CN111182928A - 导尿管 - Google Patents
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
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- A—HUMAN NECESSITIES
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- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/145—Hydrogels or hydrocolloids
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/002—Packages specially adapted therefor ; catheter kit packages
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0136—Handles therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/10—Materials for lubricating medical devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/141—Plasticizers
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
- A61M2025/0047—Coatings for improving slidability the inner layer having a higher lubricity
- A61M2025/0048—Coatings for improving slidability the inner layer having a higher lubricity with an outer layer made from silicon
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
Abstract
描述了导尿管和容器。该导尿管可以具有附接到手柄上的导管轴,以及布置在导管轴的外表面上的涂层。该涂层可以包括水凝胶、水和/或甘油,以及聚乙二醇(PEG)。PEG可以具有等于或小于600的分子量,例如聚乙二醇(PEG)300和PEG 400中的一种或多种。该涂层可以在湿润状态下施加并且在该容器中在持续延长的时间段中保持湿润,由此避免了对伴随该容器中的导管的润滑剂(例如水囊或凝胶包装)的需要。该容器可以包括不透气的箔材料。该容器可以包括覆盖穿孔区段的粘合剂接片,该粘合剂接片包括拉环。
Description
优先权
本申请要求2017年10月4日提交的美国专利申请第15/724,879号的优先权。
背景技术
患有神经源性膀胱疾病(如脊髓损伤、脊柱裂或多发性硬化)和非神经源性膀胱疾病(如前列腺增大导致的梗阻、尿道狭窄或术后尿潴留)的人需要持续插入导管以排空他们的膀胱。然而,持续导管插入术可导致诸如尿道感染(UTI)、尿道狭窄或男性不育症的问题。定期间歇的导管插入避免了连续长期导管插入的许多负面影响。间歇的导管主要有四类:(1)裸露的间歇导管(Intermittent)、(2)亲水涂层的间歇导管、(3)预润湿的间歇导管、和(4)袋中的导管或“无接触”间歇导管。
裸露的间歇导管需要使用外部润滑方法。这些导管是最便宜和最常用的。典型的材料包括天然橡胶(胶乳)(NRL)、聚氯乙烯(PVC)和有机硅。常用的润滑方法是凝胶包。将凝胶施用于尿道口或导管自身的尖端。亲水涂层的间歇导管具有润滑涂层,该润滑涂层典型地施加到导管轴的前三分之二,并且在打开包装之前通过破坏位于包装内部的水囊而被激活。当被激活时,导管是光滑的以插入尿道。裸露的间歇导管和亲水涂层的间歇导管的潜在问题包括它们产生的脏乱量(例如来自水囊的过量水和来自润滑剂包的润滑剂的脏乱量(amount of mess))和使用者完成排泄过程所需的时间。
预润湿的间歇导管可以包装在不可渗透的包装(例如箔或刚性塑料)中并悬浮在水中。理想地,导管将在其整个保存期的长度上保持湿润,并且可以非常像已经被水激活的带亲水性涂层的间歇导管。除了包装在水中之外,预润湿的间歇导管还可以具有光滑涂层。这可以消除润滑导尿管的工艺步骤,但仍可能导致要对付一些脏乱(例如,包装中储存的水),并且涂层可能在其保存期内变干而使其不可用。
袋内导管或“无接触”间歇导管可包括裸露的间歇导管或亲水涂层间歇导管。在该袋的一端上可以存在插入尖端,其中该导管的远侧端被捕获在该插入尖端中。在使用时,使用者可以使用插入尖端将导尿管推出袋子,以帮助引导导管进入尿道。该袋可用于尿液收集。然而,使用无接触导管可能是麻烦且困难的。
以下是涉及涂层的参考文献:美国专利公开第2002/0016574号、美国专利公开第2008/0179208号和美国专利第6,059,107号,其通过引用并入本文。
发明内容
本文所述的导尿管提供了目前不可获得的新型间歇导管。该涂层可以表现出吸湿特性,吸湿特性本文所述为该涂层的以下特性或意图,即不仅保留该涂层中固有的水分而且从环境中吸引水分。涂层可表现出亲水性。本文所述的涂层是一种改进的配制品(formulation),该改进的配制品是在湿润状态下施加的并且在延长的时间段内保持湿润。因此,本文所述的导尿管不需要附加的润滑剂或润湿部件(例如水囊或凝胶包装)来伴随容器中的导尿管。本文所述的导尿管可以单独包装在分立的容器中,例如不透明的箔片。根据以下描述和所附权利要求,本发明的实施例的这些和其他特征将变得更加清楚明白,或者可以通过如下文阐述的本发明的实施例的实践来了解。
在一个实施例中,导尿管可以包括附接至手柄的导管轴。该导尿管还可以包括布置在该导管轴的外表面上的吸湿和/或亲水涂层。该涂层可以包括水凝胶、甘油或水,以及聚乙二醇(PEG)。在一个实施方案中,水凝胶可以是CG水凝胶或水凝胶,并且PEG可以是PEG 300和PEG 400中的一种或两种。在本文所述的关于特定水凝胶(例如CG水凝胶)的实施方案中,可以想到其他水凝胶(例如水凝胶)替代或添加到该特定的水凝胶。同样地,在本文描述的关于特定聚乙二醇(例如PEG300)的实施方案中,可以想到其他聚乙二醇替代或添加至该特定聚乙二醇。
在一个实施方案中,导尿管包括附接到手柄的导管轴和设置在导管轴的外表面上的第一涂层,第一涂层包括水凝胶或聚丙烯酸(PAA)、甘油和/或水,以及聚乙二醇(PEG),第一涂层表现出吸湿和/或亲水特性。在一个实施例中,导管轴的外表面包括第二涂层,第一涂层设置在第二涂层上。在一个实施方案中,第二涂层是亲水性涂层。
在一个实施方案中,本文所述的涂层配置品提供对包装材料的非粘附性(或抗粘连性)。在一个实施方式中,具有涂层的导管可以通过电子束(e-beam)灭菌或环氧乙烷(EtO)灭菌进行灭菌。在一个实施方案中,可在具有本文所述涂层的导管上施加另外的可紫外(UV)固化有机硅膜。有机硅膜可限制导管上的涂层。在一个实施例中,膜可以例如朝向导管手柄移动,由此充当非接触层,同时保持导管的润滑性。在一个实施例中,可UV固化有机硅膜经由UV固化工艺设置在涂层上。
在包装的导尿管的一个实施方案中,用于导尿管的涂层配置品(例如用于基底涂层和/或外涂层的配置品)可以包括在15%重量至35%重量的CG水凝胶、10%重量至45%重量的水和20%重量至75%重量的PEG。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、20%重量至30%重量的水和40%重量至60%重量的PEG 400。在一个实施方案中,涂层配置品可包含22%重量至26%重量的CG水凝胶、25%重量的水和49%重量至53%重量的PEG 400。在一个实施方案中,涂层配置品可以包括23.5%重量的CG水凝胶、25%重量的水和51.5%重量的PEG 400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、20%重量至30%重量的甘油和40%重量至60%重量的PEG400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、40%重量至60%重量的甘油和20%重量至30%重量的PEG 300。在一个实施方案中,涂层配置品可包含10%重量至35%重量的CG水凝胶、25%重量至75%重量的甘油、25%重量至65%重量的PEG 300和25%重量至50%重量的PEG400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、40%重量至60%重量的甘油、10%重量至15%重量的丙二醇(PEG)和10%重量至15%重量的乙醇(无水)。在一个实施方案中,CG水凝胶为50%重量,甘油为25%重量,并且PEG和乙醇均为12.5%重量。
在一个实施方案中,涂层配置品可包含15%重量至35%重量的水凝胶、15%重量至30%重量的甘油和35%重量至70%重量的PEG 400。在一个实施方案中,涂层配置品可以包括25%重量的水凝胶、25%重量的甘油,以及25%重量的PEG 300和PEG400。在一个实施方案中,涂层配置品可包含40%重量的水凝胶、15%重量的甘油、15%重量的PEG 300和30%重量的PEG 400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的20%重量至30%重量的水和40%重量至60%重量的PEG400。
在一个实施方案中,涂层配置品可包含0.2%重量至3%重量的聚丙烯酸(PAA)、15%重量至25%重量的甘油、20%重量至30%重量的水和40%重量至60%重量的PEG 400。在一个实施方案中,涂层配置品可以包含0.1%重量至2.5%重量的PAA、10%重量至45%重量的水和20%重量至65%重量的PEG,例如PEG 300和/或PEG 400。
在一个实施例中,可以在导管上的涂层上形成有机硅膜。在一个实施方案中,形成具有涂层的导管的方法包括将涂覆的导管(例如亲水性涂覆导管)浸渍到含有本文中的任何涂层配置品的溶液中,所述涂层配置品例如为包含PAA、水和PEG的涂层配置品,或包含水凝胶、甘油和/或水和PEG的涂层配置品,然后将两次涂覆的导管浸渍到UV可固化溶液中,然后将涂覆区域暴露于UV源,然后将导管直接置于包装中。在一个实施方案中,将亲水涂覆导管浸渍到PAA/水/PEG溶液中0.1秒至10秒的停留时间。在一个实施方案中,在将导管浸渍到PAA/水/PEG溶液中之后,将其浸渍到具有UV固化剂的有机硅溶液中数次以获得所需的膜厚度。在一个实施方案中,所需厚度为0.001英寸至0.004英寸。在一个实施方案中,将导管浸渍到具有UV固化剂的有机硅溶液中2至6次。在一个实施方案中,在浸渍到具有UV可固化剂的有机硅溶液中之后,在0.3分钟至2.0分钟的时间范围内将导管暴露于UV源,如UV光。在一个实施方案中,在暴露于UV源后,将导管直接放置到膜、箔和/或Tyvek包装中,而不需要进一步的干燥过程。
在一个实施方案中,制造导尿管的方法包括将第一涂层施加到导管轴上以形成涂覆的导尿管,所述第一涂层包含水凝胶或聚丙烯酸(PAA)、甘油和/或水和聚乙二醇(PEG),以及包括将所述涂覆的导尿管放置到包含不透气的箔材料的包装中。在一个实施例中,导管轴包括基础亲水性涂层,并且第一涂层施加在基础亲水性涂层上。在一个实施方案中,所述施加包括将具有所述基础亲水性涂层的所述导管轴浸渍到含有所述第一涂层的配置品的溶液中。在一个实施例中,第一涂层配置品仅包含PAA、水和PEG,其进一步包含将涂覆的导管浸渍到包含紫外线(UV)可固化剂的有机硅溶液中以在第一涂层上形成有机硅膜。在一个实施例中,该方法包括将有机硅膜暴露于UV光源一段时间以固化有机硅溶液。
在一个实施例中,导尿管可以包括接近导管尖端的孔眼或多个交错的、相对的孔眼(例如3个、4个、5个、6个、7个、8个或更多个孔眼),孔眼可以以各种方式布置,包括沿周向间隔约90度定位并且以非重叠构型定位。在一个实施例中,导尿管轴包括漏斗形近侧端和配置用于便于抓握的脊。在一个实施方案中,导尿管可以具有表现出吸湿特性的涂层。在另一个实施方案中,导尿管可以具有表现出亲水特性的涂层。
在一个实施例中,包装的导尿管可以包括容器和导尿管。该导尿管可以包括附接至手柄的导管轴和布置在导管轴的外表面上的涂层。在一个实施方案中,涂层可以包括水凝胶、甘油或水和PEG,例如PEG300和PEG 400中的一种或两种。在一个实施方案中,涂层可以包括PAA、甘油、水和PEG,例如PEG 300和/或PEG 400。在一个实施方案中,涂层可以包括PAA、水和PEG,例如PEG 300和/或PEG 400。
在包装的导尿管的一个实施例中,容器可包括不透气的箔材料。在包装的导尿管的一个实施例中,容器可以包括覆盖箔片材料的穿孔部分的粘合剂接片,粘合剂接片可以包括拉环。在一个实施例中,该容器可以在其中包括水囊、凝胶包或其他类型的润滑剂。在一个实施方案中,容器可包括水分源(与导尿管接触或分离),导尿管上的吸湿涂层和/或亲水涂层可从该水分源吸收或获得水分。在包装的导尿管的一个实施例中,容器在其中不包括任何水囊、凝胶包装或其他类型的润滑剂或水分源。
在一个实施例中,导管插入方法可包括获得可包括手柄和导管轴的导尿管。该导管轴可以在其外表面上包括亲水性涂层和/或吸湿性涂层。在一个实施方案中,涂层可包括本文所述的涂层配置品。该方法可以进一步包括将导尿管插入膀胱。在一个实施例中,插入导尿管的方法可以包括从存储导尿管的容器中获得导尿管。在一个实施方案中,导管插入的方法不包括在插入膀胱之前的任何时间,包括在包装中时,向导管轴施加润滑剂或水。
在一些实施例中,本文还提供了一种导尿管,该导尿管包括手柄和附接至手柄的导管轴。该手柄包括被配置成便于抓握该手柄的多个脊。该手柄还包括与该手柄一体的一个或多个环,该一个或多个环被配置成用于至少在导管插入过程中操纵该导管。该导管轴包括在该导管轴的尖端附近的多个相对孔眼,这些孔眼通过布置在该导管中的管腔与该手柄的近端中的开口处于流体连通,该导管连接该导管轴和该手柄。
在这样的实施例中,包括手柄的横截面的第一平面垂直于包括一个或多个环的至少一个开口的第二平面。
在此类实施例中,该手柄被配置成用于放置在患者或看护者的手中,同时该一个或多个环对应地接纳该患者或看护者的一个或多个手指。
在这样的实施例中,一个或多个环(loop)分别是一个或多个圆环(ring),每个圆环通过手柄的突片延伸部连接到手柄。
在这样的实施例中,相对的孔眼包括至少两对交错的孔眼,所述至少两对孔眼沿导管轴的长度交错并且在非重叠构型中围绕导管轴偏移约90度。
在这样的实施例中,导管进一步包括在导管轴上的亲水性基底涂层,基底涂层为0.2%重量至3%重量的PAA、15%重量至25%重量的甘油、20%重量至30%重量的水,以及40%重量至60%重量的PEG 400。
在这样的实施例中,导管进一步包括在导管轴上的亲水性基底涂层,基底涂层为0.1%重量至2.5%重量的PAA、10%重量至45%重量的水,以及20%重量至65%重量的PEG。
在这样的实施方案中,所述导管还包括在所述导管轴上的吸湿性外涂层,所述外涂层为20%重量至30%重量的水凝胶、20%重量至30%重量的甘油和40%重量至60%重量的PEG 400。
在这样的实施方案中,所述导管还包括在所述导管轴上的吸湿性外涂层,所述外涂层为20%重量至30%重量的水凝胶、40%重量至60%重量的甘油和20%重量至30%重量的PEG 300。
在这样的实施方案中,所述导管还包括在所述导管轴上的吸湿性外涂层,所述外涂层为10%重量至35%重量的水凝胶、25%重量至75%重量的甘油、25%重量至65%重量的PEG 300和25%重量至50%重量的PEG 400。
在这样的实施方案中,所述导管还包括在所述导管轴上的吸湿性外涂层,所述外涂层为15%重量至35%重量的水凝胶、10%重量至45%重量的水和20%重量至75%重量的PEG 400。
在这样的实施方案中,导管还包括在导管轴上的吸湿性外涂层,外涂层为22%重量至26%重量的水凝胶、25%重量的水,以及49%重量至53%重量的PEG 400。
在一些实施例中,本文还提供了一种导尿管,该导尿管包括手柄和附接至手柄的导管轴。该手柄包括被配置成便于抓握该手柄的多个脊。该手柄还包括与该手柄一体的一个或多个环,该一个或多个环被配置成用于至少在导管插入过程中操纵该导管。包括手柄的横截面的第一平面垂直于包括一个或多个环的至少一个开口的第二平面。该导管轴包括在该导管轴的尖端附近的多个相对孔眼,这些孔眼通过布置在该导管中的管腔与该手柄的近端中的开口处于流体连通,该导管连接该导管轴和该手柄。
在这样的实施例中,一个或多个环分别是一个或多个圆环,每个环通过手柄的突片延伸部连接到手柄。
在这样的实施例中,相对的孔眼包括至少两对交错的孔眼,所述至少两对孔眼沿导管轴的长度交错并且在非重叠构型中围绕导管轴偏移约90度。
本发明还提供了一种导尿管包,在一些实施例中,该导尿管包装包括导尿管和用于导尿管的包装。该导管包括附接到导管手柄上的导管轴。该手柄包括与该手柄一体的一个或多个环,该一个或多个环被配置成用于至少在导管插入过程中操纵该导管。包括手柄的横截面的第一平面垂直于包括一个或多个环的至少一个开口的第二平面。该导管轴包括在该导管轴的尖端附近的多个相对孔眼,所述孔眼通过布置在该导管中的管腔与该手柄的近端中的开口处于流体连通,该导管连接该导管轴和该手柄。该包装包括在该包装的穿孔区域上的粘合剂拉片,该粘合剂拉片被配置成当该拉片被拉动时暴露布置在该包装中的导管。
在这样的实施例中,导尿管手柄的一个或多个环分别是一个或多个圆环,每个环通过手柄的突片延伸部连接到手柄上。
在这样的实施例中,导管轴的尖端中的相对孔眼包括至少两对交错的孔眼,所述至少两对孔眼沿导管轴的长度交错并且在非重叠构型中围绕导管轴偏移约90度。
在这样的实施方案中,导尿管还包括在导管轴上的包括PAA的亲水性基底涂层、在导管轴上的包括水凝胶的吸湿性外涂层,或在导管轴上的亲水性基底涂层上的吸湿性外涂层的组合。
在这样的实施方案中,导尿管还包括在亲水性基底涂层、吸湿性外涂层或吸湿性外涂层与亲水性基底涂层的组合的至少一部分上的UV固化有机硅膜。
附图说明
参考以下附图可以更好地理解所公开的系统和方法。附图中的部件不必按比例绘制。应当理解,这些附图仅描绘了本发明的典型实施例,因此不应被认为是对其范围的限制。通过使用附图,将更具体和详细地描述和解释本发明的示范性实施例,在附图中:
图1示出了根据本文所述实施方式的导尿管的一个实施方式,并示出了根据本文所述实施方式的男性导尿管的示例性使用。
图2示出了根据本文所述实施方式的导尿管的一个实施方式,并示出了根据本文所述实施方式的女性导尿管的示例性使用。
图3a是根据本文所述的实施例的导尿管。
图3b是根据本文所述实施例的导尿管轴的剖视图。
图4a是根据本文所述的实施例的用于导尿管的容器的制造方法的第一步骤。
图4b是根据本文所述的实施例的用于导尿管的容器的制造方法的第二步骤。
图4c是根据本文所述的实施例的用于导尿管的容器的制造方法的第三步骤。
图5是处于关闭状态的根据本文所述的实施例的图4-7的导尿管的容器。
图6是打开的根据本文所述的实施例的图4-7的用于导尿管的容器。
图7是处于打开状态的图4-7的容器,显示了导尿管手柄。
图8a提供了示出根据一些实施例的导尿管的示意图,该导尿管包括用于操纵导管的第一环。
图8b提供了示出根据一些实施例的图8a的导管的手柄的近视图的示意图。
图8c提供了示出根据一些实施例的导尿管的示意图,该导尿管包括用于操纵导管的第二环。
图8d提供了示出根据一些实施例的图8c的导管的手柄的近视图的示意图。
图9a提供了示出根据一些实施例的导尿管的示意图,该导尿管包括用于操纵导管的第三环。
图9b提供了示出根据一些实施例的图9a的导管的手柄的近视图的示意图。
虽然本发明容许各种修改和替代形式,但其具体实施例已经通过附图中的实例示出并在本文中详细描述。然而,应理解,本文中对特定实施例的描述并非意图将本发明限于所揭示的特定形式,而是意图涵盖属于如所附权利要求书所界定的本发明的精神和范围内的所有修改、等效物和替代物。
具体实施方式
以下描述和示出了某些实施例的描述和附图以非限制性的方式说明了根据本发明的各个方面和特征的导管的几种可能的构型。虽然这里的描述以举例的方式主要集中于对导尿管和相关方法的描述,但是这里描述的发明不限于此,并且该构思可以应用于其他类型的导管和装置。
本文所述的导尿管准备好在容器打开时立即使用,并且可以由患者或患者的护理者在家庭护理环境、管理护理/辅助生活环境中或在医院中插入。在家庭护理环境中,导管可在休息室和非休息室环境的范围内使用。图1和图2示出了根据本文所述的实施例的导尿管和使用它们的方法。
图1示出根据本文描述的实施例的男性导尿管10、用于男性导尿管10的包装20及其示例性使用(例如参见步骤30-33),并且图2示出根据本文所述的实施例的女性导尿管50、用于女性导尿管50的包装60及其示例性使用(例如参见步骤70-73)。图1和图2中所示的方法不要求使用者在导尿管处于包装内时或在包装已经打开之后采取任何步骤将润滑剂(例如水或凝胶)直接施加到导尿管上。因此,使用者可以直接从将导管从包装30、70移除的步骤移动到插入导管32、72的步骤,而不需要插入直接润滑或水合步骤(参见示例性步骤31、71,其表示在从包装移除时导管准备好使用,而不需要添加水或润滑剂)。在图1和图2中使用的导管可以是本文所讨论的任何实施例的导管,例如,导管可以具有涂层配置品,该涂层配置品表现出吸湿和/或亲水特性(这消除了对使用者采取润滑或水化导管的步骤的需要)。在具有吸湿涂层的导管的情况下,虽然来自周围环境的一些水可能被该涂层天然吸引,但这不被认为是该方法中采取的直接润滑或水合步骤。在使用之后,可以根据卫生程序来处理导管10、50。示例性处理步骤33、73描绘了一种可能的处理程序,包括将导管返回到包装并丢弃垃圾桶或类似容器中的包装。该包装可以是可密封的(例如通过粘合剂、拉链锁等密封),使得该包装可以在导尿管放置在其中之后密封关闭。
参照图3a,在一个实施例中,导管100包括近侧端上的手柄102和附接到手柄102的导管轴104。导尿管可以是多种不同类型的导尿管中的一种。手柄102可以在其近侧端上具有漏斗状形状106,并且可以被适配成连接到排放袋、延伸管和/或类似物。此外,在本发明的范围内可以使用不同于漏斗状形状的手柄形状。手柄102可以指示导管的尺寸,并且可以具有颜色以指示性别(例如,对于女性为粉色,对于男性为蓝色)。在一个实施例中,导管轴104由有机硅材料制成。在一个实施例中,该有机硅材料具有在70A至85A的肖氏硬度范围内的硬度以及在1.1mm至2.27mm的范围内的厚度。应当理解,导管轴104的组成可以包括具有相似物理特性的其他材料,其落入本发明的范围内。在一个实施例中,导管轴104的柱强度被配置或设计成便于插入,例如,与当前的聚氯乙烯(PVC)导管相比,要求较小的力。在一个实施例中,导管100对于肉眼将是至少部分透明的。
参见图3a和3b,导管100包括在远侧端110中的开口114,开口114与延伸穿过导管轴和手柄的管腔150流体连通。在一个实施例中,导管包括邻近导管尖端108的四个交错的、相对的孔眼114,孔眼114在圆周上间隔大约90度定位并且以非重叠构型定位。应了解,开口的其他数目和配置属于本发明的范围内。手柄102包括脊112以提供更容易抓握和握持(handling)的抓握表面。导管轴104可以包括管腔150、导管壁152、亲水性基底涂层154(例如聚丙烯酸),并且还可以包括施加在其上的预水合外涂层156(例如涂层在基底涂层上)。该预水合的涂层可以在不施加水或润滑剂凝胶的情况下保持湿润。
在一个实施例中,导管100包括吸湿涂层156(例如顶部或外部预水合涂层)。在一个实施方案中,导管100包括吸湿性涂层156,所述吸湿性涂层156包括水凝胶、甘油、水和分子量等于或小于600的聚乙二醇(PEG),例如聚乙二醇(PEG)300和PEG 400中的一种或多种。在一个实施方案中,水凝胶是水凝胶。对于本文所述的涂层实施方案,水凝胶的类型可以是CG水凝胶,其INCI名称为甘油(和)丙烯酸甘油酯/丙烯酸共聚物(和)丙二醇。对于本文所述的涂层实施方案,水凝胶的类型可以是水凝胶。在一个实施方案中,导管包括涂层,该涂层包括水凝胶(例如水凝胶)、甘油、丙二醇(PEG)和乙醇。在一个实施方案中,导管包括涂层,该涂层包括水凝胶(例如水凝胶)、甘油或水和丙二醇(PEG),例如PEG300和/或PEG 400。在一个实施例中,导管可以以直径范围为从8Fr到24Fr的尺寸(例如8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr、22Fr、24Fr)出售和包装,其具有大于155mm的长度L并且旨在用于女性使用。然而,也可以使用其他尺寸的导管。在其他实施例中,导管可以各种尺寸出售和包装用于男性使用。
在一个实施例中,基底涂层154和/或外涂层156可以通过涉及浸渍、刷涂、喷涂或挤出的方法施加到导管轴。应当理解,可以使用将一种或两种涂层施加到导管上的其他方法,并且这些方法落入本发明的范围内。在一个实施方案中,可以将导管轴浸渍到一定体积的涂层配置品中。在一个实施方案中,将涂层配置品的组分混合在一起,然后将导管轴浸渍其体积中。例如,亲水性涂层或外涂层可通过将与水和PEG混合1.5至4.0小时来制备。可以将导管(具有或不具有基底涂层)浸渍到涂层溶液中并静置0.1-10秒。然后可以将导管从涂层溶液中取出并直接置于包装中而不需要任何进一步的干燥过程。
在一个实施方案中,在浸渍一种或多种涂层配置品以形成涂层(例如基底涂层和/或外涂层)之前,在导管中冲压孔眼,使得导管的内部和外部都被涂覆,即导管轴的外表面的至少一部分和限定导管轴的内腔150的内壁的至少一部分涂覆有涂层配置品。在其他实施方案中,可以将一种或多种涂层配置品刷涂到导管轴的外表面上(例如医生刀片法)。在一个实施例中,涂层(例如外涂层和/或外涂层)仅在导管轴(整个导管轴或其远侧部分)上,而不在手柄上。本文所述的涂层提供了摩擦系数(COF)在0.03至0.15范围内的导尿管。
在一个实施方案中,用于导管的涂层配置品(例如用于基底涂层和/或外涂层的配置品)可以包括15%重量至35%重量的CG水凝胶、10%重量至45%重量的水和20%重量至75%重量的PEG。在一个实施方案中,涂层配置品可包含15%重量至35%重量的CG水凝胶、2%重量至45%重量的水和20%重量至75%重量的PEG。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、20%重量至30%重量的水和40%重量至60%重量的PEG 400。在一个实施方案中,涂层配置品可包含22%重量至26%重量的CG水凝胶、25%重量的水和49%重量至53%重量的PEG 400。在一个实施方案中,涂层配置品可以包括23.5%重量的CG水凝胶、25%重量的水和51.5%重量的PEG 400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、20%重量至30%重量的甘油和40%重量至60%重量的PEG 400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、40%重量至60%重量的甘油和20%重量至30%重量的PEG 300。在一个实施方案中,涂层配置品可包含10%重量至35%重量的CG水凝胶、25%重量至75%重量的甘油、25%重量至65%重量的PEG 300和25%重量至50%重量的PEG 400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的CG水凝胶、40%重量至60%重量的甘油、10%重量至15%重量的丙二醇(PEG)和10%重量至15%重量的乙醇(无水)。在一个实施方案中,CG水凝胶为50%重量,甘油为25%重量,并且PEG和乙醇均为12.5%重量。
在一个实施方案中,涂层配置品可包含15%重量至35%重量的水凝胶、15%重量至30%重量的甘油和35%重量至70%重量的PEG 400。在一个实施方案中,涂层配置品可以包括25%重量的水凝胶、25%重量的甘油以及25%重量的PEG 300和PEG400。在一个实施方案中,涂层配置品可包含40%重量的水凝胶、15%重量的甘油、,15%重量的PEG 300和30%重量的PEG 400。在一个实施方案中,涂层配置品可包含20%重量至30%重量的20%重量至30%重量的水和40%重量至60%重量的PEG400。
在一个实施方案中,涂层配置品可包含0.2%重量至3%重量的聚丙烯酸(PAA)、15%重量至25%重量的甘油、20%重量至30%重量的水和40%重量至60%重量的PEG 400。在一个实施方案中,涂层配置品可以包含0.1%重量至2.5%重量的PAA、10%重量至45%重量的水和20%重量至65%重量的PEG,例如PEG 300和/或PEG 400。
在一个实施例中,可以在导管上的涂层上形成有机硅膜。在一个实施方案中,形成具有涂层的导管的方法包括将涂覆的导管例(如亲水性涂覆导管)浸渍到含有本文中的任何涂层配置品的溶液中,所述涂层配置品例如包含PAA、水和PEG的涂层配置品,或包含水凝胶、甘油和/或水和PEG的涂层配置品,然后将两次涂覆的导管浸渍到UV可固化溶液中,然后将涂覆区域暴露于UV源,然后将导管直接置于包装中。在一个实施方案中,将亲水涂层导管浸渍到PAA/水/PEG溶液中0.1秒至10秒的停留时间。在一个实施方案中,在将导管浸渍到PAA/水/PEG溶液中之后,将其浸渍具有UV固化剂的有机硅溶液中数次以获得所需的膜厚度。在一个实施方案中,所需厚度为0.001英寸至0.004英寸。在一个实施方案中,将导管浸渍到具有UV固化剂的有机硅溶液中2至6次。在一个实施方案中,在浸渍到具有UV可固化剂的有机硅溶液中之后,在0.3分钟至2.0分钟的时间范围内将导管暴露于UV源,如UV光。在一个实施方案中,在暴露于UV源后,将导管直接放置到膜、箔和/或Tyvek包装中,而不需要进一步的干燥过程。具有UV可固化剂的有机硅在固化后形成覆盖导管上的涂层的膜,并且可以在导管准备好插入时移初。这有助于插入而不接触润滑涂层,同时保持涂层在导管上的润滑性。
参照图4a-7,本文所述的导尿管可以单独包装在分立的容器中。例如,包装或容器可以是不透明的并且类似于不同于导尿管的物品,例如食品等。在一个实施例中,包装或容器210由箔材料形成和/或包括箔材料。在其他实施例中,容器210包括聚烯烃膜(例如聚乙烯(PE))、乙烯乙酸乙烯酯(EVA)膜和/或金属化聚丙烯(PP)膜。在一个实施方案中,包装材料是不透气的。在一个实施方案中,在正常环境储存条件下,涂层的润滑性在包装中随时间保持或改善。包装200可以具有颜色以指示性别(例如,对于女性为粉色,对于男性为蓝色)。在一个实施例中,包装200可通过电子束处理(电子束)或用环氧乙烷(EtO)处理来灭菌。
参照图4a-4c,在此讨论的制造用于导管的包装的方法包括以任何顺序执行的以下制造包装的步骤:提供片材211;通过切割材料在片材中提供弱化区域224,例如穿孔或轻触切割;折叠并连接片材211的纵向边缘250以形成背面接缝212和空腔252(图4b)。将导管100布置在空腔252内并通过密封端部而封闭在其中以产生第一端部接缝213和第二端部接缝214(图4c)。将粘合剂接片222粘附到弱化区域224上。
在一个实施方案中,这种布置可以类似于包装,例如可以在糖块上使用的包装,其中重叠的边缘沿着背部形成接缝并且在边缘处形成接缝。重叠边缘可以折叠到一侧或另一侧。该包装材料可以呈现光滑的正面。容器的前部可包括密封开口220,其由粘合剂接片222覆盖(图4c)。该密封开口可以在该包装材料中包括弱化区域224,例如穿孔或轻触切口,该弱化区域被该粘合剂接片222的粘合剂部分覆盖。粘合剂接片222可以包括诸如拉环226的特征,以在将导管100暴露在包装中之后悬挂容器,以便于使用者接近容器210中的导管100。粘合剂接片222可以由诸如聚对苯二甲酸乙二醇酯(PET)衬底的材料形成,在粘合剂接片的部分或整个底面上具有诸如S6粘合剂的粘合剂。在一个实施例中,粘合剂接片可以包括标签。该标签可以具有印刷在该标签的顶表面上或以其他方式与该顶表面相关联的艺术品。标签可以从材料卷冲压出,并且清漆可以施加在标签的远侧端228的大约1英寸上,以便于提升以开始剥离过程。
该粘合剂接片可以包括拉环226以便于打开该容器210,该拉环在打开(图7)之后可以被定位在钩子或类似物上以便悬挂该容器以便于使用。可替代地,粘合剂接片222的粘合部分可以压靠在硬表面(例如墙壁、桌子、课桌、设备等)上以防止容器移动。在一个实施例中,导管100可以重新插入到容器210中,并且粘合剂接片222向后按压在开口220上,以重新密封容器210,以便在另一个位置进行处理。通过简单地将手指穿过拉环226(图6)并将粘合剂接片朝着容器216的近端拉动,图4-7的实施例易于打开。该拉动动作沿着该弱化区域224打开该容器以显露该导管100的手柄102,该手柄具有抓握表面以便于搬运。此外,容器可以对折以最小化在手包、提包等中运输所需的空间。
现在参考图8a-8d、图9a和图9b,提供了示出根据一些实施例的包括用于操纵导管的环的导尿管的示意图。这样的环用于在至少导管插入过程期间操纵导管,特别是对于灵巧性有限或对于在这样的导管插入过程中缺乏对其手指的完全控制的个体。
类似于导管100,导管800、801、900包括围绕导管800、900的近端部分附接到手柄802、902的导管轴804、904。相对于导管轴802、902,它包括在导管轴804、904的远侧部分中的开口814、914,这些开口与延伸穿过导管轴804、904和手柄802、902的管腔(例如参见图3b的导管100的管腔150)流体连通。导管轴804、904包括靠近导管轴804、904的尖端808、908的相对的孔眼814、914,孔眼814、914经由导管800、900的内腔与手柄802、902的近端中的开口807、907流体连通,导管800、900的内腔连接导管轴804、904和手柄802、902。如图所示,相对的孔眼814、914可包括但不限于沿导管轴804、904的长度纵向交错的至少两对孔眼814、914,其中孔眼814、914以非重叠构型沿周向间隔约90度定位。换句话说,相对的孔眼814、914可以包括至少两对交错的孔眼814、914,所述孔眼814、914沿着导管轴804、904的长度交错并且在非重叠构型中围绕导管轴804、904偏移约90度。针对手柄802、902,其在其近端包括漏斗形形状806、906,漏斗形形状806、906适于连接到排放袋、延伸管或类似物。手柄802、902进一步包括多个脊812、912以及一个或多个环816、817、916,这些脊被配置成便于由个体握持手柄802、902,这些环至少在导管插入过程中在操纵导管800、801、900中是有用的。
相对于一个或多个环816、817、916,这样的环与手柄802、902是一体的,例如与手柄802、902模制在一起,以便为环816、817、916提供足够坚固的结构完整性,以承受在导管插入过程中在环816、817、916上的拉动和拖拉。导管800、900的该一个或多个环816、916被配置成使得包括手柄802、902的横向截面的第一平面垂直于包括该一个或多个环816、916中的至少一个或该一个或多个环816、916的开口的第二平面。这样的构造使得右手或左手的个体同样能够用诸如导管800、900的导管执行导管插入过程,其中手柄802、902放置在个体(例如人、患者或护理者)的手中,同时一个或多个环816、916分别接收个体的一个或多个手指。可替代地,在一些实施例中,前述第一平面和第二平面可以是彼此倾斜的,以便为导管800、900提供左手性或右手性。也就是说,导管801的一个或多个环817被配置成使得包括手柄802的横截面的第一平面平行于包括一个或多个环817中的至少一个或一个或多个环817的开口的第二平面。照此,一个或多个环816、817、916可以被设计成具有多种构型中的任一种,包括前述构型及其组合,以适应不同的需要。
如在此使用的,“环(loop)”包括导管800、801、900的手柄802、902的延伸部,该延伸部被配置成例如在导管插入过程期间接收个体的手指,用于操纵导管800、801、900。这样的环包括图8a和图8b的导管800的环816,该环816是通过手柄的突片延伸部818附接到导管800的手柄802上的圆环(ring),该圆环和突片延伸部818一起是手柄802的一体环。这样的环还包括图8c和图8d的导管801的环817,该环817是通过手柄的突片延伸部819连接到导管801的手柄802上的圆环,该圆环和突片延伸部819一起是手柄802的一体式环,尽管其取向不同于导管800的取向。这样的环还包括图9a和9b的导管900的环916,该环916不需要、但可以包括手柄的突片延伸部,例如导管800的突片延伸部818。
在一些实施例中,导管800、801、900包括在导管轴上的包括例如PAA的亲水性基底涂层、在导管轴上的包括例如水凝胶的吸湿性外涂层,或在导管轴上的亲水性基底涂层上的吸湿性外涂层的组合。本文描述了用于导管100的这种涂层。例如,导管轴上的亲水性基底涂层可以是0.2%重量至3%重量的PAA、15%重量至25%重量的甘油、20%重量至30%重量的水和40%重量至60%重量的PEG 400的基底涂层。或者,所述亲水性基底涂层可以是0.1%重量至2.5%重量的PAA、10%重量至45%重量的水和20%重量至65%重量的PEG的基底涂层。例如,导管轴上的吸湿性外涂层可以是20%重量至30%重量的水凝胶、20%重量至30%重量的甘油和40%重量至60%重量的PEG 400的外涂层。或者,所述吸湿性外涂层可以是20%重量至30%重量的水凝胶、40%重量至60%重量的甘油和20%重量至30%重量的PEG 300的外涂层。或者,所述吸湿性外涂层可以是10%重量至35%重量的水凝胶、25%重量至75%重量的甘油、25%重量至65%重量的PEG 300和25%重量至50%重量的PEG 400的外涂层。或者,所述吸湿性外涂层可以是15%重量至35%重量的水凝胶、10%重量至45%重量的水和20%重量至75%重量的PEG400的外涂层。或者,所述吸湿性外涂层可以是22%重量至26%重量的水凝胶、25%重量的水和49%重量至53%重量的PEG 400的外涂层。另外,导管800、801、900可进一步包括在如本文针对导管100所述的亲水性基底涂层、吸湿性外涂层或吸湿性外涂层与亲水性基底涂层的组合的至少一部分上的UV固化有机硅膜。
与导管100类似,导管800、801、900可以是导管包装的一部分,其中导管包装的包装(例如图5-7的包装200)包括包装的穿孔区域(例如图4a-4c和图7的穿孔区域224)上的粘合剂拉片(例如图5-7的粘合剂拉片222),该粘合剂拉片配置用于当拉动拉片时,暴露设置在包装中的导管800、801、900。
基于需要使用诸如间歇导管的导管来排空其膀胱的损伤而被限制在轮椅中的个体通常不能完全控制其手指,因为需要以一致的方式对其自身进行导管插入。导管800、801、900的一个或多个环816、817、916通过将一个或多个手指分别滑入导管800、801、900的一个或多个环816、817、916中来为这些个体提供独立性,以帮助这些个体更好地操纵导管800、801、900以便在导管插入过程期间插入和移除。因此,导管800、801、900的一个或多个环816、817、916以更方便和可控制的方式向灵巧性有限的人们(例如患者、看护者、消费者等)提供一种方式,来使用仅仅单个手指来操纵导管800、900(例如间歇导管)。
虽然已经根据特定变化和说明性附图描述了本发明,但是本领域的普通技术人员将认识到,本发明不限于所描述的变化或附图。本领域的普通技术人员将认识到,本发明不限于导管的应用,而是可以应用于需要类似润滑的任何装置。另外,在上述方法和步骤指示以特定次序发生的特定事件的情况下,所属领域的技术人员将认识到,可修改特定步骤的次序,且所述修改是根据本发明的变化形式。另外,某些步骤可以在可能时在并行过程中同时执行,以及如上所述顺序执行。此外,在一个实施例中描述的特征通常可以与在其他实施例中描述的特征组合。因此,在存在本发明的变化的情况下,这些变化在本发明的精神内或等同于在权利要求书中找到的发明,本专利也意图涵盖这些变化。
Claims (20)
1.一种导尿管,包括:
手柄,包括:
设计用于抓握所述手柄的多个脊;以及
与所述手柄成一体的一个或多个环,所述环设计用于操纵所述导尿管;和
附接至所述手柄的导管轴,所述导管轴包括:
导管尖端;
管腔;和
邻近所述导管尖端的多个孔眼,所述孔眼与所述管腔流体连通。
2.根据权利要求1所述的导尿管,其中,包括所述手柄的横截面的第一平面垂直于包括所述一个或多个环的至少一个开口的第二平面。
3.根据权利要求1所述的导尿管,其中,所述手柄被配置用于放置在患者或护理者的手中,同时所述一个或多个环分别接收所述患者或所述护理者的一个或多个手指。
4.根据权利要求1所述的导尿管,其中,所述一个或多个环分别为一个或多个圆环,每个圆环通过所述手柄的突片延伸部附接至所述手柄。
5.根据权利要求1所述的导尿管,其中,所述多个孔眼包括至少两对交错的孔眼,所述至少两对交错的孔眼沿所述导管轴的长度交错并以非重叠构型围绕所述导管轴偏移约90度。
6.根据权利要求1所述的导尿管,进一步包括:
在所述导管轴上的亲水性基底涂层,所述基底涂层为0.2%重量至3%重量的PAA、15%重量至25%重量的甘油、20%重量至30%重量的水和40%重量至60%重量的PEG 400。
7.根据权利要求1所述的导尿管,进一步包括:
在所述导管轴上的亲水性基底涂层,所述基底涂层为0.1%重量至2.5%重量的PAA、10%重量至45%重量的水和20%重量至65%重量的PEG。
8.根据权利要求1所述的导尿管,进一步包括:
在所述导管轴上的吸湿性外涂层,所述外涂层为20%重量至30%重量的水凝胶、20%重量至30%重量的甘油和40%重量至60%重量的PEG 400。
9.根据权利要求1所述的导尿管,进一步包括:
在所述导管轴上的吸湿性外涂层,所述外涂层为20%重量至30%重量的水凝胶、40%重量至60%重量的甘油和20%重量至30%重量的PEG 300。
10.根据权利要求1所述的导尿管,进一步包括:
在所述导管轴上的吸湿性外涂层,所述外涂层为10%重量至35%重量的水凝胶、25%重量至75%重量的甘油、25%重量至65%重量的PEG 300和25%重量至50%重量的PEG400。
11.根据权利要求1所述的导尿管,进一步包括:
在所述导管轴上的吸湿性外涂层,所述外涂层为15%重量至35%重量的水凝胶、10%重量至45%重量的水和20%重量至75%重量的PEG 400。
12.根据权利要求1所述的导尿管,进一步包括:
在导管轴上的吸湿性外涂层,所述外涂层为22%重量至26%重量的水凝胶、25%重量的水和49%重量至53%重量的PEG 400。
13.一种导尿管,包括:
手柄,包括:
设计用于抓握所述手柄的多个脊;以及
与所述手柄成一体的一个或多个环,所述环设计用于操纵所述导管,其中包括所述手柄的横截面的第一平面垂直于包括所述一个或多个环的至少一个开口的第二平面;和
附接至所述手柄的导管轴,所述导管轴包括:
导管尖端;
管腔;和
邻近所述导管尖端的多个孔眼,所述孔眼与所述管腔流体连通。
14.根据权利要求13所述的导尿管,其中,所述一个或多个环分别是一个或多个圆环,每个圆环通过所述手柄的突片延伸部附接至所述手柄。
15.根据权利要求13所述的导尿管,其中,所述多个孔眼包括至少两对交错的孔眼,所述至少两对交错的孔眼沿所述导管轴的长度交错并以非重叠构型围绕所述导管轴偏移约90度。
16.一种导尿管包,包括:
导尿管,包括附接至手柄的导管轴,所述手柄包括与所述手柄成一体的一个或多个环,所述环被设计用于操纵所述导尿管,其中,包括所述手柄的横截面的第一平面垂直于包括所述一个或多个环的至少一个开口的第二平面,所述导管轴包括导管尖端、管腔以及邻近所述导管尖端的多个孔眼,所述孔眼与所述管腔流体连通;
以及包装,所述包装包括在所述包装的穿孔区域上的粘合剂拉片,所述粘合剂拉片被配置用于当所述拉片被拉动时暴露设置在所述包装中的所述导管。
17.根据权利要求16所述的导尿管包,其中,所述导管手柄的所述一个或多个环分别是一个或多个圆环,每个圆环通过所述手柄的突片延伸部附接至所述手柄。
18.根据权利要求16所述的导尿管包,其中,靠近所述导管轴的尖端的所述多个孔眼包括至少两对交错的孔眼,所述至少两对交错的孔眼沿所述导管轴的长度交错并且以非重叠构型绕所述导管轴偏移大约90度。
19.根据权利要求16所述的导尿管包,所述导尿管进一步包括在导管轴上的涂层,所述涂层包括:
包含PAA的亲水性基底涂层;
包含水凝胶的吸湿性外涂层;或
在亲水性基底涂层上的吸湿性外涂层的组合。
20.根据权利要求19所述的导尿管包,所述导尿管进一步包括在所述亲水性基底涂层、所述吸湿性外涂层,或所述吸湿性外涂层与所述亲水性基底涂层的组合的至少一部分上的UV固化有机硅膜。
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