CN1644172A - 带有整体式紧固件的皮下自连接型注射口 - Google Patents
带有整体式紧固件的皮下自连接型注射口 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
- 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
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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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
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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
- 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
Abstract
一种自连接型注射口具有从壳体延伸的相对于其固定的整体式紧固件。这种紧固件包括单向紧固件,例如由多个沿轴向相隔、同心地对齐的截头锥形环状凸缘。注射口在外科医生将远端力施加于注射口壳体上时实现自连接,引起紧固件穿入组织,与组织接合以便将注射口保持就位。
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10/741,127(应用紧固件的皮下注射口,发明人:Conlon和Hunt);以及申请序号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。提供了构制成用于接合壳体周围的组织以便将壳体保持就位的连接机构。这种连接机构相对于壳体整体地连接和固定。多个紧固件包括呈截头锥形凸缘形式的保持构件,它们用作单向紧固件以便阻止紧固件退出并且阻止注射口发生意外运动。
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所示的注射口的侧视图。
图3为图1所示的注射口的放大局部侧视图。
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。
众所周知,注射口18包括壳体20,其具有从一端向外延伸的环状凸缘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制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的一种特定构型,但是许多适当的构型可以与本发明结合使用。
现在参看图2和3,注射口18包括从壳体20远侧延伸的整体式紧固件28。紧固件28穿过形成于壳体20的凸缘22中的沿圆周相隔的孔30(看图3)中。本发明的教义可利用更小的凸缘,或者不用凸缘来实践,例如可通过在壳体20的穿过基座形成的孔周围的侧部中形成凹槽来实现。三个紧固件28有效地用于在植入后防止注射口18翻开,例如由于病人的被动或诱导运动而翻开。然而,本发明并不限于使用三个紧固件,并且可以使用一个或多个紧固件。
图1-3中所示的整体式紧固件28为单向紧固件。在此处使用时,单向紧固件为构制成插入并接合着筋膜或其它层并且阻止从其退出的紧固件。尽管有许多能够提供这种单向功能的不同结构,例如沿轴向向外延伸并且沿圆周相隔的指状部,但所示的紧固件28的实施例的单向功能来自于沿着轴部分34沿轴向相隔的多个截头锥形环状凸缘32。所示带有倾斜表面的尖端36形成于轴部分34的远端处,而头部分38位于另一端处。应当指出,尖端36可具有任意形状,但构制成便于穿入筋膜或其它层的形状降低了展开/植入注射口18所需的力。
凸缘28可替代地为扁平的相隔开的凸缘,利用组织的性质来提供对退出的阻力,而且提供的对插入的阻力大于截头锥形的向后倾斜表面。
在所示的实施例中,头部分38大于孔30,因而构制成不能穿过孔30。在将注射口18展开/植入之前,通过将紧固件28插入孔30中而将它们整体地连接于壳体20上。凸缘32可以能够充分地变形以便在穿过孔30时向内屈服。另外,凸缘32可绕着其相应的圆周不连续,例如具有延伸过轴34的长度的狭槽。凸缘32a将紧固件28保持于孔30中,相对于壳体20连接并固定,凸缘32a与头部分38的下表面38a沿轴向相隔足够长的距离以便使得凸缘32a在被推动通过孔30之后发生膨胀,并且接合着与孔30相邻的凸缘22的下表面22a,从而使得紧固件28在展开之前与注射口18形成整体。在孔30与轴部分34之间可存在径向间隙,或者在下表面38a和凸缘32a之间可存在轴向间隙。
尽管在展开之前或者展开时紧固件28可在任何点处连接于注射口18上,但期待的是,注射口18将在整体式紧固件28已预先连接的情况下作为无菌组件提供给外科医生。
通过将注射口18定位于所需位置上并且对注射口18的壳体20或者头部38施加远端力,从而引起紧固件28的尖端36与相邻的组织接合,穿入图示中的脂肪层40和筋膜层42,就可完成自连接型注射口18的植入。朝向头部分38的截头锥形凸缘32的平行角度使得紧固件28能够穿入并通过脂肪层40和筋膜层42前进,并且锁定于其上以阻止退出。凸缘32按照象同心的沿轴向相隔的锁定环一样的操作方式,将注射口18保持就位。
紧固件28可由具有足够阻力和强度以便按照此处所述发挥作用的任何适用的医学上相容的材料制成,例如聚碳酸酯、聚苯乙烯或任何适用的聚合物。凸缘32的数量、间距和尺寸可为适当的任意数量、间距和尺寸。仅供举例来说,凸缘32的中心至中心距离可为3mm,厚度(在轴处)可为1mm,而直径可为3mm,轴为5mm长。
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。举例来说,带有一个或多个截头锥形凸缘的一个或多个紧固件可在植入时安装于注射口中的具有适当形状的开口中,例如通过将注射口定位于身体内的适当位置上并且将紧固件插入开口中来安装。
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 (10)
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;
b.构制成用于接合所述壳体周围的组织以便将所述壳体保持就位的连接机构,所述机构相对于所述壳体整体地连接和固定。
2.根据权利要求1所述的口,其中所述连接机构构制成使得通过将远端力施加于所述壳体上,所述连接机构就将会接合所述组织以保持所述壳体。
3.根据权利要求1所述的口,其中所述连接机构包括至少一个从所述壳体远侧延伸的紧固件。
4.根据权利要求3所述的口,其中所述至少一个紧固件包括构制成用于穿入所述组织的相应远尖端。
5.根据权利要求3所述的口,其中所述至少一个紧固件包括至少一个与所述壳体相隔的向外延伸的凸缘。
6.根据权利要求5所述的口,其中所述至少一个凸缘包括多个相隔开的凸缘。
7.根据权利要求5所述的口,其中所述至少一个凸缘具有截头锥形状。
8.根据权利要求3所述的口,其中所述至少一个凸缘不连续。
9.根据权利要求3所述的口,其中所述至少一个紧固件包括至少一个与所述壳体相隔的向外延伸的指状部。
10.根据权利要求9所述的口,其中所述至少一个指状部包括多个相隔开的指状部。
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US10/741868 | 2003-12-19 | ||
US10/741,868 US7374557B2 (en) | 2003-06-16 | 2003-12-19 | Subcutaneous self attaching injection port with integral fasteners |
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CN1644172A true CN1644172A (zh) | 2005-07-27 |
CN100558300C CN100558300C (zh) | 2009-11-11 |
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EP (1) | EP1547643B1 (zh) |
JP (1) | JP4828119B2 (zh) |
CN (1) | CN100558300C (zh) |
AT (1) | ATE433777T1 (zh) |
AU (1) | AU2004235666A1 (zh) |
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EP1547643A1 (en) | 2005-06-29 |
CN100558300C (zh) | 2009-11-11 |
JP4828119B2 (ja) | 2011-11-30 |
JP2005177498A (ja) | 2005-07-07 |
CA2490171C (en) | 2012-12-11 |
BRPI0405617A (pt) | 2006-04-04 |
US7374557B2 (en) | 2008-05-20 |
DE602004021550D1 (de) | 2009-07-30 |
AU2004235666A1 (en) | 2005-07-07 |
ATE433777T1 (de) | 2009-07-15 |
US20040254536A1 (en) | 2004-12-16 |
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