CN107920780B - 用于图像引导治疗/诊断导管的微模制畸变反射透镜 - Google Patents
用于图像引导治疗/诊断导管的微模制畸变反射透镜 Download PDFInfo
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Abstract
一种用于光学相干断层扫描的导管系统,包括细长导管主体、细长导管主体中的光纤、以及与光纤远端耦合的畸变透镜组件。光纤和透镜组件一起构造成为从目标以及从光纤远端和透镜组件之间的参考界面反射的光辐射提供共路。
Description
相关申请的交叉引用
本申请要求于2015年7月13日提交的名称为“MICRO-MOLDED ANAMORPHICREFLECTOR LENS FOR IMAGE GUIDED THERAPEUTIC/DIAGNOSTIC CATHETERS”的美国临时专利申请No.62/191,956的优先权,以及于2015年7月13日提交的名称为“CARBONDIOXIDECARTRIDGE FOR BALLOON CATHETER”的美国临时专利申请No.62/191,986的优先权,其全部内容通过引用并入本文。
本申请可能涉及于2014年10月11日提交的美国专利申请No.14/400,140(名称为“OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICALIMAGING”),其全部内容通过引用并入本文。
通过援引加入
本说明书中提到的所有出版物和专利申请都通过引用整体并入本文,如同每个单独的出版物或专利申请都被明确地和单独地被指出通过引用并入一样。
技术领域
本文描述的是用于生物探针的成像装置和系统。具体而言,本文描述了应用光学相干断层扫描(OCT)的基于导管的成像系统,其具有适于使寄生背向反射最小化并提供优良的距离成像和射束直径特性的模制透镜。
背景技术
许多血管疾病,例如冠状动脉疾病和外周血管疾病,是由动脉中动脉粥样硬化沉积物(斑块)的积聚引起的,沉积物限制血液流向由该特定动脉供给的组织。由于人体血管的闭塞引用的失调,包括冠状动脉疾病(CAD)和外周动脉疾病(PAD),可能会使人衰弱并危及生命。慢性完全闭塞(CTO)可导致肢体坏疽,需要截肢,并可能导致其他并发症并最终导致死亡。越来越多地,这种阻塞的处理可以包括介入治疗,其中导丝通过导管插入患病动脉并穿入阻塞区域。在那里,阻塞可以例如通过来自膨胀的导管球囊的压力(例如球囊血管成形术)而扩张到更加张开的状态,和/或阻塞区域可以通过支架保持张开。这种阻塞的处理还可以包括使用导管从动脉内部手术去除斑块(例如,斑块旋切术)。
医疗领域感兴趣的是在导管上安装传感器,这些传感器可以帮助引导导管进行斑块旋切术、闭塞交叉和/或其他手术治疗。例如,具有这样的传感器是有用的,该传感器可以向外科医生提供关于特定组织是否患病和/或导管的切割部分距离特定血管层的边界多远的即时视觉反馈,以便将意外损害的风险降至最小。传统的放射成像方法和超声成像系统已经尝试用于这种手术治疗。然而,无论是超声波还是放射成像方法都没有足够的分辨率来帮助引导导管穿过小尺寸的操作。并且,除非组织已经变得严重钙化,否则标准放射技术不能轻易区分健康组织和患病组织。此外,超声系统的组件通常太大而不能小规模实施,例如不能构造成在血管内使用的系统。
已经提出了光学相干断层扫描(OCT)作为可以特别有助于对组织的区域成像的一种技术,所述组织的区域包括在诸如人体血管的体腔内。在基础层面上,OCT依赖于这样一个事实,即,从光源传播且从更远处的物体散射的光线比从附近的物体散射的光线传播回程时间要长。由于光的波动性质,由光信号传播距离的微米级不同所引起的非常小的时间差异可以造成对参考光信号的相长干涉或相消干涉。OCT系统测量产生的干扰以获得目标图像。典型的OCT系统需要一个或多个干涉仪将信号与所施加的光区分开。另外,当大多数已知的OCT系统应用于导管时,包括在导管内(通常以高速率)旋转的光纤以扫描内腔和第二大参考臂。
典型的OCT装置包括目标臂和参考臂以生成参考信号。为了提供干涉参考信号,OCT装置将来自光源的照明光信号分成两个相等或不等的部分,通过一个目标光学“目标臂”将照明光的一部分发送到感兴趣的目标,并且沿着一个单独的参考臂发送照明光的另一部分。来自单独的参考臂的光从反光镜反射回来,然后返回并干涉从目标反射后从目标光学臂返回的散射光。在传统的OCT装置中,参考臂的长度被设计为与目标臂长度完全相同,从而使干涉效应最大化。两个光束之间产生的干涉会形成干扰,可以通过测量来提取与目标相关的深度信息。利用此深度信息,可以生成对象的图像。典型的OCT装置还可以包括目标臂中的聚焦透镜,诸如渐变折射率(GRIN)透镜,其被构造成将从光纤出来的光聚焦到组织中。
然而,这些传统的OCT系统由于所需的参考臂而大而笨重,因此通常无法在医疗导管中使用,特别是无法与低成本一次性导管一起使用。使用共路OCT系统,即,没有单独参考臂的系统,是减小这种成像导管的成本和尺寸的一种方法。然而,开发具有共路OCT的导管存在几个困难。例如,共路OCT系统要求参考反射在与目标反射相同的光学导管内形成。为了避免系统中的噪声,必须微调该参考反射,要求从光源到反射界面的路径没有不必要的组件,例如会干扰参考反射的聚焦元件。此外,共路系统必须具有足够小的组件以装配在单个小导管的内部,因而难以包括额外的组件。最后,对于共路OCT,希望参考反射尽可能接近组织,以将成像范围保持在光源的相干长度内,并且避免数据处理负担,因为参考和成像的开始之间的距离进行数据处理没有用。因此,期望有一种共路OCT系统能解决一部分上述问题。
共路OCT导管的远端成像尖端应该执行两个主要功能:(1)将光束指向成像对象,以及(2)将光束聚焦在成像对象上以改善图像质量。此外,对于共路OCT,远端成像组件的几何形状和特性应该使得它仅引入一个主要的背向反射(参考反射)光源并避免任何会导致图像中的伪影的其他寄生反射。
已经提出了一种解决这些需求的方法(例如参见US-2015-0099984),其使用具有渐变折射率(GRIN)光纤的共路OCT系统,所述渐变折射率(GRIN)光纤附接到导管中的单模光纤的远侧末端以便充当用于聚焦光线的透镜。遗憾的是,这种解决方案已被证明存在问题。例如,难以附加任何透镜(例如,渐变折射率(GRIN)透镜),并且导致潜在的失效模式。图1表示例如导管的现有技术的装置100,其具有在光纤110的端部处保持渐变折射率(GRIN)光纤103的外壳109,形成格林斯(grins)透镜组件。在这个示例中,使用两个独立的部件完成光束的偏转和聚焦。首先,将反光镜101安装在与光纤110的轴成45度的位置,以使光束垂直于导管的轴偏转,如光束113所示。其次,为了聚焦光束,将渐变折射率光纤103接合到光纤110,这是一种单模光纤(SMF)组件。GRIN光纤103在SMF光纤110的前面接合,然后切割至精确的长度和角度,以与用于将GRIN光纤103固定在远侧末端的环氧树脂102共同来满足聚焦和参考反射要求。该SMF-GRIN组件的精确接合和切割要求使其成为装置100的昂贵组件。
此外,制造例如装置100中的这些SMF-GRIN组件所需的制造过程通常是困难的并且需要精确对准。而且,为了将GRIN光纤103接合在SMF光纤110的前面,必须将SMF光纤剥脱一定的长度(参见图1中剥脱的部分105)。SMF光纤特别是聚酰亚胺光纤的剥脱,通常会呈现光纤的长脆性部分132。SMF-GRIN组件的脆性部分132的总长度可以大于2.5mm。该脆性部分132通常必须封装在固体海波管内部,以防止远端部分在弯曲的解剖结构中成像时由于经受应力/应变而断裂。装置100中长(例如>2.5mm)海波管的存在降低了远侧末端的柔性。因此,当装置100是导管,诸如旋切术导管的一部分时,这种降低的柔性可能会使导管难以进入解剖体的弯曲部分。
此外,通过使用GRIN光纤103和单独的反光镜101可能会以聚焦长度为代价。GRIN光纤103的聚焦能力是光纤直径的函数。使用125微米GRIN光纤103,为了匹配SMF 110的直径,焦点被限制在离光纤末端1-1.5mm处。在光纤置于导管中间的成像导管中,光束的瑞利范围的相当一部分可位于导管内部。这降低了成像导管能够保持高分辨率的成像深度。
本文描述的是包括用于OCT(共路)成像系统的末端组件在内的装置以及使用它们的方法,这些装置和方法可以解决上面提出的问题。
发明内容
一般而言,本文描述了包括透镜组件的OCT设备(包括装置和系统),该透镜组件是或能够被定位在光纤的远侧末端,以提供共路OCT成像。透镜组件通常是畸变透镜组件。
在一些实施例中,畸变透镜组件具有透镜体和耦合到光纤的第一表面,来自光纤的光可以穿过该第一表面进入透镜体,从而能从第二反射表面以一定角度(例如以45度角)反射,以将光导出透镜组件并进入组织。第二反射表面可以具有复合半径,从而使得来自光纤的光束的射束轮廓在射出透镜组件(例如,在垂直于从第二表面反射的光束方向的第三平坦表面射出)时形成为大致圆形。
在其他实施例中,畸变透镜组件具有反射的凹面近侧表面,并且包括复合表面以反射其发出的光。
本文所述的透镜组件可以用作能够进行OCT成像的导管的一部分。例如,用于光学相干断层扫描(OCT)的导管可以包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及与光纤远端光耦合的透镜组件,其中所述光纤和所述透镜组件一起被构造成提供从目标以及从所述光纤的所述远端与所述第一表面之间的参考界面反射的光辐射的共路。
如上所述,透镜组件可以是折射或反射的畸变透镜组件,例如沿着彼此垂直的两个轴(例如,垂直于穿过透镜体的光路的轴)具有不均匀或不同的放大率或曲率半径。在一些变型中,畸变透镜可具体指反光镜部分的复合曲率半径。在其他变型中,畸变透镜可以指在两个垂直轴之间具有连续变化或不同曲率半径的反光镜。
在本文所述的任何变型中,透镜组件(例如,透镜组件的第一表面)可以通过环氧树脂层连接到光纤远端。
一般而言,在一些实施例中,第一表面(与光纤远端直接相对的表面)可以相对于光纤远端(光线从其射出)在约2度至40度之间的角度,例如,角度可以在约5度至13度之间、约2度至20度之间、6度至10度之间、约8度等等)。此外,第二(反射的或镜像的)表面相对于光纤远端形成角度,使得在通过透镜体的第一表面之后传播到光纤远端或从光纤远端离开的光被第二表面反射并横向导出透镜。例如,第二表面可以相对于光纤远端形成大约10度至大约60度之间(例如,20度至50度、30度至50度、40度至50度、大约45度等)的角度。
在一些实施例中,反射近侧表面可以相对于光纤远端形成角度,使得传播到光纤远端和从光纤远端离开并照射在近侧表面上的光被反射并且横向导出透镜。例如,近侧表面可以相对于光纤远端形成大约10度至大约60度之间(例如,20度至50度、30度至50度、40度至50度、大约45度等)的角度。
可以通过将反射材料涂覆(和/或附着)到第二表面的外表面来形成反射性第二表面。涂覆第二表面的反射材料的涂覆厚度可以被配置成反射超过70%(例如,超过75%、超过80%、超过85%、超过90%、超过95%等等)的光。可以使用任何适当的反射材料。例如,反射材料可以包括金、银、铂等
通常,反射表面可以具有复合半径,例如在x轴和y轴上具有不同半径的复合半径。复合半径可以被构造成使得从第二表面反射的光(例如,光束)具有当其离开透镜体时比在其进入透镜体时更圆的射束轮廓。
透镜(例如,透镜体)可以由任何材料形成,特别是可以模制的材料。例如,透镜体可以由具有相对于光纤的折射率不匹配的折射率的聚碳酸酯材料形成。因此,例如,来自光纤和透镜组件之间的界面的光辐射的二次反射可以小于-60dB。此外,参考界面可提供约-28与约-42dB之间的参考反射。
本文描述的任何透镜设备和/或包括这些透镜设备的任何导管可以被构造成包括光源和接收用电子器件的系统,所述电子器件可以包括用于生成OCT图像的处理器。例如,用于光学相干断层扫描(OCT)的系统可以包括:光辐射源;从远侧向近侧延伸的光纤;以及与光纤远端光耦合的透镜组件;其中光纤和透镜组件一起构造成为从光纤远端与第一表面之间的参考界面和从目标反射的光辐射提供共路。该系统还可以包括被构造成接收从参考界面和目标反射的光辐射的接收用电子器件,以及基于由接收用电子器件接收的光辐射来生成目标的图像的处理器。
本文还描述了生成OCT图像的方法,包括传导来自光纤的光并使其进入或离开如本文所述的透镜设备。该方法可包括产生最小(例如,小于-55dB)的二次反射结果。该方法还可以包括以约30度至60度(例如,约45度)之间的角度反射来自反射表面的光(光束),使其横向地从装置射出并进入组织,然后收集从组织返回的光并将其传回至镜体并进入光纤,在光纤中其可被收集并处理(例如,使用接收器和/或处理器)以形成光学相干断层扫描图像。
一般而言,在一个实施例中,用于光学相干断层扫描(OCT)的导管系统包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及与光纤远端光耦合的透镜组件。该透镜组件包括透镜体,该透镜体具有第一表面和第二表面,该第一表面与该光纤远端相对并与其成角度,该第二表面在该第一表面的远侧。第二表面涂覆有反射材料,使得从光纤远端穿过第一表面进入透镜体的光从第二表面反射而离开透镜体。光纤和透镜组件一起构造成为从目标和从光纤远端与第一表面之间的参考界面反射的光辐射提供共路。
一般而言,在一个实施例中,用于光学相干断层扫描(OCT)的导管系统包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及与光纤远端光耦合的透镜组件。该透镜组件包括透镜体,该透镜体具有第一表面和第二表面,该第一表面与该光纤远端相对并与其形成角度,该第二表面在该第一表面的远侧。第二表面具有复合半径,该复合半径具有沿着第一轴的第一半径,第一半径不同于沿着第二轴的第二半径。从光纤远端穿过第一表面进入透镜体的光从第二表面反射而离开透镜体。光纤和透镜组件一起构造成为从目标和从光纤远端与第一表面之间的参考界面反射的光辐射提供共路。
一般而言,在一个实施例中,用于光学相干断层扫描(OCT)的导管系统包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及具有第一折射率的透镜组件,其通过界面介质与光纤远端光耦合。界面介质具有第二折射率。第一折射率和第二折射率相差0.02或更小。透镜组件包括透镜体,透镜体具有与光纤远端相对的第一表面以及在第一表面远侧的第二表面。从光纤远端穿过第一表面并进入透镜体的光从第二表面反射而离开透镜体。光纤和透镜组件一起构造成为从目标和从光纤远端与界面介质之间的参考界面反射的光辐射提供共路。
这些和其他实施例可以包括以下特征中的一个或多个。透镜组件可以是畸变透镜组件。导管系统还可以包括连接光纤远端和第一表面的界面介质。界面介质可以是环氧树脂。透镜组件可以具有第一折射率,界面介质可以具有第二折射率,其中第一折射率和第二折射率可以相差0.02或更小。第一表面可以相对于光纤远端成8度或更大的角度。第二表面的切线可以相对于光纤的纵轴成约40度至50度之间的角度。导管系统还可以包括涂覆在第二表面上的反射涂层。反射涂层可以具有被配置成反射超过80%的光的厚度。反射涂层可以是金。反射材料可以是电介质。第二表面可以具有复合半径。第二表面可以具有复合半径,该复合半径具有沿着第一轴的第一半径,其不同于沿着第二轴的第二半径。透镜体可以包含聚碳酸酯材料。来自光纤和透镜组件之间界面的光辐射的二次反射可以小于-60dB。参考界面可以提供-28与-42dB之间的参考反射。第二表面相对于从光纤远端通过的光可以是凹面的。透镜组件的出射表面可相对于光纤的中心纵轴成8度或更大的角度。反射涂层可以具有大于或等于3.0的光密度。第二表面的曲率半径可以在0.2mm和1.5mm之间。导管系统还可以包括被构造成提供光的光辐射源,第二表面上的反射涂层的厚度可以是光辐射源的激发波长的至少1/6。导管系统还可以包括光辐射源、被构造成接收从参考界面和目标反射的光辐射的接收用电子器件、以及基于由接收用电子器件接收的光辐射生成目标的图像的处理器。
一般而言,在一个实施例中,用于光学相干断层扫描(OCT)的导管包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及通过界面介质与光纤远端光耦合的透镜组件。该透镜组件包括具有凹近侧表面的透镜体,所述凹的近侧表面与光纤远端相对并且相对于光纤远端形成角度。近侧表面具有复合半径,该复合半径具有沿着第一轴的第一半径,该第一半径不同于沿着第二轴的第二半径。近侧表面包括反射材料,该反射材料被配置为使得至少90%的从光纤远端穿过透镜组件的光反射离开近侧表面。光纤和透镜组件一起被构造成为从目标和从光纤远端与近侧表面之间的参考界面反射的光辐射提供共路。
这个和其他实施例可以包括一个或多个以下特征。界面介质可以是环氧树脂。近侧表面的切线相对于光纤的纵轴可以成约40度至50度之间的角度。反射材料可以包括近侧表面上的反射涂层。反射涂层可以是金。反射材料可以是电介质。透镜体可以包含聚碳酸酯材料。来自光纤和透镜组件之间界面的光辐射的二次反射可以小于-60dB。参考界面可以提供-28与-42dB之间的参考反射。反射涂层可以具有大于3.0的光密度。近侧表面的曲率半径可以在0.2mm和1.5mm之间。导管系统还可以包括被构造成提供光的光辐射源,其中近侧表面上的反射涂层的厚度可以是光辐射源的激发波长的至少1/6。导管系统还可以包括光辐射源、被构造成接收从参考界面和目标反射的光辐射的接收用电子器件、以及基于由接收用电子器件接收的光辐射生成目标的图像的处理器。
一般而言,在一个实施例中,用于光学相干断层扫描(OCT)的导管包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及与光纤远端光耦合的透镜组件。该透镜组件包括透镜体,该透镜体具有第一表面和第二表面,该第一表面与该光纤远端相对并与其形成角度,该第二表面在该第一表面的远侧。第二表面没有涂层,从而使从光纤远端穿过第一表面进入透镜体的光通过全内反射从第二表面反射而离开透镜体。光纤和透镜组件一起构造成为从目标和从光纤远端与第一表面之间的参考界面反射的光辐射提供共路。
一般而言,在一个实施例中,用于光学相干断层扫描(OCT)的导管包括:从远侧向近侧延伸的细长导管主体;细长导管主体中的光纤;以及通过界面介质与光纤远端光耦合的透镜组件。该透镜组件包括透镜体,该透镜体具有凹近侧表面,该凹近侧表面与该光纤远端相对并与其形成角度。近侧表面具有复合半径,该复合半径具有沿着第一轴的第一半径,第一半径不同于沿着第二轴的第二半径。近侧表面没有涂层,从而使从光纤远端穿过第一表面进入透镜体的光通过全内反射从第二表面反射而离开透镜体。光纤和透镜组件一起构造成为从目标和从光纤远端与近侧表面之间的参考界面反射的光辐射提供共路。
附图说明
所附权利要求中特别阐述了本发明的新颖特征。通过参考以下详细描述以及附图可获得对本发明的特征和优点的更好理解,所述详细描述阐述了利用本发明原理的说明性实施例,在附图中:
图1是现有技术设备的示例,其包括耦合到光纤远端的单独的透镜(被构造成GRIN透镜的光纤),嵌入到环氧树脂中,单独的镜元件也嵌入其中。
图2是包括如本文所述的透镜组件的导管的示例。
图3A是导管的一部分里面的透镜组件的示意图。图3B表示穿过图3A的透镜的侧视剖视图。图3C表示与图3B相反的侧面的侧面剖视图。图3D表示从图3A的端部观察的剖视图。
图4表示包括如本文所述的透镜组件的导管的另一示例。
图5A和5B表示示例性透镜组件的透视图。图3A表示近侧表面,图3B表示远侧表面。
图6A表示包括如本文所述的透镜组件的导管的另一个实施例。图6B和6C表示与图6A中类似的透镜组件的透视图。
图7A表示具有用于放置透镜组件的示例性容器的导管。
图7B表示内置于海波管中的透镜组件。
图8是表示对于标准光纤、GRIN光纤、以及如本文所述的改进的透镜设备中的每一个,距成像末端的相对距离关于射束直径的曲线图。如图所示,与现有技术(GRIN)装置以及没有任何透镜的装置相比,对于更大范围的成像末端距离,射束直径更精细(更小)。
图9表示示例性二氧化碳贮气瓶。
图10表示示例性二氧化碳贮气瓶的另一个实施例。
图11表示与本文所述的透镜组件一起使用的示例性OCT系统。
具体实施方式
本文描述的是与成像装置一起使用的透镜组件。本文所述的任何透镜组件可以是畸变透镜组件(即,透镜组件是圆形非对称的并且沿着两个不同的轴,即彼此垂直的两个不同的轴,具有或产生不等的放大率)。例如,畸变透镜可以包括沿两个不同轴的两个不同的半径。本文描述的透镜组件可以用作任何光学相干断层扫描(OCT)装置的一部分,并且特别是作为共路OCT装置的一部分,其可以被包括作为导管或其他装置的一部分。例如,可以将透镜组件放置在导管的远侧末端中和/或上方以便:(1)将光束引向成像对象,以及(2)将光束聚焦在成像对象上以改善图像质量。
本文描述的透镜组件例如可以使用模具形成。因此,任何透镜组件也可以被称为“模具”或“模具组件”。在一些实施例中,本文描述的透镜组件可以由聚碳酸酯材料制成,例如模克隆2558。在一些实施例中,透镜组件的折射率可以接近用于将透镜组件连接到成像光纤远端的界面介质(例如,环氧树脂)的折射率。
如图2所示,成像装置200可以包括用作共路OCT系统的一部分的光纤215,例如SMF光纤。装置200还包括通过界面介质202(例如粘合剂或环氧树脂)附接到光纤215的远端212的畸变透镜210。光纤215的芯的折射率和界面介质202的折射率可以不匹配,如2014年10月11日提交的美国专利申请No.14/400,140(名称为“OPTICAL COHERENCE TOMOGRAPHY WITHGRADED INDEX FIBER FOR BIOLOGICAL IMAGING”)中所描述的,其全部内容通过引用并入本文。此外,透镜210和界面介质202的折射率可以紧密匹配(例如,在0.02以内,如在0.01以内或在0.001以内)。
透镜的远侧表面221可以具有复合半径(例如沿着x轴的半径不同于沿着y轴的半径)。此外,远侧表面221的外部部分可以是凸起的(即,使得光照射凹的内部部分)。远侧表面221可以具有例如在0.2mm和1.5mm之间的曲率半径。
此外,远侧表面221可以包括附接或涂覆于其上的反光镜201。因此,反光镜201可以在透镜210的远侧表面221上包括涂层和/或附着层。反光镜可以具有配置为反射超过70%(例如,超过75%、超过80%、超过85%、超过90%、超过95%等)的光的厚度。在一个示例中,反光镜或涂层可以具有大于或等于100nm的厚度,例如大于或等于200nm或者大于或等于250nm的厚度。在一些实施方案中,反光镜或涂层可以具有3.0或更大,例如3.5或更大的光密度。任何适当的反射材料都可以用于反光镜或涂层。例如,反射材料可以包括金、银或铂。此外,反光镜201可以成大约45度的角度,其中角度被定义为光纤光轴与第二表面相交的偏角(即,光轴和其与第二表面相交处的复合第二表面的切线之间的角度)。
在该实施例中,透镜210的近侧表面211可以基本平行于光纤的远侧表面212定向。此外,透镜210的外表面217可以基本上平行于光纤215的轴(因此基本上垂直于透镜的近侧表面211和光纤的远侧表面212)。在一个实施例中,表面211、217大致可以是平的。在另一个实施例中,表面可以以0.1英寸或更大的曲率半径稍微弯曲。
在使用中,来自光源的光可以穿过光纤215。在光纤远端212和界面介质202的界面处,一些光将被反射回来,以形成参考反射。其余的光可以从光纤远端212通过界面介质202并穿过透镜的近侧表面211。因为光纤和界面介质的折射率紧密匹配,所以只有最小量(例如,小于-55dB)的光会从表面211反射回来。因此,光可以经透镜210传导并照射反光镜201。由于反光镜201的45度角及其复合表面,光可以垂直于光纤315的纵轴被反射,其中射束轮廓213在其射出透镜210的外表面217时接近于圆形。
参照图2,光纤215可以包括剥脱部分205(即,不包括涂层的部分,所述涂层例如聚酰亚胺涂层)。与常规设计(例如,图1的装置100)相反,装置200可以包括仅由剥脱部分205制成的小得多的脆性部分(即,其不包括GRIN透镜)。此外,与装置100相比,装置200可以包括组合透镜和反射元件(即,两者都可以内置到透镜210中)。
图3A-3D表示包括畸变透镜310的另一装置300。透镜310与透镜210类似,不同之处仅在于,透镜的近侧表面311相对于光纤315的远端312成2-20度角,例如大于或等于8度。通过以一定角度切割光纤远端和/或通过以一定角度切割近侧表面311可以获得上述相对角度。因为近侧表面311相对于光纤远端312成角度,所以界面介质302和透镜310的折射率可被选择为彼此进一步区分开(即,可以大于0.01或0.02)。光纤远端与近侧表面311之间的角度可以确保只有最小量(例如,小于-55dB)的光会从近侧表面311反射回来,同时也允许选择用于将透镜310附接到光纤315的界面介质(例如粘合剂或环氧树脂)的灵活性。
参照图3C-3D,在透镜310的示例性实施例中,畸变透镜的第一半径(R1)可以是0.0433英寸,而畸变透镜的第二半径(R2)可以是0.0229英寸。近侧表面311相对于光纤远端所成角度可以是8度,同时,外表面317相对于与光纤的纵轴平行的轴的角度可以是8度。在另一个实施例中,R1可以是0.0276英寸,R2可以是0.0269英寸,这可以导致将光束在目标内更紧密地聚集。此外,如图所示,远侧表面321可以相对于光纤的纵轴成大约45度的角度(即,光轴和其与第二表面相交处的复合第二表面的切线之间的角度)。
图4表示包括畸变透镜410的又一装置400。除了外表面417相对于光纤的纵轴成角度之外,透镜410与透镜310相似。也就是说,外表面417相对于与光纤417的轴平行的轴,可以具有2-20度之间的角度,诸如8度或更大的角度。使表面417成角度地倾斜8度或更多有利地确保在成像期间由表面417形成最小的二次反射。在一些实施例中,表面417可以成角度倾斜以便与近侧表面411形成90度角。在其他实施例中,表面417可以在相反方向上成角度和/或所成角度可以不同于近侧表面411以防止形成90度角(从而有助于防止进入光纤415的背向反射)。
图5A-5B表示类似于透镜410的畸变透镜510的实施例。然而,在该实施例中,在每个表面521、511上绘制圆599a、599b以表示每个表面521、511的焦点区域。因此,圆599a、599b表示光束照射表面521、511时的期望位置。理想地,光束在两个光轴的交叉处(例如,沿R1和R2)照射在圆599b内。此外,圆599a、599b的直径可以大于光纤直径,以提供相对于透镜510放置光纤的容差。例如,圆599a、599b的直径可以是10-100微米。无论光束位于圆599b内何处,涂层的光密度和/或厚度可以被配置成提供期望的反射。因此,光纤相对于透镜组件510的放置可以在设定的容差内,例如以允许在圆599b中心的50微米内移动。
图6A-6C表示包括畸变透镜610的另一装置600。透镜610包括近侧表面611,该近侧表面611都涂覆有诸如金(如上所述)的反射涂层并且具有复合半径(即,畸变的)。在使用该实施例期间,光因此不穿过透镜,而是立即反射离开表面611。表面611可以是凹形的并且可以具有如上所述与远侧表面321几乎相同的曲率半径。
因此,如上所述,许多现有技术装置所需的SMF-GRIN和反光镜组件可以用如本文所述的单一畸变透镜组件代替。
在一些实施例中,本文描述的畸变透镜可以由聚碳酸酯制成。
此外,在一些实施例中,本文描述的透镜组件可以被模制。模制诸如聚碳酸酯的材料会比较便宜并且容易制造,因而简化了制造过程并且降低了制造成像组件的成本。
参考图7A,在一些实施例中,所形成的透镜组件可以落入装置外壳709中的缝隙777或孔中,然后可以用界面介质填充所述孔。参考图7B,在一些实施例中,所形成的透镜组件可以与具有延伸穿过其中的细长通道788的海波管787集成。然后可以将光纤放置在通道788内并放置在用于将光纤附接到透镜710的界面介质内。
例如,本文所述的界面介质可以是环氧树脂,比如UV固化环氧树脂。
如所述和所示的那样,使用本文所述的畸变透镜组件可以缩短其中使用所述组件的装置的远侧末端的长度。光纤剥脱部分的长度可以小得多,因此远侧成像和治疗外壳可以做得更小。
本文所述的透镜组件可具有适合导管几何形状的明显更好的聚焦能力。例如,本文描述的畸变透镜结构的曲率半径可以是这样的,即焦点离壳体是优选的(更远的)距离。图8表示对于没有透镜801的OCT导管、具有GRIN光纤透镜803的OCT导管、以及具有本文所述的畸变透镜设备805的OCT导管,射束直径相对于距成像末端的距离的变化范围示例。在该示例中,在外壳的边缘处射束直径为0。
在一些实施例中,本文描述的透镜组件本身可以引起光束反射到组织中。也就是说,反射表面可以是未涂覆的,并且反射可以由透镜材料与界面介质和/或透镜周围的空气之间的折射率失配造成的全内反射引起。在这样的实施例中,透镜材料的折射率可以高,例如1.0或更大、1.2或更大、1.5或更大、或1.7或更大。此外,在光通过透镜的实施例中,透镜的远侧表面可以与空气接界以确保全内反射。
在一些实施例中,参考反射可以由不同于光纤/界面介质表面的表面来进行。例如,参考反射可以由透镜组件的近侧或远侧表面和/或由透镜组件的外表面进行。在这样的实施例中,界面介质和光纤的纤芯的折射率可以紧密匹配(例如在0.02以内),以便在该界面处仅提供最小的二次反射。
本文描述的透镜组件可以与各种不同的成像导管一起使用。例如,该透镜组件可以用于:2010年7月1日提交的名称为“ATHERECTOMY CATHETER WITH LATERALLY-DISPLACEABLE TIP”的美国专利申请No.12/829,277,现为美国专利申请公开No.2011/0004107;于2010年7月1日提交的名称为“CATHETER-BASED OFF-AXIS OPTICAL COHERENCETOMOGRAPHY IMAGING SYSTEM”的美国专利申请No.12/829,267,现为美国专利No.9,125,562;于2011年7月1日提交的名称为“ATHERECTOMY CATHETERS WITH LONGITUDINALLYDISPLACEABLE DRIVE SHAFTS”的美国专利申请No.13/175,232,现为美国专利No.9,345,510;2012年3月28日提交的名称为“OCCLUSION-CROSSING DEVICES,IMAGING,ANDATHERECTOMY DEVICES”的美国专利申请No.13/433,049,现为美国专利No.8,644,913;2014年11月14日提交的名称为“ATHERECTOMY CATHETERS WITH IMAGING”的美国专利申请No.14/401,175,现为美国专利申请公开No.2016/0141816;2015年2月26日提交的名称为“BALLOON ATHERECTOMY CATHETERS WITH IMAGING”的美国专利申请No.14/424,277,现为美国专利申请公开No.2015/0208922;2015年9月15日提交的名称为“CHRONIC TOTALOCCLUSION CROSSING DEVICES WITH IMAGING”的美国专利申请No.14/776,750,现为美国专利申请公开No.2016/0029902;2016年3月16日提交的名称为“ATHERECTOMY CATHETERSDEVICES HAVING MULTI-CHANNEL BUSHINGS”的美国专利申请No.15/072,272,现为美国专利申请公开No.2016/0192962;2015年2月5日提交的名称为“ATHERECTOMY CATHETERS ANDOCCLUSION CROSSING DEVICES”的美国专利申请No.15/076,568以及于2015年7月8日提交的名称为“HIGH SPEED CHRONIC TOTAL OCCLUSION CROSSING DEVICES”的国际专利申请No.PCT/US2015/039585,现在的国际专利公开No.WO2016/007652,其全部内容通过引用并入本文。
本文描述的透镜组件可以例如用作光学相干断层扫描(OCT)系统的一部分。参考图11,系统1100因此可以包括光辐射源1122、共路光纤1115(例如,延伸穿过导管细长主体)、透镜组件1110、界面介质或环氧树脂1102、以及被构造成接收从参考界面和目标1114反射的光辐射的检测器1130。系统1100还可以包括处理器,以基于由接收用电子器件接收的光辐射来生成目标的图像。如在图11中进一步表示的,诸如法拉第效应光环行器的法拉第隔离装置1112可以用于分离出射光源信号和从光纤远端返回的目标和参考信号的路径。可以使用透镜组件的示例性OCT系统在2014年10月11日提交的美国专利申请No.14/400,140(名称为“OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FORBIOLOGICAL IMAGING”)中进一步描述,其全部内容通过引用并入本文。
在一些实施例中,来自光纤和透镜组件之间的界面的光辐射的二次反射小于-60dB。此外,在一些实施例中,参考界面提供-28和-42dB之间的参考反射。
本文还描述了可用于例如使气囊导管的气囊充气的二氧化碳供气瓶。
图9表示一次性二氧化碳供气瓶或装置900。装置900包括充有二氧化碳的圆筒901和阀组件903。在一个实施例中,圆筒901和阀组件903可以彼此相对扭曲以打开圆筒并按压阀组件903。例如,圆筒901可以具有带螺纹的凸形部分905,而阀组件903可以包括带螺纹的凹形部分907。阀组件903还可以包括诸如针的刺穿元件,其被构造成当螺纹部分905、907连接在一起时破坏圆筒901上的密封。阀组件903还可以包括旋转阀919,该旋转阀919被构造成控制或限制气体从其中流过。此外,止回阀911可以被构造成控制最大充气压力。例如,止回阀911可以将充气压力限制为15psi。导管连接部909可以机械地连接到导管并为二氧化碳提供从装置900到球囊的流通路径。
图10表示具有与装置900相似的特征的一次性二氧化碳供应装置1000的另一个实施例。
二氧化碳供应装置900、1000可以与各种不同的球囊导管一起使用。例如,装置900、1000可以与球囊斑块旋切术导管一起使用,例如2013年3月15日提交的名称为“BALOONATHERECTOMY CATHETERS WITH IMAGING”的国际专利申请No.PCT/US2013/032494和2015年2月5日提交的名称为“ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES”的国际专利申请No.PCT/US2015/014613,其全部内容通过引用并入本文。二氧化碳供应装置100还可以用于例如球囊血管成形术导管。优选地,二氧化碳供应装置900、1000可以是一次性使用的无菌产品。
虽然描述为二氧化碳供应,但其他充气气体可以用于装置900、1000中。
在特征结构或元件这里被描述为位于另一特征结构或元件“上”时,它可以直接位于另一特征结构或元件上,或者也可存在中介特征结构和/或元件。相比之下,在特征结构或元件被描述为“直接”位于另一特征结构或元件“上”时,不存在中介特征结构或元件。也将理解到在特征结构或元件被描述为“连接”、“附接”或“联接”到另一特征结构或元件时,它可以直接连接、附接或联接到另一特征结构或元件,或者可以存在中介特征结构或元件。相比之下,在特征结构或元件被描述为“直接连接”、“直接附接”或“直接联接”到另一特征结构或元件时,不存在中介特征结构或元件。虽然相对于一种实施方式描述或表示,如此描述或表示的特征结构和元件可适用于其他实施方式。本领域普通技术人员也将理解到结构或特征结构被描述为“相邻”另一特征结构布置可具有与相邻特征结构重叠或位于其下侧的部分。
这里使用的术语只出于描述特定实施方式的目的,而不打算限制本发明。例如,如这里使用,单数形式“一”、“一个”和“该”也旨在包括复数形式,除非文中另外清楚指明。还将理解到此说明书中使用的术语“包括”和/或“包含”表明所述特征结构、步骤、操作、元件和/或部件的存在,但是不排除一个或多个其他特征结构、步骤、操作、元件、部件和/或其组的存在或添加。如这里使用,术语“和/或”包括相关列举项目中的一个或多个的任何和所有组合,并可以缩写为“/”。
诸如“下方”、“下面”、“之下”、“上方”、“上面”等空间相对术语可在这里用于简便描述以描述一个元件或特征结构与附图所示的另一元件或特征结构的关系。将理解到空间相对术语旨在包括该装置在使用或操作中的不同定向,除了附图所示的定向之外。例如,如果附图中的装置是倒置的,描述位于另一元件或特征结构“下方”或“之下”的元件也可以定向在另一元件或特征结构的“上方”。因此,示例性术语“下方”可包括上方和下方两种定向。该装置可通过其他方式定向(转动90度或位于其他定向上),并且这里使用的空间相对描述也相应地得到解释。类似地,术语“向上”、“向下”、“竖直”、“水平”等在这里只用于说明目的,除非另外具体指明。
虽然术语“第一”和“第二”可以在这里用来描述不同的特征结构/元件,这些特征结构/元件不应该被这些术语限制,除非文中另外指明。这些术语可用来将一个特征结构/元件与另一特征结构/元件区分。因此,下面描述的第一特征结构/元件可以称为第二特征结构/元件,并且类似地,下面描述的第二特征结构/元件可以称为第一特征结构/元件,而不偏离本发明的教导。
如本文中在说明书和权利要求书中所使用的,包括如在实施例中所使用的,除非另有明确说明,否则即使该术语没有明确地指出,所有数字可以读成如同前面加了“大约”或“近似”。当描述幅度和/或位置以指示所描述的值和/或位置在合理预期范围内时,可以使用短语“约”或“近似”。例如,数值的值可以是记载的值(或值范围)的+/-0.1%、记载的值(或值范围)的+/-1%、或者记载的值(或值范围)的+/-2%、记载的值(或值范围)的+/-5%、记载的值(或值范围)的+/-10%等。本文所列举的任何数值范围旨在包括纳入其中的所有子范围。
尽管以上描述了各种说明性实施例,但是在不脱离如权利要求所述的本发明的范围的情况下,可以对各种实施例进行多种改变中的任何一种。例如,执行各种所述的方法步骤的顺序通常可以在替代实施例中改变,并且在其他替代实施例中,可以一起跳过一个或多个方法步骤。各种装置和系统实施例的可选特征可以包括在一些实施例中而不包括在其他实施例中。因此,前面的描述主要是为了示例的目的而提供的,不应当被解释为限制权利要求中所述的本发明的范围。
本文包括的示例和说明通过说明而非限制的方式表示可以实践主题的具体实施例。如上所述,可以应用并从中导出其他实施例,使得可以在不脱离本公开的范围的情况下进行结构和逻辑上的替换和改变。如果实际上披露的多于一个实施例,在本文中可以单独地或共同地通过术语“发明”来指出本发明主题的这些实施例,则仅仅是为了方便,而非将本申请的范围自愿地限制到任何单个发明或发明构思。因此,尽管本文已经说明和描述了具体的实施例,但是为了实现相同的目的而计划的任何布置都可以代替所示的具体实施例。本公开旨在覆盖各种实施例的任何和所有修改或变化。上述实施例的组合以及本文中未具体描述的其他实施例对于阅读以上描述的本领域技术人员而言将是显而易见的。
Claims (13)
1.一种用于光学相干断层扫描(OCT)的导管,包括:
从远侧向近侧延伸的细长导管主体;
细长导管主体中的光纤;以及
透镜组件,该透镜组件包括具有凹的近侧表面的透镜体,所述凹的近侧表面与光纤远端相对并且相对于光纤远端形成角度,所述透镜体附接至光纤远端并且通过界面介质与光纤远端光耦合;
其中近侧表面具有复合半径,该复合半径具有沿着第一轴的第一半径,该第一半径不同于沿着第二轴的第二半径;
其中近侧表面包括反射材料,该反射材料被配置为使得至少90%的从光纤远端到达所述透镜体的光反射离开近侧表面;以及
其中光纤和透镜组件一起被构造成,为从目标和从光纤远端与界面介质之间形成的参考界面反射的光辐射提供共路。
2.根据权利要求1所述的导管,其中所述界面介质是环氧树脂。
3.根据权利要求1所述的导管,其中所述近侧表面的切线相对于所述光纤的纵轴成40度至50度之间的角度。
4.根据权利要求1所述的导管,其中所述反射材料包括所述近侧表面上的反射涂层。
5.根据权利要求4所述的导管,其中所述反射涂层包含金。
6.根据权利要求4所述的导管,其中所述反射材料包含电介质。
7.根据权利要求1所述的导管,其中所述透镜体包含聚碳酸酯材料。
8.根据权利要求1所述的导管,其中来自所述光纤和所述透镜组件之间的界面的光辐射的二次反射小于-60dB。
9.根据权利要求1所述的导管,其中所述参考界面提供-28至-42dB之间的参考反射。
10.根据权利要求4所述的导管,其中所述反射涂层具有大于3.0的光密度。
11.根据权利要求1所述的导管,其中所述近侧表面的曲率半径在0.2mm至1.5mm之间。
12.根据权利要求1所述的导管,还包括被构造成提供光的光辐射源,其中所述近侧表面上的反射涂层的厚度为所述光辐射源的激发波长的至少1/6。
13.根据权利要求1所述的导管,还包括光辐射源、用于接收从所述参考界面和所述目标反射的光辐射的接收用电子器件、以及基于由接收用电子器件接收的光辐射生成目标图像的处理器。
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