TWI581779B - 用於降低眼內晶體之非所欲的光效應的邊緣設計 - Google Patents

用於降低眼內晶體之非所欲的光效應的邊緣設計 Download PDF

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TWI581779B
TWI581779B TW102139525A TW102139525A TWI581779B TW I581779 B TWI581779 B TW I581779B TW 102139525 A TW102139525 A TW 102139525A TW 102139525 A TW102139525 A TW 102139525A TW I581779 B TWI581779 B TW I581779B
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羅伯特Ｄ 安吉洛波羅斯
卡瑪爾Ｋ 達斯
強納森 麥肯
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諾華公司
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
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    • A61F2/1613—Intraocular 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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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular 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
    • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
    • A61F2/164—Aspheric lenses
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular 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
    • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
    • A61F2/1645—Toric lenses
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
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    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
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    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0053—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in optical properties

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Description

用於降低眼內晶體之非所欲的光效應的邊緣設計 發明領域
本發明概略而言有關眼內晶體之領域，更特別地有關用於降低眼內晶體之非所欲的光效應的邊緣設計。
發明背景
人的眼睛最簡單之功能，是藉由將光線傳送通過稱作角膜之清澈外部分，然後利用水晶體將影像聚焦至視網膜上而提供視覺。聚焦的影像之品質取決於許多的因素，包括眼睛的大小以及形狀，角膜以及晶體之透光性。當年紀或疾病導致晶體變得較不透明時，因為可傳送至視網膜之光線減少而使得視力惡化。此在眼睛之晶體上之缺失在醫學上稱作白內障。用於此病況之治療法是手術移除晶體，然後用人工眼內晶體(IOL)取代其功能。在美國，大部分的白內障晶體，係用稱作超音波晶體乳化術之手術技術移除。在此過程期間，在前囊中切一開口，然後用薄超音波乳化切割尖嘴插進患病的晶體，然後超音波振盪。振盪的切割尖嘴會液化或乳化晶體，如此可將晶體從眼睛中吸出。患病的晶體一旦移除，就以IOL取代。
眼內晶體之已知的困難是，離軸光線可能會被反射或傳送進入視覺區，產生非所欲的光學效應。已有IOL之邊緣設計用來控制非所欲的光線至不同的位置，但視進入的光線之入射角而定，其可能無法充分地克服此問題，且可能無心地製造新的光學效應。此問題在使用特別的邊緣形狀供機械安定性之薄晶體設計中可能會更嚴重。因此仍有降低此等非所欲的光學效應之需求。
依據本發明之一實施例，係特地提出一種眼內晶體(IOL)，其由軟性、可折疊材料所形成，且包含：一具有一光學表面之鏡片，該光學表面具有對應於該鏡片之度數之基本曲率，該鏡片在該鏡片表面之外邊界處具有一邊緣厚度；一外圍邊框，其圍繞著該鏡片形成一環，該外圍邊框具有一最大厚度，該外圍邊框具有一連續彎曲的外邊緣，其在該IOL之前表面以及後表面之間延伸，且在各別的角落相交各表面；以及一厚度降低區域，其在該鏡片之光學表面之外側，介於該外圍邊框以及該鏡片之間，該厚度降低區域係與該外圍邊框以及該鏡片一體成型，且相對於該外圍邊框之最大厚度以及該鏡片之邊緣厚度，具有降低的厚度。
10‧‧‧眼內晶體
12‧‧‧鏡片
14‧‧‧襻
30‧‧‧邊框
A‧‧‧線
100‧‧‧眼內晶體
102‧‧‧外圍邊框
104‧‧‧前表面
106‧‧‧後表面
圖1說明根據本發明之一特別具體例之範例IOL10。
圖2顯示一特別具體例IOL100之橫截面視圖，在圖1中 延著線A-A取一橫截面，具有一連續彎曲的外邊緣。
圖3顯示一選擇性具體例，其中前表面104以及後表面106二者均下凹，形成該厚度降低區域。
圖4說明一選擇性具體例，其中外圍邊框102之前表面104包括一平坦、面向前，碰到該厚度降低區域之表面。
較佳實施例之詳細說明
本發明之各種具體例提供用於IOL之特定形狀的邊緣，以便降低光學效應。在特別具體例中，該IOL之前表面與連續彎曲的邊緣形成在一起，其會重新導向透射以及反射的離軸光線，以降低負面的視覺效應。在某些具體例中，連續彎曲的邊緣亦可用於連接增厚的外圍，以便改善相對薄的晶體內之機械安定性。在下列詳細的說明後，各種具體例之另外的特徵以及優點將更為清楚明瞭。
美國專利申請公開案第2009/0088842號，其在此併入本案以為參考，揭示一種使用增厚邊框以改善機械安定性之可折疊式IOL設計。此等設計可包括一在晶體的前和/或後表面上，鏡片之邊緣四周之凹下的表面，藉此減少鏡片之整個體積。接著，該凹下的表面外圍繞著附著於襻(haptics)之增厚的邊框，提供額外的機械安定性，防止鏡片屈曲或傾斜。邊框以及進來的離軸光線間之交互作用，可能產生降低IOL病人之視覺品質之光學效應。本發明之各種具體例提供用於降低此等非所欲的光學效應之IOL之邊緣設計。
圖1例示說明根據本發明之一特別具體例之範例IOL 10。IOL 10係由許多熟悉此技藝之人士已知之材料中任一種單一片軟性、可折疊、生物相容的材料形成，包括，但不限於，矽膠、水凝膠以及軟性丙烯酸材料，亦可包括可吸收特定波長範圍之光(諸如紫外光)的化合物。在描述之具體例中，IOL 10包括鏡片12以及襻(haptics)14。鏡片12指的是IOL 10之中心區域，其構形係用於聚焦入射的光線進入視網膜上，提供病人視覺。鏡片12之光學軸相應於被鏡片12聚焦，從遠方物件而來之平行光線之方向。該鏡片之光學表面定義為具有決定鏡片度數之基本弧度之區域，此光學區域之外邊界界定出該鏡片之邊緣厚度(本文中，“厚度”指的是沿著光學軸之厚度)。該光學表面之直徑較佳地在4.5-7.0mm之範圍內，相應於病人之瞳孔直徑之一般範圍。
在所述之具體例中，鏡片12描述為為單焦折射鏡片，具有決定鏡片12之度數之彎曲半徑。然而，原則上，鏡片12可具有任何適合用於將光線聚焦在視網膜上之結構，其可包括衍射或折射元件。鏡片12亦可包括適合用於校正單色或色像差(包括，但不限於，任何程度的球面像差、彗形像差(coma)、散光)之修飾，包括諸如複曲面或非球狀光學表面之構件。因此，熟悉此技藝之人士應該很明暸，本發明之各種具體例中，可包括任何有關IOL之已知的光學設計。
IOL 10描述的是典型地植入囊袋之IOL，但本發 明之各種具體例可包括置於眼睛之前室中之晶體IOL(phakic IOL)，或置於後室之溝固定晶體。襻14可包括任何用於IOL之機械支撐結構，其可維持IOL在適當的解剖位置。在描述的具體例中顯示之襻14，係置於囊袋之典型，但熟悉此技藝之人士應知道許多針對所描述的結構之其它的修飾。襻14顯示成與IOL 10之其它部分一整成型，但其等亦可為附著於IOL 10之周圍之分開的部件。
邊框30是IOL 10之增厚的最外圍，其與鏡片12一體成型，其與襻14連接在一起，且其可提供IOL 10安裝好時，鏡片12之機械安定性。邊框30連接至相對於該鏡片表面之邊緣厚度降低區域(在此之厚度是沿著IOL 10之光學軸測量)，其圍繞該光學表面。相對於此厚度降低區域，此邊框30係較厚的。為了提供適當薄的IOL側面，相對於預期的鏡片厚度0.19mm-0.45mm，以及0.1mm厚或更薄之厚度降低區域，該邊框應具有厚度0.3mm或更薄。然而，依據晶體之度數需求，可能需要厚很多的晶體，如此邊框30以及鏡片12之厚度降低區域可能較厚，同時仍容許鏡片12在沒有邊框30時，在相對厚度較薄之情況下，保有安定性。
圖2顯示一特別具體例IOL100之橫截面視圖，在圖1中延著線A-A取一橫截面，具有一連續彎曲的外邊緣。外邊緣102從光學軸面向外面，其在IOL之前表面104以及後表面106之間延伸，在角落處碰到各別的表面104以及106，其可為延著光學軸之尖銳的不連續表面，或有點更平緩反轉之表面外形。外邊緣102是“連續彎曲的”，意謂其不含任 何平行於延著其長度或在外邊緣102與表面104或106交叉處之光學軸之切線。在特別具體例中，連續彎曲的外邊緣102之曲面的半徑可為不變的以及相對平緩的，諸如0.8mm。於其它具體例中，該連續彎曲的外邊緣之曲率之半徑可相對的陡峭，諸如1.19mm。藉由在無任何一致表面方向之情況下，呈現給入射光相對大的表面積，該連續彎曲的邊緣從而防止任何離軸光線實質上透過該邊緣，至任何特別的位置，以及將視網膜內部反射的光分配離開。此等特徵之組合因此減少了非所欲的光學現象。
有利地，該連續彎曲的邊緣亦可配置成可將光線引導至特定的位置。例如，外邊緣102之第一部分可具有一反射內部光線至鏡片12之本體內之位置之構形(方向以及曲率)，而該外邊緣102之第二部份可具有一可反射鏡片12之本體外面(一般是後面)的入射光線之曲率。此結合可幫助將離軸光線重新導離視野。額外地，外邊緣102和/或前和/或後表面104以及106之周圍可具有紋理、塗層或類似物，以漫散或吸收一些程度之入射光，其可進一步減少非所欲的光學效應。
在圖2中所描述的具體例中，鏡片12周圍之厚度降低區域，是在鏡片12之光學表面的外面之前表面104處之凹陷所形成，而後表面106具有連續的曲率直到後表面106與外緣102交叉之角落。結合外邊緣102之特徵，此可促進外邊緣102將光線重新導離視野之能力。圖3顯示一選擇性具體例，其中前表面104以及後表面106二者均凹陷，形成 厚度降低區域。相對於平坦的外邊緣，該連續彎曲的外邊緣102仍產生減少的光學效應，但該凹陷的後表面106可能傾向將光線導向更接近小凹，其可能使得光學效應比圖2中所示之具體例更明顯。然而，在此等情況下，該連續彎曲的邊緣設計仍可提供改善的性能。
在圖2所描述之具體例中，IOL之前表面104在尖銳不連續處碰到外圍邊框102。圖4說明一選擇性具體例，其中該外圍邊框102之前表面104，具有相同的最大厚度，包括一碰到該厚度降低區域之平坦、面向前之表面。如圖3之情況，可能有與該前表面之平坦部份相關之額外的光學效應，諸如離軸之光線的傳送，但此等效應仍藉由連續彎曲的外邊緣，減輕至某個程度。
該等熟悉此技藝之人士應了解，在不逸離本發明之範疇之情況下，可針對以上之具體例作各種改變。
10‧‧‧眼內晶體(IOL)
12‧‧‧鏡片
14‧‧‧襻
30‧‧‧邊框
A‧‧‧線

Claims (9)

  1. 一種眼內晶體(IOL)，其由軟性、可折疊材料所形成，且包含：一具有一光學表面之鏡片，該光學表面具有對應於該鏡片之度數之基本曲率，該鏡片在該鏡片表面之外邊界處具有一邊緣厚度；一外圍邊框，其圍繞著該鏡片形成一環，該外圍邊框具有一最大厚度，該外圍邊框具有一連續彎曲的外邊緣，其在該IOL之前表面以及後表面之間延伸，且在各別的角落相交各表面；以及一厚度降低區域，其在該鏡片之光學表面之外側，介於該外圍邊框以及該鏡片之間，該厚度降低區域係與該外圍邊框以及該鏡片一體成型，且相對於該外圍邊框之最大厚度以及該鏡片之邊緣厚度，具有降低的厚度。
  2. 如請求項1之IOL，其中該連續彎曲的外邊緣包含一具有一配置成會反射在鏡片內之離軸光線之曲率的第一部份，以及一具有配置成可反射該鏡片後面之離軸光線之曲率的第二部份。
  3. 如請求項1之IOL，其中該IOL之前表面凹陷，以形成該厚度降低區域。
  4. 如請求項3之IOL，其中該IOL之前表面以及該IOL之後表面二者均凹陷，以形成該厚度降低區域。
  5. 如請求項1之IOL，其中該鏡片係單焦折射鏡片。
  6. 如請求項5之IOL，其中該鏡片是複曲面、非球面或這二者。
  7. 如請求項1之IOL，其中至少該外邊緣、該IOL之前表面以及該IOL之後表面之外面具有紋理，以漫射入射光。
  8. 如請求項1之IOL，其中該外邊緣之曲率半徑為0.8mm。
  9. 如請求項1之IOL，其中該外邊緣之曲率半徑為1.19mm。
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