CN111372645A - 药物施用器械及药物层的形成方法 - Google Patents
药物施用器械及药物层的形成方法 Download PDFInfo
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Abstract
提供能够将合适的量的药物迅速且容易地配置于医疗器械的表面的药物施用器械及药物层的形成方法。药物施用器械(10),其能够贴附于插入生物体内来使用的球囊(30),所述药物施用器械具有:柔软的片材(11);和药物层(12),其设置于片材(11)的一面。
Description
技术领域
本发明涉及用于将药物配置于球囊等医疗器械的表面的药物施用器械及药物层的形成方法。
背景技术
近年来,为了改善生物体管腔内产生的病变部(狭窄部)而使用球囊导管。球囊导管通常具有长条的轴部和设置于轴部远位侧、可以径向扩张的球囊。通过在使收缩的球囊经由细的生物体管腔到达体内的目标位置后使球囊扩张,从而能够扩开病变部。
然而,若强制性地扩开病变部,则存在平滑肌细胞过度增殖从而在病变部发生新的狭窄(再狭窄)的情况。因此,最近,使用在球囊的表面涂布有用于抑制狭窄的药物的药物洗脱球囊(Drug Eluting Balloon:DEB)。药物洗脱球囊通过扩张来将涂布于表面的药物瞬时释放至病变部,由此,能够抑制再狭窄。
作为在球囊的表面形成药物的层的方法,例如专利文献1中举出了向球囊喷雾含有药物的溶液的方法、浸涂所述溶液的方法、利用刷子涂布所述溶液的方法、利用旋转体涂布所述溶液的方法、利用移液器供给所述溶液的方法等。
专利文献2中,记载了在扩张用球囊与位于扩张用球囊的外侧的药物供给用球囊之间填充有药物的装置。记载了在药物供给用球囊上形成有许多用于释放药物的微细孔,可从外部将药物追加供给至扩张用球囊与药物供给用球囊之间。
现有技术文献
专利文献
专利文献1:美国专利第8597720号说明书
专利文献2:日本特开2010-154919号公报
发明内容
发明所要解决的课题
专利文献1中记载的方法难以将合适的量的药物迅速地配置于球囊的表面。另外,专利文献2中记载的装置虽然能够从外部向球囊供给药物,但由于结构复杂,因此无法容易地将药物配置于球囊。
本发明是为了解决上述课题而完成的,其目的在于,提供能够将合适的量的药物迅速且容易地配置于医疗器械的表面的药物施用器械及药物层的形成方法。
用于解决课题的手段
实现上述目的的本发明涉及的药物施用器械能够贴附于插入生物体内来使用的医疗器械,所述药物施用器械具有:柔软的片材;和药物层,其设置于所述片材的一面。
实现上述目的的本发明涉及的药物层的形成方法用于将药物配置于插入生物体内来使用的医疗器械的表面,所述药物层的形成方法具有下述步骤:将在柔软的片材的一面设置有药物层的药物施用器械的、设置所述药物层的一侧的相反面贴附于所述医疗器械的表面。
发明效果
如上所述地构成的药物施用器械能够通过贴附于医疗器械的表面从而将合适的量的药物层迅速且容易地配置于医疗器械的表面。
所述药物施用器械可还具有粘接层,所述粘接层设置于所述片材的与设置所述药物层的一侧呈相反侧的面。由此,将粘接层粘接至医疗器械的表面,从而能够将药物层有效地配置于医疗器械的表面而不会被剥离。
所述片材为筒状,所述药物层可设置于所述片材的外周面。由此,能够将合适的量的药物层迅速且容易地配置于球囊等筒状的医疗器械的外周面。
所述片材可以是热收缩管。由此,通过将药物施用器械覆盖于医疗器械并进行加热,能够使片材缩径,从而使其与医疗器械密合而进行配置。
所述粘接层可通过加热来发挥粘接力。由此,在加热热收缩管时粘接层也被加热,粘接层发挥粘接力。因此,能够抑制在进行加热前、粘接层粘接至意料之外的位置的情况。因此,能够在将药物层高精度地定位于医疗器械之后,将热收缩管粘接于医疗器械的表面的合适的位置。
所述医疗器械可以是能够扩张及收缩的球囊。由此,能够将合适的量的药物层迅速且容易地配置于球囊的表面。
所述药物层的药物可包含选自由雷帕霉素、紫杉醇、多西他赛、及依维莫司组成的组中的至少一者。由此,能够利用药物层良好地抑制血管内的狭窄部的再狭窄。
所述药物层的药物可包含选自由水不溶性药物、水溶性药物、亲水性聚合物组成的组中的至少一者。由此,可从多种药物中,将符合条件等的合适的药物单独、或组合地应用于药物层。
如上所述地构成的药物层的形成方法能够通过将药物施用器械贴附于医疗器械来将合适的量的药物层迅速且容易地配置于医疗器械的表面。
所述贴附的步骤中,可使在所述片材的设置所述药物层的一侧的相反面上设置的粘接层与所述医疗器械的表面粘接。由此,将粘接层粘接至医疗器械的表面,从而能够将药物层有效地配置于医疗器械的表面而不会被剥离。
所述贴附的步骤中,可将所述药物施用器械贴附于从生物体内拔除后的医疗器械。由此,能够在将在生物体内使用的医疗器械从生物体内拔除后,将药物层配置于相同的医疗器械从而再次利用。
所述医疗器械可以是能够扩张及收缩的球囊、导丝、导引鞘、导引导管或支架。由此,能够将合适的量的药物层迅速且容易地配置于球囊、导丝、导引鞘、导引导管或支架的表面。医疗器械为球囊时,能够将合适的量的药物层迅速且容易地配置于球囊的表面。由此,能够在将用于生物体内的目标部位的前扩张(预扩张)的球囊拔除后,将药物层配置于相同的球囊,再次用于目标部位的后(post)扩张。
附图说明
[图1]为示出第一实施方式涉及的药物施用器械的立体图。
[图2]为药物施用器械的剖视图。
[图3]为示出球囊导管的主视图。
[图4]为示出球囊导管的远位部的主视图。
[图5]为沿图4的A-A线的剖视图。
[图6]为示出将药物施用器械贴附于球囊的状态的立体图。
[图7]为示出贴附了药物施用器械的球囊的剖视图。
[图8]为示出第二实施方式涉及的药物施用器械的立体图。
[图9]为沿图8的B-B线的剖视图。
[图10]为示出将药物施用器械覆盖于球囊后的状态的主视图。
[图11]为沿图10的C-C线的剖视图。
[图12]为示出贴附了药物施用器械的球囊的主视图。
[图13]为沿图12的D-D线的剖视图。
[图14]为示出贴附了第三实施方式涉及的药物施用器械的球囊的主视图。
[图15]为示出药物施用器械的第一变形例的剖视图。
[图16]为示出药物施用器械变形例的主视图,(A)示出第二变形例、(B)示出第三变形例。
具体实施方式
以下,参照附图来说明本发明的实施方式。需要说明的是,根据说明的需要,附图的尺寸比率有时被夸大而与实际比率不同。
<第一实施方式>
如图1、2所示,本发明的第一实施方式涉及的药物施用器械10是用于下述用途的装置:将药物的层配置于用于插入血管等生物体管腔的狭窄部并进行扩开的球囊30(参见图3)的表面,制成药物洗脱型的球囊。需要说明的是,利用药物施用器械10配置药物的层的医疗器械不限于球囊30,也可以是例如导丝、导引鞘、导引导管、支架等。以下,示例利用药物施用器械10将药物的层配置于球囊30的情况。
药物施用器械10具有柔软的片材11、包含药物的药物层12、和具有粘接力的粘接层13。
片材11是柔软且薄的膜状的部件。片材11优选较薄以使得能与球囊30一同折叠。片材11的厚度为例如1~250μm,优选为5~100μm,更优选为10~50μm。片材11可形成有用于将球囊30折叠的、经过赋形而形成的凹部及/或凸部。赋形可通过在使力发挥作用而变形为规定的形状的状态下进行加热而实现。凹部及/或凸部具有在将药物施用器械10贴附于从折叠的状态(参见图5)扩张的球囊30后,辅助球囊30恢复为折叠的状态(重新卷起,rewrap)的功能。
片材11的构成材料为例如聚烯烃、聚氯乙烯、聚苯乙烯、聚乙烯、聚丙烯、聚对苯二甲酸乙二醇酯、氟系聚合物、热塑性弹性体、无纺布等。
药物层12设置于片材11的一面。药物层12中所含的药物可以是水溶性药物,也可以是水不溶性药物。水不溶性药物是指不溶于水或难溶于水的药物,具体而言,在水中的溶解度小于1mg/mL,进而可小于0.1mg/mL。水不溶性药物包含脂溶性药物。药物层12中所含的药物量没有特别限定,以0.1~10μg/mm2的密度被包含,优选以0.5~5μg/mm2的密度、更优选以0.5~3.5μg/mm2的密度被包含。药物层12的厚度没有特别限定,为0.1~100μm,优选为0.5~50μm,更优选为0.5~10μm或10~30μm。水不溶性或水溶性药物的形态没有特别限定,可以是例如晶体,也可以不是晶体。
几种优选的水不溶性药物的例子包括免疫抑制剂(例如包括环孢菌素在内的环孢菌素类)、雷帕霉素等免疫活性剂、紫杉醇等抗癌剂、抗病毒剂或抗菌剂、抗新生组织剂、镇痛剂及抗炎剂、抗生素、抗癫痫剂、抗焦虑剂、抗麻痹剂、拮抗剂、神经元阻断剂、抗碱胆能剂及碱胆能剂、抗蕈毒碱剂及蕈毒碱剂、抗肾上腺素能剂、抗心率失常剂、抗高血压剂、激素剂以及营养剂。
水不溶性药物优选为选自由雷帕霉素、紫杉醇、多西他赛、依维莫司组成的组中的至少一者。本说明书中,所谓雷帕霉素、紫杉醇、多西他赛、依维莫司,只要具有同样的药效,则包含它们的类似物及/或它们的衍生物。例如,紫杉醇和多西他赛为类似物的关系。雷帕霉素和依维莫司为衍生物的关系。上述药物中,更优选紫杉醇。
就水溶性药物而言,是在水中的溶解度为1mg/mL以上、优选5mg/mL以上、更优选10mg/mL以上、进一步优选33mg/mL以上的药物即可。作为水溶性的抗血小板药,有氯吡格雷硫酸盐、噻氯匹定盐酸盐、普拉格雷盐酸盐、沙格雷酯盐酸盐等(需要说明的是,水不溶性的抗血小板药有阿斯匹林、西洛他唑、替卡格雷等)。作为水溶性的血液凝固阻止剂,可举出华法林、伊多塞班对甲苯磺酸盐水合物、肝素、达比加群酯甲磺酸盐等。药物还可以是亲水性聚合物,从而能够利用亲水性聚合物进行湿润涂覆(被水润湿后发挥润滑性的涂覆)。药物不限于应用于球囊导管的表面(内外表面),也可作为亲水性聚合物而应用于插入血管内的医疗器具(例如,导丝、导引鞘、导引导管等)的表面(内外表面)。
药物层12可包含添加剂(赋形剂)。药物层12中包含添加剂的情况下,添加剂包括例如水溶性的低分子化合物。水溶性的低分子化合物的分子量为50~2000,优选为50~1000,更优选为50~500,进一步优选为50~200。相对于水不溶性药物100质量份而言,水溶性的低分子化合物优选为10~5000质量份,更优选为50~3000质量份,进一步优选为100~1000质量份。水溶性的低分子化合物的构成材料可使用丝氨酸乙酯、葡萄糖等糖类、山梨糖醇等糖醇、柠檬酸酯、聚山梨醇酯、聚乙二醇、脲、水溶性聚合物、造影剂、氨基酸酯、短链单羧酸的甘油酯、作为药物被允许的盐及表面活性剂等、或者这些材料中的两种以上的混合物等。水溶性的低分子化合物的特征在于具有亲水基团和疏水基团,溶解于水。水溶性的低分子化合物优选为非溶胀性或难溶胀性。包含水溶性的低分子化合物的添加剂具有在片材11的表面上使水不溶性药物均匀地分散的效果。添加剂优选不是水凝胶。添加剂通过包含低分子化合物,从而在与水溶液接触后不发生溶胀而迅速溶解。此外,在血管内的球囊30的扩张时,添加剂变得容易溶解从而容易释放球囊30的表面上的水不溶性药物的晶体粒子,具有增加药物的晶体粒子对于血管的附着量的效果。
水溶性低分子化合物优选分子量为50~2000,且以1mg/mL以上溶解于水中,优选以5mg/mL以上溶解于水中,进一步优选以10mg/mL以上溶解于水中,进一步优选以33mg/mL以上溶解于水中,并优选不溶胀地溶解于水中。水溶性低分子化合物优选不是水凝胶。水溶性低分子化合物优选不是聚合物,进一步优选不是水不溶性聚合物。水溶性低分子化合物优选不是聚乙二醇(PEG)及水溶性PEG(例如,聚乙二醇200-600)。
物质的溶解性可根据于20℃在30分钟以内溶解的程度定义。例如,物质的溶解性可根据溶解溶质1g(或1mL)所需要的溶剂量(水的量)定义。溶解溶质1g所需要的溶剂量小于1mL的情况下,溶质极易溶解于溶剂中。这种情况下,溶解量大于1000mg/mL。这样的物质可举出例如山梨糖醇、脲、甘油。溶解溶质1g所需要的溶剂量为1mL以上且小于10mL的情况下,溶质容易溶解于溶剂中。这种情况下,溶解量大于100mg/mL且为1000mg/mL以下。这样的物质可举出例如聚山梨醇酯、氨基酸酯、聚乙二醇200-600、丝氨酸乙酯、造影剂(碘普罗胺)、水溶性聚合物。溶解溶质1g所需要的溶剂量为10mL以上且小于30mL的情况下,溶质稍稍易溶解于溶剂中。这种情况下,溶解量大于33mg/mL且为100mg/mL以下。这样的物质可举出例如聚乙二醇。溶解溶质1g所需要的溶剂量为30mL以上且小于100mL的情况下,溶质稍稍难溶解于溶剂中。这种情况下,溶解量大于10mg/mL且为33mg/mL以下。溶解溶质1g所需要的溶剂量为100mL以上且小于1000mL的情况下,溶质难以溶解于溶剂中。这种情况下,溶解量大于1mg/mL且为10mg/mL以下。溶解溶质1g所需要的溶剂量为1000mL以上且小于10000mL的情况下,溶质极难溶解于溶剂中。这种情况下,溶解量大于0.1mg/mL且为1mg/mL以下。溶解溶质1g所需要的溶剂量为10000mL以上的情况下,溶质几乎不溶解于溶剂中。这种情况下,溶解量为0.1mg/mL以下。这样的物质可举出例如甘油的脂肪酸酯。所谓水溶性,是指“极难溶解”及“几乎不溶解”的物质以外的物质。水溶性具体指“极易溶解”、“容易溶解”、“稍稍难溶解”、及“难以溶解”的物质。水溶性优选指“极易溶解”、“容易溶解”及“稍稍难溶解”的物质。
粘接层13设置于片材11的与设置药物层12的一侧呈相反侧的面。粘接层13是与球囊30的表面粘接的层。粘接层13的厚度没有特别限定,为0.01~50μm,优选为0.1~30μm,更优选为0.1~5μm。
构成粘接层13的材料可以为水溶性,也可以为水不溶性。水溶性的粘接剂为例如氯乙烯树脂系粘接剂、乙酸乙烯酯共聚树脂系粘接剂、EVA树脂系粘接剂、丙烯酸树脂系粘接剂、丙烯酸酯系粘接剂、苯乙烯·丁二烯共聚物乳胶、水性氨基甲酸酯系粘接剂等。粘接层13为例如通过按压来进行粘接的压敏粘接剂。压敏粘接剂为例如天然橡胶乳胶系粘接剂、有机硅压敏粘接剂、MG乳胶系粘接剂、丙烯酸系粘接剂、二氧化硅系粘接剂等。
药物施用器械10优选具有能覆盖球囊30的配置药物的范围的大小。例如,将药物配置于球囊30的平直部31的情况下,药物施用器械10优选具有能覆盖平直部31的大小。
接下来,参照图3~5对使用药物施用器械10配置药物的球囊导管50进行说明。需要说明的是,本说明书中,将球囊导管50的插入生物体管腔的一侧称为“远位侧”,将进行操作的手头侧称为“近位侧”。
球囊导管50具有长条的轴部20、设置于轴部20的远位部的球囊30、和固定于轴部20的近位端的毂部26。
轴部20具有作为远位端及近位端开口的管体的外管21、和作为配置在外管21的内部的管体的内管22。内管22被收纳于外管21的中空内部,轴部20在远位部处成为双层管结构。内管22的中空内部为供导丝穿插的导丝腔24。另外,在外管21的中空内部、且于内管22的外侧形成供球囊30的扩张用流体流通的扩张内腔23。内管22在侧面开口部25处向外部开口。内管22突出至较之外管21的远位端而言更靠近远位侧。在内管22的远位部,可设有作为其它部件的前端尖端。
球囊30(医疗器械)具有形成于轴心方向上的中央部的平直部31、位于平直部31的近位侧的近位锥部32、和位于平直部31的远位侧的远位锥部33。平直部31在被扩张时呈外径大致相等的圆筒状。近位锥部32的外径从平直部31朝向近位侧缓缓减小。远位锥部33的外径从平直部31朝向远位侧缓缓减小。
平直部31是可利用药物施用器械10配置药物的部位。需要说明的是,可利用药物施用器械10配置药物的范围不限于仅平直部31,可除了平直部31之外还包含近位锥部32、远位锥部33的至少一部分。或者,可利用药物施用器械10配置药物的范围也可以仅是平直部31的一部分。
就球囊30而言,位于近位锥部32的近位端的球囊熔接部34熔接于外管21的远位部。另外,就球囊30而言,位于远位锥部33的远位端的球囊熔接部35熔接于内管22的远位部。需要说明的是,将球囊30固定于外管21及内管22的方法不限于熔接,也可进行例如粘接。由此,球囊30的内部与扩张内腔23连通。通过介由扩张内腔23向球囊30注入扩张用流体,从而能够使球囊30扩张。扩张用流体可以是气体也可以是液体,可使用例如氦气、CO2气体、O2气体、N2气体、Ar气体、空气、混合气体等气体、生理盐水、造影剂等液体。
球囊30具有以向径向突出的方式进行赋形而形成的多个翼片部37。翼片部37能够沿周向倒下而进行折叠。翼片部37是利用沿球囊30的大致轴心方向延伸的折痕形成的。翼片部37的长轴方向的长度不大于球囊30的长度。翼片部37的数量没有特别限定,为例如1~7片,本实施方式中为3片。多个翼片部37优选沿球囊30的周向均匀地配置,但不限于此。
球囊30在轴心方向上的长度没有特别限定,优选为5~500mm,更优选为10~300mm,进一步优选为20~200mm。球囊30的扩张时的外径没有特别限定,优选为1~10mm,更优选为2~8mm。
就球囊30而言,优选为:具有一定程度的柔软性,并且具有一定程度的硬度以使其能在到达血管、组织等时被扩张、并释放其表面所具有的药物。具体而言,可以由金属、树脂构成。优选的是,球囊30的至少表面由树脂构成。球囊30的至少表面的构成材料可以使用例如聚乙烯、聚丙烯、聚丁烯、乙烯-丙烯共聚物、乙烯-乙酸乙烯酯共聚物、离聚物或这些材料中的两种以上的混合物等聚烯烃、软质聚氯乙烯树脂、聚酰胺、聚酰胺弹性体、尼龙弹性体、聚酯、聚酯弹性体、聚氨酯、氟树脂等热塑性树脂、有机硅橡胶、胶乳橡胶等。其中,可优选地举出聚酰胺类。
毂部26形成有近位开口部27,所述近位开口部27与外管21的扩张内腔23连通从而作为使扩张用流体流入流出的端口发挥功能。
接下来,对本实施方式涉及的药物施用器械10的作用进行说明。
利用药物施用器械10将药物配置于球囊30时,经由毂部26的近位开口部27,使用充压装置(indeflator)或注射器等注入规定量的扩张用流体,通过扩张内腔23将扩张用流体送入球囊30的内部。由此,被折叠的球囊30扩张。然后,如图6、7所示,将药物施用器械10的粘接层13按压至扩张的球囊30的平直部31。由此,使粘接层13与平直部31粘接。药物施用器械10比平直部31更大的情况下,可切割为合适的大小。
然后,从球囊30的内部经由毂部26的近位开口部27抽吸并排出扩张用流体。由此,使球囊30收缩而成为折叠状态。由此,可将球囊30作为药物洗脱型的球囊而用于血管等生物体管腔内的狭窄部的扩张。
如上所述,本实施方式涉及的药物施用器械10能够贴附于插入生物体内来使用的球囊30(医疗器械),所述药物施用器械10具有柔软的片材11、和设置于片材11的一面的药物层12。
如上所述地构成的药物施用器械10能够通过贴附于球囊30的表面来将合适的量的药物层12迅速且容易地配置于球囊30的表面。由于药物施用器械10能够将药物层12迅速且容易地配置于球囊30,因此,能够不对使用的场所进行选择地,例如在临床现场覆盖于使用后的球囊30而进行使用。因此,例如,可应用于在狭窄部的前扩张(预扩张)中使用并从生物体拔除后的球囊30,从而制成具有药物层12的用于后(post)扩张的球囊30。因此,需要用于前扩张的球囊和用于后扩张的球囊时,能够使用1个球囊30来发挥2种作用。另外,也可从例如大小、药物的种类、药物的量等不同的多种药物施用器械10中适当选择并使用合适的药物施用器械10。另外,药物施用器械10为片状,因此也可在例如临床现场,从较大的药物施用器械10中配合球囊30的直径、长度切出合适的大小而使用。
药物施用器械10还具有粘接层13,所述粘接层13设置于片材11的与设置药物层12的一侧呈相反侧的面。由此,将粘接层13粘接至球囊30的表面,从而能够将合适的量的药物层12有效地配置于球囊30的表面而不会被剥离。
另外,粘接层13可以为水溶性。由此,粘接层13由于球囊30含有水分而发挥良好的粘接性。因此,也可在将药物施用器械10覆盖于球囊30前,润湿球囊30的表面。另外,如果是在前扩张后从生物体拔除后的球囊30,则很可能含有水分,粘接性提高。
药物层12的水不溶性药物含有选自由雷帕霉素、紫杉醇、多西他赛、及依维莫司组成的组中的至少一者。由此,利用药物层12,能够良好地抑制血管内的狭窄部的再狭窄。
药物层12的药物可包含选自由水不溶性药物、水溶性药物、亲水性聚合物组成的组中的至少一者。由此,可从多种药物中,将符合条件等的合适的药物单独、或组合地应用于药物层12。
贴附药物施用器械10的医疗器械是能够扩张及收缩的球囊30。因此,能够将药物层12迅速且容易地配置于球囊30的表面。
另外,本发明也包含用于将药物配置于球囊30的表面的药物层的形成方法。该药物层的形成方法用于将药物配置于插入生物体内来使用的球囊30(医疗器械)的表面,所述药物层的形成方法具有下述步骤:将在柔软的片材11的一面设置有药物层12的药物施用器械10的、设置药物层12的一侧的相反面贴附于球囊30的表面。
如上所述地构成的药物层的形成方法能够通过将药物施用器械10贴附于球囊30来将合适的量的药物迅速且容易地配置于球囊30的表面。
所述贴附的步骤中,可使在片材11的设置药物层12的一侧的相反面上设置的粘接层13与球囊30的表面粘接。由此,将粘接层13粘接至球囊30的表面,从而能够将药物层12有效地配置于球囊30的表面而不会被剥离。
所述贴附的步骤中,可将药物施用器械10贴附于从生物体内拔除后的球囊30。由此,能够在将在生物体内使用的球囊30从生物体内拔除后,将药物层12配置于相同的球囊30从而再次利用。
供药物施用器械10贴附的医疗器械是能够扩张及收缩的球囊30。由此,能够将合适的量的药物层12迅速且容易地配置于球囊30的表面。另外,能够在将用于生物体内的目标部位的前扩张(预扩张)的球囊30拔除后,将药物层12配置于相同的球囊30,再次用于目标部位的后(post)扩张。
<第二实施方式>
如图8、9所示,本发明的第二实施方式涉及的药物施用器械60在为筒状的方面与第一实施方式不同。需要说明的是,对具有与第一实施方式相同的功能的部位标注相同的标记,并省略说明。
药物施用器械60具有通过加热而收缩的热收缩管61(片材)、包含药物的药物层12、和具有粘接力的粘接层13。药物层12设置于热收缩管61的外周面。粘接层13设置于热收缩管61的内周面。
作为片材的热收缩管61是通过加热而缩径的管。热收缩管61具有能维持贯通孔62的强度。需要说明的是,热收缩管61可以是筒状的膜。筒状的膜柔软且较薄,因此,并不仅具有能维持贯通孔62的强度,还可变形为平板状以使贯通孔62闭合。
热收缩管61的构成材料只要通过加热而缩径则没有限定,优选为在内周面能包覆药物的材料。热收缩管61优选于温度较低的加热温度进行收缩。热收缩管61收缩的温度为例如40~150℃,优选为40~100℃。通过使热收缩管61于较低的温度进行收缩,能够抑制药物的变质、球囊30的变形等。热收缩管61的内径的收缩率(收缩后的内径/收缩前的内径)没有特别限定,优选为40~80%。热收缩管61可形成有用于将球囊30折叠的经过赋形而形成的凹部及/或凸部。赋形可通过在使力发挥作用而变形为规定的形状的状态下进行加热而实现。凹部及/或凸部具有在将药物施用器械60贴附于扩张的球囊30后,辅助球囊30恢复为折叠的状态(重新卷起,rewrap)的功能。
管状的热收缩管61的构成材料为例如聚烯烃、氟系聚合物、聚氯乙烯、热塑性弹性体等。
为筒状的膜的情况下的热收缩管61的构成材料为例如聚烯烃、聚氯乙烯、聚苯乙烯、聚乙烯、聚丙烯、聚对苯二甲酸乙二醇酯等。
构成粘接层13的材料可以是通过升温至对片材11进行加热的温度来发挥粘接力的材料。通过加热来发挥粘接力的材料为例如苯乙烯-丁二烯橡胶系粘接剂、聚(丙交酯-共-乙交酯)共聚物、聚己内酯等聚合物、聚乙二醇、聚氧乙烯脂肪酸二酯、聚氧乙烯脂肪酸单酯、聚氧乙烯聚氧丙烯嵌段聚合物等表面活性剂、作为医疗用粘接剂使用的α-氰基丙烯酸酯系粘接剂、血纤维蛋白系粘接剂等。
药物施用器械60将扩张的状态的球囊30收容于内部而进行使用。因此,药物施用器械60的内径优选为扩张的球囊30的外径以上。
药物施用器械60的轴向的长度优选在加热并进行收缩时为球囊30的供药物配置的范围的轴向的长度以上。本实施方式中,药物施用器械60的轴向的长度大于平直部31的长度。
接下来,对第二实施方式涉及的药物施用器械60的作用进行说明。
利用药物施用器械60将药物配置于球囊30时,经由毂部26的近位开口部27,使用充压装置(indeflator)或注射器等注入规定量的扩张用流体,通过扩张内腔23将扩张用流体送入球囊30的内部。由此,如图10、11所示,被折叠的球囊30扩张。然后,将球囊30插入药物施用器械60的贯通孔62。需要说明的是,也可在将球囊30插入贯通孔62后使球囊30扩张。
然后,利用通过使电流流动来供给热风的吹风机、烘箱等,将药物施用器械60加热至热收缩管61收缩的温度。由此,如图12、13所示,热收缩管11缩径,粘接层13与球囊30密合。由此,使粘接层13与球囊30的表面粘接。粘接层13为通过加热来发挥粘接力的粘接剂的情况下,在将热收缩管61加热时粘接层13也被加热,使粘接层13与球囊30的表面粘接。若收缩的药物施用器械60的轴向的长度大于平直部31的长度,则收缩的药物施用器械60能够覆盖平直部31整体。并且,收缩的药物施用器械60的远位端可覆盖远位锥部33的近位部,收缩的药物施用器械60的近位端可覆盖近位锥部32的远位部。由此,药物施用器械60的两端的直径热收缩至比覆盖平直部31的部位更小。由此,药物施用器械60不易从球囊30脱离,被牢固地固定。需要说明的是,收缩的药物施用器械60的远位端也可不覆盖远位锥部33的近位部。另外,收缩的药物施用器械60的近位端也可不覆盖近位锥部32的远位部。
然后,从球囊30的内部经由毂部26的近位开口部27抽吸并排出扩张用流体。由此,使球囊30收缩而成为折叠状态。由此,可将球囊30作为药物洗脱型的球囊而用于血管等生物体管腔内的狭窄部的扩张。
如上所述,第二实施方式中的片材为筒状,药物层12设置于片材的外周面。由此,能够将合适的量的药物层12迅速且容易地配置于球囊30等筒状的医疗器械的外周面。
另外,药物施用器械60的片材为热收缩管61。由此,通过将药物施用器械60覆盖于球囊30并进行加热,能够使作为片材的热收缩管61缩径,从而使其与球囊30密合。
粘接层13可通过加热来发挥粘接力。由此,在将热收缩管61加热时粘接层13也被加热,粘接层13发挥粘接力。因此,能够抑制在进行加热前、粘接层13粘接至意料之外的位置的情况。因此,能够在将药物层13高精度地定位于球囊30后,将热收缩管61粘接于球囊30的表面的合适的位置。
<第三实施方式>
如图14所示,本发明的第三实施方式涉及的药物施用器械70在为带状的长条的带(tape)状的方面与第一实施方式不同。需要说明的是,对具有与第一实施方式相同的功能的部位标注相同的标记,并省略说明。药物施用器械70的形状以外的结构(片材11、药物层12、粘接层13)与第一实施方式相同。
使用药物施用器械70时,将药物施用器械70切成符合球囊30的大小的长度,螺旋状地卷绕于扩张后的球囊30,使粘接层13与球囊30粘接。由此,能够将合适的大小的药物层12容易地配置于任意大小的球囊30。
需要说明的是,本发明不限于上述实施方式,本领域技术人员可以在本发明的技术构思的范围内进行各种变更。例如,球囊导管50为快速交换型(Rapid exchange type),也可以是整体交换型(Over-the-wire type)。
另外,利用药物施用器械10、60、70配置药物层12的对象只要是插入生物体内来使用的医疗器械即可,不限于球囊30,可以是例如支架、覆膜支架(covered stent)、植入物等。
另外,只要能将药物施用器械贴附于球囊30的表面,则也可不设置粘接层。这种情况下,在将药物施用器械贴附于球囊30时,使粘接剂附着于药物施用器械的进行粘接的面或球囊30的表面。粘接剂没有特别限定,优选液体粘接剂,有例如氰基丙烯酸酯系的瞬间粘接剂、血纤维蛋白粘接剂、淀粉系粘接剂、天然橡胶系粘接剂、纤维素系粘接剂、聚酰胺系粘接剂等。由此,即使不预先在药物施用器械上设置粘接层,也仍然能够将药物施用器械粘接于球囊30的表面。
另外,也可如图15所示的第一变形例那样,在粘接层13上贴附有能从粘接层13剥离的保护膜17。由此,能够抑制污物等附着于使用前的粘接层13。保护膜17可在将粘接层13粘接至球囊30前容易地剥离。另外,可在药物层12上贴附有覆盖药物层12的药物保护膜18。药物保护膜18以能够剥离的方式贴附于药物层12。或者,药物保护膜18也可以是水溶性膜。这种情况下,将粘接层13粘接至球囊30后,能够在不从药物层12除去药物保护膜18的情况下将球囊30插入血管内。贴附有搭载了药物保护膜18的药物转印装置的球囊导管50在向血管内插入时能够抑制药物的脱离。药物保护膜18的构成材料为例如明胶膜、胶原蛋白膜、淀粉膜等。药物保护膜18可介由具有生物相容性的粘接剂而贴附于药物层12。具有生物相容性的粘接剂为例如氰基丙烯酸酯系、明胶系、血纤维蛋白系等的粘接剂。
另外,药物层12也可如图16中的(A)所示的第二变形例那样局部地配置于片材11(或热收缩管61)的面。需要说明的是,设置药物层12的范围的形状没有特别限定。因此,药物施用器械10、60、70可任意地设定设置药物层12的范围。
另外,药物施用器械10、60、70也可如图16中的(B)所示的第三变形例那样具有多个孔16。孔16的数量、形状没有特别限定。
需要说明的是,本申请以于2017年11月22提出申请的日本专利申请号2017-224338号为基础,将其公开内容整体并入本文作为参照。
附图标记说明
10、60、70 药物施用器械
11 片材
12 药物层
13 粘接层
14 贯通孔
30 球囊(医疗器械)
61 热收缩管(片材)
Claims (11)
1.药物施用器械,其能够贴附于插入生物体内来使用的医疗器械,所述药物施用器械具有:
柔软的片材;和
药物层,其设置于所述片材的一面。
2.如权利要求1所述的药物施用器械,其还具有粘接层,所述粘接层设置于所述片材的与设置所述药物层的一侧呈相反侧的面。
3.如权利要求1或2所述的药物施用器械,其中,所述片材为筒状,所述药物层设置于所述片材的外周面。
4.如权利要求1~3中任一项所述的药物施用器械,其中,所述片材为热收缩管。
5.如权利要求1~4中任一项所述的药物施用器械,其中,所述粘接层通过加热来发挥粘接力。
6.如权利要求1~5中任一项所述的药物施用器械,其中,所述医疗器械为能够扩张及收缩的球囊。
7.如权利要求1~6中任一项所述的药物施用器械,其中,所述药物层的药物含有选自由水不溶性药物、水溶性药物、亲水性聚合物组成的组中的至少一者。
8.药物层的形成方法,其用于将药物配置于插入生物体内来使用的医疗器械的表面,所述药物层的形成方法具有下述步骤:
将在柔软的片材的一面设置有药物层的药物施用器械的、设置所述药物层的一侧的相反面贴附于所述医疗器械的表面。
9.如权利要求8所述的药物层的形成方法,其中,所述贴附的步骤中,使在所述片材的设置所述药物层的一侧的相反面上设置的粘接层与所述医疗器械的表面粘接。
10.如权利要求8或9所述的药物层的形成方法,其中,所述贴附的步骤中,将所述药物施用器械贴附于从生物体内拔除后的医疗器械。
11.如权利要求8~10中任一项所述的药物层的形成方法,其中,所述医疗器械为能够扩张及收缩的球囊、导丝、导引鞘、导引导管或支架。
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PCT/JP2018/043180 WO2019103098A1 (ja) | 2017-11-22 | 2018-11-22 | 薬剤付与器具および薬剤層の形成方法 |
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CN114949551A (zh) * | 2021-06-01 | 2022-08-30 | 深圳市本尚医疗科技有限公司 | 多孔球囊导管系统及其使用方法 |
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