CN115426990A - 通过鼓膜进入中耳和内耳的微创工具和方法 - Google Patents
通过鼓膜进入中耳和内耳的微创工具和方法 Download PDFInfo
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- CN115426990A CN115426990A CN202180023110.8A CN202180023110A CN115426990A CN 115426990 A CN115426990 A CN 115426990A CN 202180023110 A CN202180023110 A CN 202180023110A CN 115426990 A CN115426990 A CN 115426990A
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- tympanic membrane
- stabilizer
- stabilizer device
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- ear
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Abstract
将治疗药物在鼓室内注射到内耳中可用于治疗例如听力损失的病状。限定工作通道的一个或多个稳定装置可暂时植入鼓膜中。内窥镜、镊子和注射仪器等专用仪器可穿过稳定器装置的工作通道以进入内耳,在该内耳中可执行治疗。随后,稳定装置可从鼓膜移除并且鼓膜可愈合,通常不需要缝合。
Description
相关申请的交叉引用
本申请要求2020年1月24日提交的美国临时申请62/965,481、2020年5月13日提交的美国临时申请63/024,183、2020年6月17日提交的美国临时申请63/040,495、2020年7月14日提交的美国临时申请63/051,568、2020年9月11日提交的美国临时申请63/077,448、2020年9月14日提交的美国临时申请63/078,141,2020年9月18日提交的美国临时申请63/080,510、2020年9月21日提交的美国临时申请63/081,015和2020年9月24日提交的美国临时申请63/082,996的优先权益。在先申请的公开内容通过引用整体并入本文。
背景技术
听力损失可以是各种耳部病症的结果。传导性听力损失(CHL)涉及声音到达耳蜗中的毛细胞的正常机械途径的损失,例如由于畸形、中耳液体积聚、肿瘤存在和/或听小骨损伤。感音神经性听力损失(SNHL)是由于耳蜗毛细胞缺失或受损或者听神经受损所致。SNHL通常与暴露于大噪声、头部创伤、衰老、感染、梅尼埃病、肿瘤、耳毒性等相关。
听力损失的治疗方法是已知的。需要能够在治疗听力损失和其他耳部疾病,特别是中耳和内耳疾病中提供治疗效果的安全、直接和有效的药物递送装置和方法。
附图说明
现在将参照以下附图详细描述这些和其他方面。一般而言,这些图不是绝对或相对按比例的,而是旨在说明性的。此外,出于说明清楚起见,可修改特征和元件的相对放置。
图1示出冠状截面视图中的耳朵的解剖结构;
图2和3示出跨鼓膜定位的稳定器装置的实施方式;
图4示出了定位在插入工具上的图2的稳定器装置;
图5和6示出定位在鼓膜外部的稳定器装置的其他实施方式;
图7A-7B分别示出结合图5的稳定器装置使用的处于收缩和扩展配置的稳定器支腿;
图8A-8B示出定位在鼓膜外部的稳定器装置的另一个实施方式;
图9-10示出定位在鼓膜外部的稳定器装置的其他实施方式。
具体实施方式
传导性听力损失(CHL)涉及声音到达耳蜗中的毛细胞的正常机械途径的损失,例如由于畸形、中耳液体积聚、肿瘤存在和/或听小骨损伤。感音神经性听力损失(SNHL)是由于耳蜗毛细胞缺失或受损或者听神经受损所致。SNHL通常与暴露于大噪声、头部创伤、衰老、感染、梅尼埃病、肿瘤、耳毒性以及遗传疾病(如Usher病)等相关。
取决于病因,SNHL的治疗可包括用于毛细胞和耳蜗神经传入再生、耳蜗氧化应激损伤的逆转以及细胞凋亡抑制和炎症逆转的药物治疗。有几种用于治疗听力损失的处于临床开发最后阶段的药物,包括STS(FennecPharmaceuticals),用于预防顺铂诱导的听力损失;AM-101(AurisMedical),用于治疗耳鸣;AM-111(AurisMedical),用于急性内耳听力损失中的耳保护;OTO-104(Otonomy),用于治疗梅尼埃尔病;SPI-1005(SoundPharmaceuticals),用于治疗轻度至中度急性噪声诱导的听力损失和治疗梅尼埃尔病。
内耳难以有效治疗。例如,内耳仅占平均循环血液体积的0.004%,并且包裹在体内最致密的骨骼之一中。这些再结合血迷路屏障(BLB)的存在,限制了大多数治疗剂进入内耳。口服、静脉和肌内施药途径效率低下,并需要高剂量和全身性副作用的风险。局部药物递送方法也是已知的。例如,内耳治疗药物(例如配制为生物相容性凝胶的药物)可穿过鼓膜(TM)通过鼓室内注射递送到中耳中。由于解剖学变化,例如存在覆盖圆窗膜的假膜、注射制剂未能接触圆窗膜以及圆窗和椭圆窗膜的渗透率有限,所以在鼓室内注射之后,药剂从中耳被动扩散到内耳具有可变的功效。此外,快速清除内耳周围淋巴的药剂导致需要重复的鼓室内注射,这对于患者是不期望的并且除了较低顺应性的风险之外,还与感染、炎症和对鼓膜的长期损伤的累积风险相关。将制剂精确放置在圆窗膜附近以及评估和去除假膜结构将大大提高治疗的有效性,但利用当前的鼓室内手术无法容易地实现,该手术在不使中耳结构可视化的情况下是“盲目”进行的。
也可以通过圆窗膜或通过钻出小耳蜗造口将药剂或药物释放植入物直接注入内耳来实现将治疗药物直接输送到内耳。该手术类似于用于人工耳蜗刺激的植入物放置。然而,此类手术目前以相对侵入性的方式通过创建耳后切口并且钻穿乳突骨至中耳腔来执行。当前中耳和内耳手术的侵入性程度太高,无法证明将治疗药物精确递送到内耳以用于临床试验和随后作为内耳病症的有价值的治疗。需要采取侵入性较小的办法。
本文描述的系统提供以微创方式通过耳道和鼓膜进入中耳,提供更有效的内耳治疗药物施用,无论是通过鼓室内施药还是耳蜗内施药。本文所描述的系统还改善了各种耳科外科手术的可及性,例如胆脂瘤切除、鼓膜修复和听小骨链修复,并且允许它们以较少侵入性的方式进行。
本文所述的材料、化合物、组合物、制品和方法可以通过参考以下对所公开主题的具体方面和其中包括的示例的详细描述而更容易地理解。在公开和描述本发明材料、化合物、组合物、制品、装置和方法之前,应理解,以下描述的方面不限于特定方法或特定药剂,因此可变化。还应当理解,本文使用的术语仅用于描述特定方面的目的,并不旨在限制。
除非另外定义,否则本文使用的所有技术和科学术语具有与本发明所属领域的技术人员通常所理解的相同的含义。除非另有说明,否则本文在整个公开内容中提及的所有专利、专利申请、公开申请和出版物、网站和其他公开材料以引用的方式整体并入。如果本文中存在多个术语的定义,则以本节中的术语为准。在引用URL或其他此类标识符或地址的情况下,应理解,此类标识符可以改变并且互联网上的特定信息可以进出,但是等效信息是已知的并且可以容易地访问,例如通过搜索互联网和/或适当的数据库。对其引用可以证明此信息是可以获得和公开传播的。
如本文所使用,在本公开的全文中使用相对方向术语,例如前部、后部、近端、远端、侧向、中间、矢状、冠状、横向等。此类术语用于描述装置和装置的特征,并且并不旨在限定。例如,如本文所用,“近端”通常意指最靠近使用者植入装置并且最远离植入目标位置,而“远端”意指最远离使用者植入患者中的装置并且最靠近植入目标位置。
如本文所用,疾病或病症是指由例如感染或遗传缺陷引起的生物体中的病理状态,并且特征在于可识别的症状。
如本文所用,治疗意指改善或其他有益地改变病状、病症或疾病的症状的任何方式。治疗还包括本文描述和提供的装置的任何外科或药物用途。
如本文所用,例如通过施用特定药用组合物来改善或缓解特定病症的症状是指,可归因于施用组合物的或与施用组合物相关的任何缓解,无论是永久的或暂时的、持久的或瞬时的。
如本文所用,用于治疗特定疾病的化合物的有效量是足以改善或以某种方式减少与疾病相关的症状的量。此类量可作为单剂量施用或可根据方案施用,由此其是有效的。该量可治愈疾病,但通常施用该量以改善疾病的症状。可需要重复施用以实现所需的症状改善。药学有效量、治疗有效量、生物有效量和治疗药物量在本文中可互换地用于指足以实现期望结果(即治疗效果)的治疗药物的量,无论是定量还是定性的。特别地,药学有效量在体内是导致减少、延迟或消除受试者的不期望的作用(例如病理、临床、生物化学等)的量。
如本文所用,缓释包括在延长的时间段内释放有效量的治疗剂的活性成分。缓释可包括活性成分的一阶释放、活性成分的零阶释放或其它释放动力学,例如零阶和第一阶的中间体或其组合。缓释可包括通过由跨多孔结构的浓度梯度驱动的被动分子扩散来控制治疗机释放。
如本文所用,受试者包括计划诊断、筛选、监测或治疗的任何动物。动物包括哺乳动物,如灵长类动物和家畜。示例性灵长类动物是人。患者是指患有疾病病状或者对其而言疾病病状将被确定或疾病病状的风险将被确定的受试者,例如哺乳动物、灵长类动物、人类或牲畜受试者。
如本文所用,与商品名一起提及的治疗剂涵盖以商品名可商购获得的治疗剂的制剂、可商购获得的制剂的活性成分、活性成分的通用名称或包含活性成分的分子中的一种或多种。如本文所用,治疗药物或治疗剂是改善疾病或病症的症状或改善疾病或病症的药剂。治疗剂、治疗化合物、治疗方案或化疗包括常规药物和药物疗法,包括本领域技术人员已知且本文其他地方描述的疫苗。治疗剂包括但不限于能够控制、缓释到体内的部分。
如本文所用,组合物是指任何混合物。它可以是溶液、悬浮液、乳液、液体、粉末、糊剂、水性的、非水性的或此类成分的任何组合。
如本文所用,流体是指可流动的任何组合物。因此,流体涵盖呈半固体、糊剂、溶液、水性混合物、凝胶、洗剂、乳膏和其它此类组合物的形式的组合物。
如本文所用,试剂盒是包装的组合,任选地,包括使用该组合和/或其它用于此类用途的反应和组分的说明书。
现在参照附图,图1示出了显示外耳、中耳和内耳以及颅骨35和咽鼓管45的一部分的耳朵的解剖结构。外耳包括耳廓和耳道40。鼓膜5在外耳道40与中耳或鼓室30之间提供屏障。内耳可分为骨迷路和膜迷路。内耳的骨迷路内的结构腔包括前庭10、半规管15和耳蜗20。耳蜗20的毛细胞在将声信号转化成神经脉冲中至关重要。毛细胞被沐浴在分泌的流体中,如由排列在骨迷路中的细胞供给的外淋巴液和膜迷路内的内淋巴液,这有助于辨别振动,以帮助听觉过程,并维持平衡感和均衡感。圆窗25包括圆窗膜,该圆窗膜结合耳蜗20的椭圆窗允许耳蜗20中的流体移动。
本文描述被配置来以无缝、微创的方式通过鼓膜直接进入中耳腔的装置。例如,本文描述的装置提供到中耳的直接通路,以便将一种或多种治疗剂、植入物、储器、专用仪器(例如内窥镜、切割器、镊子、针头、抽吸装置、激光器等)直接递送到内耳或中耳腔。通过鼓膜的直接通路更安全,侵入性更低,并且在移除装置后不需要对鼓膜进行密封或缝合。
本文描述的装置可以是纯机械装置或可以是至少部分供电的仪器。在一些实施方式中,如下文将更详细描述的,该装置并入可向使用者提供稳定化、引导和/或可视化的一个或多个特征,从而允许在手术期间对注射的相对位置进行更好的控制并理解注射的相对位置,以使得可即时做出明智选择。
虽然以下描述了通过鼓膜的外科手术方面的工具和方法,但应认识到,其他外科手术可以调整该方法以在耳朵中产生其他类型的无缝合外科手术。可以使用本文所描述的任何装置和系统来递送工具和/或药剂的任何数量的组合。此外,外科手术包括针对成人以及儿科应用实施的手术。
在准备对耳朵进行外科手术之后,外科手术人员通常将稳定器装置安装在工具上,例如图4示例性示出的插入工具。稳定器装置可通过耳道40插入并且植入鼓膜5中。根据需要重复此插入手术以插入一定数量的稳定器装置以满足给定手术的需要。在一些实施方式中,外科手术同时使用两个手术仪器。可插入两个稳定器装置以容纳两个手术仪器。
图2和3示出定位在鼓膜5内的稳定器装置100的实施方式。装置100可以包括近端部分102、远端部分106及位于近端部分102和远端部分106之间的跨膜区域105。在一些实施方式中,跨膜区域105和远端部分106被配置为穿透鼓膜5,而近端部分102被配置为保持在鼓膜5的外部。
远端部分106的尺寸和形状被设定为以微创方式穿过鼓膜5,使得其定位在鼓膜5远端的中耳内。远端部分106的长轴可以被定向为在插入点处大致或基本上垂直于鼓膜5的外表面。远端部分106的远端108可被定向成使得长轴相对于鼓膜5和/或装置100的纵向轴线A呈任何角度。远端部分106的尺寸被设定成具有足够小的宽度,以使得从鼓膜5移除远端部分106留下不需要缝线来愈合的切口或开窗。在一些实施方式中,远端部分106的最大直径不大于约2mm,以使得其可插入通过长度不大于3mm的开窗。
远端部分106可从第一外径向远端逐渐变小至较小的第二外径。在一些实施方式中,远端部分106逐渐变小到远端108。远端108可被锐化以穿透鼓膜5。例如,可以在插入期间将力施加到稳定器装置100,以致使远端108刺穿鼓膜5并且在不形成先前开窗的情况下穿过鼓膜5。远端108可形成使对所穿透的组织的损伤最小化的非创伤性尖端。远端108可加入针头技术的各种非取芯斜面形状中的任一种,以促进装置100插入穿过鼓膜5。在其它实施方式中,远端部分106逐渐变小到较小外径的远端108,但是远端108通常是钝的。在这个实施方式中,稳定器装置100可插入穿过鼓膜5中的预成形开窗。在其它实施方式中,装置100可以预加载到在远端具有尖锐的管或柱元件(例如针或刀)的引入工具上,当处于加载的配置时,尖锐的管或柱元件延伸超过部分108。这个尖锐的元件可以产生开窗并且可以在装置100到位之后撤出,从而使工作通道110在最终植入的配置中保持打开。无论远端108是像针一样尖锐还是大体上钝化,远端部分106的逐渐变细都允许稳定器装置100顺利地穿过鼓膜5,以避免在远端前进期间卡在膜上。
近端部分102被配置并尺寸设定为防止稳定器装置100过度插入穿过鼓膜5。例如,近端部分102可以形成与远端部分106和介入跨膜区域105相比直径增大的凸缘。近端部分102相对于装置100的长轴A的角度布置可有助于防止近端部分102通过鼓膜5。例如,近端部分102可相对于装置100的长轴A大致以直角延伸。稳定器装置100的远端部分106可插入穿过鼓膜5,直到鼓膜5被接收在跨膜区域105内并且较大直径的近端部分102邻接在鼓膜5的外表面上。
近端部分102可将近端开口112限定到工作通道110中,工作通道110延伸穿过稳定器装置100到达在远端108处或远端108附近的远端开口114。稳定器装置100的工作通道110可以是完全封闭的内腔,该内腔从近端部分102中的近端开口112延伸到在远端108处或远端108附近的远端开口114。在其他实施方式中,工作通道110可以是未完全封闭的弯曲引导表面(例如,c形),但被配置来接收仪器的弯曲外表面以引导仪器穿过鼓膜5。工作通道110的形状被配置来对插入通过装置100的手术仪器的形状进行几何互补。工作通道110的形状通常是圆柱形的或弧形的。工作通道110的尺寸被配置来互补所插入的手术仪器的尺寸。在一些实施方式中,工作通道110可具有约25规格的或0.5mm至约1.0mm的截面直径。
应理解,稳定器装置100的总长度可变化。在一些实施方式中,稳定器装置100从近端开口112至远端开口114为约1.5mm至约3mm长,并且由相对刚性的材料形成。在其他实施方式中,稳定器装置100从近端开口112至远端开口114为约1.5mm至约5mm长,并且由与柔性插管相似的相对柔性的材料形成。在每个实施方式下,较小直径的跨膜区域延伸约0.1mm至约1.5mm的长度,该跨膜区域被配置为横穿鼓膜5并且维持稳定器装置100在膜5内的定位。
远端部分106可以在插入装置时扩张鼓膜5中的切口,使得跨膜区域105捕获在切口内。远端部分106的长度可足以允许稳定器装置100延伸到中耳中,使得远端开口114被定位成远离鼓膜5的内表面。然而,远端部分106的尺寸应最小化,以便避免装置与中耳结构之间的接触。
近端部分102可提供足够的表面积和厚度,以防止稳定器装置100被推动穿过鼓膜5,并且提供足够大的表面积,以便手术人员识别和定位位于鼓膜5内的装置100。近端部分102的尺寸(例如,外径或厚度)可变化。在一些实施方式中,近端部分102的外径可在约2mm至约5mm之间。近端部分102可以用作装置100的手柄,或者近端部分102可以另外并入抓握特征件,该抓握特征件被配置来由使用者操纵以用于将装置从耳朵插入和移除。抓握特征件可利用工具(例如成对件或镊子)或通过专门被配置来与抓握特征件配合的插入工具来抓握。
跨膜区域105可具有相对于近端部分102的外部尺寸,外部尺寸大小和形状被设定为在远端部分106插入穿过鼓膜5时接收鼓膜5。跨膜区域105可具有介于0.25mm与1.0mm之间的外径。跨膜区域105可沿着稳定器装置100的长轴A具有在约0.10mm与0.5mm之间的长度。跨膜区域105的外径和长度足以接收鼓膜5的厚度,同时防止在插入装置100时无意中将屈曲、撕裂或其它力施加在膜5上。跨膜区域105的外径可沿着其长度变化。图2示出具有跨膜区域105的稳定器装置100的实施方式,该跨膜区域105基本上是圆柱形的,使得外径沿其长度保持相对恒定。图3示出具有跨膜区域105的稳定器装置100的实施方式,跨膜区域105沿装置100的纵向轴线A具有弯曲几何形状。在这个实施方式中,在远端部分106朝向装置100的远端108逐渐变小之前,外径朝向远端扩大。跨膜区域105的至少一部分的外径可以大于远端部分106在其最近端处的外径(参见图3)。
跨膜区域105可具有被配置来帮助将装置100保持在鼓膜开窗内的形状。跨膜区域105可形成环面或环形。跨膜区域105的横截面轮廓可以是圆形的。跨膜区域105的横截面轮廓可以是细长的,并且被设定尺寸为对应于在插入装置100时穿过鼓膜的开窗的形状。例如,开窗可以是狭缝形状的小切口。跨膜区域105的细长横截面轮廓可改善装置100在这个穿过鼓膜5的狭缝形状开窗内的配合。细长横截面可包括长于第二尺寸的第一尺寸,形成扩张狭缝、扩张狭长孔、片状、椭圆形、卵形、双凸形或椭圆形形状。
稳定器装置100可由具有刚性和强度的材料形成以从鼓膜5插入和移除,同时还承受在操纵从中插入的手术仪器期间可能出现的应力。在一些实施方式中,稳定器装置100的至少一部分由外科手术金属(例如不锈钢、钛、铂、镍钛诺)和/或塑料(例如聚酰亚胺、PEEK、氟聚合物、硅酮等)形成。在一些实施方式中,装置100的插入部分可由聚酰亚胺形成并且具有不超过约20规格(8mm)的最大外径。稳定器装置100的一个或多个部分可涂覆有适形材料或由适形材料形成。例如,保持特征102可涂覆有例如硅酮或聚氨酯的材料或通过使用例如硅酮或聚氨酯的材料包覆模制而形成。
稳定器装置100可以是整体的单件结构,使得近端部分102、跨膜区域105和远端部分106全部是相同结构的一部分。还应理解,稳定器装置100的一个或多个部分可以是装置100的单独部件,其被布置来彼此一起工作,但不一定彼此刚性地附连或集成。例如,近端部分102和远端部分106可彼此可移除地联接。
稳定器装置100被配置为和尺寸设定为使得其从鼓膜5移除不需要使用缝线来密封在插入稳定器装置100期间在鼓膜中形成的切口或开窗。一般来说,穿过鼓膜5的自密封开窗的长度不大于约2mm,优选介于约0.5mm与1.5mm之间。虽然本文所描述的工具和方法提供无缝接近中耳和/或内耳的优点,但这并不排除外科医生在移除稳定器装置100后应用一种或多种闭合技术。例如,如果外科医生希望如此,那么可以执行用于闭合鼓膜5中的开窗的一个或多个技术。
在使用中,使用者可以在鼓膜5中形成一个、两个或更多个开窗。开窗直径可介于约0.25mm与1.25mm之间。可以使用适当的切割工具(例如刀片、针头、环锯、激光器或其他工具)来执行开窗。稳定器装置100可植入到每个鼓膜开窗中。在一些实施方式中,开窗是穿过鼓膜的切片,例如可以用针头制成。在其它实施方式中,开窗是鼓膜中的孔(例如,由激光或环锯制成)。定位在孔内的稳定器装置的尺寸可被设定尺寸以配合该孔,使得施加在仪器上的力围绕孔的外缘分布以防止进一步的撕裂。
在一些实施方式中,用于在鼓膜5中形成开窗的切割工具是稳定器装置100的远端108。在其它实施方式中,切割工具是用于插入稳定器装置100的工具的一部分。例如,稳定器装置100可以安装在插入工具200上(参见图4)。插入工具200可包括被配置来由使用者抓握的近端手柄205、可相对于手柄205移动的一个或多个致动器210、从手柄205的远端突出的远端递送轴210以及管心针212。管心针212可通过稳定器装置100的工作通道110插入,使得管心针212的远端尖端214从稳定器装置100延伸超过远端开口114。管心针212的远端尖端214可以像针一样有斜面,因此它可以用于形成穿过鼓膜5的开窗。致动器210可被致动以释放装置100,从而使其保持在耳朵内的适当位置。
手柄205可由高性能工程热塑性塑料(例如,PTFE)或金属(例如不锈钢或铝)制成,这取决于插入工具200旨在是耐用的还是一次性的。手柄205可以是整体、单件、模制构造,或者可以由被配置来联接在一起的两个或更多个面板形成。手柄205可包括螺纹或摩擦配合面板,螺纹或摩擦配合面板被配置来打开以接取手柄205的内部。手柄205的形式因素可以类似于耳镜、注射器、窥镜或其他用于耳朵的手持式仪器。手柄205可包括角弯曲部,以确保通过手术显微镜的畅通视图,或一个或多个抓握特征件,例如用于抓持工具200的压痕或人体工程学特征件。
如所提及,手柄205可并入一个或多个致动器210,例如安装在手柄205的一部分上的一个或多个柱塞、触发器、按钮、开关、键、滑动器或其组合,这些元件被配置来被激活例如缩回、伸展、按压、挤压、滑动或以其他方式致动以执行工具200的某些功能。一个或多个致动器210可以人体工程学上舒适的方式并入手柄205的一部分,例如手持部分。
稳定器装置100可被提供为套件的一部分,该套件包括一个或多个稳定器装置100、插入工具200、具有或不具有被配置来插入穿过稳定器装置100的手术仪器。
一旦稳定器装置100定位在鼓膜5内,就可穿过装置100的工作通道110插入一个或多个仪器。工作通道110可提供用于引入穿过装置100的各种仪器或流体中的任一种的通道。仪器可以穿过工作通道110重复插入和移除,而不会对鼓膜5造成损坏或应变。通常,插入穿过工作通道110的仪器可以具有介于0.25mm与0.80mm之间的外径。
可插入穿过工作通道110的各种仪器中的任一种包括切割仪器、输注仪器、抽吸仪器、透光仪器、能量施加仪器、组织操纵仪器、植入物递送仪器,可插入穿过稳定器装置100的工作通道110。插入穿过一个或多个稳定器装置100的工作通道110的仪器可包括具有或不具有光源并且具有或不具有工作通道的小规格内窥镜。插入穿过一个或多个稳定器装置100的工作通道110的仪器可包括定制用于中耳照明的“枝形吊灯”光纤光源。小规格枝形吊灯光纤光源可直接提供到中耳中的免提内照明,并且当用经外耳道照明观察时可减少鼓膜的反射,从而改善中耳结构的可视化。插入穿过一个或多个稳定器装置100的工作通道110的仪器可包括用于假膜解剖的微切割器/垂直剪刀。在一些实施方式中,垂直剪刀的切割角度(即,刀片相对于轴的角度)可以在45-120度之间。插入穿过一个或多个稳定器装置100的工作通道110的仪器可包括用于假膜移除的弯曲抽吸拾取器/镊子。插入穿过一个或多个稳定器装置100的工作通道110的仪器可包括可与光纤部件集成。在一些实施方式中,漫射光源可穿过工作通道110放置到中耳中,从而允许更好的跨鼓膜直接可视化。这可提供所关注特征的内部照明并且避免与外部照明相关联的问题,例如光反射。一旦植入,可通过稳定器装置100执行各种外科手术治疗中的任何一种。
用于中耳可视化的小规格内窥镜可通过侵入性较低的鼓膜穿孔插入。耳科中通常使用的内窥镜直径为约3mm。可为耳朵设计更小的高分辨率宽视野内窥镜(例如23G),以使得能够通过鼓膜中的小穿孔进行可视化而不会产生外科鼓室瓣。
在一些实施方式中,插入穿过工作通道110的仪器被配置来一旦离开工作通道110的远端开口114就改变形状和/或方向。这允许将仪器定位在例如圆窗膜缝隙处以用于穿孔、沉积材料和/或移除假圆窗膜缝隙。作为示例,仪器可以是可伸展、可铰接和/或弯曲的微型插管,以用于在RWM上、在RWM处或通过RWM精确注射和/或放置药物制剂或可植入装置。本文考虑了各种其他器械,包括弯曲、可伸展和/或可铰接的排气或小规格针、用于RWM穿孔的超锋利刀以控制进入内耳腔、金刚石粉末镊子和刮刀以改善抓握和刮擦,以及用于RWM渗透性增强的内激光。
稳定器装置100提供用于调查中耳病症并且用于递送治疗药物以治疗内耳病症。例如,稳定器装置100可用于精确地将药物产品放置在椭圆窗或RWM处或附近,去除可能抑制药物产品吸收到内耳的任何假膜或其他粘膜阻碍。稳定器装置100还可以在RWM、椭圆形窗口或用于治疗内耳病症的其他接入点处或附近提供更好的可视化或精确放置植入物或装置。
在完成外科手术或施用治疗之后,移除稳定器装置100并且留下鼓膜5单独愈合而不需要另外的治疗。
鼓膜5是易于损伤的精妙组织。然而,与膜5的直接接触可为获得适当的仪器深度(例如,在用针注射期间)提供指导。图5-6示出稳定器装置1100的相互关联的实施方式,稳定器装置1100在耳道内不穿透鼓膜5并且被配置来保持完全在鼓膜5的外部。稳定器装置1100可包括近端锚定件1105,近端锚定件1105被配置来可调节地锚定到耳道40并且联接到远端插管1106,远端插管1106被配置来定位于邻近鼓膜5的外表面。工作通道1110可从近端开口1112延伸穿过装置1100至远端开口1114。远端开口1114可定位在远端插管1106的远端1108处,以用于将微创仪器插入穿过稳定器装置1100并且穿过鼓膜5。
近端锚定件1105可从具有小外径的插入配置扩展到具有较大外径的展开配置,该展开配置被配置来将装置1100保持在耳道40内的适当位置。近端锚定件1105可以用足够的力和/或摩擦安全地接合周围耳道40,以抑制在治疗期间稳定器装置1100或插入穿过稳定器装置1100的仪器的移动。
近端锚定件1105的配置可以变化,包括一个或多个环、支撑腿、泡沫、气球、可膨胀网或其他锚定件。近端锚定件1105可以是适形的或可压缩的,使得其在插入时变形并呈现耳道40的形状。在一些实施方式中,近端锚定件1105可包括由外部可压缩层覆盖的内层。近端锚定件1105的外部可压缩层可包括可压缩泡沫,例如聚氨酯泡沫。可选地,近端锚固件1105可由以下材料形成:例如橡胶化合物、聚氨酯、氟碳弹性体、丁基橡胶、EPDM(乙丙橡胶)、乳胶橡胶、氯丁橡胶(聚氯丁二烯)、丁腈橡胶(丙烯腈)、聚丁二烯、硅橡胶、SBR(苯乙烯-丁二烯橡胶)、HNBR(氢化丁腈橡胶)、氟橡胶、氟硅橡胶。
近端锚定件1105可在耳道40内弹性膨胀或包括软固体弹性体或可塑性变形聚合物。近端锚定件1105还可包括主动膨胀特征件,例如气球、支撑环等。图5示出具有可膨胀气球作为近端锚定件1105的稳定器装置1100的实施方式。图6示出稳定器装置1100的实施方式,稳定器装置1100具有被配置来在朝向鼓膜5插入时顺应耳道40的多个支撑环或柔性凸缘。
近端锚定件1105可在耳道40内提供对准并且将远端插管1106引导朝向鼓膜5的所需位置。近端锚定件1105可以是大体上圆柱形的,外径被配置来用于平滑和舒适地插入耳道40并且与耳道40接合。近端锚定件1105可允许在耳道壁与其外表面之间形成轻微密封。近端锚定件1105的长度可变化。近端锚定件1105的至少一部分可朝向远端插管1106逐渐变小,远端插管1106可具有比近端锚定件1105的近端区域更小的外径。
工作通道1110可以具有统一的内径,如图5和6中所示。工作通道1110还可具有沿其长度变化的内径。例如,工作通道1110可以是锥形的,在远端开口1114处或附近以及邻近鼓膜5具有最小内径。这种配置将延伸穿过工作通道1110的仪器的支点定位成靠近鼓膜5,并且在仪器的操纵和移动期间减轻对鼓膜5的损坏。
在一些实施方式中,稳定器装置可并入类似于鼓室造口管或“索环”的结构。如上文所讨论的,穿过鼓膜的将稳定器放置到其中的开窗可以是由激光器或环锯制成的孔或由手术刀片或针制成的切片。定位在孔内的稳定器装置的尺寸可被设定尺寸以配合该孔,使得施加在仪器上的力围绕孔的外缘分布以防止进一步的撕裂。装配到鼓膜上的孔中的索环状稳定器装置可以被留下,并且允许仪器在手术过程中以将仪器力分布在鼓膜上从而防止撕裂的方式进出中耳。与索环状稳定器装置组合或作为单独的、独立的方法,支架或固定装置(例如本文中别处描述的近端锚定件)可定位在耳道内,从而允许仪器力朝向耳道壁而不是仅由鼓膜引导。
这个耳道支架的配置可以如本文所描述而变化。图8A-8B示出稳定器装置1100的实施方式,稳定器装置1100包括定位在耳道40内的与耳窥镜类似的近端锚定件1105。近端锚定件1105可进一步减少将在仪器操纵、旋转等期间施加在鼓膜5上的力。近端锚定件1105可以是圆锥形可调节窥镜或配合到耳道40的锥体形状。近端锚定件1105可以是螺纹的或以其他方式伸缩的,以允许在紧邻鼓膜5处进行调整。仪器可穿过近端锚定件1105的内部并且穿过位于邻近鼓膜5的近端锚定件1105的远端面上的一个或多个小环1116(例如,直径为0.5mm至1.0mm),从而提供仪器将围绕其旋转的支点。近端锚定件1105的圆锥形状可限定较大的内观察通道,并且位于圆锥的远端处的环1116可提供较小的工作通道,一个或多个仪器可插入穿过该工作通道。环1116可为如本文其他地方所描述的仪器操纵提供稳定化和引导。
在一些实施方式中,近端锚定件1105可以是可膨胀网、编织物、支架、篮子、笼子或其他结构元件,可膨胀网、编织物、支架、篮子、笼子或其他结构元件被配置来从适合于插入的较小尺寸扩大到被配置来配合耳道内并锚定在耳道上的较大尺寸(参见图9-10)。在一些实施方式中,近端锚定件1105可具有锥形形状,使得穿过锚定件1105的中心开口提供到鼓膜的通道,如上所述并且如图9中示出。在其他实施方式中,近端锚定件1105可在鼓膜5附近的远端区域处闭合(参见图10)。与鼓膜5相邻的网格中的开口可被设定尺寸以允许仪器通过。可以在放置近端锚定件1105之后在鼓膜5中产生开窗,以确保网格开口对准以用于器械通过进入中耳30。近端锚定件1105可具有多种形状中的任一种。近端锚定件1105可以是篮形的或杯形的,使得其在近端上打开,以允许仪器围绕远端网格开口最大程度地旋转。可替代地,网格开口的尺寸可以变化,从装置的近端到远端逐渐变小。在手术结束后,可折叠并移除近端锚定件1105。
在一些实施方式中,稳定器装置1100的形状和形式因素可以类似于耳窥镜。例如,稳定器装置1100可包括倾斜截头锥形形状和允许插入耳道40中到有限深度而不损伤耳朵的平滑表面。
工作通道1110可延伸穿过近端锚定件1105和远端插管1106两者。工作通道1110可被设定尺寸以接收如上所述的各种仪器中的任一种。工作通道1110可以与装置1100的纵向轴线A同轴,或者可以与该轴线A偏移。
图7A-7B示出包括多个支腿1200的稳定器装置1100的实施方式。支腿1200可从插入配置扩展到放大配置,在插入配置中支腿1200基本上平行于装置1100的纵向轴线A延伸,在放大配置中支腿以相对于纵向轴线A的某个角度向外延伸的。支腿1200可联接到中心壳体1205。在实施方式中,稳定器装置1100包括联接到中心壳体1205的区域的三个可折叠支腿1200,使得在延伸时,它们相对于远侧插管1106形成三翼稳定器。支腿1200可围绕装置1100的纵向轴线A对称地布置。支腿1200可各自相对于轴线A向外延伸一定角度。在扩展配置中的支腿1200的角度和长度允许支腿1200抵靠患者的耳道40放置。例如,第一支腿1200可以定位在患者的颌骨前面,第二支腿1200可以定位在患者的颅骨上靠近颈部的尾部,并且第三支腿1200可以定位在患者的颅骨上靠近头顶处的头部。每个支腿1200可并入可移动地联接到支腿1200的远端的脚构件,并且脚构件被配置来当支腿1200处于扩展配置中时向外折叠并且当支腿1200处于收缩配置中时向内折叠。支腿1200可以卡扣到扩展配置中,使得它们避免无意收缩。每个支腿1200的伸展程度可在相对于纵向轴线A的多个预设角度之间选择。每个脚构件可围绕其与支腿1200的附接点在向内和向外折叠配置之间旋转以提供与患者的定制配合以提供更好的稳定。在一些实施方式中,脚构件通过具有至少2自由度的筒状铰链式联接件联接到其支腿1200。在其它实施方式中,脚构件通过提供任何自由度的球和套筒型联接件联接到其支腿1200。本文所描述的任何稳定器装置可联接到多个支腿1200。
本文所描述的装置可并入有助于一个或多个仪器的可视化、瞄准和靶向的一个或多个特征,以防止在手术期间无意穿透和损坏耳朵中的精妙结构。本文描述的装置可联接到观察透镜,例如耳镜透镜或外科显微镜,以便使用者在装置朝向膜前进时观察鼓膜5。可并入内窥镜、视频可视化装置、光学相干断层扫描、超声波和其他观察仪器或技术,以及一个或多个照明元件,例如LED、透镜、光管、滤光片等,一个或多个照明元件在使用期间提高中耳内的可见性。还可使用使用手术显微镜或耳镜直接增强通过鼓膜观察的技术,例如通过将甘油或盐水施加到鼓膜以增加鼓膜透明度并且降低跨膜折射率结合中耳照明和/或波长滤光片也可以消除让内窥镜通过的额外端口的需要。增加膜透明度和减少跨膜的折射率变化,特别是当与中耳光源耦合时,可允许通过手术显微镜直接通过膜对中耳进行可视化。
也可通过红外(IR)成像或手术眼相干断层扫描(OCT)提供直接的经鼓室可视化。例如,通过耳道指向鼓膜的相机或探针可直接通过完整的鼓膜提供中耳结构的可视化。
治疗药物和疾病
本文所描述的治疗装置可用于治疗和/或预防多种其它病状,包括但不限于听力损失,包括隐性听力损失、噪声诱导的听力损失、年龄相关的听力损失、药物诱导的听力损失(例如化疗诱导的听力损失或氨基糖苷诱导的听力损失)、突发性感觉神经性听力损失(SNHL)、自身免疫性内耳疾病等。多种耳部病症中的任一种可使用本文所描述的装置来治疗。本文所描述的治疗装置可用于治疗其他耳朵病症,例如耳鸣。本文所描述的治疗装置可用于治疗平衡病症,包括眩晕、梅尼埃病、前庭神经元炎、前庭神经管瘤、迷路性炎等。本文所描述的治疗装置可用于治疗其他耳部病症,例如耳硬化、听小骨链脱位、胆脂瘤、中耳感染、鼓膜穿孔等。
以下提供可从本文所描述的治疗装置递送或借助本文所描述的治疗装置递送和/或描述于通过引用并入本文的申请中的治疗剂的示例。
可从本文所描述的治疗装置或借助于本文所描述的治疗装置递送的治疗药物包括但不限于抗氧化剂、抗炎剂、类固醇、抗微生物剂、NMDA受体拮抗剂、各向性剂、抗凋亡剂、神经营养蛋白、神经保护剂、神经保护蛋白质例如CNTF、BDNF、PEDF、NGF等、大麻素、单克隆抗体、其它蛋白质、基因疗法、iRNA、酪氨酸激酶抑制剂(TKI)、双亮氨酸拉链酶(DLK)抑制剂和类似于抗VEGF的蛋白质疗法。
例如,治疗剂可以包括但不限于抗微生物剂,例如抗生素,例如四环素、金霉素、杆菌肽、新霉素、多粘菌素、短杆菌肽、头孢氨苄、土霉素、氯霉素卡那霉素、利福平、环丙沙星、妥布霉素、庆大霉素、红霉素和青霉素;抗真菌药,如两性霉素B和咪康唑;抗菌药,例如磺胺类、磺胺嘧啶、磺胺乙酰胺、磺胺甲二唑和磺胺异恶唑、呋喃西林和丙酸钠;抗病毒药物,如碘尿苷、三氟胸苷、阿昔洛韦、更昔洛韦和干扰素;抗过敏药,如色甘酸钠、安他唑啉、甲氧嘧啶、扑尔敏、吡拉敏、西替利嗪和苯吡啶;抗炎药,例如氢化可的松、醋酸氢化可的松、地塞米松、21-磷酸地塞米松、氟轻松、甲地松、泼尼松龙、21-磷酸泼尼松龙、醋酸泼尼松龙、氟米松、倍他米松和曲安西龙;非甾体抗炎药,例如水杨酸盐、消炎痛、布洛芬、双氯芬酸、氟比洛芬和吡罗昔康;减充血剂,例如去氧肾上腺素、萘甲唑啉和四氢唑啉;缩瞳剂和抗胆碱酯酶,例如毛果芸香碱、水杨酸盐、乙酰胆碱氯化物、毒扁豆碱、丝氨酸、卡巴胆碱、氟磷酸二异丙酯、碘化膦和溴化地麦草胺;散瞳药,如硫酸阿托品、环喷托品、后马托品、东莨菪碱、托品酰胺、本领域技术人员已知的能够以本文所描述的方式控制地、持续地释放到耳朵中的其他治疗剂也适合于根据本文所描述的装置的实施例使用。
治疗剂可包括但不限于硫代硫酸钠以防止顺铂诱导的听力损失;用于治疗耳鸣的NMDA受体拮抗剂(AM-101;AurisMedical);用于急性内耳听力损失中的保护的含有合成肽D-JNKI-1(c-JunN-末端激酶抑制剂1的D-立体异构体;AurisMedical);用于治疗梅尼尔病的地塞米松;防止噪声诱导的听力损失的D-甲硫氨酸(南伊利诺伊大学);LY411575(阻断Notch活化的选择性γ分泌酶抑制剂);和NT-3神经营养因子。
治疗剂可包括但不限于用于递送至耳道中的局部麻醉剂,包括苯甲卡因、抗吡啶、丁苯、二丁卡因、利多卡因、普罗洛卡因、氧丁卡因、普拉莫辛、副卡因、代甲卡因和四卡因。
用于本文所描述的治疗剂的各种药学上可接受的载体可包括例如固体,例如淀粉、明胶、糖、天然胶例如阿拉伯胶、藻酸钠和羧甲基纤维素;聚合物,例如硅酮橡胶;液体,例如无菌水、盐水、右旋糖、在水或盐水中的右旋糖;芝麻油和环氧乙烷的缩合产物、较低分子量脂肪酸的液体甘油三酯;较低的烷醇;油,例如玉米油、花生油、芝麻油、芝麻油等,具有乳化剂,例如脂肪酸的单甘油或二甘油酸酯,或磷脂,例如卵磷脂、聚山梨酸酯80等;乙二醇和聚烷基甘油,包括P407和聚乙二醇和聚乙二醇的其它组合;水介质存在,例如悬浮剂,例如碳甲基纤维素、氢尿酸钠、氢钠、聚乙二醇酸钠、聚乙二醇(任一醇)和类似的化合物,以及单独的聚乙二醇酸酯等,以及与聚乙二醇等合适的分解剂。载体还可含有佐剂,例如保存剂、稳定剂、润湿剂、乳化剂或其它相关材料。
尽管本说明书包含许多细节,但这些不应被解释为对所要求保护的或可能要求保护的范围的限制,而是对特定实施例的特定特征的描述。在本说明书中在单独实施例的上下文中描述的某些特征也可以在单个实施例中组合实现。相反,在单个实施例的上下文中描述的各种特征也可以在多个实施例中单独地或以任何合适的子组合来实现。此外,虽然特征可以在上面描述为以某些组合起作用并且甚至最初要求如此,但是来自所要求保护的组合的一个或多个特征可以在一些情况下从该组合中删除,并且所要求保护的组合可以针对子组合或变型的子组合。类似地,虽然以特定顺序在附图中描绘操作,但是这不应被理解为要求以所示的特定顺序或按顺序执行此类操作,或者执行所有所示的操作以获得期望的结果。仅公开了几个示例和实施方式。可基于所公开的内容对所述示例和实施方式以及其他实施方式进行变型、修改和增强。已结合其详细描述来描述权利要求的主题,前述描述旨在说明而不是限制所附权利要求书的权利要求的主题的范围。
在上述描述和权利要求书中,例如“至少一个”或“一个或多个”的短语可出现在元件或特征的结合清单后。术语“和/或”也可以出现在两个或更多个元件或特征的清单中。除非另外隐含地或明确地与使用它的上下文矛盾,否则此类短语意指单独列出的任何元件或特征或任何列举的元件或特征与任何列举的其他元件或特征组合。例如,短语“A和B中的至少一个;”“A和B中的一个或多个;”和“A和/或B”各自意图意指“单独A,单独B,或A和B一起。”对包括三个或三个以上项目的清单也作类似的解释。例如,短语“A、B和C中的至少一个;”,“A、B和C中的一个或多个;”,“A、B和/或C”各自意指“单独A、单独B、单独C、A和B一起、A和C一起、B和C一起、或A和B和C一起”。
在上述和权利要求中使用术语“基于”意指“至少部分基于”,从而也允许未引用的特征或元素。
Claims (14)
1.一种用于治疗患者的内耳的系统,所述系统包括:
一个或多个稳定器装置,其配置成可移除地植入患者的鼓膜中,所述稳定器装置限定穿过所述稳定器装置的工作通道并且包括:
近端部分,其配置成在所述稳定器装置植入所述鼓膜中时抵接所述鼓膜的外表面;
远端部分,其配置成穿过所述鼓膜,使得当所述稳定器装置植入所述鼓膜中时,所述远端部分定位在所述患者的中耳内,所述远端部分从第一外径向远端渐缩至小于所述第一外径的第二外径;以及
跨膜区域,所述跨膜区域定位在所述近端部分与所述远端部分之间并且配置成在所述稳定器装置植入所述鼓膜中时接收所述鼓膜;以及
稳定器插入工具,包括:
递送轴;以及
管心针,其尺寸被设定成在所述稳定器装置安装在所述稳定器插入工具上时插入穿过所述工作通道,所述管心针包括倾斜远端,所述倾斜远端在所述稳定器装置安装在所述稳定器装置插入工具上时向远侧延伸超出所述稳定器装置的所述远端部分。
2.根据权利要求1所述的系统,其中所述管心针的所述倾斜远端的尺寸被设定成用于穿透所述鼓膜并且形成穿过所述鼓膜的开窗,所述稳定器装置可移除地植入在所述开窗中。
3.根据权利要求1或2所述的系统,其中当所述稳定器装置安装在所述稳定器插入工具上时,所述递送轴抵接所述稳定器装置的所述近端部分。
4.根据权利要求1–3中任一项所述的系统,其还包括尺寸设定成插入穿过所述工作通道的仪器,并且包括用于递送药物制剂注射剂的微型插管。
5.根据权利要求4所述的系统,其中所述微型插管是弯曲的,用于通过所述内耳的圆窗来放置所述药物制剂注射剂。
6.根据权利要求4所述的系统,其中所述微型插管是可铰接的,用于通过所述内耳的圆窗来放置所述药物制剂注射剂。
7.根据权利要求1–6中任一项所述的系统,其还包括内窥镜,所述内窥镜的尺寸被设定成插入穿过所述工作通道并且延伸到所述患者的中耳中。
8.根据权利要求1–7中任一项所述的系统,其还包括镊子,所述镊子的尺寸设定成插入穿过所述工作通道并且延伸到所述患者的中耳中。
9.一种治疗患者的听力损失的方法,所述方法包括:
将稳定器插入工具推进到所述患者的外耳中,所述稳定器插入工具携带限定第一工作通道的第一稳定器装置,所述稳定器插入工具包括递送轴和管心针,管心针具有从第一稳定器装置向远侧延伸倾斜远端;
当所述稳定器插入工具携带所述第一稳定器装置时,使用所述管心针的所述倾斜远端在所述患者的鼓膜中形成第一开窗以穿透所述鼓膜;
推进所述稳定器插入工具以将所述第一稳定器装置植入所述鼓膜中的所述第一开窗中;
将携带第二稳定器装置的所述稳定器插入工具推进到所述患者的外耳中,所述第二稳定器装置限定第二工作通道,所述倾斜远端从所述第二稳定器装置向远侧延伸;
当所述稳定器插入工具携带所述第二稳定器装置时,使用所述管心针的所述倾斜远端在所述患者的所述鼓膜中创建第二开窗;
推进所述稳定器插入工具以将所述第二稳定器装置植入所述鼓膜中的所述第二开窗中;
当所述第一稳定器装置植入所述鼓膜中时,推进第一仪器穿过所述第一工作通道;以及
当所述第二稳定器装置植入所述鼓膜中时,推进第二仪器穿过所述第二工作通道。
10.根据权利要求9所述的方法,其中,所述第一仪器包括内窥镜。
11.根据权利要求10所述的方法,其中,所述第二仪器包括微型插管。
12.根据权利要求11所述的方法,还包括经由所述微型插管将内耳治疗药物注射到所述患者的中耳中。
13.根据权利要求12所述的方法,其中,内耳治疗药物包括生物相容性凝胶。
14.根据权利要求10-13中任一项所述的方法,其中,第二仪器包括镊子。
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