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TWI472319B - 調節式眼內水晶體系統 - Google Patents

調節式眼內水晶體系統 Download PDF

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TWI472319B
TWI472319B TW97144132A TW97144132A TWI472319B TW I472319 B TWI472319 B TW I472319B TW 97144132 A TW97144132 A TW 97144132A TW 97144132 A TW97144132 A TW 97144132A TW I472319 B TWI472319 B TW I472319B
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lens
crystal
intraocular
intraocular lens
peripheral ring
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TW97144132A
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TW200930339A (en
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Weinschenk, Iii
Xiaoxiao Zhang
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Alcon Inc
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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
    • 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
    • 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
    • A61F2/1624—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 having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1635—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 having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing shape
    • 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
    • A61F2/1648—Multipart 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
    • 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
    • A61F2250/0018—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 elasticity, stiffness or compressibility

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Description

調節式眼內水晶體系統
本發明係有關於一種調節式眼內水晶體系統。
 發明背景
本發明主張於2007年11月14日提出申請之第60/987,822號美國暫准申請案之優先權。
本發明係廣泛地有關於眼內水晶體(IOL)領域；及更詳細地，係有關於調節式眼內水晶體。
最簡單來說，人類眼睛的功能係藉由將光線傳送通過一個稱作角膜之透明外部，及藉由水晶體將影像聚焦在視網膜上，而提供視覺。所聚焦影像的品質依許多因素而定，包括眼睛的大小與形狀及角膜與水晶體的透明度。
當年齡或疾病造成水晶體變得較為混濁時，因可傳送至視網膜的光線變少，而使得視力衰退。眼睛水晶體的該項毛病，在醫學上稱作白內障。該病況之可接受的一種療法，係手術摘除水晶體，及以一種人工眼內水晶體(IOL)取代水晶體的功能。
在美國，大部分的白內障水晶體係藉由一種稱作小切口超音波晶體乳化術(Phacoemulsification)的手術技術摘除。在該手術期間，在前囊袋做出一個切口，將一個薄的小切口超音波晶體乳化術切割噴嘴伸入罹病的水晶體中，及以超音波方式振動。該振動的切割噴嘴將水晶體液化或乳化，藉而可將水晶體自眼睛吸除。一旦移除罹病的水晶體後，即由一人工水晶體代替。
在天然的水晶體中，遠距離與近距離視力的雙焦點係藉由稱作調節作用之機制提供。在年輕時，天然的水晶體柔軟及包含於囊袋之中。該囊袋係由懸韌帶懸掛於睫狀肌。睫狀肌的鬆弛作用使得懸韌帶繃緊，及拉長該囊袋。結果，使得天然的水晶體變扁平。睫狀肌的繃緊作用紓解懸韌帶的張力，使得囊袋與天然的水晶體持有較為圓形的形狀。依此方式，天然的水晶體可任擇地聚焦在近或遠的物體上。
當水晶體老化時，其變得較硬及較難因應睫狀肌的繃緊作用而改變形狀。這使得水晶體較難聚焦在近的物體上，這種情況在醫學上稱作老花眼。幾乎所有超過45或50歲的成年人，都受到老花眼的影響。
在本發明之前，當因白內障或其他疾病需要摘除天然的水晶體及以一種人工眼內水晶體替代時，該眼內水晶體是一種單焦式水晶體，需要病患使用看近距離用的一附眼鏡或隱形眼鏡。先進醫學光學(Advanced Medical Opitcs)公司已銷售一種雙焦式眼內水晶體-阿雷(ARRAY)水晶體多年，但因品質問題，一直未被廣泛接受。
目前正在研究數種調節式眼內水晶體之設計。例如，由C＆C Vision公司所生產的數種設計，目前正在進行臨床實驗。見第6,197,059號、第5,674,282號、第5,496,366號與第5,476,514號美國專利(授予Cumming)，其完整內容在此併入本案以為參考資料。該等專利中所述的水晶體是一種單鏡片式水晶體，具有可撓性支撐腳而容許鏡片因應睫狀肌的運動而向前與向後移動。類似的設計係述於第6,302,911 B1號美國專利(授予Hanna)、第6,261,321 B1號及第6,241,777 B1號美國專利(二者皆授予Kellan)，其完整內容在此併入本案以為參考資料。然而，在該等單水晶體系統中的鏡片移動量，可能不足以產生適用的調節作用範圍。此外，如第6,197,059號、第5,674,282號、第5,496,366號與第5,476,514號美國專利所述，眼睛必須痲痹1或2星期，以讓囊袋纖維化裹住該水晶體，及藉此提供水晶體與囊袋之間的硬式結合作用。此外，該等水晶體的商品形式係自一種水凝膠或矽氧樹脂材質製成。該等材質對於後囊混濁(“PCO”)之形成，並無固有抗性。後囊混濁的唯一療法係一種囊切開術，其使用釹：釔鋁石榴石(Nd：YAG)雷射，將一部份的後囊汽化。該種對於後囊的破壞作用，可能摧毀該等水晶體的調節作用機制。
已試圖製作一種雙鏡片調節式水晶體系統。例如，第5,275,623號美國專利(授予Sarfarazi)、第00/66037號WIPO公開案(授予Glick等人)及WO 01/34067 A1(授予Bandhauer等人)，其完整內容在此併入本案以為參考資料；該等專利案皆揭露一種雙鏡片式水晶體系統，其中一鏡片帶有正屈光力而另一鏡片帶有負屈光力。該等鏡片係由一鉸接機制連接，其因應睫狀肌的運動而使鏡片移動至更靠近或更遠離，藉此提供調節作用。為提供該”可變焦距水晶體”效果，睫狀肌的運動必須經由連接前後鏡片的支撐腳，充分地傳送到水晶體系統。已證明很難經由該機制，提供較廣的調節作用範圍所需之充分移動作用。
習知技藝中之調節式雙水晶體系統使用一種可移動式“可變焦距”水晶體，而其移動係受到固有的限制。最大敏感度或移動倍率α(一種無單位的比值)，係定義為相對於每單位懸韌帶位移之水晶體軸向位移，及係由下列等式所得出：
α=-B/A
其中B為懸韌帶長度的伸出距離，其係介於1.0至2.0毫米之範圍；及
A為雙重鏡片之間的中面與懸韌帶終端所在之前水晶體的前表面之間之軸向距離。
就實際上而言，因為水晶體厚度與分開雙重水晶體之需求，A不可能小於約1毫米。因此，α不可能大於2，其界定了已知雙水晶體式調節作用方法之限度。該限度顯然太低，因為雙鏡片式設計若要達到創造病患正常調節作用所需之高於2.25屈光度的調節作用範圍之目標，則理想的α係高於或等於4。
因此，持續需要一種安全與穩定的雙水晶體型調節式眼內水晶體，其以最低量的水晶體移動即可提供相對大量的調節作用範圍。
 發明概要
本發明藉由提供其中至少一鏡片為可變形之一種雙鏡片調節式水晶體系統，而改良習知技藝。當被囊袋擠壓時，該二鏡片會彼此緊貼，使得鏡片中的至少一者變形。結果，該二鏡片接觸之界面改變形狀，藉此改變水晶體系統的屈光能力。該種水晶體系統需要很少的鏡片相對位移及小的移動力。
本發明的一實施例提供一種眼內水晶體，其包括一個具有藉由多個支撐腳而與第一外圍環連接的第一鏡片之第一水晶體，一個具有與第二外圍環連接的第二鏡片之第二水晶體，該第二外圍環的尺寸與形狀係可容納該第一外圍環，藉此第一鏡片與第二鏡片接觸，其中該支撐腳使第一鏡片偏倚著第二鏡片。類似地，該第二鏡片亦可藉由另外多個支撐腳而與第二外圍環連接。為提供至少一鏡片的變形作用，及因而改變該二鏡片接觸之界面/區域的形狀，該鏡片中的至少一者比另一者更具依從性。例如，第一鏡片可比第二鏡片更具依從性。
此外，在本發明的一實施例中，該眼內水晶體可為：當眼內水晶體處於鬆弛狀態時，第一鏡片在第一鏡片的第一區域與第二鏡片接觸；當眼內水晶體處於壓緊狀態時，第一鏡片在第一鏡片的第二區域與第二鏡片接觸；第一區域係小於第二區域。鬆弛狀態可為其中植入眼內水晶體之一眼睛的調節狀態，而壓緊狀態可為其中植入眼內水晶體之一眼睛的去除調節狀態。
圖式簡單說明
第1圖是本發明的水晶體系統之放大透視圖。
第2圖是本發明的水晶體系統之放大分解透視圖。
第3圖是本發明的水晶體系統之放大截面圖，其顯示鬆弛狀態的鏡片。
第4圖是本發明的水晶體系統之放大截面圖，其顯示壓緊狀態的鏡片。
 較佳實施例之詳細說明
水晶體表面的屈光力主要由二個物理參數決定：水晶體與水晶體所浸沒其中的介質(如空氣或眼房水)之間的屈光率差異，及水晶體表面的曲度半徑。該等參數中的各者皆影響光線在水晶體表面彎曲的程度，及因而測定水晶體的屈光力。
如最佳自第1與第2圖所見，在本發明的一實施例中之水晶體系統10一般包括前水晶體12與後水晶體14。前水晶體12包含藉由多個支撐腳20而與前外圍環18連接的前鏡片16。前水晶體12可自一種可變形材質諸如矽氧樹脂、水凝膠或軟式壓克力製成一個單一部件。後水晶體14包含與後外圍環24連接及與其整體成形的後鏡片22。後水晶體14可自屈光率不同於前水晶體12之一種可變形材質諸如矽氧樹脂、水凝膠或軟式壓克力製成一個單一部件。前外圍環18的尺寸與形狀係可被裝置於後外圍環24之內，藉此前水晶體12嵌套於後水晶體14之內。支撐腳20使第一鏡片16偏倚著第二鏡片22。
如最佳自第3圖所見，當眼睛處於調節狀態(睫狀肌鬆弛)時，囊袋為鬆弛的，及前鏡片16與後鏡片22可擴張至最大厚度。在鬆弛狀態，鏡片16與鏡片22在以光軸32為中心的一個小區域接觸，及鏡片16與鏡片22之間的空間充滿眼房水，其屈光率與鏡片16或鏡片22皆不相同。通過水晶體系統10的光線在前鏡片16的後側26與眼房水之界面彎曲，及再度在後鏡片22的前側28與眼房水之界面彎曲。
當眼睛處於去除調節狀態時，睫狀肌繃緊，而在囊袋中緯線產生外圍張力。該張力造成前與後囊袋膜向彼此移動，使得前鏡片16與後鏡片22彼此擠壓，如最佳自第4圖所見。該擠壓作用使得前鏡片16與後鏡片22彼此緊貼，造成前鏡片16的後側26變形，及後鏡片22的前側28一些程度的變形，因前鏡片16的剛性低於(依從性高於)後鏡片22。前鏡片16與後鏡片22彼此緊貼，係因為環18與24彼此聯鎖之性質，及當擠壓時之支撐腳20的形狀傾向於將前鏡片16向後推擠。該變形作用一般涵蓋於鏡片16與22之中央2毫米至3毫米的區域30內，因而僅需小的力量即可造成該變形作用。同時，因為將先前存在於鏡片16與鏡片22之間的區域30之所有眼房水排出，在區域30中僅因鏡片16與鏡片22之間的屈光率差異，以及前鏡片16的後側26與後鏡片22的前側28之形狀改變，造成通過水晶體系統10的光線之任一彎曲作用。此外，區域30以外的鏡片16與22之屈光力大致上不受影響，使得水晶體系統10具有雙焦性質。水晶體系統10的一個重要特性在於區域30的變形作用是逐漸發生，使得屈光力可逐漸改變。
所述部份係為了說明與解釋之目的。嫻熟相關技藝者將清楚知道可對上述的本發明進行變化與修飾，而不偏離其範圍與精神。
10．．．水晶體系統
12．．．前水晶體
14．．．後水晶體
16．．．前鏡片
18．．．前外圍環
20．．．支撐腳
22．．．後鏡片
24．．．後外圍環
26．．．前鏡片的後側
28．．．後鏡片的前側
30．．．區域
32．．．光軸
第1圖是本發明的水晶體系統之放大透視圖。
第2圖是本發明的水晶體系統之放大分解透視圖。
第3圖是本發明的水晶體系統之放大截面圖，其顯示鬆弛狀態的鏡片。
第4圖是本發明的水晶體系統之放大截面圖，其顯示壓緊狀態的鏡片。
10．．．水晶體系統
14．．．後水晶體
16．．．前鏡片
20．．．支撐腳
24．．．後外圍環

Claims (5)

  1. 一種調節式眼內水晶體，其包括：一具有一第一鏡片的第一水晶體，該第一鏡片具有藉由第一多數個支撐腳而附接至一第一外圍環之一第一界面，其中該第一鏡片、該第一外圍環以及該第一多數個支撐腳係形成為一單一部件；一具有一第二鏡片的第二水晶體，該第二鏡片具有藉由第二多數個支撐腳而附接至一第二外圍環之一第二界面，該第二外圍環的尺寸與形狀係被製作成可容納該第一外圍環，使得該第一界面區域與該第二界面區域在該第一鏡片之光軸的中心處相接觸，藉此改變該等鏡片的屈光能力，且其中該第二鏡片、該第二外圍環以及該第二多數個支撐腳係整體形成為一單一部件；其中該第一多數支撐腳使該第一鏡片偏倚著該第二鏡片。
  2. 如申請專利範圍第1項之眼內水晶體，其中該第一鏡片比該第二鏡片更具依從性。
  3. 如申請專利範圍第1項之眼內水晶體，其中該眼內水晶體被配置而使得當該眼內水晶體處於一鬆弛狀態時，在該第一鏡片與該第二鏡片間的接觸區域係小於當該眼內水晶體處於一壓緊狀態時。
  4. 如申請專利範圍第1項之眼內水晶體，其中該眼內水晶體被配置而使得當植入該眼內水晶體之一眼睛處於一調節狀態時，在該第一鏡片與該第二鏡片間的接觸區域係小於當該眼睛處於一非調節狀態時。
  5. 如申請專利範圍第1項之眼內水晶體，該第一鏡片與該第二鏡片之一組合屈光力在該接觸區域之處改變且與該接觸區域之大小有關，並且與該第一與第二鏡片的非接觸區域一起提供一程度的雙焦點。
TW97144132A 2007-11-14 2008-11-14 調節式眼內水晶體系統 TWI472319B (zh)

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