CN1942212B - 用神经毒素治疗哮喘的装置和方法 - Google Patents

用神经毒素治疗哮喘的装置和方法 Download PDF

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CN1942212B
CN1942212B CN2004800131252A CN200480013125A CN1942212B CN 1942212 B CN1942212 B CN 1942212B CN 2004800131252 A CN2004800131252 A CN 2004800131252A CN 200480013125 A CN200480013125 A CN 200480013125A CN 1942212 B CN1942212 B CN 1942212B
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马克·E·迪姆
汉森·S·吉福德
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Abstract

提供支气管内部释放神经毒素来控制哮喘作用的装置，该装置包括：一杆件，具有近端和远端以及一药物施放器布置在其远端，其中神经毒素施放器组件包括可伸出的针头组件，旋转针头组件，无针头注射组件，雾化器组件，或微孔尖端。进一步的实施例涵盖的装置包括释放药物的生物可吸收性展伸件，该展伸件具有一或多层抗哮喘药物。

Description

用神经毒素治疗哮喘的装置和方法
技术领域
本发明涉及用神经毒素施放器组件控制神经毒素的释放来治疗哮喘的装置。
背景技术
肺是从气管根部向下逐渐变小的支气管分枝构成。气管和近端支气管是包括筋膜外层的内腔，由U型内软骨层包围，其中U型开放的部位由平滑肌横跨覆盖。软骨层内是胶原弹性层和最内部的上皮层。粘液分泌杯状细胞和转运纤毛细胞散布在这些内层中。
由于支气管分枝和变得更小的分支，软骨层从U型变成不规则的和螺旋状的形状。另外，平滑肌层围绕支气管整个周缘变成螺旋状的边，杯状细胞数量上逐渐减少而纤毛细胞变得更小且数量上更少。在支气管的最远端，外软骨层完全消失，平滑肌层变成最外层且杯状细胞和纤毛细胞完全消失。
哮喘是支气管树的复杂疾病，其特征是通气管对过敏原，压力和环境触发的超敏感反应。环境触发包括刺激物如污染而非过敏原触发如冷空气下的暴露。通气管超敏感反应的结果是支气管树的急剧狭窄导致通过肺的气流减少，被动呼吸和肺泡气体交换减少。支气管树的狭窄其结果有三个基本的生理反应：(1)平滑肌收缩；(2)粘液分泌增加；以及(3)由动脉扩张和动脉渗透性造成的水肿。这些生理反应的触发机理是人体炎性反应系统的一部分。
慢性无控制的哮喘可造成支气管壁自身结构改变的结果。平滑肌增生的结果是支气管壁的平滑肌成分层变厚。加厚的上皮下胶原质层在通气管上皮和平滑肌层之间，其结果是支气管壁的渐进性变硬。研究表明通气管壁变硬的结果是对来到的哮喘发作，通气管更深度狭窄。这是由于粘膜层对平滑肌层收缩反应皱襞能力的变化。
最近，神经毒素的可控制注射已成为控制骨骼肌痉挛通常的处理方法。该方法经常使用的神经毒素是肉毒杆菌毒素，血清型A，商业销售有Allergan，Inc.公司称为BotoxTM。肉毒杆菌毒素阻断从神经到神经传递素的释放，从而控制目标肌肉的收缩。肉毒杆菌毒素的许多应用已被建议和/或被临床检验，包括颈肌张力障碍，皱纹的美容减轻和颈瘫痪相关的颤动。最近，肉毒杆菌毒素已成为减轻多汗症(过多流汗)和唾液分泌亢进临床研究的对象。这些研究表明肉毒杆菌毒素可用于控制类胆碱(功)能副交感神经以及大骨骼肌群的活动。最近的发现公开了使用如肉毒杆菌毒素的神经毒素控制某些在哮喘发作时通气管狭窄的主要机械运动，特别是控制平滑肌收缩和杯状细胞的粘液过度分泌的可能性。另外，有证据说明哮喘炎性反应的某些部分是由肉毒杆菌毒素抑制的神经传递素的释放激发的。这就公开了肉毒杆菌毒素也可在减轻炎症周期自身方面起作用的可能性。
使用神经毒素控制哮喘在美国专利号为6,063,768中首次描述，其中哮喘包括在神经性炎症异常的系列中，可通过如肉毒杆菌毒素的神经毒素控制，但没有描述使用的方法和装置。美国Sanders等人早期的专利号为5,766,605描述了使用肉毒杆菌毒素治疗哮喘和COPD。该专利还描述了肉毒杆菌毒素可喷雾和导入到肺里。进一步提出肉毒杆菌毒素和哮喘联系的是2003年2月7日的新闻发布，描述Redwan Moqbel博士在Alberta大学的工作。该发布提及Moqbel博士和其他人员研究应用如破伤风和肉毒杆菌毒素的神经毒素在哮喘发作时防止嗜曙红细胞激发和启动炎性瀑布反应的可行性。
尽管它只是可能简单地喷神经毒素雾来导入到肺里，但通过传统吸入装置导入它进入患者将使口，舌，会厌，声带等暴露于神经毒素的作用，带来显然有害的结果。为了安全和有效的治疗，要求更受控制的和直接的将神经毒素应用到所需组织。
因此需要提供可控制地将神经毒素释放到患者支气管通气管内目标治疗区的装置。
还需要提供允许神经毒素可控制地注射到患者支气管壁的装置。
进一步还需要提供无针头注射装置来减少与针头在患者支气管通气管内存在相关的潜在并发症。
另外，需要提供允许神经毒素施放到患者支气管通气管内的目标治疗区上的装置。
另外，还有已开发的用于治疗不同疾病的植入性药物释放装置，例如药物释放冠状展伸件，如那些在临床研究中和从如BostonScientific and Cordis Corporation公司商业销售的。药物释放生物可吸收性装置已有类似的设想，如那些由Synecor，Inc.(最近Guidant获得的)开发的，和由数个大学和医院基地开发的成果。Blindt等人提供的类似成果的例子，带有同时与生物活性物质结合的新生物可降解的血管内聚合体展伸件的开发，Int′l J.Artif.Organs，22(12)：843-853(1998)，以及Tsuji等人的，作为装载药物平台的生物可降解展伸件Int′l J.Cardio.Interv.，13-16(2003)。
生物可降解展伸件的其它用途包括前列腺肥大的治疗后的尿道修复的开放(性)，以及肺肿瘤侵害后支气管通气管保养的开放(性)。为治疗不同疾病控制神经毒素释放的生物可降解和非生物可降解植入物的描述在美国专利号为6,306,423,6,506,399和6,383,509中公开。进一步，美国专利号为5,766,605描述了使用神经毒素治疗自主神经功能紊乱，公开了包括详细权利要求书包括了治疗哮喘和慢性梗阻性肺部疾病(COPD)。另外，美国专利公开号为2002/0082197中描述了使用神经毒素治疗粘液分泌疾病，如哮喘和COPD，如WO 00/10598所描述的。
进一步描述是提供抗哮喘药物持续不变或周期性剂量放到患者支气管气道内目标治疗区的可植入装置。
发明内容
基于上述内容，本发明一个目的是提供能控制到患者支气管通气管内目标治疗区神经毒素释放的装置。
本发明的另一个目的是提供能控制进入患者支气管壁内神经毒素注射的装置。
本发明另外目的是提供能减少与针头在患者支气管通气管内存在有关的潜在并发症的无针头注射装置。
本发明另一个目的是提供能将神经毒素施放到患者支气管通气管内目标治疗区的装置。
本发明进一步目的是提供可植入装置，其将抗哮喘药物以持续不变或周期性剂量放到患者支气管通气管内的目标治疗区。
本发明另一个目的是通过提供支气管内部神经毒素释放系统来实现神经毒素可控制的释放到支气管通气管内目标治疗区，来减少哮喘的作用。神经毒素导入支气管通气管中，使平滑肌层失去超敏感反应和控制粘液过多分泌。
根据本发明的第一方面，支气管内部神经毒素释放系统包括神经毒素施放器组件。神经毒素施放器组件的远端可包括针头尖端，旋转针头组件，无针头注射组件，雾化器，或微孔尖端。设计的这个和下面所有施放器都可与标准气管镜工作或一致工作，或为了接近和治疗通气管而合成一独立系统。
根据本发明的这个方面，神经毒素施放器组件包括一伸长杆件，具有内腔其内流体与液体神经毒素源相连。杆件远端包括一或多个针头，当布置在气管镜内腔时预制成径向收缩，但可伸出并刺入且注射小剂量神经毒素到患者支气管壁。
或者，神经毒素施放器组件的远端可载有旋转针头组件，该组件包括沿轮的周缘布置的多个针头，以使轮可滚转越过目标治疗区。任选地，旋转针头组件包括护板保护基本上与目标治疗区相对的支气管壁的部分。
在另一个选择性实施例中，神经毒素施放器组件的远端可包括无针头注射组件，可在没有针头刺入下用于注射神经毒素到支气管壁。选择性地提供膨胀球囊帮助无针头注射组件的口定位于目标治疗区附近。
在另一选择性实施例中，神经毒素施放器组件的远端包括雾化器组件，具有雾化器将液体神经毒素转换成细小的喷雾或薄雾，直接到目标治疗区上。薄雾微粒尺寸用注射压力或雾化器头设计来控制，以达到邻近或在治疗装置下游的肺的特殊部位。任选提供的膨胀球囊可帮助雾化器定位于邻近目标治疗区，且进一步可以起到将装置下游的肺部分隔离的作用，防止薄雾流进入通气管不需要部分。另外，任选布置在球囊和雾化器之间内腔，提供通风系统允许在球囊放气之前，控制治疗区的压力，防止肺的过度膨胀，雾化液体的混合，以及在治疗终止时残留薄雾趋散。
在另一选择性实施例中，神经毒素施放器组件的远端包括杆件的关节区，该区包括微孔尖端传递抗击哮喘溶液流通过内腔和流出远端尖端。
根据本发明的另一个方面，支气管内神经毒素释放系统包括释放药物的生物可吸收性展伸件，该展伸件包括一或多层抗哮喘药物。
附图说明
本发明的上面及其它的目的和优点将从下列结合附图的详细描述而变得更为明显，其中相同的特征贯穿指相同的部分，而其中：
图1是本发明体内支气管神经毒素释放系统的侧视图；
图2是本发明神经毒素施放器组件说明性实施例的透视图；
图3A和3B分别是图2的神经毒素施放器组件在收缩和展开位置时的横截面图；
图4是本发明神经毒素施放器组件选择性实施例的透视图；
图5A和5B分别是图4的神经毒素施放器组件在收缩和展开位置时的部分横截面图；
图6是本发明神经毒素施放器组件另一个选择性实施例的透视图；
图7A和7B分别是图6的神经毒素施放器组件在收缩和展开位置时的部分横截面图；
图8是本发明神经毒素施放器组件进一步选择性实施例的透视图；
图9A和9B分别是图8的神经毒素施放器组件在收缩和展开位置时的部分横截面图；
图10是神经毒素施放器组件远端的侧视图，该组件用于对患者支气管实施抗击哮喘的解决方案；
图11A-11C是图10的施放器的侧视图，示出在不同的结构中的弯曲远端部分；
图12是在图10施放器近端提供加压力的注射器的透视图；
图13是在图10施放器近端提供加压力的选择性注射器的透视图；
图14是本发明药物释放(drug-eluting)的生物可吸收展伸件(stent)的侧视图；
图15是本发明另一个药物释放的生物可吸收展伸件(stent)的侧视图；
图16是图14药物释放的生物可吸收展伸件的横截面图；
图17是示出药物释放的生物可吸收展伸件在患者支气管内释放的透视图；
图18是示出选择性药物释放的生物可吸收展伸件在患者支气管内释放的透视图；以及
图19是示出进一步选择性药物释放的生物可吸收展伸件在患者支气管内释放的透视图。
具体实施方式
参见图1，所描述的装置用于控制神经毒素在患者支气管气管内目标治疗区的释放，以此减少哮喘作用。优选地，装置包括气管镜10和神经毒素施放器组件20。气管镜10具有近端12，远端13，和内腔14。如传统的，气管镜10也包括用于照亮患者肺内部的光源和光学元件，如微型照相机，以使医生可以观察到患者肺内部。有选择性地，气管镜10可省略光源和光学元件，而是替代包括外鞘。在后者情况下，装置10和神经毒素施放器20可用独立的传统气管镜或光源和光学元件来搭建神经毒素施放器20。
根据本发明的理论，神经毒素施放器组件20，在以下的描述中用不同的实施例加以说明，使外科医生可选择用药，控制神经毒素的剂量或在选择在患者肺部的治疗区域。更具体地，神经毒素施放器组件20可选择性地改进为通过气管镜10的内腔14释放神经毒素如肉毒杆菌毒素，血清型A到目标治疗区。
神经毒素施放器组件20包括杆件21，其近端与手柄22连接，远端23具有神经毒素施放器24，和内腔25。内腔25提供在近端和手柄22和施放器24之间流体流通。注射器26具有柱塞27与近端22上的口连接。注射器26充满液体形态的神经毒素，而当柱塞27起动时通过内腔25施放神经毒素到施放器24。
手柄22可使医生伸出和收缩在气管镜10内腔14内的施放器24，并可使用气管镜10的光学元件在直接可视的观测下，操作神经毒素施放器组件20的远端23。神经毒素施放器组件在导管插入患者支气管气管期间，优选地在气管镜内腔14内保持收缩，而一旦在理想位置内就伸出。有选择性地，施放器20可包裹在护鞘内，而两个单元可一起通过内腔14推进。
现参照图2-3，描述根据本发明理论建立的神经毒素施放器组件20施放器24的第一说明性实施例。施放器24包括针头组件28，其至少具有一个针头，它带有与内腔25有液体连通内腔31。针头设置成刺入气管上皮并直接从注射器注射小量神经毒素进入支气管壁B的胶原和平滑肌层。
在图3A中，示出针头组件28收缩入气管镜10内腔14内。有选择性地，装置10包括外径，其尺寸为以可滑动方式接受神经毒素施放器组件20，并可选择性地收缩以暴露针头组件28。在装置10是外鞘的情况下，通过独立的传统气管镜或提供内置的光学元件来实现可视化。在进一步的实施例中，护鞘包裹在内腔14内且覆盖的施放器20选择性地收缩到暴露的针头组件28。如图3B所示，针头30包括可保护已形成形状的材料，如镍一钛合金，并且当伸出气管镜10远端13(或外鞘远端，如果提供)时构成向外的径向偏斜。每一个针头30任选地包括柄36，其设置在与针头远端预定距离来控制刺入支气管壁的针头深度。
在图2和3B示出，当针头组件28展开时，针头30刺入支气管壁B的目标治疗区T，这样可在支气管壁注射神经毒素。注射器26可包括刻度以使医生在每个目标治疗区注射一预定量的神经毒素。
现参照图4和5，描述神经毒素施放器组件20施放器24选择性的实施例。施放器24在该实施例中包括旋转针头组件38，包括装配的轮39绕轮轴40旋转，当轮39明显旋转时，它优选则地可包括椭圆形或六角形或其它多角形状。多个针头41环绕设置在轮的周缘，每个针头41具有内腔42其内流体通过在轮轴40内的通道与内腔25相连。任选的护板45保护基本与目标治疗区相对的支气管壁部分。
在图5A示出，旋转针头组件38收缩在外鞘37内。外鞘37大小适合在气管镜10内腔14内，而且可选择性地收缩到暴露的旋转针头组件38。有选择性地，旋转针头组件38穿过内腔14伸出并越过气管镜10的尖端。在该实施例中，轮由收缩的护鞘覆盖，护鞘在系统插入期间覆盖轮。在图4和5B示出，旋转针头组件38在展开位置。当这样展开时，滚转轮39可横过目标治疗区T，这样轮旋转针头41优选则地刺入并注射神经毒素到支气管壁B。
用于图2-3的针头组件28和图4-5的旋转针头组件28的适合针头材料包括形状记忆合金，如镍钛合金和弹簧调节的不锈钢合金。有利地，任一针头组件都可直接注射神经毒素到支气管壁。这样防止了毛细(cilial)传输系统诱使神经毒素传输到呼吸系统的其它区域，如，口咽部，那些潜在非预定目标可能暴露给神经毒素，而且也防止喷雾神经毒素的意外呼出。
现参照图6和7，描述神经毒素施放器组件施放器24另一个选择性实施例。图6-7的施放器24包括无针头注射组件46，用于从近端控制器加压注射释放神经毒素到目标治疗区域T。有利地，无针头注射组件允许穿过气管上皮控制神经毒素的导入，而没有导入针头接近脆弱的支气管组织潜在的并发症，并且允许构造为不引人注意的系统。
无针头注射组件46包括杆件47，它有带有与内腔25有液体连通至少一个口。可膨胀球囊49任意地与杆件47相连，并且用于定位杆件邻近目标治疗区T。球囊49膨胀带有液体通过杆件47的内腔导入。当杆件与目标治疗区对准时，施加加压气体脉冲注入预定量的神经毒素穿过气管壁并进入胶原和平滑肌层。
在图7A示出，带有收缩球囊49的无针头组件46收缩入气管镜10内腔14内(或单独外鞘内)。图6和7B示出带有球囊49的无针头组件46膨胀并将口48置放到目标治疗区T的位置。一旦医生确认无针头组件46的位置，例如，通过使用气管镜10的光学元件，X线，荧光镜或其它合适的设备可视化，控制器附着在神经毒素施放器组件20的近端(代替注射器26)，它起动释放所需计量的神经毒素到气管壁。如对于球囊49的选择，组件可具有2或更多无针头注射器排列定位在支气管通道相对壁上。例如，可触发它们张开使张开部件偏离中线定位并与支气管壁接触。如进一步的选择，组件的杆件可预先弯曲或带有致动机构可激发的弯曲来迫使注射器贴在支气管通道壁上。另一个选择包括通过口48低压注射神经毒素，造成滴渗球囊施放器。在这种情况下，通过神经毒素的细胞内吞作用实现神经毒素穿过皮下表面的传输。
至于图8和9，描述根据本发明建立的神经毒素施放器组件施放器24进一步选择性实施例。施放器24包括雾化器组件50，该组件具有杆件55，带有设置在其远端雾化器51并在有流体连通的中心内腔25中。雾化器51将注射器中的液体神经毒素转换成细小的喷雾或薄雾。薄雾微粒尺寸通过雾化器头设计或由不同注射压力来控制，以达到控制薄雾侵入目标部分深度的目的。
雾化器组件50也可包括任选的膨胀球囊52设置在接近雾化器51的杆件55上。球囊52的选择性膨胀可定位雾化器51，以使成烟雾状散开的神经毒素直接喷到目标治疗区T。球囊52也可以起到将治疗区和肺的其余部分隔离的作用，防止薄雾流进入非预定区。对图6-7的实施例，可使用通过杆件55内辅助内腔导入的流体膨胀球囊52。
在图9A中，雾化器组件包括收缩的球囊52设置在气管镜10内腔14内，或有选择性地在内腔14可滑动接受的外鞘内。有选择性地，雾化器组件可插在单独递送鞘内。在图8和9B中示出雾化器组件50从内腔14(或外鞘，如果提供)伸出且球囊52膨胀。有利地，雾化器组件50尺寸可进入非常小的支气管通路，并还可用于释放神经毒素到肺的上游区域。
还是参见图9A和9B，杆件55任选地还包括附加辅助内腔或连接到入口53的内腔而出口54设置在球囊和雾化器之间。入口53允许导入目标治疗区附近的气体(如新鲜空气)，而出口54允许空气或混有雾状神经毒素的气体溢出。入口53和出口54这样就提供了气体流通系统来保护邻近和接近目标治疗区T的组织不注意地暴露在雾状神经毒素下。入口53和出口54还可致动膨胀和收缩隔离部分，或简单地使肺内目标治疗区附近的压力正常化。控制单元可与口53和54的近端出口相连，控制从肺中导入和溢出的气体而不让雾状神经毒素溢出到环境或患者。
根据某些实施例，雾化器组件可建成单独，可任意使用的光导纤维单元，它具有单向尖端偏转部件，该部件具有完全隔离球囊和喷雾尖端。含有神经毒素的罐还可与雾化器组件组成整体。有利地，这种组件可允许不引人注意的外观，用户友好的系统，适合经鼻腔式雾化器组件通过声带导入肺部。
至于图10-13，描述本发明神经毒素施放器另一个选择性实施例。在该实施例中，神经毒素或其它治疗药物释放到患者支气管枝是通过到支气管内层毒素的下级选择的局部施用来实现的。施放器组件可通过气管镜的工作通道插入(如图1中)并喷洒含有神经毒素的溶液到肺气管上皮表面。
现参照图10，神经毒素施放器组件60包括近端杆件62，弹簧加固的远端部分64，以及有斜面的远端尖端66，该尖端包括微孔过滤材料其作用作为用于抗击哮喘溶液的局部释放器。远端部分64优选地是能变成无数具有不同曲率半径的结构。另外，提供远端尖端66的扭力旋转相应的扭距施加到近端杆件62。在该说明性实施例中，神经毒素施放器组件60包括金属丝编制层加强管提供高爆发力和良好扭距响应的理想性能，并且可由镍钛合金制成。
参照图11A-11C，神经毒素施放器组件60弯曲的远端部分64伸出气管镜70的尖端。神经毒素施放器组件60优选地可相对于气管镜70和与气管镜70相结合地旋转。远端部分64不同曲度和远端尖端66斜面终止提供了远端尖端66与具有不同直径的支气管壁的密切接触。斜面远端尖端66可通过气管镜70的工作通道容易地导入。远端部分64优选地是弹簧偏压成的弯曲结构以使装置自我调节到内部支气管直径的宽范围。图11证明弯曲的远端部分将保持与直径为5mm或更小的非常小的支气管壁接触(图11A)，并保持与直径为5mm到15mm的平均的支气管壁接触(图11B)，同样保持与直径为15mm或更大的非常大的支气管壁接触(图11C)。
在操作中，导入的抗击哮喘溶液流过中心腔通过神经毒素施放器组件60。根据某些实施例，远端尖端66旋转使用扭距施加到近端杆件62的近端，加载在近端的压力，用于控制溶液流通过远端尖端66。该流控制方面，与不同曲度的远端部分64结合，可旋转地在支气管壁上“涂抹”。
参照图12，使用注射器72在神经毒素施放器组件60的近端加压，用于控制抗击哮喘溶液流通过中心内腔和装置的远端尖端。注射器72包括注射筒73和绕线活塞74，其终止于指槽75。注射筒73的近端终止于外表面突出缘76，而注射筒73的远端固定在响应扭距的神经毒素施放器组件60的近端。注射器73优选地还包括线绕半卡圈77(half-collar)，适合滑入在覆盖注射筒73和绕线活塞74的位置。线绕半卡圈77优选包括内部绕线对应于在绕线活塞74上的绕线。另外，半卡圈77优选还包括接合缘76的凹槽。当滑入的位置超过注射器72，线绕半卡圈77在相对于桶适当的位置锁住绕线活塞。
当卡圈77在适当位置，注射筒73旋转(例如在顺时针方向)的结果为活塞74相对于筒73的控制偏转。活塞74的偏转在神经毒素施放器组件60的中心内腔中增加了压力，以此造成从远端尖端66分配溶液的控制量。通过改变在活塞和半卡圈上的螺距，可使每次旋转分配的流体量不同。由于注射筒73是固定附在响应扭距的神经毒素施放器组件60上，旋转注射筒73的结果是相应的远端尖端66的旋转。可以将半卡圈从组件上去除，而使用传统注射器进行注射器72快速充满或清空操作。
参照图13，标准注射器80附在布置在气管镜85内的响应扭距的神经毒素施放器组件60的近端上，注射器包括注射筒82和无绕线活塞83。在该实施例中，没有卡圈，通过手动调节施加在活塞83上的力来提供流体控制。施加在活塞83上的力，加上注射器80的旋转(其造成相应的神经毒素施放器组件60的旋转)分配抗击哮喘溶液到患者支气管壁上。
根据本发明的另一方面，对应于图14-19是所述治疗哮喘可植入装置和方法。使用生物可吸收性植入物可控制地将一两种神经毒素导入患者支气管树支中，可通过使平滑肌层失去超敏感反应和控制粘液分泌过多来治疗哮喘。
更具体地，通过从放在支气管通道中的生物可吸收性植入物中的药物释放，使神经毒素或其它治疗药物释放到支气管树支中。植入物优选地是生物可吸收性的，但选择性地可包括带有再填充储液器(refillable reservoirs)的永久装置，和释放装置(elution devices)一样可在一段时间时例如当药物耗尽补给时移出和重置。
根据本发明的理论，治疗哮喘系统包括一或两个释放药物(drug-eluting)的生物可吸收性展伸件(stent)。参照图14，展伸件102包括单根金属丝104，该金属丝包括多个拐弯106。根据某些实施例，展伸件系统包括一个或多个分立长度盘绕的展伸件。有选择性地，展伸件系统包括一个或多个定制长度盘绕的展伸件，将其展开并在释放的端点由展伸件释放系统一部分的切割机械装置切下该长度。生物可吸收性展伸件102优选地带有神经毒素和/或其它抗哮喘药物。神经毒素和/或其它抗哮喘药物的逐渐释放可治疗潜在的引起哮喘反应的诱因性疾病。有利地，展伸件102也可使患者支气管机械强度加强。
参照图15，所示为选择性的生物可吸收性展伸件108，且包括多个金属丝110并缠绕形成狭槽或编织管。如本领域熟练技术人员理解的，可以在不脱离本发明保护范围的情况下使用其它已知的展伸件设计来释放抗哮喘药物。展伸件102，108所用的适合材料包括PEG、PLLA、胶原质和这些材料的共聚物。合适的药物包括全身通用治疗哮喘症状的类固醇和支气管扩张系列。其它适合抗哮喘药物的例子包括皮质类固醇和舒喘宁(albuterol)。
另外，用展伸件可释放神经毒素合成物如肉毒杆菌毒素或破伤风类。根据某些实施例，展伸件102可将神经毒素包裹，在支气管壁上逐渐释放它。以此极大地延长了通常为3个月活跃预期使用期限的神经毒素的有效工作寿命。
由于神经毒素对平滑肌和与哮喘相关的诱因性反应的作用不是永久的，因此需要提供神经毒素的计量可在预定间期自动释放。图16是图14药物释放的生物可吸收性展伸件102的展伸件金属丝104的横截面图。构成药物释放的生物可吸收性展伸件102的金属丝104包括基本相似的横截面。
说明性实施例中，展伸件金属丝包括交替的装有药物的和没装药物的再吸收材料层。更具体地展伸件金属丝104包括内部药物释放层114，其横截面基本为圆形而阻挡层116布置在内层114的周边。展伸件金属丝104还包括外部药物释放层118在阻挡层116的周围，并且在外层118包围着保护性的外层被覆120。用此方式，药物装入植入物不连续剂量层114，118中，并在预定间期时释放。
药物释放展伸件植入到患者支气管气管以后，保护性的外层被覆120溶解，以此暴露外部药物释放层118。外层慢慢被吸收，这样提供抗哮喘药物的第一剂量到患者支气管内的目标治疗区。在外层118被吸收后，阻挡层116在支气管内预定时间过后溶解。接着，内层114慢慢被吸收，这样提供抗哮喘药物的第二剂量到目标治疗区。当然，本领域熟练技术人员应理解，可在不脱离本发明保护范围的情况下使用附加的药物释放层(和阻挡层)来在预定间期时释放附加剂量的抗哮喘药物。用此方式，第一剂量在植入后慢慢给予，而后后续剂量在在预定间期时，例如每3个月释放。
本发明药物释放展伸件的释放优选地是提供传统气管镜的工作通道实现，通过口腔或鼻腔，或通过为放置装载的展伸件特殊设计的定制装置。参照图17，一或多个释放药物的生物可吸收性展伸件102通过气管镜122的工作通道施放到患者支气管B内的目标治疗区。展伸件102是盘绕的装载药物金属丝104的连续长度，最初放在目标支气管通道的远端。接着，展伸件102沿目标支气管通道到达近端终点后散开。在展开期间气管镜的操作让医生避免放置卷簧(coils)越过支气管树支的侧面。当达到近端终点时，用切割机械装置切下植入的卷簧(coil)。
有选择性地，如对于图18和19所示，一或多个不连续长度药物释放生物可吸收性卷簧展伸件108，130施放到患者支气管B内。展伸件108和130由金属丝部件构成，优选地包括装载药物和不装载药物的材料，如对于图16所述的。展伸件108和130优选地通过气管镜的工作通道或通过另一个施放装置施放。本领域熟练技术人员应理解，展伸件108和130可在不脱离本发明保护范围的情况下包括不同尺寸和结构的任意数量。
在上文描述的本发明的展伸件的展开可使用传统展伸件施放导管和通过展伸件的自膨胀或球囊膨胀，由加热和用特定建造的施放系统设置最终尺寸，或任何其它合适的手段实现。施放可以一次放一个，或从单独的多个展伸件施放系统放置多个植入物。
虽然上面描述了本发明优选的说明性实施例，本领域熟练技术人员应明白，可在不脱离本发明情况下作任何改变和修改。在所附的权利要求书中覆盖了所有的落在本发明保护范围和真正精髓内的这种改变和修改。

Claims (12)

1.一种用于在支气管内部释放药物来治疗肺部疾病的装置，该装置包括：
注射器，该注射器充满液体形态的神经毒素，该神经毒素抑制支气管壁中的平滑肌细胞的超敏感反应；
杆件，其具有：包括至少一个进口的近端、远端、和在所述进口和远端之间延伸的内腔；以及
包括针头组件的药物施放器，该药物施放器布置在杆件的远端，与所述注射器流体连通，
其中，所述药物施放器构造为：使得所述针头组件穿过病人的支气管壁的上皮将来自所述注射器的神经毒素释放到所述支气管壁中的平滑肌组织中，所述针头组件能够在收缩释放位置和展开位置之间移动，其中在所述展开位置，至少一个针头从杆件径向伸出刺入支气管组织，并且所述针头包括柄，其设置在与所述针头的远端相隔预定距离的位置处，以控制刺入支气管壁的针头的深度。
2.根据权利要求1所述的装置，还包括具有近端和远端的气管镜，且内腔在其间延伸，而其中杆件尺寸为以可滑动方式通过气管镜的内腔。
3.根据权利要求1所述的装置，其中神经毒素是血清型肉毒杆菌毒素。
4.根据权利要求3所述的装置，其中血清型肉毒杆菌毒素为血清型A、或血清型B、或血清型A和血清型B的组合。
5.根据权利要求1所述的装置，其中神经毒素是破伤风类或破伤风类衍生物。
6.根据权利要求1所述的装置，其中杆件能够选择性地弯曲。
7.根据权利要求1所述的装置，其中杆件是可操纵的。
8.根据权利要求1所述的装置，还包括光学元件，该光学元件布置成与药物施放器成操作关系。
9.根据权利要求1所述的装置，其中所述注射器与杆件近端相连，用于控制神经毒素的流量。
10.一种通过在支气管内部释放药物来治疗肺部疾病的装置，该装置包括：
注射器，该注射器充满液体形态的神经毒素，该神经毒素抑制支气管壁中的平滑肌细胞的超敏感反应；
伸长杆件，其具有包括至少一个进口的近端、远端、和在进口和远端之间延伸的内腔；以及
包括针头组件的药物施放器，该药物施放器布置在所述伸长杆件的远端，且与所述注射器流体连通，所述药物施放器构造为：使得所述针头组件穿过病人的支气管壁的上皮将来自所述注射器的神经毒素释放到所述支气管壁中的平滑肌组织中，并且所述针头组件能够在收缩释放位置和适合释放药物到患者支气管壁目标治疗区的展开位置之间移动，
其中，所述药物施放器包括针头组件，所述针头组件包括至少一个针头，该针头从所述伸长杆件径向伸出刺入支气管组织，并且所述针头包括柄，其设置在与所述针头的远端相隔预定距离的位置处，以控制刺入支气管壁的针头的深度。
11.根据权利要求10所述的装置，其中所述伸长杆件的远端部分能够选择性地弯曲。
12.根据权利要求10所述的装置，其中所述注射器与所述伸长杆件近端相连，用于控制神经毒素的流量。
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US8172827B2 (en) 2012-05-08
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