CN113116409B

CN113116409B - Plugging device and plugging device conveying system

Info

Publication number: CN113116409B
Application number: CN201911410628.8A
Authority: CN
Inventors: 李安宁; 单烁
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2022-12-20
Anticipated expiration: 2039-12-31
Also published as: CN113116409A

Abstract

The invention discloses a plugging device which comprises a sealing unit and a fixing unit, wherein the sealing unit is detachably connected with the fixing unit and comprises a sealing part, a limiting part and a first connecting piece, and the first connecting piece is connected with the far end of the sealing part and the near end of the limiting part; the near end of the fixed unit is provided with a sleeve, the sleeve comprises a via hole, at least part of the first connecting piece is located in the via hole, the near end of the limiting part is close to the far end of the sleeve, the maximum outer contour of the limiting part is larger than the inner diameter of the via hole in a natural state, the limiting part is compressible, and the outer diameter of the limiting part after compression is smaller than the inner diameter of the via hole. The sealing unit and the fixing unit of the plugging device are detachably connected, if the size is not proper, the sealing unit can be conveniently and quickly withdrawn to replace the sealing unit with proper size.

Description

Plugging device and plugging device conveying system

Technical Field

The invention relates to the field of medical instruments, in particular to a plugging device and a plugging device conveying system.

Background

Aiming at the risk of stroke of patients with atrial fibrillation, three methods are mainly used for prevention and treatment clinically, namely anticoagulant drug treatment, surgical operation treatment and percutaneous left atrial appendage occlusion treatment. The percutaneous left atrial appendage occlusion operation has the advantages of convenient operation, small side effect, good postoperative effect and the like. Percutaneous left atrial appendage occlusion refers to that a left atrial appendage occluder is conveyed into a left atrial appendage and released by a percutaneous puncture mode and a conveying sheath with a smaller diameter. The left auricle occluder can occlude the opening position of the left auricle, the blood in the atrium can not communicate with the left auricle, and the thrombus in the left auricle can not enter the blood circulation system, thereby achieving the purpose of preventing the thromboembolism induced by atrial fibrillation.

From the design structure, the left atrial appendage occluder mainly adopts a plug structure and a double-disc structure. The plug structure is a plug-shaped stopper, and is placed in the inner cavity of the left auricle to block the mouth of the left auricle, so that the purpose of blocking the left auricle is achieved; the left auricle plugging device structure that the two dishes of structure of two dishes of sealed dish and fixed disk promptly, wherein the fixed disk structure is placed in left auricle intracavity, has the barb mostly, plays the effect of anchor apparatus, and sealed dish structure is then placed in left atrium oral area shutoff left auricle opening position, carries out the shutoff with the fixed disk cooperation to left auricle oral area. In order to avoid the falling of the postoperative instrument, the plug structure plugging device or the double-disc structure plugging device needs to be well matched with the inner cavity of the left auricle and tightly anchored. Therefore, in surgery, strict selection of instrument specifications is required. Too large a device may cause device intervention to other organs, interfering with the normal operation of the heart tissue (e.g., mitral valve) surrounding the left atrial appendage, and too small a device may not completely seal the mouth of the left atrial appendage. Although the shape and size of the left atrial appendage of a patient can be measured by an imaging device during an operation, the size of the left atrial appendage cannot be completely judged by images due to irregular shape of the left atrial appendage, so that the situation that the size of the instrument is not suitable to be selected during the operation still can occur, and instruments with all specifications are prepared for replacement during the operation. Under the condition, the operation is continued by completely recovering and taking out the placed instruments and replacing the instruments with proper specifications. In addition, because the fixed disk of left atrial appendage occluder is the barb design of firm anchoring, frequent placing recovery apparatus can cause the damage to the inner wall of left atrial appendage. And the operation steps for placing instruments in the left auricle are complicated, and the difficulty of the operation is increased by replacing the instruments. In addition, the instrument is discarded due to the wrong specification selection, so that the operation cost is increased, and waste is caused to a certain extent.

Based on this, there is a need to design a detachable left atrial appendage occluder that is easy to replace.

Disclosure of Invention

The invention provides a plugging device which comprises a sealing unit and a fixing unit, wherein the sealing unit is detachably connected with the fixing unit and comprises a sealing part, a limiting part and a first connecting piece, and the first connecting piece is connected with the far end of the sealing part and the near end of the limiting part; the near end of the fixed unit is provided with a sleeve, the sleeve comprises a via hole, at least part of the first connecting piece is located in the via hole, the near end of the limiting part is close to the far end of the sleeve, the maximum outer contour of the limiting part is larger than the inner diameter of the via hole in a natural state, the limiting part is compressible, and the outer diameter of the limiting part after compression is smaller than the inner diameter of the via hole.

In one embodiment, the sleeve is provided with a mating location, which is connectable to a delivery device.

In one embodiment, the distal end of the fixing unit is provided with a receiving member having a through hole.

In one embodiment, the position-limiting portion includes an umbrella-shaped structure or a disc-shaped structure.

In one embodiment, the fixing unit comprises a proximal disc surface, the sleeve is arranged in the middle of the proximal disc surface, and the deformation capacity of the limiting part is greater than that of the proximal disc surface of the fixing unit.

The invention also provides a conveying system of the plugging device, which comprises a conveying device and any plugging device, wherein the conveying device comprises an outer sheath tube, a first connecting catheter and a second connecting catheter which are coaxially arranged, the first connecting catheter is sleeved on the periphery of the second connecting catheter, the outer sheath catheter is sleeved on the periphery of the first connecting catheter, and the outer sheath tube, the first connecting catheter and the second connecting catheter can move in pairs; the first connecting conduit is used for being connected with the sleeve, the second connecting conduit is used for being connected with the proximal end of the sealing unit, and the outer sheath tube is used for constricting the blocking device.

In an embodiment, the delivery device further comprises an inner sheath coaxial with the second connector and located between the first and second connection catheters, the inner sheath being configured to constrict the sealing unit.

In one embodiment, the first connecting conduit and the second connecting conduit and the occlusion device are each connected by a screw thread.

In an embodiment, the sealing unit comprises a seal provided with a gap for the passage of a guide wire.

In one embodiment, the sealing unit and the fixing unit are provided with through holes for guide wires to pass through.

In the plugging device and the conveying system thereof provided by the invention, the sealing unit and the fixing unit of the plugging device are detachably connected, and after the sealing unit and the fixing unit are released, at least part of the limiting part of the sealing unit is closer to the far end of the fixing unit than the near end of the fixing unit. And the conveying device is provided with connecting catheters which are respectively connected with the sealing unit and the fixing unit, when the plugging device is implanted, the fixing unit can be released first, and after the sealing unit is unfolded, if the size is not proper, the sealing unit can be conveniently and quickly withdrawn to replace the sealing unit with proper size. The whole plugging device does not need to be taken out, and the replacement process is simplified.

Drawings

Fig. 1 is a schematic structural view of a left atrial appendage occluder in accordance with an embodiment of the present invention, which includes a sealing unit and a fixing unit;

FIG. 2 is a schematic view of the sealing unit shown in FIG. 1;

FIG. 3 is a schematic structural diagram of a sealing unit according to another embodiment of the present invention;

fig. 4 to 6a are schematic views illustrating an internal structure of a sealing unit according to an embodiment of the present invention;

FIGS. 6b to 6d are schematic views illustrating the structure of the inner sealing member of the sealing unit according to other embodiments of the present invention;

FIG. 7 is a schematic structural diagram of a conveying apparatus according to an embodiment of the present invention;

FIG. 8 is a schematic view of a portion of the conveyor apparatus of FIG. 7;

FIG. 9 is a schematic view of a portion of a conveying apparatus according to another embodiment of the present invention;

figure 10 is a schematic diagram illustrating a portion of a left atrial appendage occluder delivery system in accordance with an embodiment of the present invention;

figures 11 and 12 are enlarged views of a portion of the left atrial appendage occluder delivery system of figure 10;

figures 13-16 are schematic views illustrating the use of a left atrial appendage occluder delivery system in accordance with one embodiment of the present invention.

Detailed Description

In order to better understand the technical scheme and the beneficial effects of the invention, the invention is described in detail by combining specific embodiments. The following specific examples are only some of the preferred embodiments, not all of the embodiments of the present invention, and are not intended to limit the present invention.

In the field of interventional medical devices, it is common to define the end closer to the operator as the "proximal end" and the end further from the operator as the "distal end". And thus defines the proximal and distal ends of any component or member. For elongate members or members that can be compressed into an elongate shape, "axial" generally refers to the length of the implant and delivery device, and "radial" generally refers to a direction perpendicular to the "axial" direction, and defines "axial" and "radial" directions for any component of the implant and delivery device in accordance with this principle.

The solution according to the invention can be used for a variety of occlusion devices, such as left atrial appendage occluders, patent ductus arteriosus intracardiac or vascular occlusion devices. The following description will be made only by taking the left atrial appendage occluder as an example.

As shown in fig. 1, an embodiment of the present invention provides a left atrial appendage occluder 100 which comprises a sealing unit 20 and a fixation unit 10. The sealing unit 20 and the fixing unit 10 are detachably connected, that is, the sealing unit 20 and the fixing unit 10 are detachable to be independent. Specifically, the fixing unit 20 includes a fixing portion 11, a sleeve 12, a receptacle 13, and an anchor 14. The fixing part 11 of the present embodiment is a cylindrical braid formed by braiding braided filaments, and concave structures are formed on both the proximal end surface and the distal end surface of the fixing part 11, and the sleeve 12 and the receiving part 13 are disposed in the concave structures. Wherein the sleeve 12 is arranged in a concave configuration on the proximal face of the fixation part 11, concave towards the distal end; the receiving member 13 is provided in a concave configuration on the distal face of the anchoring portion 11, which is concave towards the proximal end. That is, the proximal end of the braid converges to the sleeve 12 and is connected to the sleeve 12, and the distal end of the braid converges to the receptacle 13 and is connected to the receptacle 13. The anchor 14 facilitates anchoring of the fixation unit 10 to the tissue, avoiding displacement of the fixation unit. The anchoring member 14 may be an anchor barb which protrudes from the outer surface of the anchoring portion 11.

The cannula 12 includes a through-hole extending axially of the left atrial appendage occluder 100. The sleeve 12 may also be provided with a mating location to enable the attachment of the fixation unit to the delivery device, for example the sleeve may be provided with an internal or external thread to enable a threaded connection to the delivery device. The sleeve can also be provided with a clamping groove so as to be clamped with the conveying device.

The sealing unit 20 is connected to the fixing unit 10 through the bushing 12. Referring to fig. 2, the sealing unit 20 includes a sealing part 21, a stopper part 22, a first connector 24, and a second connector 23. In this embodiment, the sealing portion 21 and the limiting portion 22 are both double-disc structures formed by weaving braided filaments, and both of the two structures are disc-shaped with thick middle and thin edge (the closer the disc-shaped structure is to the edge, the closer the axial distance between the two disc surfaces of the double disc is). The first connector 24 connects the distal end of the sealing portion 21 and the proximal end of the stopper portion 22. The outer diameter of the first connector 24 is smaller than the inner diameter of the through hole in the sleeve 12, and the axial length of the first connector 24 is not smaller than the axial length of the through hole in the sleeve 12, so that the first connector 14 can pass through the through hole and the sleeve 12 does not affect the shape of the sealing portion 21 or the limiting portion 22.

It should be understood that the specific structure of the sealing portion and the limiting portion is not limited by the present invention, for example, the disc surface of the sealing portion may be recessed toward the distal end, or a waist portion may be further included between the two disc surfaces of the sealing portion.

The proximal end of the sealing portion 21 is also provided with a second connector 23. The second connecting element 23 can receive the end of the braided wire of the sealing portion 21 on the one hand and can be connected to a delivery device on the other hand. For example, the second connecting part 23 can be provided with an internal or external thread, so that a threaded connection with the delivery device is possible. A clamping groove can also be arranged on the second connecting piece 23, so that the second connecting piece can be clamped with the conveying device.

Referring to fig. 1 and 2, the position-limiting portion 22 is deployed after passing through the through hole of the casing 12, and the proximal end of the position-limiting portion 22 is close to the distal end of the casing 12. In order to ensure the stable connection between the sealing unit 20 and the fixing unit 10, the inner diameter of the limiting portion 22 when compressed should be smaller than the inner diameter of the through hole on the sleeve 12, so that the limiting portion 22 can pass through the through hole; the size of the maximum outer contour of the expanded limiting part is larger than the inner diameter of the through hole on the sleeve 12, so that the limiting part 22 cannot be easily separated from the sleeve 12.

It will be appreciated that the sealing portion and the spacing portion may be of unitary construction. For example, the sleeve can be a structure integrally woven, a pipe is sleeved on the formed structure, the pipe is close to the far end of the formed structure, the sealing part and the limiting part are shaped into a disc-shaped structure through processes such as heat shaping and the like, the sleeve is fixed, the sleeve cannot move axially relative to the sealing part and the limiting part, and the sleeve is a first connecting piece.

It is understood that in other embodiments, the sealing unit 20a may be configured as shown in fig. 3, and the limiting portion 22a is formed by cutting a tube and includes a plurality of radially-extending limiting rods 221a, and the plurality of limiting rods 221a are circumferentially spaced along the distal end surface of the first connecting member 24 a. The stop rod 221a extends distally and then radially and bends proximally. When a force is applied, the plurality of stopper rods 221a can be moved closer to the center, so that the maximum outer size of the stopper portion 20a becomes smaller. It can be understood that the limiting rod may not be bent towards the proximal end, as long as the maximum outer contour size of the limiting portion when expanded is larger than the inner diameter of the through hole on the sleeve at the proximal end of the fixing unit, and the maximum outer diameter of the limiting portion after compression is smaller than the inner diameter of the through hole.

When the limiting part is subjected to a pulling force towards the proximal end (for example, when the sealing unit needs to be replaced), the proximal end of the limiting part is abutted against the distal end of the sleeve, the sleeve is also subjected to the pulling force towards the proximal end, and the proximal end surfaces of the limiting part and the fixing unit are deformed. In order to ensure that the limiting part is firstly deformed and accommodated in the sleeve in the process, so that the tension on the fixing unit is reduced, and the deformation trend of the fixing unit is weakened, the deformation capacity of the limiting part is preferably greater than that of the proximal end face of the fixing unit. It can be understood that under the same axial force or radial force, the axial variation or radial variation of the limiting part is larger than that of the proximal end face of the fixing unit. For example, the diameter of the knitting yarn of the stopper portion may be smaller than the diameter of the knitting yarn of the proximal end surface of the fixing means.

In addition, for conveniently changing sealed unit, it is intraductal to retract into the cover more easily when making spacing portion receive the pulling force towards the near-end, and the distal end opening of via hole can set to loudspeaker form on the sleeve pipe, also is close to the distal end more, and the aperture of via hole is big more.

It will be appreciated that the receiving member, the first connecting member and the second connecting member arranged at the distal end of the fixation unit may each be of a cannula construction, i.e. all hollow tubular construction.

It will be appreciated that in other embodiments, at least one of the securing unit or the sealing unit may be formed by tube cutting.

It will be appreciated that when both the sealing unit and the fixation unit are knitted from braided filaments, the ends of the braided filaments converge either proximally or distally.

In order to allow the guide wire to pass through the left atrial appendage occluder in the axial direction, the left atrial appendage occluder of this embodiment also has an axial channel. The fixing unit 10 and the sealing unit 20 of the present embodiment are coaxially disposed, and the fixing unit 10 and the sealing unit 20 are both provided with through holes through which guide wires can pass. Specifically, the first connector 24 and the second connector 23 on the sealing unit 20, and the sleeve 12 and the accommodating member 13 of the fixing unit are coaxial and provided with through holes or through holes. In addition, the sealing unit 20 further includes a sealing member 25, and a gap for passing the guide wire is formed in the central portion of the sealing member 25. Thus, the channels on the fixation unit 10 and the sealing unit 20 and the gap on the seal 25 and the space between the three together constitute an axial channel for the guide wire to pass through.

Specifically, the seal 25 is provided between two disc surfaces 26 of the double disc structure of the seal portion 21. As shown in fig. 4 to 6a, the sealing member 25 comprises at least two membrane bodies 251. The film body 251 includes at least one fixed edge 252 and at least one free edge 253. The film body 251 is connected to the sealing portion 21 via the fixing edge 252. The free edge 253 is free with respect to the seal 21, i.e., at least partially free from relative binding therebetween. The cross section perpendicular to the axial direction of the left atrial appendage occluder is taken as a projection plane, the projection area of any film body 251 on the projection plane is smaller than the projection area of the disc surface 26 of the sealing part 21 on the projection plane, but the projection area of the sealing part 25 on the projection plane is approximately equal to the projection area of the disc surface 26 of the sealing part 21 on the projection plane, namely, the sealing part 25 can ensure the occlusion effect of the sealing part 21. The sealing member 25 of this embodiment comprises 3 membrane bodies 251, and each membrane body 251 comprises a fixed edge 252 and a free edge 253. Wherein, the fixed edge 252 is a circular arc and is substantially equal to half of the circumference of the disk surface 26; the free edge 253 is linear and has a length substantially equal to the diameter of the disk face 26. Thus, the free edge 253 of each of the film bodies 251 passes through the center of the disk face 26, and there is an overlapping portion between any two of the film bodies 251. The free edges 253 of any two film bodies 251 have an intersection point 254, a gap for the guide wire to pass through is formed between the free edges 253, particularly, the free edges of the film bodies arch to form a gap for the guide wire to pass through after the sealing unit is compressed, and the guide wire can be accommodated near the free edges after the sealing unit is expanded. In this embodiment, the plurality of intersection points 254 coincide at the center of the disc face 26 and are located substantially on the central axis of the left atrial appendage occluder 100.

It should be understood that the present invention is not limited to the particular shape of the membrane body, and in other embodiments, other shapes may be used for the membrane body. For example, the film body can be a fan-shaped structure, the fan-shaped structure comprises two straight sides and a circular arc side, and the length of the straight side of the fan shape is equal to the radius of the disk surface. The circular arc edge and one of the straight edges are fixed edges, and the other straight edge is a free edge. That is, one straight side of the fan-shaped structure is at least partially not connected with the sealing part, and the other straight side and the circular arc side of the fan-shaped structure are connected with the sealing part. Further, when the film body is of a fan-shaped structure, the fixed edges of two adjacent fan-shaped structures are far away from each other, namely the straight edge of one fan-shaped structure connected with the sealing part is far away from the straight edge of any one adjacent fan-shaped structure connected with the sealing part; or the straight edge of one fan-shaped structure connected with the sealing part is close to the straight edge of the other fan-shaped structure connected with the sealing part in two adjacent film bodies. At this time, in order to ensure that the guide wire can pass through the center of the sealing element, the top corner of the fan-shaped structure may not be connected with the sealing part.

It will be appreciated that the free edges between adjacent film bodies may be disposed adjacent one another, or the free edge of one film body may be disposed adjacent the fixed edge of another film body. Preferably, the film body and the film body are at least partially covered, and the mutually covered portions comprise at least one free edge, so that the pressure applied to the sealing portion can be released from the free edge of the covering portion. Therefore, the free edge of the sealing part is partially opened along with the beating of the heart, so that the pressure is released, and meanwhile, the overlapped covering parts exist between the thin film bodies, so that thrombus can not enter the ventricular cavity from the vicinity of the free edge. It will be appreciated that when two adjacent membrane bodies are in close proximity but not covered, the sealing unit adopts a double disk structure, and the two disk surfaces can limit the excessive opening of the free edge to a certain extent, so as to still block the passage of thrombus.

In other embodiments, the seal 21a may be configured as shown in fig. 6b and 6 c. The free edge 252a of at least one of the film bodies 251 includes two indentations 255a near the center of the seal 21a, and a raised edge 256a is formed between the two indentations 255a, the raised edge 256a being capable of straddling the free edge of the other film body such that the free edge of the other film body snaps into the indentations 255a, as shown in fig. 6 c. Therefore, after implantation of the occluder and subsequent operation are completed, when the guide wire is withdrawn, the convex edge 256a can stride over the free edge of the other thin film body by using the guide wire, so that a large opening is prevented from being formed between the free edges of the two thin film bodies due to the change of the blood pressure in the heart, and the function of locking the free edge is achieved. It will be appreciated that in other embodiments, no notches may be provided.

In other embodiments, the seal 21b may be configured as shown in FIG. 6 c. When the film bodies are sewn together, the free edge 252b of one of the film bodies 251b straddles the free edge of the other film body. That is, a portion of the free edge 252b of the membrane body 251b is positioned below an adjacent one of the membrane bodies, and another portion of the free edge 252b straddles the adjacent membrane body and is positioned above the adjacent membrane body, thereby forming an intersection 254b for the guide wire to pass through near the center of the seal 21 b. Therefore, the sealing function between the film bodies can be enhanced, a large opening between the free edges of the two film bodies due to the change of the blood pressure in the heart is avoided, and the function of locking the free edges is achieved.

A channel through which a guide wire can pass is arranged on the left atrial appendage occluder, and the replacement of the sealing unit is mainly facilitated. In addition, after the left atrial appendage occluder is implanted, if subsequent operations, such as ablation, are needed, the ablation device can be conveniently extended into the left atrial appendage along the guide wire. In addition, after the left atrial appendage occluder is completely released, the guide wire can be kept in the body, and if the fixing unit needs to be replaced after observation, the left atrial appendage occluder can be sent into the conveying device through the guide wire again, and the left atrial appendage occluder is retracted and replaced. If no guide wire is available, biopsy forceps are required to enter the body to remove the occluder, which is a relatively damaging way to the tissue.

It will be appreciated that for situations where guide wire assisted implantation is not required, the left atrial appendage occluder may not be provided with a corresponding channel for a guide wire to pass through. At this time, the sealing unit and the fixing unit may not be provided with the respective through holes. The center of the sealing body does not need to have a gap, for example, the free edges of a plurality of film bodies can be arranged in parallel, and a mutually covered part exists between two adjacent film bodies; or the shape and the area of the film body are equal to the projection plane of the disc surface of the sealing part in a direction vertical to the projection plane, but the fixed edge of the film body is smaller than the perimeter of the disc surface, namely the edge of the film body is not completely connected with the sealing part; or the sealing element comprises an annular film body and a circular film body, the diameter of the circular film body is slightly larger than the inner diameter of the annular film body, the edge of the circular film body is connected with the sealing part, the inner annular edge of the annular film body is a free edge, the outer annular edge of the annular film body is a fixed edge, and the annular film body partially covers the circular film body. Therefore, it is sufficient to ensure that the thin film body has a free edge to release stress, and that the projected area of the sealing member is substantially equal to the projected area of the sealing portion to ensure that the sealing member can block thrombus.

It will be appreciated that in other embodiments, the membrane body may be made of a resilient material, such as a woven cloth or silicone, to better accommodate blood pressure changes in the heart, and that no free edge is required on the membrane body. In addition, because the silica gel has certain viscosity, when the guide wire needs to be led in, the free edge of the silica gel allows the guide wire to pass through, and after the guide wire is withdrawn, the free edge of the silica gel is glued with another piece of silica gel, so that a good thrombus blocking effect is provided.

It should be understood that the film body may not be provided with a free edge, i.e. the edge of the film body is completely fixed to the sealing portion, for situations where it is not necessary to take into account that the film body is damaged by stress.

The invention also provides a left atrial appendage occluder delivery system which comprises any of the left atrial appendage occluders and delivery devices 200 described above. As shown in FIG. 7, delivery device 200 generally includes a control assembly 40 and a catheter assembly 30. The control assembly 40 is disposed at the proximal end of the catheter assembly 30 and is used to control the movement of the catheter assembly 30 to effect implantation, release or retrieval of the left atrial appendage occluder. The implementation of the control assembly 40 is numerous and the present invention is not described in detail.

As shown in fig. 8, the catheter assembly 30 includes an outer sheath 31, a first connecting catheter 32, and a second connecting catheter 33, which are coaxially disposed. The first connecting conduit 32 is sleeved on the periphery of the second connecting conduit 33, the sheath tube 31 is sleeved on the periphery of the first connecting conduit 32, and the three can move in pairs. The sheath 31, the first connecting conduit 32 and the second connecting conduit 33 are all hollow tubes, and in this embodiment, the guide wire 34 can also pass through the lumen of the second connecting conduit 33, so as to maintain the guide wire path all the time. The sheath 31 can fully house the fixing unit of the left atrial appendage occluder therein, and as the sheath 31 moves toward the proximal end, the restraint of the fixing unit can be gradually removed, thereby allowing the fixing unit to expand. The first connecting duct 32 is connected to the sleeve at the proximal end of the fixing unit and drives the fixing unit to move axially, while ensuring that the fixing unit is stable in position and does not shake during the releasing process. At the same time, the first connecting conduit 32 also functions to bind the sealing unit, i.e. when the first connecting conduit 32 holds the unit disconnected and moves proximally, the radial binding of the sealing unit can be removed, so that the sealing unit can be radially deployed. The second connecting duct 33 is connected to the proximal end of the sealing unit and carries the latter axially. The first connecting catheter 32 and the second connecting catheter 33 of the present embodiment are connected to the left atrial appendage occluder by means of screw connection, i.e. the distal end portions of the first connecting catheter 32 and the second connecting catheter 33 are provided with internal threads for screw connection with external threads on the sleeve at the proximal end of the fixation unit and external threads on the second connection member.

It will be appreciated that in other embodiments, external threads may be provided on the distal end portions of the first and second connecting conduits, respectively, and corresponding internal threads may be provided on the sleeve and second connecting member, although the invention is not limited to the provision of external threads.

It will also be appreciated that in other embodiments the first connecting conduit and the fixation unit and the second connecting conduit and the sealing unit may be connected in other ways, for example by snapping, as long as it is ensured that the delivery device is detachably connectable to the left atrial appendage occluder.

In other embodiments, as shown in fig. 9, catheter assembly 30 may further include an inner sheath 35. The inner sheath 35 is disposed coaxially with the second connecting conduit 33, and the inner sheath 35 is disposed between the first connecting conduit 32 and the second connecting conduit 33. At this time, the inner sheath tube 35 functions to restrain the sealing unit, which is not unfolded when the first connecting catheter 32 is disconnected from the fixing unit and moved toward the proximal end, so that the sealing unit is not directly contacted with the inner wall of the first connecting catheter 32, and frictional resistance is not generated to the axial movement of the first connecting catheter 32. Moreover, when the size of the sealing unit is not appropriate and needs to be changed, the sealing unit can be received in the inner sheath 35 by moving the inner sheath 35 towards the distal end and moving the second connecting catheter 33 towards the proximal end, and then the first connecting catheter 32 is moved towards the distal end, so that the first connecting catheter 32 is connected with the fixing unit again, and after the position of the fixing unit is ensured to be stable, the sealing unit with the appropriate size is changed.

As shown in fig. 10 to 12, when the left atrial appendage occlusion device is connected to the delivery device and the outer sheath 31 is retracted to expand the fixing portion 11, the position-limiting portion 22 is also in the expanded state, so that the fixing unit 10 is connected to the sealing unit 20, and the position-limiting portion 22 blocks the sealing unit 20 from falling off from the sleeve 12. At this point, the first connector 24 is positioned just within the throughbore of the sleeve 22. The first connecting conduit 32 is still connected to the sleeve of the fixing unit 10, and the sealing portion 21 is restrained by the first connecting conduit 32. The second connecting tube 33 is connected to the second connector 23, and when a pulling force is applied to the second connecting tube 33 toward the proximal end, the sealing portion 21 can be in a constricted state.

Figures 13 to 16 show schematic views of the use of the left atrial appendage occluder delivery system of the present invention. Before the left atrial appendage occluder is implanted into the left atrial appendage 50, according to the path established by the guide wire 34, firstly, the delivery device enters the body along the guide wire, so that the distal end of the outer sheath 31 extends into the opening of the left atrial appendage 50; then, the sheath 31 is withdrawn, so that the fixing unit 10 is unfolded and anchored on the inner wall of the left atrial appendage 50, and at this time, the limiting part of the sealing unit 20 is also unfolded following the fixing unit 10; then, the sheath tube 31 is further retracted to expose the distal end of the first connecting catheter 32, and the first connecting catheter 32 is further rotated to release the connection between the first connecting catheter 32 and the fixing unit 10; the first connecting catheter 32 is then withdrawn proximally while the second connecting catheter 33 is pushed distally, causing the sealing portion of the sealing unit 20 to expand and seal the ostium of the left atrial appendage 50. Then, contrast agent is injected through the conveying device, and the plugging effect is observed. If the occlusion is good, the second connecting catheter 33 is rotated to release the connection between the second connecting catheter 33 and the proximal end of the sealing unit 20, and the delivery device is withdrawn to complete the implantation of the left atrial appendage occlusion device. If the sealing unit has poor plugging effect and sealing units with other sizes need to be replaced, the second connecting conduit 33 is withdrawn towards the proximal end, the first connecting conduit 32 is pushed towards the distal end, the limiting part moves towards the proximal end to penetrate through the sleeve, so that the sealing unit is completely collected in the first connecting conduit 32, and the second connecting conduit 32 is rotated to be connected with the sleeve of the fixing unit again; the sealing unit is then withdrawn along the guide wire 34, replaced with a suitably sized sealing unit, and implantation of the sealing unit is again completed as described above.

It will be appreciated that in other embodiments, the delivery system may be advanced into the body via a delivery sheath, in which case the guidewire is no longer required for routing.

In summary, the left atrial appendage occluder and the left atrial appendage occluder delivery system of the present invention can release the fixation unit first, and when the sealing unit is deployed, if the sealing unit is not appropriate in size, the sealing unit can be withdrawn conveniently and quickly to replace the sealing unit with an appropriate size. The whole left auricle occluder does not need to be taken out, and the replacement process is simplified.

It should be understood that the above-mentioned embodiments are only preferred embodiments, and those skilled in the art can make simple substitutions or changes to the partial structures according to actual needs. The protection scope of the invention is subject to the claims.

Claims

1. A plugging device comprises a sealing unit and a fixing unit, wherein the sealing unit is detachably connected with the fixing unit, and the plugging device is characterized in that the sealing unit comprises a sealing part, a limiting part, a first connecting piece and a sealing piece, the sealing piece comprises at least two film bodies, each film body comprises at least one fixed edge and at least one free edge, the fixed edges are connected with the sealing part, gaps for guide wires to pass through are formed among the free edges, and overlapped parts exist between any two film bodies; the first connecting piece is connected with the far end of the sealing part and the near end of the limiting part; the near end of the fixed unit is provided with a sleeve, the sleeve comprises a via hole, at least part of the first connecting piece is located in the via hole, the near end of the limiting part is close to the far end of the sleeve, the maximum outer contour of the limiting part is larger than the inner diameter of the via hole in a natural state, the limiting part is compressible, and the outer diameter of the limiting part after compression is smaller than the inner diameter of the via hole.

2. The occlusion device of claim 1, wherein the sleeve is provided with an engagement site, the engagement site being connectable to a delivery device.

3. The occlusion device of claim 2, wherein a distal end of the fixation unit is provided with a receptacle having a through-hole.

4. The occlusion device of claim 1, wherein the retention portion comprises an umbrella-like structure or a disc-like structure.

5. The occlusion device of claim 1, wherein the fixation unit comprises a proximal face, the sleeve being disposed in a central portion of the proximal face, the stop portion having a greater deformability than the proximal face of the fixation unit.

6. An occlusion device delivery system comprising a delivery device and the occlusion device of any of claims 1-5, wherein the delivery device comprises a coaxially disposed sheath, a first connecting conduit and a second connecting conduit, the first connecting conduit is sleeved on the periphery of the second connecting conduit, the sheath is sleeved on the periphery of the first connecting conduit, and the sheath, the first connecting conduit and the second connecting conduit are movable in pairs; the first connecting conduit is used for being connected with the sleeve, the second connecting conduit is used for being connected with the proximal end of the sealing unit, and the outer sheath tube is used for constricting the blocking device.

7. The occlusion device delivery system of claim 6, wherein the delivery device further comprises an inner sheath coaxial with the second connection catheter and positioned between the first connection catheter and the second connection catheter, the inner sheath for constricting the sealing unit.

8. The occlusion device delivery system of claim 6, wherein the first connection conduit and the second connection conduit and the occlusion device are each threadably connected.

9. The occlusion device delivery system of claim 6, wherein the sealing unit and the fixation unit are each provided with a through hole through which a guide wire may pass.