0072] Alternatively, in another embodiment, as Figure 2 As shown, when not implanted in the body and in the deployed state, the guiding structure 12 is a wound three-dimensional helix, and the number of turns of the guiding structure 12 is 2 turns. At the same time, the expanding structure 11 is a wound three-dimensional helical mesh, and the number of turns of the expanding structure 11 is 1 turn. At this time, the proximal end 112 and the distal end 111 of the expanding structure 11 are preferably at the same radial position (i.e., the line connecting the proximal end 112 and the distal end 111 is parallel to the rotation axis, that is, the projections on the horizontal plane coincide) and on the same side of the rotation axis of the helix. In addition, the helical direction of the expanding structure 11 is the same as that of the guiding structure 12, and the helical axes of the two preferably coincide. In addition, the outer diameter of the first helix of the guiding structure 12 near the distal end is slightly smaller than that of the second helix, preferably not less than 2 / 3 of the outer diameter of the second helix, and the outer diameter of the second helix (i.e., the maximum helix) of the guiding structure 12 does not exceed the outer diameter of the first helix of the expanding structure 11 near the distal end. Preferably, the outer diameter of the second helix of the guiding structure 12 is not less than 2 / 3 of the outer diameter of the first helix of the expanding structure 11. In addition, in the deployed state, the maximum outer diameter D1 of the expanding structure 11 is preferably not less than 1 / 4 of its maximum helical outer diameter D2, such as 1 / 3 to 1 / 2. In this embodiment, the guiding structure 12 can guide the three-dimensional helical expanding structure 11 to rotate and form in the tumor through its own three-dimensional helix.

[0073] Alternatively, as Figure 3 shown, when not implanted in the body and in the deployed state, the guiding structure 12 is a wound planar spiral or a three-dimensional spiral, the number of turns of the spiral of the guiding structure 12 is 1 turn, and at the same time the expanding structure 11 is a wound three-dimensional spiral mesh, and the number of turns of the spiral of the expanding structure 11 is 1 turn. At this time, the spiral direction of the expanding structure 11 is opposite to the spiral direction of the guiding structure 12, and the spiral axes of the two do not coincide. In addition, in the deployed state, the outer diameter of the largest spiral of the guiding structure 12 does not exceed the outer diameter of the first spiral of the expanding structure 11 near the distal end, and is not less than 2 / 3 of the outer diameter of the first spiral of the expanding structure 11 near the distal end. In addition, in the deployed state, the maximum outer diameter D1 of the expanding structure 11 is preferably not less than 1 / 4 of the maximum outer diameter D2 of its largest spiral, such as 1 / 3 to 1 / 2.

[0074] It should be understood that in the deployed state, the expanding structure 11 may also include multiple turns of spirals, such as 1.5 turns, 2 turns, 2.5 turns, 3 turns. When the expanding structure 11 includes more turns of spirals, the packing rate of the hemangioma can be further improved, and it can be used to treat larger hemangiomas.

[0075] As described above, the maximum outer diameter D1 of the expanding structure 11 is preferably not less than 1 / 4 of the maximum outer diameter D2 of the largest spiral of the expanding structure 11, and more preferably 1 / 3 to 1 / 2. The advantages of doing so are that on the one hand, it ensures that the outer side of the largest spiral of the expanding structure 11 has sufficient friction against the tumor wall, so that the hemangioma occlusion device 10 is not easily displaced; on the other hand, it disperses the supporting force of the entire hemangioma occlusion device 10, so that the local pressure is not too high to damage the tumor wall; on the third hand, it ensures that the outer side of the largest spiral of the expanding structure 11 can cover the tumor neck as completely as possible, improves the coverage rate of the tumor neck, and accelerates the formation of thrombus in the tumor. In this embodiment, the outer diameter of the largest spiral of the expanding structure 11 is mainly set according to the size of the hemangioma to be treated. For example, the maximum outer diameter D1 of the expanding structure 11 may be 2.0 mm to 8.0 mm, and the maximum outer diameter D2 of the largest spiral may be 3.0 mm to 25 mm.

[0076] Further, a proximal developing ring 13 may be provided at the proximal end 112 of the expansion structure 11. On the one hand, the position of the proximal end 112 of the expansion structure 11 can be confirmed by the development of the proximal developing ring 13 under X-ray, improving the developability of the device. On the other hand, the ends of the respective braided wires of the expansion structure 11 can be hidden inside the proximal developing ring 13, thereby reducing the damage to the aneurysm wall. Further, a developing ring (not shown) may be provided at the distal end 111 of the expansion structure 11. On the one hand, the position of the distal end 111 of the expansion structure 11 can be confirmed by the development of the developing ring at the distal end 111 of the expansion structure 11 under X-ray, improving the developability of the device. On the other hand, the ends of the respective braided wires of the expansion structure 11 can be hidden inside the distal developing ring, reducing the damage to the aneurysm wall. Optionally, the proximal developing ring 13 is adhesively bonded to the proximal end 112 of the expansion structure 12 with glue. Similarly, the developing ring can also be adhesively bonded to the distal end 111 of the expansion structure 12 and the proximal end 121 of the guiding structure 12 with glue. It should be understood that when the expansion structure 11 itself is developable, both the proximal developing ring 13 and the developing ring can be retained, or the proximal developing ring 13 and the developing ring can be cancelled. It should also be understood that the distal developing ring 123 and the proximal developing ring 13 can be provided simultaneously, or only one of them can be provided.

[0077] In this embodiment, the area of the cross-section of the expansion structure 11 preferably increases first and then decreases from the proximal end 112 to the distal end 111, that is, the outer diameter of the three-dimensional grid of the expansion structure 11 is uneven. Further, in the direction from the distal end 111 to the proximal end 112, the expansion structure 11 includes a distal portion 113, an intermediate portion 114, and a proximal portion 115 that are axially connected in sequence; wherein, the area (or outer diameter) of the cross-section of the distal portion 113 preferably increases sequentially from the distal end 111 to the intermediate portion 114, and / or, the area (or outer diameter) of the cross-section of the proximal portion 115 preferably increases sequentially from the proximal end 112 to the intermediate portion 114. In other embodiments, the area of the cross-section of the expansion structure 11 may also increase first and then decrease repetitively from the proximal end 112 to the distal end 111, that is, repeatedly increase and decrease. Such a design facilitates the expansion structure 11 to be configured into a spindle-shaped grid body, that is, small at both ends and large in the middle, so as to be more convenient to compress, with a smaller compression size. On the other hand, it can also improve the flexibility of the hemangioma occlusion device, further reduce the pushing resistance, and reduce the impact on the aneurysm wall. Moreover, the distal portion 113 can also play a guiding role, making the expansion structure 11 easier to form. In addition, the grid density of the expansion structure 11 is greater at its distal portion 113 and proximal portion 115. Especially when the grid density of the distal portion 113 is large, the strength of the hemangioma occlusion device 10 is better, the support stability inside the helix is better, and it is less likely to shift. In addition, the present invention does not make any requirements on the distribution of the grid density of the intermediate portion 114. For example, the grid density of the intermediate portion 114 can be uniform or non-uniform.

[0078] Furthermore, an embodiment of the present invention further provides a hemangioma occlusion system, including a hemangioma occlusion device 10 and a catheter 40. The expansion structure 11 is compressed within the catheter 40 and can still return to a spiral-shaped deployed state after being separated from the catheter 40.

[0079] Finally, it should be noted that the preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed in the above embodiments. For example, the present invention does not limit the number of spiral turns of the expansion structure in the deployed state, nor the number of spiral turns of the guiding structure in the deployed state, and does not limit the outer diameter of the largest spiral of the expansion structure in the deployed state, etc.

[0080] Therefore, according to the technical solution provided by the embodiment of the present invention, the hemangioma occlusion device of the present invention is easier to achieve the occlusion of the aneurysm neck, and the distal and proximal ends of the device will not impact the aneurysm wall, avoiding the risk of hemangioma rupture. At the same time, the coverage rate of the aneurysm neck is high, which is more likely to cause intra-aneurysm embolization, and can also prevent the proximal rivet point of the expansion structure from being located in the middle of the aneurysm neck or protruding into the parent vessel, thereby accelerating the endothelialization of the aneurysm neck and avoiding the risk of vascular stenosis.

[0081] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the art of the present invention based on the above disclosure belong to the protection scope of the present invention.

Claims

1. A hemangioma occlusion device, characterized in that, It includes an expansion structure and a guiding structure; the expansion structure is a three-dimensional mesh, and the expansion structure has an expanded state wound in a spiral shape from the distal end to the proximal end and a compressed state for delivery from the blood vessel into the hemangioma; In the expanded state, the maximum outer diameter of the expansion structure is not less than 1 / 4 of the maximum spiral outer diameter of the expansion structure; the number of spiral turns of the spiral shape of the expansion structure in the expanded state is one turn or multiple turns; when the number of spiral turns is multiple turns, the outer diameter of the first spiral near the distal end of the expansion structure is smaller than the outer diameters of the remaining spirals of the expansion structure, the outer diameter of the first spiral is not less than 2 / 3 of the outer diameters of the remaining spirals, and the outer diameters of the remaining spirals of the expansion structure except the first spiral are the same; The guiding structure is arranged at the distal end of the expansion structure; the proximal end of the guiding structure is connected to the distal end of the expansion structure; the guiding structure has an expanded state wound in a spiral shape from the distal end to the proximal end and a compressed state for delivery from the blood vessel into the hemangioma; The spiral direction of the guiding structure is the same as the spiral direction of the expansion structure.

2. The hemangioma occlusion device according to claim 1, wherein The guiding structure is a three-dimensional spiral body wound by a linear body from the distal end to the proximal end.

3. The hemangioma occlusion device according to claim 1, wherein, The rotation axis of the guiding structure during spiraling coincides with the rotation axis of the expansion structure during spiraling.

4. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, A distal imaging ring is fixedly connected to the distal end of the guiding structure, and / or, a proximal imaging ring is fixedly connected to the proximal end of the expansion structure.

5. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, The cross-sectional area of the expansion structure first increases and then decreases from the proximal end to the distal end.

6. The hemangioma occlusion device according to claim 5, wherein, The expansion structure includes a proximal part, an intermediate part, and a distal part connected axially in sequence; The cross-sectional area of the proximal part increases sequentially from the proximal end to the distal end, and / or, the cross-sectional area of the distal part increases sequentially from the distal end to the proximal end.

7. The hemangioma occlusion device according to any one of claims 1-3, characterized in that The cross-sectional area of the expansion structure repeatedly first increases and then decreases from the proximal end to the distal end.

8. The hemangioma occlusion device according to any one of claims 1-3, characterized in that In the expanded state, the maximum outer diameter of the expansion structure is 1 / 3 to 1 / 2 of the maximum spiral outer diameter of the expansion structure.

9. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, The expansion structure is woven by braided wires, the material of the braided wires is a shape memory material, and the diameter of the braided wires is 0.0005 in to 0.002 in, and the total number of the braided wires is 48 to 144.

10. The hemangioma occlusion device according to claim 9, characterized in that, The expansion structure is woven by developable braided wires, or the expansion structure is woven by a mixture of developable braided wires and non-developable braided wires.

11. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, The number of spiral turns of the spiral shape of the guiding structure in the expanded state is one turn or multiple turns; When the number of spiral turns is multiple turns, the outer diameter of the first spiral near the distal end of the guiding structure is smaller than the outer diameters of the remaining spirals of the guiding structure.

12. The hemangioma occlusion device according to claim 11, wherein When the number of spiral turns is multiple turns, the outer diameters of the remaining spirals of the guiding structure except the first spiral do not exceed the outer diameter of the first spiral near the distal end of the expansion structure.

13. The hemangioma occlusion device according to claim 11, wherein, When the number of spiral turns of the guiding structure is multiple turns, the outer diameter of the first spiral near the distal end of the guiding structure is not less than 2 / 3 of the outer diameters of the remaining spirals of the guiding structure.

14. The hemangioma occlusion device according to claim 13, characterized in that, When the number of turns of the guiding structure is multiple turns, the outer diameters of the remaining turns of the guiding structure except the first turn are the same.

15. The hemangioma occlusion device according to claim 14, characterized in that, When the number of turns of the guiding structure is multiple turns, the outer diameters of the remaining turns of the guiding structure except the first turn are not less than 2 / 3 of the outer diameter of the first turn of the expanding structure near the distal end.

16. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, The expanding structure and the guiding structure are integrally braided and formed.

17. A hemangioma occlusion treatment device, characterized in that, It includes the hemangioma occlusion device according to any one of claims 1-16 and a push rod connected to the proximal end of the expanding structure; the push rod extends along the tangent direction of the spiral line of the spiral shape in the unfolded state of the expanding structure.

18. A hemangioma occlusion system, characterized in that, It includes the hemangioma occlusion device according to any one of claims 1-16 and a catheter. The expanding structure is compressed in the catheter and can still recover to the unfolded state of the spiral shape after being separated from the catheter.

19. The hemangioma occlusion system according to claim 18, wherein The inner diameter of the catheter is 0.017 inches, 0.021 inches or 0.027 inches.

Images