TW200817755A - Methods of inhibiting the distortions that occur during the production of silicone hydrogel ophthalmic lenses - Google Patents

Methods of inhibiting the distortions that occur during the production of silicone hydrogel ophthalmic lenses Download PDF

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Publication number
TW200817755A
TW200817755A TW096123618A TW96123618A TW200817755A TW 200817755 A TW200817755 A TW 200817755A TW 096123618 A TW096123618 A TW 096123618A TW 96123618 A TW96123618 A TW 96123618A TW 200817755 A TW200817755 A TW 200817755A
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Taiwan
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eye lens
hydrogel
occurs
disinfecting
hydrogel eye
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TW096123618A
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Chinese (zh)
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James D Ford
Azaam Alli
Dharmesh Dubey
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Johnson & Johnson Vision Care
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Abstract

Methods of reducing the distortion of silicone hydrogel lenses during sterilization are disclosed.

Description

200817755 九、發明說明: 【相關之申請案】 本申請案係下者之非臨時性申請案:2006年6月30 曰提出申請之美國專利申請案號6〇/817,728,其為一臨 時性的專利申請案。 【發明所屬之技術領域】 本發明係有關於減少於矽酮水凝膠隱形眼鏡製造 期間產生變形之方法。 【先前技術】 隱形眼鏡自1950年代以來即被商業地用於改良視 力,第一副隱形眼鏡係以硬質材料製造,雖然這些鏡片 目前仍被使用,但由於其初戴時之舒適度較差,故不適 合用於所有的病人。此領域爾後發展出以水凝膠為基質 之軟質隱形眼鏡,時下倍受歡迎,進一步的研究導致發 展出矽酮水凝膠鏡片,此種矽酮水凝膠鏡片已知具有較 南的氧滲透性,而且戴用時常較製自硬質材料之隱形眼 鏡舒適,然而矽酮水凝膠鏡片並非沒有難題。 矽酮水凝膠鏡片於其製造期間可能會有摺痕或被 物理地扭曲,當鏡片被消毒時可見到此難題。典型地, 矽酮水凝膠鏡片被包裝於包含眼用包裝溶液之個別容 器中,並加熱至溫度約10(rc或更高,於此程序中矽酮 水凝膠得知會黏附於其包裝材料或者被扭曲。對於此 題之一種解決方法為添加某些界面活性劑至眼 溶液,另外-種解決方法為修飾Μ之㈣表面,雖铁 200817755 =存在廷些解決方法,較佳者為擴大此難題解決方法之 範圍’本發明軒於矽酮水凝膠鏡片製造期間之變形難題 提供另外一種解決方法。 【發明内容】 圖之簡述 圖1為一於水平方位之眼部鏡片包裝。 發明詳述 本發明係包括一種抑制於矽酮水凝膠眼部鏡片消 毒期間變形之方法,其實質上包括,或包括:於一包裝 中消毒該矽酮水凝膠眼部鏡片,其中該包裝被安放於一 實質上水平的位置。 於此所使用之,,矽酮水凝膠眼部鏡片,,係指置入或 於眼上之眼部裝置,這些裝置可提供光學矯正或作為美 容之用。鏡片一詞包括,但非限制性:軟質隱形眼鏡、 眼内鏡片、覆蓋鏡片、眼睛嵌入物、及光學嵌入物。依 本發明之較佳鏡片為矽酮水凝膠鏡片,敘述於:美國專 利 5,710,302、WO 9421698、EP 406161、JP 2000016905、 美國專利5,998,498、美國專利申請案號〇9/;532,943、 美國專利6,087,415、美國專利5,760,100、美國專利 5,776,999、美國專利 5,789,461、美國專利 5,849,811、 及美國專利5,965,631,故將前述參考文獻之全文併入 本文供參考。較佳的鏡片包括,但非限制性,矽酮水凝 谬如:acquafilcon A、balafilcon A、lotrafilcon A、及如 於下者中製得之矽酮水凝膠:美國專利5,998,498、美國 200817755 專利申請案號09/532,943,為於2000年8月30日提出 申請之美國專利申請案號09/532,943之部份延續、美國 專利 6,087,415、美國專利 5,760,100、美國專利 5,776,999、美國專利 5,789,461、美國專利 5,849,811、 與美國專利5,965,631,最佳的矽酮水凝膠眼部鏡片為 acquafilcon A,故將這些專利以及所有其他揭示於本申 請案件之專利之全文,併入本文供參考。 於此所使用之消毒係指於殺滅微生物所需之溫度、 與時間下,加熱矽酮水凝膠眼部鏡片,較佳的溫度為高 於約100°C,及時間為多於約15分鐘。如前所討論, 矽酮水凝膠眼部鏡片係於眼用包裝溶液中進行消毒,依 本發明之眼用包裝溶液可為用於儲存隱形眼鏡之任何 以水為基質的溶液。典型的溶液包括,但非限制性:含 鹽溶液、其他的缓衝溶液、及去離子水,較佳的水溶液 為含鹽溶液,其包含鹽類,包括,但非限制性:氯化鈉、 硼酸鈉、磷酸鈉、磷酸氫鈉、二磷酸氫鈉、或這些之對 應鉀鹽。這些成份通常被併合以生成缓衝溶液,其包括 一種酸與其共軛鹼,故添加酸及鹼時僅引起相對較小的 pH變化。緩衝溶液可另外包括嗎啉代)乙烷磺酸 (MES)、氫氧化鈉、2,2_二(羥基曱基)-2,2’,2’’-腈基三乙 醇、正-三(羥基曱基)曱基-2-胺基乙烷磺酸、檸檬酸、 擰檬酸鈉、碳酸鈉、碳酸氫鈉、乙酸、乙酸鈉、伸乙基 二胺四乙酸、與類同物、及其組合物,較佳的溶液為一 種硼酸鹽缓衝或磷酸鹽緩衝的含鹽溶液。 7 200817755 “包裝”係指任何容器,其可被用於消毒矽酮水凝膠 眼部鏡片者,此類容器之實例揭示於下列出版物中:美 國專利 D435,966 S、4,691,820、5,467,868、5,704,468、 5,823,327、6,050,398,故將其全文併入本文供參考。 “水平’’係指包裝於消毒期間安放的位置,參見圖 1,包裝20之凸绫JJL的方位相對於桌面40之水平表面 為水平,於消毒期間,矽酮水凝膠眼部鏡片(未顯示)位 於碗狀物迎_中,其中矽酮水凝膠眼部鏡片之凸面鄰接 碗狀物Μ«之凹面(未顯示)。 【實施方式】 實例1 含有不同界面活性劑之溶液A 將etafilcon A水凝膠與acquafilcon A隱形眼鏡放 置於個別的聚丙烯隱形眼鏡包裝中,含鹽的包裝溶液被 加至每個包裝以覆蓋每只鏡片,並密封此包裝。半數的 包裝以垂直位置放置於一支架中,其他的半數以水平位 置放置於一支架中,這些包裝被加熱至121 °C維持約20 分鐘,將這些包裝冷卻及開啟,並以目視檢查鏡片。於 水平及垂直位置進行消毒之etafilcon A鏡片皆保持其 形狀,而無摺疊皺紋或其他的變形。於垂直方位進行消 毒之acquafilcon A鏡片包含摺痕及其他的變形,於水 平位置消毒之acquafilcon A鏡片則未包含此類變形。 8 200817755 【圖式簡單說明】 圖1為一於水平方位之眼部鏡片包裝。 【主要元件符號說明】 10凸緣 20包裝 30碗狀物 40桌面 9200817755 IX. INSTRUCTIONS: [RELATED APPLICATIONS] This application is a non-provisional application: US Patent Application No. 6〇/817,728, filed June 30, 2006, which is a temporary Patent application. TECHNICAL FIELD OF THE INVENTION The present invention relates to a method of reducing deformation during manufacture of an anthrone ketone hydrogel contact lens. [Prior Art] Contact lenses have been commercially used to improve vision since the 1950s. The first pair of contact lenses are made of hard materials. Although these lenses are still used today, they are less comfortable at first wear, so Not suitable for all patients. In this field, hydrogel-based soft contact lenses have been developed and are nowadays popular. Further research has led to the development of indolone hydrogel lenses, which are known to have a relatively southerous oxygen. It is permeable and is often more comfortable to wear than contact lenses made from hard materials. However, fluorenone hydrogel lenses are not without problems. Anthrone hydrogel lenses may be creased or physically distorted during their manufacture, which is seen when the lens is sterilized. Typically, the fluorenone hydrogel lenses are packaged in individual containers containing ophthalmic packaging solutions and heated to a temperature of about 10 (rc or higher), in which the fluorenone hydrogel is known to adhere to its packaging material. Or be distorted. One solution to this problem is to add some surfactant to the eye solution, and another solution is to modify the surface of the (4) surface. Although iron 200817755 = there are some solutions, it is better to expand this Scope of the Problem Solving Solution The present invention provides another solution to the deformation problem during the manufacture of the fluorenone hydrogel lens. [Summary of the Invention] Figure 1 is a package of an eye lens in a horizontal orientation. The invention includes a method of inhibiting deformation during sterilization of an anthrone hydrogel eye lens, which comprises, or comprises: disinfecting the indolone hydrogel eye lens in a package, wherein the package is placed In a substantially horizontal position. As used herein, an anthrone hydrogel eye lens refers to an eye device that is placed or placed on the eye. These devices provide optical correction. Or as a cosmetic use. The term lens includes, but is not limited to, soft contact lenses, intraocular lenses, cover lenses, eye inserts, and optical inserts. The preferred lens according to the present invention is an anthrone hydrogel lens. , described in U.S. Patent Nos. 5,710,302, WO 9 421 698, EP 406 161, JP 2000 016 905, U.S. Patent 5,998,498, U.S. Patent Application Serial No. 9/532,943, U.S. Patent No. 6,087,415, U.S. Patent 5,760,100, U.S. Patent 5,776,999, U.S. Patent 5,789,461, U.S. Patent No. 5,849,811, issued to U.S. Pat. U.S. Patent No. 5,998,498, U.S. Patent Application Serial No. 09/532,943, filed on Aug. Continuation, U.S. Patent 6,087,415, U.S. Patent 5,760,100, U.S. Patent 5,776,999, U.S. Patent 5,789,461, U.S. Patent 5, 849, 811, and U.S. Patent No. 5,965, 631, the entire entire disclosure of which is incorporated herein by reference. Disinfection refers to heating the fluorenone hydrogel eye lens at a temperature and time required to kill the microorganism, preferably at a temperature above about 100 ° C, and for a period of time greater than about 15 minutes. As discussed previously, the fluorenone hydrogel eye lens is sterilized in an ophthalmic packaging solution which can be any water-based solution for storing contact lenses. Typical solutions include, but are not limited to, salt-containing solutions, other buffer solutions, and deionized water. Preferred aqueous solutions are saline solutions containing salts including, but not limited to, sodium chloride, Sodium borate, sodium phosphate, sodium hydrogen phosphate, sodium hydrogen diphosphate, or the corresponding potassium salt of these. These ingredients are usually combined to form a buffer solution which includes an acid and its conjugate base, so that the addition of acid and base causes only a relatively small change in pH. The buffer solution may additionally include morpholino)ethanesulfonic acid (MES), sodium hydroxide, 2,2-di(hydroxyindenyl)-2,2',2''-nitrile triethanol, n-tri ( Hydroxymercapto)mercapto-2-aminoethanesulfonic acid, citric acid, sodium citrate, sodium carbonate, sodium hydrogencarbonate, acetic acid, sodium acetate, ethyldiaminetetraacetic acid, and the like, and A preferred solution of the composition is a borate buffered or phosphate buffered saline solution. 7 200817755 "Packaging" means any container that can be used to disinfect an indolone hydrogel eye lens. Examples of such containers are disclosed in the following publications: U.S. Patents D435,966 S, 4,691,820, 5,467,868 5, 704, 468, 5, 823, 327, 6, 050, 398, the entire disclosure of which is incorporated herein by reference. "Horizontal" refers to the location where the package is placed during sterilization. Referring to Figure 1, the orientation of the tongue JJL of the package 20 is horizontal relative to the horizontal surface of the tabletop 40. During sterilization, the fluorenone hydrogel eye lens (not Shown) in the bowl welcoming, wherein the convex surface of the fluorenone hydrogel eye lens is adjacent to the concave surface of the bowl Μ«. [Embodiment] Example 1 Solution A containing different surfactants etafilcon A hydrogel and acquafilcon A contact lenses are placed in individual polypropylene contact lens packages, and a salt-containing packaging solution is applied to each package to cover each lens and seal the package. Half of the package is placed in a vertical position. In one bracket, the other half are placed in a bracket in a horizontal position, and the packages are heated to 121 ° C for about 20 minutes, the packages are cooled and opened, and the lenses are visually inspected for disinfection in horizontal and vertical positions. The etafilcon A lenses retain their shape without folding wrinkles or other deformations. The acquafilcon A lenses that are sterilized in a vertical orientation contain creases and other deformations. The acquafilcon A lens disinfected in a horizontal position does not contain such deformation. 8 200817755 [Simple description of the drawing] Figure 1 shows a package of eye lenses in a horizontal orientation. [Main component symbol description] 10 flange 20 package 30 bowls 40 desktop 9

Claims (1)

200817755 十、申請專利範園: 1· 一種用於抑制於矽酮水凝膠眼部鏡片消毒期間變形 之方法,其包括:於一包裝中消毒該矽酮水凝膠眼部 鏡片,其中該包裝被安放於一實質上水平的位置。 2·根據申請專利_第丨項之方法,其中㈣水凝膠眼 部鏡片係選自群組包括如於下者中製得之矽酮水凝 膠:美國專利5,998,498、美國專利申請案號 〇9/532,943,為於2_年8月30日提出中請之美國 專利申請案號09/532,943之部份延續、美國專利 6,087,415、美國專利 5,760,1〇〇、美國專利 5 776,999、 美國專利5,789,461、美國專利5,849,811、及美國專 利 5,965,631。 ' 3·根據申請專利範圍第1項之方法,其中矽酮水凝膠眼 部鏡片係選自群組包括··叫时叫⑽A、balafile()n A、及 lotrafilcon A。 4. 根據申請專利範圍帛i項之方法,其中石夕酮水凝膠眼 部鏡片為 acquafilcon A。 5. 根據申請專利範圍第1項之方法,其中消毒係發生於 一溫度高於約100°C。 6. 根據申請專利範圍第1項之方法,其中消毒係發生於 一溫度高於約120°C。 ' 7. 根據申請專利範圍第丨項之方法,其中消毒係發生於 約10分鐘。 8·根據申請專利範圍第丨項之方法,其中消毒係發生於 200817755 約20分鐘。 9.根據申請專利範圍第1項之方法,其中消毒係發生於 約18至約20分鐘,於一溫度約118°C至約120t:。 10.根據申請專利範圍第9項之方法,其中矽酮水凝膠眼 部鏡片為 acquafilcon A。 11200817755 X. Patent application garden: 1. A method for inhibiting deformation during sterilization of an anthraquinone hydrogel eye lens, comprising: disinfecting the indolone hydrogel eye lens in a package, wherein the packaging It is placed in a substantially horizontal position. 2. The method of claim 3, wherein the (4) hydrogel eye lens is selected from the group consisting of an anthrone hydrogel prepared as in the following: U.S. Patent No. 5,998,498, U.S. Patent Application Serial No. 9/532,943, the continuation of U.S. Patent Application Serial No. 09/532,943, issued on Aug. 30, the entire disclosure of U.S. Patent No. 6,087,415, U.S. Patent 5,760,1, U.S. Patent 5,776,999, U.S. Patent 5,789,461. U.S. Patent 5,849,811, and U.S. Patent 5,965,631. 3. The method of claim 1, wherein the fluorenone hydrogel eye lens is selected from the group consisting of: (10) A, balafile () n A, and lotrafilcon A. 4. According to the method of claim 帛i, wherein the oleanyl hydrogel eye lens is acquafilcon A. 5. The method of claim 1, wherein the disinfecting occurs at a temperature above about 100 °C. 6. The method of claim 1, wherein the disinfecting occurs at a temperature above about 120 °C. 7. The method of claim </ RTI> wherein the disinfection occurs in about 10 minutes. 8. The method according to the scope of the patent application, wherein the disinfection occurs at about 200817755 for about 20 minutes. 9. The method of claim 1, wherein the disinfecting occurs from about 18 to about 20 minutes at a temperature of from about 118 ° C to about 120 t:. 10. The method of claim 9, wherein the fluorenone hydrogel eye lens is acquafilcon A. 11
TW096123618A 2006-06-30 2007-06-29 Methods of inhibiting the distortions that occur during the production of silicone hydrogel ophthalmic lenses TW200817755A (en)

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US4873424A (en) * 1988-07-19 1989-10-10 Ryder International Corporation Wall plug lens disinfector
KR20040097140A (en) * 2002-03-01 2004-11-17 존슨 앤드 존슨 비젼 케어, 인코포레이티드 In-line steam sterilizer

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