Embolization system

Abstract

An embolization system includes an embolization implant and a push assembly, wherein the embolization implant includes a spring coil, which includes a plurality of elastic coils arranged in a spiral shape in a stretched state, and the push assembly includes a push tube and a connector, wherein the push tube includes a tube body and a connecting portion connected to the tube body, wherein the connecting portion includes a connecting tube and a clasp connected to the connecting tube, wherein the clasp is a ring-shaped structure, and a gap is formed between the clasp and the connecting tube, so that the clasp can be inserted between the elastic coil at the most proximal end and the elastic coil adjacent to the most proximal end, and hooked with the elastic coil at the most proximal end, and the connector passes through the tube body and the connecting tube, and the distal end of the connector extends into the clasp and the most proximal end elastic coil, so that the embolization implant is connected to the push tube; the connector can be moved axially along the push tube to be withdrawn from the connecting tube, the clasp and the most proximal end elastic coil, so as to realize the release of the embolization implant from the push tube. During the implantation process, the embolization system is convenient to adjust the position and has good flexibility.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an embolization system. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Aneurysm is a manifestation of localized or diffuse expansion or bulging of the arterial wall due to lesions or damage to the arterial wall, with an expansive, pulsating mass as the main manifestation. Aneurysms may occur in arteries such as the intracranial arteries, aorta, and splenic arteries. When it occurs in the intracranial arteries, the gradual enlargement of the intracranial aneurysm or the increase in blood pressure may lead to rupture, causing subarachnoid hemorrhage, which may 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 will tear the arterial wall, causing massive bleeding and endangering life. When it occurs in the splenic artery, the main hazard of splenic artery aneurysm is acute rupture leading to massive bleeding, hemorrhagic shock and sudden death.

[0004] The main purpose of aneurysm treatment is to reduce the pressure in the aneurysm cavity and eliminate the risk of rupture. The principle of treatment is to preserve the continuity of the original blood supply as much as possible. Minimally invasive intracavitary treatment has become the preferred method for the treatment of aneurysms due to its advantages such as simple operation, less trauma, no need for general anesthesia, and rapid patient recovery.

[0005] Embolization therapy is a minimally invasive intracavitary treatment method. This method is to implant an embolic implant into the aneurysm cavity. Due to the presence of the embolic implant, when blood flows into the aneurysm, thrombus formation is easy, which significantly reduces the pressure in the aneurysm and reduces the possibility of aneurysm rupture, thereby achieving the purpose of treating the aneurysm.

[0006] At present, the embolization implant is generally a spring coil. Before the embolization operation, the spring coil needs to be stretched and loaded into the delivery catheter, and the proximal end of the spring coil is connected to the push rod. During the embolization operation, the delivery catheter loaded with the spring coil is inserted into the aneurysm cavity, and then the spring coil is pushed from the delivery catheter into the aneurysm cavity with a push rod. When the spring coil is stable in the aneurysm cavity, the connection between the push rod and the spring coil is released; and then the next spring coil is implanted in the same way.

[0007] During the implantation process, releasing the connection between the push rod and the spring coil, i.e., release, is the most critical step. Therefore, the connection and release mechanism of the spring coil is a particularly important design in the embolization system. A well-designed release mechanism can reduce the intervention time and ensure accurate positioning and release reliability.

[0008] Existing release mechanisms can be roughly divided into the following categories: hydrolysis, electrolysis, thermal melting and mechanical release. Among them, hydrolysis is unstable and easily increases blood vessel pressure, electrolysis takes a long time and easily generates high voltage, thermal melting introduces pyrogens and easily damages tissues, and mechanical release is currently the most reliable release mechanism.

[0009] The mechanical connection and release mechanism generally includes a pair of interactive arms (such as the Boston Scientific Interlock spring coil). When the interactive arms are radially constrained by the delivery catheter, the pair of interactive arms remain in an engaged state. When the radial restraint of the delivery catheter is released, the pair of interactive arms are released from the engaged state, thereby releasing the spring coil.

[0010] This method also has the following disadvantages: after the delivery catheter is withdrawn, it is immediately released and the spring coil is released. If the release position is inaccurate, the spring coil cannot be recovered to readjust the position. In addition, this interactive arm is a rigid structure, and the interactive arm is usually a structure extending along the axial direction. When engaged, the length of the rigid structure is large, resulting in poor flexibility of the embolization system, which is not conducive to delivery. Summary of the invention

[0011] Based on this, it is necessary to provide an embolization system that is easy to adjust the position and has good flexibility.

[0012] The invention relates to an embolization system, comprising an embolization implant and a push assembly, wherein the embolization implant comprises a spring coil, which comprises a plurality of elastic coils arranged in a spiral shape in a stretched state, the push assembly comprises a push tube and a connector, the push tube comprises a tube body and a connecting portion connected to the tube body, the connecting portion comprises a connecting tube and a clasp connected to the connecting tube, the clasp is a ring-shaped structure, and a gap is formed between the clasp and the connecting tube, so that the clasp can be inserted between the elastic coil at the most proximal end and the elastic coil adjacent to the most proximal end elastic coil, and hooked with the most proximal end elastic coil, the connector passes through the tube body and the connecting tube, and the distal end of the connector extends into the clasp and the most proximal end elastic coil, thereby connecting the embolization implant and the push tube; the connector can move axially along the push tube to be withdrawn from the connecting tube, the clasp and the most proximal end elastic coil, thereby realizing the release of the embolization implant from the push tube.

[0013] In one embodiment, the tube body includes a first tube body and a second tube body connected to the proximal end of the first tube body, the first tube body and the second tube body are connected to form the tube body, and the proximal end of the connecting piece is fixedly connected to the second tube body or the proximal end of the connecting piece is hooked with the second tube body.

[0014] In one embodiment, the first tube is a spiral tube, and the second tube is a hypotube.

[0015] In one embodiment, the ratio of the length of the first tube to the length of the second tube is 1:3 to 1:10.

[0016] In one embodiment, the second tube body includes a first constant diameter section, a reduced diameter section and a second constant diameter section, and two ends of the reduced diameter section are respectively connected to the first constant diameter section and the second constant diameter section.

[0017] In one embodiment, the length ratio of the first constant diameter section, the variable diameter section and the second constant diameter section is (1:2:3) to (1:2:11).

[0018] In one embodiment, when the proximal end of the connector is fixedly connected to the second tube body, a weak portion is formed at the proximal end of the second tube body so that the second tube body can be broken to achieve release of the embolic implant from the push tube.

[0019] In one of the embodiments, a portion of the connecting member radially opposite to the weak portion is sleeved with a protective tube.

[0020] 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.

[0021] In one embodiment, the ratio of the length of the polymer tube extending on the first tube to the length of the first tube is 0.01-1, and the ratio of the length of the polymer tube extending on the second tube to the length of the second tube is 0.003-0.12.

[0022] In one embodiment, the polymer tube only covers the proximal end of the first tube body and only covers the distal end of the second tube body, and the portion of the second tube body not covered by the polymer tube is provided with a lubricating layer.

[0023] An embolization system comprises an embolization implant and a pushing assembly, wherein the embolization implant comprises a spring coil, and in a stretched state, the spring coil comprises a plurality of elastic coils arranged in a spiral shape, the pushing assembly comprises a pushing tube and a connecting piece, the pushing tube comprises a tube body and a connecting portion connected to the tube body, the connecting portion comprises a connecting tube and a hook connected to the connecting tube, the hook comprises an extension portion and a hooking portion connected to the extension portion, an end of the extending portion away from the hooking portion is connected to the connecting tube, the hooking portion extends between the elastic coil at the most proximal end and the elastic coil adjacent to the most proximal end elastic coil, and is hooked with the most proximal end elastic coil, the connecting piece passes through the tube body and the connecting tube, and the distal end of the connecting piece extends into the hooking portion and the most proximal end elastic coil, so that the embolization implant is connected to the pushing tube; the connecting piece can be moved axially along the pushing tube to be withdrawn from the connecting tube, the hooking portion and the most proximal end elastic coil, so as to realize the release of the embolization implant from the pushing tube.

[0024] In one embodiment, the thickness of the hooking portion is greater than the distance between the most proximal elastic ring and the elastic ring adjacent to the most proximal elastic ring.

[0025] In one embodiment, the included angle between the hook portion and the extension portion is 85° to 95°.

[0026] The embolization system disclosed in the present invention has a hook arranged on the connecting part, which extends between the elastic ring at the nearest end and the elastic ring adjacent to the elastic ring at the nearest end, and hooks with the elastic ring at the nearest end; and the distal end of the connecting piece extends into the connecting part and the elastic ring at the nearest end, and can abut against the inner wall of the connecting part and the inner wall of the elastic ring at the nearest end through the outer wall of the connecting piece, thereby achieving axial and circumferential locking of the embolization implant and the pushing assembly. Even if the delivery catheter is withdrawn, when the relative axial position of the pushing tube and the connecting piece remains unchanged, the locked state of the embolization implant and the pushing assembly can be maintained. Therefore, after the delivery catheter is withdrawn, the position of the embolization implant can still be adjusted, which is convenient for adjustment.

[0027] Furthermore, by cooperating with the proximal elastic ring, the connecting part of the push tube and the connecting piece, a detachable connection between the embolic implant and the push tube is achieved, and there is no need to provide an additional rigid connection structure at the proximal end of the spring ring, so that the embolic system has better flexibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0029] in:

[0030] Figure 1 is a schematic structural diagram of an embolization system according to an embodiment;

[0031] Figure 2 is a schematic structural diagram of an embolic implant according to an embodiment;

[0032] Figure 3 is a schematic diagram of an embolic implant in a local release state according to an embodiment;

[0033] Figure 4 is a schematic structural diagram of an embolic implant according to another embodiment;

[0034] Figure 5 This is a schematic diagram of the structure of a push component of an embodiment;

[0035] Figure 6 This is a schematic structural diagram of a second tube body of a push tube according to an embodiment;

[0036] Figure 7 This is a schematic structural diagram of a connecting portion of a push tube according to an embodiment;

[0037] Figure 8 for Figure 1 A partial enlarged view of

[0038] Fig. 9 It is a partial structural schematic diagram of a push tube and a connecting piece in one embodiment;

[0039] Fig.10 for Fig. 9 A partial enlarged view of

[0040] Fig.11 is a schematic structural diagram of an embolization system according to another embodiment;

[0041] Fig.12 for Fig.11 A partial enlarged view of . DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] 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", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0044] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a replaceable connection, or an integral connection, it can be a mechanical connection, it can be an electrical connection, it can be a direct connection, it can be indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

[0045] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of a medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.

[0046] See also Figure 1 The embolization system 1 of one embodiment includes an embolization implant 10 and a push assembly 20, wherein the push assembly 20 is used to push the embolization implant 10 into the aneurysm cavity. The embolization implant 10 is disconnected from the push assembly 20, so that the embolization implant 10 remains in the aneurysm cavity to embolize the aneurysm.

[0047] See also Figure 2 The embolic implant 10 includes a spring coil 110 and a sealing head 120 connected to the distal end of the spring coil 110. The sealing head 120 is connected to the spring coil 110 by welding, gluing, etc. The sealing head 120 is a hemispherical structure with a smooth surface to avoid damaging the inner wall of the aneurysm.

[0048] In a stretched state (e.g., a state loaded in a delivery catheter), the spring coil 110 includes a plurality of elastic coils 111 arranged in a spiral shape, that is, in a stretched state, the spring coil 110 is in the shape of a spiral spring. For the convenience of description, the elastic coil at the closest end is labeled 112, referred to as the elastic coil 112. In one embodiment, the elastic coil 112 forms a gap 113 with the adjacent elastic coil 111, and the width of the gap 113 is greater than the pitch of the other parts of the spring coil 110 except the elastic coil 112 at the closest end, that is, the spacing between the two adjacent elastic coils 111, so that the spring coil 110 is a spiral structure with unequal pitches. That is, the pitch of a section of the elastic coil 111 from the farthest end to the elastic coil 111 adjacent to the elastic coil 112 at the closest end is equal, and the pitch is smaller than the distance between the elastic coil 112 at the closest end and the adjacent elastic coil 111.

[0049] In one embodiment, the spring coil 110 is a coil structure formed by spirally winding a wire, and the multiple elastic coils 111 and the elastic coil 112 at the closest end are an integrated structure. The elastic coil 112 at the closest end is separated from the adjacent elastic coil 111 by a certain angle to form a gap 113.

[0050] In another embodiment, the plurality of elastic rings 111 are an integrated structure, and the elastic ring 112 is connected to the adjacent elastic ring 111 by welding.

[0051] In one embodiment, the elastic ring 112 at the most proximal end has a free end, and an anti-damage ball head is arranged on the free end. In another embodiment, the free end of the elastic ring 112 at the most proximal end is connected to other parts by welding to form a completely closed-loop coil structure.

[0052] The spring coil 110 is made of an elastic shape memory material. In a natural state, the spring coil 110 is in a radially expanded three-dimensional state. When the spring coil 110 is axially stretched, the spring coil 110 is in a Figure 2 When the axial stretching effect (or radial restraint effect) on the spring coil 110 disappears, the spring coil 110 returns to its natural state. Figure 3 As shown, when the stretching effect (or radial restraint effect) on the embolic implant 10 is released, the distal end portion of the spring coil 110 is curled or rolled to form a three-dimensional structure. That is, when the stretching effect (or radial restraint effect) on the embolic implant 10 is released, the spring coil 110 changes from a stretched state to a radially expanded three-dimensional state. When the embolic implant 10 is disconnected from the push assembly 20, the proximal end of the spring coil 110 also curls, so that the embolic implant 10 as a whole becomes a three-dimensional structure to embolize the aneurysm.

[0053] It should be noted that, in the natural state, the shape of the spring coil 110 is not limited to Figure 3In the state shown, any three-dimensional configuration that can embolize an aneurysm is acceptable, including but not limited to a spherical shape, an ellipsoid shape, etc.

[0054] The material of the spring coil 110 is nickel-titanium alloy, platinum-tungsten alloy, etc. The material of the sealing head 120 can be metal material or polymer material, etc.

[0055] See also Figure 4 In one embodiment, a plurality of fiber hairs 130 are wound around the spring coil 110. The fiber hairs 130 are conducive to promoting the formation of thrombus, so as to reduce the pressure of the aneurysm cavity more quickly and avoid aneurysm rupture. It should be noted that the fiber hairs 130 are flexible silk thread structures, and the provision of a plurality of fiber hairs 130 will not increase the hardness of the embolic implant 10. Figure 4 The figure is only used to show the state that the fiber hair 130 is connected to the spring coil 110 , which does not necessarily mean that the fiber hair 130 is a vertical structure.

[0056] In one embodiment, the fiber bristles 130 are made of nylon material.

[0057] In other embodiments, the fiber hairs 130 may be omitted. The curled spring coil 110 itself may also promote the formation of thrombus.

[0058] In another embodiment, a thrombus-promoting coating (not shown) is provided on the surface of the spring coil 110, and the thrombus-promoting coating contains procoagulant drugs, such as protamine sulfate, thrombin, etc., to promote the formation of thrombus.

[0059] Please go back Figure 1 The push assembly 20 includes a push tube 210 and a connector 220. The connector 220 passes through the push tube 210, and the distal end of the connector 220 is connected to the embolic implant 10.

[0060] See also Figure 5 The push tube 210 includes a tube body 211 and a connecting portion 212 connected to the distal end of the tube body 211 .

[0061] In one embodiment, the tube body 211 includes a first tube body 2111 and a second tube body 2112 connected to the proximal end of the first tube body 2111. The first tube body 2111 and the second tube body 2112 are both hollow tubes with openings at both ends, so that the tube body 211 has an inner cavity with openings at both ends and extending axially.

[0062] The hardness of the first tube body 2111 is less than that of the second tube body 2112 , so that the distal end of the push tube 210 has better flexibility, so that it can pass through curved blood vessels and bend easily to enter the aneurysm cavity.

[0063] In one embodiment, the first tube body 2111 is a spiral tube, and the second tube body 2112 is a smooth tube, and the second tube body 2112 is a metal tube or a polymer tube. The hardness of the spiral tube is less than that of the metal tube or the polymer tube.

[0064] In one embodiment, the first tube 2111 is a spiral tube, and the second tube 2112 is a hypotube. In one embodiment, the length ratio of the first tube 2111 to the second tube 2112 is 1:3 to 1:10, so as to take into account the flexibility of the distal end and the overall pushing performance.

[0065] In one embodiment, a lubricating layer (not shown) is disposed on the outer surface of the second tube body 2112 to reduce friction with the inner surface of the delivery catheter, thereby facilitating pushing the push tube 210 in the delivery catheter or facilitating the withdrawal of the delivery catheter.

[0066] In one embodiment, a polymer tube (not shown) is sleeved on the tube body 211 , and the polymer tube covers the proximal end of the first tube body 2111 and the distal end of the second tube body 2112 .

[0067] Arranging the polymer tube in the above manner provides a transition from the softer first tube body 2111 to the harder second tube body 2112, avoiding a sharp transition between the first tube body 2111 and the second tube body 2112 that may cause breakage, which is beneficial to improving reliability.

[0068] In one embodiment, the polymer tube only covers the proximal end of the first tube 2111 and only covers the distal end of the second tube 2112 , that is, the polymer tube only partially covers the first tube 2111 and only partially covers the second tube 2112 , thereby not significantly increasing the hardness of the tube 211 .

[0069] In one embodiment, the ratio of the length of the polymer tube extending on the first tube body 2111 to the length of the first tube body 2111 is 0.01-1, and the ratio of the length of the polymer tube extending on the second tube body 2112 to the length of the second tube body 2112 is 0.003-0.12, so that the area with lower hardness and the area with higher hardness of the push tube 210 can transition smoothly, and the polymer tube does not significantly increase the overall hardness of the push tube 210.

[0070] The material of the polymer tube may be polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE) or polyolefin.

[0071] In one embodiment, a lubricating layer is provided 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, dipping or electrostatic spinning.

[0072] In one embodiment, the material of the lubricating layer is PTFE, silicone or polyvinyl pyrrolidone.

[0073] In one embodiment, the second tube body 2112 is a variable diameter structure, and the diameter of the second tube body 2112 gradually increases from the distal end to the proximal end.

[0074] See also Figure 6 In one embodiment, the second tube body 2112 includes a first equal diameter section 2112A, a reduced diameter section 2112B, and a second equal diameter section 2112C. From the distal end to the proximal end, the outer diameter of the reduced diameter section 2112B gradually increases. The end with a smaller diameter of the reduced diameter section 2112B is connected to the proximal end of the first equal diameter section 2112A, and the end with a larger diameter of the reduced diameter section 2112B is connected to the distal end of the second equal diameter section 2112C. The outer diameter of the first equal diameter section 2112A is equal to the minimum outer diameter of the reduced diameter section 2112B, and the outer diameter of the second equal diameter section 2112C is equal to the maximum outer diameter of the reduced diameter section 2112B, so that from the distal end to the proximal end, the first equal diameter section 2112A, the reduced diameter section 2112B, and the second equal diameter section 2112C have a smooth transition.

[0075] One end of the first equal-diameter section 2112A of the second tube 2112 away from the reduced-diameter section 2112B is connected to the proximal end of the first tube 2111 .

[0076] The first equal diameter section 2112A, the reducing 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 reducing section 2112B and the second equal diameter section 2112C increase successively. On the one hand, the second tube body 2112 has better flexibility and sufficient pushing performance; on the other hand, the first equal diameter section 2112A of the second tube body 2112 with better flexibility is connected to the first tube body 2111 with better flexibility, so as to avoid sudden change in hardness of the tube body 2111 and easy breakage.

[0077] In one embodiment, the length ratio of the first constant diameter section 2112A, the reduced diameter section 2112B, and the second constant diameter section 2112C is (1:2:3) to (1:2:11) to better balance flexibility and pushing performance.

[0078] In one embodiment, a marker 213 is provided on the push tube 210 to indicate the position of the push tube 210 during the implantation process. In one embodiment, the marker 213 is a metal ring, and the marker 213 is sleeved 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.

[0079] The marker 213 is sleeved on the first tube body 2111 , and the marker 213 and the first tube body 2111 are fixedly connected by welding or gluing.

[0080] Please also read Figure 5 and Figure 6 A weak portion 21121 is provided at the proximal end of the second tube body 2112 .

[0081] In one embodiment, if Figure 5 As shown, the weak portion 21121 is a portion with a smaller wall thickness at the proximal end of the second tube body 2112, and this portion is a portion with a smaller wall thickness in a circumferential circle of the second equal-diameter section 2112C.

[0082] In another embodiment, if Figure 6 As shown, the weak part 21121 is an open hole area on the second equal diameter section 2112C. A plurality of holes 21122 are provided on the proximal end of the second equal diameter section 2112C, and the plurality of holes 21122 form the weak part 21121. The plurality of holes 21122 are distributed at intervals along the circumference of the second equal diameter section 2112C, that is, the plurality of holes 21122 surround the circumference of the second equal diameter section 2112C. Alternatively, the plurality of holes 21122 are distributed at intervals along the semicircular surface of the second equal diameter section 2112C. That is, the second equal diameter section 2112C is evenly divided into two parts along the axial direction, and the plurality of holes 21122 are distributed at intervals on the circumference of the arc surface on one part.

[0083] Please go back Figure 5 The connecting portion 212 is fixedly connected to the distal end of the first tube body 2111. The fixed connection method is not limited, and any method that can fix the connecting portion 212 to the first tube body 2111, such as welding, gluing, etc., can be used.

[0084] See also Figure 7 In one embodiment, the connection portion 212 includes a connection tube 2121 and a hook 2122 connected to the connection tube 2121. The connection tube 2121 is provided with an axially extending through hole 21211. The hook 2122 is a ring-shaped structure. The hook 2122 is at a certain angle to the connection tube 2121, so that a gap is formed between the hook 2122 and the connection tube 2121, so that when connected, the hook 2122 can be inserted into the gap 113 ( Figure 7 Not marked), and the hook 2122 is hooked with the elastic ring 112.

[0085] The material of the connecting portion 212 can be metal or plastic.

[0086] Please also read Figure 1 and Figure 8In one embodiment, the connector 220 is a rod-shaped structure. The connector 220 passes through the push tube 210, and the distal end of the connector 220 passes through the connecting tube 2121 and extends into the hook 2122 and the elastic ring 112. In addition, the radial size (e.g., diameter) of the connector 220 matches the inner diameter of the hook 2122 and the elastic ring 112. Alternatively, the size of the connector 220 matches the inner wall size of the hook 2122 and the elastic ring 112 in at least one dimension, so that the connector 220 abuts against or forms a friction connection with the inner wall of the elastic ring 112 and the hook 2122. Therefore, when the relative axial position of the connector 220 and the push tube 210 remains unchanged, the connector 220 can maintain a state of abutment or friction connection with the inner wall of the hook 2122 and the elastic ring 112, thereby achieving axial and circumferential locking of the embolic implant 10 and the push assembly 20.

[0087] In one embodiment, the proximal end of the connecting member 220 is fixedly connected to the second tube body 2112 , so that the relative position of the connecting member 220 and the pushing tube 210 remains unchanged.

[0088] In one embodiment, the connecting member 220 is elastic and has a bendable portion at the proximal end thereof, so that the proximal end of the connecting member 220 can be hooked with the second tube body 2112. In the hooked state, the relative positions of the connecting member 220 and the pushing tube 210 remain unchanged.

[0089] Therefore, by arranging the elastic ring 112, the connecting portion 212 of the push tube 210 and the connecting piece 220 to cooperate with each other, when the relative axial position of the connecting piece 220 and the push tube 210 remains unchanged, the embolic implant 10 and the push assembly 20 can be locked in the axial and circumferential directions, thereby realizing the connection between the embolic implant 10 and the push assembly 20.

[0090] Furthermore, by moving the connecting member 220 axially upward so that the connecting member 220 no longer abuts against the inner wall of the elastic ring 112 and the hook 2122 , the connection between the embolic implant 10 and the pushing assembly 20 is released, thereby achieving release.

[0091] The second tube body 2112 is broken at the weak portion 21121 of the second tube body 2112. During the breaking process, the connecting member 220 is pulled and moves axially, so that the connecting member 220 no longer abuts against the inner wall of the hook 2122 and the elastic ring 112, thereby achieving release.

[0092] Alternatively, after the second tube body 2112 is broken at the weak portion 21121 of the second tube body 2112, the connecting member 220 is exposed, and the connecting member 220 is moved axially toward the proximal end, so that the connecting member 220 no longer abuts against the inner wall of the hook 2122 and the elastic ring 112, thereby achieving release.

[0093] Alternatively, in another embodiment, the connection member 220 is unhooked from the second tube 2112 and then the connection member 220 is moved axially toward the proximal end so that the connection member 220 no longer abuts against the inner wall of the hook 2122 and the elastic ring 112, thereby achieving release.

[0094] In one embodiment, the connecting member 220 is a slender metal wire, including but not limited to a stainless steel wire, a nickel-titanium alloy wire, etc.

[0095] Please also read Fig. 9 and Fig.10 In one embodiment, a protective tube 230 is sleeved on the connecting member 220. The length of the protective tube 230 is less than the length of the connecting member 220. When the connecting member 220 is fixedly connected to the pushing tube 210, the protective tube 230 is radially opposite to the weak portion 21121, and the protective tube 230 extends axially from the weak portion 21121 to the distal end and the proximal end for a distance. The protective tube 230 is provided to protect the connecting member 220, and when the second tube body 2112 is broken from the weak portion 21121, the connecting member 220 is prevented from being broken.

[0096] Avoiding breaking the connecting piece 220 is helpful to ensure smooth release, on the one hand, because after breaking the second tube body 2112, the connecting piece 220 can be manually moved axially toward the proximal end if necessary, thereby achieving release; on the other hand, after the release is completed, it is helpful to withdraw the connecting piece 220 and the pushing tube 210 out of the body as a whole to complete the operation.

[0097] The material of the protection tube 230 is a polymer material, including but not limited to PET, PTFE, Pebax material and the like.

[0098] The protection tube 230 is provided to protect the connector 220 and prevent the connector 220 from being broken. However, the protection tube 230 cannot be too long to avoid reducing the flexibility of the push assembly 20. In one embodiment, the protection tube 230 extends 5 to 100 mm from the weak portion 21121 to the distal end and the proximal end to protect the connector 220 and avoid reducing the flexibility of the push assembly 20.

[0099] In other embodiments, when the connecting member 220 is made of an elastic material, such as an elastic nickel-titanium alloy, the connecting member 220 is not easily broken and the protective tube 220 can be omitted.

[0100] In the above-mentioned embolization system 1, the connecting portion 212 of the push tube 210 extends between the elastic ring 112 at the most proximal end and the elastic ring 111 adjacent to the elastic ring 112 at the most proximal end, and is hooked with the elastic ring 112 at the most proximal end; and the distal end of the connecting member 220 extends into the connecting portion 212 and the elastic ring 112 at the most proximal end, and can abut against the inner wall of the connecting portion 212 and the inner wall of the elastic ring 112 at the most proximal end through the outer wall of the connecting member 220, thereby achieving the locking of the embolization implant 10 and the push assembly 20 in the axial and circumferential directions. Even if the delivery catheter is withdrawn, when the relative axial position of the push tube 210 and the connecting member 220 remains unchanged, the locking state of the embolization implant 10 and the push assembly 20 can be maintained. Therefore, after the delivery catheter is withdrawn, the position of the embolization implant 10 can still be adjusted, which is convenient for adjustment.

[0101] Furthermore, the embolic implant 10 and the push tube 210 are detachably connected by the cooperation of the elastic ring 112 at the most proximal end, the connecting portion 212 of the push tube 210, and the connecting piece 220, and there is no need to set an additional rigid connection structure at the proximal end of the spring ring 110, so that the flexibility of the embolic system 1 is better. The embolic system 1 connects the embolic implant 10 and the push assembly 20 by the cooperation of the elastic ring 112 at the most proximal end, the connecting portion 212 of the push tube 210, and the connecting piece 220. The connection and release are achieved by using the elastic ring 112 of the spring ring 110 itself, and there is no need to set an additional connection structure at the proximal end of the spring ring 110, so the structure is simple and the preparation is convenient. Moreover, due to the omitted additional connection structure, the flexibility is improved.

[0102] When the relative axial position relationship between the connector 220 and the push tube 210 remains unchanged, the embolic implant 10 and the push assembly 20 can be reliably connected, and premature release can be avoided, which is beneficial to improving the accuracy of the release position and the reliability of the operation. In addition, the release is achieved by breaking the push tube 210 or by unhooking the connector 220 from the push tube 210, and the release speed is fast, which is beneficial to shortening the operation time. When multiple embolic implants 10 need to be implanted, the effect of shortening the operation time is particularly significant.

[0103] It should be noted that, in another embodiment, when the pitch of the spring coil 110 is larger, it is not necessary to bend the most proximal elastic coil 112 apart by a certain angle. The spring coil 110 has an equal pitch structure, and the hook 2122 of the connecting portion 212 is directly inserted between the most proximal elastic coil 112 and the elastic coil 111 adjacent to the most proximal elastic coil 112. By cooperating with the connecting piece 220, the connection and release of the embolic implant 10 and the pushing assembly 20 can also be achieved.

[0104] like Fig.11As shown in FIG. 1 , in another embodiment, the spring ring 110 is an equi-pitch structure, and the hook 2112 is inserted between the elastic ring 112 at the most proximal end and the elastic ring 111 adjacent to the elastic ring 112 at the most proximal end. In addition, the opening between the elastic ring 112 at the most proximal end and the elastic ring 111 adjacent to the elastic ring 112 at the most proximal end is located at the bottom, and the hook 2122 is inserted from bottom to top (as shown in FIG. 1 ). Fig.12 The spring ring 110 extends into between the elastic ring 112 and the elastic ring 111 adjacent to the elastic ring 112 (in the direction indicated by the arrow F2), and the spring ring 110 is connected to the pushing assembly 20 through the circumferential abutment and axial hooking of the connecting member 220.

[0105] See also Fig.12 In one embodiment, the hook 2122 includes an extension portion 2122A and a hook portion 2122B connected to the extension portion 2122A, and one end of the extension portion 2122A away from the hook portion 2122B is connected to the connecting tube 2121. The hook portion 2122B extends between the elastic ring 112 at the most proximal end and the elastic ring 111 adjacent to the elastic ring 112 at the most proximal end, and the extension portion 2122A is located below the spring ring 110. In this arrangement, when the circumferential abutment of the connecting member 220 is released, the hook 2122 can automatically detach from the spring ring 110 under the action of gravity, thereby achieving release.

[0106] In one embodiment, the angle between the hook portion 2122B and the extension portion 2122A is 90° or approximately 90° (90°±5°), which can prevent the hook portion 2122B from being hooked on the elastic ring 112 at the nearest end or the elastic ring 111 adjacent to the elastic ring 112 at the nearest end, thereby facilitating smooth release.

[0107] In one embodiment, the thickness of the hook portion 2122B is greater than the pitch of the spring ring 110, that is, greater than the distance between the nearest elastic ring 112 and the elastic ring 111 adjacent to the nearest elastic ring 112, so that when the hook portion 2122B extends between the nearest elastic ring 112 and the elastic ring 111 adjacent to the nearest elastic ring 112, due to the elastic effect, the nearest elastic ring 112 and the adjacent elastic ring 111 can play a certain clamping role on the hook portion 2122B, which is conducive to reliable connection.

[0108] It should be noted that, in the embodiment where the elastic ring 112 at the most proximal end is opened to a certain angle, the connection between the embolic implant 10 and the pushing assembly 20 can be reliably achieved through the cooperation of the connecting member 220, and the release of the embolic implant 10 and the pushing assembly 20 can be smoother. Figure 4As shown, the angle θ between the elastic ring 112 at the nearest end and the elastic ring 111 adjacent to the elastic ring 112 at the nearest end is in the range of 10° to 80°, so that the hook 2122 can be reliably hooked with the elastic ring 112 at the nearest end, thereby improving the reliability of the connection. At the same time, there is a gap 113 of appropriate size to facilitate release.

[0109] In one embodiment, the angle θ is in the range of 10° to 60°. In another embodiment, the angle θ is in the range of 20° to 45°. This arrangement can better balance reliable connection and convenient release.

[0110] And, in this implementation, please return to Figure 8 , the hook 2122 moves from top to bottom (such as Figure 8 The embolic implant 10 is inserted into the gap 113 between the most proximal elastic ring 112 and the adjacent elastic ring 111 (in the direction indicated by the arrow F1). Meanwhile, the angle θ between the most proximal elastic ring 112 and the adjacent elastic ring 111 ranges from 10° to 80°. While the hook 2122 can be reliably hooked with the most proximal elastic ring 112 and easily released, the axial center axis of the embolic implant 10 can be made to be colinear with the axial center axis of the pushing assembly 20, thereby avoiding radial misalignment of the embolic implant 10 and the pushing assembly 20, and thus can be delivered using a delivery catheter with a smaller inner diameter.

[0111] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0112] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. An embolization system, comprising an embolization implant and a push assembly, characterized in that: The embolic implant comprises a spring coil, which comprises a plurality of elastic coils arranged in a spiral shape in a stretched state, the pushing assembly comprises a pushing tube and a connecting piece, the pushing tube comprises a tube body and a connecting portion connected to the tube body, the connecting portion comprises a connecting tube and a clasp connected to the connecting tube, the clasp is a ring-shaped structure, and a gap is formed between the clasp and the connecting tube, so that the clasp can be inserted between the elastic coil at the most proximal end and the elastic coil adjacent to the most proximal end elastic coil, and hooked with the most proximal end elastic coil, the connecting piece passes through the tube body and the connecting tube, and the distal end of the connecting piece extends into the clasp and the most proximal end elastic coil, thereby connecting the embolic implant to the pushing tube; the connecting piece can move axially along the pushing tube to be withdrawn from the connecting tube, the clasp and the most proximal end elastic coil, thereby realizing the release of the embolic implant from the pushing tube.

2. The embolization system according to claim 1, characterized in that: The tube body includes a first tube body and a second tube body connected to the proximal end of the first tube body, the first tube body and the second tube body are connected to form the tube body, the proximal end of the connector is fixedly connected to the second tube body or the proximal end of the connector is hooked to the second tube body.

3. The embolization system according to claim 2, characterized in that: The first tube body is a spiral tube, and the second tube body is a hypotube.

4. The embolization system according to claim 2, characterized in that: The ratio of the length of the first tube body to the length of the second tube body is 1:3 to 1:

10.

5. The embolization system according to claim 2, characterized in that: The second tube body comprises a first constant diameter section, a reduced diameter section and a second constant diameter section, and two ends of the reduced diameter section are respectively connected to the first constant diameter section and the second constant diameter section.

6. The embolization system according to claim 5, characterized in that: The length ratio of the first constant diameter section, the variable diameter section and the second constant diameter section is (1:2:3) to (1:2:11).

7. The embolization system according to claim 2, characterized in that: When the proximal end of the connecting member is fixedly connected to the second tube body, a weak portion is formed at the proximal end of the second tube body, so that the second tube body can be broken to achieve the release of the embolic implant from the pushing tube.

8. The embolization system according to claim 7, characterized in that: A protective tube is sleeved on a portion of the connecting piece that is radially opposite to the weak portion.

9. The embolization system according to claim 2, characterized in that: 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.

10. The embolization system according to claim 9, characterized in that: The ratio of the length of the polymer tube extending on the first tube body to the length of the first tube body is 0.01-1, and the ratio of the length of the polymer tube extending on the second tube body to the length of the second tube body is 0.003-0.

12.

11. The embolization system according to claim 10, characterized in that: The polymer tube only covers the proximal end of the first tube body and only covers the distal end of the second tube body, and a lubricating layer is provided on the portion of the second tube body not covered by the polymer tube.

12. An embolization system, comprising an embolization implant and a pushing assembly, characterized in that: The embolic implant comprises a spring coil, which comprises a plurality of elastic coils arranged in a spiral shape in a stretched state, the pushing assembly comprises a pushing tube and a connecting piece, the pushing tube comprises a tube body and a connecting portion connected to the tube body, the connecting portion comprises a connecting tube and a hook connected to the connecting tube, the hook comprises an extension portion and a hooking portion connected to the extension portion, the end of the extension portion away from the hooking portion is connected to the connecting tube, the hooking portion extends between the elastic coil at the most proximal end and the elastic coil adjacent to the most proximal end elastic coil, and hooks with the most proximal end elastic coil, the connecting piece passes through the tube body and the connecting tube, and the distal end of the connecting piece extends into the hooking portion and the most proximal end elastic coil, thereby connecting the embolic implant to the pushing tube; the connecting piece can be moved axially along the pushing tube to be withdrawn from the connecting tube, the hooking portion and the most proximal end elastic coil, thereby realizing the release of the embolic implant from the pushing tube.

13. The embolization system according to claim 12, characterized in that: The thickness of the hooking portion is greater than the distance between the most proximal elastic ring and an elastic ring adjacent to the most proximal elastic ring.

14. The embolization system according to claim 12, characterized in that: The included angle between the hook portion and the extending portion is 85° to 95°.

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