CN1714760A - 具有改进的紧固件的可手术植入的注射口 - Google Patents
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Abstract
一种可植入的手术注射口，它有一个未展开位置和一个固定在组织上的展开位置。所述注射口包含一个外壳，该外壳有一个封闭的远端、一个开口的近端和介于两者之间的一个流体储存器。该注射口还包括围绕开口安装在外壳上的、针头可穿透的隔膜。该注射口进一步包括沿外壳的外周边在支枢点处安装于外壳上的至少一个连接机构。该连接机构是一种可相对于外壳枢转的弓形钩，其中该弓形钩具有绕支枢点延伸明显大于90°的长度。
Description
本申请是2003年12月19日提交的美国专利申请系列号No.10/741,785的部分继续申请，该申请在此被引用作为参考。
发明领域
本发明应用于常规的内窥镜和开放手术仪器，以及应用于机器人辅助的手术。本发明进一步涉及可手术植入的可调节缚带，如治疗肥胖症的束胃带。
发明背景
世界上患有病态肥胖症的人口比例正在稳步增长。重度肥胖者患心脏病、中风、糖尿病、肺病和意外伤害的危险易于增加。由于病态肥胖症对患者生命的影响，正在研究治疗病态肥胖症的方法。
对病态肥胖症曾经尝试了大量非手术治疗，但是实际上没有取得长期的功效。饮食指导、行为矫正、用金属丝闭合患者下颌和药理学方法都曾尝试过，而且均不能矫正该疾病。在该疾病的治疗中也曾使用通过非外科方法***体内的机械装置，如使用胃气囊填充胃。然而，这些装置不能长期使用，因为它们通常引起严重的刺激，必须定期清除，因而会中断治疗。因此，医疗界研究出治疗病态肥胖症的外科手术方法。
治疗病态肥胖症的大多数手术方法通常可以被分为：致力于阻止食物吸收(吸收不良型)，或者限制胃而使患者感到饱胀(胃限制型)。最常用的吸收不良型和胃限制型技术是胃旁路术。在该技术的各种变型中，将胃水平分成两个隔离的袋，而且上袋的食物容量小。上袋通过一个小开口与小肠或空肠连接，这通过大大减少可用的胃而限制了食物的处理。由于食物绕开了大部分肠，使食物的吸收量大大减少。
上述方法存在着许多缺点。上述方法一般在开放手术环境中进行。外科医生很难掌握当前的微创技术，而且还具有许多另外的缺点。在这种激烈的手术不易逆转的想法下，也存在患者高度不适。另外，所有的吸收不良型技术都给患者带来了危险和副作用，包括营养不良和倾倒综合征。
因此，许多患者和医生更愿意采用胃限制方法来治疗病态肥胖症。最常用的方法之一包括植入可调节束胃带。可调节束胃带的例子可见于以下美国专利：授予Kuzmak的4,592,339；授予Kuzmak的RE 36176；授予Kuzmak的5,226,429；授予Jacobson的6,102,922和授予Vincent的5,601,604，所有这些专利文献均在此被引用作为参考。根据当前的实践，可操作地放置一个束胃带以环绕胃。这样用介于中间的开口将胃分成两部分：相对较小的上部或胃囊，以及相对较大的下部。胃的小的分隔部分有效地成为患者的新胃，只需极少的食物即可使患者有吃饱的感觉。
一旦环绕胃放置，就使束胃带的两端彼此紧固，通过在束胃带之上折叠一部分胃壁并用缝线缝合折叠的组织，将束胃带牢固地固定就位，由此防止束胃带滑动以及防止环绕的开口扩大。束胃带一般包括一个基本上不可延伸的柔性部分，该部分具有一个固定于其上的可展开的可膨胀部分。这个可膨胀部分与远处的注射部位或注射口流体连通。在植入期间或之后，通过向这个可膨胀部分内部注射或者从中取出膨胀流体来调节开口的大小。通过扩大该开口，患者能够吃更多的食物而不会觉得饱，但不会快速减轻体重。缩小开口的大小将发生相反的结果。医生定期调节开口的大小来调节体重减轻的速度。
用于上述束胃带的大多数流体注射口都在皮肤下面与患者的筋膜相连。这些注射口通常设有缝线孔，且将注射口与组织缝合。然而，也能够使用例如使用整体式牵引钩将注射口与患者相连的备选方法。将注射口固定在患者上的这类其它方法在共同转让但未审结的美国专利申请系列号：2003年12月19日提交的10/741,785；2003年12月19日提交的60/478,763；2003年12月30日提交的10/741,868中有所描述；这些专利文献均在此被引用作为参考。
发明概述
根据本发明，提供了一种可植入的手术注射口，它有一个未展开位置和一个与组织相连的展开位置。该注射口包括一个外壳，该外壳有一个封闭的远端、一个开放的近端和介于两者之间的一个流体储存器。该注射口还包括围绕开口地固定在外壳上的、针头可穿透的隔膜。该注射口还进一步包括至少一个沿外壳的外周边在支枢点处安装在外壳上的连接机构。该连接机构是一种可相对于外壳枢转的弓形钩，其中该弓形钩具有绕支枢点延伸明显大于90°的长度。
附图详述
所附的权利要求书中具体描述了本发明的新颖特征。但是，本发明本身，关于操作的组织和方法以及其它的目的和优点，可以参照以下描述以及附图更好地理解，其中：
图1是根据本发明制造的可手术植入的流体口的透视图，示出了与可调节束胃带连接的口。
图2是根据本发明制造的可手术植入的流体口的透视图。
图3是图1和图2所示的注射口沿图2中的线3-3的横截面图。
图4是类似于图3的视图，但是示出了植入患者体内的流体口。
发明详述
现在参见附图，其中在所有视图中相同的标号代表相同的元件，如上所述，图1显示出一种在上述引用的参考文献中描述过的那种类型的可调节束胃带1。束胃带1被植入患者体内以环绕胃12。束胃带的可膨胀部分经由一个导管52与注射口10流体连通。导管52有一个与注射口10连接的近端53和一个与可调节束胃带1连接的远端55。注射口10可以用于医疗领域中的多种装置，不只用于束胃带。例如，该注射口也可以用于给药的血管进入。
如图2和图3所示，可手术植入的注射口10包括一个外壳12。外壳12可以由包括不锈钢、钛或聚合材料的多种材料制成。外壳12有一个在远侧的背部或封闭的远端14，以及以一定角度从背部14向近侧延伸的周围壁部分16。壁部分16限定了一个近侧开口或开口的近端18，和一个在开口18与背部14之间的流体储存器20。该注射口包括围绕开口18安装在外壳上的、针头可穿透的隔膜22，以便覆盖开口并密封储存器20。隔膜22可以由包括硅酮在内的多种材料制成。隔膜22优选地置于足够邻近近侧的位置上，从而储存器20的深度足以暴露针头如Huber针头的开口针尖，以便可以进行流体转移。隔膜22优选地被布置成使其在被针头穿透并拔出针头后能够自密封。在一个实施方案中，隔膜由硅酮制成，而且在装在外壳上时受压缩。注射口10进一步包括一个与储存器20流体连通的导管连接构件30。
如图所见，注射口10包括一个或多个连接机构70。此处图中示出了三个基本上相同并且彼此等距离隔开的连接机构。连接机构70沿外壳12的外周边13在支枢点80处安装在外壳12上。如图所见，连接机构70是可相对于外壳枢转的弓形钩。连接机构70具有绕支枢点延展明显大于90°、优选至少延伸180°的弧形长度L。可植入的手术注射口10有一个未展开位置，如图3中的实线所示；和一个展开位置，如图3和图4中的假想线所示，其中使该注射口与组织相连。连接机构70可以由多种材料制成，包括不锈钢、钛或可吸收材料，如乙交酯/丙交酯共聚物(polyglactin)和ε-己内酯/乙交酯共聚物。
连接机构70在支枢点80处具有一个可绕枢轴转动地固定在外壳12上的固定端72。这种设计使外科医生能够使用镊子推动紧固件穿过组织，直到自由端74紧靠平面75。这样，保护患者免遭尖端的锋利端的伤害。连接机构70还包括一个具有锋利的或尖锐的结构的自由端74。外壳12沿其远端14进一步包括至少一个凹入部分15。将凹入部分15设计成在注射口10处于展开位置时接收连接机构70的自由端74。这种设计防止了在注射口已经被植入后使锋利的自由端暴露于组织。
上述的180°钩或连接机构提供了比在先的90°或更小角度的钩更好的优点。如图4所见，上述连接机构使钩能够嵌入较大面积的组织内，并提供两个锁定点，进入及随后退出筋膜处。这使注射口相对组织有更好的覆盖。并且，没有“锋利端”暴露于患者。这种紧固件构造的另外一个优点是，当推动这种紧固件穿过组织时，该紧固件具有恒定的半径。通过保持恒定的半径，这种紧固件决不会在筋膜上施加压力。这将使疼痛最小化，因为这种紧固件不会“压迫或挤压”神经。
实际上，医生将按照众所周知的外科技术在患者的皮肤110上形成一个切口，以露出筋膜。之后，如图4所见，可以将注射口10放置在患者的筋膜100上，而且该注射口处于其未展开位置。此后，医生可以手动地或者以其它方式将连接机构旋转明显大于90°，且优选地旋转至少180°，从而使钩进入、然后退出筋膜。这种设计使外科医生能够使用镊子驱动该紧固件穿过组织，直到自由端74靠着平面75。这样保护患者免遭尖端的锋利端的伤害。可以对该设备上的每个连接机构进行这种操作。之后，将导管52与连接构件30连接，并缝合患者的切口。
对于本领域的技术人员而言将变得容易理解的是，上述发明同样适用于其它类型的可植入式带。例如，将该带用于治疗大便失禁。在美国专利6,461,292中描述了一种这样的带，该专利在此被引用作为参考。也可以将所述带用于治疗尿失禁。在美国专利申请2003/0105385中描述了一种这样的带，该文献在此被引用作为参考。所述带还可以用于治疗胃灼热和/或酸反流。在美国专利6,470,892中描述了一种这样的带，该专利在此被引用作为参考。所述带也可以用于治疗阳萎。在美国专利申请2003/0114729中描述了一种这样的带，该文献在此被引用作为参考。
尽管在此已经显示并描述了本发明的优选实施方案，但是对于本领域的普通技术人员而言显而易见的是，这些实施方案只是作为实施例提供的。本领域的普通技术人员现在可以进行许多变化、改变和替换而不背离本发明。例如，对于本领域的技术人员而言可以理解的是，此处的公开内容同样可以应用于机器人辅助的手术。另外，也应当理解，上述的每种结构都具有一种功能，而且这种结构可以被视为用于执行这种功能的手段。因此，本发明仅由后附的权利要求书的精神和范围限制。
Claims (10)
1.一种可植入式手术注射口，它有一个未展开位置和一个可与组织相连接的展开位置，所述注射口包括：
a.外壳，它具有一个封闭的远端、一个开口的近端和介于两者之间的一个流体储存器；
b.针头可穿透的隔膜，其围绕所述开口与所述外壳相连接；以及
c.沿所述外壳的外周边在支枢点处安装在所述外壳上的至少一个连接机构，所述连接机构包括可相对于外壳枢转的弓形钩，其中该弓形钩具有绕所述支枢点延伸明显大于90°的长度。
2.如权利要求1所述的注射口，其特征为，所述外壳在其所述远端包括至少一个凹入部分，用于在所述注射口处于其展开位置时接收所述连接机构的自由端。
3.如权利要求1所述的注射口，其特征为，所述弓形钩具有延伸至少180°的长度。
4.如权利要求1所述的注射口，其特征为，所述连接机构包括一个锋利的自由端。
5.如权利要求1所述的注射口，进一步包括一个装在所述外壳上并且与所述储存器流体连通的导管连接管。
6.如权利要求1所述的注射口，其特征为，所述外壳含有钛。
7.如权利要求1所述的注射口，其特征为，所述隔膜在被针头刺穿并拔出针头后自密封。
8.如权利要求1所述的注射口，其特征为，所述隔膜含有硅酮。
9.如权利要求1所述的注射口，其特征为，所述注射口包含至少三个的所述连接机构。
10.如权利要求9所述的注射口，其特征为，所述连接机构沿所述外周边等距离地隔开。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/858,614 US20050148956A1 (en) | 2004-06-01 | 2004-06-01 | Surgically implantable injection port having an improved fastener |
| US10/858,614 | 2004-06-01 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1714760A true CN1714760A (zh) | 2006-01-04 |
| CN100471461C CN100471461C (zh) | 2009-03-25 |
Family
ID=34941531
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100733319A Expired - Fee Related CN100471461C (zh) | 2004-06-01 | 2005-05-31 | 具有改进的紧固件的可手术植入的注射口 |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20050148956A1 (zh) |
| EP (2) | EP1602392B1 (zh) |
| JP (1) | JP5128056B2 (zh) |
| KR (1) | KR101162914B1 (zh) |
| CN (1) | CN100471461C (zh) |
| AU (1) | AU2005202292B2 (zh) |
| BR (1) | BRPI0501989B8 (zh) |
| CA (1) | CA2508648C (zh) |
| MX (1) | MXPA05005810A (zh) |
| RU (1) | RU2403880C2 (zh) |
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- 2004-06-01 US US10/858,614 patent/US20050148956A1/en not_active Abandoned
-
2005
- 2005-05-26 AU AU2005202292A patent/AU2005202292B2/en not_active Ceased
- 2005-05-30 BR BRPI0501989A patent/BRPI0501989B8/pt not_active IP Right Cessation
- 2005-05-31 JP JP2005160203A patent/JP5128056B2/ja not_active Expired - Fee Related
- 2005-05-31 CN CNB2005100733319A patent/CN100471461C/zh not_active Expired - Fee Related
- 2005-05-31 RU RU2005116666/14A patent/RU2403880C2/ru not_active IP Right Cessation
- 2005-05-31 CA CA2508648A patent/CA2508648C/en not_active Expired - Fee Related
- 2005-05-31 KR KR1020050045990A patent/KR101162914B1/ko active IP Right Grant
- 2005-05-31 MX MXPA05005810A patent/MXPA05005810A/es active IP Right Grant
- 2005-06-01 EP EP05253363.5A patent/EP1602392B1/en not_active Not-in-force
- 2005-06-01 EP EP10177808.2A patent/EP2327445B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| BRPI0501989A (pt) | 2006-01-24 |
| CA2508648C (en) | 2015-10-20 |
| RU2403880C2 (ru) | 2010-11-20 |
| BRPI0501989B1 (pt) | 2017-02-07 |
| KR20060046305A (ko) | 2006-05-17 |
| EP1602392A1 (en) | 2005-12-07 |
| EP1602392B1 (en) | 2017-11-08 |
| CA2508648A1 (en) | 2005-12-01 |
| KR101162914B1 (ko) | 2012-07-09 |
| AU2005202292B2 (en) | 2012-02-02 |
| US20050148956A1 (en) | 2005-07-07 |
| BRPI0501989B8 (pt) | 2021-06-22 |
| EP2327445A1 (en) | 2011-06-01 |
| JP2005342517A (ja) | 2005-12-15 |
| EP2327445B1 (en) | 2018-10-10 |
| MXPA05005810A (es) | 2006-01-18 |
| CN100471461C (zh) | 2009-03-25 |
| JP5128056B2 (ja) | 2013-01-23 |
| AU2005202292A1 (en) | 2005-12-15 |
| RU2005116666A (ru) | 2006-11-20 |
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