TWI630007B - 醫療器材及形成其之相關方法 - Google Patents
醫療器材及形成其之相關方法 Download PDFInfo
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- TWI630007B TWI630007B TW102123976A TW102123976A TWI630007B TW I630007 B TWI630007 B TW I630007B TW 102123976 A TW102123976 A TW 102123976A TW 102123976 A TW102123976 A TW 102123976A TW I630007 B TWI630007 B TW I630007B
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- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
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Abstract
本揭露描述眾多例示醫療器材,其包含一具有一近端及一遠端之長條部分,以及一被定義穿過該長條部分的通道及一軟端部,該軟端係耦合至該長條部分之遠端。該端部可被形成自一軟材料。在一些情況下,該軟材料可具有一低於形成該長條部分的材料的硬度。該端部也可包含一通道其可與該長條部分的通道具有實質上同等的尺寸。該端部可於一囓合部位被耦合至該長條部分之遠端,該囓合部位具有一比該長條部分之截面積更大的表面積。
Description
本揭露內容一般而言係關於醫療器材。特定而言,該揭露內容係關於一用於眼科手術具有一軟端部之導管。
軟管係用於眼科手術,諸如視網膜脫離手術,該軟管係用來吸除諸如液體之物質,其包含血液、水樣液及注入之平衡的生理鹽水。於眼科手術中,該器材之端部在與眼睛進行實體接觸之時,其被設計來預防或避免對該眼睛組織之損害係重要的。
根據一面向,本揭露內容係關於一醫療器材,其包含一長條部分,該長條部分具有一遠端及一第一通道以及一端部,該端部於一囓合部位耦合至該長條部分之遠端。該端部可包含一第二通道,其尺寸實質上等同於該長條部分之第一通道。該囓合部位可具有一表面積其大於該
長條部分之截面積。
另一個面向係指向一形成一醫療器材之方法,其包含製備一長條部分的遠端以用於接合一軟端部。製備該遠端可包含雷射切割、水刀切割、碾磨、鑽孔及以上之組合,或任何其他合適之製造方法。該方法也可包含接合一端部至該長條部分之遠端。接合該端部可包含模製(molding)、注射成型(injection molding)、插入成型(insert molding)、擠出(extrusion)、黏著(adhering)及以上的組合,或任何其它合適之連接技術。
該各個面向可包含一或多個以下之特點。該囓合部位可包含一榫槽連結。該榫槽連結可包含至少一榫形成於該長條部分或該端部之一者上,以及至少一槽形成於該長條部分或該端部之另一者上。該至少一榫及該至少一槽可交互鎖定。該囓合部位可包含一增強之表面。該端部可被成型至該增強之表面。該長條部分可包含一針頭或一導管。該長條部分可具有25或更少之一針規尺寸(例如,26針規、27針規或更小之針規尺寸)。該端部之通道可為傾斜的。該端部之通道可由一位於該端部近端之較小的橫截面開口傾斜至位於該端部遠端之較大的橫截面開口。該端部之一遠端可為向外擴張的。
該端部可由一彈性材料所形成。至少該端部的一部分可形成自矽膠、聚胺酯、聚乙烯、聚丙烯、聚苯乙烯、聚四氟乙烯、氟化乙烯丙烯(FEP)、全氟烷氧基(PFA)、聚醚醚酮(PEEK)、聚醚醯亞胺(PEI)、聚醯胺-醯亞胺(PAI)、
熱塑性聚醯亞胺(TPI)、聚苯並咪唑(polybenzimidazol,PBI)、橡膠、乳膠、以上之組合或其他的聚合物或塑料化合物。
本揭露內容之一或多個實施態樣的細節列於附圖及下列說明中。其他特點、物件及優點從該說明書及圖式以及自該申請專利範圍中將是顯而易見。
10、10’、10”、10'''‧‧‧器材
100‧‧‧長條部分
101、131‧‧‧近端
105、132‧‧‧遠端
106‧‧‧圓周邊緣
115‧‧‧流量通道
119‧‧‧交互鎖定特徵
120‧‧‧榫
121、200、202‧‧‧槽
130、700‧‧‧軟端部
133‧‧‧端面
134、170、710‧‧‧通道
135‧‧‧增強之表面
137‧‧‧放大之頭部
150‧‧‧囓合部位
151‧‧‧表面積
170‧‧‧連續通道
172‧‧‧環形部分
174‧‧‧外徑
176‧‧‧內徑
178‧‧‧直徑
180‧‧‧厚度
208‧‧‧放大部分
210‧‧‧縮減部分
720‧‧‧導管
圖1A-1D顯示一具有一軟端部之例示器材的視圖。
圖2係一例示器材之詳細視圖,其顯示一形成於該器材中之例示槽的形狀。
圖3顯示一例示器材之囓合部位的詳細視圖。
圖4係圖3所示之器材的一例示剖面圖。
圖5係另一例示器材之剖面圖。
圖6係另一具有一軟端部之例示器材的剖面圖。
圖7A係一具有一軟端部之進一步例示器材的側面圖。
圖7B係圖3A所示之導管的一端之詳細視圖,其顯示一位於該軟端部及該器材之一長條部分間之囓合部位。
圖8係另一例示器材的一分解結構之局部細節視圖。
圖9係一例示器材圖解該軟端部部分分離自該長條部分之該軟端部及該長條部分之介面的詳細視圖。
圖10係不同尺寸的器材當有或沒有一軟端部時,其被動流動特性之圖形圖解。
圖11顯示一軟端部導管之遠端。
那些熟習此藝者將可理解和明白以下討論之圖式的各種特點不一定是按比例繪製,以及圖式中各種特點之尺寸可能擴大或縮小以更加清楚圖解其中所顯示之特點。
本揭露內容係針對一器材,其具有軟端部以及一形成於該軟端部與該器材之一長條部分之間的介面。在一些情況下,該長條部分可為一導管。在一些情況下,該器材可被用於手術中,諸如眼科手術。然而,本揭露內容並不受限於此,且該長條部分及被形成於其間的該介面可被使用於任何適合或所欲之環境或目的。
圖1顯示一具有一軟端部130之例示器材10。該器材10包含一長條部分100,其具有一近端101及一遠端105並定義一通道115。於一些實施態樣中,該長條部分100可為一針頭或一導管。於其他實施態樣中,該長條部分100可對應於供其他步驟類型用之其他種類空心體。因此,雖然該描述的權衡係參照眼科手術,該揭露內容之範圍並不限於此,且可被利用於醫療及非醫療之許多其他應用。
該長條部分100可被形成自任何所欲或適合的材料。舉例而言,在一些情況下,該長條部分100可被形成自
一金屬諸如不鏽鋼或鈦。然而,該細長器材本體100可被形成自任何適合之材料。舉例而言,該長條部分100可被形成自一生物相容性材料,其包含一生物相容之聚合物、金屬、陶瓷或其他材料。在其他實施態樣中,該器材本體可被形成矽膠、聚胺酯、聚乙烯、聚丙烯、聚苯乙烯、聚四氟乙烯、氟化乙烯丙烯(FEP)、全氟烷氧基(PFA)、聚醚醚酮(PEEK)、聚醚醯亞胺(PEI)、聚醯胺-醯亞胺(PAI)、熱塑性聚醯亞胺(TPI)、聚苯並咪唑(polybenzimidazol,PBI)、橡膠、乳膠,或其他醫療相容的金屬、聚合物或塑料化合物。
該通道115可被利用於進行一抽吸或灌洗溉之液體流動。該器材10亦包含一軟端部130。該軟端部130可耦合於該長條部分100之一遠端131。該軟端部130可包含一端面133且可定義一通道134。又,在一些情況下,該通道134之截面尺寸可與該通道115之截面尺寸相同。舉例而言,當通道115及134呈圓錐形,該通道115及134之直徑可為實質上相同。在其他實施態樣中,該通道115及134之尺寸和/或截面形狀可為不同。另外,該通道115及134可相互對齊。具例而言,該通道115及134之縱軸可為對齊的。該通道115及134定義一連續通道170其延伸穿過該器材10。
該軟端部130係適於提供一緩衝和/或無刮損之參與於細膩組織或膜,諸如於一病患之眼睛中。在一些情況下,該軟端部130可被形成自任何軟材料。特定地,在一些情況下,該軟端部130可被形成自任何醫療相容軟材料。該軟端部130可被形成自下列材料,其包含,如:矽膠、聚
胺酯、聚乙烯、聚丙烯、聚苯乙烯、聚四氟乙烯、氟化乙烯丙烯(FEP)、全氟烷氧基(PFA)、聚醚醚酮(PEEK)、聚醚醯亞胺(PEI)、聚醯胺-醯亞胺(PAI)、熱塑性聚醯亞胺(TPI)、聚苯並咪唑(polybenzimidazol,PBI)、橡膠、乳膠,以上之組合,或其他醫療相容的聚合物或塑料化合物。在一些情況下,形成該軟端部130之材料可具有80A之硬度計值。在一些情況下,形成該軟端部130之材料可具有落在50A至50D之範圍中的硬度計值。然而,該揭露內容並不受限。應該說,此等硬度值僅供作為例示。因此,形成該軟端部130之材料可具有任何所欲之硬度。在一些實施態樣中,該長條部分及軟端部可包含相同或相似之材料。
在一些情況下,該長條部分100可具有一長度其落在大約20.0mm至40.0mm之範圍中。在其他實施態樣中,該長條部分100具有一較長或較短之長度。更進一步,該長條部分100可具有一針規尺寸介於20及30針規。因次,舉例而言,在一些情況下,該長條部分100可具有一外徑落在0.30mm至0.40mm之範圍中。然而,該揭露內容之範圍並不如此受限。因此,在其他實施態樣中,該長條部分100可具有任何適合或所欲之尺寸。另外,在一些情況下,該通道115及134可具有一直徑其落在大約0.30mm至0.01mm之範圍中。該軟端部130可具有一長度其落在約0.5mm至1.0mm之範圍中。更進一步,該軟端部130之外觀尺寸及形狀可對應至該長條部分100之尺寸及形狀,從而於該長條部分100與該軟端部130之間產生一平滑過度。舉例而言,於
具有一圓柱形狀之一器材10,該長條部分100及該軟端部130之外徑可為相同。並且,該通道115及134之直徑亦可為相同以提供一連續通道穿過該器材10。
在其他實施態樣中,該長條部分100與軟端部130之尺寸及形狀可為不同。舉例而言,在一些情況下,該長條部分100之外徑可不同於該軟端部130之外徑。因此,在一些情況下,一階或過渡可存在於該軟端部130及該長條部分100間之介面。更進一步,在一些情況下,該軟端部130可具有一傾斜的外觀表面。因此,在一些情況下,該器材10可包含一平滑過渡於該長條部分100及該軟端部130之間,同時該軟端部130可於其一遠端132縮減至一較小之尺寸。並且,在一些情況下,該通道115及134之直徑可為不同,以至於在該通道115及通道134之間有一階或過渡。
該軟端部130及該長條部分100可包含交互鎖定之特徵119,例如,一或多個交互鎖定之榫120及槽121。在一些實施態樣中,如圖1A及1B所示,該長條部分100可定義一或多個槽121,其形成於該長條部分100之一遠端105。並且,該軟端部130可定義一或多個榫120於該軟端部130之一近端131。該等榫120被接收至該等槽121中以交互鎖定地固定該軟端部130至該長條部分100。一囓合部位150定義一位置,其係該軟端部130及該長條部分100耦合在一起之位置。該囓合部位150可定義一表面積151其大於該長條部分100之截面積,以便在該軟端部130及該長條部分100之間促成一穩固且穩定之連結,甚至是小針規尺寸(如25或更少之
針規)。更進一步,該鎖鏈特徵提供該軟端部130至該長條部分100之耦合,同時避免通過該通道115、114之不欲的流速減低。
如圖1A所示,在該囓合部位150,該軟端部130可於該長條部分100之遠端105之一圓周邊緣106被耦合。如1B-1D所圖解,該囓合部位150可具有交互鎖定特徵119其適於增加該表面積151於該囓合部位150,其係該軟端部130與該長條部分100之遠端105的囓合處。如上所解釋,在一些情況下,該表面特徵119可包含一或多個交互鎖定的榫120及槽121。如圖1A之圖解,在一些情況下,該軟端部130之一或多個榫120可囓合並交互鎖定相對應之槽121,該槽121係形成於該長條部分100之遠端105的圓周邊緣106中。在其他實施態樣中,該長條部分100可包含被形成在該軟端部130中的槽所接收的榫。
該軟端部130及該長條部分100可利用眾多製造方法被耦合在一起。舉例而言,該軟端部與該長條部分100之耦合可經由下列方法被達成:擠壓、澆鑄、模製、注射成型、插入成型、焊接、黏著劑、或其它所欲或適合的方法。舉例而言,該軟端部130可藉由插入成型被形成於該長條部分上。此外,該耦合可使用一或多種該等方法而被達成。
圖1B-1C所圖解的是該長條部分100之例示實施態樣的遠端105。然而,如上所說明的,圖1B-1C所示之該交互鎖定特徵119可交替地被形成於該軟端部130中。如圖
1B-1C所示,該長條部分100可包含一複數之槽200。舉例而言,如圖解,該長條部分100可包含兩個槽200。然而,在一些情況下,任何數目之槽200可被使用。更進一步,該等槽200的形狀可與彼此相同。然而,在一些情況下,該等槽200之形狀可與彼此不同。在一些情況下,該槽等200可為徑向彼此偏移的。舉例而言,該等槽200可以180°之偏移環繞該長條部分100之縱軸而被延著該圓周邊緣106排列。在一些情況下,該等槽200可以不同之徑向偏移被排列。並且,具有兩個以上之槽200的長條部分100或軟端部130可以固定之間距彼此偏移。在一些情況下,該等槽200可以不規則之間距彼此偏移。
該等槽可形成各種形狀或構形。舉例而言,如圖1A所示,該交互鎖定特徵119可包含槽121,該等槽121具有一般圓形的形狀。交替地,如圖1B及1C所示,該交互鎖定特徵119可包含槽200,該等槽200具有一扁的圓形或橢圓形之形狀。雖然,在其他情況下,該等槽200可具有任何所欲之形狀。再更進一步,如圖1D所示,該交互鎖定特徵119可具有深的槽200及淺的槽202之組合。該等槽202可彼此徑向偏移180°。在一些情況下,該等淺的槽202可為圓弧狀的凹部且可彼此徑向偏移180°。更進一步,該組槽200可自該組槽202徑向偏移90°。該等較深之槽200之形狀亦可為一般之圓形或橢圓形。因此,不同深度的槽可被利用。然而此結構係僅被用來作為一例示。任何數量之槽,其具有任何數量之不同形狀及結構可被使用。具備該等一種或其他種
結構的槽,該長條部分100之遠端105(或,在該軟端部130之近端131的情況中)可具有一「拼圖片」之樣貌。另外,該等槽放大該圓周邊緣106之表面積151以在該軟端部130及該長條部分100之間提供增強之接觸。圖2顯示一槽121可被形成之進一步例示。圖2顯示該等槽121具有一般扁平之末端。
圖3顯示一例示器材10之囓合部位150其根據一些實施態樣之詳細視圖。在該例示中顯示,該等交互鎖定之榫120及槽121具有一放大部分208及一縮減部分210。圖4顯示該例示器材之截面視圖,其係延著A-A線通過該縮減部分210。參照圖4,該例示器材10包含六對相對應之榫120及槽121。然而,這僅只是提供作為例示。因此,任何數目之榫120及槽121可被提供。如圖所示,在一些情況下,形成該榫120之材料亦可形成一環形部分172,該環形部分172於該囓合部位150與該通道170的一部分重疊。該環形部分172於通過該囓合部位150之至少一部分可縮減該通道170的截面積。在其他實施態樣中,雖然該囓合部位150可不包含環形部分172於該通道170中。舉例而言,圖5顯示一例示器材10不包含該環形部分172。
再次參照圖4,該圖解的例示器材10可具有一外徑174及一內徑176。該環形部分172可定義一直徑178。在一27針規導管之案例中,該外徑174可為0.40mm且該內徑176可為0.30mm。該直徑178可落在0.30mm至0.27mm之範圍中。因此,在一些情況下,該環形部分172之厚度可落在
0.0mm至.015mm之範圍中。
更進一步,該縮減部分210可具有一厚度180。該厚度180可落在0.05mm至0.10mm之範圍中。因此,在一些情況下,藉由該縮減部分210所定義之區域比該器材10之整個截面積(不包含該環形部分172)的比例可為14及27百分比之間。然而,上述之特定數值僅提供作為例示。因此,在一些情況下,該厚度180可為任何所欲之數值。更進一步,儘管顯示有六組榫120及槽121,更多或更少可被包含。又,在其他情況下,該比例可高於或小於該所指之範圍。再更進一步,該環形部分172之厚度可大於或小於上述該等例示。即,所提供之數值僅作為例示且並不打算作為限制。
雖然以一圓形截面表示,如同在此所解釋的,該揭露內容之範圍並不如此受限。因此,當圖3及4所示之例示具有一般而言圓的截面,該等截面可具有任何所欲之形狀。更進一步,該環狀部分172可符合該器材之截面形狀致使該直徑178實質上亦對應至該器材10之截面形狀,或可定義成任何其他形狀。因此,在一些情況下,當該器材10具有一非圓的截面形狀,該直徑178仍可被定義為圓的。然而,在一些情況下,該直徑178可被定義為任何所欲之形狀。
該等槽或榫之各種類型可被形成在或靠近該長條部分100之遠端。舉例而言,該等槽和/或榫可藉由雷射切割、水刀切割、碾磨、鑽孔、放電加工、化學蝕刻、電解蝕刻,或任何其他適合之方法。該交互鎖定特徵119係被設計來於該囓和部位150增加和/或增強該截面積,例如表
面積151,藉以促進該軟端部130至該長條部分100之接合。
圖6顯示一器材10’,其係根據另一個實施態樣。該器材10’包含一長條部分100其具有一近端101及一遠端105並且定義一流量通道115穿過該器材10’。該軟端部130包含一通道134。該等通道115及130可與上述者相似。該長條部分100之遠端105包含一增強之表面135藉以增強該軟端部130及該長條部分100之耦合。在一些情況下,該增強之表面135可含有一孔洞或孔隙之網絡,其係適於接收形成該軟端部130之材料,藉此增強該軟端部130及該長條部分100之鍵結。在其他情況下,該增強之表面135可為一粗糙化之表面以增加一表面積,藉以增強該軟端部130及該長條部分100之鍵結。在一些實施態樣中,該增強之表面135可在有尿素的使用下被形成。更進一步,在一些情況下,該增強之表面135可同時是多孔的及粗糙化的。仍然在其他實施態樣中,該增強之表面135可包含其他特徵以增強鍵結,無論單獨或結合一或多個在此描述之特徵。
該長條部分100之遠端105亦可被處理以增強形成該軟端部130之材料之接合。舉例而言,一電漿處理可被施行於該遠端105。該電漿處理可清潔、蝕刻及改變形成該長條部分100之材料的化學性質,藉以促進該軟端部130對其之耦合。更進一步,一矽酸鹽層可被形成在該長條部分100之遠端105上,藉以增強該軟端部130至該長條部分100之接合。
該軟端部130可被模製、擠壓上,或接合至該增
強之表面135。該增強之表面135可包含一或多個孔洞、通道或一質地,其定義額外的表面積於該囓合部位150用以與該軟端部130之交互作用。相似地,該軟端部130可包含一表面其囓合該增強之表面135以形成一鍵結於該軟端部130及該長條部分100之間。該增強之表面135所提供之額外的或增強之表面積促進該軟端部130及該長條部分100間之囓合部位與其接合度。在一些情況下,該軟端部130及該長條部分100之間之接合可藉由施用一黏著劑而獲得,該黏著劑可流進該增強之表面135及該軟端部130之相對應的表面表面特徵中,藉以增強其間之接合。或者,該軟端部130可直接被擠壓或成形至該長條部分100的增強之表面135上,諸如,舉例而言,藉由插入成型。用於形成該長條部分100之材料,諸如塑膠或彈性材料,則因此可流入該增強之表面135之表面特徵中(例如,孔洞、裂縫和/或通道)。
圖7A-7B圖解另一個例示器材10”。該器材10”之軟端部130係經由交互鎖定特徵119結合一增強之表面135來連接至該長條部分100之遠端105,該增強之表面135相似於上述之增強之表面135。該增強之表面135可被沿著一個或多個該等槽121之內表面被形成。交替地或額外地,該增強之表面135之一或多個位置可沿著該圓周邊緣106被提供。在其他實施態樣中,該增強之表面135可沿著該圓周邊緣106被提供。如圖所示,該器材10”包含六個槽121,然而任何數量之槽121可被使用。因此,該軟端部130可被耦合至該長條部分100係透過榫120及槽121配對所提供之交互
鎖定以及該增強之表面135所提供之增加的表面積兩者。再次,雖然該等槽121係以形成於該長條部分100中被表示,該等槽121可被形成於該軟端部130中,而該等榫120可被形成於該細長部位100中。
圖8圖解另一個例示器材10'''。該器材10'''包含一軟端部,該軟端部具有一圓周邊緣133其於遠端132向外擴張。在一些情況下,該軟端部130在其全部或一部分長度係自該擴張的圓周邊緣133至一縮減的截面尺寸。舉例而言,在一些情況下,該軟端部130可自一相對應於該長條部分100之外部輪廓傾斜至一放大之圓周邊緣133。更進一步,在一些情況下,該通道134可為傾斜的。
圖8也顯示該長條部分100之遠端105,其具有榫120形成於該長條部分100而非於該軟端部130。該軟端部130可包含一或多個相對應之槽121,其係適於接收形成於該長條部分100之榫120。在一些實施態樣中,該等槽121可具有一放大之頭部137。相似地,該等榫120可具有一形狀互補於該等槽121之形狀,以至於該等榫120配對地被接收至該等槽121中。該等槽121及榫120提供一交互鎖定之囓合。更進一步,該等槽121之放大之頭部137提供一放大的周長,即接觸區,其係該軟端部130及該長條部分100彼此囓合之接觸區。於是,該交互鎖定之榫120及槽121於該器材10'''之軟端部130及長條部分100之間提供一改善之連接。
圖9係一例示器材10之詳細視圖,其中顯示兩個
該等槽121及其相對應之榫120。該軟端部130可被形成自矽膠或其他材料。舉例而言,該軟端部130可被形成自一或多種如上所指出之材料。更進一步,該軟端部130可被直接模至於該長條部分100上。
在一或多個在此描述之例示中,形成於該長條部分100之遠端105的槽120可藉由雷射切割形成。相似地,對於該等榫120係形成於該長條部分100之遠端105的實施態樣,該等榫120可透過雷射切割形成。然而,其他製造方法可被利用於形成該等榫120或槽121於該長條部分100中。舉例而言,其他加工方法可被使用。因次,任何適合之製造作業可被使用於形成該等槽121及榫120。
在一些情況下,當耦合該軟端部130至該長條部分100時,該器材本體可被放置於一射出成型模中,其定義一適於形成該軟端部130之空腔。該長條部分100之一部分,諸如該遠端105,可延伸至該空腔。矽膠或其他適合或所欲之材料可被射出至該空腔以形成該軟端部130。該射出之材料流入形成於該長條部分100之遠端105的槽121中,或交替地,環繞形成於該遠端105的榫120藉以形成該相對應的交互鎖定特徵。更進一步,該射出之材料也填入該長條部分100之表面特徵,諸如由該等槽121或榫120於該遠端105所定義之周長,藉以進一步增強形成於該長條部分100及該軟端部130之間的機械鍵結。
圖9顯示該軟端部130部分分離自該長條部分100。舉例而言,圖9可圖解一情況,其中該軟端部130已被
部分扯離該長條部分100。在一些情況下,該軟端部130自該長條部分100之分離可導致該軟端部之交互鎖定特徵保留於該長條部分100。舉例而言,如圖9所示,當該軟端部130自該長條部分部分或完全分離,該等形成於該軟端部130之近端131的榫120可保留於該相對應之槽121中,即,耦合至該長條部分100。此外,由於該等榫120保持保留在該相對應之槽121中,該器材10不太可能因來自該軟端部130之碎屑而成為閉塞的。亦即,即使該軟端部130部分或完全分離自該長條部分100,該等榫120及槽121之間之交互鎖定關係能作用以保持該軟端部130之榫120,從而避免由該等分離的榫120所造成該器材10的閉塞。其結果,一病患之風險被降低。
一進一步之好處是該通道134可與形成於該長條部分之通道115的尺寸相同。此改善通過該器材之流通容量,同時降低於該軟端部130中閉塞之風險。更進一步,該軟端部130及該長條部分100之囓合包含一表面積,其係由該等槽121及榫120之輪廓所定義且超出一橫截面面積之表面積。因此,軟端部130及長條部分100之交互鎖定特徵提供機械交互鎖定及一增加之表面積兩者可用於耦合,同時提供一通過該器材之管腔,該管腔具有一連續的截面形狀。黏著劑亦可被使用以增加該軟端部130及該長條部分100之間交互鎖定連結之耦合。仍然更進一步,在一些實施態樣中,該軟端部130及穿過其之通道134可為傾斜的,且該軟端部130之一遠端132可為擴張的以改善液體通過該器
材之流動特性。
圖10圖解通過一經定義之尺寸的導管之被動流動特性。圖10也圖解具有鈍端部之導管以及具有軟端部之導管的被動流動特性。特定地,圖10顯示具有軟端部之導管所量測到的被動流動數據,該等導管具有各種直徑(如20至27針規)。該由圖10所表示之被動流動數據(以cm3/min.為單位)係收集自於66毫米汞柱之壓力(如1.25psi或0.88bar)下進行之實驗。該由圖10所圖解說明之被動流動數據係如下之表1所示。
表1包含通過該指定類型之導管的被動流動之流速數據。對於每一個指定之針規尺寸,表1包含鈍端部導管(如導管缺乏一軟端部)及導管包含軟端部兩者之流動數據。對於該20、23、25及27針規之導管以一個星號(*)表示,如圖11所示,一軟端部700被接收至導管720之通道710中。
表1中之最後一項條目係以兩個星號表示(**),其包含一鈍端部導管及一軟端部導管兩者之數據。該軟端部導管係如這裡所描述的耦合至該導管。特定地,該軟端部係藉由插入成形耦合至該導管之一端,雖然任何在此所描述之方法可被使用。更進一步,對於表1中所呈現之例示,該軟端部之通道及該導管之通道係對齊的且其形狀及尺寸實質上係相同的。
該等數據係根據66毫米汞柱之橫跨該導管(及軟端部如適用)之壓力差。所指之流速係源自於該壓力差之量測值。
參照該27*針規導管,通過具有該軟端部之導管的流速係流過該相對應之鈍端部導管的大約44%。亦即,該27*針規之軟端部導管較通過該鈍端部種類之流速少大約56%。相反地,該27**針規種類之軟端部導管具有該鈍端部種類的大約86%之流速。亦即,具有該軟端部之導管相較於該鈍端部僅有14%之流速減少。更進一步,該27**針規之軟端部導管的3.1cc/min.流速大約是該27**針規之軟端部導管的1.5cc/min.流速的107%。圖10將表1所呈現之數據以圖形表示。於圖10中,由”27Ga持續”所代表的是相對應於表1中所呈現之27**針規的數據。
在一些實施態樣中,該長條部分可為任何針規之導管。舉例而言,在一些情況下,該長條部分可具有一針規尺寸落在7至32之範圍內。因此,在一些情況下,該長條部分可具有一管腔,其具有介於0.150in(3.810mm)至0.00325in(0.0826mm)間之內徑。在一些實施態樣中,該
長條部分可具有25針規或更少之一針規尺寸。特定地,在一些情況下,該長條部分可具有一針規尺寸落在25至32針規之範圍內。
應當可被理解的是,雖然很多面相在此被描述,一些實施態樣可包含所有特徵,其他的可包含一些特徵同時包含其他、不同的特徵,以及仍然在其他情況下,其他實施態樣可忽略一些特徵同時包含其他的。亦即,各種實施態樣可包含一個、一些或所有在此所描述之特徵。那些熟習此藝者將可理解各種變化及修飾可在不脫離該揭露內容之精神及範圍下被做到,以及包含於上述說明中或如附圖所示之所有內容其用意應被解釋為說明性的,而不應被視為具有限制意義。此外,本揭露內容之範圍應被解釋為涵蓋以上及上述例示之各種修飾、組合、增加、改造等。於是,在此所論及之特徵與特性可被選擇性地互換及應用至其他解說及未解說之例示實施態樣,而眾多變化、修飾及增加可在不脫離本揭露內容之精神及範圍如所附之申請專利範圍下被做到。
Claims (20)
- 一種醫療器材,其包含:一長條部分,其包含:一遠端;及一第一通道,其延伸穿過該長條部分,該第一通道包括一第一截面尺寸;一外表面,其形成該醫療器材的一外觀表面;一壁,其被形成在該外表面及該第一通道之間;及至少一縱向延伸的槽,其被形成在該壁內且從該遠端延伸,該至少一縱向槽之一整體從該外表面至該第一通道延伸穿過該壁的整個厚度;以及一軟端部,其於一囓合部位耦合至該長條部分之該遠端,該軟端部包含:一第二通道,其包括一第二截面尺寸,該第二截面尺寸等同於該長條部分之該第一通道之該第一截面尺寸;至少一縱向延伸的榫,其從該軟端部的一近端延伸且被接收於該至少一縱向延伸的槽內,該至少一縱向延伸的榫包含:一縮減部分,其從該長條部分之該遠端延伸;及一放大部分,其在該縮減部分的一近端與該縮減部分聯接,該放大部分包含一扁平之末端;及一遠端,其中該軟端部之該遠端界定該醫療器材的一遠端。
- 如請求項1之醫療器材,其中該至少一縱向延伸的榫之截面積係介於取自一平面之該器材之整個截面積的14和27百分比之間,該至少一縱向延伸的榫之截面積係取自一通過該至少一縱向延伸的榫之該縮減部分且垂直於該器材之縱軸的平面。
- 如請求項1之醫療器材,其中該囓合部位包含一孔洞網絡、一孔隙網絡、或一粗糙化之表面。
- 如請求項3之醫療器材,其中該軟端部係成型至該囓合部位。
- 如請求項1之醫療器材,其中該長條部分包含一導管。
- 如請求項1之醫療器材,其中該長條部分具有一25或更少的針規尺寸(a gauge size)。
- 如請求項1之醫療器材,其中該第二通道為傾斜的(tapered)。
- 如請求項7之醫療器材,其中該第二通道自該軟端部之近端的較小之截面開口傾斜至於該軟端部之該遠端的較大之截面開口。
- 如請求項6之醫療器材,其中該軟端部之該遠端係向外擴張的。
- 如請求項1之醫療器材,其中該軟端部係形成自一彈性材料。
- 如請求項10之醫療器材,其中該彈性材料具有低於形成該長條部分之材料的硬度。
- 如請求項1之醫療器材,其中該軟端部之至少一部分係矽膠(silicone)、聚胺酯(polyurethane)、聚乙烯、聚丙烯、聚苯乙烯、聚四氟乙烯、氟化乙烯丙烯(FEP)、全氟烷氧基(perfluoroalkoxy,PFA)、聚醚醚酮(PEEK)、聚醚醯亞胺(PEI)、聚醯胺-醯亞胺(PAI)、熱塑性聚醯亞胺(TPI)、聚苯並咪唑(polybenzimidazol,PBI)、橡膠、乳膠、或以上之組合。
- 一種形成一醫療器材之方法,其包含:製備一長條部分之一遠端以用於接合一軟端部,該製備包含雷射切割、水刀切割、碾磨、鑽孔、化學蝕刻、電解蝕刻、放電加工或以上之組合,該長條部分包含:一遠端;及一第一通道,其延伸穿過該長條部分,該第一通道包括一第一截面尺寸;一外表面,其形成該醫療器材的一外觀表面;一壁,其被形成在該外表面及該第一通道之間;及至少一縱向延伸的槽,其被形成在該壁內且從該遠端延伸,該至少一縱向槽之一整體從該外表面至該第一通道延伸穿過該壁的整個厚度;以及接合一軟端部至該長條部分之該遠端,該接合包含模製、射出成型、插入成型、擠出、黏著或以上之組合,該軟端部包含:一遠端,其界定該醫療器材的一遠端;一第二通道,其包括一第二截面尺寸,該第二截面尺寸等同於該長條部分之該第一通道之該第一截面尺寸;至少一縱向延伸的榫,其從該軟端部的一近端延伸且被接收於該至少一縱向延伸的槽內,該至少一縱向延伸的榫包含:一縮減部分,其從該長條部分之該遠端延伸;及一放大部分,其在該縮減部分的一近端與該縮減部分聯接,該放大部分包含一扁平之末端。
- 如請求項13之方法,其中該軟端部係成型至囓合部位。
- 如請求項13之方法,其中該至少一縱向延伸的榫之截面積係介於取自一平面的該器材之整個截面積的14和27百分比之間,該至少一縱向延伸的榫之截面積係取自一通過該至少一縱向延伸的榫之該縮減部分且垂直於該器材之縱軸的平面。
- 如請求項14之方法,其中該囓合部位包含一孔洞網絡、一孔隙網絡、或一粗糙化之表面。
- 如請求項14之方法,其中該第二通道係傾斜的。
- 如請求項13之方法,其中該長條部分包含一針頭或導管。
- 如請求項18之方法,其中該長條部分具有一25或更少之針規尺寸。
- 如請求項13之方法,其中該軟端部之至少一部分係矽膠、聚胺酯(polyurethane)、聚乙烯、聚丙烯、聚苯乙烯、聚四氟乙烯、氟化乙烯丙烯(FEP)、全氟烷氧基(perfluoroalkoxy,PFA)、聚醚醚酮(PEEK)、聚醚醯亞胺(PEI)、聚醯胺-醯亞胺(PAI)、熱塑性聚醯亞胺(TPI)、聚苯並咪唑(polybenzimidazol,PBI)、橡膠、乳膠、或以上之組合。
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