CN116899083A - 一种药物灌注球囊扩张导管 - Google Patents

一种药物灌注球囊扩张导管 Download PDF

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CN116899083A
CN116899083A CN202310919005.3A CN202310919005A CN116899083A CN 116899083 A CN116899083 A CN 116899083A CN 202310919005 A CN202310919005 A CN 202310919005A CN 116899083 A CN116899083 A CN 116899083A
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tube
infusion
cavity
balloon
guide wire
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张宾
史杰
何智浩
田争
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First Affiliated Hospital Of Hebei North University
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First Affiliated Hospital Of Hebei North University
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    • A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
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Abstract

本发明公开了一种药物灌注球囊扩张导管，包括：外管、灌注管和导丝管。外管、灌注管和导丝管同轴设置，外管与灌注管之间形成充盈腔，灌注管和导丝管之间形成灌注腔，导丝从导丝进口进入经导丝腔后从导丝出口穿出，该药物灌注球囊扩张导管沿导丝到达病变位置，向充盈腔中通入造影液，从而使得球囊扩张，向灌注腔内注入消融药剂，消融药剂通过灌注腔进入血管中以对病变位置的血栓结块进行化学消融。该药物灌注球囊扩张导管的灌注腔和导丝腔互不干扰，在使用过程中无需撤出导丝，通过导丝进行导向，从而保证球囊可以准确到达病变位置，又可避免重新进入导丝，降低操作难度。

Description

一种药物灌注球囊扩张导管
技术领域
本发明涉及微创介入医疗器械技术领域，具体涉及一种药物灌注球囊扩张导管。
背景技术
射频消融已成为心房颤动患者治疗的重要方法，传统Marshall静脉消融是通过开胸或者穿刺心包腔的途径，但这两种方法创伤大，并发症风险高。经Marshall静脉无水酒精消融就是这样一种融合了电生理和冠脉的手术技术，不仅可以免去外科手术或者穿刺心包的风险，而且会毁损Marshall静脉及其分支支配区域的所有心房肌，效果远胜外科手术或者穿刺心包途径消融Marshall韧带通过向心脏冠状静脉窦内的Marshall静脉注入无水酒精来造成局部心房组织无菌性坏死从而提高房颤消融成功率，不仅可以免去外科手术或者穿刺心包的风险，而且会毁损Marshall静脉及其分支支配区域的所有心房肌，效果远胜外科手术或者穿刺心包途径消融Marshall韧带。
现有技术中，经Marshall静脉无水酒精消融多使用OTW球囊扩张导管，OTW导管沿导丝进入人体操作较繁琐，推无水乙醇时导丝需撤出，此时OTW导管失去导丝辅助定位，容易出现位移，且后续操作需重新进入导丝，操作繁琐。
发明内容
因此，本发明要解决的技术问题在于克服现有技术中的球囊扩张导管定位困难的缺陷，从而提供一种药物灌注球囊扩张导管。
为解决上述技术问题，本发明的技术方案如下：
一种药物灌注球囊扩张导管，包括：外管、灌注管和导丝管；所述外管的远端与球囊的近端连接密封；所述灌注管同轴设置于所述外管管腔内，所述灌注管的远端与所述球囊的远端密封连接，所述灌注管的外壁与所述外管的内壁之间形成充盈腔，所述充盈腔与所述球囊腔体连通；所述导丝管同轴设置于所述灌注管的管腔内，所述导丝管的外壁与所述灌注管的内壁之间形成与血管连通的灌注腔，所述导丝管的远端开设有导丝进口，所述灌注管的管壁上开设有通孔，所述外管的管壁上开设有导丝出口，所述导丝管的近端穿设于所述通孔与所述导丝出口密封连接，导丝适于经所述导丝进口穿入所述导丝管腔后从所述导丝出口穿出。
根据本发明的一些实施例，所述充盈腔内设有导向瓣片，所述导向瓣片的一端与所述灌注管的外壁转动连接，所述导向瓣片的另一端朝向远端一侧倾斜。
根据本发明的一些实施例，所述外管包括一体成型的管体和导管座，所述球囊设于所述管体的远端，所述导管座位于所述管体的近端，所述导管座的近端开设有与所述灌注腔连通的灌注入口，所述导管座的一侧开设有与所述充盈腔连通的充盈口。
根据本发明的一些实施例，所述导丝管的远端和所述灌注管的远端之间设有密封挡板，所述密封挡板上开设有若干个灌注出口，所述灌注腔通过所述灌注出口与所述血管连通。
根据本发明的一些实施例，所述灌注出口设有多个，所述灌注出口以圆心为原点呈圆周阵列分布。
根据本发明的一些实施例，所述灌注管的远端外伸于所述外管的远端端面以形成第一延伸段，所述球囊包裹于所述第一延伸段上，所述导丝管远端外伸于所述灌注管的远端端面以形成第二延伸段。
根据本发明的一些实施例，所述药物灌注球囊扩张导管还包括显影环，所述显影环设于所述导丝管内，且对应于所述球囊位置。
药物灌注球囊扩张导管所述显影环至少设有两个，且两个所述显影环间隔分布。
本发明技术方案，具有如下优点：
1.本发明提供的药物灌注球囊扩张导管，外管、灌注管和导丝管同轴设置，外管与灌注管之间形成充盈腔，灌注管和导丝管之间形成灌注腔，导丝从导丝进口进入经导丝腔后从导丝出口穿出，该药物灌注球囊扩张导管沿导丝到达病变位置，向充盈腔中通入造影液，从而使得球囊扩张，向灌注腔内注入消融药剂，消融药剂通过灌注腔进入血管中以对病变位置的血栓结块进行化学消融。该药物灌注球囊扩张导管的灌注腔和导丝腔互不干扰，在使用过程中无需撤出导丝，通过导丝进行导向，从而保证球囊可以准确到达病变位置，又可避免重新进入导丝，降低操作难度。
2.本发明提供的药物灌注球囊扩张导管，在充盈腔内设有导向瓣片，造影液在导向瓣片的作用下实现单向流动，以对球囊进行扩张，当球囊放置结束后，导向瓣片还可以避免血液回流。
3.本发明提供的药物灌注球囊扩张导管，灌注管的远端外伸于外管的远端端面以形成第一延伸段，球囊包裹于第一延伸段上，导丝管远端外伸于灌注管的远端端面以形成第二延伸段，第二延伸段的设置便于导丝进入导丝腔，以实现导向作用。
4.本发明提供的药物灌注球囊扩张导管，显影环的作用在于精准定位病变位置，以提高操作的便捷性。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明的一些实施例中提供的药物灌注球囊扩张导管的结构示意图；
图2为本发明的一些实施例中提供的药物灌注球囊扩张导管从远端方向的视图；
图3为图1所示的A处的局部视图。
附图标记说明：1、外管；2、灌注管；3、导丝管；4、球囊；5、显影环；6、密封挡板；7、导向瓣片；11、管体；12、导管座；13、充盈腔；21、灌注腔；31、导丝腔；131、充盈口；211、灌注入口；212、灌注出口；311、导丝进口；312；导丝出口。
具体实施方式
下面将结合附图对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，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，都属于本发明保护的范围。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
此外，下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
参照图1至图3所示，本发明提出了一种药物灌注球囊扩张导管，包括：外管1、灌注管2和导丝管3；外管1的远端与球囊4的近端连接密封；灌注管2同轴设置于外管1管腔内，灌注管2的远端与球囊4的远端密封连接，灌注管2的外壁与外管1的内壁之间形成充盈腔13，充盈腔13与球囊4腔体连通；导丝管3同轴设置于灌注管2的管腔内，导丝管3的外壁与灌注管2的内壁之间形成与血管连通的灌注腔21，导丝管3的远端开设有导丝进口311，灌注管2的管壁上开设有通孔，外管1的管壁上开设有导丝出口312，导丝管3的近端穿设于通孔与导丝出口312密封连接，导丝适于经导丝进口311穿入导丝管3腔后从导丝出口312穿出。
具体说明，外管1、灌注管2和导丝管3同轴设置，外管1与灌注管2之间形成充盈腔13，灌注管2和导丝管3之间形成灌注腔21，导丝从导丝进口311进入导丝腔31后从导丝出口312穿出，该药物灌注球囊4扩张导管沿导丝到达病变位置，向充盈腔13中通入造影液，从而使得球囊4扩张，向灌注腔21内注入消融药剂，消融药剂通过灌注腔21进入血管中以对病变位置的血栓结块进行化学消融。该药物灌注球囊4扩张导管的灌注腔21和导丝腔31互不干扰，在使用过程中无需撤出导丝，通过导丝进行导向，从而保证球囊4可以准确到达病变位置，又可避免重新进入导丝，降低操作难度。
可以理解的是，消融药剂为无水乙醇，消融药剂的具体类型不作为本发明的限制。
参照图3所示，在本发明的一些实施例中，充盈腔13内设有导向瓣片7，导向瓣片7的一端与灌注管2的外壁转动连接，导向瓣片7的另一端朝向远端一侧倾斜。
具体说明，在充盈腔13内设有导向瓣片7，造影液在导向瓣片7的作用下实现单向流动，以对球囊4进行扩张，当球囊4放置结束后，导向瓣片7还可以避免血液回流。
可以理解的是，在向充盈腔13内充入造影液的过程中，由于造影液从近端向远端流道，从而压迫导向瓣片7向灌注管2的外壁一侧转动，造影液可以顺利通过导向瓣片7向远端流道；当球囊4扩张至指定尺寸，球囊4从外管1和灌注管2上脱落，此时停止灌注造影液，导向瓣片7的存在可避免血液和造影液回流。
在本发明的一些实施例中，外管1包括一体成型的管体11和导管座12，球囊4设于管体11的远端，导管座12位于管体11的近端，导管座12的近端开设有与灌注腔21连通的灌注入口211，导管座12的一侧开设有与充盈腔13连通的充盈口131。
具体说明，管体11和导管座12可通过模具一体成型设置，提高制造效率，降低成本。球囊4设于管体11的远端，导管座12设于管体11的近端，在导管座12上开设灌注入口211，从灌注入口211灌注消融药剂，在导管座12的一侧开设有与充盈腔13连通的充盈口131，从充盈口131通入造影剂。
参照图2所示，在本发明的一些实施例中，导丝管3的远端和灌注管2的远端之间设有密封挡板6，密封挡板6上开设有若干个灌注出口212，灌注腔21通过灌注出口212与血管连通。
在本发明的一些实施例中，灌注出口212设有多个，灌注出口212以圆心为原点呈圆周阵列分布。
具体说明，灌注出口212呈圆周阵列分布有利于提高消融药剂分散的均匀性，通过密封挡板6对消融药剂进行格挡，避免消融药剂的流动速度过快，以便于对血栓结块进行充分消融。
在本发明的一些实施例中，灌注管2的远端外伸于外管1的远端端面以形成第一延伸段，球囊4包裹于第一延伸段上，导丝管3远端外伸于灌注管2的远端端面以形成第二延伸段。
具体说明，由于导丝先进入血管中，为了便于导丝从导丝进口311进入导丝管3内，导丝管3远端外伸于灌注管2的远端端面形成第二延伸段，在第二延伸段的远端设置导丝进口311，导丝从导丝进口311经导丝腔31后从导丝出口312穿出，以实现导向作用。
在本发明的一些实施例中，药物灌注球囊4扩张导管还包括显影环5，显影环5设于导丝管3内，且对应于球囊4位置。
药物灌注球囊4扩张导管显影环5至少设有两个，且两个显影环5间隔分布。
具体说明，显影环5的作用在于精准定位病变位置，以提高操作的便捷性。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。

Claims (8)

1.一种药物灌注球囊扩张导管，其特征在于，包括：
外管(1)，所述外管(1)的远端与球囊(4)的近端连接密封；
灌注管(2)，同轴设置于所述外管(1)管腔内，所述灌注管(2)的远端与所述球囊(4)的远端密封连接，所述灌注管(2)的外壁与所述外管(1)的内壁之间形成充盈腔(13)，所述充盈腔(13)与所述球囊(4)腔体连通；
导丝管(3)，同轴设置于所述灌注管(2)的管腔内，所述导丝管(3)的外壁与所述灌注管(2)的内壁之间形成与血管连通的灌注腔(21)，所述导丝管(3)的远端开设有导丝进口(311)，所述灌注管(2)的管壁上开设有通孔，所述外管(1)的管壁上开设有导丝出口(312)，所述导丝管(3)的近端穿设于所述通孔与所述导丝出口(312)密封连接，导丝适于经所述导丝进口(311)穿入所述导丝管(3)腔后从所述导丝出口(312)穿出。
2.根据权利要求1所述的药物灌注球囊扩张导管，其特征在于，所述充盈腔(13)内设有导向瓣片(7)，所述导向瓣片(7)的一端与所述灌注管(2)的外壁转动连接，所述导向瓣片(7)的另一端朝向远端一侧倾斜。
3.根据权利要求1所述的药物灌注球囊扩张导管，其特征在于，所述外管(1)包括一体成型的管体(11)和导管座(12)，所述球囊(4)设于所述管体(11)的远端，所述导管座(12)位于所述管体(11)的近端，所述导管座(12)的近端开设有与所述灌注腔(21)连通的灌注入口(211)，所述导管座(12)的一侧开设有与所述充盈腔(13)连通的充盈口(131)。
4.根据权利要求1所述的药物灌注球囊扩张导管，其特征在于，所述导丝管(3)的远端和所述灌注管(2)的远端之间设有密封挡板(6)，所述密封挡板(6)上开设有若干个灌注出口(212)，所述灌注腔(21)通过所述灌注出口(212)与所述血管连通。
5.根据权利要求4所述的药物灌注球囊扩张导管，其特征在于，所述灌注出口(212)设有多个，所述灌注出口(212)以圆心为原点呈圆周阵列分布。
6.根据权利要求1所述的药物灌注球囊扩张导管，其特征在于，所述灌注管(2)的远端外伸于所述外管(1)的远端端面以形成第一延伸段，所述球囊(4)包裹于所述第一延伸段上，所述导丝管(3)远端外伸于所述灌注管(2)的远端端面以形成第二延伸段。
7.根据权利要求1所述的药物灌注球囊扩张导管，其特征在于，还包括显影环(5)，所述显影环(5)设于所述导丝管(3)内，且对应于所述球囊(4)位置。
8.根据权利要求7所述的药物灌注球囊扩张导管，其特征在于，所述显影环(5)至少设有两个，且两个所述显影环(5)间隔分布。
CN202310919005.3A 2023-07-25 2023-07-25 一种药物灌注球囊扩张导管 Pending CN116899083A (zh)

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