CN116407194A - Blocking device - Google Patents
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- CN116407194A CN116407194A CN202111675280.2A CN202111675280A CN116407194A CN 116407194 A CN116407194 A CN 116407194A CN 202111675280 A CN202111675280 A CN 202111675280A CN 116407194 A CN116407194 A CN 116407194A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12154—Coils or wires having stretch limiting means
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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Abstract
本发明涉及医疗器械技术领域,提供了一种封堵装置,包括用于将封堵装置固定在预定位置的固定部,起密封作用的密封部,以及连接固定部和密封部的连接部,其中,固定部包括若干支撑杆,支撑杆包括位于近端的连接段,以及从近端连接后径向延伸形成的起支撑作用的支承段,支承段上设有限制结构,限制结构阻止相邻的支承段相互靠近。本发明通过在支承段上设置了限制结构来阻止相邻的支承段相互靠近,在支承段外翻时可将支承段充分拉开,避免固定部的支撑杆互相纠结情况的发生,从而使得固定部充分展开,并且不会影响封堵装置进出鞘管。
The present invention relates to the technical field of medical devices, and provides an occlusion device, which includes a fixing part for fixing the occlusion device at a predetermined position, a sealing part that acts as a seal, and a connecting part connecting the fixing part and the sealing part, wherein , the fixed part includes a number of support rods, the support rods include a connecting section located at the proximal end, and a supporting section formed by radially extending from the proximal end after being connected, the supporting section is provided with a restricting structure, and the restricting structure prevents adjacent The support segments are close to each other. The present invention prevents adjacent support segments from approaching each other by setting a restricting structure on the support segments, and can fully pull the support segments apart when the support segments are everted, avoiding the occurrence of entanglement of the support rods of the fixing part, thereby making the fixing Fully expanded, and will not affect the occlusion device into and out of the sheath.
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别是涉及一种封堵装置。The invention relates to the technical field of medical instruments, in particular to a blocking device.
背景技术Background technique
非瓣膜病房颤患者中,因房颤导致的脑卒中,其中90%源自左心耳。有临床资料显示房颤时,心脏外科手术中切除左心耳可降低脑卒中的发生率,这提示左心耳在血栓栓塞中的危害。既然左心耳是血栓的窝点,那么封堵左心耳的开口就可以消除左心耳内血栓形成的基础。通常,通过左心耳封堵器对左心耳封堵是一种有效的预防房颤导致的脑卒中方式。In patients with non-valvular atrial fibrillation, 90% of strokes caused by atrial fibrillation originate from the left atrial appendage. Clinical data have shown that resection of the left atrial appendage during cardiac surgery can reduce the incidence of stroke in patients with atrial fibrillation, which suggests the harm of the left atrial appendage in thromboembolism. Since the left atrial appendage is the nest of thrombus, blocking the opening of the left atrial appendage can eliminate the basis of thrombus formation in the left atrial appendage. Usually, occlusion of the left atrial appendage with a left atrial appendage occluder is an effective way to prevent stroke caused by atrial fibrillation.
为将左心耳进行有效封堵,需长期将左心耳封堵器植入于左心耳内,以实现封堵效果。目前,左心耳封堵器一般包括固定在预定位置的固定部以及起密封作用的密封部,释放时固定部向外外翻,当其在外翻过程中,其固定部的主干易发生互相纠结,导致主干无法充分外翻,进而影响左心耳封堵器固定部的展开程度。In order to effectively block the left atrial appendage, a left atrial appendage occluder needs to be implanted in the left atrial appendage for a long time to achieve the blocking effect. At present, left atrial appendage occluders generally include a fixed part fixed at a predetermined position and a sealing part that acts as a seal. When released, the fixed part turns outwards. When it is in the process of eversion, the trunk of the fixed part tends to tangle with each other. As a result, the trunk cannot be fully turned out, thereby affecting the degree of expansion of the fixed part of the left atrial appendage occluder.
发明内容Contents of the invention
基于此,本发明提供一种封堵装置,以解决现有左心耳封堵器的固定部在外翻过程中,其固定部的主干易发生互相纠结,导致主干无法充分外翻,进而影响左心耳封堵器固定部的展开程度的问题。Based on this, the present invention provides an occlusion device to solve the problem that the main trunk of the fixed part of the existing left atrial appendage occluder is easily entangled with each other during the process of eversion, resulting in the inability of the main trunk to be fully everted, thereby affecting the left atrial appendage. The problem of the expansion degree of the fixed part of the occluder.
本发明为解决上述技术问题,提出一种封堵装置,包括用于将所述封堵装置固定在预定位置的固定部,与所述固定部相连的密封部,所述固定部包括若干支撑杆,所述支撑杆包括位于近端的连接段,以及与所述连接段相连的起支撑作用的支承段,所述支承段上设有限制结构,所述限制结构阻止相邻的所述支承段相互靠近。In order to solve the above technical problems, the present invention proposes a blocking device, including a fixing part for fixing the blocking device at a predetermined position, a sealing part connected with the fixing part, and the fixing part includes a plurality of support rods , the support rod includes a connecting section located at the proximal end, and a supporting section connected to the connecting section, the supporting section is provided with a restricting structure, and the restricting structure prevents the adjacent supporting section from close to each other.
在其中一个实施例中,至少两个支撑杆的连接段在固定部与所述密封部的连接处的远端交叉。In one embodiment, the connecting sections of at least two support rods intersect at the distal end of the connection between the fixing part and the sealing part.
在其中一个实施例中,所述限制结构包括连接杆,所述连接杆的一端抵持或固定所述支承段的内侧,另一端连接所述连接段或所述固定部与所述密封部的连接处。In one of the embodiments, the restricting structure includes a connecting rod, one end of the connecting rod resists or fixes the inner side of the supporting section, and the other end connects the connecting section or the fixing part and the sealing part. Junction.
在其中一个实施例中,所述封堵装置还包括限位件,所述限位件为环形结构,所述环形结构套设于所述固定部与所述密封部的连接处和/或所述连接段外侧,所述环形结构沿轴向可活动,所述连接杆的一端抵持或固定所述支承段的内侧,另一端连接所述环形结构。In one of the embodiments, the blocking device further includes a stopper, the stopper is an annular structure, and the annular structure is sheathed at the connection between the fixing part and the sealing part and/or the On the outside of the connecting section, the annular structure is movable in the axial direction, one end of the connecting rod resists or fixes the inner side of the supporting section, and the other end is connected to the annular structure.
在其中一个实施例中,所述限制结构包括覆膜,所述覆膜嵌套在所述支撑杆上。In one of the embodiments, the restricting structure includes a membrane, and the membrane is nested on the support rod.
在其中一个实施例中,所述限制结构包括连接件,所述连接件连接相邻两个所述支承段。In one of the embodiments, the restricting structure includes a connecting piece, and the connecting piece connects two adjacent supporting segments.
在其中一个实施例中,所述连接件为弹性件,所述弹性件两端连接相邻两个所述支承段,所述弹性件处于压缩状态并撑开相邻两个所述支承段。In one embodiment, the connecting member is an elastic member, two ends of the elastic member are connected to two adjacent support segments, and the elastic member is in a compressed state and stretches apart the two adjacent support segments.
在其中一个实施例中,所述连接件为伸缩杆,所述伸缩杆两端连接相邻两个所述支承段,所述伸缩杆撑开相邻两个所述支承段。In one embodiment, the connecting member is a telescopic rod, two ends of the telescopic rod are connected to two adjacent support segments, and the telescopic rod stretches the two adjacent support segments.
在其中一个实施例中,所述伸缩杆包括可相对滑动的内管和外管,所述外管套设于所述内管外,所述内管设于所述外管内的部分设置有第一定位件,所述外管对应所述第一定位件的位置设置有第二定位件,所述支承段外翻时所述内管和所述外管相对远离,所述第一定位件与所述第二定位件对位时锁止以限制所述内管和所述外管相对滑动。In one embodiment, the telescopic rod includes an inner tube and an outer tube that can slide relatively, the outer tube is sheathed outside the inner tube, and the part of the inner tube inside the outer tube is provided with a second A locator, the outer tube is provided with a second locator at a position corresponding to the first locator, the inner tube and the outer tube are relatively far away when the support section is everted, and the first locator and the outer tube are relatively far apart. When the second locating member is aligned, it is locked to limit the relative sliding of the inner tube and the outer tube.
在其中一个实施例中,所述第一定位件与所述第二定位件之一为弹性凸起,则另一为凹槽或通孔,所述弹性凸起与所述凹槽或所述通孔对位时,所述弹性凸起卡接在所述凹槽或所述通孔内。In one of the embodiments, one of the first positioning member and the second positioning member is an elastic protrusion, and the other is a groove or a through hole, and the elastic protrusion and the groove or the When the through holes are aligned, the elastic protrusions are engaged in the grooves or the through holes.
在其中一个实施例中,所述连接件为一根衔接杆,所述衔接杆连接相邻两个所述支承段且连接的位置与所述支撑杆的远端端点的距离不同。In one of the embodiments, the connecting member is an engaging rod, and the connecting rod connects two adjacent supporting segments at different distances from the distal ends of the supporting rods.
在其中一个实施例中,所述连接件为两根衔接杆,两所述衔接杆均连接相邻两个所述支承段,且两根所述衔接杆转动连接或交叉设置。In one embodiment, the connecting member is two connecting rods, both connecting rods are connected to two adjacent supporting segments, and the two connecting rods are connected in rotation or crossed.
在其中一个实施例中,一所述衔接杆的一端与所述支承段滑动连接。In one of the embodiments, one end of the connecting rod is slidably connected with the supporting section.
在其中一个实施例中,所述连接件为四根衔接杆,四根所述衔接杆依次首尾相连,首尾相连的四根所述衔接杆的一相对两交点连接相邻两个所述支承段,另一相对两交点可沿轴向靠近或远离。In one of the embodiments, the connecting parts are four connecting rods, and the four connecting rods are connected end to end in turn, and one opposite two intersection points of the four connecting rods connected end to end connect two adjacent supporting segments , the other relative two intersections can approach or move away from each other in the axial direction.
与现有技术相比,本发明所提供的封堵装置具有如下的有益效果:Compared with the prior art, the blocking device provided by the present invention has the following beneficial effects:
本发明提供的封堵装置,支撑杆包括位于近端的连接段,以及与所述连接段相连的起支撑作用的支承段,通过在支承段上设置了限制结构来阻止相邻的支承段相互靠近,防止了固定部在外翻过程中支撑杆发生互相纠结导致支承段无法充分外翻,进而保证封堵装置的固定部的展开程度。In the occlusion device provided by the present invention, the support rod includes a connecting section located at the proximal end, and a supporting section connected with the connecting section, and a restricting structure is provided on the supporting section to prevent adjacent supporting sections from interacting with each other. The proximity prevents the supporting rods from being entangled with each other during the valgus process of the fixing part, resulting in the inability of the supporting section to fully valgus, thereby ensuring the degree of expansion of the fixing part of the occlusion device.
附图说明Description of drawings
图1为本发明实施例一提供的封堵装置的压缩状态的结构示意图;Fig. 1 is a schematic structural view of the compressed state of the blocking device provided by
图2为本发明实施例一提供的封堵装置的展开状态的结构示意图;Fig. 2 is a schematic structural view of the expanded state of the occlusion device provided by Embodiment 1 of the present invention;
图3为本发明实施例一提供的封堵装置的工作示意图;Fig. 3 is a working schematic diagram of the blocking device provided by
图4为本发明实施例二提供的封堵装置的结构示意图一;Fig. 4 is a structural schematic diagram 1 of the blocking device provided by
图5为本发明实施例二提供的封堵装置的结构示意图二;Fig. 5 is a second structural schematic diagram of the blocking device provided by the second embodiment of the present invention;
图6为本发明实施例三提供的封堵装置的结构示意图一;Fig. 6 is a schematic structural diagram 1 of the blocking device provided by Embodiment 3 of the present invention;
图7为图6中A的放大图;Figure 7 is an enlarged view of A in Figure 6;
图8为本发明实施例三提供的封堵装置的结构示意图二;Fig. 8 is the second structural schematic diagram of the blocking device provided by the third embodiment of the present invention;
图9为本发明实施例四提供的封堵装置的结构示意图;Fig. 9 is a schematic structural diagram of a blocking device provided in Embodiment 4 of the present invention;
图10为本发明实施例五提供的封堵装置的结构示意图;FIG. 10 is a schematic structural view of the blocking device provided in Embodiment 5 of the present invention;
图11为本发明实施例五提供的封堵装置之伸缩杆的内部结构示意图;11 is a schematic diagram of the internal structure of the telescopic rod of the blocking device provided in Embodiment 5 of the present invention;
图12为本发明实施例六提供的封堵装置的结构示意图;Fig. 12 is a schematic structural view of the blocking device provided in Embodiment 6 of the present invention;
图13为本发明实施例七提供的封堵装置的结构示意图;Fig. 13 is a schematic structural view of the blocking device provided by Embodiment 7 of the present invention;
图14为图13中B的放大图;Figure 14 is an enlarged view of B in Figure 13;
图15为本发明实施例八提供的封堵装置的结构示意图。Fig. 15 is a schematic structural diagram of a blocking device provided in Embodiment 8 of the present invention.
附图标识说明:Explanation of the accompanying drawings:
10、封堵装置;11、固定部;12、密封部;13、连接部;14、限位件;111、支撑杆;112、限制结构;1111、球头;1112、连接段;1113、支承段;1121、连接杆;10. Blocking device; 11. Fixed part; 12. Sealing part; 13. Connecting part; 14. Limiting part; 111. Support rod; 112. Limiting structure; Section; 1121, connecting rod;
20、封堵装置;21、固定部;23、连接部;24、限位件;211、支撑杆;212、限制结构;2112、连接段;2113、支承段;2121、覆膜;2122、绑线;2123、连接杆;20. Blocking device; 21. Fixed part; 23. Connecting part; 24. Limiting piece; 211. Support rod; 212. Limiting structure; 2112. Connecting section; 2113. Supporting section; line; 2123, connecting rod;
30、封堵装置;31、固定部;33、连接部;34、限位件;311、支撑杆;312、限制结构;3112、连接段;3113、支承段;3121、覆膜;3122、连接杆;31211、凹陷区域;30. Blocking device; 31. Fixing part; 33. Connecting part; 34. Limiting part; 311. Support rod; 312. Limiting structure; 3112. Connecting section; 3113. Supporting section; rod; 31211, recessed area;
40、封堵装置;41、固定部;411、支撑杆;412、限制结构;4113、支承段;4121、连接件;40. Blocking device; 41. Fixing part; 411. Support rod; 412. Limiting structure; 4113. Support section; 4121. Connector;
50、封堵装置;51、固定部;53、连接部;511、支撑杆;5112、连接段;5113、支承段;5121、连接件;51211、内管;51212、外管;51213、第一定位件;51214、第二定位件;50. Blocking device; 51. Fixed part; 53. Connecting part; 511. Support rod; 5112. Connecting section; 5113. Supporting section; Positioning piece; 51214, the second positioning piece;
60、封堵装置;61、固定部;611、支撑杆;6113、支承段;6121、连接件;60. Blocking device; 61. Fixed part; 611. Support rod; 6113. Support section; 6121. Connector;
70、封堵装置;71、固定部;711、支撑杆;7111、滑动槽;7113、支承段;7121、连接件;70. Blocking device; 71. Fixed part; 711. Support rod; 7111. Sliding groove; 7113. Support section; 7121. Connector;
80、封堵装置;81、固定部;811、支撑杆;8113、支承段;8121、连接件。80. Blocking device; 81. Fixing part; 811. Support rod; 8113. Support section; 8121. Connector.
具体实施方式Detailed ways
为了便于理解本发明,下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是,本发明可以以许多不同的形式来实现,并不限于本文所描述的实施方式。相反地,提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the associated drawings. Preferred embodiments of the invention are shown in the accompanying drawings. However, the present invention can be embodied in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。还需要说明的是,本实施例中的左、右、上、下等方位用语,仅是互为相对概念或是以产品的正常使用状态为参考的,而不应该认为是具有限制性的。It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and similar expressions are used herein for purposes of illustration only and are not intended to represent the only embodiments. It should also be noted that the orientation terms such as left, right, up, and down in this embodiment are only relative concepts or refer to the normal use state of the product, and should not be regarded as limiting.
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段,但是,这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出,否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此,以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terminology used herein in the description of the present invention is only for the purpose of describing specific embodiments, and is not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
另外,需要说明的是,在介入医疗器械领域,一般将植入人体或动物体内的医疗器械或者输送该医疗器械的输送系统的距离操作者较近的一端称为“近端”,将距离操作者较远的一端称为“远端”,并依据此原理定义医疗器械或者输送系统的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向,“径向”一般是指医疗器械的与其“轴向”垂直的方向,并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。In addition, it should be noted that in the field of interventional medical devices, the end of the medical device implanted in the human body or animal body or the delivery system that transports the medical device that is closer to the operator is generally referred to as the "proximal end", and the distance from the operator The far end is called the "distal end", and according to this principle, the "proximal end" and "distal end" of any part of the medical device or delivery system are defined. "Axial" generally refers to the length direction of the medical device when it is being transported, and "radial" generally refers to the direction perpendicular to the "axial" of the medical device, and the "axis" of any part of the medical device is defined according to this principle to" and "radial".
实施例一Embodiment one
参阅图1和图2所示,本发明实施例提供一种封堵装置10,该封堵装置10包括固定部11和与固定部11连接的密封部12,固定部11和密封部12通过连接部13连接,其中,固定部11用于将封堵装置10固定在预定位置,密封部12用于封堵左心耳开口。1 and 2, an embodiment of the present invention provides an
本实施例中,密封部12和固定部11沿封堵装置10的轴向方向间隔设置。密封部12位于封堵装置10的近端,固定部11位于封堵装置10的远端。封堵装置10具有收容在鞘管内的如图1所示的压缩状态,以便于输送,以及从鞘管的远端伸出并自膨胀展开后如图2所示的展开状态。封堵装置10在左心耳腔内释放后的形态与图2完全相同或大体一致。In this embodiment, the sealing
密封部12由多根编织丝编织成网管,网管的两端分别通过一个密封部远端栓头(图中未示出)将编织丝的端部收口并固定。之后将网管热定型为盘状、柱状或塞子状等形状。密封部12的内部设有至少一层薄膜体(图中未示出),薄膜体的边缘固定在密封部12边缘处的编织丝上,薄膜体用于阻止血流从密封部12的一侧流向另一侧,以阻止血流在左心耳和左心房之间流通。The sealing
固定部11包括若干支撑杆111和固定部栓头(图中未示出),密封部远端栓头与固定部栓头通过连接部13相连,也即,固定部11和密封部12通过连接部13连接。固定部11上的支撑杆111可以为通过切割金属合金管或高分子管后得到的杆,也可以为采用编织丝经过编织或缠绕等方式制成的杆。多个支撑杆111的近端均与连接部13连接,远端均从中心端部径向向外延伸并朝向密封部12翻转,从而形成用于与左心耳腔壁相接触且起支撑作用的支撑面。The
进一步地,支撑杆111的远端端点处可以设有球头1111,球头1111通过焊接、热熔、缠结、粘结等方式设置在支撑杆111的远端端点处。球头1111能够避免支撑杆111的远端刺入左心耳的内壁中,进而影响封堵装置10的固定,还能避免固定部11在外翻时,支撑杆111的远端勾到密封部12,进而影响封堵装置10的正常使用。Further, a
进一步地,支撑杆111上可以设有锚定件(图中未示出),一般而言,锚定件通过焊接、热熔、缠结、粘结等方式设置在支撑杆111上,但是不排除在切割形成支撑杆111时,直接同时切割形成锚定件。优选地,锚定件选用锚刺结构,锚刺的尖端刺入左心耳的内壁中,从而使得固定部11稳定地锚定在左心耳的内壁,使得封堵装置10实现对左心耳口部的封堵。Further, anchors (not shown in the figure) may be provided on the
具体地,支撑杆111包括位于近端的连接段1112,以及与连接段1112相连后径向延伸形成的起支撑作用的支承段1113。Specifically, the
具体地,所称连接段1112可以直接从固定部11与密封部12的连接处径向向外延伸,连接段1112之间不交叉。或者,所称连接段1112可以从固定部11与密封部12的连接处的一侧发出,朝向该连接处的另一侧或者倾斜朝向该连接处的另一侧径向向外延伸。这里的交叉包括汇聚、合拢、相交、部分相交、部分重合等状态,严格来说,即两个支撑杆111的连接段1112在连接部13的纵截面上的投影线具有投影交点。Specifically, the so-called connecting
参阅图3所示,本实施例中,至少两个支撑杆111的连接段1112在固定部11与密封部12的连接处的远端,即连接部13的远端交叉,支承段1113从连接部13伸出,能够大幅提高了封堵装置10的支撑能力,在支撑杆111受到左心耳的应力时,应力沿着支撑杆111传递,在近端位置部分由支撑杆111自身抵消,部分被连接部13抵消,从而进一步提高了封堵装置10长期的锚定稳定性。Referring to Fig. 3, in the present embodiment, the connecting
更具体地,在一实施例中,多个支撑杆111中存在2个支撑杆111交叉,交叉的支撑杆111的连接段1112从连接部13的一侧发出,朝向连接部13的另一侧或者倾斜朝向连接部13的另一侧延伸。在另一实施例中,多个支撑杆111中存在2个支撑杆111交叉,交叉的2个支撑杆111中,至少一个支撑杆111的的连接段1112从连接部13的一侧伸出并朝向或倾斜朝向连接部13的另一侧延伸。More specifically, in one embodiment, there are two
在本实施例中,优选的,多个支撑杆111交叉,支撑杆111跨越连接部13的中心线到其对侧,即弯曲着朝向对侧延伸,这样设置下,本实施例的多个支撑杆111在连接部13的中心线位置交叉。当封堵装置10植入后,左心耳随着心脏运动收缩和舒张时,左心耳的内壁对支撑杆111产生的应力的分力可以分为轴向和径向,交叉设置的支撑杆111可以使得支撑杆111与轴线的夹角相对于非交叉的设置夹角更大,这样使得左心耳内壁对支撑杆111产生的应力沿着支撑杆111传递时,由于支撑杆111与轴线的夹角更大,应力往径向方向的分力更大,往轴向的分力更小,使得密封部12适应性的轴向变形变小,保证封堵装置10的稳定性,封堵装置10在支撑杆111跨越连接部13的中心线的状态下达到最优的稳定效果。In this embodiment, preferably, a plurality of
继续参阅图2所示,本实施例中,支承段1113上设置有限制结构112,限制结构112阻止相邻的支承段1113相互靠近,防止外翻时支承段1113之间发生纠结,也即,限制结构112防止了固定部11在外翻过程中支撑杆111发生互相纠结导致支撑杆111无法充分外翻,进而保证封堵装置10的固定部11的展开程度。Continuing to refer to FIG. 2 , in this embodiment, the
作为一种实施方式,限制结构112包括连接杆1121,连接杆1121的一端抵持或固定在支承段1113的内侧,另一端连接连接部13或连接段1112。As an embodiment, the restricting
作为另一种实施方式,限制结构112包括若干连接杆1121,封堵装置10还包括限位件14,限位件14为环形结构,优选为套筒。环形结构套设于连接部13和/或连接段1112外侧,环形结构沿轴向可活动,连接杆1121的一端抵持或固定在支承段1113的内侧,另一端连接环形结构。限位件14可在连接部13和/或连接段1112外侧轴向运动。As another embodiment, the restricting
本实施例中,连接杆1121与支撑杆111一一对应,支承段1113外翻时,支承段1113与连接杆1121的弯曲方向相反。In this embodiment, the connecting
值得说明的是,限位件14只限制了支撑杆111向外扩张,而没有限制支撑杆111的靠拢,因此,限位件14的设置未影响支撑杆111的入鞘。并且,限制件14的轴向运动不影响支撑杆111的径向支撑。It is worth noting that the
本实施例中,通过在连接部13和/或连接段1112外侧套设限位件14,并通过与连接杆1121将支承段1113和限位件14进行连接,这样的设置能够对支撑杆111的远端进行限制,通过连接杆1121牵引支承段1113,在支承段1113外翻时可将支承段1113充分拉开,避免固定部11的支撑杆111互相纠结情况的发生,从而使得固定部11充分展开,并且不会影响封堵装置10进出鞘管。In this embodiment, by sheathing the limiting
实施例二Embodiment two
实施例二与实施例一的相同或相似之处在此不再赘述,实施例二的封堵装置20与实施例一的区别在于,实施例二的限制结构212包括覆膜2121和绑线2122,绑线2122优选为缝合线,覆膜2121附着在支撑杆211上并通过绑线2122与支撑杆211进行缝合固定。如图4所示,实施例二的封堵装置20可以不具有连接杆和限位件。或者,如图5所示,实施例二的封堵装置20也可以同时具有连接杆2123和限位件24,限位件24套设于连接部23和/或连接段2112外侧,限位件24沿轴向可活动,连接杆2123的一端抵持或固定在支承段2113的内侧,另一端连接限位件24。当然,实施例二的封堵装置20也可以直接通过连接杆2123的一端抵持或固定在支承段2113的内侧,另一端连接连接部23或连接段2112。本实施例不做具体限定。The same or similarities between
具体地,覆膜2121采用具有良好生物相容性的高分子材料制成,如PET膜,还可以使用PTFE/PEK等。绑线2122聚丙烯编织缝合线或者聚酯编织缝合线等。Specifically, the
值得说明的是,覆膜2121只对支撑杆211进行限位,而没有限制支撑杆211的靠拢,因此,覆膜2121的设置未影响支撑杆211的入鞘。It is worth noting that the
本实施例中,通过绑线2122将覆膜2121和固定部21连接起来,通过覆膜2121的展开和绑线2122对支撑杆211的限制作用,在支承段2113外翻时可将支承段2113充分拉开,避免固定部21的支撑杆211互相纠结情况的发生,从而使得固定部21充分展开,并且不会影响封堵装置20进出鞘管。In this embodiment, the
实施例三Embodiment Three
如图6-图8所示,实施例三与实施例二的相同或相似之处在此不再赘述,实施例三的封堵装置30与实施例二的区别在于,实施例三的限制结构312包括覆膜3121,覆膜3121嵌套在支撑杆311上,任意相邻的支撑杆311由覆膜3121隔断。As shown in Figures 6-8, the same or similarities between Embodiment 3 and
如图6所示,实施例二的封堵装置30可以不具有连接杆和限位件,或者,如图8所示,实施例二的封堵装置30也可以同时具有连接杆3122和限位件34,限位件34套设于连接部33和/或连接段3112外侧,限位件34沿轴向可活动,连接杆3122的一端抵持或固定在支承段3113的内侧,另一端连接限位件34。当然,实施例二的封堵装置30也可以直接通过连接杆3122的一端抵持或固定在支承段3113的内侧,另一端连接连接部33或连接段3112。本实施例不做具体限定。As shown in Figure 6, the blocking
具体地,覆膜3121采用具有良好生物相容性的高分子材料制成,如如PET膜,还可以使用PTFE/PEK等。Specifically, the
值得说明的是,覆膜3121只对支撑杆311进行限位,而没有限制支撑杆311的靠拢,因此,覆膜3121的设置未影响支撑杆311的入鞘。It is worth noting that the
具体地,作为一实施方式,如图7所示,可以通过对覆膜3121进行设计凹陷区域31211,然后将支撑杆311嵌设在凹陷区域31211内。作为另一实施方式,覆膜3121为双层膜结构,支撑杆311嵌设在双层膜结构之间,然后经过热处理的方式固定在一起。作为又一实施方式,可以通过引入热熔等熔结工艺,将支撑杆311直接嵌套到覆膜3121内。当然,也可以通过其他方式将覆膜3121嵌套在支撑杆311上,只要满足支撑杆311以嵌套的形式直接与覆膜3121作用,使得覆膜3121对互相交叉的支撑杆311起到限位作用即可。Specifically, as an embodiment, as shown in FIG. 7 , a recessed
本实施例中,通过对覆膜3121进行设计凹陷区域31211,或通过引入热熔等熔结工艺,将支撑杆311以嵌套的形式直接与覆膜3121作用,通过覆膜3121的展开的限制作用对支承段3113进行限位,在支承段3113外翻时可将支承段3113充分拉开,避免固定部31的支撑杆311互相纠结情况的发生,从而使得固定部31充分展开,并且不会影响封堵装置30进出鞘管。In this embodiment, by designing the recessed
实施例四Embodiment Four
如图9所示,实施例四与实施例一的相同或相似之处在此不再赘述,实施例四的封堵装置40与实施例一的区别在于,实施例四的限制结构412包括连接件4121,连接件4121连接相邻两个支承段4113。As shown in FIG. 9 , the same or similarities between Embodiment 4 and
具体地,连接件4121为弹性件,优选为弹簧。弹性件两端连接相邻两个支承段4113,支承段4113外翻时,弹性件撑开相邻两个支承段4113。当然,本实施例也可以将弹块等作为连接件4121,只要满足支承段4113外翻时,连接件4121撑开相邻两个支承段4113即可。Specifically, the connecting
值得说明的是,连接件4121只对支承段4113提供撑开的作用力,而不会影响支撑杆411的入鞘。It is worth noting that the connecting
本实施例中,通过设置弹性件将相邻两个支承段4113进行连接,通过弹性件对支承段4113支撑的力进行限制,从而对支承段4113进行限位,使得支承段4113拥有更好的径向支撑力,在支承段4113外翻时可将支承段4113充分撑开,避免固定部41的支撑杆411互相纠结情况的发生,从而使得固定部41充分展开,并且不会影响封堵装置40进出鞘管。同时,当封堵装置40植入后,左心耳随着心脏运动收缩和舒张时,左心耳的内壁对固定部41的支撑杆411产生的应力的径向分力部分被弹簧抵消,从而进一步提高了封堵装置40长期的锚定稳定性。In this embodiment, two
实施例五Embodiment five
如图10所示,实施例五与实施例四的相同或相似之处在此不再赘述,实施例五的封堵装置50与实施例四的区别在于,实施例五的连接件5121为伸缩杆,伸缩杆两端连接相邻两个支承段5113,支承段5113外翻时,伸缩杆撑开相邻两个支承段5113。As shown in Figure 10, the same or similarities between Embodiment 5 and Embodiment 4 will not be repeated here. The difference between the blocking device 50 of Embodiment 5 and Embodiment 4 is that the
本实施例中,通过设置伸缩杆将相邻两个支承段5113进行连接,通过伸缩杆对支承段5113支撑的力进行限制,从而对支承段5113进行限位,使得支承段5113拥有更好的径向支撑力,在支承段5113外翻时可将支承段5113充分撑开,避免固定部51的支撑杆511互相纠结情况的发生,从而使得固定部51充分展开,并且不会影响封堵装置50进出鞘管。In this embodiment, two
进一步地,本实施例可以通过连接杆(未图示)将伸缩杆和连接部53或连接段5112连接起来,即连接杆的一端抵持或固定在支承段5113的内侧,另一端连接连接部53或连接段5112。从而使得封堵装置50既能够避免固定部51的支撑杆511互相纠结情况的发生,又能够给固定部51提供径向支撑力,提高封堵装置50的锚定稳定性。Further, in this embodiment, the telescopic rod can be connected to the connecting
如图11所示,具体地,伸缩杆包括可相对滑动的内管51211和外管51212,外管51212套设于内管51211外。内管51211设于外管51212内的部分设置有第一定位件51213,外管51212对应第一定位件51213的位置设置有第二定位件51214,支承段5113外翻时内管51211和外管相51212对远离,第一定位件51213与第二定位件51214对位时锁止以限制内管51211和外管51212相对滑动。As shown in FIG. 11 , specifically, the telescopic rod includes an
作为一实施方式,第一定位件51213与第二定位件51214之一为弹性凸起,则另一为凹槽或通孔,内管51211和外管51212可相对轴向滑动,当弹性凸起滑动到凹槽或通孔对应的位置时,弹性凸起卡接在凹槽或通孔中,从而限制内管51211和外管51212的相对滑动。As an embodiment, one of the
本实施例中,通过设置第一定位件51213与第二定位件51214,当封堵装置50植入后,第一定位件51213与第二定位件51214限制内管51211和外管51212的相对滑动,左心耳随着心脏运动收缩和舒张时,支撑杆511之间不会被挤压变形,也即固定部51仍保持原先展开的形状,同时由于封堵装置50植入后无需回收,因此采用此方式能够对支撑杆511的远端进行锁定,最大限度提高封堵装置50长期的锚定稳定性。In this embodiment, by setting the
实施例六Embodiment six
如图12所示,实施例六与实施例四的相同或相似之处在此不再赘述,实施例六的封堵装置60与实施例四的区别在于,实施例六的连接件6121为一根衔接杆,衔接杆连接相邻两个支承段6113且连接的位置与支撑杆611的远端端点的距离不同,也即衔接杆倾斜设置在相邻两个支承段6113,倾斜设置使得支承段6113能够靠拢,也即不影响支撑杆611的入鞘。As shown in Figure 12, the same or similarities between Embodiment 6 and Embodiment 4 will not be repeated here. The difference between the blocking
可选地,相邻两个衔接杆的倾斜方向可以相同,也可以不同,本实施例不作具体限定,只要不影响支撑杆611的入鞘即可。优选地,在本实施例中,相邻两个衔接杆的倾斜方向不同,这样设置既不影响支撑杆611的入鞘,又能够给支撑杆611提供更好的径向支撑力。Optionally, the inclination directions of two adjacent connecting rods may be the same or different, which is not specifically limited in this embodiment, as long as the sheathing of the
具体地,衔接杆可以为具有较强韧性且兼备一定强度的的高分子材料或镍钛丝、镍钛合金等金属材料,也可以采用弹性较高的弹性材料如PA、PP、PET等。Specifically, the connecting rod can be made of polymer material with strong toughness and certain strength, metal material such as nickel-titanium wire, nickel-titanium alloy, or elastic material with high elasticity such as PA, PP, PET, etc.
本实施例中,通过设置衔接杆将相邻两个支承段6113进行连接,通过衔接杆对支承段6113支撑的力进行限制,从而对支承段6113进行限位,使得支承段6113拥有更好的径向支撑力,在支承段6113外翻时可将支承段6113充分撑开,避免固定部61的支撑杆611互相纠结情况的发生,从而使得固定部61充分展开,并且不会影响封堵装置60进出鞘管。同时,当封堵装置60植入后,左心耳随着心脏运动收缩和舒张时,左心耳的内壁对固定部61的支撑杆611产生的应力的径向分力部分被一字型连接件抵消,从而进一步提高了封堵装置60长期的锚定稳定性。In this embodiment, two
实施例七Embodiment seven
如图13所示,实施例七与实施例六的相同或相似之处在此不再赘述,实施例七的封堵装置70与实施例六的区别在于,实施例七的连接件7121为两根衔接杆,该两根衔接杆构成X形,也即两根衔接杆转动连接或交叉设置,该两根衔接杆均连接相邻两个支承段7113。As shown in Figure 13, the same or similarities between Embodiment 7 and Embodiment 6 will not be repeated here. The difference between the blocking
具体地,连接件7121可以为具有较强韧性且兼备一定强度的的高分子材料或镍钛丝、镍钛合金等金属材料,也可以采用弹性较高的弹性材料如PA、PP、PET等。Specifically, the
可选地,该两根衔接杆的交叉点可以活动连接,也可以不连接(仅交叉设置),只要不影响支撑杆711的入鞘即可。Optionally, the intersections of the two connecting rods may be movably connected or not connected (only crossed), as long as the sheathing of the
如图14所示,具体地,一衔接杆的一端与支承段7113滑动连接,具体可以在支承段7113上开设滑动槽7111,然后将一衔接杆的一端置于滑动槽7111中并限制其脱离滑动槽7111,且该端可在滑动槽7111内滑动,使得支撑杆711在进出鞘管以及固定部71在外翻时,一衔接杆的一端能够在滑动槽7111滑动,进而使得支撑杆711在进出鞘管以及固定部71在外翻时更加顺畅,减少卡顿感。在本实施例中,转动连接或交叉设置的两根衔接杆的相邻两端均与支承段7113滑动连接。As shown in Figure 14, specifically, one end of an engaging rod is slidably connected with the supporting
本实施例中,通过设置转动连接或交叉设置的两根衔接杆将相邻两个支承段7113进行连接,对支承段7113支撑的力进行限制,从而对支承段7113进行限位,使得支承段7113拥有更好的径向支撑力,在支承段7113外翻时可将支承段7113充分撑开,避免固定部71的支撑杆711互相纠结情况的发生,从而使得固定部71充分展开,并且不会影响封堵装置70进出鞘管。同时,当封堵装置70植入后,左心耳随着心脏运动收缩和舒张时,左心耳的内壁对固定部71的支撑杆711产生的应力的径向分力部分被转动连接或交叉设置的两根衔接杆抵消,从而进一步提高了封堵装置70长期的锚定稳定性。In this embodiment, two
实施例八Embodiment eight
如图15所示,实施例八与实施例六的相同或相似之处在此不再赘述,实施例八的封堵装置80与实施例六的区别在于,实施例八的连接件8121为四根衔接杆,四根衔接杆依次首尾相连构成菱形,首尾相连的四根衔接杆的一相对两交点连接相邻两个支承段8113,另一相对两交点可沿轴向靠近或远离。当然,四根衔接杆依次首尾相连也可以构成方形,本实施例不作具体限定。As shown in Figure 15, the same or similarities between Embodiment 8 and Embodiment 6 will not be repeated here. The difference between the blocking
具体地,连接件8121可以为具有较强韧性且兼备一定强度的的高分子材料或镍钛丝、镍钛合金等金属材料,也可以采用弹性较高的弹性材料如PA、PP、PET等。Specifically, the
本实施例中,通过设置依次首尾相连的四根衔接杆将相邻两个支承段8113进行连接,对支承段8113支撑的力进行限制,从而对支承段8113进行限位,使得支承段8113拥有更好的径向支撑力,在支承段8113外翻时可将支承段8113充分撑开,避免固定部81的支撑杆811互相纠结情况的发生,从而使得固定部81充分展开,并且不会影响封堵装置80进出鞘管。同时,当封堵装置80植入后,左心耳随着心脏运动收缩和舒张时,左心耳的内壁对固定部81的支撑杆811产生的应力的径向分力部分被依次首尾相连的四根衔接杆抵消,从而进一步提高了封堵装置80长期的锚定稳定性。In this embodiment, two
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. 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, should be considered as within the scope of this specification.
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that, for those skilled in the art, several modifications 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 for the present invention should be based on the appended claims.
Claims (14)
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