CN1520321A - 导尿管组件阀系统 - Google Patents

导尿管组件阀系统 Download PDF

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CN1520321A
CN1520321A CNA02812958XA CN02812958A CN1520321A CN 1520321 A CN1520321 A CN 1520321A CN A02812958X A CNA02812958X A CN A02812958XA CN 02812958 A CN02812958 A CN 02812958A CN 1520321 A CN1520321 A CN 1520321A
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catheter
package
flexible pipe
assembly
valve member
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CN1264487C (zh
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ƺ������
阿兰·唐赫伊
�B����ɭ
拉尔斯·B·延森
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Coloplast AS
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Priority claimed from US09/893,514 external-priority patent/US20030004496A1/en
Priority claimed from DK200101041A external-priority patent/DK200101041A/da
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • AHUMAN NECESSITIES
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    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404Details or parts
    • A61F5/4405Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0015Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0017Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/002Packages specially adapted therefor ; catheter kit packages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0111Aseptic insertion devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/16Making multilayered or multicoloured articles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046Coatings for improving slidability
    • AHUMAN NECESSITIES
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    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/221Frangible or pierceable closures within tubing
    • A61M2039/222Frangible or pierceable closures within tubing frangible within tubing or bags
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/16Making multilayered or multicoloured articles
    • B29C45/1676Making multilayered or multicoloured articles using a soft material and a rigid material, e.g. making articles with a sealing part
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037Other properties
    • B29K2995/0092Other properties hydrophilic
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7542Catheters

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Abstract

本发明涉及一种导尿管组件,该导尿管组件具有导尿管和用于该导尿管的包装件。该包装件和导尿管提供有密封件,该密封件限制在包装件和导尿管之间的流体通道。该组件使得导尿管可以在不完全从包装件中取出的情况下使用。在排尿过程中,该组件防止尿从导管的出口通过包装件沿朝着导尿管用户的方向回流。该密封件在保持密封的同时使得导尿管能够从包装件中分配,因此,该组件能够无污染地插入并在导尿管部分保持在包装件中时使用该导尿管。

Description

导尿管组件阀系统
发明领域
本发明涉及一种导尿管组件,该导尿管组件包括包装件,该包装件能够用于导尿管的储存,使该导尿管能够无污染地插入个人的尿道或人造尿道中。
发明背景
用于排空膀胱的导尿管越来越多地用于间歇性以及内置或永久性的插入导管。通常,导尿管用于患有尿失禁的病人或者象截瘫或四肢麻痹这样的残疾人,他们可能无法随意控制排尿,插入导管可以成为他们的排尿方式。
通常,供给用户的导尿管装入完全密封和无菌的包装件内。在使用过程中和插入之前,该导尿管通常完全从该包装件中取出,从而可能污染该导尿管,例如,当用户无意中接触该导尿管时,或者当该导尿管接触周围障碍物例如马桶座、洗面池等时。已经存在这样的导管包装件和导管和包装件组件,其中,该包装件的近端和远端可以打开,因此使尿能够通过仍然部分装于该包装件中的导尿管排出。因此,用户可以在不使导尿管完全暴露的情况下排尿,并可以减小污染危险。不过,因为在导管包装件的内表面和导管自身的外表面之间有间隙,尿可以沿与导尿管内部的流动方向相反的方向往回流入该包装件内。不希望发生的情况是:尿或其它液体物质例如施加在导尿管上以便减小表面摩擦的润滑剂或水弄脏该导尿管的使用者和/或周围环境。
因为在导尿管插入之前只有导尿管的插入部分从包装件中露出,因此,另一不希望发生的情况是:用户可能无意中忘记打开导尿管包装件的另一端。一定量的尿可能因此积累在导尿管包装件中,并可能在导尿管中回流。这时,有严重污染环境的危险,还可能回流至膀胱中。
而且,现有的导尿管有不同尺寸。例如,相对较长的导尿管意愿男人,而相对较短的导尿管用于女人。相同产品的更多类型意味着导尿管的供应商有更多问题和需要更大成本。
已知的、包括导尿管和包装件的导尿管组件包括一定量的、用于普通导尿管的液体物质例如润滑剂或用于亲水导尿管的液体膨胀介质。某些现有的包装件提供了在用于无菌储存导尿管的储存容积和用于收集液体物质(例如用于收集减摩擦物质或用于收集尿)的储存器之间的组合。通常,用于储存减摩擦物质和尿分别所需的储存容量很不均衡。因此,这种已知导尿管组件在相对较大的尿储存器内部提供有相对较小储存容器,用于储存减摩擦物质。该已知组件的缺点是,用户在将导尿管插入尿道之前必须使储存容器破裂,以便形成较小表面摩擦的导尿管。特别是,当导尿管是涂覆有亲水材料的导尿管时很不利。这时,用户需要打开储存容器,以便使储存在其中的液体膨胀介质能激活该涂层,随后等待至少30秒,以便在将导尿管插入之前完全激活该涂层。
发明的说明
本发明的目的是通过提供一种导尿管组件来克服已知导尿管组件的上述缺点,根据本发明的第一方面,该导尿管组件能够使导尿管直接从包装件中插入尿道中,同时不与导尿管接触和不污染外部环境。该组件包括:
导尿管,该导尿管确定了导管,并有用于插入个人尿道内的近端和相对的远端;
导尿管包装件,该导尿管包装件有软管,该软管有用于容纳导尿管的空腔,且该导尿管包装件有在它近端的导尿管出口,该导尿管出口用于使导尿管的近端与导尿管包装件分开(dismantle);以及
密封装置,该密封装置用于当导尿管与包装件分开时在导尿管包装件和导尿管之间提供基本液密的密封。
由于密封装置,导尿管可以与包装件分开,直到露出的导尿管长度足够用于膀胱的开口。这时,尿可以排入导尿管的近端,并从该导尿管进入软管,且通过该软管通向处理位置,例如通向马桶。因此,包装件的软管起到导尿管的延伸部分的作用,使得用户例如可以在不必从轮椅或床上站起来的情况下达到马桶。因为密封装置在导尿管和软管之间密封,因此它保证尿不会在软管和导尿管之间回流并在包装件的、与导尿管分开的端头(即该包装件的、沿朝着人的方向延伸的端头)处排出。显然,流体从该端排出将会污染环境和/或个人。
密封部件可以布置在包装件的近端中,例如构成用于包装件的近端的封闭件。例如,该封闭件可以有可破裂部分,该可破裂部分的形状与导尿管的外部截面形状匹配。当导尿管穿过该可破裂部分移动时,封闭件将密封环绕导尿管,同时导尿管分开。因此,该空腔确定了在导尿管和软管之间的容器。该空腔例如可以用于储存低摩擦物质。
密封装置还可以布置在导尿管的外表面和软管的内表面之间。例如,密封装置可以布置成滑动密封件的形式,该滑动密封件用于相对于软管的内表面和导尿管的外表面中的一个运动,或者相对于该软管的内表面和导尿管的外表面运动,同时仍然在该软管的内表面和导尿管的外表面之间提供基本液体密封的通道。因此,该空腔确定了在导尿管和软管之间的、位于包装件的近端附近的上部容器以及位于相对位置的下部容器。优选是,上部容器可以用于储存减小摩擦的物质,至少用于处理在包装件中的导尿管的近端。
导尿管或导尿管的至少一部分可以提供有亲水表面,该亲水表面既可以为导尿管涂层的形式,也可以是整个导尿管由亲水材料制成。当用液体膨胀介质处理时,该表面将提供用于插入的良好润滑,还能够与身体组织相容。
导尿管也可以为普通类型,其中,低摩擦特征通过施加不同于水的润滑剂而获得,该低摩擦特征例如基于硅酮的润滑剂,该润滑剂用于该导尿管的至少一部分。
当导尿管布置在包装件中时,用于亲水表面的液体膨胀介质可以布置在包装件中,尤其是在上部储存隔腔内,并靠近导尿管的近端。因此,当导尿管布置在包装件中时就已经获得低摩擦特征。该液体膨胀介质可以仅仅是盐水溶液、能够使亲水表面膨胀且能够使该表面保持无菌状态的杀菌溶液,或者它可以是任意合适的液体膨胀介质。该膨胀可以在包装导尿管之前就已经开始,然后,该导尿管装入基本不透气的包装件中,以便保持湿润表面。而且,液体膨胀介质可以布置在包囊或容器中,该包囊或容器与导尿管一起直接位于软管部件中,用于在要插入之前使亲水表面膨胀。
优选是,导尿管包装件的材料为至少基本不透气和不透水,且它对于至少中等外部条件具有耐久性,该中等外部条件例如温度变化和光照。该材料应当在12个月或更多月(例如24个月)中至少基本保持它的性质。因此,该导尿管包装件和/或软管部件优选是由以下材料制成:硅酮或热塑性弹性体材料、其它热塑性材料、可固化弹性体材料、聚酰胺树脂或弹性体、或者它们的任意组合,即,该材料组可以包括例如:PA、PP、PVC、PU、PE、乳胶、和/或KratonTM。导尿管包装件的所有部分都可以由两层沿边缘连接的材料片薄膜制成,例如通过熔化、胶接或其它任意方式将该薄膜粘接在一起。该包装件还可以由挤出的、在两端封闭的基本管形部件制成。优选是,该薄膜可以由不同材料叠片制成。例如,一层可以由铝或类似金属制成,或者由金属成分(例如包括铝)制成。该层将提供完全不透气的包装件。
导尿管包装件的近端和远端可以提供有均匀结构。不过,优选是该包装件的近端提供有开口装置,该开口装置用于使导尿管的近端移动。同样,该包装件的远端可以提供有开口装置,该开口装置特别用于将液体物质从包装件中排出。该液体物质可以是减小摩擦介质或尿。
优选是,软管部件为细长和/或管形部件,用于容纳导尿管的至少主要部分。当这种导尿管将通过用液体介质或物质处理而获得低摩擦表面特征时,优选是,使该液体介质在包装件中,特别优选是在软管部件中。因此,该导尿管将在它从包装件中取出时进行了处理。因此,优选是该软管部件用于相对紧密地包围导尿管。例如,在软管部件的内表面中的内径或截面面积可以是导尿管的外表面中的外径或截面面积的1.1-2倍,例如1.2-1.9倍、1.3-1.8倍、1.4-1.7倍、1.5-1.6倍,例如尺寸为导尿管的外径或截面面积的1.55倍。也可选择,液体介质可以装入与包装件相连的囊袋中。该囊袋例如可以构成用于封闭包装件的近端或远端的封闭件。优选是,该囊袋与用于封闭包装件的近端的封闭件成一体,该近端位于导尿管的近端附近。
当导尿管为亲水性导尿管时,即当导尿管涂覆有亲水涂层或完全由亲水材料制成时,液体物质可以是水或水/盐水溶液。当导尿管为主要具有憎水表面的普通类型时,液体物质可以是润滑剂,例如基于硅酮的润滑剂。
密封装置可以布置成障碍物的形式,它基本防止液体物质在包装件的内表面和导尿管的外表面之间通过。因此,密封装置将确定于导尿管和软管部件之间的空间分成靠近导尿管和包装件的近端的上部容器以及靠近导尿管和包装件的远端的下部容器。
例如,密封装置可以提供为导尿管外表面的、径向向外伸出的凸起,或者提供为软管部件内表面的、径向向内伸出的凸起,例如为用于分别与软管部件的内表面或导尿管的外表面接触的弹性叶片(vane)的形式。这时,导尿管的、向外伸出的凸起既可以理解为与导尿管相连的凸起,也可以是直接形成于该导尿管表面上的凸起。例如,导尿管可以与塞子部件相连,该塞子部件提供有叶片,该叶片用于沿软管或至少一部分软管的内表面滑动。同样,应当知道,软管的、向内伸出的凸起既可以理解为与软管相连的凸起,也可以理解为直接形成于该软管内表面上的凸起。
导尿管的外表面和/或软管部件的内表面的、两个或更多径向向外或向内伸出的凸起将提供用于防止液体物质在两个隔腔之间流动的更好密封。通过使软管部件内表面的、至少两个径向向内伸出的凸起具有不同径向尺寸,可以获得进一步的密封效果。
根据优选实施例,密封装置包括布置在软管部件的内表面和导尿管的外表面之间的环形部件。例如,标准环形垫圈可以布置在软管部件内部。优选是,该部件松弛布置,这样,它能够在软管内部来回运动。例如,环形部件可以相对于软管部件和导尿管有一定间隙,这样,可以基本防止液体物质通过该环形部件,并使该环形部件能够在导尿管包装件中来回纵向移动。
优选是,该环形部件可以用于与软管部件内表面的、向内伸出的凸起或者与导尿管的、向外伸出的凸起配合。
从导尿管的远端到密封装置的位置的距离优选是在导尿管的远端和导尿管的近端之间的总距离的0和100%之间,例如0%、10%、20%、30%、40%、50%、60%、70%、80%、90%、99%。
通常,将导尿管引入尿道中的问题不仅取决于导尿管的引入部分的尺寸,而且取决于引入部分的滑动性。如前所述,用于插入尿道或人造尿道中的导尿管或至少部分导尿管通常可以具有表面滑动性,以便安全、容易地插入。不过,已经发现滑动表面很难操作,至少对于灵活性较差的用户。因此,本发明的重要方面是使用户能够通过只与导尿管包装件接触而操作该导尿管,并只使导尿管露出打开膀胱所需的长度。优选是,该密封装置布置成在特定分开长度范围内以及在导尿管的外表面和软管的内表面之间密封。这使得导尿管的用户能够将该导尿管至少部分从包装件中抽出,例如通过将导尿管的近端拉出导尿管包装件。同时保持在导尿管和包装件之间的密封。该特征使得一种长度的导尿管既可以用于男用户,也可以用于女用户。用户只需要将打开膀胱所需的一定长度的导尿管从导尿管包装件中抽出,即:对于女用户,大约为50-90mm,而对于男用户,大约为180-250mm。
优选是,密封装置和/或软管部件布置成当导尿管在第一分开阶段进行分开时,在导尿管的外表面和软管部件的内表面之间不形成通道,从而在密封装置布置在所述第一阶段中时防止流体从导尿管和软管部件之间通过。
为了使减摩擦物质不污染外部环境,优选是使可能储存在上部容器中的该物质在导尿管通过包装件的近端分开之前向下排入下部容器中。因此,该密封装置和/或软管优选是布置成在第二分开阶段,在导尿管的外表面和软管部件的内表面之间确定有间隙,从而当密封装置位于所述第二阶段中时使流体从导尿管和软管部件之间通过。当导尿管离开包装件时,导尿管进入第二分开阶段。装于上部容器中的任何液体物质向下排入下部容器中,从而避免该物质不幸从包装件的近端释放。
第一分开阶段的长度优选是构成为包装件总长度的0和100%之间,例如0%、10%、20%、30%、40%、50%、60%、70%、80%、90%、100%。
根据一个实施例,在第一分开阶段,在导尿管包装件和导尿管之间连续提供基本液密密封。不过,该液密密封也可以不连续地提供,例如成阶梯式。
当用减小摩擦物质处理时,大部分导尿管的表面有低摩擦表面特征。因此,优选是包装件确定了液体密封的润湿袋,用于利用该物质处理表面部分。当导尿管为亲水性或至少在它的近端提供有亲水表面涂层时,该物质通常为水基溶液,例如盐水溶液。当导尿管并不亲水时,该物质例如可以是基于硅酮的溶液。
还优选是,使该组件所具有的物质量足以对导尿管表面的至少一部分进行处理。例如,处理可以在导尿管的第一部分上进行,该部分用于插入尿道内。优选是,该处理可以在上部容器中进行。
根据本发明的优选实施例,该物质包含在与组件相连的囊袋。例如,该囊袋可以构成为用于封闭包装件的近端或远端中的一个的封闭件。优选是,至少该包装件的近端,即靠近导尿管近端的端部由囊袋封闭,这样,该物质可以从囊袋中挤出到导尿管的可插入近端上。根据另一优选实施例,该物质在装配过程中施加到容器中,或者至少上部容器中。因此,从导尿管组件制造时导尿管就已经开始具有低摩擦表面特征。因此,优选是该包装件形成有基本不透气材料的壁,以便能够长时间保持在该包装件中的导尿管和液体物质。
优选是,使该包装件有用于将液体物质排出该包装件的开口。例如,该开口可以用于排出在处理了亲水导尿管之后在包装件中剩余的过多液体膨胀介质。在另一实例中,该开口可以用于使尿从包装件中排出。在使用时,用户只需要将足以使尿从膀胱中流出的一定长度导尿管抽出。尿将通过导尿管导管流入包装件。该尿能够通过开口排出该包装件,例如流入马桶或流入与该包装件相连的收集袋或储存器。优选是,该开口通过与导尿管相连的封闭装置封闭,从而在将导尿管从包装件中取出时打开该包装件。例如,导尿管的远端自己可以封闭该开口。
为了防止排出包装件的液体物质流回到包装件内,该开口可以提供有使液体物质只能沿流出包装件的方向流动的液体物质。例如,该开口可以提供有止回阀。这样的止回阀为本领域公知。
根据优选实施例,封闭装置包括第一阀部件,该第一阀部件与第二阀部件配合,该第二阀部件安装在导尿管上。
第一阀部件可以有第一密封凸缘,用于与第二阀部件的相应第二密封凸缘进行密封啮合,因此,该第二密封阀部件封闭第一阀部件的出口。这时,该第一和第二密封凸缘可以密封住软管和包装件的外部环境之间的通道。
第一阀部件还可以有第三密封凸缘,用于与第二阀部件的相应第四密封凸缘进行密封啮合。这时,该第三和第四密封凸缘可以密封住导尿管的导管和包装件的外部环境之间的通道。
防止液体物质回流到包装件内的止回阀可以与第一和/或第二阀部件中的任意一个形成一体,例如成片或折片的形式,以便当液体流入储存器时从在包装件和外部环境之间的开口处移开,而当液体将沿另一方向流动时,该片或折片将由液体压回到使它阻挡在外界环境和包装件之间的通道的位置。
根据本发明的优选实施例,与导尿管相连的封闭装置提供有与在包装件中的出口配合的流动槽道。在封闭装置相对于出口的第一位置,液体物质能够从导尿管的导管流出包装件。在另一位置,将防止液体物质从导尿管的导管流出包装件。这两个位置分别与导尿管从包装件中取出和正在取出时的位置以及导尿管布置在包装件内时的位置相对应。
封闭装置的流动槽道还包括至少一个进口,该进口使液体物质能够在下部和上部容器中的任意一个和导尿管的导管之间流动。为了防止通过导尿管排出的尿通过该进口流出,该进口可以提供有用于使液体物质只能沿从下部或上部储存隔腔中的任意一个进入导管的方向流动的装置。
对于残疾用户,可能很难进入洗手间。因此,优选是通过使包装件的远端与用于容纳液体物质的储存器相连,可以使导尿管的使用与洗手间的可用性完全无关。这时,甚至该导尿管包装件或至少该包装件的软管部件可以与储存器成一体。
优选是,储存器的材料为在充满液体时具有至少中等耐久性,同时不会损坏该储存器或使液体物质通过该储存器的壁蒸发。而且该储存器的壁应当在12个月或更多月(例如24个月)中至少基本保持它的性质。因此,该储存器优选是由以下材料制成:热塑性弹性体材料、其它热塑性材料、可固化弹性体材料、聚酰胺树脂或弹性体、或者它们的任意组合,即,该材料组可以包括例如:PA、PP、PVC、PU、PE、乳胶、和/或KratonTM。优选是,该储存器由两层沿边缘连接的材料片薄膜制成,例如通过熔化或胶接而将该薄膜粘接在一起。该薄膜例如可以由不同材料叠片制成,例如可以包括一层铝或类似金属层,用于提供完全不透气的包装件。
发明的详细说明
下面将参考附图详细介绍本发明的优选实施例,附图中:
图1a-1d表示了本发明优选实施例的导尿管组件的一部分;
图2a-2d表示了图1的组件的可选实施例;
图3a-3e表示了图1和2的组件的另外可选实施例;
图4a-4e表示了组件的实施例,其中,在导尿管和软管之间的通道在第一分开(dismantling)部分上密封,而该通道在第二分开部分上打开;
图5a-5c表示了本发明的简单实施例,其中,该包装件的远端通过导管自身的远端封闭;
图6a-6c表示了图5中所示的组件的实施例,其中,包装件的远端由可拆卸的封闭件来封闭;
图7表示了包括用于储存尿和其它液体物质的储存器的组件的实施例;
图8表示了组合阀部件和径向向外伸出的凸起的透视图,该凸起用于安装在导管上;
图9表示了图8的阀部件的剖视图;
图10表示了将固定在包装件的远端开口上的阀部件的透视图;以及
图11表示了图10的阀部件的侧剖图。
参考图1,本发明的导尿管组件包括:导尿管1,该导尿管1确定了用于传输尿和其它液体物质的导管2;导尿管包装件3;以及密封装置4。在本实施例中,导尿管由软管和与该软管相连的附加部件(例如图2a中的塞子25)来确定。该塞子与在导尿管和包装件之间的密封件以及用于封闭包装件的远端的封闭装置组合(见下面的说明)。该导尿管有近端5,用于插入个人的尿道中。该导尿管有孔6,该孔6环绕该导尿管的近端部分布置在外周上,以便使尿从膀胱排入导尿管的导管内。该导尿管还在相对的远端处提供有至少一个开口7,用于将液体物质排出该导管。包装件提供有软管9,该软管9确定了用于容纳导尿管的空腔10。
密封装置4布置在导尿管的外表面11和软管部件的内表面12之间,并使在软管部件和导尿管之间确定的空间基本流体密封的分成下部容器13和上部容器14。
如图1所示,密封装置优选是可以布置成径向向外伸出的凸起4的形式,例如为导尿管的柔软、弹性叶片的形式,或者该密封装置安装在导尿管上,并沿长度方向布置,它使得该叶片能够与软管部件的内表面接触。
图1a表示了组件的优选实施例,其中,流动槽道15布置成使液体物质能够从上部容器14流入导管2内,该液体物质例如:用于处理亲水导尿管的、装于上部容器中的水或水/盐水溶液;或者用于普通导尿管的、产生低摩擦表面特征的润滑剂。
图1b表示了与该导尿管相连的密封装置的一个实施例。
图1c表示了这样的情况,其中,布置在包装件的远端的开口16使得包含在下部容器中的液体物质能够从容器中排出。
图1d表示了这样的情况,其中:导尿管的封闭装置17液密密封开口16。优选是,该封闭装置布置有多个弹性和/或柔性的凸出部分18,该凸出部分18用于与开口16的内表面接触。
图1c和1d还表示了包装件的近端的可拆卸封闭件19。该封闭件可以如图1c、1d所示,优选是通过条带20安装在该包装件上,这样,该组件保持为一个单元。该封闭件可以布置有径向伸出的抓住手柄21,从而很容易除去该封闭件,即使是对于灵活性较差的人。
图2a、2b、2c和2d表示了塞子25的可选实施例和包装件远端的可选实施例,其中,该包装件的开口远端由封闭件26封闭。该封闭件既可以为可拆卸,也可以胶粘在软管部件9上。优选是,该塞子有至少一个出口开口27,从而使尿能够从膀胱流入导尿管的近端,并通过该塞子排出导尿管。该塞子还可以提供有进口28,用于将液体物质从上部容器14排入导管2中。封闭件26还提供有开口29,用于使液体物质例如尿排出下部容器。
图2c表示了这样的情况,其中:导尿管的封闭装置从该封闭件上退回,从而使通道29打开。
图2d表示了这样的情况,其中,导尿管的封闭装置封闭通道29,从而防止液体物质排出该包装件。
图2中所示的导尿管和包装件并没有画出它的全长。两个部件的近端省略,以便只集中表示在图1和图2的实施例之间的区别。
图3表示了本发明的实施例,其中,塞子35有与图2的塞子25类似的特征。该塞子还包括槽36,该槽36用于与环形密封部件37啮合。该环形密封部件37布置在包装件38的内部,既可以固定在软管的内表面上,也可以活动布置成使它能够在软管中来回滑动。
图3c表示了这样的情况,其中,环形部件与槽啮合。与图2的实施例相同,导尿管和包装件的近端都特意省略,以便只集中表示图2和图3的实施例之间的区别。
图4表示了本发明的实施例,其中,塞子45提供有弹性叶片46,该弹性叶片46的直径为这样,当塞子布置在软管的第一部分47中时,该弹性叶片46能够在软管的第一部分47的范围内与内表面接触。该软管提供有两个不同的径向尺寸。因为软管的第二部分48的径向尺寸大于软管的第一部分的径向尺寸,因此,当塞子布置在该第二部分中时,该叶片46不能与软管的内表面接触。
图5表示了本发明的简单实施例,其中,包装件在它的远端提供有开口55。该开口可以由导尿管自身的远端56封闭,因此,当导尿管从导尿管包装件中取出时,包装件的远端自动打开。如图所示,包含于包装件中的液体物质(例如用于处理亲水导尿管的液体膨胀介质)能够通过在导尿管近端的孔57而从该包装件中排出。为了简化附图,图5a和5b省略了导尿管和包装件的近端。在图5c中,包装件的近端省略。不过,包装件的近端例如可以通过任何封闭件来封闭。
图6表示了本发明的实施例,其中,包装件的远端由可拆卸的封闭件60封闭。该封闭件有出口61,用于使液体物质排出该包装件。当导尿管相对于包装件和封闭件处于第一位置时,如图6a所示,该出口由导尿管的远端封闭。当导尿管离开包装件时,该出口打开,从而使液体物质能够排出该包装件。
图7表示了本发明的实施例,其中:软管部件与用于收集液体物质的储存器相连,例如用于收集尿和/或盐水溶液,该盐水溶液用于在使用之前使导尿管形成低摩擦表面特征。阀70优选是可以布置成单向封闭件,以便保证排入储存器的液体不会通过软管部件和/或通过导尿管回流。该储存器提供有排出嘴或阀71,用于使液体物质排出该储存器。例如,排出阀可以通过撕开该阀的顶部而打开。为此,优选是该储存器可以提供有削弱线72。优选是,该储存器可以形成为具有基本扁平底部73的袋。因此,在导尿管插入尿道内时以及在尿被排放到储存器中时,用户可以将该储存器放在平表面上,例如地板上。优选是,关于打开排出阀的说明可以印在储存器上。手柄74在将储存器排空时为使用者提供了一个很好的把持部件。因此,优选是它可以使用组合的两个手柄,这样,可以用顶部手柄提起该储存器,同时可以使用后部手柄使该储存器旋转。这时,应当记住,用户通常至少部分运动残疾。该组件还包括封闭件76,用于打开和封闭组件。在图7的实施例中,隔腔77通过接头78可伸缩地与软管79连接。
图8表示了第二阀部件的视图,该第二阀部件成组合阀部件和径向向外延伸的凸起的形式。该第二阀部件用于安装在导尿管的远端。该导尿管部件在外表面上提供有滑动密封件81(活塞密封件)和锁定环82。最好如图9所示,内表面提供有第二密封凸缘93和第四密封凸缘94。
图10表示了包装件的第一阀部件。该阀部件将安装在包装件的远端开口中。第一阀部件用于与导尿管的相应第二阀部件啮合(参考图8和9)。通过在第一阀部件的第一密封凸缘101(参考图10)和第二阀部件的第二密封凸缘93之间的密封啮合,可以密封住包装件或软管和外部环境之间的通道。通过在第一阀部件的第三密封凸缘102(参考图10)和第二阀部件的第四密封凸缘93之间的密封啮合,可以密封住导尿管的导管和外部环境之间的通道。当导尿管离开包装件时,或者实际上当导尿管的第一部分离开包装件时,第二阀部件离开第一阀部件。因此,在密封凸缘之间的密封啮合消除,来自包装件以及来自导尿管的导管的液体物质都可以通过孔流出。第二阀部件的内部密封凸缘95(参考图9)用于将该第二阀部件安装在导尿管上,例如通过将该阀粘接到导尿管远端的外表面上。该导尿管也可以与集成的阀部分模制成一体,该阀部分的特征类似于图9的阀特征。第一阀部件的阶梯结构104、114(参考图10和11)用于支持在阀部件的阶梯部分的外表面和导尿管包装件的软管的内表面之间的密封啮合。该第一阀部件可以粘接到软管上,或者该软管可以与集成的阀部分模制成一体,该阀部分的特征类似于图10和11的阀特征。

Claims (20)

1.一种导尿管组件,能够无污染地将导尿管插入尿道中,所述组件包括:
导尿管,该导尿管确定了在用于插入个人身体开口的近端和相对的远端之间的导管;
包装件,该包装件有软管,该软管有用于容纳导尿管的空腔,且该包装件有在它近端的开口,该开口用于从该包装件分配导尿管的近端;以及
密封装置,该密封装置用于当导尿管从包装件中进行分配时在导尿管包装件和导尿管之间提供基本液密的密封。
2.根据权利要求1所述的组件,其中:该密封装置布置在包装件的近端中,因此,该空腔确定了在该导尿管和软管之间的容器。
3.根据权利要求1-2中任意一个所述的组件,其中:密封装置布置在导尿管的外表面和软管的内表面之间,该空腔确定了位于包装件的近端附近的上部容器以及在导尿管和软管之间的、位于相对位置的下部容器。
4.根据权利要求1-3中任意一个所述的组件,其中:该密封装置包括导尿管外表面的、径向向外伸出的凸起。
5.根据权利要求1-4中任意一个所述的组件,其中:当导尿管的第一长度分配在第一分配部分上时,该密封装置用于提供在导尿管包装件和导尿管之间的基本液密密封。
6.根据权利要求1-5中任意一个所述的组件,其中:当导尿管分配在第二分配部分上时,液体流动槽道确定于导尿管包装件和导尿管之间。
7.根据权利要求1-6中任意一个所述的组件,其中:该软管提供有锥形内表面,这样,该软管的内部间隙从在一端的第一内部间隙增加至相对端的第二内部间隙,该第一内部间隙提供在软管内表面和导尿管之间的基本液密密封,而该第二内部间隙提供在软管内表面和导尿管之间的液体流动槽道。
8.根据权利要求1-7中任意一个所述的组件,其中:该软管有基本圆形截面形状。
9.根据权利要求1-8中任意一个所述的组件,其中:该包装件提供有开口,用于使液体物质排出该包装件,所述开口由封闭装置封闭,该封闭装置与所述导尿管相连,用于当从包装件中取出导尿管时打开该包装件。
10.根据权利要求9所述的组件,其中:该开口布置在包装件的远端。
11.根据权利要求9-10中任意一个所述的组件,其中:该开口由导尿管自身的远端封闭。
12.根据权利要求9-11中任意一个所述的组件,其中:该封闭装置包括第一阀部件,该第一阀部件与导尿管的第二阀部件配合。
13.根据权利要求12所述的组件,其中:该第一阀部件有第一密封凸缘,用于与第二阀部件的相应第二密封凸缘进行密封啮合,因此,该第二密封阀部件封闭第一阀部件的出口。
14.根据权利要求13所述的组件,其中:该第一和第二密封凸缘之间的啮合将密封住在软管和包装件的外部环境之间的通道。
15.根据权利要求12-14中任意一个所述的组件,其中:该第一阀部件还有第三密封凸缘,用于与第二阀部件的相应第四密封凸缘进行密封啮合。
16.根据权利要求15所述的组件,其中:该第三和第四密封凸缘之间的啮合密封住导尿管的导管和包装件的外部环境之间的通道。
17.根据权利要求12-16中任意一个所述的组件,其中:封闭装置包括流动槽道,该流动槽道有至少一个进口,该进口使液体物质能够在下部和上部容器中的任意一个和导尿管的导管之间流动。
18.根据权利要求17所述的组件,其中:进口的封闭装置用于使液体物质只能沿一个方向流动,并防止液体物质沿相反方向流动。
19.根据权利要求18所述的组件,其中:所述方向是从下部或上部容器中的任意一个进入导管的方向。
20.根据前述任意一个权利要求所述的组件,其中:包装件的远端与用于容纳液体物质的储存器相连。
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US09/893,514 2001-06-29
US09/893,514 US20030004496A1 (en) 2001-06-29 2001-06-29 Urinary catheter divided into catheter sections and a catheter package
DK200101041A DK200101041A (da) 2001-06-29 2001-06-29 Et urinkateter inddelt i katetersektioner og en kateterpakke
DKPA200101041 2001-06-29
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DKPA200101870 2001-12-13
US10/026,819 2001-12-27
US10/026,819 US7311698B2 (en) 2001-09-24 2001-12-27 Urinary catheter assembly allowing for non-contaminated insertion of the catheter into a urinary canal
DKPA200200569 2002-04-17
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CNA028130790A Pending CN1522130A (zh) 2001-06-29 2002-06-28 用于收集体液的袋
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CN101175526B (zh) * 2005-05-13 2011-02-02 科洛普拉斯特公司 伸缩式装置,其制备方法及其保持元件的使用方法
CN102802714A (zh) * 2009-06-26 2012-11-28 科洛普拉斯特公司 注射成型导管
CN106963514A (zh) * 2010-11-03 2017-07-21 科洛普拉斯特公司 泌尿装置
CN105682618A (zh) * 2013-11-07 2016-06-15 科洛普拉斯特公司 具有防逆流阀的尿袋
CN105682618B (zh) * 2013-11-07 2018-01-12 科洛普拉斯特公司 具有防逆流阀的尿袋
CN109337492A (zh) * 2018-10-16 2019-02-15 成都德信安创新医疗技术有限公司 亲水超滑涂层以及免激活涂层导尿管

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