CN101541365A - 气管切开方法和装置 - Google Patents

气管切开方法和装置 Download PDF

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CN101541365A
CN101541365A CN 200780022806 CN200780022806A CN101541365A CN 101541365 A CN101541365 A CN 101541365A CN 200780022806 CN200780022806 CN 200780022806 CN 200780022806 A CN200780022806 A CN 200780022806A CN 101541365 A CN101541365 A CN 101541365A
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L·弗赖塔格
A·旺卡
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Breathe Technologies Inc
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0472—Devices for performing a tracheostomy
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
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    • 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
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    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222—Materials for reducing friction
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials

Abstract

本发明涉及具有管状支撑框架(9)的气管造口间隔器(8)。支撑框架(9)可以被从初始状态(A)扩展到增加直径的支撑状态(S)且在端部具有固定元件(14－17)。气管造口间隔器(8)适于被用作气管造口(气管上的开口)内的间隔器。本发明还涉及用于将气管造口间隔器插入到具有套针形式的切割器具的气管造口内的装置，气管造口间隔器能够被置于所述套针的轴上。可以在轴上在被放置的气管造口间隔器的上移动的覆盖套管也被提供。

Description

气管切开方法和装置
技术领域
本发明涉及具有管状支撑框架的气管造口间隔器，涉及气管切开方法，并且涉及用于插入气管造口间隔器的装置。
背景技术
气管切开术是在人体必须被插入管子一段时间的情况下、在上呼吸道的畸形、疾病或创伤导致急性闭塞的情况下或在出现窒息危险的情况下所实施的一种医学程序。在气管上手术制造的开口被已知为气管造口。制造这种气管造口的几种方法已经已知了：经皮扩张气管切开术、经皮穿刺气管切开术、常规手术气管切开术、ENT气管切开术和喉切除气管切开术。
发明内容
本发明的一个方面涉及经皮气管切开方法。在这些方法中，气管可以使用空心针穿刺或可以使用套针刺穿。这样形成的开口可以被加宽，且最后管可以被放置于开口内。在经皮扩张气管切开术的上下文中，通常地，导丝首先被插入开口内，然后开口可以使用可膨胀气囊加宽。接着，通过相当强有力地压在伤口周围伤口处被止血。
经皮气管切开术的问题是在拆除被放置于气管造口内的导管或管之后很短的时间内气管造口再次闭合，且很快发现重新插入很困难或根本不可能了。为此，各种导管或管已经被开发出来了，意于保持气管造口敞开。已知的导管或管的缺点是它们都很大并且很笨重；它们从患者颈部突出，它们延伸到气管内腔深处，并且它们具有相对较厚的壁和很大的固定直径。因此，对患者来说它们太难接受且需要制造相对较大的气管造口以容纳导管或管。而且，它们在气管造口扩张术中没有帮助，且它们不顺从患者的解剖，而是解剖顺从导管或管的刚性。
本发明的一个方面是针对气管造口间隔器、用于插入这种气管造口间隔器的气管切开术的方法和装置的，其中气管造口可以被制作得更小和/或不必须被扩展那么大，且其中，间隔器可以执行气管造口的某种扩张并顺从人体的解剖。
本发明的另一方面通过具有权利要求1的特征的气管造口间隔器被实现了。
这个气管造口间隔器可以包括支撑框架，其可以从初始状态被扩展到增加直径的支撑状态，且在一端具有固定元件。
因此，气管造口间隔器可以以未扩展的、被压缩的或褶皱的初始状态被插入到气管造口内，且具有非常小的直径，当其被装配就位之后，它可以被扩展或被加宽到与生理学和临床要求对应的直径，例如通过可膨胀气囊或刚性扩张器或气管造口也可以在其上面被扩展的另一器具。这样，用很少的努力被个别适应且具有很好的可容忍性的间隔器被提供了。端部的固定元件，或者被设置于皮肤外面或者被设置在气管内侧，有效地防止间隔器被推到气管外面或被吸入。
气管造口间隔器的具有优势的实施例和更多发展是附属权利要求2至32的主体。
支撑框架还可以从初始状态自我扩展到增加直径的支撑状态。这样，不需要主动加宽开口。在某一实施例中，支撑框架由于其材料和其设计所拥有的弹性力足以加宽气管造口。
支撑框架的长度是可调的。这允许气管造口间隔器适应个别的人造口长度，以使间隔器不必须很长和很难接受，但长度足以执行其功能和匹配个别的解剖。在某一实施例中，可调整性可以通过两部分的支撑框架被提供，其中一个组成部分可以以伸缩的方式被推进另一个内。自身调整的支撑框架的几何形状通过扭曲、迂回或倾斜也是可能的，以允许支撑框架的长度调整。长度调整也可以通过支撑框架的弹性力得以实现。通过适合的结构和材料的选择，支撑框架可以被设置以使长度增加时直径缩小，反之亦然，因此，当间隔器在其被加长的情况下放置到气管造口内之后，长度可以被自身缩短。或者，间隔器长度可以通过支撑框架内的形状记忆元件被自身缩短。例如，当达到体温时，形状记忆元件可以缩短气管造口间隔器的长度，例如，通过元件缩短、扭曲、弯曲、迂回、卷曲或滑动。弹性缩短力或形状记忆缩短力被选择，以不过度压缩围绕气管造口的组织，但轻轻地压缩组织，这样间隔器是稳定的。例如，允许此情形的缩短力可以在0.05磅(0.023kg)和0.5磅(0.23kg)之间。这样，支撑框架在解剖学上的恰当长度被得到了，以匹配人造口的长度。
优选地，固定元件具有无创伤性边缘。这保证了固定元件不切进气管的组织或刺激组织。固定元件的边缘可以被导圆。
在支撑状态下，固定元件横向关于纵向中心轴线突伸超出支撑框架的外圆。这样，有效地防止气管造口间隔器被推出气管造口或被吸入的抵接部被形成。
固定元件可以被提供在支撑框架的端部。例如，在某一实施例中，两个固定元件可以被提供在支撑框架的一端。分成几个固定元件意味着这些中的每一个都可以被做得更小，且气管造口间隔器的插入和拆除更容易。具有优势地，固定元件可以被折叠以进行插入和拆除。这样，气管造口不必须被制得大于支撑框架在初始状态下的外径。
支撑框架一端的固定元件可以被彼此相对设置。此结构便于气管造口间隔器在气管内的自对准，以适应解剖的情况。
固定元件被提供在支撑框架的一端或两端。当被提供于两端上时，在某一方向内，它们防止气管造口间隔器被推出气管造口，而在另一方向内，它们防止气管造口间隔器被推进或吸入气管内。这样，气管造口间隔器被周圈固定了。
在某一实施例中，一端的固定元件可以相对于另一端的固定元件绕支撑框架的纵向中心轴线偏置了一个直角。具有优势地，气管造口间隔器在气管内的自对准被此结构支撑。被置于气管内的固定元件将它们自己定位在垂直的方向内，因为气管在内侧是凹的。对应地，皮肤外表面上的固定元件将它们自己对准在水平方向内，以使头部的向前和向后运动都不会被气管造口间隔器妨碍。另外，对气管造口间隔器来说，在气管内提供支撑功能也是可能的。
在某一实施例中，固定元件可以具有孔。具有优势地，孔使抓持气管造口间隔器更容易，例如为了从气管造口内拆除气管造口间隔器。孔可以是，例如，圆形、卵形或椭圆形。
支撑框架可以具有管状导引元件。这种管状导引元件便于插入运送气体包括例如氧气到肺部或从肺部或从气管吸出粘液所需要的管。优选地，管状导引元件向外延伸超出支撑框架的一端。这一端将位于气管内，且其进一步优选是弯曲的或可以具有肩部，以在肺部的方向内偏转管。这样，管可以被插入到气管内，以使其处于从气管的后壁的需要间距处，且不抵接后壁或刺激气管粘膜。管状导引元件还可以被使用以允许气管造口间隔器滑动，同时在气管切开术装置上准确地对准。
而且，支撑框架被分配有阀单元。使用阀单元，具有优势地，可以通过气管造口吸入并通过气管呼出。在某些情况下患者仍能够说话。另外，器具可以被从外面推动穿过气管造口。用于此目的阀单元可以或者从外面被推入或者可以是支撑框架的护套结构的一部分。在第二解决方法中，护套的一部分可以被设计为鸭嘴兽形状的隔膜。
在另一实施例中，支撑框架可以被分配有增湿器。这样，从肺部吸入的呼吸空气被增湿。增湿器由能够在呼气过程中贮存湿气且能够在吸气过程中释放湿气的被成形的物件组成。
接合元件被提供以固定被穿过或被插入支撑框架内的物件。这些物件是，例如，阀单元、增湿器或管。
支撑框架可以被护套围住。经由护套，邻接气管造口间隔器的组织可以被保护，且气管造口间隔器的插入和拆除可以更容易地做到，因为护套提供了，在其它物件中，气管造口间隔器滑动能力的具有优势的增加。为实现此目的，护套还可以包括疏水或亲水的侧面促进包层。护套还防止邻接的组织粘连到气管造口间隔器上。护套可以具有纳米分子涂层。护套还可以由聚合物制成。这样，可扩展的支撑框架不会在其扩展过程中被阻止。另外地，护套可以包含具有抗炎作用且用于保护其不受细菌或微生物作用的活性药物物质，或可以包含组织生长调控器或调整器以防止肉芽瘤生长或促进肉皮化。另外适合的活性物质是，例如，盐溶液、伤口油膏和利多卡因(局部麻醉剂)。活性物质可以以流体形式被提供。
支撑框架还可以被提供有在支撑框架的圆周面上具有开口的贮存器，和/或在支撑框架的外周表面上具有一端的通道。流体可以被引入贮存器中。通过开口，流体能够到达圆周面，这样，它们可以直接作用于邻接的气管造口组织，这样，便于气管造口间隔器的插入和拆除，且一般改进了其可容忍性。经由通道，根据需要和当需要时，流体可以以需要的量被注入。
支撑框架可以具有圆形横截面。从生产工程的角度来看，此装置可以是具有优势的。但是，支撑框架也可以具有卵形横截面。在本发明的上下文中，其它横截面形状当然也是可能的。这些横截面形状允许适应气管的解剖，特别是环绕的软骨环。此外，支撑框架在其横截面上可以具有凹坑和/或突起。肾脏形状的横截面也是可能的。
根据本发明的原理和技术，支撑框架可以通过很多方式被构造为和/或被制造。例如，支撑框架可以是纺织的、编织的、从管状物激光切割来的或这些的组合和制造支撑框架的其它方式。例如，在某一实施例中，支撑框架可以具有由线材制成的支架。这样，直径可以被改变的支撑框架可以被得到。线材可以由金属制成，例如。形状记忆合金，例如镊，是特别适合的。从金属的构造有助于支撑框架的弹簧弹性的自我扩展且增长了气管造口间隔器的使用寿命。通过使用形状记忆合金，直径的变化可以另外地通过温度控制的方式得以实现。
支撑框架还可以包括纺织合成线材。具有优势地，这种支撑框架可以通过压模铸造或挤出工艺被生产。线材还可以被包覆弹性体。
优选地，在支撑状态下，支撑框架的壁厚可以小于支撑框架的外径的五分之一，优选小于十分之一。很薄的壁厚具有使气管造口可以被保持得很小的优势。气管造口越小，气管造口间隔器被拆除后开口愈合得越快越好。在某一实施例中，气管造口间隔器可以具有两个同心的支撑框架，外面的支撑框架被永久或半永久地置于气管的开口内，而内部的支撑框架在定义的周期内被从外部的支撑框架内抽出并进行清洗。
在本发明的另一方面中，该方法可以通过包括权利要求33中的步骤的气管切开方法得以实施。为实现此目的，气管造口(气管上的开口)首先被建立，接着，可扩展直径的气管造口间隔器被放置到气管的开口内。
气管切开方法的具有优势的实施例是附属权利要求34至37的主体。
穿过皮肤和气管壁的开口可以使用针形刀具、解剖刀或套针被形成。切割避免了气管造口组织的撕裂，这个撕裂将导致组织的不良愈合和更大或更厚的伤疤的形成。在这种情况下，在气管上形成开口的切口被相对于气管横向形成。这是解剖学上的优势，因为围绕气管的软骨环也被定位于此方向内。
在气管造口间隔器被装配在适当位置之前，气管上的开口，如果需要和/或必须，可以使用刚性的或直径可以被加宽的器具例如气囊扩张器加宽。
在本发明的另一方面中，该装置部分可以通过被用于制造开口和用于插入气管造口间隔器且具有权利要求38的特征的装置得以实现。
该装置可以包括切割器具，气管造口间隔器可以放置于其轴上，以及覆盖套管，其可在轴上在被放置与轴上的气管造口间隔器上移动。
该装置可以被用于刺穿气管或在气管上制造切口，且可以被引入在气管上形成的开口内。在该装置的位置已经通过支气管镜检查检验后，覆盖套管被抽回，以使被置于覆盖套管下面的气管造口间隔器从初始状态扩展到增加直径的支撑状态下，且固定元件展开。然后，用以插入气管造口间隔器的该装置被再次从开口拆除。使用这种装置插入气管造口间隔器允许间隔器最小限度的侵入和快速放置。
本装置的另外实施例和发展是附属权利要求39至51的主体。
切割器具可以具有锥形尖端。具有优势地，这种尖端可以在此装置插入时加宽气管造口。
切割器具可以具有用于导丝的通道。在切口被制造之前，导丝可以被经皮引入到气管内，然后可以被插入或被旋入通道内。这样，气管切口和气管造口间隔器的放置的精度被增加了。
切割器具可以包括针。具有优势地，气管可以使用针被穿刺。
另外地或可替代地，切割器具可以包括刀具、解剖刀或套针。气管上具有优势的水平切口可以使用这些器具被制造。
箍带可以被设置在覆盖套管上。这种箍带是环形的且可扩展。如果需要，使用箍带，气管造口可以被额外加宽。
轴可以具有送进部分。在送进部分处，轴的直径被减小，以使气管造口间隔器可以被置于此位置，且在插入过程中，可以被以初始状态固定就位。
轴还具有导引部分，其可以具有优势地允许覆盖套管在轴上运动。
轴和覆盖套管可以是弯曲的。这样，适应解剖情况可以被允许，且气管造口间隔器的插入更容易。轴和覆盖套管被沿纵向轴线适宜地弯曲。
此装置的横截面被适合于气管上的开口。因此，横截面不必须是圆形，也可以是卵形和/或具有凹坑和/或突起。
在本发明的另一方面中，抓持表面可以被提供。这可以允许牢固地人工抓持此装置。抓持表面可以具有表面结构。
本装置还可以包括安全元件。可以提供某种措施来以使切割器具可以被缩回到外壳内。这使伤害的风险和不正确切口的危险最小化。为了缩回切割器具，启动元件，例如以下压按钮的形式，被提供在抓持表面附近的自由端。
抵接部还可以被提供在切割器具的尖端或覆盖套管上，且防止本装置被推进气管内超过预定的深度。具有优势地，通过抵接部，对气管的后壁的损坏可以被防止。
用于拆除和/或重新插入气管造口间隔器的器具也被提供了。该器具可以被插入支撑框架内。优选可以在器具的纵向方向内伸展的抓持器元件在支撑框架和/或固定元件的至少一部分内接合。接着，气管造口间隔器被缩短长度且被减小直径。这样，气管造口间隔器将自身从周围的组织上脱离，且可以与器具一起从气管上的开口抽回。为了在气管的开口内重新插入气管造口间隔器，此方法可以被以相反的顺序使用。
本发明的另外特征、优势和实施例可以被提出，或从下面的具体介绍、图示和权利要求的考虑中可以是很明显的。此外，应理解，本发明的前述概要和后面详细的介绍都是实例型的，且如权利要求中所列出的那样意于提供进一步的解释，而不限制本发明的范围。
附图说明
附属图示，被包括以提供本发明的进一步理解并被引入，且组成本说明的一部分，示意出本发明的优选实施例，并与详细的介绍一起用于解释本发明的原理。因此，本发明在下面关于在图示中描述的实例型实施例被详细解释了。
图1示出了通过包括根据本发明的原理的气管造口间隔器的实施例的人体身体上部的示意性局部部分。
图2示出了处于未扩展的状态(虚线)下和剖示图(实线)形式的扩展状态下的气管造口间隔器的实施例。
图3用从前面看过去的侧视图示出了图2中的气管造口间隔器。
图4用侧视图示出了阀单元的实施例。
图5示出了沿图4中线V-V的剖示图的阀单元。
图6示出了用于插入气管造口间隔器的装置的实施例的剖示图，其中气管造口间隔器被置于覆盖套管下面。
图7示出了根据本发明的原理的气管造口间隔器的另一实施例的端视图。
图8A示出了沿处于原位的图7的气管造口间隔器的线C-C的剖示图。
图8B示出了处于原位的局部剖示图，其中，图7中的气管造口间隔器是从气管内部看出来的。
图9A示出了根据本发明的原理的导管的实施例的一侧。
图9B示出了沿图9中线B-B的导管的截面剖示图。
具体实施方式
图示中的相同或类似的特征被提供有相同的参考标志。
穿过患者2的身体上部1的示意性局部部分在图1中被示出了。在颈部3的区域内，气管4优选位于食管5和脊柱6的前面。为了帮助患者2呼吸，经皮气管切开术已经被完成了，其中气管4上的开口已经被穿透皮肤了，此开口被称为气管造口7。为了防止气管造口7再次迅速闭合，根据本发明的气管造口间隔器8被放置于气管造口7内。
气管造口间隔器8在图2和图3中被更详细地示出了。气管造口间隔器8具有管状支撑框架9。支撑框架9能够从初始状态A自我扩展(由虚线表示)到被增加直径的支撑状态S(由实线表示)。支撑框架的长度L可以是可调的。例如，为了能够调整支撑框架9的长度L，支撑框架可以被设置和/或被构造为可调的。在某一实施例中，调整方法可以被提供在框架中，例如，但不仅限于，框架内元件的伸缩特征、扭曲、迂回或倾斜，或框架内的框架或元件的弹性力或形状记忆性能。
支撑框架9可以由聚合物制成的护套10环绕。护套可以便于气管造口间隔器8的插入和拆除，且可以避免伤害相邻的组织11(请参考图1)。护套10还可以包含具有抗炎作用和用于保护不受细菌感染的活性药物物质。
支撑框架9可以具有圆形横截面，且因此可以特别容易地从管状半成品切割而来，例如。支撑框架9可以由线材形式的支架(图中没有详细示出)组成。线材可以由例如形状记忆合金，尤其从镍-钛合金也被称作镍钛诺，制成。
为了保持气管造口7尽可能小(请参考图1)，其优选具有带有很薄壁厚的支撑框架9。例如，在某一实施例中，在支撑状态S下，支撑框架的壁厚WD可以小于支撑框架9的外径AD的十分之一(1/10)。
在支撑框架9的两端12、13，固定元件14-17可以被提供，以允许气管造口间隔器8被固定在气管4内的适当位置上。在支撑状态S下，固定元件14-17可以被弯曲到80°至100°的角度β，例如，且突伸超过支撑框架9的外周A。在某一实施例中，两个固定元件14、15；16、17分别被提供在每一端12、13上，且可以被彼此相对设置。一端12的固定元件14、15可以相对于另一端13的固定元件16、17绕支撑框架9的纵向中心轴线MLA偏置一个直角α。在气管造口间隔器8的插入和拆除过程中，为了改进其操作，固定元件14-17可以具有圆形孔19-22，使其更容易抓住气管造口间隔器8，例如用钩状的结构。固定元件14-17优选具有被导圆和被抛光的无创伤性边缘23。
在支撑框架9的内表面24上还可以具有外围沟槽形式的接合元件25。接合元件25形成抵接部，以固定被插入到支撑框架9内的阀单元或固定增湿器，或固定已经被推动穿过且也被称为导管的管。
阀单元26被以实例的形式在图4和5中示出了。阀单元26具有套管形式的中间部分27，其可以通过两个喙状唇缘28、29被连接。每个唇缘28、29可以具有很薄且很柔韧的平坦部分30，以使呼吸的空气可以在方向R内通过阀单元26被吸入，只具有非常轻的阻力。在相反方向内，阀单元26在呼气过程中被关闭。本阀单元26的另一优势是管和类似物件也可以通过阀单元26在方向R内被插入。外围弹簧形式的接合元件32可以被设置在套管形状的部分27的圆周面31上。在其一端，阀单元26具有外围环部33。
用以插入气管造口间隔器8的装置34在图6中被示出了。此装置34是刚性的手术器具，其可以包括套针37形式的且被设置在套针37外侧的内部切割器具36和覆盖套管38。套针37可以具有两个非常锋利的边缘39、40，用此锋利边缘开口可以被切割在气管上。套针37被设置在轴41上。在套针37后面，具有气管造口间隔器8被放置于其上的较小直径的送进部分(magazine section)42。其与较大直径的导引部分43邻接。覆盖套管38可以通过在轴41的导引部分43上滑动而被移动，且可以在气管造口间隔器8上被推动，并可以在插入过程中将气管造口间隔器8固定在初始状态下。在这一端，轴41可以具有抓持表面44。
为了能够加宽气管造口，箍带45可以被设置在覆盖套管38的外围，且可以被注满流体。为实现此目的，箍带45具有用于管47的适合的连接器元件46。
用于插入气管造口间隔器8的装置34可以使气管造口间隔器8的放置更快捷更简单。气管可以被简单地提前刺穿一个很小的直径。然后，装置34被插入，且其在气管造口内的恰当位置通过支气管镜检查被检验。接着，覆盖套管38被撤回，且气管造口间隔器8扩展，固定元件也展开。最后，装置34可以简单地又被从开口拆除。
根据本发明，气管造口间隔器8允许最低限度入侵的气管切开术。在气管造口间隔器8的自我扩展过程中的径向作用力使气管造口7加宽，这样，其它辅助装置大致可以不用了。气管造口具有很小的直径，且在拆除气管造口间隔器8之后很短的时间内愈合。
图7介绍了插入人体后气管造口间隔器8的正视图。可以看到，固定元件16、17可以被并排地分开定位在180度的方位上。在本图中，管导引元件48被描述为从气管造口间隔器的内壁的突起，但是，这只是实例型的，且导引元件可以采用很多形式。管导引元件可以用于将被插入气管造口间隔器内的另一装置定位在正确的方位上。被插入气管造口间隔器内的另一装置的实例包括但不仅限于导管51、气管切开术装置34、气管造口间隔器拆除工具或某种器具。
请参考图8，从图7的气管造口间隔器8以剖示图的形式被示出在人体的组织11、气管4和气管壁52中。外侧或近侧上的固定元件17与内侧或远侧上的固定元件14、15也被示出了，而后者两个固定元件被分离定位在180度，且被从近侧的固定元件定位在90度。管导引元件48和管导引弯曲部49也被示出了，管导引弯曲部49可以用于导引被向下朝向肺部插入的装置。而且，管导引弯曲部49可以用于放置被插入到希望位置上的装置，例如，远离后或前气管壁，以避免与气管壁52不必要的或不希望的接触。
虽然管导引弯曲部49可以用作安全元件，但根据本发明的原理其它类型的安全元件可以被提供。
请参考图9，将要被插入气管造口间隔器内的实例型导管51被介绍了。导管的实例是，但不限于，空气导管、氧疗导管、吸引导管、诊断导管、药物输送导管、取样导管或纤维光束导管。如剖面B-B(图9B)中所介绍的，与气管造口间隔器(图7)上的管导引元件48匹配的导引元件50被介绍了。导引元件50仅以实例的形式被示出了，且可以包括很多形式和形状。在本实施例中，导管被作为实例介绍了，但相同的原理可以应用于被插入气管造口间隔器内的其它装置，例如但不仅限于气管切开术装置34、气管造口间隔器拆除工具或某种器具。
附图标记列表
1：身体上部
2：患者
3：颈部
4：气管
5：食管
6：脊柱
7：气管造口
8：气管造口间隔器
9：支撑框架
10：护套
11：组织
12：9的端部
13：9的端部
14：固定元件
15：固定元件
16：固定元件
17：固定元件
19：孔
20：孔
21：孔
22：孔
23：边缘
24：9的内表面
25：接合元件
26：阀单元
27：26的套管形状部分
28：唇缘
29：唇缘
30：28、29的平坦部分
31：圆周面
32：接合元件
33：环部
34：气管切开术装置(tracheotomy device)
36：切割器具
37：套针
38：覆盖套管
39：37的边缘
40：37的边缘
41：轴
42：送进部分
43：导引部分
44：抓持表面
45：箍带
46：连接器元件
47：管
48：管导引元件
49：管导引弯曲部
50：导引元件
51：导管
52：气管壁
A：外周
AD：外径
L：长度
MLA：纵向中心轴线
R：方向
WD：壁厚
A：直角
β：角度
虽然优选实施例是针对气管切开术的，但本发明的原理可以被应用于其它领域，特别地，例如，包括结肠的其它类型的切开术，或包括血管的其它进入装置。
此外，虽然前面的介绍是针对本发明的优选实施例的，但请注意，其它变异和修改对于本领域内的技术人员来说是很明显的，且不偏离本发明的精神或范围的变异和修改可以被制造。另外，与本发明的某一实施例有关的所介绍的特征可以与其它实施例协作使用，即使在上面没有明确指出。

Claims (52)

1.一种气管造口间隔器，具有管状支撑框架(9)，其中，支撑框架(9)能够从初始状态(A)扩展到增大直径的支撑状态(S)且在端部具有固定元件(14-17)。
2.根据权利要求1所述的气管造口间隔器，其中，支撑框架(9)能够从初始状态(A)自我扩展到增大直径的支撑状态(S)。
3.根据权利要求1或2所述的气管造口间隔器，其中，支撑框架(9)的长度是可调的。
4.根据权利要求1至3中任一所述的气管造口间隔器，其中，固定元件(14-17)具有无创伤性边缘(23)。
5.根据权利要求1至4中任一所述的气管造口间隔器，其中，在支撑状态(S)下，固定元件(14-17)相对于支撑框架(9)的纵向中心轴线(MLA)横向突伸超出支撑框架的外周(A)。
6.根据权利要求1至5中任一所述的气管造口间隔器，其中，两个固定元件(14、15；16、17)被提供在支撑框架(9)的一端(12；13)。
7.根据权利要求6所述的气管造口间隔器，其中，位于一端(12；13)的固定元件(14、15；16、17)被彼此相对设置。
8.根据权利要求1至7中任一所述的气管造口间隔器，其中，固定元件(14、15；16、17)被提供在支撑框架(9)的两端(12；13)。
9.根据权利要求8所述的气管造口间隔器，其中，位于一端(12)的固定元件(14、15)相对于另一端(13)的固定元件(16、17)绕支撑框架(9)的纵向中心轴线(MLA)以直角(α)偏置。
10.根据权利要求1至9中任一所述的气管造口间隔器，其中，固定元件(14-17)具有孔(19-22)。
11.根据权利要求1至10中任一所述的气管造口间隔器，其中，支撑框架(9)具有管状导引元件，以导引通过气管造口间隔器(8)插入的气管切开术装置(34)或导管。
12.根据权利要求11所述的气管造口间隔器，其中，管状导引元件向外延伸超出支撑框架(9)的一端(12、13)。
13.根据权利要求11或12所述的气管造口间隔器，其中，管状导引元件是弯曲的或具有肩部。
14.根据权利要求1至13中任一所述的气管造口间隔器，其中，支撑框架(9)配备有阀单元。
15.根据权利要求1至13中任一所述的气管造口间隔器，其中，支撑框架(9)配备有增湿器。
16.根据权利要求1至15中任一所述的气管造口间隔器，其中，设有接合元件(25)，用以固定穿过或插入到支撑框架(9)内的物件。
17.根据权利要求1至16中任一所述的气管造口间隔器，其中，支撑框架(9)具有护套(10)。
18.根据权利要求17所述的气管造口间隔器，其中，护套(10)由聚合物制成。
19.根据权利要求17或18所述的气管造口间隔器，其中，护套(10)包含活性药物物质。
20.根据权利要求1至19中任一所述的气管造口间隔器，其中，设有贮存器，其在支撑框架的外周表面上具有开口。
21.根据权利要求1至20中任一所述的气管造口间隔器，其中，设有通道，其一端位于支撑框架的外周表面上。
22.根据权利要求1至21中任一所述的气管造口间隔器，其中，支撑框架(9)具有圆形横截面。
23.根据权利要求1至21中任一所述的气管造口间隔器，其中，支撑框架具有卵形横截面。
24.根据权利要求1至23中任一所述的气管造口间隔器，其中，支撑框架在其横截面上具有凹坑。
25.根据权利要求1至24中任一所述的气管造口间隔器，其中，支撑框架在其横截面上具有突起。
26.根据权利要求1至25中任一所述的气管造口间隔器，其中，支撑框架(9)具有由线材制成的支架。
27.根据权利要求26所述的气管造口间隔器，其中，线材由金属制成。
28.根据权利要求27所述的气管造口间隔器，其中，线材由形状记忆合金制成。
29.根据权利要求1至25中任一所述的气管造口间隔器，其中，支撑框架(9)包括纺织合成线材。
30.根据权利要求1至29中任一所述的气管造口间隔器，其中，线材被包覆弹性体。
31.根据权利要求1至30中任一所述的气管造口间隔器，其中，在支撑状态(S)下，支撑框架(9)的壁厚(WD)小于外径(AD)的五分之一(1/5)。
32.根据权利要求1至30中任一所述的气管造口间隔器，其中，在支撑状态(S)下，支撑框架(9)的壁厚(WD)小于外径(AD)的十分之一(1/10)。
33.一种气管切开方法，其包括下述步骤：在气管上形成开口；将可扩展直径的气管造口间隔器放置于气管的开口内。
34.根据权利要求33所述的气管切开方法，其中，气管的开口被使用针形成。
35.根据权利要求33所述的气管切开方法，其中，气管的开口被使用刀具或解剖刀切割而成或使用套针穿刺而成。
36.根据权利要求35所述的气管切开方法，其中，用于形成气管开口的切口被相对于气管横向制成。
37.根据权利要求33至36中任一所述的气管切开方法，其中，在气管造口间隔器被装配就位之前，使用刚性的或其直径可被加宽的器具，穿过皮肤和气管壁的开口被加宽。
38.一种气管切开术装置(34)，用于将根据前面权利要求中任一所述的气管造口间隔器(8)插入到气管造口内，其中，气管切开术装置(34)包括：切割器具(36)，其中气管造口间隔器(8)适于被放置于切割器具的轴(41)上；和覆盖套管(38)，其可在轴(41)上在放置于轴上的气管造口间隔器(18)上移动。
39.根据权利要求38所述的气管切开术装置，其中，切割器具(36)具有锥形尖端。
40.根据权利要求38或39所述的气管切开术装置，其中，切割器具(36)具有用于导丝的通道。
41.根据权利要求38至40中任一所述的气管切开术装置，其中，切割器具(36)包括针。
42.根据权利要求38至41中任一所述的气管切开术装置，其中，切割器具(36)包括刀具、解剖刀或套针(37)。
43.根据权利要求38至42中任一所述的气管切开术装置，其中，箍带(45)被设置于覆盖套管(38)上。
44.根据权利要求38至43中任一所述的气管切开术装置，其中，轴(35)具有送进部分(36)。
45.根据权利要求38至44中任一所述的气管切开术装置，其中，轴(41)具有导引部分(43)。
46.根据权利要求38至45中任一所述的气管切开术装置，其中，轴和覆盖套管是弯曲的。
47.根据权利要求38至46中任一所述的气管切开术装置，其中，横截面的外部形状被设置成能够适应于气管的开口。
48.根据权利要求38至47中任一所述的气管切开术装置，其中，设有抓持表面(44)。
49.根据权利要求38至48中任一所述的气管切开术装置，其中，设有安全元件，以保护气管切开术装置(34)不在气管内过度插入。
50.根据权利要求49所述的气管切开术装置，其中，安全元件是外壳。
51.根据权利要求49所述的气管切开术装置，其中，安全元件是抵接部。
52.根据权利要求49所述的气管切开术装置，其中，安全元件是沿气管造口间隔器(8)的轴向长度形成的弧形形状，以便于弯曲地穿过皮肤进入气管内。
CN 200780022806 2006-05-18 2007-05-18 气管切开方法和装置 Pending CN101541365A (zh)

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US20100043786A1 (en) 2010-02-25
US8985099B2 (en) 2015-03-24
US20080029088A1 (en) 2008-02-07
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US20120145147A1 (en) 2012-06-14
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US7631642B2 (en) 2009-12-15
CA2652544A1 (en) 2007-12-13
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WO2007142812A3 (en) 2008-10-16

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