TWI380804B - 具有pco-防制特徵之小切口內眼晶體 - Google Patents

具有pco-防制特徵之小切口內眼晶體 Download PDF

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TWI380804B
TWI380804B TW94143370A TW94143370A TWI380804B TW I380804 B TWI380804 B TW I380804B TW 94143370 A TW94143370 A TW 94143370A TW 94143370 A TW94143370 A TW 94143370A TW I380804 B TWI380804 B TW I380804B
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intraocular lens
iol
disc
pco
support frame
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Jerome Vaudant
Gary A Richardson
Griffith E Altmann
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Bausch & Lomb
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/00932Combined cutting and grinding thereof
    • B29D11/00942Combined cutting and grinding thereof where the lens material is mounted in a support for mounting onto a cutting device, e.g. a lathe, and where the support is of machinable material, e.g. plastics
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/02Artificial eyes from organic plastic material
    • B29D11/023Implants for natural eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/009Special surfaces of prostheses, e.g. for improving ingrowth for hindering or preventing attachment of biological tissue
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/1689Intraocular lenses having supporting structure for lens, e.g. haptics having plate-haptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/16965Lens includes ultraviolet absorber
    • A61F2002/1699Additional features not otherwise provided for

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Description

具有PCO-防制特徵之小切口內眼晶體
本發明係關於用於植入無晶體眼之內眼晶體(IOL),其中天然的晶體因為損傷或疾病(例如內障晶體)已經移除。本發明更特定言之係關於一種新穎IOL,在第一態樣中該IOL經設計以經在眼睛中做出的3 mm以下之切口插入,且在第二態樣中該IOL包括一鋒利後邊緣以抑制在該IOL與後囊袋之間之晶體上皮細胞(下文"LEC")非吾人所樂見之生長,亦稱為後囊混濁(下文"PCO")。
治療白內障眼之常見且適當之方法為移除混濁、天然的晶體並在稱為內障摘除術之外科程序中以人造IOL置換。在囊外摘除術方法中,將天然晶體自囊袋移除,而將囊袋之後部(且較佳地至少部分該囊袋之前部)留在眼內。在此情況下,該囊袋仍藉由小帶纖維錨定於眼睫狀體。在稱為囊內摘除術之替代程序中,晶體及囊袋均藉由切斷小帶纖維全體移除並以必須錨定於缺少囊袋之眼內之IOL置換。認為囊內摘除術方法比囊外摘除術方法少有吸引力,因為在囊外方法中,囊袋仍附著於眼晶狀體且因此為IOL在眼內提供天然的居中及定位構件。該囊袋亦繼續其在眼前部水樣液與眼後部玻璃體液之間提供一天然障壁之功能。
一已知之囊外內障摘除術之問題為後囊混濁或繼發性內障,其中晶體上皮細胞之增殖或遷移沿著IOL後表面後之後囊發生,其沿著光軸產生囊之混濁。其需要隨後的外科手術(諸如Er:YAG雷射囊切開術)以打開後囊且藉此使光軸澄清。在囊切開術之後可發生不良併發症。例如,因為後囊在眼玻璃體液後部與眼水樣液前部之間提供一天然障壁,該後囊之移除允許玻璃體液遷移至水樣液,其可引起嚴重的、威脅視力的併發症。因此首先非常需要預防後囊混濁且因此消除對隨後的後囊切開術之需要。
一用於預防PCO之方法係在後囊壁中產生鋒利、不連續的彎曲,其被熟習此項技術者廣泛認同為用於最小化PCO之有效方法。例如,參閱Nishi之Posterior Capsule Opacification,Journal of Cataract & Refractive Surgery. 第25卷,1999年1月。在後囊壁中之該不連續彎曲可使用具有鋒利後邊緣之IOL產生。
另一PCO預防方法使用LEC靶向藥劑。例如,參閱Bretton之題為"Method For Destroying Residual Lens Epithelial Cells"之美國專利5,620,013。雖然該方法在理論上合乎邏輯,但因為(例如)一些LEC抑制劑本身(例如肥皂草素(saporin))之毒性引起之併發症以及難於確保全部殺死囊袋中所有LEC,使該方法進入臨床實踐困難。儘管在外科手術時試圖移除LEC,但任何剩餘的LEC可最終繁殖並遷移至IOL,最終引起PCO。
到目前為止用於抑制LEC形成於IOL之後表面上之最有前途之方法係藉由將IOL設計為尤其在後表面具有一鋒利周邊邊緣以在後囊壁中產生一不連續彎曲。後囊壁中之該不連續彎曲已在臨床上證明抑制LEC通過該彎曲並沿著IOL表面之生長及遷移。平凸IOL之該PCO抑制作用之一早期報導可見於Nishi等人之Explanation of Endocapsule Posterior Chamber Lens After Spontaneous Posterior Dislocation,J Cataract & Refractive Surgery- 第22卷,1996年3月第273頁,其中作者研究了一展開的平凸PMMA IOL,其中該IOL之後表面為平的且與IOL之周邊邊緣形成一直角邊緣:"外植之IOL與囊之宏觀圖顯示9.5 mm囊直徑。開放式環型迴路與囊中緯線配合良好。不與支撐架接觸之囊中緯線亦很好地保持(圖3)。一不透明晶體塊(Soemmering環形內障)見於支撐架與視盤之間。面對IOL視盤之後囊為澄清的。外植囊之組織病理學檢查顯示在後囊上幾乎沒有上皮細胞(LEC)。在環與視盤之間見到晶體塊在視盤之邊緣積聚(圖4)。在該位置在後囊中存在一明顯的彎曲。"(補充強調)
因此,自從該報導數年以來,工業上已見到在產生具有一鋒利後邊緣之IOL上之很多行為,以在後囊壁中產生一鋒利、不連續的彎曲。
在現代內障外科手術中之另一趨勢為盡可能減小角膜切口尺寸。其因為較大的切口尺寸已引起非吾人所樂見之手術後病狀病狀,例如切口誘發之散光。最現代的內障外科手術需要可成功將IOL經一3-mm以下切口注射之IOL及IOL注射器。因為當IOL通過IOL注射器並注入眼睛時其必須經歷壓力及其他力量,因此IOL之尺寸(尤其為橫截面)必須最小化。因此IOL設計者進一步遇到製造IOL上之挑戰,該IOL一方面將具有在眼中保持居中之強度及穩定性,且另一方面具有足夠小的尺寸以通過3-mm以下注射器並進入眼睛。應瞭解其通常為競爭性的設計目標,因為減小IOL尺寸以使IOL適合通過一較小切口可引起眼中IOL之強度及穩定性降低。IOL在眼內之強度及穩定性對獲得並保持由IOL提供之吾人所需之視力校正當然至關重要。因此,IOL設計者不能不首先考慮減小IOL尺寸並接著藉由仔細設計來補償該縮小尺寸對IOL之強度及穩定性的影響。
因此仍存在對改良之IOL設計及方法之需要,其解決LEC遷移及隨後PCO形成之問題,其IOL尺寸適合通過3 mm以下注射器,且足夠堅固及穩定以在眼中保持適當定位。
在第一態樣中,本發明藉由提供一具有一視盤周邊之IOL解決PCO形成之問題,該視盤周連包括一當將該IOL植入眼中時接觸後囊袋壁之鋒利邊緣。
在第二態樣中,本發明提供一經設計具有小尺寸之IOL,該尺寸足夠小以使該IOL能加以壓縮並注射通過一在眼中做出的3 mm以下切口,且亦在眼中保持穩定地定位。
PCO-防制之鋒利邊緣由形成銳角之兩表面界定,該鋒利邊緣位於後凹面區域與平行於光軸延伸之最外周邊緣之間。該鋒利邊緣環繞後視盤表面延伸360°以對試圖徑向向內遷移至後視盤表面之LEC形成完全障壁。在前面,一前凹面區域形成於前視盤表面與垂直於光軸延伸之可選周邊邊緣表面之間並與平行於光軸延伸之周邊邊緣表面相交成90°角。該等後及前凹面區域較佳地彼此相對定位且具有大體上相同之半徑。幫助穩定眼中IOL之一或多個支撐架較佳地與最外後邊緣表面之後界限隔開。因此IOL視盤經前及後凹面區域之尺寸減小但仍保持IOL之強度及穩定性。其至少部分歸因於支撐架厚度,其與類似設計之先前技術IOL相比未減小(參閱圖6,其中先前技術IOL以虛線展示,與以實線展示之本發明IOL比較)。前凹面區域藉由阻止IOL向前(意即朝著角膜方向)拱起增加IOL之原位穩定性並亦因此幫助保持穩固地縮入後囊袋壁之鋒利邊緣。其對LEC之向內遷移產生一障壁且因此抑制PCO。與平衡後凹面區域之前面相比該鋒利邊緣亦為後面提供額外的材料區域,因為IOL將向後拱起,儘管如上所述該後凹面區域減小了視盤之總尺寸以使其通過3 mm以下切口。換言之,由於由後鋒利邊緣引起之後面上之額外材料,雖然前凹面區域促使IOL向後拱起,但後凹面區域不促使該IOL向前拱起。將支撐架與最外後邊緣之後界限隔開亦幫助保持後拱起。
本發明之IOL具有與其他更複雜的已在先前技術中提出用於抑制LEC遷移的IOL周邊設計相比相對易於製造的周邊邊緣設計。例如一些先前技術IOL具有直角邊緣,其可需要額外的處理(例如研磨)步驟以形成直角邊緣幾何形狀。例如,參閱展示多種IOL視盤周邊設計之以下專利:1992年12月15日頒予Nishi之美國專利第5,171,320號,1997年12月2日頒予Woffinden等人之美國專利第5,693,093號,2000年12月19日頒予Deacon等人之美國專利第6,162,249號。
例如,在一較佳實施例中,本發明之IOL由諸如內眼級丙烯酸之可車床加工之IOL材料製成。將晶體材料之扣形物鎖定至軸並將其第一面用車床加工以形成視盤及支撐架之單片狀第一表面。將鈕扣自軸移除,翻過來並鎖定至相同或另一軸用於用車床加工視盤及支撐架之第二表面。用車床加工第一表面形成圍繞整個視盤延伸360°之直角邊緣。不需要其他形成直角邊緣之操作。一旦第二車床加工操作完成,即將該扣形物轉移至研磨台,在此將完成之包括支撐架及視盤之整塊IOL之周邊研磨。接著將該IOL自軸移除且若必要經歷進一步處理(例如水合、拋光、檢驗、倍率分配及包裝)。
現在參看圖式,在圖1中可見具有由虹膜30分隔之一前腔12及一後腔14之人眼10之剖視圖。在該後腔14內為具有眼之天然晶狀體17之一囊16。光藉由通過角膜18至該晶狀體17進入眼睛,角膜18與晶狀體17一起作用指引並將光聚焦在位於眼後部之視網膜20上。該視網膜連接至視神經22,其將由該視網膜接收之影像傳輸至腦以解析該影像。
在天然晶狀體已受損傷之眼睛中(例如因為白內障而混濁),該天然晶體不再能將入射光適當聚焦並指引至視網膜且影像變得模糊。治療該狀況之熟知之外科手術技術涉及移除受損之晶狀體,其可置換為稱為內眼晶體或IOL的諸如見於圖2的先前技術IOL 24之人造晶體。雖然關於精確置換眼內IOL存在多種不同的IOL設計及多種不同的選擇,但本發明本身關注用於植入眼睛10之大體上卵形之囊16內部之IOL。該植入技術在此項技術中通常稱為"袋中"(in-the-bag)技術。在該外科手術技術中,將囊袋之部分前部切除(稱為"囊部分切除術(capsularhexis)"),同時保持後囊16a完整並仍固定於睫狀體26。
因此,在IOL外科手術之"袋中"技術中,將IOL置於位於眼後腔14中之虹膜30後的囊16內。一IOL包括一中央視盤部分24a,其藉由將光指引並聚焦於視網膜上刺激摘除之天然晶體,且另外包括用於將視盤固定於囊袋內適當位置之構件。用於固定視盤之常見IOL結構稱為支撐架,其為自該視盤周邊向外徑向延伸之一彈性結構。在一常見IOL設計中,兩個支撐架24b、24c自視盤之相對面延伸並彎曲以提供對囊內部之偏置力,該偏置力將視盤固定於囊內之適當位置。
如在本文背景部分所述,可發生稱為後囊混濁或PCO之不良手術後病狀,其引起植入之IOL變得混濁且因此不再能適當地指引並聚焦通過該IOL之光。該病狀之主要原因為IOL視盤後之囊之整個後表面的晶體上皮細胞(LEC)之有絲分裂與遷移。如在圖2中所見,囊16之後表面16a接觸IOL視盤24a之後表面。當將受損天然晶體手術移除時,許多LEC可留在囊16內,尤其在其中緯線16b,其為未成熟LEC之主要來源。雖然在IOL植入外科手術時外科手術可試圖自囊袋移除所有LEC,但幾乎不可能移除每一單個LEC。任何殘存的LEC可繁殖並沿著後囊壁16a遷移。其在具有圓形邊緣之IOL中尤其如此,其中已發現臨床上顯著的PCO在外科手術後三年產生約20%-50%的患者。如在本文背景部分中解釋,目前預防PCO之流行且有效的方法為在後囊壁16a中產生一鋒利、不連續的彎曲。
現在參看圖3-6,展示本發明IOL 32之一例示性實施例。可見IOL 32包括一分別具有相對的前及後表面34a及34b的中央視盤部分34。當植入眼睛時,前視盤表面34a面對角膜18且後視盤表面34b面對視網膜20。在該例示性實施例中,將總計四個支撐架36-39連接至視盤部分34並自其延伸且組態以提供對囊16內部之偏置力以在其中適當地定位IOL 32。更特定言之,將該等支撐架36-39組態從而將IOL植入囊袋之後,該等支撐架與該囊袋之內表面嚙合。在該等支撐架與囊袋之間之嚙合產生引起IOL視盤34朝著視網膜20的方向向後拱起之偏置力,因此該IOL視盤之後表面34b緊緊壓迫囊16之後囊壁16a內部。
應注意支撐架之數目及組態可變化且在本發明之範疇內。此外,IOL 32可由任何合適之IOL材料製成,例如PMMA、聚矽氧、丙烯酸、水凝膠及其組合。IOL 32亦可為一片(例如其中視盤及支撐架自一單片材料形成)或多片設計(例如其中在視盤形成之後將支撐架連接至該視盤)。在一較佳實施例中,如以下更全面論述,將IOL自一內眼級丙烯酸之扣形物用車床加工為一單片。
仍參看圖3-6,可見IOL視盤34具有一周邊,該周邊包括一向後之鋒利邊緣40,如以上解釋,當將該IOL 32植入眼囊時,該鋒利邊緣40藉由在後囊壁中產生彎曲有效抑制PCO。鋒利邊緣40在角"A"之頂點界定,其接著由第一及第二表面40a、40b界定。角"A"較佳地在約70與120度之間,更佳地在約80與100度之間,且最佳地為約90度。鋒利邊緣40之頂點位於大體上平行於光軸OA延伸之頂點軸AA上。第一表面40a平滑地接合後凹面區域42,其接著平滑地接合後視盤表面34b。後視盤表面34b自然有助於患者的視覺並可為任何所需光學設計,包括(例如)球面、半球面、環面、多焦點、易於適應環境的(包括雙視盤型)及其組合。
當視盤後表面34b向內徑向延伸時,其周邊在該後凹面區域42開始變直處開始,該區域在圖5中表示為50p。
第二鋒利邊緣表面40b與最外周邊邊緣表面44相交且於此一起形成一鈍角"B",該鈍角"B"較佳地在約110與150度之間,更佳地在約120與140度之間,且最佳地為約130度。因此最外周邊邊緣表面44徑向位於鋒利邊緣40之外並大體上平行於光軸OA且因此亦平行於頂點軸AA延伸。諸如支撐架36-39之一或多個支撐架自最外周邊邊緣表面44延伸以適當地將IOL視盤34定位於患者眼睛之囊袋中。在說明性實施例中,支撐架厚度T1 較佳地在約0.20 mm與0.40 mm之間,更佳地在約0.25 mm與0.35 mm之間,且最佳地為約0.30 mm。支撐架厚度T1 小於最外周邊邊緣表面44之厚度T2 ,該厚度T2 較佳地在約0.25 mm與0.50 mm之間,且更佳地在約0.30 mm與0.40 mm之間,且最佳地為約0.37 mm。該等支撐架亦較佳地與最外周邊邊緣44之後界限44p隔開,意即,表面40b與周邊邊緣表面44相交。如自其頂點至支撐架所量測的,由鋒利後邊緣40產生之PCO障壁之高度H1 較佳地在約0.05 mm與0.25 mm之間,更佳地在約0.10 mm與0.20 mm之間,且最佳地為約0.13 mm。
如上所述,支撐架在眼中幫助穩定IOL並引起視盤34向後拱起,從而鋒利邊緣40穩固地縮入後囊壁16a。為了保持穩定性並進一步阻止IOL向前拱起,在IOL之前表面上提供前凹面區域46。該前凹面區域46徑向位於前視盤表面34a之外並與前視盤表面34a在或接近其交會點50a處平滑地接合。前凹面區域46向外徑向延伸並在相對方向上與前周邊邊緣表面48交叉以於此形成一鈍角"D"。前周邊邊緣表面48大體上垂直於光軸OA延伸並在一端與最外周邊邊緣表面44形成一大體上直角"C",並在其其他末端與前凹面周邊區域46形成一鈍角"D"。角"D"較佳地在約120與160度之間,更佳地在約130與150度之間,且最佳地為約140度。應注意前周邊邊緣表面48為可選的且在一替代實施例中,前凹面區域46沿著圖5中虛線51延伸且與最外周邊邊緣表面44直接相交並形成一銳角。
在說明性實施例中,前及後視盤表面34a、34b均為凸起的。在該實施例中,以上提供之尺寸適合於在約10 D至約30 D之倍率範圍之IOL。然而應注意,本發明不限於雙凸面視盤或特定倍率。
在一較佳實施例中,IOL 32自丙烯酸形成並自一內眼級丙烯酸扣形物車床加工並研磨為一片。在該方法中,將一丙烯酸扣形物鎖定(安裝)至軸,該軸隨後又安裝至具有切削工具(較佳為一金剛石切削工具)之車床。將該軸設置為旋轉的同時切削工具加工將變成後視盤表面34b者,後視盤表面34b包括鋒利邊緣40、後凹面區域42及支撐架36-39之後部相對表面。一旦該步驟完成,將該軸自車床移除並將扣形物自軸去鎖定(移除)。將該扣形物翻轉且鎖定至另一軸(後面向下)。將該軸安裝至車床並設置為旋轉的同時切削工具加工將變成視盤之前表面34a、前凹面區域46、可選前邊緣表面48及支撐架36-39之前部相對表面者。一旦該步驟完成,將軸自車床移除並轉移至一研磨機。在研磨台,該軸保持固定同時研磨工具切削完全通過扣形物之途徑以形成一片IOL(參考圖3)之完整周邊P(輪廓)。在IOL 32之例示性實施例中,研磨操作亦切掉支撐架36-39中之孔36'-39'。
參考圖6,說明本發明IOL比以虛線展示之先前技術IOL所實現之減少之區域。本發明IOL 32之中心厚度CT小於先前技術IOL 32'之中心厚度CT',前及後凹面區域46及42減少在視盤之周邊的區域且形成鋒利邊緣40。在一較佳實施例中,本發明IOL 32之CT在+10.00 D(屈光度)晶體的約0.50 mm與+30.00 D晶體的約1.1 mm之間。先前技術IOL 32'不能通過3 mm以下切口,其亦不具有抑制或預防PCO之任何特徵。
後及前凹面區域46及42較佳地彼此相對定位且具有大體上相同的半徑,其中R1 =R2 ,該半徑在約0.15 mm與0.5 mm之間,更佳地在約0.20 mm與0.40 mm之間,且最佳地為約0.30 mm。在R1 與R2 之間之最小厚度表示為T3 且其較佳地在約0.10 mm與0.3 mm之間且最佳為約0.20 mm。在眼中幫助穩定IOL之一或多個支撐架36-39較佳地與最外後邊緣表面44之後界限44p隔開。IOL視盤34為經前及後凹面區域46及42之尺寸減小者,但仍然保持IOL 32之強度及穩定性。其至少部分歸因於支撐架厚度T1 ,其與類似設計之先前技術IOL相比並未減小(參閱圖6)。此外,應認識到在前與後凹面區域46、42之間量測之視盤厚度T3 小於支撐架厚度T1 。前凹面區域46藉由阻止IOL向前(意即朝著角膜方向)拱起增加IOL之原位穩定性且因此亦幫助保持鋒利邊緣40穩固地縮入後囊袋壁。其產生對LEC向內遷移之障壁且因而抑制PCO。與平衡後凹面區域42之IOL之前面相比鋒利邊緣40亦為IOL之後面提供額外的材料區域,因為IOL將向後拱起,儘管如上所述後凹面區域42減小視盤34之總尺寸以允許其通過3 mm以下切口。換言之,雖然前凹面區域46作用以促使IOL向後拱起,但由於由後鋒利邊緣40引起之後面上之額外材料,後凹面區域42不促使IOL向前拱起。將支撐架36-39與最外後邊緣44之後界限44p隔開亦幫助保持後拱起。此外,應認識到在前與後凹面區域46、42之間量測之視盤厚度T3 小於支撐架厚度T1 (參閱以上所給值),其亦有助於IOL原位之強度及穩定性。
因此存在提供獨特的IOL及製造IOL之方法,該IOL足夠小以適合通過3 mm以下切口,足夠堅固以在眼中保持穩定,並包括如上所述大體上抑制PCO之一鋒利邊緣。
12...前腔
14...後腔
16...囊
16a...後囊壁
16b...中緯線
17...晶狀體
18...角膜
20...視網膜
22...視神經
24...先前技術IOL
24a...中央視盤部分
24b...支撐架
24c...支撐架
26...睫狀體
30...虹膜
32...本發明IOL
32'...先前技術IOL
34...中央視盤部分
34a...前視盤表面
34b...後視盤表面
36...支撐架
36'...孔
37...支撐架
37'...孔
38...支撐架
38'...孔
39...支撐架
39'...孔
40...鋒利邊緣
40a...第一表面
40b...第二表面
42...後凹面區域
44...最外周邊邊緣表面
44p...後界限
46...前凹面區域
48...前周邊邊緣表面
50a...交會點
50p...周邊在後凹面區域42開始變直處
<A...角"A"
<B...角"B"
<D...角"D"
AA...頂點軸
H1 PCO...障壁之高度
OA...光軸
P...完全周邊
R1 ...後凹面區域46之半徑
R2 ...前凹面區域42之半徑
T1 ...支撐架厚度
T2 ...最外周邊邊緣表面44之厚度
T3 ...前與後凹面區域46、42之間之視盤厚度
圖1為展示眼睛囊袋內之天然晶體之人眼之剖視圖;圖2為展示天然晶體被移除並置換為先前技術IOL之人眼之剖視圖;圖3為本發明IOL之一實施例且其後視盤表面向上之透視圖;圖4為通常沿著圖3之線4-4取得之IOL之剖視圖;圖5為展示一半IOL以說明邊緣細節之圖6之放大剖視圖;且圖6為將虛線之先前技術IOL與實線之通常沿著圖3之線6-6取得的本發明IOL比較之剖視圖。
AA...頂點軸
<A...角"A"
<B...角"B"
<D...角"D"
T1 ...支撐架厚度
T2 ...最外周邊邊緣表面44之厚度
T3 ...前與後凹面區域46、42之間之視盤厚度
H1 ...PCO障壁之高度
R1 ...後凹面區域46之半徑
R2 ...前凹面區域42之半徑
OA...光軸
34...IOL視盤
34a...前視盤表面
34b...後視盤表面
38...支撐架
40...鋒利邊緣
40a...第一表面
40b...第二表面
42...後凹面區域
44...最外後邊緣表面
44p...後界限
46...前凹面區域46
48...前周邊邊緣表面
50a...交會點
50p...周邊在後凹面區域42開始變直處

Claims (18)

  1. 一種用於植入人眼之內眼晶體,其包含:a)一具有相對的前及後視盤表面以及一光軸自該前視盤表面延伸至該後視盤表面之晶體視盤;b)與該後視盤表面平滑地接合之一後凹面區域,且該後凹面區域徑向地位於該後視盤表面之外;c)與該前視盤表面平滑地接合之一前凹面區域,且該後凹面區域徑向地位於該後視盤表面之外;d)徑向地位於該前及後凹面區域之外之一最外周邊邊緣表面;及e)一向後延伸之鋒利邊緣,其由一角"A"界定,該鋒利邊緣延伸360°環繞該後視盤表面且由第一及第二表面界定,該第一表面被接合於該鋒利邊緣與該後凹面區域之間,該第二表面被接合於該鋒利邊緣與該最外周邊邊緣表面之間。
  2. 如請求項1之內眼晶體,且其另外包含至少一自該最外周邊邊緣表面延伸之支撐架。
  3. 如請求項1之內眼晶體,且其另外包含一前邊緣表面,該前邊緣表面在該前凹面區域與該最外周邊邊緣表面之間大體上垂直於該光軸延伸。
  4. 如請求項1之內眼晶體,其中該後視盤表面係凸起的。
  5. 如請求項1之內眼晶體,其中該前視盤表面係凸起的。
  6. 如請求項1之內眼晶體,其中該前及後視盤表面均係凸起的。
  7. 如請求項1之內眼晶體,其中該前凹面區域之半徑大體上等於該後凹面區域之半徑。
  8. 如請求項7之內眼晶體,其中該前及後凹面區域大體上處於彼此相對之位置。
  9. 如請求項8之內眼晶體,其中在該等半徑之間之最小厚度"T3 "在約0.10 mm與0.3 mm之間。
  10. 如請求項1之內眼晶體,其中該第二表面與該最外邊緣之間形成一角"B",其中該角"B"係約介於110度即150度之間。
  11. 如請求項1之內眼晶體,其中該角"A"在約70與120度之間。
  12. 如請求項7之內眼晶體,其中該等前及後凹面區域大體上處於彼此相對之位置,且在該等半徑之間之最小厚度"T3 "在約0.10 mm與0.3 mm之間。
  13. 如請求項12之內眼晶體,且其另外包含至少一個自該視盤之該最外周邊邊緣延伸之支撐架。
  14. 如請求項13之內眼晶體,其中在該等半徑之間之厚度"T3 "小於該支撐架之厚度"T1 "。
  15. 如請求項14之內眼晶體,其中該支撐架與該最外周邊邊緣表面之後界限之間有一間隔距離。
  16. 如請求項15之內眼晶體,其中一由該向後延伸之鋒利邊緣所形成之PCO障壁,具有一由該PCO障壁之一頂點量測至支撐架的高度"H1 ",在約0.05 mm與0.25 mm之間。
  17. 如請求項15之內眼晶體,其中一由該向後延伸之鋒利邊緣 所形成之PCO障壁,具有一由該PCO障壁之一頂點量測至支撐架的高度"H1 ",在約0.10 mm與0.20 mm之間。
  18. 如請求項15之內眼晶體,其中一由該向後延伸之鋒利邊緣所形成之PCO障壁,具有一由該PCO障壁之一頂點量測至支撐架的高度"H1 ",約0.13 mm。
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