CN107233115B

CN107233115B - Left auricle plugging device

Info

Publication number: CN107233115B
Application number: CN201610184108.XA
Authority: CN
Inventors: 汪振; 周毅; 姚瑶; 李俊菲; 罗七一
Original assignee: Shanghai Minimally Invasive Medical Devices (group) Co Ltd
Current assignee: Shanghai Zuoxin Medical Technology Co., Ltd
Priority date: 2016-03-28
Filing date: 2016-03-28
Publication date: 2020-01-24
Anticipated expiration: 2036-03-28
Also published as: CN107233115A

Abstract

The invention provides a left atrial appendage occluder, which comprises an occlusion structure and a fixing structure, and further comprises: the detachable adjusting structure comprises a first part and a second part which can be separated from or folded with the first part, the first part and the second part can move relatively, the first part is connected with the blocking structure, and the second part is connected with the fixing structure. The depth/length of the left atrial appendage occluder can be adjusted through the relative movement between the first component and the second component in the detachable adjusting structure, so that the left atrial appendage occluder is suitable for left atrial appendages with different depths; furthermore, detachable regulation structure and fixed knot can the split between the structure to face the left auricle that shape, size are different, detachable regulation structure can select to connect the fixed knot structure of unidimensional not, with the different left auricle of adaptation shape.

Description

Left auricle plugging device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a left atrial appendage occluder.

Background

Atrial fibrillation (atrial fibrillation) is the most common sustained arrhythmia in clinic, and the incidence rate of atrial fibrillation in the common population is 0.5-1.3%. The atrial fibrillation is mainly harmed to promote thrombosis, and complications such as cerebral apoplexy, peripheral vascular embolism and the like are easily caused after thrombus falls off, so that the disability rate and the lethality rate are obviously increased. Stroke is the most common and most harmful complication of atrial fibrillation, with about 1500 million people worldwide per year suffering from stroke, with 20-25% of them being attributed to atrial fibrillation. Research shows that 60% of patients with rheumatic heart disease atrial fibrillation have cardiogenic thrombi from the left atrial appendage, and more than 90% of patients with non-valvular ward fibrillation have thrombi formed in the left atrial appendage. Therefore, the intervention of the left atrial appendage to prevent the thromboembolism of patients with atrial fibrillation, especially the stroke, has important theoretical basis and clinical significance.

Anticoagulant therapy is currently the standard method of preventing atrial fibrillation stroke complications, but there are certain limitations to anticoagulant therapy. Therefore, the method has important significance for preventing atrial fibrillation and stroke by adopting more effective and safe measures. Currently, medical intervention is used to treat left atrial appendage occlusion. Commonly used left atrial appendage occluders include a single Plug-in type occluder typified by WATCHMAN and a Plug-disk type left atrial appendage occluder typified by AMPLATZER Cardiac Plug (ACP).

1. Defects and shortcomings of inner plug type left atrial appendage occluder

The inner plug type occluder is a frame which takes nickel-titanium alloy as a self-expansion structure, fixed barbs are arranged around the inner plug type occluder, the atrial surface is covered by a polytetrafluoroethylene porous permeable membrane, and blood flow can enter and exit the left atrial appendage.

When the device is plugged into the left auricle, the shape of the oral part of the left auricle is irregular, and the device has limited deformability, so that the oral part of the left auricle can not be completely plugged, and thrombus formed on the oral part of the left auricle caused by atrial fibrillation is difficult to eliminate. The left auricle has different structural shapes and depths, and also has a multi-cavity structure, and the inner plug type left auricle occluder cannot completely adapt to all anatomical structures of the left auricle and cannot realize stable fixation.

2. Plug disc type left auricle occluder

The plug disk type occluder is a double-disk left atrial appendage occluder, which consists of a butterfly blade and a butterfly cap, wherein the butterfly blade and the butterfly cap are arranged in the left atrial appendage, the middle of the butterfly blade and the butterfly cap is connected by a sunken waist part, the butterfly blade is arranged in the left atrial appendage to prevent the occluder from shifting, and the butterfly cap seals the mouth part of the left atrial appendage.

The plug disc type left auricle plugging device is integrated with the fixed disc and cannot be completely and independently deformed, and after the plug is plugged into the left auricle, the disc part is buckled at the mouth of the left auricle and can be pulled by the plug part, so that the disc part cannot be fully attached to the mouth of the left auricle, and the best plugging effect is hardly achieved. Optimal fixation and blood flow blockage are difficult to achieve due to limited length adjustment of the plug portion and the disc portion, and the disc structure does not adapt to different shapes of left atrial appendage lumens.

In short, no matter the left atrial appendage occluder is of an inner plug type or a plug disc type, the left atrial appendage occluder has certain defects and shortcomings in different shapes and different depths, so that the structure of the occluder needs to be deeply researched to solve the defects and shortcomings in the prior art.

Disclosure of Invention

The invention aims to provide a left atrial appendage occluder to solve the problem that the existing left atrial appendage occluder is not strong in adaptability to left atrial appendages with different shapes and depths.

In order to solve the above technical problem, the present invention provides a left atrial appendage occluder, which includes an occlusion structure and a fixing structure, and further includes: the detachable adjusting structure comprises a first part and a second part which can be separated from or folded with the first part, the first part and the second part can move relatively, the first part is connected with the blocking structure, and the second part is connected with the fixing structure.

Optionally, in the left atrial appendage occlusion device, the detachable adjustment structure is a threaded nut structure, an external spline internal spline structure, or a buckle structure.

Optionally, in the left atrial appendage occluder, the left atrial appendage occluder further comprises at least one elastic connecting piece, and the first component is connected with the occlusion structure through the elastic connecting piece.

Optionally, in the left atrial appendage occluder, the left atrial appendage occluder further comprises a connecting fixing piece, one end of the connecting fixing piece is connected with one end of the elastic connecting piece, and the other end of the connecting fixing piece is connected with the detachable adjusting structure.

Optionally, in the left atrial appendage occlusion device, two ends of the elastic connecting piece are fixed installation structures, and the middle of the elastic connecting piece is a spiral spring structure.

Optionally, in the left atrial appendage occluder, the left atrial appendage occluder further comprises a connector for connecting with a left atrial appendage occluder delivery device.

Optionally, in the left atrial appendage occluder, the fixation structure comprises a plurality of fingers.

Optionally, in the left atrial appendage occlusion device, the fixing structure is a disk, and the disk is provided with a plurality of hooks.

In the left auricle occluder provided by the invention, the depth/length of the left auricle occluder can be adjusted through the relative movement between the first part and the second part in the detachable adjusting structure, so that the left auricle occluder can adapt to left auricles with different depths; furthermore, detachable regulation structure and fixed knot can the split between the structure to face the left auricle that shape, size are different, detachable regulation structure can select to connect the fixed knot structure of unidimensional not, with the different left auricle of adaptation shape.

Drawings

Fig. 1 is a schematic structural diagram of a left atrial appendage occluder in accordance with a first embodiment of the present invention;

FIG. 2 is a schematic structural diagram of a detachable adjusting structure and a connecting and fixing member according to an embodiment of the present invention;

FIG. 3 is a schematic structural view of an elastic connection unit according to an embodiment of the present invention;

figure 4 is a schematic structural diagram of another left atrial appendage occluder in accordance with a first embodiment of the present invention;

FIG. 5 is a schematic view of the use of a plurality of elastic connecting members according to a second embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a detachable adjustment structure according to a third embodiment of the present invention;

fig. 7 is a schematic structural diagram of a detachable adjustment structure according to a fourth embodiment of the present invention.

Detailed Description

The left atrial appendage occluder provided by the invention is further described in detail below with reference to the accompanying drawings and specific embodiments. Advantages and features of the present invention will become apparent from the following description and from the claims. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. In particular, different proportions are often used, as the drawing figures are to be distinguished.

[ EXAMPLES one ]

Fig. 1 is a schematic structural diagram of a left atrial appendage occluder according to an embodiment of the present invention. As shown in fig. 1, the left atrial appendage occluder 1 comprises: the left atrial appendage occluder comprises an occlusion structure 10 for occluding a left atrial appendage, a fixing structure 11 for fixing the left atrial appendage occluder 1 to the left atrial appendage, and a detachable adjusting structure 12, wherein the detachable adjusting structure 12 comprises a first part 120 and a second part 121 which can be separated from or folded with the first part 120, the first part 120 and the second part 121 can move relatively, the first part 120 is connected with the occlusion structure 10, and the second part 121 is connected with the fixing structure 11. Furthermore, the left atrial appendage occluder 1 comprises a connector 13, which connector 13 is intended to be connected to a left atrial appendage occluder delivery device (not shown in fig. 1).

The depth/length of the left atrial appendage occluder 1 can be adjusted by the relative movement between the first part 120 and the second part 121 in the detachable adjusting structure 12, so as to adapt to left atrial appendages with different depths; further, the detachable adjusting structure 12 and the fixing structure 11 can be separated (i.e. the second part 121 and the fixing structure 11 can be separated) so as to face left auricles with different shapes and sizes, and the detachable adjusting structure 12 can be selectively connected with fixing structures 11 with different sizes to adapt to left auricles with different shapes.

In particular, when the first part 120 is separated from the second part 121, the fixed structure 11 can be separated from the second part 121; when the first part 120 is brought together with the second part 121, the fixing structure 11 can be connected with the second part 121.

In the embodiment of the present application, the detachable adjusting structure 12 is a threaded nut structure, where the first member 120 is a threaded structure, the second member 121 is a nut structure, and the second member 121 can rotate on the first member 120, that is, the first member 120 and the second member 121 can move relatively.

With continued reference to fig. 1, in the embodiment of the present application, the first component 120 passes through the through hole of the fixing structure 11, and the second component 121 is screwed on the first component 120, so as to connect with the fixing structure 11 and fix the fixing structure 11. Here, the depth/length of the left atrial appendage occluder 1 can be adjusted by screwing the second part 121, so that the left atrial appendage occluder 1 can be adapted to different left atrial appendage depths. Meanwhile, the detachable adjusting structure 12 can be connected with the fixing structures 11 with different sizes, so that the left atrial appendage with different shapes can be adapted.

Further, the left atrial appendage occluder 1 further comprises at least one elastic connecting piece 14, and the first component 120 is connected with the occlusion structure 10 through the elastic connecting piece 14. Preferably, the depth of the elastic connection 14 is adjustable. Please refer to fig. 3, which is a schematic structural diagram of an elastic connecting member according to an embodiment of the present invention. As shown in fig. 3, the elastic connection member 14 is an elastic member, which may be made of metal or plastic. Specifically, the two ends of the elastic connecting piece 14 are fixed and installed structures, and the middle is a spiral spring structure. For example, the two ends of the elastic connecting member 14 are screw nut structures, and the elastic connecting member 14 can be fixedly connected with the blocking structure 10 or the first component 120 and other structures through the screw nut structures.

Referring also to fig. 1, the elastic connector 14 is connected to a joint 13 in the occlusion structure 10, and by pressing the joint 13, the depth/length of the elastic connector 14 can be changed, so that the left atrial appendage occluder 1 can better adapt to left atrial appendages of different depths. Further, a gasket may be disposed between the elastic connection member 14 and the joint 13, so as to ensure the strength and reliability of the connection between the elastic connection member 14 and the joint 13.

Further, the left atrial appendage occluder 1 further comprises a connecting and fixing member 15, one end of the connecting and fixing member 15 is connected with one end of the elastic connecting piece 14, and the other end of the connecting and fixing member 15 is connected with the detachable adjusting structure 12.

Please refer to fig. 2, which is a schematic structural diagram of a detachable adjusting structure and a connecting fixing member according to an embodiment of the present invention. In the embodiment of the present application, the connection fixing member 15 is a through hole structure, wherein both ends of the through hole structure are provided with a threaded nut structure. The elastic connecting member 14 and the first member 120 are fixedly connected to the connecting fixture 15 by the threaded nut structure. Specifically, one end 150 of the connecting and fixing member 15 is connected to the elastic connecting member 14, and the other end 151 is connected to the detachable adjusting structure 12. Here, the connecting fastener 15 is connected to the elastic connector 14 and the detachable adjusting structure 12 by screwing, so that the depth/length of the left atrial appendage occluder 1 can be further adjusted, and the left atrial appendage occluder 1 can be better adapted to different left atrial appendage depths.

In other embodiments of the present application, the end portion 150 may be a snap structure, and one end of the connection fixing member 14 is also a snap structure, and the connection fixing member 15 is fixedly connected to the elastic connection member 14 through the snap part. Here, the connection locations 15 can also be welded to the detachable adjustment structure 12.

With continued reference to fig. 1, in the embodiment of the present application, the blocking structure 10 is a disk, and the fixing structure 11 includes a plurality of hooks; in other embodiments of the present application, the fixing structure 11 may be a disk having a plurality of hooks (as shown in fig. 4).

The left atrial appendage occluder 1 is used as follows:

the left atrial appendage occluder 1 is guided to the tail end of the catheter by a channel established by the catheter by using a left atrial appendage occluder delivery device and is released at the tail end. When releasing, the fixing structure 11 with the claw firstly comes out of the sheath tube to ensure proper extension; after the left auricle cavity wall is fixed and positioned, the detachable adjusting structure 12 comes out; finally, the plugging structure 10 is buckled at the mouth of the left auricle and is fully attached, so that the best plugging effect is achieved.

When the left atrial appendage is recovered, the fixing structure 11 drives the hook claw to naturally recover from the cavity wall of the left atrial appendage in the opposite direction. In specific operation, the detachable adjusting structure 12 in this embodiment can be replaced with the fixing structure 11 of different specifications/sizes to adapt to the left atrial appendage structures with different shapes, so as to realize fixation; the length/depth of the left atrial appendage occluder can be adjusted by adjusting the position between the fixing structure 11 and the detachable adjusting structure 12 or the depth of the detachable adjusting structure 12 itself, so as to adapt to different left atrial appendage depths.

[ example two ]

The difference between the second embodiment and the first embodiment is that the number of the elastic connecting members in the first embodiment is one, and the number of the elastic connecting members in the second embodiment is multiple.

Specifically, please refer to fig. 5, which is a schematic diagram illustrating a plurality of elastic connection members according to a second embodiment of the present invention. In the present embodiment, as shown in fig. 5, the connection fixture 25 is two parallel flat plates, and the plurality of elastic connection members 24 are clamped between the two parallel flat plates. Preferably, the plurality of resilient connecting members 24 are evenly distributed in the two parallel plates.

In the present embodiment, each elastic connection member 24 may be fixed in two parallel flat plates by a fixing unit, for example, each elastic connection member 24 is fixed in two parallel flat plates by a screw and a nut. Specifically, the two ends of the elastic connecting piece 24 are fixed and installed structures, and the middle is a spiral spring structure. Here, the fixing and mounting structures at the two ends of the elastic connecting member 24 may be fixing holes, and the elastic connecting member 24 may be fixed to the connecting and fixing member 25 by passing screws through the fixing holes and a parallel plate and tightening the screws with nuts.

With continued reference to FIG. 5, in the present embodiment, a parallel plate is fixed to the removable adjustment structure (not shown in FIG. 5), preferably, the center of the parallel plate is connected to the removable adjustment structure; the further parallel plate is connected to a connector in the blocking structure, preferably with the central position of the further parallel plate connected to said connector.

In the second embodiment, the detachable adjusting structure is the same as the first embodiment, and the connection manner between the detachable adjusting structure and the fixing structure is also the same as the first embodiment, which is not described again in the second embodiment.

[ EXAMPLE III ]

The third embodiment of the present application is different from the first embodiment in that the detachable adjustment structure in the first embodiment is a threaded nut structure, and the detachable adjustment structure in the third embodiment is an external spline and internal spline structure.

Specifically, please refer to fig. 6, which is a schematic structural diagram of a detachable adjustment structure according to a third embodiment of the present invention. As shown in fig. 6, the detachable adjusting structure 32 includes a first member 320 and a second member 321 capable of being separated from or folded up from the first member 320, the first member 320 and the second member 321 are capable of moving relatively, the first member 320 is connected to the blocking structure, and the second member 321 is connected to the fixing structure. Wherein the first member 320 has an external/internal spline structure, and the second member 321 has an internal/external spline structure. The internal spline structure of the external spline has good centering property and guidance property, and more teeth and grooves have more uniform connection stress; because the groove is shallow, the stress concentration at the tooth root is small, and the strength is weakened less; the number of teeth is large, and the total contact area is large, so that a large load can be borne.

In the third embodiment, the length/depth of the left atrial appendage occluder can be adjusted by the insertion depth between the outer spline structure and the inner spline structure, so that the left atrial appendage occluder can adapt to different left atrial appendage depths.

The connection between the detachable adjusting structure and the elastic connecting member and the fixing structure can be referred to in the first embodiment, and details of the third embodiment are not repeated.

[ EXAMPLE IV ]

The difference between the fourth embodiment of the present application and the first embodiment of the present application is that the detachable adjusting structure in the first embodiment is a threaded nut structure, and the detachable adjusting structure in the fourth embodiment is a snap structure.

Specifically, please refer to fig. 7, which is a schematic structural diagram of a detachable adjustment structure according to a fourth embodiment of the present invention. As shown in fig. 7, the detachable adjusting structure 42 includes a first part 420 and a second part 421 capable of being separated from or folded with the first part 420, the first part 420 and the second part 421 are capable of making relative movement, the first part 420 is connected with the blocking structure, and the second part 421 is connected with the fixing structure. The first part 420 is a snap and/or engagement portion, and the second part 421 is a snap and/or engagement portion.

In the fourth embodiment, the length/depth of the left atrial appendage occluder can be adjusted by the insertion depth between the engaging portion and the fastening portion, so as to adapt to different left atrial appendage depths.

The connection between the detachable adjusting structure and the elastic connecting member and the fixing structure can be referred to in the first embodiment, and details thereof are not repeated in the fourth embodiment.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims

1. The utility model provides a left atrial appendage occluder, left atrial appendage occluder includes plugging structure and fixed knot structure, its characterized in that, left atrial appendage occluder still includes: the detachable adjusting structure comprises a first part and a second part which can be separated from or folded with the first part, the first part and the second part can move relatively, the first part is connected with the blocking structure, and the second part is connected with the fixing structure; the detachable adjusting structure and the fixed structure can be detached; the left atrial appendage occluder also comprises at least one elastic connecting piece, and the first component is connected with the occlusion structure through the elastic connecting piece; the left auricle occluder further comprises a connecting fixing piece, one end of the connecting fixing piece is connected with one end of the elastic connecting piece, the other end of the connecting fixing piece is connected with the detachable adjusting structure, the connecting fixing piece is of a through hole structure, both ends of the through hole structure are provided with threaded nut structures, and the elastic connecting piece reaches the first part through the threaded nut structures and is fixedly connected with the connecting fixing piece.

2. The left atrial appendage occluder of claim 1, wherein the removable adjustment structure is a threaded nut structure, an externally splined internally splined structure, or a snap-fit structure.

3. The left atrial appendage occluder of claim 1, wherein the resilient connecting members have fixed mounting structures at each end and a coil spring structure in the middle.

4. The left atrial appendage occluder of claim 1, further comprising a connector for connecting to a left atrial appendage occluder delivery device.

5. The left atrial appendage occluder of claim 1, wherein the fixation structure comprises a plurality of fingers.

6. The left atrial appendage occluder of claim 1, wherein the fixation structure is a disk having a plurality of fingers thereon.