CN116407196A - Plugging device - Google Patents

Abstract

The invention relates to a plugging device which comprises a fixing part, a sealing part and a connecting part for connecting the sealing part and the fixing part, wherein the fixing part comprises a supporting body, the supporting body radially extends outwards from a converging position and is turned over by a turning part to form the supporting part, the connecting part comprises a buffer part, the buffer part is positioned between the fixing part and the sealing part, and the buffer part comprises a telescopic structure. In the plugging device, the buffer part is additionally arranged, and when the fixing part moves along with the inner wall of the left auricle, the buffer part can partially counteract or eliminate the deformation of the fixing part, so that the deformation and stress of the fixing part are less or completely eliminated when transmitted to the sealing part, the sealing of the plugging device is always stable, and the opening position of the sealing part relative to the left auricle is kept unchanged.

Description

Plugging device

Technical Field

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

Background

In recent years, in patients with non-valve ward fibrillation, 90% of the strokes due to atrial fibrillation originate from the left atrial appendage. When clinical data shows atrial fibrillation, removal of the left atrial appendage during cardiac surgery can reduce the incidence of cerebral stroke, suggesting a risk of left atrial appendage in thromboembolism. Since the left atrial appendage is the thrombus, plugging the left atrial appendage opening eliminates the basis for thrombus formation in the left atrial appendage. Generally, left atrial appendage occlusion by a left atrial appendage occlusion device is an effective way to prevent cerebral stroke caused by atrial fibrillation.

In order to effectively seal the left auricle, the left auricle sealing device needs to be implanted into the left auricle for a long time so as to realize the sealing effect. Therefore, the left auricle occluder needs to have a certain anchoring structure, so that the left auricle occluder can be stably occluded in the left auricle opening for a long time, and the problems of instrument embolism and the like caused by falling off of the left auricle occluder are avoided.

In order to realize the long-term stability of the left auricle occluder in the left auricle opening, a plurality of anchoring structures with sharp head ends, such as anchor thorns or anchor hooks, are usually arranged on the supporting part of the left auricle occluder (the junction of the left auricle occluder and the auricle wall) so as to penetrate into the auricle wall, thereby realizing the long-term implantation stability. Meanwhile, the auricle moves along with the heart in a contraction and relaxation manner, the anchoring structure ensures the close fit between the plugging device and the inner wall of the left auricle, but after the left auricle plugging device is implanted, the fixing part of the left auricle plugging device can deform due to the influence of radial force and auricle contraction and relaxation, and the sealing part is easily driven to be separated from the left auricle along the axial direction due to overlarge deformation, so that plugging failure is caused.

Disclosure of Invention

Based on this, it is necessary to provide an improved plugging device for solving the problem that the deformation of the fixing part of the existing left atrial appendage plugging device easily drives the sealing part to displace so as to separate from the left atrial appendage to cause leakage.

The utility model provides a plugging device, includes fixed part, sealing part and connects sealing part and fixed part's connecting portion, the fixed part includes the supporter, the supporter radially outwards extends from the position of gathering and forms the supporting part through upset of upset portion upset, the connecting portion includes the buffer part, the buffer part is located between the fixed part with the sealing part, the buffer part includes telescopic extending structure.

In one embodiment, the cushioning portion includes a radially telescoping structure.

In one embodiment, the plurality of support bodies extend after crossing at the distal end side of the buffer portion.

In one embodiment, the cushioning portion includes a circumferentially distributed mesh structure.

In one embodiment, the projection of the free end of the support part on the longitudinal section falls within the projection range of the buffer part on the longitudinal section.

In one embodiment, the maximum outer diameter of the buffer portion in the unstressed state is larger than the maximum inner diameter of the fixing portion.

In one embodiment, the distal outer diameter of the bumper is greater than the proximal outer diameter thereof.

In one embodiment, the proximal outer diameter of the bumper is greater than the distal outer diameter.

In one embodiment, a blocking film is attached to the buffer portion.

In one embodiment, the fixing portion and the buffer portion are integrally formed.

Compared with the prior art, the plugging device has the advantages that the buffer part is additionally arranged between the fixing part and the sealing part, and when the fixing part moves along with the inner wall of the left auricle, the buffer part can partially counteract or eliminate the deformation of the fixing part, so that the deformation and the stress of the fixing part are less or completely eliminated when transmitted to the sealing part, the sealing of the plugging device is always stable, and the opening position of the sealing part relative to the left auricle is kept unchanged.

Drawings

FIG. 1 is a schematic view showing the structure of an occluding device in embodiment 1 of the present invention;

FIG. 2 is a schematic view showing the structure of the plugging device in embodiment 2 of the present invention;

FIG. 3 is a schematic view showing the structure of a buffer portion of the plugging device in embodiment 2 of the present invention;

FIG. 4 is a schematic view showing the structure of the plugging device in embodiment 3 of the present invention;

FIG. 5 is a schematic view showing the structure of an occluding device in embodiment 4 of the present invention;

FIG. 6 is a schematic view showing the structure of the plugging device in embodiment 5 of the present invention;

FIG. 7 is a schematic view showing the structure of an occluding device in embodiment 6 of the present invention;

fig. 8 is a schematic structural view of an occlusion device according to still another embodiment of embodiment 6 of the present invention;

FIG. 9 is a schematic view showing the structure of an occluding device in embodiment 7 of the present invention;

FIG. 10 is a schematic view showing the structure of an occluding device in embodiment 8 of the present invention;

fig. 11 is a schematic cross-sectional view showing the structure of the plugging device in embodiment 9 of the present invention.

Detailed Description

The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of 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 a "proximal end", the end farther from the operator is generally referred to as a "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 longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle. Reference in the examples to "connected" includes both the case where two components are directly connected and the case where they are indirectly connected by other components.

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

Example 1

The occlusion device of example 1 can be used to occlude the left atrial appendage and also to occlude other body tissues having openings, such as atrial septal defects. The following will describe the plugging device in detail taking the plugging of the left atrial appendage as an example.

Referring to fig. 1, fig. 1 is a schematic structural diagram of a plugging device 100 in embodiment 1 of the present invention, wherein the plugging device 100 includes a fixing portion 120 and a sealing portion 110 connected to the fixing portion 120. The sealing portion 110 and the fixing portion 120 are disposed at intervals in the axial direction of the occlusion device 100. The sealing portion 110 is located at the proximal end of the occluding device 100 and the securing portion 120 is located at the distal end of the occluding device 100. The occluding device 100 has a compressed state housed within the sheath for delivery and a deployed state shown in figure 1 after extending from the distal end of the sheath and self-expanding deployment. The occlusion device 100 has a configuration after release in the cavity of the left atrial appendage that is identical or substantially identical to that of fig. 1. In other implementations, such as for atrial septal defect occlusion, the sealing portion 110 and the securing portion 120 may abut one another after release to secure the occluding device 100 to the space between the left atrium and the right atrium.

The sealing part 110 is a mesh tube formed by braiding a plurality of braiding wires 111, and both ends of the mesh tube are respectively closed and fixed at the ends of the braiding wires 111 through a sleeve. The mesh tube is then heat-set into a disk-like, columnar, plug-like or the like shape, thereby obtaining a sealing portion 110 for sealing the opening of the left atrial appendage. The sealing portion 110 includes a distal disc surface 112 facing the fixing portion 120, and a proximal disc surface 113 opposite to the distal disc surface 112. The inside of the sealing part 110 is provided with at least one layer of film body (not shown in the drawing), the edges of which are fixed to the woven wires 111 at the edges of the sealing part 110. The membrane 114 serves to block blood flow from one side of the seal 110 to the other to block blood flow between the left atrial appendage and the left atrium.

The fixed part 120 includes a central end 121 and a plurality of supporters 122, and the distal sleeve 115 of the sealing part 110 is connected to the central end 121. The support 122 on the fixing portion 120 may be a rod obtained by cutting a metal alloy tube or a polymer tube, or may be a rod formed by braiding or winding the braided wire 111.

The proximal ends of the plurality of support bodies 122 are each connected to the central end portion 121, and the distal ends thereof extend radially outwardly from the central end portion 121 to form connection sections which are extended and then flipped toward the sealing disk to form flipping portions 123. The support 122 continues to extend from the distal end of the flip portion 123 toward the sealing portion 110 to form a support segment 124, the support segment 124 is configured to bear against the left atrial appendage, the support segment 124 continues to extend toward the sealing portion 110 to form a suspension segment 126, and the suspension segment 126 can either continue to extend along the direction of the support segment 124 or deflect and flip inwardly of the support segment 124 to avoid damage to the left atrial appendage.

As shown in fig. 1, the outer side of the support section 124 is provided with an anchoring structure 125 which is inclined outwards and towards the sealing portion 110, the anchoring structure 125 comprising a spike-like structure arranged at its tip, the anchoring structure 125, after implantation of the occlusion device 100, achieving anchoring by penetrating the inner wall of the left atrial appendage with its spike-like structure, thereby anchoring the entire occlusion device 100.

In another embodiment, the outer portion of the fixing portion 120 is covered with a covering film, so as to further seal the left atrial appendage and prevent the left atrial appendage from concentrating on the surface of the fixing portion when the anchoring member 125 of the fixing portion 120 pierces the inner wall of the left atrial appendage to cause a micro wound, and the covering film can block the root of the anchoring member 125, thereby preventing blood flow from flowing out of the micro wound and accelerating rapid climbing of the micro wound.

When the plugging device 100 is implanted in the left auricle, the fixing portion 120 is anchored on the inner wall of the left auricle by the anchor 125, and the left auricle is driven to contract and expand due to the contraction and expansion of the left auricle following the beating of the heart, to be precise, the supporting section 124 is driven to contract and expand firstly, so as to drive the whole of the fixing portion 120 to contract and expand, wherein when the supporting section 124 contracts, the relative position of the anchor 125 and the left auricle remains unchanged, the inward contracted deformation of the supporting section 124 is transferred to the position of the central end 121 of the fixing portion 120, so that the central end 121 is driven to be axially far away from the inside of the left auricle, and the sealing portion 110 is driven to be separated from the left auricle, so that the sealing failure is caused.

For the plugging device 100, the turning part 123 shares a part of the stress from the supporting section 124 and changes its orientation, and the turning part 123 also deforms to counteract the deformation from the supporting section 124, so in this embodiment, the buffer part of the plugging device 100 is disposed at the position of the turning part 123, the turning part 123 includes a plurality of turning sections, the turning sections change the orientation of the supporting body, and the buffer part of this embodiment includes at least a first turning section 1231, a second turning section 1232 and a third turning section 1233 disposed adjacently.

When the left atrial appendage moves in a contraction and relaxation manner following the beating of the heart, the contraction and relaxation of the supporting segment 124 is transmitted to the third overturning segment 1233, the third overturning segment 1233 deforms, the deformation is continuously transmitted, and when the deformation is transmitted to the first overturning segment 1231 through the connecting segment, the deformation of the supporting segment 124 is largely counteracted, so that the axial displacement of the central end 121 is small and even approaches 0, and the sealing state of the plugging device 100 is maintained.

Further, in another embodiment, for the cushioning portion, the cushioning portion includes an odd number of overturning segments, which has the effect that, on one hand, the odd number of overturning segments can ensure that the free end of the supporting segment 124 faces the sealing portion 110, and on the other hand, when the left atrial appendage follows the beating of the heart and performs the contraction and relaxation movements, the deformation is transferred to the overturning segments and then transferred to the connecting segments, and when the overturning segments overturn the supporting body extending towards the distal end to the proximal end, the connecting segments are used for connecting the overturning segments, which just overturn the supporting body extending towards the distal end, the deformation transferred to the connecting segments is largely counteracted or even reversed, and the deformation transferred to the next overturning segments is further counteracted, so as to compensate the deformation of the supporting segments to the greatest extent.

In the case of example 2,

the same parts of this embodiment and embodiment 1 will not be repeated, and the main difference is that, referring to fig. 2-3, fig. 2 is a schematic structural diagram of the plugging device 200 in embodiment 2 of the present invention, and fig. 3 is a schematic structural diagram of a buffer portion of the plugging device 200 in embodiment 2 of the present invention, where the buffer portion includes a first flip section 2231, a second flip section 2232 and a third flip section 2233, and the first flip section 2231 and the third flip section 2232 are partially overlapped to reduce the overall diameter of the fixing portion 220, so as to avoid that the fixing portion 220 cannot be implanted into an implantation site with a smaller partial caliber.

Importantly, the buffer portion of the present embodiment may be provided with a plurality of turnover portions without enlarging the diameter of the fixing portion 220, so as to obtain the best deformation resistance effect.

Example 3

The same parts of this embodiment as those of embodiment 1 will not be repeated, and the main difference is that, referring to fig. 4, fig. 4 is a schematic structural diagram of an occlusion device 300 in embodiment 3 of the present invention, where a supporting section 324 of the occlusion device extends towards the distal end, and a buffer portion of this embodiment includes a first turnover section 3231 and a second turnover section 3232, and an even number of turnover sections are added up. In this embodiment, the axial length of the support section 324 is shorter, and the deformation of the support section 324 is transmitted to the position of the second turning section 3232 to a greater extent, so that the deformation is sufficiently counteracted by the buffer portion, preferably, the axial length of the support section 324 is less than half of the maximum axial distance from any position of the turning portion to the most distal end of the fixing portion.

Example 4

The main difference between this embodiment and embodiment 3 is that, referring to fig. 5, fig. 5 is a schematic structural diagram of the plugging device 400 in embodiment 4 of the present invention, the supporting section 424 of the plugging device extends distally, the buffer portion of this embodiment includes a first turning section 4231 and a second turning section 4232, but, additionally, the supporting section 424 is provided with an auxiliary buffer portion 4243 at a distal end, the auxiliary buffer portion 4243 extends gradually and spirally inwards, a free end of the auxiliary buffer portion 4243 is located at an innermost side of the spiral structure, when the supporting section 424 is deformed by pressure from the left atrial appendage, the distal end of the supporting section 424 is close to the second turning section 4232, and the distance between the auxiliary buffer portion 4243 and the second turning section 4232 is smaller, the auxiliary buffer portion 4243 is abutted against a surface of the second turning section 4232, and when the supporting section 42424 is continuously deformed by pressure, besides the deformation of the first turning section 31 and the second turning section 4232, a part of the auxiliary buffer portion 4243 is also transferred to the auxiliary buffer portion 4243, and thus the auxiliary buffer portion 4243 is also transferred to the spiral buffer portion 4243. In summary, the auxiliary buffer 4243 also functions as a buffer.

Example 5

The same parts of this embodiment and embodiment 1 will not be repeated, and the main difference is that, referring to fig. 6, fig. 6 is a schematic structural diagram of the plugging device 500 in embodiment 5 of the present invention, where the buffer portion 530 of the plugging device 500 of this embodiment is disposed at the connection position of the sealing portion 510 and the fixing portion 520, and it should be noted that the connection position includes not only the buffer portion 530 as a part of the connection structure of the connection position, but also the buffer portion 530 as a connection structure of the sealing portion 530 and the fixing portion 520. The buffer part 530 is provided in a telescopic structure or an elastic structure, whereby when deformation of the fixing member 520 in the axial direction is transferred to the position of the buffer part 530, the deformation is counteracted by the deformation of the buffer part 530, thereby ensuring the sealing reliability of the sealing part 510.

Furthermore, it should be noted that since the axial length of the buffer 530 is variable, the occluding device 500 in this embodiment is still able to accommodate a shallower depth left atrial appendage configuration when facing that configuration.

In this embodiment, the buffer portion 530 is a spring structure.

In another embodiment, the connecting piece is of an axially telescopic structure and comprises a first pipe and a second pipe sleeved along an axis, wherein the first pipe and the second pipe can move relatively, and the first pipe and the second pipe are connected by a spring.

In another embodiment, the connecting member is an axially telescopic structure, and the connecting member comprises a plurality of rods which are axially arranged, and the rods are mutually arranged to form a diamond structure.

Example 6

The main difference between this embodiment and embodiment 5 is that, referring to fig. 7, fig. 7 is a schematic structural diagram of the plugging device 600 in embodiment 6 of the present invention, where the buffer portion 630 of the plugging device 600 is disposed at a connecting piece between the sealing portion 610 and the fixing portion 620, and it should be noted that, the buffer portion 630 of this embodiment is a mesh structure distributed along a circumferential direction, that is, a disc-shaped structure, except for the axial and radial stretchability of the mesh structure, in this embodiment, when the support section 624 of the fixing portion 620 is deformed by the pressure from the left atrial appendage, the support section 624 is drawn toward the axial direction until abutting against the edge of the buffer portion 630, so as to enhance the radial supporting force of the plugging device 600, preferably, the free end of the support section 624 is located between the proximal end and the distal end of the buffer portion 630 in the axial direction, that is, the projection of the free end of the buffer portion 624 on the longitudinal section passing through the axis falls within the projection range of the buffer portion 630 on the longitudinal section passing through the axis.

Further, the outer diameter of the buffer portion 630 in the unstressed state is larger than the inner diameter of the fixing portion 620, so that the buffer portion 630 abuts against the inner side of the supporting section 624 of the fixing portion 620 in the natural state, and the radial supporting force of the fixing portion 620 has been improved.

In another embodiment, referring to fig. 8, both the fixing portion 621 and the buffering portion 631 are cut and shaped by a nickel-titanium tube, so that the total height of the plugging device can be reduced, and the plugging device can be stretched along the axial direction (i.e. the height direction) by combining with the arrangement of the buffering portion 631, so that the plugging device can adapt to the left auricle environment with a larger depth range. Preferably, the plurality of support rods cross at the distal end side of the buffer portion 631, and the support rods extend to opposite sides through the center line of the buffer portion 631, i.e., are bent to extend toward the opposite sides, so that the plurality of support rods of the present embodiment cross at the center line position of the buffer portion 631. When the plugging device is implanted, the component force of the stress generated by the inner wall of the left auricle on the support rod can be divided into an axial direction and a radial direction along with the movement of the heart when the plugging device is contracted and expanded, the included angle between the support rod and the axis line can be larger relative to the non-crossed included angle by the support rod, so that the component force of the stress generated by the inner wall of the left auricle on the support rod along with the transmission of the support rod is larger because of the included angle between the support rod and the axis line, the component force of the stress in the radial direction is larger, the component force in the axial direction is smaller, and the component force in the radial direction can be counteracted by the deformation of the buffer part 631, thereby the adaptive axial deformation of the buffer part 631 is smaller, and the stability of the plugging device is ensured.

Example 7

The main difference between this embodiment and embodiment 6 is that, referring to fig. 9, fig. 9 is a schematic structural diagram of the plugging device 700 in embodiment 7 of the present invention, the structure of the buffer portion 730 of the plugging device 700 in this embodiment is changed relative to that of embodiment 6, and the buffer portion 730 has a tapered structure or a trapezoid structure, in this embodiment, the outer diameter of the distal end side of the buffer portion 730 is larger than the outer diameter of the proximal end side thereof, so that the large outer diameter portion of the buffer portion 730 is close to the inner side of the fixing portion 720 as much as possible, and the supporting force of the buffer portion 730 to the fixing portion 720 is further ensured to be improved.

In another embodiment, the cross section of the buffer portion 730 may be a combination of multi-layered trapezoids with gradually changing outer diameters.

Example 8

The main difference between the present embodiment and embodiment 7 is that, referring to fig. 10, fig. 10 is a schematic structural diagram of the plugging device 800 in embodiment 8 of the present invention, the structure of the buffer portion 830 of the plugging device 800 is changed relative to embodiment 7, the buffer portion 830 has a tapered structure or a trapezoid structure, in this embodiment, the outer diameter of the proximal side of the buffer portion 830 is larger than the outer diameter of the distal side thereof, and a plugging film is attached in the proximal side of the buffer portion 830, so that the plugging device plays a role in assisting in plugging on the basis of the sealing portion 810, i.e., the dual plugging role is realized.

Preferably, the maximum outer diameter of the buffer portion 830 is equal to the outer diameter of the sealing portion 810.

Example 9

The same parts of this embodiment and embodiment 5 will not be described again, and the main difference is that, referring to fig. 11, fig. 11 is a schematic structural section of the plugging device 900 in embodiment 9 of the present invention, the buffer portion 930 of the plugging device 900 of this embodiment is disposed at the position of the connecting member between the sealing portion 910 and the fixing portion 920, specifically, the buffer portion 930 is located at the contact position between the connecting member 931 and the sealing portion 910, in this embodiment, the sealing portion 910 is a woven structure, the converging position of which is concave inwards to form the buffer portion 930, and then is connected with the connecting member 931, and since the flexibility of the sealing portion 910 is higher, the flexibility of the buffer portion 930 is also higher, and thus the deformation from the fixing portion 920 can be counteracted.

In another embodiment, the fixing portion and the buffer portion are integrally formed, so that the overall volume of the plugging device is reduced to a greater extent.

In another embodiment, the fixing portion, the buffer portion and the sealing portion are integrally formed.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. The utility model provides a plugging device, includes fixed part, sealing part and the connecting portion of connecting sealing part and fixed part, its characterized in that, the fixed part includes many support bodies, the support body radially outwards extends and forms the supporting part through the upset, the connecting portion includes the buffering portion, the buffering portion is located between fixed part with the sealing part, the buffering portion includes telescopic extending structure.

2. The occlusion device of claim 1, wherein said cushioning portion comprises a radially telescoping structure.

3. The occlusion device of claim 1, wherein a plurality of said struts extend after crossing at a distal side of the cushioning portion.

4. The occlusion device of claim 2, wherein said cushioning portion comprises a circumferentially distributed mesh structure.

5. The occlusion device of claim 4, wherein a projection of a free end of said support portion at a longitudinal section falls within a projection of said cushioning portion at a longitudinal section.

6. The occlusion device of claim 4, wherein a maximum outer diameter of said buffer portion in an unstressed condition is greater than a maximum inner diameter of said anchor portion.

7. The occlusion device of claim 6, wherein said cushioning portion has a distal outer diameter greater than a proximal outer diameter thereof.

8. The occlusion device of claim 4, wherein a proximal outer diameter of said cushioning portion is greater than a distal outer diameter.

9. The occlusion device of claim 1, wherein an occlusion membrane is attached within said buffer.

10. The occlusion device of any of claims 1-9, wherein said securing portion and said cushioning portion are integrally formed.

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