Occluder and occlusion system

Abstract

The present invention relates to an occluder and an occluding system. The occluder comprises an occluding frame and a first end cap and a second end cap connected to both ends of the occluding frame, the occluding frame has an inner cavity, a first through hole and a receiving portion are formed on the first end cap, the receiving portion is located on one side of the first through hole, a second through hole is formed on the second end cap, and the first through hole, the inner cavity and the second through hole are connected to form a path. The occluder can omit the locking piece.

Description

Technical Field

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

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

[0003] Percutaneous interventional therapy is a rapidly developing disease treatment method in recent years, and the application areas of this therapy are becoming more and more extensive. Among them, the use of transcatheter interventional therapy can place devices and / or drugs into the heart, arteries and veins of the human body. Among them, the device can be a heart occluder, a vascular occluder, a vascular filter, etc.

[0004] Traditional heart occluders or vascular occluders are generally made of shape memory alloys, which have good elasticity and can return to their original shape after release and fit the tissue of the defect well. However, current shape memory alloy materials are generally non-corrosive or non-degradable in the body. After endothelialization is completed and complete occlusion is achieved, the occluder made of shape memory alloy will remain in the body permanently, which may pose long-term clinical risks.

[0005] Occluders or other implantable devices made of absorbable polymer materials, although the polymer materials can be degraded in the body, so that the occluder can gradually degrade and the degradation products are absorbed by the body without residue in the organism. However, polymer materials are relatively soft and not easy to shape. After the occluder is delivered into the body, since the occluder made of polymer materials cannot automatically return to the final shape, that is, it cannot be automatically formed, it is necessary to assist the occluder in forming. In order to achieve the above functions, in the existing occluders, a locking piece extending in the axial direction is provided in the occluding frame, and the locking piece is required to have a certain rigidity and length to assist the occluder in forming.

[0006] However, the rigid locking piece extends axially in the occlusion frame, which increases the rigidity of the occluder after stretching to a certain extent, making it more difficult to deliver and not conducive to passing through curved blood vessels. In addition, for the vascular occluder, since the length of the diseased blood vessels varies greatly, the presence of the locking piece will affect the adjustment of the length of the vascular occluder. Summary of the invention

[0007] Based on this, it is necessary to provide an occluder and an occluding system that can omit the locking member.

[0008] A plugger comprises a plugging frame and a first head and a second head connected to both ends of the plugging frame, the plugging frame having an inner cavity, the first head having a first through hole and a receiving portion, the receiving portion being located on one side of the first through hole, the second head having a second through hole, the first through hole, the inner cavity and the second through hole being connected to form a path.

[0009] In one embodiment, the blocking frame includes a first blocking unit, a middle blocking unit, a second blocking unit and a waist, the number of the middle blocking unit is one, the number of the waists is two, the two ends of the middle blocking unit are respectively connected to the first blocking unit and the second blocking unit through the two waists, the first head is connected to the first blocking unit, the second head is connected to the second blocking unit, and the inner cavity extends axially from the first blocking unit to the second blocking unit;

[0010] Alternatively, the blocking frame includes a first blocking unit, a middle blocking unit, a second blocking unit and a waist, the number of the middle blocking units is greater than one, the number of the waists is greater than two, the plurality of middle blocking units greater than one and the plurality of waists greater than two are alternately arranged axially, and the middle blocking unit located at the distal end is connected to the first blocking unit through the waist, the middle blocking unit located at the proximal end is connected to the second blocking unit through the waist, the first head is connected to the first blocking unit, the second head is connected to the second blocking unit, and the inner cavity extends axially from the first blocking unit to the second blocking unit.

[0011] In one embodiment, the axial length of the middle blocking unit is greater than the axial lengths of the first blocking unit and the second blocking unit.

[0012] In one embodiment, the occluder further includes a fixing member, and the fixing member is sleeved on the waist.

[0013] In one embodiment, the fixing member is a sleeve formed of a polymer material or a ring structure formed by a polymer wire wrapped around the outer circumference of the waist.

[0014] In one embodiment, the axial length of the fixing element is smaller than the axial length of the waist.

[0015] In one embodiment, the receiving portion is a receiving hole or a receiving groove.

[0016] A closure system comprises a conveying device and the above-mentioned closure device, wherein the conveying device comprises an adjusting member, the adjusting member having a bending section, and in a loaded state, the adjusting member passes through the path, and at least a portion of the bending section of the adjusting member is accommodated in the accommodating portion, so that the adjusting member is hooked with the first head.

[0017] In one of the embodiments, the conveying device further includes a pushing member having an inner cavity, the pushing member can move along the path to the distal end of the pushing member to abut against the first head, and the adjusting member can movably pass through the pushing member.

[0018] In one embodiment, the adjusting member includes a straight section, the bending section includes a first bending portion and a second bending portion connected to the first bending portion, an end of the first bending portion away from the second bending portion is connected to the straight section, and in the loaded state, the second bending portion is accommodated in the accommodating portion, and the first bending portion is abutted against the first head.

[0019] The first through hole, the inner cavity and the second through hole of the above-mentioned occluder are connected to form a path, and the receiving part of the first head is located on one side of the first through hole. During the implantation process, the adjusting member of the conveying device can enter the path and the bending section of the adjusting member is at least partially received in the receiving part, and can be hooked with the first head to avoid the adjusting member from falling off before the occluder needs to be adjusted to form. In addition, the occluder can be formed by withdrawing the bending section of the adjusting member from the receiving part and continuing to move toward the proximal end to support the occluder. Then, the adjusting member is continued to move toward the proximal end to withdraw the adjusting member from the occluder. Through the cooperation of the first through hole, the inner cavity, the second through hole and the receiving part, it is possible to achieve the hooking of the adjusting member with the occluder and the withdrawal of the adjusting member from the occluder. Therefore, in the case of omitting the locking member, it is also more convenient to adjust the axial length of the occluder through the adjusting member of the conveying device to form the occluder. Therefore, the locking member can be omitted in the occluder. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic structural diagram of a blocking system according to an embodiment;

[0021] Figure 2 is a schematic structural diagram of an occluder according to an embodiment;

[0022] Figure 3 is a schematic structural diagram of an occluder according to an embodiment (showing the inner cavity);

[0023] Figure 4 is a schematic structural diagram of an occluder according to another embodiment;

[0024] Figure 5 is an exploded schematic diagram of a conveying device according to one embodiment;

[0025] Figure 6 is a schematic structural diagram of an adjusting member according to an embodiment;

[0026] Figure 7 is a schematic structural diagram of an adjusting member according to another embodiment;

[0027] Figure 8 A schematic diagram of the positional relationship between an adjusting member and a pushing member in one embodiment;

[0028] Figure 9a to Figure 9b is a schematic diagram of different relative positional relationships between an occluder and an adjusting member in one embodiment;

[0029] Fig.10 This is a schematic diagram of the positional relationship between the occluder, the adjusting member and the pushing member according to one embodiment;

[0030] Fig.11 A schematic diagram of a partial structure of a first drive assembly and a structure of a second drive assembly in one embodiment;

[0031] Fig.12 for Fig.11 sectional view of

[0032] Fig.13 for Fig.12 A partial enlarged view of

[0033] Fig.14 is a schematic structural diagram of a second rotating member in one embodiment;

[0034] Fig.15 A schematic cross-sectional structure diagram of a first drive assembly and a second drive assembly in one embodiment;

[0035] Figure 16a to Figure 16b It is a schematic diagram of a disconnected state and a connected state of an occluder and a delivery device according to one embodiment;

[0036] Figure 16c to Figure 16d is a schematic diagram of an occluder in a stretched state according to an embodiment;

[0037] Figures 17a-17b This is a schematic diagram of the change in positional relationship between the occluder and the adjusting member in one embodiment;

[0038] Fig.18 This is a schematic structural diagram of a first sealing head and a pushing member of an occluder according to an embodiment;

[0039] Fig.19 It is a schematic structural diagram of a first sealing head and a pushing member of an occluder in another embodiment;

[0040] Fig. 20It is a schematic structural diagram of a first sealing head and a pushing member of an occluder in another embodiment;

[0041] Fig.21 is a schematic structural diagram of a transition piece according to an embodiment;

[0042] Fig. 22 It is a structural schematic diagram of a limit assembly in one implementation mode;

[0043] Fig.23 for Fig. 22 Schematic cross-sectional view of ;

[0044] Fig.24 is a schematic structural diagram of an occluder according to another embodiment;

[0045] Fig.25 is a schematic structural diagram of an occluder according to another embodiment;

[0046] Fig.26 It is a schematic structural diagram of an occluder according to another embodiment. DETAILED DESCRIPTION

[0047] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0048] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0049] In the field of interventional medical devices, the “distal end” is defined as the end away from the operator during surgery, and the “proximal end” is defined as the end close to the operator during surgery. “Axial” refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, and “radial” refers to the direction perpendicular to the above axial direction.

[0050] See also Figure 1 The occlusion system 100 of one embodiment includes an occluder 20 and a conveying device 40. The occluder 20 is detachably connected to the conveying device 40. After the occluder 20 is pushed to the lesion site in the body by the conveying device 40 and released, the connection between the occluder 20 and the conveying device 40 is disconnected, and the conveying device 40 is withdrawn from the body to complete the implantation operation.

[0051] See also Figure 2 In one embodiment, the occluder 20 includes an absorbable occluding frame 210. The occluding frame 210 is a mesh structure woven from polymer materials or formed by other methods such as 3D printing.

[0052] In one embodiment, the material of the blocking frame 210 is at least one selected from L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoic acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid and polydioxanone.

[0053] In one embodiment, the material of the blocking frame 210 is a copolymer formed by copolymerizing at least two of the monomers forming left-handed polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoic acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid and polydioxanone.

[0054] The above polymer material has good biocompatibility and can be degraded in the body, so that the occluder 20 can be degraded without residue after completing the intended use.

[0055] See also Figure 3 The blocking frame 210 has an inner cavity 211, and the blocking frame 210 has a first opening 212 and a second opening 213 opposite to each other (the inner cavity 211 is located inside the blocking frame 210, for the convenience of illustration, Figure 3 The inner cavity 211 is roughly drawn to show the positional relationship between the inner cavity 211 and the first opening 212 and the second opening 213). The first opening 212 and the second opening 213 are respectively located at the distal end and the proximal end of the blocking frame 210, and the inner cavity 211, the first opening 212 and the second opening 213 are connected to form a path. In one embodiment, a plurality of braided wires are woven to form the blocking frame 210, and the two free ends of the plurality of braided wires are respectively closed to form the first opening 212 and the second opening 213. In one embodiment, the two free ends of the plurality of braided wires are respectively closed using an annular closing member.

[0056] In one embodiment, the plugging device 20 further includes a first plug 220 and a second plug 230. The first plug 220 and the second plug 230 are respectively disposed at opposite ends of the plugging frame 210. The first plug 220 is provided with a first through hole 221, which is communicated with the first opening 212. The second plug 230 is provided with a second through hole 231, which is communicated with the second opening 213.

[0057] In one embodiment, the first end cap 220 and the second end cap 230 are used to close the two free ends of the plurality of braided wires, and form a first opening 212 communicating with the first through hole 221 and a second opening 213 communicating with the second through hole 231. For example, the first end cap 220 and the second end cap 230 respectively form a receiving groove or a receiving cavity, and the two free ends of the plurality of braided wires are respectively embedded and fixed in the receiving groove (or receiving cavity) of the first end cap 220 and the receiving groove (or receiving cavity) of the second end cap 230, and form a first opening 212 communicating with the first through hole 221 and a second opening 213 communicating with the second through hole 231.

[0058] In one embodiment, the first sealing head 220 and the second sealing head 230 are both located outside the sealing frame 210. Such a configuration facilitates processing.

[0059] In one embodiment, the first head 220 and the second head 230 are both located inside the occluding frame 210. Such a configuration is helpful in avoiding thrombosis and preventing the first head 220 and / or the second head 230 from scratching tissue due to improper operation during the release process.

[0060] In one embodiment, the first head 220 is disposed inside the blocking frame 210, and the second head 230 is disposed outside the blocking frame 210, to prevent the first head 220 from scratching the tissue and facilitate the detachable connection between the conveying device 40 and the second head 230.

[0061] Please also read Figure 2 and Figure 3 The first sealing head 220 is provided with a receiving portion 222, and the receiving portion 222 is used to assist in the molding of the occluder 20. In one embodiment, the receiving portion 222 is a through hole. Figure 4 As shown, the receiving portion 222 is a groove. When the receiving portion 222 is a groove, the opening end of the receiving portion 222 is located at the distal end.

[0062] The receiving portion 222 is located at one side of the first through hole 221 . A spacing portion 223 is defined between the receiving portion 222 and the first through hole 221 .

[0063] The central axis II of the first through hole 221 along the axial direction and the central axis II-II of the receiving portion 222 along the axial direction are not on the same straight line. Figure 2 As shown, in one embodiment, the central axis II of the first through hole 221 along the axial direction is parallel to the central axis II-II of the receiving portion 222 along the axial direction. In other embodiments, the central axis II and the central axis II-II are not parallel.

[0064] In one embodiment, an external thread 232 is formed on the outer wall of the second head 230. Figure 3 As shown, to facilitate connection with the delivery device 40.

[0065] In one embodiment, the materials of the first and second end caps 220 and 230 are both degradable polymer materials, so that the occluder 20 is completely absorbable in vivo. The materials of the first and second end caps 220 and 230 can be the same as or different from the material of the occluding frame 210.

[0066] The first end cap 220 and the second end cap 230 are generally rigid polymer tubes. Since the blocking frame 210 is relatively soft, the first end cap 220 and the second end cap 230 are provided to facilitate the loading, pushing, releasing and molding of the occluder 20 .

[0067] The aperture of the first through hole 221 is D1 , and the aperture of the second through hole 231 is D2 .

[0068] Please continue reading Figure 3 The blocking frame 210 includes a first blocking unit 214, a middle blocking unit 215, and a second blocking unit 216. The opposite ends of the middle blocking unit 215 are respectively connected (directly or indirectly) to the first blocking unit 214 and the second blocking unit 216. The first opening 212 is formed on the first blocking unit 214, and the second opening 213 is formed on the second blocking unit 216.

[0069] In one embodiment, the blocking frame 210 further includes a waist 217. There are two waists 217. Two ends of one waist 217 are respectively connected to the first blocking unit 214 and the middle blocking unit 215, and two ends of the other waist 217 are respectively connected to the middle blocking unit 215 and the second blocking unit 216. The radial dimensions of the waist 217 are all smaller than the radial dimensions of the first blocking unit 214, the middle blocking unit 215, and the second blocking unit 216.

[0070] In one embodiment, the axial length of the middle blocking unit 215 is greater than the axial length of the first blocking unit 214 and the second blocking unit 216, so that after implantation, the contact area between the occluder 20 and the lesion site (such as the blood vessel wall) is larger, which is beneficial to improving the anchoring of the occluder 20 at the lesion site and maintaining the morphology of the occluder 20.

[0071] In one embodiment, the first blocking unit 214 and the second blocking unit 216 are both disc-shaped, and the middle blocking unit 215 is columnar, and the columnar middle blocking unit 215 is connected to the disc-shaped first blocking unit 214 and the second blocking unit 216 through a waist 217 with a smaller radial dimension. On the one hand, the combination of the columnar middle blocking unit 215 and the disc-shaped first blocking unit 214 and the second blocking unit 216 ensures the contact area with the lesion site (such as the blood vessel wall). On the other hand, the middle blocking unit 215 is connected to the first blocking unit 214 and the second blocking unit 216 through a waist 217 with a smaller radial dimension, so that the angle between the first blocking unit 214 and the middle blocking unit 215 and between the middle blocking unit 215 and the second blocking unit 216 can be adjusted, which is conducive to the occluder 20 adapting to different forms of lesions to adapt to different individuals. On the other hand, the above connection method makes the occluder 20 more flexible, which is conducive to smooth delivery to the lesion site through a curved blood vessel.

[0072] In other embodiments, at least one of the two waists 217 may be omitted.

[0073] Please also read Figure 1 and Figure 5 The conveying device 40 includes an operating handle 410, an adjusting member 420, a pushing member 430 and a conveying member 440. The adjusting member 420 has a distal end and a proximal end, and the proximal end of the adjusting member 420 is connected to the operating handle 410. The pushing member 430 has a distal end and a proximal end, and the proximal end of the pushing member 430 is connected to the operating handle 410. The conveying member 440 has a distal end and a proximal end, and the proximal end of the conveying member 440 is connected to the operating handle 410. The loading, pushing, releasing and molding of the occluder 20 are achieved by operating the operating handle 410 to control the displacement of the adjusting member 420, the pushing member 430 and the conveying member 440. The pushing member 430 is movably accommodated in the conveying member 440, and the adjusting member 420 is movably accommodated in the pushing member 430.

[0074] The operating handle 410 includes a shell 411 and an upper cover 412. The shell 411 and the upper cover 412 are detachably connected. When the shell 411 and the upper cover 412 are connected, the shell 411 and the upper cover 412 enclose a receiving cavity.

[0075] The edge of the housing 411 is provided with a first groove 4111, and the edge of the upper cover 412 is provided with a second groove 4121. The first groove 4111 and the second groove 4121 form a track 413. Figure 1 In one embodiment, the number of the first groove 4111 and the number of the second groove 4121 are both two, forming two opposite and parallel tracks 413 .

[0076] See also Figure 6The adjusting member 420 is a slender rod. For example, the adjusting member 420 is a slender metal rod or metal wire with a certain rigidity.

[0077] In one embodiment, the material of the adjusting member 420 is a shape memory metal material or a shape memory alloy material. In one embodiment, the material of the adjusting member 420 is a nickel-titanium alloy.

[0078] The adjusting member 420 includes a straight section 421 and a bent section 422 connected to the straight section 421. In a natural state, the bent section 422 is bent relative to the straight section 421.

[0079] In one embodiment, the bending section 422 includes a first bending portion 4221 and a second bending portion 4222 connected to the first bending portion 4221. One end of the first bending portion 4221 away from the second bending portion 4222 is connected to the straight section 421, and one end of the second bending portion 4222 away from the first bending portion 4221 is a free end. In a natural state, the first bending portion 4221 is not parallel to the straight section 421, so that the bending section 422 is bent relative to the straight section 421. In addition, the second bending portion 4222 is bent relative to the first bending portion 4221.

[0080] In one embodiment, in a natural state, the angle between the first bending portion 4221 and the straight section 421 is a right angle, and the angle between the second bending portion 4222 and the first bending portion 4221 is a right angle, so that the straight section 421 and the second bending portion 4222 are parallel.

[0081] In other embodiments, in a natural state, the angle between the first bending portion 4221 and the straight extension section 421 is not limited to a right angle, and the angle between the second bending portion 4222 and the first bending portion 4221 is not limited to a right angle. It is sufficient to ensure that the bending section 422 is bent as a whole relative to the straight extension section 421, and the second bending portion 4222 is bent relative to the first bending portion 4221, so that when the second bending portion 4222 is accommodated in the accommodating portion 222, the first bending portion 4221 and the spacer portion 223 of the first head 220 can be hooked when subjected to force.

[0082] When the adjusting member 420 is restrained, for example, restrained in the tubular structure, the bent section 422 is generally straightened; or, the free end of the bent section 422 is accommodated in the tubular structure in a manner of being axially away from the straight section 421. When the restraint is removed, the bent section 422 returns to a natural state, that is, a state of being bent relative to the straight section 421.

[0083] One end of a slender shape memory metal rod or metal wire, or a shape memory alloy rod or alloy wire is bent twice and shaped to obtain an adjustment member 420 of an integrated structure.

[0084] It can be understood that in other embodiments, the straight section 421, the first bending portion 4221 and the second bending portion 4222 may be connected separately, for example, by welding or bonding to form the adjusting member 420.

[0085] In one embodiment, see Figure 7 , the adjusting member 420 includes a straight section 421 and a bending section 422 connected to the straight section 421. In a natural state, the bending section 422 is bent relative to the straight section 421. The bending section 422 itself is a straight rod or a straight metal wire, that is, the bending section 422 of this embodiment does not include a first bending portion 4221 and a second bending portion 4222. The angle α between the bending section 422 and the straight section 421 is less than 90°. The bending section 422 is at least partially accommodated in the accommodating portion 222, so that the connection between the bending section 422 and the straight section 421 can be hooked with the spacing portion 223 of the first head 220. In this embodiment, the metal rod or wire is bent once and shaped to form the adjusting member 420.

[0086] In one embodiment, the adjusting member 420 is an alloy rod or alloy wire of equal diameter. In one embodiment, the diameter of the adjusting member 420 is 0.3 to 0.35 mm. The adjusting member 420 of 0.3 to 0.35 mm is used to make the adjusting member 420 have sufficient strength. On the one hand, it is convenient to adjust the occluder 20; on the other hand, it is helpful to avoid the breaking of the adjusting member 420, so that the connection between the adjusting member 420 and other components is more reliable.

[0087] In one embodiment, the adjusting member 420 is an alloy rod or alloy wire of unequal diameters, including a first portion with a larger diameter and a second portion with a smaller diameter.

[0088] In one embodiment, the first portion with a larger diameter is the straight section 421 , and the second portion with a smaller diameter is the bent section 422 .

[0089] In another embodiment, if Figure 6 and Figure 7As shown, in the straight section 421, the L1 section is a rod or wire of equal diameter, and the other regions of the straight section 421 except the L1 section and the bent section 422 are another section of rod or wire of equal diameter, and the diameter of the L1 section is greater than the diameter of the other sections, that is, the L1 section is the first part with a larger diameter, and the other section is the second part with a smaller diameter. One end of the straight section 421 of the adjusting member 420 away from the bent section 422 is connected to other components of the conveying loading 40, and the diameter of the L1 section is larger, so as to facilitate avoiding the breakage of the adjusting member 420, so that the connection between the adjusting member 420 and other components is more reliable. During the conveying process, the region of the adjusting member 420 except the L1 section will extend out of the outside of the occluder 20, and at least part of the region is the part in contact with the first end cap 220, and the diameter of the region is smaller, so that the resilience of the region is smaller, which is conducive to avoiding damage to the tissue, and at the same time avoiding damage to the first end cap 220 due to excessive resilience of the bent section 422.

[0090] In one embodiment, the first portion with a larger diameter has a diameter of 0.3-0.35 mm, and the second portion with a smaller diameter has a diameter of 0.18-0.22 mm, so as to achieve both connection strength and avoid excessive resilience of the second portion.

[0091] In one embodiment, when the first portion with a larger diameter is the L1 segment, the ratio of the axial length of the L1 segment to the axial length of the adjusting member 420 (the sum of the axial length of the straight section 421 and the axial length of the bent section 422 after straightening) is (90-99):100, so that the adjusting member 420 has a certain pushing performance to facilitate the adjustment of the occluder 20.

[0092] See also Figure 8 The push member 430 is a hollow tube. The push member 430 has an inner cavity 432 extending axially from the distal end to the proximal end. The adjusting member 420 is movably accommodated in the inner cavity 432 of the push member 430, that is, the adjusting member 420 is movably arranged through the push member 430. When the bending section 422 of the adjusting member 420 is located in the inner cavity 432, the bending section 422 is substantially straightened, such as Figure 9a Alternatively, the free end of the bent section 422 is received in the pusher 430 in a manner that it is axially away from the straight section 421. When the bent section 422 of the adjusting member 420 is located outside the inner cavity 432 and is no longer constrained, the bent section 422 returns to a natural bent state, as shown in FIG. Figure 8 and Figure 9b shown.

[0093] When the occluder 20 is loaded into the conveying device 40, the operating handle 410 is controlled to make the push member 430 enter the path formed by the first opening 212, the inner cavity 211 and the second opening 213 of the occluding frame 210 from the second through hole 231 of the second end cap 230 of the occluder 20, and the push member 430 can move from the second through hole 231 until the distal end of the push member 430 abuts against the proximal end face of the first end cap 220, and the abutting state is as shown in FIG. Fig.10 As shown, or the distal end of the pushing member 430 extends into the first end cap 220 and abuts against the first end cap 220. In addition, the bending section 422 of the adjusting member 420 extends from the pushing member 430, passes through the first through hole 221 of the first end cap 220 and extends to the outside of the occluder 20. The second bending portion 4222 of the bending section 422 extends into the receiving portion 222.

[0094] See also Fig.10 , the outer diameter of the push member 430 is D3, and the inner diameter is D4. The outer diameter of the adjusting member 420 is D5 ( Fig.10 Please refer to Figure 3 and Fig.10 , D2>D3>D1>D4>D5, so that the occluder 20, the adjusting member 420 and the pushing member 430 cooperate to achieve the loading, pushing, releasing and forming of the occluder 20.

[0095] It should be noted that when the first through hole 221 and the second through hole 231 are through holes of irregular shapes, the aperture D1 of the first through hole 221 refers to the aperture at the minimum position, and the aperture D2 of the second through hole 231 also refers to the aperture at the minimum position.

[0096] Please go back Figure 1 , the conveying member 440 is a hollow tube. In one embodiment, the conveying member 440 is a hollow stainless steel spring tube. In one embodiment, the conveying member 440 is a hollow nickel-titanium cable.

[0097] In one embodiment, a connecting portion 442 is provided at the distal end of the conveying member 440, and an inner wall of the connecting portion 442 is provided with an internal thread, which cooperates with the external thread 232 of the second head 230, so that the second head 230 and the conveying member 440 are detachably connected.

[0098] Please refer again Figure 5 The proximal end of the conveying member 440 extends into the operating handle 410 and is fixedly connected to the operating handle 410. The pushing member 430 is movably disposed through the conveying member 440. The adjusting member 420 is movably disposed through the pushing member 430.

[0099] The conveying device 40 further includes a first driving assembly 450 and a second driving assembly 460 .

[0100] Please also read Fig.11 and Fig.12 The first driving assembly 450 includes a guide rail 451 and a first rotating member 452 and a second rotating member 453 (see Fig.14 The guide rail 451 is received in the receiving cavity of the operating handle 410 and extends in the axial direction. The guide rail 451 is parallel to the track 413.

[0101] like Fig.12 As shown, the first rotating member 452 includes a fixed portion 4521, a rotating portion 4522 and a supporting portion 4523. The fixed portion 4521 is received in the accommodating cavity of the operating handle 410, and the rotating portion 4522 is rotatable and axially displaceable relative to the fixed portion 4521. A through hole extending axially from one end to the other end is provided on the rotating portion 4522. In one embodiment, the adjusting member 420 extends into the pushing member 430, and the proximal end of the adjusting member 420 extends into the through hole of the rotating portion 4522, and a gap is formed between the adjusting member 420 and the hole wall of the through hole of the rotating portion 4522, and the adjusting member 420 is not fixedly connected to the rotating portion 4522. Please refer to Fig.13 There are two abutting parts 4523, which are sleeved on the adjusting member 420 and fixedly connected to the adjusting member 420, and the two abutting parts 4523 are located on both sides of the rotating part 4522. The two abutting parts 4523 are not fixedly connected to the rotating part 4522. When the rotating part 4522 rotates relative to the fixed part 4521, the rotating part 4522 synchronously moves axially and pushes the abutting parts 4523, so that the abutting parts 4523 move axially in the same direction, so as to drive the adjusting member 420 to move axially, and the adjusting member 420 does not rotate.

[0102] In one embodiment, an internal thread is formed on the inner wall of the fixed portion 4521 , and an external thread is formed on the outer wall of the rotating portion 4522 . The internal thread and the external thread cooperate to enable the rotating portion 4522 to rotate and axially displace relative to the fixed portion 4521 .

[0103] See also Fig.13 In one embodiment, the first rotating member 452 further includes a reinforcing tube 4524, and the proximal end of the adjusting member 420 is fixedly connected to the reinforcing tube 4524. For example, the proximal end of the adjusting member 420 extends into the reinforcing tube 4524 and is fixedly connected to the reinforcing tube 4524, or the reinforcing tube 4524 is sleeved on the proximal end of the adjusting member 420, covers the proximal end surface of the adjusting member 420, and the reinforcing tube 4524 is fixedly connected to the adjusting member 420. The reinforcing tube 4524 extends into the through hole of the rotating portion 4522 and forms a gap with the hole wall of the through hole. Two abutting portions 4523 are sleeved on the reinforcing tube 4524 and are fixedly connected to the reinforcing tube 4524, and the two abutting portions 4523 are located at both ends of the rotating portion 4522.

[0104] Since the radial dimension (such as diameter) of the adjusting member 420 is relatively small, the reinforcing tube 4524 is provided to facilitate the connection between the adjusting member 420 and the abutting portion 4523 and to improve the connection strength between the adjusting member 420 and the abutting portion 4523 so that the adjusting member 420 can reliably pass through the through hole of the rotating portion 4522 .

[0105] It is understood that in other embodiments, the reinforcing tube 4524 can be omitted. When the reinforcing tube 4524 is omitted, other methods can be used to reliably connect the adjusting member 420 with the abutting portion 4523. For example, the adjusting member 420 is a metal wire or a metal rod with uneven outer diameter, and the outer diameter of the proximal end of the adjusting member 420 is larger, so that the adjusting member 420 can be reliably connected with the abutting portion 4523.

[0106] Please also read Fig.14 and Fig.15 The second rotating member 453 includes a base 4531, a rotary cover 4532 and an adjusting rod 4533. The base 4531 is connected to the housing 411 and the upper cover 412, and the base 4531 is rotatably connected to the operating handle 410. The adjusting rod 4533 is inserted into the base 4531, and the rotary cover 4532 is sleeved on the adjusting rod 4533 and the base 4531. The second rotating member 453 can rotate relative to the operating handle 410.

[0107] In one embodiment, the first drive assembly 450 further includes two connecting members 454, such as Fig.11 and Fig.15 The rotating part 4522 is provided with a fixing hole, the guide rail 451 is provided with a fixing hole, and the two ends of the guide rail 451 are respectively connected to two connecting members 454. Fig.15 The connecting member 454 at the proximal end extends into the base 4531 and is fixedly connected to the base 4531. The second rotating member 453 is rotated to drive the guide rail 451 to rotate, thereby driving the rotating portion 4522 to rotate and move axially relative to the fixed portion 4521.

[0108] In one embodiment, the first driving assembly 450 further includes a balancing rail 457, and the balancing rail 457 is parallel to the guide rail 451. In this embodiment, there are two fixing holes on the rotating part 4522, and the guide rail 451 and the balancing rail 457 extend into the two fixing holes respectively, and the guide rail 451 and the balancing rail 457 extend toward the proximal end. The two fixing holes are located on both sides of the through hole, that is, when assembled, the adjustment member 420 is located between the guide rail 451 and the balancing rail 457. When the second rotating member 453 is rotated, the guide rail 451 and the balancing rail 457 rotate simultaneously.

[0109] Please continue reading Fig.11 and Fig.12The second driving assembly 460 includes a sliding button 461, which at least partially extends from the track 413. The sliding button 461 is connected to the guide rail 451 and the balance rail 457, and the sliding button 461 can move axially along the guide rail 451 and the balance rail 457.

[0110] In one embodiment, the sliding button 461 includes two operating portions, which extend from two rails 413 and are located outside the operating handle 410 .

[0111] In one embodiment, two through holes are formed on the sliding button 461 , and the guide rod 451 and the balancing slide rail 457 penetrate the sliding button 461 through the two through holes respectively.

[0112] The balanced slide rail 457 is provided to make the axial movement of the slide button 461 more stable, which is beneficial to improving the stability of the operation. It is understandable that the balanced slide rail 457 can be omitted to make the internal structure of the operating handle 410 more compact.

[0113] The sliding button 461 is also provided with another through hole, and one end of the pushing member 430 extends from the operating handle 410 into the through hole and is fixedly connected to the sliding button 461 (eg, Fig.12 As shown), when the sliding button 461 moves axially, it drives the pushing member 430 to move axially.

[0114] Please go back Fig.12 In one embodiment, the fixed portion 4521 is fixedly connected to the sliding button 461, so that when the sliding button 461 is axially displaced along the guide rail 451, the rotating member 452 is driven to be axially displaced, so that the pushing member 430 and the adjusting member 420 can be axially displaced at the same time, so that the operation is more convenient and quick. In this embodiment, the adjusting member 420 can be independently driven to be axially displaced by the first driving assembly 450, and the adjusting member 420 and the pushing member 430 can be driven to be axially displaced at the same time by the second driving assembly 460.

[0115] It is understandable that in other embodiments, the fixing portion 4521 is not fixedly connected to the sliding button 461 , and the adjusting member 420 is independently driven to move axially by the first driving assembly 450 , and the pushing member 430 is independently driven to move axially by the second driving assembly 460 .

[0116] When planning an implant surgery, first refer to Fig.16a and Fig.16b, connect the connecting part 442 of the conveying member 440 (with the adjusting member 420 and the pushing member 430 therein) to the second end cap 230 of the occluder 20, and when the sliding button 461 is not fixedly connected to the fixing part 4521, the sliding button 461 is operated to make the pushing member 430 enter the path formed by the first through hole 221, the first opening 212, the inner cavity 211 of the occluding frame 210, the second opening 213 and the second through hole 231 from the second end cap 230, and continue to translate to the distal end of the pushing member 430 to abut against the first end cap 220. Then, continue to move the pushing member 430 toward the distal end to straighten the occluder 20, so that the occluder 20 is in a stretched state. Then, the second rotating member 453 is rotated to drive the adjusting member 420 to move axially, so that the adjusting member 420 moves axially along the inner cavity 432 of the pushing member 430 until the adjusting member 420 extends from the first end cap 220 to the outside of the occluder 20, and the bending section 422 restores the shape in the natural state, and further extends the second bending portion 4222 of the bending section 422 into the receiving portion 222, as shown in FIG. Fig.16c shown.

[0117] When the sliding button 461 is fixedly connected to the fixing portion 4521, the sliding button 461 is operated to move along the guide rod 451 and the track 413, thereby driving the adjusting member 420 and the pushing member 430 to enter the path formed by the first through hole 221, the first opening 212, the inner cavity 211 of the blocking frame 210, the second opening 213 and the second through hole 231 from the second end cap 230, and continue to translate to the distal end of the pushing member 430 to abut against the first end cap 220. Then, the pushing member 430 and the adjusting member 420 continue to move toward the distal end to straighten the occluder 20 so that the occluder 20 is in a stretched state. When the occluder 20 is in the stretched state, the position of the sliding button 461 is kept unchanged, and the second rotating member 453 is rotated to drive the adjusting member 420 to move axially toward the distal end so that the bending section 422 extends to the outside of the pushing member 430 and the occluder 20, and the bending section 422 restores the shape in the natural state, and further extends the second bending portion 4222 of the bending section 422 into the receiving portion 222, as shown in FIG. Fig.16c Further, the occluder 20 is moved as a whole toward the delivery sheath 490 to pull the stretched occluder 20 into the delivery sheath 490, even if the occluder 20 is loaded into the delivery sheath 490, as shown in FIG. Fig.16d shown.

[0118] After the occluder 20 is delivered to the target site through the delivery sheath 490, the delivery device 40 is pushed as a whole to push the occluder 20 out of the delivery sheath 490 as a whole. At this time, the distal end of the pusher 430 is still in contact with the first end cap 220, and the position of the sliding button 461 remains unchanged, so that the occluder 20 is still in a stretched state, the adjustment member 420 still passes through the inner cavity 432 of the pusher 430, and the second bent portion 4222 of the bent section 422 remains in a state of being accommodated in the accommodating portion 222, as shown in FIG. Fig.17a shown.

[0119] Further, it is necessary to change the occluder 20 to the expanded state. When the sliding button 461 is not fixedly connected to the fixing portion 4521, the sliding button 461 is moved axially toward the proximal end to drive the push member 430 and the adjusting member 420 to move axially toward the proximal end at the same time, so that the bending section 422 of the adjusting member 420 abuts against the first head 220, and in the abutting state, the pushing member 430 and the adjusting member 420 continue to move proximally to compress the occluder 20, adjust the axial distance of the occluder 20, shape the occluder 20, abut the outer wall of the occluder 20 against the tissue wall, and maintain the shape of the occluder 20 after being formed, as shown in FIG. Fig.17b shown.

[0120] Keeping the position of the sliding button 461 unchanged, the second rotating member 453 is rotated to drive the guide rail 451 and the balancing slide rail 453 to rotate, thereby driving the rotating portion 4522 to rotate relative to the fixed portion 4521 and synchronously displace axially, driving the adjusting member 420 to move toward the distal end, so that the second bending portion 4222 leaves the receiving portion 222, as shown in FIG. Fig.17b The second rotating member 453 is continuously rotated to move the adjusting member 420 toward the proximal end, so as to pull the second bending portion 4222 into the inner cavity 430 of the pushing member 430. The sliding button 461 is continuously moved toward the proximal end, so as to withdraw the pushing member 430 and the adjusting member 420 from the occluder 20 together.

[0121] When the sliding button 461 is fixedly connected to the fixing portion 4521, the sliding button 461 is similarly moved axially toward the proximal end to simultaneously drive the adjusting member 420 and the pushing member 430 to move axially toward the proximal end. When the adjusting member 420 moves axially toward the proximal end until the bending section 422 of the adjusting member 420 abuts against the first end cap 220, the adjusting member 420 and the pushing member 430 are continuously moved axially toward the proximal end to further compress the occluder 20 to form the occluder 20. Further, the second rotating member 453 is rotated to make the adjusting member 420 retreat into the inner cavity of the pushing member 430, and then the sliding button 461 is operated to simultaneously withdraw the adjusting member 420 and the pushing member 430 from the occluder 20.

[0122] The above respectively describes the use of the delivery system 100 when the sliding button 461 is fixedly connected and not fixedly connected to the fixing part 4521. It should be noted that the use of the delivery system 100 is not limited to the method described above. According to the structure of the delivery device 40 itself and the matching relationship with the occluder 20, different operation sequences can be used as long as the loading, delivery and release of the occluder 20 can be achieved.

[0123] The first through hole 221, the inner cavity 211 and the second through hole 231 of the occluder 20 are connected to form a path, and the receiving portion 222 of the first head 220 is located on one side of the first through hole 221. During the implantation process, the adjusting member 420 of the conveying device 40 can enter the path and the bending section 422 of the adjusting member 420 is at least partially received in the receiving portion 222, and can be hooked with the first head 220 to prevent the adjusting member 420 from falling off before the occluder 20 needs to be adjusted to form. In addition, the occluder 20 can be formed by withdrawing the bending section 422 of the adjusting member 420 from the receiving portion 222 and continuing to move toward the proximal end to resist the occluder 20. Then, the adjusting member 420 is continued to move toward the proximal end to withdraw the adjusting member 420 from the occluder 20. Through the cooperation of the first through hole 221, the inner cavity 211, the second through hole 231 and the receiving portion 222, the adjusting member 420 can be hooked with the occluder 20 and the adjusting member 420 can be withdrawn from the occluder 20. Therefore, in the case where the locking member is omitted, the axial length of the occluder 20 can be conveniently adjusted by the adjusting member 420 of the conveying device 40 to shape the occluder 20. Therefore, the occluder 20 can omit the locking member.

[0124] Furthermore, the locking piece is omitted, and the occluding frame 210 is not constrained by the locking piece. Its axial length can be precisely adjusted with the aid of the delivery device 40, so that it can be suitable for different implantation sites and can be released at any lumen position to realize the occluder.

[0125] The second bending portion 4222 is received in the receiving portion 222 , and the first bending portion 4221 abuts against the first sealing head 220 . When the position of the adjusting member 420 is fixed, the occluder 20 can be prevented from being released in advance, thereby improving the reliability of the operation.

[0126] Furthermore, in the conveying state, the second bending portion 4222 of the bending section 422 is received in the receiving portion 222 , so as to prevent the adjusting member 420 from being scratched against the inner wall of the conveying sheath tube 490 .

[0127] The above-mentioned occlusion system 100 realizes loading, pushing, releasing and molding of the occluder 20 by setting the adjusting member 420 and the pushing member 430 that cooperate with the occluder 20 in the conveying device 40. No additional components are required to be set in the occluder 20 to realize loading, pushing, releasing and molding of the occluder 20, so that the structure of the occluder 20 is relatively simple, the preparation process is simple, the preparation efficiency is high, and the preparation cost is low.

[0128] Furthermore, no additional components are required in the occluder 20, which is beneficial to reducing the radial size of the stretched occluder 20, so that it can be delivered using a delivery sheath 490 with a smaller outer diameter. At the same time, the stretched occluder 20 has better flexibility, which is beneficial for passing through a curved blood vessel path.

[0129] For a smaller size of the occluder 20, the size of the first end cap 220 is smaller, and accordingly, the aperture of the first through hole 221 is smaller. The outer diameters of the matching adjusting member 420 and pushing member 430 are also smaller, which makes it more difficult to load the occluder 20.

[0130] Furthermore, in actual use, whether before or after delivery, after the occluder 20 is loaded into the delivery sheath 490 according to the above method, it is sometimes necessary to remove the occluder 20 from the delivery sheath 490 and reinstall it. For example, before delivery, the occluder 20 needs to be removed from the delivery sheath 490 and reloaded due to inspection requirements. After delivery, for example, during surgery, the occluder 20 needs to be removed due to poor release, and the occluder 20 needs to be reloaded into the delivery sheath 490 before the implantation surgery is performed.

[0131] During loading or reloading, it is not necessarily possible to ensure that the pusher 430 is strictly aligned with the first through hole 221 in the first end cap 220 (the axial center axis coincides), which makes loading difficult. When the axial center axis of the pusher 430 deviates from the axial center axis of the first through hole 221 to a large extent, the adjusting member 420 is easily scratched with the first end cap 220 during the process of moving in the distal direction to extend out of the first end cap 220, which may damage the first end cap 220 made of polymer material, or cause a certain degree of damage to the adjusting member 420 itself. Even if the pusher 430 is strictly aligned with the first through hole 221, since the distal end of the adjusting member 420 is a bent section 422, even when constrained, the bent section 422 is in a straightened state, but it naturally has a tendency to restore the bent state, which increases the difficulty of passing through a straight small hole (first through hole 221), making loading or reloading more difficult.

[0132] In one embodiment, see Fig.18, the first through hole 221 is a trapezoidal hole, the larger end of the trapezoidal hole is located at the proximal end, and the smaller end is located at the distal end. The distal end of the push member 430 is trapezoidal, so that the shape of the distal end of the push member 430 matches the shape of the first through hole 221. During the loading process, the pushing process and the releasing process, the distal end of the push member 430 extends into the first through hole 221, and the distal end of the push member 430 abuts against the hole wall of the first through hole 221. In this way, it is helpful to slow down or avoid the deviation of the push member 430 and the first through hole 221 during the loading process and the surgical process, so that the adjusting member 420 can smoothly extend from the first through hole 221 to the outside of the first head 220.

[0133] In one embodiment, see Fig.19 , the first through hole 221 is a stepped hole, the larger end of the stepped hole is located at the proximal end, and the smaller end is located at the distal end. There are steps on the hole wall of the stepped hole. The distal end of the push member 430 is stepped so that the shape of the distal end of the push member 430 matches the shape of the first through hole 221. There is also a step at the distal end of the push member 430. During the loading process, the pushing process and the releasing process, the distal end of the push member 430 extends into the first through hole 221, and the step of the push member 430 abuts against the step of the first through hole 221. In this way, it is beneficial to keep the push member 430 and the first through hole 221 facing each other during the loading process and the surgical process, so that the adjusting member 420 can smoothly extend from the first through hole 221 to the outside of the first head 220. Furthermore, even if improper force is applied during operation, the step at the far end of the push member 430 conflicts with the step of the first through hole 221 , thereby preventing the push member 430 from extending from the first through hole 221 and damaging the first head 220 .

[0134] In one embodiment, see Fig. 20 The first through hole 221 is a stepped hole, the larger end of the stepped hole is located at the proximal end, and the smaller end is located at the distal end. There are steps on the hole wall of the stepped hole. The pusher 430 is a hollow cylindrical tube. The conveying device 40 also includes a transition piece 402. Please refer to Fig.21The transition piece 402 is a hollow structure with a cross-sectional shape of a "convex" character. A step 4021 is formed at the distal end of the outer wall of the transition piece 402, and the step 4021 surrounds the distal outer peripheral surface of the transition piece 402. An opening 4022 extending axially from the distal end of the transition piece 402 to the proximal end is provided in the middle of the transition piece 402. The cross-section of the opening 4022 is roughly in the shape of a "convex" character, and the small end of the opening 4012 is located at the distal end, and the large end is located at the proximal end. The shape and size of the large end of the opening 4022 match the shape and size of the distal end of the push piece 430, so that the transition piece 402 can be sleeved on the distal end of the push piece 430 and fixedly connected to the push piece 430. During the loading process, the pushing process and the releasing process, the distal end of the transition piece 402 extends into the first through hole 221, and the step 4021 of the transition piece 402 abuts against the step of the first through hole 221. In this way, it is not only convenient to operate, but also avoids damaging the first head 220 and / or the adjusting member 420. At the same time, the outer diameter of the push member 430 is very small, usually less than 1 mm. It is very difficult to form a step on the outer wall of the push member 430, which requires high process and is difficult to ensure precision. The transition member 402 is additionally provided to avoid processing the far end of the push member 430 to form a step. Therefore, the additional provision of the transition member 402 can reduce the difficulty of processing, help improve the preparation efficiency, ensure precision, and improve the production yield.

[0135] It can be understood that when the first through hole 221 is a trapezoidal hole, the aperture D1 of the first through hole 221 refers to the minimum width in the radial direction of the first through hole 221. When the first through hole 221 is a stepped hole, the aperture D1 of the first through hole 221 refers to the aperture of the smaller part of the first through hole 221, that is, the radial width of the part of the first through hole 221 away from the second head 230 is D1.

[0136] Please refer again Figure 5 The conveying device 40 further includes a limiting assembly 470, which is used to limit the pushing member 430 to avoid improper release of the occluder 20 due to misoperation.

[0137] Please also read Fig. 22 and Fig.23The limiting assembly 470 includes a clamping member 471 and a locking member 472 connected to the clamping member 471. The locking member 472 is used to adjust the clamping force of the clamping member 471 to achieve limiting or non-limiting. The clamping member 471 is disposed in the housing 411. In one embodiment, the clamping member 471 includes a first clamping portion 4711 and a second clamping portion 4712, and a receiving area is formed between the first clamping portion 4711 and the second clamping portion 4712, and the push member 430 extends into the receiving area. The locking member 472 is simultaneously sleeved on the first clamping portion 4711 and the second clamping portion 4712, and the locking member 472 is rotated to adjust the proximity of the first clamping portion 4711 and the second clamping portion 4712, so that the size of the receiving area can be controlled. When the radial size of the receiving area is greater than the radial size of the push member 430, the push member 430 can be displaced with the displacement of the sliding button 452. When the size of the receiving area is smaller than the radial size of the pushing member 430 , the pushing member 430 cannot be displaced, that is, it is limited.

[0138] The housing 411 of the operating handle 410 is provided with a first operating window, and the upper cover 412 is provided with a second operating window, the first operating window and the second operating window are opposite to each other. The locking member 472 is provided in the housing 411, and the locking member 472 extends from the first operating window and the second operating window to facilitate operation.

[0139] The delivery device 40 of the above-mentioned occlusion system 100 can deliver the occluder 20 to the lesion site, and after pushing the occluder 20 out of the delivery sheath 490, control the displacement of the adjustment member 420 to restore the occluder 20 to the expanded state, thereby realizing the molding of the occluder 20. The operation is convenient and reliable. In addition, the structure of the occluder 20 is relatively simple, and no additional molding auxiliary structure is required.

[0140] In one embodiment, the occluder 20 is a cardiac occluder, such as an atrial septal defect occluder, a ventricular septal defect occluder, a left atrial appendage occluder, and the like.

[0141] In one embodiment, the occluder 20 is a vascular occluder, which can be used to block blood flow to treat vascular malformations or block blood flow to treat tumors, etc.

[0142] See also Fig.24 In one embodiment, the occluder 20 further includes a fixing member 218. The fixing member 218 is sleeved on the waist 217 of the occluding frame 210. A channel 219 is formed in the middle of the fixing member 218, extending axially from the distal end of the fixing member 218 to the proximal end of the fixing member 218. The channel 219 should be large enough so that after the fixing member 218 is sleeved on the waist 217, the inner cavity 211 of the occluding frame 210 can still be kept unobstructed in the axial direction, that is, the inner cavity 211 ( Fig.24 (not shown), the first opening 212 and the second opening 213 are connected to form a path.

[0143] The number of the fixing members 218 corresponds to the number of the waist portions 217 . Fig.24 In the illustrated embodiment, the number of the waist portions 217 is two, and accordingly, the number of the fixing members 218 is two.

[0144] In another embodiment, the number of the middle blocking units 215 is multiple, the number of the waists 217 is greater than two, and the multiple middle blocking units 215 and the multiple waists 217 are alternately arranged along the axial direction. Among them, the middle blocking unit 215 located at the farthest end is connected to the first blocking unit 214 through the waist 217, and the middle blocking unit 215 located at the closest end is connected to the second blocking unit 216 through the waist 217. Multiple fixing members 218 are respectively sleeved on the multiple waists 217. The channel 219 should be large enough so that after the fixing member 218 is sleeved on the waist 217, there is still space in the middle of the channel 219, and the inner cavity 211 of the blocking frame 210 can still extend axially from the first blocking unit 214 to the second blocking unit 216.

[0145] The axial lengths of the multiple middle blocking units 215 may be equal or unequal. Among the multiple middle blocking units 215, the axial lengths of all the middle blocking units 215 may be greater than the axial lengths of the first blocking unit 214 and the second blocking unit 216, or the axial lengths of some of the middle blocking units 215 may be greater than the axial lengths of the first blocking unit 214 and the second blocking unit 216, or the axial lengths of some of the middle blocking units 215 may be equal to the axial lengths of the first blocking unit 214 and the second blocking unit 216.

[0146] The first opening 212, the second opening 213, the passage 219, the first through hole 221 and the second through hole 231 are coaxial, so that during the loading process, when the pusher 430 is axially displaced from the second through hole 231 through the second opening 213 into the inner cavity 211 until the distal end of the pusher 430 abuts against the first end cap 220, it assists in achieving loading and subsequent molding. By sleeved with a fixing member 218 on the waist 217, the fixing member 218 further fixes the above path, that is, further fixes the path of the pusher 430 moving inside the blocking frame 210, which is conducive to preventing the pusher 430 from deviating from the preset direction and poking the blocking frame 210, causing damage to the blocking frame 210. At the same time, it is also conducive to the good alignment of the pusher 430 with the first through hole 221, so as to facilitate the adjustment member 420 to smoothly extend from the inner cavity 432 of the pusher 430 into the first through hole 221 of the first end cap 220.

[0147] Therefore, the locking piece can be omitted from the occluder 20, and the occluder 20 can be loaded more conveniently after the locking piece is omitted. The occluder 20 without the locking piece has better flexibility, which is conducive to passing through a curved blood vessel path or adapting to a curved vascular lesion.

[0148] In one embodiment, the fixing member 218 is a sleeve formed of a polymer material, and a channel extending axially from the distal end of the sleeve to the proximal end is formed in the middle of the sleeve. The sleeve is sleeved on the waist 217, and the inner wall of the sleeve contacts the outer peripheral surface of the waist 217. The channel should be large enough so that after the sleeve is sleeved on the waist 217, there is still enough space in the channel to facilitate the passage of the pusher 430. However, the channel should not be too large, otherwise the limiting effect on the pusher 430 is small. The polymer material forming the sleeve is a polymer material that can be absorbed by the organism, so that the occluder 20 as a whole can be absorbed by the organism.

[0149] The axial length of the sleeve is less than or equal to the axial length of the waist 217. In one embodiment, the ratio of the axial length of the sleeve to the axial length of the waist 217 is 1:(2-5) to avoid the axial length of the sleeve being too large to affect the overall flexibility of the occluder 20, but at the same time avoid the axial length of the sleeve being too small to cause difficulty in processing.

[0150] In one embodiment, see Fig.25 , the fixing piece 218 is a ring structure formed by a polymer wire wrapped around the periphery of the waist 217. The polymer wire is a flexible wire such as a polymer fiber wire, a polymer medical suture wire, etc. In one embodiment, the polymer wire is an absorbable polymer wire, so that the occluder 20 as a whole can be absorbed by the organism. Polymer wires such as polymer fiber wires and polymer medical suture wires are relatively soft, and the ring structure formed by the polymer wire wrapped around the periphery of the waist 217 is also relatively soft, so that the setting of the fixing piece 218 will not significantly increase the overall rigidity of the occluder 20, even if the number of fixing pieces 218 is greater than 2, the occluder 20 can still maintain sufficient flexibility. In addition, the method of using a polymer wire to form the fixing piece 218 sleeved on the waist 217 is relatively simple to prepare or process, and easy to operate.

[0151] The polymer line is wrapped around the waist 217 ( Fig.25 ) or multiple turns ( Fig.26 ) forms a fixing member 218. It is understood that the tightness of the polymer wire winding should be appropriate, on the one hand, so that the polymer wire can be more reliably fixed to the waist 217, and on the other hand, after the polymer wire is wound around the waist 217, the channel formed by the polymer wire should be large enough to facilitate the passage of the pusher 430.

[0152] When the polymer wire is wound around the waist 217 for one turn, the diameter of the polymer wire is relatively large. When the polymer wire is wound around the waist 217 for multiple turns, a polymer wire with a smaller diameter can be used. The polymer wire is wound around the waist 217 for multiple turns to form the fixing member 218, which is conducive to the reliable connection between the fixing member 218 and the waist 217.

[0153] In one embodiment, whether the fixing member 218 is a sleeve formed of a polymer material or a ring structure formed by winding a polymer line around the outer periphery of the waist 217, the width of the channel of the fixing member 218 is D6, and in a natural state, the radial width of the waist is D7. The outer diameter D3 of the push member 430 is smaller than D6, so that the push member 430 can pass through the fixing member 218 smoothly. D7 is larger than D6, which is conducive to the reliable connection between the fixing member 218 and the waist 217.

[0154] In one embodiment, D3 is 0.1 to 4 mm smaller than D6, and D7 is 2 to 60 mm larger than D6, so that the pushing member 430 can smoothly pass through the fixing member 218, and the fixing member 218 is reliably connected to the waist 217 to prevent the fixing member 218 from falling off the waist 217 when the occluder 20 is axially stretched and loaded into the delivery sheath 490. This is particularly important for an embodiment in which the fixing member 218 is a ring structure formed by a polymer wire wrapped around the outer periphery of the waist 217.

[0155] The above-mentioned occluder 20 is provided with a fixing member 218 on the waist 217. The fixing member 218 is conducive to fixing the displacement path of the push member 430 on the occluding frame 210, so that the push member 430 is displaced along the fixed path to the far end of the push member 430 and abuts against the first end cap 220 of the occluder 20, so as to achieve axial stretching of the occluder 20 for easy loading. In addition, during the loading process, due to the limitation of the fixing member 218, it is possible to prevent the far end of the push member 430 from being separated from the abutment with the first end cap 220 due to slipping or improper operation, so that the push member 430 can maintain the state of abutting against the first end cap 220 without deviation, thereby ensuring that the loading of the occluder 20 can proceed smoothly.

[0156] Furthermore, after the occluder 20 is delivered to the diseased site through the delivery sheath 490, when the occluder 20 is pushed out of the delivery sheath 490, and before confirming whether the occluder 20 is in the correct position, due to the limiting effect of the fixing member 218, the pushing member 430 can maintain abutment with the first head 220 without shifting, thereby enabling the occluder 20 to reliably maintain an axially stretched state, so as to facilitate the operator to adjust the position of the occluder 20.

[0157] At the same time, the fixing member 218 is helpful to fix the relative position of the pushing member 430 and the first head 220, which is helpful to avoid unnecessary scratches between the pushing member 430 and the first head 220 and / or the sealing frame 210, thereby avoiding damage to the first head 220 and / or the sealing frame 210.

[0158] Therefore, the locking piece can be omitted from the occluder 20. The occluder 20 of the occluding system 100 cooperates with the conveying device 40, so that the loading and molding of the occluder 20 are more convenient and reliable.

[0159] In one embodiment, when the number of the middle occluding units 215 is one and the number of the waists 217 is two, and the fixing part 218 is an annular structure formed by a polymer wire wrapped around the outer periphery of the waist 217, the tightness of the polymer wires wrapped as the two fixing parts 218 is different, and the width D6 of the channels of the two fixing parts 218 is not equal. The value of D6 of the fixing part 218 located at the distal end is larger. This arrangement makes it easier to adjust the axial length of the occluder 20 while ensuring convenient loading and molding, so that the operation can be carried out smoothly.

[0160] 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.

[0161] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An occluder, comprising an absorbable occluding frame and a first end cap and a second end cap connected to both ends of the occluding frame, characterized in that: The blocking frame has an inner cavity, a first through hole and a receiving portion are formed on the first end cap, the receiving portion is located on one side of the first through hole, a second through hole is formed on the second end cap, the first through hole, the inner cavity and the second through hole are connected to form a path, the path is used for the passage of an adjusting member of a conveying device, and the receiving portion is used to receive the free end of the bent section of the adjusting member, and the first end cap is used to abut against a pushing member of a conveying device.

2. The occluder according to claim 1, characterized in that: The blocking frame comprises a first blocking unit, a middle blocking unit, a second blocking unit and a waist, wherein the number of the middle blocking unit is one, the number of the waists is two, the two ends of the middle blocking unit are respectively connected to the first blocking unit and the second blocking unit through the two waists, the first head is connected to the first blocking unit, the second head is connected to the second blocking unit, and the inner cavity extends axially from the first blocking unit to the second blocking unit; Alternatively, the blocking frame includes a first blocking unit, a middle blocking unit, a second blocking unit and a waist, the number of the middle blocking units is greater than one, the number of the waists is greater than two, the plurality of middle blocking units greater than one and the plurality of waists greater than two are alternately arranged axially, and the middle blocking unit located at the distal end is connected to the first blocking unit through the waist, the middle blocking unit located at the proximal end is connected to the second blocking unit through the waist, the first head is connected to the first blocking unit, the second head is connected to the second blocking unit, and the inner cavity extends axially from the first blocking unit to the second blocking unit.

3. The occluder according to claim 2, characterized in that: The axial length of the middle blocking unit is greater than the axial lengths of the first blocking unit and the second blocking unit.

4. The occluder according to claim 2, characterized in that: The occluder further comprises a fixing piece, which is sleeved on the waist, and the axial length of the fixing piece is smaller than the axial length of the waist.

5. The occluder according to claim 4, characterized in that: The fixing piece is a sleeve formed of a polymer material or a ring structure formed by winding a polymer line around the outer periphery of the waist.

6. The occluder according to claim 1, characterized in that: The first through hole is a stepped hole, the larger end of the stepped hole is located at the proximal end, the smaller end is located at the distal end, there is a step on the hole wall of the stepped hole, the first through hole can be used for the distal end of the pushing member to extend into, and the step of the first through hole is used to abut against the step of the pushing member.

7. The occluder according to claim 1, characterized in that: The receiving portion is a receiving hole or a receiving groove. When the receiving portion is a groove, the opening end of the receiving portion is located at the distal end; the material of the blocking frame is selected from at least one of left-handed polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoic acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid and polydioxanone; or, the material of the blocking frame is a copolymer formed by copolymerizing at least two of the monomers forming left-handed polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoic acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid and polydioxanone.

8. A blocking system, characterized in that: It comprises a conveying device and the occluder as described in any one of claims 1 to 7, wherein the conveying device comprises an adjusting member, the adjusting member has a bending section, and in a loaded state, the adjusting member passes through the path, and at least a part of the bending section of the adjusting member is accommodated in the accommodating portion, so that the adjusting member is hooked with the first head.

9. The blocking system according to claim 8, characterized in that: The conveying device further comprises a pushing member having an inner cavity. The pushing member can move along the path to a distal end of the pushing member to abut against the first sealing head, and the adjusting member can movably pass through the pushing member.

10. The blocking system according to claim 8, characterized in that: The adjusting member includes a straight section, and the bending section includes a first bending portion and a second bending portion connected to the first bending portion, and one end of the first bending portion away from the second bending portion is connected to the straight section, and in a loaded state, the second bending portion is accommodated in the accommodating portion, and the first bending portion abuts against the first head; the adjusting member includes a first part with a larger diameter and a second part with a smaller diameter, wherein the first part is a straight section and the second part is a bending section.

Images