CN106102608B - 旋切术导管和闭塞穿越设备 - Google Patents
旋切术导管和闭塞穿越设备 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0062—Arrangements for scanning
- A61B5/0066—Optical coherence imaging
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
- A61B2017/320791—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter with cutter extending outside the cutting window
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/373—Surgical systems with images on a monitor during operation using light, e.g. by using optical scanners
- A61B2090/3735—Optical coherence tomography [OCT]
Abstract
本文描述了旋切术导管及它们的使用方法。特别地,本文描述的是光学相干断层扫描(OCT)导管,其可包括远侧末端和可旋转切割器,所述远侧末端可在偏移的铰接点处(例如,位于细长主体的靠近细长主体的远端的一侧)偏转远离设备的长轴线;所述可旋转切割器靠近成像组件,所述成像组件可被高机械效益地抵靠壁驱动。还描述了用于使导管的操作状态可视化以及用于打包切割组织的装置和方法。
Description
相关申请的交叉引用
本申请要求2014年2月6日提交的标题为“ATHERECTOMY CATHETERS ANDOCCLUSION CROSSING DEVICES”的美国临时申请No.61/936,837的优先权,所述申请通过引用整体合并于此。
通过援引加入
本说明书中提到的所有公开文献和专利申请通过引用合并于此,就如同具体地且单独地指明每个单独的公开文献或专利申请通过引用合并一样。
背景技术
仅在美国就有数百万人患有外周动脉疾病(PAD)和冠状动脉疾病(CAD)。PAD和CAD是无明显症状的危险疾病,如果不加以治疗会具有灾难性后果。在美国CAD是死亡的主要原因,而PAD是50岁以上患者截肢的主要原因,并且导致美国每年约160000例截肢。
冠状动脉疾病(CAD)和外周动脉疾病(PAD)都是由血管的过度狭窄引起的,而这通常又是由沿动脉壁的内层积聚的斑块或脂肪物质,即动脉粥样硬化造成的。该物质会随着时间变硬和变厚,这可导致动脉的闭塞,完全或部分限制通过动脉的流动。到手臂、腿、胃、肾脏、大脑和心脏的血液循环会减少,从而患中风和心脏疾病的风险会增加。
对CAD和PAD的介入治疗可包括动脉内膜切除术和/或旋切术。动脉内膜切除术是从堵塞的动脉外科移除斑块以恢复或改善血液流动。诸如旋切术的血管内治疗是用于打开或拓宽变得狭窄或被堵塞的动脉的典型的微创技术。通常,可利用闭塞穿越设备来使这种设备更易于穿过堵塞。
可利用机载成像来改善微创技术,例如光学相干断层扫描(“OCT”)成像。然而,由于成像传感器放置在远离切割器的位置,通过旋切术设备得到的图像可能不够精确。导致难以看见正被切割的组织。此外,微创技术比较低效,通常需要很多设备来实施单个手术。
下面描述和说明可解决这些问题的旋切术导管设备、闭塞穿越设备以及相应的系统和方法。
发明内容
总的来说,本文描述的是旋切术导管以及它们的使用方法。
特别地,本文描述的是光学相干断层扫描(OCT)导管,其可包括本文示出、讨论、描述的一个或多个特征的任意组合。例如,本文描述的是具有远侧末端的导管,所述远侧末端可在偏移的铰接点处(例如,位于细长主体的靠近细长主体的远端的一侧)偏转远离设备的长轴线。远侧末端可包括套管,所述套管铰接到主体并与可旋转成像组件和/或切割组件的颈部区域相互作用以使远侧末端移位和/或恢复。所述导管可被构造成使得远侧末端由第一机构(例如,气动机构、拉筋等)移位并由第二机构恢复,例如成像/切割组件的横向运动。本文描述的设备可被构造成使得能够通过OCT成像来探测或确定远侧末端的状态(例如,位移、填充),所述OCT成像还对导管的成像/切割组件的周界周围的区域(例如,血管)进行成像。例如,所述设备可被构造成使得远侧末端的移位在OCT成像中是可视的,以提供旋切术设备的切割状态(准备好切割/没有准备好切割)的直接反馈。
本文还描述了被构造成当抵靠围绕导管的血管壁驱动横向切割边缘时提供机械效益的导管。例如,所述旋切术设备可在设备的远端处包括彼此稍微分开的一对球囊;位于切割器附近的第一球囊朝血管壁推动切割器,而位于近侧的球囊以相反方向推动,从而由第二球囊(例如,支点球囊)建立的枢转点朝血管壁枢转导管的仅端部区域。作为另一示例,导管可包括既能够朝壁推动切割器又能够闭塞血管的单个新月形球囊。
本文还描述了包括大功率冲洗“喷嘴”的导管,所述大功率冲洗“喷嘴”可用来将材料(切割材料)打包到中空鼻锥中,以及用来清理成像区域。这些喷嘴冲洗口还可被构造成形成文丘里效应,用来将材料抽吸到鼻锥中和/或抽吸远离成像/切割头部和/或细长主体的远端区域。
本文还描述了用于管理导管的近端处(例如手柄)的光纤的技术和结构。在其中光纤和驱动轴旋转并可横向运动(近侧地/远侧地)的设备中,在设备的近端处的光纤管理室在用于将光纤联接到成像系统的联接区域之前。光纤管理室可以是柱形的。光纤管理室通常包括中空空间,在所述中空空间中,光纤可随着其相对于近侧联接区域横向运动而安全地弯曲。光纤管理室随着光纤旋转,所以光纤管理室与光纤之间没有相对旋转运动。
本文还描述了具有可替换的切割末端的一般性闭塞穿越设备。
一般来说,在一个实施例中,旋切术导管设备包括细长主体、中空远侧末端、驱动轴、套管、以及切割和成像组件。所述中空远侧末端自细长主体的远端延伸。驱动轴在细长主体内从远侧到近侧延伸。套管被联接到远侧末端并且具有连接到细长主体的一侧的铰接点和位于所述铰接点远侧的内部凸缘。切割和成像设备被联接到驱动轴并且具有远侧切割边缘和穿过套管的颈部区域。驱动轴在套管内的远侧运动导致内部凸缘沿着切割和成像组件的颈部区域运动,围绕铰接点旋转中空远侧末端和套管并将中空远侧末端与细长主体轴向对准,以至少部分覆盖远侧切割边缘。
该实施例和其他实施例可包括一个或多个以下特征。套管可具有远端面。驱动轴在套管内的近侧运动可导致切割和成像组件的近侧表面沿所述远端面的至少一部分滑动,以围绕枢转点枢转套管和中空末端并露出远侧切割边缘。所述远端面可相对于细长主体的中央纵向轴线成角度。所述角度可以大于90度。所述角度可以小于90度。所述远端面可以垂直于细长主体的中央纵向轴线。所述套管还可包括从其穿过的第一通道和相对于第一通道成角度延伸的第二通道。所述第二通道可与第一通道重叠,并且当中空远侧末端与细长主体对准时,所述颈部区域可位于第一通道内,而当中空远侧末端相对于细长主体成角度时,所述颈部区域穿过第二通道。所述套管可包括通过套管的顶部外周区域形成的铰接通道。所述铰接通道可沿横向于第一通道的方向延伸。所述设备还可包括光纤,所述光纤延伸穿过驱动轴并联接到切割和成像组件中的反射器以形成光学相干断层扫描(OCT)成像传感器。切割和成像组件可被构造成在套管内旋转。切割和成像组件可被构造成延伸到套管之外并进入中空远侧末端中以将组织打包到中空远侧末端中。
一般来说,在一个实施例中,旋切术导管设备包括细长主体、中空远侧末端、驱动轴、套管、以及切割和成像组件。所述中空远侧末端自细长主体的远端延伸。驱动轴在细长主体内从远侧到近侧延伸。套管被联接到中空远侧末端并且具有连接到细长主体的一侧的铰接点和远端面,所述远端面相对于细长主体的中央纵向轴线成小于90度的角度从而形成内部远侧边缘。切割和成像组件被联接到驱动轴并且具有远侧切割边缘和近侧表面。驱动轴在套管内的近侧运动导致切割和成像设备的近侧表面沿着套管的内部远侧边缘滑动,以使套管和中空远侧末端围绕铰接点枢转从而露出远侧切割边缘。
该实施例和其他实施例可包括一个或多个以下特征。所述切割和成像组件还可包括被构造成位于套管内的颈部区域。所述套管还可包括穿过套管的第一通道和相对于第一通道成角度延伸的第二通道。所述第二通道可与第一通道重叠,并且当中空远侧末端与细长主体对准时,所述颈部区域可位于第一通道内,而当中空远侧末端相对于细长主体成角度时,所述颈部区域穿过第二通道。所述套管可包括通过套管的顶部外周区域形成的铰接通道。所述铰接通道可沿横向于第一细长通道的方向延伸。所述设备还可包括光纤,所述光纤延伸穿过驱动轴并联接到切割和成像组件中的反射器以形成光学相干断层扫描(OCT)成像传感器。切割和成像组件可被构造成在套管内旋转。切割和成像组件可被构造成延伸到套管之外并进入中空远侧末端中以将组织打包到中空远侧末端中。
一般来说,在一个实施例中,旋切术导管设备包括细长主体、中空远侧末端、驱动轴、光学相干断层扫描纤维、以及切割和成像组件。所述中空远侧末端自细长主体的远端延伸。驱动轴在细长主体内从远侧到近侧延伸。光学相干断层扫描纤维沿驱动轴的中央纵向轴线延伸驱动轴的整个长度。切割和成像组件被联接到驱动轴并且具有远侧切割边缘和狭槽,所述狭槽被构造成将纤维的远端保持在其中。所述狭槽的长度等于或大于切割和成像组件的半径使得光纤从驱动轴延伸笔直穿过切割和成像组件进入狭槽中而不弯曲。
该实施例和其他实施例可包括一个或多个以下特征。驱动轴的近侧或远侧运动可导致中空远侧末端运动偏离细长主体的轴线,以露出远侧切割边缘。所述设备还可包括位于狭槽内的反射元件,所述反射元件可被构造成将来自光纤的光径向引导到细长主体外。光纤的远端距远侧切割边缘的距离可小于3mm。光纤可被固定到狭槽,但也可在切割和成像组件和驱动轴内自由浮动。切割和成像组件可被构造成相对于细长主体和中空远侧末端旋转。切割和成像组件可被构造成延伸到中空远侧末端中以将组织打包到中空远侧末端中。
一般来说,在一个实施例中,旋切术导管设备包括细长主体、中空远侧末端、套管、切割和成像组件、以及新月形球囊。细长主体自远侧向近侧延伸。中空远侧末端自细长主体的远端延伸。套管被联接到中空远侧末端并且铰接在细长主体的一侧上。切割和成像组件具有远侧切割边缘和成像传感器。新月形球囊缠绕在细长主体、中空远侧末端、以及套管的部分上,同时露出远侧切割边缘。球囊被构造成朝血管壁推进远侧切割边缘并闭塞围绕血管壁的血液流动。
该实施例和其他实施例可包括一个或多个以下特征。所述球囊还可被构造成使远侧末端相对于细长主体移位以露出远侧切割边缘。导丝腔可在球囊内延伸球囊的整个长度。成像传感器可以是光学相干断层扫描成像传感器。驱动轴的近侧或远侧运动可导致中空远侧末端围绕铰接点运动偏离细长主体的轴线以露出远侧切割边缘。
一般来说,在一个实施例中,具有多个成像位置的OCT成像旋切术导管设备包括细长主体、中空远侧末端、以及可旋转的切割和成像组件。细长主体自远侧向近侧延伸。中空远侧末端自细长主体的远端延伸并被铰接在细长主体的一侧。可旋转的切割和成像组件联接到可旋转并且可轴向运动的驱动轴上,所述驱动轴在细长主体内自远侧向近侧延伸并且具有近侧地邻近远侧切割边缘的OCT成像传感器。可旋转切割和成像组件被构造成能够在可旋转的切割和成像组件位于中空远侧末端内的第一位置时对穿过中空远侧末端的导管周围的生物组织全景成像。所述可旋转的切割和成像组件还被构造成能够对围绕导管的生物组织的一部分成像以及对中空远侧末端相对于细长主体自第二位置的位移成像,所述第二位置在第一位置的近侧以指示远侧切割边缘是否露出。
该实施例和其他实施例可包括一个或多个以下特征。所述导管还可包括第一成像窗和第二成像窗。第一成像窗和第二成像窗之间的角度可进一步指示远侧切割边缘是否露出。成像传感器在位于第二位置时可与第一成像窗和第二成像窗对准。所述设备还可包括第三成像窗。切割和成像组件可具有第三位置,其中,成像传感器与第三成像窗对准。可旋转切割和成像组件的OCT成像传感器可包括位于可旋转切割和成像组件内的光纤和反射器。远侧末端可包括位于近端的套管。所述套管可铰接到细长主体。
一般来说,在一个实施例中,被构造成抵靠血管壁驱动可旋转切割组件的旋切术导管设备包括柔性细长主体、中空远侧末端、可旋转切割组件、第一球囊、以及支点球囊。中空远侧末端自细长主体的远端延伸并且铰接在细长主体的一侧。可旋转切割组件联接到可旋转且可轴向运动的驱动轴上,所述驱动轴在细长主体内自远侧向近侧延伸并且具有远侧切割边缘。第一球囊位于细长主体的远端区域附近并且被构造成通过沿第一方向朝血管壁推动可旋转切割组件的远侧切割边缘将其横向驱动至血管壁中。支点球囊位于第一球囊的近侧并且被构造成能够膨胀以沿着与第一方向相反的方向推靠在血管壁上。支点球囊距第一球囊小于100cm。
该实施例和其他实施例可包括一个或多个以下特征。所述设备还可包括位于切割组件上的近侧地邻近于远侧切割边缘的光学相干断层扫描(OCT)传感器。第一球囊可与形成于导管的一侧上的位于远侧末端和细长主体之间的横向开口相对。当远侧末端弯曲远离细长主体以露出远侧切割边缘时,第一球囊可与可旋转切割组件的远侧切割边缘相对。支点球囊距第一球囊可小于75cm。支点球囊距第一球囊可小于50cm。
一般来说,在一个实施例中,旋切术导管设备包括细长主体、中空远侧末端、套管、切割和成像组件、以及位于套管内的多个喷射通道。中空远侧末端自细长主体的远端延伸。套管联接到远侧末端并铰接在细长主体的一侧。切割和成像组件联接到可旋转并且可轴向运动的驱动轴上,所述驱动轴在细长主体内自远侧向近侧延伸并且包括远侧切割边缘。套管内的所述多个喷射通道向远侧导向并与延伸穿过细长主体的流体线路联接。通过喷射通道发送的流体被构造成将由远侧切割边缘切割的组织打包到中空远侧末端中。
该实施例和其他实施例可包括一个或多个以下特征。所述多个喷射通道可包括沿套管的内周延伸的两个通道。喷射通道可被定位成能够在切割和成像组件的远端形成文丘里效应。
一般来说,在一个实施例中,旋切术设备包括细长主体、远侧末端、可旋转切割和成像组件、光纤、以及附接到细长主体的手柄。远侧末端自细长主体的远端延伸并且铰接在细长主体的一侧。可旋转切割和成像组件联接到在细长主体内自远侧向近侧延伸的可旋转且可轴向运动的驱动轴上。切割和成像组件具有OCT成像传感器。光纤自OCT成像传感器延伸并且向近侧穿过驱动轴。附接到细长主体的手柄包括柱形光纤保持室和光纤联接区域。柱形光纤保持室位于导管的近端并且被构造成随着驱动轴和光纤旋转。光纤保持室具有内部区域,光纤延伸到所述内部区域中。光纤联接区域被构造成将光纤联接到光源。光纤和驱动轴被构造成在手柄内相对于柱形光纤保持室和光纤联接区域轴向运动。光纤被构造成随着光纤和驱动轴轴向运动而在光纤保持室内弯曲。
该实施例和其他实施例可包括一个或多个以下特征。手柄还可包括驱动轴张紧弹簧,所述驱动轴张紧弹簧被构造成使得当驱动轴朝近侧运动时,弹簧可压缩以在驱动轴上施加控制的拉伸载荷。细长主体还可包括连接在其上的球囊以及沿细长主体延伸的球囊充气腔。手柄中可包括充气室,充气室被构造成连接到球囊充气腔。细长主体可被构造成独立于球囊充气室旋转。
附图说明
图1A-1C示出示例性旋切术设备的端部的侧向立体视图,所述旋切术设备具有偏移铰接区域、套管、以及具有与套管接合的颈部区域的成像/切割组件。图1B示出移除了用于中空远侧末端的壳体的导管。图1C示出图1B的导管,其中移除了到细长主体的外套筒的近侧连接器,示出套管和可旋转驱动轴。
图2A示出穿过如图1A-1C所示的旋切术导管的截面视图,其中远侧末端与细长(近侧)主体区域同轴。
图2B示出图2A的导管,其中末端向下移位。
图2C示出图2A的导管,其中末端完全向下移位,露出切割/成像组件的切割边缘。
图3示出切割/成像组件向远侧延伸到远侧末端区域的导管。
图4A-4D示出旋切术导管的另一变型。图4B、4C和4D分别示出移除了各种构件的图4A的导管,以描述内部零件。
图5示出用于旋切术导管的手柄。
图6示出具有多个球囊的旋切术的远端的一种变型,所述多个球囊被布置成并且可用于在抵靠血管壁驱动切割边缘时提供机械效益。
图7A-7D分别示出用于旋切术设备的套管的立体视图、侧向视图、俯视图和前向视图。
图8A示出穿过旋切术导管的如图8B中箭头所示的鼻锥的血管的全景OCT图像。
图9A示出当如图9B中箭头所示的鼻锥关闭并且切割器位于被动位置时用穿过一个或多个切割窗的旋切术导管获得的血管的全景OCT图像。
图10A示出当如图10B中箭头所示的鼻锥打开时用穿过一个或多个切割窗的旋切术导管获得的血管的全景OCT图像。
图11A-11B示出旋切术导管的另一实施例,所述旋切术导管具有正交于导管的纵向轴线的切割器接合远侧表面。图11A示出导管的截面,图11B示出套管的侧视图。
图12A-12B示出旋切术导管的另一实施例,所述旋切术导管具有切割器接合远侧表面,所述切割器接合远侧表面相对于纵向轴线成一角度从而提供与切割器的远侧表面的唯一接触点。图12A示出导管的截面,图12B示出套管的侧视图。
图13A示出通过本文所描述的旋切术套管从组织切下的单根长条材料的移除。图13B和13C示出移除的组织长度。
图14示出闭塞穿越导管。
图15A、15B、15C和15D示出可用于闭塞穿越导管的末端的示例。
图16A和16B示出具有喷射通道的套管,其中喷射通道穿过套管以辅助将组织打包到旋切术导管的鼻锥中。
图17A-17D示出具有新月形球囊的旋切术导管。
具体实施方式
本文所描述的是旋切术导管和闭塞穿越导管。
旋切术导管
本文描述的旋切术导管可包括一端具有驱动底盘的导管轴。驱动底盘包括结实的转矩线圈(stout torque coil)(“成像转矩线圈”/驱动轴),用于在转矩线圈的中央旋转成像元件、切割器、以及成像光纤。成像元件和切割器都可以是随着驱动轴旋转的头部的一部分。所述头部可单方向旋转(例如顺时针)。所述头部还可通过推动或拉动转矩线圈/驱动轴而向远侧/近侧滑动。由于驱动轴的运动,被构造成保持组织的鼻锥可以移位。在一些实施例中,可以利用偏离轴线铰接装置来打开和关闭鼻锥。在其他实施例中,可利用凸轮部件和凸轮槽来打开和关闭鼻锥。
图1A-3示出包括鼻锥的旋切术导管100的示例,其中鼻锥偏转以露出切割器。旋切术导管100可包括导管主体101,导管主体101具有外轴111、位于导管主体101远端的切割器103、以及位于导管主体101远端的鼻锥105。鼻锥105还可包括切割窗107,切割器103的切割边缘112可通过切割窗107露出。如下文进一步描述的,鼻锥105可被构造成围绕铰接点1109偏转远离导管主体101的纵向轴线。该偏转可通过切割窗107露出切割器103并且/或者将切割器103径向推入到旋切术导管所插入的血管的壁中。
参照图1A-2C,切割器103可通过套管155定位在导管主体101和鼻锥105之间。在一些实施例中,切割器103可以是具有锋利远侧边缘112的环形切割器。切割器103可以附接到能够旋转切割器103的驱动轴113上。
另外,仍然参照图2A-2B,旋切术导管100可包括位于切割器103内并且位于切割器103的切割边缘112近侧的成像元件192,例如OCT成像元件。成像元件192可包括穿过细长主体的中央大致同轴延伸的光纤197,例如穿过驱动轴113以传输OCT信号。此外,光纤197可沿着整个导管主体101笔直延伸而不弯曲。光纤197可附接在切割器103的远端处,例如切割器103中的狭槽177中。所述狭槽的长度至少延伸到切割器103的中央,从而允许光纤197保持同轴没有弯曲地通过导管主体101和切割器103的长度。除附接到切割器103之外,光纤197还可在导管主体或驱动轴113内自由浮动。在其他实施例中,光纤197可沿驱动轴113的长度附接到驱动轴113上。
如图2A-2C所示,成像元件192可包括反射元件199,例如镜子。反射元件199可以位于切割器103中的狭槽177内以将来自光纤197的光径向引导到相邻组织中(通过切割器窗107)。反射元件199可以定向成相对于光纤197的轴线成一角度,例如35-55度角,例如45度角,以将光反射到组织中。光纤197的远端可以定位成距切割边缘小于3mm,例如距切割边缘小于1mm,例如小于0.5mm。通过具有靠近切割边缘的成像元件192,得到的图像可以有利地与血管的正被切割的部分对准。
在使用中,外轴111可被构造成能够转动,例如人工转动,以朝理想位置定位切割器窗107、切割器103、和/或成像元件192。接着驱动轴113可以旋转以旋转切割器103和成像元件197。切割器的旋转可以通过切割边缘的旋转运动提供切割,并且可以提供必要的旋转以通过成像元件对血管壁成像。驱动轴的旋转可以高达2000rpm,例如单向约1000rpm,当然双向旋转或更高或更低的速度也是可能的。
参照图2A-2C,驱动轴113还可被构造成以近侧方向和/或远侧方向轴向平移。驱动轴113的该轴向运动可围绕铰接点1109(例如,套管155中的销)打开和/或关闭鼻锥105,以露出或隐藏以及保护切割器103的切割边缘112。例如,套管155可包括径向向内延伸的内部凸缘170。内部凸缘170可以位于铰接点1109的远侧。套管155还可包括倾斜的外部远侧表面143,其从远端到近端径向向内成角度。最后,切割器103可包括近侧边缘166和从驱动轴113到切割器103的头部变窄的锥形颈部168。这些各种元件的相互作用可以打开和关闭鼻锥105。
在一个实施例中,驱动轴113的近侧回缩打开鼻锥105以露出切割器。例如,随着驱动轴113被向近侧拉动,切割器103的近侧边缘166被迫使抵靠套管155的倾斜远侧表面143。因为所述倾斜远侧表面143从远端到近端径向向内成角度,切割器103迫使套管155以及鼻锥105偏转远离导管主体101的纵向轴线,从而打开鼻锥105(参见图2A到2B以及图2B到2C的转变)。切割窗107可具有比切割器103和切割边缘112的直径大的开口,以允许切割器103在鼻锥105偏转时凸出到鼻锥105之外。
在一个实施例中,驱动轴113的远侧运动关闭鼻锥105。例如图2A-2C所示,当驱动轴113被朝远侧推动时,切割器103的锥形颈部168会相应地向远侧运动。锥形颈部168的远侧运动导致套管155的内部凸缘170沿着锥形颈部168的变宽边缘牵引,进而举升套管155,并且相应地关闭鼻锥105(参见图2C到2B和图2B到2A的转变)。因为铰接点位于内部凸缘170的近侧,实现了允许鼻锥完全关闭的机械效益。
图7A-7D示出套管155的放大视图。如图所示,套管155可包括两个相交的通道721、723,该两个通道被构造成在鼻锥处于打开构型(通道723)和关闭构型(通道721)时将成像子组件的颈部部分168保持在其中。通道721延伸通过套管155的从远侧到近侧的长轴线,通道723相对于通道721成角度延伸并且与其重叠。套管155还可包括铰接通道745,铰接通道745穿过套管155的顶部外周区域形成以提供枢转点1109。铰接通道745可以横向于通道721。
打开和关闭鼻锥的其他机构也是可能的。例如图4A-4D所示,在一个实施例中,导管200(具有与导管100类似的特征,除了打开和关闭机构)在套管155中可包括凸轮槽228,其从近端到远端朝切割窗107成角度。此外,凸轮部件290可附接到切割器103并且被构造成延伸穿过凸轮槽228。因此,随着驱动轴113以及凸轮部件290被朝远侧推动,凸轮部件290会在成角度的凸轮槽180内运动。凸轮部件290在成角度凸轮槽180内的运动导致套管155以及鼻锥150下落。相反地,若要关闭鼻锥,可向近侧拉动驱动轴113,从而导致凸轮部件290骑在凸轮槽228内并将套管155向后拉动成与细长主体101对齐。
图11A-11B和12A-12B所示为打开和关闭旋切术导管400a、400b的鼻锥的另一机构。导管400a、400b可具有与导管100相同的特征,只是套管455a、455b的外部远侧表面443a、443b可以正交于设备的纵向轴线(使得角度α为90度),如图11B所示,也可以从远端到近端径向向外倾斜(使得角度α大于90度,并且与纵向轴线的角度小于90度),如图12B所示。在图12A-12B所示的实施例中,切割器的近侧边缘166和远侧表面443b之间设置有成角度空间,使得所述唯一接触点为套管455b的内部径向边缘444。导管400a会与参照导管100所描述的类似地打开和关闭。但是,导管500b的打开稍有不同,即当驱动轴113被朝近侧拉动时,并不是整个表面443而是仅最内的径向边缘444会与切割器103的近侧边缘166相互作用。该构造可有利地减少打开鼻锥105时的摩擦。在一些实施例中,近侧边缘166可以相对于导管的纵向轴线成角度;在这种情况下,套管455的相对表面443可以平行于近侧边缘166或与其成角度(锐角或钝角)。
如图3所示,旋切术导管100(或200或400)还可包括将组织打包到鼻锥中的机构,例如通过使驱动轴轴向运动。在一个实施例中,驱动轴113的远侧运动关闭鼻锥105。驱动轴113的进一步远侧运动会使切割器103运动到被动位置(即,抵靠窗107的远侧边缘),在该位置时切割器103可由窗107的边缘保护,以避免使用中对血管的意外切割。驱动轴113的更进一步远侧运动会使切割器103运动入鼻锥105中,从而用切割器103的远侧面打包组织,如图3中所示。切割器103可运动大于0.5英寸,例如大于1英寸或大于2英寸进入鼻锥105中以打包组织。在一些实施例中,鼻锥105由OCT半透明的材料(例如非金属)形成使得可通过其获得全景OCT图像。
参照图16A-16B,在一些实施例中套管1655可包括以上描述的套管的所有特征,但可另外包括切入其内周并从近端向远端延伸的喷射通道1785a、1785b。喷射通道1785a、1785b可将细长主体101内的流体线路连接至鼻锥105。流体流过喷射通道1785a、1785b可增加速度并从而提供足够的力以将切割材料打包到鼻锥中并清理鼻锥内的成像区域。另外,喷射通道可在套管1655的远端形成文丘里效应,其可将材料抽吸到鼻锥中并且/或者远离成像/切割头部和/或细长主体的远端区域。
在一个实施例中,旋切术导管100(或200或400)在鼻锥105中包括导丝腔,例如单轨,用于引导导管。有利的是,导丝腔可在成像过程中被用作标记物。
在旋切术导管100、200或400的一些实施例中,鼻锥105中可以有与切割窗107相对的一个或多个小成像窗207、307,如图1A和2A-2C所示。这些额外的成像窗207可在成像过程中提供大于180度的视角。另外,一组窗207可以位于更加近侧的位置并且可被构造成当鼻锥打开时与切割器103和成像元件192轴向对准,而另一组窗307可以位于更加远侧的位置并且可被构造成当鼻锥关闭并且切割器103位于被动位置时与切割器103和成像元件192轴向对准。在一些实施例中,成像窗307、207具有彼此不同的形状以进一步帮助在得到的OCT图像中识别切割器位置。
参照图8A-11B,设备与OCT成像导管会根据成像设备在三种不同构型(鼻锥打开、鼻锥关闭并且切割器位于切割位置、鼻锥关闭并且切割器位于打包位置)中的布置而变化。因此,使用者可以简单地通过观察图像显示来识别鼻锥105是否移位以及切割器103是否位于切割位置或打包位置。
例如,图8A示出当切割器103(以及相应地成像传感器)位于切割位置(如图8B所示)时周围血管的全景图像800。在图像800中,鼻锥105的壁被显示为圆形特征部808。另外,由于鼻锥105是由透明材料制成的,所以甚至可以透过鼻锥105对血管组织806成像。如在图像800中可见的,可以获得组织806的180度视角。图像中的圆形人造物803(以及此处的径向线801)对应于沿着鼻锥105旁边延伸的导丝和/或导丝通道。
与图像800形成对照,图9A示出当切割器103位于被动位置并且鼻锥105关闭时(如图9B所示),周围血管的全景图像900。180度视角的血管组织906示出于图像的右侧(通过窗107获得),关闭的鼻锥909示出于图像的左侧(线909a、909b对应于套管壁)。通过套管中额外的窗307可获得线909a、909b之间的空间913,通过其可以看到组织906位于图像的左侧。此外,图像900中箭头之间的距离表示远侧末端“关闭”(并且因此在导管的中线附近关闭)。
最后,与图像900形成对照,图10A示出当切割器103位于切割位置并且鼻锥105打开时(如图10B所示),周围血管的全景图像1000。血管组织1006(通过窗107获得)示出于图像右侧,关闭的鼻锥1009示出于图像左侧(线1009a、1009b对应于套管壁)。通过窗207获得线1009a、1009b之间的空间1013,通过其可以看见组织1006。图9A和10A中箭头之间相对距离的比较示出导管主体和鼻锥之间距离增加,进而建议操作人员鼻锥105位于打开位置。另外,在一些实施例中,当鼻锥打开或关闭时,由于窗207/307和成像元件297之间的角度变化和/或窗207/307的形状不同,通过窗207/307得到的图像看起来是不同的。
在一个实施例中,旋切术导管100(或200或400)包括位于切割器103附近的冲洗口。冲洗口可以用来将冲洗流体递送到成像区域,从而改善图像质量。在一些实施例中,可以通过设备手柄上的机构启动冲洗。可以例如在导管主体101和驱动轴113之间的环形空间中冲洗流体。另外,在套管中有喷射通道的实施例中,环形空间可连接到喷射通道以向其提供流体。
参照图6,在一些实施例中,旋切术导管100、200、400还可包括被构造成帮助将切割器103推进到组织中的两个或更多个球囊。第一球囊333可以是最远侧球囊。第一球囊333可以位于铰接点1109附近并且与切割窗1107相对。球囊333可以通过使切割器103向上偏转进入组织中来推进切割器103抵靠组织。远侧球囊333近侧的第二球囊335可以位于导管100的与切割窗107相同的一侧,并且可进一步帮助将切割器103驱动到组织中。在一些实施例中,第二球囊335可以是环形的。在一些实施例中,第二球囊335可帮助闭塞血管。此外,在一些实施例中(如图6所示),第三球囊337可以用于闭塞。一个或多个球囊333、335、337可以被构造成利用小压强膨胀,例如小于2psi。该低压强有利地防止球囊333、335、337过度推靠血管壁,但仍然可以提供足够的压力来将切割器103推进到组织中。球囊333、335、337还可包括位于近侧边缘和远侧边缘上的锥形边缘,以允许球囊沿着血管滑动并且/或者通过扭曲区域适配。
参照图17A-17D,在另一实施例中,旋切术导管100、200、400可包括单个球囊,其被构造成将切割器103推进到组织中以及闭塞血流以改善成像。参照图17A,球囊1733可具有新月形状,即,可以缠绕导管100从而覆盖导管100的整个外周除了露出切割器103的位置。通过使用具有该形状的球囊1733,导管100和血管1723之间的间隙可以充分减少,有利地消除或减少从视觉区域移位血液所要求的局部冲洗。在一个实施例中,为了形成新月形状,球囊在两端都包括宽颈部,所述宽颈部又缠绕鼻锥105和细长主体101使得它们覆盖外周表面的至少一半。图17B示出缠绕的球囊边缘1735,而图17C示出在两端熔合的宽颈部1737。图17C示出包含在球囊1733内部的充气口1739以及跨越球囊1733长度的导丝腔1741。在一些实施例中,球囊1733可以用来打开或关闭鼻锥而无需驱动轴的近侧或远侧运动。
参照图5,手柄300可以用来控制用于导管100、200或400的驱动轴的旋转或平移。手柄300可有利地允许光纤在切割器被驱动时随着切割器向远侧和近侧运动而无需光纤在近侧位置处运动,例如,无需光纤组件在驱动组件内运动。因此,手柄300可以被设计成完全应对驱动轴的运动。图5中示出示例性的驱动轴管理系统555。驱动轴管理系统555允许使用者在驱动轴高速旋转的同时远侧地或近侧地定位驱动轴。在一些实施例中,驱动轴可以被构造成使得在驱动轴管理系统555位于其最近侧位置之前,驱动轴被完全张紧。也就是说,驱动轴管理系统555可包括驱动轴张紧弹簧556。弹簧556可以被构造成使得随着使用者近侧地定位可滑动用户环557(或按钮),驱动轴被完全张紧并且驱动轴管理系统555向近侧运动,导致弹簧556压缩并向驱动轴施加控制的拉伸载荷。该光纤管理系统555通过以下方式有利地改善导管的性能:以预定载荷张紧驱动轴进而适当地定位切割和成像构件在导管的远端抵靠套管,改善导管的切割和成像。
驱动轴管理系统555可传递源自驱动组件的转矩,以下将会进一步描述。可以在光学连接器559处实现到驱动组件的连接。转矩可因此被从光学连接器559通过光纤托架551传递至驱动键560,通过驱动轴管理系统555,接着直接传递至导管驱动轴,所有都可一起旋转。光纤托架551可包括一组构件(即,一对工件以形成整个光纤托架)用来容纳光纤的近端并在驱动轴系统内传递转矩。光纤托架构件可以被设计成薄壁式的,从而在内部形成中空空间。在光纤托架551的该中空空间中,光纤可以随着设备驱动轴向近侧或远侧定位而被插入或撤回。由于当用户环557近侧定位时光纤被插入光纤托架551中,光纤能够在光纤托架551的内部空间内盘绕同时在其到远侧末端的整个长度上保持成像。相反地,由于当用户环557远侧定位时光纤从光纤托架551撤回,光纤的盘绕区段能够拉直同时在其到远侧末端的整个长度上保持成像。该设计特征有利地为整个驱动轴系统提供更大的光纤容量或“松弛”,以增加驱动轴系统可以平移的范围。
手柄300还可包括球囊充气室552,其被构造成一侧连接至球囊充气腔(例如,与如上所述的导管上的球囊一起使用)而另一侧连接至球囊充气管553和/或口554。由于充气流体通过球囊充气室552传递至球囊,外轴111可以有利地独立于球囊充气室552旋转(例如,通过旋转旋钮558),允许管553和/或口554在外轴111的旋转过程中保持静止。
此外,如图5所示,手柄300还可包括导管冲洗室663和导管冲洗管664和/或冲洗口665以通过导管提供冲洗,如上所述。
本文描述的导管可利用驱动组件进行驱动。示例性的驱动组件在以下共同未决申请中进行了描述:2013年3月15日提交的标题为“ATHERECTOMY CATHETER DRIVEASSEMBLIES”的PCT申请PCT/US13/32089;以及2012年10月17日提交的标题为“ATHERECTOMYCATHETERS AND NON-CONTACT ACTUATION MECHANISM FOR CATHETERS”的美国专利申请13/654,357,所述申请均通过引用整体合并于此。
有利地,本文描述的旋切术导管100、200、400可以用来移除组织条。图13A示出通过本文描述的旋切术导管移除从组织切下的单根长条材料。图13B和13C示出移除的组织长度(重70.4mg)。
本文描述的旋切术导管可额外地包括以下共同未决申请中所描述任意特征:2013年3月15日提交的标题为“ATHERECTOMY CATHERES WITH IMAGING”的PCT申请PCT/US2013/031901;以及2013年3月15日提交的标题为“BALLOON ATHERECTOMY CATHERS WITHIMAGING”的PCT申请PCT/US2013/032494,所述申请均通过引用整体合并于此。
闭塞穿越导管
参照图14,闭塞穿越导管700可包括附接有锥形闭塞球囊535的外鞘511。
在一些实施例中,导管700的切割头503可以是可互换的,以使设备的用途更加广泛适应性更强。例如,末端503可以互换为:锥形的且钻孔的末端(如图15A中的末端503a所示);压制有切割边缘的末端(如图15B中的末端503b所示);包括用于进取切割的向前突出末端的末端(如图15C中的末端503c所示);和/或具有单个锋利刀刃的凿形末端(如图15D中的末端503d所示)。为了使得末端是能够互换的,末端503可以例如具有以与头部503的旋转方向相反的方向绕行的螺纹近侧边缘。在其他实施例中,近侧边缘可以卡扣方式或其他方式配合进入和离开设备700的细长主体501。
其他细节
如上所述,本文描述的设备和技术可与OCT成像一起使用。示例性成像系统在以下共同未决申请中进行了描述:2010年5月28日提交的标题为“OPTICAL COHERENCETOMOGRAPHY FOR BIOLOGICAL IMAGING”、公布号为US-2010-0305452-A1的美国专利申请12/790,703;2010年7月1日提交的标题为“CATHETER-BASED OFF-AXIS OPTICAL COHERENCETOMOGRAPHY IMAGING SYSTEM”、公布号为US-2010-0021926-A1的美国专利申请12/829,267;2013年3月15日提交的标题为“OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEXFIBER FOR BIOLOGICAL IMAGING”、公布号为WO-2013-172972的国际专利申请,所述申请全部通过引用整体合并于此。
如说明书和权利要求书中所使用的,包括示例中使用的,除非另有明确说明,所有数字前都应被认为有“大约”或“近似”,即使该词语没有明确出现。在描述量和/或位置以表示所描述的值和/或位置位于值和/或位置的合理预期范围内时可使用短语“大约”或“近似”。例如,数值可具有阐述值(或值范围)+/-0.1%的值、阐述值(或值范围)+/-1%的值、阐述值(或值范围)+/-2%的值、阐述值(或值范围)+/-5%的值、阐述值(或值范围)+/-10%的值等。本文所记载的任何数值范围旨在包括其中所含的任何子范围。
关于本发明的额外细节,包括材料和制造技术,可以在相关领域技术人员的水平下采用。这对于本发明的基于方法的方面的通常或逻辑上所采用的额外动作来说同样适用。另外,可以想到,所描述的发明变型的任何可选特征可以单独地或与本文描述的任何一个或多个特征结合提出并请求保护。同样地,对单个项目的引用有可能包括多个所提出的项目。更具体地,如本文以及所附权利要求书中使用的,单数形式“一”、“一个”以及“所述”包括多个指示物,除非上下文另有明确说明。还要说明的是,所起草的权利要求不包括任何可选元素。因此,该说明旨在作为与权利要求元素的记载有关的这种排他性术语“仅”、“只”等的引用基础,或“否定”限制的引用基础。除非本文另有限定,本文使用的所有技术和科学术语的含义与本发明所属领域的普通技术人员的惯常理解相同。本发明的范围不由所描述的实施例限定,而仅由所采用的权利要求术语的一般意义限定。
Claims (10)
1.一种旋切术导管设备,所述设备包括:
细长主体;
中空远侧末端,所述中空远侧末端自细长主体的远端延伸并且能够与细长主体对准或者相对于细长主体成角度;
驱动轴,所述驱动轴在细长主体内从近侧向远侧延伸;
套管,所述套管联接至中空远侧末端,所述套管具有连接到细长主体的一侧的铰接点、位于铰接点远侧的内部凸缘、穿过套管的第一通道和相对于第一通道成一角度延伸并与第一通道重叠的第二通道;以及
切割和成像组件,所述切割和成像组件联接至驱动轴,所述切割和成像组件具有远侧切割边缘和穿过套管的颈部区域,其中当中空远侧末端与细长主体对准时颈部区域位于第一通道内,当中空远侧末端相对于细长主体成角度时颈部区域穿过第二通道;
其特征在于,内部凸缘径向向内延伸且颈部区域为锥形,从而驱动轴在套管内的远侧运动导致径向延伸的内部凸缘沿切割和成像组件的锥形颈部区域运动,使中空远侧末端和套管围绕铰接点旋转并使中空远侧末端与细长主体轴向对准,进而至少部分覆盖远侧切割边缘。
2.根据权利要求1所述的设备,其中,套管具有远端面,并且其中,驱动轴在套管内的近侧运动导致切割和成像组件的近侧表面沿套管的远端的至少一部分滑动,导致切割和成像组件以及中空末端围绕铰接点枢转并露出远侧切割边缘。
3.根据权利要求2所述的设备,其中,套管的远端面相对于细长主体的中央纵向轴线成角度。
4.根据权利要求3所述的设备,其中,套管的远端面相对于细长主体的中央纵向轴线成大于90度的角度。
5.根据权利要求3所述的设备,其中,套管的远端面相对于细长主体的中央纵向轴线成小于90度的角度。
6.根据权利要求2所述的设备,其中,所述远端面垂直于细长主体的中央纵向轴线。
7.根据权利要求1所述的设备,其中,套管包括穿过套管的顶部外周区域形成的铰接通道,并且其中,铰接通道以横向于第一通道的方向延伸。
8.根据权利要求1所述的设备,还包括光纤,所述光纤延伸穿过驱动轴并且联接到切割和成像组件中的反射器以形成光学相干断层扫描(OCT)成像传感器。
9.根据权利要求1所述的设备,其中,切割和成像组件能够在套管内旋转。
10.根据权利要求1所述的设备,其中,切割和成像组件能够延伸到套管之外并进入中空远侧末端中以将组织打包到中空远侧末端中。
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2015
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- 2015-02-05 JP JP2016550604A patent/JP6539669B2/ja active Active
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CN106102608A (zh) | 2016-11-09 |
CA2938972A1 (en) | 2015-08-13 |
US10568655B2 (en) | 2020-02-25 |
JP6539669B2 (ja) | 2019-07-03 |
US20160192962A1 (en) | 2016-07-07 |
WO2015120146A1 (en) | 2015-08-13 |
US20170273711A1 (en) | 2017-09-28 |
EP3102127B1 (en) | 2019-10-09 |
EP3102127A1 (en) | 2016-12-14 |
EP3102127A4 (en) | 2017-07-26 |
MX2016010141A (es) | 2017-04-06 |
JP2017506100A (ja) | 2017-03-02 |
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