CN101574554A - 集成导管插入型医疗器械 - Google Patents
集成导管插入型医疗器械 Download PDFInfo
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Abstract
此医疗器械含有柔性导管,导管内有一根镍钛合金长条,它具有远端、近端、从远端延伸至近端的纵轴、从远端延伸而成的尖头,以及在其上刻蚀的凹槽。此外,凹槽设置成沿着纵轴。医疗器械柔性导管还包括一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管共同形成导管。医疗器械还包括插入装置,用以将柔性导管的一部分(包括尖头)插入使用者的目标部位,以便导管可将液体输注至目标部位。
Description
[0001]技术领域
[0002]本发明主要涉及医疗器械,尤其是柔性导管和相关医疗器械及其制造方法。
[0003]背景技术
[0004]多种医疗器械利用导管插入体腔,抵达某个目标部位,以便进行诊断、治疗和外科手术。举例而言,人们经常采用由硬针插入的柔性套管输注治疗药物(如胰岛素)。
发明内容
针对以上问题,本发明提供一种医疗器械,包括:一根医疗器械柔性导管,包括:一根镍钛合金长条,具有:远端;近端;从远端延伸至近端的纵轴;从远端延伸而成的尖头;以及在其上形成的凹槽,凹槽设置成沿着纵轴;一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管形成导管;一个插入装置,用于将柔性导管的一部分,包括尖头,插入使用者的目标部位,以便导管可将液体输注至目标部位。
本发明还提供一种医疗器械,包括:一根医疗器械柔性导管,包括:一根镍钛合金长条,具有:远端;近端;从远端延伸至近端的纵轴;从远端延伸而成的尖头;以及在其上形成的凹槽,凹槽设置成与纵轴平行;一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管形成导管;一个插入装置,用于将柔性导管的一部分,包括尖头,插入使用者的目标部位,以便导管可将液体输注至目标部位。
[0005]本发明的新特征载于所附权利要求中。为更好地理解本发明的特征和优,可参阅下述详细说明,包括应用本发明原理的说明性实施例以及附图,其中相应的数字表示相应的部件。
附图说明
图1A是根据本发明的典型实施例描绘的医疗器械柔性导管横截面简图;
图1B是沿图1A中的线条B-B截取的图1A所示医疗器械柔性导管的横截面简图;
图1C是沿图1A中的线条C-C截取的图1A所示医疗器械柔性导管的横截面简图;
图2A和2B分别为可运用于本发明之实施例的带凹槽镍钛合金长条的侧面和底部简图;
图3是可运用于本发明之实施例的另一种镍钛合金长条的横截面简图,并载明以英寸计量的示意尺寸;
图4是可运用于本发明之实施例的另一种镍钛合金长条的横截面简图,并载明以英寸计量的示意尺寸;
图5是可运用于本发明之实施例的另一种镍钛合金长条的简图,并载明以英寸计量的示意尺寸;
图6是可运用于本发明之实施例的另一种镍钛合金长条的简图;
图7A-7D为可运用于本发明之实施例的另一种镍钛合金长条的简图,并载明以英寸计量的示意尺寸。
图8A和8B是可运用于根据本发明制造的医疗器械导管的等向性蚀刻过程简图。
图9A和9B分别为根据本发明之实施例制造的医疗器械在配置集成软管之前和之后的简图;
图10、11、12和13是根据本发明之实施例制造的带有柔性导管导轨的其他医疗器械的不同简图。
具体实施方式
[0006]阅读以下详细说明时应参考图纸,类似部件在不同图纸中的编号相同。图纸(并不一定按比例)仅出于解释之目的图示了选定的实施例,其意图并不在于限制本发明的应用范围。此说细说明通过举例(而不是限制)的方式对发明原理进行了图示。此说明能够清楚地让业内专业人士实施和使用本发明,并介绍了本发明的几种实施例、修改例、变例、替代例及其应用,包括目前公认的实施本发明的最佳模式。
[0007]本文用以表示任何数值或范围的“约”或“近似”表示适当的尺寸公差,该尺寸公差容许部件或组件集按本文所述的预定用途起作用。此外,本文所称的“患者”、“宿主”和“受试者”指任何人或动物受试者,无意将系统或方法囿于人类使用范围内,尽管将本发明用于人类患者是更好的实施例。
[0008]图1A、1B和1C是根据本发明的实施例描绘的医疗器械软管100。医疗器械柔性导管100包括一根长条102(如柔性镍钛合金(Nitinol)条或其他合适的高柔韧性长条),它具有远端104、近端106(仅显示于近端所在方向)、从远端104至近端106的纵轴108(以虚线表示)、自远端104延伸而成的尖头110,以及形成的凹槽112(例如刻蚀而成)。凹槽112设置成至少部分沿着或平行纵轴108。
[0009]医疗器械柔性导管100还包括一根软管114,该软管至少部分包覆远端和近端之间的长条,凹槽和软管共同形成导管。凹槽112局部延伸至尖头110,形成位于柔性导管100一侧的导管开口116。
[0010]如需要,软管114可延伸越过近端106,形成与相关医疗器械组件(如注射组件)相连的液密接头。此外,如需要,可在医疗器械柔性导管上涂上一层润滑材料,以便更轻松地插入使用者的目标部位。
[0011]下文说明了依照本发明制造的医疗器械柔性导管的其他方面,包括使用方法、制造方法和在集成医疗器械中的运用。
[0012]图2A和2B分别为可运用于本发明之实施例的带凹槽212之镍钛合金长条202的侧面和底部简图。图2A和2B载有以英寸计量的示意(非限制性)尺寸。
[0013]图3为可运用于本发明之实施例的另一种带双凹槽312的镍钛合金长条302的横截面简图,并载明以英寸计量的示意尺寸。双凹槽使镍钛合金长条的横截面构成“H”形。双凹槽使提供备用导管,或用每条导管输注不同液体(如胰岛素和Smylin)成为可能。此外,与图4所绘并于下文说明的C形横截面相比,H形横截面具有更大的灵活性。
[0014]图4为可运用于本发明之实施例的另一种带凹槽412的镍钛合金长条402的横截面简图,并载明以英寸计量的示意尺寸。
[0015]图5是可运用于本发明之实施例的另一种带凹槽512和尖头504的镍钛合金长条502的简图,并载明以英寸计量的示意尺寸。图6是可运用于本发明之实施例的另一种带尖头604和凹槽612的镍钛合金长条602的简图。
[0016]图7A-7D是可运用于本发明之实施例的另一种带尖头704和凹槽712的镍钛合金长条700的简图,并载明以英寸计量的示意尺寸。
[0017]根据本发明的实施例制造医疗器械柔性导管的方法包括在镍钛合金长条上刻蚀凹槽,并在镍钛合金长条的远端上形成尖头。此方法还包括随后用一根软管包覆扁平的镍钛合金长条,使软管和凹槽形成导管。
[0018]图8A和8B是可在根据本发明制造医疗器械柔性导管时运用的等向性蚀刻过程的简图。可使用业内专业人士所知的任何适用刻蚀技术,如等向化学刻蚀技术,刻蚀出本发明之实施例中应用的凹槽。等向性刻蚀采用了掩膜层,通过侧蚀掩膜层,在移除掩膜层之后,刻蚀表面的底部形成带尖利边缘的半圆形横截面边壁,参见图8A和8B。
[0019]若需要弯曲的长条(如弯曲的镍钛合金长条),可使用弯曲的片材,而非平片。在这种情况下,刻蚀掩模必须与片材弧度相对应。也可在后续制造过程中弯曲长条。
[0020]凹槽可刻蚀于长条的一侧(形成“C”形横截面,示例参见图2B)或两侧(形成“H”形横截面,示例参见图3)。还可在一根长条的一侧或两侧刻蚀多个凹槽。若刻蚀多个凹槽,则在其中一个凹槽堵塞时将有备用凹槽可供使用,或可利用其余凹槽输注不同药物,如胰岛素和Symlin。
[0021]带尖利边缘的长条尖头的宽度大于长条的其余部分,以便在将软管(如聚合物护套)套在长条四周,以形成导管时,软管的前缘可与尖头的肩部相合。这种结构可缩小医疗器械柔性导管的正剖面,减轻了插入力,防止软管抵住使用者目标部位的插入点,导致聚合管“折叠”。所刻蚀的凹槽延伸至尖头,形成一个越过软管的开口,使液体得以流入使用者的目标部位。将开口置于尖头的一侧可减少凹槽在插入期间因组织取样而堵塞的几率。为了使刻蚀部位形成适当的形状,可在长条的头部与身体接触的位置应用常见的掩膜技术,如削角补偿技术。
[0022]由于刻蚀技术使尖头形状的设计得以独立于主体,故而有多种尖头形态可供选择(参见图7A至7D)。
[0023]根据本发明之实施例制造的医疗器械柔性导管可使用由经刻蚀的镍钛合金长条(带尖头),覆以热收缩PTFE聚合物护套(还原后最大内径0.012”,还原壁厚0.002”,扩张后最小内径0.048”,Zeus制造)。在本实施例中,镍钛合金长条的刻蚀凹槽延伸至PTFE护套以外,以便液体流出。此外,热收缩PTFE管在尖头的接合处逐渐变细,有助于插入使用者的目标部位。
[0024]根据本发明之实施例制造的医疗器械包括医疗器械柔性导管,导管内的镍钛合金长条带有远端、近端、从远端延伸至近端的纵轴、从远端延伸而成的尖头,以及在其上刻蚀的凹槽。也可使用其他适用方法制作凹槽,如冲压法。此外,凹槽设置成沿着或平行纵轴。医疗器械柔性导管还包括一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管共同形成导管。医疗器械还包括插入装置,用以将柔性导管的一部分(包括尖头)插入使用者的目标部位,以便导管可将液体输注至目标部位。
[0025]上文已说明了应用于此等医疗器械的柔性导管(例如图1A至8B)。下文将说明集成插入装置的实施例。应注意的是,柔性导管与插入装置合于一体,在使用过程中,柔性导管不可移除、分拆或弃用。
[0026]图9A和9B分别为根据本发明之实施例制造的医疗器械900在配置集成柔性导管之前和之后的简图。医疗器械900包含柔性导管902和插入装置904。插入装置的不同组件(如释放按钮、击针簧、锁栓和导向槽)参见图9A和9B所示)。从图中可以看出,医疗器械柔性导管也可称为柔性套管,其软管可与胰岛素供给源相连。
[0027]医疗器械900可通过按压释放按钮,松开锁栓后启动,也可通过使用机电开关(未显示)自动启动。可向使用者提供以弹簧承载的医疗器械900,参见图9A。器械由锁栓固定在承载位置,使用者可通过按压释放按钮,移开锁栓。医疗器械柔性导管位于与使用者皮肤表面大体平行的凹槽内,尖端弯曲45度,朝向使用者的身体。医疗器械柔性导管通常是直的,但因镍钛合金具有超强柔韧性,故可45度弯曲。在设置角度时,可使用除45度以外的其他角度。
[0028]要使用医疗器械,应除去医疗器械底部的粘合底布(未显示),并将医疗器械应用于(粘附于)使用者的皮肤。由于与其他带自动插入装置的输注系统相比,使用此医疗器械无需熟练技能,且尺寸较小,故而可将其轻松应用于使用者可碰触的任何身体部位,例如臀部上方、手臂背面、体侧、腹部和大腿(后面、前面或侧面)。
[0029]要部署(插入)医疗器械柔性导管,使用者须按压释放按钮,使锁栓移开,令弹簧启动医疗器械。医疗器械柔性套管沿着导向槽,穿过45度弯头,插入使用者的皮肤。使用者可用一根或多根手指、拇指、手掌、手或手臂的任何部位按压器械。启用插入装置几乎无需熟练技能或力量。也可使用机电装置自动启动器械,故使用者不必按压释放按钮。
[0030]图9A和9B所示的医疗器械带有一卷软管,使柔性导管在与胰岛素供给源相连时,可向前移动。也可在医疗器械的背面安放一个可随柔性导管滑动的连接器。在安放之后,管道可通过合适的连接器附着于器械的背面,用以连接胰岛素供给源。
[0031]医疗器械900的水平配置具有诸多优势,其中包括:
·小型化设计十分适合与注射泵集成
·镍钛合金条可扁平制作,减少了制造步骤
·器械设计简单,部件不多
·弹簧设计十分直接,弹簧力度易于调整
·灵活的镍钛合金/聚合物套管(即医疗器械柔性导管)在穿透皮肤时不会弯曲变形,因其全程受到支撑
·器械带有预载弹簧,故而使用者不必为装载弹簧所需的力量而担忧
·由于运转部件体积小巧,器械在使用期间几乎不发出噪音。可在器械中装入阻尼材料,进一步降低噪音
·使用者在注射之前、期间和之后均不会看到针头,故而在心理上更易于接受注射
[0032]图10、11、12和13是根据本发明之实施例制造的医疗器械1000的不同简图。医疗器械1000含有插入装置1002(带有柔性防屈导向槽1004)和集成医疗器械柔性导管1006。图10和图11描绘了在将柔性导管应用于(插入)使用者目标部位之前医疗器械的状态。图12描绘了在应用之后的状态。图13是与医疗器械柔性导管导轨结合使用的柔性防屈导管的横截面简图。
[0033]从图10、11、12和13可以看出,医疗器械1000含有柔性防屈导管导轨1004,用以防止柔性导管1006在插入使用者目标部位时发生弯曲。医疗器械1000的结构为柔性导管全程提供防曲支撑。
[0034]医疗器械柔性防屈导管导轨1004可采用镍钛合金制作,带有凹槽(或轨道),可与柔性导管(示例参见图13)结合使用。在应用之前,应将医疗器械柔性导管置于防屈导管导轨的凹槽内(示例参见图10)。
[0035]在使用期间(以及使用者利用医疗器械底部的粘接层,将医疗器械粘附于身体之后),一旦对医疗器械柔性导管的末端施加插入力,柔性导管将向防屈导轨弯曲,挤压导轨。镍钛合金防屈导轨限制了医疗器械柔性导管弯曲的幅度,从而防止柔性导管发生屈曲。当插入装置闭合时(即通过使用者施力,从图10的位置转变为图11的位置),柔性导管将穿透使用者的皮肤,进入皮下组织(图中未显示)。同时,镍钛合金防屈导轨向上穿入插入装置中的一个凹槽(参见图12的标注),并发生弯曲(参见图12)。由于镍钛合金具有超强柔韧性,它可轻松弯曲,不会发生扭结。
[0036]尽管本公开说明的重点是与胰岛素注射有关的医疗器械和方法,但本发明的实施例也可用于输注其他药物或生物制剂(如DNA或细胞),输送传感器,或提取血液、间隙流体或组织样本。
[0037]从上述说明和讨论中,业内专业人士将认识到,本发明的实施例涵盖将医疗器械柔性导管插入使用者目标部位的各种方法,包括利用带柔性导管和集成插入装置的医疗器械,将器械附着于使用者身体。
[0038]此外,医疗器械柔性导管含有镍钛合金长条,该长条具有远端、近端、从远端延伸至近端的纵轴、从远端延伸而成的尖头,以及在其上刻蚀的凹槽。凹槽设置成沿着或平行纵轴。医疗器械柔性导管还包括一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管共同形成导管。插入装置用于将柔性导管的一部分(包括尖头)插入使用者的目标部位,以便导管可将液体输注至目标部位。此方法还包括将医疗器械柔性导管插入使用者的目标部位。
[0039]在使用医疗器械期间(例如在输注胰岛素期间),医疗器械柔性导管的尖头保留在目标部位,只在从目标部位移除整个柔性导管时,方可移除尖头。由于医疗器械柔性导管具有高柔韧性(例如镍钛合金条和聚合物管),它在插入期间不会引起过度疼痛,使用时不会引起不适。
[0040]尽管本文陈述和说明了本发明优先考虑的实施例,但业内专业人士明白,提供的此等实施例仅为示例。业内专业人士可在不背离本发明的前提下,创造出许多变例、更改和替换。应理解的是,在实施本发明时,可应用本文所说明的本发明之实施例的不同替代例。下列权利要求规定了发明的范围,涵盖了此等权利要求范围内的器械、方法及其等效物。
Claims (2)
1.医疗器械,包括:
一根医疗器械柔性导管,包括:
一根镍钛合金长条,具有:
远端;
近端;
从远端延伸至近端的纵轴;
从远端延伸而成的尖头;以及
在其上形成的凹槽,凹槽设置成沿着纵轴;
一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管形成导管;
一个插入装置,用于将柔性导管的一部分,包括尖头,插入使用者的目标部位,以便导管可将液体输注至目标部位。
2.医疗器械,包括:
一根医疗器械柔性导管,包括:
一根镍钛合金长条,具有:
远端;
近端;
从远端延伸至近端的纵轴;
从远端延伸而成的尖头;以及
在其上形成的凹槽,凹槽设置成与纵轴平行;
一根软管,该软管至少部分包覆远端和近端之间的镍钛合金长条,凹槽和软管形成导管;
一个插入装置,用于将柔性导管的一部分,包括尖头,插入使用者的目标部位,以便导管可将液体输注至目标部位。
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- 2008-10-29 SG SG200808019-4A patent/SG152201A1/en unknown
- 2008-10-30 KR KR1020080106864A patent/KR20090045062A/ko not_active Application Discontinuation
- 2008-10-30 KR KR1020080106865A patent/KR20090045063A/ko not_active Application Discontinuation
- 2008-10-30 CN CNA2008101731193A patent/CN101574554A/zh active Pending
- 2008-10-30 US US12/261,450 patent/US20090112185A1/en not_active Abandoned
- 2008-10-30 JP JP2008280114A patent/JP5301950B2/ja not_active Expired - Fee Related
- 2008-10-31 CN CNA2008101739547A patent/CN101439216A/zh active Pending
- 2008-10-31 US US12/262,302 patent/US20090112180A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108472444B (zh) * | 2016-01-25 | 2021-05-18 | 豪夫迈·罗氏有限公司 | 医疗设备和用于制造的过程 |
US11627897B2 (en) | 2016-01-25 | 2023-04-18 | Roche Diabetes Care, Inc. | Medical device and process for manufacturing |
Also Published As
Publication number | Publication date |
---|---|
AU2008237561A1 (en) | 2009-05-14 |
SG152201A1 (en) | 2009-05-29 |
US20090112185A1 (en) | 2009-04-30 |
KR20090045062A (ko) | 2009-05-07 |
JP5265304B2 (ja) | 2013-08-14 |
US20090112180A1 (en) | 2009-04-30 |
KR20090045063A (ko) | 2009-05-07 |
CA2641699A1 (en) | 2009-04-30 |
AU2008237545A1 (en) | 2009-05-14 |
AU2008237545B2 (en) | 2013-07-11 |
CA2641701A1 (en) | 2009-04-30 |
CN101439216A (zh) | 2009-05-27 |
SG152202A1 (en) | 2009-05-29 |
CA2641701C (en) | 2015-12-08 |
AU2008237561B2 (en) | 2013-07-04 |
JP2009106754A (ja) | 2009-05-21 |
JP2009106758A (ja) | 2009-05-21 |
JP5301950B2 (ja) | 2013-09-25 |
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