CN1479588A - 微刀片阵列的冲击式敷贴器 - Google Patents
微刀片阵列的冲击式敷贴器 Download PDFInfo
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Abstract
一种敷贴器装置(10)设置用于施加具有微凸起阵列(90)的贴(44)到角质层上。敷贴器装置(10)包括装置主体(12)和在装置主体(12)内可运动的活塞。盖件(16)设置在装置主体(12)上以便用微凸起阵列(44,90)冲击角质层。装置(10)可以由手上无力并缺乏灵活性击发其他类型敷贴器装置的患者使用。
Description
技术领域
本发明涉及一种用于通过冲击将刺入构件施加到皮肤角质层的装置和方法,并且本发明尤其涉及一种使用例如微凸起阵列的刺入构件重复刺入角质层以便通过皮肤输送或采样介质。
背景技术
随着可以在市场上得到大量和纯态的医用肽和蛋白质,对于肽和蛋白质通过皮肤输送到人体的兴趣日益增长。通过皮肤输送肽和蛋白质面临很大的问题。在许多场合,由于多肽大尺寸和分子重量,通过皮肤输送多肽的速度和流量不足以产生所需治疗效果。另外,多肽和蛋白质在到达目标细胞之前容易在刺入皮肤期间和之后降级。同样,许多低分子重量的化合物的被动通过皮肤的流量过于受到限制从而不能达到治疗效果。
一种增加通过皮肤输送介质的方法倚靠使用皮肤刺入增强器对于皮肤预处理或与有益介质一起输送。刺入增强器物质在施加到输送介质的身体表面时例如通过增加身体表面的选择刺入性和/或刺入性来增强介质的通过皮肤的流量和/或降低介质的降级。
增加介质流量的另一方法涉及在身体表面上施加电流并称之为“电迁移”。“电迁移”通常指的是有例如药物或药引的有益介质通过例如皮肤、黏膜、指甲和类似物。通过施加电位引起或增强介质输送,该电位由施加电流产生并用于输送或增强介质的输送。电迁移输送增强介质的输送并降低通过皮肤输送期间的多肽的降级。
已经有许多尝试以便机械地刺入或穿过皮肤从而增加通过皮肤的流量。参考例如授予Godshall等人的US 5,879,326,授予Ganderton等人的US 5,814,097,授予Gross等人的US 5,279,544,授予Lee等人的US 5,250,023,授予Gerstel等人的US 3,964,482,授予Kravitz等人的Reissue25,637,和PCT公开号WO 96/37155,WO 96/37256,WO96/17648,WO 97/03718,WO 98/11937,WO 98/00193,WO 97/48440,WO97/48441,W O97/48442,WO 98/00193,WO 99/64580,WO 98 28037,WO98/29298,WO 98/29365。这些装置使用不同形状和尺寸的穿刺元件刺透皮肤的最外层(即,角质层)。这些参考文件所披露的刺入元件通常从例如垫或片的薄的平构件垂直延伸。某些这种装置的刺入元件极小,有些具有只有大约25~400μm的尺寸(微刀片长度和宽度)以及大约5~500μm的微刀片厚度。其他刺入元件是具有大约10μm或更小直径以及大约50~100μm长度的中空针。这些小的角质层穿刺/切割元件意欲在角质层内形成相应小的微切口/微裂口以便增强介质通过皮肤通过其中。在许多场合,角质层内的微切口/微裂口具有小于150μm的长度和显著小于其长度的宽度。
皮肤刺入装置用来以多个微凸起刺入皮肤的最外层(角质层)以便形成通路,通过该通路引入(输送)例如药物的介质或抽出例如身体分析物的介质(采样)。穿孔皮肤对于通过皮肤持续输送介质或采样提供改善的流量。
当微凸起阵列用来改善通过皮肤输送或采样介质时,需要连续、完整和可重复的刺入。用手施加具有从其接触皮肤侧突出的微凸起的皮肤贴经常导致在该贴的长度和宽度上穿刺深度的显著变化。另外,由于使用者施加阵列的方式,用手施加导致施加之间的穿刺深度的很大变化。因此,希望使用自动装置以连续和可重复的方式将微凸起阵列施加到角质层上,角质层不仅在微凸起阵列的长度和宽度上进行穿刺而且在施加一个微凸起到另一个穿刺。
在WO 99/26539和WO 97/42886中描述用于输送用于采样体液(例如血液)的小刀的已知弹簧加载敷贴器装置。然而,这些装置由于其需要在施加之前两手击发敷贴器装置所以难以使用。特别是,已知弹簧加载的小刀敷贴器需要该装置的的两个部段拉开以便击发或需要该装置的一部分相对于该装置的另一部分扭转以便击发。在两种运动中,需要两手击发操作。许多使用这些装置的患者不具有力量或手的灵活性击发这些已知的敷贴器装置。
因此,需要提供一种用于皮肤刺入构件的弹簧加载敷贴器,它可通过使用者单手操作并需要最小的手击发力。
发明内容
本发明涉及一种使用冲击施加刺入构件到角质层的敷贴器。该刺入构件可以是用来改善介质通过皮肤输送的微凸起阵列。该敷贴器包括允许单手击发操作的击发机构。由于该击发力可由使用者手臂来施加,该击发机构需要最小的手的力量和灵活性。
按照本发明的一个方面,用于将刺入构件压靠角质层的装置包括施加刺入构件到角质层上的装置主体,安装在该装置主体内以便将刺入构件压靠角质层的活塞,位于该活塞和装置主体之间以便对活塞提供冲击力的冲击弹簧以及用于通过使用容易由单手实施的压缩力将该装置主体和活塞一起压缩在击发位置以便击发和锁定活塞的击发机构。
按照本发明的另一方面,用于冲击微刀片阵列压靠角质层的装置包括装置主体,安装在该装置主体内的活塞,该活塞具有微刀片阵列施加表面,位于该装置主体和该活塞之间以便用该微刀片冲击角质层的冲击活塞,可运动地安装在该装置主体上的盖件,作用在该装置主体和该盖件之间的压紧弹簧,用于通过使用单手将该装置主体和活塞一起压缩在击发位置以便击发和锁定活塞的击发机构,以及用于从该击发位置松开该活塞以便当压紧弹簧压缩时用微刀片阵列冲击角质层的活塞松开装置。
按照本发明的又一方面,击发用于冲击刺入构件压靠角质层的装置的方法包括以下步骤,即通过只用单手一起压缩活塞和装置主体将活塞相对于装置主体运动到击发位置并用单手将活塞锁定在该击发位置上的步骤。
按照本发明的另一方面,冲击刺入构件压靠角质层的方法包括设置具有装置主体、活塞和冲击弹簧的刺入构件;只使用单手运动活塞相对于装置主体到击发位置并在击发位置锁定活塞来击发冲击装置;将刺入构件安装在活塞上并松开活塞以便冲击刺入构件压靠角质层。
附图说明
本发明现在将壳体附图中所示的优选实施例进行更详细描述,其中相同元件具有相同的参考标号,并且附图中:
图1是在击发之前处于初始构形的敷贴器装置的侧截面图;
图2是在击发位置上图1敷贴器装置的侧截面图,其中贴保持件连接在敷贴器上;
图3是在活塞已经松开施加该贴之后带有图2贴保持件的图1敷贴器装置的侧截面图;
图4是图1敷贴器装置的分解透视图;
图5是敷贴器装置的可选择实施例的透视图;
图6是图5敷贴器装置的局部剖视的侧视图;以及
图7是微凸起阵列实例一部分的透视图。
具体实施方式
本发明的敷贴器装置用来与通过皮肤输送治疗介质(例如药物)或通过皮肤采样身体分析物(例如葡萄糖)相结合可重复地将微凸起阵列施加到角质层上。尽管所述敷贴器装置10使用某种连续的微凸起阵列,应该理解该敷贴器装置同样可使用其他类型的角质层微刺入构件。该敷贴器装置可通过手上无力或灵活性使用其他类型弹簧加载敷贴器的患者使用。另外,该敷贴器装置可用单手操作来击发和松开,这提供一定的优点,例如使得患者在患者自己手臂的部位上通过药物输送微凸起阵列局部治疗。
现参考图1,其中表示包括装置主体12和可在装置主体内运动的活塞14的敷贴器装置10。盖件16设置在装置主体12上以便致动敷贴器用微凸起阵列(在图1中未示出)冲击角质层。冲击弹簧20围绕活塞14的杆22定位并相对于装置主体12向下偏置活塞。活塞14具有下表面18,该表面是大致平的并略微凸起或构造成一身体表面(即特定皮肤位置)。活塞14的下表面18造成包括微凸起阵列的微凸起阵列或皮肤贴冲击并穿刺角质层。
图1表示活塞14在未击发位置,而图2表示活塞14在击发位置。当敷贴器装置10击发时,活塞14向上压在装置主体12的内部并通过锁定机构锁定就位。锁定机构包括在杆22上的卡扣26和位于装置主体12上并具有相应锁栓30的柔性指部28。
当活塞14向装置主体12运动压缩冲击弹簧20时,卡扣26柔曲指部28并卡扣在柔性指部28的相应锁栓30之上。通过将活塞击发和锁定在击发位置的简单压缩运动实现击发步骤。此击发步骤便于只用单手在使用者手和另一表面(例如桌面)之间压缩敷贴器装置10来实现。
图2表示敷贴器装置10,其中活塞14处于击发构形。如图2所示,在击发位置,卡扣26和活塞14上的锁栓20以及装置主体12可松开地接合以便防止活塞在装置主体内的向下运动。
图2同样表示安装在装置主体12上的贴保持件34。保持件34具有环形形状,其第一端40构造成与装置主体12接合。保持件34的第二端设置角质层接触表面。贴44安装在保持件34的第一和第二端40、42之间。贴44悬置在保持件34内。尽管贴44在保持件34内的安装方式以及贴44在保持件34内的安装位置可以变化(例如,贴44可以靠近保持件34的第二端42定位),最好将贴44从端40、42凹入一段距离安装(图1所示)以便避免该贴的微凸起与其他物体(例如使用者的手指)无意的接触。
按照实例,贴44通过贴底部材料的易断部分连接到粘接到击发环件34上的贴材料的环形件上。贴44通过活塞14的向下力从击发环件34上分开。作为选择,贴可松开地连接到活塞14和定位在活塞之下的皮肤上。
敷贴器装置10可使用通常包括微凸起阵列、介质储槽和衬垫的贴44。然而,敷贴器装置10同样可以使用没有介质储槽的微凸起阵列。在这种情况下,微凸起阵列用作预处理,随后通过单独的通过皮肤输送介质或采样的装置进行施加介质。作为选择,例如对于通过皮肤输送疫苗,该微凸起阵列可将介质作为涂层结合在微凸起阵列上。敷贴器装置10同样可用来冲击其他微穿刺元件压靠角质层,例如Godshall等人的US 5,879,326和Zuck的WO 99/29364,这些披露结合于此作参考。
除了只用单手击发装置10之外,装置10同样设计成只用单手操作(即使得弹簧加载活塞14松开并使得贴44冲击皮肤)。由松开锁定机构致动敷贴器装置10通过施加在敷贴器盖件16的向下力以及将敷贴器装置的第二端42击发压靠皮肤来实现。盖件16通过定位在装置主体12和盖件之间的压紧弹簧24向上偏置。盖件16包括从盖件向下延伸的销46。当盖件16下压抵抗压紧弹簧24的偏置时,销46接触柔性指部28上的斜面48以便将柔性指部向外运动并将柔性指部28的锁栓30从卡扣26松开。这松开活塞14并且活塞向下运动,用贴44冲击角质层。
图3表示在装置已经松开并且贴已经施加到角质层之后的敷贴器装置10。压紧弹簧24选择成在该装置松开之前必须实现预定的压紧力。该压紧力造成角质层由保持件34的第二端42延展,使得皮肤在贴44冲击皮肤时处于最佳的张力下。由压紧弹簧24施加的压紧力最好选择成造成第二端42对于皮肤施加大约0.01~100Mpa范围内的张力,更优选为0.05~2Mpa。
压紧弹簧24和冲击弹簧20之间的平衡使得可以通过按压盖件16击发活塞14而不造成手指46松开锁定机构。冲击弹簧20选择成适于特定贴的预定冲击以便提供所需刺入。冲击和压紧弹簧的选择进一步描述在这里同时提交的在美国临时专利申请系列号60/240,307中,该申请整体结合于此作参考。
保持件34在击发活塞14之后连接到装置主体12上。保持件34由卡扣连接器连接,与所需松开活塞的力相比,该卡扣连接器需要较小的卡扣力。保持件34同样可通过使得保持件34在垂直于敷贴器轴线的方向滑动到装置主体12内的卡口接头或滑动接头连接到装置主体上。
图4以分解透视图表示盖件16、装置主体12和活塞14。如图4所示,活塞14包括与装置主体12的下边缘54(图3)接合并防止活塞排出装置主体之外的活塞保持突片52。另外,盖件16包括简单地与装置主体12的上边缘58(图3)接合并防止盖件从主体脱出的保持突片(未示出)。
图4同样表示可选择锁定配置,该配置使得盖件16转动到一锁定位置上,在该位置上由于销46与柔性指部28不对齐而不可以致动敷贴器。通过盖件内的窗口60提供盖件16的锁定和未锁定位置的指示。当盖件16处于未锁定位置之外的位置时,销46不与柔性指部28上的斜面对齐,并因此敷贴器不可以松开。在此可选择的锁定结构防止敷贴器装置10无意致动的同时,主体12和盖件16的相对转动需要使用两只手,这在某些情况下是不希望的。
图5和6表示敷贴器80的可选择实施例,敷贴器具有不同的形状和略微不同的击发配置,它们同样可以实现简单单手击发操作。按照此实施例,使用者抓握作为装置手柄的外圆筒81。活塞82可滑动地接合在圆筒81内。如图6所示压缩的冲击弹簧83将活塞82偏置离开圆筒81的顶部或皮肤远端。设置可松开的卡扣机构84(未在图6中详细示出),由此按钮85的下压造成锁栓86缩回,因此锁定压缩弹簧83向下(即在向皮肤的方向上)运动活塞82。具有指示器凹口96的中间壳体87可滑动接合圆筒81的皮肤近端。总体为环形的下壳体87旋到壳体87上。其功能在这里同时提交并结合于此作参考的美国临时专利申请系列号60/240,379详细描述的保持件93旋在圆筒81的皮肤近端上。连接在活塞82上的冲击头94位于保持件93内。冲击头94适于在其皮肤近表面上保持具有多个微凸起的贴(该贴在图6中未示出)。图6中压缩状态下的压紧弹簧95设置在圆筒81和中间壳体87之间。压紧弹簧95在使用者抓握圆筒、将边缘89放置在将要穿刺的皮肤位置上并将装置80压靠皮肤位置时压缩。由于弹簧95压缩,缺口96变得与带97的下边缘对齐。在对齐中,压紧弹簧95处于在边缘89处提供所需压紧力和皮肤延展的预定压缩下。一旦缺口96与带97的下边缘对齐,操作者简单地按压按钮85,松开锁栓86,继而松开活塞82和头94,造成头94冲击微凸起构件压靠患者的皮肤。
按照本发明敷贴器装置10和80已经描述成直立定向,其中贴44从该装置的活塞侧施加,该活塞侧在附图中表示为装置的底部/或皮肤近端。应该理解到该敷贴器装置可用于其他定向(即侧向和颠倒),只要该装置适当压靠将要穿刺的皮肤位置即可。
图7表示使用本发明的角质层刺入构件的实施例。图7以微刀片90的形式表示多个微凸起。微刀片90从具有开口94的金属片92成大致90°角延伸。片92可结合在包括介质储槽和将该贴粘接到角质层上的粘合剂的介质输送贴或介质采样贴中。结合有微凸起的介质输送和采样贴的实例在WO 97/48440,WO 97/48441,WO 97/48442中可以发现。没有储槽的图7微凸起阵列可单独作为皮肤处理施加。
这里使用的术语“微凸起”指的是非常小的角质层穿刺元件,其通常具有小于500μm的长度,最好小于250μm,并穿透角质层进入表皮下层或表皮和真皮层以便造成流血。为了刺入角质层,微凸起最好具有至少10μm的长度,更优选为50μm的长度。通常,微凸起进入皮肤不大于500μm的深度,优选为小于400μm的深度。微凸起可形成不同形状,例如针、真空针、刀片、销、冲孔及其组合。
这里使用的术语“微凸起阵列”指的是多个配置成阵列以便穿刺角质层的微凸起。该微凸起阵列可以通过由薄金属片切割成多个刀片形成并将每个刀片从该片的平面向外折弯形成图7的构形。该微凸起阵列同样可以例如通过连接多个条带的其他方式形成,该条带沿每个条带的边缘具有微凸起。该微凸起阵列可包括注射液体制剂的中空针。
微凸起阵列描述在授予Godshall等人的US 5,879,326,授予Ganderton等人的US 5,814,097,授予Gross等人的US 5,279,544,授予Lee等人的US 5,250,023,授予Gerstel等人的US 3,964,482,授予Kravitz等人的Reissue25,637,和PCT公开号WO 96/37155,WO96/37256,WO 96/17648,WO 97/03718,WO 98/11937,WO 98/00193,WO97/48440,W0 97/48441,WO 97/48442,WO 98/00193,WO 99/64580,WO98 28037,WO 98/29298,WO 98/29365,所有这些专利结合于此作参考。
本发明的装置可与介质输送、介质采样或两者结合使用。特别是,本发明的装置与通过皮肤输送药物、通过皮肤采样分析物(例如葡萄糖)或两者结合使用。使用本发明的通过皮肤输送装置包括(但不局限于)被动装置、刺入装置、压力驱动装置和电迁移装置。使用本发明的通过皮肤采样装置包括(但不局限于)被动装置、负压驱动装置、刺入装置和反向电迁移装置。本发明的通过皮肤的装置可以与例如皮肤刺入增强器的增加介质流量的方法结合使用。
本发明的装置可以使用微凸起阵列,该阵列包括通过皮肤输送或采样贴,该贴具有将该贴连接到皮肤上的粘合剂。作为选择,微凸起阵列和输送或采样贴可以是两个带有微凸起阵列的分开的元件,以便在施加输送或采样贴之前预处理。
在本发明已经参考其优选实施例详细描述的同时,对于本领域技术人员将明白可进行多种变型和改型以及采用等同结构,而不偏离本发明。
Claims (22)
1.一种用于冲击刺入构件压靠角质层的装置,其包括
具有第一和第二端的主体;
所述第一端适于容纳该刺入构件;
可滑动地配置在输送主体内以便冲击该刺入构件压靠该角质层的活塞;
适于提供冲击力到该活塞上并偏置所述活塞到所述主体的所述第一端之外的冲击弹簧;其中所述冲击弹簧在所述活塞进一步位于所述主体内时聚集能量,
锁栓机构,其中所述锁栓机构在所述活塞已经充分位于所述主体内时可松开地将所述活塞与所述主体接合;以及
用于脱开所述锁栓机构的松开机构,由此所述冲击弹簧冲击所述活塞压靠该刺入构件,强迫该刺入构件进入所述角质层。
2.如权利要求1所述的装置,其特征在于,所述主体和活塞适于使用单手可松开地接合。
3.如权利要求1所述的装置,其特征在于,该锁栓机构包括该主体和活塞上的相互接合的锁栓构件。
4.如权利要求3所述的装置,其特征在于,其还包括所述主体上的柔性指部和所述活塞上的止挡,其中所述柔性指部和所述止挡包括所述相互接合的锁栓构件。
5.如权利要求1所述的装置,其特征在于,所述松开机构适于在力施加在所述松开机构上之后松开所述活塞。
6.如权利要求5所述的装置,其特征在于,所述锁栓机构和所述活塞松开机构适于使得每个机构单手操作。
7.如权利要求5所述的装置,其特征在于,其还包括盖件,该盖件可运动地安装在所述主体上以便当所述盖件运动到所述主体上时致动该松开机构。
8.如权利要求7所述的装置,其特征在于,其还包括配置在该主体和该盖件之间的压紧弹簧,该弹簧抵抗该松开机构的启动直到所述压紧弹簧已经充分聚集能量使得所述压紧弹簧施加预定压紧力为止。
9.如权利要求7所述的装置,其特征在于,其还包括用于防止所述盖件相对于所述主体运动的锁定机构,由此防止松开机构的启动。
10.如权利要求9所述的装置,其特征在于,其还包括用于指示何时所述盖件位于所述锁定位置的指示器。
11.如权利要求1所述的装置,其特征在于,当所述活塞已经充分位于所述主体内时所述锁栓机构将所述活塞相对于所述主体自动锁定在击发位置。
12.如权利要求1所述的装置,其特征在于,所述活塞包括施加表面,该表面具有如下形状和尺寸,以便有效施加将被冲击的特定贴。
13.如权利要求12所述的装置,其特征在于,所述施加表面具有包括凸起形状、大致平的形状和构造成与预定身体表面位置相配的形状的组中选出的形状。
14.一种用于冲击微凸起阵列压靠角质层的装置,该装置包括:
装置主体;
安装在装置主体内的活塞,该活塞具有微刀片阵列施加表面;
作用在该装置主体和该活塞之间以便用该微刀片冲击该角质层的冲击弹簧;
可运动地安装在该装置主体上的盖件;
作用在该装置主体和该盖件之间的压紧弹簧;
使用单手一起压缩该装置主体和活塞将活塞锁定在击发位置的锁栓机构;以及
用于从该击发位置松开活塞以便在该压紧弹簧压缩时用微刀片阵列冲击角质层的活塞松开装置。
15.如权利要求14所述的装置,其特征在于,该活塞松开装置包括松开指部。
16.如权利要求15所述的装置,其特征在于,该锁栓机构包括柔性指部和止挡。
17.如权利要求14所述的装置,其特征在于,该压紧弹簧抵抗该活塞松开装置的启动直到达到预定压紧力为止。
18.一种击发用于冲击刺入构件压靠角质层的装置的方法,该方法包括:
通过压缩活塞和装置主体相对于装置主体运动活塞到击发位置;以及
通过所述压缩将活塞锁定在击发位置,由此该装置可使用单手击发和锁定。
19.如权利要求18所述的方法,其特征在于,通过沿装置轴线运动该活塞以便击发该活塞并沿装置轴线下压启动盖来松开活塞。
20.如权利要求18所述的方法,其特征在于,该活塞自动锁定在击发位置。
21.如权利要求18所述的方法,其特征在于,该活塞手动锁定在击发位置。
22.一种冲击刺入构件压靠角质层的方法,该方法包括:
设置具有装置主体、活塞和冲击弹簧的冲击装置;
使用单手一起运动活塞和装置主体到击发位置并将活塞锁定在击发位置来击发冲击装置;
设置刺入构件;
将所述刺入构件安装在所述活塞上;以及
松开所述活塞以便冲击刺入构件压靠角质层。
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