CN102458553B - 额窦扩张导管 - Google Patents
额窦扩张导管 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
- A61B2017/246—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers for cleaning of the nose
Abstract
一种球囊扩张导管,包括:基本上刚性的内引导件;以及可移动的轴,接合至球囊,所述球囊可滑动地安装在基本上刚性的内引导件上。为使用球囊扩张来治疗受治疗者的窦腔,基本上刚性的内引导件经由鼻通路被推进到受治疗者的窦的排放通道(例如,额隐窝)中。轴和球囊在基本上刚性的内引导件上在远端方向上被推进,以将球囊设置在排放通道中。球囊膨胀,以扩大或以其他方式重塑排放通道。
Description
技术领域
总的来说,本发明的领域涉及球囊膨胀(balloon inflation)装置和方法。更特别地,本发明的领域涉及用于窦炎的治疗的球囊扩张装置和方法。
背景技术
窦炎是一种正在影响着超过3500万美国人的疾病,并且同样地正在影响着其他发达国家的大量人口。当四对窦腔(即,上颌窦腔、筛窦腔、额窦腔、蝶窦腔)中的一个或多个变得堵塞、或者具有异常排放时,出现窦炎。通常,这些窦腔中的每个都装衬有产生粘液的粘膜,粘液然后由于纤毛的颤动而离开窦腔移动到鼻腔并向下移动到咽喉。这些相联合的窦每天产生近一升的粘液,因而对于窦的健康来说,此粘液的有效运输是重要的。
每个窦腔都具有通向鼻道的排放通道或流出道。该排放通道可包括孔(ostium)、以及孔的区域中的“过渡空间”,诸如,对于额窦而言,为“额隐窝”,或者对于上颌窦而言,为“筛漏斗”。当一个或多个孔的粘膜或者一个或多个靠近孔的区域的粘膜变得发炎时,中断粘膜的排出(egress),处于窦腔的感染和/或发炎(即,窦炎)的阶段。尽管有许多可用适当的药物来治疗窦炎的实例,但在一些情况下,窦炎会持续数月或更长(一种被称为慢性窦炎的疾病),并且可能药物治疗不起作用。一些患者还倾向于在给定的时间段内多次出现窦炎(一种被称为复发性窦炎的疾病)。
已将球囊扩张应用于治疗收缩的窦通路,从而用于窦炎的治疗。这些球囊扩张装置典型地涉及设置在导管(诸如球囊导管)的远端处的可膨胀球囊的使用。通常,将可膨胀球囊以紧缩状态插入到收缩的窦通路中。球囊然后扩大以打开正在治疗的窦通路或降低正在治疗的窦通路的收缩度,从而促进更好的窦的排放和通风。同时,保护窦及其排放通路的如果不是全部则是大部分功能粘膜组织衬层。
例如,美国专利No.7,520,876和美国专利申请公开No.2008-0172033中公开了特别适用于与上颌窦和前组筛窦(anterior ethmoid sinus)相关联的解剖结构的扩张的示例性装置和方法。已描述了用于包括额窦在内的各种其他窦的治疗的其他系统。例如,美国专利申请公开No.2008-0097295公开了一种额窦引导导管(图6B)和治疗额窦的方法(例如,图8B-图8C)。美国专利申请公开2008-0125626公开了另一用于经鼻进入额窦以进行治疗的引导装置(例如图10C和图10C’)。
发明内容
在本发明的第一实施例中,一种球囊扩张导管,包括:基本上刚性的内引导件;以及可移动的轴,接合至一球囊,所述球囊可滑动地安装在基本上刚性的内引导件上。为使用球囊扩张导管来治疗受治疗者的窦腔(例如,额窦腔)的排放通道,基本上刚性的内引导件经由鼻通路被推进到受治疗者的排放通道中。轴和球囊然后在基本上刚性的内引导件上在远端方向上被推进,以将球囊设置在排放通道中。这使得球囊能够在内引导件上行进(track)。球囊膨胀,以扩大或以其他方式重塑排放通道。当窦腔是额窦腔时,排放通道是额隐窝。
在本发明的另一方面中,一种用于使窦腔的流出道扩张的装置,包括:基本上刚性的内引导件,具有近端和远端;以及轴,接合至球囊,所述轴具有第一管腔,沿所述第一管腔的至少一部分包含有基本上刚性的内引导件,所述轴具有可操作地接合至球囊的内部的第二管腔。沿基本上刚性的内引导件的近端部设置有把手,所述把手包括可操作地接合至轴的可移动的钮,其中,对所述钮的远端推进使得在基本上刚性的内引导件上在远端方向上推进轴和球囊。
附图说明
图1示出了根据一个实施例的球囊扩张导管的透视图。
图2A示出了图1中的球囊扩张导管的侧视图。示出了推进钮处于拉回近端位置中。
图2B示出了图2A中的球囊扩张导管的横截面图。
图3A示出了图1中的球囊扩张导管的侧视图。示出了推进钮处于推进远端位置中。
图3B示出了图3A中的球囊扩张导管的横截面图。
图4是图3B中的把手部(虚线部分)的横截面图。
图5A是沿图2B中的线A-A’截取的球囊扩张导管的横截面图。
图5B是沿图4中的线B-B’截取的球囊扩张导管的横截面图。
图6A是根据一个实施例的内引导件的侧视图。
图6B是根据另一实施例的内引导件的侧视图。
图6C是根据另一实施例的内引导件的侧视图。
图7示出了根据另一实施例的球囊扩张导管的透视图。
图8示出了当将球囊扩张导管的内引导件推进到受治疗者(subject)的额隐窝中时受治疗者的额窦的横截面图。
图9示出了当球囊扩张导管的内引导件定位在受治疗者的额隐窝中时受治疗者的额窦的横截面图。示出了穿过导管推进导丝并将导丝推进到受治疗者的额窦腔中。
图10示出了当将球囊(处于紧缩状态中)和轴推进到受治疗者的额隐窝中时受治疗者的额窦的横截面图。
图11示出了当图10中的球囊处于膨胀状态中且由此拓宽和重塑额隐窝时受治疗者的额窦的横截面图。
图12示出了在额窦已被拓宽并抽出球囊扩张导管之后受治疗者的额窦的横截面图。
具体实施方式
图1示出了特别适用于受治疗者的额窦的流出道(额窦孔和额隐窝)的治疗的球囊扩张导管10的一个实施例。球囊扩张导管10包括构造成由操作员抓握或以其他方式操纵的把手12。细长形状的内引导件14在远端方向上从把手12纵向地延伸。内引导件14由合适的刚性材料形成,诸如不锈钢海波管(hypotube)。内引导件14从把手12伸出或以其他方式向远端延伸预定的距离。内引导件14可预成形为具有如图1、图2A、图2B、图3A、图3B、图6A、图6B、图7、图8和图9中所示的弯曲远端部16。例如,弯曲远端部16的性质和程度可构造成与额窦流出道或额隐窝相匹配。
可替代地,内引导件14可具有一定程度的延展性,以使用户可将内引导件14的远端弯曲或为之赋予一些期望的形状或构造。如在此更详细地说明的,内引导件14可包括可选的管腔(lumen)18(在图5A中最佳示出),所述管腔使内引导件14的长度延伸。特别地,内引导件14和所包含的管腔18可从远端20延伸至近端21(在图2B和图3B中最佳可见),所述近端与具有设置在把手12的近端24处的端口22的密封装置接合。端口22可用常规接口(诸如鲁尔接头)来构造。端口22可用作流体和/或药物的抽吸端口或传送端口,或者用于导丝(guide wire)的引入。
仍参照图1,围绕内引导件14的周界安装有轴30。特别地,轴30的尺寸形成为响应于设置在把手12上的推进钮(advancer knob)32的致动而在内引导件14上滑动。推进钮32可沿把手12的一表面中所包含的狭槽42移动。轴30的远端34包括球囊36,如在此所说明的,所述球囊构造成选择性地膨胀或紧缩。在使用期间,操纵内引导件14,并穿过感兴趣的解剖空间推进所述内引导件或将所述内引导件推进到感兴趣的解剖空间中。图1中示出了轴30和所附接的球囊36处于拉回状态中。尽管为了更佳地示出,图1示出了球囊36处于膨胀状态中,但当轴30处于如图2A和图2B中所示的近端位置中时,球囊36典型地处于紧缩状态中。在适当地定位内引导件14之后,用户通过在远端方向上滑动推进钮来致动推进钮32,这又在预置的内引导件14上在远端方向上推进轴30和球囊36。一旦适当地设置球囊36,则使球囊36膨胀。球囊36的膨胀使用连接至设置在把手12的近端24处的端口38的膨胀装置(未示出)来实现。美国专利申请No.12/372,691中描述了可连同球囊扩张导管10一起使用的一个示例性膨胀装置,就好像充分地进行阐述那样,将其通过引证结合于此。当然,也可使用其他膨胀装置。轴30(在下文中更详细地描述)内所包含的膨胀管腔48将端口38流体地连接至球囊36的内部。
仍参照图1,围绕轴30的一部分的外周可设置有管子形式的可选的支撑件40,以便为球囊扩张导管10赋予更大的刚度。支撑件40的特定长度可依据应用而变化,并可沿轴30的一部分或整个延伸。支撑件40可由金属材料制成,诸如固定于轴30的不锈钢海波管。支撑件40可沿一段轴30焊接或结合。通常,支撑件40未覆盖轴30的包含在把手12内的螺旋部(在下文中详细描述)。
图2A和图2B分别示出了当推进钮32且因此球囊36处于近端位置中时球囊扩张导管10的侧视图和横截面图。在实际使用中,如在此所说明的,当推进钮32处于如图2A和图2B中所示的近端位置中时,球囊36典型地处于紧缩状态中。如在图1中最佳可见,推进钮32在狭槽42内沿一段把手12可滑动地设置。推进钮32因此能够沿狭槽42的长度在远端/近端方向上来回滑动。狭槽42可结合有止挡件(stop)等(未示出),以防止沿内引导件14的长度将球囊36推进得过远。在不同的装置中,狭槽42的长度可变化,以调整球囊36可推进的长度。尽管其他尺寸可落入本发明的范围内,但通常,狭槽42具有在约1英寸到约2英寸的范围内的长度。
如在图2B中可见,推进钮32可直接接合至安装在轴30上的支撑件40。可替代地,推进钮32可直接接合至轴30。推进钮32可构造成或以其他方式形成为使得用户的手指(例如,食指或拇指)能够容易地沿把手12中所包含的狭槽42推进或拉回钮32。
图3A和图3B分别示出了当推进钮32且因此球囊36处于远端位置中时球囊扩张导管10的侧视图和横截面图。因此,不同于图2A和图2B的构造,推进钮32位于把手12的远端26处或靠近把手的远端。对推进钮32的推进还使轴30和所附接的球囊36沿内引导件14在远端方向(图3A中的箭头A)上滑动。球囊36因此定位在内引导件14的远端20处或邻近内引导件的远端。球囊扩张导管10可设计成使得推进钮32可定位在如图2A、图2B、图3A、图3B所示的最近端或最远端处。可替代地,推进钮32可定位在上述最近端与最远端之间的某处。例如,球囊36的最优位置可通过使推进钮42滑过狭槽42的全部距离的一部分(例如,3/4)来实现。
参照图2B和图3B,球囊扩张导管10的内引导件14从远端20延伸至近端21,所述近端终止于具有设置在把手12的近端24处的端口22的密封接合件中。内引导件14可选地包括设置在其中的管腔18,所述管腔可用来经由接合至端口22的抽吸装置(未示出)提供抽吸功能。抽吸功能容许去除血液和其他分泌物。这使得更容易看见球囊扩张导管10的设置。内引导件14有利地是刚性的,以使得能够在如果不是全部则是大部分情况下无需单独的引导导管或导丝来定位球囊扩张导管10。
尽管可使用其他尺寸,但是内引导件14在装载到把手12中时从远端20到近端21可具有约7英寸到约11英寸的长度。内引导件14可由不锈钢海波管形成,所述不锈钢海波管具有的内径在约0.020英寸到约0.050英寸的范围内,且更优选地在约0.036英寸到0.040英寸之间,所述不锈钢海波管的壁厚在约0.005英寸到约0.020英寸的范围内,且更优选地在约0.008英寸到约0.012英寸之间。内引导件14的弯曲远端部16可形成在远端20右侧,并且具有的曲率半径可为约0.25英寸到约1.5英寸,且更优选地为约0.75英寸到约1.25英寸。
当球囊36处于完全拉回状态(例如,图2A和图2B中所示)中时,内引导件14的从球囊36的最远端部向远端伸出的长度为约0.5英寸到约2.0英寸,且更优选地为约0.8英寸到约1.2英寸。如图1、图2A、图2B、图3A、图3B、图6A-6C、图7-图11中所示,内引导件14的远端20可结合有可选的球根状末端(bulbous tip)44,以使远端20更无创伤。球根状末端44另外用于当向远端推进球囊36和所附接的轴30时限制它们的向前移动。末端44的外径优选地在约1mm到约3mm之间。
球囊36安装在轴30上,以便在这两个部件之间形成流体密封。可使用焊接、粘合剂等使球囊36结合至所述轴。可替代地,可使用机械连接件将球囊36固定于所述轴。通常,可使用本领域技术人员已知的任何技术来将球囊36固定于轴30。假定球囊36直接固定于轴30,则这两个结构都可滑动地安装在内引导件14上。球囊36在膨胀时通常呈圆柱形。尽管不限于特定的尺寸,但膨胀的球囊36在膨胀时具有的直径在约3mm到约9mm的范围内,且更优选地在约5到约7mm的范围内。尽管可使用其他长度,但球囊36的长度通常可落入约10mm到约25mm的范围内。轴30和球囊36两者优选地由高强度但具柔性的聚合物材料(诸如聚酰胺(例如尼龙)、PEBAX等)形成。球囊36可“吹塑”到相对薄的壁厚,并能够将膨胀压力保持在从约6个大气压到约20个大气压的相对高的压力下。使用典型地为液体(诸如水或盐水)的流体使球囊36膨胀。
现在参照图4,示出了把手12的一部分的放大横截面图。把手12的近端24处设置有端口22、38。端口22可用常规接口(诸如鲁尔接头)或本领域技术人员已知的任何其他连接件来构造。端口22可与把手12成一体地形成,或者可替代地,端口22可以是在组装过程中固定于把手12的单独的结构。如图4中所示,内引导件14的近端21与端口22形成密封布置。如在此所说明的,端口22可用作流体和/或药物的抽吸端口或传送端口。
图4还示出了可以与如上所述的端口22相同或相似的方式构造的端口38。端口38流体地接合至轴30中的膨胀管腔48。在这点上,来自膨胀装置(未示出)的膨胀液能够通过端口38并进入到轴30的膨胀管腔48中。端口38可用常规接口(诸如鲁尔接头)来构造。然后膨胀液能够经由管腔48沿轴30的长度行进,在所述管腔中,膨胀液进入球囊36的内部。膨胀液因此能够在膨胀装置的致动之后使球囊36膨胀。
如图4中最佳所示,把手12的一部分包括接收内引导件14和轴30两者的凹入区50。在把手13的凹入区50中,轴30成螺旋状地环绕在内引导件14的外周周围,形成螺旋部52。螺旋部52促进轴30和所附接的球囊36沿内引导件14的远端推进和近端拉回,并仍保持与端口38的流体连通。轴30的邻近推进钮32设置的螺旋部52为环绕在内引导件14周围的螺旋形,并构造成在推进钮32的移动之后伸长和缩短。图4示出了在已向远端推进推进钮32之后螺旋部52的状态。因此,在伸长状态中,螺旋部52的长度贯穿如果不是全部则是大部分凹入区50。该图与示出了由于推进钮32处于近端位置中而将螺旋部52压缩至凹入区50的近端部的图2B形成对照。因此,螺旋部52因此能够以比弹簧响应于拉伸载荷或压缩载荷所表现出的大得多的方式展开或压缩。内引导件14和轴30的螺旋部52中的一者或两者可选地可涂覆或装衬有光滑的涂层,以防止接触面受到任何期望的摩擦束缚等。
轴30的螺旋部52可通过“削磨”掉轴30的一部分而形成。图5A示出了沿图2B中的线A-A’截取的轴30、内引导件14、以及支撑件40的横截面图。如图2B中所示,对于设置有轴30的螺旋部52的地方来说,该区域位于远端。现在参照图5A,轴30包含套设(rider)管腔54,所述套设管腔的尺寸形成为具有的直径稍大于内引导件14的外径。套设管腔54因此使得能够以密配合布置在内引导件14上推进和拉回轴30。轴30的外径通常可落入约0.050英寸到约0.110英寸的范围内,或者落入约0.070英寸到约0.100英寸的范围内。内引导件14的外表面和套设管腔54的内表面中的一者或两者可选地可涂覆有光滑的涂层,以减小摩擦接触力。图5B示出了沿图4中的线B-B’截取的内引导件14和轴30的螺旋部52的横截面图。如图5B中所示,轴30的包含套设管腔54的一部分被削磨掉。结果是在成螺旋状地环绕在内引导件14周围的轴30中留有单个管腔(膨胀管腔48)。
图6A-图6C示出了内引导件14的各种实施例。内引导件14可具有各种形状和构造,取决于特定的应用或患者。内引导件14的不同形状可由工厂按照特定的形状加工而成,并在完全组装好之后作为不同的模型而提供,或者可替代地,内引导件14能是可替换的或是可在套设管腔54内滑动的并以压配合型密封布置插入到端口22中的模块元件。在另一可替代方案中,这些形状可表现为这样的期望的形状,即,具延展性的内引导件14可由用户形成,以更好地适合特定的应用或受治疗者的解剖体。
图6A示出了包括终止于直区段(straight segment)46中的弯曲远端部16的内引导件14。在图6A的实施例中,弯曲远端部16中的弯曲是显著的,并以“U”形(其中远端20以倒转方式折回)折回到其自身上。如果鼻解剖体将允许经鼻途径,那么该实施例对于经由经鼻路径难以到达的孔或其他结构(例如,上颌孔或漏斗)的治疗而言是有用的。尽管图6A示出了“U”形弯曲,但可设想其他的弯曲程度。图6B示出了根据另一实施例的内引导件14。在该实施例中,弯曲远端部16也终止于直区段46中,尽管曲率半径较不显著。尽管可使用其他长度,但在该实施例中,直区段46具有的长度可在约8mm到约10mm的范围内。认为该实施例特别适于大多数额隐窝解剖体。图6C示出了其中内引导件14基本上是直的实施例。此后一实施例可特别适于治疗受治疗者的蝶骨、或直进的额隐窝解剖体。
图7示出了根据另一实施例的球囊扩张导管10。在该实施例中,球囊扩张导管10的把手12上设置有跟踪元件60。跟踪元件60可包括传送无线信号的天线、发射器、光学反射体等,然后接收并处理该无线信号,以确定球囊扩张导管10的定向和/或定位。在某些实施例中,球囊扩张导管10上可设置有一个以上的跟踪元件60。然后可处理与球囊扩张导管10的定向和/或定位有关的数据并显示在显示器上,以便医生观看。例如,图像引导手术正变得日益平常,容许医生在手术过程中回顾受治疗者体内的特定装置的实时真实或虚拟图像。
例如,通过引证结合于此的美国专利No.5,391,199和美国专利No.5,443,489描述了一种系统,其中,使用探针上所承载的一个或多个场传感器(诸如,霍尔效应装置)、线圈或天线来确定体内探针的坐标。同样通过引证结合于此的美国专利申请公开No.2002-0065455描述了这样的一个系统,即,所述系统能够使用传感器和辐射线圈的结合来生成导管的末端的六维位置和定向表示。同样通过引证结合于此的美国专利申请公开No.2008-0269596描述了在整形过程中具有特别应用的另一监控系统。商诸如LANDMARX元件(佛罗里达州杰克逊维尔市的Medtronic XomedProducts有限公司)的商业系统可结合ENT过程一起使用。
在图7的实施例中,跟踪元件60容许对球囊扩张导管10的远端20的精确跟踪,以使球囊扩张导管10的远端部的图像可叠加在患者的解剖影像上。例如,可使用先前执行的患者的计算机断层(CT)扫描来生成感兴趣的患者的解剖区域的视觉图像。基于跟踪元件60的位置,图像引导手术(IGS)系统于是可将球囊扩张导管10的图像叠加到该图像上,以使得医生能够更好地操纵和定向球囊扩张导管10。
其他商业系统也可连同图7中所示的球囊扩张导管10一起使用。例如,来自英格兰查尔芬特圣贾尔斯的GE医疗集团的INSTATRAK 3500Plus-ENT可与球囊扩张导管10结合在一起和/或一起使用。使用CT引导来定位球囊扩张导管10是优选的,因为操作员仅用一只手就可定位该装置,而在操纵把手12的同时观看CT图像界面(例如,显示器)。可选地,最初可使用内窥镜或其他可视化工具来定位球囊扩张导管10。例如,可在球囊扩张导管10旁边操纵常规“霍普金斯杆”内窥镜(未示出),以辅助设置。
图8-图12示出了经历用球囊扩张导管10治疗的受治疗者的额窦的各种横截面图(矢形面)。这些横截面图示出了鼻通路100、额隐窝102、以及额窦腔104。参照图8,当推进钮32处于拉回位置(例如,如图1、图2A、图2B中所示)中时将球囊扩张导管10插入到鼻通路100中,以同样向近端拉回轴30和球囊36。另外,球囊36处于如图8中所示的紧缩状态中。然后将内引导件14的弯曲部16定位在受治疗者的额隐窝102内,如图8中所示。内引导件14的这种定位可使用定位在球囊扩张导管10旁边的常规内窥镜(诸如霍普金斯杆内窥镜)在内窥镜的可视化下实现。可替代地,可使用IGS技术来定位内引导件14,所述IGS技术使用一个或多个例如图7的实施例中所示的跟踪元件60来跟踪球囊扩张导管10的位置。例如,可在来自CT成像的引导下推进内引导件14。
现在参照图9,可通过穿过内引导件14的管腔18设置通过荧光镜可见的导丝64来实现内引导件14在额隐窝102内的精确定位的确认。可经由端口22将导丝64插入到管腔18中。在荧光镜的可视化下,一旦将内引导件14适当地定位在额隐窝102内,则可看到导丝64被推进到额窦腔104。如果导丝64没有被推进到额窦腔104中,那么重新定位球囊扩张导管10,并且随后尝试确认。作为通过荧光镜可视的导丝64的可替代方案,导丝64可以是发光导丝,诸如在通过引证结合于此的美国专利申请公开No.2007-0249896中公开的发光导丝。当然,由于内引导件14可在没有导丝的帮助或无需导丝的情况下设置,因此导丝64是可选的。可替代地,在球囊导管10的设置之前,最初可将导丝64设置在额窦中。
现在参照图10,一旦适当地定位内引导件14的弯曲部16,则在远端方向(图3A中的箭头A)上推进推进钮32,由此将轴30和所附接的球囊36推进到额隐窝102中。这在图10中示出。在将球囊36定位在额隐窝102中之后,如图11中所示地使球囊36膨胀。膨胀通过将膨胀装置(未示出)接合到端口38来实现。所述膨胀装置可包括注射器等,推压所述注射器,以使流体注入到膨胀管腔48中,流体然后进入到球囊36的内部中,从而实现使球囊36扩大到图11中所示的状态。典型地用来实现额隐窝102的拓宽或重塑的压力在约3个大气压到约12个大气压的范围内。球囊36可仅膨胀一次,或者可替代地,球囊36可膨胀、紧缩并再次膨胀多次,以实现期望的拓宽程度。每个膨胀步骤都可在将球囊36定位在额隐窝102内的不同位置中之后执行。
在已拓宽或以其他方式重塑额隐窝102之后,如图12中所示地使球囊36紧缩并取出。认为图12中所示的拓宽的额隐窝102使额窦腔104的排放和通风功能以及健康恢复。球囊36的紧缩通过降低球囊36的内部中的流体压力来实现。例如,可抽出流体地接合至端口38的注射器的活塞等,以使流体从球囊36的内部流出。然后可从鼻通路100向近端抽出球囊扩张导管10。
在某些患者体内,如上所述的对一个或两个额窦104的治疗可能是足够的。在其他患者体内,可能需要治疗另外的窦,特别是上颌窦和/或前组筛窦。在这样的患者体内,组合过程可能是非常适合的。上颌窦和/或前组筛窦可用诸如在美国专利No.7,520,876和美国专利申请公开No.2008-0172033中描述的、如明尼苏达州枫叶林市的Entellus医疗有限公司的FinESS系统的商业上可购得的系统来治疗。可替代地,其他窦更常规地可使用例如功能性内窥镜窦手术(FESS)的手术技术来治疗。
同样,可用上述球囊导管10的实施例来使蝶窦和/或上颌窦流出道扩张。同样设想球囊导管10,特别是结合有合适的IGS装置的、并且内支撑件14具有合适的形状(优选地是如图6C中所示的直的)的图7的实施例,可用来经由犬齿窝路径使上颌窦流出道扩张。合适的进入工具在通过引证结合于此的共同待决美国专利申请No.12/038,719中描述。这可在无需另外的内窥镜可视化的情况下执行,容许通过相对小直径的进入通路进入到犬齿窝的区域内的窦腔中的治疗。如果需要,可利用穿过内支撑件14的管腔18的小内窥镜(未示出),以进一步有助于上颌窦流出道的可视化。
尽管已示出和描述了本发明的实施例,但不背离本发明的范围的情况下,可做出各种修改。因此,除了下述的权利要求书及其等同物之外,本发明不应受限制。
Claims (20)
1.一种用于使窦腔的流出道扩张的装置,包括:
金属内部件,具有近端和远端;
轴,接合至球囊,所述轴具有第一管腔,所述第一管腔沿所述轴的包含所述金属内部件的至少一部分,所述轴具有可操作地接合至所述球囊的内部的第二管腔;以及
把手,沿所述金属内部件的近端部设置,所述把手包括可操作地接合至所述轴的可移动的钮,其中,对所述钮的远端推进使得所述轴和所述球囊在所述金属内部件上滑动并在所述金属内部件上沿远端方向推进所述轴和所述球囊。
2.根据权利要求1所述的装置,其中,所述金属内部件沿其长度包含一管腔。
3.根据权利要求2所述的装置,进一步包括柔性丝线,所述柔性丝线的尺寸形成为用于在所述金属内部件的所述管腔中可滑动地移动。
4.根据权利要求1所述的装置,其中,所述金属内部件的所述远端包括弯曲部。
5.根据权利要求4所述的装置,其中,所述弯曲部的远端终止于直区段中。
6.根据权利要求4所述的装置,其中,所述弯曲部具有的曲率半径在0.25英寸到1.5英寸之间。
7.根据权利要求1所述的装置,其中,所述金属内部件的所述远端包括球根状末端。
8.根据权利要求1所述的装置,其中,所述金属内部件的所述远端包括具延展性的部分。
9.根据权利要求1所述的装置,其中,所述轴沿所述把手的一部分成螺旋状地环绕在一段所述金属内部件周围。
10.根据权利要求1所述的装置,进一步包括设置在所述把手处的至少一个跟踪元件。
11.根据权利要求1所述的装置,其中,所述金属内部件在所述把手内是可替换的。
12.根据权利要求1所述的装置,其中,所述把手包括一狭槽,并且所述钮的一部分可滑动地设置在所述狭槽中。
13.根据权利要求12所述的装置,其中,所述狭槽的长度在1英寸到2英寸之间。
14.根据权利要求1所述的装置,其中,所述把手包括止挡件。
15.根据权利要求1所述的装置,其中,所述金属内部件是不锈钢管,所述不锈钢管具有的内径在0.020英寸到0.050英寸之间的范围内,所述不锈钢管具有的壁厚在0.005英寸到0.020英寸之间的范围内。
16.根据权利要求1所述的装置,其中,所述装置构造成防止所述球囊前进超过所述金属内部件的远端。
17.根据权利要求1所述的装置,进一步包括设置在所述把手的近端处的端口,其中,所述轴从接合至所述球囊的远端邻近地延伸至与所述端口以密封布置接合的近端。
18.根据权利要求17所述的装置,其中,所述端口与所述把手成一体地形成。
19.根据权利要求17所述的装置,其中,所述端口是固定于所述把手的单独的结构。
20.根据权利要求1所述的装置,其中,所述金属内部件固定于所述把手。
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US12/479,521 US8282667B2 (en) | 2009-06-05 | 2009-06-05 | Sinus dilation catheter |
US12/479,521 | 2009-06-05 | ||
PCT/US2010/037508 WO2010141894A1 (en) | 2009-06-05 | 2010-06-04 | Frontal sinus dilation catheter |
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CN201080024851.XA Active CN102458553B (zh) | 2009-06-05 | 2010-06-04 | 额窦扩张导管 |
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EP (5) | EP3583975B1 (zh) |
JP (2) | JP5755642B2 (zh) |
CN (1) | CN102458553B (zh) |
DK (2) | DK3583975T3 (zh) |
ES (3) | ES2564456T3 (zh) |
HU (1) | HUE027215T2 (zh) |
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