TWI672159B - 止回閥 - Google Patents

止回閥 Download PDF

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TWI672159B
TWI672159B TW103143375A TW103143375A TWI672159B TW I672159 B TWI672159 B TW I672159B TW 103143375 A TW103143375 A TW 103143375A TW 103143375 A TW103143375 A TW 103143375A TW I672159 B TWI672159 B TW I672159B
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medical
port
manifold
valve
check valve
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TW103143375A
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TW201536367A (zh
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大衛 奈爾森
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美商Icu醫學公司
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    • 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
    • A61M39/24Check- or non-return valves
    • 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
    • A61M39/10Tube connectors; Tube couplings
    • 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
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407Infusion of two or more substances
    • A61M5/1408Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16KVALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K15/00Check valves
    • F16K15/14Check valves with flexible valve members
    • F16K15/144Check valves with flexible valve members the closure elements being fixed along all or a part of their periphery
    • 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
    • A61M39/24Check- or non-return valves
    • A61M2039/2433Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
    • A61M2039/2446Flexible disc
    • 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
    • A61M39/24Check- or non-return valves
    • A61M2039/2433Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
    • A61M2039/2446Flexible disc
    • A61M2039/2453Flexible disc not being fixed to the valve body
    • 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
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/267Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
    • 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
    • A61M2207/00Methods of manufacture, assembly or production

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • General Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Check Valves (AREA)
  • Reciprocating Pumps (AREA)

Abstract

本發明揭示一種用於一流體路徑中的止回閥。該止回閥可具有一隔膜及從該隔膜延伸之複數個支撐件。該止回閥及該等支撐件具有一對稱線,且該止回閥在其從一閉合位置移動至一敞開位置時之變形可大致沿著該對稱線。

Description

止回閥 相關申請案交叉參考
本申請案主張於2013年12月11日申請之標題為「CHECK VALVE」之美國臨時申請案第61/914,892號之權利,該案之全部內容以引用的方式併入本文中且成為本說明書之一部分。
存在各種裝置及技術用於醫院及醫療場所中的流體操縱,且特定言之用於選擇性促進往返於患者或往返於一流體流動線的流體移動。流體流動線依靠各種連接器來幫助形成較佳流動特性或接取點。許多連接器包含止回閥。
當前流體流動系統、醫療連接器及止回閥具有各種限制及缺陷,且存在進一步改良之需要。
在醫院及醫療場所中使用用於選擇性促進往返於患者之流體移動之各種流體流動線及系統。例如,中心靜脈導管可用於投予IV流體、各種藥物或血液製品及/或腸胃外營養。在一些實施例中,醫療連接器可提供於一流動線之一端上以容許對一流動線之定期接取或容許施加不同輸入至該流動線。一般而言,此等結構需要閥以容許流體進入主流動線,同時阻止逆流。
在特定情境中,可期望提供至進入一患者之血流中的一流動線 之多個連接。此可容許至多個流體或藥物源之簡單連接。此在需要多個輸入之治療(諸如化學療法)方面尤其有用。當需要多個連接時,可使用一歧管、延伸套組或其他多輸入結構。此等結構亦需要閥以容許流體進入主流動線但此較佳阻止逆流。在本文中所描述之各項實施例中,此等閥可經設計以最大化效率及所要流速以及流動特性,同時仍提供對逆流的控制。在一些情境中,可期望提供具有單向流動的一單一連接點。
在各項實施例中,一種醫療止回閥,其用於一醫療裝置中以提供一第一流體位置與一第二流體位置之間的單向流體流動,該醫療止回閥可包含:一可撓性隔膜,其具有一頂表面、一底表面及該頂表面與該底表面之間的一側壁;及一第一支撐部件,其從該可撓性隔膜之該底表面延伸;以及一第二支撐部件,其從該可撓性隔膜之該底表面延伸,該第一支撐部件及該第二支撐部件經定位以界定一對稱線或對稱軸,該對稱線或對稱軸在不通過該第一支撐部件或該第二支撐部件的情況下平分該底表面。該可撓性隔膜可具有一第一位置及一第二位置,在該第一位置中,該頂表面大致平坦且經結構設計以封抵一流體開口,在該第二位置中,該隔膜之該頂表面大致圍繞該對稱線彎曲且經結構設計以自該流體開口移位。
在一些實施例中,該對稱線可為在不通過第一支撐部件或第二支撐部件的情況下平分底表面之唯一對稱線。在一些實施例中,可撓性隔膜可為一圓盤。在一些實施例中,支撐部件可圍繞該圓盤按180度間隔定位。在一些實施例中,可撓性隔膜可為無孔的。在一些實施例中,可撓性隔膜、第一支撐部件及第二支撐部件可一體地形成及/或模製成一單一單體件。
在一些實施例中,隔膜可經結構設計以在不同量之壓力下從第一位置移動至第二位置。例如,在一些實施例中,可撓性隔膜之頂表 面上之小於3psi之一淨壓力足以使該隔膜從第一位置移動至第二位置。在一些實施例中,可撓性隔膜之頂表面上之小於1psi之一淨壓力足以使該隔膜從第一位置移動至第二位置。在一些實施例中,需要可撓性隔膜之底表面上之一正的淨壓力以將該可撓性隔膜維持於第一位置中。
在各項實施例中,一種用於提供對一流體流動路徑之接取之醫療歧管可包含一外殼,該外殼具有:一第一端口;一第二端口;一第一通道,其連接該第一端口與該第二端口且界定一第一流動路徑;及一第三端口,其具有該外殼之一外壁中之一凹口及流體連接該凹口與該第一流動路徑之一第二通道。該歧管亦可包含一閥部件,該閥部件具有一隔膜及複數個支撐部件,該複數個支撐部件經結構設計以定位於凹口中以藉此界定該凹口之一底壁與該隔膜之間的一空間。該歧管亦可包含一醫療連接器,該醫療連接器經結構設計以附接至第三端口,其中在一閉合位置中的閥部件經結構設計以封抵至該醫療連接器之一開口,且在一敞開位置中的閥部件經結構設計以容許流體從該醫療連接器流動,經過該閥部件,通過第二通道且進入第一流動路徑中。
在一些實施例中,凹口之一外壁可為圓柱形的。在一些實施例中,凹口之一外壁可包含多個壁。在一些實施例中,第三端口可具有至少兩個突部,該等突部從凹口之底壁且鄰近第二通道延伸,其中該等突部界定該等突部與該凹口之一外壁之間的一外通道,及該等突部之間的至少兩個橫向通道。在一些實施例中,複數個支撐部件可經結構設計以定位於該等突部之至少兩者上。在此等實施例中,在一敞開位置中的閥部件經結構設計以容許流體從醫療連接器流動,經過該閥部件至該外通道,通過該等橫向通道且進入第二通道中。
在一些實施例中,閥部件可朝閉合位置偏置。在一些實施例 中,閥部件可經結構設計以由於來自醫療連接器中之流體之壓力而從閉合位置移動至敞開位置中。在一些實施例中,外殼可為單體的。在一些實施例中,閥部件上之小於3psi之一淨壓力可足以使該閥部件從閉合位置移動至敞開位置。
在各項實施例中,一種用於提供對一流體流動路徑之接取之醫療歧管可包含:一第一端口;一第二端口;一第一通道,其連接該第一端口與該第二端口且界定一第一流動路徑;及一外殼,其具有該外殼之一外壁中之一第三端口及流體連接該第三端口與該第一流動路徑之一第二通道。該歧管亦可包含一閥部件,該閥部件具有一隔膜及複數個支撐部件,該複數個支撐部件經結構設計以定位於該第三端口中以藉此界定該第三端口之一底壁與該隔膜之間的一空間。該歧管亦可包含一醫療連接器,該醫療連接器經結構設計以附接至該第三端口,其中在一閉合位置中的閥部件經結構設計以封抵至該醫療連接器之一開口,且在一敞開位置中的閥部件經結構設計以容許流體從該醫療連接器流動,經過該閥部件,通過第二通道且進入第一流動路徑中。
在一些實施例中,第三端口進一步包含至少兩個突部,該等突部從該第三端口之底壁且鄰近第二通道延伸,其中該等突部界定該等突部之間的至少兩個橫向通道。複數個支撐部件可經結構設計以定位於該等突部之至少兩者上。在一些實施例中,醫療歧管之第三端口包含一凹口且突部從該凹口之底壁延伸。圍繞該凹口之一壁可從外殼向外延伸,且醫療連接器之一部分可經結構設計以圍繞該壁之至少一部分。在一些實施例中,醫療連接器係經音波熔接至第三端口。
在一些實施例中,第三端口之一外壁可為圓柱形的。在一些實施例中,第三端口之一外壁可包含多個壁。在一些實施例中,第三端口可具有至少兩個突部,該等突部從該第三端口之底壁且鄰近第二通道延伸,其中該等突部界定該等突部與該第三端口之一外壁之間的一 外通道,及該等突部之間的至少兩個橫向通道。在一些實施例中,複數個支撐部件可經結構設計以定位於該等突部之至少兩者上。在此等實施例中,在一敞開位置中的閥部件經結構設計以容許流體從醫療連接器流動,經過該閥部件至該外通道,通過該等橫向通道且進入第二通道中。
在各項實施例中,一種用於提供對一流體流動路徑之接取之醫療歧管可包含:一第一端口;一第二端口;一第一通道,其連接該第一端口與該第二端口且界定一第一流動路徑;及一外殼,其具有該外殼之一外壁中之一第三端口及流體連接該第三端口與該第一流動路徑之一第二通道。該歧管亦可包含一閥部件,該閥部件具有一隔膜及複數個支撐部件,該複數個支撐部件經結構設計以定位於該第三端口中以藉此界定該第三端口之一底壁與該隔膜之間的一空間。該歧管亦可包含一醫療連接器,該醫療連接器經結構設計以附接至該第三端口,其中在一閉合位置中的閥部件經結構設計以封抵至該醫療連接器之一開口,且在一敞開位置中的閥部件經結構設計以容許流體從該醫療連接器流動,經過該閥部件,通過第二通道且進入第一流動路徑中。該醫療歧管亦可包含一第二外殼,該第二外殼包含一第四端口,該第四端口具有流體連接該第四端口與第一流動路徑之一第三通道。在一些實施例中,歧管可包含一第二閥部件,該第二閥部件具有一隔膜及複數個支撐部件,該複數個支撐部件經結構設計以定位於第四端口中以藉此界定該第四端口之一底壁與該隔膜之間的一空間。一些歧管可包含一第二醫療連接器,該第二醫療連接器經結構設計以附接至第四端口,其中在一閉合位置中的第二閥部件經結構設計以封抵至該第二醫療連接器之一開口,且在一敞開位置中的第二閥部件經結構設計以容許流體從該第二醫療連接器流動,經過該第二閥部件,通過第三通道且進入第一流動路徑中。在一些實施例中,第一外殼及第二外殼係單 體的,而在其他實施例中,其中該第一外殼及該第二外殼係藉由一可撓性連接元件接合。
2‧‧‧對稱軸
10‧‧‧歧管
10`‧‧‧六端口歧管/歧管
10``‧‧‧歧管
10```‧‧‧歧管
10````‧‧‧歧管
10`````‧‧‧歧管
12‧‧‧歧管外殼/單層外殼/外殼
12`‧‧‧外殼
12``‧‧‧雙層外殼/外殼
12```‧‧‧外殼
12````‧‧‧外殼
12`````‧‧‧單層外殼/外殼
13```‧‧‧延伸部分/鰭狀物
13````‧‧‧延伸部分/鰭狀物
14‧‧‧主通道/主流動通道
16‧‧‧連接部分/接合件
16`‧‧‧接合件
16``‧‧‧接合件
16```‧‧‧接合件
16````‧‧‧接合件
20‧‧‧第一端口
20`‧‧‧第一端口
22‧‧‧螺紋端
30‧‧‧第二端口
32‧‧‧公魯爾鎖
34‧‧‧錐狀套管
40‧‧‧接取端口
40`‧‧‧端口/接取端口
42‧‧‧接取通道
42`‧‧‧接取通道
43‧‧‧側壁
43`‧‧‧側壁
44‧‧‧外凹口
44`‧‧‧突出環
46‧‧‧橫向通道
48‧‧‧外通道/通道
50‧‧‧醫療連接器
50`‧‧‧醫療連接器/經修改連接器/連接器
60‧‧‧連接器主體/主體
60`‧‧‧連接器主體/主體
70‧‧‧連接器基底/基底
70`‧‧‧連接器基底/基底
72‧‧‧環形突部
74‧‧‧環/密封環
74`‧‧‧環
76‧‧‧開口
76`‧‧‧開口
80‧‧‧連接器閥部件/閥
80`‧‧‧連接器閥部件/閥
90‧‧‧內部突部
92‧‧‧開口
100‧‧‧單向閥/止回閥/閥/閥部件
110‧‧‧隔膜
112‧‧‧底表面/下表面
114‧‧‧側壁
116‧‧‧頂表面/上表面
120‧‧‧支撐件/最近支撐件
122‧‧‧外壁
140‧‧‧凹口/接取端口凹口
140`‧‧‧端口凹口
142‧‧‧外壁
142`‧‧‧外壁
144‧‧‧基底
144`‧‧‧基底
146‧‧‧通道
146`‧‧‧通道
150‧‧‧突部
150`‧‧‧突部
152‧‧‧中心壁
152`‧‧‧中心壁
154‧‧‧側壁
154`‧‧‧側壁
156‧‧‧外壁
200‧‧‧醫療器具
202‧‧‧套管
R1‧‧‧半徑
R2‧‧‧曲率半徑
R3‧‧‧半徑
R4‧‧‧半徑/距離
R5‧‧‧最小距離/距離
R6‧‧‧內半徑/半徑
t1‧‧‧厚度
h1‧‧‧高度
h2‧‧‧高度
h3‧‧‧高度
w1‧‧‧寬度
w2‧‧‧寬度
圖1係一歧管之一實施例之一透視圖。
圖1A係具有一經修改之突部附接之一歧管之一實施例之一透視圖。
圖1B係一歧管組件之一實施例之一透視圖。
圖2係一歧管之一實施例之一透視圖。
圖2A係具有一經修改之突部附接之一歧管之一實施例之一透視圖。
圖2B係一歧管組件之一實施例之一透視圖。
圖3係圖1之歧管之一橫截面圖。
圖3A係圖1A之歧管之一橫截面圖。
圖3B係圖1B之歧管之一橫截面圖。
圖4係圖2之歧管之一橫截面圖。
圖4A係圖2A之歧管之一橫截面圖。
圖4B係圖2B之歧管之一橫截面圖。
圖5係一歧管之一端口之一實施例之一透視圖。
圖5A係一歧管之一端口之一實施例之一透視圖。
圖6係圖5之端口之一俯視圖。
圖7係一止回閥之一實施例之一仰視透視圖。
圖8係圖7之止回閥之一俯視透視圖。
圖9係圖8之止回閥之一仰視圖。
圖10係圖9之止回閥之一側視圖。
圖11A係具有一止回閥之一歧管之一端口的一實施例之一橫截面圖。
圖11B係具有一經附接之醫療連接器之一歧管之一端口的一實施例之一橫截面圖,其中未展示一止回閥。
圖12A係一歧管之一端口的一實施例之一橫截面圖,該歧管具有一經附接之醫療連接器及在一閉合位置中的一止回閥。
圖12B係具有在一敞開位置中的止回閥之圖12A的實施例之一橫截面圖。
圖13A係一歧管之一端口的一實施例之一橫截面圖,該歧管具有一經附接之醫療連接器及在一閉合位置中的一止回閥。
圖13B係具有在一敞開位置中的止回閥之圖13A的實施例之一橫截面圖。
現將參考附圖描述流體流動系統、醫療連接器及閥之某些實施例及實例。本文中所描述之止回閥之各項實施例係關於一歧管或延伸套組,但其等並不限於此。在一些態樣中,止回閥之該等實施例可應用於任何系統以提供一醫療連接器與一流體流動線之間的單向流動,舉例而言,諸如在IV套組、活栓或包含y位點連接器之其他分支連接器以及其他系統中。如本文中所使用,術語「流體」係指氣體或液體。
圖1繪示一歧管10之一實施例,該歧管10可用於提供對一流體流動路徑之接取。該歧管可包含一歧管外殼12,該歧管外殼12可包含一第一端口20及一第二端口30。在一些實施例中,該外殼可為一整合件,且在一些實施例中,該外殼可包含多個件,使得歧管包含藉由一流體路徑連接之第一端口及第二端口,但該等端口係藉由個別形成之單元(例如,圓管)連接至該外殼。在一些實施例中,多個外殼可連接於第一端口與第二端口之間。較佳地,即使在藉由可撓性接合件連接時,在一靜止位置中的歧管亦界定介於第一端口與第二端口之間的一 大致線性流體路徑,其中一或多個端口從該路徑分叉出來。在一些實施例中,該一或多個端口從介於第一端口與第二端口之間的流動路徑以約90度分叉出來。歧管可插入至一流體流動線中,該第一端口20經結構設計以附接至該線之一端,且該第二端口30經結構設計以附接至該線之一第二端。該等端口可經結構設計以容納任何標準醫療連接器或器具,且可經調適以符合ANSI(美國國家標準協會)或其他適用的標準。在一些實施例中,不同端口亦可經結構設計以具有非標準連接。
在一些實施例中,一第一端口20可具有一螺紋端22,該螺紋端22可用於連接至一螺紋醫療連接器。在一些實施例中,一第二端口30可具有一公魯爾(luer)鎖32,該公魯爾鎖32包含一錐狀套管34(圖3及圖4中可見)。
在一些實施例中,歧管10可包含下文更詳細地描述及繪示之複數個接取端口40。該等接取端口可經調適以連接或附接至各種類型的醫療連接器50。在一些實施例中,如所繪示,一醫療連接器50可為一無針連接器。在所繪示之實施例中,歧管包含六個醫療連接器50,其中三個醫療連接器位於該歧管之一第一側上且三個醫療連接器位於該歧管之一第二側上。
在各項實施例中,一歧管可具有各種數目之接取端口及醫療連接器。例如,圖2繪示一歧管10```之一實施例,該歧管10```在其一側上具有三個接取端口及三個醫療連接器50。外殼12```包含接合件16```,且可包含一延伸部分或鰭狀物13```,該延伸部分或鰭狀物13```可定位於與醫療連接器相對之側上。鰭狀物13```可經提供以增加穩定性至歧管10```,且可經結構設計以在使用期間便於一護士或該歧管10```之其他使用者進行處置或控制,或將該歧管10```附接至一方便的靜止位置。圖2A展示一替代歧管10````,該歧管10````亦在一側上包含三個接取端口及三個醫療連接器50`。外殼12````包含接合件 16````,且可包含一延伸部分或鰭狀物13````,該延伸部分或鰭狀物13````可定位於與醫療連接器相對之側上。鰭狀物13````可經提供以增加穩定性至歧管10````,且可經結構設計以在使用期間便於一護士或該歧管10````之其他使用者進行處置或控制,或將該歧管10````附接至一方便的靜止位置。如所展示,相較於圖2中所展示之接合件16```上之彎曲部分,接合件16````可包含較淺彎曲部分。彎曲部分及其他結構可用於改變外殼之強度且提供一方便位置以固持歧管。
端口之其他組合亦係可行的。例如,圖1B展示包含兩個雙層外殼12``之一歧管10``。圖2B展示包含兩個單層外殼12`````之一歧管10`````。如上所述,根據需要,一單一歧管可包含此等外殼之各種組合。
本發明之實施例可提供各種方式以將醫療連接器連接至外殼端口,如下文將更詳細論述。例如,圖1A展示具有替代端口40`及經修改連接器50`之一個六端口歧管10`。如繪示,歧管10`可包含外殼12`。
如所展示,在一些實施例中,可對端口之間的連接部分或接合件16作出各種修改。例如,圖1展示接合件16之一第一版本,而圖1A展示一替代接合件16`,該替代接合件16`包含淺拱形或彎曲部分。如圖1B中所展示,在一些實施例中,一歧管10``可具有藉由一可撓性連接部分(例如,管路)接合之複數個外殼12``,而非具有一單層外殼12(例如,參見圖1)。因此,舉例而言,在一些實施例中,歧管之接合件16``可由管路形成,該等接合件16``連接具有若干醫療連接器或若干對醫療連接器之外殼。
圖1B展示兩個雙層外殼12``。各種組合亦係可行的。在一些實施例中,可提供具有雙端口之一單層外殼12``,且可藉由第一端口20`及第二端口30接取該單層外殼12``。第一端口20`可類似於第一端口20, 惟剛性部分可為較長以容納一醫療器具之適當區段(例如,一公魯爾連接器)除外。在一些實施例中,歧管可包含具有對應醫療連接器之3個或3個以上外殼12``。因此,歧管可易於根據一使用者之需求而客製化以提供一適當解決方案。此外,歧管可包含外殼及端口之一組合,例如,一歧管可具有一或多個雙層外殼12``及一或多個單層外殼12`````(參見圖2B)。提供可撓性接合件容許歧管撓曲及適於使用者之需求。例如,可使一端口旋轉以方便接取,同時最小化可能已被各種醫療裝置接取之其他端口之移動。歧管之可撓性接合件係(例如)藉由黏合或膠合而永久附接至其等各別外殼及端口,使得該歧管係一單一整體。
在一些實施例中,各種端口可保持連接或未連接至一或多個流體源及/或一患者。例如,在一些實施例中,第一端口20及第二端口30之一者可連接至一患者,該第一端口及該第二端口之另一者可經密封(諸如使用一醫療連接器50或一類似經密封接取端口)且未連接至一流體源,且該等醫療連接器50之一或多者可連接至患者之一流體源。在一些實施例中,可在無患者的情況下使用歧管之實施例,(例如)以將一或多個流體組合至一單一流體容器(未展示)中。因此,本發明之實施例未必用於與一患者直接連接。
圖3及圖4分別繪示圖1及圖2之歧管之橫截面圖。如所繪示,醫療連接器50可在接取端口40處附接至歧管。在一些實施例中,一醫療連接器50可為一無針醫療連接器,該無針醫療連接器包含一連接器主體60、一連接器基底70及至少部分定位於該連接器主體60內之一連接器閥部件80。關於可使用之無針醫療連接器之進一步細節係在2013年12月11日申請之美國臨時專利申請案第61/914680號中找到,該案之全部內容據此以引用的方式併入本文中且經包含作為此申請案之一附錄。
在一些實施例中,其他類型的醫療連接器或其他類型的無針醫療連接器可經附接至歧管之接取端口40。此等可包含經結構設計以接納不同設計的注射器及連接器的連接器。在一些實施例中,歧管可包含一或多個第一類型的醫療連接器及一或多個第二類型的醫療連接器。在一些實施例中,一歧管可包含兩個以上類型的醫療連接器。在一些實施例中,第一端口20及/或第二端口30可包含經密封之接取端口,該等經密封之接取端口類似於可用於接取端口40之該等經密封之接取端口。類似地,其等可包含止回閥,諸如本文中所描述之止回閥。
圖3A及圖4A分別繪示圖1A及圖2A之歧管之橫截面圖。如所繪示,醫療連接器50`可在接取端口40`處附接至歧管。類似於上述醫療連接器50,醫療連接器50`可為一無針醫療連接器,該無針醫療連接器包含一連接器主體60`、一連接器基底70`及至少部分定位於該連接器主體60`內之一連接器閥部件80`。在一些實施例中,分別展示於圖1A、圖3A及圖2A、圖4A中之歧管10`及10````可經修改以併入醫療連接器50。
圖3B及圖4B分別繪示圖1B及圖2B中展示之歧管之橫截面圖。如所繪示,醫療連接器50`可在接取端口40`處附接至歧管,且可包含開口76`。在一些實施例中,分別展示於圖1B、圖3B及圖2B、圖4B中之歧管10``及10`````可經修改以併入醫療連接器50。
醫療連接器可依各種方式附接至外殼。舉例而言,如圖4B中所展示,醫療連接器50`可併入特徵以促進將連接器音波熔接至外殼。在所繪示之實施例中,醫療連接器50`係經由連接器基底70`附接至外殼12`````。連接器基底70`中之一內凹口係經定大小以接納接取端口40`之突出環44`。突出環可有助於將醫療連接器50`穩定於外殼12`````上。
較佳地,醫療連接器50可各提供一流體流動路徑,該流體流動路徑從附接至該醫療連接器之一醫療器具,通過該醫療連接器,進入接取端口40中且通過一接取通道42進入歧管之一主通道14中。以一類似方式,醫療連接器50`可各提供一流體流動路徑,該流體流動路徑從附接至該醫療連接器之一醫療器具,通過該醫療連接器,且進入接取端口40`中並通過一接取通道42`進入歧管之一主通道14中。較佳地,接取端口40或40`可包含一單向閥或止回閥100,該單向閥或止回閥100可容許流體流動通過醫療連接器進入主通道14中,但阻止流體從該主通道流回至該醫療連接器中。下文更詳細描述一止回閥100之各項實施例。
圖5繪示一歧管之一接取端口40之一透視圖。該接取端口可包含一凹口140,該凹口140具有一外壁142及一基底144。較佳地,該凹口呈圓柱形,使得該外壁呈圓柱形,但是在一些實施例中,該凹口可具有其他形狀。一接取通道42可將該基底144連接至一歧管之一主通道或其他裝置。複數個突部150可從凹口140之基底向上延伸。該等突部可各包含面向接取通道42之一中心壁152、側壁154及一外壁156。在一些實施例中,突部之該等中心壁152可與接取通道42之一側壁43齊平。在一些實施例中,中心壁152可與接取通道之一側壁43一起界定一連續表面。如繪示,通道146可於鄰接突部150之側壁154之間延伸。
較佳地,突部之外壁156並未一直延伸至接取端口凹口140之外壁142,藉此界定該等突部與該外壁142之間的一外通道48。該等突部可彼此間隔開以界定其等之間的橫向通道46,該等橫向通道46可將外通道48連接至接取通道42。在一些實施例中,接取端口40亦可包含一外凹口44,該外凹口44可用於幫助安置附接至接取端口之一醫療連接器。
圖5A繪示一歧管之一接取端口40`之一透視圖,該接取端口40`在許多方面類似於接取端口40。該接取端口可包含一凹口140`,該凹口140`具有一外壁142`及一基底144`。較佳地,該凹口呈圓柱形,使得該外壁呈圓柱形,但是在一些實施例中,該凹口可具有其他形狀。一接取通道42`可將該基底144`連接至一歧管之一主通道或其他裝置。複數個突部150`可從凹口140`之基底向上延伸。該等突部可各包含面向接取通道42`之一中心壁152`及側壁154`。在一些實施例中,突部之該等中心壁152`可如展示般與接取通道42`之一側壁43`反向內凹。從中心壁152`至側壁43`之過渡部分可經彎曲以促進流體流動通過其中。在一些實施例中,中心壁152`可與接取通道之一側壁43`一起界定一連續表面。如所展示,突部150`可形成為與外壁142`齊平,但在一些實施例中,該等突部150`可偏離該壁且提供如同圖5中所展示之通道48之一外流體通道。接取端口40`亦可包含突出環44`,該突出環44`可用於如所展示般穩定連接器50`。如繪示,通道146`可於鄰接突部150`之側壁154`之間延伸。
圖6繪示一接取端口40之一俯視圖。在圖6之實施例中,接取端口包含四個突部150,該等突部150圍繞接取通道42之一中心對稱間隔。較佳地,該等突部之側壁154大致互相平行。然而,在一些實施例中,該等側壁在其等靠近接取通道42之中心時可朝彼此成角度,且在一些實施例中,該等側壁可在其等朝向該接取通道之該中心靠近時分開。在一些實施例中,接取端口40可包含各種數目之突部150,諸如2個、3個、5個、6個或更多個突部。該等突部可圍繞接取通道42對稱間隔或圍繞其他配置的接取通道間隔。
在一些實施例中,接取端口40之各種組件可以接取通道42為中心。在一些實施例中,如所繪示,接取通道自身可大致呈圓柱形且具有一半徑R1。在一些實施例中,接取端口凹口140之外壁142可具有以 接取通道42之中心為中心之一半徑R3。類似地,突部150之外壁156可經彎曲且具有以接取通道42之中心為中心之一曲率半徑R2。可由接取端口40`定義類似曲率半徑。在圖5A中所繪示之實施例中,接取端口40`之R2及R3將為相等的。
當流體流動通過附接至一接取端口40之一醫療連接器時,該流體將流動通過該接取端口之通道以到達一流體流動線之一主通道。在各項實施例中,接取端口之特定組件的定大小可影響外通道48、橫向通道46及/或接取通道42之大小,且因此可影響接取端口40之流體流動特性。
因此,舉例而言,在一些實施例中,接取端口凹口140之半徑R3對突部150之外壁156之半徑R2之比率可改變。在一些實施例中,R3對R2之比率可在約1.0與2.0之間。在一些實施例中,R3對R2之比率可在約1.0與1.7之間。在一些實施例中,R3對R2之比率可在約1.0與1.5之間。在一些實施例中,R3對R2之比率可在約1.1與1.3之間。此等比率亦可適用於接取端口凹口140`。
類似地,在一些實施例中,接取端口凹口140之半徑R3對接取通道42之半徑R1之比率可改變。在一些實施例中,R3對R1之比率可在約2.0與3.3之間。在一些實施例中,R3對R1之比率可在約2.3與3.0之間。在一些實施例中,R3對R1之比率可在約2.5與2.8之間。在一些實施例中,R3對R1之比率可在約2.6與2.7之間。此等比率亦可適用於接取端口凹口140`。
此外,在一些實施例中,突部150之外壁156之半徑R2對接取通道42之半徑R1之比率可改變。在一些實施例中,R2對R1之比率可在約1.5與2.9之間。在一些實施例中,R2對R1之比率可在約1.8與2.6之間。在一些實施例中,R2對R1之比率可在約2.1與2.3之間。此等比率亦可適用於接取端口凹口140`。
圖7及圖8繪示一止回閥100之透視圖,該止回閥100可定位於一接取端口40或40`內。圖7繪示一仰視透視圖,且圖8繪示一俯視透視圖。該止回閥較佳包含一隔膜110,該隔膜110具有一底表面或下表面112、一側壁114及一頂表面或上表面116。該隔膜較佳為實心的,但是在一些實施例中,其可具有穿孔。複數個支撐件120可從該隔膜之底表面或下表面112延伸。該等支撐件可用於為隔膜提供空間以從一閉合位置撓曲至一敞開位置,其在下文更詳細論述。較佳地,隔膜與支撐件係經一體地形成(例如,其等可經模製為一單件),但是在一些實施例中,其等可由分離組件形成。
支撐件可具有一外壁122,該外壁122較佳與隔膜之側壁114齊平,且與該隔膜之該側壁114形成一連續表面。然而,在一些實施例中,支撐件120可從側壁114插入,使得在該等支撐件120與該側壁114之間存在底表面112之一部分。
圖9繪示閥100之一仰視圖。該閥較佳為具有一半徑R4之圓形,但是在一些實施例中,該閥可具有其他形狀,諸如一正方形、卵形、矩形等。在一些實施例中,半徑R4可近似等於接取端口凹口140之半徑R3,使得閥100可齊平地配合於該凹口內。在一些實施例中,半徑R4可略微小於或大體上小於半徑R3,使得當閥100居於接取端口凹口之中心時,在該閥100之側壁114與接取端口凹口之外壁142之間存在一間隙。一間隙之存在可使閥的製造更簡單。改變該間隙之大小亦可影響通過閥之流速。在一些實施例中,半徑R4可比半徑R3小約0.02英寸至約0.09英寸。在一些實施例中,半徑R4可比半徑R3小約0.03英寸至約0.08英寸。在一些實施例中,半徑R4可比半徑R3小約0.05英寸至約0.06英寸。
在一些實施例中,如所繪示,支撐件120可圍繞閥之中心按約180度間隔定位。如所繪示,閥可具有一對稱軸2,該對稱軸2平分該 閥且並不通過任一支撐件。在一些實施例中,閥可具有兩個以上支撐件120,其中每對支撐件按彼此間隔約180度定位。例如,一閥可具有四個支撐件及多個對稱軸,各支撐件間隔90度,該多個對稱軸平分該閥且並不通過任意支撐件。在一些實施例中,對稱軸可定義在該閥經歷其底表面112與其頂表面116之間的一差壓的情況下,該閥如何變形。例如,在所繪示之實施例中,閥部件之頂表面上的一正的淨壓力將引起該閥部件大致圍繞對稱軸或平行於該對稱軸之一軸折曲、變彎或彎曲。
在一些實施例中,支撐件120可全部定位成與閥中心相距相同最小距離R5。在一些實施例中,一或多個支撐件可具有不同於一或多個其他支撐件之距閥中心之一最小距離,在此情況下R5可係指從閥中心至最近支撐件120的最小距離。在一些實施例中,距離R5與R4之間的關係可影響閥部件由於隔膜110之頂表面116及底表面112上的差壓而變形的容易程度。在一些實施例中,例如,R4對R5之比率可在約1.2與約1.8之間。在一些實施例中,R4對R5之比率可在約1.3與約1.6之間。在一些實施例中,R4對R5之比率可在約1.3與約1.5之間。在一些實施例中,R4對R5之比率可在約1.35與約1.45之間。在一些實施例中,R4對R5之比率可大於1.8或小於1.2。
圖10繪示閥100之一側視圖,該閥100經定向使得對稱軸2垂直於所繪示平面。在各項實施例中,隔膜110及支撐件120的尺寸大小可經修改以調整使閥部件折曲或變彎所需要的差壓。例如,支撐件可具有一寬度w1且該等支撐件之間的距離可具有一寬度w2。類似地,隔膜可具有一厚度t1且支撐件可具有一高度h1。在一些實施例中,寬度w2對厚度t1之比率可影響閥抵抗差壓的能力。在一些實施例中,寬度w2對厚度t1之比率可在約7與約10之間。在一些實施例中,寬度w2對厚度t1之比率可在約7.5與約9.5之間。在一些實施例中,寬度w2對厚度t1之比 率可在約8與約9之間。在一些實施例中,寬度w2對厚度t1之比率可在約8.2與約8.5之間。
在一些實施例中,支撐件之寬度w2對高度h1之比率可影響在閥處於一敞開位置時,隔膜110可折曲的容易程度及折曲量,其在下文論述。此亦可影響閥處置高流速之能力及/或影響閥敞開以容許流體流動之迅速程度。在一些實施例中,寬度w2對高度h1之比率可在約3與約8之間。在一些實施例中,寬度w2對高度h1之比率可在約4與約7之間。在一些實施例中,寬度w2對高度h1之比率可在約4.5與約6.5之間。在一些實施例中,寬度w2對高度h1之比率可在約5與約6之間。
圖11A繪示如上所述定位於一接取端口40內之一閥100。支撐件120可定位於突部150上以將隔膜提升至該等突部上方。在一些實施例中,接取端口凹口140可能無突部,且閥之支撐件可直接定位於凹口之基底144上或定位於一流動通道之任何內凹部分之基底上。因此,例如,在一些實施例中,閥可定位於一歧管、延伸套組或其他連接系統之一入口端口及/或一出口端口內。在一些實施例中,閥可定位於僅具有一單一入口端口及出口端口之一醫療連接器內。
圖11B繪示一接取端口40之一橫截面圖,該接取端口40具有附接至該接取端口之一醫療連接器。該接取端口可具有一閥100,出於闡釋性目的未展示該閥100。如圖11B中所展示,當一醫療連接器經附接至一接取端口時,在該醫療連接器之一環74與從凹口140之基底延伸之突部150之一頂表面之間可存在一高度h2。在醫療連接器(不含任何環74)之基底70之一底表面與突部150之頂表面之間亦可存在一高度h3。又,圖11B中可見到醫療連接器之環74之一內半徑R6(即,從該環之中心至形成該環之一壁之一內表面的一半徑)。
圖12A及圖12B繪示一接取端口40之一橫截面圖,該接取端口40包含一閥部件100且具有附接至該接取端口之一醫療連接器50。在一 些實施例中,該醫療連接器之一基底70可具有一環形突部72,該環形突部72可用於諸如藉由音波熔接或膠合而幫助該醫療連接器附接至接取端口。其他形式的附接亦係可行的,包含按扣配合構造。在所繪示之實施例中,突部72係較佳膠合至外凹口44中。
圖12A繪示在一閉合位置中的閥部件100,且圖12B繪示在一敞開位置中的閥部件。該閥係與圖10中一樣定向,使得該閥之對稱軸係垂直於圖式之平面。在閉合位置中,該閥之隔膜110可在兩側上大致平坦且可封抵醫療連接器之基底70。在一些實施例中,如所繪示,醫療連接器可具有一環74或其他突部,其等可經設定大小及構造以在閥100處於一閉合位置中時,接觸該閥100之隔膜110且封抵該閥100之該隔膜110。如圖4B中所展示,醫療連接器50`可包含一類似環74`。
在一些實施例中,醫療連接器50及/或接取端口40可經設定大小及構造,使得該醫療連接器之基底70或環74可壓縮閥100之至少一部分。此可有助於建立隔膜110與該醫療連接器之間的密封。因此,在其中隔膜封抵該醫療連接器之一環74或其他突部的實施例中,高度h2(展示於圖11B中)可小於閥部件100之總高度(即,圖10中所繪示之h1與t1之總和)。類似地,在其中連接器無一環或其他突部的實施例中,高度h3(展示於圖11B中)可小於閥部件之總高度。在各項實施例中,高度之間的相對差可影響密封量。例如,在一些實施例中,閥部件之總高度對高度h2之比率可在約1.0與約1.5之間。在一些實施例中,閥部件之總高度對高度h2之比率可在約1.0與約1.3之間。在一些實施例中,閥部件之總高度對高度h2之比率可在約1.0與約1.2之間。在一些實施例中,閥部件之總高度對高度h2之比率可在約1.1與約1.2之間。在無一密封環74或其他突部的實施例中,閥部件之總高度對高度h3之各個比率可如參考高度h2所描述。在一些實施例中,閥部件之總高度可小於高度h2,使得該閥部件作為一浮動式止回閥。在一些此等例項 中,隔膜110之底表面上之支撐件120可提供穩定性且阻止該隔膜之反轉。類似比率可適用於醫療連接器50`。
在各項實施例中,一環74之半徑R6(展示於圖11B中)與介於支撐件120與閥中心之間的距離R5(展示於圖10中)之間的關係可影響閥如何回應於以下各者變形:來自該環之一壓縮力及該環與該閥之間的一密封及/或該閥之一啟流壓力(其在下文進一步描述)之任何最終變化。較佳地,R5可近似等於R6。在一些實施例中,R5可小於R6。在一些實施例中,R5可大於R6。在一些實施例中,R5與R6之間的關係可根據止回閥100之硬度而改變,以確保該閥視需要進行密封。可對醫療連接器50`進行類似調整。
若底表面112與上表面或頂表面116之間的隔膜上存在一負的差壓,即,在頂表面上的一負的淨壓力,則該壓力趨於將該隔膜推抵於基底70或內環形突部72,此可建立或加強一密封且阻止流體流動至醫療連接器中。相比而言,若存在一正的差壓,即,在頂表面116上的一正的淨壓力,則隔膜110將趨於如上所述般變形,且使閥從一閉合位置移動至一敞開位置,如圖12B中所繪示。在敞開位置中,閥可向下撓曲(在其頂表面上產生一凹度),從而容許流體流動通過醫療連接器之基底中的一開口76,進入接取端口凹口140中,且通過接取通道42以到達主通道14。
在一些實施例中,當閥在一敞開位置與一閉合位置之間轉變時,閥部件100之至少一部分保持固定。此可幫助閥更容易地從一敞開位置移動至一閉合位置,從而有助於阻止非所要的逆流。亦可容許在較低壓力下從一閉合位置轉變至一敞開位置的設計,如下文進一步描述。在一些實施例中,當閥處於一敞開位置時,隔膜之至少一部分可保持與在該閥處於一閉合位置時大體相同的位置。在一些實施例中,當閥處於敞開位置時,隔膜110之至少一部分可保持與一醫療連 接器之基底70接觸。
在一些實施例中,閥100可由一彈性材料形成,使得在缺少一差壓的情況下,該閥趨於朝向閉合位置移動(即,係朝向閉合位置偏置)。
如上所述,閥可經不同設計以影響其從一閉合位置移動至一敞開位置的容易程度。將閥100從一閉合位置移動至一敞開位置所需要的差壓可稱為啟流壓力。在一些實施例中,閥可具有一最小啟流壓力,使得該閥非常容易地從一閉合位置轉變至一敞開位置。此可更容易地使流體通過閥且進入一主流體流動線中。此亦容許閥與高流速連接器(舉例而言,諸如容許450mL/min或甚至更大之流速之連接器)一起有效地運作。在一些實施例中,閥可具有處於或低於約5psi之一啟流壓力。在一些實施例中,閥可具有處於或低於約4psi之一啟流壓力。在一些實施例中,閥可具有處於或低於約3psi之一啟流壓力。在一些實施例中,閥可具有處於或低於約2psi之一啟流壓力。在一些實施例中,閥可具有處於或低於約1psi之一啟流壓力。在一些實施例中,閥可具有一啟流壓力,該啟流壓力小於從懸掛於一標準IV架上的一儲液器中之流體施加於該閥上的壓力。在一些實施例中,此可近似等於36英寸的水之壓力。在一些實施例中,此可近似等於1.3psi。
在一些實施例中,啟流壓力可為零,使得即使在隔膜110之下表面112與上表面116之間差壓為零的情況下,閥仍將處於一敞開位置。換言之,在一些實施例中,閥之閉合位置並非該閥之一平衡位置。在此等實施例中,該閥可能並非處於一閉合位置中,直至一流體逆流在隔膜110上產生一負的差壓。在具有一零啟流壓力之一些實施例中,閥可作為一浮動式止回閥,舉例而言,如上文所描述。
圖13A及圖13B繪示一接取端口40之一橫截面圖,該接取端口40包含一閥100且具有附接至該接取端口之一醫療連接器。圖13A及圖 13B係類似於圖12A及圖12B,但包含可附接至接取端口之整個醫療連接器50之一圖解說明。此外,圖13A繪示處於一閉合位置的閥100,且圖13B繪示連接至醫療連接器之一醫療器具200。
如上所述,在一些實施例中,醫療連接器50可為一無針連接器,該無針連接器具有一基底70、一主體60及一連接器閥部件80。該基底亦可包含位於該主體60內之一內部突部90。醫療器具之一套管202可將連接器閥部件80壓縮至一敞開位置中,暴露該內部突部中之一開口92,該套管中之流體可通過該開口92。一旦在該內部突部內,流體即可流動至接取端口凹口140中,通過接取通道42,且進入主流動通道14中。醫療連接器50`可發生類似啟動。
在一些實施例中,本文中所描述之裝置及元件之一或多個組件可為半透明及/或透明的,使得通過該等組件之流體流動路徑係可見的。此等組件可包含(例如)一歧管之外殼12、醫療連接器50(包含主體60、基底70及/或閥部件80)、醫療連接器50`(包含主體60`、基底70`及/或閥部件80`)及/或止回閥100。此外,在一些實施例中,一或多個組件可包含經結構設計或經調適以滅殺病原體之元件。例如,在一些實施例中,閥80、80`或100之一或多者可包含抗微生物劑。在一些實施例中,抗微生物劑可為一塗層或可被併入組件之結構中,該等抗微生物劑可從該結構(諸如從一閥之聚矽氧基質)滲出。
如本文中所使用之術語「近似」、「約」及「大體上」表示接近於所陳述量之一量,該量仍執行一所要功能或達成一所要結果。例如,術語「近似」、「約」及「大體上」可係指一量,該量係在所陳述量之小於10%內、小於5%內、小於1%內、小於0.1%內及小於0.01%內。
雖然已在某些較佳實施例及實例之背景內容中揭示本發明,但是熟習此項技術者將理解,本發明的範圍擴大超出具體揭示之實施例 至其他替代實施例及/或本發明及其明顯修改以及等效物之使用。此外,雖然已詳細展示及描述本發明之諸多變動,但熟習此項技術者基於本發明將易於明白本發明之範疇內之其他修改。亦預期,可進行實施例之特定特徵及態樣之各種組合或子組合,且該等組合或子組合仍落在本發明之範疇內。因此,應理解,所揭示實施例之各種特徵及態樣可互相組合或互相取代以形成所揭示發明之變化模式。因此,希望本文中所揭示之本發明之範疇不應受上文所描述之特定所揭示實施例限制。
類似地,本發明之此方法不應解釋為反映任意請求項需要多於該請求項中所明確敘述之特徵之一意向。而是,本發明態樣可在於少於任何單一上文所揭示實施例之全部特徵之一組合。因此,緊隨【實施方式】之後的申請專利範圍明確併入此【實施方式】中,其中每一請求項獨立作為一單獨實施例。

Claims (29)

  1. 一種醫療止回閥,其用於一醫療裝置中以提供一第一流體位置與一第二流體位置之間的單向流體流動,該止回閥包括:一可撓性隔膜,其包括一頂表面、一底表面及該頂表面與該底表面之間的一側壁;一第一支撐部件及一第二支撐部件,該第一支撐部件從該可撓性隔膜之該底表面延伸,該第二支撐部件從該可撓性隔膜之該底表面延伸,該第一支撐部件及該第二支撐部件經定位以界定一對稱線,該對稱線在不通過該第一支撐部件或該第二支撐部件的情況下平分該底表面;其中該可撓性隔膜具有一第一位置及一第二位置,在該第一位置中,該頂表面係大致平坦的且經結構設計以封抵一流體開口,在該第二位置中,該隔膜之該頂表面圍繞該對稱線彎曲且經結構設計以自該流體開口移位。
  2. 如請求項1之醫療止回閥,其中該對稱線係在不通過該第一支撐部件或該第二支撐部件的情況下平分該底表面的該唯一對稱線。
  3. 如請求項1之醫療止回閥,其中該可撓性隔膜係一圓盤。
  4. 如請求項3之醫療止回閥,其中該等支撐部件係圍繞該圓盤按180度間隔定位。
  5. 如請求項1之醫療止回閥,其中該可撓性隔膜係無孔的。
  6. 如請求項1之醫療止回閥,其中該可撓性隔膜、該第一支撐部件及該第二支撐部件係經一體地形成。
  7. 如請求項1之醫療止回閥,其中該可撓性隔膜之該頂表面上之小於3psi之一淨壓力足以使該隔膜從該第一位置移動至該第二位 置。
  8. 一種醫療歧管,其用於提供對一流體流動路徑之接取,該醫療歧管包括如請求項1-7中之任何一項之醫療止回閥。
  9. 如請求項8之醫療歧管,進一步包括:一第一端口;一第二端口;一第一通道,其連接該第一端口與該第二端口且界定一第一流動路徑;一外殼,其包括:一第三端口,其包括流體連接該第三端口與該第一流動路徑之一第二通道;其中該醫療止回閥被定位於該第三端口中以藉此界定該第三端口之一底壁與該隔膜之間的一空間;一醫療連接器,其經結構設計以附接至該第三端口,其中在一閉合位置中的該醫療止回閥經結構設計以封抵至該醫療連接器之一開口,且在一敞開位置中的該醫療止回閥經結構設計以容許流體從該醫療連接器流動,經過該醫療止回閥,通過該第二通道且進入該第一流動路徑中。
  10. 如請求項9之醫療歧管,其中該第三端口之一外壁係圓柱形的。
  11. 如請求項9之醫療歧管,其中該第三端口之一外壁包括多個壁。
  12. 如請求項9之醫療歧管,其中該第三端口進一步包括至少兩個突部,該等突部從該第三端口之該底壁且鄰近該第二通道延伸,其中該等突部界定該等突部與該第三端口之一外壁之間的一外通道,及該等突部之間的至少兩個橫向通道。
  13. 如請求項12之醫療歧管,其中該第一及第二支撐部件經結構設計以定位於該等突部之至少兩者上。
  14. 如請求項9之醫療歧管,其中該醫療止回閥係朝向該閉合位置偏置。
  15. 如請求項9之醫療歧管,其中該醫療止回閥經結構設計以由於來自該醫療連接器中之流體之壓力而從該閉合位置移動至該敞開位置。
  16. 如請求項9之醫療歧管,其中該外殼係單體的且包含該第一端口及該第二端口。
  17. 如請求項9之醫療歧管,其中該醫療止回閥上之小於3psi之一淨壓力係足以使該醫療止回閥從該閉合位置移動至該敞開位置。
  18. 如請求項9之醫療歧管,其中該第三端口進一步包括至少兩個突部,該等突部從該端口之該底壁且鄰近該第二通道延伸,其中該等突部界定該等突部之間的至少兩個橫向通道。
  19. 如請求項18之醫療歧管,其中該第一及第二支撐部件經結構設計以定位於該等突部之至少兩者上。
  20. 如請求項18之醫療歧管,其中該第三端口包含一凹口且該等突部從該凹口之該底壁延伸。
  21. 如請求項20之醫療歧管,其中圍繞該凹口之一壁從該外殼向外延伸,且該醫療連接器之一部分經結構設計以圍繞該壁之至少一部分。
  22. 如請求項21之醫療歧管,其中該醫療連接器係經音波熔接至該第三端口。
  23. 如請求項9之醫療歧管,其中該外殼進一步包括一第四端口,該第四端口包括流體連接該第四端口與該第一流動路徑之一第三通道,該歧管進一步包括:一第二閥部件,其包括一隔膜及複數個支撐部件,該複數個支撐部件經結構設計以定位於該第四端口中以藉此界定該第四 端口之一底壁與該隔膜之間的一空間;及一第二醫療連接器,其經結構設計以附接至該第四端口,其中在一閉合位置中的該第二閥部件經結構設計以封抵至該第二醫療連接器之一開口,且在一敞開位置中的該第二閥部件經結構設計以容許流體從該第二醫療連接器流動,經過該第二閥部件,通過該第三通道且進入該第一流動路徑中。
  24. 如請求項9之醫療歧管,其中該第一端口經結構設計以接合一醫療魯爾連接器。
  25. 如請求項9之醫療歧管,其中該歧管進一步包括:一第二外殼,其包括一第四端口,該第四端口具有流體連接該第四端口與該第一流動路徑之一第三通道;一第二閥部件,其包括一隔膜及複數個支撐部件,該複數個支撐部件經結構設計以定位於該第四端口中以藉此界定該第四端口之一底壁與該隔膜之間的一空間;及一第二醫療連接器,其經結構設計以附接至該第四端口,其中在一閉合位置中的該第二閥部件經結構設計以封抵至該第二醫療連接器之一開口,且在一敞開位置中的該第二閥部件經結構設計以容許流體從該第二醫療連接器流動,經過該第二閥部件,通過該第三通道且進入該第一流動路徑中。
  26. 如請求項25之醫療歧管,其中該第一外殼及該第二外殼係單體的。
  27. 如請求項25之醫療歧管,其中該第一外殼及該第二外殼係藉由一可撓性連接元件接合。
  28. 如請求項1之醫療止回閥,其中,在該第二位置,該隔膜之頂表面向下彎曲圍繞該對稱線藉此在該頂表面上形成一凹度。
  29. 如請求項1之醫療止回閥,其中,在該第二位置,該隔膜向下撓曲藉此在其頂表面上產生一凹度。
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