TWI520755B - 靜脈進入口總成及其組合方法 - Google Patents
靜脈進入口總成及其組合方法 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
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- A—HUMAN NECESSITIES
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
- A61M2039/0063—Means for alignment of the septum, e.g. septum rim with alignment holes
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
- A61M2039/0072—Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
- A61M2039/0211—Subcutaneous access sites for injecting or removing fluids with multiple chambers in a single site
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
- A61M2039/0229—Subcutaneous access sites for injecting or removing fluids having means for facilitating assembling, e.g. snap-fit housing or modular design
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- Infusion, Injection, And Reservoir Apparatuses (AREA)
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Description
本發明係關於醫學領域之裝置且更特定言之係關於可植入式靜脈進入口總成。
已知從患者輸注及/或抽取液體之輸注口,此係緊固至一植入式導管之近端。此等輸注口一般用於藥物輸注或少量血液抽取,其中無須大量液體流動。可植入式靜脈進入口之優勢在於其可長時期保持在患者體內,可有多用途並降低相關感染之風險。該等輸注口為具有與導管及輸注口殼內之貯槽或室流體連通之排出口的針頭不可穿透之殼的總成,並提供皮下自封式隔片,其在無需連續尋找新的進入部位下界定用於多個針刺穿過患者被覆之皮膚組織、穿過該隔片並進入貯槽之一進入部位。該隔片係由諸如聚矽氧彈性體之材料組成,該隔片每次當抽出針頭時其可自封閉。此等輸注口之實例揭示於例如美國專利第4,704,103號、第4,762,517號、第4,778,452號、第5,185,003號、第5,213,574號與第5,637,102號,及第6,113,572號中。另一種導管輸注口揭示於在2006年8月17日公開之美國專利公開案第US 2006/0184142號中。
一些輸注口正付諸應用,已知如雙口或多口。此等口提供兩個或兩個以上隔片及內室,均藉由各自的分開排出口或者單一桿中之分開通道對應該附接導管之不同管腔,以便與一雙或多管腔導管之分開管腔連通,如揭示於諸如美國專利第5,360,407號中。
一般而言,一輸注口殼包括一基座與一蓋,其一起協作以藉由將隔片之座凸緣壓入殼基座之座中,以將針頭可穿透之隔片緊固於總成內部。諸多此等口之殼係經接合(或焊接)在一起,其中當接合劑乾燥時(或當完成焊接時),夾具將該蓋固持至基座,從而壓縮隔片凸緣以在製造完成後確保壓縮該隔片凸緣。一種固定蓋與基座之方式揭示於2007年11月22號公開之美國專利公開案第US 2007/0270770號中,其中該殼蓋及基座係機械自保持以在接合劑固化時壓縮隔片凸緣。在此口中,水平肋段係形成於蓋之內表面上或基座之外表面上,而蓋或基座中之另一者為肋段提供凹槽,使得該蓋係藉由固定結構而卡扣裝配至基座以在蓋與基座之間壓縮隔片凸緣,因此在製造期間當接合劑乾燥時排除使用夾具之必要。
需要的是提供一種以確定密封方式確定固定在一起之靜脈進入口總成。
簡而言之,本發明為一種具有殼之靜脈進入口總成,該殼界定至少一個室或貯槽、至少一個與該室相接連之隔片及一排出端,該排出端具有至少一個貫穿其之通道,其與各自之至少一個室流體連通以供流體流入一導管之對應管腔中,該導管可附接於排出桿,其附接至輸注口殼總成。該殼為包括一基座或下殼及於該至少一個隔片周圍而可固定至其之一蓋或上殼的總成。該上殼包括至少兩個諸如懸垂於其側邊之閂臂的閂鎖段,從而以壓縮至少一個隔片之凸緣之方式,閂扣地接合在組合時下殼上或側所界定之對應閂扣部分或卡扣部。一種本發明之組合方法包括以在上殼與下殼之間壓縮各隔片之周邊凸緣的方式,藉由閂臂,將上殼與下殼彼此機械固定的步驟。
在本發明雙口總成之較佳實施例中,隔片包括在組合時於上殼及下殼之間壓縮的周邊凸緣,該等凸緣進一步包括從該等周邊凸緣之上表面及下表面突出之脊部,其配置於上殼及下殼之對應凹槽中,全部皆以於該等上開口周圍呈密封關係將該等隔片緊固至該等室。在兩個隔片之間為其各自的重疊凸緣;較佳地,該上殼包括一陣列懸垂於其之柱部,其在組合時延伸通過重疊凸緣之開口並進入下殼之對應孔洞中。當結合劑固化時或在超音波焊接期間,閂臂、凸緣壓縮結構及柱陣列均作以壓縮隔片之周邊凸緣的方式使該等殼彼此固定,從而排除在組合過程中使用夾具之必要,及亦用以在針頭穿透及抽出期間以與殼密封的方式固定隔片。
併入本文中且構成本說明書的一部分之附圖說明本發明之當前較佳實施例,且與以上給定之綜述及以下給定之實施內容一起,用於解釋本發明之特徵。
在文中所使用某些術語僅出於方便,且不視為限制本發明。術語包括明確提及之詞、其衍生物及具有相似意義之詞。下列實施例不欲詳盡說明或以揭示之精確形式限制本發明。此實施例經選擇及敘述以最佳說明本發明之原則、其應用及實際用途,及使熟悉該項技藝者最佳地應用本發明。
圖示中之靜脈進入口總成10包括一下殼或基座殼12、一上殼或蓋殼14及分別與在總成10中並列配置之室或貯槽20、22相接連之兩個隔片16、18。可見一排出端24具有一對通道26、28,在將排出桿組合至排出端時一對排出桿管道(未顯示)將連接至該等通道,以於室20、22與可固定於排出端24之排出桿的雙管腔導管(未顯示)之各管腔之間建立流體連通。各隔片16及18係由自封式材料組成,以使針頭可穿透並在抽出各自針頭(未顯示)後會關閉且密封;此一材料可為聚矽氧彈性體。下殼12及上殼14係由針頭可穿透之物質組成,諸如聚碸或聚丙烯。
上殼14係藉由至少兩個閂扣部分(較佳為閂臂30,位於該上殼之每一邊)而可附接至下殼12,每個閂臂於其自由端具有閂扣部分32,其在組合時與下殼之閂扣部分或卡扣部34建立閂扣連接;在此實例中顯示4個此等閂臂30。在閂扣之前,隔片16、18係位於下殼12之隔片座36、38中,以使隔片之周圍凸緣40在上殼14之壓縮表面42與下殼12之壓縮表面44之間壓縮,從而以抵抗由針頭穿透進入各自隔片並從中抽出所產生之壓力的方式在每一室20及22周圍建立周圍密封。除剛敘述之閂扣配置外,較佳係使用結合或超音波焊接以建立密封;在結合劑固化時或在超音波焊接時,該閂扣配置用來排除將殼夾在一起之夾具之需要。
可看見周圍脊部46係設於該等各自隔片之周圍凸緣40的上表面及下表面上,該等各自隔片係位於上殼14之對應凹槽48及下殼12之對應凹槽50中,此有助於將隔片緊固於適當位置。較佳地,隔片16、18包括彼此相鄰之直邊部並具有沿其重疊之凸緣56。亦可看見一柱部52陣列(圖2及圖4)自上殼14之中間肋60懸垂,穿過重疊凸緣56之孔口54並進入下殼12之中間肋62中之對應孔洞58中,以在結合或焊接時及隨後在針頭穿透及抽出期間進一步緊固隔片於適當位置。較佳地,閂臂30係沿下殼12之各自凹部64配置,因此為口總成提供光滑之連續外表面。而且較佳地,隔片16、18之頂部向上突出穿過上殼14中之開口66並超過其頂端表面68,以使醫師藉由觸感或按診可辨明隔片之位置,從而確認針頭穿透之目標部位。
熟悉此項技藝者應理解可對上述實施例做出變動而不脫離其廣泛範圍的本發明概念。因此,應理解本發明不受限於揭示之特定實施例,而計畫在經附加請求項定義之本發明範圍內涵蓋各種修改。
10‧‧‧可植入式口總成
12‧‧‧下殼
14...上殼
16...隔片
18...隔片
20...室
22...室
24...排出端
26...通道
28...通道
30...閂臂
32...閂扣部分
34...卡扣部
36,38...隔片座
40...隔片周圍凸緣
46...周圍脊部
48...上殼凹槽
50...下殼凹槽
52...柱部
54...孔口
56...重疊凸緣
58...孔洞
60...中間脊部
62...中間肋
64...下殼凹部
66...上殼開口
68...上殼表面
圖1為本發明之口總成的等角視圖;圖2為圖1之口總成的分解圖;圖3及4為沿圖1之平面3-3及4-4取得的剖面圖;及圖5為圖4之剖面圖之分解圖。
12...下殼
14...上殼
16...隔片
18...隔片
20...室
22...室
24...排出端
26...通道
28...通道
30...閂臂
32...閂扣部分
34...卡扣部
36,38...隔片座
40...隔片周圍凸緣
46...周圍脊部
52...柱部
54...孔口
56...重疊凸緣
58...孔洞
60...中間肋
62...中間肋
64...下殼凹部
66...上殼開口
68...上殼表面
Claims (7)
- 一種可植入式靜脈進入口總成(10),其具有界定兩室之一殼,及兩隔片(16或18),一隔片連接至其中一室(20或22),及一排出端(24)具有至少一個貫穿其間之通道(26或28),其與各自一室(20或22)流體連通,且其中該等隔片(16、18)更進一步為並列配置,且在該等兩隔片之間為彼此重疊之凸緣(56、56),藉此該等重疊凸緣(56、56)有助於在組合時與組合後固定該等隔片(16、18)。
- 如請求項1之口總成(10),其中該殼包括一下殼體(12)與一上殼體(14),其中該上殼體(14)包括多個依附於其上之柱部(52),該等柱部穿過該等重疊隔片凸緣而與孔口(54)對準,且該下殼體(12)包括多個與其對準之孔洞(58)以在組合時容納該等柱部(52)之各者,藉此該等柱部在組合時或組合後有助於固定該等隔片。
- 如請求項1之口總成(10),其中該殼包括一下殼體(12)與一上殼體(14),該上殼體或下殼體之一者包括至少一對閂臂(30),每個閂臂具有一配置於其各邊之閂扣部分(32),以便閂扣地接合藉由其餘該上殼體(14)或下殼體(12)所界定之各自對應的卡扣部(34),從而將該上殼體或下殼體(14、12)以壓縮該等隔片(16、18)其一之一周圍凸緣(40)之方式機械地固定在一起。
- 如請求項3之口總成(10),其中該等閂臂(30)依附於該上殼體(14),且該下殼體(12)包括沿其邊表面之凹部(64),且其中該上殼體(14)之該等閂臂在組合時配置於其內,因此為口總成(10)提供光滑之連續外表面。
- 一種組合一可植入式靜脈進入口總成(10)之方法,該可植入式靜脈進入口總成(10)具有一外殼,包括一下殼體(12)與一上殼體(14),及界定兩室(20或22)及兩隔片(16或18),一隔片連接至其中一室(20或22),及一排出端(24)具有至少一個貫穿其間之通道(26或28),其與各自一室(20或22)流體連通,包括下列步驟:提供該等上殼及該等下殼(14、12)及該等兩隔片(16或18),其中該等上殼及下殼中之至少一者包括多個閂扣部分(32或34),且其另一者包括相同數量之對應閂扣部分(34或32);使每一隔片(16、18)置於一各自隔片座(36、38)內,其中該等隔片(16、18)為並列配置,且在該等兩隔片之間為彼此重疊之凸緣(56、56),藉此該等重疊凸緣(56、56)有助於在組合時與組合後固定該等隔片(16、18);將該等上殼及下殼(14、12)以在其間壓縮至少各一個隔片(16或18)之一周圍凸緣(40)的方式而彼此並列;及將該等上殼及下殼中之一者的該等閂扣部分(32或34)與該等上殼及下殼中之另一者的對應閂扣部分(34或32)閂扣在一起,藉此該等上殼及下殼(14、12)在其結合或超音波焊接時機械地固定在一起,同時該周圍隔片凸緣(40)處於壓縮狀態。
- 如請求項5之方法,其中該等閂扣部分為依附於該上殼體(14)懸垂之閂臂(30),而該下殼體(12)包括沿其邊表面之凹部(64),且其中該上殼體(14)之該等閂臂在組合時 沿凹部配置於其內,因此為口總成(10)提供光滑之連續外表面。
- 如請求項5之方法,其中彼此並列該等上殼及下殼(14、12)包括***依附於該上殼體(14)之多個柱部(52),通過在該重疊凸緣(56,56)各自對準之孔口(54),及進入位於該下殼體(12)各自對準之孔口(58),藉由該等柱部在結合或超音波焊接期間使該等殼(14、12)彼此固定。
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US10893508P | 2008-10-28 | 2008-10-28 |
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US (1) | US9149620B2 (zh) |
EP (1) | EP2365838A1 (zh) |
AU (1) | AU2009320117B2 (zh) |
CA (2) | CA2742178C (zh) |
MX (1) | MX339760B (zh) |
TW (1) | TWI520755B (zh) |
WO (1) | WO2010062633A1 (zh) |
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US8177762B2 (en) | 1998-12-07 | 2012-05-15 | C. R. Bard, Inc. | Septum including at least one identifiable feature, access ports including same, and related methods |
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- 2009-10-28 AU AU2009320117A patent/AU2009320117B2/en active Active
- 2009-10-28 MX MX2011004462A patent/MX339760B/es active IP Right Grant
- 2009-10-28 US US12/607,202 patent/US9149620B2/en active Active
- 2009-10-28 CA CA2742178A patent/CA2742178C/en active Active
- 2009-10-28 CA CA3003238A patent/CA3003238A1/en not_active Abandoned
- 2009-10-28 WO PCT/US2009/062283 patent/WO2010062633A1/en active Application Filing
- 2009-10-28 EP EP09745209A patent/EP2365838A1/en not_active Withdrawn
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EP2365838A1 (en) | 2011-09-21 |
AU2009320117A1 (en) | 2010-06-03 |
US20100106094A1 (en) | 2010-04-29 |
US9149620B2 (en) | 2015-10-06 |
TW201021869A (en) | 2010-06-16 |
MX2011004462A (es) | 2011-10-11 |
AU2009320117B2 (en) | 2015-06-18 |
CA2742178A1 (en) | 2010-06-03 |
WO2010062633A1 (en) | 2010-06-03 |
MX339760B (es) | 2016-06-08 |
CA3003238A1 (en) | 2010-06-03 |
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