CN219516695U - Implant delivery system packaging device - Google Patents
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Abstract
Description
技术领域technical field
本申请涉及医疗器械包装的技术领域,具体是一种植入物输送系统包装装置。The present application relates to the technical field of medical device packaging, in particular to a packaging device for an implant delivery system.
背景技术Background technique
人工心脏瓣膜置换术是用于治疗心脏瓣膜障碍的有效治疗手段,一般可利用输送系统将人工心脏瓣膜递送至体内。Prosthetic heart valve replacement is an effective treatment for heart valve disorders, typically using a delivery system to deliver the prosthetic heart valve into the body.
其中输送系统一般包括控制手柄,导管组件(也可以将介入器械预连接或装载于导管组件的远端),输送系统通常嵌装固定于托盘中,在结合外包装进行保护和储运,但由于介入器械的尺寸多样化,导致同一系列的产品也需要配置不同托盘,相应增加了包装成本。The delivery system generally includes a control handle and a catheter assembly (interventional instruments can also be pre-connected or loaded on the distal end of the catheter assembly), and the delivery system is usually embedded and fixed in a tray, which is combined with the outer packaging for protection and storage. However, due to The size diversification of interventional devices leads to the need to configure different trays for the same series of products, which increases the packaging cost accordingly.
实用新型内容Utility model content
本申请提供了一种植入物输送系统包装装置,可进一步提高通用性,降低包装成本。The present application provides a packaging device for an implant delivery system, which can further improve versatility and reduce packaging costs.
本申请提供了一种植入物输送系统包装装置,包括托盘,所述托盘包括盘体,所述盘体具有相对的顶侧和底侧,所述盘体的顶侧带有凹陷部位并形成供植入物输送系统放置的容置区,所述容置区中、与介入器械相对应的部位为盛液池,在所述盛液池中设有固定托架,在邻近所述固定托架的部位还设有配合结构、供可拆卸的安装拓展托架;The application provides an implant delivery system packaging device, including a tray, the tray includes a tray body, the tray body has opposite top sides and bottom sides, the top side of the tray body has a recess and forms a The accommodating area where the implant delivery system is placed, the part corresponding to the interventional instrument in the accommodating area is a liquid storage pool, a fixed bracket is arranged in the liquid storage pool, and a fixed bracket is adjacent to the fixed bracket The part is also equipped with a matching structure for detachable installation and expansion brackets;
所述固定托架以及所述拓展托架均带有与介入器械相匹配的定位槽。Both the fixed bracket and the expanded bracket have positioning slots matching the interventional instruments.
以下还提供了若干可选方式,但并不作为对上述总体方案的额外限定,仅仅是进一步的增补或优选,在没有技术或逻辑矛盾的前提下,各可选方式可单独针对上述总体方案进行组合,还可以在多个可选方式之间进行组合。The following also provides several optional ways, but they are not used as additional limitations on the above-mentioned overall scheme, but are only further additions or optimizations. On the premise of no technical or logical contradiction, each optional way can be carried out independently for the above-mentioned overall scheme Combination, you can also combine multiple options.
可选的,所述配合结构包括:Optionally, the matching structure includes:
卡块,设置于所述拓展托架与所述盛液池的池底这两者中的其中一者Block, set on one of the expansion bracket and the bottom of the liquid tank
嵌槽,设置于所述拓展托架与所述盛液池的池底这两者中的另一者。The embedding groove is arranged on the other of the expansion bracket and the bottom of the liquid storage pool.
可选的,所述固定托架凸设于所述盛液池的池底,所述拓展托架罩设于所述固定托架,且所述固定托架与所述拓展托架两者之间的至少一部分形状互补。Optionally, the fixed bracket is protruded from the bottom of the liquid storage tank, the expanded bracket is covered by the fixed bracket, and the gap between the fixed bracket and the expanded bracket is At least a portion of them are complementary in shape.
可选的,所述固定托架的外周缘与所述拓展托架的内周缘相互贴合限位。Optionally, the outer peripheral edge of the fixed bracket and the inner peripheral edge of the expansion bracket are mutually fitted and limited.
可选的,所述植入物输送系统包括容纳所述介入器械的压握装置,所述压握装置为筒状结构,所述定位槽与所述压握装置相匹配且其内壁为弧形。Optionally, the implant delivery system includes a crimping device for accommodating the interventional instrument, the crimping device is a cylindrical structure, the positioning groove matches the crimping device and its inner wall is arc-shaped .
可选的,所述盛液池的底部设有排液口、以及与所述排液口相配合的塞子。Optionally, a liquid discharge port and a plug matching the liquid discharge port are provided at the bottom of the liquid storage tank.
可选的,所述盘体的顶侧可拆卸的安装有多个限位件,所述限位件的至少一部分跨设于容置区上方、将植入物输送系统限制在容置区内。Optionally, a plurality of stoppers are detachably installed on the top side of the tray, at least a part of the stoppers straddles above the accommodating area to limit the implant delivery system in the accommodating area .
可选的,所述限位件为条形且两端与所述盘体的顶侧带有相互配合的卡合结构;Optionally, the limiting member is in the shape of a bar, and both ends have engaging structures that cooperate with the top side of the disc body;
所述卡合结构包括:The engaging structure includes:
卡槽,位于所述限位件的端部或所述盘体的顶侧;a card slot, located at the end of the limiting member or the top side of the disc body;
卡柱,与所述卡槽相配合,相应的位于所述盘体的顶侧或所述限位件的端部。The clamping posts are matched with the clamping slots and are correspondingly located on the top side of the disc body or at the end of the limiting member.
可选的,所述植入物输送系统包括控制手柄,由所述控制手柄延伸的导管组件以及连接于所述导管组件的介入器械,所述容置区相应的包括手柄容置区、导管组件容置区以及作为所述盛液池的介入器械容置区;Optionally, the implant delivery system includes a control handle, a catheter assembly extending from the control handle, and an interventional device connected to the catheter assembly, and the accommodating area includes a handle accommodating area, a catheter assembly accommodating area and an interventional instrument accommodating area serving as the liquid holding pool;
所述导管组件容置区为狭长的沟槽结构,相对于所述导管组件容置区、所述盛液池的宽度增加且底部加深。The conduit component accommodating area is a long and narrow groove structure. Compared with the conduit component accommodating area, the width of the liquid holding pool is increased and the bottom is deepened.
可选的,所述导管组件容置区中,在邻近所述盛液池的位置设有密封塞。Optionally, in the accommodating area of the conduit assembly, a sealing plug is provided at a position adjacent to the liquid storage pool.
可选的,所述限位件包括三组,分别对应所述手柄容置区、导管组件容置区以及作为所述盛液池的介入器械容置区;Optionally, the limiter includes three groups, respectively corresponding to the handle accommodating area, the catheter assembly accommodating area, and the interventional instrument accommodating area serving as the liquid holding pool;
与所述盛液池相对应的限位件跨设于所述定位槽、且可拆卸的连接于所述托架。The limiting member corresponding to the liquid storage pool straddles the positioning groove and is detachably connected to the bracket.
可选的,所述导管组件的远端活动插设有支撑杆,所述盛液池中设有定位台,所述定位台带有与所述支撑杆适配的限位槽。Optionally, a support rod is movably inserted into the distal end of the catheter assembly, and a positioning platform is provided in the liquid storage pool, and the positioning platform has a limiting groove adapted to the support rod.
可选的,所述手柄容置区的至少一部分区域相对于所述控制手柄的外周进一步向外扩展,与控制手柄之间构成避让区。Optionally, at least a part of the handle accommodating area further expands outward relative to the outer circumference of the control handle, forming an avoidance area with the control handle.
可选的,所述控制手柄上带有可控制导管组件的操作部件,所述避让区的位置与所述操作部件相对应。Optionally, the control handle is equipped with an operating part that can control the catheter assembly, and the position of the avoidance area corresponds to the operating part.
可选的,所述植入物输送系统包装装置包括:Optionally, the implant delivery system packaging device includes:
密封袋,所述托盘被包裹于所述密封袋内;a sealed bag, the tray is wrapped in the sealed bag;
包装盒,所述密封袋处在所述包装盒内。A packing box, the sealed bag is inside the packing box.
可选的,所述包装盒内设有温度传感器,所述包装盒上嵌装有与所述温度传感器相连以显示温度信号的温度显示器。Optionally, a temperature sensor is provided in the packaging box, and a temperature display connected to the temperature sensor to display a temperature signal is embedded in the packaging box.
本申请的植入物输送系统包装装置,其中托盘的固定托架能够适配一种或多种型号的介入器械,而其他型号的介入器械可以通过加装拓展托架完成适配。因此体积较大的盘体所对应的模具数量减少或仅需要一套,提高通用性,进而降低了包装成本。In the implant delivery system packaging device of the present application, the fixed bracket of the tray can be adapted to one or more types of interventional instruments, while other types of interventional instruments can be adapted by adding expansion brackets. Therefore, the number of molds corresponding to the larger disc body is reduced or only one set is required, which improves the versatility and further reduces the packaging cost.
附图说明Description of drawings
图1为本申请一实施例中植入物输送系统的立体视图;FIG. 1 is a perspective view of an implant delivery system in an embodiment of the present application;
图2为本申请一实施例中植入物输送系统和托盘的爆炸视图;Figure 2 is an exploded view of an implant delivery system and a tray in an embodiment of the present application;
图3为本申请一实施例中托盘的立体视图;Fig. 3 is a perspective view of the pallet in an embodiment of the present application;
图4为本申请一实施例中托盘的盛液池部分在另一视角下的局部立体视图;Fig. 4 is a partial perspective view of the liquid holding pool part of the tray in another viewing angle in an embodiment of the present application;
图5为本申请一实施例中拓展托架从底侧向顶侧观察的立体视图;Fig. 5 is a perspective view of the expansion bracket viewed from the bottom side to the top side in an embodiment of the present application;
图6a为本申请一实施例中压握装置的立体视图;Fig. 6a is a perspective view of a crimping device in an embodiment of the present application;
图6b为本申请一实施例中压握装置处的局部结构示意图;Fig. 6b is a schematic diagram of the local structure of the crimping device in an embodiment of the present application;
图7为本申请一实施例中植入物输送系统装载在托盘上的立体视图;Fig. 7 is a perspective view of an implant delivery system loaded on a tray in an embodiment of the present application;
图8为本申请一实施例中植入物输送系统装载在托盘上的主视图;Fig. 8 is a front view of an implant delivery system loaded on a tray in an embodiment of the present application;
图9为本申请一实施例的包装组件中包装盒的立体视图;Fig. 9 is a perspective view of a packaging box in a packaging assembly according to an embodiment of the present application;
图10为本申请一实施例的包装组件中密封袋的立体视图;Fig. 10 is a perspective view of a sealed bag in a packaging assembly according to an embodiment of the present application;
图11为本申请一实施例的托盘从密封袋内移出的立体视图;Fig. 11 is a perspective view of a pallet removed from a sealed bag according to an embodiment of the present application;
图12为向盛液池倒入冰水的立体视图;Figure 12 is a perspective view of pouring ice water into the liquid holding tank;
图13为排气设备对接延长管后进行排气操作的立体视图;Fig. 13 is a stereoscopic view of the exhaust device after the exhaust device is docked with the extension pipe;
图14为排气设备对接控制手柄近端进行排气操作的立体视图。Fig. 14 is a perspective view of the exhaust device docking with the proximal end of the control handle for exhaust operation.
图中附图标记说明如下:The reference signs in the figure are explained as follows:
1、托盘;10、盘体;101、顶侧;102、底侧;103、安装面;1. Tray; 10. Disk body; 101. Top side; 102. Bottom side; 103. Installation surface;
110、容置区;111、盛液池;1110、排液口;1111、嵌槽;1112、卡块;1113、定位槽;1114、冰水;1115、标记指示;1116、定位台;1117、限位槽;1118、限位凹槽;1119、限位凸台;110. Accommodating area; 111. Liquid storage tank; 1110. Liquid outlet; 1111. Embedding groove; 1112. Block; 1113. Positioning groove; 1114. Ice water; Limit groove; 1118, limit groove; 1119, limit boss;
112、手柄容置区;1121、避让区;112. Handle accommodation area; 1121. Avoidance area;
113、导管组件容置区;1131、引导部;1132、密封塞;113. Conduit component accommodating area; 1131. Guide part; 1132. Sealing plug;
114、介入器械容置区;115、密封塞容置区;114. Interventional device accommodation area; 115. Sealing plug accommodation area;
116、固定托架;116, fixed bracket;
117、拓展托架;117. Expansion bracket;
118、塞子;118, stopper;
1191、避让区;1191. Avoidance area;
120、限位件;122、卡柱;123、捏手部;120, limit piece; 122, card column; 123, knob part;
13、密封袋;14、包装盒;141、温度显示器;13. Sealed bag; 14. Packing box; 141. Temperature display;
2、输送系统;210、导管组件;211、引导头;212、钢丝;213、定位头;2101、第一段;2102、第二段;2103、第三段;2. Delivery system; 210, catheter assembly; 211, guide head; 212, steel wire; 213, positioning head; 2101, first section; 2102, second section; 2103, third section;
220、介入器械;230、控制手柄;231、操作部件;232、延长管;240、压握装置;241、连接段;242、扩张段;243、延伸段;250、排气设备。220. Interventional instrument; 230. Control handle; 231. Operating part; 232. Extension tube; 240. Crimping device; 241. Connecting section; 242. Expansion section;
具体实施方式Detailed ways
下面将结合本申请实施例中的附图,对本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本申请一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the drawings in the embodiments of the application. Apparently, the described embodiments are only some, not all, embodiments of the application. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.
需要说明的是,当组件被称为与另一个组件“连接”时,它可以直接与另一个组件连接或者也可以存在居中的组件。当一个组件被认为是“设置于”另一个组件,它可以是直接设置在另一个组件上或者可能同时存在居中组件。It should be noted that when a component is said to be "connected" to another component, it may be directly connected to the other component or intervening components may also exist. When a component is said to be "set on" another component, it may be set directly on the other component or there may be an intervening component at the same time.
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申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的,不是在于限制本申请。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 to which this application belongs. The terms used herein in the description of the application are only for the purpose of describing specific embodiments, and are not intended to limit the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
本申请中,术语“第一”、“第二”等仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量、次序。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本申请的描述中,“多个”的含义是至少两个,例如两个、三个等,除非另有明确具体的限定。In the present application, the terms "first", "second" and so on are only used for descriptive purposes, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity and order of the indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.
本文公开的植入物输送系统包装装置的植入物可以是介入器械,例如人工心脏瓣膜,人工心脏瓣膜已经至少部分地干燥或脱水以允许自身在不浸没液体或防腐剂溶液中存储。其中图1示出了输送系统2的结构,其至少包括导管组件210,以及与导管组件两端分别接驳的介入器械220和控制手柄230,为了方便叙述,植入物输送系统2(简称输送系统)在控制手柄230一侧为近端,介入器械220一侧为远端。The implant of the implant delivery system packaging set disclosed herein may be an interventional device, such as a prosthetic heart valve that has been at least partially dried or dehydrated to allow itself to be stored in a non-immersion liquid or preservative solution. 1 shows the structure of the delivery system 2, which at least includes a catheter assembly 210, and an interventional instrument 220 and a control handle 230 respectively connected to both ends of the catheter assembly. For convenience of description, the implant delivery system 2 (abbreviated as delivery system) on the side of the control handle 230 is the proximal end, and on the side of the interventional instrument 220 is the distal end.
参阅图2~图5,本申请提供一种植入物输送系统包装装置,包括托盘1,托盘1包括盘体10,盘体10具有相对的顶侧101和底侧102。盘体10的顶侧101带有凹陷部位并形成供输送系统2放置的容置区110,容置区110的深度、形状等变化,用于适应输送系统2的不同部位或满足相应的功能。盘体10的材料选用PET(PETG、PETE)或PP等。而盘体顶侧101的凹陷部位还起到对盘体10结构的加强作用。其中,再结合图7,容置区110中、与介入器械220相对应的部位为盛液池111,相对理解为介入器械220的周围与盛液池池壁间隔设置。术者在向导管组件210中装载介入器械时,可向盛液池111内倒入一定体积的冰水1114(提供适宜的温度环境,也可采用其他可接受的流体),冰水能够浸没介入器械220。具体地冰水的体量控制可以通过设置在盛液池侧壁上的标记指示1115确定。需要注意的是,标记指示1115设置在距离盛液池111的顶侧最高位一定距离,降低因误操作导致冰水溢出的可能性。Referring to FIGS. 2 to 5 , the present application provides a packaging device for an implant delivery system, including a tray 1 . The tray 1 includes a tray body 10 , and the tray body 10 has a top side 101 and a bottom side 102 opposite to each other. The top side 101 of the tray body 10 has a recessed portion and forms an accommodating area 110 for the conveying system 2 to be placed. The depth and shape of the accommodating area 110 vary for adapting to different parts of the conveying system 2 or satisfying corresponding functions. The material of the disc body 10 is PET (PETG, PETE) or PP. The concave portion on the top side 101 of the disc body also plays a role of strengthening the structure of the disc body 10 . Wherein, in combination with FIG. 7 , the part corresponding to the interventional instrument 220 in the accommodating area 110 is the liquid storage pool 111 , which is relatively understood to be that the periphery of the interventional instrument 220 is spaced apart from the wall of the liquid storage pool. When loading interventional instruments into the catheter assembly 210, the operator can pour a certain volume of ice water 1114 into the liquid reservoir 111 (to provide a suitable temperature environment, and other acceptable fluids can also be used), and the ice water can immerse the interventional equipment. Apparatus 220. Specifically, the volume control of the ice water can be determined through the marking indicator 1115 arranged on the side wall of the liquid storage tank. It should be noted that the marking indicator 1115 is set at a certain distance from the highest position on the top side of the liquid storage tank 111 to reduce the possibility of ice water overflow due to misoperation.
在盛液池111中设有固定托架116,且在邻近固定托架116的部位还设有配合结构、供可拆卸的安装拓展托架117。固定托架116以及拓展托架117均带有与介入器械220相匹配的定位槽1113。其中固定托架116可以适配一种或多种型号的介入器械220,拓展托架117根据不同型号的介入器械220配置相应数量,各拓展托架117之间仅定位槽1113不同。则一个盘体10可以适配多个型号的介入器械,只要盛液池111足够大,使得盘体10所对应的大型模具仅需要一套,相较于传统包装,降低了开模的费用。A fixed bracket 116 is provided in the liquid storage tank 111 , and a matching structure is provided at a position adjacent to the fixed bracket 116 for detachably installing an expansion bracket 117 . Both the fixing bracket 116 and the expanding bracket 117 have positioning slots 1113 matching with the interventional instrument 220 . The fixed bracket 116 can be adapted to one or more types of interventional instruments 220 , and the number of expansion brackets 117 is configured according to different types of interventional instruments 220 , and only the positioning groove 1113 is different between each expansion bracket 117 . Then one tray 10 can be adapted to multiple types of interventional instruments, as long as the liquid pool 111 is large enough, only one set of large molds corresponding to the tray 10 is needed, which reduces the cost of mold opening compared with traditional packaging.
固定托架116和拓展托架117可选用与盘体10相同或不同的材质,例如PET(PETG、PETE)或PP等。The fixing bracket 116 and the expanding bracket 117 can be made of the same or different material as that of the tray body 10, such as PET (PETG, PETE) or PP.
参考一实施例,配合结构包括:Referring to an embodiment, the matching structure includes:
卡块,设置于拓展托架与盛液池的池底这两者中的其中一者;The clamping block is arranged on one of the expansion bracket and the bottom of the liquid storage tank;
嵌槽,设置于拓展托架与盛液池的池底这两者中的另一者。The embedding groove is arranged on the other of the expansion bracket and the bottom of the liquid storage tank.
如图4和图5所示,配合结构为两组,布置于固定托架116的两侧,卡块1112凸设于盛液池111的池底,嵌槽1111对应设置于拓展托架117。As shown in Fig. 4 and Fig. 5, there are two sets of matching structures arranged on both sides of the fixed bracket 116, the clamping block 1112 protrudes from the bottom of the liquid storage tank 111, and the embedded groove 1111 is correspondingly set on the expanding bracket 117.
继续参阅图4和图5,在一实施例中,固定托架116凸设于盛液池111的池底,拓展托架117罩设于固定托架116,且固定托架116与拓展托架117两者之间的至少一部分形状互补。互补的理解为固定托架116的外周缘与拓展托架117的内周缘相互贴合限位。提高拓展托架117与盘体10的连接强度。Continue to refer to Fig. 4 and Fig. 5, in one embodiment, the fixed bracket 116 is protruded from the bottom of the liquid storage tank 111, the expansion bracket 117 is covered on the fixed bracket 116, and the fixed bracket 116 and the expansion bracket 117 and at least a part of them are complementary in shape. Complementary means that the outer peripheral edge of the fixed bracket 116 and the inner peripheral edge of the expansion bracket 117 fit and limit each other. The connection strength between the expansion bracket 117 and the disk body 10 is improved.
固定托架116包括凸设于盛液池111的两限位凸台1119,两限位凸台1119之间构成固定托架116的定位槽1113,拓展托架117具有与两限位凸台1119互补的限位凹槽1118。为了保护瓣膜在包装时不受损伤,介入器械输送系统包括容纳介入器械220的压握装置240,如图6a、图6b所示,压握装置240为筒状结构,定位槽1113与压握装置240相匹配且其内壁为弧形。The fixed bracket 116 includes two position-limiting bosses 1119 protruding from the liquid storage tank 111, and the positioning groove 1113 of the fixed bracket 116 is formed between the two space-limiting protrusions 1119. Complementary limiting groove 1118 . In order to protect the valve from being damaged during packaging, the interventional device delivery system includes a crimping device 240 for accommodating the interventional device 220, as shown in Figures 6a and 6b, the crimping device 240 is a cylindrical structure, and the positioning groove 1113 and the crimping device 240 and its inner wall is curved.
压握装置240包括由近至远端布置的套设在导管组件210外周的连接段241、引导介入器械装载入导管组件内的扩张段242,以及供膨胀状态下的介入器械置入的延伸段243,延伸段243罩设在介入器械220外周避免其外露,起到保护介入器械220的作用。其中延伸段243设置有供冰水流入浸没介入器械的开口。The crimping device 240 includes a connection section 241 sleeved on the outer periphery of the catheter assembly 210 arranged from proximal to distal end, an expansion section 242 for guiding the interventional instrument to be loaded into the catheter assembly, and an extension section 242 for inserting the interventional instrument in the expanded state. Section 243 , the extension section 243 is provided on the periphery of the interventional instrument 220 to prevent it from being exposed, and plays a role in protecting the interventional instrument 220 . The extension section 243 is provided with an opening for the ice water to flow into the submerged interventional instrument.
一实施例中,导管组件210包括向远端伸出压握装置240的引导头211。引导头211远端形状收敛便于在体内介入穿行。In one embodiment, the catheter assembly 210 includes an introducer head 211 protruding distally from the crimping device 240 . The shape of the distal end of the guide head 211 is convergent to facilitate intervention and passage in the body.
为了便于导管组件210远端的定位装载,导管组件的远端可插入支撑杆(例如图7中的钢丝212)包括伸出引导头211进一步向远端延伸的钢丝212,钢丝212的远端设置有定位头213,盛液池111中设有定位台1116,定位台1116上带有与定位头213适配的限位槽1117。可保持导管组件远端部位的空间姿态。其中盛液池111的底部设有排液口1110,排液口1110带有塞子118。术者将盘体10置于台面,完成介入器械220的装载后,可移除塞子118将冰水1114排出。In order to facilitate the positioning and loading of the distal end of the catheter assembly 210, the distal end of the catheter assembly can be inserted into the support rod (such as the steel wire 212 in FIG. There is a positioning head 213, and a positioning platform 1116 is arranged in the liquid storage pool 111, and a limiting groove 1117 adapted to the positioning head 213 is provided on the positioning platform 1116. The spatial posture of the distal end portion of the catheter assembly can be maintained. Wherein, the bottom of the liquid holding pool 111 is provided with a liquid discharge port 1110 , and the liquid discharge port 1110 has a plug 118 . The operator places the tray 10 on the table, and after loading the interventional instruments 220 , the plug 118 can be removed to drain the ice water 1114 .
盛液池111的底壁为平面或者斜面,排液口1110优选处在最低点。The bottom wall of the liquid holding pool 111 is a plane or an inclined surface, and the liquid outlet 1110 is preferably at the lowest point.
为了保证定位效果,盘体10的顶侧101可拆卸地安装有多个限位件120,限位件120的至少一部分跨设于容置区110的上方、将介入器械输送系统2限制在容置区110内,便于运输。限位件120至少存在与盘体10连接的两端,安装和拆卸时操作一端或两端均可。多个限位件120之间的形状、大小等变化以适应不同形状的容置区110。In order to ensure the positioning effect, a plurality of stoppers 120 are detachably installed on the top side 101 of the tray body 10, at least a part of the stoppers 120 straddles above the accommodating area 110 to limit the interventional instrument delivery system 2 in the accommodating area. Placed in the area 110, it is convenient for transportation. The limiting member 120 has at least two ends connected to the disc body 10 , and one end or both ends can be operated during installation and removal. The shapes and sizes of the plurality of limiting members 120 are changed to adapt to the accommodating areas 110 of different shapes.
相较于传统的托盘,尤其是用于与导管组件相适应的容置区设置有突出部,导管组件在预装或拆卸时需要施加外力驱使突出部形变后置入或脱离容置区,对导管组件造成相应的损伤,术者需要集中精力以免损伤导管组件,操作费力。而本申请中,预装或取出输送系统对输送系统轻拿轻放即可,术者仅需在取出操作前,拆卸限位件。而拆卸限位件后,输送系统的上方没有任何阻碍,因此并不会对输送系统造成损伤,术者无需担心会损坏输送系统,相应就能够提高操作效率。Compared with the traditional tray, especially the accommodating area used to adapt to the catheter assembly is provided with a protrusion, the catheter assembly needs to be applied to the external force to drive the protrusion to deform and then be placed into or out of the accommodating area when pre-installed or disassembled. The catheter assembly causes corresponding damage, and the operator needs to concentrate on avoiding damage to the catheter assembly, and the operation is laborious. However, in this application, the delivery system can be pre-installed or taken out, and the delivery system can be handled with care, and the operator only needs to disassemble the stopper before taking out the operation. After the stopper is removed, there is no obstacle above the conveying system, so it will not cause damage to the conveying system, and the operator does not need to worry about damaging the conveying system, and the operation efficiency can be improved accordingly.
其中,限位件120为条形且两端与盘体10的顶侧101带有相互配合的卡合结构。多个限位件120之间的差别主要在于长度的变化,用于满足不同容置区110的跨度(包括高低差)。限位件120至少中部(位于容置区110的上方)柔性可弯曲。Wherein, the limiting member 120 is in the shape of a strip, and the two ends have engaging structures that cooperate with the top side 101 of the tray body 10 . The difference between the plurality of limiting members 120 is mainly the change in length, which is used to meet the spans (including height differences) of different accommodating areas 110 . At least the middle portion (located above the accommodating area 110 ) of the limiting member 120 is flexible and bendable.
卡合结构包括位于限位件120的端部或盘体10的顶侧101的卡槽(图示角度未示出),以及与卡槽相配合的卡柱122,卡柱122相应的位于盘体10的顶侧101或限位件120的端部。一实施例中,限位件120至少一端对应的卡柱122为圆柱或圆筒状,则限位件120可以只需拆卸一端,再旋转解除对输送系统2的限制。The snap-fit structure includes a slot (not shown in the figure) at the end of the stopper 120 or the top side 101 of the disc body 10, and a post 122 that matches the slot, and the post 122 is correspondingly located on the disc body The top side 101 of the body 10 or the end of the stopper 120 . In one embodiment, at least one end of the limiting member 120 corresponds to a column 122 that is in the shape of a cylinder or a cylinder, so only one end of the limiting member 120 can be disassembled, and then rotated to release the restriction on the delivery system 2 .
参阅图3,本实施例中,盘体10的顶侧101具有设置卡柱122的安装面103,限位件120与安装面103相对应的一端设置有捏手部123,安装面103为水平面,且面积大于限位件120的一端以及捏手部123,捏手部123高于安装面103,便于术者捏持拆卸限位件120。Referring to FIG. 3 , in this embodiment, the top side 101 of the disc body 10 has a mounting surface 103 provided with a clamping post 122 , and a handle portion 123 is provided at the end of the limiter 120 corresponding to the mounting surface 103 , and the mounting surface 103 is a horizontal plane. , and the area is larger than one end of the limiting member 120 and the handle portion 123 , the handle portion 123 is higher than the mounting surface 103 , which is convenient for the operator to pinch and disassemble the limiting member 120 .
前述提及容置区110形状不同以适应输送系统2的不同位置,具体的容置区110包括手柄容置区112、导管组件容置区113以及作为盛液池111的介入器械容置区114。导管组件容置区113为狭长的沟槽结构,相对于导管组件容置区113、盛液池的宽度增加且底部加深。避免冰水流入其他容置区,也可保证足够的冰水体积。As mentioned above, the accommodation area 110 has different shapes to adapt to different positions of the delivery system 2. The specific accommodation area 110 includes a handle accommodation area 112, a catheter assembly accommodation area 113, and an interventional instrument accommodation area 114 as a liquid storage pool 111 . The conduit assembly accommodating area 113 is a long and narrow groove structure, and compared with the conduit assembly accommodating area 113 , the width of the liquid storage pool is increased and the bottom is deepened. Prevent ice water from flowing into other accommodation areas, and also ensure sufficient ice water volume.
导管组件容置区113与盛液池111的交界部位设置有引导导管组件210置入容置区的引导部1131。引导部1131为向上(即顶侧)扩口的V形结构,起到导管组件210预装时的导向,导管组件210的部分预装入相应容置区后,其余部分顺势预装。A guide portion 1131 for guiding the catheter assembly 210 to be placed in the accommodating area is provided at the junction of the catheter assembly accommodating area 113 and the liquid storage pool 111 . The guide part 1131 is a V-shaped structure that flares upward (that is, the top side), and serves as a guide for the pre-installation of the catheter assembly 210. After part of the catheter assembly 210 is pre-installed in the corresponding accommodation area, the rest is pre-installed along the way.
考虑到盘体10的体积,以及导管组件210和介入器械220之间的布置,冰水在浸没介入器械时,流入其他容置区。在一实施例中,导管组件容置区113中,在邻近盛液池111的位置设有阻止冰水流动的密封塞1132。导管组件容置区113具有相对应的进一步向周围外扩(包括加深和/或加宽)的密封塞容置区115。密封塞1132为一块或多块拼接而成且与密封塞容置区115卡合的柱状(例如长方体或圆柱),以便于套接或卡接在导管组件外周。Considering the volume of the tray body 10 and the arrangement between the catheter assembly 210 and the interventional instrument 220 , ice water flows into other accommodating areas when the interventional instrument is submerged. In one embodiment, a sealing plug 1132 is provided at a position adjacent to the liquid storage tank 111 in the conduit component accommodating area 113 to prevent the flow of ice water. The catheter assembly receiving area 113 has a corresponding sealing plug receiving area 115 that is further expanded (including deepened and/or widened) around. The sealing plug 1132 is a cylindrical shape (such as a rectangular parallelepiped or a cylinder) which is spliced by one or more pieces and engages with the sealing plug accommodating area 115, so as to be sleeved or clamped on the outer periphery of the catheter assembly.
为了保证密封效果,优选的实施中,其中一限位件120跨设并作用于密封塞1132的顶部。以避免密封塞1132松动。In order to ensure the sealing effect, in a preferred implementation, one of the limiting members 120 straddles and acts on the top of the sealing plug 1132 . In order to avoid the sealing plug 1132 from loosening.
其中,限位件120包括三组,分别对应手柄容置区112、导管组件容置区113以及作为盛液池111的介入器械容置区。如图8所示,第一组限位件位于手柄容置区112,第二组限位件位于导管组件容置区113,第三组限位件位于盛液池111且至少具有一个限位件120跨设在定位槽1113的上方并作用于压握装置240。第一组限位件至少包括两个限位件120,分别跨设在控制手柄230的近端和远端。Wherein, the limiter 120 includes three groups, respectively corresponding to the handle accommodating area 112 , the catheter assembly accommodating area 113 , and the interventional instrument accommodating area serving as the liquid storage pool 111 . As shown in Figure 8, the first set of limiters is located in the handle accommodating area 112, the second set of limiters is located in the catheter assembly accommodating area 113, and the third set of limiters is located in the liquid storage pool 111 and has at least one limiter The member 120 straddles above the positioning slot 1113 and acts on the crimping device 240 . The first set of limiting members includes at least two limiting members 120 straddling the proximal end and the distal end of the control handle 230 respectively.
由于导管组件210包括分别接驳控制手柄230和介入器械220的第一段2101和第二段2102,以及连接在第一段2101和第二段2102之间的第三段2103。第一段2101和第二段2102为直段,第三段2103为弯曲段(不考虑在深度方向上的变化)。使得盘体10的长度不会太长,长度和宽度比例和谐,方便包装和运输。The catheter assembly 210 includes a first section 2101 and a second section 2102 respectively connected to the control handle 230 and the interventional instrument 220 , and a third section 2103 connected between the first section 2101 and the second section 2102 . The first section 2101 and the second section 2102 are straight sections, and the third section 2103 is a curved section (the change in the depth direction is not considered). The length of the tray body 10 is not too long, and the ratio of length and width is harmonious, which is convenient for packaging and transportation.
因此,第二组限位件至少包括三个分别作用跨设在第一段、第二段和第三段上的限位件120。一实施例中,导管组件容置区113局部进一步下沉并向周围外扩形成避让区1191,避让区1191用于供手或工具伸入至导管组件210的下方后上提导管组件使其脱离容置区110。Therefore, the second group of limiting members includes at least three limiting members 120 respectively acting on the first segment, the second segment and the third segment. In one embodiment, the catheter assembly accommodating area 113 partially further sinks and expands outwards to form an avoidance area 1191. The avoidance area 1191 is used for hands or tools to penetrate below the catheter assembly 210 and then lift the catheter assembly to make it disengage. The accommodation area 110 .
在一实施例中,手柄容置区112的至少一部分区域相对于控制手柄230的外周进一步向外扩展,与控制手柄230之间构成避让区1121。传统的结构在装载时需完全取出控制手柄,其余组件仍处于预装状态,对于导管组件与控制手柄的连接部分容易造成损伤,术者操作需要小心谨慎,降低效率。本实施例的避让区用于输送系统在预装或者控制手柄局部取出的情况下,即可操作控制手柄来完成装载。待装载完成后,再将输送系统取出。In one embodiment, at least a part of the handle accommodating area 112 further expands outwards relative to the outer periphery of the control handle 230 , and forms a avoidance area 1121 between the control handle 230 . In the traditional structure, the control handle needs to be completely removed when loading, and the rest of the components are still in the pre-installed state. The connection between the catheter assembly and the control handle is easy to cause damage, and the operator needs to be careful in operation, which reduces efficiency. The avoidance area of this embodiment is used for the conveying system when the conveying system is pre-installed or the control handle is partly taken out, and the control handle can be operated to complete the loading. After the loading is complete, take out the delivery system.
如图13和图14所示,控制手柄230连接有延长管232(例如通过软管连接),用于对接排气设备250(如注射器或泵等)排气,使用时可抬起控制手柄的近端并对接排气设备250完成排气操作。As shown in Fig. 13 and Fig. 14, the control handle 230 is connected with an extension tube 232 (for example, connected by a hose), which is used to connect with an exhaust device 250 (such as a syringe or a pump, etc.) The proximal end is docked with the exhaust device 250 to complete the exhaust operation.
其中导管组件210包括与控制手柄230活动连接的导管,控制手柄230上带有可控制该导管的操作部件231。如图7所示,操作部件231为多个且仅示意性标出,为了方便操作,避让区1121的位置与操作部件231相对应。The catheter assembly 210 includes a catheter that is movably connected to a control handle 230, and the control handle 230 is provided with an operating part 231 that can control the catheter. As shown in FIG. 7 , there are multiple operating parts 231 and are only schematically marked. For the convenience of operation, the position of the avoidance area 1121 corresponds to the operating parts 231 .
如图9、图10所示,包括上述任一实施例的托盘,包裹托盘的密封袋13,以及装载密封袋13用于运输的包装盒14。As shown in FIG. 9 and FIG. 10 , it includes the pallet of any one of the above embodiments, a sealed bag 13 wrapping the pallet, and a packing box 14 containing the sealed bag 13 for transportation.
其中,包装盒14上设置有温度显示器141,内部配置有相应的温度传感器,用于监测盒内温度。Wherein, the packaging box 14 is provided with a temperature display 141, and a corresponding temperature sensor is arranged inside for monitoring the temperature inside the box.
尤其人工心脏瓣膜以干膜形态保存时,更便于监控保存环境,同理也可以监测湿度或其他参数。Especially when the artificial heart valve is stored in the form of a dry film, it is easier to monitor the storage environment, and the humidity or other parameters can also be monitored in the same way.
图9~图14描绘了使用包装组件的示例性步骤:Figures 9 to 14 depict exemplary steps for using package components:
操作之前可根据温度显示器预判包装盒14是否经历了非预期的温度值或时间、以及包装盒14外观的完好程度,而后打开包装盒14、密封袋13,将承载托盘1取出。将冰水1114注入盛液池111直到水位达到标记指示1115,以便完全地浸没介入器械。Before operation, it is possible to predict whether the packaging box 14 has experienced an unexpected temperature value or time and the integrity of the packaging box 14 according to the temperature display, and then open the packaging box 14 and the sealed bag 13 to take out the carrier tray 1 . Ice water 1114 is poured into the sump 111 until the water level reaches the mark indication 1115 to completely submerge the interventional instrument.
操作控制手柄230,完成对介入器械的装载后,移除塞子1111。The control handle 230 is operated, and the stopper 1111 is removed after loading of the interventional instrument is completed.
排空冰水。Drain the ice water.
本申请的托盘,一个盘体可以适配多个拓展托架(对应不同尺寸的介入器械),盘体与拓展托架配合的固定托架也能够适配一种或多种型号的介入器械,因此盘体所对应的模具仅需要一套,相较于传统,降低了开模的费用。且输送系统在预装和拆卸过程中,无需施加额外的作用力,至少避免导管组件和介入器械的损伤。且术者可以在输送系统装载于吸塑盒中进行介入器械的装载,降低术者在装载和取出操作时的失误率,提高效率。In the tray of the present application, one tray body can be adapted to multiple expansion brackets (corresponding to interventional instruments of different sizes), and the fixed bracket matched with the tray body and the expansion bracket can also be adapted to one or more types of interventional instruments. Therefore, only one set of molds is required for the disc body, which reduces the cost of mold opening compared with the traditional one. Moreover, during the pre-installation and disassembly process of the delivery system, there is no need to apply additional force, at least avoiding damage to catheter components and interventional instruments. In addition, the operator can load the delivery system in the blister box to load the interventional instruments, reducing the operator's error rate during loading and taking out operations, and improving efficiency.
以上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。不同实施例中的技术特征体现在同一附图中时,可视为该附图也同时披露了所涉及的各个实施例的组合例。The technical features of the above embodiments can be combined arbitrarily. For the sake of concise description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be It is considered to be within the range described in this specification. When the technical features in different embodiments are embodied in the same drawing, it can be considered that the drawing also discloses the combination examples of the various embodiments involved.
以上实施例仅表达了本申请的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对申请专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本申请构思的前提下,还可以做出若干变形和改进,这些都属于本申请的保护范围。The above examples only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application.
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Denomination of utility model: Packaging device for implant delivery system Granted publication date: 20230815 Pledgee: Hangzhou Yingzhiqin No.2 Venture Capital Partnership Enterprise (Limited Partnership) Pledgor: Hangzhou Qiming Medical Devices Co.,Ltd. Registration number: Y2025980011063 |