CN114642467B

CN114642467B - Occluder and occlusion system

Info

Publication number: CN114642467B
Application number: CN202011502329.XA
Authority: CN
Inventors: 陈贤淼; 付明娟
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-12-17
Filing date: 2020-12-17
Publication date: 2024-12-31
Anticipated expiration: 2040-12-17
Also published as: WO2022127354A1; CN114642467A

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

Plugging device and plugging system

Technical Field

The invention relates to the field of interventional medical instruments, in particular to an occluder and an occlusion system.

Background

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

Percutaneous interventional therapy is a treatment for diseases that has progressed very rapidly in recent years, and the field to which this therapy is applicable is also becoming widespread. Wherein, the device and/or the medicine can be placed on the heart, the artery and vein of the human body and other parts by adopting a transcatheter interventional therapy method. Wherein, the apparatus can be heart occluder, vascular filter, etc.

The traditional heart occluder or vascular occluder and other instruments are generally made of shape memory alloy materials, the shape memory alloy materials have good elasticity, and after being released, the devices can better recover the original shape and better fit with the tissue of the defect part. However, the existing memory alloy material is generally a material which cannot be corroded or degraded in organisms, and after endothelialization is completed and complete plugging is achieved, the plugging device made of the shape memory alloy material is permanently kept in the body, and long-term clinical risks may exist.

The plugging device or other implantable devices made of absorbable polymer materials can be degraded in the organism, so that the plugging device can be gradually degraded, and after degradation products are absorbed by the organism, no residue exists in the organism. But the polymer material is soft and is not easy to be molded. After the occluder is conveyed into the body, the occluder made of high polymer materials cannot automatically return to a shaping state, namely cannot be automatically shaped, and auxiliary shaping of the occluder is needed. In order to achieve the above functions, in the existing occluder, a locking piece extending along the axial direction is arranged in the occlusion frame, and the locking piece is required to have certain rigidity and length to play a role in assisting the molding of the occluder.

However, the rigid locking member extends axially within the occluding frame to some extent to increase the rigidity of the occluding device after stretching, adding difficulty to delivery and being detrimental to passage through a tortuous vessel. Moreover, in the case of vascular occluders, the presence of the locking element affects the adjustment of the length of the vascular occluder, since the diseased vessels vary greatly in length.

Disclosure of Invention

Based on this, it is necessary to provide an occluder and an occlusion system which can omit the locking element.

The utility model provides a plugging device, includes the shutoff frame and with first head and the second head that the both ends of shutoff frame link to each other, the shutoff frame has the inner chamber, set up first through-hole and acceping portion on the first head, acceping portion is located one side of first through-hole, set up the second through-hole on the second head, first through-hole inner chamber with the second through-hole intercommunication forms a route.

In one embodiment, the plugging frame comprises a first plugging unit, a middle plugging unit, a second plugging unit and waist parts, wherein the number of the middle plugging units is one, the number of the waist parts is two, two ends of the middle plugging unit are respectively connected with the first plugging unit and the second plugging unit through two waist parts, the first sealing head is connected with the first plugging unit, the second sealing head is connected with the second plugging unit, and the inner cavity axially extends from the first plugging unit to the second plugging unit;

Or the shutoff frame includes first shutoff unit, middle part shutoff unit, second shutoff unit and waist, the quantity of middle part shutoff unit is greater than one, the quantity of waist is greater than two, a plurality of that quantity is greater than one middle part shutoff unit and a plurality of that quantity is greater than two the waist sets up alternately along the axial to the middle part shutoff unit that is located the distal end with first shutoff unit passes through the waist links to each other, the middle part shutoff unit that is located the proximal end with second shutoff unit passes through the waist links to each other, first head with first shutoff unit links to each other, the second head with second shutoff unit links to each other, the inner chamber is followed axially first shutoff unit extends to second shutoff unit.

In one embodiment, the axial length of the middle occlusion unit is greater than the axial length of both the first occlusion unit and the second occlusion unit.

In one embodiment, the occluder further comprises a fixing member, and the fixing member is sleeved on the waist portion.

In one embodiment, the fixing member is a sleeve formed by a polymer material or an annular structure formed by winding a polymer wire around the outer periphery of the waist portion.

In one embodiment, the axial length of the fastener is less than the axial length of the waist.

In one embodiment, the accommodating portion is an accommodating hole or an accommodating groove.

The plugging system comprises a conveying device and the plugging device, wherein the conveying device comprises an adjusting piece, the adjusting piece is provided with a bending section, the adjusting piece penetrates through the path in a loading state, and at least part of the bending section of the adjusting piece is accommodated in the accommodating part, so that the adjusting piece and the first sealing head are hooked.

In one embodiment, the conveying device further comprises a pushing member, the pushing member is provided with an inner cavity, the pushing member can move along the path until the distal end of the pushing member abuts against the first sealing head, and the adjusting member can movably penetrate through the pushing member.

In one embodiment, the adjusting member includes a straight extension section, the bending section includes a first bending portion and a second bending portion connected to the first bending portion, one end, far away from the second bending portion, of the first bending portion is connected to the straight extension section, in a loading state, the second bending portion is accommodated in the accommodating portion, and the first bending portion is abutted to the first sealing head.

The first through hole, the inner cavity and the second through hole of the plugging device are communicated to form a path, the accommodating part of the first sealing head is positioned at one side of the first through hole, in the implantation process, the adjusting part of the conveying device can enter the path, the bending section of the adjusting part is at least partially accommodated in the accommodating part, and the adjusting part can be hooked with the first sealing head, so that the adjusting part is prevented from falling off before the plugging device is required to be adjusted to be molded. And, the occluding device can be shaped by withdrawing the bent segment of the adjustment member from the receiving portion and continuing to move proximally to hold the occluding device. The adjustment member is then moved proximally to withdraw the adjustment member from the occluding device. Through the cooperation of first through-hole, inner chamber, second through-hole and acceping portion, can realize that regulating part takes place the hook with the stopper and the regulating part withdraws from the stopper, consequently, under the condition of omitting the locking piece, also can be more convenient through the axial length of regulating part adjustment stopper of conveyor so that the stopper shaping. Thus, the occluder can omit the locking member.

Drawings

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

FIG. 2 is a schematic structural view of an occluder in accordance with an embodiment;

FIG. 3 is a schematic structural view of an occluder of an embodiment (illustrating a lumen);

FIG. 4 is a schematic structural view of an occluder in another embodiment;

FIG. 5 is an exploded schematic view of a conveyor of an embodiment;

FIG. 6 is a schematic structural view of an adjusting member according to an embodiment;

FIG. 7 is a schematic view of another embodiment of an adjuster;

FIG. 8 is a schematic diagram illustrating a positional relationship between an adjusting member and a pushing member according to an embodiment;

FIGS. 9 a-9 b are schematic diagrams illustrating different relative positional relationships of an occluder and an adjustment member in accordance with one embodiment;

FIG. 10 is a schematic view of the relationship between the occluder and the adjustment member and pushing member according to one embodiment;

FIG. 11 is a schematic view showing a part of the structure of a first driving assembly and a second driving assembly according to an embodiment;

FIG. 12 is a cross-sectional view of FIG. 11;

FIG. 13 is an enlarged view of a portion of FIG. 12;

FIG. 14 is a schematic view of a second rotary member according to an embodiment;

FIG. 15 is a schematic cross-sectional view of a first driving assembly and a second driving assembly according to an embodiment;

FIGS. 16 a-16 b are schematic views of an occluder and delivery device in an open state and a connected state in accordance with one embodiment;

FIGS. 16 c-16 d are schematic diagrams illustrating an occluder in a stretched state according to an embodiment;

17 a-17 b are schematic diagrams illustrating a change in the position relationship between the occluder and the adjusting member according to an embodiment;

fig. 18 is a schematic structural view of a first end cap and a pushing member of an occluder in accordance with an embodiment;

fig. 19 is a schematic structural view of a first end cap and a pushing member of an occluder in another embodiment;

Fig. 20 is a schematic structural view of a first end cap and a pushing member of an occluder in another embodiment;

FIG. 21 is a schematic structural view of a transition piece according to an embodiment;

FIG. 22 is a schematic structural view of a limiting assembly according to an embodiment;

FIG. 23 is a schematic cross-sectional view of FIG. 22;

FIG. 24 is a schematic view of the structure of an occluder in another embodiment;

FIG. 25 is a schematic view of the structure of an occluder in another embodiment;

Fig. 26 is a schematic structural view of an occluder in another embodiment.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, "distal" is defined as the end of the procedure that is distal to the operator, and "proximal" is defined as the end of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and "radial" refers to a direction perpendicular to the axial direction.

Referring to fig. 1, an embodiment of an occlusion system 100 includes an occluding device 20 and a delivery device 40. The occluding device 20 is detachably connected to the delivery device 40. After the occluder 20 is pushed to the focus part in the living body by the delivery device 40 and released, the connection between the occluder 20 and the delivery device 40 is disconnected, and the delivery device 40 is withdrawn from the living body, so that the implantation operation is completed.

Referring to fig. 2, in one embodiment, the occluding device 20 includes an absorbable occluding frame 210. The plugging frame 210 is a mesh structure formed by weaving a polymer material or by other means such as 3D printing.

In one embodiment, the material of the plugging frame 210 is at least one selected from the group consisting of l-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid, and polydioxanone.

In one embodiment, the material of the plugging frame 210 is a copolymer formed by copolymerizing at least two monomers of the group consisting of l-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polyglycolic acid, and polydioxanone.

The polymeric materials described above are relatively biocompatible and can degrade within an organism, such that the occluder 20 can degrade without residue after the intended use is completed.

Referring to fig. 3, the plugging frame 210 has an inner cavity 211, and the plugging frame 210 has a first opening 212 and a second opening 213 opposite to each other (the inner cavity 211 is located inside the plugging frame 210, and for convenience of illustration, fig. 3 generally shows the inner cavity 211 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 located at the distal end and the proximal end of the occlusion frame 210, respectively, and the inner cavity 211, the first opening 212 and the second opening 213 communicate to form a path. In one embodiment, the plurality of braided wires are braided to form the plugging frame 210, and 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, two free ends of the plurality of woven wires are respectively necked in by annular necking members.

In one embodiment, the occluding device 20 further comprises a first head 220 and a second head 230. The first seal head 220 and the second seal head 230 are respectively disposed at two opposite ends of the plugging frame 210. The first sealing head 220 is provided with a first through hole 221, and the first through hole 221 is communicated with the first opening 212. The second sealing head 230 is provided with a second through hole 231, and the second through hole 231 is communicated with the second opening 213.

In one embodiment, the two free ends of the plurality of braid wires are respectively necked in using the first and second caps 220 and 230, and a first opening 212 communicating with the first through hole 221 and a second opening 213 communicating with the second through hole 231 are formed. For example, the first seal head 220 and the second seal head 230 respectively form a receiving groove or a receiving cavity, and two free ends of the plurality of braided wires are respectively embedded and fixed in the receiving groove (or the receiving cavity) of the first seal head 220 and the receiving groove (or the receiving cavity) of the second seal head 230, and form a first opening 212 communicated with the first through hole 221 and a second opening 213 communicated with the second through hole 231.

In an embodiment, the first seal head 220 and the second seal head 230 are both located outside the plugging frame 210, so that the arrangement is convenient for processing.

In an embodiment, the first seal head 220 and the second seal head 230 are both located inside the plugging frame 210, which is beneficial to avoiding thrombosis and to avoiding scratching of tissue by the first seal head 220 and/or the second seal head 230 due to improper operation during release.

In an embodiment, the first sealing head 220 is disposed inside the plugging frame 210, the second sealing head 230 is disposed outside the plugging frame 210, and the first sealing head 220 is prevented from scratching the tissue, and the conveying device 40 and the second sealing head 230 are convenient to be detachably connected.

Referring to fig. 2 and fig. 3, the first sealing head 220 is provided with a receiving portion 222, and the receiving portion 222 is used for assisting in forming the plugging device 20. In one embodiment, the receiving portion 222 is a through hole. In one embodiment, as shown in fig. 4, the accommodating portion 222 is a groove, and when the accommodating portion 222 is the groove, the open end of the accommodating portion 222 is located at the distal end.

The receiving portion 222 is located at one side of the first through hole 221. A spacer 223 is provided between the housing portion 222 and the first through hole 221.

The central axis I-I in the axial direction of the first through hole 221 and the central axis II-II in the axial direction of the housing portion 222 are not on the same straight line. In one embodiment, as shown in fig. 2, the central axis I-I of the first through hole 221 in the axial direction is parallel to the central axis II-II of the receiving portion 222 in the axial direction. In other embodiments, central axis I-I and central axis II-II are not parallel.

In one embodiment, the outer wall of the second head 230 is formed with external threads 232, as shown in FIG. 3, to facilitate connection with the delivery device 40.

In one embodiment, the materials of the first seal head 220 and the second seal head 230 are both degradable polymeric materials, such that the occluding device 20 is fully absorbable within the living body. The material of the first seal head 220 and the second seal head 230 may be the same as or different from the material of the sealing frame 210.

The first seal head 220 and the second seal head 230 are approximately rigid polymer tubes, and the plugging frame 210 is soft, so that the first seal head 220 and the second seal head 230 are arranged, which is beneficial to loading, pushing, releasing and forming of the plugging device 20.

The first through hole 221 has an aperture D1, and the second through hole 231 has an aperture D2.

With continued reference to fig. 3, the occlusion frame 210 includes a first occlusion unit 214, a middle occlusion unit 215, and a second occlusion unit 216. Opposite ends of the central blocking unit 215 are connected (directly or indirectly) to the first blocking unit 214 and the second blocking unit 216, respectively. 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.

In one embodiment, the occlusion frame 210 further includes a waist 217. The number of waists 217 is two. Two ends of one waist portion 217 are respectively connected with the first plugging unit 214 and the middle plugging unit 215, and two ends of the other waist portion 217 are respectively connected with the middle plugging unit 215 and the second plugging unit 216. The radial dimensions of the waist portion 217 are smaller than the radial dimensions of the first occlusion unit 214, the intermediate occlusion unit 215 and the second occlusion unit 216.

In one embodiment, the axial length of the middle plugging unit 215 is greater than the axial lengths of the first plugging unit 214 and the second plugging unit 216, so that the contact area between the plugging device 20 and the lesion (such as the vessel wall) is larger after implantation, which is beneficial to improving the anchoring of the plugging device 20 at the lesion and maintaining the shape of the plugging device 20.

In an embodiment, the first blocking unit 214 and the second blocking unit 216 are both disc-shaped, the middle blocking unit 215 is columnar, and the columnar middle blocking unit 215 is connected with the disc-shaped first blocking unit 214 and the second blocking unit 216 through waists 217 with smaller radial dimensions. In one aspect, the combination of the columnar middle occlusion element 215 with the disk-shaped first occlusion element 214 and second occlusion element 216 ensures contact area with the lesion (e.g., vessel wall). On the other hand, the middle blocking unit 215 is connected with the first blocking unit 214 and the second blocking unit 216 through the waist 217 with smaller radial dimension, so that the angles 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, and the blocking device 20 is beneficial to adapting to focus positions with different forms so as to adapt to different individuals. On the other hand, the above-mentioned connection method makes the occluder 20 have better flexibility, and is beneficial to smoothly conveying to the focus part through the curved blood vessel.

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

Referring to fig. 1 and 5, the conveying device 40 includes an operating handle 410, an adjusting member 420, a pushing member 430 and a conveying member 440. The adjustment member 420 has a distal end and a proximal end, the proximal end of the adjustment member 420 being coupled to the operating handle 410. The pusher member 430 has a distal end and a proximal end, and the proximal end of the pusher member 430 is coupled to the operating handle 410. The delivery member 440 has a distal end and a proximal end, the proximal end of the delivery member 440 being coupled to the operating handle 410. Loading, pushing, releasing and shaping of the occluding device 20 is achieved by controlling the displacement of the regulating member 420, pushing member 430 and delivering member 440 by operation on the operating handle 410. 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.

The operation handle 410 includes a housing 411 and an upper cover 412. The housing 411 and the upper cover 412 are detachably connected, and when the housing 411 and the upper cover 412 are connected, the housing 411 and the upper cover 412 enclose a receiving chamber.

The edge of the housing 411 is provided with a first groove 4111, the edge of the upper cover 412 is provided with a second groove 4121, and the first groove 4111 and the second groove 4121 form a track 413, as shown in fig. 1. In one embodiment, the number of first grooves 4111 and second grooves 4121 is two, forming two opposing parallel tracks 413.

Referring to fig. 6, the adjusting member 420 is an elongated rod member. For example, the adjustment member 420 is an elongated, rigid rod or wire.

In one embodiment, the material of the adjustment 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 nitinol.

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

In an 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 portion 421, such that the bending portion 422 bends relative to the straight portion 421. The second bending portion 4222 is bent with respect to the first bending portion 4221.

In an embodiment, in a natural state, the angle between the first bending portion 4221 and the straight portion 421 is a right angle, and the angle between the second bending portion 4222 and the first bending portion 4221 is a right angle, such that the straight portion 421 is parallel to the second bending portion 4222.

In other embodiments, in a natural state, the angle between the first bending portion 4221 and the straight portion 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, so long as the bending portion 422 is guaranteed to bend relative to the straight portion 421 as a whole, and the second bending portion 4222 bends relative to the first bending portion 4221, so that when the second bending portion 4222 is received in the receiving portion 222, the first bending portion 4221 and the spacing portion 223 of the first sealing head 220 can be hooked when being stressed.

When the adjustment member 420 is constrained, for example, within a lumen structure, the bending section 422 is substantially straightened, or the free end of the bending section 422 is received within the lumen structure axially away from the straight section 421. When the binding is removed, the bent segment 422 returns to its natural state, i.e., a curved configuration relative to the straight segment 421.

The elongated shape memory metal rod or wire, or one end of the shape memory metal rod or wire is bent twice and shaped to obtain the integrally structured adjusting member 420.

It will be appreciated that in other embodiments, the straight portion 421, the first bending portion 4221 and the second bending portion 4222 may be connected by welding or bonding, for example, to form the adjusting member 420.

In an embodiment, referring to fig. 7, the adjusting member 420 includes a straight portion 421 and a bending portion 422 connected to the straight portion 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 wire, i.e., the bending section 422 of this embodiment does not include the first bending portion 4221 and the second bending portion 4222. The angle alpha between the bending section 422 and the straight section 421 is smaller than 90 deg.. The bending section 422 is at least partially accommodated in the accommodating portion 222, so that the connection portion between the bending section 422 and the extending section 421 can be hooked with the spacer 223 of the first seal head 220. In this embodiment, the metal rod or wire is bent once and shaped to form the adjustment member 420.

In one embodiment, the adjustment member 420 is an equal diameter alloy rod or wire. In one embodiment, the diameter of the adjusting member 420 is 0.3-0.35 mm. The adjusting piece 420 with the thickness of 0.3-0.35 mm is adopted, so that the adjusting piece 420 has enough strength, on one hand, the plugging device 20 is convenient to adjust, and on the other hand, the breakage of the adjusting piece 420 is avoided, and the adjusting piece 420 is connected with other parts reliably.

In one embodiment, the adjustment member 420 is a non-uniform diameter alloy rod or wire that includes a first portion having a larger diameter and a second portion having a smaller diameter.

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

In another embodiment, as shown in fig. 6 and 7, the L1 section is a constant diameter rod or wire, the other region of the straight section 421 except the L1 section and the bending section 422 are another constant diameter rod or wire, and the diameter of the L1 section is larger than that of the other sections, i.e., the L1 section is a first portion with a larger diameter, and the other section is a second portion with a smaller diameter. One end of the straight section 421 of the adjusting member 420, which is far away from the bending section 422, is connected to other components of the conveying load 40, and the diameter of the L1 section is larger, so that the breakage of the adjusting member 420 is avoided, and the connecting between the adjusting member 420 and the other components is reliable. During the delivery process, the area of the adjusting member 420 except the L1 segment extends out of the occluder 20, and at least part of the area is in contact with the first seal head 220, and the diameter of the area is smaller, so that the resilience force of the area is smaller, which is beneficial to avoiding damage to tissues, and meanwhile, avoiding damage to the first seal head 220 due to the excessive resilience force of the bending segment 422.

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 the connection strength and the effect of avoiding the excessive resilience of the second portion.

In an embodiment, when the first portion with the 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 extending segment 421 and the axial length of the straightened bending segment 422) is (90-99): 100, so that the adjusting member 420 has a certain pushing performance, so as to facilitate the adjustment of the occluder 20.

Referring to fig. 8, the pushing member 430 is a hollow tube. The pusher member 430 has a lumen 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 pushing member 430, i.e. the adjusting member 420 movably penetrates the pushing member 430. When the bending section 422 of the adjustment member 420 is positioned within the lumen 432, the bending section 422 is substantially straightened, as shown in fig. 9 a. Or the free end of the bending section 422 is accommodated in the pushing member 430 in a manner away from the straight section 421 in the axial direction. When the bending section 422 of the adjusting member 420 is located outside the inner cavity 432 and is not bound any more, the bending section 422 resumes the natural bending state as shown in fig. 8 and 9 b.

When the occluding device 20 is loaded in the delivery device 40, the pushing member 430 is moved from the second through hole 231 of the second end cap 230 of the occluding device 20 into the path formed by the first opening 212, the inner cavity 211 and the second opening 213 of the occluding frame 210 by controlling the operation handle 410, and the pushing member 430 may be moved from the second through hole 231 until the distal end of the pushing member 430 abuts against the proximal end surface of the first end cap 220, as shown in fig. 10, or the distal end of the pushing member 430 extends into the first end cap 220 and abuts against the first end cap 220. And, the bending section 422 of the adjusting member 420 extends from the pushing member 430 to the outside of the stopper 20 through the first through hole 221 of the first sealing head 220. The second bending portion 4222 of the bending section 422 extends into the accommodating portion 222.

Referring to fig. 10, the pushing member 430 has an outer diameter D3 and an inner diameter D4. The outer diameter of the adjustment member 420 is D5 (not labeled in fig. 10). Please refer to fig. 3 and 10, d2> d3> d1> d4> d5, such that the plugging device 20, the adjusting member 420 and the pushing member 430 cooperate to realize loading, pushing, releasing and forming of the plugging device 20.

When the first through hole 221 and the second through hole 231 are irregularly shaped through holes, the aperture D1 of the first through hole 221 refers to the aperture at the minimum position. The aperture D2 of the second through hole 231 also refers to the aperture at the minimum position.

Returning to fig. 1, the conveying member 440 is a hollow pipe. In one embodiment, the delivery member 440 is a hollow stainless steel spring tube. In one embodiment, the delivery member 440 is a hollow nitinol cable.

In one embodiment, the distal end of the conveying member 440 is provided with a connecting portion 442, and an inner wall of the connecting portion 442 is provided with an internal thread, and the second sealing head 230 is detachably connected to the conveying member 440 by the internal thread being matched with the external thread 232 of the second sealing head 230.

Referring again to fig. 5, the proximal end of the delivery member 440 extends into the operating handle 410 and is fixedly coupled to the operating handle 410. The pushing member 430 is movably inserted through the conveying member 440. The adjusting member 420 is movably inserted through the pushing member 430.

The delivery device 40 also includes a first drive assembly 450 and a second drive assembly 460.

Referring to fig. 11 and 12 together, the first driving assembly 450 includes a guide rail 451 and first and second rotating members 452 and 453 (see fig. 14). The guide rail 451 is accommodated in the accommodation chamber of the operation handle 410, and the guide rail 451 extends in the axial direction. The guide rail 451 is parallel to the rail 413.

As shown in fig. 12, the first rotating member 452 includes a fixing portion 4521, a rotating portion 4522, and a holding portion 4523, the fixing portion 4521 is accommodated in the accommodating chamber of the operating handle 410, and the rotating portion 4522 is rotatable and axially displaceable with respect to the fixing portion 4521. The rotating portion 4522 is provided with a through hole extending axially from one end to the other end. 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 the adjusting member 420 forms a gap with the hole wall of the through hole of the rotating portion 4522, and the adjusting member 420 is not fixedly connected with the rotating portion 4522. Referring to fig. 13, there are two abutting portions 4523, the two abutting portions 4523 are sleeved on the adjusting member 420 and fixedly connected with the adjusting member 420, and the two abutting portions 4523 are located at two sides of the rotating portion 4522. Both of the abutting portions 4523 are not fixedly connected with the rotating portion 4522. When the rotating portion 4522 rotates relative to the fixed portion 4521, the rotating portion 4522 synchronously axially displaces to push the supporting portion 4523, so that the supporting portion 4523 axially displaces in the same direction to drive the adjusting member 420 to axially move, and the adjusting member 420 does not rotate.

In an embodiment, the inner wall of the fixing portion 4521 is provided with an internal thread, and the outer wall of the rotating portion 4522 is provided with an external thread, and the internal thread and the external thread cooperate to enable the rotating portion 4522 to rotate and axially displace relative to the fixing portion 4521.

Referring to fig. 13, in an embodiment, the first rotating member 452 further includes a reinforcing tube 4524, 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 to cover the proximal end surface of the adjusting member 420, and the reinforcing tube 4524 is fixedly connected to the adjusting member 420. The reinforcing pipe 4524 extends into the through hole of the rotating portion 4522 and forms a gap with the wall of the through hole. The two abutting parts 4523 are sleeved on the reinforcing pipe 4524 and fixedly connected with the reinforcing pipe 4524, and the two abutting parts 4523 are positioned at two ends of the rotating part 4522.

Since the radial dimension (e.g., diameter) of the adjusting member 420 is smaller, the reinforcing tube 4524 is provided to facilitate connection between the adjusting member 420 and the abutting portion 4523, and to facilitate improvement of the connection strength between the adjusting member 420 and the abutting portion 4523, so that the adjusting member 420 reliably penetrates through the through hole of the rotating portion 4522.

It will be appreciated that in other embodiments, stiffening tube 4524 may be omitted. When the reinforcing tube 4524 is omitted, other means may be used to reliably connect the adjustment member 420 to the abutment 4523, for example, the adjustment member 420 may be a wire or rod having a non-uniform outer diameter, and the proximal end of the adjustment member 420 may have a larger outer diameter so that the adjustment member 420 may be reliably connected to the abutment 4523.

Referring to fig. 14 and 15, the second rotator 453 includes a base 4531, a screw cap 4532, and an adjustment lever 4533. Base 4531 is connected to housing 411 and upper cover 412, and base 4531 is rotatably connected to operating handle 410. The adjusting lever 4533 is inserted into the base 4531, and the screw cap 4532 is sleeved on the adjusting lever 4533 and the base 4531. The second rotating member 453 can rotate the operation handle 410 relatively.

In one embodiment, the first drive assembly 450 further includes two connectors 454, as shown in fig. 11 and 15. The rotating portion 4522 is provided with a fixing hole, the guide rail 451 is penetrated through the fixing hole, and two ends of the guide rail 451 are respectively connected with the two connecting members 454. Referring to fig. 15, a proximal connector 454 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 axially move with respect to the fixed portion 4521.

In one embodiment, the first drive assembly 450 further includes a counter rail 457, the counter rail 457 being parallel to the rail 451. In this embodiment, the number of the fixing holes in the rotating portion 4522 is two, the guide rail 451 and the balance rail 457 are respectively extended into the two fixing holes, and the guide rail 451 and the balance rail 457 are extended proximally. Two fixing holes are located on both sides of the through hole, i.e., the adjusting member 420 is located between the guide rail 451 and the balance rail 457 when assembled. When the second rotating member 453 is rotated, the guide rail 451 and the balance slide rail 457 are simultaneously rotated.

With continued reference to fig. 11 and 12, the second drive assembly 460 includes a slider button 461, the slider button 461 extending at least partially from the track 413. The slide button 461 is connected to the guide rail 451 and the balance slide rail 457, and the slide button 461 is axially movable along the guide rail 451 and the balance slide rail 457.

In one embodiment, the slide button 461 includes two operating portions that protrude from the two rails 413 to be located outside the operating handle 410, respectively.

In one embodiment, the sliding button 461 is provided with two through holes, and the guide rod 451 and the balance rail 457 respectively pass through the sliding button 461 through the two through holes.

The balance slide rail 457 is arranged to enable the axial movement of the sliding button 461 to be more stable, which is beneficial to improving the stability of operation. It is understood that the balance slide 457 may be omitted so that the internal structure of the operating handle 410 is compact.

The sliding button 461 is further provided with another through hole, and one end of the pushing member 430 extends into the through hole from the operating handle 410 and is fixedly connected with the sliding button 461 (as shown in fig. 12), so that the pushing member 430 is driven to axially move when the sliding button 461 axially moves.

Referring back to fig. 12, in an embodiment, the fixing portion 4521 is fixedly connected to the sliding button 461, so that when the sliding button 461 axially displaces along the guide rail 451, the rotating member 452 is driven to axially displace, so that the pushing member 430 and the adjusting member 420 can simultaneously axially displace, thereby facilitating and improving the operation. In this embodiment, the adjusting member 420 may be independently driven to axially displace by the first driving assembly 450, and the adjusting member 420 and the pushing member 430 may be simultaneously driven to axially displace by the second driving assembly 460.

It will be appreciated that in other embodiments, the fixed portion 4521 is not fixedly connected to the sliding button 461, and the adjustment member 420 is independently driven to axially displace by the first driving assembly 450, and the pushing member 430 is independently driven to axially displace by the second driving assembly 460.

When the implantation operation is to be performed, first, referring to fig. 16a and 16b together, the connecting portion 442 of the conveying member 440 (the adjusting member 420 and the pushing member 430 are penetrated inside) is connected with the second sealing head 230 of the occluder 20, and when the sliding button 461 is not fixedly connected with the fixing portion 4521, the pushing member 430 is moved from the second sealing head 230 into 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 by operating the sliding button 461, and is further translated until the distal end of the pushing member 430 abuts against the first sealing head 220. The pusher 430 is then continued to be moved distally to straighten the occluding device 20 and place the occluding device 20 in tension. 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 out of the stopper 20 from the first sealing head 220, the bending section 422 resumes the shape in the natural state, and the second bending portion 4222 of the bending section 422 further extends into the accommodating portion 222, as shown in fig. 16 c.

When the sliding button 461 is fixedly connected with the fixing portion 4521, the sliding button 461 is moved along the guide rod 451 and the track 413 by operating the sliding button 461, so as to drive 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 plugging frame 210, the second opening 213 and the second through hole 231 together from the second sealing head 230, and further translate until the distal end of the pushing member 430 abuts against the first sealing head 220. The pusher member 430 and the adjustor 420 are then continued to be moved in a distal direction to straighten the occluding device 20 and place the occluding device 20 in tension. When the occluder 20 is in a stretched state, the sliding button 461 is kept stationary, the second rotating member 453 is rotated to drive the adjusting member 420 to move axially and distally, so that the bending section 422 extends out of the pushing member 430 and the occluder 20, the bending section 422 resumes the shape in the natural state, and the second bending portion 4222 of the bending section 422 further extends into the accommodating portion 222, as shown in fig. 16 c. Further, the entire occluding device 20 is moved in a direction approaching the delivery sheath 490 to pull the occluding device 20 in a stretched state into the delivery sheath 490 even if the occluding device 20 is loaded in the delivery sheath 490, as shown in fig. 16 d.

After delivery of the occluding device 20 to the target site through the delivery sheath 490, the delivery device 40 is pushed entirely to push the occluding device 20 entirely out of the delivery sheath 490. At this time, the distal end of the pushing member 430 is still in an abutting state with the first sealing head 220, and the position of the sliding button 461 is unchanged, so that the occluder 20 is still in a stretched state, the adjusting member 420 is still inserted into the inner cavity 432 of the pushing member 430, and the second bending portion 4222 of the bending section 422 is kept in a state of being accommodated in the accommodating portion 222, as shown in fig. 17 a.

Further, it is desirable to change the occluding device 20 to the expanded state. When the sliding button 461 is not fixedly connected with the fixing portion 4521, the sliding button 461 is moved axially proximally to drive the pushing member 430 and the adjusting member 420 to move axially proximally at the same time, so that the bending section 422 of the adjusting member 420 abuts against the first sealing head 220, and the pushing member 430 and the adjusting member 420 are continuously moved proximally in the abutting state to compress the stopper 20, adjust the axial distance of the stopper 20, shape the stopper 20, make the outer wall of the stopper 20 abut against the tissue wall, and keep the shape of the stopper 20 after being molded, as shown in fig. 17 b.

The second rotating member 453 is rotated to drive the guide rail 451 and the balance rail 453 to rotate, so that the rotating portion 4522 is driven to rotate relative to the fixed portion 4521 and axially displace synchronously, and the adjusting member 420 is driven to move distally, so that the second bending portion 4222 leaves the accommodating portion 222, as shown in fig. 17 b. Continued rotation of the second rotating member 453 moves the adjustment member 420 proximally to draw the second bend 4222 into the interior cavity 430 of the pusher member 430. Continued proximal movement of the slide button 461 withdraws the pusher 430 and the adjustor 420 together from the occluding device 20.

When the sliding button 461 is fixedly connected with the fixing portion 4521, the sliding button 461 is also moved axially proximally to simultaneously drive the adjusting member 420 and the pushing member 430 to axially displace proximally, and when the adjusting member 420 is axially displaced proximally until the bending section 422 of the adjusting member 420 abuts against the first sealing head 220, the adjusting member 420 and the pushing member 430 are continuously axially displaced proximally to further compress the stopper 20 to form the stopper 20. Further, the second rotating member 453 is rotated to retract the regulating member 420 into the inner cavity of the pushing member 430, and then the regulating member 420 and the pushing member 430 are simultaneously withdrawn from the occluding device 20 by operating the sliding button 461.

The above describes the method of using the delivery system 100 with and without the slide button 461 fixedly attached to the fixed portion 4521, respectively. It should be noted that the method of using the delivery system 100 is not limited to the above method, and may be performed in different operation sequences according to the structure of the delivery device 40 itself and the cooperation relationship with the occluder 20, so long as loading, delivering and releasing the occluder 20 can be achieved.

The first through hole 221, the inner cavity 211 and the second through hole 231 of the plugging device 20 are communicated to form a path, and the accommodating portion 222 of the first sealing head 220 is located at one side of the first through hole 221, in the implantation process, the adjusting member 420 of the conveying device 40 can enter the path, the bending section 422 of the adjusting member 420 is at least partially accommodated in the accommodating portion 222, and can be hooked with the first sealing head 220, so that the adjusting member 420 is prevented from falling off before the plugging device 20 needs to be adjusted to be molded. And, the occluding device 20 can be molded by withdrawing the bent segment 422 of the adjustment member 420 from the receiving portion 222 and continuing to move proximally to abut the occluding device 20. The proximal movement of the adjustment member 420 is then continued to withdraw the adjustment member 420 from the occluding device 20. Through the cooperation of the first through hole 221, the inner cavity 211, the second through hole 231 and the accommodating portion 222, the adjustment member 420 and the stopper 20 can be hooked and the adjustment member 420 can be withdrawn from the stopper 20, so that the axial length of the stopper 20 can be conveniently adjusted by the adjustment member 420 of the conveying device 40 to form the stopper 20 under the condition that the locking member is omitted. Thus, the occluding device 20 may omit the locking member.

Moreover, the locking member is omitted, the plugging frame 210 is not constrained by the locking member, and the axial length of the plugging frame can be accurately adjusted by means of the conveying device 40, so that the plugging frame can be suitable for different implantation positions and can be released at any lumen position to realize the plugging device.

The second bending portion 4222 is accommodated in the accommodating portion 222, and the first bending portion 4221 abuts against the first seal head 220, so that when the position of the adjusting member 420 is fixed, the stopper 20 can be prevented from being released in advance, and the reliability of operation can be improved.

In the delivery 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 rubbing against the inner wall of the delivery sheath 490.

The plugging system 100 described above implements loading, pushing, releasing and shaping of the occluder 20 by providing an adjustment member 420 and a pushing member 430 in the delivery device 40 which cooperate with the occluder 20. No additional components are required to be arranged in the plugging device 20 to realize loading, pushing, releasing and forming of the plugging device 20, so that the plugging device 20 has a simple structure, a simple preparation process, high preparation efficiency and low preparation cost.

Furthermore, no additional components are required in the occluding device 20, which is advantageous in reducing the radial dimension of the occluding device 20 after stretching so that delivery may be performed using a delivery sheath 490 having a smaller outer diameter. At the same time, the stretched occluder 20 is made more compliant, facilitating passage through a curved vascular path.

For smaller gauges of occluder 20, the first closure head 220 is smaller in size and, correspondingly, the first through hole 221 is smaller in aperture. The outer diameters of the adjusting member 420 and the pushing member 430 are smaller. This makes loading of the occluding device 20 difficult.

In addition, in the actual use process, after the stopper 20 is loaded into the delivery sheath 490 in the above-described manner, the stopper 20 may be removed from the delivery sheath 490 and reinstalled. For example, prior to shipment, the occluding device 20 needs to be removed from the delivery sheath 490 and reloaded due to testing requirements. After shipment, for example, in surgery, the occluder 20 must be removed due to a release failure and reloaded into the delivery sheath 490 before implantation.

During loading or reloading, it is not necessarily ensured that the pushing member 430 is exactly aligned (axially centered) with the first through hole 221 in the first head 220, which makes loading difficult. When the axial center axis of the pushing member 430 deviates from the axial center axis of the first through hole 221 to a high extent, the adjusting member 420 is easily scratched with the first sealing head 220 in the process of moving in the distal direction to extend out of the first sealing head 220, which may damage the first sealing head 220 made of a polymer material or damage the adjusting member 420 itself to a certain extent. Even though the pushing member 430 is exactly opposite to the first through hole 221, since the distal end of the adjusting member 420 is the bending section 422, the bending section 422 is in a straightened state even if being restrained, but naturally has a tendency to recover a bent state, so that the difficulty of passing through a straight small hole (the first through hole 221) is increased, making loading or reloading difficult.

In one embodiment, referring to fig. 18, the first through hole 221 is a trapezoidal hole, where 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 pushing member 430 has a trapezoidal shape so that the distal end shape of the pushing 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 pushing member 430 is extended into the first through hole 221, and the distal end of the pushing member 430 is abutted against the wall of the first through hole 221. In this way, it is advantageous to slow or avoid the deviation of the pushing member 430 and the first through hole 221 during the loading process and the operation process, so that the adjusting member 420 smoothly protrudes from the first through hole 221 outside the first closure head 220.

In one embodiment, referring to fig. 19, the first through hole 221 is a stepped hole, where the larger end of the stepped hole is located at the proximal end and the smaller end is located at the distal end. The hole wall of the stepped hole has steps. The distal end of the pushing member 430 is stepped so that the distal end shape of the pushing member 430 matches the shape of the first through hole 221. There is also a step at the distal end of the pusher 430. During the loading process, the pushing process, and the releasing process, the distal end of the pushing member 430 is extended into the first through hole 221, and the step of the pushing member 430 is abutted against the step of the first through hole 221. In this way, the pushing member 430 and the first through hole 221 are advantageously kept opposite to each other during the loading process and the operation process, so that the adjusting member 420 can smoothly extend out of the first sealing head 220 from the first through hole 221. And, even in the course of operation, when there is an improper force, since the step of the distal end of the pushing member 430 is in contact with the step of the first through hole 221, the pushing member 430 is prevented from protruding from the first through hole 221 to damage the first closure 220.

In one embodiment, referring to fig. 20, the first through hole 221 is a stepped hole, and the larger end of the stepped hole is located at the proximal end and the smaller end is located at the distal end. The hole wall of the stepped hole has steps. The pushing member 430 is a hollow cylindrical tube. The delivery device 40 also includes a transition piece 402. Referring to fig. 21, the transition piece 402 has a hollow structure with a "convex" cross-section, and a step 4021 is formed at a distal end of an outer wall of the transition piece 402, and the step 4021 surrounds a distal peripheral surface of the transition piece 402. An aperture 4022 is defined in the middle of the transition piece 402 extending axially from the distal end to the proximal end of the transition piece 402. The aperture 4022 is generally "convex" in cross-section, with the small end of the aperture 4012 being distally located and the large end being proximally located. The shape and size of the large end of the aperture 4022 matches the shape and size of the distal end of the pusher member 430 so that the transition member 402 can be positioned over the distal end of the pusher member 430 and fixedly coupled to the pusher member 430. During loading, pushing and releasing, 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 the step of the first through hole 221. In this way, not only is the operation facilitated, but damage to the first head 220 and/or the adjustment member 420 is avoided. Meanwhile, the outer diameter of the pushing member 430 is very small, usually less than 1 mm, and it is very difficult to process steps on the outer wall of the pushing member 430, and the requirements on the process are high and the precision is difficult to guarantee. The transition piece 402 is additionally provided to avoid machining the distal end of the pusher 430 to form a step. Thus, the additional provision of the transition piece 402 can reduce the processing difficulty, facilitate the improvement of the preparation efficiency, ensure the precision, and improve the production yield.

It is 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 portion of the first through hole 221, that is, the radial width of the portion of the first through hole 221 away from the second cap 230 is D1.

Referring to fig. 5 again, the delivery device 40 further includes a limiting assembly 470, wherein the limiting assembly 470 is used for limiting the pushing member 430, so as to avoid the bad release of the occluder 20 caused by the misoperation.

Referring to fig. 22 and 23, the limiting assembly 470 includes a clamping member 471 and a locking member 472 coupled to the clamping member 471. The locking member 472 is used for adjusting the clamping force of the clamping member 471 to achieve a limit or no limit. The holder 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, into which the pushing member 430 protrudes. The locking piece 472 is sleeved on the first clamping portion 4711 and the second clamping portion 4712 at the same time, and the locking piece 472 is rotated to adjust the approaching degree of the first clamping portion 4711 and the second clamping portion 4712, so that the size of the accommodating area is controllable. When the radial dimension of the receiving area is greater than the radial dimension of the pushing member 430, the pushing member 430 can be displaced along 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, i.e., is limited.

The casing 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, wherein the first operating window is opposite to the second operating window. The locking member 472 is provided in the housing 411, and the locking member 472 protrudes from the first and second operation windows to facilitate operation.

The delivery device 40 of the occlusion system 100 can deliver the occluder 20 to the lesion site, and after pushing the occluder 20 out of the delivery sheath 490, the displacement of the adjusting member 420 is controlled to restore the occluder 20 to the expanded state, so as to realize the molding of the occluder 20. The operation is convenient and reliable. In addition, the stopper 20 has a simple structure, and no additional molding auxiliary structure is required.

In one embodiment, the occluding device 20 is a heart occluding device such as a atrial septal defect occluding device, a ventricular septal defect occluding device, a left atrial appendage occluding device, or the like.

In one embodiment, the occluder 20 is a vascular occluder, which may be used to block blood flow for treatment of vascular malformations, or to block blood flow for treatment of tumors, etc.

Referring to fig. 24, in one embodiment, the occluding device 20 further includes a securing member 218. The fixing member 218 is sleeved on the waist portion 217 of the plugging frame 210. A channel 219 is formed in the middle of the anchor 218 that extends axially from the distal end of the anchor 218 to the proximal end of the anchor 218. The passage 219 should be large enough to maintain the lumen 211 of the occlusion frame 210 axially clear after the fasteners 218 are placed over the waist 217, i.e., the lumen 211 of the occlusion frame 210 (not shown in fig. 24), the first opening 212 and the second opening 213 communicate to form a path.

The number of fasteners 218 corresponds to the number of waists 217. In the embodiment shown in fig. 24, the number of waists 217 is two, and correspondingly, the number of fasteners 218 is two.

In another embodiment, the number of the middle blocking units 215 is plural, the number of the waist portions 217 is greater than two, and the plural middle blocking units 215 and the plural waist portions 217 are alternately arranged in the axial direction. Wherein the middle blocking unit 215 at the most distal end is connected to the first blocking unit 214 through the waist portion 217, and the middle blocking unit 215 at the most proximal end is connected to the second blocking unit 216 through the waist portion 217. The waist portions 217 are respectively sleeved with a plurality of fixing pieces 218. The channel 219 should be large enough so that after the fixing member 218 is sleeved on the waist portion 217, a space remains in the middle of the channel 219, and the inner cavity 211 of the plugging frame 210 can still axially extend from the first plugging unit 214 to the second plugging unit 216.

The axial lengths of the plurality of middle occlusion units 215 may or may not be equal. Among the plurality of 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 middle blocking units 215 may be greater than the axial lengths of the first blocking unit 214 and the second blocking unit 216, and the axial lengths of some middle blocking units 215 may be equal to the axial lengths of the first blocking unit 214 and the second blocking unit 216.

The first opening 212, the second opening 213, the channel 219, the first through hole 221 and the second through hole 231 are coaxial, so that when the pushing member 430 axially displaces during loading, the pushing member 430 enters the inner cavity 211 from the second through hole 231 through the second opening 213 until the distal end of the pushing member 430 abuts against the first sealing head 220, thereby assisting in loading and subsequent forming. By sleeving the fixing member 218 on the waist portion 217, the fixing member 218 further fixes the path, that is, the path along which the pushing member 430 moves inside the plugging frame 210, so that the plugging frame 210 is prevented from being damaged due to the pushing member 430 being poked to the plugging frame 210 in a direction deviating from a preset direction. Meanwhile, the pushing member 430 is well aligned with the first through hole 221, so that the adjusting member 420 can smoothly extend into the first through hole 221 of the first sealing head 220 from the inner cavity 432 of the pushing member 430.

Therefore, the stopper 20 can omit the locking member, and the stopper 20 can be conveniently loaded after omitting the locking member. The occluder 20, omitting the locking element, is more flexible, facilitating passage through a curved vascular path, or for accommodating curved vascular lesions.

In one embodiment, the anchor 218 is a sleeve formed of a polymeric material, and a central portion of the sleeve is formed with a channel extending axially from a distal end to a proximal end of the sleeve. The sleeve is fitted over the waist portion 217, and the inner wall of the sleeve is in contact with the outer peripheral surface of the waist portion 217. The passageway should be large enough so that after the sleeve is over the waist 217, the passageway still leaves sufficient space for the pushing member 430 to pass through. But the channel should not be too large or otherwise have a small limiting effect on the pusher 430. The polymeric material forming the sleeve is a bioabsorbable polymeric material such that the occluding device 20 as a whole is bioabsorbable.

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 compliance of the occluding device 20, but at the same time avoid the axial length of the sleeve being too small to cause difficult processing.

In one embodiment, referring to fig. 25, the fixing member 218 is a ring-shaped structure formed by winding polymer wires around the outer periphery of the waist portion 217. The polymer thread is a flexible thread such as a polymer fiber thread, a polymer medical suture, and the like. In one embodiment, the polymer threads are absorbable polymer threads so that the entire occluding device 20 is absorbable by a living body. The polymer fiber lines, the polymer medical suture lines and other polymer lines are soft, and the ring-shaped structure formed by winding the polymer lines around the periphery of the waist 217 is also soft, so that the setting of the fixing pieces 218 can not significantly increase the overall rigidity of the occluder 20, and even if the number of the fixing pieces 218 is greater than 2, the occluder 20 can still keep enough flexibility. In addition, the fixing piece 218 which is sleeved on the waist part 217 is made of a polymer wire shape, so that the preparation or processing is simple and the operation is easy.

The polymer wire is wound around the waist portion 217 one or more turns (fig. 25) to form a fastener 218. It can be appreciated that the tightness of the polymer wire winding should be suitable, so that the polymer wire can be reliably fixed to the waist 217, and the channel formed by the polymer wire after the polymer wire is wound around the waist 217 should be large enough to facilitate the passage of the pushing member 430.

When the polymer wire is wound around the waist portion 217 once, the wire diameter of the polymer wire is correspondingly large. When the polymer wire is wound around the waist portion 217 for a plurality of turns, a polymer wire having a smaller wire diameter may be used. The polymer wire is wound around the waist 217 for a plurality of turns to form the fixing member 218, which is advantageous for reliable connection of the fixing member 218 and the waist 217.

In one embodiment, whether the fixing member 218 is a sleeve formed of a polymer material or a ring-shaped structure formed by winding a polymer wire around the outer circumference of the waist portion 217, the width of the passage of the fixing member 218 is D6, and the radial width of the waist portion is D7 in a natural state. The outer diameter D3 of the pushing member 430 is smaller than D6 so that the pushing member 430 smoothly passes through the fixing member 218. D7 is greater than D6, facilitating secure attachment of the anchor 218 to the waist 217.

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

The stopper 20 is sleeved with the fixing piece 218 at the waist 217, and the fixing piece 218 is beneficial to fixing the displacement path of the pushing piece 430 on the stopper frame 210, so that the pushing piece 430 is displaced along the fixed path until the distal end of the pushing piece 430 abuts against the first sealing head 220 of the stopper 20, and thus the axial stretching of the stopper 20 is realized, and the loading is facilitated. In addition, during the loading process, due to the limitation of the fixing member 218, the distal end of the pushing member 430 can be prevented from being separated from the contact with the first sealing head 220 due to slipping, improper operation, and the like, so that the pushing member 430 can be kept in a contact state with the first sealing head 220 without being deviated, thereby ensuring that the loading of the occluder 20 can be smoothly performed.

After the occluder 20 is delivered to the lesion through the delivery sheath 490, the pusher 430 can be kept in contact with the first seal head 220 without being displaced due to the restriction of the fixing member 218 before confirming whether the occluder 20 is positioned at the correct position after the occluder 20 is pushed out of the delivery sheath 490, so that the occluder 20 can be reliably kept in an axially stretched state to facilitate the adjustment of the position of the occluder 20 by the operator.

Meanwhile, the fixing piece 218 is beneficial to fixing the relative positions of the pushing piece 430 and the first sealing head 220, and is beneficial to avoiding unnecessary scraping and rubbing between the pushing piece 430 and the first sealing head 220 and/or the sealing frame 210, so that the first sealing head 220 and/or the sealing frame 210 are prevented from being damaged.

Thus, the occluding device 20 can omit the locking member. The occluding device 20 of the occluding system 100 is mated with the delivery device 40 such that the occluding device 20 is more convenient and reliable to load and form.

In an embodiment, when the number of the middle plugging units 215 is one and the number of the waists 217 is two, and the fixing members 218 are of a ring structure formed by winding polymer wires around the peripheries of the waists 217, the tightness of the polymer wires as the two fixing members 218 is unequal, the widths D6 of the channels of the two fixing members 218 are unequal, and the value of D6 of the fixing member 218 at the distal end is larger, so that the axial length of the plugging device 20 is more convenient to adjust while ensuring convenient loading and molding, and the operation is performed smoothly.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. The utility model provides a plugging device, includes absorbable shutoff frame and with first head and the second head that the both ends of shutoff frame link to each other, a serial communication port, the shutoff frame has the inner chamber, first through-hole and acceping portion have been seted up on the first head, acceping portion is located one side of first through-hole, the second through-hole has been seted up on the second head, first through-hole the inner chamber with the second through-hole intercommunication forms a route, the route is used for supplying conveyor's regulating part to pass through, just acceping portion is used for acceping the free end of the bending section of regulating part, first head is used for with conveyor's propelling movement spare butt.

2. The occluder of claim 1, wherein said occlusion frame comprises a first occlusion unit, a middle occlusion unit, a second occlusion unit and a waist, said middle occlusion unit is one in number and said waist is two in number, two ends of said middle occlusion unit are connected to said first occlusion unit and said second occlusion unit through two of said waist, respectively, said first end cap is connected to said first occlusion unit, said second end cap is connected to said second occlusion unit, and said lumen extends axially from said first occlusion unit to said second occlusion unit;

3. The occluder of claim 2, wherein the axial length of the central occlusion unit is greater than the axial length of both the first occlusion unit and the second occlusion unit.

4. The occluder of claim 2, further comprising a securing member disposed over the waist, the securing member having an axial length less than an axial length of the waist.

5. The occluder of claim 4, wherein the fixing member is a sleeve formed of a polymer material or a ring-shaped structure formed by winding a polymer wire around the outer circumference of the waist portion.

6. The occluder of claim 1, wherein the first through hole is a stepped hole, the larger end of the stepped hole is located at the proximal end, the smaller end of the stepped hole is located at the distal end, a step is located on the wall of the stepped hole, the distal end of the pushing member can extend into the first through hole, and the step of the first through hole is used for propping against the step of the pushing member.

7. The device according to claim 1, wherein the receiving portion is a receiving hole or a receiving groove, and the open end of the receiving portion is located at a distal end when the receiving portion is a groove, the material of the sealing frame is at least one selected from the group consisting of a levorotatory polylactic acid, a racemic polylactic acid, a polyglycolic acid, a polylactic acid-glycolic acid copolymer, a polyhydroxyalkanoate, a polydioxanone, a polycaprolactone, a polygluconic acid, a polyhydroxybutyrate, a polyanhydride, a polyphosphonate, a polyglycolic acid, and a polydioxanone, and the material of the sealing frame is a copolymer formed by copolymerizing at least two monomers selected from the group consisting of a levorotatory polylactic acid, a racemic polylactic acid, a polyglycolic acid, a polylactic acid-glycolic acid copolymer, a polyhydroxyalkanoate, a polydioxanone, a polycaprolactone, a polygluconic acid, a polyhydroxybutyrate, a polyanhydride, a polyphosphonate, a polyglycolic acid, and a polydioxanone.

8. A plugging system comprising a conveying device and the plugging device according to any one of claims 1 to 7, wherein the conveying device comprises an adjusting member, the adjusting member has a bending section, in a loading state, the adjusting member penetrates through the path, and at least 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 sealing head.

9. The occlusion system of claim 8, wherein said delivery device further comprises a pusher having an interior cavity, said pusher being movable along said path to a distal end of said pusher abutting said first closure head, and said adjustment member being movably disposed through said pusher.

10. The plugging system of claim 8, wherein the adjustment member comprises a straight section, the bending section comprises a first bending portion and a second bending portion connected with the first bending portion, one end of the first bending portion away from the second bending portion is connected with the straight section, the second bending portion is received in the receiving portion and is abutted with the first sealing head in a loading state, and the adjustment member comprises a first portion with a larger diameter and a second portion with a smaller diameter, wherein the first portion is the straight section, and the second portion is the bending section.