CN101507619A - 可植入装置的紧固系统和其使用方法 - Google Patents

可植入装置的紧固系统和其使用方法 Download PDF

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CN101507619A
CN101507619A CNA2009101262937A CN200910126293A CN101507619A CN 101507619 A CN101507619 A CN 101507619A CN A2009101262937 A CNA2009101262937 A CN A2009101262937A CN 200910126293 A CN200910126293 A CN 200910126293A CN 101507619 A CN101507619 A CN 101507619A
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雅内尔·比尔克
弗雷德里克·L·科
罗伯特·E·小霍伊特
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Inamed Medical Products Corp
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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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0684—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0223—Subcutaneous access sites for injecting or removing fluids having means for anchoring the subcutaneous access site
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0229—Subcutaneous access sites for injecting or removing fluids having means for facilitating assembling, e.g. snap-fit housing or modular design
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1414—Hanging-up devices
    • A61M5/1415—Stands, brackets or the like for supporting infusion accessories

Abstract

本发明公开了一种可植入的进入端口元件与传递工具的系统，包括：可植入的进入端口元件，其包括底座、多个紧固件和第一可旋转元件，所述紧固件可枢转地连接着所述底座并且可在非配设位置与配设位置之间移动，所述第一可旋转元件连接着所述底座并且被构造和定位成通过第一可旋转元件的转动而配设所述多个紧固件；以及传递工具，其便于将所述进入端口元件植入软组织中，所述传递工具包括：第二可旋转元件，其被构造成可移除地接合所述第一可旋转元件；和致动组件，其用于移动所述紧固件进入配设位置，所述致动组件包括可操作地连接着第二可旋转元件的传动元件。

Description

可植入装置的紧固系统和其使用方法
本申请是申请日为2005年1月21日、申请号为200580001352.8、发明名称为“可植入装置的紧固系统和其使用方法”的发明专利申请的分案申请。
技术领域
本发明涉及可植入医疗装置和手术器械以及紧固件的技术领域。本发明包括在外科手术中紧固装置或植入件的方法以及用于所述过程中的手术紧固件和器械。
背景技术
手术紧固件，如缝合钉、夹子、钳子、带子、钉子或其它伤口或切口封闭装置在手术过程中通常用于允许外科医生紧固、固定和/或修补身体组织。在美国专利No.4994073或4950284或4934364和4932960中说明了手术紧固件的一些例子。
手术紧固件已经用于外科手术中以消除对缝合的需要，因为缝合既费时间又不方便。在这些应用场合中，外科医生经常使用装有一个或多个手术紧固件的紧固件植入装置以在几秒钟内完成采用缝合需要花费几分钟才能完成的工作。这种手术时间的缩短减小了患者的失血和创伤。
通常，这种紧固系统已经主要用于封闭切口或伤口，或者用于将组织紧固在一起。可以用于多种类型的可植入装置的手术紧固系统将非常利于外科医生。目前，结合有紧固系统的手术装置通常使用非常专业化的系统，这些系统可能过于复杂并且不适合用于其它应用场合。结果，大多数可植入装置仍然采用缝合方式固定。例如，当插入胃带(gastric band)和相关进入端口元件(accessport)时，端口元件采用4至5道缝线在腹直肌鞘上被缝合就位。这种缝线的位置经常很有挑战性，因为端口元件被设置在脂肪以下几英寸处，并且缝合端口元件经常要花费与放置胃带本身一样长的时间。改进的紧固系统将允许以相当于缝合装置的安全性进行简单的单步连接。
本发明将解决该技术领域中的这些问题。
发明内容
本发明包括手术紧固系统，其中可植入装置包括多个位于配设前位置的紧固件，或者其中可植入装置可包括装配在所述装置上的壳体，其中所述壳体包括多个位于配设前位置的紧固件。因此，本发明还包括可以随意地放置可植入装置并且导致紧固件运动进入配设后位置的配设系统。
附图说明
结合下面说明和附图将可以更完全地理解本发明的上述目的和优势，其中：
图1是径向枢转紧固件的透视图，其中缝合钉位于配设前位置；
图2是图1所示径向枢转紧固件的透视图，其中缝合钉位于配设位置；
图3是图1所示径向枢转紧固件的详细透视图，其中缝合钉位于配设前位置；
图4是图2所示径向枢转紧固件的详细透视图，其中缝合钉位于配设位置；
图5是传递系统的透视图；
图6是图5所示传递系统以及端口元件紧固件的剖切视图；
图7是图6所示传递系统的远端以及位于配设前位置中的端口元件紧固件的详细剖切透视图；
图8是图6所示传递系统的远端以及位于配设位置中的端口元件紧固件的详细剖切透视图；
图9是用于传递系统的笔式握柄结构的透视图；
图10是示于开始位置中的图9所示传递系统手柄的详细剖切透视图；
图11是示于触发位置中的图9所示传递系统手柄的详细剖切透视图；
图12是用于传递系统的手枪式握柄结构的正视图；
图13是示于开始位置中的图12所示传递系统手柄的详细正视图；
图14是示于触发位置中的图12所示传递系统手柄的详细正视图；
图15是用于传递系统的另一个手枪式握柄结构的透视图；
图16是图15所示传递系统的齿轮传动机构的详细视图；
图17是示于开始位置中的图15所示传递系统的详细剖切正视图；
图18是示于弹簧完全回弹位置中的图15所示传递系统的详细剖切正视图；
图19是示于触发位置中的图15所示传递系统的详细剖切正视图；
图20是位于配设前位置中的连续NiTi丝式紧固件的透视图；
图21是位于配设后位置中的图20所示连续NiTi丝式紧固件的透视图；
图22是直腿、钝头连续金属丝式紧固件的底侧透视图；
图23是弯曲腿、钝头连续金属丝式紧固件的底侧透视图；
图24是模制尖端连续金属丝式紧固件的底侧透视图；
图25是连续NiTi丝式紧固件的透视图，其中磨利尖端位于配设后外侧位置；
图26是连续NiTi丝式紧固件的透视图，其中磨利尖端位于配设后内侧位置；
图27是连续NiTi丝式紧固件的底侧透视图，其中图26所示磨利尖端位于配设后内侧位置；
图28是带有直腿和缝合钉导向件的径向滑动紧固件的透视图；
图29是图28所示径向滑动紧固件的透视图；
图30是带有弯曲腿的径向滑动紧固件的透视图；
图31是安装之前的两部件式紧固系统的透视图；
图32是安装之后的图31所示两部件式紧固系统的透视图；
图33是安装之前的另一个两部件式紧固系统的透视图；
图34是安装之后的图33所示两部件式紧固系统的透视图；
图35是结合在装置中的独立紧固件的透视图；
图36是结合在装置中的另一个独立紧固件的透视图；
图37是结合在装置中的另一个独立紧固件的透视图；
图38是结合在装置中的另一个独立紧固件的透视图；
图39是结合在位于配设前位置的注射端口元件中的另一个独立紧固件的透视图；
图40是位于配设后位置中的图39所示独立紧固件的透视图；
图41是螺旋线圈紧固件的透视图；
图42是另一个螺旋线圈紧固件的透视图；
图43是水平线圈紧固系统底座的俯视图；
图44是图43所示水平线圈紧固系统底座的侧视图；
图45是图43所示水平线圈紧固系统底座的仰视图；
图46是用于图43所示水平线圈紧固系统的紧固系统驱动工具的透视图；
图47是图43所示水平线圈紧固系统底座的详细视图；
图48是结合在装置中的封闭金属圈紧固系统的侧视图；
图49是包括图48所示封闭金属圈紧固系统的装置的俯视图；
图50是两部件式咬扣配合紧固系统的侧视图；
图51是使用弯曲形销或钩子的另一个封闭金属圈系统的透视图；
图52是结合在装置中的图51所示使用弯曲形销或钩子的封闭金属圈系统的侧视图；
图53显示了结合在装置中的弯曲形销紧固系统的俯视图和侧视图；
图54显示了结合在装置中的另一个弯曲形销紧固系统的俯视图和侧视图；
图55显示了弹簧线圈紧固系统的仰视图和侧视图；
图56显示了位于其打开和闭合位置中的带有弯曲式紧固件的折叠基板的侧视图；
图57显示了结合在装置中的旋转钩紧固件的俯视图和侧视图；
图58是旋转盘紧固系统的顶侧透视图，其中紧固件位于配设前位置；
图59是图58所示旋转盘紧固系统的底侧透视图，其中紧固件位于配设后位置；
图60是图58所示旋转盘紧固系统的仰视图，其中紧固件位于配设后位置；
图61是图58所示旋转盘紧固系统的侧视图，其中紧固件位于部分配设位置；和
图62是图58所示旋转盘紧固系统的弯曲式紧固件的透视图，显示了旋转轴线；
图63是传递系统的剖切侧视图；
图64是传递系统的侧向透视图；
图65是图63和图64所示传递系统的致动杆的俯视图；
图66是图63和图64所示传递系统的致动杆的侧视图；
图67是图63和图64所示传递系统的致动杆的仰视图；
图68是图63和图64所示传递系统的致动杆的侧向透视图；
图69是图63和图64所示传递系统的端口元件盖的局部分解及剖切视图；
图70是图63和图64所示传递系统的端口元件盖的局部剖切视图；
图71是图63和图64所示传递系统的端口元件盖的后侧视图；
图72是图63和图64所示传递系统的端口元件盖的侧向透视图；
图73是承载夹具的底侧透视图；
图74是承载夹具的仰视图；
图75是承载夹具的透视图；
图76是盘形紧固件/端口元件/承载夹具组件的透视图；
图77是盘形紧固件/承载夹具组件的分解视图。
具体实施方式
本发明包括手术紧固系统，其中可植入装置包括多个位于配设前位置中的紧固件(例如，缝合钉)，或者其中紧固件设置为适合于缝合装置上的孔，或者其中可植入装置可以包括安装在装置上的可分离壳体，其中所述壳体包括多个位于配设前位置中的紧固件。
可分离壳体和紧固件可以由本领域公知的用于制造手术紧固件和植入件的各种材料制成。紧固件可以由金属、聚合物或其它合适的材料制成。可分离壳体可以由金属、聚合物、陶瓷或复合材料制成；例如通常使用聚砜、醋酸基共聚物、钛、弹性体和不锈钢。
这些材料必须具有生物适应性，也就是说，它们不会负面影响活体周围环境，并且反过来，它们的性能不会受活体周围环境负面影响。材料可以是惰性的、不可吸收的或者生物可降解的。惰性材料相当不容易被破坏并且在更长的时间内保持它们的形状和功能。
金属和金属合金，具体地说钛和钛合金被用于各种不同的医疗应用场合的可植入制品中。所有可植入制品都具有一定程度的生物不适应性，这可能表现为组织发炎、坏死、增生、突变、中毒和其它反应，例如受到巨细胞、白细胞和巨噬细胞攻击。虽然通常认为钛及其合金在植入时具有惰性，但是仍然可能出现一些生物和生物化学相互作用，并且已经发现理想的是在钛和钛合金植入件的表面上提供各种不同的涂层以便用于特定用途。对于很多其它的金属和金属合金也同样如此。因此，本发明包括在紧固件、可分离壳体或装置的表面上使用这种涂层。
可以用于(不论是由钛制成或是由其它材料制成的)待植入材料中的一些涂层包括生物制剂(例如遗传物质或细胞材料)或化学制剂(例如抗增殖试剂或细胞生长因子)以减小与增生或发炎有关的问题。这些制剂可以与粘合剂，如弹性体或生物可吸收聚合物混合到金属或聚合物体的表面上。
这里关注的、包括缝合钉的紧固件经常由丝线(wire)构成并因此对于它们的尺寸具有相对较大的表面积。因此，允许将生物和生物化学制剂添加到植入件表面上的方法可有利于将植入件对身体组织的不良反应降至最低。这些可包括应用于不锈钢和钛合金(例如，NiTi合金)上以延缓组织反应的涂层。这些涂层是基于稳定的生物适应性聚合物(例如苯乙烯—异丁烯—苯乙烯三嵌段共聚物(SIBS))和生物可吸收聚合物，例如聚羟基乙酸。在迄今为止公知的技术中，将活性化学或生物制剂与聚合物涂层材料混合，然后在将植入件放入体内之后从涂层中洗提制剂。
本发明另外关注的是紧固件可以由形状记忆合金(SMA)制成。与该应用场合中所使用的传统合金相比，由形状记忆合金制造金属医疗装置的主要原因在于它们对于永久变形的巨大抵抗力。用于各种医疗器械的合金一直依赖于不锈钢、诸如ElgiloyTM的高镍合金和钛基合金，所有这些材料可以通过加工硬化获得很高的屈服强度。普通金属，即使具有很高屈服强度的金属也不能承受远高于0.2％的应变而不遭受永久变形。由一种上述传统合金制造的设备一旦遭受弯曲或扭曲，实际上就不可能消除。形状记忆合金，如Au-Cd、Cu-Zn-Al、Ni-Ti和很多其它合金所显示的非同寻常的拟弹性特性(pseudoelasticity)使得有可能实现高达10％的应变的完全“弹性”恢复。因为其很高的可恢复应变及其优秀的抗腐蚀性，用于医疗部件所首选的形状记忆合金属于Ni-Ti合金族。
形状记忆合金属于表现出热弹性马氏体相变的那类合金。术语“马氏体”表示钢在从高温进行淬火时所产生的晶相。存在于升高温度中的相被称为奥氏体；这些术语已经被转而用于描述形状记忆合金中出现的相变。当钢已经从奥氏体温度淬火为马氏体时，再次形成奥氏体需要将结构加热到非常高的温度，通常超过1400℉。
对比之下，热弹性形状记忆合金可以从马氏体转变为奥氏体并且在很小的温度范围内，通常在18到55℉之间反复加热和冷却。形状记忆合金的相变通常由滞后曲线描述，其中显示为在从经常称为母相的奥氏体相进行冷却时，马氏体在表示为MS的温度处开始形成，并且在达到较低温度MF之后，合金完全成为马氏体。在从温度MF以下进行加热之后，马氏体在温度AS处开始回复到奥氏体结构，并且当达到表示为AF的温度时，合金完全成为奥氏体。这两个相或晶体结构具有差异很大的力学特性：奥氏体的杨氏模量大约为12×106psi，而马氏体的杨氏模量大约为4×106psi；并且取决于赋予合金的冷加工量的屈服强度对于奥氏体在28至100ksi之间，而对于马氏体在10至20ksi之间。
形状记忆合金的独特特征在于它们能够恢复变形。当处于马氏体形态的形状记忆合金样品遭受应力时，应变由各个马氏体变体的增长和收缩适应，而不是通过传统合金中常见的方式：滑动、晶界滑移和位错运动。当变形的马氏体被加热到奥氏体完成温度AF时，部件回复到其初始未变形状态。因此，对于医疗植入应用，有可能开发一种结构，其中装置保持在体温以下而处于其未变形形状，并且在插入身体之后，装置的温度升高至体温，此时装置回复到奥氏体结构。在当前应用中，紧固件可以由诸如NiTi的SMA可选制成。
属于本发明范围内的是，能够在比将装置缝合就位所需更短的时间内，将这里说明的这种紧固系统紧固到身体组织中。在这里所述的情况下(放置胃带的进入端口元件)，紧固系统的放置和固定应该花费不超过5分钟。另外，为了便于重新定位装置或者完全取出已植入的装置，固定系统能够完全解开并且从组织中取出。这种植入和取出不会对患者造成更大的创伤，并且固定系统不会导致比传统缝合方法更多的粘连。普通外科医生或其它医疗专业人员能够可靠并且连贯地完成紧固系统的固定和取出。
另外，在这里说明的这种固定系统的制作过程中，紧固件的尺寸决定紧固件将安装在身体组织内的深度。在当前应用的情况下，进入端口元件应该固定在装置以下不超过3mm的深度处。而且，在这种应用中，安装紧固件的身体组织是筋膜(fascia)。然而，属于本发明范围内的是，装置所连接的身体组织将取决于特定的装置而变化。另外，紧固系统在组织内的连接不会导致在放置过程中或在身体运动过程中的组织损伤；例如，用于胃带的进入端口元件经常直接连接在腹直肌上。此外，为了适应长期的植入，装置的固定具有与缝合相当或比其更大的强度并且抵抗移位或者分离。
这里所述本发明可以与任何类型的可植入装置一起使用。这种实例包括内部监视器、端口元件、起搏器、治疗剂、投药系统、神经刺激器、外科整形装置、肌腱修复件等。为了便于说明，现在将根据图1至图40所示说明本发明，其中本发明显示为与进入端口元件一起使用。本领域的技术人员将会认识到，本发明可以与其它类型的可植入装置一起使用，并且本发明可以采取与图中所示类似的形式。
另外，在附图中，壳体形成为圆环，因此可以如此进行说明。然而，本领域的技术人员将会认识到，壳体的形状取决于装置的形状，因此本发明不限于其中壳体为圆形的装置。
图1显示了根据本发明一个实施例的进入端口元件紧固系统。进入端口元件10包括隔膜11，该隔膜在实践中由针刺穿以将流体，如盐水输入到进入端口元件中用于与例如液压操作的胃带一起使用。
进入端口元件10包括围绕进入端口元件外周的可分离壳体12。壳体12包括切口或开口15。切口容纳紧固件14。切口或开口15可以采取适合容纳紧固件14同时允许紧固件14运动所需的任何形式。属于本发明范围内的是，为了使装置运动或移位的可能性降至最小而采用至少三个紧固件14。如图1至图4中所示，紧固件14通过穿过孔接合并由此枢转连接到环12上的垂直区段与环12连接。紧固件14具有如图1和图3所示的第一位置以及如图2和图4所示的第二或固定位置。为了从第一位置运动到第二位置，紧固件绕其轴线旋转。切口15允许该旋转并且小锁定凸耳在紧固件旋转之后将其保持就位。在一个实施例中，紧固件14可以是两腿式缝合钉。在另一个实施例中，缝合钉为刚性的，以至于在旋转进入患者筋膜的过程中它们不会变形。对于这种应用，传统金属也适合。此外，缝合钉可以形成为“U”形或者其改型，包括基本上形成为：
Figure A200910126293D00151
当位于第二位置时，紧固件14通过锁定凸耳16被刚性保持就位，并且紧固件14可挠曲以允许紧固件通过锁定位置。锁定凸耳16的形成可以使得在紧固件14从第一位置运动到第二位置之后外科医生可以听到清晰的喀哒声以表示紧固件14完全由锁定凸耳16接合。喀哒声还可以是可触知的，允许外科医生感觉到紧固件被锁定凸耳16接合。当位于第二位置时，进入端口元件10由与患者筋膜连接的紧固件14固定在患者体内的壳体12内。实质上，筋膜或其它身体组织被固定在紧固件14与壳体12或装置10之间。此外，壳体12可以包括与围绕装置10周边的缝合孔(未示出)接合的栓(未示出)。
图5至图8显示了图1所示的进入端口元件及其与进入端口元件传递系统20的相互作用。如图5中所示，进入端口元件传递系统20可以包括手指凹陷25，该凹陷由操作者用于帮助将进入端口元件和传递系统保持就位并且准确对正。
传递系统20包括端口元件罩体21。端口元件罩体21容纳柱塞22、滑动推件24和滑动组件26。端口元件罩体可以形成为基本上覆盖进入端口元件10所需的任何形状。
柱塞22为传递系统20提供操作装置并且与下面将要说明的触发装置连接。在起动触发装置之后，柱塞22沿进入端口元件10的方向运动。该运动导致滑动推件24被致动。滑动推件24将运动柱塞22的能量传递给滑动组件26。滑动组件26具有基本上为圆形的形状并且包围进入端口元件10。在其它应用中，滑动组件可以采取适合于待植入装置和壳体的形式。在致动之后，滑动组件26沿着进入端口元件10的方向被推动。对正凸片30帮助对正滑动组件26。对正凸片30与端口元件罩体21连接并且与进入端口元件10相互作用以确保准确对正。滑动组件26的运动导致与滑动装置26连接的梁28作用于紧固件14上。施加于紧固件14上的力允许它们在环孔(未示出)内旋转并且适应基本上由切口15限定的弧线。该旋转对应于上述从第一位置到第二位置的运动。由于梁28继续朝向进入端口元件10运动，所以紧固件14到达第二位置并且通过锁定凸耳16被保持就位。在该位置，进入端口元件10通过紧固件14及它们与患者的筋膜或其它组织的相互作用而被刚性保持就位。
图9显示了包括触发装置40的进入端口元件传递系统。图10显示了位于开始或加载位置的触发装置40的横截面图。在该位置，弹簧42被压缩，并且与杆46连接的栓销44通过肋部48固定以防止压缩弹簧42伸展。触发装置包括与操纵杆52连接的触发件50。如图10中所示，弹簧42和杆46位于壳体54中。
如图11中所示，在触发件50上施加预定力之后，操纵杆52作用于壳体54上。壳体54在支点(未示出)上枢转，该枢转动作将栓销44抬高到肋部48的端部上方。在抬高之后，压缩弹簧42的弹簧力沿着进入端口元件方向驱动柱塞22并且如上所述致动其周围的装置。在这种结构中，可以确定柱塞行程、速度和冲击力以满足应用需要。根据测试，取决于实际应用中所使用的弹簧，柱塞行程在0.25至0.75英寸之间，并且可以在柱塞上产生高达50磅的力。
弹簧驱动装置的可选形式示于图12中。图12显示了手掌抓握致动触发装置60。手掌抓握是非常简单的设计，只需要单个运动部件来移动柱塞22。在如图13所示的第一位置中，有活动手柄61、固定手柄62、枢转点64和致动尖端66。
在操作中，使用者挤压活动手柄61，将其沿着固定手柄62的方向推动。该运动沿着与活动手柄61的运动方向相反的方向推动与活动手柄61和枢转点64连接性接合的致动尖端66。通过使用简单的杠杆作用，施加于活动手柄61上的相对较小的力通过枢转点64放大并且由致动尖端66施加于柱塞22上。柱塞22通过致动尖端66沿着进入端口元件10的方向被移动并且如上所述致动其周围的装置。手掌抓握致动装置所产生的力只受使用者的力量限制，根据测试，该装置能够产生超过50磅的力以及0.25英寸的柱塞行程。作为选择，可以制造齿轮机构，其尽管需要活动手柄61更大的行进距离但是能够产生相等或更大的力。由图12至图14中所示装置产生的力也可以根据需要通过以下方式而改变，即将枢转点64移动为更靠近柱塞22以产生更大的力，或者远离枢转点以产生更小的力。
另一个可选的触发装置示于图15至图19中。手枪式抓握触发装置70包括在一端安置有齿轮传动齿73的触发件72、与齿轮传动齿73啮合的齿轮74、由齿轮74驱动的齿条75和弹簧76。齿条还可以包括用于握紧柱塞22的装置78。
操作过程示于图17至图19中。在图17中，触发件伸出并且弹簧几乎没有或完全没有压力。齿轮传动齿73与齿轮74的对应齿和齿条75上的齿啮合。柱塞22位于伸出位置。当压下触发件72时，齿轮传动齿73致动齿轮74并且转而导致齿条75压缩弹簧76，如图18中所示。在预定距离处，齿轮传动齿73不再接合齿轮74。在该位置处，齿轮74自由旋转。弹簧76中储存的能量推动齿条75朝向柱塞22运动。自由旋转的齿轮74允许齿条75运动，而齿条75转而推动柱塞朝向进入端口元件10并且如上所述致动其周围的装置。
另一个可以结合在手枪式抓握触发装置70中的结构是锁(未示出)，该锁在弹簧76被压缩之后防止齿轮74旋转。然后在需要时，操作者可以释放锁，由此允许弹簧76如上所述伸展。
根据测试，手枪式抓握触发装置70允许柱塞行进大约0.4英寸并且可以产生超过50磅的力。例如，该实施例优于，例如上述活动抓握装置的明显优势在于具有很高冲击速度的瞬时配设。
在图20中，显示了本发明的另一个实施例。如上所述，NiTi或SMA合金材料的使用在医疗领域众所周知。如图20中所示，NiTi紧固件示于配设前状态中。紧固件14是连续的并且与进入端口元件10连接而穿过其中的孔。在操作中，紧固件14被压入患者的筋膜中以固定进入端口元件。NiTi紧固件14具有能够在例如加热至体温时改变其形状的独特能力。如图21中所示，在安装紧固件后，它们可以改变形状以至在进入端口元件10下方弯曲并且将进入端口元件固定就位。
在图22中，紧固件14显示为带有处于配设状态的直腿80。可选结构包括如图23所示的弯曲腿81。使用弯曲腿81，可以将筋膜夹在紧固件与进入端口元件下侧之间。另一个可选结构示于图24中，其中紧固件腿81的尖端覆盖有模制尖端82。模制尖端可以形成为帮助刺穿患者筋膜的形状。这样就不需要使紧固件14形成为用于刺穿的形状。另外，尖端82可以由生物可吸收材料形成。
在本发明的另一个实施例中，NiTi紧固件可以连续形成于环84中。环84的使用允许紧固件14形成有连续的结构。在形成带有紧固件14的环84之后，可以磨掉腿80的端部以产生各个基本上为U形的紧固件14。环84确保紧固件14可以如上所述作为一个整体插入，并且研磨腿确保具有足够刺穿筋膜的锋利尖端。如图25和图27中所示，腿可以形成于环84中并且置于其中以至于在因为受热而弯曲之后，腿80向内朝向进入端口元件10或者向外朝向进入端口元件10。
本发明的另一个实施例是如图28至图34中所示的两部件式紧固系统。图28显示了形成有多个单独紧固件14的导向件90。紧固件14可以在导向件90中从第一位置滑动到第二位置。在操作中，将导向件90放在进入端口元件10之上并且与切口15对正。紧固件14由弹簧形材料形成并且成形为与进入端口元件10连接。紧固件14从图28中所示的第一位置滑动到图29中所示的第二位置。紧固件14刺穿筋膜并且将进入端口元件10牢固保持于此。如前所述，紧固件可以具有直的或弯曲形的腿。在所有紧固件从导向件90滑动到进入端口元件10上之后，如果导向件不是最终植入装置的部件就可以将其取出。作为选择，导向件90也可以是可植入装置的永久部件。
另一个两部件式紧固装置包括预成形环100(图31和图32)。该环包括用于将环100连接到筋膜上的第一固定装置104。该环还包括用于将进入端口元件10连接到固定环100上的第二固定装置102。在操作中，将环100放在筋膜上，然后扭动以将筋膜接合在第一固定装置104中。然后将进入端口元件10放在环100上并且通过进入端口元件中的孔106接合第二固定装置102。该结构允许正向连接和重新安装的可重复性，而不分离预成形环。
图33和图34显示了另一个两部件式紧固装置，该装置包括置放装置112和具有NiTi紧固件114的环110。在实际应用中，环110插入置放装置112中。置放装置112放在进入端口元件10上方，使紧固件14与切口15和孔106对正。推动紧固件114穿过孔106并且接合进入端口元件10所坐靠的患者筋膜。通过加热过程，紧固件14改变形状并且将进入端口元件固定在筋膜上。在预定时间之后，可以取出置放装置。
本发明的另一个实施例涉及独立紧固件。如图35至图38中所示，可以使用各种不同的结构以将进入端口元件10固定在患者的筋膜上。紧固件可以采用NiTi以至于在施加预定热量之后紧固件改变形状。紧固件14可以单独插入，或者如上所述作为预成形环的部件插入。当单独插入时，紧固件14可以是直杆或者可以具有某些可以通过加热过程而显著变形(heightened)的预成形形状。在图35中，紧固件14呈现卷曲发辫形状。在图36中，紧固件呈现基本上为C形的外形。图37和图38使用U形紧固件14，其端部在加热时线性弯曲以至形成如图37所示的Ω形，或者垂直弯曲成图38所示的形状。这些形状可以针对特定的应用按需要选择。
本发明的另一个实施例示于图39中。在图39中，紧固件14滑动安装在进入端口元件10中。这可以通过将NiTi紧固系统冷模制到装置中而实现，并且允许正向连接和可重复的重新安装。通过使用安装工具120，可以推动紧固件穿过进入端口元件10底部的孔并且接合筋膜。通过将紧固件安装为进入端口元件10的一体部件，不需要如上所述的环或壳体用于容纳紧固件。安装工具120可以是这里所公开的触发装置的一部分。图40显示了位于接合位置中的紧固件14。
如上所述并且如图1至图8中所示，径向枢转紧固件是采用直接驱动的简单传递系统。相关传递系统启动枢转以径向进入。缝合钉可以是不锈钢、钛、镍钛诺或ElgiloyTM，或者包括其它金属或塑料的其它合适的材料。模制枢转/锁闭系统可以设计为咬扣到可植入装置上的已有缝合孔中。另外，简单的缝合钉形状允许很容易地制造。这种系统为自刺穿系统，即不需要预先刺穿身体组织，例如筋膜。缝合钉的弯曲形结构允许预知缝合钉前进时刺入身体组织的深度；并且弯曲形缝合钉的枢转特征产生轻松穿过组织的路径。拆卸紧固系统需要取出工具，并且缝合钉将伴随着向内生长的周围组织所产生的非常小的阻力旋出初始进入路径。然而，除了拆卸过程之外，拆卸系统所需的力很适当以允许缝合钉保持锁定就位。
这里关注的紧固系统的连续金属丝形状包括钝头、模制尖端和研磨或削锐尖端。如图20至图23中所示的钝头连续金属丝系统可能需要预刺穿以便插入钝头金属丝。紧固组件可被制造成需要锁定结构以保持金属丝形状或包覆模制(overmolded)环。简单金属丝形状可以由不锈钢、钛、ElgiloyTM、NiTi，或者其它合适的材料制成。因为钝头提供最小的组织损伤和创伤，因此可以很轻松地取出紧固装置。另外，钝头减小取出装置所需的力。如图20和图24中所示带有模制尖端的连续金属丝式装置不需要预先刺穿身体组织，并且这些尖端允许轻松进入身体组织。此外，图25至图27中所示削锐或磨利尖端连续金属丝式装置也不需要预先刺穿身体组织，它们也允许轻松进入身体组织。
这里所示带有平坦紧固件(图28和图29)和弯曲式紧固件(图30)的径向滑动紧固装置需要比其它紧固装置更大的进入位置。紧固件产生穿过身体组织的简单而可靠的路径，在使用弯曲式紧固件系统中将获得更大的保持力。系统的拆卸采用将每个紧固件从其中心位置撤出的相关取出工具来实现。作为选择，紧固件可被制造成：通过向上提装置，此时紧固件被弯曲到矫直位置以允许轻松取出紧固件，从而实现系统的拆卸。
图41显示了一种螺旋线圈紧固件201，该紧固件可选与包括从底座中心延伸的导管连接器的端口元件一起使用。螺旋形结构被安装在单独的盘203上，而所述盘在凸块202处咬扣端口元件上，或者可选安装在端口元件本身上，居中位于基板上。通过盘或端口元件的旋转而将盘或端口元件手动固定在组织上，这导致线圈沿穿过组织的螺旋路径前进。在一个实施例中，线圈可以具有锋利的尖端。
螺旋线圈紧固件的改型示于图42中。图42显示了一种扁形螺旋弹簧204，其向下偏转以开始其穿过组织的路径。在植入之后可撤出偏移装置205，允许弹簧在康复过程中压缩。弹簧的压缩将减小植入的线圈紧固件的轮廓并且可以减小产生疼痛的可能性。凸块202可被用来将端口元件或其他装置锁定进入紧固件。
图43至图47以及图55显示了一种水平线圈植入系统。在该水平线圈系统中，金属线圈被水平使用以将端口元件缝合到组织上。众所周知，通过在侵入性最小的疝气手术过程中用作网钉(mesh tack)，这种线圈可以刺穿组织并且保持在组织中。在该情况下，如上述螺旋线圈紧固件一样，线圈与组织表面平行而非垂直地前进。期望小配设工具206以有助于驱动线圈208穿过组织和底座线圈插座209中的配合孔207(参见图46和47)。这种孔可以是穿过底座底部上的脊部的直孔(参见图44、图45和图47)，或者是模制在具有平坦表面的底座中的弯曲形孔。底座的俯视图示于图43中。期望的是，最后的孔将为盲孔，并且线圈的端部将形成于可以倾斜滑动并且锁定就位例如进入狭槽中的横杆中。一种改型包括这样的线圈的路径，即其绕端口元件或底座边缘弯曲而有助于工具接触到线圈。这也可以通过改变线圈的挠性而实现。为了防止旋转线圈在前进穿过孔之前勾到组织纤维，可以在工具上增加导管作为遮蔽。
图48至图62显示了金属缝合系统的各种不同的实施例。该端口元件固定方法涉及通过使用底座本身作为封闭弯曲形金属构件形成的圈的装置(例如，参见图48和图52)，而在端口元件底座之下形成一个或多个封闭金属圈。图48显示了一个封闭圈，其中单弯曲金属构件示出处于其配设后位置。图49是本发明一个实施例的剖切仰视图，显示了位于其配设前位置的弯曲金属构件211。图57显示了本发明一个实施例的仰视图和侧视图，显示了与底座的底部形成圈的弯曲金属构件。图51显示了弯曲金属构件，其中箭头表示它们的配设旋转。上述方式的端口元件紧固可以采用单部件式系统和两部件式系统完成，由此两部件式系统可包括通过与图50所示凸块202咬扣配合而连接到端口元件或其它装置上的环201。这可以用于单部件式系统和两部件式系统，由此两部件式系统可以具有采用图50所示系统与端口元件或其它装置连接的环。一个实施例包括偏移工具，所述偏移工具使金属构件尖端与底座的接触分离，从而允许构件尖端开始其向下穿过组织的路径。所述偏移工具可以是圆盘或端口元件本身。在尖端已经前进一定距离之后，撤出工具，允许弯曲形构件然后遵循与底座相交的路径运动。同样，另一个实施例包括在两个平面内弯曲的多个构件，以至于底座的旋转完成多个圈的形成。
获得这种圈的一种可选方法是采用弯曲形销212，所述弯曲形销在到达其期望的组织位置之后被插入穿过底座，如图53和图54中所示。这种销自然地具有穿过组织的弧形并且很容易指回端口元件底座。这种销可以制造成：通过在咬扣于底座上的狭槽214中的销上增加直角弯曲213，或者通过其它此类公知的方式，所述销在完全行程之后被锁定就位。该设计思想的改型包括位于销的端部并且与弯曲形部分平行的附加直部分。杠杆臂215被用于驱动弯曲形部分穿过底座并且完成其设计行程。
在另一个实施例中，可以使用两部件式系统，其中端口元件与带有锋利、弯曲延伸部217(参见图56)的折叠基板218连接。将折叠后的板放在组织上，使延伸部指向组织。当基板展开(平坦)时，延伸部沿着旋转路径被驱动旋转90度(参见图56)。端口元件然后咬扣到基板上，将延伸部锁定就位。在一个实施例中，延伸部的尖端将与另一半部的尖端重叠，从而半遮蔽这些尖端。
图58至图62显示了一种优选的旋转盘紧固系统。在将待植入装置放入其期望的位置之后，使用多个弯曲形销或钩子501(参见图62)将其固定到组织上，这些弯曲形销或钩子的尖端旋转经过一弧线并且在它们行进的末端向回容纳在基板510中或其附近。基板510内的盘520旋转，由此导致杠杆臂525压在弯曲形钩子501上，而弯曲形钩子501反过来绕它们的固定轴线在基板中旋转经过一弧线直到盘的旋转动作停止。在完全配设位置中(图59和图60)，优选的是，钩子501的尖端向回容纳在基板510中以形成封闭圈。作为选择，尖端可以形成非封闭圈。无论为何种情况，优选的是，旋转盘520在其行进的末端锁定就位以将钩子锁定就位。与止挡件515接合的单向挠性锁定凸块527或其它锁定装置可以用于通过阻止盘的向回旋转而将钩子锁定就位。例如前面结合图5至图19所述的配设工具或传递系统可用于将装置紧固就位。柱塞22和滑动推件24的直线运动通过使用齿轮的传动系统或其它公知装置而转变为旋转运动。
图63至图72显示了优选的入口传递系统。参看图63，其显示了位于配设前位置的端口元件传递系统，操纵杆605在铰链621处与手柄607连接。缆线护皮619通过固定销623固定到手柄607上。缆线护皮619包围缆线617，所述缆线在缆线止挡件615处与位于装置手柄端的操纵杆605连接。缆线护皮619允许缆线617的直线运动。在配设端，缆线617与咬扣在端口元件盖631中的致动杆701连接。如图66和图70中所示，致动杆701和端口元件盖631具有用于抓握盘形紧固件基板的弯曲唇部721。另外，致动杆701具有凹槽723以允许致动杆以最小接触方式绕基板旋转，唯一的接触来自弯曲唇部721。图66显示了致动杆的边缘713，所述边缘咬扣在端口元件盖631的配合凹槽中并且固定致动杆但是允许其转动。图65显示了致动杆的俯视图，并且显示了缆线止挡件705，缆线617的配设端连接于该缆线止挡件处。缆线617穿过狭槽707延伸并且穿过切口709沿着凹槽711伸出。当配设工具的使用者朝向手柄607拉操纵杆605时，缆线617被拉动通过护皮朝向手柄607。由于缆线被拉动通过护皮拉动，它在缆线止挡件705处拉动致动杆，导致致动杆沿着边缘713及其在端口元件盖631中的相应凹槽限定的路径旋转。图69和图70显示了致动杆、端口元件盖和缆线组件的各个部件的局部分解和剖切详细视图。因此，缆线607的直线运动被转变为安装紧固系统所需的旋转运动。
图71和图72更详细地显示了端口元件盖631的实施例。连接位置735是缆线护皮可以与端口元件盖连接的位置。另外，图71和图72显示了装置通道737。装置通道737允许端口元件盖与端口元件或其它装置连接而不会干扰可能从端口元件或装置延伸的任何导管或其它器械。在该实施例中，通道为矩形形状，然而，通道可以为适合各种不同装置的各种不同形状。
图73至图77显示了用于保持组合的端口元件/盘形紧固件组件的承载夹具。端口元件/盘形紧固件系统咬扣到承载夹具中，所述承载夹具保护组件，避免使用者意外接触到用于将组件紧固到组织上的钩子、锋利尖端等，防止组件的不成熟的配设，并且允许使用者将端口元件/盘形紧固件系统装到配设工具中而不需实际接触组件。配设工具咬扣到组件中，而其仍然位于承载夹具中。与端口元件盖的装置通道相似，承载夹具包括装置通道739以允许任何导管自由从待连接的装置上悬挂而承载夹具没有任何干扰。图75显示了装置通过锁定凸耳743和/或栓741牢固保持就位的方式。图76显示了由承载夹具牢固保持的端口元件/盘形紧固件组件。图77显示了没有连接端口元件装置的盘形紧固件/承载夹具组件的分解视图。
图58至图62所示盘形紧固件系统的优选实施例、图63至图68所示配设工具的优选实施例和图73至图77所示承载夹具的组合使用的简要说明有助于理解本发明。使用者在手柄607处握住端口元件传递系统。端口元件/盘形紧固件组件将被保持在承载夹具中，如图76中所示。使用者操纵端口元件/盘形紧固件组件上的端口元件盖631，并且致动杆的弯曲唇部721和端口元件盖与基板510咬扣配合，以至于使用者听到清晰的喀哒声并且感觉到可触觉感知的卡扣。使用者然后从承载夹具拉动配设工具，而组合的端口元件/盘形紧固件连接并且已经准备配设。使用者然后定位组合的端口元件/盘形紧固件系统使得盘形紧固件被设置在其进行配设的位置。在就位之后，使用者就拉动操纵杆，使致动杆运动。致动边缘725与单杠杆臂525接合，旋转杠杆臂直到紧固件被完全配设。在完全配设之后，因为端口元件从端口元件传递系统中弹出，使用者听到清晰的喀哒声并且感觉到可触觉感知的卡扣，并且完成配设。
尽管已经结合某些优选实施例，具体地说结合进入端口元件或注射端口元件尤其显示并说明了本发明，但是本领域的普通技术人员很容易认识到，任何多个可植入医疗装置可以与本发明的紧固系统一起使用，并且在不脱离本发明的精神和范围的前提下，可以对进行各种变化和改型。

Claims (11)

1、一种可植入的进入端口元件与传递工具的系统，包括：
可植入的进入端口元件，其包括底座、多个紧固件和第一可旋转元件，所述紧固件可枢转地连接着所述底座并且可在非配设位置与配设位置之间移动，所述第一可旋转元件连接着所述底座并且被构造和定位成通过第一可旋转元件的转动而配设所述多个紧固件；以及
传递工具，其便于将所述进入端口元件植入软组织中，所述传递工具包括：
第二可旋转元件，其被构造成可移除地接合所述第一可旋转元件；和
致动组件，其用于移动所述紧固件进入配设位置，所述致动组件包括可操作地连接着第二可旋转元件的传动元件。
2、如权利要求1所述的系统，其特征在于，所述致动组件被构造成使得所述传动元件的直线运动引起所述第二可旋转元件的转动。
3、如权利要求1所述的系统，其特征在于，所述第一可旋转元件包括旋转盘。
4、如权利要求3所述的系统，其特征在于，所述第二可旋转元件包括致动边缘，其被构造成在所述传递工具接合所述进入端口元件时接触所述旋转盘的一部分。
5、如权利要求1所述的系统，其特征在于，所述传动元件包括缆线。
6、如权利要求5所述的系统，其特征在于，所述传递工具包括容纳所述缆线的轴。
7、如权利要求1所述的系统，其特征在于，所述传递工具还包括轴。
8、如权利要求7所述的系统，其特征在于，所述传递工具包括细长轴和偏离所述轴的纵向轴线的近侧配设端。
9、如权利要求1所述的系统，其特征在于，每个所述紧固件包括弯曲部和大致直的枢转部。
10、如权利要求9所述的系统，其特征在于，所述大致直的枢转部基本上垂直于所述弯曲部延伸。
11、如权利要求1所述的系统，其特征在于，每个所述紧固件包括枢转部，其相对于所述第一可旋转元件的旋转轴线沿径向延伸。
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