CN1636527A - 应用紧固件的皮下注射口 - Google Patents
应用紧固件的皮下注射口 Download PDFInfo
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
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- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
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- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/005—Gastric bands
- A61F5/0053—Gastric bands remotely adjustable
- A61F5/0056—Gastric bands remotely adjustable using injection ports
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- A—HUMAN NECESSITIES
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61M2039/0232—Subcutaneous access sites for injecting or removing fluids having means for facilitating the insertion into the body
Abstract
一种注射口包括与分离的紧固件输送设备配合工作的输送设备引导结构。输送设备引导结构引导和容放着设备输送端以便将其定位于适当位置上以应用紧固件。尽管并不限定于其,但示出了一种用于注射口的特定设备和紧固件,其中引导孔引导和容放着设备输送端以便将其适当地定位以将紧固件输送于适当位置。
Description
相关申请
本申请对2003年6月16日提交的申请序号为60/478,763、标题为“可调整式胃箍所用的流体注射口”的临时专利申请的优先权提出要求,其公开内容在此引入作为参考。本申请还将与本申请同一天提交的以下共同未决的美国专利申请引入作为参考:申请序号No.10/741,868(带有整体式紧固件的皮下自连接型注射口,发明人:Conlon和Kolata);以及申请序号No.10/741,785(带有整体式可移动保持构件的皮下自连接型注射口,发明人:Conlon、Byrum、Hunt、Nuchols和Schulze)。
技术领域
本发明整体上涉及外科上可植入式流体注射口,更具体而言,涉及用于紧固皮下的周围连接的口的紧固件和方法。特别地,本发明将与用于可调整式胃箍的注射口进行公开,但是本发明的紧固件可以用于许多不同的皮下连接的设备,包括进出脉管所用的注射口,例如用于注入药物和抽血。
背景技术
注射口被置于身体皮肤的下方以便将流体注射入身体中,例如用于注入药物、抽血以及许多其它应用,包括可调整式胃箍。自从二十世纪八十年代早期以后,可调整式胃箍就已经为病态肥胖的病人提供了胃旁路和其它不可逆外科重量减轻治疗设备的有效替代方案。胃箍可缠绕于病人的胃的上部上,形成了限制食物从胃的上部传送至下部的孔。当孔具有适当尺寸时,保持于胃的上部中的食物就提供了充满的感觉,从而阻止过食。然而,随着时间过去,胃中的最初失调或变化可能导致孔具有不适当的尺寸,就需要对胃箍进行调整。否则,当孔太小因而不能适度地传送食物时,病人就可能遭受呕吐发作和不适。按照另一极端,孔可能会太大因而不能减缓食物从胃的上部的运动,从而完全地失去了胃箍的用途。
除了用于设置胃箍的外径的闩锁位置之外,胃箍的可调整性基本上使用指向内的可膨胀式囊形件来实现,其类似于血压套头,流体例如盐水通过流体注射口注入其中以便得到所需的直径。由于可调整式胃箍可长期保持于病人体内,因此流体注射口通常安装于皮下以避免感染,例如安装于胸骨前部。对可调整式胃箍中的流体量的调整通过将Huber针通过皮肤插入注射口的硅隔片中来实现。一旦针被除去之后,隔片就利用由隔片所产生的压缩载荷而将孔密封。柔性导管在注射口与可调整式胃箍之间连通。
用来固定开发应用于脉管用途的流体注射口的传统外科方法是穿过绕着外围基座凸缘相隔的一系列孔来应用缝线。尽管基本上有效,但缝合操作常常比较证明比较困难并且耗费时间,对于打算由病态肥胖的病人所用的可调整式胃箍来说问题甚至更加突出。脂肪组织的显著厚度可位于皮肤下方,当外科医生试图将缝线应用于深凹的组织(例如5-10cm)上以便固定口时就会造成很多困难,常常需要10-15分钟来完成。而且,如果注射口并未适当地缝合,则口可能会翻开,使得随后的注射难以进行或者不可能进行。
近来,在授予Pier的德国专利申请No.197 51 791.9中描述了一种外科钉合机,其中帽状的注射口包括绕着其周边相隔的沿切向对齐的线性槽。每个线性槽中的一对孔容放着传统的弯曲U形钉。钉合机将钉保持就位并且具有压在每个钉的肩部上的向下运动的形成构件。由于孔在线性槽中的位置,因此钉的尖端就向内变形以便抓住下方的组织。
这样,这种Pier钉合机就通过变形连接着钉,而如果最初的安放情况不合要求或者需要除去胃箍时,其证明难以松脱。而且,由于这种设备必须使多个不锈钢或钛钉永久性地变形,因此就需要更加复杂的机构来为外科医生提供足够的机械效益以便易于形成钉。Pier注射口还需要定制的钉合机手柄,其并不能用于任何其它用途,对于并不会很多次安放Pier注射口的外科医生而言可能并不希望付出这些费用。
尽管注射口所用的定制钉合机,例如在完成连接所需的时间方面,可优于缝合方式,但人们相信其它用于连接注射口的方法可能具有传统的缝合或使用弯曲U形钉的钉合机所不能提供的其它优点或特征。
因此,就非常需要一种适用于皮下连接的流体注射口,其可迅速连接但能长期保持安全可靠。
发明内容
如此处所述,提供了一种用于将流体注射入身体中的注射口。这种口包括用于安放在身体的皮肤下方的壳体和用于容放针的装置。提供了用于容放至少一个紧固件并且使紧固件对齐于其适当位置上以便展开于与所述壳体相邻的组织中的装置,其相对于口整体地连接和固定。根据本发明的另一个方面,注射口包括引导结构,其适于容放和引导用于将紧固件植入就位以便保持住壳体的设备的输送端。
附图说明
附图包括于本说明书中并且构成了本说明书的一部分,其示出了本发明的若干方面,并且与文字描述一起用于说明本发明的原理。附图中:
图1为示出了根据本发明构造的注射口的示意图,其连接于缠绕于胃的上部上的可调整式胃箍上。
图2为图1所示的注射口的透视图。
图2A为沿图2的线2A-2A剖开的局部放大侧视图。
图3为图1的注射口在使用现有的外科器械连接于筋膜层期间的透视图。
图4为图3所示的注射口和外科器械的局部放大侧视图。
图5为示出了将注射口固定就位的紧固件的透视图。
图6为图5所示的紧固件的侧视图。
图7为外科器械与紧固件的传送管的剖视图。
现在将详细地参看本发明的目前优选的实施例,其一个实例示于附图中。
具体实施方式
现在详细地参看附图,其中在所有各图中,相同的数字标示的是相同的元件,图1示出的可调整式胃箍10缠绕于胃12的上部,其通过利用将部分14缝合于胃上来将两端部连接在一起并且使得胃12的部分14在可调整式胃箍10上方延伸而保持就位。柔性导管16的一端与囊形件(未示出)的内腔保持流体连通,而另一端与注射口18的内腔(未示出)保持流体连通。在可调整式胃箍10被植入胃的一部分周围时,也将遥控注射口18植入适当的位置处,通常位于直肌鞘内,以便利用Huber针经皮进入。
另外参看图2和2A,注射口18包括截头锥形壳体20,其具有四个形成于其中的沿圆周相隔的凹槽22。接管24与由壳体20所限定的内腔保持流体连通,柔性导管16在程序中的某些点上,通常在注射口18已经植入之后,连接于接管24上。通过将Huber针经皮插入注射口18的硅树脂隔片26中,就可将流体加入注射口18的内腔中或者从其除去。尽管隔片26由硅制成,但注射口的用于容放针的装置包括构置成能够在用非去芯式针刺穿之后自密封的任意结构。
尽管此处公开了注射口18的一种特定结构,但是许多适当的结构可以与本发明结合使用。例如,注射口18可包括绕着其基座的环状凸缘来代替凹槽22,其中紧固件开口和引导结构形成于环状凸缘中。
每个凹槽22包括侧壁22a和基座28,基座28具有基本上平行于壳体20的远端20a的上表面28a(看图4)。每个基座28包括相应的紧固件开口30并且包括设备引导结构,该设备引导结构适于容放和引导用于植入紧固件以便将紧固件输送至紧固件开口30中的适当位置和深度的设备的输送端。在所示的实施例中,设备引导结构被构置成设备引导孔32,其适于引导和容放具有圆柱形输送端的设备,并且如图所示为沿轴向与紧固件开口30对齐的、形成于表面28a中的沉孔。在所示的实施例中,引导孔32包括截头锥形壁32a,其在表面28a处具有较大直径,通往表面30b处的较小直径。孔32在表面28a处的直径大于端部直径,这有助于最初将输送端定位于孔32中,壁32a引导输送端前进至表面30a处的适当位置中。孔32在表面30a处的直径将输送端相对于紧固件开口30保持于适当位置中,从而提供足够大的间隙,以便并不需要捆绑并且不需要过大的力来将输送端靠着表面30a安放于孔32中。引导孔32和壁32a并不限于截头锥形或倾斜形状。例如,壁32a可垂直于表面30a,具有适当的尺寸以便容许输送端进入适当位置以植入紧固件。
由于输送设备具有各种端结构,因此设备引导结构可具有各种结构,只要其具有与特定端结构互补并且将与其配合工作的形状即可。单种形状例如所示的设备引导孔32可与输送设备的各种端结构配合工作。替代地,设备引导结构可包括在表面28a上方延伸以便容放和引导输送端的凸起部分。
参看图3,示出了构置成用于植入紧固件的外科设备34。一种适用的设备在美国专利No.6,447,524中进行了描述,其在此引入作为参考。凹槽22为设备34和由其输送的紧固件提供了适当的间隙。设备34包括输送端36,如图3中所示,其通过孔32被引导至与紧固件开口30轴向对齐的适当位置上。当设备34被致动时,操纵装置38从输送端36延伸以安放和释放紧固件,从而延伸通过紧固件开口30并进入筋膜层40,为紧固件形成路径。紧固件被输送至筋膜层40中并且当操纵装置38从设备34中取出以及将设备34从孔32中取出时接合着上表面28a。
参看图5,示出了紧固件42,其处于其适当展开位置上,由侧壁22a、基座28和开口30对齐和定位,从而将注射口18固定于展开/植入位置上。另外参看图6,紧固件42包括口保持下部腿44、组织保持腿或倒钩46和将口保持下部腿44与保持腿46连接在一起的连续式主体构件48。口保持下部腿44沿相反方向延伸并且接合着上表面28a。
紧固件44的构造基本上与美国专利No.6,447,524的紧固件相同,只是口保持下部腿44基本上为平面,从而容许与上表面28a形成基本上为平的接合关系,因此保持腿46进一步延伸至筋膜层40中的适当深度。基座28的厚度选择成使得保持腿46所穿入的深度将会保证适当地将注射口18定位。由于腿44为平面,就容许更多个紧固件42在远端底部20a下方延伸,而不是象如果口保持下部腿为美国专利No.6,447,524中所示的弓形那样,只有相同长度的一个紧固件在此延伸。这样,就容许紧固件42具有与美国专利No.6,447,524中所示的紧固件相同的总长度,从而容许紧固件42在美国专利No.6,447,524中所公开的外科设备中起作用,如图7所示。
本发明的实践并不限于此处所公开的特定输送设备和紧固件。其它紧固件输送设备和其它紧固件,不管目前是否可以在市场上买到,都可以用于根据本发明所构造的注射口,引导结构适于容放和引导此类设备的输送端,并且为设备和紧固件提供适当的间隙。
例如,引导结构32可适于容放和引导编号为5,634,584、5,829,662、5,588,581、5,381,943的美国专利中所述的钉合机的输送端,其公开内容在此引入作为参考。为了用于此类钉合机,或者任何其它紧固件输送设备,使得引导结构32的形状与钉合机输送端的足够数量的物理特征互补,以便适当地容放和引导输送端。引导结构32可将钉合机定位成沿切向,其中每个钉合机需要基座中的两个开口,或者可将钉合机定位成朝外,例如沿径向朝外,从而只使用基座中的单个开口。
因此,尽管本发明的输送设备引导结构在此处被描述为与紧固件开口30相邻的基座28的部分,但此类引导可按照适用于所使用的特定输送设备的各种结构和位置形成。
总之,以上对使用本发明的概念所得到的众多益处进行了描述。对本发明的一个或多个实施例所进行的以上描述用于进行示例说明和描述。并不想将本发明限定于所公开的精确形式。根据以上教义可以做出显著的改动或变型。所选择和描述的一个或多个实施例用于对本发明的原理及其实际应用进行最佳地示例说明,以便因此使得本发明所属领域的普通技术人员能够在各种实施例和各种适于所考虑的特定应用的改动中最佳地利用本发明。本发明的范围由所附的权利要求来限定。
Claims (8)
1.一种用于将流体注射入身体中的注射口,所述口包括:
a.用于安放在身体的皮肤下方的壳体,所述壳体包括用于容放针的装置;以及
b.相对于所述口整体地连接和固定的装置,用于容放至少一个紧固件并且使所述至少一个紧固件对齐于其适当位置上以便展开于与所述壳体相邻的组织中。
2.根据权利要求1所述的口,其中所述装置在所述壳体的远端上方附近延伸。
3.根据权利要求1所述的口,其中所述壳体包括至少一个基座,所述装置包括至少一个穿过所述至少一个基座形成的相应开口。
4.根据权利要求3所述的口,其中所述壳体包括与所述至少一个基座中的每个相关联的相应凹槽,所述装置包括每个所述相应凹槽的侧壁。
5.根据权利要求1所述的口,其中所述用于容放和对齐的装置包括用于容放和引导设备的输送端以便将所述至少一个紧固件植入组织中的装置。
6.根据权利要求5所述的口,其中所述壳体包括至少一个基座,所述用于容放和对齐的装置包括至少一个穿过所述至少一个基座中的每个形成的开口,并且所述用于容放和引导的装置包括与所述开口对齐的每个相应基座中的相应引导结构,其适于容放和引导输送端。
7.根据权利要求6所述的口,其中所述引导结构包括沉孔。
8.一种用于将流体注射入身体中的注射口,所述口包括:
a.用于安放在身体的皮肤下方的壳体,所述壳体包括用于容放针的装置;以及
b.相对于所述口整体地连接和固定的装置,用于容放和引导用来植入紧固件的设备的输送端,以便将至少一个紧固件植入与所述壳体相邻的组织中的保持着所述壳体的位置上。
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US10/741,127 US20050131352A1 (en) | 2003-06-16 | 2003-12-19 | Subcutaneous injection port for applied fasteners |
US10/741127 | 2003-12-19 |
Publications (1)
Publication Number | Publication Date |
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CN1636527A true CN1636527A (zh) | 2005-07-13 |
Family
ID=34523222
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CNA2004101019232A Pending CN1636527A (zh) | 2003-12-19 | 2004-12-20 | 应用紧固件的皮下注射口 |
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US (1) | US20050131352A1 (zh) |
EP (1) | EP1543861B1 (zh) |
JP (1) | JP2005177497A (zh) |
CN (1) | CN1636527A (zh) |
AT (1) | ATE356647T1 (zh) |
AU (1) | AU2004237912A1 (zh) |
BR (1) | BRPI0405736A (zh) |
CA (1) | CA2490507A1 (zh) |
DE (1) | DE602004005294T2 (zh) |
ES (1) | ES2281763T3 (zh) |
MX (1) | MXPA05000019A (zh) |
PL (1) | PL1543861T3 (zh) |
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-
2004
- 2004-12-14 AU AU2004237912A patent/AU2004237912A1/en not_active Abandoned
- 2004-12-17 JP JP2004366372A patent/JP2005177497A/ja active Pending
- 2004-12-17 CA CA002490507A patent/CA2490507A1/en not_active Abandoned
- 2004-12-17 MX MXPA05000019A patent/MXPA05000019A/es active IP Right Grant
- 2004-12-20 BR BR0405736-8A patent/BRPI0405736A/pt not_active IP Right Cessation
- 2004-12-20 PL PL04257963T patent/PL1543861T3/pl unknown
- 2004-12-20 CN CNA2004101019232A patent/CN1636527A/zh active Pending
- 2004-12-20 ES ES04257963T patent/ES2281763T3/es active Active
- 2004-12-20 AT AT04257963T patent/ATE356647T1/de not_active IP Right Cessation
- 2004-12-20 DE DE602004005294T patent/DE602004005294T2/de not_active Expired - Fee Related
- 2004-12-20 EP EP04257963A patent/EP1543861B1/en not_active Not-in-force
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US20050131352A1 (en) | 2005-06-16 |
EP1543861B1 (en) | 2007-03-14 |
DE602004005294T2 (de) | 2007-12-20 |
BRPI0405736A (pt) | 2005-08-30 |
ATE356647T1 (de) | 2007-04-15 |
JP2005177497A (ja) | 2005-07-07 |
DE602004005294D1 (de) | 2007-04-26 |
CA2490507A1 (en) | 2005-06-19 |
MXPA05000019A (es) | 2005-08-26 |
ES2281763T3 (es) | 2007-10-01 |
PL1543861T3 (pl) | 2007-08-31 |
EP1543861A1 (en) | 2005-06-22 |
AU2004237912A1 (en) | 2005-07-07 |
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