CN104812339B - 尿导管固定护套 - Google Patents
尿导管固定护套 Download PDFInfo
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
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Abstract
本发明涉及一种装置，所述装置用于在男性患者的尿路中固定直型导管或弗利导管。所述装置包括可耦合到患者阴茎的部分，以及可耦合到所述直型导管或所述弗利导管的部分。本发明还涉及制造和使用所述装置的方法，以及涉及包括所述装置和直型或弗利导管的组件。
Description
优先权
本申请要求于2012年11月20日提交的美国专利申请No.13/682,406的优先权益，该专利申请以引用方式全文并入本文。
技术领域
本发明涉及一种装置，该装置用于在男性患者的尿路中固定直型导管或弗利导管(Foley catheter)。该装置包括可耦合到患者阴茎的部分，以及可耦合到直型导管或弗利导管的部分。本发明还涉及制造和使用该装置的方法，以及涉及包括该装置和直型导管或弗利导管的组件。
背景技术
当尿导管位于患者的尿道或膀胱中时，其移动会引起患者的不适。仍需要能够在导管插入患者的尿道中后减少或消除其移动的装置。
发明内容
本发明包括导管保持护套。导管保持护套可包括被配置成配合在阴茎上的护套。护套可包括导管保持器，该保持器可被配置成耦合到尿导管的杆(shaft)。导管保持器可限定孔。孔的第一部分可被配置成允许尿导管的杆通过孔进行轴向运动。孔的第二部分可被配置成保持尿导管的杆。
本发明包括一种将导管插入患者的方法。该方法可包括提供导管保持护套。该导管保持护套可包括被配置成耦合到尿导管的杆的导管保持器。导管保持器可限定孔。孔的第一部分可被配置成允许尿导管的杆通过孔进行轴向运动。孔的第二部分可被配置成保持尿导管的杆。该方法还包括将尿导管的杆插入孔的第一部分中，将尿导管的杆的一部分插入患者的尿道中，并将尿导管的杆从孔的第一部分推进到孔的第二部分中。
本发明包括制造导管保持护套的方法。该方法包括在芯轴的一部分上施加硅酮橡胶并在硅酮橡胶中形成孔。孔的第一部分可被配置成允许尿导管的杆通过孔进行轴向运动。孔的第二部分可被配置成保持尿导管的杆。该方法还包括固化硅酮橡胶以形成限定孔的导管保持护套。
在一个实施例中，本发明包括导管系统。该导管系统包括具有杆和本发明的导管保持护套的尿导管。
附图说明
图1示意性地展示根据本发明的导管系统的实施例，并且包括本发明的导管保持器以及带杆的尿导管的实施例。
图2示意性地展示本发明的导管保持器的实施例。
图3示意性地展示本发明的管的实施例，其显示内腔和狭缝的实施例。
图4示意性地展示根据本发明的导管系统的实施例，并且包括本发明的导管保持器以及带杆的尿导管的实施例。尿导管在导管保持开口的实施例中示出。
图5示意性地展示本发明的导管保持护套的剖视图，所述导管保持护套包括卷起的护套部分。
图6示意性地展示本发明的导管保持器的实施例，所述导管保持器包括凸耳形状的、限定开口的过渡段。
具体实施方式
本发明涉及一种装置，该装置用于在男性患者的尿路中固定尿导管(如，直型导管或弗利导管)。该装置包括可耦合到患者阴茎的部分，以及可耦合到直型导管或弗利导管的部分。可耦合到患者阴茎的部分可以是被配置成配合阴茎(如正常、萎软的阴茎)的护套或避孕套形式。包括护套或避孕套部分以及耦合到尿导管的部分的该装置可以称为导管保持护套。
导管保持护套的耦合到尿导管的部分可以限定具有两个部分的孔。孔的第一部分被配置成使得尿导管可沿此第一部分自由移动(至少在其杆的轴向上)。孔的此第一部分可以比尿导管的杆的外径大，从而可允许尿导管进入并穿过护套或避孕套部分。孔的第二部分可被配置成限制尿导管的运动。例如，孔的此第二部分在松弛状态下的尺寸可与尿导管的杆外径大致相同或比其更小。可将尿导管埋入孔的此第二部分中，并限制其相对于护套和患者的运动(至少在其杆的轴向上)。
导管保持护套的耦合到尿导管的部分可包括颈部分，所述颈部分用于限定孔的第二部分的部分或全部。该颈部分可包括如沿其具有狭缝的、耦合到护套部分的管。
本发明包括导管保持护套。导管保持护套可包括被配置成配合在阴茎上的护套。护套可包括导管保持器，该保持器可被配置成耦合到尿导管的杆。导管保持器可限定孔。孔的第一部分可被配置成允许尿导管的杆通过孔进行轴向运动。孔的第二部分可被配置成保持尿导管的杆。
在一个实施例中，孔的第一部分大于尿导管的杆的外径。例如，孔的第一部分可被配置成允许尿导管进入导管保持护套的护套或避孕套部分并穿过该部分。
在一个实施例中，孔的第二部分被配置成将尿导管固定在护套中。在一个实施例中，在将尿导管插入患者体内后，孔的第二部分被配置成限制尿导管相对于患者的阴茎和膀胱的运动。例如，孔的第二部分在松弛状态下的尺寸与尿导管的杆外径大致相同或更小。在一个实施例中，导管保持器限定将孔的第一部分耦合到孔的第二部分的狭缝。
在一个实施例中，本发明的导管保持护套包括颈部分，所述颈部分限定孔的第二部分的部分或全部。在一个实施例中，该颈部分包括耦合到护套的管，所述管限定轴向狭缝。在一个实施例中，导管保持器包括更厚材料的一体的锥形部分，所述部分限定孔的第二部分的部分或全部。
本发明的导管保持护套可与多种尿导管中的任一种配合使用。合适的尿导管包括直型导管和弗利导管。
在一个实施例中，护套包括内表面和外表面，所述内表面包含被配置成附着到阴茎上的粘合剂。例如，护套可包括弹性材料的沿自身向外卷曲的管状套构件，所述套构件具有外表面和内表面。套构件的外表面可接触粘合剂层，而该粘合剂层可接触套构件的内表面。在一个实施例中，粘合剂包含或为水性胶体组合物。在一个实施例中，粘合剂组合物位于一个或多个连续辊的内表面和外表面之间，使得在护套处于卷起状态时粘合剂被内表面覆盖。
在一个实施例中，本发明的导管保持护套包括由弹性材料制成并被配置成将护套保持在阴茎上的粘合剂带。
在一个实施例中，导管保持护套由包含硅酮的组合物制成。例如，导管保持护套可由硅酮橡胶制成。在一个实施例中，导管保持护套由硅酮橡胶组成。
在一个实施例中，本发明包括导管系统。该导管系统包括具有杆和本发明的导管保持护套的尿导管。
图示实施例
图1示意性地示出根据本发明的导管保持护套和直型尿导管的实施例。导管保持器1包括套3、管5和套3与管5之间的过渡段7。套3以其卷曲配置示出。过渡段7限定导管进入开口9，所述开口被配置成允许直型尿导管11的移动。在图1中，示出了以适于如插入患者体内的配置，直型尿导管11突起穿过导管进入开口9。管5限定导管保持开口(如图2和图3所示)，其被配置成减少直型尿导管11的移动或固定直型尿导管11。
图2示意性地示出了图1的导管保持器1的另一个视图，并显示管5、导管进入开口9和由管5限定的狭缝13。管5的狭缝13和内腔(如图3所示)形成导管保持开口15。图3示意性地示出了管5，其显示形成导管保持开口15的内腔17和狭缝13。
图4示意性地示出了导管保持器1的实施例，其中直型尿导管位于由管5限定的导管保持开口15中。直型尿导管11可以从导管进入开口9被推进到内腔17中。在一个实施例中，直型尿导管11在其定位于导管保持开口中之前已先插入患者的尿道中。套3未在图4中示出，但在将直型尿导管11插入患者尿道中时可以处于其卷曲配置，并在插入后展开到患者的阴茎上。
图5示意性地示出了导管保持器1的一个实施例的特征，但未显示直型尿导管11、进入开口9或狭缝13。在此实施例中，导管保持器1具有包括套3、管5和套3与管5之间的过渡段7的一体构造。导管保持器1可以由硅酮橡胶制成。导管保持器1具有内表面19和外表面21。在经过制造和使用前储存过程后，导管保持器1可处于图1所示的使用前配置，其中套3的第一部分23沿自身卷起，使得除了下文指出的情况外，内表面19抵靠外表面21卷起并接触外表面21。在套3的内表面19和外表面21的大部分区域之间可以插入粘合剂层25。粘合剂层25附着到内表面19，且在套3展开时不附着到外表面21。出现此现象的原因将在下文中更详细地讨论。粘合剂层25还可包括形成于过渡段7的很大一部分上的第二部分27。在过渡段7改变形式为套3时，粘合剂层25的第一部分23和第二部分27可为连续的。
套3可成形为直径适于疲软阴茎的圆柱体。套3的长度可为约1至约5英寸。可将套3的长度选择为足够长从而在套3内表面上的粘合剂层25的第一部分23与阴茎杆之间提供足够的紧固粘合，但不会过长使得在缩回的阴茎向外被拉出以露出阴茎杆相对于骨盆皮肤的总长度时套3无法完全展开。第一部分23可包括套3的所有内表面，但套3的邻近其开口端的内表面上的无粘合剂带31除外。带31可以为执业医生或装置使用者提供松弛端，以用于抓住套3并开始将其卷回自身，或以其他方式移除安装好的导管保持器1。
过渡段7提供从套3到管5的直径缩小。第二部分27包括过渡段7的大部分锥形部分，可通过第一部分23上的水性胶体连续地将粘合剂施加至第二部分27。在一个实施例中，第二部分27可在过渡段7内提供一个非常有利的大粘合表面，用于接触并附着到阴茎头。在一个实施例中，与管5相连且通向管5的顶端部分33不含粘合剂。套3可以使用前配置卷曲。因此，过渡段7的内表面19上的第二部分27可以露出(但整个套保持器1可在包装中得到适当的保护)。套3和过渡段7的厚度可允许其在粘合剂附着到阴茎时适形于阴茎的形状。管5具有更大的厚度，以便保持其形状并提供对直型尿导管11的合适保持。
管5可被配置成提供能在以较小直径段35和较大直径段37形成时保持其形状(如不会塌缩)的结构。该装置可包括可选的短过渡颈39，其在段35和37之间延伸。在一个实施例中，过渡段7的锥形窄部可以在较大直径段37与过渡段7的其余部分之间延伸，从而得到具有较大厚度的短部分，其连接到过渡段7的具有较薄厚度的较大部分。
虽然粘合剂层25附着到内表面19，但在套3展开时粘合剂层25不附着到外表面21。粘合剂层25可以直接附着到内表面19，或者可以通过催化过程粘结到内表面19，所述催化过程例如固化过程，其中粘合剂组合物中的组分与硅酮橡胶中的组分发生交联，该硅酮橡胶在固化过程中由未固化的硅酮橡胶溶液外涂层形成。一旦粘合剂层25附着到或粘结到内表面19且外表面形成(例如根据下文所述的过程)，粘合剂就不再不可逆地附着到外表面21。虽然粘合剂以可剥离的方式附着到外表面21上，但以中等力量分离两个表面，从而导致粘合剂保持附着到内表面19上。粘合剂层25和外表面21之间的接触称为“可剥离的接触”或“可剥离的粘附”。如所指出的那样，这类接触或粘附的特征在于其允许相对容易地将水性胶体与接触面分离。
图6示意性地示出了本发明的导管保持器1的一个实施例，其中凸耳形状的过渡段7限定导管进入开口9和导管保持开口15。
护套
导管保持器可具有多种配置中的任一种，所述配置具有配合在阴茎上的管状套或护套。管状套或护套可由弹性材料制成(如硅酮橡胶)，并且可具有内表面和外表面。在一个实施例中，本发明的导管保持器包括尺寸被设定为适于围绕正常、萎软的阴茎配合的护套。
护套可包括柔性的圆柱体构件，该构件沿自身向外卷曲，不断形成越来越大的辊。该圆柱体构件在连续辊之间可以具有粘合剂组合物。圆柱体构件的外表面可以在该构件展开时释放粘合剂组合物，而圆柱体构件的内表面在该构件展开时保持粘合剂。这样，护套可以在粘合剂组合物在构件的连续辊之间得到保护的情况下进行保存，并且可以通过将构件展开到阴茎上从而允许粘合剂从外表面剥离以及允许粘合剂附着到内表面和阴茎来使用。
粘合剂
粘合剂组合物可位于内表面的一部分上。在包装中和使用前，管状套或护套可以沿自身卷起。在卷起的配置下，管状套或护套可以将粘合剂组合物从周围分离。例如，粘合剂组合物可以位于卷曲的套或护套的各层之间。在卷曲的配置下，套或护套的外表面可接触粘合剂组合物层，而该粘合剂组合物层可接触套或护套的内表面。例如，粘合剂组合物可位于一个或多个连续辊的内表面和外表面之间，使得在护套卷起时粘合剂被内表面覆盖。
在一个实施例中，粘合剂组合物呈层状，并直接且以不可剥离的方式粘结到内表面的一部分上。粘合剂组合物可以可剥离的方式接触外表面的一个或多个部分。硅酮橡胶护套的内表面可以沿外表面卷起。内表面部分上的粘合剂组合物层与外表面的一个或多个部分发生可剥离的接触。当用力展开硅酮橡胶护套时，外表面上的粘合剂组合物可随后从之前接触到的外表面剥离，而保持粘结到内表面。
粘合剂可以是或可以包括水性胶体组合物或粘合剂。水性胶体可具有(强)粘合性能以及与皮肤和导管材料两者的相容性。水性胶体组合物可包含丙烯酸压敏粘合剂(一种聚丙烯酸聚合物)，以及任选地中和剂。聚丙烯酸聚合物可为交联聚丙烯酸聚合物。此类交联聚合物可提供有效的流变学改性和增强的自润湿性。合适的聚丙烯酸聚合物包括由俄亥俄州克里夫兰的路博润公司(Lubrizol,Cleveland,Ohio)以商品名CARBOPOL ULTREZ 10出售的产品。合适的中和剂包括胺类，如氨甲基丙醇。
适用的氨甲基丙醇包括陶氏化学公司(Dow Chemical)的子公司安格斯(Angus)以商品名出售的产品。该商品含有93-97重量％的2-氨基-2-甲基-1-丙醇和约5％的水。在某些实施例中，本申请所列出的中和剂的量可乘以例如约0.93、约0.97或约0.93至约0.97，以针对该商品中的活性物质含量进行修正。在某些实施例中，本申请中所列的中和剂的量指代含有约93-97重量％的2-氨基-2-甲基-1-丙醇的中和剂储备溶液。
对于导管保持器的制造，水性胶体制备组合物可包含：约90至约99.99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；约0.01至约10重量％(如约0.5重量％)的聚丙烯酸聚合物；以及任选地，约0.01至约5重量％(如约0.5重量％)的中和剂。在一个实施例中，水性胶体制备组合物可包含：约90至约99.99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；以及约0.01至约10重量％的聚丙烯酸聚合物和中和剂；中和剂和聚丙烯酸聚合物的比率为约0.9至约1(如0.9:1)。中和剂的量可为刚好足够中和聚丙烯酸聚合物，而不会对聚丙烯酸和中和剂的混合物增加额外的碱性。在一个实施例中，中和剂和聚丙烯酸聚合物的比率为0.7-0.99:0.95-1.2(如0.9:1)。一旦在导管或芯轴上干燥或固化，水性胶体粘合剂组合物就可包含：约55至约99.98重量％的丙烯酸压敏粘合剂；约0.02至约30重量％的聚丙烯酸聚合物；以及任选地，约0.02至约15重量％的中和剂。
对于导管保持器的制造，水性胶体制备组合物可包含：约90至约99.99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；约0.01至约10重量％(如约0.5重量％)的聚丙烯酸聚合物；以及任选地，约0.01至约5重量％(如约0.5重量％)的中和剂。在一个实施例中，水性胶体制备组合物可包含：约90至约99.99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；约0.01至约10重量％(如约0.5重量％)的聚丙烯酸聚合物；以及约0.01至约5重量％(如约0.5重量％)的中和剂。在一个实施例中，水性胶体制备组合物可包含：约96至约99.6重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；约0.2至约2重量％的聚丙烯酸聚合物；以及约0.2至约2重量％的中和剂。在一个实施例中，水性胶体制备组合物可包含：约98至约99.4重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；约0.3至约1重量％的聚丙烯酸聚合物；以及约0.3至约1重量％的中和剂。在一个实施例中，水性胶体制备组合物可包含：约99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)；约0.5重量％的聚丙烯酸聚合物；以及约0.5重量％的中和剂。
在一个实施例中，水性胶体制备组合物可包含约90至约99.99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)。在一个实施例中，水性胶体制备组合物可包含约96至约99.6重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)。在一个实施例中，水性胶体制备组合物可包含约98至约99.4重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)。在一个实施例中，水性胶体制备组合物可包含约99重量％的丙烯酸压敏粘合剂和溶剂(约35至约45重量％的固体(如粘合剂组合物)，剩余的为溶剂)。
在一个实施例中，水性胶体制备组合物可包含约0.01至约10重量％(如约0.5重量％)的聚丙烯酸聚合物。在一个实施例中，水性胶体制备组合物可包含约0.2至约2重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体制备组合物可包含约0.3至约1重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体制备组合物可包含约0.5重量％的聚丙烯酸聚合物。
在一个实施例中，水性胶体制备组合物不含添加的中和剂。在一个实施例中，水性胶体制备组合物不含中和剂。在一个实施例中，水性胶体制备组合物可包含约0.01至约5重量％(如约0.5重量％)的中和剂。在一个实施例中，水性胶体制备组合物可包含约0.2至约2重量％的中和剂。在一个实施例中，水性胶体制备组合物可包含约0.3至约1重量％的中和剂。在一个实施例中，水性胶体制备组合物可包含约0.5重量％的中和剂。
一旦在导管或芯轴上干燥或固化，水性胶体粘合剂组合物就可包含：约55至约99.98重量％的丙烯酸压敏粘合剂；约0.02至约30重量％的聚丙烯酸聚合物；以及任选地，约0.02至约15重量％的中和剂。在一个实施例中，水性胶体粘合剂组合物可包含：约55至约99.96重量％的丙烯酸压敏粘合剂；约0.02至约30重量％的聚丙烯酸聚合物；以及约0.02至约15重量％的中和剂。在一个实施例中，水性胶体组合物可包含：约90至约99.4重量％的丙烯酸压敏粘合剂；约0.3至约5重量％的聚丙烯酸聚合物；以及约0.3至约5重量％的中和剂。在一个实施例中，水性胶体组合物可包含：约94至约99重量％的丙烯酸压敏粘合剂；约0.5至约3重量％的聚丙烯酸聚合物；以及约0.5至约3重量％的中和剂。在一个实施例中，水性胶体组合物可包含：约97至约98重量％的丙烯酸压敏粘合剂；约1至约1.5重量％的聚丙烯酸聚合物；以及约1至约1.5重量％的中和剂。在一个实施例中，水性胶体组合物可包含：约97重量％的丙烯酸压敏粘合剂；约1.5重量％的聚丙烯酸聚合物；以及约1.5重量％的中和剂。在一个实施例中，水性胶体组合物可包含：约98重量％的丙烯酸压敏粘合剂；约1重量％的聚丙烯酸聚合物；以及约1重量％的中和剂。
一旦在导管或芯轴上干燥或固化，水性胶体粘合剂组合物就可包含约55至约99.98重量％的丙烯酸压敏粘合剂。在一个实施例中，水性胶体粘合剂组合物可包含约55至约99.96重量％的丙烯酸压敏粘合剂。在一个实施例中，水性胶体组合物可包含约90至约99.4重量％的丙烯酸压敏粘合剂。在一个实施例中，水性胶体组合物可包含约94至约99重量％的丙烯酸压敏粘合剂。在一个实施例中，水性胶体组合物可包含约97至约98重量％的丙烯酸压敏粘合剂。在一个实施例中，水性胶体组合物可包含约97重量％的丙烯酸压敏粘合剂。在一个实施例中，水性胶体组合物可包含约98重量％的丙烯酸压敏粘合剂。
一旦在导管或芯轴上干燥或固化，水性胶体粘合剂组合物就可包含约0.02至约30重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体组合物可包含约0.02至约30重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体组合物可包含约0.3至约5重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体组合物可包含约0.5至约3重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体组合物可包含约1至约1.5重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体组合物可包含约1.5重量％的聚丙烯酸聚合物。在一个实施例中，水性胶体组合物可包含约1重量％的聚丙烯酸聚合物。
一旦在导管或芯轴上干燥或固化，水性胶体粘合剂组合物就可包含约0.02至约15重量％的中和剂。在一个实施例中，水性胶体组合物可包含约0.02至约15重量％的中和剂。在一个实施例中，水性胶体组合物可包含约0.3至约5重量％的中和剂。在一个实施例中，水性胶体组合物可包含约0.5至约3重量％的中和剂。在一个实施例中，水性胶体组合物可包含约1至约1.5重量％的中和剂。在一个实施例中，水性胶体组合物可包含约1.5重量％的中和剂。在一个实施例中，水性胶体组合物可包含约1重量％的中和剂。
水性胶体可包含生物粘合剂。合适的生物粘合剂的例子包括聚异丁烯和丙烯酸系粘合剂。水性胶体可以与生物粘合剂紧密混合，形成一体材料。
其他合适的水性胶体包括：天然树胶，如植物分泌物(阿拉伯树胶、茄替胶、刺梧桐胶和黄蓍胶)；植物籽胶(瓜耳胶、刺槐豆和金合欢)、海藻提取物(琼脂、褐藻胶、海藻酸盐和角叉菜胶)、谷物胶(淀粉和改性淀粉)、发酵或微生物胶(葡聚糖和黄原胶)、改性纤维素(羟甲基纤维素、微晶纤维素和羧甲基纤维素)、果胶、明胶、酪蛋白和合成树胶(聚乙烯吡咯烷酮、低甲氧基果胶、褐藻酸丙二醇酯、羧甲基刺槐豆胶和羧甲基瓜耳胶)以及水可溶胀或能水合的水性胶体。不论其水合状态，均使用术语“水性胶体”。
水性胶体组合物可包含多种组分。水性胶体组合物可以包含，例如，粘合剂基体、胶凝剂、吸收剂、定形剂、抗微生物剂，或上述组分的混合物。
合适的粘合剂基体包括聚异丁烯和丙烯酸类，两者均具有生物相容性的所需特性，且对皮肤及导管材料具有强粘合性。其他合适的粘合剂基体包括多种无毒的聚合物，如聚苯乙烯、聚丁二烯、苯乙烯异戊二烯嵌段共聚物、聚氨酯、硅酮橡胶、苯乙烯丁二烯共聚物、丙烯酸甲酯共聚物、聚丙烯酸、聚丙烯酸酯和以上聚合物的混合物或共聚物。
合适的基体包括用于涂敷于上皮的、能与粘膜表面和暴露的真皮相容的生物粘合剂。当使用聚异丁烯(PIB)时，合适的类型是热熔融的无溶剂高分子量(MW)化合物。可接受的高分子量聚异丁烯的例子是得自埃克森公司(Exxon Corp.)的“L-140”，其分子量范围为117,000至135,000道尔顿。组合物可包含低分子量聚异丁烯，如“LMH”，其分子量范围为11,600至12,300道尔顿。组合物可包含高分子量丙烯酸系粘合剂，如得自纽约州斯克内克塔迪的斯克内克塔迪国际公司(SchenectedyInternational,Inc.,of Schenectedy N.Y.)的“HRJ-4326”，其分子量范围为105,000至125,00道尔顿。组合物可以包含较低分子量丙烯酸系粘合剂，如同样得自斯克内克塔迪国际公司(Schenectedy International,Inc.)的“HRJ-10753”，其分子量范围为81,000-91,000道尔顿。在水性胶体组合物的实施例中，粘合剂基体构成水性胶体组合物的约20至约60重量％。
此处所用的术语“生物粘合剂”指一种粘合剂，其能附着到或(例如)可牢固地附接到生物表面，如皮肤或粘膜组织。合适的生物粘合剂包括能在潮湿或湿润的体内或体外环境下保持粘合的粘合剂。水性胶体组合物对表面的粘附强度可以通过用于测量力(如以达因每平方厘米为单位)的标准测试来测量，如美国专利No.4,615,697中所公开。
合适的胶凝剂包括在暴露于水或水溶液时能形成固体凝胶、明胶或高粘度液体的生物相容性化合物。合适的胶凝剂包括海藻酸钠、果胶、明胶和琼脂。
合适的吸收剂包括硅酸钙，以及天然或合成多糖。合适的多糖包括纤维素衍生物，如甲基纤维素、醋酸纤维素、羧甲基纤维素、羟乙基纤维素等。
某些吸收剂具有吸收水分或水性流体，并将其保留在胶体块中的能力。在典型的含水胶体块中，所吸收的水分或水性流体的重量可为吸收剂重量的许多倍。这些吸收剂包括多糖如刺梧桐树胶、黄蓍胶、果胶、瓜耳胶，纤维素和纤维素衍生物如甲基纤维素、丙基纤维素、醋酸纤维素等，以及其他已知可单独或与多种粘合剂基体组合用于形成能附着到皮肤和粘膜的固体胶体的物质。
其他合适的吸收剂包括任选地由部分酯化聚丙烯酸聚合物制备的吸收剂，包括但不限于与聚烯基聚醚轻度交联的聚丙烯酸聚合物，如商购自俄亥俄州辛辛那提的B.F.古德里奇公司(B.F.Goodrich,Cincinnati,Ohio)、商标为“934”、“934P”、“940”和“941”的产品。
其他合适的吸收剂包括亲水性多糖胶，如包括刺梧桐树胶、茄替胶、黄蓍胶、黄原胶、加拉亚胶等的天然植物分泌物，以及如瓜耳胶、刺槐豆胶、车前籽胶等种籽胶。
适用于组合物的定形剂包括如氯化钙、磷酸钙和硫酸钙等钙盐。对应的镁盐也可以用作定形剂。
可用于水性胶体组合物的抗微生物剂包括抗真菌剂(如硼酸镁)和其他已知的局部抗微生物剂，包括杆菌肽锌、聚维酮碘、苯扎氯铵、硫酸新霉素、多粘菌素B硫酸盐、磺胺嘧啶银盐和莫匹罗星。
包含水性胶体的硅胶护套
在一个实施例中，本发明可包括含有水性胶体硅酮组合物的护套。水性胶体硅酮组合物可包括硅酮橡胶、聚丙烯酸聚合物以及任选地中和剂。在此类实施例中，水性胶体组合物可为粘合剂层、一个或多个硅酮橡胶层，或者粘合剂层和硅酮橡胶层二者的组分。
在一个实施例中，本发明的导管保持器可包括由水性胶体硅酮组合物制成的套或护套。本发明的导管保持器可包括在粘合剂下方设置有一层水性胶体硅酮组合物的套或护套。虽然不限于本发明，但据信在粘合剂下方的水性胶体硅酮组合物可提高使用者在如移除避孕套导管时的舒适度。例如，粘合剂下方的水性胶体硅酮组合物可减少粘合剂所附着到的组织(如皮肤)的浸渍。
在一个实施例中，弹性材料的至少一部分可包含水性胶体。或者，粘合剂和弹性材料的至少一部分均包含水性胶体。
在一个实施例中，管状套或护套可由弹性材料制成(如硅酮橡胶、水性胶体硅酮组合物，或这两者的层)，并且可具有内表面和外表面。
在制造本发明的导管保持器的本方法的一个实施例中，该方法可包括：将水性胶体硅酮组合物涂敷于芯轴上和粘合剂组合物上；以及固化该硅酮橡胶以形成避孕套导管，该导管包含水性胶体粘合剂组合物、水性胶体硅酮组合物或两者的层；以及从芯轴上移除避孕套导管。
参见图，在一个实施例中，导管保持器1可由硅酮橡胶制成(例如，本发明的水性胶体硅酮组合物)。在某些实施例中，导管保持器1可通过结合两层或更多层硅酮橡胶溶液、或结合两层或更多层不同的硅酮橡胶溶液来制得。例如，一种溶液可以是硅酮橡胶溶液，而另一种溶液可以是水性胶体硅酮组合物溶液。
方法
本发明包括一种将导管插入患者的方法。该方法可包括提供导管保持护套。该导管保持护套可包括被配置成耦合到尿导管的杆的导管保持器。导管保持器可限定孔。孔的第一部分可被配置成允许尿导管的杆通过孔进行轴向运动。孔的第二部分可被配置成保持尿导管的杆。该方法还包括将尿导管的杆插入孔的第一部分中，将尿导管的杆的一部分插入患者的尿道中，并将尿导管的杆从孔的第一部分推进到孔的第二部分中。
本发明包括制造导管保持护套的方法。该方法包括在芯轴的一部分上施加硅酮橡胶并在硅酮橡胶中形成孔。孔的第一部分可被配置成允许尿导管的杆通过孔进行轴向运动。孔的第二部分可被配置成保持尿导管的杆。该方法还包括固化硅酮橡胶以形成限定孔的导管保持护套。
应当指出的是，如本说明书和所附权利要求中所用，除非内容另有明确说明，否则单数形式“一个”、“一种”和“所述”包括复数含义。因此，例如在提及包含“化合物”的组合物时，将包括两种或更多种化合物的混合物。还应当指出的是，除非内容另有明确说明，否则术语“或”通常包含“和/或”的含义。
还应当指出的是，如在本说明书和所附权利要求中所用，术语“配置成”描述了被构造或配置成执行一项特定任务或采用一种特定配置的系统、设备或其他结构。术语“配置成”可以同其他类似的短语互换使用，如布置和配置成、构造和布置成、适于和配置、适于、构造成、制造和布置等。
本说明书中的所有出版物和专利申请表明在本发明所属领域的普通技术人员的水平。
已结合多个具体且优选的实施例和技术来描述本发明。然而应当理解，可在保持在本发明的精神和范围内的同时进行多种变型和修改。
Claims (21)
1.一种导管保持护套，所述导管保持护套包括：
护套，所述护套被配置成配合在阴茎上；所述护套包括导管保持器，所述导管保持器被配置成耦合到尿导管的杆；
所述导管保持器限定围绕所述尿导管的所述杆的孔，所述孔的第一部分被配置成允许所述尿导管的所述杆通过所述孔的轴向运动，所述孔的第二部分被配置成保持所述尿导管的所述杆。
2.根据权利要求1所述的导管保持护套，其中所述孔的所述第一部分大于所述尿导管的杆的外径。
3.根据权利要求2所述的导管保持护套，其中所述孔的所述第一部分被配置成允许所述尿导管进入所述护套或避孕套部分并穿过所述护套或避孕套部分。
4.根据权利要求1所述的导管保持护套，其中所述孔的所述第二部分被配置成将所述尿导管固定在所述护套中。
5.根据权利要求1所述的导管保持护套，其中在将所述尿导管插入患者体内后，所述孔的所述第二部分被配置成限制所述尿导管相对于所述患者的阴茎和膀胱的运动。
6.根据权利要求1所述的导管保持护套，其中所述孔的所述第二部分在松弛状态下的尺寸与所述尿导管的所述杆的外径大致相同或比所述尿导管的所述杆的外径更小。
7.根据权利要求1所述的导管保持护套，还包括颈部分，所述颈部分限定所述孔的所述第二部分的部分或全部。
8.根据权利要求7所述的导管保持护套，其中所述颈部分包括耦合到所述护套的管，所述管限定轴向狭缝。
9.根据权利要求1所述的导管保持护套，其中所述导管保持器包括限定所述孔的所述第二部分的部分或全部的一体的锥形部分，所述一体的锥形部分比所述孔的所述第一部分更厚。
10.根据权利要求1所述的导管保持护套，其中所述导管保持器还限定狭缝，所述狭缝将所述孔的所述第一部分耦合到所述孔的所述第二部分。
11.根据权利要求1所述的导管保持护套，其中所述孔的所述第一部分和所述孔的所述第二部分彼此相邻且连通。
12.根据 权利要求1所述的导管保持护套，其中所述尿导管包括直型导管或弗利导管。
13.根据权利要求1所述的导管保持护套，其中所述护套还包括内表面和外表面，所述内表面包含被配置成附着到阴茎的粘合剂。
14.根据权利要求1所述的导管保持护套，还包括带，所述带由弹性材料制成并被配置成将所述护套保持在阴茎上。
15.根据权利要求1所述的导管保持护套，其中所述导管保持护套由包含硅酮的组合物制成。
16.根据权利要求1所述的导管保持护套，其中所述导管保持护套由硅酮橡胶制成。
17.根据权利要求1所述的导管保持护套，其中所述护套包括弹性材料的沿自身向外卷曲的管状套构件，所述套构件具有外表面和内表面，其中所述套构件的所述外表面与粘合剂层接触，而所述粘合剂层与所述套构件的所述内表面接触。
18.根据权利要求17所述的导管保持护套，其中所述粘合剂包含水性胶体组合物。
19.根据权利要求17所述的导管保持护套，其中所述粘合剂组合物位于一个或更多个连续辊的所述内表面和所述外表面之间，使得在所述护套处于卷起状态时所述粘合剂被所述内表面覆盖。
20.一种导管系统，所述导管系统包括：
尿导管，所述尿导管包括杆；以及
导管保持护套，所述导管保持护套包括：
护套，所述护套被配置成配合在阴茎上；所述护套包括导管保持器，所述导管保持器被配置成耦合到所述尿导管的所述杆；
所述导管保持器限定围绕所述尿导管的所述杆的孔，所述孔的第一部分被配置成允许所述尿导管的所述杆通过所述孔的轴向运动，所述孔的第二部分被配置成保持所述尿导管的所述杆。
21.一种制造导管保持护套的方法，所述制造导管保持护套的方法包括：
将硅酮橡胶施加到芯轴的一部分上；
在所述硅酮橡胶中形成围绕尿导管的杆的孔，所述孔的第一部分被配置成允许所述尿导管的杆通过所述孔的轴向运动，所述孔的第二部分被配置成保持所述尿导管的所述杆；并且
固化所述硅酮橡胶以形成限定所述孔的所述导管保持护套。
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| US13/682,406 | 2012-11-20 | ||
| PCT/US2013/071046 WO2014081853A1 (en) | 2012-11-20 | 2013-11-20 | Sheath for securing urinary catheter |
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| CN104812339B true CN104812339B (zh) | 2018-04-10 |
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| Publication number | Publication date |
|---|---|
| MX362377B (es) | 2019-01-14 |
| ES2864698T3 (es) | 2021-10-14 |
| CA2887790A1 (en) | 2014-05-30 |
| EP2922509A4 (en) | 2016-07-20 |
| CA2887790C (en) | 2020-03-24 |
| JP2015534899A (ja) | 2015-12-07 |
| US10092728B2 (en) | 2018-10-09 |
| JP6316837B2 (ja) | 2018-04-25 |
| CN104812339A (zh) | 2015-07-29 |
| US20140142554A1 (en) | 2014-05-22 |
| WO2014081853A1 (en) | 2014-05-30 |
| MX2015006058A (es) | 2015-08-07 |
| BR112015011239A2 (pt) | 2017-07-11 |
| EP2922509A1 (en) | 2015-09-30 |
| EP2922509B1 (en) | 2021-03-03 |
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