Intraluminal occluder
By designing an intraluminal occluder with a mesh skeleton and a flow-blocking membrane as a concave and convex surface, combined with a thrombosis-promoting component, the problem of existing occluders being difficult to release quickly and promoting false lumen thrombosis is solved, and efficient occlusion and thrombosis effects are achieved.
Patent Information
- Application Number
- CN201911342706.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2019-12-23
- Publication Date
- 2025-09-12
- Estimated Expiration
- 2039-12-23
AI Technical Summary
Existing occluders are difficult to simultaneously meet the requirements of being smaller in size after compression, rapidly releasing to occlude the false lumen, and promoting thrombosis of the false lumen, resulting in an increased risk of incomplete thrombosis of the false lumen in aortic dissection.
An intraluminal occluder with a mesh skeleton structure is designed. The skeleton and the flow-blocking membrane have concave and convex surfaces. Combined with a thrombus-promoting component, it can bend and fit in the false lumen to promote thrombosis.
The occluder can be quickly released and fit well in the false lumen, promoting thrombosis of the false lumen, improving the occlusion effect and adaptability, and reducing the risk of re-intervention.
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Figure CN113081078B_ABST
Abstract
Description
Technical Field
[0001] The present application relates to a medical device, and in particular to an intracavitary occluder. Background Art
[0002] Interventional therapy is an emerging treatment approach between surgical and medical treatments, encompassing both intravascular and non-vascular interventional therapies. Simply put, interventional therapy involves creating a tiny channel, a few millimeters in diameter, through blood vessels or skin, or through existing body channels, without surgically exposing the lesion. This minimally invasive treatment approach involves treating the lesion locally under the guidance of imaging equipment (angiography, fluoroscopy, etc.). Interventional therapy offers advantages such as minimal trauma, simplicity, safety, effectiveness, minimal complications, and significantly shortened hospital stays.
[0003] As implants for interventional therapy, occlusion devices can be used to block defects, tissue ruptures, lumens, and organ passages in the human and / or animal body. For example, these devices are widely used in clinical practice to treat congenital heart disease, including atrial septal defects, ventricular septal defects, and patent arterial sheaths. The principle behind these occlusion devices is to block the "holes" between the left and right atria, the "holes" between the left and right ventricles, and the passages between the aorta and pulmonary artery.
[0004] Aortic dissection, on the other hand, is caused by a tear in the aortic intima and media, resulting in separation of the intima from the media, allowing blood to flow in and dividing the aortic lumen into a true and false lumen. Typical aortic dissections demonstrate a septum or intimal flap between the true and false lumens, which may or may not communicate. Current conventional endovascular aortic repair for aortic dissection generally aims to occlude the primary rupture and reduce pressure in the false lumen to achieve aortic remodeling. However, data indicate that this objective is not achieved in 7% to 20% of cases due to incomplete thrombosis of the false lumen. The presence of a distal rupture and continued perfusion (unthrombotic false lumen) increases the risk of continued false lumen enlargement, which in turn increases the risk of further dissection tears and aneurysm rupture, and also increases the incidence of surgical re-intervention after endovascular repair. Currently, standard endovascular aortic repair is followed by the use of adjunctive occlusion techniques to promote thrombosis of the false lumen.
[0005] Occluders are delivered through interventional methods to defects, tissue ruptures, lumens, and organ passageways within the human and / or animal body, including arteries, veins, and / or the heart, to provide localized treatment. Occluders must possess a reasonable design, such as a small size after compression, the ability to rapidly release and occlude the false lumen, and the ability to promote thrombosis of the false lumen. Existing occluders often fail to meet all of these requirements simultaneously. Summary of the Invention
[0006] The purpose of the present application is to provide an intraluminal occluder that is smaller in size after compression, can be quickly released to occlude the false lumen, and can promote thrombosis of the false lumen.
[0007] In order to solve the above-mentioned technical problems, the present application provides an intracavitary occluder, comprising: a mesh skeleton, which is a hollow structure, and includes two end faces and a side face connected between the two end faces; a flow-blocking membrane, formed on the mesh skeleton, and includes two end faces and a side face connected between the two end faces; and a plug-promoting member, formed on the surface of the intracavitary occluder; wherein the side face of the mesh skeleton and / or the side face of the flow-blocking membrane are concave and convex surfaces.
[0008] In the intraluminal occluder provided in the present application, the mesh skeleton is easy to compress, and after compression, its body is small and can be quickly released to block the false cavity; and a flow-blocking membrane is formed on the mesh skeleton, and after release, the flow-blocking membrane can fit well with the false cavity, and the fitting area is large, so that the false cavity can be better blocked; in addition, the surface of the intraluminal occluder in this case is formed with a thrombus-promoting member, and after release, the thrombus-promoting member effect is formed to disturb the blood in the false cavity and fill the false cavity, which can promote thrombosis of the false cavity; further, the side of the mesh skeleton and / or the side of the flow-blocking membrane in this case are concave and convex surfaces, which can improve the adaptability of the intraluminal occluder, so that the intraluminal occluder can bend in the false cavity according to the shape of the false cavity, so as to fully fit the cavity wall to block the false cavity. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the implementation. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.
[0010] Figure 1 It is a three-dimensional schematic diagram of the intracavitary occluder provided in the first embodiment of the present application.
[0011] Figure 2 It is a cross-sectional schematic diagram of the intracavitary occluder provided in the first embodiment of the present application.
[0012] Figures 3 to 7 It is a schematic end view of the skeleton of the intracavitary occluder provided in the first embodiment of the present application.
[0013] Figure 8 yes Figure 2 An enlarged cross-sectional schematic diagram of a local position of an intraluminal occluder including a plug head and a sleeve head.
[0014] Figures 9 to 11 Schematic diagram of the formation position of the plug-promoting member of the intracavitary occluder provided in the first embodiment of the present application, wherein: Figure 9 The plug-promoting member is formed on the flow-blocking membrane. Figure 10 and Figure 11 The plug-promoting member is formed on the mesh skeleton.
[0015] Figures 12 to 14 This is a partial schematic diagram of the embolization member of the intracavitary occluder provided in the first embodiment of the present application.
[0016] Figure 15 It is a cross-sectional schematic diagram of the intracavitary occluder provided in the second embodiment of the present application.
[0017] Figure 16 It is a cross-sectional schematic diagram of the intracavitary occluder provided in the third embodiment of the present application.
[0018] Figure 17 It is a cross-sectional schematic diagram of the intracavitary occluder provided in the fourth embodiment of the present application. DETAILED DESCRIPTION
[0019] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.
[0020] Please also refer to Figures 1 to 14 The first embodiment of the present technical solution provides an intraluminal occluder 100, comprising: a reticular skeleton 11 having a hollow structure and including two end surfaces 111 and a side surface 112 connected between the two end surfaces 111; a flow-blocking membrane 12 formed on the reticular skeleton 11, including two end surfaces 121 and a side surface 122 connected between the two end surfaces 121, wherein the maximum axial length of the flow-blocking membrane 12 is greater than or equal to the maximum axial tensile length of the reticular skeleton 11; and a plug-promoting member 13 formed on the surface of the intraluminal occluder 100; wherein the side surface 112 of the reticular skeleton 11 and / or the side surface 122 of the flow-blocking membrane 12 are concave and convex surfaces. The plug-promoting member 13 is a slender linear or ribbon-like structure, one end of which is fixed to the surface of the occluder and the other end is free.
[0021] In this embodiment, the mesh skeleton is easy to compress, and after compression, its body is small and can be released quickly to block the false cavity; in addition, a flow-blocking membrane is formed on the mesh skeleton, and after release, the flow-blocking membrane can fit well with the false cavity, and the fitting area is large, so that the false cavity can be better blocked; in addition, a thrombus-promoting member is formed on the surface of the intraluminal occluder in this case, and after release, the slender thrombus-promoting member with a free end can disturb the blood in the false cavity and fill the false cavity, reducing the volume of the false cavity, and promoting thrombosis in the false cavity; further, the surface of the intraluminal occluder in this case is a concave and convex surface, which can improve the adaptability of the intraluminal occluder, so that the intraluminal occluder can bend in the false cavity according to the shape of the false cavity, so as to fully fit the cavity wall to block the false cavity.
[0022] In this embodiment, the mesh skeleton 11 is a hollow columnar structure; in the radial direction of the mesh skeleton 11 , the shape of the cross-sectional profile of the mesh skeleton 11 can be set to various shapes as needed to meet the requirements of different placement positions.
[0023] Because the blood vessel wall is generally arc-shaped, preferably, at least part of the cross-section of the mesh skeleton 11 in the radial direction of the mesh skeleton 11 is an arc, so that the intraluminal occluder 100 can fit tightly with the tissue at the release position when released, thereby achieving a better occlusion effect.
[0024] For example, in this embodiment, Figure 3 As shown, in the radial direction of the mesh skeleton 11, the cross-section of the mesh skeleton 11 is circular, that is, the mesh skeleton 11 is a hollow cylindrical structure. This smooth shape is conducive to the delivery of the intraluminal occluder 100, and the cylindrical structure is also conducive to the intraluminal occluder 100 fitting with the inner wall of the false lumen.
[0025] For example, in another embodiment, Figure 4 As shown, in the radial direction of the mesh skeleton 11, the profile of the cross section of the mesh skeleton 11 is composed of two arcs with different radii, wherein, preferably, the angle range of the arc with a small radius is between 180° and 360°; this shape setting can be applicable to a false cavity with an asymmetric cavity shape formed due to different pressures on the inner and outer walls, that is, it is conducive to the intraluminal occluder 100 fitting with the inner wall of the false cavity with an asymmetric cavity shape.
[0026] For example, in other embodiments, reference may be made to Figures 5 to 7 As shown, in the radial direction of the mesh skeleton 11, the cross-sectional shape of the mesh skeleton 11 can also be a large semicircle, a crescent shape, a semicircle, etc.
[0027] Of course, the cross-sectional shape of the mesh skeleton 11 can also be other shapes and is not limited to the above.
[0028] In this embodiment, transition fillets are provided at the connections between the two end faces 111 and the side faces 112 of the mesh skeleton 11, that is, the two end faces 111 and the side faces 112 are smoothly connected; this setting can prevent the intraluminal occluder 100 from having sharp edges and corners that damage blood vessels, and is also conducive to the recovery of the intraluminal occluder 100.
[0029] In other embodiments, the transition fillets may not be provided at the connections between the two end surfaces 111 and the side surfaces 112 .
[0030] The mesh skeleton 11 has a grid structure, wherein the mesh skeleton 11 can be woven from filaments or cut into a grid structure. Preferably, the mesh skeleton 11 is woven from filaments; the filaments can be metal wires, metal tubes, polymer wires, polymer tubes, etc., or a composite of at least two of these.
[0031] In one embodiment, the mesh skeleton 11 is woven from a plurality of wires made of a memory alloy, such as nickel-titanium shape memory alloy, copper-nickel shape memory alloy, copper-aluminum shape memory alloy, copper-zinc shape memory alloy, iron shape memory alloy (Fe-Mn-Si, Fe-Pd), etc., so that the shape can be restored to its original shape after being released after compression.
[0032] In a preferred embodiment, the mesh skeleton 11 is woven from a plurality of titanium-nickel wires; wherein the nickel-titanium wires have better elasticity and memory resilience, have a good adaptability to the shape, and can improve the blocking effect.
[0033] In this embodiment, the mesh frame 11 is woven from filaments to form a grid structure, and the filaments converge at the center of the two axial end surfaces 111 of the mesh frame 11 to form end heads 115 respectively. Figure 8 The intracavitary occluder 100 further includes a sleeve 14 respectively sleeved on both ends, and a plug 15 is provided on the outside of the sleeve 14. The end of the plug 15 away from the sleeve 14 is formed with a thread (not shown), and the thread is used to cooperate with other devices, for example, to cooperate with a conveyor. The material of the sleeve 14 and the plug 15 is preferably stainless steel, such as 316L stainless steel. It should be noted that for the convenience of expression, Figure 2 The cross-sectional view of the embodiment does not show the cross-section of the sleeve and the bolt head, and the same is true for other similar cross-sectional views.
[0034] The end of the mesh frame 11 that connects to the delivery device is defined as the proximal end of the mesh frame 11. In this embodiment, the end housing the plug 15 is the proximal end, and the end distal to the plug 15 is the distal end. In this embodiment, the proximal end of the mesh frame 11 is concave. This configuration prevents the proximal end of the mesh frame 11 from deforming under pressure, thereby facilitating the smooth release and retraction of the intraluminal occluder 100.
[0035] In this embodiment, the side surface 122 of the flow-blocking membrane 12 is concave-convex, or in other words, the distances between at least multiple points of the side surface 122 of the flow-blocking membrane 12 and the central axis of the mesh skeleton 11 are different; this shape setting can improve the adaptability of the intraluminal occluder, so that the intraluminal occluder can bend in the false cavity along with the shape of the false cavity, so as to fully fit the cavity wall to block the false cavity.
[0036] In one embodiment, the side surface 122 of the baffle film 12 includes evenly distributed concavities and convexities along the radial direction of the mesh frame 11 , and the side surface 122 of the baffle film 12 is centrally symmetrical with respect to the axis along the mesh frame 11 .
[0037] In this embodiment, the side surface 122 of the flow-blocking film 12 is in a regularly changing wave-shaped fold shape; specifically, as shown in FIG. Figure 1 and Figure 2 As shown, the side surface 122 of the flow-blocking film 12 includes at least one annular trough 123 and multiple annular peaks 124; troughs 123 are formed between adjacent peaks 124, and there is a smooth transition between the peaks 124 and the troughs 123. For ease of description, the distance between the peaks 124 of the flow-blocking film 12 and the central axis of the mesh skeleton 11 is defined as the height of the peaks, and the distance between the troughs 123 of the flow-blocking film 12 and the central axis of the mesh skeleton 11 is defined as the height of the troughs. In this embodiment, the heights of the peaks 124 are approximately the same, the heights of the troughs 123 are also approximately the same, and the distances between adjacent peaks 124 are also approximately the same. Preferably, the number of peaks 124 of the flow-blocking film 12 ranges from 2 to 6. In this embodiment, the number of peaks 124 is 3, and the number of troughs 123 is 2.
[0038] The specific shape parameters of the crest 124 and the trough 123 , such as aspect ratio, etc., can be set according to requirements such as stretching length, and are not limited in this embodiment.
[0039] In another embodiment, the side surface 122 of the baffle film 12 may also be a uniform concave-convex shape different from that of this embodiment. For example, the crest of the baffle film 12 is not annular but spiral, so the trough is also spiral.
[0040] In another embodiment, the side surface 122 of the flow-blocking film 12 may also include unevenly distributed concave and convex portions, such as irregular wave folds, with different heights of wave crests, different heights of wave troughs, and / or different distances between adjacent wave crests.
[0041] In the natural state, the axial length of the baffle film 12 is the same as the axial length of the mesh skeleton 11; when the mesh skeleton 11 is axially stretched, the baffle film 12 gradually unfolds, so that the baffle film 12 is axially stretched along with the mesh skeleton 11, and the maximum axial length of the baffle film 12 is greater than or equal to the maximum axial stretching length of the mesh skeleton 11.
[0042] In this embodiment, when the folds of the flow-blocking membrane 12 are all flattened, the axial length of the flow-blocking membrane 12 is greater than or equal to the maximum axial stretching length of the mesh skeleton 11. When the intraluminal occluder 100 is released, the mesh skeleton 11 returns to its original shape, and the flow-blocking membrane 12 also returns to its wrinkled shape. With this flow-blocking membrane structure, when the intraluminal occluder 100 needs to be compressed in a delivery sheath, the mesh skeleton 11 will not be unable to be compressed in the delivery sheath due to the inability of the flow-blocking membrane 12 to stretch. That is, the flow-blocking membrane 12 and the mesh skeleton 11 can be stretched and contracted together, so that the flow-blocking membrane 12 bound to the mesh skeleton 11 will not limit the axial stretching of the mesh skeleton 11; when the intraluminal occluder 100 is released, the mesh skeleton 11 returns to its original shape, and the flow-blocking membrane 12 also returns to its wrinkled shape, which can increase the adhesion performance with the tissue at the release position and enhance the occlusion effect.
[0043] It can be understood that in other embodiments, the side 122 of the mesh skeleton 11 may also be concave and convex; further, the undulations of the side 122 of the mesh skeleton 11 may be consistent with the undulations of the side 112 of the baffle film 12, that is, in the axial direction of the mesh skeleton 11, the undulating position of the side 122 of the mesh skeleton 11 is the same as the undulating position of the side 112 of the baffle film 12.
[0044] The material of the flow-blocking membrane 12 can be a material with good biocompatibility such as polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET) film.
[0045] In one embodiment, the thickness of the baffle film 12 is 0.02 mm to 0.1 mm; preferably, the thickness of the baffle film 12 is 0.04 mm to 0.08 mm; more preferably, the thickness of the baffle film 12 is 0.04 mm, 0.06 mm or 0.08 mm.
[0046] The flow-blocking membrane 12 can be connected to the mesh frame 11 by suturing with sutures 16; the suturing method can be single-point suturing. The sutures 16 can be sewn to any one or both axial ends of the mesh frame 11, or to any location between the two ends of the mesh frame 11; for example, the sutures 16 can be sewn to the sleeve 14, the plug 15, or the cylindrical surface of the mesh frame 11. The sutures 16 can be made of a biocompatible material such as polytetrafluoroethylene.
[0047] In this embodiment, the flow-blocking film 12 is covered on the outside of the end surface 111 and the side surface 112 of the mesh frame 11, and the flow-blocking film 12 is sutured to the sleeve 14 by a single-strand single-point suture method using a suture 16 (see FIG. Figure 2 ) and the intersections of the metal wires of the mesh skeleton 11 (not shown).
[0048] The thrombus-promoting member 13 can be disposed on part or all of the outer surface of the intraluminal occluder 100. After the intraluminal occluder 100 is released, the elongated thrombus-promoting member 13 with a free end can disturb the blood flow in the false lumen and fill the false lumen, thereby reducing the volume of the false lumen and promoting thrombosis in the false lumen.
[0049] The plug-promoting member 13 is a slender linear or ribbon-like structure. The length of the plug-promoting member 13 is 2-20 mm and the width is 0.01-2 mm. When the width is small, it can be called a linear structure, and when the width is large, it can be called a ribbon-like structure.
[0050] The embolization member 13 can be arranged on the mesh frame 11 or on the flow-blocking membrane 12. In this embodiment, the embolization member 13 is distributed on the outside of the flow-blocking membrane 12. The embolization member can be fixed to the outside of the flow-blocking membrane 12 by means of suturing, gluing, etc., and the fixing method can be single-strand fixing or multi-strand fixing. In this embodiment, Figure 2 and Figure 9 As shown, the plug promoting member 13 is fixedly connected to the flow blocking membrane 12 by suturing, and the suturing is fixed by a single strand of suturing. The plug promoting member 13 extends generally in a direction away from the flow blocking membrane 12, that is, generally extending toward the outside of the intraluminal occluder 100.
[0051] In other embodiments, Figure 10 and Figure 11 As shown, the tethering member 13 can also be fixed at the intersection of the mesh of the mesh frame 11; of course, the tethering member 13 can also be fixed at other positions of the mesh of the mesh frame 11. The tethering member 13 can be fixed by winding a single strand or by winding multiple strands.
[0052] In this embodiment, Figure 2 and Figures 9 to 11 As shown, each bolt-promoting member 13 is a non-bifurcated structure.
[0053] In other embodiments, the thrombus-promoting member 13 may also be a bifurcated structure, and the bifurcated structure can enhance the effect of the thrombus-promoting member in promoting thrombosis of the false lumen; wherein, the bifurcated structure of the thrombus-promoting member 13 may also be configured in various ways. Figures 12 to 14 Three bifurcation structures are shown in the figure, one is a unilateral uniform bifurcation, another is a bilateral alternating bifurcation, and another is a bilateral opposite bifurcation; it can be understood that the structure of the bolt-promoting member 13 is not limited to the structure shown in the figure, and other structures can also be used.
[0054] The plug-promoting member 13 can be made of chemical synthetic fibers or natural plant and animal materials, such as wool, silk, etc. In this embodiment, the plug-promoting member 13 is made of a linear or sheet-like PET material.
[0055] See also Figure 15 , a second embodiment of the present technical solution provides an intraluminal occluder 100a. The intraluminal occluder 100a in this embodiment is basically the same as the intraluminal occluder 100 in the first embodiment. The flow-blocking membrane 12 is also covered on the outside of the end face 111 and the side face 112 of the mesh skeleton 11. The difference is that the side face 112 of the mesh skeleton 11 is not columnar, but has roughly the same shape as the side face 122 of the flow-blocking membrane 12, that is, the side face 112 of the mesh skeleton 11 is also concave and convex, and the distances between at least multiple points of the side face 112 of the mesh skeleton 11 and the central axis of the mesh skeleton 11 are different, and the undulations of the side face 112 of the flow-blocking membrane 12 are consistent with the undulations of the side face 122 of the mesh skeleton 11; this structural setting makes the flow-blocking membrane 12 fit more closely to the mesh skeleton 11, and can increase the axial adaptability of the intraluminal occluder 100a, so that it can conform to the vascular structure.
[0056] Furthermore, in this embodiment, the side surface 112 of the mesh skeleton 11 also presents a regularly changing wave fold shape. The side surface 112 of the mesh skeleton 11 includes at least one annular trough 113 and multiple annular peaks 114. The troughs 113 are formed between adjacent peaks 114 of the mesh skeleton 11. There is a smooth transition between the peaks 114 and the troughs 113 of the mesh skeleton 11; the peaks 124 of the flow-blocking membrane 12 correspond one-to-one to the peaks 114 of the mesh skeleton 11; and the distance between adjacent peaks 114 of the mesh skeleton 11 is the same.
[0057] The distance between the crest 114 of the mesh skeleton 11 and the central axis of the mesh skeleton 11 is defined as the height of the crest 114 of the mesh skeleton 11, and the distance between the trough 113 of the mesh skeleton 11 and the central axis of the mesh skeleton 11 is defined as the height of the trough 113 of the mesh skeleton 11; in this embodiment, the heights of the crests 114 of the mesh skeleton 11 are substantially the same, and the heights of the troughs 113 of the mesh skeleton 11 are also substantially the same; the heights of the two crests 124 connecting the two end faces 121 of the flow-blocking membrane 12 are smaller than the heights of the crests 124 in the middle position, and the flow-blocking membrane 1 2. The height of the peaks 124 at both ends of the baffle film 12 is slightly greater than the height of the peaks 114 of the mesh skeleton 11 at the corresponding radial position, and the height of each peak 124 at the middle position of the baffle film 12 is much greater than the height of the peaks 114 of the mesh skeleton 11 at the corresponding radial position. Because the wavy mesh skeleton 11 has a larger stretchable length, in this embodiment, the height of each peak 124 at the middle position of the baffle film 12 is much greater than the height of the peaks 114 of the mesh skeleton 11 at the corresponding radial position, so that the stretchable length of the baffle film 12 is larger and it is easy to adapt to the mesh skeleton 11.
[0058] Preferably, the number of the wave peaks 124 and 114 ranges from 2 to 6. In this embodiment, the number of the wave peaks 124 and 114 ranges from 4 to 6.
[0059] The specific shape parameters of the crests 124 and 114 and the troughs 123 and 113 , such as aspect ratio, etc., can be set according to requirements such as stretching length, and are not limited in this embodiment.
[0060] In another embodiment, the side surface 112 of the mesh skeleton 11 may also be a uniform concave-convex shape different from that of this embodiment. For example, the crest of the mesh skeleton 11 is not annular but spiral, so the trough is also spiral.
[0061] In another embodiment, the side surface 112 of the mesh skeleton 11 may also include unevenly distributed concave and convex portions, such as irregular wave folds, with different heights of wave crests, different heights of wave troughs, and / or different distances between adjacent wave crests.
[0062] In this embodiment, reference may be made to Figure 3 As shown, in the radial direction of the mesh skeleton 11 , the cross-section of the mesh skeleton 11 is circular, which is beneficial for the delivery of the intraluminal occluder 100 , and the cylindrical structure is also beneficial for the intraluminal occluder 100 to fit the inner wall of the false lumen.
[0063] In another embodiment, reference may be made to Figure 4As shown, in the radial direction of the mesh skeleton 11, the profile of the cross section of the mesh skeleton 11 is composed of two arcs with different radii, wherein, preferably, the angle range of the arc with a small radius is between 180° and 360°; this shape setting can be applicable to a false cavity with an asymmetric cavity shape formed due to different pressures on the inner and outer walls, that is, it is conducive to the intraluminal occluder 100 fitting with the inner wall of the false cavity with an asymmetric cavity shape.
[0064] In other embodiments, reference may be made to Figures 5 to 7 As shown, in the radial direction of the mesh skeleton 11 , the cross-sectional shape of the mesh skeleton 11 may also be at least partially arc-shaped, such as a large semicircle, a crescent shape, a semicircle, and the like.
[0065] In other embodiments, the cross-sectional shape of the mesh skeleton 11 may be other shapes and is not limited to the above.
[0066] In the drawings of this embodiment, the bolt-promoting member 13 is provided on the flow-blocking membrane 12 as an example for description; of course, the bolt-promoting member 13 can also be provided on the mesh skeleton 11 .
[0067] In this embodiment, the mesh skeleton 11 with a concave-convex surface is provided to increase the axial adaptability of the intraluminal occluder 100 so that it can conform to the vascular structure. In addition, the mesh skeleton 11 with a concave-convex surface allows the flow-blocking membrane 12 to fit more closely with the mesh skeleton 11 .
[0068] It should be noted that, for the contents not described in the specification and drawings of this embodiment, reference may be made to the description of the first embodiment, and no further details will be given here.
[0069] See also Figure 16 The third embodiment of the present technical solution provides an intracavitary occluder 100b. The intracavitary occluder 100b in this embodiment is basically the same as the intracavitary occluder 100a in the second embodiment. The flow-blocking membrane 12 is also covered on the outside of the end face 111 and the side face 112 of the mesh skeleton 11. The difference is that: in this embodiment, the heights of the peaks 124 of the flow-blocking membrane 12 are roughly the same, and the heights of the troughs 123 of the flow-blocking membrane 12 are also roughly the same. The heights of the peaks 124 of the flow-blocking membrane 12 are slightly greater than the heights of the peaks 114 of the mesh skeleton 11 at the corresponding radial position. The flow-blocking membrane 12 with this arrangement has good adhesion to the mesh skeleton 11, which is conducive to the smooth delivery of the intracavitary occluder 100.
[0070] In the drawings of this embodiment, the bolt-promoting member 13 is provided on the flow-blocking membrane 12 as an example for description; of course, the bolt-promoting member 13 can also be provided on the mesh skeleton 11 .
[0071] It should be noted that, for the contents not described in the specification and drawings of this embodiment, reference may be made to the description of the first and second embodiments, and no further details will be given here.
[0072] See also Figure 17 The fourth embodiment of the present technical solution provides an intracavitary occluder 100c. The intracavitary occluder 100c in this embodiment is basically the same as the intracavitary occluder 100b in the third embodiment, except that the flow-blocking membrane 12 is coated on the inner side of the end face 111 and the side face 112 of the mesh skeleton 11, that is, it is fixed inside the mesh skeleton 11; and the height of each crest 124 of the flow-blocking membrane 12 is slightly smaller than the height of the crest 114 of the mesh skeleton 11 at the corresponding radial position.
[0073] In this embodiment, the flow-blocking membrane 12 is disposed within the mesh frame 11, which reduces resistance to loading and releasing the intraluminal occluder 100, facilitates smooth operation during delivery, and prevents damage to the flow-blocking membrane during release and retrieval of the intraluminal occluder 100. Furthermore, the side surfaces of the flow-blocking membrane 12 and the mesh frame 11 are concave and convex, which improves the efficiency of suturing the flow-blocking membrane inside the frame.
[0074] like Figure 17 As shown, in this embodiment, the bolt-promoting member 13 is provided on the mesh frame 11; specifically, refer to Figure 10 and Figure 11 As shown, the tethering member 13 is wrapped around and fixed at the intersection of the meshes of the mesh frame 11; of course, the tethering member 13 can also be fixed at other locations of the meshes of the mesh frame 11. In this embodiment, the flow-blocking film 12 is disposed within the mesh frame 11, which is exposed, and the tethering member 13 is disposed on the mesh frame 11, thereby making it easier to fix the tethering member 13.
[0075] Of course, in other embodiments, the plug-promoting member 13 may also be disposed on the flow-blocking membrane 12 .
[0076] It should be noted that, for the contents not described in the specification and drawings of this embodiment, reference may be made to the description of the first to third embodiments, and no further details will be given here.
[0077] The intracavitary occluder provided by the technical solution of the present application is made of a skeleton-coated flow-blocking membrane, and both the skeleton and the flow-blocking membrane have good compressibility, so that the volume of the intracavitary occluder after compression is small; and the intracavitary occluder provided by the technical solution of the present application is made of a skeleton-coated flow-blocking membrane, which can quickly return to its original shape when released and has good wall-adherence performance after release; further, the maximum axial length of the flow-blocking membrane of the intracavitary occluder provided by the technical solution of the present application is greater than or equal to the maximum axial tensile length of the skeleton, so that it can be suitable for occluding organ channels with longer axial lengths. For example, when the intracavitary occluder is compressed in the delivery sheath, the flow-blocking membrane can be extended along with the axial extension of the intracavitary occluder. After the intracavitary occluder is released at the lesion position and restores its shape, the flow-blocking membrane can also change accordingly and can cover the intracavitary occluder, which can completely prevent blood from passing through the intracavitary occluder into the defect opening or tissue rupture, thereby completing the repair of the defect opening. The occluder can be used to seal or block openings or tissue ruptures; because its flow-blocking membrane does not limit the elongation of the skeleton, even an occluder with a longer axial length can still be compressed in a smaller size in the sheath, which is particularly suitable for interventional treatment of aortic dissection. Placing the occluder in the false lumen of the dissection can promote thrombosis of the false lumen; in addition, the intraluminal occluder provided by the technical solution of the present application adopts a concave and convex surface, thereby improving the adaptability of the occluder, so that it can bend in the false lumen along with the shape of the false lumen to fully fit the lumen wall and block the false lumen; and, the surface of the intraluminal occluder provided by the technical solution of the present application is distributed with thrombosis-promoting members, which can further promote thrombosis of the false lumen; on the other hand, the false lumens of different individuals have different shapes, and the present application provides occluders with different cross-sections such as circular, two arc splicing, large semicircular, crescent-shaped and semicircular for selection, which are more adaptable to the shape of the false lumen and improve the fit between the occluder and the inside of the false lumen.
[0078] The above is an implementation method of the embodiment of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present application. These improvements and modifications are also considered to be within the scope of protection of the present application.
Claims
1. An intracavitary occluder, comprising: A mesh skeleton having a hollow structure, comprising two end faces and side faces connected therebetween; a cross-section of the mesh skeleton having a profile formed by connecting two arcs of different radii in a radial direction of the mesh skeleton, wherein the angle of the arc of smaller radius ranges from 180° to 360°; and the intraluminal occluder is used for placement in the false lumen of aortic dissection; A flow-blocking film is formed on the mesh skeleton, the flow-blocking film includes two end faces and side faces connected between the two end faces, the flow-blocking film is covered on the outside of the mesh skeleton, and the maximum axial length of the flow-blocking film is greater than or equal to the maximum axial tensile length of the mesh skeleton; the side face of the flow-blocking film includes at least one annular trough and multiple annular peaks; among the multiple peaks of the flow-blocking film, the height of the two peaks connecting the two end faces of the flow-blocking film is less than the height of each peak in the middle position; and the height of the peaks at the two ends of the flow-blocking film is slightly greater than the height of the peaks of the mesh skeleton at the corresponding radial position, and the height of each peak in the middle position of the flow-blocking film is much greater than the height of the peaks of the mesh skeleton at the corresponding radial position; and a plug-promoting member formed on the surface of the intracavitary occluder, and the plug-promoting member is arranged on the flow-blocking membrane; Wherein, the side surface of the mesh skeleton and the side surface of the flow-blocking membrane are concave-convex surfaces.
2. The intracavitary occluder according to claim 1, characterized in that: The flow-blocking film has a smooth transition between the wave crest and the wave trough.
3. The intracavitary occluder according to claim 1, wherein: A transition fillet is provided at the connection between the end face and the side face of the mesh skeleton.
4. The intracavitary occluder according to claim 1, characterized in that: The end of the mesh frame used for connecting with the conveyor is defined as the proximal end of the mesh frame, wherein the proximal end surface of the mesh frame is concave.
5. The intracavitary occluder according to claim 1, characterized in that: The bolt-promoting member is a non-forked structure or a forked structure; the forked structure is a unilateral forked structure, a bilateral alternating forked structure or a bilateral opposing forked structure.
Citation Information
Patent Citations
Closure device
CN102697528A
Plugging device and manufacturing method thereof
CN105455922A
Intracavity occluder
CN211934141U
Patent arterial duct blockage device
CN2191632Y