WO2021136380A1 - Thrombus retrieving device and thrombus retrieving system - Google Patents

Abstract

A thrombus retrieving device (2, 2a, 2b, 2c, 2d) comprises a thrombus retrieving stent (4, 4a, 4b, 4c, 4d) and a protective umbrella (6, 6a, 6b, 6c, 6d) provided at a distal end of the thrombus retrieving stent (4, 4a, 4b, 4c, 4d). The protective umbrella (6, 6a, 6b, 6c, 6d) comprises a main body structure (601) and a connection structure (603) adjacent to each other. The main body structure is formed by interlacing rib members (61). At least two connection elements (63) are separately connected to a proximal end of the main body structure (601). The connection structure (603) is bounded by the at least two connection elements (63) which are joined.

Description

Bolt removing device and bolt removing system

This application requires the priority of the Chinese patent application filed with the Chinese Patent Office on December 30, 2019, the application number is CN 201911423136.2, and the invention title is "Suppressor Removal Device and Throttle Removal System" and submitted to China on December 30, 2019 The Patent Office, the application number is CN 201911424621.1, the priority of the Chinese patent application with the title of the invention is "bolt removal stent and bolt removal system", the entire content of which is incorporated into this application by reference.

Technical field

The present invention relates to the technical field of medical equipment, in particular to a thrombus removal device and a thrombus removal system.

Background technique

Thrombus is a small piece of blood that forms on the surface of the exfoliated or repaired part of the inner surface of the blood vessel of the cardiovascular system. Thrombosis spreads throughout the cardiovascular system and spreads to tissues and organs throughout the body. It is not limited to myocardial infarction, deep vein thrombosis or cerebrovascular thrombosis. Thrombosis can occur in blood vessels in any part of the body. Intracranial thrombosis is a special clinical type of cerebrovascular disease. It is easy to cause cerebral embolism. It has the characteristics of high morbidity, disability, mortality and recurrence. It is fatal and disabling for middle-aged and elderly people. The main disease.

The recanalization of blood vessels is the key to the treatment of acute ischemic stroke. At present, the conventional methods for the treatment of ischemic stroke include two categories: drug thrombolysis or mechanical thrombectomy.

Drug thrombolysis is a catheter injecting a thrombolytic agent into the attachment of the lesion in the blood vessel referred to by the lesion, and a high concentration of thrombolytic agent is formed in the local area of the lesion, thereby accelerating the speed of thrombolysis and increasing the chance of vascular recanalization. According to the findings of the National Institute of Neurological Diseases and Stroke, intravenous thrombolysis should be performed within 3 hours of onset, and the arterial thrombolysis time window is within 6 hours. Therefore, drug thrombolytic therapy is only suitable for smaller blood clots. When the volume of the thrombus is too large, a very large dose is needed to dissolve the large blood clot, and it is easy to cause various complications and the risk is high.

In order to solve the above-mentioned drug thrombolytic problem, mechanical methods are used to eliminate thrombosis. Mechanical thrombectomy includes the following methods: thrombectomy, laser thrombectomy, thrombectomy with catcher, thrombectomy with thrombectomy net. The thrombectomy is more thorough in removing the thrombus, but it damages the blood vessel wall too much, which can easily cause various concurrent inflammations. The operation of laser thrombus breaking is very difficult. If the laser energy is too low, it will be ineffective. If the energy is too high, the blood vessels will be damaged, and it is also easy to cause various complications. The operation of the catcher to remove the thrombus is simple, and it does little damage to the blood vessel wall, but it often fails to catch the blood clot. The operation of the thrombus-trapping net to remove the thrombus is simple, but it cannot be used in intracranial blood vessels because of the large volume of the thrombus-trapping net. To sum up, the existing mechanical thrombectomy method fails to effectively capture the thrombus falling or overflowing from the thrombectomy stent, which easily causes the re-embolization of the blood vessel and the complications caused by thrombectomy treatment.

Summary of the invention

In view of this, it is necessary for the present invention to provide a plug removal device and a plug removal system to solve the above technical problems.

In the first aspect, an embodiment of the present invention provides a bolt removal device, which includes a bolt removal bracket and a protective umbrella provided at the distal end of the bolt removal bracket. The protective umbrella includes a main body structure and a connecting structure that are adjacent to each other. The main structure is formed by interlacing ribs, at least two connecting bones are scattered and connected to the proximal end of the main structure, and the connecting structure is formed by joining the at least two connecting bones.

In a second aspect, an embodiment of the present invention provides a thrombus retrieval system, including a push rod, a micro catheter, and the thrombus retrieval device described above. The thrombus retrieval device includes a thrombus retrieval stent and a thrombus retrieval stent provided at the distal end of the thrombus retrieval stent. Protective umbrella, the push rod is connected to the proximal end of the thrombus removal stent, the push rod, the thrombus removal stent and the protective umbrella are crimped into the micro catheter, the thrombus removal stent and the protective umbrella The push rod can be moved inside and outside the micro catheter through the push and pull of the push rod. When the push rod moves toward the proximal end of the push rod, the thrombus removal stent and the protective umbrella are recovered into the micro catheter; When the push rod moves in a direction away from its proximal end, the thrombus removal stent and the protective umbrella are pushed out of the micro catheter.

Compared with the prior art, the thrombus retrieval device and thrombus retrieval system provided by the embodiments of the present invention are based on the provision of a protective umbrella at the distal end of the thrombus retrieval stent, thereby effectively preventing the thrombus falling off or overflowing from the thrombus retrieval stent from escaping. In addition, the protective umbrella includes an adjacent main structure and a connecting structure. The main structure is formed by interlacing umbrella ribs. At least two connecting bones are scattered and connected to the proximal end of the main structure. Said at least two connecting bones are enclosed. In this way, the thrombus falling off or overflowing from the thrombus removal stent can easily enter the main structure from the connecting structure, so that the protective umbrella can effectively recover the thrombus falling or overflowing from the thrombus removal stent, thereby avoiding blood vessels caused by the thrombus falling off or overflowing from the thrombus removal stent. Re-embolization problems and prevent complications caused by thrombectomy treatment, thereby increasing the recanalization rate of blood vessels.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative labor.

Fig. 1 is a schematic diagram of the structure of the bolt removal device provided by the first embodiment of the present invention.

Fig. 2 is a schematic structural diagram of the protective umbrella of the bolt removal device in Fig. 1.

Fig. 3 is a bottom view of the protective umbrella in Fig. 2.

Fig. 4 is a schematic structural view of the main structure of the protective umbrella in Fig. 2.

FIG. 5 is a three-dimensional plan view of a partial structure of the bolt removing bracket of the bolt removing device in FIG. 1.

FIG. 6 is a schematic diagram of the bolt removing process of the bolt removing device in FIG. 1.

Fig. 7 is a schematic structural diagram of a bolt removal device provided by a second embodiment of the present invention.

FIG. 8 is a schematic diagram of the structure of the bolt removing bracket and the connecting piece of the bolt removing device in FIG. 7.

Fig. 9 is a schematic structural diagram of a thrombus removal device provided by a third embodiment of the present invention.

Fig. 10 is a schematic structural diagram of a thrombus removal device provided by a fourth embodiment of the present invention.

FIG. 11 is a schematic diagram of the structure of the bolt removal device provided by the fifth embodiment of the present invention.

Fig. 12 is a schematic structural diagram of a bolt removal system provided by an embodiment of the present invention.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

It should be noted that in the field of interventional medicine, the end of the instrument that is relatively close to the operator is usually called the proximal end, and the end of the instrument that is relatively far away from the operator is called the distal end. Specifically, the distal end refers to the end of the instrument that can be freely inserted into the animal or human body. The near end refers to the end used for user or machine operation or the end used to connect to other devices.

It can be understood that the terms in the specification and claims of the present invention and the above-mentioned drawings are only for describing specific embodiments, and are not intended to limit the present invention. The terms "first", "second", "third", "fourth", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish different objects, rather than to describe a specific sequence. Unless the context clearly states otherwise, the singular forms "a" and "the" are also intended to include the plural forms. The term "including" and any variations of them are intended to cover non-exclusive inclusion. In addition, the present invention can be implemented in a variety of different forms, and is not limited to the embodiment described in this embodiment. The purpose of providing the following specific embodiments is to facilitate a clearer and thorough understanding of the disclosure of the present invention, wherein the words indicating directions such as up, down, left, and right are only for the position of the structure shown in the corresponding drawings. The term "axial direction" refers to the direction in which the thrombus removal device of the present invention is advanced, that is, the longitudinal axis of the thrombus removal device is also coincident with the longitudinal axis of the blood vessel. The term "closed" does not mean that a certain element structure is a completely sealed object, and its structure only represents a characteristic of the element structure, that is, the mesh body can form a storage space for thrombus, and the thrombus is not easy to escape from the place. The sealing structure of the net body.

The following descriptions of the specification are preferred embodiments for implementing the present invention. However, the above description is for the purpose of explaining the general principles of the present invention and is not intended to limit the scope of the present invention. The protection scope of the present invention shall be subject to those defined by the appended claims.

Please refer to FIG. 1, which is a schematic structural diagram of a bolt removal device 2 provided by the first embodiment of the present invention. The thrombus removal device 2 includes a thrombus removal bracket 4 and a protective umbrella 6 arranged at the distal end of the thrombus removal bracket 4. The protective umbrella 6 includes an umbrella rib 61 and at least two connecting the umbrella rib 61 and the thrombus removal bracket 4. Connecting bones 63. The protective umbrella 6 includes a main structure 601 and a connecting structure 603 that are adjacent to each other. The main structure 601 is interlaced and woven by the ribs 61. The proximal end of the main structure 601 is scattered and connected. Said at least two connecting bones 63, the connecting structure 603 is formed by enclosing the at least two connecting bones 63. A protective umbrella 6 is provided at the distal end of the thrombus removal stent 6, thereby effectively preventing the thrombus falling off or overflowing from the thrombus removal stent 4 from escaping. In this way, the thrombus falling off or overflowing from the thrombus removal stent 4 easily enters the main structure 601 from the connecting structure 603, so that the protective umbrella 6 can effectively recover the thrombus falling or overflowing from the thrombus removal stent 4, thereby avoiding falling off from the thrombus removal stent 4 Or overflow thrombosis can cause vascular re-embolization, and prevent complications caused by thrombus removal treatment, such as vasospasm, thereby increasing the recanalization rate of blood vessels.

Please refer to Figures 1 to 4 together. Figure 2 shows a schematic diagram of the protective umbrella 6, Figure 3 shows a bottom view of the protective umbrella 6, and Figure 4 shows the structure of the main structure 601 (net body 62) of the protective umbrella 6 Schematic. As shown in FIG. 1, in this embodiment, the connecting structure 603 is gradually condensed from the distal end toward the proximal direction, and the proximal end of the connecting structure 603 extends in the direction parallel to the axis L of the thrombus removal stent 4 to form Connect the connecting part 631 of the fetching branch. The number of connecting bones 63 forming the connecting structure 603 is 2-8, and the connecting bones 63 do not overlap each other, that is, the connecting structure 603 does not have a cross grid structure, so the connecting structure 603 has a larger space. The thrombus falling off or overflowing from the thrombus removal stent 4 enters the main structure 601.

The protective umbrella 6 is fixed on the bolt-removing bracket 4. Specifically, in this embodiment, the protective umbrella 6 further includes a fixing sleeve 8. The connecting portion 631 of the connecting structure 603 is connected to the bolt-removing bracket 4 through the fixing sleeve 8, and the distal end of the connecting structure 603 is smoothly connected to the proximal end of the main structure 601. The connecting portion 631 of the connecting structure 603 can be connected to the fixing sleeve 8 by means of adhesive or mechanical fixing. The mechanical fixing method is, for example, but not limited to welding, crimping, hot melting or crimping, and other common technical means in the art to fix the connection together. In some other embodiments, the connecting portion 631 of the connecting structure 603 can also be integrally formed with the bolt removing bracket 4 to improve the stability and reliability of the connection between the bolt removing bracket 4 and the protective umbrella 6.

In this embodiment, the fixing sleeve 8 and the bolt removal bracket 4 are integrally formed. The fixing sleeve 8 is located inside the thrombus removal stent 4, so that the structure of the thrombus removal device 2 is compact, and the protective umbrella 6 is closer to the distal end of the thrombus removal stent 4, effectively preventing the thrombus falling off or overflowing from the thrombus removal stent from escaping. In some other embodiments, the fixing sleeve 8 and the bolt removal bracket 4 can also be detachably connected together.

A positioning wire 41 connected to the fixing sleeve 8 is provided at the distal end of the bolt-removing bracket 4. The positioning wire 41 extends along the periphery of the bolt removal bracket 4 toward its axis line, and is used to position the fixing sleeve 8 on the axis line L of the bolt removal bracket 4, so as to save the protective umbrella 6 occupying the space of the bolt removal device 2, and Ensure the smooth movement of the embolization stent 4 and the protective umbrella 6 in the blood vessel. In some other embodiments, in order to improve the stability of the bolt removal bracket 4 connected to the protective umbrella 6, the positioning wires 41 are symmetrically distributed from the axis L of the bolt removal bracket 4. In this embodiment, the number of positioning wires is 2-8. It should be noted that the number of connecting bones 63 and positioning wires 41 can be set according to actual conditions, which is not limited in the present invention.

The axis line L of the bolt removing bracket 4 is collinear with the axis line P of the umbrella 6, that is, the axis line of the axis line connecting structure 603 of the bolt removing bracket 4 is collinear with the axis line of the main structure 601. In this way, the stability of the thrombus removal device is improved, and the smooth movement of the thrombus removal stent 4 and the protective umbrella 6 in the blood vessel is ensured.

In this embodiment, the radial dimension of the rib 61 is greater than or equal to the radial dimension of the distal end of the thrombus removal stent 4, and the radial dimension of the rib 61 gradually decreases from the proximal end to the distal direction to ensure The thrombus falling off or overflowing from the embolization stent enters the protective umbrella.

Among them, the main structure 601 is configured as a semi-closed cone-shaped mesh body 62. Specifically, the proximal end of the net body 62 forms an opening structure 621, and the distal end of the net body 62 forms a sealing structure 622. The opening structure 621 covers the orthographic projection of the blocking structure 622 on the opening structure 621 in the axial direction, so that the protective umbrella 6 can capture more thrombi that fall off or overflow from the thrombus removal stent 4. The radial size of the opening structure 621 is greater than or equal to the radial size of the distal end of the plug removal stent 4. In some embodiments, the blocking structure 622 is that the ribs 61 constituting the net body 62 are gradually condensed and closed from the proximal end to the distal direction. In other embodiments, the blocking structure 622 can also be closed by wrapping the distal end of the mesh body 62 tightly by the tightening structure. In this way, the space for the thrombus to enter the protective umbrella 6 is increased, and the thrombus in the protective umbrella 6 is prevented from escaping, thereby improving the thrombus capture performance of the thrombus removal device 2 so that the thrombus removal device 2 removes the thrombus cleanly and prevents vasospasm. And can quickly restore blood flow speed.

Further, the mesh area of the mesh unit of the mesh body 62 gradually increases from the distal end to the proximal end, that is, the mesh design of the mesh body 62 is gradually dense from the proximal end to the distal end to prevent the thrombus entering the mesh body 62 from escaping .

Among them, the mesh body 62 is a mesh structure formed by a plurality of grid units connected to each other. The mesh area of the mesh unit of the mesh body 62 gradually increases from the distal end to the proximal end. In this way, the thrombus falling off or overflowing from the thrombus removal stent easily enters the net 62 from the proximal end of the net 62, and is not easy to escape from the distal end of the net 62, so that it will fall off or overflow from the thrombus removal stent 4 The thrombus is recovered to increase the recanalization rate of blood vessels.

The net body 62 is configured in a tapered kaleidoscope pattern. Specifically, the mesh body 62 is composed of a multi-layer flower-shaped ring structure 6211 along the axial direction of the protective umbrella 6, and the multi-layer flower-shaped ring structures 6211 are seamlessly connected to each other, and each layer of the flower-shaped ring structure 6211 is composed of multiple mesh areas. The same grid unit 6212 is connected. Specifically, one grid unit 6212 of one layer of flower-shaped ring structure 6211 faces the gap between two adjacent grid units 6212 of the other layer of flower-shaped ring structure 6211, so that the protective umbrella 6 is more easily compressed and more capable Adapt to small blood vessels.

In this embodiment, the net body 62 is formed by interlacing a plurality of umbrella ribs 61. The plurality of umbrella ribs 61 are structured in a petal structure and distributed radially. The proximal end of each rib 61 protrudes outward relative to the net body 62 to form an arc-shaped end 611 to increase the overall area of the net body 62 and prevent the thrombus falling off or overflowing from the thrombus removal stent 4 from escaping.

The connecting bone 63 can be woven and formed by converging a plurality of umbrella bones 61. The connecting bone 63 and the umbrella bone 61 are an integral structure, which can improve the stability and reliability of the main structure 601 and the connecting structure 603 of the protective umbrella. Preferably, 4-8 The umbrella ribs 61 converge into a connecting bone 63.

Wherein, a convex rib 6111 is provided in the middle of the edge of the arc-shaped end 611. The distal end of each connecting bone 63 is smoothly connected to the corresponding rib 6111, and the proximal end of each connecting bone 63 is connected to the fixing sleeve 8 to improve the stability of the connecting bone 63 to the umbrella body 62. In this embodiment, the center of the edge of the arc-shaped end 6111 coincides with the flower axis C of the petal structure. In addition, the flower axis C of the petal structure and the axis P of the umbrella 6 form an acute angle. At least two connecting bones 63 are symmetrically distributed from the axis P of the umbrella 6.

In some other embodiments, the protective umbrella 6 further includes a protective sleeve 65. The protective sleeve 65 is fixedly sleeved on the distal end of the umbrella rib 61 to wrap and tighten the distal end of the umbrella rib 61. Wherein, the protective sleeve 65 can be used as the blocking structure 622 of the net body 62. In this way, contact between the distal end of the rib 61 and the blood vessel wall is avoided, thereby reducing damage to the blood vessel wall, and ensuring that the thrombus falling off or overflowing from the thrombus removal stent 4 is always contained in the protective umbrella 6.

Please refer to FIG. 1 and FIG. 5 together. FIG. 5 is a three-dimensional plan view of a partial structure of the bolt removal support 4 of the bolt removal device 2. The bolt removal stent 4 includes a stent body 101 having a tubular and/or cage-like structure. The stent body 101 includes a first stent body 10 and a second stent body 30 provided at the distal end of the first stent body 10. The first bracket body 10 and the second bracket body 30 are integrally formed and smoothly transitionally connected. The second bracket body 30 includes a large pipe diameter section 31 and a small pipe diameter section 33 that are alternately connected. In this way, while the thrombus removal stent 4 has flexibility, it also has a certain radial and axial support force, and effectively prevents the thrombus removal stent 4 from collapsing when it passes through the blood vessel completely, thereby improving the efficiency of thrombus capture, and During the embolization process, the damage to the blood vessel of the embolization stent is reduced. In addition, the existing thrombectomy stent requires a large radial size in the catheter and cannot pass through tortuous intracranial blood vessels, while the thrombus removal device 2 of the present application requires a small radial size inside the catheter, so it is suitable for smaller intracranial and other smaller diameters. Blood vessels.

Specifically, in some embodiments, the first bracket body 10 and the second bracket body 30 are integrally formed so as to improve the stability and reliability of the connection between the first bracket body 10 and the second bracket body 30. In some other embodiments, the first bracket body 10 and the second bracket body 30 may also be fixedly connected together by technical means commonly used in the art, such as pressing, hot melting, bonding, welding, or pressure riveting.

Wherein, both the proximal end and the distal end of the second stent body 30 are configured as large diameter sections 31. The small pipe diameter section 33 is arranged between two adjacent large pipe diameter sections 31. In this embodiment, the second stent body 30 includes three large diameter sections 31 and two small diameter sections 33. The three large diameter sections 31 are respectively located at the proximal, middle and distal ends of the second stent body 30 . The small pipe diameter section 33 is located between two adjacent large pipe diameter sections 31. It should be noted that the number of the large pipe diameter section 31 and the small pipe diameter section 33 can be set according to actual requirements, which is not limited in the present invention.

Both the large pipe diameter section 31 and the small pipe diameter section 33 are formed by connecting a plurality of closed loop units 32 to each other. The shape of the closed-loop unit 32 includes, but is not limited to, one or more of a circle, an ellipse, a triangle, a diamond, a trapezoid, and a hexagon. The same bracket body 30 may include one, two or more at the same time. Kind of closed-loop unit 32. Two adjacent closed-loop units 32 are connected together by connecting ribs 103. The connecting rib 103 is parallel to the axis L of the bolt removal bracket 4. In the axial direction parallel to the bolt removal bracket 4, in two adjacent rows, the closed-loop unit 32 of one row faces the gap between two adjacent closed-loop units 32 in the other row, so that the bolt removal bracket 4 is more easily compressed. It is more suitable for small blood vessels and is easy to introduce into the micro catheter 300 (refer to FIG. 12).

The proximal end of the first stent body 10 is configured as an oblique cone cylindrical structure. Specifically, the first bracket body 10 also includes a plurality of closed loop units 11. A plurality of closed loop units 11 are connected to each other to form the oblique cone cylindrical structure. The proximal end of the first stent body 10 forms an entrance 15 with a slope. The shape of the inlet 15 is tapered, such as a drop shape. In this embodiment, the shape of the inlet 15 is a fusiform. In this way, based on the slope design of the entrance 15 of the first stent body 10, not only can it effectively block the transfer of the withdrawal force of the retraction bolt removal stent 4 to the entire circumference of the bolt removal stent 4, but also avoid the pipe diameter of the first stent body 10 It becomes smaller during the withdrawal of the thrombus-removing stent 4, so as to ensure that the thrombus will not easily fall off during the thrombus-removing stent 4 is withdrawn.

The proximal end of the first stent body 10 is also provided with a connecting head 13. The connecting head 13 extends in a direction parallel to the axis L of the bolt-removing bracket 4. When the thrombus removal stent 4 is withdrawn, the traction force will be concentrated on the extension line where the connecting head 13 is located, ensuring that the diameter of the distal end of the stent body 101 remains unchanged, thereby improving the efficiency of thrombus capture.

In some embodiments, the connecting head 13 is provided with a developing positioning element 102, so that the position of the developing positioning element 102 can be used to indicate the position of the plug-removing device 2 under the detection of the instrument. The developing positioning member 102 is made of a radiopaque material. The radiopaque material is preferably a precious metal material such as gold, platinum, or tantalum. The developing positioning element 102 can take various forms such as ring shape, filament shape, ribbon shape, or dot shape, and is fixed to the bolt removal bracket 4 by pressing, hot melting, bonding, welding, or riveting and other technical means commonly used in the art. on. In some embodiments, the developing positioning element 102 may be ring-shaped, and the developing positioning element 102 is sleeved outside the connecting head 13.

In this embodiment, the proximal end of the thrombus retrieval stent 4 is provided with a visualization positioning element 102 to accurately locate the position of the thrombus, so that the thrombus can be captured during the thrombus retrieval by using the thrombus retrieval stent 4, as well as in the thrombus retrieval stent. 4 During the withdrawal process, it is judged whether the thrombus is separated from the thrombus removal stent 4 for real-time observation, and then the specific thrombus removal operation is guided, that is, the thrombus removal stent 4 is instructed to switch between the compressed state and the released state, so that the thrombus removal is more accurate. In some other embodiments, the middle part of the thrombus removal stent 4 may also be provided with multiple visualization positioning elements to more accurately locate the position of the thrombus.

In this embodiment, the first stent body 10, the second stent body 30, and the protective umbrella 6 are all made of a metal material with a memory effect or an elastic polymer material, so that the stent body 101 and the protective umbrella 6 are formed by self-expanding. Tubular and/or cage-like structure. The metal material is, for example, but not limited to nickel-titanium alloy or cobalt-based alloy. Specifically, the first stent body 10, the second stent body 30, and the protective umbrella 6 can be formed by laser cutting a plate-shaped nickel-titanium alloy into a tubular or cage-like structure with a hollow structure, and then crimping, heat treatment and shaping. In another embodiment, the first stent body 10, the second stent body 30 and the protective umbrella 6 can also be formed into a tubular or cage-like structure with the hollow structure by weaving a wire-like Nitinol alloy. In some other embodiments, the first bracket body 10, the second bracket body 30 and the protective umbrella 6 may also be processed by using elastic plastic materials.

In this embodiment, the bolt-removing bracket 4 further includes a plurality of capturing units 20. In this embodiment, multiple capture units 20 are arranged at the junction of the large pipe diameter section 31 and the small pipe diameter section 33, that is, the proximal end and the distal end of the small pipe diameter section 33 are both provided with multiple capture units. 20, in order to further improve the thrombus capture efficiency of the thrombus removal stent 4. The multiple catching units 20 are evenly distributed in the circumferential direction of the bolt-removing bracket 4. A plurality of catching units 20 form a circle from the circumference of the bolt-removing bracket 4. A circle can include 2-6 capture units. The bolt-removing bracket 4 can be provided with 2-4 rounds of capture units in the axial direction.

Among them, each capture unit 20 is configured in a closed loop structure. Each catching unit 20 includes a connecting part 21 and a catching part 22 opposite to each other. The connecting portion 21 is substantially in an inverted V shape, and the capturing portion 22 is substantially in a V shape. The connecting portion 21 is connected to the bracket body 101, and the capturing portion 22 can extend outward or inward relative to the bracket body 101, so that a receiving space 201 is formed between the capturing portion 22 and the bracket body 101. The catching portion 22 can move in a direction perpendicular to the axis L of the bolt removal bracket 4. In this way, it is avoided that when the thrombus removal stent 4 moves in the blood vessel, the capturing portion 22 does not directly contact the blood vessel wall, thereby avoiding damage to the blood vessel wall tissue.

The distal end of the capturing portion 22 is provided with a circular arc chamfer to further prevent the capturing portion 22 of the capturing unit 20 from damaging the blood vessel wall. In addition, when the bolt-removing bracket 4 is in an expanded state, the capturing portion 22 of each capturing unit 20 is located outside the closed loop unit 32 of the bracket body 101, that is, there is a gap between the capturing portion 22 and the bracket body 101 for capturing The capturing part 22 of the unit 20 is inserted into the thrombus or clamps the thrombus in the accommodating space 201, thereby improving the anchoring of the thrombus by the thrombus removal stent 4.

In some embodiments, the bolt removal bracket 4 further includes a plurality of connecting members 53. The plurality of connecting members 53 and the plurality of capturing units 20 are alternately arranged and connected to each other to ensure the flexibility of the bolt removal stent 4 and a certain supporting force in the radial and axial directions of the bolt removal stent 4. In addition, the design of the connecting piece 53 can also increase the space between the capturing portion 22 and the stent body 101, and provide more accommodating space for thrombus. Specifically, the proximal end of each connecting piece 53 is connected to the distal end of the connecting portion 21 of one of the catching units 20 (that is, the proximal end of the catching portion 22), and the distal end of each connecting piece 53 is connected to the other catching unit. 20 of the proximal end of the connecting portion 21. In this embodiment, each connecting member 53 can be integrally formed with the bracket body 101. In some other embodiments, each connecting member 53 may also be fixed on the bracket body 101 by a mounting structure. The mounting structure is, for example, but not limited to an adhesive, a crimping structure or a riveting structure.

In some embodiments, the bolt removal bracket 4 further includes a plurality of auxiliary capturing units 50. Each auxiliary catching unit 50 is arranged at the connection between the connecting member 53 and the catching unit 20. Specifically, each auxiliary catching unit 50 is fixed at the junction of the connecting part 21 and the catching part 22 of the catching unit 20. In this embodiment, each auxiliary capture unit 50 is arranged between two adjacent capture units 20.

The plurality of auxiliary capture units 50 are all configured in a barbed structure. Each auxiliary catching unit 50 includes opposite connecting ends 51 and free ends 52. The proximal end of each auxiliary capturing unit 50 is a connecting end 51, and the distal end of each auxiliary capturing unit 50 is a free end 52. In some embodiments, each auxiliary capture unit 50 is connected to the bracket body 101 through a corresponding connecting member 53. Specifically, the connecting end 51 of the auxiliary capturing unit 50 is connected to the proximal end of the connecting piece 53. In some other embodiments, each auxiliary capture unit 50 can also be directly connected to the connecting rib 103 of the bolt-removing bracket 4. Each auxiliary catching unit 50 and the connecting rib 103 are integrally formed.

The free end 52 of the auxiliary catching unit 50 can extend outward or inward relative to the bracket body 101 and move in a direction perpendicular to the axis L of the bolt removal bracket 4. Wherein, the auxiliary catching unit 50 can be arranged in 2-6 circles along the axial direction of the stent body 101, and each circle has 2-6 auxiliary catching units 50, so as to further improve the thrombus catching efficiency of the thrombus removal stent 4.

Among them, the auxiliary capture unit 50 has self-expandability. The material contained in the auxiliary capture unit 50 can be the material contained in the bolt-removing bracket 4, which will not be repeated here.

In some embodiments, a receiving space 501 is formed between the free end of each auxiliary capture unit 50 and the bracket body 101. In this way, when the thrombus removal stent 4 is in the released state, there is a gap between the free end of each auxiliary catching unit 50 and the stent body 101, so that the auxiliary catching unit 50 can be inserted into the thrombus, or the thrombus can be held in the containing space. Within 501, the anchorage of thrombus by the thrombus removal stent 4 is further improved.

The distal end 52 of each auxiliary capture unit 50 is provided with an arc-shaped chamfer to avoid damage to the blood vessel wall by the auxiliary capture unit 50. In this embodiment, a plurality of auxiliary capturing units 50 are located at the junction of the large diameter section 31 and the small diameter section 33 to reduce the risk of the auxiliary capturing unit 50 damaging the blood vessel wall.

It should be noted that the number of capture units 20 and auxiliary capture units 50 can be set according to the diameter of the bolt-removing bracket 4, and the arrangement positions, lengths, and inclination angles of multiple auxiliary capture units 50 can be the same as each other. They may also be different from each other, and the present invention is not limited.

Please refer to FIGS. 1 and 6 together. FIG. 6 shows a schematic diagram of the bolt removal process of the bolt removal bracket 4. During the thrombus removal process, the distal end of the thrombus removal stent 4 is attached to the blood vessel wall 104, and the proximal end of the thrombus removal stent 4 is deployed in the thrombus so that the large thrombus 105 enters the stent body 101, and the thrombus removal stent 4 drives the grasping During the retreat of the captured large thrombus 105, that is, when the thrombus removal stent 4 moves in the proximal direction, the proximal end of the thrombus removal stent 4 falls off or the smaller volume thrombus 106 that overflows from the embolism removal stent 4 is removed. The protective umbrella 6 intercepts, that is, the smaller-volume thrombus 106 enters the main structure 603 from the connecting structure 601 of the protective umbrella 6, so the protective umbrella 6 can effectively recover the smaller-volume thrombus 106 that falls off in the embolization stent 4, thereby reducing the loss of thrombus. The problem of re-embolization of blood vessels, thus increasing the recanalization rate of blood vessels, and preventing vasospasm.

Please refer to FIGS. 7 and 8 together. FIG. 7 is a schematic structural diagram of a plug-removing device 2a provided by a second embodiment of the present invention, and FIG. 8 is a connecting piece of the plug-removing bracket 4a of the plug-removing device 2a. Schematic diagram of the structure. In the second embodiment, the structure of the bolt removing device 2a is similar to the structure of the bolt removing device 2 of the first embodiment. The difference is that each connecting piece 53a is configured as a curved structure, thereby improving the flexibility of the connecting position, while reserving more thrombus accommodating space, and improving the thrombus capture rate.

In this embodiment, each connecting piece 53a is bent inwardly relative to the bracket body 101a to increase the receiving space 201a formed between the catching unit 20a and the bracket body 101a and to increase the gap between the auxiliary catching unit 50a and the bracket body 101a. The accommodating space 501a is formed between, thereby providing more accommodating space for thrombus. Specifically, a distance is formed between the inner side of each connecting piece 53a and the axis L of the stent body 101a, and the outer side of each connecting piece 53a is connected to the periphery of the stent body 101a, so as to prevent the connecting piece 53a from intercepting the thrombus. Enter the bolt-removing bracket 4a. The plurality of connecting members 53a are evenly distributed from the circumferential direction of the bracket body 101a.

Please also refer to FIG. 9. FIG. 9 is a schematic structural diagram of a bolt removal device 2 b according to a third embodiment of the present invention. In the second embodiment, the structure of the bolt removing device 2b is similar to the structure of the bolt removing device 2a of the second embodiment. The difference is that the free end 52b of the auxiliary catching unit 50b is configured as a curved structure, and the bending direction of the auxiliary catching unit 50b is opposite to the bending direction of the connecting member 53b.

In this embodiment, each auxiliary catching unit 50b is bent outwards relative to the bolt-taking bracket 4b to further increase the receiving space 201b formed between the catching unit 20b and the bracket body 101b, and to increase the size of the auxiliary catching unit 50b and The accommodating space 501b formed between the stent bodies 101b provides more accommodating space for further thrombosis. In addition, the design of the curved structure of the auxiliary capture unit 50b can hold the thrombus more firmly, and improve the safety of the thrombus removal device 2b, prevent the free end 52b from piercing the direction of the blood vessel wall, and increase the adhesion to the blood vessel wall. Avoid damaging the blood vessel wall tissue.

Please refer to FIG. 10, which is a schematic structural diagram of a bolt removing device 2c according to a fourth embodiment of the present invention. In the fourth embodiment, the structure of the plug removal device 2c is similar to the structure of the plug removal device 2b of the third embodiment. The difference is that the first stent body 10c is configured as a funnel structure, and the second stent body 30c is configured as a straight tube structure, so that the thrombus is prevented from falling off when the thrombus removal stent 4c is retracted toward the proximal end thereof. Specifically, the first bracket body 10c also includes a plurality of closed loop units 11c. A plurality of closed loop units 11c are connected to each other to form the funnel structure. Wherein, the tube diameter of the first stent body 10c gradually increases from its proximal end to the distal direction, thereby preventing the proximal end of the first stent body 10c from being removed due to bolt removal during the withdrawal of the bolt removal stent 4c in the proximal direction. The effect of the withdrawal force of the stent 4c causes its overall tube diameter to be reduced or kinked, thereby improving the efficiency of thrombus capture and reducing the damage to the blood vessel of the thrombus removal stent 4c. In this way, a smooth transitional connection between the first stent body 10c and the second stent body 30c is ensured, thereby reducing the damage to the blood vessel caused by the embolization stent during the embolectomy process.

It should be noted that the structural design of the first bracket body 10c of the bolt removal device 2c of the fourth embodiment is applicable to the bolt removal brackets 2, 2a, 2b in the first to third embodiments, and details are not described herein again.

Please refer to FIG. 11, which is a schematic structural diagram of a bolt removing device 2d according to a fifth embodiment of the present invention. In the fifth embodiment, the structure of the plug removing device 2d is similar to the structure of the plug removing device 2b of the third embodiment. The difference is that the protective umbrella 6d also includes a developing positioning element 65d.

In this embodiment, the bolt removal device 2d may not include a protective cover. The imaging positioning element 65d is fixedly sleeved on the distal end of the umbrella rib 61d to wrap and tighten the distal end of the umbrella rib 61d. The developing positioning member 65d is, for example, but not limited to a developing ring or a developing wire. In some embodiments, the developing wire is spirally wound at the distal end of the protective umbrella 6d. In some other embodiments, the imaging ring is sleeved on the distal end of the protective umbrella 6d. The imaging positioning element 65d is fixed on the distal end of the umbrella rib 61d as a distal end marker of the entire thrombus removal device 2d, so as to more accurately locate the position of the thrombus. The fixing method of the developing positioning element 65d is, for example, but not limited to welding, crimping, hot melting, or pressure riveting, etc., to be fixedly connected together by technical means commonly used in the art.

It should be noted that the structural design of the protective umbrella 6d of the bolt removal device 2d of the fifth embodiment is applicable to the bolt removal brackets 2, 2a, 2b, 2c in the first to fourth embodiments, and will not be repeated here.

Please refer to FIG. 12, which is a schematic structural diagram of a bolt removal system 1000 according to an embodiment of the present invention. The thrombus removal system 1000 includes the above-mentioned thrombus removal device 2, a push rod 200 and a micro catheter 300. The bolt removal device 2 includes a bolt removal bracket 4 and a protective umbrella 6 arranged at the distal end of the bolt removal bracket 4. The push rod 200 is connected to the proximal end of the bolt removal bracket 4, and the push rod 200, the bolt removal bracket 4 and the protective umbrella 6 are It is crimped and introduced into the microcatheter 300. The plug-removing bracket 4 and the protective umbrella 6 can move inside and outside the microcatheter 300 by pushing and pulling the push rod 200. When the push rod 200 moves toward its proximal end, the bolt removal stent 4 and the protective umbrella 6 are recovered into the micro catheter 300; when the push rod 200 moves away from its proximal end, the bolt removal stent 4 and the protective umbrella 6 It is pushed out of the microcatheter 300.

In this embodiment, the connection between the proximal end of the plug-removing device 2 and the distal end of the push rod 200 includes welding, sleeve connection, or glue-fixed connection. Optionally, welding includes, but is not limited to silver welding or gold welding. Adhesives include, but are not limited to UV glue or epoxy glue. The micro catheter 300 is sleeved outside the pushing rod 200. The bolt removal system 1000 further includes a loading tube 400. The loading tube 400 is used to fix the micro catheter 300.

When in use, first connect the proximal end of the thrombus removal bracket 4 and the distal end of the push rod 200, and then compress the installed thrombus removal device 2 and the push rod 200 into the microcatheter 300 in advance. During the interventional treatment, the microcatheter 300 is delivered to the diseased part of the blood vessel, passes through the thrombus, and fixes the microcatheter 300. Push the thrombus removal device 2 through the push rod 200 to the position of the thrombus determined according to the imaging positioning element 102, and withdraw the microcatheter 300 to release the thrombus removal device 2 at its distal end, and the thrombus removal device 2 bounces at the distal end to anchor the blood vessel Then, push the push rod 200 forward slowly, and at the same time withdraw the micro-catheter 300 under the reaction force to release the tension of the micro-catheter 300, and repeat it many times until the thrombus removal device 2 is fully released.

Since the thrombus retrieval device 2 is made of a shape memory material, the thrombus retrieval device 2 has elasticity, so that the thrombus retrieval device 2 can be switched between a compressed state and a released state. By releasing the thrombus retrieval device 2, the thrombus retrieval device 2 can be completely embedded in the thrombus. After waiting for a certain period of time, the push rod 200 is pulled back, and the thrombus removal device 2 is retracted to capture the thrombus, until the thrombus removal device 2 and the microcatheter 300 are retracted and withdrawn from the body, and the entire thrombus removal process is completed. The thrombus removal device 1000 as a whole is crimped and introduced into the microcatheter 300, that is, the thrombus removal device 2 is delivered to the diseased part of the blood vessel through the microcatheter 300.

It should be noted that the thrombus removal devices 2a, 2b, 2c, and 2d in the second embodiment to the fifth embodiment can all be applied to the thrombus removal system, which will not be repeated here.

The thrombus removal stent and thrombus removal system provided by the embodiments of the present invention are based on the provision of a protective umbrella at the distal end of the thrombus removal stent, thereby effectively preventing thrombus falling or overflowing from the thrombus removal stent from escaping. In addition, the protective umbrella includes an adjacent main structure and a connecting structure. The main structure is formed by interlacing umbrella ribs. At least two connecting bones are scattered and connected to the proximal end of the main structure. Said at least two connecting bones are enclosed. In this way, the thrombus falling off or overflowing from the thrombus removal stent can easily enter the main structure from the connecting structure, so that the protective umbrella can effectively recover the thrombus falling or overflowing from the thrombus removal stent, thereby avoiding blood vessels caused by the thrombus falling off or overflowing from the thrombus removal stent. Re-embolization problems, and prevent complications caused by thrombectomy therapy, such as vasospasm, thereby increasing the recanalization rate of blood vessels, and suitable for smaller blood vessels such as intracranial.

The embodiments of the present invention are described in detail above, and specific examples are used in this article to illustrate the principles and embodiments of the present invention. The descriptions of the above embodiments are only used to help understand the method and core ideas of the present invention; at the same time, for Those of ordinary skill in the art, based on the idea of the present invention, will have changes in specific embodiments and application ranges. In summary, the content of this specification should not be construed as limiting the present invention.

Claims (20)

1. A thrombus removing device includes a thrombus removing bracket and a protective umbrella arranged at the distal end of the thromb removing bracket. The protective umbrella includes a main structure and a connecting structure that are adjacent to each other, and the main structure is formed by interlacing ribs of the umbrella. At least two connecting bones are scattered and connected to the proximal end of the main structure, and the connecting structure is formed by joining the at least two connecting bones.
2. The thrombus removal device according to claim 1, wherein the connecting structure gradually contracts from the distal end toward the proximal end, and the proximal end of the connecting structure faces in a direction parallel to the axis of the thrombus removal stent Extending to form a connecting portion connecting the bolt removing bracket.
3. The thrombus removing device according to claim 2, further comprising a fixing sleeve, the connecting portion is connected to the thrombus removing bracket through the fixing sleeve, and the distal end of the connecting structure is smoothly connected to the fixing sleeve. The proximal end of the main structure.
4. The thrombus removal device of claim 3, wherein the distal end of the thrombus removal bracket is provided with a positioning wire connected to the fixing sleeve, and the positioning wire extends from the periphery of the thrombus removal bracket toward its axis. The wire extends and is used to position the fixing sleeve at the position of the axis of the bolt-removing bracket.
5. 5. The thrombus removal device according to claim 4, wherein the positioning wires are symmetrically distributed from the axis of the thrombus removal bracket.
6. The plug removal device of claim 1, wherein the axis line of the connecting structure and the axis line of the main structure are collinear with the axis line of the plug removal bracket.
7. The thrombus removal device according to claim 1, wherein the radial size of the main structure is greater than or equal to the radial size of the distal end of the thrombus removal stent, and the radial size of the main structure is close to The end gradually decreases toward the distal end.
8. 8. The plug removal device according to claim 3, wherein the main structure is configured as a semi-closed cone-shaped net body.
9. 8. The thrombus removal device according to claim 8, wherein the proximal end of the net body forms an opening structure, and the distal end of the net body forms a sealing structure.
10. 9. The plug removal device according to claim 9, wherein the opening structure covers the orthographic projection of the blocking structure on the opening structure along the axial direction.
11. The plug removal device according to claim 8, wherein the mesh body is a mesh structure formed by interconnecting a plurality of mesh units, and the mesh area of the mesh unit of the mesh body faces from the distal end. The proximal end gradually increases.
12. 8. The bolt removal device according to claim 8, wherein the net body is composed of a multi-layer flower-shaped ring structure along the axial direction of the protective umbrella, and the multi-layer flower-shaped ring structures are seamlessly connected to each other, Each layer of the flower-shaped ring structure is formed by connecting a plurality of grid units with the same mesh area.
13. The thrombus removal device according to claim 8, wherein the net body is formed by interlacing a plurality of the ribs, and the plurality of ribs are structured in a petal structure and distributed radially, and each The proximal end of the umbrella rib protrudes outward relative to the mesh body to form an arc-shaped end.
14. The thrombus removal device according to claim 13, wherein a convex rib is provided in the middle of the edge of the arc-shaped end, and the distal end of each connecting bone is smoothly connected to the corresponding convex rib, The proximal end of each connecting bone is connected to the fixing sleeve.
15. The thrombus removal device according to claim 13, wherein the center of the edge of the arc-shaped end coincides with the flower axis of the petal structure, and the flower axis of the petal structure and the axis line of the protective umbrella form An acute angle.
16. The thrombus removal device according to claim 1, wherein the at least two connecting bones are symmetrically distributed from the axis line of the protective umbrella, and the at least two connecting bones are woven by a plurality of the umbrella bones. to make.
17. The thrombus removal device of claim 1, wherein the protective umbrella further comprises a protective sleeve, and the protective sleeve is fixedly sleeved on the distal end of the umbrella rib to wrap and tighten the ribs. remote.
18. The thrombus removal device according to claim 1, wherein the protective umbrella further comprises a visualization positioning element, the visualization positioning element is fixedly sleeved on the distal end of the umbrella bone to wrap and tighten the umbrella The distal end of the bone.
19. The thrombus removal device according to claim 1, wherein the thrombus removal stent further comprises a stent body having a tubular and/or cage structure, and the stent body comprises a first stent body and a stent body disposed on the first stent. A second stent body at the distal end of the body, the first stent body and the second stent body are smoothly transitionally connected, and the second stent body includes a large pipe diameter section and a small pipe diameter section that are alternately connected.
20. A thrombus retrieval system, comprising a push rod, a microcatheter, and the thrombus retrieval device according to any one of claims 1-19, the thrombus retrieval device comprising a thrombus retrieval stent and a distal end of the thrombus retrieval stent The protective umbrella, the push rod is connected to the proximal end of the thrombus removal stent, the push rod, the thrombus removal stent and the protective umbrella are crimped into the micro catheter, the thrombus removal stent and the The protective umbrella can be moved inside and outside the micro-catheter through the push and pull of the push rod. When the push rod moves in the direction close to its proximal end, the thrombus removal stent and the protective umbrella are recovered into the micro-catheter When the push rod moves in a direction away from its proximal end, the plug-removing stent and the protective umbrella are pushed out of the micro-catheter.

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