WO2017113632A1

WO2017113632A1 - Left atrial appendage occluder

Info

Publication number: WO2017113632A1
Application number: PCT/CN2016/086116
Authority: WO
Inventors: 李安宁
Original assignee: 先健科技(深圳)有限公司
Priority date: 2015-12-31
Filing date: 2016-06-17
Publication date: 2017-07-06
Also published as: CN106923885A; CN106923885B

Abstract

A left atrial appendage occluder comprises a closure member (21), a fixing member (22) disposed at the distal end of the closure member (21), and a connecting member (23) for connecting the closure member (21) and the fixing member (22). The closure member (21) comprises a frame (215) and a cover (212) on the frame (215). The frame (215) comprises a proximal end face at least covered by the cover (212), and a supporting circumferential surface connected to the proximal end face and extending toward the distal end. The fixing member (22) is a cylindrical braided structure and the connecting member (23) is a flexible connecting member. After the fixing member (22) of said left atrial appendage occluder is placed at a corresponding position in the left atrial appendage, it deforms to adapt to the irregular shape of the chamber wall and the friction between the occluder and the chamber walls increases, causing it to be stably arranged inside the chamber. Harm to the chamber walls is eliminated due to there being no need to arrange an anchoring hook to secure the occluder.

Description

Left atrial appendage occluder

[Technical Field]

The present invention relates to medical devices, and more particularly to a left atrial appendage occluder.

【Background technique】

At present, the occluder can be placed into the left atrial appendage by catheter intervention to prevent the formation of a thrombus in the left atrial appendage due to atrial fibrillation, to prevent the thrombus from reaching the stroke caused by the brain, or to prevent the thrombus from reaching the rest of the body through the human blood circulation system. Systemic embolism caused. Such left atrial appendage occlusion devices can generally include an integrated occluder and a split occluder. For example, a split occluder typically includes a fixation member and a sealing member that are coupled to each other, the fixation member being placed in the left atrial appendage cavity to secure the entire occluder, and the sealing member sealing the mouth of the left atrial appendage for blocking blood flow inflow Left atrial appendage.

The fixation member is typically placed in the left atrial appendage cavity in the form of an anchor, and the anchoring member is secured in the left atrial appendage cavity by piercing the left atrial appendage wall. In order to reduce the risk of occluder detachment, the fixed component is usually placed in a deeper part of the left atrial appendage. However, the deeper part of the left atrial appendage is also a thin part of the left atrial appendage wall, which easily causes the fixed component to puncture the left atrial appendage wall, thereby causing adverse effects such as pericardial effusion and even tamponade.

[Summary of the Invention]

Based on this, it is necessary to provide a left atrial appendage occluder that can ensure a stable fixation effect without puncturing the left atrial appendage wall in response to the above problems.

The technical solution adopted by the present invention to solve the technical problem thereof is to provide a left atrial appendage occluder, comprising a sealing member, a fixing member on a distal end side of the sealing member, and connecting the sealing member and the fixing a connector comprising: a skeleton and a coating disposed on the skeleton, the skeleton comprising a proximal side and a supporting circumferential surface connected to the proximal side and extending distally, the covering The film covers at least the proximal side; the fixing member is a cylindrical wire woven structure, and the connecting member is an elastic connecting member.

In the left atrial appendage occluder according to the embodiment of the present invention, the radial deformation ability of the sealing member is greater than the radial deformation ability of the fixing member and/or the axial deformation ability of the sealing member is greater than the fixing member. Axial deformation ability.

In the left atrial appendage occluder according to the embodiment of the present invention, the radial length change of the sealing member is greater than the radial length variation of the fixing member under the same radial force; or under the same radial force The change rate of the diameter of the sealing member is greater than the change rate of the diameter of the fixing member; or the displacement of the sealing member along the axial force direction is greater than the edge of the fixing member under the same axial force The amount of displacement in the direction of the axial force.

In a left atrial appendage occluder according to an embodiment of the present invention, the connecting member passes through a space enclosed by the skeleton, one end is connected to the proximal side of the skeleton, and the other end is near the proximal end of the fixing member. Connected to the fixing member.

In a left atrial appendage occluder according to an embodiment of the present invention, the skeleton includes a plurality of elastic support rods, the plurality of support rods radiating from a proximal end center of the seal to form the proximal side, the bend Extending the distal end to form the support circumferential surface; or the skeleton includes a plurality of meshes surrounded by elastic support rods.

In a left atrial appendage occluder according to an embodiment of the invention, at least one proximally facing anchor is also provided on the skeleton.

In the left atrial appendage occluder according to the embodiment of the invention, the end face of the fixing member that is connected to the connecting member forms a recess near the joint.

In the left atrial appendage occluder according to an embodiment of the present invention, the fixing member has at least one braided projection on the cylindrical surface.

In a left atrial appendage occluder according to an embodiment of the invention, the connection between the connector and the fixture is an angularly adjustable articulation.

In a left atrial appendage occluder according to an embodiment of the present invention, the connecting member includes a proximal end end, a distal end connecting end, and a connecting body connected between the proximal end connecting end and the distal end connecting end; The proximal end is connected to the seal, the distal end is connected to the fixing member; the distal end includes a distal ball socket, and the distal end of the connecting body includes the distal end The distal ball head of the end ball socket.

In a left atrial appendage occluder in accordance with an embodiment of the present invention, the connection between the connector and the seal is an angularly adjustable articulation.

In a left atrial appendage occluder according to an embodiment of the present invention, the connecting member includes a proximal end end, a distal end connecting end, and a connecting body connected between the proximal end connecting end and the distal end connecting end; The proximal end is connected to the seal, the distal end is connected to the fixing member; the distal end includes a distal ball socket, and the distal end of the connecting body includes the distal end A distal ball joint mating distal ball end, the proximal end end including a proximal ball socket, the proximal end of the connector including a proximal ball head that mates with the proximal ball socket.

In the left atrial appendage occluder according to an embodiment of the present invention, the connecting member is a twisted structure in which a connecting rod, a spring structure or a wire bundle is twisted.

In the left atrial appendage occluder of the present invention, the fixing member is a woven structure, and has a convex-free, smooth appearance. When the fixing member is placed at the corresponding position of the left atrial appendage, the deformation can not only be deformed in the depth of the adaptive left atrial appendage cavity. Irregular cavity wall shape, and the friction between the cavity and the cavity wall can be adaptively enhanced by the deformation, so that the left atrial appendage occluder is stably disposed in the left atrial appendage cavity, and there is no need to provide an anchor for fixing the occluder The thorns also prevent the anchor thorn from piercing the thin wall of the left atrial ear to avoid the resulting pericardial effusion and even tamponade.

[Description of the Drawings]

FIG. 1 is a schematic diagram of a state in which a left atrial appendage occluder is implanted into a left atrial appendage according to an embodiment of the present invention.

FIG. 2 is a schematic structural diagram of a left atrial appendage occluder according to an embodiment of the present invention.

Figure 3 is another schematic view of the left atrial appendage occluder of Figure 2 with the membrane on the seal removed.

FIG. 4 is a schematic structural diagram of a skeleton of a sealing member in a left atrial appendage occluder according to another embodiment of the present invention.

FIG. 5 is a schematic structural view of a fixing member in the left atrial appendage occluder shown in FIG. 2. FIG.

FIG. 6 is a schematic structural diagram of a fixing member in a left atrial appendage occluder according to another embodiment of the present invention.

Figure 7 is a schematic view showing the structure of the connecting member in the left atrial appendage occluder shown in Figure 2.

Figure 8 is a cross-sectional view showing the structure of the connecting member shown in Figure 7.

9 is a schematic view showing a test method for the radial deformation ability of the fixing member of the left atrial appendage occluder shown in FIG. 2.

Figure 10 is a schematic view showing a test method for the radial deformation ability of the seal of the left atrial appendage occluder shown in Figure 2.

Figure 11 is a schematic view showing another specific test structure of the radial deformation ability of the seal/fixing member of the left atrial appendage occluder shown in Figure 2.

Figure 12 is a schematic view showing the first test method of the axial deformability of the fixing member of the left atrial appendage occluder shown in Figure 2.

Figure 13 is a schematic illustration of a first test method for the axial deformability of the seal of the left atrial appendage occluder shown in Figure 2.

Figure 14 is a schematic illustration of a second test method for the axial deformability of the fastener of the left atrial appendage occluder shown in Figure 2.

Figure 15 is a schematic illustration of a second test method for the axial deformability of the seal of the left atrial appendage occluder shown in Figure 2.

【detailed description】

To more clearly describe the structure of the left atrial appendage occluder, the present invention defines the terms "distal" and "proximal", which are conventional terms in the field of interventional medical devices. Specifically, "distal" refers to the end away from the operator during the procedure, and "proximal" refers to the end near the operator during the procedure.

1 shows a schematic view of a left atrial appendage occlusion device implanted behind a left atrial appendage in accordance with an embodiment of the present invention, with the left atrial appendage 2 located within the left atrium 1. The left atrial appendage occluder includes a sealing member 21, a fixing member 22 on the distal end side of the sealing member 21, and a connecting member 23 connecting the sealing member 21 and the fixing member 22.

2 and 3, the fixing member 22 is a wire woven structure and has a smooth appearance, for example, a cylindrical wire woven structure placed in the left atrial appendage 2 and fitted to the cavity wall 3 of the left atrial appendage 2. The fixing member 22 has elasticity and is deformed when subjected to an external force. When the fixing member 22 is placed at the corresponding position of the left atrial appendage 2, it is subjected to the compression deformation of the cavity wall 3 of the left atrial appendage 2, and the cavity wall 3 generates frictional force to form an effective fit, thereby ensuring the stability of the left atrial appendage occluder. Since the fixing member 22 has a smooth outer surface, the fixing member 22 can be placed at a deep position of the left atrial appendage 2 without fear of puncturing the cavity wall 3 of the left atrial appendage 2, and the deformability of the fixing member 22 can also be adapted to the left atrial appendage 2 Various locations and various shapes.

As shown in FIGS. 2 and 3, the seal 21 includes a skeleton 215 and a coating 212 bonded to the skeleton 215. The skeleton 215 may be cut into a corresponding shape from a metal (preferably nickel-titanium material) tube and then heat-treated to form a frame structure. The skeleton 215 in the naturally deployed state includes a proximal side and a support perimeter that is coupled to the proximal side and extends distally. After implantation, the proximal side is located at the left atrial appendage and the left atrial appendage is blocked. The support peripheral surface is located in the left atrial appendage and is closely attached to the cavity wall, and is fixed in the left atrial appendage by radial support.

The skeleton 215 includes a delivery connection end 211 and a plurality of support rods 218. The proximal end of each support rod 218 is connected to the transport connection end 211, and the plurality of support rods 218 are radiated from the transport connection end 211 (ie, the proximal end center) to form a proximal side surface, and after bending, extend distally to form a support peripheral surface. The distal end of each of the support rods 218 extends toward the fixture 22 to form an end 217. The connecting member 23 passes through a space enclosed by the support rod 218 and is connected to the transport connecting end 211.

An anchor 213 is also formed on the support rod 218, and the anchor 213 can face the proximal end. The anchor 213 is used to penetrate into the cavity wall 3 of the left atrial appendage 2 to assist in securing the seal 21. It can be understood that since the fixing member 22 adopts the wire woven structure to form a firm fit with the cavity wall 3 of the left atrial appendage 2, the anchor thorn 213 on the support rod 218 can also be omitted in some embodiments, avoiding the left atrial appendage 2 Any puncture of the cavity wall 3.

The end 217 is open, that is, the end 217 is cut by a metal tube to form separate rods. In still other embodiments, as shown in FIG. 4, the skeleton 2151 can also assume a different shape. Compared with the skeleton 215 shown in FIG. 3, the skeleton 2151 also has a conveying connection end 2111, a support rod 2181, and an anchor 2131, except that the end 2171 of the support rod 2181 is closed, that is, at least two supports. The ends 2171 of the rod 2181 are joined together to form a closed loop. The end 2171 thus provided can reduce the risk of puncturing the cavity wall 3 of the left atrial appendage 2 while maintaining the relative independence of the support rod 2181.

A thread is provided on the proximal side of the delivery connection end 211 to facilitate connection with the conveyor. The thread on the delivery connection end 211 can be formed by cutting or etching, or by welding a nut on the proximal side of the delivery connection end 211. The distal end side of the delivery connection end 211 is for connection with the connector 23.

The film 212 is a polymer film having a thickness of 0.01 to 1 mm, and the material is preferably PET. PET or PTFE or silica gel materials or other film materials having biocompatibility and physical properties can be used. The film 212 is fixed to the outer surface of the elastically approximately spherical body 215 by the anchor 213 and the stitching fit. When the left atrial appendage occluder is implanted in the left atrial appendage, the anchor 213 is inserted into the lumen wall 3 of the left atrial appendage 2, and the membrane 212 constitutes the outer surface of the seal 21 in contact with the lumen wall 3 of the left atrial appendage 2.

Referring to FIG. 1, FIG. 2 and FIG. 3, when the sealing member 21 is placed at the mouth of the left atrial appendage 2, the support rod 218 on the skeleton 215 is adapted to the irregular shape of the lumen of the left atrial appendage 2, and the left atrial appendage 2 The cavity wall 3 is better fitted, and the membrane 212 is fixedly attached to the skeleton 215 to seal the mouth of the left atrial appendage 2, preventing blood 9 in the left atrium 1 from flowing into the left atrial appendage 2, and preventing thrombus from the left atrial appendage. The cavity flows into the left atrium.

As shown in Fig. 5, the fixing member 22 is woven from a wire to form a braid. In some embodiments, the fixing member 22 is woven by 16 to 144, preferably 36 to 72, wires having a wire diameter of 0.01 to 0.8 mm (preferably a nickel-titanium material) and then formed by heat treatment. The molded fixture 22 is a columnar body in a naturally unfolded state. The fixing member 22 has elasticity and is deformed when subjected to an external force.

The fixing member 22 has two end faces. The fixing member 22 may be provided with end caps at the two end faces, and the braid formed by the braiding of the fixing member 22 is received and fixed by the end cap at both end faces, specifically, by welding. Only the proximal end cap 222 is shown in FIG. This proximal end cap 222 is connected to the connector 23.

The end face of the fixing member 22 connected to the connecting member 23 forms a recess 223 near the joint. The provision of the recess 223 on the end face will facilitate the length deformation and angular deformation of the fixing member 22 under the pulling action of the connecting member 23, while ensuring that the overall contour of the fixing member 22 during the deformation process is not affected by the pulling action.

In still other embodiments, as shown in FIG. 6, at least one protrusion may be provided on the cylindrical surface of the fixing member 22, for example, it may be an annular protrusion 221. The number of the annular protrusions 221 may be one or more than one, which can increase the contact area and supporting force between the fixing member 22 and the cavity wall 3 of the left atrial appendage 2, increase the friction between the two, and improve the left atrial appendage sealing. The robust performance of the device.

As shown in FIGS. 7 and 8, the connector 23 includes a proximal end end 231, a distal end end 235, and a connecting rod 232 coupled between the proximal end end 231 and the distal end end 235.

The proximal connection end 231 is connected to the seal 21. Specifically, the proximal end connection end 231 and the distal end side of the delivery connection end 211 of the sealing member 21 are connected, and may be connected by welding or interference fit crimping or the like.

The connecting rod 232 extends from the proximal connecting end 231, passes through a space enclosed by the support rod 218 of the sealing member 21, and is connected to the distal connecting end 235. The connecting rod 232 is a metal rod with a small outer diameter and a diameter of 0.1 to 5 mm. It has high strength and elasticity and can be bent at any angle from 0 to 180 degrees.

The distal end 235 is coupled to a fixture 22 that includes a mating ball head structure 233 and a ball and socket structure 234. The ball head structure 233 is coupled to the connecting rod 232. In some embodiments, the ball stud structure 233 is integrally formed with the connecting rod 232. The ball stud structure 233 is spherical and has a diameter larger than the diameter of the connecting rod 232. The ball and socket structure 234 is coupled to the proximal end cap 222 of the fastener 22, such as by welding or interference fit.

The ball head structure 233 and the ball and socket structure 234 can be 360° active. When the left atrial appendage occluder is implanted in the left atrial appendage 2, the connector 23 can be curved with the shape of the left atrial appendage 2 to accommodate the positioning requirements of the seal 21 and the fixation member 22 in different axes of the left atrial appendage 2, As shown in Figure 1.

The connecting rod 232 on the connecting member 23 can be made into a twisted structure twisted by not less than one wire for satisfying various angle requirements of the left atrial appendage anatomy. The connecting rod 232 can also be constructed as a spring structure for satisfying the length and angle requirements of the left atrial appendage occlusion device for a larger curved left atrial appendage anatomy.

The connection angle of the connecting rod 232 and the fixing member 22 is adjustable, and the fixing member 22 can be deformed in length and angle under the pulling action of the connecting rod 232, so the left atrial appendage occluder can be applied to the left atrial appendage of various shapes. The cavity, especially the cavity with a large bending angle, at this time, the fixing member 22 can penetrate deep into the cavity without causing damage to the cavity, and also ensure that the sealing member 21 can be effectively sealed at the opening of the cavity. Left atrial appendage.

Further, the radial deformability of the seal 21 of the left atrial appendage occluder is greater than the radial deformability of the fixture 22 and/or the axial deformability of the seal 21 is greater than the axial deformability of the fixture 22. Specifically, under the same radial force, the diameter change of the sealing member 21 is greater than the diameter change of the fixing member 22; or under the same radial force, the diameter change rate of the sealing member 21 is greater than the fixing member. The change rate of the path length of 22; or under the same axial force, the displacement of the seal 21 in the axial direction is greater than the displacement of the stator in the axial direction.

The plate length method can be used to test the change of the diameter of the fixing member and the sealing member under the same radial force. For example, referring to Figures 9 and 10, the above-described left atrial appendage occluder can be tested using the plate method.

Referring to Fig. 9, first, a radial force F is applied to the fixing member 22 by the two parallel plates 61 and 62 on the premise that the sealing member 21 is kept in a freely unfolded state. Specifically, parallel plates 61 and 62 are respectively placed on opposite sides of a diameter of the fixing member 22, and radial forces F of opposite magnitudes are applied to the plates 61 and 62 respectively along the diameter; the fixing member 22 is The diameter passes through and is perpendicular to the central axis 140; the two parallel plates 61 and 62 remain parallel to each other throughout the test, ie, are always parallel to the central axis 140 during testing; any plate covers at least the maximum diameter of the fixture 22. To the contour, it is preferred to cover the entire fixture 22 in a direction parallel to the central axis 140. If the diameter of the fixing member 22 at the loading plate is R1 in the naturally unfolded state, the diameter change of the fixing member 22 under the action of the radial force F is the difference in diameter between before and after the radial compression, which can be expressed by ΔR1. The diameter change rate is ΔR1/R1. In order to ensure that the plate itself does not deform during the application of the radial force, the radial force can be applied uniformly throughout the plate, the thickness of the plate being at least 5 mm.

Referring to Fig. 10, the sealing member 21 is tested by the same flat test method as described above, that is, the same radial force F is used, including the force F, the direction, and the action time are the same respectively, and the fixing member 22 is naturally deployed. On the premise, the diameter change amount ΔR2 of the seal member 21 or the diameter change rate ΔR2/R2 is tested, and at this time, the maximum radial profile of the seal member 21 is located at the support peripheral surface thereof. Based on the above test conditions, the radial length change amount ΔR2 of the seal 21 of the left atrial appendage occluder according to the embodiment of the present invention is greater than the radial length change amount ΔR1 of the fixed member 22; or The diameter change rate ΔR2/R2 of the seal 21 of the left atrial appendage occluder according to the embodiment of the present invention is larger than the diameter change rate ΔR1/R1 of the fixed member 22.

After the left atrial appendage occlusion device is implanted into the human body, there may be an inappropriate selection of the implantation position. For example, the fixing member may be too deep into the left atrial appendage cavity, thereby causing the natural expansion axial length of the occluder to be smaller than that after implantation. The relative distance between the fixing member and the sealing member causes the fixing member and the sealing member to pull each other; or the occluder will move with the heart after the implantation, due to the difference in the magnitude or direction of movement, It is also possible to cause mutual pulling between the fixing member and the sealing member. Usually, the fixing member and the sealing member are pulled together by the connecting member.

When the fixing member is pulled by the sealing member, the fixing member is fixed in the left atrial appendage cavity by the radial supporting force around the circumferential region of the central axis 140, so that the circumferential portion of the left atrial appendage cavity is mainly adhered by the fixing member. To resist this pulling force, so that the axial pulling of the fixing member will cause its radial deformation. If the pulling effect is large enough, the fixing member may be separated from the left atrial appendage wall, thereby making the left atrial appendage sealed. The plug is detached, causing the implant to fail. The seal is similar to the fixture and is secured within the left atrial appendage by a radial support force about a circumferential region of the central axis 140 such that when the seal is pulled by the fastener, the seal abuts the circumference of the left atrial cavity The area will resist this pulling force, causing its radial deformation.

Thus, when the fixing member and the sealing member are pulled to each other, the one of the two which is easily deformed radially will be pulled by the other, for example, under the same radial force, the fixing member according to the embodiment of the invention The change in the path length is smaller than the change in the diameter of the seal, or the rate of change in the path length of the fixing member according to the embodiment of the present invention is smaller than the rate of change in the diameter of the seal, so that during the pulling process of each other, the fixing member will The pull-up seal is dominated to deform the seal toward the direction of the fixture (or toward the distal end). The fixing member is mainly pulled and is not easily pulled by the sealing member away from the left atrial appendage wall, so that the occluder is better fixed in the left atrial appendage, and the occluder is prevented from falling off from the left atrial appendage.

The above-mentioned flat test method is only an exemplary test method, and is not intended to limit the present invention. Those skilled in the art can perform any test equivalent to the flat test method by any suitable method, for example, also in the component to be tested. The radial force is applied uniformly in the circumferential direction for testing. Specifically, referring to Fig. 11, three curved plates 63 may be uniformly arranged in the same circumferential direction at the maximum radial profile of the member to be tested (fixing member or seal), and the same diameter is simultaneously formed on the above-mentioned curved plate 63 in the test. A radial force F is applied to the test, and the amount of change or rate of change of the diameter R of the component is tested. Likewise, in order to achieve a uniform application of the radial force, the thickness of the curved plate can be set to be at least 5 mm. In addition, you can also use Machine The left atrial appendage occluder was tested by Solution Inc (MSI) RX550-100 radial support tester.

In addition, the axis of the component can be characterized by the amount of displacement of the component in the axial direction (direction along the central axis 140) under the same axial force, under the condition that a part of the component to be tested (fixing member or seal) is restrained. Ability to deform. In the first axial deformation capability test method, the above constraint is an equal-size constraint, that is, the component to be tested does not undergo elastic deformation or the elastic deformation variable is very small during the constraint process, and is substantially negligible; in addition, the component to be tested is selected. An axial force is applied at a position where no elastic deformation occurs. For example, the same axial force can be applied to one end of the component to be tested connected to the connecting member, and the axial displacement of the component is tested to characterize its respective deformability. Here, the axial displacement of the component is the applied point. The amount of axial displacement at which the left atrial appendage occluder satisfies the axial displacement of the fastener is less than the axial displacement of the seal. The fixture and seal were tested separately in the test, for example, only a single fixture or a single seal was tested at a time.

Referring to Fig. 12, during the test of the holder 22, the holder 22 is circumferentially clamped at the maximum radial profile of the holder 22 by the annular holder 71. The annular holder 71 is about the central axis 140 and perpendicular to the middle. The axis 140, during the clamping process, the radial dimension of the clamping portion of the fixing frame 22 is substantially maintained in the state of the natural unfolded state, the elastic deformation is substantially negligible; the proximal end cap 222 is connected to the connecting member at the fixing frame 22, An axial force F1 is applied along the central axis 140 and toward the seal 21, the proximal end cap 222 does not elastically deform during application of the axial force F1, and the proximal end cap 222 is measured on the central axis 140. The projection O1 with the axial displacement amount ΔO1 of F1 is used to characterize the deformation amount (or deformation ability) of the fixing frame 22, and the clamping state of the clamping member 71 itself during the entire loading process of the axial force F1. constant.

It can be seen from the above that after the left atrial appendage occluder is implanted into the human body, the fixing frame is clamped under the condition that a part is clamped, for example, the fixing frame 22 is clamped at the maximum contour, and the measured axial tensile force is applied. The axial displacement reflects the axial deformation ability of the stent after being implanted in the left atrial appendage and being pulled by the sealing disc under the restraint of the left atrial appendage. Under the same axial tension, the larger the ΔO1, the easier the bracket is to be pulled and deformed.

Referring to Figure 13, during the test of the seal member 21, the seal member 21 is circumferentially clamped at the maximum radial profile of the seal member 21 by an annular retaining member 71 which is about the central axis 140 and perpendicular to the middle. The axis 140, during the clamping process, the radial dimension of the clamping portion 21 is substantially maintained in a naturally unfolded state, the elastic deformation is substantially negligible; at the conveying connection end 211 of the sealing member 21 and the connecting member, along the sealing member The axial axis 140 applies an axial force F1 in the direction of the fixing member 22, and the conveying connection end 211 does not elastically deform during the application of the axial force F1, and the projection O2 of the conveying connection end 211 on the central axis 140 is measured. With the axial displacement amount ΔO2 of F1, the deformation amount (or deformation ability) of the sealing member 21 is characterized by the ΔO2, and the clamping state of the clamping member 71 itself is maintained during the entire loading process of the axial force F1. change.

It can be seen from the above that after the left atrial appendage occluder is implanted into the human body, the sealing member is clamped under the condition that a part is clamped, for example, the sealing member 21 is clamped at the maximum contour, and the measured axial tensile force is applied. The axial displacement amount reflects the axial deformation ability of the seal member to be pulled by the fixing member under the restraint of the left atrial appendage cavity after being implanted into the left atrial appendage cavity. Under the same axial tensile force, the larger the ΔO2, the easier the seal is to be pulled and deformed.

It is measured that under the same axial force, the axial displacement ΔO1 of the fixing member is smaller than the axial displacement ΔO2 of the sealing member. It can be understood that when the fixing member and the sealing member are pulled to each other, the one with the larger axial displacement amount will be pulled by the other party, for example, under the same axial force, according to the embodiment of the present invention. The axial displacement of the fastener is greater than the axial displacement of the seal, and during the pulling of each other, the fixture will dominate the tension seal, deforming the seal toward the fixture (or toward the distal end). The fixing member is mainly pulled and is not easily pulled by the sealing member away from the left atrial appendage wall, so that the occluder is better fixed in the left atrial appendage, and the occluder is prevented from falling off from the left atrial appendage.

A second axial deformation capability test method can also be employed. Referring to FIG. 14, during the test fixture 22, the annular retaining member 76 is used to clamp the retaining member 22 circumferentially at the maximum radial contour of the retaining member 22, which The annular clamping member is about the central axis 140 and perpendicular to the central axis 140. During the clamping process, the radial dimension of the clamping portion of the fixing member 22 is smaller than that in the naturally deployed state, and the fixing member 22 is radially compressed at the clamping portion. For example, the maximum diameter after compression is 80% of the maximum path length before compression. Of course, other compression ratios may also be used, which are not enumerated here. For example, a radial force F0 can be applied to the annular clamp 76 to radially compress the fastener 22. An axial end force F2 is applied along the central axis 140 and toward the seal 21 at a proximal end cap 222 to which the fastener 22 is coupled to the connector, the proximal end cap 222 not in the process of applying the axial force F2 Elastic deformation occurs, and the projection O3 of the proximal end cap 222 on the central axis 140 is measured by the axial displacement amount ΔO3 of F2, and the deformation amount (or deformation ability) of the fixing member 22 in the test method is characterized by the ΔO3.

It can be seen from the above that after the left atrial appendage occluder is implanted into the human body, the fixing member 22 is clamped under a condition that a part is clamped, for example, the fixing member 22 is clamped at the maximum contour, and the measured axial tensile force is applied. The axial displacement amount reflects the deformability of the fixing member 22 being pulled by the sealing member 21 under the restraint of the left atrial appendage cavity after being implanted into the left atrial appendage cavity. Under the same axial tensile force, the larger the ΔO3, the more easily the fixing member 22 is pulled and deformed.

Referring to Figure 15, during testing of the seal 21, the seal member 21 is circumferentially clamped at the maximum radial profile of the seal 21 using an annular clamp 76 that is about the central axis 140 and perpendicular to the central axis. 140, during the clamping process, the radial dimension of the clamping portion 21 is smaller than the size in the natural unfolded state, and the sealing member 21 is radially compressed at the clamping portion, for example, the maximum diameter after compression is the maximum before compression. 80% of the path length, of course, other compression ratios can also be used, which are not listed here. For example, a radial force F0 can be applied to the annular clamp 76 to radially compress the seal 21. In the conveying connection end 211 of the sealing member 21 connected to the connecting member, an axial force F2 is applied along the central axis 140 and toward the fixing member 22, and the conveying connecting end 211 does not elastic during the application of the axial force F2. For deformation, the projection O4 of the conveying connection end 211 on the central axis 140 is measured by the axial displacement amount ΔO4 of F2, and the deformation amount (or deformation ability) of the sealing member 21 in the test method is characterized by the ΔO4.

It can be seen from the above that after the left atrial appendage occluder is implanted into the human body, the sealing member 21 is clamped under a condition that a part is clamped, for example, the sealing member 21 is clamped at the maximum contour, and the measured axial tensile force is applied. The axial displacement amount reflects the deformability of the sealing member 21 being pulled by the sealing member 21 under the restraint of the left atrial appendage cavity after implantation into the left atrial appendage cavity. Under the same axial tensile force, the larger the ΔO4, the easier the seal 21 is to be pulled and deformed.

It is measured that under the same axial force (F2), the axial displacement ΔO3 of the fixing member is smaller than the axial displacement ΔO4 of the sealing member. It can be understood that when the fixing member and the sealing member are pulled to each other, the one with the larger axial displacement amount will be pulled by the other party, for example, under the same axial force, according to the embodiment of the present invention. If the axial displacement of the fixing member is smaller than the axial displacement of the sealing member, the fixing member is mainly pulled during the pulling process of each other, and is not easily pulled by the sealing member away from the wall of the left atrial appendage cavity, so that the occluder is better. The ground is fixed in the left atrial appendage to prevent the occluder from falling out of the left atrial appendage.

Referring to Figures 1-3, in the naturally unfolded state, at least a portion of the connecting member of the left atrial appendage can extend beyond the space formed by the support rods in the sealing member; at this time, the remaining portion of the connecting member can be located. The support rods in the seal are enclosed within the space formed. In this way, a part of the connecting member protrudes into the space formed by the sealing member, which can reduce the distance between the fixing member and the sealing member (which can be called the waist length), and a part of the connecting member protrudes from the space formed by the sealing member. It is avoided that the fixing member and the sealing member interact with each other because the spacing between the two is too small, for example, the fixing member and the sealing member can be prevented from intertwining.

The fixing member of the invention has a woven structure and has a bump-free, smooth appearance. When the fixing member is placed at the corresponding position of the left atrial appendage, the deformation can not only deform the shape of the irregular cavity wall deep in the left atrial appendage cavity, but also The deformation can be adaptively enhanced to the frictional force with the cavity wall, so that the left atrial appendage occluder is stably disposed in the left atrial appendage cavity, and the anchor thorn for fixing the occluder is not required, thereby avoiding the anchor thorn Pierce the thin wall of the left atrial appendage to avoid the resulting pericardial effusion and even tamponade.

The technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be considered as the scope of this manual.

The above-described embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims

A left atrial appendage occluder comprising a seal, a fixing member on a distal end side of the sealing member, and a connecting member connecting the sealing member and the fixing member; wherein the sealing member comprises a skeleton And a coating disposed on the skeleton, the skeleton comprising a proximal side surface and a support circumferential surface coupled to the proximal side surface and extending distally, the coating covering at least the proximal side surface; The fixing member is a cylindrical wire woven structure, and the connecting member is an elastic connecting member.
The left atrial appendage occluder according to claim 1, wherein the radial deformation ability of the sealing member is greater than the radial deformation ability of the fixing member and/or the axial deformation ability of the sealing member is greater than The axial deformation ability of the fixing member.
The left atrial appendage occluder according to claim 2, wherein the change in the diameter of the seal is greater than the change in the length of the fastener under the same radial force; or in the same radial direction The rate of change of the diameter of the sealing member is greater than the rate of change of the diameter of the fixing member; or the displacement of the sealing member along the axial force is greater than the The amount of displacement of the fixture along the axial force direction.
The left atrial appendage occluder according to any one of claims 1 to 3, wherein the connecting member passes through a space surrounded by the skeleton, one end is connected to the proximal side of the skeleton, and the other end is The proximal end of the fixing member is connected to the fixing member.
A left atrial appendage occluder according to any one of claims 1 to 3, wherein the skeleton comprises a plurality of elastic support rods, the plurality of support rods radiating from the proximal center of the seal Forming the proximal side surface, extending to the distal end to form the support circumferential surface; or the skeleton comprises a plurality of meshes surrounded by elastic support rods.
The left atrial appendage occluder according to any one of claims 1 to 3, characterized in that the skeleton is further provided with at least one proximally facing anchor.
The left atrial appendage occluder according to any one of claims 1 to 3, characterized in that the end face of the fixing member connected to the connecting member forms a recess near the joint.
A left atrial appendage occluder according to any one of claims 1 to 3, wherein the fixing member has at least one braided projection on the cylindrical surface.
The left atrial appendage occluder according to any one of claims 1 to 3, wherein the connection between the connecting member and the fixing member is an angularly adjustable movable connection.
The left atrial appendage occluder according to claim 9, wherein the connector comprises a proximal end connection, a distal end connection end, and a connection between the proximal end connection end and the distal end connection end. a connector; the proximal connector is coupled to the seal, the distal connector is coupled to the fixture; the distal connector includes a distal socket, the distal end of the connector including The distal ball joint of the distal ball and socket.
A left atrial appendage occluder according to claim 9 wherein the connection between the connector and the seal is an angularly adjustable articulation.
The left atrial appendage occluder according to claim 11, wherein the connector comprises a proximal end connection, a distal end connection end, and a connection between the proximal end connection end and the distal end connection end. a connector; the proximal connector is coupled to the seal, the distal connector is coupled to the fixture; the distal connector includes a distal socket, the distal end of the connector including The distal ball socket mates a distal ball end, the proximal end end includes a proximal ball socket, and the proximal end of the connector includes a proximal ball head that mates with the proximal ball socket.
The left atrial appendage occluder according to any one of claims 1 to 3, wherein the connecting member is a twisted structure in which a connecting rod, a spring structure or a wire bundle is twisted.