TW201700074A - 平衡型水晶體乳化術尖端（一） - Google Patents

平衡型水晶體乳化術尖端（一） Download PDF

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TW201700074A
TW201700074A TW105127520A TW105127520A TW201700074A TW 201700074 A TW201700074 A TW 201700074A TW 105127520 A TW105127520 A TW 105127520A TW 105127520 A TW105127520 A TW 105127520A TW 201700074 A TW201700074 A TW 201700074A
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麥克海爾Ａ 歐辛尼柯夫
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愛爾康研究有限公司
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    • A—HUMAN NECESSITIES
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320098—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with transverse or torsional motion

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Abstract

在各種實施例中，一水晶體乳化術尖端可能包括一桿身及具有至少一第一與第二彎曲的切邊部分。該尖端幾何形狀可能配置以導致從該尖端之錐形部分末端延伸貫穿該尖端切邊部分中之第一彎曲的該桿身部分整個在該尖端於10kHz與60kHz之間之頻率下的扭轉振動期間垂直於該桿身之一側向位移(ux)係小於該尖端於遠端點側向位移之大概5至25%(例如，15%)。軟體及/或物理模擬可能使用以決定該尖端幾何形狀。

Description

平衡型水晶體乳化術尖端(一)
本發明一般地關於水晶體乳化術。更特別地，但非做為限制，本發明關於水晶體乳化術尖端。
人類眼睛就其最簡單的功能而言係為提供視力，該者係藉由傳送光線穿經由一稱之為角膜的清澈外部部分，及取道於該晶狀體聚焦影像在視網膜上。該聚焦影像之品質取決於許多因子，包括眼睛的大小與形狀，及角膜與晶狀體之透明度。
當老化或疾病造成晶狀體變得不那麼透明時，視力惡化因為可以傳送到視網膜的光線縮減。在眼睛之晶狀體中的此種缺陷醫學上知悉為白內障。針對此種情況，一個公認的治療係為手術移除該晶狀體並由一眼內晶狀體(IOL)取代該晶狀體的功能。
白內障晶狀體可能藉由稱之為水晶體乳化術之一外科技術移除。在此過程中，一薄薄的水晶體乳化術尖端可能插入該病變的晶狀體中並超音波地振動。該振動的尖端可能液化或乳化該晶狀體，藉由此，該晶狀體可以被抽吸出該眼睛外。該病變晶狀體，一旦移除，可能由一人 工晶狀體取代。
在各種實施例中，一水晶體乳化術尖端可能包括一桿身及具有至少一第一與第二彎曲的切邊部分。該桿身及該至少第一與第二彎曲之幾何形狀可能配置以導致該桿身沿其長度之一側向位移，在該尖端超音波扭轉振動期間垂直於該桿身，係小於該尖端之遠端點位移之大概5%到25%(如15%)(其他閾值亦可以使用的)。在一些實施例中，該桿身可能從一錐形部分之末端延伸(該者可能，舉例而言，距該尖端之遠端點大概12mm)穿經由在該切邊部分之第一彎曲(該者可能，舉例而言，距該尖端之遠端點大概5mm)。該第一彎曲之其他位置亦為預期的(如距該尖端之遠端點3mm、8mm等等)。在一些實施例中，該錐形部分之一近端(即該集線器)可能配置以連接一超音波角件(ultrasonic horn)。
在一些實施例中，決定一尖端幾何形狀之方法可能包括提供二或多種尖端幾何形狀(如在電子格式中，諸如一計算機可讀的輸入檔案其具備一或多種描述該幾何形狀的儲存變量者)、在超音波扭轉振動期間模擬該尖端幾何形狀之行為、並比較該等各種尖端幾何形狀的側向位移以選擇一尖端其在水晶體乳化術過程期間沿著配置以沿著在眼睛中之一切口的該尖端桿身部分(該者可能是，舉例而言，從該錐形部分之一端至該第一彎曲)具備一最小的側向位移。
在一些實施例中，決定一尖端幾何形狀之方法可能包括提供二或多種具備不同幾何形狀(如沿著該尖端於二或更多位置上之手持彎曲(hand bent))之物理尖端、超音波扭轉振動該等不同之尖端、決定該等各種尖端之側向位移、及比較該等決定的側向位移以選擇一尖端其在水晶體乳化術過程期間沿著配置以沿著在眼睛中之一切口的該尖端桿身部分具備一最小的側向位移。
100‧‧‧(平衡型)尖端
102‧‧‧(第一)彎曲
104‧‧‧(第二)彎曲
106‧‧‧遠端點
108‧‧‧(尖端)桿身
110‧‧‧錐形部分
112‧‧‧切邊部分
114‧‧‧近端
116‧‧‧尖端軸
204‧‧‧手持件
206‧‧‧灌流線
208‧‧‧抽吸線
210‧‧‧電纜
212‧‧‧腳踏開關
214‧‧‧控制台
216‧‧‧(超音波)角件
224‧‧‧對角槽縫/溝槽
226‧‧‧(灌洗)套管
227‧‧‧壓電元件/壓電晶體
501‧‧‧角膜
503‧‧‧前房
507‧‧‧鞏膜
509‧‧‧眼
511‧‧‧切口
513‧‧‧部分
901-909、1001-1013‧‧‧步驟
為了更完全地了解本發明，與該等伴隨圖式一起為例之下面說明係作參考的，其中：圖1例示根據一實施例之一平衡型水晶體乳化術尖端，該者具備具有兩個彎曲之一遠端；圖2例示根據一實施例之一水晶體乳化術外科控制台，該者透過一灌流線與一抽吸線連結到一手持件；圖3例示根據一實施例之一超音波角件，該者係依附至該平衡型尖端；圖4例示根據一實施例之該平衡型尖端之運動；圖5例示根據一實施例之一平衡型尖端，該者係插入眼睛中之一切口；圖6例示相對於該平衡型尖端之扭轉振動與側向振動，該者係根據一實施例；圖7a例示針對沿著該尖端z軸之扭轉位移的模擬方程式，該者係根據一實施例；圖7b例示針對沿著該尖端z軸之側向位移的模擬方程 式，該者係根據一實施例；圖7c例示該模擬方程式之分量(l(z))，該者係根據一實施例；圖8a-b例示輸入的尖端形狀及根據該等模擬方程式沿著尖端長度相應的輸出側向位移與扭轉角之實施例；圖9例示用於決定一尖端幾何形狀之方法的流程圖，該者係根據一實施例；圖10例示用於決定一尖端幾何形狀之另一方法的流程圖，該者係根據一實施例；及圖11例示六種可能的平衡型尖端實施例。
係為不言而明的是，前述的一般描述與下列的詳細說明兩者係僅僅示範與解釋的，且係意欲如訴求項般提供本發明進一步之解釋。
圖1例示一水晶體乳化術平衡型尖端100，該者具備一近端114及一相對於尖端桿身108彎曲之切邊部分112。該平衡型尖端100可能包括一接近筆直的桿身108及在該切邊部分112中之至少兩個彎曲(第一彎曲102與第二彎曲104)。其他之彎曲數目亦為可預期的(如3彎曲、4彎曲、7彎曲等等)。該平衡型尖端100可能與一水晶體乳化術手持件204一道使用(如，見圖2)。當與該手持件204使用時，該平衡型尖端100可能縱向地振動及/或扭轉地振動，即藉由環繞其軸反復地旋轉該尖端100。該等彎曲102/104可能定位於，舉例而言，沿著該平衡型尖端100長度遠端大概5至 25%(該者可能為一部分其定位從尖端之遠端點106大概5mm(沿尖端軸116測量)到尖端100遠端點106大概12mm處)。該長度之其他部分亦為預期的。
在一些實施例中，平衡該尖端100可能包括配置該尖端100之幾何形狀(如，該尖端之錐形部分110、該桿身108、及/或該至少第一彎曲102與第二彎曲104之幾何形狀)，藉由此，在該尖端100超音波扭轉振動期間，桿身108沿著其長度之一側向位移，垂直於該桿身108，可能小於該尖端100之遠端點106側向位移之大概5%至25%(如15%)(在一眼科過程期間於該尖端振動頻率期間所測量)。其他閾值亦可能使用的(如10至20%、15至30%、10至40%等等)。在一些實施例中，該尖端在遠端點106之側向位移(在預期的操作頻率期間)可能大概在30至200微米之一範圍中。作為一個例子，假若該遠端點106在該尖端100之超音波扭轉振動期間具有大概+/- 0.035mm之一側向位移，該尖端之幾何形狀可能這樣配置以致於沿著該桿身之最大側向位移係小於5微米(其他位移亦為可能的)。作為另一個例子，假若該遠端點106在該尖端100之超音波扭轉振動期間具有大概+/- 0.055mm之一側向位移，該尖端之幾何形狀可能這樣配置以致於沿著該桿身之最大側向位移係小於8微米。在一些實施例中，該桿身可能從一錐形部分110之末端延伸(該者可能是，舉例而言，距該遠端點106大概12mm)貫穿至在切邊部分112中之第一彎曲102(該者可能是，舉例而言，距該遠端點106大概5mm處)。該第一彎曲102之其他位置亦為預期 的(如，距該遠端點106 3mm、8mm處等等)。
圖2例示透過一灌流線206與一抽吸線208連結至一手持件204的水晶體乳化術外科的控制台214。在一些實施例中，電源可能透過電纜210提供至手持件204，且透過灌流/抽吸線206與208之水流可能由一使用者控制(如，經由腳踏開關212)以執行一水晶體乳化術過程。用於水晶體乳化術過程之手持件的一個例子係於由Mikhail Boukhny、James Y.Chon及Ahmad Salehi於2005年7月18日提申，公開案第2006/0041220，序號11/183,591，題名為「超音波手持件」之美國專利申請公開案中描述的，該者係以其整體宛如完整並完全地陳述併入於此以做為參考。
在一些實施例中，手持件204可能連接至一水晶體乳化術平衡型尖端100。在一些實施例中，該手持件204可能包括至少一組壓電元件227，其於一恰當共振頻率下激發時極化以產生縱向運動。如於圖3中所見，該壓電晶體227可能連結到一平衡型尖端100依附的超音波角件216。該角件216及/或該平衡型尖端100可能包括數個對角槽縫或溝槽224。當該壓電晶體在一共振頻率下激發時，該等槽縫或溝槽224在該平衡型尖端100中可能會產生扭轉移動。由溝槽224嚙合該手持件204中之固定元件所造成之平衡型尖端100的移動可能包括相對於該角件216中心線之一扭轉轉動分量。
如圖4中所見，在一些實施例中，該平衡型尖端100可能配置用於超音波反復扭轉旋轉，經過大概一弧形其 在大概2至6度(如4度之一弧形)該範圍內。其他弧形亦為預期的(如10度弧形(如偏離中心正或負5度(見中圖2)，偏離中心正或負20度，偏離中心正或負90度等等))。在一些實施例中，該平衡型尖端100可能於大概10-60kHz之間(如31kHz)之一頻率下超音波扭轉振動。其他弧形與頻率亦為預期的。舉例而言，正或負20度之一弧形及/或42kHz之一頻率可能使用的。在圖4中顯示之該弧形係誇大地以顯示移動(即該顯示之總弧形係為180度，而該平衡型尖端100可能具有4度之一弧形)。在一些實施例中，在圖4中的尖端移動亦可能包括一個縱向分量(如沿著平行於該桿身之一軸上下)。
如圖5中所見，當使用以執行水晶體乳化術時，該平衡型尖端100之末端與一灌洗套管226可能插入在該角膜501、鞏膜507、或該眼組織其他位置中之一小型的切口511，以得到進入，舉例而言，眼509前房503的機會。在各種實施例中，該平衡型尖端100之一部分或全部可能在該灌洗套管226之內。沿著切口511之該尖端100之部分513可能透過灌洗套管226在水晶體乳化術過程期間與該切口511(及/或其他的眼部位)熱接觸。在一些實施例中，沿著切口511之該部分513可能與切口511直接接觸(如在沒有套管226存在下)。該平衡型尖端100可能藉由一晶體驅動的超音波角件216在該灌洗套管226之內沿其縱軸超音波扭轉振動，從而依靠接觸在原位乳化該所選擇的組織。該平衡型尖端100之中空孔可能與在該角件中之孔相通，該者又可能與抽吸線從手持件204至控制台214相通的(如見圖2)。在該 控制台214中一降低壓力或真空源可能從該眼509中汲取或抽吸出該乳化組織，經由該平衡型尖端100之一開口端、該平衡型尖端100之孔、該角件孔、及該抽吸線208並進入一收集裝置。該乳化組織之抽吸可能藉助於一食鹽沖洗溶液或灌洗液，該等可能經由在該灌洗套管226內側表面與該平衡型尖端100之外側表面之間小的環狀間隙注入至該外科手術位置。
如圖6中所見，該平衡型尖端100之超音波扭轉振動可能導致至少兩種運動：1)該平衡型尖端100從其平衡位置之側向位移，垂直於與一筆直桿身部分共線之一軸116(軸116可能表示為「z軸」)且垂直於該尖端之一彎曲之軸(表示為圖1之y-軸)(該y軸與z軸形成包括該彎曲之平面)；2)沿著該平衡型尖端100 z軸之扭轉角。一個未平衡型尖端在扭轉振動作用之下可能沿著該尖端長度具有顯著的彎曲(尤其是在該桿身中)。藉由如於此所描述般平衡該尖端，沿著該尖端100桿身之側向位移可能降低的，而在該尖端100遠端點106之側向位移可能提高的。扭轉振動可能出現於該尖端100(如沿著相對於該z軸之一扭轉角反復扭轉)，該者可能在該桿身108之側向位移之外或在沒有該桿身108之側向位移存在下導致一相對大的遠端點106側向位移。
在一些實施例中，平衡該尖端100可能包括調整該尖端幾何形狀並物理測試具備該調整的尖端幾何形狀之一尖端，或使用模擬方程式或有限元件分析(FEA)以模擬尖端振動以找到一個尖端幾何形狀其導致一沿著該桿身108 降低的側向位移並伴隨在該遠端點106著提高的側向位移與扭轉(如使用諸如ANSYS軟體)。尖端幾何形狀特徵可能包括，舉例而言，彎曲的數目(如彎曲102、104)、該等彎曲之位置、該桿身的長度、該桿身108的直徑、該錐形部分110的長度及該錐形部分的直徑。其他尖端幾何形狀特徵亦可能被修改。在一些實施例中，不同的尖端幾何形狀亦可能被測試，舉例而言，藉由物理創造具有各種尖端幾何形狀的尖端，振動該等尖端(如使用在水晶體乳化術期間使用的頻率與模式)，及監測由該等各種尖端幾何形狀所產生的側向位移及/或熱。測試不同的尖端幾何形狀之一或多種重複(如藉由固定一彎曲在該尖端中之位置並測試具備不同第二彎曲位置與曲率之不同的尖端)可能導致一或多個優化尖端幾何形狀之確認。其他彎曲數目與幾何形狀之修飾(如修改該二彎曲兩者之位置而同時保持該二彎曲兩者之曲率恆定、修改該等彎曲之位置與曲率、修改該等彎曲之數目、修改該桿身之長度、修改該錐形部分之長度、修改該桿身之半徑、修改該錐形部分之半徑等等)亦為可能的。
在一些實施例中，模擬方程式可能使用的(代替或除了FEA及/或物理測試之外)以測試不同的尖端幾何形狀。舉例而言，描述當超音波扭轉振動一筆直(接近圓柱形)尖端時扭轉角()與側向位移(u x )如何沿著該z軸變化(如墊基於一般的彈性理論)之方程式可能表示如下列(亦見於圖7a-b)： 其中；；C(z)=I(z)* μ
其中，；且
其中係為該尖端之扭轉角，ρ係為該尖端材料之密度，I(z)係為圓柱形尖端截面環繞z軸的慣性矩，R1(z)係為該圓柱形尖端體之一中空內截面之內徑(假若該圓柱形體係為實心的，R1(z)沿著該整個z軸可能為0)；R2(z)係為該圓柱形尖端體之外徑；t係為時間，u x 係為沿著該X軸之側向位移，S(z)係為該圓柱形尖端沿著z軸之橫截面區域，E係為該尖端材料之楊氏模數，I y (z)係為一圓柱形尖端環繞該y軸之橫截面慣性矩，及μ係為該尖端材料之扭轉模量。特徵諸如ρ對該整個尖端可能為相同的，而特徵諸如R1(z)與R2(z)等可能沿著該z軸變化的(且因此可能表示為，舉例而言，一數值矩陣)。描述當超音波扭轉振動一彎曲的(接近圓柱形)尖端(如具有102/104彎曲之一尖端)時該扭轉角()與側向位移(u x )如何沿著該z軸變化的該等方程式可能表示為如下(亦見於圖7a-b)： 其中；
其中；
其中係為該尖端之扭轉角，ρ係為該尖端材料之密度，I(z)係為該圓柱形尖端截面環繞z軸之慣性矩，R1(z)係為該圓柱形尖端體之一中空內截面之內徑(假若該圓柱形體係為實心的，R1(z)可能為0)；R2(z)係為該圓柱形尖端體之外徑；t係為時間，u x 係為沿著該x軸之側向位移，S(z)係為該圓柱形尖端沿著z軸之橫截面區域，E係為該尖端材料之楊氏模數，I y (z)係為一圓柱形尖端環繞該y軸之橫截面慣性矩，μ係為該尖端材料之扭轉模量，且l(z)係為如圖7c中所見沿該y軸之側向位移。在一些實施例中，一或多個輸入及/或方程式可能被修改以解釋該尖端於其中振動之一介質(如水、玻璃體等等)的存在。舉例而言，對於該尖端側向位移之方程式可能如下修改的：
其中，γ係為一經驗參數其表示歸因於介質(諸如水)之耗散(dissipation)。γ值可能被調整以校準方程式與現有的尖端於該介質中之測量位移。在分母中之該ρ 介質 S 介質 (z)術語表示繼之該尖端運動後歸因於該介質的尖端質量提高。該ρ 介質 術語係為介質之密度，且該S 介質 (z)係為與該尖端一起運動之介質橫截面，該者可能使用理想的流體理論評估為：S 介質 (z)=π(R 1 2(z)+R 2 2(z))(其中R1係為跟隨該尖端之介質質量之內徑且R2係為跟隨該尖端之介質質量之外徑)。其它修改亦為可預期的。
在一些實施例中，除了各種尖端特徵之外(如ρ、 E等等)，幾何特徵(S(z)、I(z)、C(z)、I y (z)等等)可能由一使用者輸入，或墊基於由該使用者提供之其他輸入(如該使用者可能提供一內徑(假若該尖端在中心係為中空的)、該尖端沿著該z軸之一外部半徑、一位置(如(沿該Z軸)之啟始點與停止點、及一或多個彎曲之曲率等等)，而由模擬軟體計算(如MatlabTM)。該使用者亦可以使用一圖形使用者界面繪製該尖端形狀(如見圖8a-b中之輸入圖)，該使用者可能預載一尖端幾何形狀(如三維描繪)等等。在一些實施例中，該外徑在小的z值時可能為大的(即在該尖端之錐形部分中)且在該尖端末端係為相對小的。其他輸入亦為可預期的。
在一些實施例中，從上述方程式對與u x 之該等解可能使用以檢視對不同的尖端幾何形狀沿著該z軸之側向位移與扭轉角，且一平衡型/微調的尖端幾何形狀可能從數個尖端幾何形狀選擇的，該者最大化該遠端點106之側向位移u x 與扭轉角度而同時最小化沿著該尖端長度(如沿著該桿身108)之側向位移。在一些實施例中對於與u x 之解可能包括使用調和分析。對於與u x 方程式之解可能提供扭轉角及/或側向位移作為z與t兩者之函數(如u(z,t)與(z,t))。這些解然後可能被使用以根據一調和力模擬該尖端。根據一調和力之模擬可能包括模擬該尖端宛若該尖端於頻率ω振盪如cos(ωt)。根據上文提供針對與ii x 之方程式，調和因此可能使用以簡化針對u(z,t)與(z,t)之該等模擬方程式。在一些實施例中，該解可能根據u(z)cos(ωt)模擬的(即該振動幅度可能僅取決於z以模擬)。該公式u(z)cos(ωt)可能在該運動 方程式(與ii x )中使用以提供針對u(z)振動幅度之一不同的方程式，該者係獨立於時間。針對尖端位移幅度與扭轉幅度之解然後可能標繪的(如見圖8a-b中之輸出)。在一些實施例中，調和分析可能不會使用的(如取決於時間與z之各種解可能決定並分析的)。
圖8a-b例示輸入尖端形狀與根據上文提供之模擬方程式沿著該尖端長度相應的之位移與扭轉角度。在一些實施例中，該第一彎曲102之位置與曲率可能墊基於各種因素而選擇，諸如人體工程學與製造方面的考量。該第二彎曲104可能定位於較靠近該平衡型尖端100之遠端點106。此彎曲之曲率然後可以使用上文提供該模擬方程式之預測而選擇。由此產生的尖端形狀然後可能藉由執行有限元件分析模仿而驗證及/或調整。該理想曲率可能為如此以致於該平衡型尖端100之扭轉振動模式與彎曲振動模式係不耦合的。該平衡型尖端100在扭轉力下之運動可能相同於其之扭轉振動模式。在一些實施例中，該等尖端彎曲(如102/104)可能如此定位，以致於在該平衡型尖端100中的超音波扭轉振動能量可能在沿著該桿身108之一實質部分在一扭轉振動模式中(具備降低的側向運動)。在一些實施例中，該桿身108之長度亦可能被調整以微調該扭轉振動模式，藉由此該扭轉振動係與超音波驅動機構共振的(如在手持件中與角件結合的壓電元件227)，以增加在該遠端點106之扭轉位移。
在一些實施例中，該平衡型尖端100遠端點側向 位移之幅度可能取決於該扭轉驅動力與該扭轉振動模式之間的共振。雖然該驅動頻率可能由該扭轉角件設定，該扭轉模式之頻率可能藉由選擇而調整，舉例而言，該平衡型尖端100錐形部分110之長度。該錐形部分110之長度可能選擇以最大化該平衡型尖端100之扭轉振動，從而導致該遠端點106之最大扭轉位移。其他尖端特徵亦可能變化的。
在一些實施例中，該平衡型尖端100可能具有在大概0.5mm至2mm(如1.5mm)之一範圍中之一直徑。在一些實施例中，該平衡型尖端100在該尖端頂部可能具有大概1.5mm之一直徑，且在靠近該尖端遠端處0.9mm之一直徑(其他直徑與配置亦為可預期)。在一實施例中，該平衡型尖端100可能具有大概1又3/8英吋之長度，且該等彎曲102、104可能位於沿該遠端大概約1/8與2/8英吋處。其他維度亦為可預期的。在一些實施例中該第一彎曲102可能在大概-10至-30度之一範圍中，而該第二彎曲104可能在大概20至50度之一範圍內。其他彎曲角度亦為可預期的。該切邊部分112可能具有一喇叭形、圓錐及/或有斜面(在一些實施例，切邊部分112可能為平坦的)。該平衡型尖端100可能從不銹鋼或鈦製成的(其他材料亦可能使用的)。該平衡型尖端100可能具有0.50英吋及1.50英吋之間(如1.20英寸)之一總長度。其它長度亦為可預期的。該平衡型尖端100可能使用傳統的金屬加工技術且可能被電拋光的。桿身108一般可能為管狀，其具備介於0.005英吋與0.100英吋之間之一外徑及0.001英吋與0.090英吋之間之一內徑(其他直徑亦為可預期 的)。
圖9例示用於決定一尖端幾何形狀之方法的流程圖，該者係根據一實施例。在該流程圖中所提供之該等元件係僅為例示的。各種提供的元件可能被省略的，額外的元件可能添加的，及/或各種元件可能在非於下文提供之一不同秩序中執行的。
在步驟901，一尖端幾何形狀可能會被輸入至該系統中。舉例而言，幾何形狀輸入可能儲存在一輸入檔案中。在一些實施例中，該尖端幾何形狀可能包括一或多下列界定為該幾何形狀於尖端切片的值(如該尖端可能被劃分成500切片且該尖端於每一切片的幾何特徵可能儲存在一分開的矩陣其分配到各自的幾何變量者)。舉例而言，針對該尖端切片之幾何特徵可能包括曲率(如度單位)、扭轉剛度(如C(z))、環繞X軸之慣性矩(如I(z))、橫截面區域(如S(z))、環繞該y軸、控制該尖端彎曲剛度之切片慣性矩(如Iy(z))、該尖端距z軸之距離(如l(z))。其他輸入亦為可預期的。
在一些實施例，這些墊基於切片的矩陣可能由一使用者直接輸入，或可能墊基於其他幾何形狀輸入而計算的。舉例而言，該使用者可能提供該尖端之長度、該錐形部分之長度、沿著該尖端其中該第一彎曲起始的位置、沿著該尖端其中該第一彎曲終止的位置、該第一彎曲之曲率、沿著該尖端其中該第二彎曲起始的位置、沿著該尖端其中該第二彎曲終止的位置、該第二彎曲之曲率、該尖端 材料之剪切模量、該尖端材料之楊氏模數、該尖端材料之密度等等，且對於不同切片，其等之特定輸入可能被計算並儲存在一輸入檔案中或提供至模擬軟體。在一些實施例中，該計算機系統可能自動產生該等輸入。舉例而言，該計算機系統可能循環經由可能的尖端幾何形狀之各種重複。在一些實施例中，該使用者可能繪製一尖端(如經由一圖形使用者界面)，而該計算機系統可能墊基於該繪圖計算該幾何形狀。其它輸入類型亦為可預期的。
在步驟903中，該系統可能使用模擬方程式與調和分析，以決定對於該給定的尖端幾何形狀與超音波扭轉振動頻率(如大概31kHz)，沿著該尖端長度之一側向位移與扭轉角。其他頻率亦為可預期的。舉例而言，該等方程式 可能使用輸入(如上文界定)與調和分析(如使用以u(z)cos(ωt)、(z)cos(ωt)調和者)針對u x 與求解的，以藉由移除時間而簡化該等結果。根據調和分析，在一些實施例中，其可能假設的是：u x (z,t)=u(z)cos(ωt)，且(z,t)=φ(z)cos(ωt)
藉由導入一時間導數：cos(ωt)n=-ω 2cos(ωt)
且將其代入該原本方程式並消去該時間餘弦可能得到 時間獨立性方程式： 上述該等方程式然後可能用於解該位移幅度u(z)與該扭轉角φ(z)。其他方程式亦可能使用於解u x 。
在步驟905中，對於該尖端幾何形狀，該系統可能標繪一或多個側向位移及/或扭轉角(如見圖8a-8b)。
在步驟907中，該使用者(或系統)可能提供一第二尖端幾何形狀(或修改該第一尖端幾何形狀)，並重新計算沿著該尖端長度之側向位移(u x )與扭轉角()。其他模擬技術亦可能使用的。舉例而言，有限元件分析(FEA)可能使用以決定各種幾何形狀遭受各種振動沿著尖端長度之側向位移(u x )及/或扭轉角()。進一步，其他方程式亦可能使用的(如，對於方形尖端模擬，不同的方程式可能使用的)。
在步驟909中，具備不同幾何形狀的數個尖端之特徵可能根據步驟901-907計算並比較，用於選擇該等尖端幾何形狀中之一者(或產生一新的尖端幾何形狀以分析)。選擇該等尖端幾何形狀之一者可能包括墊基於何者之尖端幾何形狀在水晶體乳化術過程期間沿著配置以沿著在一眼睛中之切口之該尖端桿身部分具有一較小的側向位移而選擇一尖端幾何形狀。在一些實施例中，在一水晶體乳化術過程期間，假若沿著該尖端桿身配置以沿著在一眼睛中之切 口之該部分(如從該桿身近端(諸如該錐形部分末端)延伸至該切邊部分之第一彎曲之該桿身部分整個)(該被分析之尖端幾何形狀)之該側向位移係大於該遠端點106側向位移之大概5%至25%(如15%)，(其他閾值(如1微米、2微米、100微米、2mm等等)亦可能使用的)，另一種尖端幾何形狀可能被產生的，該新的尖端幾何形狀之側向位移可能被模擬並相較於該第一或第二尖端幾何形狀至少一者之側向位移，用於進一步在該第一、第二及新的幾何形狀之間選擇(在這一點上，該等尖端之一者可能被選擇的，或另一尖端幾何形狀可能為了比較的目的而被產生)。
在一些實施例中，生成新的幾何形狀可能包括修改先前測試的幾何形狀用於額外的模擬。在一些實施例中，該使用者可能進一步修改一選定的尖端幾何形狀以根據額外的標準微調幾何形狀。舉例而言，該使用者可能修改該錐形部分110之長度(或其他幾何特徵，諸如該桿身之長度)，以提高該平衡型尖端100之扭轉振動，以提供該遠端點106一較大的側向位移。在一些實施例中，該使用者可能會嘗試該等彎曲一或多者之不同位置與曲率，以降低對該尖端近端之側向位移，同時增加對該尖端遠端之側向位移。該等修飾可能用於一第三、第四等等之尖端，且相較於先前尖端的該等結果導致該尖端幾何形狀特徵選擇的優化。
圖10例示用於決定一尖端幾何形狀之另一種方法之流程圖，該者係根據一實施例。在該流程圖中所提供 的該等元件係僅僅例示的。各種提供的元件可能省略的，額外的元件可能添加的，及/或各種元件可能在不同於下文中所提供之一順序中執行的。
在步驟1001中，具有第一幾何形狀之第一尖端可能物理構建或模擬的(如使用有限元件分析)。在一些實施例中，該第一尖端可能具有一圓形截面、方形截面、或一橫截面其沿著該尖端軸變化者。
在步驟1003中，該第一尖端可能在類似於水晶體乳化術過程情況下振動(如藉由固定在如圖2-3中所顯示之一水晶體乳化術手持件，並於大概31kHz之頻率下振動，及/或使用諸如ANSYS模擬軟體「振動」)。其他頻率亦為可預期的(如大概在10kHz與60kHz之間)。在一些實施例中，該第一尖端可能固定在一水晶體乳化術手持件以振動。在一些實施例，尖端可能固定至一不同的設備(如一測試夾具)用於施用該振動。在一些實施例中，該第一尖端之末端可能放置在水中或一材料其具備類似玻璃體之特徵(其他液體亦為可預期的)。在一些實施例中，該第一尖端可能包括兩個彎曲(如102、104)。其他彎曲數目亦為可預期的。
在步驟1005中，該第一尖端可能在振動期間分析的。舉例而言，熱成像、閃光測頻、位移之物理測量等等可能使用以確定該尖端之側向位移(u x )及/或扭轉角()(或象徵側向位移(u x )及/或扭轉角()之特徵)。舉例而言，在該振動尖端之一熱掃描中，沿著尖端長度之較高熱量的位置可能象徵較大的側向位移(u x )。
在步驟1007中，一第二尖端可能構建的(如第一尖端之幾何形狀可能會被修改)。對不同的幾何特徵，可以做如上文提供之修飾。舉例而言，該第二彎曲104之位置及/或曲率可能會被修改的。
在步驟1009中，該第二尖端可能在類似於該第一尖端之情況下振動。
在步驟1011中，該第二尖端可能在振動期間分析的，以決定如對該第一尖端決定之類似特徵(諸如側向位移與扭轉角)。
在步驟1013中，該第一尖端與第二尖端之特徵可能被比較，且該第一與第二尖端幾何形狀之一者可能被選擇，或一新的尖端幾何形狀可能為了比較之目的被產生與測試的。舉例而言，選擇該第一尖端幾何形狀或該第二尖端幾何形狀可能墊基於何者之尖端幾何形狀在水晶體乳化術過程期間沿著配置以沿著在一眼睛中之切口之該尖端桿身部分具有一較小的側向位移。在一些實施例中，在一水晶體乳化術過程期間，假若沿著該尖端桿身配置以沿著在一眼睛中之切口之該部分(如從該桿身近端(諸如該錐形部分末端)延伸至該切邊部分之第一彎曲之該桿身部分整個)(該被分析之尖端幾何形狀)之該側向位移係大於該尖端遠端點106側向位移之大概5%至25%(如15%)，(如上文所表明，其他閾值(如1微米、2微米、100微米、2mm等等)亦可能使用的)，一第三尖端幾何形狀可能被產生與測試的，該第三尖端幾何形狀之側向位移及/或扭轉角可能決定的並 相較於該第一或第二尖端幾何形狀之側向位移及/或扭轉角，用於進一步在該第一、第二及第三幾何形狀之間選擇(在這一點，該等尖端之一者可能被選擇的，或另一尖端幾何形狀可能為了比較的目的而被產生)。
圖11例示六種可能的平衡型尖端之實施例(其他實施例亦為可能的)。該等平衡型尖端100可能具有一幾何形狀其係根據在圖11表中提供該等組參數中之一者。該平衡型尖端100可能具有一OD英吋之外部直徑；一ID英吋之內部孔直徑；從該尖端100之集線器(該尖端100之近端點其係配置以依附至該超音波角件者)至該遠端點106之一總長度L英吋。該尖端100之錐形部分可能從集線器110延伸L c 英吋。該尖端100之第一彎曲102可能具有α1度之角度，並在位於距該遠端點106 x1與x2英吋之一距離處的點之間延伸。該第二彎曲104可能具有α2度之一角度，並在位於距該遠端點106 y1與y2英吋之一距離處的點之間延伸。該切邊部分112可能有一個斜邊(即在該切邊部分最遠端的邊緣)，該者係如表中所指出朝上30或45度或朝下30度(作為一例子，在該圖1中顯示之斜面係為朝下的)。
在一些實施例中，一模擬系統可能包括一或多個處理器。該處理器可能包括單一處理元件或數個處理元件。此一處理元件可能為一微處理器、控制器(該者可能為一微控制器)、數位訊號處理器、微電腦、中央處理單元、現場可規劃閘陣列、可規劃邏輯元件、狀態機、邏輯電路、控制電路、類比電路、數位電路及/或任何元件其根據操作 指令運作信號(類比及/或數位)者。連接至及/或嵌入該處理器中之該記憶體可能為一單一記憶體元件或數個記憶體元件。此一記憶體元件可以為一只讀取記憶體、隨機存取記憶體、依電性記憶體、非依電性記憶體、靜態記憶體、動態記憶體、快閃記憶體、快取記憶體(cache memory)、及/或任何儲存數位資訊的元件。注意的是，當該等處理器透過狀態機、類比電路、數位電路及/或邏輯電路實行其一或多個功能時，儲存該相應操作指令之記憶體可能嵌入至或外接至包含該狀態機、類比電路、數位電路及/或邏輯電路之電路。該記憶體可能儲存，且該處理器可能履行操作指令其相應於結合該等圖式(如圖9與10)例示與描述之該等元件中至少一些。
一般技藝人士對本實施例可以做各種修飾。考量本說明書及於此揭露之本發明實施，本發明之其他實施例對熟習該項技藝者亦將為明顯的。其意欲的是，本說明書與實施例係僅僅視為範例，本發明之真正發明範圍與精神係藉由下列之申請專利範圍及由此之相當件被指出。
100‧‧‧尖端
102‧‧‧第一彎曲
104‧‧‧第二彎曲
106‧‧‧遠端點
108‧‧‧尖端桿身
110‧‧‧錐形部分
112‧‧‧切邊部分
114‧‧‧近端
116‧‧‧尖端軸

Claims (12)

  1. 一種水晶體乳化術尖端，其包含：具有一近端與一遠端之一桿身；在該桿身之該遠端之一切邊部分，其中該切邊部分包含至少一第一與第二彎曲；其中該桿身及該至少第一與第二彎曲之一幾何形狀係組配以致整個在該桿身中從該桿身之該近端延伸至該切邊部分之該第一彎曲的部分於該尖端之超音波扭轉振動期間垂直於該桿身之該桿身的一側向位移，係小於該尖端於一遠端點之側向位移之5至25%；其中該至少第一及第二彎曲係設置成於超音波扭轉振動期間該桿身中的超音波扭轉振動能係在一扭轉振動模式下沿著該桿身的一實質部分。
  2. 如請求項1之水晶體乳化術尖端，其中該切邊部分係為喇叭形、圓錐、有斜面或平坦的。
  3. 如請求項1之水晶體乳化術尖端，其中該側向位移(u x )係使用下列方程式而至少部分界定 ，其中 係為該尖端之扭轉角，ρ係為尖端材料之密度，S(z)係為該尖端沿著與該桿身共線之軸的一橫截面面積， E係為一尖端材料之楊氏模數，I y (z)係為該尖端環繞垂直於與該桿身共線之該軸之一軸的一橫截面慣性矩，及l(z)係為沿著與該桿身共線之該軸垂直之該軸的側向位移。
  4. 如請求項3之水晶體乳化術尖端，其中係透過下列方程式提供： 其中I(z)係為一圓柱形尖端橫截面在環繞與該桿身共線之一軸的慣性矩，C(z)=I(z)*μ，而μ係為該尖端材料之扭轉模數。
  5. 如請求項4之水晶體乳化術尖端，其中下列方程式 係經由調和分析求解。
  6. 如請求項5之水晶體乳化術尖端，其中該尖端之該近端包括一錐形部分，且其中該錐形部分之長度係選擇以提高該尖端在超音波扭轉振動期間之扭轉振動，用以在該尖端之該遠端點提供一較大的側向位移。
  7. 如請求項1之水晶體乳化術尖端，其中該尖端於該尖端之該遠端點的側向位移係在40至200μm之一範圍中。
  8. 如請求項1之水晶體乳化術尖端，其中該超音波扭轉振動包含在大約10kHz至60kHz範圍的一頻率。
  9. 如請求項1之水晶體乳化術尖端，其更包含穿過與一真空源相通之該尖端的一中空孔。
  10. 如請求項1之水晶體乳化術尖端，其中該超音波扭轉振動包含在介於大約2至6度範圍中之一弧形上的反復超音波扭轉振動。
  11. 如請求項1之水晶體乳化術尖端，其中該尖端係以不銹鋼或鈦製成。
  12. 如請求項5之水晶體乳化術尖端，其更包含穿過與一真空源相通之該尖端的一中空孔；其中該超音波扭轉振動包含在大約10kHz至60kHz範圍的一頻率；以及其中該超音波扭轉振動包含在介於大約2至6度範圍中之一弧形上的反復超音波扭轉振動。
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