CN115153676A

CN115153676A - Plugging device

Info

Publication number: CN115153676A
Application number: CN202210621925.2A
Authority: CN
Inventors: 李安宁; 刘建勇; 林志宏; 刘国良
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2021-12-28
Filing date: 2021-12-28
Publication date: 2022-10-11
Also published as: CN113974716A; CN113974716B

Abstract

The invention relates to an occlusion device, comprising a fixing part for fixing the occlusion device at a predetermined position and a sealing part for sealing, wherein the fixing part comprises a plurality of support rods, and at least one support rod spans over another adjacent support rod from the side of the proximal end. Through setting up at least one the bracing piece is strideed across adjacent another from near-end one side the bracing piece for when the bracing piece received the great deformation that takes place for the stress, the deformation of bracing piece can make it receive the supporting role of adjacent bracing piece, and then makes the bearing capacity of bracing piece promote, when a plurality of bracing pieces satisfy this design, the stress of exclusive action on certain bracing piece can be shared for whole fixed part.

Description

Plugging device

The application is a divisional application with application number 202111622600.8.

Technical Field

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

Background

In recent years, in patients with non-valvular ward fibrillation, stroke due to atrial fibrillation, 90% of which originates from the left atrial appendage. There are clinical data showing that when atrial fibrillation, the resection of the left atrial appendage during cardiac surgery can reduce the incidence of stroke, which suggests a hazard of the left atrial appendage in thromboembolism. Since the left atrial appendage is the pit for a thrombus, plugging the opening of the left atrial appendage can eliminate the basis for thrombus formation in the left atrial appendage. Generally, plugging the left atrial appendage by a left atrial appendage plugging device is an effective way to prevent stroke caused by atrial fibrillation.

In order to effectively block the left auricle, a left auricle blocking device needs to be implanted into the left auricle for a long time so as to realize the blocking effect. Therefore, the left atrial appendage occlusion device needs to have a certain anchoring structure, so that the left atrial appendage occlusion device can be stably occluded at the mouth of the left atrial appendage for a long time, and the problems of embolism of instruments and the like caused by falling of the left atrial appendage occlusion device are avoided.

In order to achieve long-term stability of the left atrial appendage occluder in occlusion of the left atrial appendage, a plurality of anchoring structures with sharp head ends, such as anchors or anchors hooks, are usually disposed on the left atrial appendage occluder support (at the junction of the left atrial appendage occluder and the atrial appendage wall) to penetrate into the atrial appendage wall, thereby achieving long-term implantation stability. Meanwhile, the auricle moves along with the contraction and relaxation of the heart, and the anchoring structure ensures that the plugging device is tightly attached to the inner wall of the left auricle, but the plugging device is driven to deform and move due to the movement of the auricle, and the sealing failure or weakening of the plugging device is easily caused by excessive deformation and movement, so that the left auricle plugging device with long-term anchoring stability needs to be designed.

Disclosure of Invention

Based on this, there is a need to provide a new occlusion device to solve the problem of the prior art that the occlusion device is easily deformed or moved by the pressure of the left atrial appendage to cause the seal to fail or weaken.

An occluding device comprising a fixing portion for fixing the occluding device at a predetermined position and a sealing portion for sealing, the fixing portion comprising a plurality of support rods, at least one of the support rods spanning from a proximal end side to another of the support rods adjacent thereto.

In one embodiment, the fixing portion further includes a connecting member, the connecting member connects the support rod and the sealing portion, the support rod includes a connecting portion, an extending portion and an expanding portion, which are sequentially connected from a proximal end to a distal end, and the connecting portion is connected to the connecting member.

In one embodiment, at least a portion of the extension of at least one of the support rods is located on a distal side of the extension of another adjacent support rod.

In one embodiment, the plurality of support bars includes a first support bar, a second support bar and a third support bar which are adjacent in sequence, and the first support bar spans the second support bar and the third support bar when extending.

In one embodiment, the extension of the first support bar is located at a distal end of the extension of the second support bar and the extension of the third support bar.

In one embodiment, the flared portions of a single support rod are deflected to opposite sides of the connecting portion.

In one embodiment, the extension angle of the expansion part is deflected by a value between 90 ° and 135 ° with respect to the extension angle of the connection part.

In one embodiment, any one of the support rods spans at least one other of the support rods.

In one embodiment, the number of the plurality of support bars is a, each support bar simultaneously spans b remaining support bars, the minimum deflection angle of the support bars is 360 ° · b/a, and the maximum deflection angle of the support bars is 360 ° · (b + 1)/a.

In one embodiment, at least two projections of the extending parts of the adjacent supporting rods on the same cross section have projection intersection points, and the projection intersection points are not overlapped with each other.

According to the plugging device provided by the invention, at least one supporting rod is arranged to cross another adjacent supporting rod from one side of the near end, so that when the supporting rod is subjected to larger stress and is deformed greatly, the supporting rod is subjected to the supporting action of the adjacent supporting rod due to the deformation of the supporting rod, the supporting capacity of the supporting rod is further improved, and when a plurality of supporting rods meet the design, the stress independently acting on one supporting rod can be distributed to the whole fixing part.

Drawings

Fig. 1 is a schematic structural view of a plugging device in embodiment 1 of the present invention;

fig. 2 is a schematic structural view of a fixing portion of a plugging device in embodiment 1 of the present invention;

fig. 3 is a schematic perspective view of a fixing portion of a plugging device in embodiment 1 of the present invention;

fig. 4 is a schematic structural diagram of a plugging device in embodiment 2 of the present invention;

fig. 5 is a schematic structural view of a fixing portion of a plugging device in embodiment 2 of the present invention;

fig. 6 is a schematic perspective view of a fixing portion of a plugging device in embodiment 2 of the present invention;

fig. 7 is a schematic diagram of the position of the support rod of the fixing portion of the plugging device in embodiment 2 of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the invention.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

The technical solution of the present invention will be described in further detail with reference to specific examples.

Example 1

As shown in fig. 1 to 3, fig. 1 is a schematic structural view of a plugging device 100 in embodiment 1 of the present invention, the plugging device includes a fixing portion 10 and a sealing portion 20 connected to the fixing portion 10, fig. 2 is a schematic structural view of the fixing portion 10 of the plugging device 100 in embodiment 1 of the present invention, fig. 3 is a schematic perspective view of the fixing portion 10 of the plugging device 100 in embodiment 1 of the present invention, and the sealing portion 20 and the fixing portion 10 are spaced apart from each other along an axial direction of the plugging device 100. The sealing portion 20 is located at the proximal end of the occluding device 100 and the fixing portion 10 is located at the distal end of the occluding device 100. The occluding device 100 has a collapsed state housed within the sheath for delivery and an expanded state as shown in figure 1 after extending from the distal end of the sheath and self-expanding. The configuration of the occluding device 100 after release in the left atrial appendage lumen is identical or substantially identical to that of figure 1.

The sealing part 20 is formed by weaving a plurality of woven wires into a net tube, and the two ends of the net tube close and fix the ends of the woven wires through a distal end plug of the sealing part respectively. The mesh tube is then heat set into a disc, cylinder or plug shape, etc., to obtain the seal 20 for sealing the left atrial appendage opening. At least one film (not shown) is disposed inside the sealing portion 20, and the edge of the film is fixed to the woven wire at the edge of the sealing portion 20. The membrane serves to prevent blood flow from one side of the seal 20 to the other, preventing blood flow communication between the left atrial appendage and the left atrium.

The fixing part 10 comprises a connecting piece 11 of the fixing part and a plurality of supporting rods 12, and the distal bolt head of the sealing part is fixed with the connecting piece 11 of the fixing part. The support rod 12 of the fixing portion 10 may be a rod obtained by cutting a metal alloy tube or a polymer tube, or may be a rod made of a braided wire by braiding, winding, or the like.

The proximal ends of the support rods 12 are connected with the connecting piece 11 of the fixing part, and the distal ends of the support rods extend radially outwards from the central end part and turn towards the sealing part, so that a support surface for contacting and supporting the wall of the left auricle cavity is formed.

The support pole 12 may have an anchor member 13, and the anchor member 13 is typically welded, heat fused, tangled, adhered, etc. to the support pole 12, but it is not excluded that the anchor member 13 is cut directly at the same time as the support pole 12 is cut.

In the present embodiment, the anchoring member 13 is a barbed structure, and the tip of the barbed structure pierces into the inner wall of the left atrial appendage, so that the fixing portion 10 is stably anchored on the inner wall of the left atrial appendage, and the occlusion device 100 achieves occlusion of the oral portion of the left atrial appendage.

In another embodiment, the fixing portion 10 is covered with a covering film to further seal the left atrial appendage while ensuring that the sealing portion 20 can achieve sealing, and to avoid excessive stress concentration on the surface of the fixing portion, and meanwhile, when the anchoring member 13 of the fixing portion 10 pierces the inner wall of the left atrial appendage to cause a micro wound, the covering film can block the root of the anchoring member 13, so as to avoid blood flowing out of the micro wound, and accelerate rapid climbing of the micro wound.

In this embodiment, referring to fig. 2-3, the proximal portion of the support rod 12 includes a connecting portion 121, an extending portion 122 and a spreading portion 123 which are connected in sequence, it should be noted that the support rod 12 may be integrally formed, and the connecting portion 121, the extending portion 122 and the spreading portion 123 are connected in sequence and do not mean that the support rod 12 is a separate structure. The connecting portion 121 is connected to the connecting member 11 on one side, and connected to the extending portion 122 on the other side, the extending portion 122 connects the connecting portion 121 and the extending portion 123, the extending portion includes a deflecting structure, so that the extending portion 123 is angularly deflected with respect to the connecting portion 121, in this embodiment, the deflecting structure of the extending portion 122 includes a spiral structure, and the proximal end of the extending portion 123 begins to extend outward from the distal end of the extending portion 122 as a starting point.

For a plurality of support rods 12, since the proximal ends of the expansion parts 123 are dispersed and the extension parts 122 of the respective support rods 12 are helical and parallel to each other, the support rods 12 are not easily twisted and knotted with each other. Since the spiral structure of the extension portion 122 reserves a part of space for the deformation of the support rod 12, the fixing portion 10 can be compressed better when the fixing portion 10 is sheathed, that is, the fixing portion 10 can adapt to a sheath tube with a smaller diameter.

Further, when the support rod 12 is gradually unfolded away from the sheath, since the helical structure itself has a restoring force to the original state, the unfolding of the support rod 12 is promoted, i.e., the presence of the extension portion 122 provides a better unfolding force for the unfolding of the support rod 12.

In this embodiment, the diameter of the connecting member 100 is equal to the diameter of the extending portion 122, when the left atrial appendage contracts and expands with the movement of the heart after the occlusion device 100 is implanted, the force component of the stress generated by the inner wall of the left atrial appendage to the supporting rod 12 can be divided into an axial direction and a radial direction, and since the extending portion 122 has reserved a partial space for the supporting rod 12 to move in the axial direction due to the arrangement of the spiral structure, the supporting rod 12 can adapt to the axial force component of the stress generated by the left atrial appendage to move adaptively, and meanwhile, the radial force component of the stress generated by the left atrial appendage is transmitted along the rod of the supporting rod 12, when reaching the spiral structure of the extending portion 122, the spiral structure is driven to move radially to the opposite side of the proximal end of the expanding portion 123 (i.e., the diameter of the extending portion 122 is expanded), and when the radial force is eliminated, the restoring force of the spiral structure and the restoring force of the supporting rod 12 act simultaneously to restore the fixing portion 10 to be always tightly attached to the inner wall of the left atrial appendage.

That is, since the expansion portion 123 of the supporting rod 12 is angularly deflected with respect to the connecting portion 121, when the stress of the left atrial appendage on the supporting rod 12 is transmitted along the supporting rod 12, a part of the stress is offset by the radial deformation of the supporting rod 12, so as to avoid the excessive axial deformation of the supporting rod 12 with the sealing portion 20.

In another embodiment, the diameter of the connecting member 11 is smaller than the diameter of the extending portion 122, and when the left atrial appendage contracts and expands with the movement of the heart after the occlusion device 100 is implanted, since the diameter of the extending portion 122 is larger than the diameter of the connecting member 11, the axial movement space reserved by the extending portion 122 is larger, and the axial movement of the support rod 12 is facilitated to accommodate the axial stress component brought by the left atrial appendage.

In the present embodiment, the extending portion 123 is linear after being separated from the extending portion 122, and in order to avoid excessive concentration of stress at the corner when the stress is transmitted to the extending portion, the connecting position of the extending portion 123 and the extending portion 122 forms an angle α (preferably an obtuse angle), and similarly, the connecting position of the extending portion 122 and the connecting portion 121 forms an angle β (preferably an obtuse angle), and in order to make the transmission of the stress more smooth, the obtuse angle α ≧ obtuse angle β.

In another embodiment, the expansion portion 123 is gradually and spirally expanded outwards along the spiral line of the extension portion 122, and when the stress generated by the left atrial appendage is transmitted along the expansion portion 123 and transmitted to the position of the extension portion 122, the stress is maximally counteracted by the spiral structure, so that the stress applied to the sealing portion 20 is reduced. In this embodiment, the obtuse angle α has a value of approximately or equal to 180 °, and the expansion 123 can also be considered as a spiral arrangement.

In the present embodiment, the extension angle of the spiral structure of the extension portion 122 (i.e., the central angle of the corresponding arc from the start point to the end point of the spiral) is greater than 90 ° and less than 180 °, so that the risk of winding and kinking between the plurality of support rods 12 can be minimized.

In another embodiment, the helical configuration of the extension 122 extends over an angle greater than 180 °.

In another embodiment, the helical structure of the extension 122 extends over one or more turns.

Example 2

The difference between the plugging device of embodiment 2 and embodiment 1 is that, referring to fig. 4-6, the deflecting structure of the extending portion 322 does not include a spiral structure, fig. 4 is a schematic structural view of the plugging device of embodiment 2 of the present invention, fig. 5 is a schematic structural view of the fixing portion 30 of the plugging device of embodiment 2 of the present invention, and fig. 6 is a schematic perspective view of the fixing portion 30 of the plugging device of embodiment 2 of the present invention.

In this embodiment, the fixing portion 30 also includes a connecting member 31 and a plurality of support rods 32, and the proximal ends of the support rods 32 are fixed to the connecting member 31.

The inner side of the support bar 32 includes a connecting portion 321, an extending portion 322 and an expanding portion 323, which are connected in sequence, it should be noted that the support bar 32 may be integrally formed, and the description of the connecting portion 321, the extending portion 322 and the expanding portion 323 does not mean that the support bar 32 is a separate structure. The connecting portion 321 is connected to the connecting member 31 at one side and connected to the extending portion 322 at the other side, the extending portion 322 includes an arc-shaped deflecting structure, and the proximal end of the expanding portion 323 starts to expand outward from the distal end of the extending portion 322.

In the present embodiment, the expanding portion 323 follows the extending curve of the extending portion 322, so there is no obvious boundary between the expanding portion 323 and the extending portion 322, and for making a difference, the portion of the supporting rod 32 projected on the distal plane of the connecting member is regarded as the expanding portion 323 of the supporting rod 32 in the present embodiment, and the portion of the supporting rod 32 projected beyond the boundary of the connecting member 31.

For example 1, the support rods are actually separated from each other, and the stress and deformation of the support rods do not affect each other, whereas in example 2, the support rods have a certain relation with each other, specifically as follows:

in this embodiment, it is preferable that there are 8 support rods 32, including the optional first support rod 41 and the second support rod 42 and the third support rod 43 which are adjacent to each other in the counterclockwise direction, and it should be noted that the counterclockwise direction is selected because the support rods 32 of this embodiment are deflected in the counterclockwise direction from the proximal end to the distal end, and the direction itself has no effect as long as it is satisfied that all the support rods 32 are deflected in the same direction.

For the first support bar 41, the connection portion 411 thereof is close to a straight line, and a large deflection occurs at the extension portion 412, so that the development portion 413 of the first support bar 41 is deflected to an obliquely opposite side of the connection portion 411. The reason why the extension portions 413 of the first support rod 41 are arranged on the oblique opposite sides is that when the extension portions 413 of the first support rod 41 extend to the opposite sides of the connecting portion 411, the extension portions of the other support rods also extend to the opposite sides of the connecting portion, so that the extension portions of all the support rods are intersected or spaced too close to each other, the support rods are wound and knotted, and the influence on the normal operation of the plugging device due to the fact that the support force of each support rod is too large or deformed due to the intersection of the extension portions is also prevented.

Referring to fig. 6-7, fig. 7 is a schematic diagram of only the first support bar, the second support bar and the third support bar, in this embodiment, the first support bar 41 spans the second support bar 42 and the third support bar 43 when extending, and the extension portion 412 of the first support bar 41 is located at the distal end of the extension portion of the second support bar 42 and the third support bar 43, so that when the first support bar 41 is subjected to a larger stress and is deformed greatly, the deformation of the first support bar 41 can make it supported by the second support bar 42 and the third support bar 43, and further the supporting ability of the first support bar 41 is improved, and the second support bar 42 and the third support bar 43 simultaneously span the other support bars, so as to distribute the stress acting on the first support bar 41 to the whole fixing portion 30.

If the first support bar 41 is deformed distally by a stress, the first support bar 41 is also spanned by the other support bars, and thus the same force is transmitted to the other support bars.

Further, since the first support rod 41 is an optional support rod, and the expanded portion 413 of the first support rod 41 is deflected to an oblique side of the connecting portion 411, while the first support rod 41 extends to span the second support rod 42 and the third support rod 43, the projection intersection point of the first support rod 41 and the second support rod 42 and the projection intersection point of the second support rod 42 and the second support rod 43 do not overlap on the plane of the distal end of the connecting member 31, and in another embodiment, the projection intersection points of any two support rods do not overlap with each other.

In order to make the support bar 32 achieve the effect of the present embodiment, the extension 42 of the first support bar 41 intersects with the extension of the second support bar 42 and the extension of the third support bar 43 at the same time on the plane of the distal end of the connecting member 31.

In the present embodiment, the supporting rod is angularly deflected from the connecting portion to the spreading portion, and the deflection angle of the supporting rod is between 90 ° and 135 °.

In another embodiment, the number of struts is a, each strut spans b of the remaining struts, the strut is deflected by a minimum angle of 360 ° · b/a and a maximum angle of 360 ° · (b + 1)/a.

In another embodiment, each support rod spans 1 support rod adjacent to the support rod, and at least a part of the extension of the support rod is located at the distal end side of the extension of the support rod adjacent to the support rod, so that when the support rod is pressed by the left atrial appendage, the pressure is transmitted to the extension to deform the extension of the support rod towards the proximal end, and at the same time, the extension of the support rod adjacent to the proximal end can support the support rod.

It should also be noted that, since the extension part of the support rod of the present embodiment has the same deflection structure as the spiral structure in embodiment 1, it also has the same technical effects as the spiral structure in embodiment 1.

It should be noted that the technical features of the above-mentioned embodiments can be combined arbitrarily, and can also be applied to the above-mentioned left atrial appendage occluders and similar left atrial appendage occluders. For the sake of brevity, all possible combinations of features in the above-described embodiments are not described, but rather, the scope of the description should be construed as being limited only to the combinations of features described in this specification as long as such combinations are not inconsistent.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. An occlusion device comprising a fixing portion for fixing said occlusion device at a predetermined position and a sealing portion for sealing, characterized in that said fixing portion comprises a plurality of support rods, at least one of said support rods spanning from a proximal end side over another of said support rods which is adjacent.

2. The occlusion device of claim 1, wherein the fixation portion further comprises a connector connecting the support rod and the sealing portion, the support rod comprising a connecting portion, an extending portion, and a deployment portion sequentially connected from a proximal end to a distal end, the connecting portion being connected to the connector.

3. The occlusion device of claim 2, wherein at least a portion of the extension of at least one of the support rods is located on a distal side of the extension of another support rod that is adjacent.

4. The occlusion device of claim 2, wherein the plurality of support bars comprises a first support bar, a second support bar, and a third support bar that are sequentially adjacent, the first support bar spanning the second support bar and the third support bar when extended.

5. The occlusion device of claim 4, wherein the extension of the first support rod is distal to the extension of the second support rod and the extension of the third support rod.

6. The occlusion device of claim 2, wherein the flared portion of a single support rod is deflected to an opposite side of the connection portion.

7. The occlusion device of claim 6, wherein the angle of extension of the deployment portion is deflected by a value between 90 ° and 135 ° relative to the angle of extension of the connection portion.

8. The occlusion device of any of claims 1-7, wherein any of the support rods spans at least one other of the support rods.

9. The occlusion device of any of claims 1-7, wherein the plurality of struts is a, each strut spanning b remaining struts simultaneously, the struts deflecting a minimum angle of 360 ° -b/a and a maximum angle of 360 ° - (b + 1)/a.

10. The occlusion device of any of claims 1-7, wherein there are projection intersections of projections of the extensions of at least two adjacent support rods on the same cross-section, and wherein a plurality of the projection intersections do not coincide with each other.