CN115137432A

CN115137432A - Embolization system

Info

Publication number: CN115137432A
Application number: CN202210711708.2A
Authority: CN
Inventors: 张蕾
Original assignee: Shenzhen Baite Micro Medical Technology Co ltd
Current assignee: Shenzhen Baite Micro Medical Technology Co ltd
Priority date: 2022-04-25
Filing date: 2022-04-25
Publication date: 2022-10-04
Also published as: CN114521933B; CN114521933A; CN115137433A

Abstract

A embolism system comprises an embolism implant body and a pushing assembly, wherein the embolism implant body comprises a spring ring, the spring ring comprises a plurality of elastic rings which are arranged spirally under a stretching state, the pushing assembly comprises a pushing pipe and a connecting piece, the connecting piece comprises a main body part and a hooking part connected with the main body part, the hooking part comprises a first hooking part and a second hooking part, one ends of the first hooking part and the second hooking part, which are far away from the main body part, are free ends, the free ends of the first hooking part and the second hooking part are both in a bent shape, the connecting piece penetrates through the pushing pipe, and the first hooking part and the second hooking part both extend into the space between the adjacent elastic rings and are connected with the elastic rings to enable the embolism implant body to be connected with the pushing pipe; and first hook portion and the equal deformable of second hook portion make the connecting piece along the release of release tube of pushing tube first hook portion and second hook portion deformation in order to realize the embolism implant and release of release tube when the near-end axial displacement is followed to the propelling movement pipe. In the implantation process, the flexibility of the embolism system is better, and the spring ring releasing process is simple and easy.

Description

Embolization system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an embolism system.

Background

This section provides background information related to the present disclosure only and is not necessarily prior art.

Aneurysms are due to lesions or lesions of the arterial wall, forming the appearance of localized or diffuse dilatation or bulging of the arterial wall, mainly represented by distending, pulsating masses. Aneurysms may occur in arterial vessels such as intracranial arteries, aorta, splenic arteries, and the like. When occurring in intracranial arteries, a gradual increase in intracranial aneurysm or an increase in blood pressure can lead to rupture, resulting in subarachnoid hemorrhage, which can be life threatening. When it occurs in the aorta, if the blood pressure in the aneurysm exceeds the tolerable range of the arterial wall, it tears the arterial wall, causing massive bleeding and life threatening. When occurring in the splenic artery, the major hazard of splenic aneurysms is acute rupture leading to massive hemorrhage, hemorrhagic shock and sudden death.

The aim of aneurysm treatment is mainly to reduce the pressure in the aneurysm cavity and eliminate the risk of rupture. The principle of treatment is to preserve as long a blood supply as possible. The intracavity minimally invasive treatment is a preferred method for treating the aneurysm at present due to the advantages of simple operation, small wound, no need of general anesthesia, quick recovery of patients and the like.

Embolotherapy is one of the minimally invasive methods of treatment in the lumen. The method is to implant the embolism implant body into the aneurysm cavity, because of the existence of the embolism implant body, when blood flows into the aneurysm, thrombus is easily formed, so that the pressure in the aneurysm is obviously reduced, the possibility of aneurysm rupture is reduced, and the purpose of treating the aneurysm is achieved.

Currently, embolic implants are typically coils. Prior to embolization, the coil is stretched and loaded into the delivery catheter, with the proximal end of the coil attached to a pusher rod. In embolization, a delivery catheter loaded with a coil is inserted into an aneurysm cavity, and the coil is then pushed from the delivery catheter into the aneurysm cavity with a push rod. When the spring ring is stable in the aneurysm cavity, the connection between the push rod and the spring ring is released; the same procedure is continued again for the next coil.

In the implantation process, the connection between the push rod and the spring ring is released, namely the release is the most critical step. Therefore, the connection and release mechanism of the spring ring is an important design in an embolism system, and the release mechanism with excellent design can reduce the intervention time and ensure the positioning accuracy and the release reliability.

Existing disengagement mechanisms can be broadly classified into the following categories: hydrolytic release, electrolytic release, thermal melt release and mechanical release. Among them, hydrolytic dissociation is unstable, it is easy to increase the pressure of blood vessel, the time of electrolytic dissociation is long and it is easy to generate high voltage, the thermal dissociation introduces pyrogen and it is easy to damage the tissue, the mechanical dissociation is the most reliable dissociation mechanism at present.

The mechanical coupling and decoupling mechanism typically includes a pair of interacting arms (e.g., boston scientific Interlock coils) that remain engaged when the interacting arms are radially constrained by the delivery catheter and disengage when the radial constraint of the delivery catheter is released, thereby releasing the coils.

This also has the disadvantage that the delivery catheter is withdrawn and then released to release the coil, and if the release position is not correct, the coil cannot be retrieved to readjust the position. Also, such an interacting arm is a rigid structure, and the interacting arm is typically an axially extending structure. When the plug is engaged, the rigid structure is longer, resulting in a less flexible plug system that is not conducive to delivery.

Disclosure of Invention

In view of the above, there is a need for an embolic system that is flexible and easy to release the coil.

A embolism system comprises an embolism implant body and a pushing assembly, wherein the embolism implant body comprises a spring ring, the spring ring comprises a plurality of elastic rings which are arranged spirally under a stretching state, the pushing assembly comprises a pushing pipe and a connecting piece, the connecting piece comprises a main body part and a hooking part connected with the main body part, the hooking part comprises a first hooking part and a second hooking part, one ends of the first hooking part and the second hooking part, which are far away from the main body part, are free ends, the free ends of the first hooking part and the second hooking part are both in a bent shape, the pushing pipe is penetrated by the connecting piece, and the first hooking part and the second hooking part both extend into the space between the adjacent elastic rings and are hooked with the elastic rings, so that the embolism implant body is connected with the pushing pipe; and the first hook part and the second hook part can be deformed, so that when the connecting piece moves axially towards the near end along the pushing pipe, the first hook part and the second hook part are deformed to realize the release of the embolism implant and the pushing pipe.

In one embodiment, the free ends of the first and second hooks are bent in opposite directions so that the distal ends of the first and second hooks are radially spread apart from the main body.

In one embodiment, the first hook has a bent portion length greater than a bent portion length of the second hook.

In one embodiment, the thickness of the free end of the first hook part and the thickness of the free end of the second hook part are both larger than the distance between the adjacent elastic rings.

In one embodiment, the pushing tube includes a tube body, the tube body includes a first tube body and a second tube body connected to a proximal end of the first tube body, the first tube body and the second tube body are connected to form the tube body, the connecting member is inserted through the tube body, and the proximal end of the connecting member is fixedly connected to the second tube body or the proximal end of the connecting member is hooked to the second tube body.

In one embodiment, the first tube is a helical tube and the second tube is a hypotube.

In one embodiment, the ratio of the lengths of the first tube and the second tube is 1:3-1.

In one embodiment, the second pipe body includes a first diameter section, a variable diameter section, and a second diameter section, and both ends of the variable diameter section are connected to the first diameter section and the second diameter section, respectively.

In one embodiment, the ratio of the lengths of the first diameter section, the reducer section and the second diameter section is (1.

In one embodiment, when the proximal end of the connector is fixedly connected to the second tube, the proximal end of the second tube is formed with a weakened portion such that the second tube can be broken to effect disengagement of the embolic implant from the pusher tube.

In one embodiment, a polymer tube is sleeved on the tube body, and the polymer tube covers the proximal end of the first tube body and the distal end of the second tube body.

In one embodiment, the ratio of the length of the polymer tube extending over the first tube to the length of the first tube is 0.01 to 1, and the ratio of the length of the polymer tube extending over the second tube to the length of the second tube is 0.003 to 0.12.

This public embolism system sets up first hook portion and second hook portion at the distal end of connecting piece, stretches into between the adjacent elastic ring through first hook portion and second hook portion to take place the hook with the elastic ring, realize the embolism implant and be connected with dismantling of propelling movement pipe. On one hand, the embolism system arranged in the way does not need to be additionally provided with a rigid connecting structure at the near end of the spring ring, so that the flexibility of the embolism system is better; on the other hand, a connecting structure is not required to be additionally arranged at the far end of the pushing tube, so that the structure of the embolism system and the process of releasing the spring ring are simplified to the greatest extent, and the flexibility of the embolism system is further improved.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Wherein:

FIG. 1 is a schematic structural diagram of an embolization system according to an embodiment;

FIG. 2 is a schematic view of an embodiment of an embolic implant;

FIG. 3 is a schematic illustration of an embolic implant according to an embodiment in a partially released state;

FIG. 4 is a schematic view of another embodiment of an embolic implant;

FIG. 5 is a schematic diagram of a pushing assembly according to an embodiment;

FIG. 6 is a schematic view of a second tube of the push tube according to one embodiment;

FIG. 7 is a schematic view of a connection portion of a push tube according to an embodiment;

FIG. 8 is an enlarged view of a portion of FIG. 1;

FIG. 9 is a partial schematic structural view of a pusher tube and connector according to one embodiment;

FIG. 10 is an enlarged view of a portion of FIG. 9;

FIG. 11 is a schematic structural view of an embolization system according to another embodiment;

fig. 12 is a partially enlarged view of fig. 11.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the embodiments of the present invention, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like are based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the embodiments of the present invention and simplifying the description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be configured in a specific orientation, and operate, and thus, should not be construed as limiting the embodiments of the present invention. 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.

In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly stated or limited, the terms "mounted," "connected" and "connected" should be interpreted broadly, and may be, for example, fixedly connected, interchangeably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected through an intermediate medium, or communicated between two elements. Specific meanings of the above terms in the embodiments of the present invention may be understood as specific cases by those of ordinary skill in the art.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to an operator is generally referred to as the "proximal end", the end that is farther from the operator is generally referred to as the "distal end", and the "proximal" and "distal" ends of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

Referring to fig. 1, an embolization system 1 of an embodiment includes an embolization implant 10 and a pushing assembly 20, the pushing assembly 20 being used to push the embolization implant 10 into the aneurysm cavity. The embolic implant 10 is disconnected from the pusher assembly 20, leaving the embolic implant 10 in the lumen of the aneurysm for embolizing the aneurysm.

Referring to fig. 2, embolic implant 10 includes a coil 110 and a cap 120 attached to the distal end of coil 110. The end socket 120 is connected with the spring ring 110 by welding, gluing, etc. The end cap 120 has a hemispherical structure with a smooth surface to avoid damaging the inner wall of the aneurysm.

In a stretched state (e.g., loaded in a delivery catheter), the spring coil 110 comprises a plurality of spring coils 111 arranged in a spiral, i.e., in a stretched state, the spring coil 110 is in the shape of a helical spring. For convenience of description, the elastic ring located at the most proximal end is designated by 112, and is simply referred to as the elastic ring 112. In one embodiment, the spring coil 112 forms a gap 113 with the adjacent spring coil 111, and the width of the gap 113 is larger than the pitch of the spring coil 110 except for the proximal-most spring coil 112, i.e., the distance between the adjacent two spring coils 111, so that the spring coil 110 has a helical structure with unequal pitches. That is, the pitch of a section of the most distal elastic ring 111 to the elastic ring 111 adjacent to the most proximal elastic ring 112 is equal and smaller than the distance between the most proximal elastic ring 112 and the adjacent elastic ring 111.

In one embodiment, the spring coil 110 is a coil structure formed by spirally winding a wire, the plurality of elastic coils 111 and the proximal-most elastic coil 112 are formed as a single body, and the proximal-most elastic coil 112 is separated from the adjacent elastic coil 111 by a certain angle to form a gap 113.

In another embodiment, the plurality of elastic rings 111 are of an integrated structure, and the elastic ring 112 is connected with the adjacent elastic ring 111 by welding.

In one embodiment, the proximal-most resilient ring 112 has a free end with an anti-tamper ball head disposed thereon. In another embodiment, the free end of the proximal-most elastic loop 112 is connected to other portions by welding to form a completely closed loop coil structure.

Spring coil 110 is made of a resilient shape memory material. In the natural state, spring ring 110 is in a radially expanded three-dimensional state. When spring ring 110 is axially stretched, spring ring 110 assumes the state shown in FIG. 2. When the axial tension (or radial constraint) experienced by coil 110 is removed, coil 110 returns to its natural state. As shown in FIG. 3, when the stretching (or radial restraint) of embolic implant 10 is released, the distal portion of coil 110 is crimped or coiled to form a three-dimensional structure. That is, when the stretching (or radial constraint) applied to embolic implant 10 is released, coil 110 changes from the stretched state to the radially expanded three-dimensional state. When the embolic implant 10 is disconnected from the pusher assembly 20, the proximal end of the coil 110 is also crimped, causing the embolic implant 10 as a whole to become a solid structure for embolizing the aneurysm.

It should be noted that in its natural state, coil 110 is not limited to the configuration shown in FIG. 3, and may have any configuration that allows embolization of an aneurysm. For example, including but not limited to spherical, ellipsoidal, etc.

The material of spring ring 110 is nickel titanium alloy, platinum tungsten alloy, etc. The material of the sealing head 120 may be a metal material or a polymer material.

Referring to FIG. 4, in one embodiment, spring coil 110 has a plurality of fibers 130 wound therearound. The fiber hairs 130 are beneficial to promote thrombus formation to quickly reduce the pressure in the aneurysm cavity and avoid rupture of the aneurysm. It should be noted that the fiber hairs 130 are flexible filament structures, and the provision of a plurality of fiber hairs 130 does not increase the stiffness of the embolic implant 10. Fig. 4 is only intended to show the state in which the fiber bristles 130 are coupled to the spring rings 110, and does not necessarily show the structure in which the fiber bristles 130 are vertical.

In one embodiment, the fiber bristles 130 are made of a nylon material.

In other embodiments, the fiber bristles 130 may be omitted. The crimped coil 110 itself may also promote thrombus formation.

In another embodiment, coil 110 is provided with a thrombus-promoting coating (not shown) on its surface, which contains a clot-promoting drug, e.g., protamine sulfate, thrombin, etc., to promote thrombus formation.

Referring back to FIG. 1, the pushing assembly 20 includes a pushing tube 210 and a connector 220. A connector 220 is disposed through the pusher tube 210, and the distal end of the connector 220 is connected to the embolic implant 10.

Referring to fig. 5, the pushing tube 210 includes a tube 211 and a connecting portion 212 connected to a distal end of the tube 211.

In one embodiment, the tube 211 includes a first tube 2111 and a second tube 2112 connected to a proximal end of the first tube 2111. The first tube 2111 and the second tube 2112 are hollow tubes each having both ends open, so that the tube 211 has an inner cavity which is open at both ends and extends axially.

The first tube 2111 has a lower hardness than the second tube 2112, allowing the distal end of the pusher tube 210 to be more flexible to pass through a tortuous vessel and easily bend into the aneurysm cavity.

In one embodiment, the first tube 2111 is a helical tube, the second tube 2112 is a smooth tube, and the second tube 2112 is a metal or polymer tube. The hardness of the helical tube is less than that of the metal or polymer tube.

In one embodiment, the first tube 2111 is a helical tube and the second tube 2112 is a hypotube. In one embodiment, the ratio of the lengths of the first tube 2111 and the second tube 2112 is 1:3 to 1:10 to compromise the compliance of the distal end and the overall push performance.

In one embodiment, a lubricant layer (not shown) is disposed on the outer surface of the second tube 2112 to reduce friction with the inner surface of the delivery catheter to facilitate pushing the pusher tube 210 through the delivery catheter or to facilitate withdrawal of the delivery catheter.

In one embodiment, a polymer tube (not shown) is sleeved on the tube 211, and covers the proximal end of the first tube 2111 and the distal end of the second tube 2112.

The polymer tube is arranged in the above manner, so that transition from the softer first tube 2111 to the harder second tube 2112 is provided, and rapid transition between the first tube 2111 and the second tube 2112 is avoided and breakage is easily caused, which is favorable for improving reliability.

In one embodiment, the polymer tube covers only the proximal end of first tube body 2111 and only the distal end of second tube body 2112, i.e., the polymer tube only partially covers first tube body 2111 and only partially covers second tube body 2112, thus not significantly increasing the stiffness of tube body 211.

In one embodiment, the ratio of the length of the polymer tube extending over the first tube 2111 to the length of the first tube 2111 is 0.01 to 1, and the ratio of the length of the polymer tube extending over the second tube 2112 to the length of the second tube 2112 is 0.003 to 0.12, so that the region with low hardness and the region with high hardness of the push tube 210 can be smoothly transited, and the overall hardness of the push tube 210 is not significantly increased by the polymer tube.

The material of the polymer tube may be polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyolefin, or the like.

In one embodiment, a lubricating layer is disposed on the surface of the second tube 2122 not covered by the polymer tube to improve the smoothness of pushing. The lubricating layer can be prepared by spraying, dip coating or electrostatic spinning and the like.

In one embodiment, the material of the lubricating layer is PTFE, silicone or polyvinylpyrrolidone.

In one embodiment, the second tube 2112 has a variable diameter structure. The second tube 2112 has a diameter that gradually increases from the distal end to the proximal end.

Referring to fig. 6, in one embodiment, the second tube 2112 includes a first equal-diameter section 2112A, a variable-diameter section 2112B, and a second equal-diameter section 2112C. The outer diameter of the tapered section 2112B gradually increases from the distal end to the proximal end. The smaller diameter end of the variable diameter section 2112B is connected to the proximal end of the first equal diameter section 2112A, and the larger diameter end of the variable diameter section 2112B is connected to the distal end of the second equal diameter section 2112C. The first equal-diameter section 2112A has an outer diameter equal to the minimum outer diameter of the variable-diameter section 2112B, and the second equal-diameter section 2112C has an outer diameter equal to the maximum outer diameter of the variable-diameter section 2112B, so that the first equal-diameter section 2112A, the variable-diameter section 2112B, and the second equal-diameter section 2112C smoothly transition from the distal end to the proximal end.

An end of first reduced-diameter section 2112A of second tubular body 2112 remote from reduced-diameter section 2112B is connected to a proximal end of first tubular body 2111.

The first equal-diameter section 2112A, the variable-diameter section 2112B and the second equal-diameter section 2112C are made of the same material, and the diameters of the first equal-diameter section 2112A, the variable-diameter section 2112B and the second equal-diameter section 2112C are sequentially increased, so that the second pipe body 2112 is good in flexibility on one hand, and the second pipe body 2112 has enough pushing performance; on the other hand, the first equal-diameter section 2112A with better flexibility of the second pipe body 2112 is connected with the first pipe body 2111 with better flexibility, so that the pipe body 211 is prevented from being broken easily due to abrupt hardness change.

In an embodiment, the ratio of the lengths of the first equal-diameter section 2112A, the variable-diameter section 2112B, and the second equal-diameter section 2112C is (1.

In one embodiment, markers 213 are provided on the pusher tube 210 to indicate the position of the pusher tube 210 during implantation. In one embodiment, the tag 213 is a metal ring, and the tag 213 is disposed on the first tube 2111. The material of the marker 213 is a material with good visibility under medical imaging equipment, such as platinum-iridium alloy, platinum-tungsten alloy, etc.

The tag 213 is sleeved on the first tube 2111, and the tag 213 and the first tube 2111 are fixedly connected by welding or gluing.

Referring to fig. 5 and 6, a weakened portion 21121 is provided at the proximal end of the second tube 2112.

In one embodiment, as shown in fig. 5, the weakened portion 21121 is a portion of reduced wall thickness at the proximal end of the second tube 2112, which is a circumferential ring of reduced wall thickness of the second radiused section 2112C.

In another embodiment, as shown in FIG. 6, the weakened portion 21121 is an aperture area in the second equal-diameter segment 2112C. A plurality of apertures 21122 are formed in the proximal end of the second radiused section 2112C, the plurality of apertures 21122 forming a weakened portion 21121. The plurality of apertures 21122 are spaced circumferentially along the second isometric segment 2112C, i.e., the plurality of apertures 21122 circumferentially surround the second isometric segment 2112C. Alternatively, the plurality of apertures 21122 are spaced along the half-perimeter of the second equal-diameter section 2112C. That is, the second equal-diameter section 2112C is uniformly divided into two portions in the axial direction, and a plurality of holes 21122 are spaced apart in the circumferential direction of the circular-arc surface on one portion thereof.

Referring back to fig. 5, the connecting portion 212 is fixedly connected to the distal end of the first tube 2111. The fixing manner is not limited, and any manner such as welding or gluing may be used to fix the connection portion 212 and the first tube 2111.

Referring to fig. 7, in one embodiment, the connecting portion 212 includes a connecting tube 2121 and a hook 2122 connected to the connecting tube 2121. The connecting tube 2121 is provided with an axially extending through hole 21211. The clasp 2122 is a loop-like structure. The hook 2122 is angled to the connecting tube 2121 such that a gap is formed between the hook 2122 and the connecting tube 2121, when connected, the hook 2122 can be inserted into the gap 113 (not labeled in fig. 7) between the elastic ring 112 and the elastic ring 111 adjacent to the elastic ring 112, and the hook 2122 is hooked on the elastic ring 112.

The material of the connecting portion 212 may be metal or plastic.

Referring to fig. 1 and 8, in one embodiment, the connecting member 220 is a rod-shaped structure. The connector 220 is inserted through the pushing tube 210, and the distal end of the connector 220 passes through the connecting tube 2121 and extends into the clasp 2122 and the elastic ring 112. Also, the radial dimension (e.g., diameter) of the connector 220 matches the inner diameter of the clasp 2122 and the resilient ring 112. Alternatively, the size of the link 220 matches the size of the inner walls of the clasp 2122 and the resilient ring 112 in at least one dimension such that the link 220 abuts or forms a frictional connection with the inner walls of the resilient ring 112 and the clasp 2122. Therefore, when the relative axial position of the connector 220 and the pushing tube 210 is kept unchanged, the connector 220 can be kept in a state of abutting or frictional connection with the inner walls of the clasp 2122 and the elastic ring 112, so as to realize the axial and circumferential locking of the embolic implant 10 and the pushing assembly 20.

In one embodiment, the proximal end of the connector 220 is fixedly coupled to the second tube 2112 such that the relative position of the connector 220 and the pusher tube 210 remains unchanged.

In one embodiment, the connection element 220 has elasticity, and the proximal end of the connection element 220 has a bendable portion, so that the proximal end of the connection element 220 can be hooked with the second tube 2112, and in the hooked state, the relative position between the connection element 220 and the pushing tube 210 is kept unchanged.

Thus, by providing the elastic ring 112, the connecting portion 212 of the pushing tube 210 and the connecting member 220 to cooperate with each other, the embolic implant 10 and the pushing assembly 20 can be locked in the axial and circumferential directions while the relative axial positions of the connecting member 220 and the pushing tube 210 are kept constant, thereby achieving the connection of the embolic implant 10 and the pushing assembly 20.

And, by moving the connecting member 220 axially upward, the plug implant 10 is released from the pushing assembly 20 when the connecting member 220 no longer abuts against the inner walls of the elastic ring 112 and the clasp 2122, thereby releasing the plug implant.

The second tube 2112 is broken at the weakened portion 21121 of the second tube 2112, and during the breaking process, the connecting element 220 is pulled to move axially, so that the connecting element 220 no longer abuts against the inner walls of the clasp 2122 and the elastic ring 112, and thus the second tube 2112 is released.

Alternatively, after the second tube 2112 is broken at the weakened portion 21121 of the second tube 2112, the coupling member 220 is exposed, and the coupling member 220 is axially moved toward the proximal end, so that the coupling member 220 is no longer held against the inner walls of the clasp 2122 and the elastic ring 112, thereby achieving the disengagement.

Alternatively, in another embodiment, the coupling element 220 is unhooked from the second tube 2112 and the coupling element 220 is then moved axially proximally so that the coupling element 220 no longer abuts the inner walls of the clasp 2122 and resilient ring 112, thereby effecting disengagement.

In one embodiment, the connector 220 is an elongated metal wire, including but not limited to stainless steel wire, nitinol wire, or the like.

Referring to fig. 9 and 10, in one embodiment, a protection tube 230 is sleeved on the connection element 220. The length of protective tube 230 is less than the length of connector 220. When coupling member 220 is fixedly coupled to pusher tube 210, protective tube 230 is diametrically opposed to weakened portion 21121, and protective tube 230 extends axially a distance distally and proximally from weakened portion 21121, respectively. A protective tube 230 is provided to protect the connector 220 from breaking the connector 220 when the second tube 2112 is broken at the weakened portion 21121.

The connecting element 220 is prevented from being broken, on one hand, the smooth proceeding of the releasing is ensured, and after the second tube body 2112 is broken, if necessary, the connecting element 220 can be manually moved towards the proximal end axially, so that the releasing is realized; on the other hand, after the detachment is completed, the connecting element 220 and the pushing tube 210 are integrally withdrawn to the outside of the body, so as to complete the operation.

The material of the protection tube 230 is a polymer material, including but not limited to PET, PTFE, pebax material, etc.

A protective tube 230 is provided to protect the connector 220 from being broken. However, protective tube 230 cannot be too long to avoid reducing the compliance of pusher assembly 20. In one embodiment, protective tube 230 extends distally and proximally from weakened portion 21121 by 5-100 mm, respectively, to protect coupling member 220 and avoid compromising the compliance of pusher assembly 20.

In other embodiments, when the connector 220 is made of an elastic material, such as nitinol with elasticity, the connector 220 is not easily broken, and the protection tube 220 may be omitted.

In the embolization system 1, the connecting part 212 of the pushing tube 210 extends between the most proximal elastic ring 112 and the elastic ring 111 adjacent to the most proximal elastic ring 112, and is hooked with the most proximal elastic ring 112; and the far end of the connecting piece 220 extends into the connecting part 212 and the elastic ring 112 at the most proximal end, and can be abutted against the inner wall of the connecting part 212 and the inner wall of the elastic ring 112 at the most proximal end through the outer wall of the connecting piece 220, so that the locking of the embolic implant 10 and the pushing assembly 20 can be realized in the axial direction and the circumferential direction, and even if the delivery catheter is withdrawn, when the relative axial positions of the pushing tube 210 and the connecting piece 220 are kept unchanged, the locking state of the embolic implant 10 and the pushing assembly 20 can be kept, therefore, the position of the embolic implant 10 can still be adjusted after the delivery catheter is withdrawn, and the adjustment is convenient.

Moreover, the most proximal elastic ring 112, the connecting part 212 of the pushing tube 210 and the connecting part 220 are matched to realize the detachable connection of the embolic implant 10 and the pushing tube 210, and a rigid connecting structure is not required to be additionally arranged at the proximal end of the elastic ring 110, so that the embolic system 1 has better flexibility. The embolic system 1 connects the embolic implant 10 to the pusher assembly 20 by the cooperation of the proximal-most resilient ring 112, the connecting portion 212 of the pusher tube 210, and the connector 220. The elastic ring 112 of the spring ring 110 is used for realizing connection and disconnection, a connecting structure is not required to be additionally arranged at the near end of the spring ring 110, the structure is simple, and the preparation is convenient. And, because of the additional connection structure that omits, improved compliance.

When the relative axial position relationship between the connecting member 220 and the pushing tube 210 is kept unchanged, the embolic implant 10 and the pushing assembly 20 can be reliably connected, and can be prevented from being disengaged in advance, which is beneficial to improving the accuracy of the release position and the reliability of the operation. In addition, the release is realized by breaking the pushing tube 210 or releasing the hooking between the connecting member 220 and the pushing tube 210, so that the release speed is high, and the operation time is shortened. The effect of shortening the operation time is particularly significant when it is desired to implant a plurality of embolic implants 10.

It should be noted that, in another embodiment, when the pitch of the spring ring 110 is larger, the most proximal elastic ring 112 does not need to be bent to a certain angle, the spring ring 110 has a uniform pitch structure, the hook 2122 of the connecting portion 212 is directly inserted between the most proximal elastic ring 112 and the elastic ring 111 adjacent to the most proximal elastic ring 112, and the plug implant 10 can be connected to and disconnected from the pushing assembly 20 by cooperation with the connecting member 220.

In addition, in the embodiment of bending the most proximal elastic ring 112 to a certain angle, the connection between the plug implant 10 and the pushing assembly 20 can be reliably realized by the cooperation of the connecting member 220, and the plug implant 10 and the pushing assembly 20 can be released more smoothly. In one embodiment, as shown in fig. 4, the included angle θ between the nearest elastic ring 112 and the elastic ring 111 adjacent to the nearest elastic ring 112 is in the range of 10 ° to 80 °, so that the clasp 2122 can be reliably hooked with the nearest elastic ring 112, thereby improving the connection reliability. At the same time, the gap 113 is of a suitable size to facilitate release.

In one embodiment, the included angle θ ranges from 10 ° to 60 °. In another embodiment, the included angle θ ranges from 20 ° to 45 °. So set up to compromise reliably and connect and conveniently release better.

In this embodiment, referring back to fig. 8, the hooks 2122 are inserted into the gap 113 between the nearest elastic ring 112 and the adjacent elastic ring 111 from the top to the bottom (as indicated by the arrow F1 in fig. 8), and the included angle θ between the nearest elastic ring 112 and the adjacent elastic ring 111 ranges from 10 ° to 80 °, so that the hooks 2122 can be reliably hooked on the nearest elastic ring 112 and conveniently released, and the axial central axis of the embolic implant 10 and the axial central axis of the pusher 20 can be axially collinear, thereby preventing the embolic implant 10 and the pusher 20 from being dislocated in the radial direction, and thus the delivery catheter with a smaller inner diameter can be used for delivery.

Referring to fig. 11, another embodiment of an embolic system 3 includes an embolic implant 30 and a pusher assembly 50. The embolic implant 30 has the same structure as the embolic implant 10 and will not be described in detail here. The pusher assembly 50 includes a pusher tube 510 and a connector 520. The difference from the pusher tube 210 of the embolization system 1 is that the pusher tube 510 does not contain a connection 212, and the structure of the connector 520 is different from the structure of the connector 220.

Referring to fig. 12, the connecting member 520 includes a main body 521, a first hooking portion 522 and a second hooking portion 523. In a natural state, the main body portion 521 is an elongated rod structure or a filament structure. Alternatively, the body portion 521 is an elongated rod structure or a filament structure with a resiliently bendable section at the proximal end. The first hook 522 and the second hook 523 are each a curved wire-like structure. The first and

second hooks

521 and 522 are made of an elastic material so that the first and

second hooks

522 and 523 are deformable. For example, the first hook 522 and the second hook 523 are each made of nickel-titanium alloy. The material of the body 521 may be the same as or different from the materials of the first hook-and-hold portion 522 and the second hook-and-hold portion 523.

One end of the first hook 522 is connected to the distal end of the main body 521, and one end of the first hook 522 away from the main body 521 is a free end and is curved. One end of the second hook 523 is connected to the distal end of the main body 521, and one end of the second hook 523, which is away from the main body 521, is a free end and is curved. Further, the bending directions of the first hook 522 and the second hook 523 are opposite, so that the distal ends of the first hook 522 and the second hook 523 are radially expanded with respect to the body 521.

Referring to fig. 11 and 12, the connecting member 520 penetrates the pushing tube 510, the first hooking portion 522 and the second hooking portion 523 extend from the pushing tube 510, and the first hooking portion 522 and the second hooking portion 523 extend into the spring ring 310 to hook with the spring ring 311 and/or the proximal-most spring ring 312, so as to connect the plug implant 30 to the pushing member 50. Since the bending directions of the first hooking part 522 and the second hooking part 523 are opposite, the plug implant 30 can be hooked from both sides, so that the stress of the plug implant 30 is balanced, and the connection is more reliable.

After the plug-in implantable body 30 is delivered to the target site, the push tube 510 is broken off or the proximal end of the connector 520 is released from the hooking state with the push tube 510, and the connector 520 is pulled axially in the proximal direction. Since the first and

second hooks

522 and 523 are made of an elastic material, the first and

second hooks

522 and 523 deform to disengage from the elastic loop 311 and/or the proximal-most elastic loop 312 when pulled, thereby enabling the release of both the plug implant 30 and the pushing assembly 50.

In an embodiment, the length of the first hooking portion 522 is greater than that of the second hooking portion 523 (the lengths are both arc lengths), so that the first hooking portion 522 can extend into the space between two adjacent elastic rings 311 at the far end, and the second hooking portion 523 extends into the space between the nearest elastic ring 312 and the adjacent elastic ring 311, so that the connection portions are distributed at different axial positions, which is beneficial to improving the connection reliability and avoiding being released in advance.

In one embodiment, the coils 310 are of a constant pitch configuration. The thickness of the parts of the first hook part 522 and the second hook part 523 extending between the elastic ring 312 and the adjacent elastic ring 311 or between the adjacent elastic rings 311 is greater than the thread pitch of the plug implant 30, so that the first hook part 522 and the second hook part 523 can be elastically clamped by the most proximal elastic ring 312 and the adjacent elastic ring 311 (or two adjacent elastic rings 311), thereby improving the reliability of connection and being beneficial to avoiding the early release.

According to the embolism system 3 of the embodiment, the embolism implant 30 is not additionally connected with a connecting part, the pushing pipe 510 is also not additionally connected with a connecting part, and the embolism implant 30 and the pushing assembly 50 are connected and disconnected through the matching of the connecting part 520 and the embolism implant 30, so that the embolism system 3 is good in flexibility, convenient to adjust the position, reliable in releasing and accurate in positioning.

It should be noted that in other embodiments, the connecting member 520 includes a main body 521 and a hook, i.e., the connecting member 520 includes only one hook, and the pushing assembly 50 can be connected to the embolic implant 30 through a deformable hook.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention, and it is therefore to be understood that the invention is not limited by the scope of the appended claims.

Claims

1. The embolism system comprises an embolism implant body and a pushing assembly, and is characterized in that the embolism implant body comprises a spring ring, the spring ring comprises a plurality of elastic rings which are arranged spirally, the pushing assembly comprises a pushing pipe and a connecting piece, the connecting piece comprises a main body part and a hook part connected with the main body part, the hook part comprises a first hook part and a second hook part, one ends of the first hook part and the second hook part, which are far away from the main body part, are free ends, the free ends of the first hook part and the second hook part are both in a bent shape, the connecting piece penetrates through the pushing pipe, and the first hook part and the second hook part extend into the space between the adjacent elastic rings and are hooked with the elastic rings, so that the embolism implant body is connected with the pushing pipe; and the first hook part and the second hook part can be deformed, so that when the connecting piece moves axially towards the near end along the pushing pipe, the first hook part and the second hook part are deformed to realize the release of the embolism implant and the pushing pipe.

2. The embolization system of claim 1, wherein the free ends of the first and second hooks are bent in opposite directions such that the distal ends of the first and second hooks are radially expanded relative to the body portion.

3. The embolization system of claim 1, wherein the first hook has a curved portion length that is greater than a curved portion length of the second hook.

4. The embolization system of claim 1, wherein the thickness of the free end of the first hook and the thickness of the free end of the second hook are each greater than the distance between adjacent elastic loops.

5. The embolization system of claim 1, wherein the pusher tube comprises a tube body, the tube body comprises a first tube body and a second tube body connected to a proximal end of the first tube body, the first tube body and the second tube body are connected to form the tube body, the connector is inserted through the tube body, and a proximal end of the connector is fixedly connected to the second tube body or hooked to the second tube body.

6. The embolization system of claim 5, wherein the first tube is a spiral tube and the second tube is a hypotube.

7. The embolization system of claim 5, wherein the ratio of the lengths of the first tube and the second tube is 1:3-1.

8. The embolization system of claim 5, wherein the second tubular body comprises a first radiused section, a reducer section and a second radiused section, the reducer section being connected at each end to the first and second radiused sections respectively.

9. The embolization system of claim 8, wherein the ratio of the lengths of the first radiused section, the tapered section and the second radiused section is (1.

10. The embolization system of claim 5, wherein the proximal end of the second tube is formed with a weakened section when the proximal end of the connector is fixedly connected to the second tube, such that the second tube is breakable to effect disengagement of the embolic implant from the pusher tube.

11. The embolization system of claim 5, wherein the tube body is sleeved with a polymer tube covering the proximal end of the first tube body and covering the distal end of the second tube body.

12. The embolization system of claim 11, wherein the ratio of the length of the polymer tube extending over the first tube to the length of the first tube is 0.01 to 1, and the ratio of the length of the polymer tube extending over the second tube to the length of the second tube is 0.003 to 0.12.