Blocking device

Abstract

The present invention relates to a blocking device, comprising a fixing portion for fixing the blocking device at a predetermined position and a sealing portion for sealing, wherein the fixing portion comprises a plurality of support rods, and at least one of the support rods crosses over another adjacent support rod from the proximal side. By arranging at least one of the support rods to cross over another adjacent support rod from the proximal side, when a support rod is subjected to a large stress and undergoes a relatively large deformation, the deformation of the support rod will cause it to be supported by the adjacent support rod, thereby improving the support capacity of the support rod. When there are multiple support rods that meet this design, the stress acting on a single support rod will be distributed to the entire fixing portion.

Description

[0001] This case is a divisional application with application number 202111622600.8. Technical Field

[0002] The present invention relates to the technical field of medical devices, and in particular to a blocking device. Background Art

[0003] In recent years, 90% of strokes caused by atrial fibrillation in patients with non-valvular atrial fibrillation originate from the left atrial appendage. Clinical data show that when atrial fibrillation occurs, the removal of the left atrial appendage during cardiac surgery can reduce the incidence of stroke, which suggests the harm of the left atrial appendage in thromboembolism. Since the left atrial appendage is the nest of thrombi, blocking the opening of the left atrial appendage can eliminate the basis for thrombus formation in the left atrial appendage. Usually, blocking the left atrial appendage with a left atrial appendage occluder is an effective way to prevent stroke caused by atrial fibrillation.

[0004] In order to effectively block the left atrial appendage, the left atrial appendage occluder needs to be implanted in the left atrial appendage for a long time to achieve the blocking effect. Therefore, the left atrial appendage occluder needs to have a certain anchoring structure to enable it to block the left atrial appendage opening stably for a long time, while preventing it from falling off and causing problems such as device embolism.

[0005] In order to achieve the long-term stability of the left atrial appendage occluder at the left atrial appendage mouth, more anchoring structures with sharp heads, such as anchor thorns or anchor hooks, are usually set at the left atrial appendage occluder support part (the junction of the left atrial appendage occluder and the atrial appendage wall) to penetrate into the atrial appendage wall to achieve long-term implantation stability. At the same time, since the atrial appendage contracts and relaxes with the heart, the anchoring structure ensures that the occluding device and the inner wall of the left atrial appendage are in close contact. However, due to the movement of the atrial appendage, the occluding device is deformed and moved. Excessive deformation and movement can easily lead to failure or weakening of the sealing of the occluding device. Therefore, it is now necessary to design a left atrial appendage occluder with long-term anchoring stability. Summary of the invention

[0006] Based on this, it is necessary to provide a new occlusion device to address the problem that the occlusion device in the prior art is easily deformed or moved by the left atrial appendage pressure, resulting in sealing failure or weakening.

[0007] A blocking device comprises a fixing part for fixing the blocking device at a predetermined position and a sealing part for sealing, wherein the fixing part comprises a plurality of support rods, at least one of the support rods spans over another adjacent support rod from a proximal end side.

[0008] In one embodiment, the fixing portion further includes a connecting piece, which connects the support rod and the sealing portion, and the support rod includes a connecting portion, an extending portion and an unfolding portion which are sequentially connected from the proximal end to the distal end, and the connecting portion is connected to the connecting piece.

[0009] In one of the embodiments, at least a portion of the extension portion of at least one of the support rods is located at a distal end side of the extension portion of another adjacent support rod.

[0010] In one embodiment, the plurality of support rods include a first support rod, a second support rod and a third support rod that are adjacent to each other in sequence, and the first support rod spans over the second support rod and the third support rod when extended.

[0011] In one embodiment, the extension portion of the first support rod is located at the distal end of the extension portion of the second support rod and the extension portion of the third support rod.

[0012] In one embodiment, the expanded portion of a single support rod is deflected to an opposite side of the connecting portion.

[0013] In one embodiment, the extension angle of the expansion portion is deflected by a value ranging from 90° to 135° relative to the extension angle of the connection portion.

[0014] In one of the embodiments, any one of the support rods spans over at least one other of the support rods.

[0015] In one embodiment, the number of the plurality of support rods is a, each support rod simultaneously spans b remaining support rods, and the minimum deflection angle of the support rod is 360°·b / a, and the maximum deflection angle is 360°·(b+1) / a.

[0016] In one of the embodiments, projections of at least two adjacent extension portions of the support rods on the same cross section have a projection intersection, and the multiple projection intersections do not overlap with each other.

[0017] The blocking device provided by the present invention arranges at least one of the support rods to cross over another adjacent support rod from the proximal side, so that when the support rod is subjected to relatively large stress and undergoes relatively large deformation, the deformation of the support rod will cause it to be supported by the adjacent support rod, thereby enhancing the supporting capacity of the support rod. When there are multiple support rods that meet this design, the stress acting on a single support rod will be shared by the entire fixing portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic structural diagram of the blocking device in Example 1 of the present invention;

[0019] Figure 2 It is a schematic structural diagram of the fixing part of the blocking device in Example 1 of the present invention;

[0020] Figure 3 It is a schematic diagram of the three-dimensional structure of the fixing part of the blocking device in Example 1 of the present invention;

[0021] Figure 4 is a schematic structural diagram of a blocking device in Example 2 of the present invention;

[0022] Figure 5 It is a schematic structural diagram of the fixing part of the blocking device in Embodiment 2 of the present invention;

[0023] Figure 6 It is a schematic diagram of the three-dimensional structure of the fixing part of the blocking device in Example 2 of the present invention;

[0024] Figure 7 Schematic diagram of the position of the support rod of the fixing part of the blocking device in Example 2 of the present invention. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0026] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of a medical device are defined based on this principle. "Axial" generally refers to the length direction of a medical device when it is transported, and "radial" generally refers to the direction of a medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.

[0027] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments.

[0028] Example 1

[0029] like Figure 1-3 As shown, Figure 1 1 is a schematic structural diagram of a blocking device 100 in Embodiment 1 of the present invention. The blocking device comprises a fixing portion 10 and a sealing portion 20 connected to the fixing portion 10. Figure 2 is a schematic structural diagram of the fixing portion 10 of the blocking device 100 in Embodiment 1 of the present invention, Figure 3 1 is a three-dimensional schematic diagram of the fixing portion 10 of the occluding device 100 in Example 1 of the present invention. The sealing portion 20 and the fixing portion 10 are arranged at intervals along the axial direction of the occluding 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 compressed state contained in the sheath for easy delivery, and extends from the distal end of the sheath and expands after self-expansion. Figure 1The occlusion device 100 is in the expanded state after being released in the left atrial appendage cavity. Figure 1 Identical or substantially the same.

[0030] The sealing part 20 is woven into a mesh tube by a plurality of braided wires, and the ends of the braided wires are closed and fixed by a sealing part distal plug at each end of the mesh tube. The mesh tube is then heat-formed into a disc-like, columnar or plug-like shape, thereby obtaining a sealing part 20 for blocking the opening of the left atrial appendage. At least one layer of film body (not shown in the figure) is provided inside the sealing part 20, and the edge of the film body is fixed on the braided wire at the edge of the sealing part 20. The film body is used to prevent blood flow from flowing from one side of the sealing part 20 to the other side, so as to prevent blood flow from flowing between the left atrial appendage and the left atrium.

[0031] The fixing part 10 includes a connecting piece 11 of the fixing part and a plurality of supporting rods 12, and the plug head at the distal end of the sealing part is fixed to the connecting piece 11 of the fixing part. The supporting rods 12 on the fixing part 10 can be rods obtained by cutting a metal alloy tube or a polymer tube, or can be rods made by braiding or winding braided wires.

[0032] The proximal ends of the plurality of support rods 12 are connected to the connector 11 of the fixing portion, and the distal ends extend radially outward from the central end and flip toward the sealing portion, thereby forming a support surface for contacting and supporting the left atrial appendage cavity wall.

[0033] The support rod 12 may be provided with an anchor 13. Generally speaking, the anchor 13 is set on the support rod 12 by welding, hot melting, entanglement, bonding, etc., but it is not excluded that the anchor 13 is directly cut and formed at the same time when the support rod 12 is cut.

[0034] In this embodiment, the anchor 13 is an anchor barb structure, and the tip of the anchor barb pierces the inner wall of the left atrial appendage, so that the fixing part 10 is stably anchored on the inner wall of the left atrial appendage, so that the occluding device 100 can achieve occlusion of the left atrial appendage opening.

[0035] In another embodiment, the outside of the fixing part 10 is covered with a coating to further seal the left atrial appendage while ensuring that the sealing part 20 can achieve sealing, and to prevent excessive stress of the left atrial appendage from being concentrated on the surface of the fixing part. At the same time, when the anchor 13 of the fixing part 10 pierces the inner wall of the left atrial appendage to cause a micro-wound, the coating can block the root of the anchor 13, prevent blood from flowing out of the micro-wound, and accelerate the rapid covering of the micro-wound.

[0036] In this embodiment, refer to Figure 2-3The proximal portion of the support rod 12 includes a connecting portion 121, an extending portion 122 and an unfolding portion 123 which are connected in sequence. It should be noted that the support rod 12 can be integrally formed. The connecting portion 121, the extending portion 122 and the unfolding portion 123 being connected in sequence does not mean that the support rod 12 is a split structure. The connecting portion 121 is connected to the connector 11 on one side and to the extending portion 122 on the other side. The extending portion 122 connects the connecting portion 121 and the unfolding portion 123. The extending portion includes a deflection structure so that the unfolding portion 123 is angularly deflected relative to the connecting portion 121. In this embodiment, the deflection structure of the extending portion 122 includes a spiral structure. The proximal end of the unfolding portion 123 begins to unfold outward from the distal end of the extending portion 122 as a starting point.

[0037] For multiple support rods 12, since the proximal ends of the unfolded portions 123 are relatively dispersed, and the extension portions 122 of each support rod 12 are spiral and parallel to each other, the support rods 12 are not easily entangled or knotted. Since the spiral structure of the extension portion 122 reserves some space for the deformation of the support rod 12, the fixing portion 10 can be better compressed when the fixing portion 10 is sheathed, that is, the fixing portion 10 can adapt to a sheath tube with a smaller diameter.

[0038] In addition, when the support rod 12 is gradually deployed from the sheath, the helical structure itself has a restoring force to restore its original state, which promotes the deployment of the support rod 12, that is, the existence of the extension part 122 provides a better deployment force for the deployment of the support rod 12.

[0039] In this embodiment, the diameter of the connecting piece 100 is equal to the diameter of the extension portion 122. After the occlusion device 100 is implanted, when the left atrial appendage contracts and relaxes with the movement of the heart, the stress component generated by the inner wall of the left atrial appendage on the support rod 12 can be divided into axial and radial components. Since the extension portion 122 has reserved some space for the support rod 12 to move axially due to the setting of the spiral structure, the support rod 12 can adapt to the axial stress component brought by the left atrial appendage and undergo adaptive movement. At the same time, the radial stress component brought by the left atrial appendage is transmitted along the rod of the support rod 12, and when it reaches the spiral structure of the extension portion 122, it drives the spiral structure to move radially to the opposite side of the proximal end of the expansion portion 123 (that is, the diameter of the extension portion 122 expands). When the radial stress disappears, the restoring force of the spiral structure and the restoring force of the support rod 12 act simultaneously to restore the fixing portion 10 to its original state and always close to the inner wall of the left atrial appendage.

[0040] That is to say, since the unfolded portion 123 of the support rod 12 is angularly deflected relative to the connecting portion 121, when the stress of the left atrial appendage on the support rod 12 is transmitted along the support rod 12, part of the stress is offset by the radial deformation of the support rod 12, thereby avoiding excessive axial deformation of the support rod 12 and the sealing portion 20.

[0041] In another embodiment, the diameter of the connector 11 is smaller than the diameter of the extension portion 122. When the occlusion device 100 is implanted, when the left atrial appendage contracts and relaxes with the movement of the heart, since the diameter of the extension portion 122 is larger than the diameter of the connector 11, the extension portion 122 has a larger axial movement space reserved, which is more conducive to the axial movement of the support rod 12 to adapt to the axial stress component brought by the left atrial appendage.

[0042] In this embodiment, the expansion portion 123 is straight after leaving the extension portion 122. In order to prevent the stress from being excessively concentrated at the corner when being transmitted to the extension portion, the connection position of the expansion portion 123 and the extension portion 122 forms an angle α (preferably an obtuse angle). Similarly, the connection position of the extension portion 122 and the connection portion 121 forms an angle β (preferably an obtuse angle). In order to make the stress transmission more stable, the obtuse angle α ≥ the obtuse angle β.

[0043] In another embodiment, the expansion portion 123 gradually expands outward along the spiral line of the extension portion 122. 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 will be offset by the spiral structure to the maximum extent, thereby reducing the stress on the sealing portion 20. In this embodiment, the value of the obtuse angle α is close to or equal to 180°, and the expansion portion 123 can also be regarded as a spiral arrangement.

[0044] In this embodiment, the extension angle of the spiral structure of the extension portion 122 (i.e., the central angle of the corresponding arc from the starting point to the end point of the spiral) is greater than 90° and less than 180°, which can minimize the risk of entanglement and entanglement between multiple support rods 12.

[0045] In another embodiment, the extension angle of the spiral structure of the extension portion 122 is greater than 180°.

[0046] In another embodiment, the helical structure of the extension portion 122 extends over more than one or more turns.

[0047] Example 2

[0048] The difference between the blocking device of Example 2 and Example 1 is that Figure 4-6 , the deflection structure of the extension portion 322 does not include a helical structure, Figure 4 is a schematic structural diagram of a blocking device in Example 2 of the present invention, Figure 5 is a schematic structural diagram of the fixing portion 30 of the blocking device in Embodiment 2 of the present invention, Figure 6 It is a three-dimensional schematic diagram of the fixing portion 30 of the blocking device in embodiment 2 of the present invention.

[0049] In this embodiment, the fixing portion 30 also includes a connecting member 31 and a plurality of supporting rods 32 , and the proximal ends of the supporting rods 32 are fixed on the connecting member 31 .

[0050] The inner side of the support rod 32 includes a connecting portion 321, an extending portion 322 and an unfolding portion 323 which are connected in sequence. It should be noted that the support rod 32 can be integrally formed, and the description of the connecting portion 321, the extending portion 322 and the unfolding portion 323 does not mean that the support rod 32 is a split structure. The connecting portion 321 is connected to the connecting member 31 on one side and to the extending portion 322 on the other side. The extending portion 322 includes an arc-shaped deflection structure, and the proximal end of the unfolding portion 323 starts to unfold outward from the distal end of the extending portion 322 as a starting point.

[0051] In this embodiment, the unfolded portion 323 unfolds along the extension curve of the extension portion 322, so there is no obvious dividing line between the unfolded portion 323 and the extension portion 322. To make a distinction, the support rod 32 of this embodiment is projected on the far end plane of the connecting member, and the portion where the projection of the support rod 32 exceeds the boundary of the connecting member 31 is regarded as the unfolded portion 323 of the support 32 of this embodiment.

[0052] For Example 1, the support rods are actually separated from each other, and their forces and deformations do not affect each other. However, in Example 2, the support rods have certain connections with each other, as follows:

[0053] In this embodiment, there are preferably 8 support rods 32, including an optional first support rod 41 and a second support rod 42 and a third support rod 43 adjacent thereto in a counterclockwise direction. It should be noted that the counterclockwise direction is selected because the support rods 32 of this embodiment are deflected in a counterclockwise direction from the proximal end to the distal end. The direction itself does not have an effect, as long as all the support rods 32 are deflected in the same direction.

[0054] For the first support rod 41, its connection portion 411 is close to a straight line, and a large deflection occurs at the extension portion 412, so that the unfolded portion 413 of the first support rod 41 is deflected to the diagonally opposite side of the connection portion 411. The reason why it is set at the diagonally opposite side is that when the unfolded portion 413 of the first support rod 41 extends to the opposite side of the connection portion 411, the unfolded portions of other support rods will also extend to the opposite side of the connection portion, so that the extension portions of all support rods have intersections or are too close to each other, causing the support rods to be entangled and tangled, and also preventing the support force of each support rod from being too large or deformation due to the intersection of the extension portions, which affects the normal operation of the blocking device.

[0055] Reference Figure 6-7 , Figure 7In order to more intuitively show the positional relationship of each support rod, only the schematic diagram of the first support rod, the second support rod and the third support rod is retained. In this embodiment, the first support rod 41 crosses over the second support rod 42 and the third support rod 43 when extended, and the extension portion 412 of the first support rod 41 is located at the far end of the extension portion of the second support rod 42 and the third support rod 43, so that when the first support rod 41 is subjected to a large stress and undergoes a relatively large deformation, the deformation of the first support rod 41 will cause it to be supported by the second support rod 42 and the third support rod 43, thereby enhancing the supporting capacity of the first support rod 41, and the second support rod 42 and the third support rod 43 also cross over other support rods at the same time, thereby distributing the stress acting solely on the first support rod 41 to the entire fixed portion 30.

[0056] If the first support rod 41 is deformed toward the distal end after being subjected to stress, since the first support rod 41 is also spanned by other support rods at the same time, the force will also be transmitted to the other support rods.

[0057] Furthermore, since the first support rod 41 is an optional support rod, and the unfolded portion 413 of the first support rod 41 is deflected to the diagonally opposite side of the connecting portion 411, and the first support rod 41 crosses the second support rod 42 and the third support rod 43 when extended, therefore, on the plane of the far end of the connecting member 31, the projected intersection point of the first support rod 41 and the second support rod 42 does not overlap with the projected intersection point of the second support rod 42 and the second support rod 43. In another embodiment, the projected intersection points of any two support rods do not overlap with each other.

[0058] In order for the support rod 32 to achieve the effect of this embodiment, on the plane of the distal end of the connecting member 31 , the extension portion 42 of the first support rod 41 intersects with the extension portion of the second support rod 42 and the extension portion of the third support rod 43 at the same time.

[0059] In this embodiment, the support rod is deflected at an angle from the connecting portion to the unfolding portion, and the deflection angle of the support rod is between 90° and 135°.

[0060] In another embodiment, the number of support rods is a, each support rod spans b remaining support rods, the minimum deflection angle of the support rod is 360°·b / a, and the maximum deflection angle is 360°·(b+1) / a.

[0061] In another embodiment, each support rod spans over one adjacent support rod, and at least a portion of the extension portion of the support rod is located on the distal side of the extension portion of its adjacent support rod, so that when the support rod is subjected to pressure from the left atrial appendage, the pressure is transmitted to the position of the extension portion to cause the extension portion to deform toward the proximal end, and at this time, the extension portion of the adjacent support rod located at the proximal end can support the support rod.

[0062] It should also be noted that, since the extension portion of the support rod of this embodiment has the same deflection structure as the spiral structure in Embodiment 1, it also has the same technical effect as the spiral structure in Embodiment 1.

[0063] It should be noted that the technical features of the above-mentioned embodiments can be combined arbitrarily and can also be applied to the various types of left atrial appendage occluders and left atrial appendage occluders with similar structures. In order to make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0064] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these 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 attached claims.

Claims

1. A plugging device, comprising a fixing portion for fixing the plugging device at a predetermined position and a sealing portion for sealing, characterized in that: The fixing portion includes a plurality of support rods and connecting pieces, wherein the connecting pieces connect the support rods and the sealing portion, the proximal ends of the support rods are connected to the connecting pieces, the distal ends of the support rods extend radially outward from the central end portions and flip toward the sealing portion, at least one of the support rods spans over another adjacent support rod from the proximal end side, and at least a portion of an extension portion of at least one of the support rods is located on the distal end side of an extension portion of another adjacent support rod.

2. The blocking device according to claim 1, characterized in that: The support rod comprises a connecting portion, an extending portion and an expanding portion which are sequentially connected from the proximal end to the distal end, and the connecting portion is connected to the connecting piece.

3. The blocking device according to claim 2, characterized in that: An included angle between the expansion portion and the connecting position of the extension portion is greater than or equal to an included angle between the extension portion and the connecting position of the connection portion.

4. The blocking device according to claim 2, characterized in that: The plurality of support rods include a first support rod, a second support rod and a third support rod that are adjacent to each other in sequence, and the first support rod spans over the second support rod and the third support rod when extended.

5. The blocking device according to claim 4, characterized in that: The extending portion of the first supporting rod is located at the distal end of the extending portion of the second supporting rod and the extending portion of the third supporting rod.

6. The blocking device according to claim 2, characterized in that: The expanded portion of the single support rod is deflected to an opposite side of the connecting portion relative to the axis of the occluding device.

7. The blocking device according to claim 6, characterized in that: The extension angle of the expansion portion is deviated from the extension angle of the connection portion by a value between 90° and 135°.

8. The blocking device according to any one of claims 1 to 7, characterized in that: Any of the support rods spans over at least one other of the support rods.

9. The blocking device according to any one of claims 1 to 7, characterized in that: The number of the plurality of support rods is a, each of the support rods spans b remaining support rods simultaneously, the minimum deflection angle of the support rod is 360°·b / a, and the maximum deflection angle is 360°·(b+1) / a.

10. The blocking device according to any one of claims 1 to 7, characterized in that: There are projection intersections of at least two adjacent extension portions of the support rods in the same cross section, and the plurality of projection intersections do not overlap with each other.

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