TWI551281B - 活節式眼科手術探針 - Google Patents
活節式眼科手術探針 Download PDFInfo
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Description
本申請案係主張於2011年8月3日申請之美國臨時申請案序號第61/514,751號的優先權,該臨時申請案之內容在此併入本案以為參考資料。
本發明係有關於眼科手術設備且更詳細地,係有關於眼睛後部之眼科手術探針。
典型上,外科醫師使用微手術儀器以自人體內的脆弱且受限空間移除組織,特別是用於對眼睛進行的手術,且更特別的是,用於移除玻璃狀體、血液、瘢痕組織、或晶狀體。此等儀器包括一控制台及一外科醫師用以解剖並移除該組織的手術牙鑽機頭。就眼睛後部之手術而言,該牙鑽機頭可以是玻璃體切機探針、雷射探針、或用切削或打碎該組織之超音波破碎器,且係藉一長氣壓(氣動式)線及/或電力電纜、光學電纜、或用於將輸注流體送至手術部位並用於自該部位取回或抽吸流體及切開的/破碎的組織之可撓性管而連接至該控制台。該牙鑽機頭之切削、輸注、及抽吸功用係受控於該遙控台,該遙控台不僅提供用於該手術牙鑽機頭(群)(例如往復或旋轉切削葉片或超音波振動針)的電力,而且控制輸注流體的流動且提供用抽吸流體及
切開的/破碎的組織之真空(相對於氣氛)源。該控制台之功用係藉該外科醫師而手動控制,通常係經由腳操作開關或比例控制而控制。
在眼睛後部手術期間,在該程序期間,該外科醫師典型上使用數種牙鑽機頭或儀器。本程序要求這些儀器可***切口內且自其移除。本重複移除及***可導致該眼之切口部位的創傷。為了處理本問題,於1980年代中期至少已研發套筒式環管。這些元件係由一具有連接套筒之窄管組成。係將該管***該眼內之一切口處直達該套筒,該殼可作為一阻擋物以防止該管完全進入該眼內。可經由該管而將手術儀器***該眼內,且該管可保護切口側壁免於被該等儀器重複接觸。此外,在手術期間,當該儀器係經由該管而***眼內時,該外科醫師可經由操控該儀器而利用該儀器以幫助定位該眼睛。
許多外科程序需要進入視網膜之側部或前部位。為了到達這些區域,該等手術探針必需預先彎曲或可在內部操作時彎曲。用於提供雷射及/或照明光之各種活節式光學手術探針係已知。見,例如美國專利第5,281,214號(Wilkins等人)及美國專利第6,984,130號(Scheller等人)。然而,活節裝置會增加額外複雜性及支出。雖然不需要活節裝置之其它可撓性雷射探針在市面上有售,但是本元件係使用已包護在一含該遠側尖端之可撓性管內相當大直徑光纖,其會導致具有顯著彎曲勁度之大彎曲半徑及大遠側尖端直徑。這些特徵要求該遠側尖端含有一非彎曲平直部份以便輕易
地***該彎曲部份,當其通過該套筒式環管時,其必需可撓性地拉直。該遠側尖端之平直部份可以使該彎曲部份可撓性通過該套筒式環管,然後該牙鑽機頭之遠側環管可進入該套筒式環管內以使該可撓性部份得到最大彎曲餘隙率,因此可以使彎曲應變及對應的摩擦***力減至最小。此種大彎曲半徑、大直徑可撓性管、及平直遠側尖端可導致該纖維之可使用部份延伸離該探針之遠側尖端相當長的距離並限制該探針之進入。
該已知技藝之另一缺點為該遠側環管的可撓性,如藉塞在該套筒式環管內之該環管之外徑、以及接受該可撓性管之該環管的內徑之量規尺寸(gauge size)所測定,該遠側環管的可撓性與材料性質及橫截面轉動慣量有關。就任何特定材料而言,該環管之外徑及內徑可測定該環管之可撓性。本可撓性會限制該外科醫師在手術期間使用該儀器以操控眼睛的位置之能力。
一可撓性尖端探針揭示在美國專利申請公開案2009/0093800(Auld,等人)內,其並不需要可撓性管的平直部份,因此可得到更小巧的可用尖端長度,藉此可在不會犧牲***力的情況下進入該眼之內部的後部結構。該可撓性尖端探針可以使該遠側環管增加剛性以在手術期間有助於眼內之位置的操控。雖然與先前探針(諸如藉Scheller等人而揭示的探針)比較,本探針可提供相當小的橫截面,但是在廣範圍的角度下,其並不能如同先前探針一樣提供可控制的活節。
活節式眼科手術探針包括一按一定大小製作以適合單手使用的柄以及一自該柄延伸之具有20 Ga或較小的直徑之單硬質環管。該探針進一步包括一溝槽式尖端(其位於該環管之遠側端)及至少一穿過該柄,該單硬質環管及該溝槽式尖端之光纖、以及一牢固於該溝槽式尖端之拉線。當該拉線對該溝槽式尖端施加拉力時,受控於該拉線之拉力,該溝槽式尖端可自平直偏移至一彎曲角度。該溝槽式尖端係自一當藉該拉線而施加之拉力釋放時可回復至平直位置的彈性材料所形成。
參考圖式、及該等圖式之以下說明以及申請專利範圍可清楚本發明的其它目標、特性及優點。
圖1為根據本發明之一特定實施例之活節式眼科手術終端探針的圖解;圖2係闡明根據本發明之一特定實施例之溝槽式尖端20的實例之端視圖;圖3A-3H係闡明根據本發明之特定實施例之用於一溝槽式尖端的各種溝槽設計;圖4A-4K係闡明根據本發明之特定實施例之用於增加拉線22的拉據之各種裝置。
本發明之各種實施例可避免與先前之活節式眼科手術探針有關的麻煩。特別是,本發明之某些實施例可提供具小直徑的單一硬質環管,其不僅可***很小切口內,而且可以以受控形式活節式穿過多種角度。因此,本發明之此等實施例可合併具有需要大直徑之雙環管探針之可控式活節的相當硬質之活節式眼科手術探針的優點。
本發明之特定實施例包括一具有已牢固於一拉線之含彈性材料之溝槽式尖端的單一硬質環管。該拉線內之拉力可導到該溝槽式尖端以一特定方向彎曲,且當釋放該拉力時,可以使該彈性尖端回復其平直位置。拉線技術先前業經用以偏移一手術導管之遠側端,而非用於用在手握式眼科手術探針之小直徑硬質環管,亦非以角移動角度用於在眼之內部所發現的相當小空間內。因此,就手握式手術探針而言,拉線拉力的施加特別有利。在本發明之特定實施例中,用於終端探針10內之該等光纖中之一或多者亦可作為該拉線。
圖1為根據本發明之一特定實施例之活節式眼科手術終端探針10的圖解,其包含適於以單手握的柄12、及環管14。(為了容易闡明,該柄12及環管14並非按一定比例表示,且並未顯示該柄12之某些外部特徵,諸如用於一內拉線之控制裝置)。該終端探針10之一近側端係一或多可經由連接至至少一穿過該終端探針10之內部的光纖而提供雷射及/或照明光的光源(圖中未表示)連接。
該環管14係由硬質之生物可降解材料(諸如不銹鋼)形
成。根據本發明之各實施例的終端探針之所以使用一“單一”硬質環管的原因在沒有可各別在該單一環管之內側或外側形成及/或可相對於該單一環管獨立移動的其它相當硬質之自承載環管。然而,該名詞“單一”並無意排除使用多層或塗覆物以形成該單一環管,亦無意排除使用符合該環管之形狀的軟聚合物套管或鞘。該環管14之遠側端(亦即在使用時離該外科醫師最遠的末端)具有一溝槽式尖端20。藉施加拉力至一已牢固在該溝槽式尖端20內之拉線,該溝槽式尖端20可以以可控制方式在一特定方向活節連接(圖1內未顯示)。
該溝槽式尖端20係自一彈性材料(亦即移除該拉線之拉力後,可回復至平直定位的材料)形成。用於該溝槽式材料的彈性材料可以是,例如鎳鈦諾(nitinol),其兼具可穿過一切口套筒的充份硬性以及活節連接後可回復的充份彈性。可使用本項技藝中已知之其它金屬,諸如彈簧鋼、或具有類似性質的其它材料。根據該溝槽式尖端之特殊溝槽構形,可使用並非具有優異彈性的相當硬質材料,諸如不銹鋼、以Ni為基礎的超合金、Co-Cr合金等,且不必施加會超過降伏點,因而使該材料永久變形之很大的力。該等彈性材料本身可具生物可降解性,或其等可被包封在另一材料(諸如聚合物護套)內以防止接觸組織。該環管14及溝槽式尖端20可(但未必)自相同材料形成。該環管14及/或溝槽式尖端20亦可經硬化材料(諸如合成鑽石或金屬電鍍(例如鉻)塗覆以得到可***一切口套筒內並可減少破碎的可能性之
改良勁度。
圖2係闡明根據本發明之一特定實施例之溝槽式尖端20之一實例的端視圖。在圖2內所述之實施例中,拉線22係牢固於圖內所示之溝槽式尖端20的上側。該溝槽式尖端20可包封2條光纖24及26(一條具有直徑為183微米之照明纖維24、及一條具有直徑為108微米之雷射纖維26)。考慮到該溝槽式尖端20之寬度,相對於雙環管系統,可製成較小之直徑的環管14。
圖3A-3H係闡明根據本發明之特定實施例之用於該溝槽式尖端20的各種溝槽設計(分別標記為“20A”、“20B”等,且統稱為“溝槽式尖端20”。在圖3A中,係將深於溝槽式尖端20A之半徑的溝槽切削成該溝槽式尖端20A所欲彎曲之側面。將淺溝槽切削成亦可以側面彎曲的對側。圖3B及3C係闡明隨著該溝槽延伸更深入各該溝槽式尖峰20B及20C內而具有較寬底座的平直及彎曲“鎖眼(keyhole)”溝槽。該較寬底座可減少使該溝槽式尖端20B或20C偏移至其彎曲位置所需之力,潛在上可以使該終端探針10在使用時更舒適。
圖3D-3G係闡明可用於更硬質之尖端材料以使該溝槽式尖端20在偏移入該彎曲位置內之後可彈性地回復平直位置的溝槽設計。在圖3D內,沿著環管14之長度通常呈長方形的溝槽之位置係與淺背溝槽反向,其有助於減少使該溝槽式尖端20D偏移至該彎曲位置所需的力。在圖3E中,可以使該溝槽式尖端20E彎曲之一連續螺旋切口係夾雜背溝
槽(在本情況下係為鎖眼溝槽),因此可以使該溝槽式尖端20E沿著該等背溝槽的方向彎曲。圖3F表示一螺旋切口圖案,其中該螺旋路徑係與該溝槽式尖端20F之一側上的縱軸垂直,因此可以使該溝槽式尖端20F優先朝其中該螺旋路徑係垂直的一側偏移。圖3G表示一螺旋切口圖案,該開口在一側上係選擇性變寬,因此可以使溝槽式尖端20G選擇性地朝其中該螺旋切口係較寬的一側偏移。
圖3H表示自一繞線材料(諸如藉拉製成圍繞在一心軸上之繞線材料)形成的溝槽式尖端20H。該繞線之線圈係於溝槽式尖端20H之近側端及遠側端經熔接在一起。在該近側端與遠側之間的中間區域內,該管子的一側具有在該繞線之線圈之間所形成的變寬之間隙溝槽,因此當經由該拉線而施加拉力時,該溝槽式尖端20H可選擇性地朝該等變寬之溝槽偏移。由於可使用能更輕易形成線而非管之材料,所以形成具有繞線材料的該溝槽式尖端20可具有優點。雖然單一繞線示於圖3H中,但是亦可使用多線股。
圖4A-4K係闡明根據本發明之特定實施例之用於增加該拉線22的拉力之各種裝置。在圖4A及4B中,該拉線22係纏繞在已牢固在控制鈕42與基座44間之小齒輪40上。該小齒輪40包含兩表面(一可在該控制鈕42與基座44之間滾轉的較小直徑表面r、及一該拉線22纏繞於其上之較大直徑表面R)。該較小與較大直徑表面r及R的徑向差異會隨著小齒輪40旋轉並平移時導致拉線之示差位移△1。藉選擇用於該較小及較大直徑表面r及R的合適直徑,在相當大量之控制
鈕平移期間。可獲得相當小量之拉線平移△1,因此可以讓使用者精確地控制該溝槽式尖端20內之偏斜。在一實施例中,該較小直徑表面r包含具有匹配齒輪齒在該控制鈕42及基座44上之齒輪齒。其可減少滑動的可能性。
圖4C及4D係闡明具有一藉於該臂之樞軸的固定銷54而維持在適當位置的滑動起動銷52之槓桿臂50。可使用控制鈕(圖中未顯示)以使該滑動銷52前進,其可以使該槓桿臂50之遠側部份上升,因此會使位於該槓桿臂50之近側端的繫索56旋轉以施加拉力至該拉線22。圖4E及4F表示一穿過滑動銷60與第一固定銷62並固定於第二固定銷64的拉線22。使附著於該滑動銷60之控制鈕66前進可增加拉線22的拉力。
圖4G及4H係闡明一在滑動鎖70(當控制鈕74前進時,其係藉導軌72通常以向上方向傳送)在繞行的拉線22。該導軌72之路徑可測定該拉線22之拉力隨該控制鈕之前進的改變。因此可提供拉力之平順及受控性增加。就線性引導而言,如圖4G及4H中所闡明,該拉線捲緊可發生在控制鈕74之前進的後半部。在圖4I內所示的可替代構形內,該導軌72係經改造以於控制鈕74前進開始時使該拉線得到更大的捲緊,因此可以使控制鈕74之撞擊從頭至尾之拉力產生更均衡地增加。在圖4J中,該導軌72傾斜地甚至更急劇,因此大部份的拉力增加係發生在該控制鈕74之撞擊初期。圖4K闡明具有止動器80(其可以沿著相當於該溝槽式尖端20之不同角度的路徑明顯的“中止”)之導軌72的可供替代實施
例。具有止動器之架或表面亦可併用使用一滑動銷或類似起動裝置之終端探針10的各種實施例中之任一者,其包括在圖4A-4K中所示的各該實施例中之任一者。
雖然本發明之某些實施例業經上文說明,但是這些說明文係用於闡明及解釋,只要不違背如以下申請專利範圍中所列舉之本發明範圍,可採用為熟悉本項技藝者已知之不同於上文揭示之系統及方法的變異、改變、修飾及變更。
10‧‧‧活節式眼科手術終端探針
12‧‧‧柄
14‧‧‧環管
20、20A、20B、20C、20D、20E、20F、20G、20H‧‧‧溝構式尖端
22‧‧‧拉線
24‧‧‧照明纖維
26‧‧‧雷射纖維
40‧‧‧小齒輪
42、66、74‧‧‧控制鈕
44‧‧‧基座
50‧‧‧槓桿臂
52、60、70‧‧‧滑動銷
54‧‧‧固定銷
56‧‧‧繫索
62‧‧‧第一固定銷
64‧‧‧第二固定銷
72‧‧‧導軌
80‧‧‧止動器
r‧‧‧較小直徑表面
R‧‧‧較大直徑表面
△1‧‧‧拉線位移
圖1為根據本發明之一特定實施例之活節式眼科手術終端探針的圖解;圖2係闡明根據本發明之一特定實施例之溝槽式尖端20的實例之端視圖;圖3A-3H係闡明根據本發明之特定實施例之用於一溝槽式尖端的各種溝槽設計;圖4A-4K係闡明根據本發明之特定實施例之用於增加拉線22的拉據之各種裝置。
10‧‧‧活節式眼科手術終端探針
14‧‧‧環管
20‧‧‧溝構式尖端
22‧‧‧拉線
24‧‧‧照明纖維
26‧‧‧雷射纖維
40‧‧‧小齒輪
42‧‧‧控制鈕
44‧‧‧基座
Claims (15)
- 一種活節式眼科手術探針,其包括:一其大小適於單手操作的柄;一自該柄延伸之單一硬質環管,其具有20Ga或較小的直徑,該單一硬質環管具有在常規手術使用過程中足以實質上防止其相對於該環管之縱軸彎曲的一剛性;一溝槽式尖端,其包含多數個沿著該溝槽式尖端之整個長度均勻間隔的溝槽,該溝槽式尖端自該單一硬質環管的最遠端延伸至該活節式眼科手術探針的最遠端;至少一穿過該柄、該單一硬質環管及該溝槽式尖端至該溝槽式尖端之遠端的光纖;及一穿過該溝槽式尖端至該溝槽式尖端之遠端及該至少一光纖之遠端的拉線,其中:該拉線通過在該柄中的一第一固定銷,且固定於在該柄中的一第二固定銷;且該拉線通過一滑動銷,該滑動銷係位於介在該第一固定銷與該第二固定銷之間的拉線之沿線,致使該滑動銷的遠端移動導致該拉線內的拉力增加,而該增加的拉力導致該溝槽式尖端自平直位置偏移至一彎曲位置;且該溝槽式尖端係自當藉該拉線所施加之增加的拉力釋放時可回復至該平直位置之彈性材料來形成的。
- 如申請專利範圍第1項之探針,其進一步包括一位於該柄上且耦接於該滑動銷之控制鈕,其中該滑動銷的遠端移動係藉由滑動該控制鈕來控制的。
- 如申請專利範圍第1項之探針,其進一步包含一用於位於該柄內之滑動銷的導軌,該導軌可引導該滑動銷之前進。
- 如申請專利範圍第3項之探針,其中該導軌係經彎曲以控制藉該滑動銷而使拉線捲緊的速率,因此該拉線之拉力可隨沿著該導軌前進的滑動銷而均勻地增加。
- 如申請專利範圍第3項之探針,其中該導軌係於近側端以一初急轉彎曲,致使當該滑動銷係經由該導軌之初急彎而前進時,該拉線之拉力的增加速率最高,且在該滑動銷通過該導軌之初急轉後,該拉力之增加速率下降。
- 如申請專利範圍第1項之探針,其中該拉線為一光纖。
- 如申請專利範圍第1項之探針,其中該溝槽式尖端包含延伸超過該溝槽式尖端朝其偏移之一側上的該溝槽式尖端的半徑之深槽、及延伸短於該溝槽式尖端自其偏移之一反向側上的該溝槽式尖端之半徑的淺槽。
- 如申請專利範圍第7項之探針,其中該等深槽係隨著深槽之深度增加而變寬。
- 如申請專利範圍第7項之探針,其中該等深槽包含一沿著該溝槽式尖端縱向延伸的長方形區段。
- 如申請專利範圍第7項之探針,其中該等深槽係呈彎曲狀。
- 如申請專利範圍第1項之探針,其中該溝槽式尖端係自鎳鈦諾形成。
- 如申請專利範圍第1項之探針,其中該單一硬質環管係 由不銹鋼形成。
- 如申請專利範圍第1項之探針,其中該單一硬質環管係經一硬化材料塗覆。
- 如申請專利範圍第1項之探針,其中該溝槽式尖端係經一軟聚合物皮包層塗覆。
- 如申請專利範圍第1項之探針,其中該至少一光纖包括兩條光纖。
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EP2720600A4 (en) | 2015-01-07 |
JP2014527430A (ja) | 2014-10-16 |
CA2842440A1 (en) | 2013-02-07 |
CN103717121B (zh) | 2016-05-25 |
DK2720600T3 (da) | 2017-01-02 |
RU2606106C2 (ru) | 2017-01-10 |
KR102000243B1 (ko) | 2019-07-15 |
BR112014002383B1 (pt) | 2021-08-10 |
CN103717121A (zh) | 2014-04-09 |
AU2012290158A1 (en) | 2014-02-13 |
US9795505B2 (en) | 2017-10-24 |
WO2013019859A1 (en) | 2013-02-07 |
PT2720600T (pt) | 2016-12-09 |
PL2720600T3 (pl) | 2017-07-31 |
AU2012290158B2 (en) | 2016-07-07 |
BR112014002383A2 (pt) | 2017-02-21 |
RU2014107927A (ru) | 2015-09-10 |
AR087455A1 (es) | 2014-03-26 |
US20180049919A1 (en) | 2018-02-22 |
US10085883B2 (en) | 2018-10-02 |
US20130035551A1 (en) | 2013-02-07 |
MX347448B (es) | 2017-04-27 |
MX2014001119A (es) | 2014-02-27 |
EP2720600A1 (en) | 2014-04-23 |
KR20140057313A (ko) | 2014-05-12 |
ES2606310T3 (es) | 2017-03-23 |
JP5997272B2 (ja) | 2016-09-28 |
TW201311210A (zh) | 2013-03-16 |
EP2720600B1 (en) | 2016-09-21 |
CA2842440C (en) | 2019-09-03 |
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