CN113116407B

CN113116407B - Plugging device

Info

Publication number: CN113116407B
Application number: CN201911404922.8A
Authority: CN
Inventors: 单烁; 李安宁
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: 2023-05-02
Anticipated expiration: 2039-12-31
Also published as: CN113116407A

Abstract

The invention discloses a plugging device, which comprises a sealing unit, wherein the sealing unit comprises a sealing piece and a sealing part, and the sealing piece at least partially covers the sealing part; the sealing element comprises at least two film bodies, at least one film body comprises at least one fixed edge and at least one free edge, and the film body is connected with the sealing part through the at least one fixed edge; and taking a cross section perpendicular to the axial direction of the plugging device as a projection surface, wherein the projection area of the sealing piece on the projection surface is approximately equal to the projection area of the sealing part on the projection surface, and the length of the fixed edge of any film body is smaller than the perimeter of the sealing part. Therefore, when the heart beats, the free edge of the film body can release a part of stress, so that the traction force on the film body when the blood pressure in the heart changes is reduced, and the plugging effect on thrombus in the left auricle can be ensured.

Description

Plugging device

Technical Field

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

Background

Aiming at the risk of cerebral apoplexy of patients with atrial fibrillation, three methods for preventive treatment, namely anticoagulation medicine treatment, surgical operation treatment and percutaneous left auricle plugging treatment are mainly carried out clinically at present. The percutaneous left auricle plugging operation has the advantages of convenient operation, small side effect, good postoperative effect and the like. Percutaneous left atrial appendage occlusion refers to the delivery and release of a left atrial appendage occlusion device into the left atrial appendage by means of a percutaneous puncture using a delivery sheath of relatively small diameter. The left auricle occluder can occlude the opening position of the left auricle, blood in the atrium can not be communicated with the left auricle, and thrombus in the left auricle can not enter into the blood circulation system, so that the aim of preventing thromboembolism induced by atrial fibrillation is fulfilled.

The left atrial appendage occlusion device is usually provided with a membrane body for preventing thrombus in the left atrial appendage from falling into the ventricle, and the membrane body is often fixed on the left atrial appendage occlusion device by a suturing mode. After the left auricle occluder is implanted, the heart beats, the central part of the flow blocking film can bulge or dent, and under the condition that the flow blocking film has smaller elasticity, the edge of the whole flow blocking film is pulled by a suture line, so that the situation that a suture hole is enlarged or the edge of the flow blocking film is torn can occur, the occlusion is failed, and thrombus can enter into blood circulation, thereby causing a series of risks.

Based on the above, it is necessary to design a left auricle occluder, which is a choked flow membrane on the left auricle occluder can not break due to heart beating, and can also well occlude thrombus.

Disclosure of Invention

The invention provides a plugging device, which comprises a sealing unit, wherein the sealing unit comprises a sealing piece and a sealing part, and the sealing piece at least partially covers the sealing part; the sealing element comprises at least two film bodies, at least one film body comprises at least one fixed edge and at least one free edge, and the film body is connected with the sealing part through the at least one fixed edge; and taking a cross section perpendicular to the axial direction of the plugging device as a projection surface, wherein the projection area of the sealing piece on the projection surface is approximately equal to the projection area of the sealing part on the projection surface, and the length of the fixed edge of any film body is smaller than the perimeter of the sealing part.

In an embodiment, the free edge is at least partially unattached to the sealing unit.

In an embodiment, the free edges of any two film bodies have an intersection point, and the intersection point is close to the center of the sealing unit.

In an embodiment, the plugging device further comprises a fixing unit, the fixing unit and the sealing unit are coaxially arranged, the fixing unit and the sealing unit are respectively provided with a through hole for a guide wire to pass through, and the through hole and the intersection point are approximately on the same axis of the plugging device.

In one embodiment, the sealing unit and/or the fixing unit is/are formed by braiding wires, the ends of which are housed in a sleeve having a through hole through which the guide wire can pass.

In one embodiment, the film body comprises an elastic material.

In an embodiment, the plurality of film bodies are all of a fan-shaped structure, one straight edge of the fan-shaped structure is at least partially not connected with the sealing part, and the other straight edge and the circular arc edge of the fan-shaped structure are connected with the sealing part.

In one embodiment, the straight edge of any one film body connected with the sealing part is far away from the straight edge of any adjacent film body connected with the sealing part.

In one embodiment, adjacent film bodies are at least partially covered, and the overlapping portions include at least one free edge.

In one embodiment, the free edge of at least one of the adjacent film bodies spans the free edge of the other film body.

The sealing piece on the plugging device provided by the invention comprises at least two film bodies, wherein each film body comprises at least one fixed edge and at least one free edge, and the film bodies are connected with the sealing unit through the fixed edges; the projections of the two film bodies on the cross section perpendicular to the axial direction of the left atrial appendage occlusion device are smaller than the projections of the sealing unit on the cross section, but the projections of the sealing piece on the cross section are approximately equal to the projections of the sealing unit. Therefore, when the heart beats, the free edge of the film body can release a part of stress, so that the traction force on the film body when the blood pressure in the heart changes is reduced, and the plugging effect on thrombus in the left auricle can be ensured.

Drawings

FIG. 1 is a schematic view of a left atrial appendage closure in accordance with one embodiment of the present invention, including a sealing unit and a securing unit;

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

FIG. 3 is a schematic view 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 showing the structure of the inner seal of the seal unit according to other embodiments of the present invention;

FIG. 7 is a schematic 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 shown in FIG. 7;

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

FIG. 10 is a schematic view of a portion of a left atrial appendage occlusion delivery system in accordance with one embodiment of the present invention;

fig. 11 and 12 are enlarged views of a portion of the left atrial appendage occlusion device delivery system of fig. 10;

fig. 13-16 are schematic views illustrating a use procedure of the left atrial appendage occlusion device delivery system of one embodiment of the present invention.

Detailed Description

In order to better understand the technical scheme and beneficial effects of the present invention, the present invention is described in detail below with reference to specific embodiments. The following specific examples are only some of the preferred embodiments, not all of the embodiments of the present invention, nor are they intended to limit the invention.

In the field of interventional medical devices, one end closer to the operator is typically defined as the "proximal end" and one end farther from the operator is typically defined as the "distal end". And thereby defines the proximal and distal ends of any one component or member. For elongate components or components that may be compressed into an elongate form, "axial" generally refers to the length direction of the implant and delivery device, and "radial" generally refers to a direction perpendicular to the "axial" direction, and defines the "axial" and "radial" directions of any of the components of the implant and delivery device in accordance with this principle.

The technical scheme of the invention can be used for various plugging devices, such as a left atrial appendage plugging device, an arterial catheter patent heart or a vascular plugging device. The left atrial appendage occlusion device is described in detail below.

As shown in fig. 1, a left atrial appendage occlusion device 100 according to an embodiment of the present invention includes a sealing unit 20 and a fixing unit 10. The connection between the sealing unit 20 and the fixing unit 10 is a detachable connection, i.e., the sealing unit 20 and the fixing unit 10 are detachable as separate units. Specifically, the fixing unit 20 includes a fixing portion 11, a sleeve 12, a receiving piece 13, and an anchor piece 14. The fixing portion 11 of this embodiment is a cylindrical braid formed by braiding wires, and has a concave structure formed on both the proximal end face and the distal end face of the fixing portion 11, and the sleeve 12 and the receiving piece 13 are disposed in the concave structure. Wherein the sleeve 12 is arranged in a concave structure which is concave towards the far end on the near end surface of the fixed part 11; the receiving piece 13 is provided in a concave structure recessed toward the proximal end on the distal end face of the fixing portion 11. That is, the proximal ends of the braided wires are gathered in the sleeve 12 and connected to the sleeve 12, and the distal ends of the braided wires are gathered in the housing 13 and connected to the housing 13. The anchor 14 facilitates anchoring of the fixation unit 10 to tissue, avoiding displacement of the fixation unit. The anchor 14 may be an anchor protruding from the outer surface of the fixing portion 11.

The sleeve 12 includes a via extending axially of the left atrial appendage occlusion device 100. The sleeve 12 may also be provided with a mating position for connection of the fixation unit to the delivery device, e.g. the sleeve may be provided with an internal or external thread for threaded connection to the delivery device. The sleeve can also be provided with a clamping groove so as to realize clamping connection with the conveying device.

The sealing unit 20 is connected to the fixing unit 10 through the sleeve 12. Referring to fig. 2, the sealing unit 20 includes a sealing portion 21, a limiting portion 22, a first connector 24, and a second connector 23. In this embodiment, the sealing portion 21 and the limiting portion 22 are both formed by knitting a double-disc structure with knitting yarns, and both are disc-shaped with a thin middle thick edge (i.e., the closer to the edge, the closer to the axial distance between two disc surfaces of the double-disc). 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 via hole in the sleeve 12, and the axial length of the first connector 24 is not smaller than the axial length of the via hole in the sleeve 12, so that the first connector 14 can pass through the via hole without the sleeve 12 affecting 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 disk surface of the sealing portion may be recessed toward the distal end, or a waist portion or the like may be further included between the two disk surfaces of the sealing portion.

The sealing portion 21 is further provided with a second connector 23 at its proximal end. The second connecting piece 23 can accommodate the ends of the filaments of the sealing portion 21 on the one hand and can also be connected to a conveying device on the other hand. For example, the second connecting piece 23 may be provided with an internal or external thread, so as to be screwed with the delivery device. A clamping groove can also be arranged on the second connecting piece 23 so as to realize clamping connection with the conveying device.

Referring to fig. 1 and 2, the retainer 22 is deployed through the bore of the cannula 12 with the proximal end of the retainer 22 adjacent the distal end of the cannula 12. In order to ensure stable connection of the sealing unit 20 and the fixing unit 10, the inner diameter of the limiting portion 22 should be smaller than the inner diameter of the through hole on the sleeve 12 when compressed, so that the limiting portion 22 can pass through the through hole; the dimension of the maximum outer contour of the expanded limit portion is larger than the inner diameter of the through hole on the sleeve 12, so that the limit portion 22 cannot be easily removed from the sleeve 12.

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

It will be appreciated that in other embodiments, the sealing unit 20a may be configured as shown in fig. 3, where 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 stopper rod 221a extends distally and then radially and is bent proximally. When being stressed, the plurality of limiting rods 221a can approach towards the center, so that the maximum outer contour size of the limiting part 20a is reduced. It is understood that the stop lever may not bend toward the proximal end, as long as the maximum outer dimension of the stop portion when deployed is greater than the inner diameter of the via hole on the sleeve at the proximal end of the fixing unit, and the maximum outer diameter of the stop portion after compressed is less than the inner diameter of the via 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 abuts 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 deforms and is retracted into the sleeve in the process, so that the pulling force on the fixing unit is reduced, the deformation trend of the fixing unit is weakened, and the deformation capacity of the limiting part is preferably larger than that of the proximal end face of the fixing unit. It is understood that the axial variation or radial variation of the limiting portion is greater than the axial variation or radial variation of the proximal surface of the fixation unit under the same axial or radial force. For example, the wire diameter of the braided wire of the stopper portion may be smaller than the wire diameter of the braided wire of the proximal end face of the fixing unit.

In addition, in order to facilitate replacement of the sealing unit, the limiting part can be more easily retracted into the sleeve when pulling force towards the proximal end is received, and the distal opening of the via hole on the sleeve can be arranged in a horn shape, namely, the closer to the distal end, the larger the aperture of the via hole is.

It will be appreciated that the receiving member, the first connecting member and the second connecting member disposed at the distal end of the fixing unit may each be of a sleeve structure, i.e. a hollow tubular structure.

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

It will be appreciated that when both the sealing unit and the fixation unit are braided by a braided wire, the ends of the braided wire converge at either the proximal or distal ends.

The left atrial appendage occlusion device of this embodiment also has an axial passageway for allowing the guidewire to pass axially through the left atrial appendage occlusion device. 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 provided with through holes through which the 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 receiving member 13 of the fixing unit are coaxial and are provided with through holes or vias. In addition, the sealing unit 20 further includes a sealing member 25, and a central portion of the sealing member 25 has a gap through which the guide wire can pass. Thus, the passages in the fixing unit 10 and the sealing unit 20 and the gap in the sealing member 25 and the space between the three together constitute an axial passage through which the guide wire passes.

Specifically, the seal 25 is provided between two disk surfaces 26 of the double-disk structure of the seal portion 21. As shown in fig. 4 to 6a, the sealing member 25 includes at least two film 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 by a fixing edge 252. The free edge 253 is free relative to the seal 21, i.e., at least partially free of relative binding therebetween. The cross section perpendicular to the axial direction of the left auricle plugging device is taken as a projection surface, the projection area of any film body 251 on the projection surface is smaller than the projection area of the disk surface 26 of the sealing part 21 on the projection surface, but the projection area of the sealing part 25 on the projection surface is approximately equal to the projection area of the disk surface 26 of the sealing part 21 on the projection surface, namely, the sealing part 25 can ensure the plugging effect of the sealing part 21. The seal 25 of the present embodiment includes 3 membrane bodies 251, and each membrane body 251 includes a fixed edge 252 and a free edge 253. Wherein the fixed edge 252 is circular and is substantially equal to half the circumference of the disk surface 26; the free edge 253 is rectilinear and has a length substantially equal to the diameter of the disk surface 26. Thus, the free edge 253 of each film body 251 passes through the center of the disk surface 26, and there is an overlap of any two film bodies 251. The free edges 253 of any two film bodies 251 have intersection points 254, and gaps for the guide wires to pass are formed among the free edges 253, particularly when the sealing unit is compressed, the free edges of the film bodies arch to form the gaps for the guide wires to pass, and when the sealing unit is unfolded, the guide wires can be accommodated near the free edges. In this embodiment, the plurality of intersection points 254 coincide at the center of the disk surface 26 and are located substantially on the central axis of the left atrial appendage occlusion device 100.

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

It will be appreciated that the free edges between adjacent film bodies may be disposed adjacent, or the free edge of one film body may be disposed adjacent the fixed edge of the other film body. Preferably, the one film body and the other film body are at least partially covered, and the mutually covered portions comprise at least one free edge, so that the pressure exerted by the seal can be released from the free edge of the covered portion. Thus, as the heart beats, the free edge of the seal opens partially, releasing pressure, while there is an overlapping overlap between the film bodies, and thrombus does not enter the chamber from the vicinity of the free edge. It will be appreciated that when two adjacent film bodies are in close proximity but uncovered, the sealing unit adopts a double disk structure, and the two disk surfaces can also limit the free edges from being excessively opened to a certain extent, so that thrombus can still be blocked from passing through.

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 notches 255a, with the notches being proximate the center of the seal 21a, and a flange 256a is formed between the notches 255a, the flange 256a being capable of bridging the free edge of the other film body such that the free edge of the other film body snaps into the notch 255a, as shown in FIG. 6 c. Thus, when the guide wire is withdrawn after the implantation of the occluder and the subsequent operation are completed, the guide wire can be utilized to enable the convex edge 256a to cross the free edge of the other film body, so that a larger 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 effect of locking the free edges is achieved. It will be appreciated that in other embodiments, no notch may be provided.

In other embodiments, the seal 21b may also be configured as shown in fig. 6 c. When the film bodies are sewn, the free edge 252b of one film body 251b spans the free edge of the other film body. That is, a portion of the free edge 252b of the film body 251b is positioned below an adjacent one of the film bodies and another portion of the free edge 252b spans the adjacent film body and is positioned above the adjacent film body, thereby forming an intersection 254b for the passage of the guidewire where the seal 21b is near the center. Therefore, the sealing effect between the film bodies can be enhanced, and the phenomenon that a larger opening is formed between the free edges of the two film bodies due to the change of the blood pressure in the heart is avoided, so that the effect of locking the free edges is achieved.

The left auricle occluder is provided with a channel through which the guide wire can pass, mainly for facilitating the replacement of the sealing unit. In addition, when the left atrial appendage occlusion device is implanted, if a subsequent procedure, such as an ablation procedure, is desired, the ablation device can be conveniently extended along the guidewire into the left atrial appendage. In addition, after the left auricle occluder is completely released, the guide wire can be reserved in the body, and if the fixing unit needs to be replaced after observation, the occluder can be retracted and replaced by sending the guide wire into the conveying device again. If no guide wire exists, the biopsy forceps are needed to enter the body to take out the occluder, and the way has great damage to tissues.

It will be appreciated that for situations where guidewire assist is not required, the left atrial appendage occlusion device may not be provided with a corresponding passageway for the guidewire to pass through. At this time, the sealing unit and the fixing unit may not be provided with the corresponding 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 part which is mutually covered is arranged between two adjacent film bodies; or the shape and the area of the film body are equal to the projection surface of the disk surface of the sealing part perpendicular to the projection surface, but the fixed edge of the film body is smaller than the perimeter of the disk surface, namely the edge of the film body is not connected with the sealing part; or the sealing piece 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, only the free edge of the film body is ensured to release stress, and the projection area of the sealing element is approximately equal to that of the sealing part, so that the sealing element can be ensured to seal thrombus.

It will be appreciated that in other embodiments, the membrane body may be made of an elastic material, such as woven cloth or silicone, to better accommodate changes in blood pressure within the heart, without the need for a free edge on the membrane body. In addition, because the silica gel has certain viscosity, when the guide wire needs to be led through, 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 will be appreciated that the membrane body may be free of free edges, i.e. the edges of the membrane body are fully secured to the seal, without concern for the membrane body being subjected to stress and being broken.

It should be understood that other integrally formed occluding devices may employ the multiple film body designs of the present invention, that is, in other embodiments, the sealing unit and the securing unit may be integrally formed, for example, the sealing unit and the securing unit may be formed from the same central tube material by cutting; or in other embodiments, at least one of the fixing unit or the sealing unit is formed by braiding a braiding wire, and the end part of the braiding wire is accommodated in a sleeve, and a through hole for the guide wire to pass through is further formed in the sleeve; or in other embodiments, at least one of the securing unit or the sealing unit is a structure formed by cutting tubing. In addition, the sealing unit and the fixing unit may be directly fixedly connected through the first connecting member, i.e., the sealing unit does not include a limiting portion.

The present invention also provides a left atrial appendage occlusion device delivery system comprising any of the left atrial appendage occlusion devices described above and a delivery device 200. As illustrated in fig. 7, the delivery device 200 generally includes a control assembly 40 and a catheter assembly 30. A control assembly 40 is provided at the proximal end of the catheter assembly 30 and is used to control movement of the catheter assembly 30 to effect implantation, release or retrieval of the left atrial appendage occlusion device. The implementation of the control assembly 40 is numerous and the present invention will not be 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 coaxially disposed. Wherein, the first connecting conduit 32 is sleeved on the outer periphery of the second connecting conduit 33, the outer sheath 31 is sleeved on the outer periphery of the first connecting conduit 32, and the three can move mutually. The outer sheath 31, the first connecting catheter 32 and the second connecting catheter 33 are hollow, and the inner cavity of the second connecting catheter 33 in this embodiment can be used for the guide wire 34 to pass through, so as to always maintain the guide wire path. The outer sheath 31 may fully house the fixation unit of the left atrial appendage occlusion device therein, and as the outer sheath 31 is moved proximally, the fixation unit may be gradually removed, thereby allowing the fixation unit to expand. The first connecting conduit 32 is connected with the sleeve at the proximal end of the fixing unit and drives the fixing unit to axially move, and meanwhile, the fixing unit is ensured to be stable in position and not to shake in the releasing process. At the same time, the first connecting catheter 32 also functions to bind the sealing unit, i.e., when the first connecting catheter 32 is moved proximally with the fixed unit disconnected, the radial binding of the sealing unit may be removed, allowing the sealing unit to be radially deployed. The second connecting conduit 33 is connected to the proximal end of the sealing unit and drives the sealing unit to move axially. The first connecting catheter 32 and the second connecting catheter 33 of this embodiment are connected with the left atrial appendage occlusion device by threaded connection, that is, the distal end portions of the first connecting catheter 32 and the second connecting catheter 33 are provided with internal threads, so as to be in threaded connection with external threads on the sleeve at the proximal end of the fixing unit and external threads on the second connecting member.

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

It will also be appreciated that in other embodiments, the first connecting conduit may be connected to the fixing unit, the second connecting conduit may be connected to the sealing unit by other means, for example, by a snap-fit connection, so long as the delivery device is detachably connected to the left atrial appendage occlusion device.

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 duct 33, and the inner sheath 35 is disposed between the first connecting duct 32 and the second connecting duct 33. At this time, the inner sheath 35 functions to bind the sealing unit, and when the first connecting tube 32 is disconnected from the fixing unit and moves proximally, the sealing unit is not unfolded, so that the sealing unit does not directly contact the inner wall of the first connecting tube 32, and frictional resistance is not generated to the axial movement of the first connecting tube 32. When the size of the sealing unit is not suitable and needs to be replaced, 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 a proper size is replaced.

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 stopper 22 is also in an expanded state, so that the fixing unit 10 is connected to the sealing unit 20, and the stopper 22 blocks the sealing unit 20 from falling off from the sleeve 12. At this point, the first connector 24 is located just inside the via of the sleeve 22. The first connecting duct 32 remains connected to the sleeve of the fixing unit 10, and the sealing part 21 is restrained by the first connecting duct 32. The second connecting tube 33 is connected to the second connector 23, and the sealing portion 21 may be placed in the contracted state when a proximally-directed pulling force is applied to the second connecting tube 33.

Fig. 13-16 illustrate schematic views of the use of the left atrial appendage occlusion device delivery system of the present invention. Before the left auricle occluder is implanted into the left auricle 50, according to the path established by the guide wire 34, firstly, a conveying 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 auricle 50; then the outer sheath 31 is withdrawn, the fixing unit 10 is unfolded and anchored on the inner wall of the left atrial appendage 50, and at this time, the limiting portion of the sealing unit 20 is also unfolded following the fixing unit 10; then, the outer sheath 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 simultaneously pushed distally, causing the seal of the sealing unit 20 to be deployed, sealing against the mouth of the left atrial appendage 50. Then, the contrast agent is injected through the conveying device, and the blocking effect is observed. If the occlusion is good, the second connecting catheter 33 is turned, the connection between the second connecting catheter 33 and the proximal end of the sealing unit 20 is released, and the delivery device is withdrawn, completing the implantation of the left atrial appendage occlusion device. If the sealing unit has poor plugging effect and other sealing units with different sizes need to be replaced, the second connecting guide tube 33 is retracted towards the proximal end, the first connecting guide tube 32 is pushed towards the distal end, and the limiting part moves towards the proximal end to pass through the sleeve, so that the sealing unit is completely converged into the first connecting guide tube 32, and the second connecting guide tube 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 properly sized sealing unit, and the implantation of the sealing unit is again completed as described above.

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

In summary, the left atrial appendage occlusion device and the left atrial appendage occlusion device delivery system of the present invention may first release the fixation unit, and after the sealing unit is deployed, if the sealing unit is not properly sized, the sealing unit may be conveniently and quickly withdrawn to replace the properly sized sealing unit. The whole left auricle occluder is not required to be taken out, and the replacement process is simplified.

It should be understood that the above embodiments are only preferred embodiments, and those skilled in the art may simply replace or vary some of the structures according to actual needs. The scope of the invention is defined by the appended claims.

Claims

1. A closure device comprising a sealing unit, characterized in that the sealing unit comprises a seal and a sealing part, the seal at least partially covering the sealing part; the sealing element comprises at least two film bodies, at least one film body comprises at least one fixed edge and at least one free edge, and the film body is connected with the sealing part through the at least one fixed edge; taking a cross section perpendicular to the axial direction of the plugging device as a projection surface, wherein the projection area of the sealing piece on the projection surface is equal to the projection area of the sealing part on the projection surface, and the length of a fixed edge of any film body is smaller than the circumference of the sealing part;

at least partially overlapping adjacent film bodies, and the overlapping portions include at least one free edge;

the free edge of at least one of the adjacent film bodies spans the free edge of the other film body.

2. The occlusion device of claim 1, wherein said free edge is at least partially unattached to said sealing unit.

3. The occlusion device of claim 2, wherein the free edges of any two film bodies have an intersection point, said intersection point being near the center of said sealing unit.

4. The occlusion device of claim 3, further comprising a fixation unit coaxially arranged with said sealing unit, said fixation unit and said sealing unit each being provided with a through hole for passage of a guidewire, said through hole and said intersection point being substantially on the same axis of said occlusion device.

5. The occlusion device of claim 4, wherein said sealing unit and/or said securing unit are formed by braiding wires, the ends of said braiding wires being received within a sleeve having a through hole through which a guidewire can pass.

6. The occlusion device of claim 1, wherein said film body comprises an elastic material.

7. The occlusion device of claim 1, wherein each of said plurality of membrane bodies has a fan-shaped configuration, wherein one of said fan-shaped configuration has at least a portion of its straight edge unconnected to said sealing portion, and wherein the other of said fan-shaped configuration has its straight edge and circular edge connected to said sealing portion.

8. The occlusion device of claim 7, wherein a straight edge of any one of the membrane bodies connected to the sealing portion is remote from a straight edge of any adjacent membrane body connected to the sealing portion.