CN106333749A - Unfolded catheter - Google Patents

Unfolded catheter Download PDF

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Publication number
CN106333749A
CN106333749A CN 201610855500 CN201610855500A CN106333749A CN 106333749 A CN106333749 A CN 106333749A CN 201610855500 CN201610855500 CN 201610855500 CN 201610855500 A CN201610855500 A CN 201610855500A CN 106333749 A CN106333749 A CN 106333749A
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Prior art keywords
portion
catheter
catheter shaft
handle
deployment
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CN 201610855500
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Chinese (zh)
Inventor
D·奥康奈尔
E·利杰格伦
D·H·迪拉德
H·X·冈萨雷斯
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斯波瑞申有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/044Oesophagi or esophagi or gullets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9517Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0051Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid

Abstract

The invention discloses an unfolded catheter. Preferably, one medical device (such as a valve) is conveyed to a position, such as a trachea, in a body of a patient. Preferably, the unfolded catheter can be configured to combine with a tracheoscope. In certain implementation schemes, a locking lever is arranged so as to reduce the possibility of unfolding the device by accident; and the locking lever is convenient to reset after being used and the device is allowed to be unfolded for a plurality of times.

Description

展开导管 Expand the catheter

[0001] 本申请是于20 11年5月13日提交的名称为"展开导管"的发明专利申请2011800024509的分案申请。 [0001] This application is a name of May 13, 2011 entitled "deployment catheter" in invention patent is a divisional application 2011800024509. 背景技术技术领域 BACKGROUND skilled

[0002] 本发明的实施方案总体涉及医疗装置领域,更具体地,涉及利用导管将装置一一例如阀或其它医疗装置一一展开和/或植入体内的方法、系统和装置。 Embodiment [0002] The present invention generally relates to the field of medical devices, and more particularly, relates to a catheter device-for example a valve or other medical device start one by one and / or implanted in vivo methods, systems and apparatus.

[0003] 相关技术描述 [0003] Description of Related Art

[0004] 肺部疾病--例如C0PD、慢性支气管炎和肺气肿--的发病率、流行程度和花费都在提高。 [0004] lung diseases - such as C0PD, chronic bronchitis and emphysema - the incidence, prevalence and costs are improving. 新的治疗方法包括通过选择微创的非外科手术进行的肺减容治疗。 The new method of treatment comprises the treatment of lung volume reduction carried out by selecting a non-minimally invasive surgery. 在这些治疗情形中,可将阀植入病人的肺中,以减小肺的大小和/或治疗漏气。 In the treatment of these situations, the valve can be implanted in the patient's lungs, the lungs to reduce the size and / or treatment of leakage. 因此需要一种用于安全且一致地将这样的阀或其它医疗装置植入病人气管(airways)从而治疗肺部疾病的设备和方法。 Therefore a need for a safe and consistent manner to such a valve or other medical device implanted in the patient airway (Airways) apparatus and method to treat lung disease. 发明内容 SUMMARY

[0005] 本发明的各实施方案总体涉及用于经由导管将医疗装置(例如阀)引入体内的装置、系统和方法。 Various embodiments [0005] The present invention relates generally to apparatus for introducing a medical device in vivo via a catheter (e.g., a valve), the system and method. 导管是一种可被插入体内、或体腔、管道或脉管的管。 A catheter is inserted into the body, or a body cavity, duct or vessel tube. 导管可被用于允许将流体排出或注射至体内,或者通过手术仪器和/或可植入的装置提供进入体内的通路。 Catheter may be used to allow fluid is discharged or injected into the body, or to provide a passage into the body through the surgical instrument and / or implantable device. 为了使可植入的装置进入体内,首先可将可植入的装置插入导管中。 In order to make implantable device into the body, the implantable device may first be inserted into the catheter. 为了将装置输送至合适的位置,例如肺中的气道,气管镜或其他装置可设有一个工作通道,所述导管可引入该工作通道中。 To transport means to a suitable location, such as lung airways, bronchoscope, or other means may be provided with a working channel, the catheter may be introduced into the working channel. 然后可以进行对插在所述导管中的装置的输送和展开。 May then be transported to the apparatus in the conduit is inserted and expanded. 在一个优选的实施方案中,装载有阀的导管将阀输送至肺气管中的一个位置。 In a preferred embodiment, the valve catheter will be loaded into a delivery valve position lung tube.

[0006] 使用本文描述的方法、系统和装置,可将阀或其它医疗装置(可展开的或其他形式的)引入导管或其它展开器械。 [0006] Using the methods described herein, systems and means may be a valve or other medical device (deployable or otherwise) into the deployment catheter or other instrument. 在所述阀或其它医疗装置已经装载进所述导管或其它展开器械之后,可使用所述导管或其它展开器械将所述阀或其它医疗装置植入或定位在病人体内。 After the valve or other medical device has been loaded into the deployment catheter or other instrument may be deployed using a catheter or other instrument to the valve or other medical device implanted in a patient or positioned. 优选地,所述阀或其它医疗装置被装载进所述导管或其它展开器械的远端末梢区域中设置的腔或其它空间。 Preferably, the valve or other medical device is loaded into the deployment catheter or other cavities or other spaces distal tip region of the instrument set. 在一些实施方案中,所述导管或其它展开器械可装载进气管镜或其它此类器械的工作通道,并被穿行(navigated)至合适的展开位置,例如病人的气管。 In some embodiments, the deployment catheter or other instrument may be loaded into the working channel of a bronchoscope or other such devices, and walk through (the Navigated) appropriate to the deployed position, for example the trachea of ​​a patient.

[0007] 所述器械的实施方案可具有附加的特征(单独的或组合的),这些特征可显现出在帮助展开方面的优势和用处。 Embodiment of the [0007] devices may have additional features (alone or in combination), which exhibit the advantages and features may be useful in helping deployment area. 例如,可以设置一个锁定杠杆,其降低或消除阀或其它装置意外展开的可能性,还可在展开之后复位,以便进行多次装置展开。 For example, a lock lever may be provided which reduce or eliminate the possibility of accidental deployment valves or other apparatus, but also reset after deployment, for multiple device deployment. 此外,可设置一个夹持部, 在某些实施方案中为C形手柄,其可夹在气管镜上,以帮助阀或其它医疗装置展开,同时还设置一个人体工学手柄。 Further, a holding portion may be provided in some embodiments is a C-shaped lever which can be clamped on the bronchoscope, to help expand the valve or other medical device, and also provided an ergonomic grip. 还可在该器械上设置定位标记,尤其是在靠近器械的远端处,所述定位标记可帮助操作者将可植入的装置与选定的展开部位对准。 Positioning marks may also be provided on the instrument, in particular near the distal end of the instrument, the positioning site marker deployment may assist the operator to the implantable device with the selected alignment. 远端末梢部分还可被构造成笼套状结构,且可设有一个或多个窗孔(fenestration),所述窗孔允许观察和确认所述阀或医疗装置已经被正确地装载进远端末梢中。 The distal tip portion may also be configured as a sleeve-like cage structure, and may be provided with one or more apertures (Fenestration), the aperture allows viewing and confirmation of the medical device or the valve has been properly loaded into the distal end endings. 当然,本文还将详细地讨论其他特征和细To Of course, this feature will be discussed in detail and other fine To

[0008] 在一个实施方案中,描述了用于将一个装置展开进肺部的展开导管,其中该展开导管包括: [0008] In one embodiment, there is described a device for deployment catheter deployed into the lungs, where the deployment catheter comprising:

[0009] 包括手柄部分的近端,所述手柄部分包括一个柱塞,该柱塞被一个可移动的手柄围绕,所述可移动的手柄被配置为在沿着所述柱塞的长度的至少一部分的方向上轴向滑动,且其中所述柱塞还包括能够在锁定位置和解锁位置之间切换的锁定杠杆,该锁定杠杆被配置为当在所述锁定位置时,防止所述可移动的手柄在近端方向上滑向所述柱塞,但是当在所述解锁位置时,允许所述可移动的手柄在近端方向上滑动,且其中所述锁定杠杆还被配置为复位至锁定位置; [0009] includes a proximal handle portion, the handle portion comprises a plunger movable by a handle around the movable handle is disposed along the length of the plunger to at least sliding a portion of the axial direction, and wherein the plunger further comprises a locking lever can be locked and unlocked positions between the handover, the locking lever is configured, when in the locked position, preventing said movable handle slides said plunger in the proximal direction, but when in the unlocked position, to allow the movable handle to slide in the proximal direction, and wherein the locking lever is further configured to reset to the locking position ;

[0010]导管轴部分,该导管轴部分包括导管轴和所述导管轴内部的稳定线,其中所述导管轴在该导管轴的近端处被固定至所述可移动的手柄,且其中所述稳定线被固定至所述柱塞;以及 [0010] The portion of the catheter shaft, the catheter shaft comprises a catheter shaft and an inner portion of the catheter shaft stabilization line, wherein the catheter shaft is fixed to the movable handle at the proximal end of the catheter shaft, and wherein said stabilization line secured to said plunger; and

[0011] 远端末梢部分,其被配置为将一个医疗装置接收在一个腔中,其中所述远端末梢部分固定至所述中空的导管轴的远端,且所述远端末梢部分还包括接收在所述腔中的推进器柱塞,所述推进器柱塞连接至所述稳定线的远端。 [0011] The distal tip portion is configured for receiving a medical device in a cavity, wherein the distal tip portion is fixed to the distal end of the hollow catheter shaft and the distal tip portion further comprises received in the pusher plunger cavity, we said plunger advancing the distal end of the stabilizer is connected to the line.

[0012] -些实施方案提供使近端的柱塞在其近端包括C形手柄。 [0012] - Some embodiments provide that the proximal end of the plunger at its proximal end comprises a C-shaped handle. 在一些实施方案中,所述锁定杠杆包括被配置为与所述可移动的手柄中的凹口接合的锁定翼片。 In some embodiments, the locking lever comprises a locking tab configured to be movable with the handle engagement notch. 所述锁定杠杆还可包括附接至所述锁定杠杆的弹簧,该弹簧被配置为在所述医疗装置已经从所述展开导管展开后,将所述锁定杠杆复位到锁定位置。 The locking lever may further include a lock lever attached to the spring, the spring is configured to expand after the medical device has been deployed from the catheter, the locking lever is reset to the locked position.

[0013] 在一些实施方案中,所述导管轴部分包括位于其远端的高柔性(flexibility)区域,所述高柔性区域可包括犬牙交错(jigsaw)构造、蛇纹构造或交叠的直线切割部。 [0013] In some embodiments, the catheter shaft includes a portion at its distal end a high flexibility (Flexibility) region, the region may include a highly flexible cut straight indented portion (Jigsaw) configuration, or overlapping serpentine configuration .

[0014] 其他实施方案提供使所述远端末梢部分包括笼套,该笼套带有至少一个被配置为接收一个医疗装置的腔。 [0014] Other embodiments provide that the distal tip portion comprises a sleeve cage, the cage having at least one sleeve is configured to receive a medical device lumen. 所述笼套可具有形成螺旋构造的撑条布置,且可包括一个或多个大的窗孔。 The sleeve may have a cage struts arranged to form a helical configuration, and may include one or more large apertures. 在一些实施方案中,所述一个或多个大的窗孔被配置为允许观察和确认所述医疗装置已经被装载进所述腔中。 In some embodiments, the one or more large apertures are configured to allow the medical device to observe and confirm that has been loaded into the cavity. 所述远端末梢部分还可包括至少一个定位标记,所述定位标记被配置为指示所述医疗装置的大致展开位置。 The distal tip portion further comprises at least one positioning mark, the mark is positioned substantially deployed position is configured to instruct the medical device. 在一些实施方案中,所述定位标记是黄色的,两个额外的黑色带位于两侧。 In some embodiments, the positioning mark is a yellow, two additional black stripes on both sides. 在一些实施方案中,所述导管轴部分的远端还包括至少一个长的定位标记。 In some embodiments, the distal end of said catheter shaft further comprises at least a portion of the length of the registration mark.

[0015] 在一些实施方案中,所述手柄部分还包括一个截头圆锥的应变消除件,其围绕所述导管轴部分的近端区域。 [0015] In some embodiments, the handle portion further includes a frusto-conical strain relief member, surrounding a proximal region of the catheter shaft portion. 一些实施方案还可包括外部鞘,其至少围绕所述导管轴部分的近端区域。 Some embodiments may further include an outer sheath, which surrounds at least a proximal region of the catheter shaft portion. 优选的实施方案可被配置为装载进一个气管镜。 Preferred embodiments may be configured loaded into a bronchoscope.

[0016] 另一个实施方案提供了一种将一个医疗装置展开至病人肺部的方法,该方法包括: [0016] Another embodiment provides a method of deploying the medical device to a patient's lungs, the method comprising:

[0017] 将所述医疗装置装载进位于展开导管的远端末梢部分的腔中; [0017] The medical device is loaded into the cavity in the extended portion of the distal tip of the catheter;

[0018] 将所述展开导管引入一个气管镜; [0018] The deployment catheter introducing a bronchoscope;

[0019] 将所述气管镜插入肺气管; [0019] The bronchoscope inserted pulmonary tract;

[0020] 使所述气管镜穿行至肺气管的待被治疗的部分; [0020] the bronchoscope lung portion to be crossed to the tube to be treated;

[0021] 将所述肺气管的待被治疗的部分与位于所述展开导管的远端末梢部分上的至少一个定位标记对准; [0021] A portion of the lung to be treated and the tube is in the deployed distal tip portion of the catheter is aligned at least one positioning mark;

[0022] 解锁所述展开导管上的锁定杠杆;以及 [0022] unlocking the locking lever on the deployment catheter; and

[0023] 将所述医疗装置展开至所述肺气管的待被治疗的部分。 [0023] The portion of the medical device to be deployed in the lung airway to be treated.

[0024] 在一些实施方案中,在所述装置展开后,所述锁定杠杆复位到锁定位置。 [0024] In some embodiments, upon deployment of the device, reset the lock lever to the locked position. 在另一些实施方案中,所述展开导管包括在其近端的C形手柄,且其中所述C形手柄附接至所述气管镜的一部分。 In other embodiments, the catheter comprises at its proximal end deployed in the C-shaped handle, and wherein said C-shaped handle is attached to a portion of the bronchoscope. 在另外的实施方案中,使所述气管镜穿行的步骤还包括使用射线成像工具追踪所述展开导管。 In a further embodiment, the step of walking through the bronchoscope further comprising using the tracing-ray imaging tool deployment catheter. 附图说明 BRIEF DESCRIPTION

[0025] 下文参考各个实施方案的附图详细描述了本发明的前述以及其他特征、方面和优势,所述附图旨在示出而非限制本发明。 [0025] Hereinafter with reference to the accompanying drawings of various embodiments of the foregoing detailed description of the invention and other features, aspects, and advantages of, the drawings are intended to illustrate rather than limit the invention. 所述附图包括以下各图,其中: The drawings include the following figures, wherein:

[0026] 图1示出了导管的一个实施方案的侧视图。 [0026] FIG. 1 shows a side view of one embodiment of a catheter.

[0027] 图2示出了导管的手柄部分的一个实施方案的特写侧视图。 [0027] FIG. 2 shows a close up of one embodiment of a side view of the handle portion of the catheter.

[0028]图3-4分别示出了导管的手柄部分的一个实施方案的俯视图和仰视图。 [0028] Figures 3-4 illustrate a top view and a bottom view of one embodiment of the handle portion of the catheter.

[0029] 图5A-B不出了导管的一个实施方案的左视图和右视图。 [0029] Figures 5A-B not left and right views of one embodiment of a catheter.

[0030] 图6示出了导管轴的一个实施方案的截面图。 [0030] FIG. 6 shows a sectional view of an embodiment of the catheter shaft.

[0031]图7是导管的手柄部分的一个实施方案的截面图。 [0031] FIG. 7 is a cross-sectional view of one embodiment of the handle portion of the catheter.

[0032]图8示出了导管闭锁机构的一个实施方案的特写截面图。 [0032] FIG. 8 shows a close-up cross-sectional view of one embodiment of a catheter locking mechanism.

[0033]图9A-B示出了将导管轴附接至导管手柄的一个实施方案的叉状物的特写图。 [0033] Figures 9A-B shows the catheter shaft is attached to the fork close-up view of an embodiment of the catheter handle.

[0034] 图10A-C示出了在导管轴上呈现的高柔性区域的实施方案。 [0034] FIGS. 10A-C illustrate an embodiment of the present highly flexible catheter shaft region.

[0035] 图11A-B分别示出了其中没有装载阀以及其中装载有阀的导管的远端末梢的实施方案的特写图。 [0035] Figures 11A-B show a close-up view wherein the valve is not loaded, and embodiments wherein the distal tip of the catheter loaded valve.

[0036] 图12A-B分别示出了其中没有装载阀以及其中装载有阀的导管的远端末梢的实施方案的特写截面图。 [0036] FIGS. 12A-B show a close-up cross-sectional view in which the valve is not loaded, and embodiments wherein the distal tip of the catheter loaded valve.

[0037] 图13是导管的一个实施方案的远端末梢的最远端的特写图。 [0037] FIG. 13 is a close-up view of the distal end of the distal-most tip of one embodiment of a catheter.

[0038]图14示出了可用于将远端末梢附接至导管轴的连接件机构的实施方案。 [0038] FIG 14 shows a distal tip may be used to attach the connector to the embodiment of the catheter shaft mechanism.

[0039] 图15示出了添加有定位器标记的导管轴的实施方案的远端末梢的特写图。 [0039] FIG. 15 shows a close-up view of the distal tip of the catheter shaft there is added labeled locator embodiment.

[0040] 图16A-H示出了导管的远端末梢的不同实施方案。 [0040] FIGS. 16A-H show different embodiments of the distal tip of the catheter.

[0041] 图17是封装的导管和阀装载器系统的实施方案的视图。 [0041] FIG 17 is a view of an embodiment of conduits and valves loader system package.

[0042]图18A示出了装载进插入肺气管的气管镜的导管的实施方案。 [0042] FIG. 18A shows an embodiment of a bronchoscope is inserted lung loaded into the catheter tube.

[0043] 图18B示出了带有附接至气管镜的夹持部的导管的实施方案。 [0043] FIG 18B illustrates an embodiment of a bronchoscope having attached to the conduit gripping portion.

[0044] 图19A-C示出了呈现在导管手柄的一个实施方案中的闭锁机构如何操作。 [0044] FIGS. 19A-C illustrate how the locking mechanism present in one embodiment of the catheter handle in the operation.

[0045] 图20A-C示出了使用装载进导管的一个实施方案的阀将阀展开进气管。 [0045] FIGS. 20A-C illustrate the use of one embodiment of a valve loaded into the catheter to expand the intake valve. 具体实施方案 Specific embodiments

[0046] 现在将参考一个或多个实施方案的附图描述导管展开系统以及系统的相关构件和部件。 [0046] Reference will now be made reference to one or more embodiments described catheter deployment systems and associated components and the system components. 在此处提供的说明书中使用的术语不旨在以任何局限或限制方式被解释。 The terms used in the specification provided herein are not intended to be construed in any way restricted or limited. 相反,仅结合系统、方法和相关构件的实施方案的详细描述使用术语。 Instead, only the system in conjunction with the detailed description of embodiments of the method and the use of the term associated components. 此外,各实施方案可包括一些新的特征,这些特征中的单个特征都不单独做出预期的贡献,或不应认为单个特征对于实现本文描述的发明是必不可少的。 Further, various embodiments may include several novel features, individual these features alone are not expected to make a contribution to, or not to be considered a single feature for realizing the invention described herein is essential.

[0047] 本文使用的术语"阀(valve) "、"可展开的医疗装置(deployable medical device)"、"医疗装置(medical device)"和"装置(device)"是广义的可互换术语,除非另有指出,在其含义中,所述术语可非限制性地包括支架、阀、肺减容阀、气囊、探针、标记(包括不透射线的标记和其他形式的基准标记)、锚固装置、或任何其他被配置为装载或引入导管或其它展开器械并随后被输送或展开的医疗装置(可展开或其他形式的)。 [0047] As used herein, the term "valve (Valve)", "expandable medical device (deployable medical device)", "medical device (medical device)" and "device (Device)" is a broad term used interchangeably, unless otherwise indicated, in its meaning, the term may include without limitation stents, valves, lung volume reduction valve, a balloon, a probe, labeled (including radiopaque markers and other forms of reference numerals), the anchor devices, or any other configured to stow or into a catheter or other instrument to expand and is then delivered or deployed medical device (expand or otherwise). 尽管本文描述的一些实施方案针对将医疗装置展开到气管中,但是本公开内容不限于此,而是可展开到例如但不限于人和动物的其他脉管、通路和体腔。 Although some embodiments described herein to expand into the trachea for a medical device, but the present disclosure is not limited thereto, but may be expanded to other vessels such as, but not limited to humans and animals, and the passage of the body cavity. 在某些实施方案中,所述阀和/或医疗装置是在美国专利第6,293,951号或第7,757,692号中公开的类型,所述两篇专利各自全部纳入本文。 In certain embodiments, the valve and / or the medical device is of the type disclosed in U.S. Patent No. 6,293,951 or No. 7,757,692, the entire two patents are each incorporated herein by reference.

[0048] 图1示出了展开导管系统101的一个实施方案。 [0048] FIG. 1 shows an expanded embodiment of a catheter system 101. 该系统101包括一些共同作用的不同部分。 The system 101 includes a number of different portions of the role. 系统101的近端包括手柄部分103,该手柄部分联接至导管轴部分105,导管轴部分105终止于系统101远端处的远端末梢部分107。 The system 101 includes a proximal handle portion 103, handle portion of the shaft portion 105 is coupled to the catheter, the catheter shaft distal end portion 105 terminates in a distal tip portion 101 of the system 107. 在一个优选实施方案中,近端手柄部分103 经所述导管部分105连接至远端末梢部分107,所述远端末梢部分107优选地包含使用系统101待被展开到合适部位的医疗装置。 In a preferred embodiment, the proximal portion of the handle portion 103 through the conduit 105 is connected to a distal tip portion 107, the distal tip portion 107 preferably comprises using the system 101 to be deployed to the appropriate parts of the medical device. 在一些实施方案中,远端末梢部分107可包含(或被配置为接收)例如待被展开在气管通路中的阀的装置。 In some embodiments, the distal tip portion 107 may include (or be configured to receive a) means, for example, be a valve in the pipe passage is expanded.

[0049] 图2-5示出了手柄部分103的其他外视图。 [0049] Figures 2-5 show other external view of the handle portion 103. 手柄部分103优选适于使用者握住或握持,并包括一些部件。 The handle portion 103 preferably is adapted to hold or holding a user, and comprises some components. 手柄部分103包括连接至柱塞204的夹持部202。 103 includes a handle portion connected to the clamping portion 204 of the plunger 202. 可移动的手柄206附接至柱塞204,例如可围绕柱塞204布置。 A movable handle 206 connected to the plunger 204 is attached, for example, be arranged around the plunger 204. 导管轴部分105在手柄部分103的远端连接至手柄部分103〇 Catheter shaft portion connected to the handle portion 105 at a distal end of the handle portion 103〇 103

[0050] 手柄部分103的夹持部202可被构造为带有凹口,当准备展开包含在远端末梢部分107中的装置时,该凹口可允许使用者的大拇指握住或抓住手柄部分103。 Holding portion [0050] 103 handle portion 202 may be configured with a recess, when in the ready deployment device includes a distal tip portion 107, the notch may allow the user to grasp or hold the thumb handle portion 103. 如示出的,夹持部202可形成C形夹持部。 As shown, the gripping portion 202 may form a C-shaped clamping portion. 夹持部202可采用其他形状,例如但不限于,夹持部202可具有U形、V 形或凹陷的内表面。 Gripping portion 202 may take other shapes such as, but not limited to, the gripping portion 202 may have a U-shaped, V-shaped or inner surface of the recess. 在一些实施方案中,如下文图18B进一步详细描述的,夹持部202可附接至一个装置,例如内窥镜,或者更具体地附接至气管镜。 In some embodiments, as described in further detail in FIG. 18B, the holding portion 202 may be attached to a device, such as an endoscope, or more specifically attached to the bronchoscope. 可供使用者的手握住或操作的夹持部202、以及系统101的其他部件可设有防滑的或橡胶处理的覆层,以向使用者提供额外的握力。 For the user's hand holding the holding portion 202 or operation, as well as other components of system 101 may be provided with non-slip coating or rubber processing, to provide additional grip to the user.

[0051] 夹持部202附接至柱塞204。 [0051] clamping portion 202 is attached to the plunger 204. 柱塞204可设有人体工学手指压花205,当操作系统101 时,人体工学手指压花205可为使用者的手指提供更稳固或舒适的握持。 The plunger 204 may be provided with ergonomic finger embossing 205, when the operating system 101, ergonomic finger embossing 205 may provide a more secure or comfortable grip for the user's finger.

[0052] 可移动的手柄206被构造为可移动地与柱塞204接合,以使得可移动的手柄206例如可沿着柱塞204的至少一部分在纵向轴向方向前后滑动。 [0052] A movable handle 206 is configured to be movably engaged with the plunger 204, such that the movable handle 206 may be, for example, along at least a portion of the plunger 204 slides back and forth in the longitudinal axial direction. 从图2示出的位置,可移动的手柄206可在近端方向移向夹持部202。 From the position shown in FIG. 2, the movable handle 206 may be moved toward the nip portion 202 in a proximal direction.

[0053] 在可移动的手柄206的远端,稳固翼片(securement tab) 208和锁定杜杆210可附接至柱塞204。 [0053] The distal end of the movable handle 206, and securely flap (securement tab) 208 DU and the lock lever 210 may be attached to the plunger 204. 锁定杠杆210被配置为当在示出的锁定位置时,其与可移动的手柄206接合, 以降低或消除可移动的手柄206在近端方向移向夹持部202的可能性。 The lock lever 210 is configured to, when in the illustrated locking position, engaged with the movable handle 206, to reduce or eliminate the possibility of the movable handle 206 toward the nip portion 202 in a proximal direction. 可移动的手柄206优选地包括人体工学辅助物一一例如脊207,其使得使用者在展开医疗装置期间可容易地操作和拉动可移动的手柄206。 Movable ergonomic handle 206 preferably includes ridges 207 aid-for example, which operate so that the user can easily pull the handle 206 and is movable in the medical device during deployment. 在一些实施方案中,可移动的手柄206的所有部分或一部分可设有防滑的或橡胶处理的覆层,以向使用者提供额外的握力。 In some embodiments, all portions of the movable handle 206 may be provided or a portion of the non-slip coating or rubber processing, to provide additional grip to the user.

[0054] 手柄部分103还可包括应变消除构件212。 [0054] The handle portion 103 may further include a strain relief member 212. 优选地,该应变消除构件212联接至手柄部分103,并由如下的弹性材料制成,例如聚合物,包括(例如但不限于)橡胶、热塑性弹性体(例如Santoprene™,Kraton®)、聚氨酯、聚氯乙烯、ΡΕΒΑΧ®和硅氧烷。 Preferably, the strain relief member 212 is coupled to the handle portion 103, and made of an elastic material as, for example, polymers, including (but not limited to for example) rubber, thermoplastic elastomers (e.g. Santoprene ™, Kraton®), polyurethanes, polyvinyl chloride, ΡΕΒΑΧ® and silicone. 应变消除构件212 的形状可以是近似圆锥形或截头圆锥形,带有纵向延伸的中央开口,该中央开口被配置为与导管轴部分105的外部鞘316 (如果设置有)或导管轴302紧密贴合。 The shape of the strain relief member 212 may be approximately conical or frustoconical, with a longitudinally extending central opening, the central opening 316 is configured with an outer sheath of the catheter shaft portion 105 (if provided) or a catheter shaft 302 in close fit. 应变消除构件212可在导管轴部分105与手柄部分103的接合点附近降低导管轴部分105扭折或弯曲的可能性,尤其是当导管轴部分105被插入仪器(例如气管镜)时,以及在使用中被操作时。 When the strain relief member 212 can reduce the possibility of a kink or bend in the catheter shaft in the vicinity of the junction portion 105 of the catheter shaft portion 105 and handle portion 103, especially when the catheter shaft portion 105 is inserted into the instrument (e.g., bronchoscope), as well as in use is operated.

[0055] 现参考图6,其示出导管轴部分105的截面图。 [0055] Referring now to Figure 6, which shows a cross-sectional view of the catheter shaft portion 105. 导管轴302是中空的,并包括在其中纵向延伸的稳定线304。 Catheter shaft 302 is hollow and includes therein longitudinally extending line 304 stably. 导管轴302优选地由弹性和耐用(robust)材料构造(例如一种金属或多种金属),所述材料抗拉伸和塑性变形,同时保持足够的柔性,以被引导通过曲折通路和其他类似收敛管道。 Catheter shaft 302 is preferably made of an elastic and durable (Robust) constructed of a material (e.g., metal or metals), a stretch resistant material and plastic deformation, while maintaining sufficient flexibility to be guided through the tortuous path and the like convergence pipeline. 合适的金属可包括不锈钢、镍钛诺(Nitinol)等。 Suitable metals may include stainless steel, nitinol (as Nitinol) and the like. 在一些实施方案中, 聚合物管的效果良好,一些实施方案例如可由连续的聚合物挤出制造。 In some embodiments, the effect of polymer tube well, some embodiments may be, for example, a continuous polymer manufacturing extrusion. 这些挤出还可包括交织以获得额外的强度和耐用性,且可由聚合物一一例如聚酰亚胺一一构造。 The extrusion may also include interleaving in order to obtain additional strength and durability, and may be a polymer such as polyimide eleven eleven configuration. 稳定线304同样可由类似材料构造。 Stabilization line 304 may be formed of the same material similarly configured.

[0056] 在一些实施方案中,光滑覆层或材料可被添加至稳定线304或导管轴302中的一个或两者,这可帮助这两个部件更自如地相互滑动通过,且总体不会有阻塞或粘卡。 [0056] In some embodiments, the smooth layer or coating material may be added to the stabilization line 304 or one or both of the catheter shaft 302, which may help these two components to each other more freely slide through, and generally not there blocked or sticky card. 例如,聚合物(例如PTFE或聚对二甲苯)可被涂覆在稳定线304上。 For example, polymers (e.g. parylene or PTFE) may be coated on the stabilization line 304. 覆层(例如FEP)还可被挤压至稳定线。 Coating (e.g., FEP) may be pressed to a stable line. 热缩聚合物(例如PTFE或聚乙烯)也可被添加至稳定线304。 Heat shrink polymers (e.g. polyethylene or PTFE) can also be added to the stabilization line 304.

[0057] 在一些实施方案中,优选地,所述稳定线304可沿其长度具有变化的直径。 [0057] In some embodiments, preferably, the stabilizing wire 304 may have a varying diameter along its length. 该直径例如可以连续或逐渐减小的方式变化,或者以阶式(stepwise)方式变化。 For example, or the change in the diameter is gradually reduced continuously manner or in a stepwise manner (StepWise) changes. 在不希望被理论限制的情况下,我们认为稳定线304的如下一些实施方案是有利的,即,在近端(即朝向手柄部分103)具有较大的直径,以降低或消除在施加较高负载的情况下屈曲的可能性;同时朝着远端(即靠近末梢部分107)具有较小的直径,以提供额外的柔性。 Without wishing to be bound by theory, we believe that the following embodiments some stability is advantageous in line 304, i.e., at the proximal end (i.e., toward the handle portion 103) has a larger diameter, to reduce or eliminate the application of high possibility of buckling under load; simultaneously toward the distal end (i.e., near the tip portion 107) has a smaller diameter, to provide additional flexibility. 在一个实施方案中,稳定线304从近端开始一直具有0.020英寸的直径,直到通过外部鞘316近似1英寸才变化。 In one embodiment, stabilization line beginning from the proximal end 304 has a diameter of 0.020 inches with approximately 1 inch by only the outer sheath 316 until the change. 稳定线304的剩余部分的直径阶式变化至0.016英寸。 Stepped change in diameter the remaining portion of line 304 is stable to 0.016 inches. 该实施方案可用在内径为近似0.022-0.024英寸的导管轴302中,以使得导管轴302和稳定线304之间在每一侧上的间隙在近端为近似0.001-0.002英寸,远端为0.003英寸。 This embodiment can be used in an inner diameter of approximately 0.022-0.024 inch of catheter shaft 302, so that the clearance on each side at the proximal end 304 is approximately 0.001-0.002 inches between the catheter shaft and stabilization line 302, distal to 0.003 inch.

[0058] 参考图7,其示出了手柄部分103的截面图。 [0058] Referring to Figure 7, which shows a cross-sectional view of the handle portion 103. 图8示出了该截面图的特写图。 Figure 8 shows a close-up view of the section of FIG. 在一优选的实施方案中,夹持部202连接至稳定线304,尽管在一些实施方案中,稳定线304还可连接至柱塞204,或者替代地连接至柱塞204。 In a preferred embodiment, the gripping portion 202 is connected to the stabilization line 304, although in some embodiments, the stabilization line 304 may also be connected to the plunger 204, or alternatively connected to the plunger 204. 稳定线304被布置在导管轴302内,导管轴302优选地被配置为在纵向方向上关于稳定线304滑动。 Stabilization line 304 is disposed within the catheter shaft 302, the catheter shaft 302 is preferably configured to slide on the stability of the line 304 in the longitudinal direction.

[0059] 在某些实施方案中,卷曲管305用于将稳定线304连接至夹持部202。 [0059] In certain embodiments, the coiled tube 305 for connecting the line 304 to stabilize the clamping portion 202. 卷曲管305优选地由比稳定线304更硬的金属构造,例如不锈钢合金(例如SS304),并形成为海波管(hypotube)。 Crimp tube 305 is preferably made of a harder metal than 304 stabilizing wire construction, such as stainless steel alloys (e.g. SS304), and is formed as a hypotube (hypotube). 优选地,卷曲管305卷曲在稳定线304的近端,卷曲管305的近端被保持在夹持部202内部,卷曲管305的远端被保持在柱塞204的主体的剩余部分内。 Preferably, the coiled tube 305 at the proximal end crimp stabilization line 304, the proximal end crimp tube 305 is held inside the holding portion 202, the distal end of coiled tube 305 is held in the remaining portion of the body 204 of the plunger. 在一些实施方案中, 卷曲管305可部分延伸在导管轴302上,例如延伸0.1英寸的短长度,因为当力施加至导管轴302时,这可为导管轴302提供额外的抗屈曲性。 In some embodiments, the tube 305 may extend partially coiled on the catheter shaft 302, for example, extending a short length of 0.1 inches, because when a force is applied to the catheter shaft 302, which may provide additional resistance to buckling of the catheter shaft 302. 在一些实施方案中,卷曲管305可具有近似0.039英寸的内径,壁厚0.010英寸。 In some embodiments, the coiled tube 305 may have an inner diameter of approximately 0.039 inches, a wall thickness of 0.010 inches.

[0060] 导管轴302经一个叉状物216连接至可移动的手柄206。 [0060] The catheter shaft 302 connected to the handle 206 via a movable fork 216. 因为可移动的手柄206优选地被配置为沿着柱塞204前后滑动,且因为可移动的手柄206被联接至导管轴302,所以可移动的手柄206的移动会导致导管轴302相对于稳定线304的相应移动。 Because the movable handle 206 is preferably configured to slide back and forth along the plunger 204, and because the movable handle 206 is coupled to the catheter shaft 302, the movable handle 206 will cause movement of the catheter shaft 302 with respect to the stabilization line 304 corresponding movement. 如下文将讨论的,该移动允许装在远端末梢107的装置弹出和展开。 As will be discussed, the mobile device allows the tip to the distal end 107 of the pop-up and deployment. 此外,锁定杠杆210可设有一个锁定翼片222, 该锁定翼片222与可移动的手柄206上的凹口220接合,从而帮助降低或消除可移动的手柄206沿着柱塞204滑动的可能性。 Further, the lock lever 210 may be provided with a locking tab 222, the locking tab 222 and the notch 206 of the movable handle 220 engagement to help reduce or eliminate the movable handle 206 of the plunger 204 may slide along sex. 这种设置可用于帮助降低或消除非预期或过早地从导管系统101展开装置。 Such an arrangement can be used to help reduce or eliminate unintended or premature deployment device 101 from the catheter system. 在某些实施方案中,导管轴302可替代地连接至柱塞204,稳定线304可经所述叉状物216连接至可移动的手柄206。 In certain embodiments, the catheter shaft 302 may alternatively be connected to the plunger 204, stabilization line 304 via the prongs 216 may be connected to the movable handle 206.

[0061] 导管轴302优选地固定至手柄部分103,且在某些实施方案中,一个或多个中间构件可形成该连接的一部分。 [0061] The catheter shaft 302 is preferably secured to the handle portion 103, and in certain embodiments, one or more intermediate members may form part of the connection. 在一些实施方案中,现参考图9A-B,导管轴302可固定至叉形中间构件,例如叉状物216,且导管轴302例如可夹持在叉形中间构件的凹口中。 In some embodiments, Referring now to Figure 9A-B, the catheter shaft 302 may be fixed to the fork intermediate member, for example a fork 216, and the catheter shaft 302, for example, may be clamped in a recess of the fork-shaped intermediate member. 叉状物216本身又连接至可移动的手柄206。 Prongs 216, in turn connected to the movable handle 206. 为清晰,省略了可移动的手柄206,但可移动的手柄206与其他部件的关系可在图7-8中看出。 For clarity, omitted the movable handle 206, the handle 206 is movable relationship with other components can be seen in FIG 7-8.

[0062] 叉状物216优选地包括至少两个叉齿217。 [0062] prongs 216 preferably includes at least two prongs 217. 这些叉齿217彼此之间具有一间隔,该间隔小于导管轴302的直径。 The tine 217 having a space between each other, the spacer 302 is smaller than the diameter of the catheter shaft. 为了将导管轴302连接至叉状物216,导管轴302 (优选地构造有圆形横截面)可由此具有在其上形成的一个或多个缺口或腔308。 In order to connect the catheter shaft 302 to the fork 216, the catheter shaft 302 (preferably configured with circular cross-section) may thus have one or more notches or cavities 308 formed thereon. 所述缺口或腔308允许将导管轴302接收在两个叉齿217之间的间隔中,这是因为腔308沿着导管轴302的距离将导致导管轴302具有较小的横截面的一段距离,以允许导管轴302插入和固定在两个叉状物217之间的间隔中。 The gap or cavity 308 allows the catheter shaft 302 received in the interval between the two tines 217, the cavity 308 because the distance along the catheter shaft 302 will result in a catheter shaft 302 having a length of smaller cross section from to allow the catheter 302 is inserted and fixed shaft 217 between the two prongs interval. 相应地,可在导管轴302和叉状物216之间形成轴向固定连接。 Accordingly, it may be formed axially fixed connection between the catheter shaft 302 and the prongs 216. 因为稳定线304 位于导管轴302内,因此必须注意缺口或腔308、310实质上不干涉导管轴304的相对自由移动,或不切进导管轴304。 Because the stabilization line 304 is located within the catheter shaft 302, care must be taken not interfere with notches or cavities 308, 310 is substantially free to move relative to the catheter shaft 304, or 304 cut into the catheter shaft.

[0063] 测试已经显示出,一个实施方案的由不锈钢构造的叉状物216 (叉状物216可由任何合适的刚性材料构造,例如包括不锈钢的金属)在失效之前可承受大于20镑的力。 [0063] Testing has shown that the configuration of one embodiment of a stainless steel prongs 216 (fork 216 may be constructed of any suitable rigid material such as metal including stainless steel) can withstand before failure greater than 20 pounds of force. 因为使用者不可能在展开期间施加这样大的力,因此该构造使得系统101更可能保持完好,且叉状物216的失效不太可能导致导管轴302与系统101的其余部分分离。 Because the user can not exert such a large force during deployment, so that the system 101 is configured such that more likely to remain intact, and the fork 216 is less likely to result in failure separated from the rest of the catheter system 101 with the shaft 302.

[0064] 重新参考图1,还可在导管轴部分105上设置外部鞘316。 [0064] Referring back to FIG 1, outer sheath 316 may also be provided on the shaft portion 105 of the catheter. 外部鞘316可位于导管轴302和应变消除构件212之间,且可用于(与应变消除构件212-起,如果设置有应变消除构件212的话)使导管部分105的扭折和扭转负载最小化。 Outer sheath 316 and the shaft 302 of the catheter may be positioned between the strain relief member 212, and can be used (with the strain relief member from 212-, if provided with a strain relief member 212 words) of the catheter kinking and twisting minimize the load portion 105. 为确保鞘316的可靠连接,优选地将鞘316固定至柱塞204,例如通过嵌件成型(insert molding)或粘结剂。 To ensure reliable connection of the sheath 316, the sheath 316 is preferably fixed to the plunger 204, for example, molding (insert molding) by an adhesive or insert. 在一些实施方案中, 外部鞘尺寸在22到39英寸之间,壁厚在近似0.005-0.015英寸之间,优选地0.010英寸。 In some embodiments, the outer sheath sizes between 22 to 39 inches, a wall thickness of between approximately 0.005-0.015 inches, preferably 0.010 inches. 优选地,外部鞘316在其本身和导管轴302之间具有空隙或间隙。 Preferably, the outer sheath 316 having a void or gap between itself and the catheter shaft 302. 在一些实施方案中,该间隙的尺寸在大约0.003-0.010英寸之间,优选地每一侧为0.005英寸。 In some embodiments, the size of the gap is between about 0.003 to 0.010 inches, preferably 0.005 inches per side. 在一些被配置为无菌(例如使用环氧乙烷气体灭菌法)的实施方案中,导管轴302和外部鞘316之间的间隙可被设计为允许两部件之间杀菌剂的充分流动。 In some embodiments, be configured as a sterile (e.g., using ethylene oxide gas sterilization), the gap between the catheter shaft 302 and the outer sheath 316 may be designed to allow sufficient flow of sterilant between the two parts.

[0005] 外部鞘316优选地由以下材料构造,包括例如以单聚合物挤出(single polymer extrus i on)形成的聚合物,例如HDPE、尼龙-12、PEBΑΧ®.、聚氨酯,或者以上材料的混合物。 [0005] The outer sheath 316 is preferably constructed from a material, for example, comprise a single polymer extrusion (single polymer extrus i on) polymers formed, for example HDPE, nylon -12, PEBΑΧ®., Polyurethane, or the above materials mixture. 在一些实施方案中,外部鞘316由两种不同材料共挤形成。 In some embodiments, the outer sheath 316 is formed of a coextrusion of two different materials. 在外部鞘316面向导管轴302 的一侧,可使用光滑材料,例如HDPE、FEP,或其它合适材料。 In the outer sheath 316 facing the side of the catheter shaft 302, using a smooth material, for example HDPE, FEP, or other suitable material. 在鞘316的外侧,可使用聚合物一一例如ΡΕΒΑΧ®、或尼龙-12、或其它合适材料一一以获得如下各因素之间的平衡,所述因素诸如可推动能力(例如限制使用者可施加的力的量)、机械强度(例如在负载下的抗变形能力)、抗弯折性、与气管镜内部的摩擦、以及可制造性。 In the outer sheath 316, may be a polymer-for example ΡΕΒΑΧ®, or nylon-12, or other suitable materials to obtain eleven to balance between the following factors, factors such as the ability to be driven (e.g., a user may limit the amount of force applied), the mechanical strength (e.g., resistance to deformation under load), flexural frictional resistance, and the interior of the bronchoscope, and manufacturability. 在一些实施方案中,射线不可透材料(例如硫酸钡)可被纳入鞘316和/或导管系统101的其他元件。 In some embodiments, a radiopaque material (e.g., barium sulfate) may be incorporated into other elements of the sheath 316 and / or 101 of the catheter system.

[0066] 参考图10A-C,可沿着导管轴302的大体全部或部分形成一系列切割部。 [0066] with reference to FIGS. 10A-C, may be disposed along the catheter shaft 302 substantially all or a part of a series of cutting portion. 这些切割部可限定一个或多个柔性增大的区域330,区域330通常能够比剩下的未切割的导管轴302 更好地弯曲或折曲。 The cutting portion may define one or more flexible regions of increased 330, region 330 is generally better able to 302 curved or bent than the remaining uncut catheter shaft. 在一些实施方案中,已经发现如果导管轴302的远端的一部分具有切割进其中的高柔性区域330,则导管系统101表现得好,这是因为导管轴302的远端部分需要更大程度的弯曲,以通过例如曲折的气管通路。 In some embodiments, it has been found that if a portion of the distal end of a catheter shaft 302 having a high flexibility therein into a cutting area 330, the catheter system 101 to perform well, since the distal end portion of the catheter shaft 302 requires a greater degree of bent, for example through a tortuous path trachea. 高柔性区域330的柔性可以根据具体应用的要求被设计。 High flexibility of the flexible region 330 may be designed according to specific application requirements. 例如通过修改导管轴302的厚度、其中使用的材料、以及高柔性区域330中的切割部之间的间隔、节距(pitch)和角度来改变柔性。 For example, by modifying the thickness of the catheter shaft 302, spacing, pitch (Pitch) and wherein the angle between a material used, a high flexibility and a cutting portion area 330 to change flexibility. 优选地,切割部沿着导管轴302以螺旋方式延伸。 Preferably, the cutting portion extending in helical fashion along the catheter shaft 302.

[0067] 此外,高柔性区域330不需要是图10A示出的单一节距,而是参考图10B,高柔性区域330替代地可以是可变节距,其中间隔或节距可以连续变化或阶式变化。 [0067] In addition, a high flexibility region 330 need not be a single pitch shown in FIG. 10A, but with reference to Figure 10B, a high flexibility region 330 may alternatively be a variable pitch, where the pitch or spacing can be varied continuously or stepwise Variety. 此外,尽管在这些图中示出的切割部可以制成连续的单个切割部,但是可使用一个或多个不连续的切割部制造高柔性区域。 Further, although in these figures the cutting unit shown may be made of a single continuous cutting part, but may use one or more discrete cutting portion for producing highly flexible regions. 在这些图中,构成高柔性区域330的切割部以形成锯齿或之字形样式的"犬牙交错"配置制成。 In these figures, the flexible region 330 constituting the high-cut portion to form a zig-zag or sawtooth pattern "interlocking" configuration is made. 其他可行的切割部是如下文图16B和C示出和讨论的"蛇纹(serpentine)"配置。 Other possible below the cutting portion is shown in FIG. 16B and C and discussion "serpentine (Serpentine)" configuration. 在该蛇纹配置中,切割部比犬牙交错样式更光滑、更圆,且具有较长的幅度。 In the serpentine configuration, the cutting portion smoother than jagged pattern, more rounded, and has a longer range. 其他切割部类型也是可行且可设想的,包括直线切割部、局部或虚线切割部、之字形切割部、正弦式切割部等。 Other types are possible and the cutting portion may be contemplated, including the linear cutting portion, partially or dashed cutting portion, the cutting portion zigzag, sinusoidal cutting portion and the like.

[0068]图10C示出了包括交叠的不连续直线切割部的高柔性区域330的一个实施方案,每个切割部近似围绕导管轴302的圆周的一半延伸。 [0068] FIG 10C shows comprising overlapping portions of a discontinuous straight cut a high-flexible region 330 of the embodiment, each cutting portion extends around approximately half the circumference of the catheter shaft 302. 在该实施方案中,冲孔331可设置在每个切割部的一个或多个末端处。 In this embodiment, the punch 331 may be provided in one or more of each cutting portion at the end. 在一些情形中,冲孔331可作为用于产生切割部的激光切割工艺的一部分而制成,但是这些切割部可使用任何合适的工艺制造,例如化学蚀刻。 In some cases, the punch 331 can be used to produce the laser cutting unit as a part of the cutting process is made, but these portions may be cut using any suitable manufacturing process, such as chemical etching. 冲孔331 还可用于向导管轴302提供额外的强度,这是因为相信冲孔331可帮助降低或消除在导管轴302经历不同应力时裂纹扩展的可能性。 331 for punching the catheter shaft 302 may also provide additional strength, it is believed that because the punch 331 can help reduce or eliminate the possibility of the catheter when subjected to different stress crack extension shaft 302.

[0069] 在实际中,高柔性区域330和构成该高柔性区域330的切割部的加工可如期望的在要求的柔性和切割部类型之间找到恰当的平衡。 [0069] In practice, flexible region 330 and a high high-flexible region constituting the cutting portion 330 may be processed as desired to find the right balance between the flexible portion and the type of cutting required. 例如,虽然较宽或较大的切割部可提供额外的柔性,但是在一些情形中这些会削弱导管轴302至不可接受的程度。 For example, although a wider or larger cut portion may provide additional flexibility, in some cases weaken the catheter shaft 302 to an unacceptable degree. 不同的切割部类型还可在疲劳试验中或多或少满意地工作。 Different types of cutting portions may be more or less work satisfactorily in fatigue. 此外,某些切割部可导致高柔性区域330的一部分磨损气管镜的工作通道,但是在切割部产生后的后加工可包括至少可部分减轻这种顾虑的例如修边或超声波清洗的步骤。 Additionally, some portion of the cutting portion may cause wear highly flexible bronchoscope working channel region 330, but after processing the cut portion may comprise generating at least partially alleviate this concern, for example, the step of trimming or ultrasonic cleaning. 上文描述的切割部类型还可根据一个或多个高柔性区域330的长度而调整。 Cutting unit of the type described above may also be adjusted according to the length of one or more highly flexible regions 330.

[0070] 在优选的实施方案中,已经发现尺寸在3到6英寸的高柔性区域330 (切割部之间的节距在0.010到0.100英寸之间)可有效工作。 [0070] In a preferred embodiment, it has been found (pitch between the cutting portion between .010 to .100 inches) in size 3-6 inches high flexibility region 330 can work effectively. 已经发现,在一些实施方案中,切割部宽度(切缝)在0.0015-0.0030英寸之间的范围内是令人满意的。 It has been found, in some embodiments, the width of the cut portion (slit) in the range of between 0.0015-0.0030 inches is satisfactory.

[0071] 在某些实施方案中,可优选采用柔性保护层一一例如聚合物或热收缩材料一一至少覆盖高柔性区域330。 [0071] In certain embodiments, the protective layer may be preferably a flexible polymer, for example, eleven or eleven heat shrinkable material covering flexible region is at least 330. 这种保护层可至少部分减少由于切割部导致的气管镜的工作通道内部的磨损,且还可降低或消除导管轴302损坏或过度伸长的可能性,这可帮助使得导管可用于多次展开。 The possibility of such a protective layer may be at least partially reduce the wear of the cutting portion results in the interior of the working channel of the bronchoscope, and may also reduce or eliminate damage to the catheter shaft 302 or excessive elongation, which may help to expand the catheter may be used multiple times . 此外,该保护层还可以是光滑的或润滑的,从而允许导管轴302在气管镜工作通道内更容易地滑动。 Further, the protective layer may also be smooth or lubricated, thereby allowing the catheter shaft 302 to more easily slide within working channel of a bronchoscope.

[0072] 现参考图11A-B和12A-B,远端末梢部分107可以经连接件402接合至导管轴部分105。 [0072] Referring now to Figures 11A-B and 12A-B, a distal tip portion 107 may be bonded to the catheter shaft 105 through the connecting portion 402. 更具体地,在一些实施方案中,连接件402将外导管轴302连接至远端末梢部分107。 More specifically, in some embodiments, connector 402 connects the outer catheter shaft 302 to the distal tip portion 107. 在优选的实施方案中,远端末梢部分107可包括笼套404,该笼套404经连接件402连接至导管轴302。 In a preferred embodiment, the distal tip portion 107 may include a cage sleeve 404, the cage member 402 through the connection sheath 404 are connected to the catheter shaft 302. 该笼套404可由一种或多种足够耐用的材料制成,所述材料包括金属,例如不锈钢和镍钛诺。 The cage 404 is made by one or more sets of sufficiently durable material, said material comprising a metal, such as stainless steel and nitinol. 在一些实施方案中,笼套404可由预成形的管材构造,且一些其他的实施方案可具有由材料的平坦部分构造的笼套404,所述材料随后在纵向方向或螺旋方向被卷绕形成管。 In some embodiments, the cage of the pipe 404 may be preformed configuration, and other embodiments may have a structure formed by a flat portion 404 of the cage of the material, the material is then wound in a longitudinal direction or a spiral direction of the tube . [0073] 远端末梢部分107优选地被配置为包含位于其内的腔405,腔405的大小被设计为容纳随后待被展开的合适的装置。 Suitable apparatus [0073] The distal tip portion 107 is preferably configured to include a cavity located therein 405, the size of the cavity 405 is designed to receive subsequently to be expanded. 优选地,笼套404包括位于笼套404内部空间的腔405。 Preferably, the cage includes a cage sleeve 404 sleeve 404 internal space 405 of the chamber. [0074] 在一些实施方案中,如图11B和12B示出的,腔405可容纳医疗装置,例如阀500。 [0074] In some embodiments, shown in FIG. 11B and 12B, the cavity 405 can receive a medical device, such as a valve 500. 在一些情形中,使用在US序列号12/249,243和12/422,179中所述类型的阀装载器,可通过远端开口410将阀500装载进腔405,所述US序列号12/249,243和12/422,179在此各自全文纳入本文。 In some cases, in US Serial No. 12 / 249,243 and 12 / 422,179 in the loader type of valve, the valve 410 may be loaded into the chamber 500 through the distal opening 405, as described in US Serial No. 12 / 249,243 and 12 / 422,179 herein each incorporated herein. 一旦装载进腔405,装置(例如阀500)的近端邻接抵靠推进器柱塞408,推进器柱塞408转而连接至稳定线304。 Once loaded into the proximal end chamber 405, an apparatus (e.g., valve 500) of the plunger abuts against the pusher 408, pusher plunger 408 is in turn connected to the line 304 stably. 在使用中,可移动的手柄206关于柱塞204在手柄部分103中的近端移动,导致笼套404相对于推进器柱塞408缩回,从而从开口410释放容纳在腔405中的装置(例如阀500)。 In use, the movable handle 206 on the proximal end of the plunger 204 in the handle portion 103 moves, causing the cage relative to the pusher sleeve 404 retracts plunger 408, so that the device housed in the cavity 405 is released from the opening 410 ( for example, valve 500).

[0075] 窗孔409优选地位于笼套404的至少一部分上,且可用于改善位于其中的装置的可视性、以及改善远端末梢部分107的柔性。 [0075] The aperture 409 is preferably located on at least part of the cage sleeve 404, and may be used to improve the visibility of which is located in the apparatus, and to improve the distal tip 107 of the flexible portion. 剩余的撑条411形成笼套或框架式结构,且可包括螺旋或交错螺旋样式,尽管如此不同的配置和样式也是可行的。 The remaining sets of struts 411 form a cage structure or framework, and may comprise a helical or spiral pattern interleaved, though different configurations and styles are possible. 窗孔409例如可以被激光切害J。 Aperture 409 may be laser cut, for example, J. Injury 还可利用其它方法,例如光化学铣削。 Other methods may also be utilized, such as photochemical milling.

[0076] 优选地,笼套404还包括一个或多个大的窗孔413。 [0076] Preferably, the cage or sleeve 404 further includes a plurality of large apertures 413. 这个大的窗孔413有利于观察位于腔405内的装置,且确认装置已经被适当或正确地装载在腔405中。 This large aperture 413 facilitate observation means located in the chamber 405, and the confirmation means has been properly or properly loaded in the cavity 405. 大的窗孔413还可用于提供一个用于定位标记带或其它定位标记(下文详细讨论)的空白区。 Large aperture 413 can also be used to provide a blank area for positioning the tag tape or other positioning marks (discussed in detail below). 优选地,整个笼套404 由单片材料构造,且包括边沿415的笼套404的远端部分可经纵向撑条414连接至笼套404的近端部分。 Preferably, the entire cage sleeve 404 constructed from a single sheet material, and includes a cage sleeve 415 distal edge portion 404 may be connected to the proximal end of sleeve portion 404 of the cage through the longitudinal struts 414.

[0077] 在远端末梢部分107的制造中,有利地是涂覆远端末梢部分107和笼套404的内部部分和/或外部部分。 [0077] In producing the distal tip portion 107, advantageously coated distal tip portion 107 and the cage inner sleeve 404 and / or outer portion. 例如,涂覆较软的材料(例如聚合物)可有效地避免在使用导管时对身体组织的伤害,且帮助远端末梢部分107在气管镜或其它仪器的工作通道内自由地滑动。 For example, the coated softer material (e.g. a polymer) can effectively prevent damage to the body tissue during use of the catheter, the distal tip portion 107 and helps to slide freely within the working channel of the bronchoscope or other instruments. 此外,涂覆导管的内部部分可帮助降低或消除对装载在其中的医疗装置的破坏,或者降低或消除阻碍医疗装置展开的可能性。 Further, the inner portion of the catheter may be coated to help reduce or eliminate damage to the medical device loaded therein, or to reduce or eliminate the possibility of obstruction of the medical device deployed.

[0078] 因此,某些实施方案提供位于笼套404或腔405的内表面的至少一部分上的衬里(例如由聚合物一一例如聚四氟乙烯一一组成),结合至少位于远端末梢107部分的外表面上的衬里(可由聚合物一一例如PEBAX®-一组成)。 [0078] Thus, certain embodiments provide the inner surface of the cage sleeve 404 or liner 405 on the chamber at least a portion (e.g. a polymer such as polytetrafluoroethylene eleven eleven composition), located at least in the distal tip 107 binding the outer surface of the liner portion (e.g. PEBAX®- may be a polymer composed of eleven).

[0079] 在一些实施方案中,这些覆层或衬里可软恪(reflowed)至远端末梢部分107上。 [0079] In some embodiments, the coating may be a soft or liner Verified (reflowed) to the distal tip portion 107. 使用心轴,可施加热以将这些衬里软熔在远端302的金属部分上。 Use of a mandrel, the heat may be applied to these portions of the metal liner 302 at the distal end of reflow. 优选地,所选择的衬里关于窗孔409、413至少部分透明,以使得可以检查装载其中的医疗装置。 Preferably, the selected aperture 409, 413 about the liner at least partially transparent, so that the load can be checked wherein the medical device. 沿着远端末梢107的不同部分,可使用不同的聚合物和聚合物类型,其中例如仅沿着远端末梢107的一个部分使用透明聚合物,而沿着远端末梢107的一个不同部分使用不透明或有颜色的聚合物,以允许将导管专门加工成预期的应用和用途。 Along a different portion of the distal tip 107, may use different types of polymers and polymer, which, for example only along the distal tip portion 107 of a transparent polymer, and use a different portion of the 107 along the distal tip opaque or colored polymer specially machined to allow the catheter to the intended applications and uses. 如下文和图15中讨论的,这些聚合物覆层以及软熔还可将定位标记纳入在远端末梢部分107上或远端末梢部分107中。 These polymer coating and reflow may be positioned below and discussed in FIG. 15 into the marker 107 on the distal end or tip portion of the distal tip portion 107. 可使用不同的方法来使远端末梢部分107覆层,包括浸渍涂覆、挤压、施加热收缩材料等。 Different methods can be used to make the distal tip portion of the cladding layer 107, including dip coating, extrusion, heat shrinkable material or the like is applied.

[0080] 在一个优选实施方案中,围绕位于远端末梢部分107远端处的开口410的边沿415 被配置为光滑且防止损伤的,以降低或消除在插入和展开位于腔405中的装置时对身体组织的损伤的可能性。 When [0080] In a preferred embodiment, the distal tip portion is located around the rim 107 of the opening 410 at the distal end 415 is configured as a smooth and atraumatic, or to reduce the insertion and deployment means positioned in the cavity 405 to eliminate the possibility of damage to body tissue.

[0081] 优选地,参考图13,边沿415包括围绕开口410周向布置的一系列小的焊接部(welds),所述焊接部例如可采用激光焊接制成,以提供光滑、圆形端部。 [0081] Preferably, the reference 13, comprises a rim 415 surrounding the opening 410 weeks to a series of small welding portion (Welds) arranged in the welding portion can be formed, for example, laser welding, to provide a smooth, rounded end . 在这种情形中,边沿415由此可被配置为提供防止损伤的末梢,该末梢使得对从腔405展开的装置的阻碍或其他卡接最小,同时还使得其耐用并能够支持多种用途。 In this case, the edge 415 may thus be configured to provide an atraumatic tip, such that the distal minimal obstruction to access device is deployed from the cavity 405 or other cards, so it is also robust and can support a variety of purposes. 在其他实施方案中,边沿415可被聚合物或其它软材料层覆盖。 In other embodiments, the rim 415 may be covered with polymers or other soft material.

[0082] 现重新参考图11A-B和12A-B,在一些实施方案中,经由笼套404或导管轴302的远端,连接件402可沿着将连接件402接合至远端末梢部分107的边界被滚焊(seam-welded)。 [0082] Referring now again Figures 11A-B and 12A-B, in some embodiments, the distal end of the cage sleeve 404, or via a catheter shaft 302, the connecting member 402 may be bonded to the distal tip portion 107 along the connecting member 402 the boundaries are seam welding (seam-welded). 这种焊接是优选的,因为其提供了从导管轴部分105到远端末梢部分107的更光滑的过渡, 由此降低了操作者的操作难度,并帮助提供系统101在展开期间的光滑连续的移动。 This welding is preferred because it provides a smoother transition from the catheter shaft portion 105 to the distal tip portion 107, thereby reducing the difficulty of the operation of the operator, and to help provide a smooth deployment system 101 during successive mobile. 也可以使用点焊,但是应注意减小点焊的大小,防止过度突出,这是因为存在这种焊接部在气管镜内卡住或阻碍的危险性。 Spot welding can be used, it should be noted that the spot size is reduced, preventing excessive projection, this is because of the risk of such jamming or obstruction of the welded portion in the bronchoscope.

[0083] 参考图14,某些实施方案提供了由多部件设计构造的连接件402。 [0083] Referring to Figure 14, certain embodiments provide a design configuration by the connecting member 402 of the multi-component. 在这些实施方案中,压缩圆锥430例如通过焊接附接至外部导管轴302的远端。 In these embodiments, the compression cone 430 is attached for example by welding to the distal end 302 of the outer catheter shaft. 套圈(ferrule) 432例如通过焊接或者简单地通过机械联锁附接至远端402,套圈432随后可被推动越过压缩圆锥430,以将笼套404的近端夹在中间。 Ferrule (Ferrule) 432, for example, by welding or by mechanical interlocking simply attached to a distal end 402, the collar 432 may then be pushed over the compression cone 430 to the proximal end of the cage sleeve 404 is sandwiched. 该联锁连接包括连接件402,并形成能够抵抗多数拉力的强连接。 The interlocking connection comprises a connecting member 402, and forms a strong connection capable of resisting most tension. 已经测试样品能够承受至少100N的拉力。 Samples have been tested to withstand the force of at least 100N.

[0084] 现转到图15,系统101的一个实施方案可设有定位标记。 [0084] Turning now to FIG. 15, one embodiment of system 101 may be provided with positioning marks. 这些定位标记例如可设置在远端末梢部分107和导管轴部分105的远端的一部分上。 These may be, for example, positioning marks provided on a portion of the distal tip portion 107 and a distal end portion 105 of the catheter shaft. 通常,定位标记帮助操作者确定系统101关于外部目标的位置。 Typically, alignment marks help the operator determine the position on the external target system 101. 定位标记可以是可视的,因此在可视度受限的环境一一例如通过气管镜看到的观察视野范围一一中是有用的。 Positioning mark can be visible, and therefore are useful in the eleven visibility constrained environment-for example seen by observation field of view of the bronchoscope. 更具体地,定位标记可有助于为装载在导管中的医疗装置选择和指示合适的展开部位,并且用于允许操作者确定导管是否已经从气管镜的工作通道或其它输送装置延伸出太远。 More specifically, the positioning mark can be loaded in the catheter contribute to the medical device and selecting an appropriate indication deployment site, and for allowing the operator to determine whether or not too far out of the catheter has been extended from the working channel of a bronchoscope or other delivery device .

[0085] 某些实施方案可设有一个或多个定位标记,例如线445、446、447,这些定位标记可帮助为装载在导管中的医疗装置选择和指示合适的展开部位。 [0085] Certain embodiments may be provided with one or more alignment marks, such as lines 445,446,447, these positioning marks can be loaded in the catheter to assist a medical indication and selection means suitable deployment site. 此处,当容纳有装置的导管被装载进气管镜,并被引导至要求治疗的身体的一部分(例如肺气管)时,操作者可使用线445将导管与医疗装置待被展开的部位对准,因为线445会指示医疗装置从开口410释放的近似位置。 Here, when a conduit containing means is loaded into a bronchoscope and is guided to a desired part of the body of treatment (e.g. lung pipe), an operator may use the catheter and the wire 445 is deployed medical device to be aligned with a portion , because the line 445 indicates the approximate position of the medical device is released from the opening 410. 在一些实施方案中,装置可以是在气管中展开的阀500,且在这些情形中,线445 通常与阀500的膜将要密封抵住的气道区域对准。 In some embodiments, a valve device 500 may be deployed in the trachea, and in these cases, the line 445 and the membrane valve 500 generally will be sealed against airway aligned region. 这些实施方案在下文以及图20A-C进一步详细描述。 These embodiments are described in further detail hereinafter and in FIGS. 20A-C.

[0086] 线445可尤其有利于帮助通过气管镜观察通道看见合适的展开部位,且一些实施方案使得线445被其他的黑色或者有不同对比的颜色带446、447围绕或者夹在中间,以提供额外的对比。 [0086] In particular, line 445 may help facilitate proper deployment site visible through a bronchoscope observation channels, and some of such embodiments, the line 445 is black or another color contrasting with different sandwich or about 446, 447, to provide extra contrast. 尽管可采用合适的手段一一例如移印或喷墨印刷一一将线445标记在远端末梢部分107,但是考虑到生物相容性,有时必须使线445在其构造中不采用暴露的颜料。 Although suitable means may be employed, for example, pad printing or ink jet printing eleven eleven wire 445 at the distal tip portion of the mark 107, but taking into account the biocompatibility, the wire 445 may be exposed without using a pigment in their construction . 在这些情形中,一些实施方案可使用围绕远端末梢部分107布置的标记带。 In these cases, some embodiments may use the distal portion 107 disposed around the distal end of the marker band. 这些标记带可由聚合物带组成,例如由可热收缩的聚合物一一例如PEBAX®-一构造。 These polymers may be labeled with a belt composed of, for example, a heat-shrinkable polymer-for example a PEBAX®- configuration. 由于已经发现黄色线445 在某些应用中是有利的,因此可将金色标记带套在远端末梢部分107上。 Since it has been found in the yellow wire 445 is advantageous in certain applications, thus may be gold marker band sleeve 107 in the distal tip portion. 标记带可由任何合适的材料构成,优选地由高度可见的材料构成。 The tag tape be made of any suitable material, preferably a material formed of a highly visible. 已经发现,例如混有铱的金或铂的材料是可接受的材料。 It has been found, for example, mixed with gold or platinum iridium material is acceptable materials. 可选的,作为线445的标记带可以包封在上文的软熔过程中描述的衬里下方, 或者包封在一个另外的、且优选地至少部分透明的聚合物(例如PEBAX®)层下方。 Alternatively, the strip line 445 as a marker may be encapsulated in the lower liner reflow process described above, the encapsulated or in a further, and below (e.g. Pebax®) layer is preferably at least partially transparent polymer .

[0087] 在一些实施方案中,可通过将一排或一系列窗孔切割进远端末梢部分107形成线445或其它定位标记,以使得不需要额外的材料来形成相应的定位标记。 [0087] In some embodiments, a row or may be formed by cutting a series of apertures formed into the wire distal tip portion or other positioning marks 107,445, so that no additional material to form the corresponding positioning marks. 此外,尽管上文描述的线445位于远端末梢部分107上,但是其他实施方案可将线445置于系统101的其他部分。 Further, although the above-described line 445 at the distal tip portion 107, but other embodiments may be placed in other parts of the 445 line system 101. 例如,线445可在稳定线304或柱塞408上,其中如果需要,可带有相关联的切割进远端末梢部分107的孔口或窗孔,以允许看到线445。 For example, line 445 may be on a stable line 304 or plunger 408, which, if desired, can be cut with an associated aperture or opening into the distal tip portion 107, 445 to allow viewing of the line.

[0088] 此外,某些实施方案可设置长的定位标记448,例如位于导管轴105的远端部分。 [0088] Further, some embodiments may be provided long positioning mark 448, for example at the distal portion of the catheter shaft 105. 该长的定位标记448可以用作对操作者的警告特征,警告导管系统101已经延伸穿过气管镜太远。 The length of positioning marks 448 may be used as a warning to the operator characterized in, warning the catheter system 101 has extending too far through the bronchoscope. 该长的定位标记448优选是着色或有色的,例如为对比颜色(例如黄色),以容易地在导管将要延伸穿过气管镜时被操作者看见。 The length of the positioning mark 448 is preferably colored or colored, for example, contrasting colors (e.g. yellow), while to easily extend through the bronchoscope to the operator to see the catheter. 可使用任何合适的手段(包括之前描述的用于线445、446、447的手段)将长的定位标记448置于导管轴105上。 Any suitable means (including a means for previously described lines 445,446,447) using long alignment mark 448 is placed on the catheter shaft 105. 优选地,长的定位标记448可以由合适的热收缩聚合物构造,在一些情形中,该聚合物可以随后被纯净的或无色的保护聚合物层所覆盖。 Preferably, the length of the registration mark 448 may, in some cases, the polymer may then be covered by a suitable heat-shrinkable polymer structure or pure colorless protective polymer layer. 在一些实施方案中,长的定位标记448的尺寸可在5到10英寸之间,优选为6 英寸,且可以位于距离远端末梢近似2英寸处。 In some embodiments, the long dimension of the positioning mark 448 may be between 5-10 inches, preferably 6 inches, and may be located approximately two inches from the distal tip.

[0089] 尽管上文讨论的定位标记主要指的是可视的指示物,但系统101中使用的定位标记还可被配置为使用其他手段定位。 [0089] While the alignment mark discussed above mainly refer to the visual indicator, but the positioning markers used in the system 101 may also be configured to use other means of targeting. 例如,任何定位标记或线445、446、447、448可由射线不透材料(例如硫酸钡)构造,或包含有射线不透材料(例如硫酸钡),以便使用射线成像方法来定位。 For example, any mark or line 445,446,447,448 may be radiopaque material (e.g., barium sulfate) configuration, or with radiopaque material (e.g., barium sulfate), to be positioned using radiographic imaging method. 在系统101的MRI兼容的实施方案中,MRI对比剂还可被结合进定位标记。 In an embodiment of the MRI-compatible system 101, MRI contrast agents may also be incorporated into the positioning mark. 有源(被提供动力的)或无源(例如无源RFID)定位标志灯(beacon)也可结合进远端末梢部分107,所述定位标志灯可与上述的定位标记一同起作用,或替代上文讨论的定位标记起作用,且所述定位标记灯可连同绘图软件起作用,以实时追踪远端末梢部分107的位置,且不需要要求视觉确认远端末梢部分107相对于展开部位的位置。 The active (being powered) or passive (e.g. passive RFID) positioning lights (Beacon) may also be incorporated into the distal tip portion 107, the alignment mark light can act together with the above-described positioning mark, or alternatively work positioning mark discussed above, the alignment mark and light can act together with the drawing software, in real-time to track the position of distal tip portion 107, and is not necessarily required to confirm visually the position of the distal tip portion 107 with respect to the deployment site . 这些定位标记还可是结合多种定位方法的混合定位标记,例如既射线不透、又可视的定位标记。 The positioning marks can also be mixed with a variety of alignment marks positioning method, e.g. both radiopacity, and a visual alignment mark.

[0090] 图16A-H示出了远端末梢部分107的不同实施方案。 [0090] FIGS. 16A-H illustrate various embodiments of the distal tip portion 107. 尽管这些设计与图11A-B和12A-B有一些类似,但是在此将讨论额外的不同之处和特征。 Although these designs of Figures 11A-B and 12A-B have some similar, but here the discussion of additional features and differences. 首先转到图16A,示出远端末梢部分107的一个实施方案,其包括笼套404中交错的螺旋配置(与图11A-B中的连续的螺旋或螺旋线配置对比)。 Turning first to Figure 16A, shows an embodiment of the distal tip portion 107, which includes a cage sleeve 404 interleaved helical configuration (in contrast to Figures 11A-B of the continuous spiral or helix). 将撑条411连结在一起的额外的材料可提供附加的强度,来抵抗在使用时可施加至末梢的外部力和内部力(例如扭转力或弯曲力)。 The additional material stays 411 may be joined together to provide additional strength to resist external forces and internal forces applied to the tip during use (e.g., torsional or bending forces). 在一个优选实施方案中,笼套404可由镍钛诺片材构造,被化学蚀刻,并滚制成圆柱形。 In a preferred embodiment, cage sleeve 404 may be constructed of nitinol sheet is chemically etched, and rolled to a cylindrical shape.

[0091] 此外,连接件402在此设有一类似于图14讨论的多部件连接件。 [0091] In addition, this connecting member 402 is provided with a multi-part connecting member 14 similar to the one discussed in FIG. 还可呈现包括线445的定位标记。 Presenting further includes a line 445 of the positioning marks. 如之前讨论的,该实施方案包括导管轴302上带有犬牙交错的切割部配置的高柔性区域330。 This embodiment includes a high As previously discussed with interlocking flexible region 330 disposed on the cutting portion 302 of the catheter shaft.

[0092]图16B示出了在导管轴302上带有不同的高柔性区域330的类似实施方案,这次高柔性区域330以蛇纹设计形成。 [0092] FIG. 16B shows a similar embodiment with a different embodiment of a high flexibility catheter shaft 302 in the region 330, the region 330 formed in a highly flexible serpentine designs.

[0093] 现转至图16C,该实施方案包括已经集成至远端末梢部分107上的高柔性区域450, 且该高柔性区域450其他方面类似于图16A中示出的高柔性区域330,除了此处的区域450是在远端末梢部分107上。 [0093] Turning now to FIG. 16C, this embodiment includes a flexible region has been integrated into the high section 107 on the distal tip 450, and the highly flexible region 450 in FIG. 16A is similar to other aspects of high flexibility region 330 shown, in addition to 450 is a region where the tip on the distal end portion 107. 此处以蛇纹切割部配置制成的高柔性区域450经连接件402连接至导管轴部分105,并经由第二连接件430连接至笼套404。 Here the cutting portion in serpentine configuration composed of a highly flexible region 450 through the connection member 402 is connected to the catheter shaft portion 105, and through the second connecting member 430 is connected to the cage sleeve 404. 此外,除了此处示出的高柔性区域450,一些应用可能需要向导管轴302增加另一个额外的之前描述类型的高柔性区域330。 In addition to high flexibility shown here region 450, some applications may require the catheter shaft 302 of the type described previously adding another additional high-flexible region 330. 在一些情形中,可在高柔性区域和/或笼套区域的内部设有PTFE或其他光滑的聚合物的衬里, 以使得稳定线延伸穿过成品导管的屈曲最小。 In some cases, it may be provided, or other smooth PTFE lining polymer is highly flexible in the interior region and / or the cage of the region, so that the finished stable extending through the catheter buckling is minimized.

[0094] 图16D示出了类似于在图16C中描述的实施方案的远端末梢部分107的另一个实施方案。 [0094] FIG 16D shows a distal end similar to the embodiment described in FIG. 16C another embodiment of the tip section 107. 此处,高柔性区域450包括犬牙交错设计。 Here, region 450 comprises a highly flexible interlocking design.

[0095] 图16E示出了类似于在图11A中示出的实施方案的远端末梢部分107的一个实施方案,其中笼套404包括螺旋配置。 [0095] FIG 16E shows a distal tip similar to the embodiment of FIG. 11A shows an embodiment of section 107, sleeve 404 includes a cage in which a helical configuration. 此处,位于导管轴302上的高柔性区域330包括交叠的不连续直线切割部,每个切割部围绕导管轴302的近似一半圆周延伸。 Here, a high flexibility region 330 is positioned on the catheter shaft 302 comprises a straight cutting discontinuous overlapping portions, each cutting portion 302 extends around approximately half the circumference of the catheter shaft. 这些切割部可类似于在图10C中示出的配置。 The cutting portion may be similar to the configuration shown in FIG. 10C. 由于这些切割部是不连续的,因此导致相比较本文示出的其他高柔性区域类型,这种高柔性区域330的一些实施方案可具有额外的强度。 Since these cut portions are not continuous, thus resulting in a high flexibility as compared to other types of regions illustrated herein, this high flexible region 330 of some embodiments may have additional strength.

[0096] 图16F示出了包括锥形部分的远端末梢部分107的一个实施方案。 [0096] FIG 16F illustrates an embodiment of a distal end portion 107 includes a tapered tip portion. 此处,笼套404经第二连接件403连接至锥形部分452,该锥形部分452的直径朝着其近端逐渐变小。 Here, the cage sleeve 404 through the second connecting member 403 is connected to the tapered portion 452, the diameter of the tapered portion 452 tapers toward its proximal end. 锥形部分452经连接件402连接至导管轴302,且可设有类似于前文描述的高柔性区域330。 A tapered portion 452 via the connecting member 402 is connected to the catheter shaft 302, and may be similar to that described before with high flexibility region 330. 在一些实施方案中,锥形部分和/或笼套可以通过如下方式形成,即,使用经过光化学蚀刻的刚性材料(例如镍钛诺)的片料制成螺旋包裹物来形成(尽管如此也可采用不同的金属或材料)。 In some embodiments, the tapered portion and / or the cage sleeve may be formed by, i.e., photochemical etching through the use of a rigid material (e.g., Nitinol) flakes formed into spiral wrap (nonetheless be using different metals or materials). 该锥形实施方案的一些优势可包括导管系统101更平滑移动通过气管镜工作通道移动。 Some advantages of this embodiment may include a tapered catheter system 101 moves more smoothly moved through the working channel of the bronchoscope.

[0097] 图16G示出了包括一个不同的锥形部分的远端末梢部分107的另一个实施方案。 [0097] FIG 16G shows a distal end comprising a tapered portion of a different embodiment of another embodiment of the tip section 107. 此处,笼套404本身形成为单个单元(与图16E对比),且朝向其近端尺寸逐渐变小。 Here, the cage sleeve 404 itself is formed as a single unit (in contrast to FIG. 16E), and a proximal end toward its size becomes gradually smaller. 在一些情形中,相比较图16E的多件设计,图16G的这种笼套设计的制造和装配更廉价,且在一些情形中可以由单个镍钛诺片材经过光化学蚀刻,随后滚制成形。 In some cases, multi-piece design as compared to FIG. 16E, the cage of FIG. 16G design cheaper manufacturing and assembly, and in some cases may be made of a single sheet passing nitinol photochemical etching, followed by molding roll . 这个单件锥形实施方案还可以被这样制造,使得此处示出的交错的螺旋配置不延伸得像此处示出的一样近,以使得这种实施方案可类似于图16F中示出的实施方案但是不具有第二连接件403。 The single piece embodiment may also be tapered so manufactured, so that a staggered spiral configuration shown here like herein do not extend nearly as illustrated, so that this embodiment may be similar to the embodiment shown in FIG. 16F but it does not have a second embodiment of the connecting member 403. 优选地,笼套404使用上述图14中描述的连接件402类型附接至导管轴部分105。 Preferably, the cage sleeve 404 in FIG. 14 using the above-described type connecting member 402 is attached to the catheter shaft portion 105. 如同图16F,高柔性区域330 (此处是"犬牙交错"类型)可以呈现在导管轴302上。 As FIG. 16F, a high flexibility region 330 (here, "indented" type) can be presented on the catheter shaft 302.

[0098]图16H示出了可以在远端末梢部分107的某些实施方案中使用的笼套404的一个不同配置。 [0098] FIG 16H illustrates a different tip configurations can be used in the cage of certain embodiments of the distal end portion 107 404. 此处,笼套404不是螺旋或螺旋线配置,而是以示出的交织配置形成。 Here, the cage sleeve 404 is not helical or spiral configuration, but in an interleaved arrangement shown is formed. 这种配置优选激光切割形成,但是不同的制造方法(例如光化学铣削)也是可行的。 This configuration preferably laser cutting, but different manufacturing methods (e.g. milling photochemical) are also possible. 笼套404的这个实施方案的配置在远端末梢部分107要求额外的柔性的应用中是有利的。 The cage 404 of this embodiment configuration is advantageous additional application of the flexible distal tip portion 107 of the claims. 在一些配置中,例如当笼套404由镍钛诺构造时,可使用镍钛诺压缩环将笼套404固定至导管轴部分105,而不是连接件402或图14中所示的连接件类型。 In some configurations, such as when the cage sleeve 404 is constructed of nickel-titanium Connaught, using nitinol cage of the compression ring 404 is fixed to the catheter shaft portion 105, instead of connecting member of the type shown in FIG. 14 or 402 is connected .

[0099] 现参考图17,导管系统101可以与用于保护导管轴部分105和远端末梢部分107的管110-同封装。 [0099] Referring now to Figure 17, the catheter system 101 may be used to protect the shaft portion 105 and the distal tip of the catheter tube with the packaging section 107 110-. 还可提供阀装载器115,阀装载器115用于将阀或其他医疗装置装载进远端末梢部分107。 Loader 115 may also be provided a valve, the valve 115 for the loader valve or other medical device 107 is loaded into the distal tip portion. 这种阀装载器115的实例在US序列号12/249,243和12/422,179中描述,这两篇文献各自全部纳入本文。 Examples of such valves in the loader 115 US Serial No. 12 / 249,243 and 12 / 422,179 described, both of which are each totally incorporated herein by reference. 可使用包装118将整个系统101和阀装载器115封装在一起,并共同形成整套组件120。 Package 118 can be used the whole valve system 101 and loader 115 are packaged together, and together form a complete 120 assembly.

[0100] 图18A示出了导管系统101的一个可能用途。 [0100] FIG. 18A shows one possible use of the catheter system 101. 此处,导管系统101可以插入气管镜510的工作通道511。 Here, the catheter system 101 can be inserted into the working channel of the bronchoscope 510 511. 气管镜510可以是市售型号的气管镜,例如Olympus制造的BF-P180。 Bronchoscope 510 may be a commercially available model bronchoscope, e.g. BF-P180 Olympus manufactured. 优选地,除了允许气管镜操纵进入通向肺600的病人气管601的可视通道,这种气管镜设有至少2.Omm的工作通道。 Preferably, in addition to allowing access to the lungs bronchoscope into the trachea of ​​the patient to manipulate the 600 visual channel 601, which is provided with a bronchoscope working channel of the at least 2.Omm. 当然,除了气管镜,内窥镜可用于不同的操作,且这些内窥镜优选地设有至少2.0mm的工作通道。 Of course, in addition bronchoscope, endoscope can be used for different operations, and these are preferably provided with an endoscope working channel of at least 2.0mm. 与系统101-同使用的内窥镜(包括气管镜)优选不超过110cm的长度。 Preferably with the endoscope system 101 (including a bronchoscope) does not exceed the length of 110cm.

[0101]图18B示出了连同气管镜510使用导管系统101的替代方法。 [0101] FIG. 18B illustrates a bronchoscope 510 together with alternative methods using a catheter system 101. 此处,如示出的,夹持部202可被夹至气管镜510的一部分上,其中气管镜被接收在夹持部202的凹口内。 Here, as the clamping portion 202 may be shown to a portion sandwiched bronchoscope 510, wherein the bronchoscope is received within recess 202 of the clamping portion. 夹持部202的一些实施方案可被构造为形成C形手柄,该手柄可有利地允许与气管镜更稳固的连接。 Some embodiments of the holding portion 202 may be configured to form a C-shaped handle, the handle may advantageously allow the bronchoscope more secure connection. 在夹持部202固定至气管镜510后,将导管轴部分105和远端末梢部分107插入气管镜510 的工作通道511。 After holding portion 202 is fixed to the bronchoscope 510, the distal end portion 105 and the distal portion of the catheter shaft 107 is inserted into the working channel of a bronchoscope to 511,510. 在一些实施方案中,有利地是使用Tuohy-Borst转接器515,如目前示出的。 In some embodiments, it is advantageous to use Tuohy-Borst adapter 515, as presently shown. 因为Tuohy-Borst转接器515帮助固定外导管鞘316,在展开期间,装置的精确放置不需要第二个人或其它固定方法来捏住或保持导管鞘。 Because the Tuohy-Borst adapter 515 helps to secure the outer catheter sheath 316, during deployment, the second person does not require precise placement or other fixing method to grip or holding apparatus introducer sheath.

[0102] 图19A-C示出了可以在本文描述的某些实施方案中使用的闭锁机构的一个实施方案的使用和释放。 [0102] FIGS. 19A-C illustrate one embodiment of the use and release of the latching mechanism may be used in certain embodiments described herein. 图19A呈现了手柄部分103的初始配置,该系统101优选地随后被提供以装载其中的阀或其它医疗装置。 Figure 19A presents the initial configuration of the handle portion 103, the system 101 preferably is then provided to a valve or other medical device loaded therein. 此处,锁定杠杆210在锁定位置,在该实施方案中,锁定位置发生在锁定杠杆210相对于稳固翼片208向远端延伸时。 Here, the lock lever 210 in the locked position, in this embodiment, locking position occurs when the lock lever 210 with respect to the solid flap 208 extends distally. 如图8中示出的以及上文描述的,当锁定杠杆210在该位置时,附接至锁定杠杆210的锁定翼片222与可移动的手柄206上的凹口220接合,从而降低或消除可移动的手柄206移动的可能性。 Shown in FIG. 8 and described above, when the locking lever 210 in this position, is attached to the locking lever 210 the locking tabs 222 and notches 206 on the movable handle 220 engagement, thereby reducing or eliminating the possibility of moving the handle 206 is movable.

[0103] 图19B示出了在解锁(但是未展开)位置的系统101。 [0103] FIG. 19B shows the unlocking (but not expanded) position 101 of the system. 此处,在该情形中通过关于枢轴点226枢轴旋转锁定杠杆210,锁定杠杆210已经被推向稳固翼片208。 Here, pivoting about pivot point 226 of the lock lever 210, the lever 210 has a locking tab 208 is pushed firmly in this case through. 当在该位置时,再次参考图8,锁定翼片222向下枢轴旋转或移动,且脱离可移动的手柄206上的凹口220,因此允许可移动的手柄206在近端纵向方向朝向夹持部202轴向滑动。 When in this position, referring again to FIG. 8, the lock 222 to pivot or move down tab, and from the notch 206 of the movable handle 220 thereby allowing the handle 206 is movable in the longitudinal direction toward the proximal clamp holding portion 202 slides axially.

[0104] 图19C示出了在装载在远端末梢107中的装置展开后,手柄部分103的配置。 [0104] FIG 19C shows the apparatus mounted on the distal tip 107 to expand, the handle portion 103 is disposed. 此处, 可移动的手柄206已经在近端纵向方向上轴向滑向或移向夹持部202。 Here, the movable handle 206 has been slid in the proximal axial direction or a longitudinal portion 202 toward the nip. 一些实施方案可设置锁定杠杆210自动复位至锁定位置。 Some embodiments of the lock lever 210 may be provided to automatically reset to the locking position. 例如,在可移动的手柄206移动经过锁定翼片222的端部后,弹簧或其它恢复力可推动或枢轴旋转锁定杠杆210朝向锁定位置返回,例如经由附接在锁定翼片222下方的弹簧228 (如图8示出的)。 For example, the handle 206 through the movement of the movable end of the locking flap 222, the springs or other restoring force may push or pivotable lock lever 210 toward the lock position returns, via an attachment such as a spring underneath the locking tab 222 228 (shown in FIG. 8). 相应地,如果使用者沿远端方向返回滑动可移动的手柄206,手柄部分203将会自动复位至图19A示出的配置,由此允许另一个装置的展开,而不需要使用者记得复位闭锁杠杆210。 Accordingly, if the user returns the slide is movable in the distal direction of handle 206, the handle portion 203 will automatically reset to the configuration shown in FIG. 19A, thereby allowing deployment of another device, without requiring the user to remember to reset the latch lever 210.

[0105]图20A-C示出了带有装载进远端末梢部分107中的腔405内的阀500的导管系统101 的实施方案。 [0105] FIGS. 20A-C illustrate an embodiment of a catheter system 500 of the valve within the distal tip portion 107 with a cavity loaded into 405,101. 注意到一些结构元件已经以虚线示出,或出于清晰的目的未示出。 Some have noted that structural elements shown in dashed lines, or for purposes of clarity, not shown. 导管系统101已经被插入气管镜(未示出),气管镜被引至肺的要求治疗的部分,在该情形中是气管601 〇 The catheter system 101 has been inserted into a bronchoscope (not shown), the bronchoscope is introduced to part of the lungs requires treatment, tracheal 601 billion in this case

[0106] 在确定阀500的合适展开部位(此处由展开部位606表示)时,操作者可使用线445 将远端末梢部分107与阀将被展开的部位606对准,阀500会从导管的远端410在线445表不的接近位置处释放。 [0106] In determining the appropriate valve 500 to the deployment site (here represented by a deployment site 606), the operator can using a wire 445 to the distal tip portion 107 and the valve 606 will be aligned with the expanded portion, the conduit from the valve 500 will the distal end of the table 410 does not release line 445 at a position close. 在一些实施方案中,线445大体与阀500会密封抵靠的气道区域对准,因此可与预期的展开部位606对准。 In some embodiments, line 445 and valve 500 will be substantially sealed against airway aligned region, thus can be aligned with the expected 606 deployment site. 位于线445侧面的线446、447优选地是更暗的颜色,或者用黑色着色,以提供额外的对比,从而允许操作者容易地通过气管镜观察端口看到线445。 Line 445 is located in the side of the lines 446, 447 is preferably a darker color, black or colored, to provide additional comparison, allowing the operator to easily observe see line 445 through port bronchoscope. 再者,在使用中,操作者可使导管向远端延伸超过线447,随后向近端收回导管,直到到达线445。 Further, in use, the operator may extend distally beyond the catheter line 447, and then withdrawing the catheter proximally until it reaches the line 445. 在收回时,遇到的第一线447可被用作界标,指示正在临近线445。 When retracted, encountered first line 447 can be used as a landmark to indicate the line is approaching 445. 如果这样设置,则呈现在导管轴部分105的远端部分上的长的定位标记448 (如图15示出的)还可有利地作为另一个安全特征,以确保操作者不会将导管延伸超出气管镜太远。 If so set, presented on a distal portion of the catheter shaft portion 105 of the alignment mark length 448 (shown in FIG. 15) may also be advantageous as a further safety feature to ensure that the operator does not extend beyond the catheter bronchoscope too far.

[0107] 在线445与预期的展开部位606对准时,以及锁定杠杆210移动至其解锁位置时,操作者在近端方向上将可移动的手柄206拉向夹持部202 (总体参见图19A-C)。 [0107] line 445 with the expected deployment site 606 pairs of aligned, and the locking lever 210 is moved to its unlocked position, the operator can move in the proximal direction on the handle 206 is pulled toward the holding portion 202 (see generally FIG. 19A- C). 该展开移动收回导管轴302和笼套404,同时稳定线304保持大体静止。 The deployment shaft 302 and withdrawing the catheter moving cage sleeve 404, while stabilizing the line 304 remains substantially stationary. 在稳定线304端部的推动器柱塞408 优选地被配置为接触插入在腔405中的阀500的中央杆502,由此保持阀500在笼套404围绕阀500收回时处在基本同一位置。 Pusher plunger end portion 304 stably line 408 is preferably configured to contact with a valve inserted in the cavity 405 of the center 500 of the lever 502, thereby holding the valve cage 500 when the sleeve 404 is in the retracted position about the valve 500 substantially identical . 经远端开口410从导管释放后,阀500的锚固装置扩展,从而与气道601的壁接触,且阀500扩展,以使得其杯状部分的顶点总体在沿着肺气管601选择的部位606处发生接触。 By the distal end portion 410 is released from the catheter, expansion valve anchoring device 500 so as to contact with the wall of the airway 601 and the expansion valve 500, so that the top of its cup-shaped portion is generally in the choice of opening 601 along the tube 606 lung It occurs at the contact. 该展开方法是有用的,因为通过与线445对准,其允许待被展开的装置非常接近所选定的展开部位606。 This expansion method is useful because the alignment by line 445, which allows the device to be deployed in close proximity to the selected deployment site 606. 由于远端末梢部分107围绕该装置(例如阀500)收回,相比较仅从导管的远端弹出装置的现有技术中的装置,本发明中的该装置可被更准确地定位和展开。 Since the distal tip portion 107 surrounding the apparatus (e.g., valve 500) to recover, as compared to the prior art device only from the distal end of the catheter in the pop-up apparatus, the apparatus of the present invention may be more accurately positioned and deployed.

[0108] 导管系统101的一些实施方案还可符合某些基准和规格,以在某些情况和应用中可接受地运作。 Some embodiments [0108] The catheter system 101 may also reference and to meet certain specifications to be acceptable in some cases, and the operating applications. 例如,在系统101被用于在气管中展开阀的一个实施方案中,如上文描述的, 系统101会部分插入气管镜510的工作通道511。 For example, the system 101 is deployed to an embodiment of the valve in the trachea, as described above, the system 101 is partially inserted into the working channel of a bronchoscope to 511,510. 由于气管镜510会经病人的曲折气管被插入和穿行,其中的系统1 〇1必须能够充分屈曲,并承受将施加至其的力,包括扭转、弯曲和扭折力。 Since the bronchoscope 510 may be inserted into the trachea and walk through twists and turns of a patient, wherein the system must be able to fully flexion 〇1 1, and subjected to a force applied thereto, including twisting, bending and kinking forces. 优选地,系统101-一尤其是导管轴部分105-一被配置为平衡如下需求:需要足够刚性,以便传递用于使系统101穿行至合适展开部位的力,同时足够柔性,以穿行通过曲折空间,并降低在延伸穿过气管镜工作通道时损伤或穿透气管壁的可能性。 Preferably, the system 101 is a particular portion of the catheter shaft is configured as a 105- balancing the following requirements: the need to be rigid enough to walk through the delivery system 101 for deployment to the appropriate parts of the force, at the same time flexible enough to walk through the space through tortuous and reduce the likelihood of damage or penetration of the tracheal wall when extending through the working channel of the bronchoscope. 此外,系统101优选地被设计使得,任何构件的可能失效都不会将部件留在病人体内。 In addition, the system 101 is preferably designed such that failure of any component is not possible member will remain in the patient.

[0109] 由于在操作过程中系统101通常会遭受张力或拉力,因此远端末梢部分107优选地被配置为保持附接至导管轴部分105,以降低或消除将某些部分留在病人体内的可能性。 [0109] Since the system 101 during operation typically suffer tension or pulling of distal tip portion 107 is preferably configured to remain attached to the catheter shaft portion 105, to reduce or eliminate certain portions of the patient's stay in the possibility. 远端末梢部分107还优选地抵抗笼套404或其他构件的扭折,这可成功地输送和展开装载在其中的医疗装置。 The distal tip portion 107 is also preferably resistant to the cage sleeve 404 kinking or other member, which can be successfully delivering and deploying a medical device loaded therein.

[0110] 如图19A-C和20A-C示出的,系统101的实施方案优选地被配置使得在气管镜中的插入和操作期间,以及在将装载进远端末梢部分107的装置展开期间,其构件对移动的约束和阻力最小。 [0110] FIG. 19A-C and 20A-C are shown, embodiments of the system 101 are preferably arranged such that the bronchoscope insertion and during operation of the apparatus and loaded into the distal tip portion 107 during the deployment , which is the smallest member of the movement and resistance constraints. 导管轴部分105和远端末梢部分107的外部优选地都被配置为相对光滑,产生最小的摩擦,以使得这些构件在气管镜工作通道内自如地滑动。 The catheter shaft outer portion 105 and a distal tip portion 107 preferably is configured to be relatively smooth, with minimal friction, so that these members slidably within a working channel of a bronchoscope. 此外,稳定线304与导管轴302和/或远端末梢部分107的内部之间的摩擦优选也被最小化。 Further, preferably the friction between the line 304 and the internal stability of the catheter shaft 302 and / or the distal tip portion 107 is minimized. 优选地,用于克服装载进远端末梢107的腔405中的装置(例如阀500)的摩擦的力应小于如图19A-C和20A-C讨论的由于展开系统101而通过手柄部分103可施加的力。 Preferably, the friction force for overcoming loaded into the distal end of the apparatus (e.g., valve 500) in the cavity 107 of tip 405 should be less than 101 in FIG deployment system since the handle 19A-C and 20A-C portion 103 may be discussed applied force. 当以这种方式配置时,这些实施方案可将装置更平滑、更准确展开至目标部位。 When configured in this manner, the device of these embodiments may be smoother and more accurate deployment to the target site.

[0111] 在使用中,使用者将气管镜510插入病人的肺部,以使用待从导管系统101展开的装置进行治疗。 [0111] In use, the user bronchoscope 510 inserted into the patient's lungs, in order to use the device to be deployed from the catheter system 101 for treatment. 随后,导管系统101 (带有例如阀500的装置,该装置已经被预装载进远端末梢107的腔405中)被插入气管镜510的工作通道511。 Subsequently, the catheter system 101 (e.g., device 500 with a valve, the apparatus has been pre-loaded into the distal tip 107 of the chamber 405) is inserted into the working channel of a bronchoscope to 511,510. 现参考图19A-C,在选择并穿行至合适的展开部位之后,锁定杠杆210被移动至其解锁位置。 Referring now to FIGS. 19A-C, and after selecting the appropriate walking to the deployment site, the locking lever 210 is moved to its unlocked position.

[0112] 在确认远端末梢部分107关于展开部位的位置之后,这可包括将预期的展开部位与任何定位标记例如线445 (在图15中示出)对准,使用者在近端方向上将滑动筒206滑向夹持部202,由此在病人的气管处在展开部位展开医疗装置(例如阀500)。 [0112] In confirming the distal tip portion 107 after the position on the deployment site, which may include the intended deployment site such as a wire 445 (shown in FIG. 15) aligned with any positioning mark, the user in the proximal direction the sliding cylinder 206 slides nip 202, thereby deploying the medical device at the deployment site (e.g., valve 500) in the patient's trachea.

[0113] 在一些实施方案中,可以通过如下方式提高导管装置展开的准确性:捏住或以其他方式固定导管轴部分上的外部鞘316,以在导管轴302向近端收回时,将稳定线304保持在相对静止的位置。 [0113] In some embodiments, the catheter can be improved by the accuracy of the apparatus deployed in the following manner: a fixed grip or on the outer sheath of the catheter shaft portion 316 in other ways, retracted proximally to the catheter shaft 302, the stationary line 304 remains in a relatively stationary position. 在优选的实施方案中,导管101可以从气管镜工作通道511中移除,且可移动的手柄206回到其初始位置,以重新装载另一个装置。 , Catheter 101 may be removed from the working channel of a bronchoscope 511 In a preferred embodiment, the handle 206 and movable back to its initial position, in order to reload another device. 因此,可在病人气管内进行多次装置展开,而不需要将气管镜510从病人的肺部600移除。 Thus, multiple devices may be deployed in the trachea of ​​the patient, without the need bronchoscope 510 600 removed from the patient's lungs.

[0114] 应理解,目前示出的展开进肺中的导管系统101不是限制性的,且应理解,系统101 可用于将不同装置展开进入病人其他位置,包括胃、内窥镜或其它合适位置。 [0114] It should be understood, the current 101 shown deployed into the lung not restrictive catheter system, and it should be understood that system 101 may be used to expand the device into the patient's various other locations, including the stomach, an endoscope or other suitable location . 类似地,气管镜不是必须的,且还可使用能够容纳系统101、并且能够被引导至展开位置的其他合适装置,包括但不限于不同的内窥镜或腹腔镜插管。 Similarly, the bronchoscope is not necessary, and may also be capable of receiving system 101, and can be guided to the deployed position other suitable means, including but not limited to various endoscopic or laparoscopic cannula.

[0115] 尽管已经在某些实施方案和实施例的描述下公开了本发明,但是本领域技术人员应理解,本发明的范围不仅涵盖具体公开的实施方案,而且还延及其他替代实施方案和/或本发明的用途和明显的改型以及等同物。 [0115] Although the present invention has been disclosed in the description of certain embodiments and examples, those skilled in the art should understand that the scope of the present invention encompasses not only the specifically disclosed embodiments, but also extends to other alternative embodiments and / or uses and obvious modifications and equivalents of the present invention. 此外,虽然已经详细示出和描述了本发明的若干变型,但是在本公开内容的基础上,本领域技术人员容易明了其他落在本发明的范围内的改型。 In addition, it is having been shown and described several variants of the invention, but on the basis of the present disclosure, be readily apparent to those skilled in the art other modifications within the scope of the present invention. 还应预见,可做出对实施方案的具体特征和方面的组合或子组合,它们仍落在本发明的范围内。 It should also be foreseen, may be made of combinations or subcombinations of the specific features and embodiments of aspects, they still fall within the scope of the present invention. 应理解,所公开的实施方案的不同特征和方面可相互组合或替换,以形成此处公开的本发明的不同形式或实施方案。 It should be understood that various features and aspects of the disclosed embodiments may be combined or interchanged, to form different forms or embodiments of the invention disclosed herein. 因此,应注意,本文公开的本发明的范围不应由上文描述的具体公开的实施方案限定。 Thus, it should be noted that the scope of the present invention herein disclosed should not be disclosed by the specific embodiments described hereinabove defined.

Claims (17)

  1. 1. 一种用于将一个装置展开进入肺部的展开导管,该展开导管包括: 包括手柄部分的近端,所述手柄部分包括柱塞,该柱塞被可移动的手柄围绕,所述可移动的手柄被配置为在沿着所述柱塞的长度的至少一部分的方向上轴向滑动,且其中所述柱塞还包括能够在锁定位置和解锁位置之间切换的锁定杠杆,该锁定杠杆被配置为当在所述锁定位置时防止所述可移动的手柄在近端方向上滑向所述柱塞,但是当在所述解锁位置时允许所述可移动的手柄在近端方向上滑动,且其中所述锁定杠杆还被配置为复位至锁定位置; 导管轴部分,该导管轴部分包括导管轴和所述导管轴内部的稳定线,其中所述导管轴在该导管轴的近端处被固定至所述可移动的手柄,且其中所述稳定线被固定至所述柱塞; 以及远端末梢部分,其被配置为将一个医疗装置接收在一个腔中,其 CLAIMS 1. A device for deployment into the lungs of a deployment catheter, the deployment catheter comprising: a proximal handle portion, the handle portion comprises a plunger which is movable around the handle, said movable handle is configured to slide axially along the length direction of at least a portion of the plunger, and wherein the plunger further comprises a locking lever capable of switching between a locked position and an unlocked position, the locking lever but when configured to allow the movable handle in the unlocked position of the slide in the proximal direction when the movable handle to prevent the plunger slide in the proximal direction in the locked position, and wherein said locking lever is further configured to reset to the locking position; portion of the catheter shaft, the catheter shaft comprises a catheter shaft and an inner portion of the catheter shaft stabilization line, wherein the catheter shaft at the proximal end of the catheter shaft is secured to the movable handle, and wherein the stabilizing wire is fixed to the plunger; and a distal tip portion, which is configured to receive a medical device in a cavity, which 所述远端末梢部分被固定至中空的导管轴的远端,且该远端末梢部分还包括接收在所述腔中的推进器柱塞, 所述推进器柱塞连接至所述稳定线的远端; 其中近端的柱塞在其近端还包括C形手柄,该C形手柄包括用于接收内窥镜的开口。 The distal tip portion is secured to the distal end of a hollow catheter shaft and the distal tip portion further includes a receiving cavity in the pusher plunger, said plunger connected to the propulsion line stable a distal end; wherein the proximal end of the plunger at its proximal end further comprises a C-shaped handle, the handle comprising a C-shaped opening for receiving an endoscope.
  2. 2. 根据权利要求1所述的展开导管,其中所述锁定杠杆在可移动的手柄的远端被附接至柱塞。 The deployment catheter according to claim 1, wherein the locking lever is attached to the plunger at the distal end of the movable handle.
  3. 3. 根据权利要求1所述的展开导管,其中所述锁定杠杆包括附接至所述锁定杠杆的弹簧,该弹簧被配置为在所述医疗装置已经从所述展开导管展开后,将所述锁定杠杆复位到锁定位置。 3. The deployment catheter according to claim 1, wherein said locking lever comprises a lock lever attached to the spring, the spring is configured as the medical device has been deployed from the deployment catheter, the reset the lock lever to the locked position.
  4. 4. 根据权利要求1所述的展开导管,其中所述导管轴部分包括位于其远端的高柔性区域。 4. Expand catheter according to claim 1, wherein said shaft portion comprises a highly flexible catheter at its distal end region.
  5. 5. 根据权利要求4所述的展开导管,其中所述高柔性区域为犬牙交错形式的构造。 5. Expand catheter according to claim 4, wherein the region is a highly flexible structure in the form of interlocking.
  6. 6. 根据权利要求4所述的展开导管,其中所述高柔性区域为蛇纹形式的构造。 6. Expand catheter according to claim 4, wherein the region is a highly flexible structure serpentine form.
  7. 7. 根据权利要求4所述的展开导管,其中所述高柔性区域包括交叠的不连续直线切割部。 7. The deployment catheter according to claim 4, wherein the region comprises a highly flexible overlapping discontinuous straight cut portion.
  8. 8. 根据权利要求1所述的展开导管,其中所述远端末梢部分包括笼套,该笼套带有至少一个被配置为接收医疗装置的腔。 8. The deployment catheter according to claim 1, wherein the distal tip portion comprises a sleeve cage, the cage having at least one sleeve configured to medical device receiving cavity.
  9. 9. 根据权利要求8所述的展开导管,其中所述笼套具有形成螺旋构造的撑条布置。 Deployment catheter according to claim 8, wherein the cage sleeve having a spiral structure formed of struts disposed.
  10. 10. 根据权利要求8所述的展开导管,其中所述笼套包括一个或多个大的窗孔。 Deployment catheter according to claim 8, wherein said cage comprises a sleeve or a plurality of large apertures.
  11. 11. 根据权利要求10所述的展开导管,其中所述一个或多个大的窗孔被配置为允许观察和确认所述医疗装置已经被装载进所述腔中。 Deployment catheter according to claim 10, wherein the one or more large apertures are configured to allow the medical device to observe and confirm that has been loaded into the cavity.
  12. 12. 根据权利要求1所述的展开导管,其中所述远端末梢部分包括至少一个定位标记, 所述定位标记被配置为指示所述医疗装置的大致展开位置。 12. The deployment catheter according to claim 1, wherein the distal tip portion includes at least one positioning mark, the mark is positioned substantially deployed position is configured to instruct the medical device.
  13. 13. 根据权利要求12所述的展开导管,其中所述定位标记是黄色的,两个额外的黑色带位于两侧。 Deployment catheter according to claim 12, wherein said positioning mark is a yellow, two additional black stripes on both sides.
  14. 14. 根据权利要求1所述的展开导管,其中所述导管轴部分的远端还包括至少一个长的定位标记。 14. The deployment catheter according to claim 1, wherein the distal end of the catheter shaft further comprises at least a portion of the length of the registration mark.
  15. 15. 根据权利要求1所述的展开导管,其中所述手柄部分还包括一个截头圆锥的应变消除件,其围绕在所述导管轴部分的近端区域周围。 15. The deployment catheter according to claim 1, wherein said handle portion further includes a frusto-conical strain relief member, which surrounds the proximal region of the catheter shaft portion.
  16. 16. 根据权利要求1所述的展开导管,还包括一个外部鞘,其至少围绕所述导管轴部分的近端区域。 16. The deployment catheter of claim 1, further comprising an outer sheath, which surrounds at least a portion of the proximal region of the catheter shaft according to claim.
  17. 17. 根据权利要求1所述的展开导管,其中所述展开导管被配置为装载进一个气管镜。 17. The deployment catheter according to claim 1, wherein the conduit is configured to expand loaded into a bronchoscope.
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GB2511375A (en) 2014-09-03 application

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