occlusion device

Abstract

This invention relates to a sealing device, comprising a fixing part, a sealing part, and a connecting part connecting the sealing part and the fixing part. The fixing part includes a support body that extends radially outward from a converging position and is flipped by a flipping part to form the supporting part. The connecting part includes a buffer part located between the fixing part and the sealing part, and the buffer part includes a retractable telescopic structure. In the sealing device of this invention, a buffer part is added. When the fixing part moves with the inner wall of the left atrial appendage, the buffer part can partially offset or eliminate the deformation of the fixing part. Therefore, the deformation and stress of the fixing part are minimized or completely eliminated when transmitted to the sealing part, thereby ensuring a stable seal of the sealing device and maintaining a constant position of the sealing part relative to the opening of the left atrial appendage.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an occlusion device. Background Technology

[0002] In recent years, among patients with non-valvular atrial fibrillation, 90% of strokes caused by atrial fibrillation originate from the left atrial appendage. Clinical data shows that resection of the left atrial appendage during cardiac surgery in patients with atrial fibrillation can reduce the incidence of stroke, suggesting the danger of the left atrial appendage in thromboembolism. Since the left atrial appendage is a thrombus-forming site, occluding its opening can eliminate the basis for thrombus formation within the left atrial appendage. Generally, occlusion of the left atrial appendage using a left atrial appendage occluder is an effective way to prevent stroke caused by atrial fibrillation.

[0003] To effectively occlude the left atrial appendage, a left atrial appendage occluder needs to be implanted in the left atrial appendage long-term to achieve the occlusion effect. Therefore, the left atrial appendage occluder must have a certain anchoring structure to ensure its stable occlusion at the opening of the left atrial appendage for a long period of time, while preventing it from falling out and causing problems such as device embolism.

[0004] To achieve long-term stability of the left atrial appendage occluder at the left atrial appendage orifice, multiple anchoring structures with sharp tips, such as anchor spikes or hooks, are typically installed in the support portion of the occluder (the junction between the occluder and the atrial appendage wall) to penetrate the atrial appendage wall and ensure long-term implantation stability. Simultaneously, because the atrial appendage contracts and relaxes with the heart, the anchoring structures ensure close contact between the occluder and the inner wall of the left atrial appendage. However, after implantation, the fixing portion of the occluder can deform due to radial forces and the contraction and relaxation of the atrial appendage. Excessive deformation can cause the sealing portion to detach axially from the left atrial appendage, leading to occlusion failure. Summary of the Invention

[0005] Therefore, it is necessary to provide an improved occlusion device to address the problem that deformation of the fixing part of existing left atrial appendage occluders can easily cause the sealing part to shift and detach from the left atrial appendage, resulting in leakage.

[0006] A sealing device includes a fixing part, a sealing part, and a connecting part connecting the sealing part and the fixing part. The fixing part includes a support body that extends radially outward from a converging position and is flipped over by a flipping part to form the support part. The connecting part includes a buffer part located between the fixing part and the sealing part. The buffer part includes a retractable telescopic structure.

[0007] In one embodiment, the buffer includes a radially expandable telescopic structure.

[0008] In one embodiment, the plurality of said supports extend after crossing at the distal end of the buffer section.

[0009] In one embodiment, the buffer section includes a mesh structure distributed circumferentially.

[0010] In one embodiment, the projection of the free end of the support in the longitudinal section falls within the projection range of the buffer in the longitudinal section.

[0011] In one embodiment, the maximum outer diameter of the buffer portion in the unstressed state is greater than the maximum inner diameter of the fixing portion.

[0012] In one embodiment, the outer diameter of the distal side of the buffer is larger than its outer diameter of the proximal side.

[0013] In one embodiment, the outer diameter of the proximal end of the buffer is larger than the outer diameter of the distal end.

[0014] In one embodiment, the buffer section is fitted with a sealing membrane.

[0015] In one embodiment, the fixing part and the buffer part are integrally formed.

[0016] Compared with the prior art, the above-mentioned sealing device adds a buffer part between the fixing part and the sealing part. When the fixing part moves with the inner wall of the left atrial appendage, the buffer part can partially offset or eliminate the deformation of the fixing part. As a result, the deformation and stress of the fixing part are less or completely eliminated when they are transmitted to the sealing part, so that the sealing of the sealing device is always stable and the position of the sealing part relative to the opening of the left atrial appendage remains unchanged. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the sealing device in Embodiment 1 of the present invention;

[0018] Figure 2 This is a schematic diagram of the sealing device in Embodiment 2 of the present invention;

[0019] Figure 3 This is a schematic diagram of the buffer section of the sealing device in Embodiment 2 of the present invention;

[0020] Figure 4 This is a schematic diagram of the sealing device in Embodiment 3 of the present invention;

[0021] Figure 5 This is a schematic diagram of the sealing device in Embodiment 4 of the present invention;

[0022] Figure 6 This is a schematic diagram of the sealing device in Embodiment 5 of the present invention;

[0023] Figure 7 This is a schematic diagram of the sealing device in Embodiment 6 of the present invention;

[0024] Figure 8 This is a schematic diagram of the sealing device according to yet another embodiment of Embodiment 6 of the present invention;

[0025] Figure 9 This is a schematic diagram of the sealing device in Embodiment 7 of the present invention;

[0026] Figure 10 This is a schematic diagram of the sealing device in Embodiment 8 of the present invention;

[0027] Figure 11 This is a schematic cross-sectional view of the sealing device in Embodiment 9 of the present invention. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the 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 merely illustrative and not intended to limit the invention.

[0029] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the 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." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. The "connection" mentioned in the embodiments includes both direct connection between two components and indirect connection via other components.

[0030] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0031] Example 1

[0032] The occlusion device proposed in Example 1 can be used to occlude the left atrial appendage, as well as other in vivo tissues with openings, such as atrial septal defects. The following will provide a detailed description of the occlusion device using the occlusion of the left atrial appendage as an example.

[0033] Please refer to Figure 1 , Figure 1 This is a schematic diagram of the sealing device 100 in Embodiment 1 of the present invention. The sealing device 100 includes a fixing part 120 and a sealing part 110 connected to the fixing part 120. The sealing part 110 and the fixing part 120 are spaced apart along the axial direction of the sealing device 100. The sealing part 110 is located at the proximal end of the sealing device 100, and the fixing part 120 is located at the distal end of the sealing device 100. The sealing device 100 has a compressed state housed within a sheath for easy delivery, and extends from the distal end of the sheath and expands upon self-expansion as... Figure 1The deployed state is shown. The morphology of the occlusion device 100 after release within the left atrial appendage is similar to... Figure 1 They are identical or substantially the same. In other implementations, such as for closure of atrial septal defects, the sealing part 110 and the fixing part 120 can abut against each other after release to fix the closure device 100 to the septum between the left and right atria.

[0034] The sealing portion 110 is a mesh tube woven from multiple braided filaments 111. Both ends of the mesh tube are secured and fixed by sleeves. The mesh tube is then heat-set into a disc, column, or plug shape to obtain the sealing portion 110 used to seal 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 interior of the sealing portion 110 has at least one thin film (not shown), the edges of which are fixed to the braided filaments 111 at the edges of the sealing portion 110. The thin film 114 prevents blood flow from one side of the sealing portion 110 to the other, thereby preventing blood flow between the left atrial appendage and the left atrium.

[0035] The fixing part 120 includes a central end 121 and a plurality of supports 122, and the distal sleeve 115 of the sealing part 110 is connected to the central end 121. The supports 122 on the fixing part 120 can be rods obtained by cutting metal alloy tubes or polymer tubes, or rods made by braiding or winding braided yarns 111.

[0036] The proximal ends of multiple supports 122 are connected to the central end 121, and the distal ends of each support extend radially outward from the central end 121 to form a connecting section. After extending, the connecting section flips towards the sealing disc to form a flipped portion 123. The supports 122 continue to extend towards the sealing portion 110 from the distal ends of the flipped portion 123 to form a support section 124. The support section 124 is used to support the left atrial appendage. The support section 124 continues to extend towards the sealing portion 110 to form a suspended section 126. The suspended section 126 can either continue to extend along the direction of the support section 124 or deflect and flip inward towards the support section 124 to avoid damage to the left atrial appendage.

[0037] like Figure 1 As shown, the outer side of the support section 124 is provided with an anchoring structure 125 that is inclined outward and toward the sealing part 110. The anchoring structure 125 includes a spike-like structure at its tip. After the occlusion device 100 is implanted, the anchoring structure 125 is anchored by its spike-like structure piercing the inner wall of the left atrial appendage, thereby anchoring the entire occlusion device 100.

[0038] In another embodiment, the outside of the fixing part 120 is covered with a membrane to further seal the left atrial appendage while ensuring that the sealing part 1100 can achieve a seal, and to avoid excessive stress concentration of the left atrial appendage on the surface of the fixing part. At the same time, when the anchor 125 of the fixing part 120 pierces the inner wall of the left atrial appendage and causes a micro-wound, the membrane can block the root of the anchor 125, prevent blood from flowing out of the micro-wound, and accelerate the rapid healing of the micro-wound.

[0039] After the occlusion device 100 is implanted in the left atrial appendage, the fixing part 120 is anchored to the inner wall of the left atrial appendage by the anchor 125. Since the left atrial appendage will contract and relax with the heartbeat, it will cause the fixing part 120 to contract and expand. To be precise, the supporting part 124 will contract and expand first, thereby causing the fixing part 120 to contract and expand as a whole. When the supporting part 124 contracts, since the relative position of the anchor 125 and the left atrial appendage remains unchanged, the deformation of the supporting part 124 inward is transmitted to the central end 121 of the fixing part 120, which will cause the central end 121 to move away from the interior of the left atrial appendage axially, thereby causing the sealing part 110 to detach from the opening of the left atrial appendage and resulting in sealing failure. Therefore, it is necessary to add a buffer part to the occlusion device 100.

[0040] For the sealing device 100, the flipping part 123 will share part of the stress from the support section 124 and change its orientation. The flipping part 123 will also deform to counteract the deformation from the support section 124. Therefore, in this embodiment, the buffer part of the sealing device 100 is located at the flipping part 123. The flipping part 123 includes multiple flipping sections. The flipping sections change the orientation of the support. In this embodiment, the buffer part includes at least a first flipping section 1231, a second flipping section 1232 and a third flipping section 1233 arranged adjacent to each other.

[0041] When the left atrial appendage contracts and relaxes in response to the heartbeat, the contraction and relaxation of the support section 124 are transmitted to the third flip section 1233. The third flip section 1233 deforms, and the deformation continues to be transmitted. When it is transmitted to the first flip section 1231 through the connecting section, it greatly offsets the deformation of the support section 124. As a result, the axial displacement of the central end 121 is small or even close to 0, maintaining the sealing state of the sealing device 100.

[0042] Furthermore, in another embodiment, the buffer section includes an odd number of flip segments. The function of the odd number of flip segments is that, on the one hand, the odd number of flip segments can ensure that the free end of the support section 124 faces the sealing section 110. On the other hand, when the left atrial appendage contracts and relaxes with the heartbeat, the deformation is transmitted to the flip segments and then to the connecting segments. Since the flip segments flip the support extending to the distal end to face the proximal end, and the connecting segments are used to connect the flip segments, they flip the support extending to the proximal end to face the distal end. The deformation of the flip segments transmitted to the connecting segments will be greatly offset or even reversed. This deformation is then transmitted to the next flip segment and will be further offset, thereby compensating for the deformation of the support section to the greatest extent.

[0043] Example 2,

[0044] The parts that are the same as in Example 1 will not be repeated here. The main difference is that, referring to... Figure 2-3 As shown, Figure 2 This is a schematic diagram of the sealing device 200 in Embodiment 2 of the present invention. Figure 3 This is a schematic diagram of the structure of the buffer section of the sealing device 200 in Embodiment 2 of the present invention. The buffer section includes a first flip section 2231, a second flip section 2232 and a third flip section 2233. The first flip section 2231 and the third flip section 2232 partially overlap to reduce the overall diameter of the fixing part 220 and prevent the fixing part 220 from being unable to be implanted in implantation sites with smaller diameters.

[0045] Importantly, the buffer portion of this embodiment can be provided with multiple flip portions without increasing the diameter of the fixing portion 220, so as to obtain the best resistance to deformation.

[0046] Example 3

[0047] The parts that are the same as in Example 1 will not be repeated here. The main difference is that, referring to... Figure 4 As shown, Figure 4 This is a schematic diagram of the sealing device 300 in Embodiment 3 of the present invention. In this embodiment, the support section 324 of the sealing device extends towards the distal end. The buffer section includes a first flip section 3231 and a second flip section 3232, totaling an even number of flip sections. In this embodiment, the axial length of the support section 324 is relatively short, and the deformation of the support section 324 is largely transmitted to the position of the second flip section 3232, thereby being fully offset by the buffer section. Preferably, the axial length of the support section 324 is less than half the maximum axial distance from any position of the flip section to the farthest end of the fixing section.

[0048] Example 4

[0049] The parts that are the same as in Example 3 will not be repeated here. The main difference is that, referring to... Figure 5 As shown, Figure 5 This is a schematic diagram of the occlusion device 400 in Embodiment 4 of the present invention. In this embodiment, the support section 424 of the occlusion device extends distally. The buffer section includes a first flip section 4231 and a second flip section 4232. However, additionally, this embodiment provides an auxiliary buffer section 4243 at the distal end of the support section 424. The auxiliary buffer section 4243 extends gradually inward in a spiral shape, with its free end located at the innermost side of the spiral structure. When the support section 424 deforms under pressure from the left atrial appendage, the distal end of the support section 424... The first flip section 4231 and the second flip section 4232 are close to each other, while the auxiliary buffer section 4243 is closer to the second flip section 4232. The auxiliary buffer section 4243 will abut against the surface of the second flip section 4232. When the support section 424 continues to be deformed under pressure, in addition to the first flip section 4231 and the second flip section 4232 compensating for the deformation of the support section 424, part of the deformation will also be transmitted to the auxiliary buffer section 4243 and compensated by the spiral structure of the auxiliary buffer section 4243. Similarly, the pressure on the support section 424 will also be transmitted to the auxiliary buffer section 4243 at the same time. In summary, the auxiliary buffer section 4243 actually also plays the same role as the buffer section.

[0050] Example 5

[0051] The parts that are the same as in Example 1 will not be repeated here. The main difference is that, referring to... Figure 6 As shown, Figure 6 This is a schematic diagram of the sealing device 500 in Embodiment 5 of the present invention. In this embodiment, the buffer portion 530 of the sealing device 500 is located at the connection between the sealing portion 510 and the fixing portion 520. It should be noted that this connection includes not only the buffer portion 530 as part of the connection structure, but also the case where the buffer portion 530 serves as the connection structure between the sealing portion 530 and the fixing portion 520. By configuring the buffer portion 530 as a telescopic or elastic structure, when the fixing member 520 undergoes axial deformation and this deformation is transmitted to the buffer portion 530, the deformation is offset by the deformation of the buffer portion 530, thereby ensuring the sealing reliability of the sealing portion 510.

[0052] Furthermore, it should be noted that because the axial length of the buffer portion 530 is variable, the occlusion device 500 in this embodiment can still adapt to the structure when facing a shallow left atrial appendage structure.

[0053] In this embodiment, the buffer 530 is a spring structure.

[0054] In another embodiment, the connector is an axially telescopic structure, including a first tube and a second tube sleeved along the axis, the first tube and the second tube being able to move relative to each other, wherein the first tube and the second tube are connected by a spring.

[0055] In another embodiment, the connector is an axially telescopic structure, comprising a plurality of rods arranged axially, the rods being arranged to form a rhomboid structure.

[0056] Example 6

[0057] The parts that are the same as in Example 5 will not be repeated here. The main difference is that, referring to... Figure 7 As shown, Figure 7 This is a schematic diagram of the sealing device 600 in Embodiment 6 of the present invention. In this embodiment, the buffer part 630 of the sealing device 600 is located at the connection position between the sealing part 610 and the fixing part 620. It is worth noting that the buffer part 630 in this embodiment is a mesh structure distributed circumferentially, i.e., a disc structure. In addition to the axial and radial extensibility of the mesh structure, in this embodiment, when the support section 624 of the fixing part 620 is deformed by the pressure from the left atrial appendage, the support section 624 moves towards the axial direction until it abuts against the edge of the buffer part 630, thereby receiving the support of the buffer part 630 and improving the radial support force of the sealing device 600. Preferably, the free end of the support section 624 is located between the proximal end and the distal end of the buffer part 630 in the axial direction. That is, the projection of the free end of the support part 624 in the longitudinal section through the axis falls within the projection range of the buffer part 630 in the longitudinal section through the axis.

[0058] Furthermore, the outer diameter of the buffer portion 630 in its unloaded state is larger than the inner diameter of the fixing portion 620, so that in its natural state, the buffer portion 630 abuts against the inner side of the support section 624 of the fixing portion 620, thereby increasing the radial support force of the fixing portion 620.

[0059] In another embodiment, reference Figure 8As shown, both the fixing part 621 and the buffer part 631 are cut and shaped from a single nickel-titanium tube, which reduces the overall height of the occlusion device. Combined with the buffer part 631, the occlusion device can be stretched axially (i.e., in the height direction), allowing it to adapt to a wider range of left atrial appendage environments. Preferably, multiple support rods cross at the distal end of the buffer part 631, extending through the centerline of the buffer part 631 to the opposite side, i.e., curving towards the opposite side. With this arrangement, in this embodiment, the multiple support rods cross at the centerline of the buffer part 631. After the occlusion device is implanted, as the left atrial appendage contracts and relaxes with the heart, the stress exerted by the inner wall of the left atrial appendage on the support rod can be divided into axial and radial components. The cross-arranged support rods allow the angle between the support rod and the axis to be larger than that of the non-cross-arranged ones. This means that when the stress exerted by the inner wall of the left atrial appendage on the support rod is transmitted along the support rod, the radial component of the stress is larger and the axial component is smaller because the angle between the support rod and the axis is larger. The radial component is offset by the deformation of the buffer part 631, thereby reducing the adaptive axial deformation of the buffer part 631 and ensuring the stability of the occlusion device.

[0060] Example 7

[0061] The parts that are the same as in Example 6 will not be repeated here. The main difference is that, referring to... Figure 9 As shown, Figure 9 This is a schematic diagram of the sealing device 700 in Embodiment 7 of the present invention. The structure of the buffer part 730 of the sealing device 700 in this embodiment is different from that in Embodiment 6. The buffer part 730 is a conical structure or a trapezoidal structure. In this embodiment, the outer diameter of the distal side of the buffer part 730 is larger than its outer diameter of the proximal side, so that the large outer diameter part of the buffer part 730 is as close as possible to the inner side of the fixing part 720, further ensuring the improvement of the supporting force of the buffer part 730 on the fixing part 720.

[0062] In another embodiment, the cross-section of the buffer portion 730 may also be a combination of multiple trapezoids with gradually changing outer diameters.

[0063] Example 8

[0064] The parts that are the same as in Example 7 will not be repeated here. The main difference is that, referring to... Figure 10 As shown, Figure 10 This is a schematic diagram of the sealing device 800 in Embodiment 8 of the present invention. The structure of the buffer part 830 of the sealing device 800 in this embodiment is different from that in Embodiment 7. The buffer part 830 is a conical structure or a trapezoidal structure. In this embodiment, the outer diameter of the proximal side of the buffer part 830 is larger than the outer diameter of its distal side. A sealing membrane is attached to the inner side of the proximal side of the buffer part 830, thereby playing an auxiliary sealing role on the basis of the sealing part 810, that is, realizing the double sealing role.

[0065] Preferably, the maximum outer diameter of the buffer portion 830 is equal to the outer diameter of the sealing portion 810.

[0066] Example 9

[0067] The parts that are the same as in Example 5 will not be repeated here. The main difference is that, referring to... Figure 11 As shown, Figure 11 This is a cross-sectional schematic diagram of the sealing device 900 in Embodiment 9 of the present invention. In this embodiment, the buffer part 930 of the sealing device 900 is disposed at the connecting position of the sealing part 910 and the fixing part 920. Specifically, the buffer part 930 is located at the contact position between the connecting part 931 and the sealing part 910. In this embodiment, the sealing part 910 has a woven structure, and its converging position is recessed inward to form the buffer part 930, which is then connected to the connecting part 931. Since the sealing part 910 has high flexibility, the buffer part 930 also has high flexibility, which can then offset the deformation from the fixing part 920.

[0068] In another embodiment, the fixing part and the buffer part are integrally formed, thereby further reducing the overall volume of the sealing device.

[0069] In another embodiment, the fixing part, the buffer part, and the sealing part are integrally formed.

[0070] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are 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.

[0071] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An occlusive device comprising a fixed portion, a sealing portion, and a connecting portion connecting the sealing portion and the fixed portion, characterized in that, The fixing part includes multiple support bodies, which extend radially outward and are flipped to form the support part. The connecting part includes a buffer part, which is located between the fixing part and the sealing part. The buffer part includes a telescopic structure that can be extended and retracted. The fixing part and the buffer part are integrally formed. The buffer section includes a mesh structure distributed circumferentially. The outer diameter of the proximal end of the buffer section is larger than the outer diameter of the distal end. The maximum outer diameter of the buffer section is equal to the maximum outer diameter of the sealing section. A sealing membrane is attached inside the buffer section.

2. The sealing device according to claim 1, characterized in that, The buffer section includes a radially expandable telescopic structure.

3. The sealing device according to claim 1, characterized in that, The plurality of supports extend after crossing at the distal end of the buffer section.

4. The sealing device according to claim 1, characterized in that, The sealing part has a woven structure.

5. The sealing device according to claim 1, characterized in that, The projection of the free end of the support in the longitudinal section falls within the projection range of the buffer in the longitudinal section.

6. The sealing device according to claim 1, characterized in that, The maximum outer diameter of the buffer part when it is not under stress is greater than the maximum inner diameter of the fixing part.

7. The sealing device according to claim 1, characterized in that, The buffer section has a conical structure.

8. The sealing device according to claim 1, characterized in that, The buffer section has a trapezoidal structure.

Images