TWI574663B - 水晶體乳化術用之鉤端 - Google Patents

水晶體乳化術用之鉤端 Download PDF

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TWI574663B
TWI574663B TW099121211A TW99121211A TWI574663B TW I574663 B TWI574663 B TW I574663B TW 099121211 A TW099121211 A TW 099121211A TW 99121211 A TW99121211 A TW 99121211A TW I574663 B TWI574663 B TW I574663B
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axis
cutting tip
surgical handpiece
shaft
centerline
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TW201103489A (en
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亞歷山大 亞特蘇柯維斯
小雷蒙 迪瑪蘭塔
麥克海爾 包克尼
詹姆士Ｙ 鍾
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愛爾康研究有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00745—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • 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
    • A61B2017/32007—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Hooks, Suction Cups, And Attachment By Adhesive Means (AREA)

Description

水晶體乳化術用之鉤端 發明領域
本發明大體上是有關於水晶體乳化術(phacoemulsification)。更特別地，但不作為限制，本發明是有關於水晶體乳化術切割尖端(phacoemulsification cutting tips)。
 發明背景
人類眼睛最簡單地說是藉由將光線傳送通過一被稱為角膜(cornea)的清澈外部，並且藉由水晶體(lens)將影像聚焦(focusing)於視網膜(retina)上來提供視覺而起作用。聚焦影像的品質端視許多因素[包括眼睛的大小與形狀，以及角膜與水晶體的透明度(transparency)]而定。
當年齡或疾病導致水晶體變得較不透明時，視覺會因為可以被傳送至視網膜的光線減少而退化。這種在眼睛的水晶體中的缺陷在醫學上被知曉為一白內障(cataract)。一種用於這種病況(condition)之被認可的治療是外科手術移除該水晶體，並且藉由一眼內水晶體(intraocular lens,IOL)來取代水晶體功能。
白內障的水晶體(cataractous lenses)可藉由一種被稱為水晶體乳化術(phacoemulsification)的外科手術技術被移除。在這個操作的期間，一細的水晶體乳化術切割尖端可被插入至患病的水晶體內並且被超音波地振動(vibrated)。該振動的切割尖端可液化(liquefy)或乳化(emulsify)水晶體，而使得該等水晶體可以被抽吸(aspirated)出眼睛。一旦患病的水晶體被移除，可藉由一人工水晶體予以取代。
 發明概要
在各種不同的具體例中，一個具有一直軸(straight shaft)以及一偏離該直軸的斜向部(angled portion)的水晶體乳化術尖端(phacoemulsification tip)可包括一在該斜向部上的鉤(hook)以帶動該尖端的一旋轉軸線更接近於與該軸的一中心線對齊。該尖端可被設置成在一條垂直於該軸的一中心線的軸線上來回扭轉地旋轉(例如，繞著一y-軸線旋轉)。在一些具體例中，在一不具有鉤的尖端中由繞著該y-軸線扭轉旋轉所導致的側向振動(lateral vibrations)(亦即，邊對邊沿著一垂直於該y-軸線的x-軸線或z-軸線)可經由使用該鉤來平衡不同的偏心加重的鉤(eccentrically weighted hook)而被降低。
圖式簡單說明
為了本發明的一個更加完整的瞭解，參考下列連同隨文檢附的圖式而被舉用的說明，其中：第la-b圖例示說明一具有一遠端的水晶體乳化術尖端，該遠端相對於該尖端軸(tip shaft)的中心線被彎曲(angled)；第2a圖例示說明依據一具體例之一經由一灌注管線(irrigation line)以及一抽吸管線(aspiration line)被連結至一手持件(handpiece)的水晶體乳化術外科手術控制台(phacoemusification surgical console)；第2b圖例示說明依據一具體例之一被接附至該鉤形尖端(hooked tip)的超音波操縱桿(ultrasonic horn)；第3a-b圖例示說明該鉤形尖端的一具體例；第4圖例示說明依據一具體例之該鉤形尖端的運動；第5圖例示說明依據一具體例之一被插入至眼睛的一切口內的鉤形尖端；以及第6a-c圖例示說明該鉤形尖端的額外具體例。
要被瞭解的是：前述的一般說明以及下列的詳細說明這兩者僅是示範性以及說明性，並且被意欲要提供一個如所請求之本發明的進一步說明。
較佳實施例之詳細說明
第1a-b圖例示說明一具有一遠端的水晶體乳化術切割尖端100，該遠端相對於一尖端軸108被彎曲。該切割尖端100可包括一主要為直的軸(predominantly straight shaft)108，該軸108具有以一角度(angle)102彎曲(例如大約一為20度的彎曲)之較遠的遠端部。其它的角度亦被預期(例如5度的彎曲、35度的彎曲等等)。該遠端部可具有一喇叭形(flared)和/或斜向(beveled)的遠端。該切割尖端100可連同一水晶體乳化術手持件(phacoemusification handpiece)204一起被使用(例如，參見第2圖)。當與該手持件204一起使用時，該切割尖端100可利用縱向運動(longitudinal movement) 和/或橫向運動(transverse movement)。切割尖端100可利用尖端材料而僅在該延伸的軸中心線104的一側被偏心地加重(因為角度102)。如此處所用的，“延伸的軸中心線(extended shaft centerline)”意指一條包括並且與該軸中心線(shaft centerline)共線(collinear)的線(如同例示說明於，例如第1a以及3a圖中的)。該偏心加重的切割尖端因此可具有一從該軸108之延伸的軸中心線104被位移過該切割尖端100的至少一部分(例如，至少沿著該切割尖端100的底部10%長度)之旋轉中心106。其它長度的部分亦可被預期(例如，該旋轉中心106可從該延伸的軸中心線104被位移過該切割尖端100之長度的50%或逐漸地超過整個長度)。例如，如同在第3a圖中所見的，該旋轉中心306可順著一大約為0至10度的角度偏離與該延伸的軸中心線316平行。該旋轉中心306的其它角度或構形(configurations)亦可被預期(例如，該旋轉中心306可從該延伸的軸中心線316被位移以及平行於該延伸的軸中心線316)。當該切割尖端202經由該軸304而被振動(例如，旋轉地和/或縱向地)時，旋轉該偏心加重的尖端和/或對抗運動的切割尖端202之流體的阻力(resistance of fluid)可在該偏心加重的切割尖端202引起側向振動(lateral vibration)。
第2a圖例示說明一經由一灌注管線(irrigation line)206以及一抽吸管線(aspiration line)208被連結至一手持件204的水晶體乳化術外科手術控制台(phacoemusification surgical console)214。在一些具體例中，電力可經由電纜 (electrical cable)210而被供應給手持件204，並且通過管線206以及208的流量(flow)可由一使用者所控制[例如，經由腳踏開關(footswitch)212]以執行一水晶體乳化術操作程序。一用於一水晶體乳化術操作程序的手持件的一個實例被描述在由Mikhail Boukhny、James Y.Chon以及Ahmad Salehi於2005年7月18日所提申的美國專利申請公開案[標題為“超音波手持件(Ultrasound Handpiece)”，公開號2006/0041220，序號11/183,591]中，該件美國專利申請公開案猶如在此所完全地並且完整地描述的以它的整體被併入以作為參考資料。
在一些具體例中，該手持件204可包括至少一組壓電元件(piezoelectric elements)227，當以一適切的共振頻率(resonant frequency)予以激發時，它們會被極化而產生縱向運動。如同在第2b圖中所見的，壓電晶體(piezoelectric crystals)227可被連結至一超音波操縱桿(ultrasonic horns)216(一切割尖端202被接附至該超音波操縱桿216)。該操縱桿216和/或該切割尖端202可包括數個斜向的狹縫(diagonal slits)或溝槽(grooves)224。當該等壓電晶體227以一共振頻率被激發時，該等狹縫或溝槽224可在該切割尖端202產生扭轉運動。由在該手持件204中嚙合(engaging)固定元件的該等溝槽224所引起之該切割尖端202的運動可包括一相對於一與該操縱桿216的一中心線共線的旋轉軸線之扭轉旋轉分力(torsional rotational component)。
在一些具體例中，手持件204可被連結至一水晶體乳化 術切割尖端202。如同在第3a圖中所見的，該水晶體乳化術切割尖端202具有一第一部分，該第一部分包含一直軸304，該直軸304包含被固定在該外科手術用手持件之操縱桿中的一切割尖端長度的一近端部分；以及一遠端部分。該遠端部分包含一第二部分，該第二部分具有與該延伸的軸中心線316對齊的一第一部位和從該延伸的軸中心線316離開的一第二部位；一形成一鉤310的第三部分；以及一具有一斜切端(beveled end)的遠端。該水晶體乳化術切割尖端202可包括一個位於該切割尖端202的一軸304的角度312附近的鉤(hook)310。在一些具體例中，該鉤310可包括一曲線(curve)、一凸出(bump)或一彎頭幾何學(elbow geometry)，它可藉由將尖端材料放置在該延伸的軸中心線316的一相反側上，而尖端材料彎曲偏離該延伸的軸中心線，而在角度312之下作用有如一平衡錘(counterweight)。在一些具體例中，該切割尖端可具有一範圍大約為0.5mm至2mm(例如1.5mm)的直徑。在一些具體例中，該切割尖端可具有一喇叭形尖端，該喇叭形尖端具有一在該尖端的一頂部大約為1.5nm的直徑，以及一在該尖端的一遠端附近為0.5nm的直徑(其它的直徑以及構形亦被預期)。在一個具體例中，該切割尖端202可具有一大約為1又3/8吋的長度，有一大約為5/32吋的鉤部長度。其它尺寸亦可被預期。鉤310可作用來將一旋轉中心306帶動至位在接近(例如，在一為0.25*軸直徑的距離314之內)或在延伸的軸中心線316上。其它介於該旋轉中心306以及該延伸的軸中心線316之 間的距離亦可被預期(例如，在一為0.5*軸直徑的距離之內、在一相等於軸直徑的距離之內等等)。在一些具體例中，該切割尖端202的一頂部的運動可能因為它緊鄰著扣住該切割尖端202的操縱桿而受限制，藉此該切割尖端202的頂部之旋轉軸線可沿著該延伸的軸中心線316延展，而該切割尖端202的一遠端(例如，沿著該切割尖端202的底部長度的大約10%)可遠離該延伸的軸中心線316。在一些具體例中，可能有一相對於該延伸的軸中心線316從該切割尖端202頂部向該切割尖端202的底部逐漸位移之旋轉中心306。如上面所提及的，該鉤310可有效地在該切割尖端202的底部處將該旋轉中心306帶動至位在接近(例如，在一為0.25*軸直徑的距離314之內)或在延伸的軸中心線316上。
該鉤310可包括各種不同的彎頭(bend)之角度、長度或深度等等(例如，參見第3a圖以及第6a-6c圖)的多樣幾何學。該鉤310的幾何學亦可被設置成帶動一條通過該尖端的重量中心並且平行於該切割尖端202之延伸的軸中心線的線更接近於該延伸的軸中心線316，俾以降低在旋轉和/或縱向運動的期間於該切割尖端202上的偏心運動(eccentric movement)(包括側向振動)。
在一些具體例中，該切割尖端202可沿著一小弧(arc)(例如，+/-5度)而被超音波地扭轉振動。該切割尖端202的扭轉振動可導致在該軸304以及切割尖端202中的側向運動。攪打運動(whipping motion)可包括該切割尖端202垂直於該延伸的軸中心線316之一邊對邊扭轉運動(side to side torsional motion)(例如，如同在第3a圖中所見的繞著y-軸線旋轉)。在一些具體例中，由該偏心加重的切割尖端和/或對抗繞著y-軸線(例如，在第1a圖中的切割尖端100)來回地扭轉旋轉的流體阻力(fluid resistance)所導致的側向振動(例如，如同在第3a圖中所見的邊對邊沿著x-軸線或z-軸線)可經由使用該鉤來平衡不同的偏心加重的鉤而被降低。
如同在第4圖中所見的，在一些具體例中，該切割尖端202可經由大約一為10度的弧[例如，偏離中心正或負5度(參見中間圖2)]來回地扭轉旋轉。在一些具體例中，該切割尖端202可以一大約為31kHz的速率來回地旋轉。其它的弧或速率亦可被預期。例如，一為正或負20度的弧，和/或一為10-60kHz的速率可以被使用。在第4圖中所顯示的弧被誇大以顯示出運動(亦即，所顯示的全弧是180度，而該切割尖端可在一為10度的弧上有限度地來回旋轉)。
如同在第5圖中所見的，當被用於執行水晶體乳化術時，該切割尖端202的末端以及一灌注套管(irrigating sleeve)226可被插入至角膜(cornea)501、鞏膜(sclera)507或眼睛組織中的其它位置的一個小切口內，俾以獲得進入，例如，該眼睛509的前房(anterior chamber)503。在各種不同的具體例中，該切割尖端202的一部分或全部可在該灌注套管226內。在原位(in situ)接觸所選定的組織之後，該切割尖端202可藉由一晶體-驅動的超音波操縱桿216沿著它的縱向軸線在該灌注套管226之內被超音波地扭轉振動而藉此乳化。該切割尖端202的中空孔(hollow bore)可與該操縱桿 中的孔相通，而依序地以該抽吸管線從該手持件204連通至該控制台214(例如，參見第2a圖)。在該控制台214中一減壓或真空來源(vacuum source)可從該眼睛509中將經乳化的組織吸引或抽吸通過該切割尖端202的一開放端(open end)、該切割尖端202的孔、該操縱桿孔(horn bore)以及該抽吸管線208，並且至一收集裝置內。經乳化的組織的抽吸可藉著一鹽水沖洗溶液(saline flushing solution)或灌洗液(irrigant)予以輔助，該鹽水沖洗溶液或灌洗液可經由小環狀間隙(annular gap)(介於該灌注套管226的內表面以及該切割尖端202的外表面之間)而被注射至手術位置內。
切割尖端202可由不鏽鋼或鈦所製成(其它材料亦可被使用)。切割尖端202可具有一介於0.50吋以及1.50吋之間(例如，1.20吋)的全長。其它長度亦可被預期。切割尖端202可使用傳統的金工技術(metalworking technology)而被形成，並且可被電拋光(electropolished)。軸304一般可為管狀(tubular)，具有一介於0.005吋以及0.100吋之間的外徑(outside diameter)以及一介於0.001吋以及0.090吋之間的內徑(inside diameter)(其它直徑亦可被預期)，使得在該軸304內的中空空間可以用作抽吸管腔(aspiration lumen)。
對於所呈現之具體例的各種不同的修飾可藉由一在本技藝中具有通常技術的人士而被作出。本發明的其它具體例對於那些熟習此技藝者從本說明書的斟酌以及在此所揭示的本發明的實施中亦將變得明顯。所意欲的是，本說明書以及實施例被認為僅作為示範性而具有一藉由下列申請 專利範圍以及它們的等效物所指明的本發明的確切範疇以及精神。
100‧‧‧切割尖端
102‧‧‧角度
104‧‧‧延伸的軸中心線
106‧‧‧旋轉中心
108‧‧‧尖端軸、軸
202‧‧‧切割尖端
204‧‧‧手持件
206‧‧‧灌注管線
208‧‧‧抽吸管線
210‧‧‧電纜
212‧‧‧腳踏開關
214‧‧‧控制台
216‧‧‧超音波操縱桿、操縱桿
224‧‧‧溝槽
226‧‧‧灌注套管
227‧‧‧壓電元件、壓電晶體
304‧‧‧軸
306‧‧‧旋轉中心
310‧‧‧鉤
312‧‧‧角度
314‧‧‧距離
316‧‧‧延伸的軸中心線
501‧‧‧角膜
503‧‧‧前房
507‧‧‧鞏膜
509‧‧‧眼睛
第1a-b圖例示說明一具有一遠端的水晶體乳化術尖端，該遠端相對於該尖端軸的中心線被彎曲；第2a圖例示說明依據一具體例之一經由一灌注管線以及一抽吸管線被連結至一手持件的水晶體乳化術外科手術控制台；第2b圖例示說明依據一具體例之一被接附至該鉤形尖端的超音波操縱桿；第3a-b圖例示說明該鉤形尖端的一具體例；第4圖例示說明依據一具體例之該鉤形尖端的運動；第5圖例示說明依據一具體例之一被插入至眼睛的一切口內的鉤形尖端；以及第6a-c圖例示說明該鉤形尖端的額外具體例。
202．．．切割尖端
304．．．軸
306．．．旋轉中心
310．．．鉤
312．．．角度
314．．．距離
316．．．延伸的軸中心線

Claims (14)

  1. 一種切割尖端及水晶體乳化術外科手術用手持件，其包含有：一水晶體乳化術外科手術用手持件，其包含一被組構成以10至60kHz的速率扭轉振動一切割尖端的操縱桿；以及一切割尖端，其包含有：一第一部分，其包含一直軸，該直軸包含被固定在該外科手術用手持件之操縱桿中的一切割尖端長度的一近端部分，其中該直軸具有一軸中心線；一遠端部分，其包含有：一與該第一部分形成一角度的第二部分，一形成一鉤的第三部分，及一具有一斜切端(beveled end)的遠端；以及一通過至少該第一部分的抽吸管腔(aspiration lumen)，其中該抽吸管腔具有一介於0.001吋與0.09吋之間的內徑；其中該切割尖端具有範圍為0.5mm至2mm的直徑；其中該切割尖端長度之近端部分係受該外科手術用手持件之操縱桿限制，以使該近端部分之軸中心線與該操縱桿之旋轉軸線對齊；其中該第一部分、第二部分、第三部分及遠端係包含在一個單件中； 其中當該切割尖端長度之近端部分係經由該水晶體乳化術外科手術用手持件以10至60kHz的速率在一弧(arc)上扭轉振動時，其中該弧具有一與在該近端部分上之軸中心線對齊的旋轉軸線，該第二部分、第三部分及遠端一起具有一相對於該軸的旋轉軸線，該旋轉軸線是與一延伸的軸中心線實質上對齊。
  2. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中實質上對齊包含該旋轉軸線在該切割尖端之遠端從該延伸的軸中心線以一少於該軸直徑之0.25倍的距離被偏移。
  3. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中實質上對齊包含該旋轉軸線在該切割尖端之遠端從該延伸的軸中心線以一少於該軸直徑之0.5倍的距離被偏移。
  4. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中該第二部分之一第一部位係與該延伸的軸中心線對齊，以及其中該第二部分之一第二部位係從該延伸的軸中心線離開。
  5. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中該操縱桿以正5度至負5度的一弧來回地扭轉振動該切割尖端之近端部分。
  6. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中該切割尖端之近端部分係在一與該軸中心線平行的軸線上被來回地扭轉旋轉；以及其中該 第三部分平衡該切割尖端，以降低垂直於該軸線的來回側向振動。
  7. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中實質上對齊包括與該延伸的軸中心線平行至與該延伸的軸中心線平行偏離5度的一範圍。
  8. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中實質上對齊包含有與該延伸的軸中心線平行至與該延伸的軸中心線平行偏離10度的一範圍。
  9. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中該第二部分形成相對於該第一部分為20度的一角度。
  10. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中該鉤包括一曲線(curve)，該曲線可藉由將尖端材料放置在該延伸的軸中心線的一側上並使遠端的尖端材料朝向該延伸的軸中心線往回彎曲並遠離該鉤，來作為一平衡錘。
  11. 如申請專利範圍第1項的切割尖端及水晶體乳化術外科手術用手持件，其中該遠端部分相對於該延伸的軸中心線改變方向至少三次。
  12. 一種切割尖端及水晶體乳化術外科手術用手持件，其包含有：一水晶體乳化術外科手術用手持件，其包含一被組構成以10至60kHz的速率扭轉振動一切割尖端的操縱 桿；以及一切割尖端，其包含：一包含有一直軸的第一部分，該直軸包含被固定在該外科手術用手持件之操縱桿中的一切割尖端長度的一近端部分，其中該直軸具有一軸中心線；一與該第一部分形成一角度的第二部分；一形成一鉤的第三部分；及一具有一斜切端(beveled end)的遠端；其中該切割尖端具有範圍為0.5mm至2mm的直徑；其中該切割尖端長度之近端部分係受該外科手術用手持件之操縱桿限制，以使該近端部分之軸中心線與該操縱桿之旋轉軸線對齊；其中該鉤包括一作為平衡錘的曲線；其中該第一部分、第二部分、第三部分及遠端係被包含在一個單件中；以及一通過至少該第一部分的抽吸管腔(aspiration lumen)，其中該抽吸管腔具有一介於0.001吋與0.09吋之間的內徑；其中當該切割尖端長度之近端部分係經由該水晶體乳化術外科手術用手持件以10至60kHz的速率在具有一與在該近端部分上之軸中心線對齊的旋轉軸線的一弧(arc)上扭轉振動時，該第二部分、第三部分及遠端一 起具有一相對於該軸的旋轉軸線，該旋轉軸線是與一延伸的軸中心線實質上對齊。
  13. 如申請專利範圍第12項的切割尖端及水晶體乳化術外科手術用手持件，其中該第二部分形成相對於該第一部分為20度的一角度。
  14. 如申請專利範圍第12項的切割尖端及水晶體乳化術外科手術用手持件，其中該切割尖端之近端部分係在一與該軸中心線平行的軸線上被來回地扭轉旋轉；以及其中該第三部分平衡該切割尖端，以降低垂直於該軸線的來回側向振動。
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