CN115474981A

CN115474981A - Occlusion device and occlusion system

Info

Publication number: CN115474981A
Application number: CN202110604710.5A
Authority: CN
Inventors: 郭爽; 常孟琪; 钱少君; 陈冰; 卢惠娜
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2021-05-31
Filing date: 2021-05-31
Publication date: 2022-12-16

Abstract

The invention provides a plugging device and a plugging device, wherein the plugging device comprises: two ends, at least two support structures, and a cover film; the two end parts are arranged at two ends of the plugging device along the axial direction; the at least two support structures are circumferentially arranged around the axis of the plugging device, and two ends of the at least two support structures are respectively converged at one end part; the support structure is transitionable between an expanded state and a contracted state; the support structure protrudes radially outward of the occlusion device when the support structure is in the expanded state; the covering film is coated outside the at least two supporting structures and used for contracting or expanding along with the state conversion of the supporting structures. So set up for the dependence of plugging device to doctor's technique is low, and treatment effeciency is high, easy operation, and the operation is with low costs, need not to take the dual-antibody for a long time, and can also realize non-oriented shutoff, can treat apical aneurysm and lateral wall aneurysm.

Description

Occlusion device and occlusion system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a plugging device and a plugging system.

Background

Intracranial aneurysms are pathological protuberances of the wall of an intracranial artery. The fundamental treatment of intracranial aneurysms is to completely isolate the aneurysm from the blood circulation by therapeutic means. At present, the treatment means mainly comprise intravascular interventional treatment, and the following treatment means mainly comprise the following treatment methods:

(1) The treatment of the coil spring ring for embolization in the cavity of the aneurysm is a main method for treating the aneurysm at present, and the treatment principle of the coil spring ring promotes thrombosis by changing local hemodynamic factors, so that the aneurysm plugging and treatment are realized. However, aneurysms vary in morphology, incomplete occlusion with coils results in recanalization of the aneurysm, while over-occlusion results in ineffective embolization, possibly even rupture of the aneurysm, and these also require long term skill and experience accumulation by physicians. Moreover, coil packing requires repeated packing, is complex and expensive to operate, and is prone to herniation of aneurysms when used alone.

(2) The blood flow guiding device is used as a swelling breakthrough of intracranial aneurysm blood vessel treatment, and brings a brand-new method for treating complex aneurysm, the treatment principle is that a dense mesh stent is arranged on a parent artery, after the intracavity of a diseased blood vessel is reconstructed, the inner surface of the blood vessel cavity is reshaped through a neovascular intima on the surface of a tumor neck. The application of the blood flow guiding device obviously improves the long-term curative effect of large and huge aneurysms, and greatly reduces the use of spring rings. The computer hemodynamics simulation analysis shows that when the metal coverage rate reaches 30-50%, the blood flow in the aneurysm cavity can be obviously reduced. However, the use of blood flow directing devices has led patients to rely on dual anti-platelet therapy for long periods of time, with the risk of postoperative bleeding complications. In addition, there is a risk of delayed rupture after treatment of a portion of a large aneurysm.

(3) Still other occlusion systems, typically made of shape memory materials and pre-shaped, are delivered through a catheter, pushed out of the sheath after reaching a specific location, and self-expand to a pre-shaped configuration to achieve the purpose of occluding the aneurysm. The main principle of the device is similar to that of a blood flow guiding device, and the reconstruction of the inner surface of a blood vessel cavity is realized through the obstruction of blood flow. However, in these occlusion systems, due to the different sizes of the metal meshes, the blood flow blockage at the neck of the aneurysm has orientation, the proximal structure may herniate into the parent artery, the location of the occlusion needs to be repeatedly adjusted and placed, and the occlusion system is suitable for the bifurcation aneurysm and the apical aneurysm, is not suitable for the side wall aneurysm, and affects the stability of the occlusion system in the aneurysm. In addition, the distal end structure is relatively sharp, can bring great impact for weak aneurysm top, and the protruding structure of near-end also can be because the tumour wall extrusion and the hernia is gone into the parent artery in, disturbs the blood flow, influences the endothelialization process of tumour neck. Moreover, the internal cavity of such occlusion systems is usually large, and the stability of the occlusion systems is affected under the action of the water hammer of blood, and the internal cavity of the occlusion systems has small resistance to the flow of blood in the aneurysm, so that the formation of thrombus in the aneurysm is not facilitated.

Therefore, there is a need to develop a new occlusion device to solve at least the above problems.

Disclosure of Invention

The invention aims to provide a plugging device and a plugging system, which are used for solving the problems that the existing aneurysm treatment efficiency is low, the dependence on doctor technology is strong, the operation is complex, the cost is high, a patient needs to take double antibodies for a long time, the plugging device has orientation on the blockage of blood flow, and the plugging device is not suitable for treating the side wall aneurysm.

In order to solve the above technical problem, the present invention provides a plugging device and a plugging device, including: two ends, at least two support structures, and a cover film; the two end parts are arranged at two ends of the plugging device along the axial direction; the at least two support structures are arranged circumferentially around the axis of the occlusion device, and two ends of the at least two support structures are respectively converged at one end part; the support structure is transitionable between an expanded state and a contracted state; the support structure protrudes radially outward of the occlusion device when the support structure is in the expanded state; the covering film is coated outside the at least two support structures and used for contracting or expanding along with the state conversion of the support structures.

Optionally, a single support structure comprises at least one support wire, and at least one support wire is knitted.

Optionally, a single support structure comprises at least two support filaments, and at least two support filaments in the single support structure are twisted with each other.

Optionally, at least two of the support filaments of a single support structure are uniformly twisted.

Optionally, the support wires of a single support structure form at least one closed loop structure.

Optionally, the two end portions respectively comprise a first developing part and a second developing part; the first developing part is of a sheet structure, the sheet structure comprises at least two holes, and the far end of each supporting structure is connected with the first developing part; the proximal end of the support structure is coupled to the second visualization element.

Optionally, a single support structure includes at least two support wires, at least two support wires in the single support structure are twisted with each other, the sheet-like structure includes an even number of holes, the support wires are respectively inserted into two holes diagonally arranged, and adjacent support wires that are not the same are twisted and fixed, so that at least one closed loop is formed between the support wires that are not the same.

Optionally, the maximum dimension of the closed loop in the axial direction of the occlusion device is not less than one half of the maximum dimension of the support structure in the axial direction of the occlusion device.

Optionally, when the at least two support structures are in the expanded state, the second developing part is recessed towards the inside of the at least two support structures, so that the recessed depth of the second developing part is not less than the length of the second developing part along the axial direction of the blocking device.

Optionally, the coating has a porous structure, and pores of the porous structure are uniformly distributed.

Optionally, the cover film is sewn, dip-formed or electrostatically woven onto the at least two support structures.

In order to solve the above technical problem, the present invention further provides a plugging system, including: the occlusion device, the sheath and the push-pull device as described above; the plugging device is movably arranged in the sheath tube in a penetrating way; the push-pull device is connected with the proximal end of the plugging device and is used for moving the position of the plugging device relative to the sheath; when the blocking device is in the sheath, the blocking device is in a telescopic state; when the occluding device is outside the sheath, the occluding device is in an expanded state.

In the present invention, there are provided an occlusion device and an occlusion device, the occlusion device including: two ends, at least two support structures, and a cover film; the two end parts are arranged at two ends of the plugging device along the axial direction; the at least two support structures are circumferentially arranged around the axis of the plugging device, and two ends of the at least two support structures are respectively converged at one end part; the support structure is transitionable between an expanded state and a contracted state; the support structure protrudes radially outward of the occlusion device when the support structure is in the expanded state; the covering film is coated outside the at least two support structures and used for contracting or expanding along with the state conversion of the support structures. So set up for the dependence of plugging device to doctor's technique is low, and treatment efficiency is high, easy operation, and the operation cost is low, need not to take the dual-antibody for a long time, and can also realize non-oriented shutoff, can treat apical aneurysm and lateral wall aneurysm.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:

figure 1 is a top view of an occluding device of a first embodiment of the present invention in an expanded state.

Figure 2 is a front view of an occluding device of a first embodiment of the invention in an expanded state.

Fig. 3 is a schematic view of an occluding device in a contracted state according to a first embodiment of the invention.

Figure 4 is a top view of an occluding device of a second embodiment of the present invention in an expanded state.

Figure 5 is a front view of an occluding device of a second embodiment of the present invention in an expanded state.

Figure 6 is a top view of an occluding device of a third embodiment of the present invention in an expanded state.

Figure 7 is a front view of an occluding device of a third embodiment of the present invention in an expanded state.

Fig. 8 is a schematic view of the first developing device according to the third embodiment of the present invention.

In the drawings:

a-a push-pull device;

b-a sheath;

100-end, 110-first developing member, 111-hole, 120-second developing member;

200-support structure, 210-support wires, 211-first support wires, 212-second support wires, 213-third support wires;

300-coating.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are intended to be part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

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 including "and/or" unless the content clearly dictates otherwise. The terms "a number of" are generally used in a sense including "at least one," the terms "at least two" are generally used in a sense including "two or more," furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features and the terms "mounted", "connected" and "connected" are to be construed broadly and may be, for example, a fixed connection, a detachable connection or an integral part; either directly or indirectly through intervening media, either internally or in any other relationship. The "distal end" refers to the end distal to the caregiver's operation and the "proximal end" refers to the end proximal to the caregiver's operation. In addition, as used in the present invention, the arrangement of one element in another element generally only means that there is a connection, coupling, fit or transmission relationship between the two elements, and the connection, coupling, fit or transmission between the two elements may be direct or indirect through an intermediate element, and cannot be understood as indicating or implying a spatial positional relationship between the two elements, i.e. one element may be in any orientation of the inside, outside, above, below or one side of another element, unless the content clearly indicates otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the invention.

The embodiment of the invention provides a plugging device and a plugging device, wherein the plugging device comprises: two ends, at least two support structures, and a cover film; the two end parts are arranged at two ends of the plugging device along the axial direction; the at least two support structures are circumferentially arranged around the axis of the plugging device, and two ends of the at least two support structures are respectively converged at one end part; the support structure is transitionable between an expanded state and a contracted state; the support structure protrudes radially outward of the occlusion device when the support structure is in the expanded state; the covering film is coated outside the at least two supporting structures and used for contracting or expanding along with the state conversion of the supporting structures. So set up for the dependence of plugging device to doctor's technique is low, and treatment effeciency is high, easy operation, and the operation is with low costs, need not to take the dual-antibody for a long time, and can also realize non-oriented shutoff, can treat apical aneurysm and lateral wall aneurysm.

The following description refers to the accompanying drawings.

[ EXAMPLES one ]

Figure 1 is a top view of an occluding device of a first embodiment of the present invention in an expanded state. Figure 2 is a front view of an occluding device of a first embodiment of the invention in an expanded state. Fig. 3 is a schematic view of an occluding device in a contracted state according to a first embodiment of the invention.

Referring to fig. 1 to fig. 3, the plugging device provided in this embodiment can be used for treating an aneurysm, for example, an intracranial saccular aneurysm. The occlusion device comprises: two end portions 100, at least two support structures 200, and a cover film 300.

As shown in fig. 2, two end portions 100 are provided at both ends of the occlusion device in the axial direction. The two ends 100 may be, for example, the proximal and distal ends of the occluding device. The at least two support structures 200 are circumferentially arranged around the axis of the occlusion device, and two ends of the at least two support structures 200 respectively converge at one end, for example, the distal ends of the at least two support structures 200 converge at the distal end, and the proximal ends of the at least two support structures 200 converge at the proximal end, so that the at least two support structures 200 circumferentially arranged can be in the form of a fusiform skeleton. Understandably, the axial direction and the axial line of the plugging device are the directions which are the same as the axial direction of the blood vessel when the plugging device is loaded into the blood vessel. Preferably, the two support structures 200 may be symmetrically disposed along the axis, so that the skeleton of the support structure 200 can be a symmetrical structure, and the metal coverage rate of each part is the same, thereby simplifying the filling process without excessive position adjustment, and improving the plugging efficiency. Preferably, the number of the supporting structures 200 may be between 3 and 8, so as to ensure the supporting force of the supporting framework formed by the supporting structures 200.

As shown in fig. 1 and 3, the support structure 200 transitions between an expanded state and a contracted state. When the support structure 200 is in the expanded state, the support structure 200 bulges outward in a radial direction of the occlusion device. Preferably, the radially outward convex dimension of the support structure 200 is not greater than half of the distance between the proximal end and the distal end, so that the support structure 200 has high occlusion efficiency and less damage to the blood vessel. More preferably, the radially outward protruding dimension of the support structure 200 is equal to half of the distance between the proximal end and the distal end, so that the support structure 200 is a spherical skeleton, and compared with a fusiform skeleton, the support structure 200 having the spherical skeleton has a smaller volume, a spherical structure is mellow and non-oriented, the plugging efficiency is higher, and the damage to the blood vessel is smaller.

As shown in fig. 1 to 3, the covering film 300 is wrapped outside at least two of the support structures 200 and is used for contracting or expanding along with the state transition of the support structures 200. Specifically, when the supporting structure 200 is in the expanded state, the covering membrane 300 is extended, and when the supporting structure 200 is in the expanded state, the covering membrane 300 is contracted, so that when the supporting structure 200 is in the expanded state, the arrangement of the supporting structure 200 and the covering membrane 300 of the plugging device realizes intra-tumor support, so that the covering membrane 300 can obstruct blood flow, prevent the blood flow from entering the aneurysm, and further achieve the purpose of treating the aneurysm. So make plugging device can not get into the parent artery, avoid adopting blood flow guider, and then make the patient need not to rely on dual antiplatelet treatment for a long time, and then need not to take dual resistance for a long time. In addition, unlike the currently used occlusion system in which a metal mesh is provided, the stent 300 can achieve non-oriented occlusion, and can be applied to the treatment of apical aneurysm and side wall aneurysm. The arrangement of the covering film 300 can also provide a scaffold structure for cell growth, thereby realizing the treatment of the aneurysm. The cover 300 is preferably a porous structure, for example. More preferably, it is a porous film, for example. More preferably, the coating film 300 is, for example, a micro-nano composite porous film. The cover film 300 is made of, for example, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET) nonwoven film, polyurethane (PU), polycaprolactone (PCL), or poly (lactide-co-caprolactone) (PLC). In this embodiment, the membrane 300 is expanded polytetrafluoroethylene (ePTFE). The porosity of the porous structure of the coating 300 is between 50% and 80%, the pore diameter is between 50nm and 500 μm, and the thickness of the porous membrane can be selected between 5 μm and 100 μm. The skilled person can adjust the size of the gaps and the density of the cover film 300 according to the actual requirements, so that the cover film can provide a scaffold for cell growth while blocking blood flow, thereby promoting the healing of the aneurysm.

Preferably, a single support structure 200 includes at least one support wire 210, and at least one support wire 210 is braided. The support structure 200 includes at least one support filament 210, for example, and one support filament 210 is woven by bending or winding the filament structure to form the support structure 200. The support structure 200 may further include two or more support wires 210, and the support structure 200 is formed by the two or more support wires 210 through inter-woven wires.

Further, as shown in fig. 1 to 3, the two end portions 100 include a first developing part 110 and a second developing part 120, respectively. The first visualization element 110 is, for example, located at the distal end of the occlusion device and the second visualization element 120 is, for example, located at the proximal end of the occlusion device. The first developing part 110 and the second developing part 120 have a developing function. The first developing device 110 has a sheet structure including at least two holes 111, and a distal end of each of the supporting structures 200 is connected to the first developing device 110. The sheet structure can be square sheet, and also can be round, triangular, trapezoidal and polygonal sheet, so that the sheet structure is arranged compared with a sharp far end, the sheet structure can be more suitable for fragile blood vessels and aneurysms, the plugging device is further isotropic in all directions, the influence of far-end riveting points on the aneurysms is reduced, and the plugging device can be plugged with the aneurysm of a top bifurcation part and the aneurysm of a side wall. Preferably, the sheet structure can also be in a petal shape, so that the sheet structure is in an arc-shaped curve design, and the sheet structure is more suitable for fragile blood vessels and aneurysms. As shown in fig. 2 and 3, the sheet-like structure makes the plugging device more gentle to the top of the blood vessel and the aneurysm, and avoids the impact of the distal end on the top of the weak aneurysm. The sheet structure comprises holes 111, the holes 111 being used for connection and fixation of the support structure 200. Specifically, the support structure 200 includes, for example, support wires 210, and one support wire 210 is inserted into one hole 111, so that the support wire 210 has a fixed point. The proximal end of the support structure 200 is connected to the second visualization member 120 such that the proximal end of the support structure 200 can be captively fixed by the second visualization member 120. The second developing member 120 is, for example, a ring, and the supporting structure 200 is connected to the ring, and specifically, the supporting structure 200 includes at least one supporting wire 210, and each supporting wire 210 is connected to the ring. Preferably, the supporting structure 200 is fixedly connected with the second developing device 120. Of course, the number of the holes 111 of the first developing part 110 may be plural, for example, 3, 4, or 5, and preferably, the number of the holes 111 may be any one of 3 to 8. As shown in fig. 1, in the first embodiment, the number of the holes 111 is preferably 4, and the sheet structure has four vertexes, and each of the four vertexes includes one hole 111. Preferably, in the first embodiment, the number of the holes 111 is preferably the same as the number of the support structures 200, and one support structure 200 corresponds to one hole 111. Of course, in other embodiments, the number of the holes 111 and the number of the supporting structures 200 may not correspond, for example, two holes 111 are respectively disposed on one supporting structure 200. The skilled person can arrange the number of holes 111 according to the actual situation and select the relation of the number between the holes 111 and the support structure 200 according to the actual situation. The shape of the hole 111 may be a circular hole, a triangular hole, a square hole, etc., and those skilled in the art can select the shape according to practical situations, which is not limited herein.

Further, as shown in fig. 2, when the at least two support structures 200 are in the expanded state, the second visualization component 120 is recessed toward the inside of the at least two support structures 200, so that the recessed depth of the second visualization component 120 is not less than the axial length of the second visualization component 120 along the occlusion device, and further, the second visualization component 120 is prevented from protruding out of the skeleton of the support structures 200, and the proximal end of the occlusion device is prevented from herniating into the parent artery due to the extrusion of the tumor wall and interfering with blood flow, and further, the endothelialization process of the tumor neck is prevented from being affected. In addition, the second developing component 120 is arranged in a concave manner, so that the plugging device is not oriented, the operation time of a doctor is shortened, and the operation efficiency and the treatment efficiency are improved.

Preferably, as shown in fig. 1, a single support structure 200 includes at least two support filaments 210, and at least two support filaments 210 in the single support structure 200 are twisted with each other. In the first embodiment, the blocking device includes 4 supporting structures 200, the sheet structure of the first developing wire 110 includes 4 holes 111, and each supporting structure 200 corresponds to one hole 111. Each of the support structures 200 includes two support wires 210, the two support wires 210 are respectively connected with the corresponding holes 111, and the two support wires 210 are twisted with each other to form a structure for mutually reinforcing the rigidity of the support wires 210, so that the strength of the support structure 200 is ensured, and the support force of the support structure 200 is improved. It is understood that the twisting means that at least two of the support wires 210 can be twisted with each other, and the stress condition between at least two of the support wires 210 is similar. For example, two support wires 210 are twisted together, and the force between the two support wires 210 is the same. It should be understood that the two support wires 210 may be tightly wound, and the gap between the two support wires 210 is small, so as to ensure the rigidity of the support structure 210; the winding gaps of the two supporting wires 210 can also have gaps, so that the metal coverage rate of the supporting framework of the supporting structure 210 is increased, and the framework supporting force is improved. Of course, in other embodiments, a person skilled in the art may include a single support wire 210 for a single support structure 200, as the case may be. Preferably, the filament diameter of each strut wire 210 may be between 0.0005 inches and 0.003 inches, thereby allowing the strut wires 210 to have a thinner filament diameter, thereby allowing the strut structure 210 to be smaller in size, thereby allowing access to a thinner sheath B and into a thinner blood vessel. Preferably, the material of the support wire 210 may be selected from metals with shape memory function, such as nickel titanium (Ni-Ti) alloy, nickel titanium cobalt (Ni-Ti-Co) alloy, etc.; polymeric materials having shape recovery such as Polydioxanone (PDO), (lactide-epsilon-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymers, and the like may also be selected.

Preferably, at least two of the support wires 210 of a single support structure 200 are twisted uniformly, that is, at least two of the support wires 210 are wound uniformly, the winding angle between each support wire 210, the gap formed by winding each support wire 210 and the number of windings are the same, so as to ensure that the stress between the support wires 210 is uniform and the support force of the support structure 200 is the same. Of course, two of the support wires 210 of the support structure 200 are twisted uniformly, and all of the support wires 210 may also be twisted uniformly. In the occlusion device provided in this embodiment, a smaller number of support wires 210 are used to complete the establishment of the support framework, so that the occlusion device can reach more lesion sites through a sheath B with a smaller size.

Further, the coating 300 has a porous structure, and pores of the porous structure are uniformly distributed, so that the coating 300 can uniformly block blood flow, the plugging device is non-oriented in the aneurysm, and the plugging efficiency is high. In addition, the tectorial membrane 300 with a porous structure can block blood flow and provide a scaffold for cell growth and climbing, thereby promoting the healing of the aneurysm.

Preferably, the cover film 300 is sewn, dip-formed, or electrostatically woven onto the at least two support structures 200. In the first embodiment, the coating 300 is fixed on the support structure 200 by sewing, the coating 300 is fixed at the positions of the distal end, the proximal end and the middle of the support structure 200, and specifically, the coating 300 is fixed at the positions of the first developing part 110, the second developing part 120 and the middle of the support structure 200. In other embodiments, the membrane 300 may be impregnated directly onto the support structure 200, and the membrane 300 may also be electrospun onto the support structure 200.

The first embodiment further provides a plugging system, which includes a plugging device, a sheath B and a push-pull device a. The blocking device is movably arranged in the sheath tube B in a penetrating way. The push-pull device A is connected with the proximal end of the plugging device and is used for moving the position of the plugging device relative to the sheath tube B. And after the push-pull device A pushes the plugging device to a target position outside the sheath B, the push-pull device A and the plugging device are disengaged, and the plugging device expands. Preferably, one end of the proximal end of the blocking device is connected to the push-pull device a, the proximal end includes, for example, the second visualization component 120 is connected to the push-pull device a, and the blocking device can grasp the position of the proximal end through the visualization mark of the second visualization component 120. Preferably, the proximal end of the support structure 200 of the blocking device is connected to the second visualization part 120, so that the push-pull device a, the second visualization part 120 and the support structure 200 can be fixedly connected together. Of course, the technical personnel in the field can set according to the actual requirement. As shown in fig. 3, when the pusher a causes the occluding device to be within the sheath B, the occluding device is in a collapsed state, and when the occluding device is in the collapsed state, the support structure 200 is compressed into a bundle, thereby providing conditions for pushing. When the pushing device A pushes the plugging device so that the plugging device is positioned outside the sheath tube B, the plugging device is in an expanded state. It should be understood that, as shown in fig. 3, the pushing device can push the plugging device out of the sheath B to reach the position of the aneurysm, and if the plugging device is not directly positioned at the position of the aneurysm, the plugging device can be pulled back, so that the plugging device can be repeatedly positioned at the position of the aneurysm, and the treatment efficiency is further improved. The occlusion system has the beneficial effects brought by the occlusion device, which are not described in detail herein. Other structures and principles of the plugging system can refer to the prior art, and are not described in detail herein.

[ example two ]

FIG. 4 is a top view of an occluding device of a second embodiment of the present invention in an expanded state; figure 5 is a front view of an occluding device of a second embodiment of the present invention in an expanded state.

The same parts of the occlusion device in the second embodiment as those in the first embodiment are not described again, and only different points are described below.

As shown in fig. 4 to 5, the support wires 210 of a single support structure 200 form at least one closed loop structure. In the second embodiment, each of the support structures 200 includes two support wires 210, two closed-loop structures are formed between the two support wires 210, and the two closed-loop structures are spaced apart from each other by a winding knot between the two support wires 210, so as to improve the metal coverage rate of the occlusion device, that is, improve the skeleton supporting force of the support skeleton formed by the support structures 200. Of course, in other embodiments, a single closed loop structure may be formed between the support wires 210 of a single support structure 200, or three closed loop structures may be formed between the support wires 210, and the sizes of the single closed loop structures may be the same or different, and those skilled in the art may set the number of closed loops and the relative size of each closed loop according to actual requirements.

Preferably, the coating 300 is a polyurethane film, and is directly formed on the surface of the supporting structure 200 by electrostatic spraying, and is simultaneously bonded to the framework of the supporting structure 200, thereby improving the production efficiency of the plugging device.

[ EXAMPLE III ]

FIG. 6 is a top view of the occluding device of the third embodiment of the present invention in an expanded state; FIG. 7 is a front view of an occluding device of a third embodiment of the present invention in an expanded state; fig. 8 is a schematic view of a first developing unit according to a third embodiment of the present invention.

The same portions of the occluding device of the third embodiment as those of the first and second embodiments will not be described, and different points will be described below.

As shown in fig. 6 to 7, the sheet structure of the first developing device 110 includes an even number of holes 111, the supporting wires 210 are respectively inserted into the two holes 111 arranged diagonally, and adjacent supporting wires 210 of different roots are fixed by twisting, so that at least one closed loop is formed between the supporting wires 210 of different roots. As shown in fig. 8, in the third embodiment, the sheet structure has six holes 111, three support structures 200, each support structure 200 includes one support wire 210, and the three support wires 210 are a first support wire 211, a second support wire 212, and a third support wire 213. The first supporting wires 211 are respectively inserted into the two holes 111 arranged along the diagonal from top to bottom and then from bottom to top. The support wires 210 at both sides of the two holes 111 diagonally arranged have the same length. Then, the second support wire 212 is passed through the adjacent two diagonally symmetrical holes 111 in the same manner. Finally, the third support wire 213 is passed through two adjacent diagonally symmetrical holes 111 in the same manner, thereby forming 6 support wires 210 each having one free end. Then adjacent non-same support wires 210 are twisted and fixed for 1 twist in pairs, and then wound into a large closed loop, and are bound and fixed by the second developing part 120 after being twisted for 2-4 twists continuously and tightly. By such arrangement, the metal coverage rate of the supporting structure 200 is higher, and the supporting force of the supporting framework is further improved.

Preferably, the maximum dimension of the closed loop in the axial direction of the occlusion device is not less than half of the maximum dimension of the support structure 200 in the axial direction of the occlusion device, so as to ensure the rigidity and flexibility of the support structure 200 while ensuring the metal coverage.

Optionally, after the closed loop is tightly twisted for 2 to 4 turns, another closed loop is wound, and then tightly twisted for 1 turn, and bound and fixed by the second developing part 120. Wherein the maximum diameter of the other closed loops is no greater than the maximum diameter of the first closed loops and each is less than 1/2 of the radial dimension of the support structure 200. Of course, the person skilled in the art can set the number of closed loops, for example three or four, according to the actual requirements.

More preferably, the coating 300 is a polyurethane film, and is directly formed on the support structure 200 by a dipping method, and simultaneously, the coating is bonded to the support structure 200, so that the coating 300 can be tightly connected to the support structure 200.

Of course, the different twisting and closed loop forming cases in the first, second and third embodiments can be combined together. For example, in the first embodiment, two support wires 210 of one support structure 200 are uniformly twisted, in the second embodiment, two support wires 210 of one support structure 200 form two closed loop structures, and in other embodiments, one support structure 200 in the first embodiment and one support structure 200 in the second embodiment may be combined to form a support skeleton, so as to improve the skeleton supporting force of the plugging device. For another example, in the third embodiment, the support filaments 210 of different support structures 200 are twisted with each other to form a closed loop structure, in other embodiments, one support structure 200 in the first embodiment may be combined with two support structures 200 in the third embodiment to form a support skeleton, and two support structures 200 in the second embodiment may be combined with two support structures 200 in the third embodiment to form a support skeleton. Of course, in other embodiments, the number of the supporting structures 200 may be set according to practical requirements, and is not limited herein.

In summary, in the present invention, an occlusion device and an occlusion system are provided, the occlusion device including: two end portions, at least two support structures, and a cover film; the two end parts are arranged at two ends of the plugging device along the axial direction; the at least two support structures are circumferentially arranged around the axis of the plugging device, and two ends of the at least two support structures are respectively converged at one end part; the support structure is transitionable between an expanded state and a contracted state; the support structure protrudes radially outward of the occlusion device when the support structure is in the expanded state; the covering film is coated outside the at least two support structures and used for contracting or expanding along with the state conversion of the support structures. So set up for the dependence of plugging device to doctor's technique is low, and treatment effeciency is high, easy operation, and the operation is with low costs, need not to take the dual-antibody for a long time, and can also realize non-oriented shutoff, can treat apical aneurysm and lateral wall aneurysm.

It should be noted that the embodiments in the present specification are mainly described as different from other embodiments, and the same and similar parts in the embodiments may be referred to each other.

It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. It will be apparent to those skilled in the art from this disclosure that many changes and modifications can be made, or equivalents modified, in the embodiments of the invention without departing from the scope of the invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the protection scope of the technical solution of the present invention, unless the content of the technical solution of the present invention is departed from.

Claims

1. An occlusion device, comprising: two end portions, at least two support structures, and a cover film;

the two end parts are arranged at two ends of the plugging device along the axial direction; the at least two support structures are circumferentially arranged around the axis of the plugging device, and two ends of the at least two support structures are respectively converged at one end part;

the support structure is transitionable between an expanded state and a contracted state; the support structure protrudes radially outward of the occlusion device when the support structure is in the expanded state;

the covering film is coated outside the at least two support structures and used for contracting or expanding along with the state conversion of the support structures.

2. The occlusion device of claim 1, wherein a single support structure comprises at least one support wire, at least one of the support wires being braided.

3. The occlusion device of claim 1, wherein a single support structure comprises at least two support wires, at least two of the support wires in the single support structure being twisted relative to each other.

4. The occlusion device of claim 3, wherein at least two of the support filaments of a single support structure are uniformly twisted.

5. The occlusion device of claim 3, wherein the support wires of a single support structure form at least one closed loop structure.

6. The occlusion device of any of claims 1-3, wherein both of the end portions comprise a first and a second developer member, respectively;

the first developing part is of a sheet structure, the sheet structure comprises at least two holes, and the far end of each supporting structure is connected with the first developing part;

the proximal end of the support structure is coupled to the second development member.

7. The occlusion device of claim 6, wherein a single support structure comprises at least two support filaments, wherein at least two support filaments in the single support structure are twisted with respect to each other, wherein the sheet-like structure comprises an even number of holes, wherein the support filaments are respectively disposed through two holes diagonally arranged, and wherein adjacent support filaments of different roots are twisted and fixed, so that at least one closed loop is formed between the support filaments of different roots.

8. The occlusion device of claim 7, wherein a maximum dimension of the closed loop in an axial direction of the occlusion device is no less than one-half of a maximum dimension of the support structure in the axial direction of the occlusion device.

9. The occlusion device of claim 6, wherein the second visualization member is recessed toward an interior of the at least two support structures when the at least two support structures are in the expanded state such that a depth of the recess of the second visualization member is no less than a length of the second visualization member in an axial direction of the occlusion device.

10. The occlusion device of claim 1, wherein the covering membrane has a porous structure with pores uniformly distributed.

11. The occlusion device of claim 1, wherein the covering membrane is stitched, dip-formed, or electro-statically woven onto the at least two support structures.

12. An occlusion system, comprising: the occlusion device, sheath and push-pull device of any one of claims 1-11;

the plugging device is movably arranged in the sheath tube in a penetrating way;

the push-pull device is connected with the proximal end of the plugging device and is used for moving the position of the plugging device relative to the sheath;

when the blocking device is in the sheath, the blocking device is in a telescopic state; when the occluding device is outside the sheath, the occluding device is in an expanded state.