CN108283758B - 一种具有破、溶栓血栓抽吸功能的药物洗脱球囊导管 - Google Patents
一种具有破、溶栓血栓抽吸功能的药物洗脱球囊导管 Download PDFInfo
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Abstract
本发明公开了一种血栓抽吸和血管扩张成形功能的药物洗脱球囊导管,属于医疗器械领域。本发明中所述导管结构包括:球囊腔1,辅助腔2,RX口3,导丝腔4,显影环5,抽吸腔6、Y型连接头7。所述球囊腔在抽吸导管最外层,辅助腔2在抽吸腔6内壁上,导丝腔4在抽吸腔6远端内壁上。本发明可经抽吸腔6打入溶栓药进行药物溶栓。本发明在抽吸腔6内壁上设置辅助腔道,可实行改良的体外超声辅助溶栓(ETUS)功能,经辅助腔2通过输送***在体内放置具有多微孔的细小金属圆柱体,通过体外超声探头发出的超声波,经过微孔圆柱体向多个方向反射超声波,放大超声波的空化作用,提高破栓效率;也可通过辅助腔2送入干扰丝,用机械力破栓。
Description
技术领域
本发明涉及医疗器械领域。具体涉及一种具有超声破栓药物溶栓、血栓抽吸和血管成形功能的药物洗脱球囊导管。
背景技术
数据表明,目前我国心血管疾病人数达到2.3亿,其中,急性心肌梗塞(AMI)患者已超过200万人,每年至少新发50至80万例,并且呈逐年上升的趋势,每年死于急性心肌梗塞的人数超过100万。据预测,2015年至2030年,中国将新增2100万急性冠状动脉患者,发生至少700万例心源性死亡。在世界上,2013年美国心脏病协会(AHA)公布的数字显示,2009年美国每10万人口就有236.1人死于心血管疾病,占总死亡人数的32.3%,加拿大为605/10万,芬兰为824/10万,英国为823/10万,法国为314/10万,意大利为270/10万,澳大利亚为422/10万。
目前AMI最有效的治疗方法是对行急诊经皮冠状动脉介入治疗(PCI),大量临床研究证实了急诊PCI能够大大减少冠心病的早期死亡率。但是,临床上发现,即使是及时进行PCI治疗,尽管随着医疗保健的改善和急性AMI的规范化治疗及管理,仍有许多患者不能从中获益,因为,急诊PCI术中会发生无复流现象,使缺血心肌得不到有效再灌注,甚至受到进一步损伤。
由于动脉粥样硬化是导致急性心脑血管事件的病理基础,导致急性心血管事件的主要原因是局部动脉粥样硬化斑块破裂和血栓形成,而血栓形成取决于动脉粥样硬化斑块的易损性,易损斑块容易出现斑块破裂及血栓形成,从而导致急性冠脉综合征的发生。而直接行PCI治疗,支架置入后,在球囊或支架的挤压作用下,一方面,血小板易被不稳定斑块中裸露脂质所激活,形成微血栓在病变血管部位黏附聚集,导致微循环阻塞;另一方面,治疗过程中血栓容易碎裂、脱落,造成血栓碎块流向冠状动脉远端,导致远端血管阻塞,从而出现“ 慢血流”现象。随着阻塞量的增加,远端血管完全再阻塞,即出现“ 无复流”现象,最后导致充血性心力衰竭、恶性心律失常和心源性碎死的风险增加,从而增加了介入治疗的难度,提高了心血管事件的发生率,严重影响PCI的疗效,增加了AMI患者的病死率。
因此,一直以来,PCI治疗后,如何避免出现支架内急性和亚急性血栓形成以及冠脉微循环障碍导致的无复流,已经成为急诊PCI面临的一大难题。血栓抽吸是近年来应用于临床的一种新方法,其目的是通过机械作用,迅速抽出阻塞病变血管的血栓,其操作简便,手术时间短,治疗效果明显,但是仍然存在一些血栓抽吸后效果不佳的病例。
专利CN104323823A公布了一种血栓抽吸导管,涉及一种血栓抽吸导管***,包括抽吸装置、注药装置和四通管,主管的中心轴上设有金属搅丝,在金属搅丝的近端设有手柄,金属搅丝的远端设有菱形圈,既能够实施在抽吸前对血栓及斑块的处理、又能够实施抽吸,同时也能够及时注入溶栓药剂。
CN107468306A公布了一种血栓抽吸导管,具体包括导管本体,在导管本体的远端设置软头和内嵌于软头中的可膨胀的示踪标记;远端的软头和可膨胀示踪标记可以有效增大抽吸孔和抽吸腔的径向截面积,解决由于抽吸腔的径向截面积较小所带来的抽吸效率、血栓脱落的问题。
CN104586470A公布了一种血栓抽吸导管,包括导管本体和设置在所述导管本体行进端的导丝腔,所提供的血栓抽吸导管希望能解决径向截面积较小所带来的抽吸速率低、抽吸腔易堵塞的问题。
专利CN102319097A公布了一种血栓抽吸导管,其包括抽吸管、管座,管座连接导管,抽吸管的外壁上可活动的套设有套管,吸管内可***干扰金属丝,此发明的套管可移动地设置于抽吸管外,使抽吸管活动时不会受到球囊限制,让本发明可以快速清除散布在血管广泛区域的血栓及处理冠脉末梢微血管的栓塞 ;当遇到体积大及高黏稠的血栓时,可利用干扰金属丝打散血栓后再进行抽吸。
专利CN104874033A公布了一种新型血栓抽吸导管,抽吸管包括编网抽吸管主体和编网抽吸管头端,编网抽吸管主体一端连接编网抽吸管头端、另一端连接鲁尔接头,鲁尔接头另一端安装有单向阀体,单向阀体连接抽吸装置。此发明在血栓抽吸过程中,将血栓快速吸入导管体部,采用单向阀门技术,可最大程度上预防血栓脱落事件的发生。
专利CN104984461A公布了一种新型血栓抽吸导管,导管包括:抽吸腔、导丝腔、囊体、囊体充压通道和管座,此发明提供的血栓抽吸导管提高了抽吸效果。
美国专利US2017/0348014公布了一种可从原位导管中部署的滚动式牵引管机械血栓切除装置。这个装置可以从导管中运输,在导管内是处于被压紧状态,通过导管后恢复到一个展开的结构, 同一根导管在管式牵引车和细长牵引车之间被重新***,属于一种反向切除装置。
美国专利US2017/0303948公布了一种可以被配置成防止或减少阻塞(例如,“抗干扰”血栓切除装置),抓住血块和/或使血栓(例如血块)浸软的机械血栓切除装置。这些机械血栓切除装置可以包括牵引机,该牵引机包括柔性的材料管,所述材料在其被翻转成类似于传送带的运动中的导管时翻转。具体而言,机械血栓切除装置牵引机具有可选择性地伸出的突出部,其可帮助抓取和/或浸软凝块,还描述了一种用于机械血栓切除装置的棘轮式牵引机。
PCT国际公布的荷兰专利WO2016/075586 EN,公开了一种被配置为提供心脏超声溶栓治疗的医学成像***。所述设备可以被配置为确定一个或多个超声探头,根据是否具有心脏的恰当视图,将波束操控到期望的位置,超声探头可以用于成像和心脏超声溶栓治疗两者。
通过检索PubMed和 百度学术数据库,可以了解到超声溶栓的发展现状。1976年Trubestein首次使用血管内高频超声照射直接溶解血栓取得成功。1997年中国学者沈学东等从活体犬冠脉血栓栓塞模型上验证了经皮冠状动脉内超声消融血栓的有效性和安全性。Kristen A等人也证实了导管引导超声辅助溶栓治疗是安全有效的治疗栓塞的方法。超声溶栓的主要机制与空化效应和机械效应有关,超声空化效应是指液体中存在的微小气泡在超声波作用下产生振荡 、膨胀 、收缩以至内爆等一系列动力学过程 ,在组织和细胞内足以引发高达 1 ~ 3 个大气压的“内***”效应 , 足以使血栓在极短的时间内碎解成细小的颗粒 。目前超声直接溶栓形式主要为利用导管小型探头腔内消融血栓 , 已应用于临床,取得了很好的溶栓效果 ,但因其有创和对操作要求较高而无法普及 ,而体外超声辅助溶栓治疗(ETUS)相比于体内微探头超声治疗具备一定的优越性和更好的适应性。
本发明设计了一种同时具有超声破栓、药物溶栓、血栓抽吸和血管成型防止再狭窄功能的药物洗脱球囊导管。与检索到的国内外公布的专利技术在结构,功能和材料上均有所不同。
发明内容
本发明通过增加一辅助腔2,可以向输送多微孔金属头9,配合体外超声探头8辅助超声溶栓,当超声波经过比表面积较大的金属头9时,将会向多个方向多次反射,提高超声波利用率,形成一种改良的ETUS治疗方法。同时在球囊充起后,从抽吸腔打进去的溶栓药,由于球囊在近端的阻隔作用,可以在血管局部形成较高浓度的药物含量,配合超声的空化作用,可以使溶栓效率提高。同时辅助腔2也可以输送其他辅助工具例如金属干扰丝,特型金属干扰丝可以帮助打破血栓。本发明提供一种具有血栓抽吸功能的药物洗脱球囊。其特征在于,同时具备血栓抽吸、腔内球囊血管成型两项功能。所述具有血栓抽吸功能的药物洗脱球囊结构包括:球囊腔1,辅助腔2,RX口3,导丝腔4,显影环5,抽吸腔6、Y型连接头7、体外超声探头8、微孔金属头9和导丝10。所述Y型连接头从近端连接三腔管(或具有间隙的双层管),球囊设置于三腔管的远端外壁上,血管抽吸组件设置于三腔管的末端。所述球囊表面可带有药物涂层,所述血栓抽吸组件包括一个可走行导丝的导丝腔及一个血栓抽吸腔。三腔管远端分别开口于球囊及血栓抽吸组件的血栓抽吸腔。
1. 所述导管主体结构包括:球囊腔1,辅助腔2,RX口3,导丝腔4,显影环5,抽吸腔6、Y型连接头7、体外超声探头8、微孔金属头9和导丝10。
2.Y型连接头7可为塑料材质,通过注塑等工艺成型,通过粘结或注塑成型于抽吸导管近端连接。其中Y型连接头7的两个开口分别与抽吸导管的两个腔分别在近端连通。Y型连接口的外接口可设计为具有6%锥度的鲁尔接口或锁定接口或其它要求的尺寸。
3.抽吸导管由抽吸导管腔6、辅助腔2、导丝腔4构成,其中导管6可通过专用设备编织为金属网、高分子材料的复合型管材,具有一定支撑力,便于血栓抽吸操作;外层可由具有生物相容性的高分子材料制成,可带有亲水涂层或润滑涂层;辅助腔2为一细小的高分子材料管道,可容多微孔金属头微探头或金属干扰丝通过。
4.导丝腔近端和辅助腔远端,都在抽吸腔外壁上开一RX口,RX口长度为1mm~3mm。
5.球囊通过激光或红外或热风焊接的方式,分别连接于外管(近端)和内层管(远端);组装完成后,折叠压握,便于通过血路。
6.血栓抽吸组件可为尼龙等高分子材质,通过粘结或者焊接方式,固定于内层管远端。
7.本发明的特点是:导丝腔和球囊腔不重叠,优化血栓抽吸球囊导管的产品复杂度,提高了产品的可靠度。球囊腔在导丝腔后端,如附图2所示。
8.多微孔金属头为直径0.2mm、长度为2mm的细圆柱,圆柱体布满微孔,配合体外超声探头,可以使超声波在微孔内多次反射,放大超声波的空化作用,使破栓安全高效。金属头通过特定的输送***经通道腔4到达病灶处。
9.体外超声头工作功率在0.4~15W/cm2,频率在0.02~3.4MHz。
10.球囊载药种类包含但不限于紫杉醇、雷帕霉素、依维莫司等药物;
11.溶栓药物包括但不限于链激酶、尿激酶、人重组t-PA(rt-PA,阿替普酶)、瑞替普酶(r-PA),兰替普酶(n-PA)和替奈普酶(TNK-tPA)等药物;
12.抽吸导管管腔6具有一定的强度,防止在负压时工作时被压扁;
13.本发明血栓抽吸导管的使用方法,包括如下步骤:步骤①将抽吸导管通过导丝放置在血管病变处;步骤②将多微孔金属头通过腔道4放入靠近病变处的位置,同时将体外超声探头放到血栓发生对应体表处;步骤③开启超声碎栓,同时抽吸血栓;步骤④在抽吸结束后,可以直接再向前将导管***输送一段距离,到达球囊位置,实行血管成形术;
14.操作需三人及以上可以完成,并且可以根据病人血栓程度,可以选择不放多微孔金属头,通过抽吸腔打进溶栓药即可溶栓;
15.微孔金属头和输送***通过纳米连接技术焊接形成,可靠性高,不易脱落;
16.微孔金属头比表面积增大,在体内与血液接触,形成的界面增多,会将超声波向多个方向多次反射;
17.根据血栓位置和病变程度,可以选用金属干扰丝或超声溶栓其中合适的一种方式去除血栓;
18.金属干扰丝的材料成分包括但不限于镍钛合金、镍锰合金、镍锰钙等形状记忆金属;
19.显影环材料为铂铱合金、铂铬合金等X光显影良好的材料。
与现有技术相比,本发明的有益效果是:
1.结构简单可靠,操作方便,材料来源广泛,成本降低;
2.带有改良的体外辅助超声溶栓功能;
3.抽吸腔内设置一辅助腔,可以用来输送辅助工具;
4.辅助工具包括多微孔金属头和金属特型干扰丝,头部可以为椭圆形或菱形;
5.可在血栓抽吸后立即进行血管成形术;
6.球囊表面带有药物,有一定的抗再狭窄功能。
附图说明:
图1为一种高效溶栓的具有血栓抽吸功能的药物洗脱球囊结构示意图;
图2为超声放大作用示意图;
图3为金属干扰丝示意图;
图4为改良的超声辅助溶栓示意图。
具体实施方式:
下面结合实施例对本发明做进一步的详细说明,但并不限制本发明的内容,任何在本发明基础上做出的改动,都应视为本发明的保护范围。
实施例:
参考图1~图3。如图1所示,一种具有溶栓、超声破栓、血栓抽吸功能的药物洗脱球囊,抽吸导管整体长度为1400mm~1800mm,内径为1.10mm~2.00mm。前端导丝腔4长度为10mm~20mm,内径为0.02mm~0.20mm。抽吸腔前部开一RX口,长度为1.00mm~2.00mm,将导丝腔从RX口穿入并装配到抽吸管前端内壁上,RX口处焊接,导丝腔前端带有一mark环5,便于手术过程中定位。在导丝腔4的对侧内壁上也开一RX口,辅助腔管从RX口穿入,从抽吸腔后端穿出并装配到抽吸导管内壁上,辅助腔长度为1000mm~1200mm,直径为0.2mm~0.6mm。再装载外层球囊,球囊前端焊接到RX口3后方。最后安装Y型连接头,一个接口连接抽吸腔,用来连接注射器,抽吸血栓或注射药物;另一个接口连接球囊腔,连接压力泵充起球囊用。前端抽吸口在抽吸腔导管上通过模具切割而成斜切口。如图2所示,多孔金属头9圆柱体直径尺寸为0.01mm~0.2mm,长度为0.01mm~2.00mm,加工方式可采用激光加工或者纳米多孔金属铸造方式加工,尾端连接导丝10,此辅助装置可以在血管内反射并放大超声波的空化作用。特型金属干扰丝如图三所示,经辅助腔2输送到患病处,转动金属丝可以达到切割血栓的目的,金属丝头部表面光滑且具有形状记忆功能,脱离辅助腔道后可自膨胀为附图所示的形状。
本产品改良的超声辅助溶栓(ETUS)功能原理示意图如图4所示。当体外超声探头8产生的超声波经过多微孔金属头9时,由于多微孔金属头的比表面积大,界面增多,多次反射超声波使血管内壁的血栓12由于超声波的空化作用而化成小块掉落到血管内,及时经施以负压的抽吸导管抽出血管。
Claims (11)
1.一种有高效溶栓和血栓抽吸功能的药物洗脱球囊导管,包括球囊腔(1),辅助腔(2),RX口(3),导丝腔(4),显影环(5),抽吸腔(6)、Y型连接头(7),以及体外超声探头(8)和辅助工具(9)、(11),其特征在于:血栓抽吸组件具有可走行导丝的导丝腔和可抽吸血栓的血栓抽吸腔,抽吸腔内壁上具有一辅助腔道,辅助腔道为导管内壁的单独腔道,辅助腔道远端开口在球囊导管侧壁上;辅助工具包括多微孔金属头或金属干扰丝,可经辅助腔道由导丝输送到病变部位,具备内径范围为0.01mm~1mm的导丝腔,长度最短可为1mm,导丝腔和球囊腔不并行,导丝腔内涂有超滑涂层,可以使血栓抽吸导管顺利通过导丝,球囊腔在导丝腔后端;微孔金属头的材料为惰性无毒的金属材料,包括但不限于铂、铱、金、不锈钢等惰性金属或其他合金材料;微孔金属头输送***为一种导丝,导丝远端与金属头端面连接,导丝材料可以是金属或高分子材料,导丝为具有一定韧性的细丝;微孔金属头的微孔尺寸在10μm~60μm。
2.如权利要求1所述的药物洗脱球囊导管,其特征在于:所述球囊固定于导管远端。
3.如权利要求1所述的药物洗脱球囊导管,其特征在于:所述球囊的表面带有抗再狭窄药物涂层。
4.如权利要求1所述的药物洗脱球囊导管,其特征在于:所述辅助腔、所述导丝腔、所述抽吸腔可为管径不同的套管结构。
5.如权利要求1所述的药物洗脱球囊导管,其特征在于:管腔材质为金属编织管、PTFE、尼龙或其它材质或多种材质的复合。
6.如权利要求1所述的药物洗脱球囊导管,其特征在于:所述导管的管身最外层表面具有亲水涂层。
7.如权利要求1所述的药物洗脱球囊导管,其特征在于:所述辅助腔通过Y型连接头连接,将多微孔金属头送入血管病变处。
8.如权利要求1所述的药物洗脱球囊导管,其特征在于:腔道材料包括但不限于PTFE、pebax或其他高分子材料,通过热风焊、激光焊等焊接方式连接。
9.如权利要求3所述的药物洗脱球囊导管,其特征在于:所述药物涂层的种类包括但不限于紫杉醇、雷帕霉素、依维莫司等。
10.如权利要求9所述的药物洗脱球囊导管,其特征在于:所述药物涂层的涂敷工艺包括但不限于喷涂、浸泡等工艺。
11.如权利要求1所述的药物洗脱球囊导管,其特征在于:前端抽吸口通过激光切割或机械切割进行加工,形状包括但不限于斜切口、凹形切口或楔形切口。
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CN205548629U (zh) * | 2016-03-24 | 2016-09-07 | ***广州总医院 | 一种超声微泡空化溶栓*** |
CN105664338A (zh) * | 2016-04-26 | 2016-06-15 | 业聚医疗器械(深圳)有限公司 | 球囊导管 |
CN205759114U (zh) * | 2016-06-17 | 2016-12-07 | 韩宇 | 超声引导下肺动脉瓣狭窄经皮球囊扩张术用引导导管 |
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