WO2022121630A1

WO2022121630A1 - Occlusion device

Info

Publication number: WO2022121630A1
Application number: PCT/CN2021/130899
Authority: WO
Inventors: 李安宁; 刘建勇; 贾佳
Original assignee: 先健科技(深圳)有限公司
Priority date: 2020-12-10
Filing date: 2021-11-16
Publication date: 2022-06-16
Also published as: CN114617603B; CN114617603A

Abstract

An occlusion device (100), comprising a fixing part (120), the fixing part (120) comprises a plurality of support bodies (122), the plurality of support bodies (122) comprise a plurality of suspended support segments (124) spaced apart along the circumferential direction of the fixing part (120), at least one support segment (124) is provided with a deformable buffer segment (126), and when the support segment (124) is compressed, the buffer segment (126) disperses a force applied on the support segment (124) by means of the predetermined deformation of the buffer segment. In the occlusion device (100), at least one support segment (124) is provided with a deformable buffer segment (126), and when the corresponding support segment (124) is compressed by tissue in the body, the buffer segment (126) disperses a force applied on the support segment (124) by means of the predetermined deformation of the buffer segment. A buffer is provided for the force applied on the support segment (124), so as to avoid damage caused by the support segment (124) imparting a large reaction force to the tissue in the body.

Description

Blocking device

technical field

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

Background technique

For the existing umbrella-shaped left atrial appendage occluder, each support body on the fixed disc of the left atrial appendage occluder is a single rod that is independent and suspended from each other, and the fixed disc is cut from a metal alloy tube. After each support body is formed by heat setting, it has sufficient supporting force for the cavity wall of the left atrial appendage. However, in some special cases, when the end of a single support body abuts against a relatively weak area on the wall of the left atrial appendage, since the single rod has a greater supporting force on the wall of the left atrial appendage, with the continuous contraction of the heart, In the long term, the wall of the left atrial appendage may be worn away, or even the left atrial appendage may be ruptured, causing symptoms such as pericardial effusion.

SUMMARY OF THE INVENTION

Based on this, it is necessary to provide an improved occlusion device in view of the problem of abrasion or rupture of the left atrial appendage that may occur due to the single rod end abutting on a relatively weak area in the existing left atrial appendage occluder .

A plugging device, comprising a fixing part, the fixing part includes a plurality of supporting bodies, the plurality of supporting bodies comprise a plurality of suspended support segments arranged at intervals along the circumferential direction of the fixing part, at least one of which is A deformable buffer section is arranged on the support section, and when the support section is pressed, the buffer section disperses the acting force on the support section through its own predetermined deformation.

In one of the embodiments, the buffer section is expandable and retractable along the axial direction of the support section.

In one of the embodiments, the support segment includes a first support area and a second support area that are connected to each other, and after the fixation portion is released and deployed, the first support area occurs along the circumferential direction of the fixation portion deformation, thereby forming the buffer segment; the maximum width of the buffer segment along the circumferential direction of the fixing portion is greater than the maximum width of the second support region along the circumferential direction of the fixing portion.

In one of the embodiments, the buffer section is in the shape of a broken line or a wave shape, and the curved surface on which the buffer section is located is an arc surface curved toward the outside of the fixing portion.

In one of the embodiments, the second support area is also deformed along the circumferential direction of the fixing portion after the fixing portion is released and deployed.

In one embodiment, the buffer section includes at least one polygonal rod, and the curved surface on which at least one of the polygonal rods is located is an arc surface curved toward the outside of the fixing portion.

In one of the embodiments, the polygonal rod includes first and second rods at the distal end thereof, and third and fourth rods at the proximal end thereof, the first rod The proximal end is slidably connected with the distal end of the third strut, and the proximal end of the second strut is slidably connected with the distal end of the fourth strut.

In one embodiment, the polygonal rod includes a first end located at the distal end thereof and a second end located at the proximal end thereof, at least one of the polygonal rods except the first end and the second end The outer corners are rounded.

In one embodiment, the polygonal rod includes a first end at its distal end and a second end at its proximal end, the polygonal rod in a straight line defined by the first end and the second end symmetry.

In one of the embodiments, at least two of at least one of the polygonal rods located at the proximal ends thereof are bent toward the interior of the fixing portion.

In one of the embodiments, the buffer section includes an inner hollow mesh member, and two ends of the mesh member are respectively connected with other parts of the support body and closed.

In one embodiment, the buffer section includes a spherical piece and a hollow shell surrounding a part of the spherical piece, and the part of the support body connected to the shell passes through the spherical piece and the hollow shell. The housing is rotatably connected to other parts of the support body.

In one embodiment, the blocking device further includes a sealing portion connected to the fixing portion, one end of the plurality of support bodies is connected to the sealing portion, and the other end faces away from the sealing portion extend.

In one embodiment, the fixing portion further includes a central end portion, the blocking device further includes a sealing portion connected to the central end portion and located on one side of the fixing portion, the plurality of supporting bodies have a sealing portion. One end is connected with the central end portion, and the other end extends radially outward from the central end portion and is turned over toward the sealing portion, thereby forming an overturned segment; the support body continues from the end of the overturned segment toward the The sealing portion extends to form the support segment.

In one embodiment, the sealing portion includes a distal disk surface facing the fixing portion, and at least a portion of the distal disk surface is covered with at least one layer of thin film.

In the above-mentioned blocking device, at least one support segment is provided with a deformable buffer segment. When the corresponding support segment is squeezed by the tissue in the body, the buffer segment will disperse the force on the support segment through its own predetermined deformation, that is, , to disperse the support segment subjected to the pressing force of the body tissue, provide a buffer for the force of the support segment, and avoid damage caused by the support segment giving a large reaction force to the body tissue, such as abrasion of the left atrial appendage cavity wall, or even rupture Left atrial appendage, etc.

Description of drawings

1 is a schematic diagram of the overall structure of the plugging device of Example 1;

2 is a schematic structural diagram of a fixing portion in another embodiment;

3 is a schematic diagram of a partial structure in which the end of the support body is provided with a woven mesh in another embodiment;

4 is a schematic structural diagram of a fixing portion in another embodiment;

5 is a schematic structural diagram of a fixing portion in another embodiment;

6 is a schematic structural diagram of a fixing portion in another embodiment;

Fig. 7 is a partial enlarged view of A in Fig. 6;

Fig. 8 is a partial enlarged view of another structure of A in Fig. 6;

9 is a cross-sectional view of the occlusion device in another embodiment;

Figure 10 is a cross-sectional view of the occlusion device in another embodiment;

Fig. 11 is a partial enlarged view of B in Fig. 10;

Fig. 12 is a partial enlarged view of another structure of B in Fig. 10;

FIG. 13 is a schematic structural diagram of a plugging device in another embodiment.

Detailed ways

In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention, but not to limit the present invention.

It should be noted that, in the field of interventional medical devices, the end of the medical device implanted in the human body or animal body that is closer to the operator is generally called the "proximal end", and the end farther from the operator is called the "distal end". ”, and define the “proximal end” and “distal end” of any part of the medical device according to this principle. "Axial" generally refers to the length direction of the medical device when it is delivered, and "radial" generally refers to the direction perpendicular to the "axial" of the medical device. According to this principle, the "axial" of any part of the medical device is defined Towards" and "Radial". The "connection" mentioned in the embodiment includes the case where two components are directly connected and indirectly connected by means of other components. Unless otherwise specified, the following description is directed to the device in its natural state or after deployment in vivo.

The technical solutions of the present invention will be further described in detail below with reference to specific embodiments.

Example 1

The occlusion device proposed in Example 1 can be used to occlude the left atrial appendage, and can also be used to occlude other in vivo tissues with openings, such as atrial septal defect. The following will take the occlusion of the left atrial appendage as an example to introduce the occlusion device in detail.

Referring to FIG. 1 , the blocking 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 arranged at intervals along the axial direction Y of the blocking device 100 . The sealing part 110 is located at the proximal end of the occlusion device 100 , and the fixing part 120 is located at the distal end of the occlusion device 100 . The occlusion device 100 has a compressed state contained within the sheath for ease of delivery, and a deployed state as shown in FIG. 1 after extending from the distal end of the sheath and self-expanding. The shape of the occlusion device 100 after being released in the cavity of the left atrial appendage is exactly the same as or substantially the same as that shown in FIG. 1 . In other implementations, such as for atrial septal defect closure, the sealing portion 110 and the fixation portion 120 may abut each other after release to fix the occlusion device 100 on the septum between the left atrium and the right atrium.

The sealing portion 110 is braided into a mesh tube by a plurality of braided wires 111 , and two ends of the mesh tube are respectively closed and fixed with the ends of the braided wires 111 through a sleeve. After that, the mesh tube is heat-set into a shape of a disc, a column, or a plug, so as to obtain 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 opposite to the distal disc surface 112 (not shown, located at the proximal end of the sealing portion 110 and opposite to the distal disc surface 112). At least one layer of film body (not shown) is provided inside the sealing part 110 , and the edge of the film body is fixed on the braided wire 111 at the edge of the sealing part 110 . The membrane body is used to prevent blood flow from one side of the sealing portion 110 to the other side, so as to prevent blood flow from circulating between the left atrial appendage and the left atrium.

The fixing portion 120 includes a central end portion 121 and a plurality of supporting bodies 122 , and the distal sleeve 113 of the sealing portion 110 is connected to the central end portion 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 a rod made by braiding or winding braided wires.

As shown in FIG. 1 , the proximal ends of the plurality of supporting bodies 122 are all connected with the central end portion 121 , and the distal ends thereof all extend radially outward from the central end portion 121 and are turned toward the sealing portion 110 , thereby forming a turning segment with a concave area. 123. The support body 122 continues to extend from the end of the inversion section 123 toward the sealing portion 110 , thereby forming a suspended support section 124 . The proximal end of each support segment 124 is connected with the distal end of a corresponding one of the inversion segments 123, respectively. An anchor barb (not shown) may be provided on the support section 124 , and the end of the anchor barb faces the sealing portion 110 . After the fixation portion 120 is released and deployed, the anchor barb penetrates the body tissue, thereby assisting in fixing the occlusion device 100 and preventing the occlusion device 100 from being displaced. Further, the fixing portion 120 may be covered with at least one layer of annular or spherical film to prevent kinking between the supports 122 and to alleviate the problem of stress concentration that occurs after the supports 122 abut against the body tissue. .

The number of the support bodies 122 can be set as required. In the present embodiment, the fixing portion 120 includes 8 supporting bodies 122 . The 8 supporting bodies 122 are correspondingly formed with 8 turning segments 123 and 8 supporting segments 124 , and the 8 supporting segments 124 are spaced apart along the circumferential direction of the fixing portion 120 . set up. The distal end of each supporting segment 124 is bent and extended toward the interior of the fixing portion 120 , so as to form a constricted segment 125 , so as to prevent the distal end of the fixing portion 120 from contacting the body tissue and causing scratches. The gathering section 125 is bent in an L-shape or a U-shape, and can also be in other shapes. In other implementations, the distal ends of several support segments 124 may be bent and extended toward the interior of the fixing portion 120, thereby forming several retracted segments 125, and not all the distal ends of the support segments 124 are connected with retracted segments 125; or , the ends of the supporting segments 124 do not bend and extend toward the interior of the fixing portion 120 , that is, the fixing portion 120 is not provided with a retracting segment 125 .

In this embodiment, all the supporting segments 124 are provided with deformable buffer segments 126 . The buffer section 126 disperses the force on the support section 124 through its own predetermined deformation when the corresponding support section 124 or the gathering section 125 is compressed by the body tissue, that is, the support section 124 is compressed by the body tissue. The pressure provides a buffer for the force of the support segment 124, and avoids damage caused by the support segment 124 imparting a large reaction force to the body tissue, such as abrasion of the left atrial appendage cavity wall, or even rupture of the left atrial appendage. In other implementations, only one or several support segments 124 can be provided with buffer segments 126 , which can also reduce the stress on the corresponding support segments 124 . The predetermined deformation mentioned here refers to the predictable deformation of the buffer segment 126 according to its structural characteristics according to a predetermined trajectory when the buffer segment 126 is subjected to force in the body tissue.

Specifically, the buffer section 126 can expand and contract along the axial direction of the support section 124, and thus has a good axial buffer capacity. In some implementations, the support section 124 includes a first support area 1241 and a second support area 1242 that are connected to each other, and both the first support area 1241 and the second support area 1242 are compressed and compressed when the fixation portion 120 is received in the sheath. The constraint is approximately a straight line; after the fixing portion 120 is released and unfolded, the first supporting area 1241 is deformed along the circumferential direction of the fixing portion 120 to form the buffer section 126 in the shape shown in FIG. 1 ; the second supporting area 1242 will not be along the The fixing portion 120 is deformed in the circumferential direction; the maximum width of the buffer section 126 along the circumferential direction of the fixing portion 120 is greater than the maximum width of the second support area 1242 along the circumferential direction of the fixing portion 120 . The buffer section 126 is generally the part of the fixation portion 120 most in contact with the body tissue.

The deformation of the first support area 1241 can be a broken line shape as shown in FIG. 1 , a wave shape, a polygonal shape as shown in FIG. 2 , etc., or any combination of these shapes. The form is not limited, as long as it can be released at the fixing portion 120 . After unfolding, the maximum width of the buffer section 126 formed by the deformation of the first support area 1241 along the circumferential direction of the fixing portion 120 is larger than that of the undeformed second support area 1242 , and the curved surface of the buffer section 126 is facing The outer curved surface of the fixing portion 120 is sufficient. In this embodiment, the buffer section 126 is in the shape of a broken line, and the curved surface on which the buffer section 126 is located is an arc surface that is curved toward the outside of the fixing portion 120 , so that it can better fit the cavity wall of the left atrial appendage and improve the stability of the fixing portion 120 . sex. In addition, such a buffer section 126 also has good elastic deformation ability and axial buffering ability.

The above shape of the buffer section 126 is compared with the linear single rod, because the buffer section 126 extends along the circumferential direction of the fixing portion 120, and the rods constituting the buffer section 126 have a plurality of different extension directions in different regions, the second The support area 1242 extends along the axial direction Y of the fixing portion 120. The buffer section 126 cooperates with the second support area 1242 and has a larger circumferential contact area with the body tissue, so the support section 124 can be avoided with a greater probability. Abutting in the gully between the pectinate muscles of the left atrial appendage greatly reduces the possibility of breaking the gully between the pectinate muscles, avoids the occurrence of pericardial effusion, and also avoids the problem of stress concentration existing in a single rod. Avoid excessive local stress on the body tissue. In addition, the support section 124 or the retraction section 125 can also reduce the impact strength of the left atrial appendage cavity wall during the contraction and relaxation of the left atrial appendage, so as to avoid long-term wear of the left atrial appendage cavity wall, or even rupture of the left atrial appendage.

Further, in other implementations, the second support area 1242 also deforms along the circumferential direction of the fixing portion 120 after the fixing portion 120 is released and deployed. The deformed shape of the second support area 1242 may be the same as that of the buffer section 126, or may be different. Since the buffer section 126 is generally the area where the fixing portion 120 has the most contact with the body tissue, the maximum width of the second supporting area 1242 along the circumferential direction of the fixing portion 120 after deformation is generally smaller than that after the first supporting area 1241 is deformed. The maximum widths along the circumferential direction of the fixing portion 120 and the specific widths of the two can be adjusted as required, and are not limited thereto.

Further, in other implementations, at least a part of the distal disk surface 112 of the sealing portion 110 is covered with at least one layer of film (not shown), and one layer of film covers the entire area of the distal disk 112 , or cover a partial area in the axial direction opposite to the one or more gathering segments 125; or, the multilayer film bodies are superimposed or connected to each other to cover the entire area of the distal disk surface 112, or cover the axial direction part of the area opposite one or more gather segments 125 . In this way, not only can the sealing performance of the sealing part 110 be enhanced, but also the retraction section 125 of the fixing part 120 can be prevented from being hooked on the sealing part 110 to affect the normal operation of the occlusion operation.

In other implementations, as shown in FIG. 3 , the end of the support segment 124 (or the end of the gathering segment 125 ) is connected with a closed and hollow woven mesh 127 , and the woven mesh 127 can be spherical or cylindrical, etc. The structure, which can also be a non-closed woven mesh at the distal end, is used to reduce the pressing force and irritation or damage caused by the end of the support segment 124 or the gathering segment 125 when it contacts the body tissue.

The occlusion device 100 can be delivered and controlled release in vivo with existing sheaths and delivery rods. The proximal sleeve of the sealing portion 110 is detachably connected to the distal end of the delivery rod. During the occlusion operation, the sealing part 110 is connected with the delivery rod and both are accommodated in the sheath, and are transported to the target position in the body along with the sheath. The delivery rod is then pushed distally to release and deploy the fixation portion 120 from the distal end of the sheath. After the fixation portion 120 is released and fixed at the target position in the body, the delivery rod is further pushed distally, so that the sealing portion 110 protrudes from the distal end of the sheath for release and deployment, so as to close the opening of the tissue in the body. Finally, the connection between the delivery rod and the sealing part 110 is released, and the delivery rod and the sheath are recovered to the outside of the body, thereby completing the occlusion operation.

Example 2

The occlusion device 100 of Embodiment 2 is substantially similar to the occlusion device 100 of Embodiment 1, and the same features are not repeated here. The main difference between Embodiment 2 and Embodiment 1 is that, as shown in FIG. 4 , each support body 122 on the fixing portion 120 includes a lead-out section 127 , a lead-out section 127 , a radially radiating section 127 , radially radiating from the central end 121 to the distal end. Two branch segments 128 with a certain included angle connected to the distal end of the lead-out segment 127 , and a support segment 124 connected to the two branch segments 128 located in the middle of two adjacent support bodies 122 . Each lead-out section 127 surrounds the central end 121 and radiates radially from the central end 121 to the distal end, and cooperates with each other to form a concave area. The proximal ends of each branch segment 128 are respectively connected with the distal ends of the corresponding lead-out segments 127 , and the distal ends are turned toward the direction of the sealing portion 110 . The lead-out section 127 of each support body 122 and the two branch sections 128 connected thereto constitute a part of the inversion section 123 . The extending direction of each support segment 124 is parallel or approximately parallel to the central axis Y of the fixing portion 120 . The fixing part 120 with the plurality of branch segments 128 can prevent the local area of the inversion segment 123 from being deformed too much to affect the fixing effect, and at the same time, it can also reduce the stimulation of the body tissue caused by the excessive deformation. At least one support segment 124 is provided with a buffer segment 126 that is the same as or similar to that in Embodiment 1, and details are not described herein again. The end of the support segment 124 is connected with a retractable segment 125 , and the end of the retracted segment 125 is connected with a ball head 129 .

In other implementation manners, the number of supports 122 can be set as required, and the number of branch segments 128 corresponding to each lead-out segment 127 can also be set as required. An anchor barb (not shown) may be provided on the support section 124 , and the end of the anchor barb faces the sealing portion 110 . After the fixation portion 120 is released and deployed, the anchor barb penetrates the body tissue, thereby assisting in fixing the occlusion device 100 and preventing the occlusion device 100 from being displaced. Further, the fixing portion 120 may be covered with at least one layer of annular or spherical film to prevent kinking between the supports 122 and to alleviate the problem of stress concentration that occurs after the supports 122 abut against the body tissue. .

Example 3

The plugging device 100 of Embodiment 3 is generally similar to the plugging device 100 of Embodiment 1 and Embodiment 2, and the same features are not repeated here. The main difference between Embodiment 3 and Embodiment 1 and Embodiment 2 is that the buffer section 126 includes at least one polygonal rod 1261 , and the curved surface on which the at least one polygonal rod 1261 is located is an arc surface curved toward the outside of the fixing portion 120 . . The polygonal rod 1261 has at least 4 sides, and the total number of sides may be even or odd, and preferably an even number of sides.

Taking a quadrilateral rod as an example, as shown in FIG. 2 , the quadrilateral rod 1261 includes a first end 1262 at its distal end and a second end 1263 at its proximal end. The end sections are connected, the buffer section 126 is located at the distal end section of the support section 124 , and the second end 1263 of the quadrilateral rod 1261 is connected with the retracting section 125 . The corners 1264 of the quadrilateral rod 1261 except the first end 1262 and the second end 1263 are all rounded, so as to prevent the outer corner 1264 of the quadrilateral rod 1261 from easily scratching the wall of the left atrial appendage cavity after the buffer section 126 is unfolded . The position where the two adjacent rods of the quadrilateral rod 1261 are connected can be set as an arc segment, or a silicone sleeve can be placed on it, or a smooth coating can be applied, etc. 1264 is set to be sleek. The end of the gathering section 125 is connected with a ball head 129 or a hollow woven mesh 127 as shown in FIG. 3 , so as to prevent the end from puncturing the body tissue.

The polygonal rod 1261 can be made of a superelastic metal alloy rod or a polymer rod, so it has good elasticity and shape memory properties, and is easy to be compressed into a linear shape when it is radially constrained, and it is easy to release the radial constraint. Self-expanding into the agreed polygonal shape. In addition, when subjected to an axial force, the outer diameter of the polygonal rod 1261 in the circumferential direction can be increased through deformation in the radial direction, thereby decomposing the force in the axial direction and buffering the wall of the left atrial appendage cavity A force is given to the supporting segment 124 or the retracting segment 125, so as to avoid the abrasion of the left atrial appendage cavity wall caused by the long-term force, or even the rupture of the left atrial appendage cavity wall.

In other implementations, the second end 1263 of the polygonal rod 1261 may not be connected to the retracting section 125 , the second end 1263 may serve as the end of the supporting body 122 , or when the buffer section 126 is the middle section of the supporting section 124 , the second end 1263 may The two ends 1263 may be connected to the distal end of the support segment 124 .

Further, the polygonal rod 1261 is symmetrical with a line defined by its first end 1262 and second end 1263 . In the case where the first end 1262 and the second end 1263 are both coincident with the central axis of the support section 124, the polygonal rod 1261 of the symmetrical structure is more easily compressed into a regular linear member with a smaller outer diameter, and the adjacent ones after compression It is not easy to twist or hook between the rods.

Further, in other implementations, as shown in FIG. 5 , the two rods 1265 of the quadrilateral rod 1261 located at the proximal ends thereof are bent toward the interior of the fixing portion 120 , thereby forming the retracted section 125 . The gathering section 125 is bent in a V-shape or a U-shape, and other shapes are also possible. In other implementations, at least two rods 1265 of the polygonal rod 1261 located at the proximal end thereof can also be both bent toward the interior of the fixing portion 120 , thereby forming the constricted section 125 . Such a tucked segment 125 can not only avoid scratching the tissue, but also can prevent the tucked segment 125 from abutting in the groove between the pectinate muscles of the left atrial appendage with a higher probability. The second end 1263 of the polygonal rod 1261 can be connected with a ball head 129 or a hollow woven mesh 127 as shown in FIG. 3 , so as to prevent the end from puncturing the body tissue.

In other implementations, anchor barbs may be provided on the proximal end section of the support section 124 to enhance the fixing strength of the fixing portion 120 and prevent the occluding device 100 from being displaced. Further, the fixing portion 120 may be covered with at least one layer of annular or spherical film to prevent kinking between the supports 122 and to alleviate the problem of stress concentration that occurs after the supports 122 abut against the body tissue. .

Example 4

The occlusion device 100 of Embodiment 4 is substantially similar to the occlusion device 100 of any of the above-mentioned embodiments, and the same features are not repeated here. The main difference is that the polygonal rod 1261 on the support section 124 in Embodiment 4 includes a first rod 1266 and a second rod 1267 at its distal end, and a third rod 1268 and a second rod at its proximal end. Four rods 1269 , the proximal end of the first rod 1266 is slidably connected with the distal end of the third rod 1268 , and the proximal end of the second rod 1267 is slidably connected with the distal end of the fourth rod 1269 .

In one implementation, taking a quadrilateral rod as an example, as shown in FIG. 6 and FIG. 7 , a quadrilateral rod 1261 is provided on the support section 124 , and the distal end of the first rod 1266 of the quadrilateral rod 1261 is connected to the second rod. The distal ends of the rods 1267 are fixedly connected to form the first ends 1262 of the quadrilateral rods 1261 . The proximal end of the third support rod 1268 is fixedly connected with the proximal end of the fourth support rod 1269 to form the second end 1263 of the quadrangular rod 1261 . The first end 1262 of the quadrilateral rod 1261 is located at its most distal end, and the second end 1263 is located at its most proximal end. The first end 1262 of the quadrilateral rod 1261 is connected with the distal end of the turning segment 123 , and the second end 1263 of the quadrilateral rod 1261 is connected with the retracting segment 125 .

As shown in FIG. 7 , the proximal end of the first support rod 1266 is provided with a first opening 12661 , and the proximal end of the second support rod 1267 is provided with a second opening 12671 . The distal end of the third strut 1268 passes through the first opening 12661 and protrudes outward, and the distal end of the fourth strut 1269 passes through the second opening 12671 and protrudes outward. The distal end of the third rod 1268 and the distal end of the fourth rod 1269 are respectively provided with a ball head 12662 , and the outer diameter of the ball head 12662 is larger than the diameter of the first opening 12661 and the diameter of the second opening 12671 . The third pole 1268 can slide in the first opening 12661 without disconnecting from the first pole 1266, and the fourth pole 1269 can slide in the second opening 12671 without being disconnected from the second pole The rod 1267 is disconnected, thereby realizing the slidable connection between the proximal end of the first rod 1266 and the distal end of the third rod 1268, and the proximal end of the second rod 1267 and the distal end of the fourth rod 1269 are slidable ground connection.

In other implementations, as shown in FIG. 8 , the distal end of the third strut 1268 protrudes outward in the first opening 12661 and then bends to one side, and the proximal end of the first strut 1266 and the third The distal ends of struts 1268 are slidably connected. Similarly, the distal end of the fourth strut 1269 protrudes outward in the second opening 12671 and then bends toward one side, so that the proximal end of the second strut 1267 and the distal end of the fourth strut 1269 can be slidably connected. connect. Thus, interference of the fixing portion 120 into and out of the sheath can be avoided. Preferably, both the distal end of the third strut 1268 and the distal end of the fourth strut 1269 are bent toward the direction of the sealing portion 110 .

Example 5

The occlusion device 100 of Embodiment 5 is substantially similar to the occlusion device 100 of any of the above-mentioned embodiments, and the same features are not repeated here. The main difference is that in Embodiment 5, the fixing portion 120 includes more than two supporting segments 124, and a part or all of the supporting segments 124 are provided with buffer segments 126, and the buffer segments 126 include a hollow inner mesh member 12610, Two ends of the mesh member 12610 are respectively connected with other parts of the support body 122 and closed.

As shown in FIG. 9, the mesh member 12610 may be a woven mesh formed using woven filaments. Both ends of the mesh member 12610 are closed and fixed by a sleeve respectively. The proximal sleeve 12611 of the mesh element 12610 is connected to the proximal end of the support segment 124 , the mesh element 12610 is the middle segment, and the distal sleeve 12612 of the mesh element 12610 is connected to the distal end of the support segment 124 . In other implementations, the distal sleeve 12612 of the mesh 12610 can also be directly connected to the tucked segment 125. When the fixing portion 120 is accommodated in the sheath, the mesh member 12610 is restrained in a linear shape. After the fixing portion 120 is released and expanded, the mesh member 12610 self-expands and expands into a mesh tube shape with closed ends and a hollow interior. When the support segment 124 is compressed in the axial direction, the mesh member 12610 can be deformed compliantly, specifically, the distance between the proximal sleeve 12611 and the distal sleeve 12612 in the axial direction is shortened, and the The outer diameter of the mesh member 12610 in the radial direction becomes larger, so as to buffer the pressing force received by the support section 124, reduce the reaction force given by the support section 124 to the wall of the left atrial appendage, and avoid wear or tear on the wall of the left atrial appendage. break. In addition, since the contact area between the mesh member 12610 and the wall of the left atrial appendage is increased, the support segment 124 can be prevented from abutting in the groove between the pectinate muscles of the left atrial appendage with a higher probability.

In other implementations, the anchoring barbs may be provided on the mesh member 12610 , or may be provided on the portion of the support segment 124 other than the mesh member 12610 to enhance the fixing strength of the fixing portion 120 and prevent the occlusion device 100 shift. Further, the fixing portion 120 may be covered with at least one layer of annular or spherical film to prevent kinking between the supports 122 and to alleviate the problem of stress concentration that occurs after the supports 122 abut against the body tissue. .

Example 6

The occlusion device 100 of Embodiment 6 is substantially similar to the occlusion device 100 of any of the above-mentioned embodiments, and the same features are not repeated here. The main difference is that, as shown in FIG. 10 and FIG. 11 , the fixing part 120 in Embodiment 6 includes more than two support segments 124 , some or all of the support segments 124 are provided with buffer segments 126 , and the buffer segments 126 A hollow shell 12614 comprising a spherical member 12613 and a part of the spherical member 12613, the part of the support body 122 connected to the shell 12614 is rotatably connected to other parts of the support body 122 through the spherical member 12613 and the shell 12614 . The restricted rotation of the spherical member 12613 in the housing 12614 is the predetermined deformation of the buffer section 126 itself.

The spherical member 12613 is a hollow or solid spherical structure. The proximal end of the support segment 124 is connected to the spherical member 12613, and an anchor bar (not shown) can be provided on the proximal end segment to strengthen the fixing force of the fixing portion 120 and prevent the occluding device 100 from shifting. The casing 12614 is a hollow sphere with an opening, and the size is such that the spherical member 12613 can just be accommodated in the casing 12614 and will not fall out of the casing 12614 . The buffer section 126 is the middle section of the support section 124 , and the distal end of the housing 12614 is connected to the distal end section of the support section 124 . The distal segment of the support segment 124 may be connected to a retracted segment 125 .

When the distal end segment of the support segment 124 or the retracted segment 125 is axially compressed, the distal end segment of the support segment 124 will rotate with the rotation of the housing 12614 around the spherical member 12613, thereby dispersing the compression force. , reducing the reaction force imparted to the left atrial appendage cavity wall by the support section 124 or the constricting section 125 to avoid abrasion or rupture of the left atrial appendage cavity wall.

In other implementations, as shown in FIG. 12 , a plurality of individual protrusions 12615 or an annular protrusion 12615 may be provided on the spherical member 12613 at a position close to the opening of the housing 12614 and not covered by the housing 12614, so as to The direction or degree of rotation of the housing 12614 around the spherical member 12613 is restricted, so as to prevent excessive rotation from reducing the fixing force of the fixing portion 120 .

Further, the fixing portion 120 may be covered with at least one layer of annular or spherical film to prevent kinking between the supports 122 and to alleviate the problem of stress concentration that occurs after the supports 122 abut against the body tissue. .

Example 7

The occlusion device 200 of Embodiment 7 is substantially similar to the occlusion device 100 of any of the above-mentioned embodiments, and the same features are not repeated here. The main difference is that, as shown in FIG. 13 , one end of the plurality of supports 221 of the fixing portion 220 is directly connected to the sealing portion 210 , and the other end extends away from the sealing portion 210 .

Specifically, the fixing part 220 and the sealing part 210 in the blocking device 200 are integrally formed. The occlusion device 200 includes a central end 230 at the proximal end, and a plurality of supports 221 surrounding the central end 230 and extending radially outward from the central end 230 and toward the distal end. Each support body 221 includes a lead-out section 222 that expands radially outward from the central end 230 , and a support section 223 that is connected to the distal end of the lead-out section 222 and extends toward the distal end. All the support segments 223 are spaced apart and suspended in the circumferential direction of the fixing portion 220 .

In another implementation, the distal end of the at least one support segment 223 is bent and extended toward the interior of the fixing portion 220 , thereby forming a constricted segment 224 . The central end 230 can be detachably connected to the delivery rod. The blocking device 200 is covered with at least one layer of thin film body 211 (for the convenience of observing the structure of the support body 221, the thin film body 211 is made transparent in FIG. 13 ), and the thin film body 211 covers at least the proximal end of the blocking device 200, for example , the film body 211 covers a part of the respective proximal ends of all the lead-out segments 222 and all the support segments 223, so as to block the opening of the tissue in the body. All of the lead-out segments 222 and the portion of the film body 211 covering them constitute the sealing portion 210 . All the support segments 223 , or all the support segments 223 and all the retracted segments 224 , constitute the fixing portion 220 .

Further, an anchor barb (not shown) may be provided on the support section 223, and the end of the anchor barb is toward the proximal end. After the fixation portion 220 is released and deployed, the anchor barb penetrates the body tissue, thereby assisting in fixing the occlusion device 200 and preventing the occlusion device 200 from being displaced.

Although the distal end portion of the support body 221 in the seventh embodiment is directed away from the sealing portion 210 , that is, extends in the distal direction, the distal end portion of the supporting body 121 in any of the above embodiments is directed toward the sealing portion 110 , that is, toward the distal end. It extends in the proximal direction, but the buffer section 225 provided on the support section 223 in Embodiment 7 can also adopt the relevant technical features of the buffer section 126 in any of the above embodiments, but is not limited to this, as long as the differences in any of the above embodiments are different It is only necessary that the technical features in the implementation are combined into Embodiment 7 without conflict, and details are not repeated here.

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

The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the appended claims.

Claims

A plugging device, comprising a fixing part, the fixing part comprising a plurality of supporting bodies, the plurality of supporting bodies comprising a plurality of suspended support segments arranged at intervals along the circumferential direction of the fixing part, characterized in that At least one of the support segments is provided with a deformable buffer segment, and when the support segment is squeezed, the buffer segment disperses the acting force on the support segment through its own predetermined deformation.
The plugging device according to claim 1, wherein the buffer section is expandable and retractable along the axial direction of the support section.
The occlusion device according to claim 2, wherein the supporting section comprises a first supporting area and a second supporting area that are connected to each other, and after the fixing part is released and deployed, the first supporting area is along the The fixing portion is deformed in the circumferential direction to form the buffer section; the maximum width of the buffer section along the circumferential direction of the fixing portion is greater than the width of the second support area along the circumferential direction of the fixing portion. maximum width.
The plugging device according to claim 2 or 3, characterized in that, the buffer section is in the shape of a broken line or a wave shape, and the curved surface on which the buffer section is located is an arc surface curved toward the outside of the fixing portion.
The occlusion device according to claim 3, wherein the second support area is also deformed along the circumferential direction of the fixing portion after the fixing portion is released and deployed.
The plugging device according to claim 2 or 3, wherein the buffer section comprises at least one polygonal rod, and the curved surface on which at least one of the polygonal rods is located is an arc surface curved toward the outside of the fixing portion.
6. The occlusion device of claim 6, wherein the polygonal rod comprises first and second struts at its distal ends, and third and fourth struts at its proximal ends , the proximal end of the first support rod is slidably connected with the distal end of the third support rod, and the proximal end of the second support rod is slidably connected with the distal end of the fourth support rod.
The occlusion device according to claim 6, wherein the polygonal rod comprises a first end located at the distal end thereof and a second end located at the proximal end thereof, and at least the polygonal rod except for the first end Both the end and the corners beyond the second end are rounded.
6. The occlusion device according to claim 6, wherein the polygonal rod comprises a first end at its distal end and a second end at its proximal end, and wherein the polygonal rod is formed by the first end and the proximal end. The line defined by the second end is symmetrical.
6. The occlusion device according to claim 6, wherein at least two rods located at the proximal ends of at least one of the polygonal rods are bent toward the interior of the fixing portion.
The occlusion device according to claim 2 or 3, wherein the buffer section comprises an inner hollow mesh member, and two ends of the mesh member are respectively connected to other parts of the support body and closed.
The occlusion device according to claim 1, wherein the buffer section comprises a spherical member and a hollow casing surrounding a part of the spherical member, and the part of the support body connected to the casing, It is rotatably connected to other parts of the support body through the ball and the housing.
The blocking device according to claim 1, wherein the blocking device further comprises a sealing part connected to the fixing part, one end of the plurality of support bodies is connected to the sealing part, and the other end is connected to the sealing part. extending in a direction away from the sealing portion.
The blocking device according to claim 1, wherein the fixing portion further comprises a central end portion, and the blocking device further comprises a sealing portion connected to the central end portion and located on one side of the fixing portion , one end of the plurality of supports is connected with the central end, and the other ends extend radially outward from the central end and are turned over toward the sealing portion, thereby forming a turning section; the supports are from The tip of the inversion segment continues to extend towards the seal, thereby forming the support segment.
The occlusion device according to claim 14, wherein the sealing portion comprises a distal disk surface facing the fixing portion, and at least a part of the distal disk surface is covered with at least one layer of thin film.