Disclosure of Invention
Accordingly, it is necessary to provide an intravascular thrombus removal device that is advantageous in removing thrombus and capturing thrombus fragments, and that can avoid escape of thrombus fragments.
An intravascular thrombus taking-out device comprises a bracket main body which is in a net tubular structure along the axial direction, wherein the bracket main body is in a self-expansion state and a compression state after being stressed;
The bracket main body comprises a proximal end part, a middle part and a distal end part which are arranged along the axial direction, wherein the middle part comprises a plurality of repeating units, and the repeating units are sequentially arranged along the axial direction;
the repeating units comprise a plurality of closed grid units which are sequentially arranged along the circumferential direction of the network management structure, each closed grid unit comprises a first mesh and a plurality of second meshes which are arranged adjacent to the first mesh, and the area of the first mesh is larger than that of the second mesh.
The first meshes and the second meshes are adjacently arranged, the area of the first meshes is larger than that of the second meshes, the first meshes with larger sizes can be favorable for cutting thrombus, cut thrombus fragments can enter the stent body with the net tubular structure through the first meshes, the second meshes with smaller sizes can effectively prevent the thrombus fragments from escaping from the inside of the stent body, and the first meshes and the second meshes are mutually matched, so that the thrombus fragments can be better captured.
In one embodiment, the proximal portion, the plurality of repeating units, and the distal portion are helically distributed along the axial direction.
In one embodiment, two adjacent repeating units are connected by an angle alpha rotated in the axial direction.
In one embodiment, the proximal portion, the distal portion and the plurality of repeating units are each provided with a plurality of developing units, the plurality of developing units on the proximal portion and the distal portion are arranged at intervals, and the developing units on two adjacent repeating units are spirally distributed along the axial direction.
In one embodiment, the developing units on the distal end portion form a plurality of groups of developing structures arranged at intervals along the circumferential direction of the mesh-like structure, two adjacent developing units in the same group are arranged in parallel in the axial direction, and the mesh-like structure is provided with intervals in the circumferential direction.
In one embodiment, each of the repeating units includes two developing units, and the two developing units in the same repeating unit are symmetrically arranged with respect to the axial direction.
In one embodiment, the proximal portion is gathered at an end distal from the distal portion and forms a proximal tubular structure, the intravascular thrombus retrieval device further comprising:
The first developing spring comprises a proximal end connecting part and a distal end connecting part, and the proximal end connecting part is connected with the proximal end tubular structure;
The pushing device comprises a pushing rod, wherein a connecting clamping head is formed at one end, close to the proximal end, of the pushing rod, one end, close to the proximal end, of the pushing rod penetrates through the proximal connecting portion and the proximal tubular structure, the distal connecting portion is arranged between the connecting clamping head and the proximal tubular structure, and the connecting clamping head is in butt joint with the distal connecting portion.
In one embodiment, the distal portion is gathered at an end distal from the proximal portion and forms a distal tubular structure, and the intravascular thrombus retrieval device further includes a second visualization spring coupled to the distal tubular structure.
In one embodiment, the area of the first mesh is 1.5-2.5 times that of the second mesh, the distal end part comprises a plurality of closed meshes, the closed meshes are arranged in a preset mode so that one end of the distal end part far away from the proximal end part is in a closed structure, and the area of the closed meshes is less than or equal to that of the second mesh.
In one embodiment, the material of the bracket main body is nickel-titanium alloy tubular material, and the pipe diameter of the nickel-titanium alloy tubular material is less than or equal to 0.4mm.
According to the scheme, the first mesh openings and the plurality of second mesh openings are adjacently arranged, the area of the first mesh openings is larger than that of the second mesh openings, the first mesh openings with larger sizes can be favorable for cutting thrombus, cut thrombus fragments can enter the stent body with the net tubular structure through the first mesh openings, the second mesh openings with smaller sizes can effectively prevent the thrombus fragments from escaping from the inside of the stent body, and the first mesh openings and the plurality of second mesh openings are matched with each other, so that the thrombus fragments can be better captured.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.
In the description of the present invention, it is to be understood that the term "axial" is to be understood as the direction in which the device of the present invention is advanced, i.e. the longitudinal axis of the device of the present invention, also coincides with the longitudinal axis of the vessel along which the device of the present invention is advanced. The term "circumferential" is to be understood as a circumferential direction of the device according to the invention, i.e. around the axis of the device according to the invention, which is perpendicular to the longitudinal axis of the device according to the invention, and coincides with the circumference of the vessel along which the device according to the invention is moved forward. The term "radial" is to be understood as a radial direction of the inventive device, i.e. a straight direction perpendicular to the longitudinal axis of the inventive device, also coinciding with the radial direction of the vessel along which the inventive device is moved forward.
For ease of description and understanding, the terms "distal" and "proximal" should be understood to refer to the direction of the hand-held end of the attending physician or medical intervention physician. The distal end is the side distal from the hand-held end of the attending physician or medical intervention physician, while the proximal end represents the side toward the hand-held end of the attending physician or medical intervention physician. If the phrase "axial" is used in this document, it is understood to mean the direction in which the device of the invention is advanced, i.e. the longitudinal axis of the device also coincides with the longitudinal axis of the vessel along which the device is advanced.
Referring to fig. 1, an intravascular thrombus removal device 10 is provided according to an embodiment of the present invention, comprising a stent body 100 having a mesh-like structure in an axial direction, wherein the stent body 100 has a self-expanded state and a compressed state after being subjected to a force, and in the compressed state, delivery in a blood vessel is facilitated to deliver the stent body 100 to a thrombus site. Under the self-expansion state, the thrombus at the thrombus position can be cut and captured, and finally the captured thrombus is retracted, so that the dredging of the blocked blood vessel is realized, and the arterial blood flow of the blood vessel is recovered.
It is understood that the compression degree or the self-expansion degree of the stent body 100 is mainly influenced by the thickness of a blood vessel at a position, the thinner the blood vessel is, the larger the compression degree is, the smaller the self-expansion degree of the stent body 100 is, the expansion degree of the stent body 100 is also influenced by the thrombus texture at the position, the softer the thrombus texture is, the more loose the expansion degree of the stent body 100 is, the harder the thrombus texture is, the denser the expansion degree of the stent body 100 is, and the smaller the expansion degree of the stent body 100 is, normally, the stent body 100 stays for 3-5 min after being released, so that the stent body 100 is expanded as much as possible, and is further embedded into thrombus tissues to be fully combined with the stent body 100.
Referring to fig. 1,2 and 3, the stent body 100 includes a proximal portion 110, an intermediate portion and a distal portion 130 disposed in an axial direction. The middle part comprises a plurality of repeating units 120, and the repeating units 120 are sequentially arranged along the axial direction. The repeating unit 120 includes a plurality of closed mesh units 121 sequentially arranged in the circumferential direction of the mesh-like structure. Each of the closed mesh units 121 includes a first mesh 1211 and a plurality of second mesh 1212 disposed adjacent to the first mesh 1211, the area of the first mesh 1211 being larger than the area of the second mesh 1212. In the present embodiment, the first mesh 1211 and the first mesh 1211 in the same repeating unit 120 are disposed adjacent to each other in the circumferential direction of the mesh tubular structure.
The area of the first mesh 1211 is 1.5-2.5 times the area of the second mesh 1212. In the present embodiment, the middle portion includes three repeating units 120, and the repeating units 120 include two closed mesh units 121 sequentially arranged in the circumferential direction of the mesh-like structure. In other embodiments, the number of the repeating units 120 and the closed grid units 121 may be single or plural, and may be adjusted according to specific needs without limitation.
When thrombus is cleaned, the first mesh 1211 and the plurality of second meshes 1212 are adjacently arranged, the area of the first mesh 1211 is larger than that of the second mesh 1212, the first mesh 1211 with larger size is beneficial to cutting thrombus, cut thrombus fragments can enter the stent main body 100 with a net tubular structure through the first mesh 1211, the second mesh 1212 with smaller size can effectively prevent the thrombus fragments from escaping from the inside of the stent main body 100, and the first mesh 1211 and the plurality of second meshes 1212 are mutually matched, so that the thrombus fragments can be better captured.
The first mesh 1211 generates weak radial supporting force when catching thrombus, which can reduce excessive stimulation to the vessel wall, and at the same time, the second mesh 1212 generates large radial supporting force when catching thrombus, which can be quickly embedded into thrombus, increase the stability of thrombus catching, and can effectively prevent thrombus fragments from escaping from the inside of the stent body 100. It should be understood that the radial supporting force is a force generated by the stent body 100 to the vessel wall in the self-expanding state, and when the first mesh 1211 of a larger size receives the same force, the first mesh 1211 of a larger size receives a larger pressure and is more easily deformed due to a smaller coverage per unit area, so that the radial supporting force generated when the first mesh 1211 of a larger size catches thrombus is weaker. The smaller size second mesh 1212 receives less pressure when subjected to the same force due to the greater coverage per unit area, and therefore the radial support force generated by the second mesh 1212 when capturing thrombus is greater.
Referring to fig. 1,2 and 3, the proximal portion is gathered at an end distal from the distal portion, and the distal portion is gathered at an end distal from the proximal portion. That is, the proximal end and the distal end of the stent body 100 are in a closed state, so that the thrombus fragments can be effectively prevented from escaping from the proximal end and the distal end of the stent body, and the thrombus fragments can be captured more easily.
The proximal portion 110 includes a plurality of closed cells 131, the plurality of closed cells 131 being arranged in a predetermined pattern such that the proximal end is in a closed configuration. A plurality of closed cells 131 are interconnected and meet at a proximal end such that the end of the proximal portion distal from the distal portion is in a closed configuration. The distal portion 130 includes a plurality of closed cells 131, the plurality of closed cells 131 being arranged in a predetermined pattern such that an end of the distal portion remote from the proximal portion is in a closed configuration. That is, the distal portions 130 are interconnected by a closed mesh 131, and meet at the distal-most end such that the distal-most end assumes a closed configuration,
The area of the closed mesh 131 is smaller than or equal to the area of the second mesh 1212, and when the stent body 100 is retracted, the distal end portion 130 formed by the interconnection of the smaller closed mesh 131 can block thrombus fragments that have fallen into the stent body 100, and in the retraction process, the thrombus is not easily fallen off, dragging the thrombus is facilitated, and escape of the thrombus fragments can be prevented. ,
The inventor finds that the stent main body which is marketed in China at present can only reach the blood vessel with the diameter of more than 1.5mm, and the thrombus can not be removed from the vascular embolism part with the smaller blood vessel diameter (the blood vessel diameter is less than 1.5 mm) for the thinner distal blood vessel. In order to solve the above problems, the applicant has made the following arrangement:
Referring to FIG. 1, the stent body 100 is made of a nickel-titanium alloy tubular material, and the pipe diameter of the nickel-titanium alloy tubular material is less than or equal to 0.4mm. Specifically, the holder body 100 is integrally manufactured using a machining process of laser engraving or laser cutting. It should be appreciated that nickel titanium alloys have superelasticity and shape memory properties and can be heat treated to set to memorize the set shape. Therefore, the stent body 100 made of nitinol has a sufficient radial supporting force, and also has superelasticity and shape memory, while ensuring good adherence. It should be further understood that the stent body 100 can be maintained in a compressed state all the time under the external circumferential restraining force, and when the external circumferential restraining force is removed, the stent body 100 made of nitinol can be restored to its original shape.
For example, the tube diameter of the nitinol tube is 0.4mm, it being understood that when the tube diameter of the nitinol tube is 0.4mm, the minimum compressed diameter of the stent body 100 in the compressed state is also the tube diameter of the nitinol tube, i.e., 0.4mm. The invention can be delivered in smaller diameter blood vessels, and the minimum can be delivered through 0.43mm blood vessels, so that the far-end blood vessels with more tortuosity and tiny intracranial can be reached.
Referring to fig. 2 and 3, the proximal portion 110, the plurality of repeating units 120, and the distal portion 130 are spirally distributed in the axial direction. Specifically, the plurality of closed cells 131 of the distal end portion 130, the plurality of repeating units 120, and the plurality of closed cells 131 of the proximal end portion 110 are sequentially spirally distributed in the axial direction.
More specifically, the adjacent two repeating units 120 are connected by an angle α of rotation in the axial direction, that is, the second of the two adjacent repeating units 120 is rotated by an angle α of rotation in the circumferential direction with respect to the first. The angle of alpha is in the range of 0 deg. -90 deg.. The preferred angular range of alpha is 45 deg.. For example, the repeating unit 120 includes a first repeating unit, a second repeating unit rotated by an angle α with respect to the first repeating unit, and a third repeating unit rotated by an angle α with respect to the second repeating unit.
By rotating the adjacent two repeating units 120 in the axial direction by an angle of α, so that the first mesh 1211 of the adjacent two repeating units 120 are not on the same connecting line in the axial direction, the first mesh 1211 can be spirally distributed in the axial direction. When thrombus is cleaned, the stent body 100 can be rotated by itself, and the first mesh 1211 is spirally arranged in the axial direction, so that the first mesh 1211 having a larger size in both the axial direction and the circumferential direction is arranged, thereby more advantageously rotating the thrombus.
In the present embodiment, the first cells 1211 of adjacent two repeating units 120 are disposed adjacent. The adjacent two first cells 1211 are connected to each other by an angle α in the axial direction, and the angle α is in the range of 0 ° -90 °. The preferred angular range of alpha is 45 deg..
The inventor finds that the poor effect of the radiopaque line of the stent main body can also cause the problems of inaccurate positioning of the stent main body, overlong thrombus taking time, thrombus falling off and the like. In order to solve the above problems, the applicant has made the following arrangement:
Referring to fig. 1 and 3, the developing units 200 are distributed on the proximal end portion 110, the distal end portion 130, and the plurality of repeating units 120. The connection modes of the developing unit 200 and the proximal portion 110, the distal portion 130, and the plurality of repeating units 120 may be mechanical nesting, crimping, metal collar, laser welding, adhesive bonding, or the like, and may be one of them, or a combination of a plurality of connection modes, which are not limited and may be adjusted according to specific needs.
Specifically, the developing units 200 on the adjacent two repeating units 120 are spirally distributed in the axial direction such that the developing units 200 on the adjacent two repeating units 120 are not on the same line. Each of the repeating units 120 includes two developing units 200, and the two developing units 200 in the same repeating unit 120 are symmetrically disposed with respect to the axial direction. By spirally distributing the developing units 200 on the adjacent two repeating units 120 in the axial direction and symmetrically arranging the two developing units 200 of each repeating unit 120 in the axial direction, the spatial resolution and visibility of the developing units 200 can be increased, thereby improving the spatial resolution and visibility of the rack main body 100. More specifically, the developing units 200 on the adjacent two repeating units 120 are arranged at an angle α ranging from 0 ° to 90 °. The preferred angular range of alpha is 45 deg..
The developing units 200 on the proximal end portion 110 and the distal end portion 130 are disposed at intervals. More specifically, the developing units 200 on the distal end portion 130 form a plurality of groups of developing structures arranged at intervals along the circumferential direction of the mesh-like structure, and two adjacent developing units 200 in the same group are arranged in parallel in the axial direction with intervals in the circumferential direction of the mesh-like structure. In the present embodiment, the number of the developing structures is two, each of the developing structures includes two developing units 200, and two developing units 200 are provided on the proximal end portion 110. In other possible embodiments, two adjacent developing units 200 have a spacing in both the axial direction and the circumferential direction of the mesh-like structure. The number of groups of the developing structure and the number of developing units 200 may be plural, and are not limited thereto, and may be adjusted according to specific needs.
The developing unit 200 is made of a metal material impermeable to X-rays, and may be any one of gold, platinum, tungsten gold, tantalum gold, or platinum iridium alloy. The main doctor or the medical intervention doctor can check the position of the developing unit 200 through DSA (digital subtraction angiography), so that the main doctor or the medical intervention doctor can be helped to better observe the state of the stent main body 100, and further judge the catching condition of thrombus by the stent main body 100.
Referring to fig. 1,2 and 3, the intravascular thrombus removal device 10 further includes a first visualization spring 300, a second visualization spring 400, the proximal portions converging at an end distal from the distal portions and forming a proximal tubular structure 700, the first visualization spring 300 being connected to the proximal tubular structure 700. The distal portion gathers at an end distal from the proximal portion and forms a distal tubular structure. The second developer spring 400 is connected to the distal tubular structure 800. The connection modes of the first developing spring 300 and the proximal tubular structure 700 and the connection mode of the second developing spring 400 and the distal tubular structure 800 can be nesting, crimping, metal collar, laser welding, adhesive bonding and the like of mechanical structures, can be one of the connection modes, can be a combination of a plurality of connection modes, are not limited, and can be adjusted according to specific needs.
The first developing spring 300 and the second developing spring 400 are made of a metal material impermeable to X-rays, and may be any one of gold wires, platinum wires, or platinum tungsten wires. The main doctor or medical intervention doctor can view the positions of the first and second visualization springs 300 and 400, which are not transparent to X-rays, through DSA (digital subtraction angiography), and can help the main doctor or medical intervention doctor to better observe the positions of the proximal and distal ends of the stent body 100.
The inventor finds that most of the bracket main bodies on the market at present are connected with the pushing rod and the developing spring in a simple welding mode, and the welding points are easy to fall off or break due to the technical defects of welding, so that the bracket main bodies are damaged and fall in the blood vessels of a human body, and serious clinical accidents are caused. In order to solve the above problems, the applicant has made the following arrangement:
Referring to fig. 1,3 and 4, the intravascular thrombus removal device 10 further includes a push rod 500, with a connecting clip 600 formed at an end of the push rod 500 near the proximal end. The first developer spring 300 includes a proximal connection portion 310 and a distal connection portion 320, the proximal connection portion 310 being connected to a proximal tubular structure 700. One end of the push rod 500 near the proximal end is penetrated through the proximal connecting portion 310 and the proximal tubular structure 700, the distal connecting portion 320 is disposed between the connecting chuck 600 and the proximal tubular structure 700, and the connecting chuck 600 can be abutted against the distal connecting portion 320.
Specifically, the inner diameter of the proximal tubular structure 700 is larger than the diameter of the connecting chuck 600, the inner diameter of the proximal connecting portion 310 is larger than the diameter of the connecting chuck 600, and the connecting chuck 600 and the push rod 500 can pass through the proximal connecting portion 310 and the proximal tubular structure 700 when assembled. The inner diameter of the distal end connecting portion 320 is smaller than the diameter of the connecting chuck 600 and larger than the inner diameter of the proximal end tubular structure 700, and the distal end connecting portion 320 is arranged between the connecting chuck 600 and the proximal end tubular structure 700, so that the connecting chuck 600 can be effectively prevented from falling off from the proximal end of the stent main body 100, and the problem that the stent main body 100 is damaged and falls off in a human blood vessel can be effectively solved.
The connection manner of the proximal tubular structure 700 and the first developing spring 300 and the pushing rod 500 may be the above-mentioned nested manner, and then be connected by welding, adhesive bonding, etc., which is a combination of various connection manners, and is not limited herein, and may be adjusted according to specific needs. For example, the proximal connector 310 is welded to the proximal tubular structure 700 and the connector clip 600 is welded to the proximal tubular structure 700 via the distal connector 320.
The intravascular thrombus removal device 10 of the present invention is used in conjunction with a microcatheter by first determining the location of the thrombus within the vessel by DSA (digital subtraction angiography) and then delivering the microcatheter to the thrombus location and through the thrombus.
The stent body 100 is pushed to the thrombus position by the pushing action of the push rod 500, and the second developing spring 400 is checked by DSA (digital subtraction angiography) to determine the position of the distal-most end of the stent body 100. After the distal-most end of the stent body 100 is adjusted to the proper position, the microcatheter is withdrawn. With the withdrawal of the microcatheter, the stent body 100 will self-expand and deploy at the thrombus site, the repeating unit 120 of the middle portion of the stent body 100 will embed into the thrombus, and at the same time, the several closed cells 131 of the distal end portion 130 of the stent body 100 will self-expand and deploy.
The first mesh 1211 and the plurality of second mesh 1212 of the repeating unit 120 are disposed adjacent to each other, and the area of the first mesh 1211 is larger than that of the second mesh 1212, the first mesh 1211 with a larger size is beneficial to cutting thrombus, and the cut thrombus fragments can enter the stent body 100 with a mesh-tube structure through the first mesh 1211, the second mesh 1212 with a smaller size can effectively prevent the thrombus fragments from escaping from the stent body 100, and the first mesh 1211 and the plurality of second mesh 1212 are mutually matched, so that the thrombus fragments can be better captured.
The distal outlet of the microcatheter is aligned with the first visualization spring 300 as the microcatheter is withdrawn and the stent body 100 is fully released from the microcatheter. Waiting for 3min to 5min, and fully embedding the stent body 100 and thrombus. Then the microcatheter, the stent body 100 and the pushing rod 500 are synchronously retracted until the stent body 100 and the thrombus are pulled out of the body, thus completing the thrombus taking operation.
Wherein, the distal portions 130 are interconnected by smaller closed meshes 131 and meet at the distal-most end to make the distal-most end in a closed structure, when the stent body 100 is retracted, the distal portions 130 formed by the interconnection of the smaller closed meshes 131 can block thrombus fragments that have fallen into the stent body 100, and in the retraction process, the thrombus is not easy to fall off, which is more favorable for dragging the thrombus, and can prevent the thrombus fragments from escaping.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.