Vascular malformation occlusion device, vascular malformation occlusion treatment device, and vascular malformation occlusion system

Abstract

The present application relates to a kind of hemangioma occlusion device, hemangioma occlusion treatment device and hemangioma occlusion system, hemangioma occlusion device includes mesh expansion structure and guide structure, the mesh expansion structure has from the unwinding state of spiral shape around from distal end to proximal end and the compressed state for being delivered from inside blood vessel to hemangioma;At least a part of the guide structure is arranged in the lumen of mesh expansion structure, and when the mesh expansion structure is in spiral shape, at least a part of the guide structure is unwound in the lumen of mesh expansion structure in spiral shape.The present application has the advantages of preventing hemangioma rupture, preventing vascular embolism, improving the coverage of tumor neck, promoting the formation of intratumoral thrombus, accelerating hemangioma embolism and the like while realizing stable and compliant tamponade.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a vascular tumor occlusion device, a vascular tumor occlusion treatment device and a vascular tumor occlusion system. BACKGROUND

[0002] An intracranial aneurysm is a pathological protrusion of the intracranial artery wall, with an incidence of 5% to 10%. MRA studies show that the incidence of unruptured aneurysms in Chinese adults aged 35 to 75 is about 7.0%. Although subarachnoid hemorrhage caused by the rupture of an intracranial aneurysm accounts for about 5% of cerebral apoplexy, the mortality rate of the first rupture is 20% to 30%, and the mortality rate of the second rupture is as high as 60%. The fundamental treatment for an aneurysm is to completely isolate the aneurysm from the blood circulation through treatment means. Current treatment methods mainly include craniotomy clipping treatment and endovascular interventional treatment. Among them, the endovascular interventional treatment method can avoid the brain tissue and directly reach the lesion, and the minimally invasive characteristics make it the mainstream of the current treatment of intracranial aneurysms. Current endovascular interventional treatment mainly includes the following:

[0003] (1) The aneurysm coil embolization is the main method for treating aneurysms at present, and its treatment principle is to change the local hemodynamic factors, promote thrombosis, and then achieve the occlusion and treatment of aneurysms. However, the shape of an aneurysm varies, and incomplete coil filling can lead to aneurysm recanalization, and excessive filling may lead to intraoperative rupture of the aneurysm, requiring high skills and experience of the doctor. Moreover, coil filling needs to be repeated multiple times, and the embolization efficiency is low, and in some cases, a stent, a balloon and a catheter are needed for assistance, which is complicated. Moreover, for wide-diameter aneurysms, the coil is easy to herniate into the parent artery, affecting blood flow, and in severe cases, it may also cause vascular stenosis.

[0004] (2) The flow diversion device is a major breakthrough in the endovascular treatment of intracranial aneurysms, which brings a new method for the treatment of complex aneurysms. Its treatment principle is to place a dense mesh stent in the parent artery, and after the reconstruction of the lumen of the diseased blood vessel, the lumen surface is reshaped through the neointima of the tumor neck surface. The application of the flow diversion device significantly improves the long-term efficacy of large and giant aneurysms, and significantly reduces the use of coils. According to the computer hemodynamic simulation analysis, when the metal coverage rate reaches 30% to 50%, the blood flow in the aneurysm lumen can be significantly reduced, and the cure rate is high. However, the application of the flow diversion device makes the patient rely on double antiplatelet therapy for a long time, and there is a risk of hemorrhagic complications after the operation. In addition, there is a certain risk of delayed rupture after treating some large aneurysms.

[0005] (3) At present, there are also some new embolic devices, which are usually made of shape memory material and shaped into spherical, cylindrical or disc-shaped, delivered through catheter, pushed out from the sheath tube after reaching the specific position, self-expanding to spherical shape, and then achieving the purpose of occluding aneurysm. For example, the first embolic device is provided, which is a spherical or cylindrical dense mesh device with rivet points at both ends. The whole device expands in the aneurysm cavity, covers the aneurysm neck through the proximal dense mesh to achieve the treatment of aneurysm. Another second embolic device is provided, which is composed of a visible wire and a peripheral self-expanding memory alloy to form a three-dimensional mesh structure. It can be released and recovered through the catheter like a spring coil, and can be spherical when filling in the aneurysm, and then play the role of turbulence. The third embolic device is provided, which is woven by double-layer nickel-titanium alloy. The fourth embolic device is provided, which is woven by double-layer memory alloy. It is disc-shaped without restriction, and will be limited to tulip shape when released in the aneurysm, which can be stable at the lower part of the aneurysm and cover the aneurysm neck, and then play the role of reconstructing hemodynamics. However, the rivet point design at the proximal end of the first embolic device makes the device a symmetrical structure, which makes the coverage of the aneurysm neck have orientation, is mainly used for treating bifurcated wide diameter aneurysm, and is especially suitable for regular aneurysm. Moreover, the rivet point design at the distal end of the first embolic device has impact on the aneurysm wall, which is easy to cause the rupture of the aneurysm wall and the bleeding of the aneurysm. And in some cases, the proximal rivet point of the first embolic device will be herniated into the parent artery due to the extrusion of the aneurysm wall, which affects the endothelialization process of the aneurysm neck. In addition, the first embolic device is usually single spherical or cylindrical, although the contact area is large, but the supporting force is insufficient, the long-term stability in the aneurysm cavity is not good, and the device is easy to shift. The second embolic device is shaped into a three-dimensional mesh structure by multiple sheet-shaped meshes, which is similar to a spherical shape. Due to the large friction between the three-dimensional mesh structure and the aneurysm wall, the stability of the device in the aneurysm is not good, and it is not easy to recover to the predetermined shape, which affects the filling effect, and the spring coil needs to be used, and the operation is complex. The third embolic device has basically the same working principle as the first embolic device, so it also has the same problems. The proximal rivet point of the fourth embolic device is also easy to be herniated into the parent artery due to the extrusion of the aneurysm wall, which is suitable for top aneurysm, and the position of the device needs to be repeatedly adjusted and placed, otherwise it will affect the stability of the device in the aneurysm, therefore, the efficiency is low. SUMMARY

[0006] In order to solve the above technical problems, the purpose of the present application is to provide a vascular tumor occlusion device, a vascular tumor occlusion treatment device and a vascular tumor occlusion system, which are used for realizing the occlusion treatment of vascular tumor, and have the advantages of realizing stable and compliant filling, preventing vascular tumor rupture, preventing vascular embolism, improving the coverage rate of aneurysm neck, promoting the formation of aneurysm thrombus, accelerating vascular tumor embolism and the like.

[0007] In order to achieve the above purpose, the vascular tumor occlusion device provided by the present application comprises:

[0008] a net-like expanded structure having an expanded state of being wound into a helical shape from a distal end to a proximal end and a compressed state for being delivered from inside a blood vessel to a hemangioma; and

[0009] a guide structure, at least a part of which is arranged in the inner cavity of the net-like expanded structure and is unwound into a helical shape in the inner cavity of the net-like expanded structure when the net-like expanded structure is wound into a helical shape.

[0010] Optionally, at least a part of the guide structure is made of a visualizing material.

[0011] Optionally, the net-like expanded structure has an expanded state of being wound into a three-dimensional helical shape from a distal end to a proximal end.

[0012] Optionally, a part of the guide structure is arranged in the inner cavity of the net-like expanded structure and another part extends out of the distal end of the net-like expanded structure.

[0013] Optionally, the part of the guide structure extending out of the distal end of the net-like expanded structure is wound into a helical shape in the expanded state.

[0014] Optionally, the part of the guide structure extending out of the distal end of the net-like expanded structure is wound into a three-dimensional helical shape.

[0015] Optionally, the guide structure is a linear structure.

[0016] Optionally, the proximal end and the distal end of the net-like expanded structure are fixedly connected with the guide structure, and the part of the guide structure arranged in the inner cavity of the net-like expanded structure has an axial length in the expanded state not less than an axial length of the net-like expanded structure in the compressed state.

[0017] Optionally, a distal end visualizing ring is fixed to the distal end of the net-like expanded structure, and / or a proximal end visualizing ring is fixed to the proximal end of the net-like expanded structure.

[0018] Optionally, the cross-sectional area of the net-like expanded structure increases first and then decreases from the proximal end to the distal end.

[0019] Optionally, the net-like expanded structure comprises a proximal end part, a middle part and a distal end part connected in sequence in the axial direction; the cross-sectional area of the proximal end part increases in sequence from the proximal end to the distal end, and / or the cross-sectional area of the distal end part increases in sequence from the distal end to the proximal end.

[0020] Optionally, the cross-sectional area of the net-like expanded structure increases first and then decreases repeatedly from the proximal end to the distal end.

[0021] Optionally, in the expanded state, the maximum outer diameter of the meshed expanded structure is not less than 1 / 4 of the maximum helical outer diameter of the meshed expanded structure.

[0022] Optionally, in the expanded state, the maximum outer diameter of the meshed expanded structure is 1 / 3 to 1 / 2 of the maximum helical outer diameter of the meshed expanded structure.

[0023] Optionally, in the expanded state, the maximum outer diameter of the meshed expanded structure is 2.0mm to 8.0mm, and the maximum helical outer diameter of the meshed expanded structure is 3.0mm to 25mm.

[0024] Optionally, the meshed expanded structure is woven by braided wires, and the material of the braided wires comprises a shape memory material.

[0025] Optionally, the outer diameter of the braided wires is 0.0005in to 0.002in, and the total number of the braided wires is 48 to 144.

[0026] Optionally, the meshed expanded structure is woven by visible braided wires, or the meshed expanded structure is woven by mixed braided wires of visible braided wires and non-visible braided wires.

[0027] Optionally, the number of the helical turns of the meshed expanded structure in the expanded state is one or more turns.

[0028] When the number of the helical turns is more than one, the outer diameter of the first helical turn close to the distal end is smaller than the outer diameter of the helical turn at the middle position.

[0029] Optionally, when the number of the helical turns is more than one, the outer diameter of the last helical turn close to the proximal end is smaller than the outer diameter of the helical turn at the middle position.

[0030] Optionally, the outer diameter of the first helical turn close to the distal end is the same as the outer diameter of the last helical turn close to the proximal end.

[0031] Optionally, the outer diameter of the first helical turn close to the distal end is 2 / 3 of the outer diameter of the helical turn at the middle position.

[0032] Optionally, when the number of the helical turns at the middle position is more than one, the outer diameters of the helical turns at the middle position are the same.

[0033] Optionally, the number of the helical turns close to the distal end of the guide structure is not less than 1 / 4 turn.

[0034] Optionally, the number of the helical turns close to the distal end of the guide structure is 1 / 4 turn to 3 turns.

[0035] Optionally, the number of turns of the helical shape of the portion of the guide structure extending out of the distal end of the meshed expanded structure in the deployed state is one or more turns.

[0036] When the number of turns is more than one, the outer diameter of the first helical turn of the guide structure near the distal end is smaller than the outer diameter of the remaining helical turns.

[0037] Optionally, when the number of turns of the helical shape of the portion of the guide structure extending out of the distal end of the meshed expanded structure in the deployed state is more than one, the outer diameter of all the helical turns of the guide structure is not more than the outer diameter of the first helical turn of the meshed expanded structure near the distal end.

[0038] Optionally, the outer diameter of the first helical turn of the guide structure near the distal end is 2 / 3 to 3 / 4 of the outer diameter of the remaining helical turns, the outer diameter of the remaining helical turns is the same, and the outer diameter of the remaining helical turns is not less than 2 / 3 of the outer diameter of the first helical turn of the meshed expanded structure near the distal end.

[0039] To achieve the above-mentioned purpose, the present application provides a hemangioma occlusion treatment device, which comprises any one of the hemangioma occlusion devices and a push rod; the push rod is connected to the proximal end of the meshed expanded structure of the hemangioma occlusion device.

[0040] Optionally, the push rod extends along the tangent direction of the helical line of the helical shape of the meshed expanded structure in the deployed state.

[0041] To achieve the above-mentioned purpose, the present application provides a hemangioma occlusion system, which comprises any one of the hemangioma occlusion devices and a catheter; the meshed expanded structure is compressed in the catheter and can restore to the deployed state of the helical shape after being separated from the catheter.

[0042] Optionally, the inner diameter of the catheter is 0.017 inches, 0.021 inches or 0.027 inches.

[0043] To achieve the above-mentioned purpose, the present application further provides a method for treating hemangioma, wherein the neck of the hemangioma leads to a blood vessel, and the method comprises:

[0044] Placing the hemangioma occlusion device in the hemangioma;

[0045] Firstly, releasing the portion of the guide structure extending out of the distal end of the meshed expanded structure in the hemangioma, so that the portion of the guide structure extending out of the distal end of the meshed expanded structure is rotated and formed along the predetermined shape in the hemangioma;

[0046] Then the meshed expanding structure is released in the hemangioma, and the meshed expanding structure continues to rotate and form in the hemangioma under the guidance of the part of the guiding structure extending out of the distal end of the meshed expanding structure, and the outer side surface of the meshed expanding structure is arranged across the neck of the hemangioma.

[0047] Optionally, the method further comprises:

[0048] The proximal end of the meshed expanding structure is located between the tumor wall of the hemangioma and the outer side surface, and the proximal end of the meshed expanding structure is parallel to the tumor wall of the hemangioma and does not herniate into the blood vessel.

[0049] Compared with the prior art, the hemangioma occlusion device, the hemangioma occlusion treatment device and the hemangioma occlusion system have the following advantages:

[0050] Firstly, the hemangioma occlusion device comprises a meshed expanding structure, which has an expanded state of being spirally wound from a distal end to a proximal end and a compressed state for being delivered from a blood vessel to a hemangioma. In this way, the frictional force acting on the meshed expanding structure when it is released in the hemangioma cavity is small, the meshed expanding structure is more stable in forming in the hemangioma, it is easier to restore the predetermined shape, and it is easier to occlude the tumor neck. On the other hand, based on the spiral configuration of the meshed expanding structure, the distal end of the device is not directed towards the tumor wall, and the proximal end of the device is bound between the outer side surface of the largest spiral of the meshed expanding structure and the tumor wall, and is parallel to (including tangent to) the tumor wall. In this way, neither the proximal end nor the distal end of the device impacts the tumor wall, avoiding the risk of rupture of the hemangioma. On the other hand, the tumor neck is occluded by the outer side surface of the largest spiral of the meshed expanding structure after the meshed expanding structure is expanded in the hemangioma, the coverage rate of the tumor neck is high, it is easier to cause intratumoral embolism, and the proximal end of the meshed expanding structure can be prevented from being located in the middle of the tumor neck or herniating into the blood vessel carrying the tumor, so as to accelerate the endothelialization of the tumor neck and avoid the risk of blood vessel stenosis.

[0051] Secondly, during the delivery process, that is, the process of being delivered from a blood vessel to a hemangioma, the meshed expanding structure and the guiding structure can be linearly shaped and loaded in a catheter for delivery, the delivery size of the device is small, it is convenient to deliver in a catheter with a small inner diameter, so as to reach more lesion positions or narrower blood vessels, and the treatment is more extensive. In particular, the spiral structure of the meshed expanding structure does not have the problem of orientation, and can be suitable for regular or irregular hemangiomas, and can also conform to the shape of the hemangioma, so as to more easily achieve occlusion of the hemangioma. In addition, the hemangioma occlusion device of the present application can achieve embolization only once, that is, without filling multiple embolization devices, the embolization efficiency is high, and the operation is simple, which can reduce the dependence on the experience of doctors during the operation, reduce the difficulty of the operation, and reduce the operation time.

[0052] Thirdly, the outer side of the largest spiral of the meshed expanding structure blocks the neck of the aneurysm, at this time, the outer diameter of the largest spiral matches the inner diameter of the aneurysm, the contact area is large, the supporting strength is high, the aneurysm blocking device can realize stable blocking, and displacement is not easy to occur. Especially when the meshed expanding structure has an expanded state of being wound into a three-dimensional spiral shape from the distal end to the proximal end, the contact area with the aneurysm wall is larger, the aneurysm blocking device is more stable in the aneurysm, and displacement is less likely to occur. At the same time, it further reduces the risk of proximal herniation of the meshed expanding structure into the aneurysm.

[0053] Fourthly, the guide structure of the aneurysm blocking device of the application is preferably partially arranged in the inner cavity of the meshed expanding structure, and the other part extends out of the distal end of the meshed expanding structure, and the part of the guide structure extending out of the distal end of the meshed expanding structure is wound into a spiral shape in the expanded state. In this way, the meshed expanding structure is guided by the spiral at the distal end of the guide structure, and the meshed expanding structure is more easily restored to a spiral shape in the aneurysm under the driving of the spiral at the distal end of the guide structure, the forming effect is better, and the entire aneurysm is more easily filled. Moreover, the spiral at the distal end of the guide structure can also reduce the pushing resistance of the meshed expanding structure, and can also buffer the release tension of the meshed expanding structure through the guide structure, reducing the impact on the aneurysm wall. Especially when at least part of the guide structure is made of a developing material, the developing and guiding are integrated on one component, the structure is simpler, and the developing components at the proximal end and the distal end of the meshed expanding structure can be omitted, or the meshed expanding structure can be prepared into a developing component, thereby improving the developing performance of the device while improving the flexibility of the meshed expanding structure, making it easier to be pushed into shape.

[0054] Fifthly, the guide structure of the aneurysm blocking device of the application is preferably a linear structure, which is relatively long and soft in structure, and causes less damage to the aneurysm wall, further reducing the risk of aneurysm rupture. In addition, the cross-sectional area of the meshed expanding structure is preferably increased and then decreased from the proximal end to the distal end, or the cross-sectional area of the expanding structure is repeatedly increased and then decreased from the proximal end to the distal end. In this way, the meshed expanding structure is constructed into a shuttle shape, i.e. both ends are small and the middle is large, which 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 meshed expanding structure is preferably fixed with a distal end developing ring, which can make the distal end of the meshed expanding structure smooth, further reducing the damage to the aneurysm wall.

[0055] Sixth, the mesh expansion structure of the vascular aneurysm occlusion device of the present application is formed by weaving a mesh with woven wires, and the diameter of the woven wires is 0.0005in-0.002in, and the number of the woven wires is 48-144. In this way, a dense mesh can be constructed, which is more likely to cause embolism in the aneurysm, and the stress on the aneurysm wall is more uniform, further reducing the risk of aneurysm rupture.

[0056] Seventh, the proximal end of the mesh expansion structure of the vascular aneurysm occlusion treatment device of the present application is connected to a push rod, and the push rod preferably extends along the tangent direction of the helical line of the spiral shape of the expansion structure in the unfolded state. In this way, the outer side of the largest spiral of the mesh expansion structure can be covered with the aneurysm neck by means of the push rod, making the operation more accurate and the covering effect better. BRIEF DESCRIPTION OF DRAWINGS

[0057] Figure 1 is a top view of the vascular aneurysm occlusion device provided by the preferred embodiment of the present application, wherein the number of spiral turns of the mesh expansion structure in the unfolded state is one, and the other part of the guide structure extends from the distal end of the mesh expansion structure and is wound into a spiral shape in the unfolded state, and the number of spiral turns of the guide structure is also one;

[0058] Figure 2 is a perspective view of the vascular aneurysm occlusion device provided by the preferred embodiment of the present application, wherein the number of spiral turns of the mesh expansion structure in the unfolded state is two, and the other part of the guide structure extends from the distal end of the mesh expansion structure and is wound into a spiral shape in the unfolded state, and the number of spiral turns of the guide structure is also two;

[0059] Figure 3a is a top view of the vascular aneurysm occlusion device provided by the preferred embodiment of the present application, wherein the number of spiral turns of the mesh expansion structure in the unfolded state is three, and the other part of the guide structure extends from the distal end of the mesh expansion structure and is wound into a spiral shape in the unfolded state, and the number of spiral turns of the guide structure is also three;

[0060] Figure 3b is Figure 3a the front view of the vascular aneurysm occlusion device shown;

[0061] Figure 4 is a diagram of the vascular aneurysm occlusion device provided by the preferred embodiment of the present application in a state of not being completely released in the aneurysm;

[0062] Figure 5 is a diagram of the vascular aneurysm occlusion device provided by the preferred embodiment of the present application in a state of being completely released in the aneurysm;

[0063] Figure 6 is a local enlarged view of the vascular aneurysm occlusion device provided by the preferred embodiment of the present application covering the aneurysm neck.

[0064] Figures:

[0065] 10 - vascular malformation occlusion device;

[0066] 11 - mesh expansion structure; 111 - distal end of mesh expansion structure; 112 - proximal end of mesh expansion structure; 113 - distal portion; 114 - middle portion; 115 - proximal portion; 116 - protrusion;

[0067] 12 - guide structure; 121 - another portion of guide structure; 122 - proximal end of guide structure; 123 - distal end of guide structure; 13 - proximal visualization ring; 14 - distal visualization ring;

[0068] 20 - push rod; 30 - vascular malformation; 40 - microcatheter;

[0069] D1 - maximum outer diameter of guide structure; D2 - maximum outer diameter of mesh expansion structure; D3 - maximum outer diameter of mesh expansion structure.

[0070] The same reference numerals in the figures indicate the same or similar components. DETAILED DESCRIPTION

[0071] To make the objects, advantages and features of the present application more clearly, the following further describes the present application in conjunction with the accompanying drawings. It should be noted that the drawings are all very simplified and use non-precise proportions, only to facilitate and clearly assist the purpose of explaining the embodiments of the present application.

[0072] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of meaning at least one of the referenced items, unless the content clearly dictates otherwise. The term "plurality" is generally employed in its sense of meaning two or more, unless the content clearly dictates otherwise. The term "number" is generally employed in its sense of meaning an indefinite quantity, unless the content clearly dictates otherwise. The term "proximal" generally refers to the end closer to the operator of the medical device, and "distal" generally refers to the end further from the operator of the device, unless the content clearly dictates otherwise.

[0073] Reference Figure 1An embodiment of the present application provides a vascular aneurysm occlusion device 10 for achieving occlusion treatment of a vascular aneurysm, including but not limited to intracranial aneurysm. The vascular aneurysm occlusion device 10 specifically includes a meshed expanding structure 11 and a guide structure 12. At least a portion of the guide structure 12 is arranged in the inner cavity of the meshed expanding structure 11. Preferably, a portion of the guide structure 12 is arranged in the inner cavity of the meshed expanding structure 11, and another portion extends out of the distal end 111 of the meshed expanding structure 11, so that the distal end portion 121 of the guide structure 12 is exposed outside the distal end of the meshed expanding structure 11.

[0074] The meshed expanding structure 11 has an expanded state of being spirally shaped from the distal end 111 to the proximal end 112 and a compressed state for being delivered from the blood vessel to the vascular aneurysm. In some embodiments, the meshed expanding structure 11 has an expanded state of being three-dimensionally spirally shaped from the distal end 111 to the proximal end 112. In other embodiments, the meshed expanding structure 11 has an expanded state of being planarly spirally shaped (i.e. planar vortex) from the distal end 111 to the proximal end 112. In addition, the guide structure 12 is configured such that when the meshed expanding structure 11 is spirally shaped, the portion of the guide structure 12 arranged in the inner cavity of the meshed expanding structure 11 and the portion of the guide structure 12 extending out of the distal end 111 of the meshed expanding structure 11 are spirally shaped. Preferably, the distal end portion 121 of the guide structure 12 is spirally shaped in the expanded state. Further, the distal end portion 121 of the guide structure 12 can be spirally shaped in a three-dimensional spiral shape or a planar spiral shape (i.e. planar vortex).

[0075] When the distal end portion 121 of the guide structure 12 is spirally shaped in the expanded state, the spiral direction of the distal end portion 121 of the guide structure 12 can be the same as or different from the spiral direction of the meshed expanding structure 11. Preferably, the spiral direction of the distal end portion 121 of the guide structure 12 is the same as the spiral direction of the meshed expanding structure 11, which is good for guiding effect and can avoid the problem of bending of the spiral at the distal end portion 121 during the pushing process, affecting the shape recovery of the meshed expanding structure 11 in the aneurysm. Further, the rotation axis of the distal end portion 121 of the guide structure 12 when spirally shaped can coincide with or not coincide with the rotation axis of the meshed expanding structure 11 when spirally shaped, without particular requirements.

[0076] In this embodiment, the meshed expanding structure 11 is configured to have a three-dimensionally spirally shaped expanded state, which is convenient for more stable support in the aneurysm and has strong anchoring force and is less likely to be displaced. Alternatively, the meshed expanding structure 11 is configured to have a planar vortex shaped expanded state, in which case the meshed expanding structure 11 is more likely to recover into a spiral shape in the aneurysm, and has good forming stability.

[0077] It should be understood that the netted expanding structure 11 and the guiding structure 12 are both elastic structures, and can be compressed under external force and recover to the original shape after the external force is removed. In more detail, the netted expanding structure 11 has a compressed state and an expanded state. When the netted expanding structure 11 is loaded in the catheter 40 (see Figure 4 ), it has the compressed state, and at this time, the netted expanding structure 11 can be compressed into a straight line shape to minimize the radial dimension, so as to be conveniently transported in the catheter 40 with small inner diameter; and after the netted expanding structure 11 is separated from the catheter 40, it expands by itself to the expanded state, and at this time, the netted expanding structure 11 recovers to the spiral shape. Similarly, the guiding structure 12 also has a compressed state and an expanded state. When the guiding structure 12 is loaded in the catheter 40 together with the netted expanding structure 11, it has the compressed state, and at this time, the guiding structure 12 is compressed synchronously with the netted expanding structure 11, for example, compressed into a straight line shape to be transported in the catheter 40; and after the guiding structure 12 is separated from the catheter 40, it also expands by itself to the expanded state, and at this time, the guiding structure 12 expands to the spiral shape, and more preferably, the distal end portion 121 of the guiding structure 12 recovers to the spiral shape.

[0078] Referring back to Figure 1 , the present application also provides a hemangioma occlusion treatment device, which comprises the hemangioma occlusion device 10 and a pushing rod 20 for pushing the hemangioma occlusion device 10. The proximal end 112 of the netted expanding structure 11 is used for detachable connection with the pushing rod 20. Alternatively, a connecting member (not shown) is additionally arranged at the proximal end 112 of the netted expanding structure 11, and used for detachable connection with the pushing rod 20. Further, when the netted expanding structure 11 is in the expanded state, the pushing rod 20 preferably extends along the tangent direction of the helical line of the netted expanding structure 11, and this design facilitates that the largest helical outer side of the netted expanding structure 11 covers the tumor neck 31 (see Figure 6 ) when the netted expanding structure 11 is pushed and released. By blocking the tumor neck 31 with the largest helical outer side of the netted expanding structure 11, on the one hand, the coverage of the tumor neck 31 is ensured, and on the other hand, the proximal end 112 of the netted expanding structure 11 is prevented from being located in the middle of the tumor neck 31 and herniated into the tumor-bearing blood vessel 50 (see Figure 5 ), so as to avoid affecting the healing of the tumor neck while preventing vascular embolism. The detachment mode of the pushing rod 20 and the proximal end 112 of the netted expanding structure 11 can adopt the heating detachment, electrolytic detachment, mechanical detachment or hydrolysis detachment of the prior art, and is not limited. The main function of the pushing rod 20 is to push the hemangioma occlusion device 10 to separate from the catheter 40, so as to realize the release of the hemangioma occlusion device 10 in the hemangioma 30.

[0079] The guide structure 12 is preferably elongated after unfolding (i.e., linear), such as a spring coil or a cut elastic tube. Therefore, the outer diameter of the guide structure 12 is much smaller than the outer diameter of the mesh expansion structure 11 after unfolding, making the guide structure 12 more slender and flexible than the mesh expansion structure 11. The main functions of the guide structure 12 are, on the one hand, to increase the support strength of the mesh expansion structure 11 by utilizing the portion of the guide structure 12 within the mesh expansion structure 11, and on the other hand, preferably to guide the mesh expansion structure 11 through the spiral of the distal portion 121, making it easier for the mesh expansion structure 11 to return to a spiral shape. Moreover, the distal portion 121 can buffer the release tension of the mesh expansion structure 11, reducing the impact on the tumor wall and reducing the pushing resistance, making pushing easier. In particular, the guide structure 12 is relatively slender and flexible, causing less damage to the tumor wall and avoiding damage to the tumor wall.

[0080] Next, combine Figure 4 to Figure 6 The following description further explains the usage of the hemangioma occlusion device 10 of the present invention. However, the following usage is not intended to limit the present invention, but is only explained as a preferred operating method.

[0081] First, the hemangioma occlusion device 10 is inserted into the catheter 40 for delivery. Before delivery, the hemangioma occlusion device 10 is inserted into the catheter 40. After insertion, the hemangioma occlusion device 10 is compressed. At this time, the mesh expansion structure 11 and the guide structure 12 are elongated and preferably straight, making the radial dimension of the entire device small, allowing delivery within the small-diameter catheter 40. Optionally, the inner diameter of the catheter 40 is 0.017 inches, 0.021 inches, or 0.027 inches. Then, as... Figure 4 As shown, once the distal end of the catheter 40 is positioned at the proximal end of the hemangioma 30, the hemangioma occlusion device 10 can be released. During the release process, the push rod 20 can be used as a means to... Figure 4 (Not shown) The guide structure 12 is pushed distally or retracted proximally, causing the distal portion 121 of the guide structure 12 to release first and rotate within the aneurysm. Because the distal portion 121 of the guide structure 12 is a slender and flexible spiral structure, the friction within the aneurysm is relatively small, making it easy to return to a spiral shape and thus rotate within the aneurysm. Further pushing then causes the mesh expansion structure 11 to release, and under the spiral guidance of the distal portion 121 of the guide structure 12, the mesh expansion structure 11 continues to rotate, with the spiral outer diameter continuously increasing until the entire aneurysm occlusion device 10 is completely filled. Figure 5In this state, the outer surface of the largest spiral of the aneurysm occlusion device 10 covers the inner side of the aneurysm neck, allowing the entire device to be stably coiled within the aneurysm 30, forming a stable and compliant occlusion. Finally, after confirming that the occlusion is correct, the push rod 20 can be electrically disengaged to separate from the proximal end 112 of the mesh expansion structure 11, and the microcatheter 40 and push rod 20 can be withdrawn, completing the embolization of the aneurysm 30. It should be explained that in Figure 4 to Figure 6 For ease of explanation, the portion of the guide structure 12 within the mesh expansion structure 11 is omitted.

[0082] like Figure 5 As shown, after embolization, the distal end of the aneurysm occlusion device 10, especially the distal end of the mesh expansion structure 11, does not face the aneurysm wall, thus having no impact on the aneurysm wall. Furthermore, the proximal end of the mesh expansion structure 11 is also bound between the outer surface of the largest spiral of the mesh expansion structure 11 and the aneurysm wall, remaining parallel to the aneurysm wall. This ensures that neither the proximal nor distal end of the entire device impacts the aneurysm wall. Simultaneously, the parts in contact with the aneurysm wall are all woven into a dense mesh, resulting in more even force distribution on the aneurysm wall and less damage. In particular, the mesh expansion structure 11 forms multiple layers of barrier within the aneurysm, effectively blocking blood flow and facilitating thrombus formation within the aneurysm, thereby accelerating aneurysm embolization. See also... Figure 6 Because the outer surface of the largest spiral of the mesh expansion structure 11 is used to block the neck of the aneurysm 30, the blockage is achieved by matching the outer surface of the largest spiral with the inner wall of the aneurysm 30. The device has good stability, and the proximal end of the device is not prone to herniation into the aneurysm-bearing vessel 50 (see...). Figure 5 It does not affect the endothelialization of the aneurysm neck, can accelerate the healing of the aneurysm neck opening, and has a good embolization effect. In particular, when the mesh expansion structure 11 is in a planar spiral shape in the unfolded state, the distal end of the device can be completely wrapped inside the mesh expansion structure 11, which makes it less likely to cause impact on the aneurysm wall and more effectively reduces the risk of aneurysm rupture.

[0083] Further, the guide structure 12 is preferably made at least partially of a radiopaque material, and more preferably the portion of the guide structure 12 disposed within the lumen of the meshed expanding structure 11 is radiopaque. The radiopacity of the guide structure 12 facilitates the determination of the position of the meshed expanding structure 11 under X-ray, and eliminates the need for additional radiopaque components, thereby simplifying the structure and providing the meshed expanding structure 11 with better flexibility and easier recovery of the helical shape within the aneurysm. Further, the guide structure 12 can be radiopaque as a whole, for example, the guide structure 12 can be made of a radiopaque material as a whole. The radiopaque material of the guide structure 12 is not limited, and can be, for example, platinum (Pt), platinum-iridium (Pt-Ir), gold (Au), platinum-tungsten (Pt-W), or the like. In some embodiments, the guide structure 12 can be made of a non-radiopaque material, such as nickel-titanium alloy or stainless steel, or the like. In one embodiment, the guide structure 12 is made by winding a wire (such as platinum-tungsten alloy, nickel-titanium alloy, or stainless steel, or the like) around a metal mandrel to form a primary coil, and the primary coil is tightly wound. Further, the distal portion 121 of the primary coil (i.e., the wire structure, which can also be referred to as a spring coil) can be shaped to form a helical guide structure 12 with a helical distal portion 121. In another embodiment, the guide structure 12 is cut from a flexible hollow tube, and then the flexible hollow tube is stretched to form an elongated structure. Preferably, the distal portion 121 of the guide structure 12 is shaped to form a helical guide structure 12 with a helical distal portion 121. In yet another embodiment, the guide structure 12 is braided to form a tube, and then the tube is stretched to form an elongated structure. Further, the distal portion 121 of the guide structure 12 can be shaped to form a helical guide structure 12 with a helical distal portion 121. It should be understood that in other embodiments, the guide structure 12 can be formed without stretching, but by braiding or cutting to form an elongated structure. Further, the distal end 123 of the guide structure 12 is preferably smooth, and for example, a hemispherical structure formed by light-cured glue can be disposed at the distal end 123 to form a smooth head to reduce damage to the aneurysm wall.

[0084] The meshed expanding structure 11 is preferably spirally wound by a braided tube. Preferably, the braided tube is formed by braided filaments with an outer diameter of 0.0005-0.002 inches and a total number of 48-144, so as to construct a dense mesh with a large grid density, effectively block the blood flow in the aneurysm, promote the formation of intramural thrombus, and make the stress on the aneurysm wall more uniform while improving the coverage of the aneurysm neck, further reducing the risk of aneurysm rupture. The material of the braided filaments includes shape memory materials, which can be metal materials with shape memory function, 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 filaments can also include polymer materials with certain shape recovery ability, such as polydioxanone (PDO), poly(lactide-co-ε-caprolactone) (PLC), polyurethane (PU), poly (norbornene) amorphous polymer, etc., or a combination of these materials. Here, the braided filaments are made of shape memory metal materials or polymer materials with certain shape recovery ability, so that the braided mesh has shape memory function to restore the original shape. Preferably, the meshed expanding structure 11 is woven by visible braided filaments, or the meshed expanding structure 11 is woven by a mixture of visible braided filaments and non-visible braided filaments. Such design can not only make the meshed expanding structure 11 itself visible under X-ray, but also ensure the elasticity of the meshed expanding structure 11, so that the meshed expanding structure 11 has strong recovery ability and the ability to maintain the original shape, and can also improve the flexibility of the meshed expanding structure 11 while eliminating the need for additional developing components. The developing material of the visible braided filaments is not particularly limited in the present application, for example, platinum (Pt), platinum-iridium (Pt-Ir), Au (gold), platinum-tungsten (Pt-W), etc. It should also be understood that when the guide structure 12 is visible, the meshed expanding structure 11 itself can be visible or not.

[0085] Further, the number of turns of the helical shape of the distal portion 121 of the guide structure 12 in the expanded state can be one or more turns. Further considering that the helical outer diameter of the distal portion 121 of the guide structure 12 is too large, it can easily affect the pushing of the meshed expanding structure 11, or affect the expansion of the meshed expanding structure 11. Therefore, when the distal portion 121 of the guide structure 12 is in the helical shape in the expanded state, the maximum helical outer diameter D1 of the distal portion 121 of the guide structure 12 is limited to not more than the outer diameter of the first helix of the meshed expanding structure 11 close to the distal end, and this condition applies to the case where the number of turns of the helical shape of the distal portion 121 of the guide structure 12 is one or more turns. Further, when the number of turns of the helical shape of the distal portion 121 of the guide structure 12 in the expanded state is more than one turn, the outer diameter of the first helix of the guide structure 12 close to the distal end is preferably smaller than the outer diameter of the remaining helices, and the outer diameter of the remaining helices of the guide structure 12 is preferably not more than the outer diameter of the first helix of the meshed expanding structure 11 close to the distal end. The outer diameter of the remaining helices of the guide structure 12 can be the same or different, preferably the same. Here, it should be understood that when the helical shape of the distal portion 121 of the guide structure 12 is a planar helix, the outer diameter of the remaining helices of the guide structure 12 is different, and when the helical shape of the distal portion 121 of the guide structure 12 is a three-dimensional helix, the outer diameter of the remaining helices of the guide structure 12 can be the same or different. Further, the outer diameter of the first helix of the guide structure 12 close to the distal end is 2 / 3 to 3 / 4 of the outer diameter of the remaining helices of the guide structure 12, and the outer diameter of the remaining helices of the guide structure 12 is preferably not less than 2 / 3 of the outer diameter of the first helix of the meshed expanding structure 11 close to the distal end. The advantage of this design is that during the release molding of the meshed expanding structure 11, space is provided for the packing of the meshed expanding structure 11, so that the helix of the distal portion 121 of the guide structure 12 does not occupy additional space, thereby avoiding affecting the release molding of the meshed expanding structure 11 in the tumor. It should be understood that the first helix of the guide structure 12 refers to the first helix wound from the distal end of the guide structure 12.

[0086] Further, the number of turns of the meshed expanding structure 11 is mainly set according to the size of the hemangioma to be treated in practice. When the number of turns of the meshed expanding structure 11 is small, it is suitable for the treatment of small hemangioma, and as the number of turns increases, larger hemangioma can be treated. In the present embodiment, the number of turns of the meshed expanding structure 11 in the spiral shape in the expanded state can be one or more, and can be selected to be one to three turns. Further, considering the case where the number of turns exceeds three, the pushing resistance of the hemangioma occlusion device 10 will increase, and the friction force formed in the tumor will also be greater, making it difficult to restore the meshed expanding structure 11 to a spiral shape. Therefore, the number of turns of the meshed expanding structure 11 in the spiral shape in the expanded state is preferably not more than three, and more preferably one to three turns.

[0087] In the present embodiment, when the number of turns of the meshed expanding structure 11 in the spiral shape in the expanded state is multiple turns, for example Figure 3b As shown in FIG. 2, the outer diameter d1 of the first spiral near the distal end of the meshed expanding structure 11 is preferably smaller than the outer diameter d2 of the spiral at the middle position of the meshed expanding structure 11, and more preferably, the outer diameter d3 of the last spiral near the proximal end of the meshed expanding structure 11 is also smaller than the outer diameter d2 of the spiral at the middle position of the meshed expanding structure 11. It should be understood that the spiral at the middle position refers to the remaining spirals other than the first spiral near the distal end and the last spiral near the proximal end. The advantage of this design is to reduce the forming resistance of the spirals of the meshed expanding structure 11 as much as possible, so that it can be better formed, while at the same time providing sufficient support force to make the hemangioma occlusion device 10 more stable, and providing space for the final packing to obtain a more dense packing effect. Preferably, the outer diameter d1 of the first spiral near the distal end of the meshed expanding structure 11 is the same as the outer diameter d3 of the last spiral near the proximal end of the meshed expanding structure 11, as shown in FIG. 2. Figure 3a and Figure 3b Further, the outer diameter d1 of the first spiral near the distal end of the meshed expanding structure 11 is 2 / 3 of the outer diameter d2 of the spiral at the middle position of the meshed expanding structure 11. In addition, when the number of spirals at the middle position of the meshed expanding structure 11 is multiple, the outer diameters d2 of the respective spirals at the middle position are preferably the same. It should also be understood that the first spiral of the meshed expanding structure 11 refers to the first spiral wound from the distal end of the meshed expanding structure 11.

[0088] For example, as shown in FIG. 2, Figure 1As shown, the distal portion 121 of the guide structure 12, when in the unfolded state, has one spiral turn, and the spiral shape of the mesh expansion structure 11, when in the unfolded state, also has one spiral turn. Preferably, the proximal end 112 and the distal end 111 of the mesh expansion structure 11 are at the same radial position and located on the same side of the spiral's rotation axis, and the spiral direction of the mesh expansion structure 11 is the same as the spiral direction of the distal portion 121 of the guide structure 12. More preferably, the maximum spiral outer diameter D1 of the guide structure 12 is 2 / 3 of the maximum spiral outer diameter D2 of the mesh expansion structure 11, and the maximum outer diameter D3 of the mesh expansion structure 11 is preferably 1 / 2 of its maximum spiral outer diameter D2. In this example, the guide structure 12 can guide the formation of the mesh expansion structure 11 within the tumor through the single spiral of the distal portion 121, and reduce damage to the tumor wall from the distal end of the mesh expansion structure 11.

[0089] Or, such as Figure 2 As shown, the distal portion 121 of the guide structure 12, when in the unfolded state, can have two spiral turns in a spiral shape. Similarly, the mesh expansion structure 11, when in the unfolded state, can also have two spiral turns in a spiral shape. In this case, the outer diameter of the first spiral near the distal end of the guide structure 12 is preferably 2 / 3 of the outer diameter of the second spiral, and the outer diameter of the second spiral of the guide structure 12 is preferably equal to the outer diameter d1 of the first spiral near the distal end of the mesh expansion structure 11. Furthermore, the outer diameter d1 of the first spiral near the distal end of the mesh expansion structure 11 is preferably 3 / 4 of the outer diameter d2 of its second spiral (i.e., the outer diameter of the largest spiral). Additionally, the maximum outer diameter D3 of the mesh expansion structure 11 is preferably 1 / 3 of its maximum spiral outer diameter D2. Compared to a single spiral, the two-spiral mesh expansion structure 11 can further improve the filling rate of hemangiomas, allowing the outer surface of the largest spiral to seal the neck of the aneurysm, increasing coverage, and can be used to treat larger hemangiomas.

[0090] Or, as Figure 3a and Figure 3bAs shown, the number of turns of the helical shape of the distal portion 121 of the guide structure 12 in the expanded state can also be three turns, and the number of turns of the helical shape of the mesh expansion structure 11 in the expanded state can also be three turns. In this case, the outer diameter of the first helix near the distal end of the guide structure 12 is preferably 2 / 3 of the outer diameter of the second helix, and the outer diameter of the second helix of the guide structure 12 is the same as the outer diameter of the third helix. More preferably, the outer diameter of the third helix of the guide structure 12 is the same as the outer diameter of the first helix near the distal end of the mesh expansion structure 11, and the outer diameter dl of the first helix near the distal end of the mesh expansion structure 11 is preferably 2 / 3 of the outer diameter d2 of the second helix, and the outer diameter d3 of the third helix of the mesh expansion structure 11 is preferably 2 / 3 of the outer diameter d2 of the second helix, i.e., the outer diameter d2 of the second helix of the mesh expansion structure 11 is the largest. In addition, the maximum outer diameter D3 of the mesh expansion structure 11 is preferably 1 / 4 of the maximum helical outer diameter D2. In this case, the mesh expansion structure 11 includes more helices, further improving the embolization rate of the hemangioma, occluding the outer side of at least one helix to the tumor neck, improving the coverage rate, and can be used to treat larger hemangiomas.

[0091] It should be understood that in the expanded state, the mesh expansion structure 11 can also include multiple turns of helices, not limited to the above-mentioned example. In addition, the number of turns of the helices of the mesh expansion structure 11 and the number of turns of the helices of the distal portion 121 of the guide structure 12 can be the same or different, and there is no requirement. It should also be understood that when the mesh expansion structure 11 includes more turns of helices, the embolization rate of the hemangioma can be further improved, and can be used to treat larger hemangiomas.

[0092] Further, when the number of turns of the helical shape of the distal portion 121 of the guide structure 12 in the expanded state is multiple turns, the outer diameter of the first helix near the distal end of the guide structure 12 is slightly smaller than the outer diameter of the remaining helices of the guide structure 12, preferably 2 / 3 to 3 / 4 of the outer diameter of the remaining helices of the guide structure 12, and the outer diameter of the remaining helices of the guide structure 12 is preferably not less than 2 / 3 of the outer diameter of the first helix near the distal end of the mesh expansion structure 11, and not more than the outer diameter of the first helix near the distal end of the mesh expansion structure 11.

[0093] Further, in the expanded state, the maximum outer diameter D3 of the meshed expanded structure 11 is preferably not less than 1 / 4 of the maximum helical outer diameter D2 of the meshed expanded structure 11, more preferably 1 / 3 to 1 / 2. This has the advantages of, on the one hand, ensuring that the outer side of the maximum helix of the meshed expanded structure 11 has sufficient friction against the tumor wall, so that the vascular malformation occlusion device 10 is not easily displaced, on the other hand, dispersing the support force of the entire vascular malformation occlusion device 10, so that the local pressure is not too large to damage the tumor wall, and on the other hand, ensuring that the outer side of the maximum helix of the meshed expanded structure 11 can completely cover the tumor neck as much as possible, improving the coverage rate of the tumor neck and accelerating the thrombosis in the tumor. In this embodiment, the maximum helical outer diameter D2 of the meshed expanded structure 11 is mainly set according to the size of the vascular malformation to be treated, for example, the maximum outer diameter D3 of the meshed expanded structure 11 can be 2.0mm to 8.0mm, and the maximum helical outer diameter D2 can be 3.0mm to 25mm.

[0094] Further, the proximal end 112 and the distal end 111 of the meshed expanded structure 11 are preferably fixedly connected with the guide structure 12, so as to better push the meshed expanded structure 11. Preferably, the part of the guide structure 12 arranged in the inner cavity of the meshed expanded structure 11 has an axial length after expansion which is not less than the axial length of the meshed expanded structure 11 in the compressed state, so as to ensure that the meshed expanded structure 11 can be smoothly compressed and expanded without being restricted by the guide structure 12.

[0095] Further, the proximal end 112 of the meshed expanded structure 11 is fixed with a proximal end developing ring 13. On the one hand, the position of the proximal end 112 of the meshed expanded structure 11 can be confirmed by developing the proximal end developing ring 13 under X-ray, thereby improving the developing property of the device, and on the other hand, the ends of each braided wire of the meshed expanded structure 11 can be hidden in the proximal end developing ring 13, thereby reducing the damage to the tumor wall. Further, the distal end 111 of the meshed expanded structure 11 is fixed with a distal end developing ring 14 (see Figure 1 ). On the one hand, the position of the distal end 111 of the meshed expanded structure 11 can be confirmed by developing the distal end developing ring 14 under X-ray, thereby improving the developing property of the device, and on the other hand, the ends of each braided wire of the meshed expanded structure 11 can be hidden in the distal end developing ring 14, thereby reducing the damage to the tumor wall. Optionally, the proximal end developing ring 13 is bonded together with the proximal end 112 of the meshed expanded structure 12 and the proximal end 122 of the guide structure 12 by glue. Similarly, the distal end developing ring 14 can also be bonded together with the distal end 111 of the meshed expanded structure 12 and the guide structure 12 by glue. It should be understood that when the meshed expanded structure 11 itself is developable or the guide structure 11 is developable, either the proximal end developing ring 13 and / or the distal end developing ring 14 can be provided or the proximal end developing ring 13 and / or the distal end developing ring 14 can be cancelled.

[0096] In the embodiment, the cross-sectional area of the meshed expansion structure 11 preferably increases first and then decreases from the proximal end 112 to the distal end 111, which can be specifically referred to Figure 1 and Figure 2 At this time, the outer diameter of the meshed expansion structure 11 is non-uniform. Further, the meshed expansion structure 11 comprises a distal end portion 113, a middle portion 114 and a proximal end portion 115 connected in sequence in the axial direction; wherein the cross-sectional area (or the outer diameter) of the distal end portion 113 preferably increases from the distal end 111 to the middle portion 114 in sequence, and / or the cross-sectional area (or the outer diameter) of the proximal end portion 115 preferably increases from the proximal end 112 to the middle portion 114 in sequence. In other embodiments, the cross-sectional area of the expansion structure 11 can repeatedly increase first and then decrease from the proximal end 112 to the distal end 111, that is, repeatedly increase and decrease. Such a design facilitates the meshed expansion structure 11 to be constructed into a shuttle-shaped mesh body, that is, small at both ends and large in the middle, so as to be more convenient to compress, and the compression size is smaller. On the other hand, the flexibility of the vascular tumor occlusion device is also improved, the pushing resistance is further reduced, and the impact on the tumor wall is reduced. Moreover, the distal end portion 113 of the meshed expansion structure 11 can also play a guiding role, so that the meshed expansion structure 11 is easier to form. In addition, the meshed expansion structure 11 has a larger mesh density at the distal end portion 113 and the proximal end portion 115, and especially when the mesh density of the distal end portion 113 is large, the strength of the vascular tumor occlusion device 10 is better, the support stability of the spiral inside is better, and the displacement is less likely to occur. In addition, the present application does not require the distribution of the mesh density of the middle portion 114 of the meshed expansion structure 11, for example, the mesh density of the middle portion 114 can be uniform or non-uniform.

[0097] It should be understood that the distal portion 121 of the guiding structure 12 can also be wound into a planar spiral shape, and the meshed expanding structure 11 can also be wound into a planar spiral shape, in which case the spiral direction of the distal portion 121 of the guiding structure 12 is the same as that of the meshed expanding structure 11, and preferably both are in the same rotation plane. In addition, when the meshed expanding structure 11 is wound into a planar spiral shape, a protrusion is preferably provided at the proximal end 112 of the meshed expanding structure 11, so as to increase the friction between the meshed expanding structure 11 and the tumor wall, improve the stability of the device, and at the same time reduce the risk of herniation of the proximal portion 115 and the risk of vascular embolism, and also improve the coverage of the tumor neck and accelerate the embolism in the tumor. The protrusion can be a circumferentially continuous closed ring, i.e., a plurality of convex structures distributed continuously in the circumferential direction form a protrusion. Alternatively, the protrusion is a circumferentially discontinuous closed ring, i.e., a plurality of convex structures distributed intermittently in the circumferential direction form a protrusion. Alternatively, the protrusion extends in a non-closed ring shape along the circumferential direction of the proximal portion 115, such as a 1 / 4 ring, a half ring or a 3 / 4 ring. In addition, when the distal portion 121 of the guiding structure 12 is also wound into a planar spiral shape, the outer diameter of the largest spiral of the guiding structure 12 is preferably not more than the outer diameter of the first spiral near the distal end of the meshed expanding structure 11, so as to avoid affecting the pushing and forming of the meshed expanding structure 11, and preferably the outer diameter of the largest spiral of the guiding structure 12 is not less than 2 / 3 of the outer diameter of the first spiral near the distal end of the meshed expanding structure 11, so as to enhance the support force of the entire device. In addition, the adjacent spirals of the planar spiral meshed expanding structure 11 are preferably in contact with each other, which is better for forming and easier to control the size of the plug.

[0098] Further, the embodiment of the present application also provides a vascular tumor occlusion system, which comprises the vascular tumor occlusion device 10 and a catheter 40, and the meshed expanding structure 11 is compressed in the catheter 40 and can restore the expanded state of the spiral shape after being separated from the catheter 40.

[0099] Finally, it should be noted that the preferred embodiment of the present application is as described above, but is not limited to the scope disclosed in the above embodiment, for example, the present application does not limit the number of spirals of the meshed expanding structure 11 in the expanded state, and does not limit the number of spirals of the guiding structure 12 in the expanded state, and for example, the present application does not limit the outer diameter of the largest spiral of the meshed expanding structure 11 in the expanded state, and does not limit the length of the guiding structure 12 provided in the meshed expanding structure 11, etc. It should also be noted that in other embodiments, the guiding structure 12 is entirely provided in the lumen of the meshed expanding structure 11.

[0100] Thus, according to the technical scheme provided by the embodiment of the present application, the hemangioma occlusion device of the present application is easier to achieve occlusion of the tumor neck, and the distal end and the proximal end of the device will not impact the tumor wall, avoiding the risk of hemangioma rupture, and at the same time, the coverage rate of the tumor neck is high, which is more likely to cause intratumoral embolism, and can also avoid the situation that the proximal rivet point of the expansion structure is located in the middle of the tumor neck or herniates into the blood vessel carrying the tumor, thereby accelerating the endothelialization of the tumor neck, and also avoiding the risk of blood vessel stenosis.

[0101] The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application in any way. Any modification or change made by a person skilled in the art according to the above disclosure is within the scope of protection of the present application.

Claims

1. A hemangioma occlusion device, characterized in that, include: A reticular expansion structure, having an expanded state in a spiral shape from distal to proximal and a compressed state for delivery from within the blood vessel to the hemangioma, wherein the outer surface of the largest spiral of the reticular expansion structure after expansion within the hemangioma is located at the neck of the hemangioma, capable of covering and sealing the neck of the hemangioma, and the outer diameter of the largest spiral of the reticular expansion structure matches the inner diameter of the hemangioma; and, A guide structure, a portion of which is disposed within the inner cavity of the mesh expansion structure, and another portion extending from the distal end of the mesh expansion structure, wherein when the mesh expansion structure is spiral-shaped, the portion of the guide structure disposed within the inner cavity of the mesh expansion structure and the distal portion extending from the distal end of the mesh expansion structure unfold into a spiral shape, and the spiral direction of the distal portion is the same as the spiral direction of the mesh expansion structure; the guide structure is a spring coil or a cut elastic tube; The outer diameter of the guide structure is much smaller than the outer diameter of the mesh expansion structure after unfolding, making the guide structure more slender and flexible relative to the mesh expansion structure; the distal portion has one or more spiral turns in the unfolded state; when the distal portion has one spiral turn in the unfolded state, the outer diameter of the spiral of the distal portion does not exceed the outer diameter of the first spiral near the distal end of the mesh expansion structure; when the distal portion has multiple spiral turns in the unfolded state, the outer diameter of the first spiral near the distal end of the guide structure is 2 / 3 to 3 / 4 of the outer diameter of the remaining spirals, the outer diameter of the remaining spirals of the distal portion does not exceed the outer diameter of the first spiral near the distal end of the mesh expansion structure, and the outer diameter of the remaining spirals of the distal portion is not less than 2 / 3 of the outer diameter of the first spiral near the distal end of the mesh expansion structure.

2. The hemangioma occlusion device according to claim 1, characterized in that, The mesh-like expanded structure has an unfolded state in which it winds into a three-dimensional spiral shape from the distal end to the proximal end.

3. The hemangioma occlusion device according to claim 1, characterized in that, At least a portion of the guide structure is made of a developing material.

4. The hemangioma occlusion device according to claim 1, characterized in that, The guide structure extends from the distal end of the mesh expansion structure and is wound into a three-dimensional spiral shape.

5. The hemangioma occlusion device according to claim 1, characterized in that, The guide structure is a linear structure.

6. The aneurysm occlusion device according to any one of claims 1-3, characterized in that, Both the proximal and distal ends of the mesh expansion structure are fixedly connected to the guide structure, and the portion of the guide structure disposed in the inner cavity of the mesh expansion structure has an axial length after unfolding that is not less than the axial length of the mesh expansion structure in the compressed state.

7. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, The distal end of the reticular expansion structure is fixed with a distal imaging ring, and / or the proximal end of the reticular expansion structure is fixed with a proximal imaging ring.

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

9. The hemangioma occlusion device according to claim 8, characterized in that, The mesh-like expanded structure includes a proximal portion, a middle portion, and a distal portion connected axially in sequence; 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.

10. The hemangioma occlusion device according to claim 8, characterized in that, The cross-sectional area of ​​the mesh-like expanded structure repeatedly increases and then decreases from the proximal end to the distal end.

11. The hemangioma occlusion device according to any one of claims 1-3, characterized in that, In the unfolded state, the maximum outer diameter of the mesh expansion structure is not less than 1 / 4 of the maximum spiral outer diameter of the mesh expansion structure.

12. The hemangioma occlusion device according to claim 11, characterized in that, In the unfolded state, the maximum outer diameter of the mesh expansion structure is 1 / 3 to 1 / 2 of the maximum spiral outer diameter of the mesh expansion structure.

13. The aneurysm occlusion device according to any one of claims 1-3, characterized in that, The mesh-like expanded structure is woven from braided filaments, the material of which includes shape memory materials.

14. The hemangioma occlusion device according to claim 13, characterized in that, The outer diameter of the braided yarn is 0.0005in to 0.002in, and the total number of braided yarns is 48 to 144.

15. The hemangioma occlusion device according to claim 13, characterized in that, The mesh-expanded structure is woven from developable braided yarns, or the mesh-expanded structure is woven from a mixture of developable and non-developable braided yarns.

16. The aneurysm occlusion device according to any one of claims 1-3, characterized in that, The number of spiral turns in the spiral shape of the expanded mesh structure in the unfolded state is one or more turns; When the number of spiral turns is multiple, the outer diameter of the first spiral near the far end of the mesh expansion structure is smaller than the outer diameter of the spiral in the middle position.

17. The hemangioma occlusion device according to claim 16, characterized in that, When the number of spiral turns is multiple, the outer diameter of the last spiral near the proximal end of the mesh expansion structure is smaller than the outer diameter of the spiral in the middle position.

18. The hemangioma occlusion device according to claim 16, characterized in that, The outer diameter of the first spiral near the distal end of the spiral-shaped mesh expansion structure in the unfolded state is the same as the outer diameter of the last spiral near the proximal end.

19. The hemangioma occlusion device according to claim 16, characterized in that, The outer diameter of the first spiral near the distal end of the spiral in the unfolded state of the mesh expansion structure is 2 / 3 of the outer diameter of the spiral in the middle position.

20. The hemangioma occlusion device according to claim 1 or 4, characterized in that, The remaining spirals in the distal portion have the same outer diameter.

21. A device for occluding and treating hemangiomas, characterized in that, The device includes a hemangioma occlusion device and a push rod as described in any one of claims 1-20, wherein the push rod is connected to the proximal end of the mesh expansion structure of the hemangioma occlusion device, and the push rod extends in the tangential direction of the spiral line of the mesh expansion structure in the spiral shape when it is in the unfolded state.

22. A hemangioma occlusion system, characterized in that, The device includes a hemangioma occlusion device and catheter as described in any one of claims 1-20, wherein the mesh expansion structure is compressed within the catheter and can return to a spiral-shaped unfolded state after being removed from the catheter.

23. The hemangioma occlusion system according to claim 22, characterized in that, The inner diameter of the catheter is 0.017 inches, 0.021 inches, or 0.027 inches.

Images