CN102665580A - 眼科带阀的套针套管 - Google Patents
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Abstract
在各个实施例中，套针套管（101）可被构造成用于插入眼睛中以利于手术期间器械的插入和去除。套管可被固定到盖帽（103），以阻止盖帽相对于包括密封件（111）的套管）旋转。在一些实施例中，密封件可以被模制到盖帽中或可以包括固定到套管和盖帽之间以阻止相对于套管和盖帽旋转的圆片。在某些实施例中，套管和盖帽可通过突片/槽接口（107，109）以永久方式卡扣在一起，使得在不损坏套管或盖帽的情况下套管和盖帽不可分离。在一些实施例中，排出套管能够被接收在密封件的狭缝中以允许流体经由套管（套管可包括至少一个缩进部，以与排出件摩擦接合）从眼睛排出。
Description
优先权声明
本申请要求于2009年12月23日提出的名称为“眼科带阀的套针套管”的美国临时专利申请序号No.61/289449的优先权，其发明人为Jose Luis Lopez,Anil K.Patnala和Michel M.Martin，该申请的全部内容通过参考在此并入，就像在本文中充分且完全阐述了一样。
技术领域
本发明整体上涉及眼科手术。更具体地，但不是限制性的，本发明涉及眼科套针套管和排出件。
背景技术
显微手术器械可被外科医生用于从人体的纤细且受限制的空间取出组织，例如在眼睛上手术（诸如用于去除玻璃体、血液、疤痕组织或晶状体的手术）。这种器械可包括控制台和手术手持件，外科医生利用它们将组织切断和去除。对于后面部分的手术，手持件可以是玻璃体切割探针、激光探针、或用于切割或打碎组织的超声打碎器，且可通过长的气压（气动）管线和/或电缆、光缆或用于将输注流体供应到手术点且用于从该点抽出或吸出流体和切割/打碎的组织的柔性管连接到控制台。手持件的切割、输注和吸出功能可通过远程控制台控制，该控制台不仅提供用于外科手持件的电源（例如往复或旋转切割刀片或超声振动针），而且可以控制输注流体的流动且提供用于流体和切割/打碎的组织的吸出的真空源（相对于大气）。控制台的功能可由外科医生手动控制（例如通过使用脚操作开关或比例控制）。
在后面部分的手术期间，外科医生在手术期间可能使用几个手持件或器械。该手术可能需要这些器械被插入切口中和从切口中去除。该重复的去除和插入可能在切口处导致对眼睛的损伤。为了解决该问题，至少在1980年代中期开发了带有插座的套管。这些设备可包括带有附接的插座的窄管。该管可被插入眼睛的切口中直到插座处，该插座可作为止挡件，防止管完全进入眼睛。该插座可被缝合到眼睛以防止意外的移除。手术器械可被通过该管插入眼睛中，管可保护切口侧壁不被器械重复接触。另外，当器械被经由管插入眼睛中时，通过操纵器械，外科医生可使用该器械帮助在手术期间定位眼睛。现有技术的套管的缺陷可包括在眼睛表面上的突出的高度，以及没有任何在器械更换或去除期间控制眼内压损失的装置。当手术装置不存在时，作为压力球的眼睛可能会将眼房水或玻璃体从开放的套管排出。用现有技术的套管，通过在管中插入塞子或帽以密封套管且防止流体和组织的压出，可防止眼内压损失。这可能是需要附加器械以及其它操作室人员的辅助的消耗时间的处理且可能增加手术后感染的风险。
发明内容
在各个实施例中，套针套管（trocar cannula）可被构造成用于插入眼睛中以利于手术期间器械的插入和去除。套管可被固定到盖帽（固定成阻止盖帽相对于套管旋转）。盖帽可包括用于在套管被插入眼睛时（当器械未插入时）阻止流体流出套管的密封件。在一些实施例中，密封件可以被模制到盖帽中或可以包括固定到套管和盖帽之间使得密封件相对于套管和盖帽不旋转的圆片。在某些实施例中，套管和盖帽可通过突片/槽接口以永久方式卡扣在一起，使得在不损坏套管或盖帽的至少一部分的情况下套管和盖帽不可分离。在一些实施例中，排出套管（vent cannula）能够可滑动地接收在密封件的狭缝中以允许流体经由套管从眼睛排出。在一些实施例中，套管可包括至少一个缩进部，以当排出件被插入套管中时与排出件的一部分摩擦接合。
附图说明
为了更彻底地理解本发明，对结合附图的以下说明做出参考，在附图中：
图1示出根据一实施例的套管和盖帽；
图2示出根据一实施例的固定到盖帽的套管；
图3a示出俯视图，该俯视图示出根据一实施例的盖帽上的密封件中的狭缝；
图3b示出根据一实施例的具有几个示例尺寸的套管和盖帽的侧视图；
图4a-d示出盖帽和密封件的实施例的剖面图；
图5a示出根据一实施例的套针插入件上的套管；
图5b示出根据一实施例的带有运输帽的套针插入件上的套管；
图6a-b示出根据一实施例的排出件（vent）；
图7示出根据一实施例的带阀的套针套管中的排出件；
图8示出根据一实施例的带阀的套针套管中的排出件的剖面图；
图9a-b示出排出件的第二实施例；
图10a-c示出排出件的第三实施例；
图11示出根据一实施例的用于形成带阀的套针套管的方法的流程图；
图12示出根据另一实施例用于形成带阀的套针套管的方法的流程图；
图13示出根据一实施例的将排出件与带阀的套针套管一起使用的方法的流程图；和
图14示出根据一实施例的被插入眼睛中的带阀的套针套管。
应该理解前文的一般描述和以下详细描述仅是示范和说明性的，且打算提供如权利要求的本发明的进一步解释。
具体实施例方式
图1示出套针套管101和盖帽103的实施例。套针套管101可被构造成用于插入眼睛中以有利于手术期间器械的插入和去除。套管101可包括能够延伸到眼睛中（例如通过巩膜、结膜等）的杆105。在一些实施例中，套管101可被附接到盖帽103。例如，套管101可包括一个或更多被构造成与套管101上的对应槽109接合的突片107（例如图1中示出的套管101包括四个突片107以与盖帽103上的四个对应槽109接合）。其它附接方式也是可以预期的。例如，套管101可包括槽而盖帽可包括突片。在一些实施例中，套管101可通过粘合剂、热结合等附接到盖帽103。在一些实施例中，密封件111可被结合到盖帽103（例如密封件111可至少部分地设置在杆105和盖帽103之间）以形成二次注塑成型（overmolded）的阀。如图1所示，密封件111的表面可在盖帽103上露出。在一些实施例中，密封件111的露出表面可包括一个或更多狭缝113以允许手术工具通过并进入套管101中。在没有手术器械的情况下，密封件111可阻止流体流经密封件111。
图2示出固定到盖帽103的套管101的实施例（例如突片107在相应槽109中接合之后）。在一些实施例中，突片/槽接口可防止盖帽103相对于套管101旋转（例如在套管101插入到眼睛中期间）。在一些实施例中，突片107可被构造成永久地将盖帽103保持到套管101上（使得在不毁坏套管101和/或盖帽103的一部分的情况下盖帽103不能从套管101去除）。例如，突片107（和套管101）可由不锈钢制成且盖帽103可由塑料（例如聚碳酸酯）制成。其它材料也是可以预期的。在盖帽103和套管101的之间的永久保持可防止手术（例如玻璃体视网膜手术）期间盖帽103从套管101的意外去除。
图3a示出盖帽103上的密封件111中的狭缝113的实施例的俯视图。图3b示出带有几个示例尺寸（以英寸提供）的套管101和盖帽103的实施例的侧视图。其它尺寸也是可以预期的。例如，虽然套管101的外径被示出为0.029英寸（对应于23gauge套管），在另一实施例中，套管的外径可以是0.0243英寸（对应于25gauge套管）。其它外径也是可以预期的。
图4a-c示出盖帽103和密封件111的实施例的剖视图。密封件111可由弹性体（例如硅树脂）制成。在一些实施例中，密封件111可被附接到盖帽103以阻止密封件111相对于盖帽103旋转。例如，密封件111可经二次注塑成型工艺模制到盖帽103的凹陷403和一个或更多孔401中。在一些实施例中，密封件111可包括硅圆片405，该硅圆片与盖帽103分离地形成且在将盖帽103组装到套管101上期间插入盖帽103和套管101之间。在这种情况下，密封件111可通过摩擦配合附接到盖帽103和套管101。其它附接方式也是可以预期的（例如粘合剂）。
图5a示出套针插入件501上的套管101的实施例。在一些实施例中，套针插入件501可以包括附接到手柄505的套针刀503。在一些实施例中，手柄505可由塑料制成且刀503可由不锈钢制成。其它材料也是可以预期的。套针刀503可以延伸通过杆105的端部且可以包括一个或更多尖锐边缘以刺破眼睛1401（例如刺破穿过巩膜1403的孔且进入玻璃体1405），从而用于插入套管101。在一些实施例中，引导件507可安装到引导槽115中以在套管101插入眼睛1401期间阻止盖帽103/套管101相对于手柄505旋转。在一些实施例中，引导件507可释放地与引导槽115接合，使得当套管插入件501被从盖帽103/套管101抽出时，引导件507并不将盖帽103/套管101拉出眼睛1401。例如，当套管101在眼睛中时，引导件507可通过比眼睛作用在套管101外侧上的摩擦力小的摩擦力与引导槽115摩擦接合。
虽然引导件507被示出为将被接收在引导槽115中的突片，但是其它互锁特征也是可以预期的。例如，引导件507和引导槽115可包括不同的互锁特征（例如环或棒）或可以包括其它互锁部件（例如互锁磁体（在手柄和盖帽103上各一个）、接合O形环（在手柄和盖帽103上各一个等））。在一些实施例中，引导件507/引导槽115的相互作用可防止套管101和盖帽103之间旋转，从而套针手柄505绕手柄轴线的任何角度运动可被传递到盖帽103且然后到套管101。该相互作用可在套管101插入到巩膜1403期间给玻璃体视网膜外科医生提供套管101相对于套针手柄505的角度控制。图5b示出带有运输帽511（其可被卡扣到套管101上和/或套针插入件501上，以保护套管101和/或套针插入件501）的套针插入件501上的套管101的实施例。
图6a-b示出排出件601的实施例。虽然带阀的套针套管的密封件111可封闭套管，使得当例如手术器械闭塞套管时流体不流入或流出套管，排出套管603可被构造成滑入密封件111的狭缝113中以允许流体从眼睛经由套管101排出（例如见图7）。在一些实施例中，排出件601可保持密封件111处于打开位置以允许流体（例如气体或液体）经由套管101排出。例如，在用另一流体置换气体的手术中，气体（或另一流体）可流动经过套管101且流出排出件601。排出件601可进一步包括边缘609以提供用于防止排出件一路畅通无阻地滑到密封件111中的止动件。排出套管603可具有比套针套管101的内径小的外径，以允许排出套管603滑动通过密封件111且进入套针套管101。排出套管603可进一步包括边缘609，边缘609的至少一个尺寸足够大以防止排出件601完全滑入套针套管101（例如边缘609的尺寸可以大于套针套管101的内径）。
在一些实施例中，排出件601可以是与套管分离的装置，以允许在不增加或去除套管101的部件（例如不必去除套管101的盖帽103）的情况下插入和去除排出件601。排出件601的尺寸还可以允许使用者（例如外科医生）在排出件601的插入和去除期间用手指（或例如镊子）操纵排出件601。
在一些实施例中，排出件601可包括与排出套管603摩擦接合的柔性管605（例如硅树脂管）。管605可提供排出处理（例如如果物质从眼睛溢出（诸如在粘性流体控制输注手术中的硅树脂））的视觉指示器（例如至少部分透明），硅树脂可能流入管605且使用者能够看到。在一些实施例中，管605可被用作用于从套管101去除排出件的抓持表面（例如通过手指或镊子辅助抓持）。排出套管603可包括管部607，该管部被构造成沿着管607（例如可以由不锈钢制成）的外周接收柔性管605。在一些实施例中，管607和排出套管603可由单个部件形成。图6b示出根据一实施例的几个示例尺寸（以英寸提供）。其它尺寸也是可以预期的。在一些实施例中，排出件601的尺寸可允许当排出件601处于密封件111中时器械经由排出件601通过。
图8示出排出件601在套管101中的实施例的剖面图。在一些实施例中，套管101可包括至少一个缩进部801，当排出件601被插入套管101中时所述缩进部801与排出套管603的一部分摩擦接合。缩进部801的尺寸可以设计成对排出件601提供足够阻力，以在手术期间将排出件601保持就位。在一些实施例中，当从套管101抽出排出件601时，缩进部801和排出件601之间的阻力可以小于将套管101从眼睛拉出所需的力（使得当套管101处于眼睛中、将排出件601从套管101拉出时，套管101不从眼睛拉出）。
还可以预期排出件的其它实施例。例如，图9a-b示出排出件901的实施例。如图9a-b所示，排出件901可不包括管605，而是可替代地是单个部件。排出件901可以是深拉成型且可包括用于与套管101上的保持特征匹配的保持特征。还可以预期其它成型技术（例如排出件901可以被模制）。在一些实施例中，排出件可不包括保持特征。另一实施例被示出为图10a-c中的排出件1001。排出件1001可包括大钟状的入口，使得当排出件1001被插入套管101中时工具容易通过排出件1001插入和去除。排出件1001可还包括一个或更多保持特征1003，以增加当排出件1001被插入套管101中时排出件1001和套管101之间的抓持力。
图11示出根据一实施例的用于形成带阀套针套管的方法的流程图。流程图中的提供的要素仅是说明性的。各个提供的要素可以被省略，可增加另外的要素，和/或可以与以下提供的不同的顺序执行各要素。
在1101处，可以形成盖帽103。例如，盖帽103可以被模制以包括用于接收硅树脂密封件111的通孔401。用于盖帽103的模制工艺可包括注射成型、压制成型、吹塑成型、滚塑成型等。还可以预期用于形成盖帽103的其它技术（例如铸造）。
在1103处，密封件111可通过二次注塑成型工艺模制到盖帽103上。例如，密封件111可包括模制到盖帽103的凹陷403中的弹性体（诸如硅树脂），且可流入孔401中以将密封件111固定到盖帽103上。在一些实施例中，盖帽103可以被放置在通过盖帽103限定了用于密封件111的空间的模具中。然后弹性体可被注射到模具中且流经通过盖帽103限定的空间以在盖帽103中形成密封件111。其它制造工艺也是可以预期的。例如，密封件111和盖帽103可作为单个部件进行模制（例如在单个模具中使用相同材料来制作盖帽103和密封件111）。在一些实施例中，密封件111可与盖帽103分离地形成（例如见图10）。在一些实施例中，密封件可形成有狭缝隙113，或可在密封件111形成之后在密封件111中形成狭缝113（例如可利用尖锐边缘在密封件111中切割出狭缝113）。
在1105处，可形成套管101。例如，套管101可被深拉成型。深拉成型套管101可包括从被压入一个或更多组阳/阴模子之间的材料的盘开始深拉套管101。套管形成的最后步骤可包括去多余的材料和/或抛光套管101。在一些实施例中，突片107之间的材料可以在阳/阴模子之间被剪去或以其它方式去除（例如切割）。在一些实施例中，套管101可被模制（例如注射成型、压制成型、吹塑成型、滚塑成型、挤出成型等）。也可以预期用于套管形成的其它技术。在一些实施例中，套管101可由不锈钢或塑料制成。也可以使用其它材料。在一些实施例中，套管101可形成有卡扣突片107。例如，用于套管101的模子或模具可包括用于形成突片的空间，或突片可通过机加工形成在套管101上。也可以预期其它突片形成技术。
在1107处，盖帽103可被固定到套管101。例如，突片107可被卡扣到对应槽109中。在一些实施例中，在盖帽103被压到套管101上时，盖帽103可略微变形以接收突片107或突片107可被构造成略微变形，且在盖帽103的对应槽109通过突片107之后恢复其初始状况。突片107可以具有足够刚性（例如由不锈钢制成），使得在不毁坏套管101和/或盖帽103的一部分的情况下盖帽103不能从套管101去除。
图12示出根据另一实施例的用于形成带阀的套针套管的方法的流程图。流程中提供的要素仅是示例性的。各种提供的要素可被省略，可增加另外的要素，和/或可以与以下提供的不同的顺序执行各要素。
在1201处，可形成盖帽1103（例如通过模制）。在一些实施例中，盖帽1103可形成有接收槽109。
在1203处，可形成密封件111（诸如硅树脂圆片405）。在一些实施例中，硅树脂圆片405可被模制有狭缝113或可在模制后在硅树脂圆片405中形成狭缝113（例如可利用尖锐边缘在硅树脂圆片中切割出狭缝113）。
在1205处，可形成套管101。例如，套管101可以由不锈钢模制且可包括突片107。
在1207处，硅树脂圆片405可被插入套管101和盖帽103之间，且盖帽103可被固定到套管101（例如盖帽101可被卡扣到套管101上使得槽109可接收突片107）。
图13示出根据一实施例的将排出件与带阀的套针套管一起使用的方法的流程图。流程中提供的要素仅是示例性的。各种提供的要素可被省略，可增加另外的要素，和/或可以与以下提供的不同的顺序执行各要素。
在1301处，套针刀503可经由密封件111中的狭缝113且经由套管101插入。在1303处，可用套针刀503刺破眼睛1401且可将套管101推入眼睛中。在1305处，套针刀503和套管101在插入期间可被按需要旋转。在1307处，套针刀503可被抽出、将套管101留在眼晴1401中。在1309处，排出件601可被按需要插入以打开密封件111以允许流体/气体经由套管101排出且排出眼睛1401之外。在手术期间，排出件601可按需要被去除和/或再插入到密封件111和套管101中，而不会从眼睛抽出套管101。例如，使用使用者的手指或一对镊子进行排出件601的插入和抽出。
本领域普通技术人员可对当前的实施例进行各种变型。考虑本说明书和这里公开的本发明的实践，本发明的其它实施例将对本领域技术人员而言是显而易见的。本说明书和示例打算被认为是仅示范性的，本发明的真正范围和精神由以下权利要求和其等价物指示。
Claims (18)
1.一种设备，包括：
套管，所述套管被构造成插入眼睛中；
盖帽，所述盖帽被固定到所述套管，其中所述盖帽被构造成相对于所述套管不旋转；和
密封件，所述密封件处于所述套管和所述盖帽之间，其中所述密封件被构造成允许手术工具通过所述密封件中的狭缝进入所述套管，同时当所述密封件中不存在手术工具时阻止流体流经所述密封件。
2.根据权利要求1所述的设备，其中所述密封件包括经二次注塑成型工艺模制到所述盖帽的凹陷中的硅树脂。
3.根据权利要求2所述的设备，其中所述硅树脂被模制到所述盖帽的孔中，以阻止所述密封件相对于所述盖帽旋转。
4.根据权利要求1所述的设备，其中所述密封件包括硅树脂圆片。
5.根据权利要求1所述的设备，
其中所述套管包括至少一个突片；
其中所述盖帽包括至少一个槽；和
其中所述盖帽通过在所述至少一个槽中接收所述至少一个突片而被固定到所述套管。
6.根据权利要求1所述的设备，还包括排出套管，所述排出套管被构造成滑动到所述密封件的狭缝中，用于允许流体经由所述套管从眼睛排出。
7.根据权利要求6所述的设备，其中所述套管包括至少一个缩进部，以当所述排出件被插入所述套管中时与所述排出件的一部分摩擦接合。
8.根据权利要求1所述的设备，其中所述盖帽包括引导槽，其中所述引导槽被构造成接收套针手柄的引导件，且其中所述引导槽和所述引导件之间的相互作用在所述套管插入到眼睛期间阻止所述盖帽相对于所述手柄旋转。
9.一种设备，包括：
手柄；
套针刀，所述套针刀连接到所述手柄；
套针套管，所述套针套管被固定到盖帽，所述盖帽包括模制到所述盖帽上的密封件，其中所述密封件包括狭缝，所述狭缝被构造成接收从其穿过的所述套针刀，其中所述套针刀被构造成刺破眼睛以将所述套管推入到眼睛中；
其中所述盖帽被构造成相对于所述套管不旋转；
其中所述密封件被构造成允许手术工具通过所述密封件中的狭缝进入所述套管中，同时当所述密封件中不存在手术工具时阻止流体流经所述密封件；和
其中所述手柄还包括引导件，其中所述盖帽进一步包括引导槽，其中所述引导槽被构造成接收所述手柄的所述引导件，其中所述引导槽和所述引导件之间的相互作用在所述套管插入到眼睛期间阻止所述盖帽相对于所述手柄旋转。
10.根据权利要求9的设备，其中所述密封件包括经由二次注塑成型工艺模制到所述盖帽的凹陷中的硅树脂。
11.根据权利要求10所述的设备，其中所述硅树脂被模制到所述盖帽的孔中以阻止所述密封件相对于所述盖帽旋转。
12.根据权利要求9所述的设备，其中所述密封件包括硅树脂圆片。
13.根据权利要求9所述的设备，
其中所述套管包括至少一个突片；
其中所述盖帽包括至少一个槽；和
其中所述盖帽通过在所述至少一个槽中接收所述至少一个突片而被固定到所述套管。
14.根据权利要求9所述的设备，其中所述套管包括至少一个缩进部，以当所述排出件被插入所述套管中时与所述排出件的一部分摩擦接合。
15.一种方法，包括：
形成盖帽；
形成套管；
将密封件固定到所述盖帽；
将所述盖帽固定到所述套管。
16.根据权利要求8所述的方法，其中将密封件固定到盖帽包括：将硅树脂模制到所述盖帽的凹陷中。
17.根据权利要求8所述的方法，其中所述密封件包括硅树脂圆片，其中，将密封件固定到盖帽包括：在将所述盖帽固定到所述套管之前，将硅树脂圆片放置在所述盖帽和所述套管之间。
18.根据权利要求8所述的方法，
其中形成所述盖帽包括在所述盖帽中形成至少一个槽；
其中形成所述套管包括在所述套管中形成至少一个突片；和
其中将盖帽固定到套管包括使所述至少一个突片接收在所述至少一个槽中。
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