TWI444408B - Wettable silicone hydrogel contact lenses and related compositions and methods - Google Patents

Wettable silicone hydrogel contact lenses and related compositions and methods Download PDF

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TWI444408B
TWI444408B TW96121908A TW96121908A TWI444408B TW I444408 B TWI444408 B TW I444408B TW 96121908 A TW96121908 A TW 96121908A TW 96121908 A TW96121908 A TW 96121908A TW I444408 B TWI444408 B TW I444408B
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contact lens
hydrogel contact
lens
precursor composition
polymerizable
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TW200815501A (en
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Ye Hong
Charlie Chen
Nick Manesis
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Coopervision Int Holding Co Lp
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Description

可溼性矽氧水凝膠隱形眼鏡及相關組合物及方法Wettable hydrogel hydrogel contact lens and related compositions and methods 相關申請案之前後參照Refer to the relevant application before and after

本申請案係主張2006年6月15日提出申請之美國專利申請案號60/804,911；2007年1月31日提出申請之美國專利申請案號60/887,513；及2007年3月13日提出申請之美國專利申請案號60/894,609之權益，其全部內容均據此併於本文供參考。U.S. Patent Application Serial No. 60/804,911, filed on Jun. 15, 2006, filed on Jun. The benefit of U.S. Patent Application Serial No. 60/894,609, the entire disclosure of which is incorporated herein by reference.

本發明係針對矽氧水凝膠眼用裝置及相關組合物與方法。更特定言之，本發明係關於可潤溼經模製之矽氧水凝膠隱形眼鏡，及相關組合物與方法。The present invention is directed to a silicone hydrogel ophthalmic device and related compositions and methods. More particularly, the present invention relates to wettable molded oxygenated hydrogel contact lenses, and related compositions and methods.

矽氧水凝膠隱形眼鏡已變得普及，此係由於隱形眼鏡配戴者配戴此種鏡片在其眼睛上，相較於非矽氧水凝膠隱形眼鏡，歷經較長時間之能力所致。例如，依特定鏡片而定，矽氧水凝膠隱形眼鏡可針對每日配戴、每週配戴、每兩週配戴或每月配戴作配戴或開立。對鏡片配戴者，與矽氧水凝膠隱形眼鏡有關聯之利益，可至少部份歸因於隱形眼鏡之含矽聚合材料之親水性成份與疏水性質之組合。Hydroxyl hydrogel contact lenses have become popular because of the ability of contact lens wearers to wear such lenses on their eyes compared to non-oxygenated hydrogel contact lenses. . For example, depending on the particular lens, the oxygenated hydrogel contact lens can be worn or opened for daily wear, weekly wear, bi-weekly wear, or monthly wear. For lens wearers, the benefits associated with silicone hydrogel contact lenses can be attributed, at least in part, to the combination of hydrophilic and hydrophobic properties of the bismuth-containing polymeric materials of contact lenses.

非矽氧水凝膠隱形眼鏡，譬如甲基丙烯酸2－羥乙酯(HEMA)為基料之水凝膠隱形眼鏡，係經常在非極性樹脂隱形眼鏡模中製成，例如製自聚烯烴為基料樹脂之隱形眼鏡模。換言之，對於非矽氧水凝膠隱形眼鏡之鏡片先質組合物，係在非極性樹脂隱形眼鏡模中聚合，以製造HEMA為基料之聚合體或經聚合之鏡片產物。由於HEMA為基料隱形眼鏡之聚合體成份之親水性性質，故HEMA為基料之鏡片為眼睛上可相容，且具有眼睛上可接受之表面可潤溼性，儘管即使是使用非極性樹脂模具製成亦然。Non-oxygenated hydrogel contact lenses, such as 2-hydroxyethyl methacrylate (HEMA) based hydrogel contact lenses, are often made in non-polar resin contact lens molds, for example, from polyolefins. Contact lens mold for base resin. In other words, a lens precursor composition for a non-oxygenated hydrogel contact lens is polymerized in a non-polar resin contact lens mold to produce a HEMA-based polymer or a polymerized lens product. Because HEMA is the hydrophilic nature of the polymeric components of base contact lenses, HEMA-based lenses are eye-compatible and have acceptable eye wettability, even with non-polar resins. The mold is also made.

但是，得自非極性樹脂模具之現行矽氧水凝膠隱形眼鏡係具有疏水性鏡片表面。換言之，此種矽氧水凝膠隱形眼鏡之表面具有低可潤溼性，因此不為眼睛上可相容或眼睛上可接受。例如，此種矽氧水凝膠隱形眼鏡可與增加之脂質沉積、蛋白質沉積及對鏡片配戴者之刺激有關聯。表面處理或表面改質已被使用於此種矽氧水凝膠隱形眼鏡或鏡片產物之表面上，以增加鏡片表面之親水性與可潤溼性。矽氧水凝膠鏡片之表面處理之實例，係包括塗覆鏡片之表面，使化學物種吸附至鏡片之表面上，改變鏡片表面上化學基團之化學性質或靜電荷。表面處理已被描述，其包括使用電漿氣體以塗覆經聚合鏡片之表面，或在形成經聚合鏡片之前，於隱形眼鏡模具表面上使用電漿氣體以處理模具。與未使用表面處理或改質之製造方法比較，隱形眼鏡之表面處理係需要較多手段與時間，以製造隱形眼鏡。此外，當鏡片正被鏡片配戴者配戴及/或觸摸時，經表面處理之矽氧水凝膠隱形眼鏡可顯示降低之表面可潤溼性。例如，經表面處理鏡片之增加觸摸可能會造成親水性表面降解或磨損。However, current oxygenated hydrogel contact lenses from non-polar resin molds have hydrophobic lens surfaces. In other words, the surface of such a silicone hydrogel contact lens has low wettability and is therefore not compatible or ocularly acceptable on the eye. For example, such silicone hydrogel contact lenses can be associated with increased lipid deposition, protein deposition, and irritation to lens wearers. Surface treatment or surface modification has been used on the surface of such hydroxyl hydrogel contact lenses or lens products to increase the hydrophilicity and wettability of the lens surface. An example of surface treatment of a helium-hydrogel lens includes coating the surface of the lens to adsorb a chemical species onto the surface of the lens, altering the chemical nature or electrostatic charge of the chemical groups on the surface of the lens. Surface treatment has been described which involves the use of a plasma gas to coat the surface of the polymerized lens or the use of a plasma gas on the surface of the contact lens mold to process the mold prior to forming the polymerized lens. The surface treatment of contact lenses requires more means and time to manufacture contact lenses than manufacturing methods that do not use surface treatment or modification. In addition, surface treated hydroxyl hydrogel contact lenses can exhibit reduced surface wettability when the lens is being worn and/or touched by the lens wearer. For example, an increased touch of a surface treated lens may result in degradation or wear of the hydrophilic surface.

增加矽氧水凝膠鏡片之可潤溼性與眼睛相容性之一種替代途徑，係為於包含聚合體潤溼劑譬如聚乙烯基四氫吡咯酮(PVP)之不同組合物存在下，使矽氧水凝膠隱形眼鏡先質組合物聚合。可明瞭此等類型之鏡片係為具有聚合體內部潤溼劑之矽氧水凝膠隱形眼鏡。此外，可進一步明瞭的是，此等鏡片包含互穿聚合體網狀組織(IPN)，其含有高分子量聚合體，譬如PVP。正如一般熟諳此藝者所明瞭，IPN係指兩種或多種不同聚合體之組合，呈網狀組織形式，其中至少一種係於另一種存在下經合成及/或交聯，而在彼等之間無任何共價鍵。IPN可由形成兩個各別網狀組織之兩種鏈所組成，但呈並列或互穿方式。IPN之實例包括連續IPN、同時IPN、半－IPN及均－IPN。雖然包含聚合體潤溼劑之IPN之矽氧水凝膠隱形眼鏡會避免與表面處理有關聯之問題，但此等鏡片可能不會長時期保持其眼睛相容性，包括表面可潤溼性。例如，內部潤溼劑，由於其並未共價結合至其他形成經聚合鏡片之成份，故當被鏡片配戴者配戴時，可自鏡片濾出，於是隨著時間導致對鏡片配戴者降低之表面可潤溼性與增加之不舒適性。An alternative way to increase the wettability and eye compatibility of a hydrogel gel lens is in the presence of a different composition comprising a polymeric wetting agent such as polyvinyltetrahydropyrrolidone (PVP). The hydroxyl hydrogel contact lens precursor composition is polymerized. It is understood that these types of lenses are silicone hydrogel contact lenses having a polymeric internal wetting agent. Furthermore, it will be further appreciated that such lenses comprise an interpenetrating polymer network (IPN) containing a high molecular weight polymer such as PVP. As is well known to those skilled in the art, IPN refers to a combination of two or more different polymers in the form of a network of tissues, at least one of which is synthesized and/or crosslinked in another form, and in which There are no covalent bonds between them. The IPN can be composed of two chains forming two separate network structures, but in a side-by-side or interpenetrating manner. Examples of IPNs include continuous IPN, simultaneous IPN, semi-IPN, and average-IPN. While oxygenated hydrogel contact lenses containing IPN of polymeric wetting agents may avoid problems associated with surface treatment, such lenses may not retain their eye compatibility for extended periods of time, including surface wettability. For example, internal wetting agents, because they are not covalently bonded to other components that form a polymerized lens, can be filtered from the lens when worn by the lens wearer, thus causing the lens wearer over time Reduced surface wettability and increased discomfort.

作為如上文所述之表面處理或使用聚合體潤溼劑IPN之一種替代方式，已發現具有眼睛上可接受表面可潤溼性之矽氧水凝膠隱形眼鏡，可使用極性樹脂模具代替非極性樹脂模具製造。例如，在乙烯－乙烯醇或聚乙烯醇為基料之模具中形成之矽氧水凝膠隱形眼鏡，具有所要之表面可潤溼性。對於不含聚合體潤溼劑之IPN之未經表面處理矽氧水凝膠隱形眼鏡，用於製造隱形眼鏡模具之可用極性樹脂之一項實例，係為乙烯－乙烯醇共聚物之樹脂，譬如以商標名SOARLITETM ，由Nippon Gohsei公司銷售之乙烯－乙烯醇共聚物樹脂。除了其極性以外，SOARLITETM 據稱具有下列特徵：極端高機械強度、抗靜電性質、當使用於模製方法中時之低收縮性、優越油與溶劑抵抗性、小熱膨脹係數及良好耐磨性。As an alternative to the surface treatment or the use of the polymeric wetting agent IPN as described above, it has been found that silicone hydrogel contact lenses with acceptable surface wettability on the eye can be replaced with polar resin molds instead of non-polar Resin mold manufacturing. For example, a hydroxamed hydrogel contact lens formed in a mold comprising ethylene-vinyl alcohol or polyvinyl alcohol as a base material has a desired surface wettability. An example of an available polar resin for making a contact lens mold for an IPN-free, surface-treated, oxygen-free hydrogel contact lens that does not contain a polymeric wetting agent, such as an ethylene-vinyl alcohol copolymer resin, such as An ethylene-vinyl alcohol copolymer resin sold under the trade name SOARLITE (TM) by Nippon Gohsei. In addition to its polarity, SOARLITE TM said to have the following characteristics: extremely high mechanical strength, antistatic properties, low contractility when used in the time of the molding process, excellent oil and solvent resistance, small coefficient of thermal expansion, and good abrasion resistance .

雖然SOARLITETM 為基料之模具對於製造眼睛上可相容矽氧水凝膠隱形眼鏡提供所要之替代方式，而無需使用表面處理或聚合體潤溼劑IPN，但SOARLITETM 模具係比非極性樹脂模具，譬如聚丙烯模具，較不具可變形性或可撓性，且與非極性樹脂模具比較，相對較難以進行工作。Although SOARLITE TM of a mold base material for the manufacture of eye compatible silicone hydrogel contact lens to provide the desired alternative embodiment, the surface treatment or without the use of wetting agent an IPN polymer, but SOARLITE TM than non-polar resin based molds Molds, such as polypropylene molds, are less deformable or flexible and are relatively difficult to work with than non-polar resin molds.

可相關於製造隱形眼鏡譬如矽氧水凝膠隱形眼鏡之文件實例，係包括美國專利案號4,121,896；4,495,313；4,565,348；4,640,489；4,889,664；4,985,186；5,039,459；5,080,839；5,094,609；5,260,000；5,607,518；5,760,100；5,850,107；5,935,492；6,099,852；6,367,929；6,822,016；6,867,245；6,869,549；6,939,487；與美國專利公報案號20030125498；20050154080；及20050191335。Examples of documents relating to the manufacture of contact lenses, such as silicone hydrogel contact lenses, include U.S. Patent Nos. 4,121,896; 4,495,313; 4,565,348; 4,640,489; 4,889,664; 4,985,186; 5,039,459; 5,080,839; 5,094,609; 5,260,000; 5,607,518; 5,760,100; 5,850,107; 5,935,492; 6,099,852; 6,367,929; 6,822,016; 6,867,245; 6,869,549; 6,939,487; and U.S. Patent Publication Nos. 20030125498; 20050154080; and 20050191335.

鑒於上述，與得自SOARLITETM 隱形眼鏡模之矽氧水凝膠隱形眼鏡比較，仍然需要可更容易地製造之眼睛上可相容矽氧水凝膠隱形眼鏡，而不需要表面處理或使用聚合體潤溼劑IPN，包括PVP IPN，以達成眼睛相容性。一項現存問題係關於自非極性樹脂或聚烯烴為基料之隱形眼鏡模構件，獲得眼睛上可相容矽氧水凝膠隱形眼鏡，譬如具有眼睛上可相容表面可潤溼性之矽氧水凝膠隱形眼鏡，而無需使用表面處理或聚合體潤溼劑IPN。In view of the above, the upper silicon SOARLITE TM available from contact lens molds of the comparative hydrogel contact lenses still need to be more easily manufactured of ophthalmically compatible silicone hydrogel contact lenses without the need for surface treatment or use of polymeric Body wetting agent IPN, including PVP IPN, for eye compatibility. An existing problem relates to contact lens mold members that are based on non-polar resins or polyolefins, and to obtain compatible oxygenated hydrogel contact lenses on the eye, such as having wettability on the compatible surface of the eye. Oxygen hydrogel contact lenses without the use of a surface treatment or polymeric wetting agent IPN.

本發明隱形眼鏡、鏡片產物、組合物及方法係企圖尋求解決與現行矽氧水凝膠隱形眼鏡有關聯之需求與問題。已令人驚訝地發現，眼睛上可相容矽氧水凝膠隱形眼鏡可藉由提供相對較大量之可移除物質於經萃取與水合之萃取前經聚合之矽氧水凝膠隱形眼鏡產物中而獲得，以造成矽氧水凝膠隱形眼鏡。具有可移除成份之萃取前經聚合之矽氧水凝膠鏡片產物，該可移除成份為一或多種可移除物質，包括可萃取物質等，意即至少10%(w/w)萃取前經聚合之矽氧水凝膠鏡片產物之重量，可被萃取與水合，以形成具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡，如上文所述。本發明鏡片具有氧透氣性、表面可潤溼性、模數、水含量、離子通量及設計，其允許本發明鏡片被舒適地配戴於病患之眼睛上，歷經長時期，譬如歷經至少一天，至少一週，至少兩週，或約一個月，而不需要自眼睛移除鏡片。The contact lenses, lens products, compositions and methods of the present invention seek to address the needs and problems associated with current silicone hydrogel contact lenses. It has been surprisingly found that an on-eye compatible oxygenated hydrogel contact lens can be produced by providing a relatively large amount of removable material prior to extraction and hydration of the polymerized hydrogel contact lens product. Obtained in order to cause a helium oxygen hydrogel contact lens. A pre-extracted polymerized hydrogel lens product having a removable component, the removable component being one or more removable materials, including extractable materials, etc., meaning at least 10% (w/w) extraction The weight of the previously polymerized oxygenated hydrogel lens product can be extracted and hydrated to form a hydroxyl hydrogel contact lens having an ocularly acceptable surface wettability, as described above. The lenses of the present invention have oxygen permeability, surface wettability, modulus, water content, ion flux, and design that allow the lenses of the present invention to be comfortably worn on the patient's eyes over a long period of time, such as at least One day, at least one week, at least two weeks, or about one month, without the need to remove the lens from the eye.

本發明矽氧水凝膠隱形眼鏡包括鏡片物體，其具有具眼睛上可接受可潤溼性之表面，譬如前表面與後表面。本發明矽氧水凝膠隱形眼鏡之表面可潤溼性係與存在於萃取前經聚合之矽氧水凝膠隱形眼鏡產物中之可移除成份量有關。本發明矽氧水凝膠隱形眼鏡之鏡片物體不需要表面處理或聚合體潤溼劑之IPN，以獲得眼睛上可接受之表面可潤溼性。本發明矽氧水凝膠隱形眼鏡不需要使用極性樹脂模具，譬如SOARLITETM 為基料之模具，以獲得眼睛上可接受之表面可潤溼性。此外，本發明鏡片於熟化程序或脫除鏡片程序後，不需要進一步機製。但是，可明瞭的是，若需要，則本發明之某些具體實施例可視情況包括表面處理、聚合體潤溼劑IPN及/或使用極性樹脂模具或熟化後機製或脫除鏡片後機製。The oxygenated hydrogel contact lenses of the present invention comprise a lens object having a surface that is hygroscopically acceptable to the eye, such as a front surface and a back surface. The surface wettability of the oxygenated hydrogel contact lenses of the present invention is related to the amount of removable components present in the polymerized hydrogel contact lens product prior to extraction. The lens objects of the oxygenated hydrogel contact lenses of the present invention do not require surface treatment or IPN of the polymeric wetting agent to achieve acceptable eye wettability on the eye. The oxygenated hydrogel contact lenses of the present invention do not require the use of a polar resin mold, such as a SOARLITE (TM) based mold, to achieve acceptable eye wettability on the eye. In addition, the lens of the present invention does not require further mechanisms after the curing process or the lens removal procedure. However, it will be appreciated that certain embodiments of the invention may optionally include surface treatment, polymeric wetting agent IPN, and/or use of a polar resin mold or post-maturing mechanism or post-lens removal mechanism, if desired.

本發明之一方面係關於矽氧水凝膠隱形眼鏡。本發明矽氧水凝膠隱形眼鏡包括具有眼睛上可接受表面可潤溼性之鏡片物體。在某些具體實施例中，可明瞭鏡片物體包含矽氧水凝膠材料，且明瞭係具有乾重不大於萃取前鏡片物體乾重之90%。可明瞭乾重係為未含有顯著量之水或任何量之水之鏡片物體重量。在某些其他具體實施例中，可明瞭鏡片物體係為得自萃取前經聚合之矽氧水凝膠隱形眼鏡產物之鏡片物體，其具有可移除成份之量為至少10%(w/w)。換言之，萃取前經聚合之矽氧水凝膠隱形眼鏡產物係具有至少10%(w/w)之可移除成份含量。在其他具體實施例中，可明瞭鏡片物體係為以下述方式製成之鏡片物體，自萃取前經聚合之矽氧水凝膠隱形眼鏡產物萃取可萃取之成份，以製造經萃取聚合之矽氧水凝膠隱形眼鏡產物，並水合此經萃取聚合之矽氧水凝膠隱形眼鏡產物，以製造具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡。萃取前經聚合之矽氧水凝膠隱形眼鏡產物係具有可萃取成份含量為萃取前鏡片物體之至少10%(w/w)。One aspect of the invention relates to a helium oxygen hydrogel contact lens. The oxygenated hydrogel contact lenses of the present invention comprise lens objects having acceptable surface wettability on the eye. In some embodiments, it will be appreciated that the lens object comprises a helium oxygen hydrogel material and that the dry weight is no greater than 90% of the dry weight of the lens object prior to extraction. It is clear that the dry weight is the weight of the lens object that does not contain significant amounts of water or any amount of water. In certain other embodiments, it will be appreciated that the lens system is a lens object obtained from a pre-extracted polymerized hydrogel contact lens product having a removable component in an amount of at least 10% (w/w) ). In other words, the polymerized hydroxyl hydrogel contact lens product prior to extraction has a removable component content of at least 10% (w/w). In other embodiments, it is understood that the lens system is a lens object produced in the following manner, and the extractable component is extracted from the polymerized hydrogel contact lens product prior to extraction to produce an extracted polymerized oxygen. The hydrogel contact lens product, and the extracted polymerized hydroxyl hydrogel contact lens product, is hydrated to produce a silicone hydrogel contact lens having an ocularly acceptable surface wettability. The polymerized hydroxyl hydrogel contact lens product prior to extraction has an extractable component content of at least 10% (w/w) of the pre-extracted lens object.

在某些具體實施例中，具有可移除成份含量為至少10%(w/w)之萃取前經聚合之矽氧水凝膠隱形眼鏡產物，係實質上或完全不含非反應性添加劑，譬如稀釋劑等。例如，此種萃取前之鏡片產物可得自不含稀釋劑、相容劑或其他非反應性添加劑之可聚合組合物。當於本文中使用時，不含稀釋劑、相容劑或其他非反應性添加劑之可聚合組合物可被稱為"總體配方"或"總體組合物"。總體配方不包含非反應性添加劑，且能夠形成本發明萃取前經聚合之矽氧水凝膠隱形眼鏡產物，具有可萃取成份含量為萃取前鏡片物體之至少10%(w/w)。In certain embodiments, the pre-extracted polymerized hydroxyl hydrogel contact lens product having a removable component content of at least 10% (w/w) is substantially or completely free of non-reactive additives, Such as thinner and the like. For example, such pre-extracted lens products can be obtained from polymerizable compositions that are free of diluents, compatibilizers, or other non-reactive additives. As used herein, a polymerizable composition that is free of diluents, compatibilizers, or other non-reactive additives can be referred to as a "total formulation" or "total composition." The overall formulation does not comprise a non-reactive additive and is capable of forming the pre-extracted polymerized hydroxyl hydrogel contact lens product of the present invention having an extractable ingredient content of at least 10% (w/w) of the pre-extracted lens object.

與得自總體配方之鏡片產物比較，其他配方或可聚合組合物可包含一或多種添加劑，於是造成又較大量之可萃取成份存在於萃取前經聚合之鏡片產物中。例如，當得自總體配方之萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有可萃取成份含量為15%時，可明瞭得自相同配方並以15%(w/w)之量添加稀釋劑之第二種萃取前經聚合之矽氧水凝膠隱形眼鏡產物，係具有可萃取成份含量為30%(w/w)。於萃取與水合程序後，得自萃取前鏡片產物之矽氧水凝膠隱形眼鏡之乾重，係為萃取前鏡片產物乾重之70%。Other formulations or polymerizable compositions may contain one or more additives as compared to lens products derived from the overall formulation, thereby causing a greater amount of extractable components to be present in the polymerized lens product prior to extraction. For example, when the polymerized hydroxyl hydrogel contact lens product obtained from the overall formulation has an extractable ingredient content of 15%, it can be understood from the same formulation and diluted in 15% (w/w). The second pre-extracted polymerized hydrothermal hydrogel contact lens product has an extractable component content of 30% (w/w). After the extraction and hydration procedures, the dry weight of the oxygenated hydrogel contact lenses obtained from the pre-extracted lens product is 70% of the dry weight of the lens product prior to extraction.

本發明之另一方面係關於萃取前經聚合之矽氧水凝膠隱形眼鏡產物。可明瞭此種鏡片產物係為例如在模具之模穴中，製自熟化程序或聚合程序，且尚未進行萃取程序，或未曾與萃取組合物接觸之產物。在某些具體實施例中，隱形眼鏡產物係包括萃取前之物體構件，其具有乾重至少10%大於使該物體構件接受萃取程序以形成經萃取聚合之矽氧水凝膠隱形眼鏡產物後之物體構件乾重。例如，萃取前之物體構件可包含可萃取成份含量為萃取前物體構件之至少10%(w/w)。在進一步具體實施例中，可萃取成份含量係大於萃取前物體構件之15%(w/w)，且小於萃取前物體構件之80%(w/w)。在某些具體實施例中，可萃取成份含量係大於萃取前物體構件之20%(w/w)，且小於萃取前物體構件之75%(w/w)。本發明萃取前經聚合之矽氧水凝膠隱形眼鏡產物之萃取前物體構件，可包含一或多種可移除添加劑，譬如可在萃取程序期間被移除之添加劑。例如，物體構件可包含一或多種相容劑、脫模助劑、脫除鏡片助劑、可潤溼性增強劑及離子通量降低劑。可明瞭可移除添加劑係為非反應性添加劑，或可明瞭係為在萃取程序期間，可自經聚合矽氧水凝膠隱形眼鏡產物移除之反應性添加劑。Another aspect of the invention relates to a hydrogenated hydrogel contact lens product that is polymerized prior to extraction. It will be appreciated that such lens products are, for example, in the mold cavity of the mold, from the ripening procedure or the polymerization procedure, and have not been subjected to an extraction procedure, or a product that has not been contacted with the extraction composition. In some embodiments, the contact lens product comprises an object member prior to extraction having a dry weight of at least 10% greater than after the object member is subjected to an extraction procedure to form an extracted polymeric hydrogel contact lens product. The object member is dry weight. For example, the object member prior to extraction may comprise at least 10% (w/w) of the extractable component content of the pre-extracted object member. In further embodiments, the extractable ingredient content is greater than 15% (w/w) of the pre-extracted object member and less than 80% (w/w) of the pre-extracted object member. In some embodiments, the extractable ingredient content is greater than 20% (w/w) of the pre-extracted object member and less than 75% (w/w) of the pre-extracted object member. The pre-extracted object member of the pre-extracted polymerized hydroxyl hydrogel contact lens product of the present invention may comprise one or more removable additives, such as additives that may be removed during the extraction procedure. For example, the article member can comprise one or more compatibilizers, release aids, lens removal aids, wettability enhancers, and ion flux reducers. It will be appreciated that the removable additive is a non-reactive additive or that it is a reactive additive that can be removed from the polymerized hydrogel hydrogel contact lens product during the extraction procedure.

本發明之另一方面係關於可聚合矽氧水凝膠隱形眼鏡先質組合物。本發明可聚合矽氧水凝膠隱形眼鏡先質組合物係包含形成鏡片之成份，譬如單體性物質，及一或多種選用添加劑，如本文中所述，其係形成具有實質量可移除成份之經聚合矽氧水凝膠隱形眼鏡產物。在某些具體實施例中，可聚合矽氧水凝膠隱形眼鏡先質組合物係包含可聚合之含矽成份與可聚合之非含矽成份。該兩種成份係被合併為可聚合矽氧水凝膠隱形眼鏡先質組合物。此先質組合物之一部份可從製自該先質組合物之經聚合矽氧水凝膠隱形眼鏡產物移除。該部份係以萃取前經聚合之矽氧水凝膠隱形眼鏡產物之至少10%(w/w)之量存在。在某些具體實施例中，先質組合物包含具有第一個反應性比之第一種單體，與具有小於第一個反應性比之第二個反應性比之第二種單體。正如一般熟諳此藝者所明瞭，反應性比可被定義為添加其自有單體之各傳播物種之反應速率常數對其添加其他單體之速率常數之比例。此種組合物亦可包含具有反應性比類似第一個反應性比之交聯劑。在某些具體實施例中，鏡片先質組合物可包含一或多種可移除添加劑。例如，鏡片先質組合物之具體實施例可包含可移除之一或多種相容劑、脫模助劑、脫除鏡片助劑、可潤溼性增強劑及離子通量降低劑。Another aspect of the invention pertains to a polymerizable silicone hydrogel contact lens precursor composition. The polymerizable silicone hydrogel contact lens precursor composition comprises a lens forming component, such as a monomeric material, and one or more optional additives, as described herein, which are formed to have a mass removable A polymeric oxygenated hydrogel contact lens product of the composition. In certain embodiments, the polymerizable silicone hydrogel contact lens precursor composition comprises a polymerizable rhodium containing component and a polymerizable non-quinone containing component. The two components are combined into a polymerizable silicone hydrogel contact lens precursor composition. A portion of the precursor composition can be removed from the polymerized hydrogel contact lens product prepared from the precursor composition. This portion is present in an amount of at least 10% (w/w) of the polymerized hydroxyl hydrogel contact lens product prior to extraction. In certain embodiments, the precursor composition comprises a first monomer having a first reactivity ratio and a second monomer having a second reactivity ratio less than the first reactivity ratio. As is well known to those skilled in the art, the reactivity ratio can be defined as the ratio of the rate constant of the various propagating species to which their own monomers are added to the rate constant for which other monomers are added. Such compositions may also comprise a crosslinker having a reactivity comparable to that of the first reactivity. In certain embodiments, the lens precursor composition can comprise one or more removable additives. For example, specific embodiments of the lens precursor composition can include one or more compatibilizers, release aids, lens release aids, wettability enhancers, and ion flux reducers.

本發明之又另一方面係關於製造眼睛上可相容矽氧水凝膠隱形眼鏡之方法。在某些具體實施例中，本發明方法係包括形成一種鏡片物體，其包含矽氧水凝膠材料，且具有眼睛上可接受之表面可潤溼性，及乾重不大於萃取前鏡片物體乾重之90%。方法亦可包括自萃取前經聚合之矽氧水凝膠隱形眼鏡產物萃取可萃取之成份，其中可萃取成份含量係為萃取前經聚合之矽氧水凝膠隱形眼鏡產物之至少10%(w/w)。方法亦可包括形成可聚合矽氧水凝膠隱形眼鏡先質組合物，其可用於本發明萃取前矽氧水凝膠隱形眼鏡產物與本發明矽氧水凝膠隱形眼鏡之製造。Yet another aspect of the invention relates to a method of making a compatible oxygenated hydrogel contact lens on the eye. In certain embodiments, the method of the present invention comprises forming a lens object comprising a helium oxygen hydrogel material having an ocularly acceptable surface wettability and a dry weight no greater than the dry weight of the lens prior to extraction Weighing 90%. The method may further comprise extracting the extractable component from the polymerized hydroxyl hydrogel contact lens product prior to extraction, wherein the extractable component content is at least 10% of the polymerized hydroxyl hydrogel contact lens product before extraction (w) /w). The method can also include forming a polymerizable silicone hydrogel contact lens precursor composition useful in the manufacture of the pre-extracted oxygenated hydrogel contact lens product of the present invention and the inventive oxygenated hydrogel contact lens.

本發明鏡片、鏡片產物、組合物及方法之其他具體實施例,將自下文說明、附圖、實例及請求項而明瞭。正如可自前文與下文說明所明瞭者，本文中所述之每一個與各特徵，及兩個或多個此種特徵之每一個與各組合，係被包含在本發明之範圍內，其條件是被包含在此種組合中之特徵不會相互地不一致。此外，任何特徵或特徵之組合可特別地被排除在本發明之任何具體實施例之外。本發明之其他方面與優點係敘述於下文說明與請求項中，特別是當搭配隨文所附之實例與附圖一起考量時。Other embodiments of the lenses, lens products, compositions and methods of the present invention will be apparent from the description, drawings, examples and claims. Each and every feature described herein, and each and every combination of two or more such features are included within the scope of the invention, as the invention may be. Features that are included in such a combination are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded from any particular embodiment of the invention. The other aspects and advantages of the invention are set forth in the description which follows and the claims, particularly when considered in conjunction with the accompanying drawings.

詳細說明Detailed description

圖1係說明一種製造矽氧水凝膠隱形眼鏡之方法。所示之方法為一種鑄造模製矽氧水凝膠隱形眼鏡之方法。經鑄造模製之隱形眼鏡可以適合安置於人們眼睛上之形式製造。例如，經鑄造模製之隱形眼鏡不需要任何進一步機製以改變鏡片，以製造適合用於眼睛上之鏡片。可明瞭使用鑄造模製程序，譬如圖1中所示之程序，所製成之本發明矽氧水凝膠隱形眼鏡，係為經鑄造模製之矽氧水凝膠隱形眼鏡。此外，可明瞭本發明鏡片若未使用進一步機製以改變鏡片設計，則係為經完全模製之矽氧水凝膠隱形眼鏡。Figure 1 illustrates a method of making a silicone hydrogel contact lens. The method shown is a method of casting a molded hydrogel contact lens. The cast molded contact lens can be manufactured in a form suitable for placement on the eye of a person. For example, cast molded contact lenses do not require any further mechanism to modify the lens to make a lens suitable for use on the eye. It is apparent that the helium oxygen hydrogel contact lens of the present invention produced by the casting molding process, as shown in Fig. 1, is a cast molded hydroxyl hydrogel contact lens. In addition, it will be apparent that the lens of the present invention is a fully molded oxygenated hydrogel contact lens if no further mechanism is used to modify the lens design.

於本文中使用之"水凝膠"一詞係指聚合體鏈之網狀組織或基質，其中一部份或全部可為水溶性，且其可含有高百分比之水。水凝膠係指聚合材料，包括隱形眼鏡，其係為水可膨潤性或被水膨潤。因此，水凝膠可為未經水合且為水可膨潤性，或水凝膠可為經部份水合且被水膨潤，或水凝膠可為經完全水合且被水膨潤。"矽氧水凝膠"或"矽氧水凝膠材料"術語係指包含矽成份或矽氧成份之水凝膠。例如，矽氧水凝膠係包括一或多種親水性含矽聚合體。矽氧水凝膠隱形眼鏡為包含矽氧水凝膠材料之隱形眼鏡，包括視覺矯正隱形眼鏡。As used herein, the term "hydrogel" refers to a network or matrix of polymeric chains, some or all of which may be water soluble, and which may contain a high percentage of water. Hydrogel refers to polymeric materials, including contact lenses, which are water swellable or swellable by water. Thus, the hydrogel may be unhydrated and water swellable, or the hydrogel may be partially hydrated and swelled by water, or the hydrogel may be fully hydrated and swelled by water. The term "hydrogenated hydrogel" or "oxygenated hydrogel material" means a hydrogel comprising a bismuth component or a bismuth component. For example, a hydroxyl hydrogel comprises one or more hydrophilic cerium-containing polymers. The helium oxygen hydrogel contact lens is a contact lens comprising a helium oxygen hydrogel material, including a vision correcting contact lens.

含矽氧之成份係為含有至少一個[－Si－O－Si]基團在呈單體、巨體或預聚合體中之成份。Si與所連接之O可存在於含矽氧成份中，其量為含矽氧成份之總分子量之大於20重量百分比，例如大於30重量百分比。可使用之含矽氧成份係包含可聚合官能基，譬如丙烯酸酯、甲基丙烯酸酯、丙烯醯胺、甲基丙烯醯胺、N－乙烯基內醯胺、N－乙烯基醯胺及苯乙烯基官能基。可使用於本發明鏡片中之一些含矽氧成份之實例，可參閱美國專利3,808,178；4,120,570；4,136,250；4,153,641；4,740,533；5,034,461及5,070,215，以及EP080539。The oxygen-containing component is a component containing at least one [-Si-O-Si] group in a monomer, a giant or a prepolymer. The Si and the attached O may be present in the oxygen-containing component in an amount greater than 20 weight percent, such as greater than 30 weight percent, of the total molecular weight of the oxygen-containing component. The antimony-containing component which can be used comprises a polymerizable functional group such as acrylate, methacrylate, acrylamide, methacrylamide, N-vinyl decylamine, N-vinyl decylamine and styrene. Base functional group. Examples of some of the oxygen-containing components that can be used in the lenses of the present invention are described in U.S. Patent Nos. 3,808,178; 4,120,570; 4,136,250; 4,153,641; 4,740,533; 5,034,461 and 5,070,215, and EP 080,539.

適當含矽氧單體之進一步實例為聚矽氧烷基烷基(甲基)丙烯酸系單體，包括但不限於甲基丙烯醯氧基丙基參(三甲基矽烷氧基)矽烷、五甲基二矽氧烷基甲基丙烯酸甲酯及甲基二(三甲基矽烷氧基)甲基丙烯醯氧基甲基矽烷。Further examples of suitable oxygen-containing monomers are polydecyloxyalkyl (meth)acrylic monomers including, but not limited to, methacryloxypropyl ginseng (trimethyldecyloxy) decane, five Methyl dioxoalkyl methyl methacrylate and methyl bis(trimethyl decyloxy) methacryloxymethyl decane.

含矽氧成份之一種可使用類別為聚(有機矽氧烷)預聚合體，譬如α,ω－雙甲基丙烯醯基氧基－丙基聚二甲基矽氧烷。另一項實例為mPDMS(單甲基丙烯醯氧基丙基封端之單－正－丁基封端之聚二甲基矽氧烷)。含矽氧成份之另一種可使用類別包括含矽氧乙烯基碳酸酯或乙烯基胺基甲酸酯單體，包括但不限於1,3－雙[4－(乙烯基氧基羰氧基)丁－1－基]四甲基矽氧烷3－(乙烯基氧基羰基硫基)丙基－[參(三甲基矽烷氧基矽烷]；3－[參(三甲基矽烷氧基)矽烷基]丙基烯丙基胺基甲酸酯；3－[參(三甲基矽烷氧基)矽烷基]丙基乙烯基胺基甲酸酯；三甲基矽烷基乙基乙烯基碳酸酯；及三甲基矽烷基甲基乙烯基碳酸酯。適當材料之實例包括以下式表示之作用劑： One type of oxygen-containing component can be used as a poly(organosiloxane) prepolymer such as α,ω-bismethylpropenyloxy-propylpolydimethyloxane. Another example is mPDMS (monomethacryloxypropyl terminated mono-n-butyl terminated polydimethyloxane). Another useful class of oxime-containing components includes oxime-containing vinyl carbonate or vinyl urethane monomers including, but not limited to, 1,3-bis[4-(vinyloxycarbonyloxy) But-1-yl]tetramethylphosphoxane 3-(vinyloxycarbonylthio)propyl-[para(trimethyldecyloxydecane]; 3-[paraxyl (trimethyldecyloxy)]矽alkyl]propylallyl carbazate; 3-[ cis (trimethyl decyloxy) decyl] propyl vinyl carbazate; trimethyl decyl ethyl vinyl carbonate And trimethyldecylmethyl vinyl carbonate. Examples of suitable materials include the agents represented by the following formula:

適當材料之另一項實例包括以下式表示之作用劑： Another example of a suitable material includes an agent represented by the following formula:

除了含矽成份以外，本發明鏡片、鏡片產物及組合物可包含一或多種親水性成份。親水性成份包括當與其餘反應性成份合併時，能夠對所形成之鏡片提供至少約20%，例如至少約25%水含量者。適當親水性成份可以約10至約60重量%間之量存在，以所有反應性成份之重量為基準。約15至約50重量%，例如在約20至約40重量%之間。可用以製造供本發明鏡片用之聚合體之親水性單體，係具有至少一個可聚合雙鍵與至少一個親水性官能基。可聚合雙鍵之實例包括丙烯酸、甲基丙烯酸、丙烯醯胺基、甲基丙烯醯胺基、反丁烯二酸、順丁烯二酸、苯乙烯基、異丙烯基苯基、O－乙烯基碳酸酯、O－乙烯基胺基甲酸酯、烯丙基、O－乙烯基乙醯基與N－乙烯基內醯胺及N－乙烯基醯胺基雙鍵。此種親水性單體本身可作為交聯劑使用。"丙烯酸型"或"含丙烯酸"單體係為含有丙烯酸基團(CR'H＝CRCOX)之單體，其中R為H或CH3 ，R'為H、烷基或羰基，且X為O或N，亦已知其可容易地聚合，譬如N,N－二甲基丙烯醯胺(DMA)、丙烯酸2－羥乙酯、甲基丙烯酸甘油酯、2－羥乙基甲基丙烯醯胺、聚乙二醇單甲基丙烯酸酯、甲基丙烯酸、丙烯酸及其混合物。In addition to the bismuth-containing component, the lenses, lens products and compositions of the present invention may comprise one or more hydrophilic components. The hydrophilic component includes those which, when combined with the remaining reactive components, are capable of providing at least about 20%, such as at least about 25%, water to the formed lens. Suitable hydrophilic components may be present in an amount between about 10 and about 60% by weight, based on the weight of all reactive components. From about 15 to about 50% by weight, for example between about 20 and about 40% by weight. A hydrophilic monomer useful for making a polymer for use in the lenses of the present invention has at least one polymerizable double bond and at least one hydrophilic functional group. Examples of the polymerizable double bond include acrylic acid, methacrylic acid, acrylamide, methacrylamide, fumaric acid, maleic acid, styryl, isopropenylphenyl, O-ethylene. A carbonate, an O-vinyl urethane, an allyl group, an O-vinyl ethyl fluorenyl group, an N-vinyl decylamine, and an N-vinyl guanamine-based double bond. Such a hydrophilic monomer itself can be used as a crosslinking agent. "Acrylic-type" or "acrylic-containing" monomers containing monomer system is an acrylic group (CR'H = CRCOX) of, where R is H or CH 3, R 'is H, alkyl or carbonyl, and X is O Or N, which is also known to be easily polymerizable, such as N,N-dimethyl acrylamide (DMA), 2-hydroxyethyl acrylate, glyceryl methacrylate, 2-hydroxyethyl methacrylamide , polyethylene glycol monomethacrylate, methacrylic acid, acrylic acid and mixtures thereof.

可被併入本發明鏡片之材料中之親水性含乙烯基單體，可包括一些單體，譬如N－乙烯基內醯胺(例如N－乙烯基四氫吡咯酮(NVP))、N－乙烯基－N－甲基乙醯胺、N－乙烯基－N－乙基乙醯胺、N－乙烯基－N－乙基甲醯胺、N－乙烯基甲醯胺、N－2－羥乙基乙烯基胺基甲酸酯、N－羧基－β－丙胺酸N－乙烯酯。於一項具體實施例中，親水性含乙烯基單體為NVP。Hydrophilic vinyl-containing monomers which may be incorporated into the materials of the lenses of the present invention may include monomers such as N-vinyl decylamine (e.g., N-vinyltetrahydropyrrolidone (NVP)), N- Vinyl-N-methylacetamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylformamide, N-vinylformamide, N-2-hydroxyl Ethyl vinyl urethane, N-carboxy-β-alanine N-vinyl ester. In one embodiment, the hydrophilic vinyl-containing monomer is NVP.

可被採用於本發明鏡片中之其他親水性單體，係包括具有一或多個末端羥基被含有可聚合雙鍵之官能基置換之聚氧化乙烯多元醇。實例包括具有一或多個末端羥基被含有可聚合雙鍵之官能基置換之聚乙二醇。實例包括與一或多個莫耳當量之封端基團反應之聚乙二醇，該封端基團譬如甲基丙烯酸異氰酸基乙酯("IEM")、甲基丙烯酸酐、氯化甲基丙烯醯、氯化乙烯基苯甲醯或其類似物，以產生一種聚乙烯多元醇，具有一或多個末端可聚合烯烴基團，經過連結部份基團，譬如胺基甲酸酯或酯基，結合至該聚乙烯多元醇。Other hydrophilic monomers which may be employed in the lenses of the present invention include polyoxyethylene polyols having one or more terminal hydroxyl groups replaced by a functional group containing a polymerizable double bond. Examples include polyethylene glycols having one or more terminal hydroxyl groups replaced by a functional group containing a polymerizable double bond. Examples include polyethylene glycol reacted with one or more molar equivalents of a capping group such as isocyanatoethyl methacrylate ("IEM"), methacrylic anhydride, chlorinated Methyl methacrylate, vinyl benzamidine chloride or the like to produce a polyethylene polyol having one or more terminally polymerizable olefin groups through a linking moiety such as a urethane Or an ester group, bonded to the polyethylene polyol.

其他實例為於美國專利5,070,215中所揭示之親水性碳酸乙烯酯或胺基甲酸乙烯酯單體，與美國專利4,190,277中所揭示之親水性唑酮單體。其他適當親水性單體係為熟諳此藝者所明瞭。可被併入本發明聚合體中之更佳親水性單體包括一些親水性單體，譬如N,N－二甲基丙烯醯胺(DMA)、丙烯酸2－羥乙酯、甲基丙烯酸甘油酯、2－羥乙基甲基丙烯醯胺、N－乙烯基四氫吡咯酮(NVP)、聚乙二醇單甲基丙烯酸酯及聚乙二醇二甲基丙烯酸酯。在某些具體實施例中，係採用包括DMA、NVP及其混合物之親水性單體。Other examples are the hydrophilic vinyl carbonate or vinyl carbamate monomers disclosed in U.S. Patent No. 5,070,215, the disclosure of which is incorporated herein by reference. Azole ketone monomer. Other suitable hydrophilic single systems are well known to those skilled in the art. More preferred hydrophilic monomers which may be incorporated into the polymers of the present invention include hydrophilic monomers such as N,N-dimethyl decylamine (DMA), 2-hydroxyethyl acrylate, glyceryl methacrylate. 2-Hydroxyethylmethacrylamide, N-vinyltetrahydropyrrolidone (NVP), polyethylene glycol monomethacrylate, and polyethylene glycol dimethacrylate. In certain embodiments, hydrophilic monomers comprising DMA, NVP, and mixtures thereof are employed.

用以製造矽氧水凝膠隱形眼鏡之材料之其他實例，係包括美國專利6,867,245中所揭示之材料。Other examples of materials for making a silicone hydrogel contact lens include those disclosed in U.S. Patent No. 6,867,245.

所示之方法包括將鏡片先質組合物放置在隱形眼鏡模構件上或其中之步驟102。關於本申請案，可明瞭鏡片先質組合物係為可聚合矽氧水凝膠鏡片先質組合物202，如圖2中所示。可明瞭可聚合矽氧水凝膠鏡片先質組合物係為適用於聚合反應之經預聚合或經預熟化之組合物。當於本文中使用時，本發明可聚合組合物亦可被稱為單體混料或反應混合物。可聚合組合物或鏡片先質組合物較佳係不在組合物熟化或聚合反應之前經聚合。但是，可聚合組合物或鏡片先質組合物可在進行熟化程序之前經部份聚合。在如本文中所述之熟化或聚合程序之前，本發明鏡片先質組合物可被提供於容器、分配裝置或隱形眼鏡模中。回復參考圖1，鏡片先質組合物係被放置在隱形眼鏡母模構件之形成鏡片之表面上。可明瞭隱形眼鏡母模構件係為第一個隱形眼鏡模構件或前面隱形眼鏡模構件。例如，隱形眼鏡母模構件係具有形成鏡片之表面，其係界定製自隱形眼鏡模之隱形眼鏡之前面或前方表面。The method shown includes the step 102 of placing a lens precursor composition on or in a contact lens mold member. With respect to the present application, it is apparent that the lens precursor composition is a polymerizable silicone hydrogel lens precursor composition 202, as shown in FIG. It is understood that the polymerizable hydrogel lens precursor composition is a prepolymerized or pre-cooked composition suitable for polymerization. As used herein, the polymerizable compositions of the present invention may also be referred to as monomer blends or reaction mixtures. The polymerizable composition or lens precursor composition is preferably polymerized prior to curing or polymerization of the composition. However, the polymerizable composition or lens precursor composition can be partially polymerized prior to the aging process. Prior to the curing or polymerization procedure as described herein, the lens precursor compositions of the present invention can be provided in a container, dispensing device or contact lens mold. Referring back to Figure 1, the lens precursor composition is placed on the lens forming surface of the contact lens master member. It will be appreciated that the contact lens master member is the first contact lens mold member or the front contact lens mold member. For example, the contact lens master member has a lens-forming surface that is bound to the front or front surface of the contact lens of the contact lens mold.

第一個隱形眼鏡模構件係被放置，與第二個隱形眼鏡模構件接觸，以形成具有隱形眼鏡成形模穴之隱形眼鏡模。因此，圖1中所示之方法係包括閉合隱形眼鏡模之步驟104，其方式是將兩個隱形眼鏡模構件放置而互相接觸，以形成隱形眼鏡成形模穴。可聚合矽氧水凝膠鏡片先質組合物202係位於隱形眼鏡成形模穴中。可明瞭第二個隱形眼鏡模構件係為隱形眼鏡公模構件或後面隱形眼鏡模構件。例如，第二個隱形眼鏡模構件包括形成鏡片之表面，其係界定隱形眼鏡模中所製成隱形眼鏡之後表面。A first contact lens mold member is placed in contact with the second contact lens mold member to form a contact lens mold having a contact lens forming cavity. Thus, the method illustrated in Figure 1 includes the step 104 of closing the contact lens mold by placing two contact lens mold members in contact with one another to form a contact lens forming cavity. The polymerizable silicone hydrogel lens precursor composition 202 is located in a contact lens forming cavity. It is apparent that the second contact lens mold member is a contact lens male mold member or a rear contact lens mold member. For example, the second contact lens mold member includes a lens-forming surface that defines the rear surface of the contact lens made in the contact lens mold.

在步驟106下，此方法包括使可聚合矽氧水凝膠鏡片先質組合物熟化，以形成萃取前經聚合之矽氧水凝膠隱形眼鏡產物204，如圖2中所示。在熟化期間，可聚合矽氧水凝膠鏡片先質組合物之形成鏡片成份係聚合以形成經聚合之鏡片產物。因此，亦可明瞭熟化係為聚合步驟。熟化106可包括將可聚合鏡片先質組合物曝露至有效使鏡片先質組合物之成份聚合之輻射。例如，熟化106可包括其中特別是將可聚合鏡片先質組合物曝露至聚合量之熱或紫外光(UV)。熟化亦可包括使組合物在無氧環境中熟化。例如，熟化可於氮或其他惰性氣體存在下發生。At step 106, the method includes curing the polymerizable silicone gel lens precursor composition to form a pre-extracted polymerized hydrogel contact lens product 204, as shown in FIG. During aging, the lens forming component of the polymerizable hydrogel lens precursor composition is polymerized to form a polymerized lens product. Therefore, it is also understood that the curing step is a polymerization step. The aging 106 can include exposing the polymerizable lens precursor composition to radiation effective to polymerize the components of the lens precursor composition. For example, aging 106 can include heat or ultraviolet light (UV) in which the polymerizable lens precursor composition is exposed, in particular, to a polymerization amount. Curing can also include aging the composition in an oxygen free environment. For example, curing can occur in the presence of nitrogen or other inert gases.

萃取前經聚合之矽氧水凝膠隱形眼鏡產物204，係指在進行從經聚合產物移除實質上所有可萃取成份之萃取程序前之經聚合產物。在被萃取組合物接觸之前，萃取前經聚合之矽氧水凝膠隱形眼鏡產物可被提供於隱形眼鏡模、萃取盤或其他裝置上或其中。例如，萃取前經聚合之矽氧水凝膠隱形眼鏡產物可於熟化程序後，被提供於隱形眼鏡模之鏡片成形模穴中，可於隱形眼鏡模之脫模後，被提供於一個隱形眼鏡模構件上或其中，或可於脫除鏡片程序之後與萃取程序之前，被提供於萃取盤或其他裝置上或其中。萃取前經聚合之矽氧水凝膠隱形眼鏡產物係包括形成鏡片之成份，譬如呈鏡片形狀之含矽聚合體網狀組織或基質，與可自形成鏡片之成份移除之可移除成份。可明瞭相對於形成鏡片之成份，可移除成份係包括未經反應之單體、寡聚物、經部份反應之單體或尚未變成以共價方式連接或以其他方式固定化之其他作用劑。亦可明瞭可移除成份係包括一或多種添加劑，包括有機添加劑，包括稀釋劑，其可在萃取程序期間自經聚合之鏡片產物萃取，如本文中討論。因此，相對於鏡片物體之聚合體主鏈、網狀組織或基質，可移除成份之物質可包括可萃取物質之線性未交聯、交聯或分枝狀聚合體，其係為未經交聯或以其他方式固定化。The pre-extracted polymerized hydrogel contact lens product 204 is the polymerized product prior to the extraction procedure to remove substantially all of the extractable components from the polymerized product. The pre-extracted polymerized oxygenated hydrogel contact lens product can be provided on or in a contact lens mold, extraction tray or other device prior to contact with the extraction composition. For example, the polymerized oxygenated hydrogel contact lens product can be provided in the lens forming cavity of the contact lens mold after the ripening process, and can be provided in a contact lens after the release of the contact lens mold. On or in the mold member, or after the lens removal procedure and prior to the extraction procedure, it is provided on or in the extraction tray or other device. The pre-extracted polymerized hydrogel contact lens product comprises a lens-forming component, such as a lens-containing cerium-containing polymeric network or matrix, and a removable component that is removable from the lens-forming component. It is clear that the removable component comprises unreacted monomers, oligomers, partially reacted monomers or other functions that have not yet become covalently attached or otherwise immobilized relative to the components forming the lens. Agent. It will also be appreciated that the removable component comprises one or more additives, including organic additives, including diluents, which can be extracted from the polymerized lens product during the extraction procedure, as discussed herein. Thus, the material of the removable component may comprise a linear uncrosslinked, crosslinked or branched polymer of extractable material relative to the polymer backbone, network or matrix of the lens object, which is uncrossed. Linked or otherwise fixed.

在使可聚合鏡片先質組合物熟化後，此方法包括將隱形眼鏡模脫模之步驟108。脫模係指將含有萃取前經聚合之隱形眼鏡產物或經聚合裝置之模具之兩個模具構件(譬如公與母模構件)分離之方法。萃取前經聚合之矽氧水凝膠隱形眼鏡產物係位在經脫模之模具構件之一上。例如，經聚合之矽氧水凝膠隱形眼鏡產物可位在公模構件或母模構件上。After curing the polymerizable lens precursor composition, the method includes the step 108 of demolding the contact lens mold. Demolding refers to the separation of two mold members (such as male and female mold members) containing a contact lens product that has been polymerized prior to extraction or a mold that is passed through a polymerization device. The polymerized hydroxyl hydrogel contact lens product prior to extraction is tied to one of the demolded mold members. For example, the polymerized oxygenated hydrogel contact lens product can be positioned on a male mold member or a master mold member.

然後，將萃取前經聚合之矽氧水凝膠隱形眼鏡產物204，在脫除鏡片步驟110期間，自其被置放之隱形眼鏡模構件上分離，如圖1中所示。萃取前經聚合之隱形眼鏡產物可自公模構件或母模構件脫除鏡片，依隱形眼鏡模之脫模期間，經聚合之隱形眼鏡產物仍然保持黏附於何種模具構件上而定。The pre-extracted polymerized hydrogel hydrogel contact lens product 204 is then separated from the contact lens mold member on which it is placed during the lens removal step 110, as shown in FIG. The contacted contact lens product prior to extraction can be removed from the male mold member or the female mold member, depending on which mold member the polymerized contact lens product remains adhered to during the release of the contact lens mold.

在將萃取前之矽氧水凝膠隱形眼鏡產物脫除鏡片後，此方法包括自該萃取前之矽氧水凝膠隱形眼鏡產物萃取可萃取物質之步驟112。萃取步驟112會造成經萃取之矽氧水凝膠隱形眼鏡產物206，如圖2中所示。萃取步驟112係指其中使萃取前經聚合之矽氧水凝膠隱形眼鏡產物與一或多種萃取組合物接觸之程序。例如，經聚合之矽氧水凝膠隱形眼鏡產物或一批次之經聚合矽氧水凝膠隱形眼鏡產物，可與一或多份體積之一種液體萃取媒質或多種液體萃取媒質接觸。萃取媒質可包括溶劑。例如，萃取媒質可包括乙醇、甲醇、丙醇及其他醇類。萃取媒質亦可包括醇類與水之混合物，譬如50%乙醇與50%去離子水之混合物，或70%乙醇與30%去離子水之混合物，或90%乙醇與10%去離子水之混合物。或者，萃取媒質可實質上或完全不含醇，且可包括幫助疏水性未經反應之成份自經聚合之矽氧水凝膠鏡片產物移除之一或多種作用劑。例如，萃取媒質可包含、基本上包含或完全包含水、緩衝溶液等。萃取步驟112可在不同溫度下實施。例如，萃取可在室溫(例如約20℃)下發生，或其可在高溫(例如約25℃至約100℃)下發生。此外，在某些具體實施例中，萃取步驟112可包括使鏡片產物與醇及水之混合物接觸之步驟，其可為多步驟萃取程序之最後步驟。After the pre-extracted oxime hydrogel contact lens product is removed from the lens, the method includes the step 112 of extracting the extractable material from the oxirane hydrogel contact lens product prior to the extraction. Extraction step 112 results in an extracted hydroxyl hydrogel contact lens product 206, as shown in FIG. Extraction step 112 refers to a procedure in which the pre-extracted polymerized hydrogel hydrogel contact lens product is contacted with one or more extraction compositions. For example, the polymerized hydrothermal hydrogel contact lens product or a batch of the polymerized hydroxyl hydrogel contact lens product can be contacted with one or more volumes of a liquid extraction medium or a plurality of liquid extraction media. The extraction medium can include a solvent. For example, the extraction medium can include ethanol, methanol, propanol, and other alcohols. The extraction medium may also comprise a mixture of an alcohol and water, such as a mixture of 50% ethanol and 50% deionized water, or a mixture of 70% ethanol and 30% deionized water, or a mixture of 90% ethanol and 10% deionized water. . Alternatively, the extraction medium may be substantially or completely free of alcohol, and may include one or more agents that assist in the removal of hydrophobic unreacted components from the polymerized hydrogel lens product. For example, the extraction medium can comprise, consist essentially of, or completely comprise water, a buffer solution, and the like. The extraction step 112 can be carried out at different temperatures. For example, the extraction can occur at room temperature (e.g., about 20 °C), or it can occur at elevated temperatures (e.g., from about 25 °C to about 100 °C). Moreover, in some embodiments, the extracting step 112 can include the step of contacting the lens product with a mixture of alcohol and water, which can be the final step of the multi-step extraction procedure.

在將萃取前經聚合之矽氧水凝膠隱形眼鏡產物萃取後，此方法包括使經萃取聚合之矽氧水凝膠隱形眼鏡產物水合之步驟114。水合步驟114可包括使經萃取聚合之矽氧水凝膠隱形眼鏡產物或一或多批次之此種產物與水或水溶液接觸，以形成經水合之矽氧水凝膠隱形眼鏡208，如圖2中所示。例如，經萃取聚合之矽氧水凝膠隱形眼鏡產物可經由被放置在二或多份個別體積之水中而被水合，包括去離子水。在某些方法中，水合步驟114可與萃取步驟112合併，以致兩個步驟係在隱形眼鏡生產線中之單一工作站上進行。在某些方法中，水合步驟114可在室溫下或在高溫下，於容器中進行，及若需要，則在高壓下。例如，水合作用可在約120℃(例如121℃)之溫度與103 kPa(15 psi)之壓力下，於水中發生。After extracting the polymerized hydroxyl hydrogel contact lens product prior to extraction, the method includes the step 114 of hydrating the extracted polymeric oxygenated hydrogel contact lens product. The hydration step 114 can include contacting the extracted polymeric oxygenated hydrogel contact lens product or one or more batches of such product with water or an aqueous solution to form a hydrated hydrogenated hydrogel contact lens 208, as shown in the figure. Shown in 2. For example, the extracted polymeric oxygenated hydrogel contact lens product can be hydrated, including deionized water, by being placed in two or more separate volumes of water. In some methods, the hydrating step 114 can be combined with the extraction step 112 such that the two steps are performed on a single workstation in the contact lens production line. In some methods, the hydrating step 114 can be carried out in a vessel at room temperature or at elevated temperatures and, if desired, under high pressure. For example, hydration can occur in water at a temperature of about 120 ° C (e.g., 121 ° C) and a pressure of 103 kPa (15 psi).

鑒於上述，可明瞭的是，萃取前經聚合之矽氧水凝膠隱形眼鏡產物與經萃取聚合之矽氧水凝膠隱形眼鏡產物係為水可膨潤性產物或元件，且經水合之矽氧水凝膠隱形眼鏡係為已以水膨潤之產物或元件。於本文中使用之矽氧水凝膠隱形眼鏡係指已進行水合步驟之矽氧水凝膠元件。因此，可明瞭矽氧水凝膠隱形眼鏡係為經完全水合之矽氧水凝膠隱形眼鏡、經部份水合之矽氧水凝膠隱形眼鏡或經脫水之矽氧水凝膠隱形眼鏡。經脫水之矽氧水凝膠隱形眼鏡係指已進行水合程序，且已接著被脫水以自鏡片移除水之隱形眼鏡。In view of the foregoing, it will be appreciated that the polymerized hydroxyl hydrogel contact lens product and the extracted polymeric hydroxyl hydrogel contact lens product are water swellable products or components and are hydrated by oxygenation. Hydrogel contact lenses are products or components that have been swollen with water. Oxygenated hydrogel contact lenses as used herein refer to hydroxyl hydrogel elements that have undergone a hydration step. Thus, it is understood that the hydroxyl hydrogel contact lens is a fully hydrated hydrogel contact lens, a partially hydrated hydrogel contact lens or a dehydrated oxygenated hydrogel contact lens. A dehydrated oxygenated hydrogel contact lens refers to a contact lens that has undergone a hydration procedure and has been subsequently dehydrated to remove water from the lens.

在將經萃取之矽氧水凝膠隱形眼鏡產物水合，以製造矽氧水凝膠隱形眼鏡後，此方法包括包裝矽氧水凝膠隱形眼鏡208之步驟116。例如，可將矽氧水凝膠隱形眼鏡208放置在氣泡包裝或包含一體積液體之其他適當容器中，該液體譬如鹽水溶液，包括緩衝鹽水溶液。適合本發明鏡片之液體實例包括磷酸鹽緩衝之鹽水與硼酸鹽緩衝之鹽水。可將氣泡包裝或容器密封，且接著滅菌，如在步驟118中所示。例如，可將經包裝之矽氧水凝膠隱形眼鏡曝露至滅菌量之輻射，包括熱，譬如藉由進行熱壓鍋法、γ輻射、電子束輻射或紫外線輻射。After hydrating the extracted oxygenated hydrogel contact lens product to produce a silicone hydrogel contact lens, the method includes the step 116 of packaging the silicone hydrogel contact lens 208. For example, the helium oxygen hydrogel contact lens 208 can be placed in a bubble wrap or other suitable container containing a volume of liquid, such as a saline solution, including a buffered saline solution. Examples of liquids suitable for the lenses of the present invention include phosphate buffered saline and borate buffered saline. The bubble wrap or container can be sealed and then sterilized as shown in step 118. For example, the packaged silicone hydrogel contact lens can be exposed to a sterile amount of radiation, including heat, such as by autoclaving, gamma radiation, electron beam radiation, or ultraviolet radiation.

本發明眼睛上可相容之矽氧水凝膠隱形眼鏡可藉由提供相對較大量之可移除物質在萃取前經聚合之矽氧水凝膠隱形眼鏡產物中而獲得。具有可移除成份之萃取前經聚合之矽氧水凝膠鏡片產物，該可移除成份為一或多種可移除物質，包括可萃取物質等，其係為萃取前經聚合之矽氧水凝膠鏡片產物重量之至少10%(w/w)，該鏡片產物可經萃取與水合，以形成具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡。本發明鏡片具有氧透氣性、表面可潤溼性、模數、水含量、離子通量、設計及其組合，其允許本發明鏡片被舒適地配戴於病患之眼睛上，歷經長時期，譬如歷經至少一天，至少一週，至少兩週，或約一個月，而不需要自眼睛移除鏡片。The ocularly compatible neodymium hydrogel contact lenses of the present invention can be obtained by providing a relatively large amount of removable material in the polymerized oxygenated hydrogel contact lens product prior to extraction. A pre-extracted polymerized hydrogel lens product having a removable component, the removable component being one or more removable materials, including extractable materials, etc., which are polymerized hydrogen peroxide prior to extraction. At least 10% (w/w) by weight of the gel lens product, the lens product can be extracted and hydrated to form a silicone hydrogel contact lens having an ocularly acceptable surface wettability. The lenses of the present invention have oxygen permeability, surface wettability, modulus, water content, ion flux, design, and combinations thereof, which allow the lenses of the present invention to be comfortably worn on the patient's eyes over a long period of time. For example, at least one day, at least one week, at least two weeks, or about one month, without the need to remove the lens from the eye.

於本文中使用之"眼睛上可相容之矽氧水凝膠隱形眼鏡"，可明瞭係指可被配戴於人們眼睛上，而不會有人歷經或報告實質不舒適，包括眼部刺激等之矽氧水凝膠隱形眼鏡。眼睛上可相容之矽氧水凝膠隱形眼鏡係具有眼睛上可接受之表面可潤溼性，且典型上不會造成或不會伴隨著顯著角膜腫脹、角膜脫水作用("眼乾")、上皮弧狀損傷("SEAL")或其他顯著不舒適。可明瞭具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡係指矽氧水凝膠隱形眼鏡，其不會不利地影響鏡片配戴者眼睛之淚膜，至造成鏡片配戴者歷經或報告與放置或配戴矽氧水凝膠隱形眼鏡於眼睛上有關聯之不舒適之程度。眼睛上可相容之矽氧水凝膠隱形眼鏡係滿足對於每日配戴或長期配戴隱形眼鏡之臨床可接受性要求條件。As used herein, "eye-compatible neodymium hydrogel contact lenses" can be used to mean that they can be worn on people's eyes without any person experiencing or reporting substantial discomfort, including eye irritation, etc. Oxygen hydrogel contact lenses. An eye-compatible, oxygenated hydrogel contact lens has an eye-acceptable surface wettability and typically does not or is not accompanied by significant corneal swelling and corneal dehydration ("eye dry") , epithelial arcuate injury ("SEAL") or other significant discomfort. It is clear that a hydrogel contact lens having an eye-acceptable surface wettability refers to a silicone hydrogel contact lens that does not adversely affect the tear film of the lens wearer's eyes, resulting in lens matching. The wearer experiences or reports the degree of discomfort associated with placing or wearing a silicone hydrogel contact lens on the eye. Eye-compatible neohydrogenohydrate contact lenses satisfy the requirements for clinical acceptability of daily or long-term wear of contact lenses.

本發明矽氧水凝膠隱形眼鏡包括鏡片物體，其具有具眼睛上可接受可潤溼性之表面，譬如前表面與後表面。可潤溼性係指隱形眼鏡之一或多個表面之親水性。當於本文中使用時，若鏡片在如下述所進行之可潤溼性檢測中得到3或以上之評分，則鏡片之表面可被認為是可潤溼，或具有眼睛上可接受之可潤溼性。將隱形眼鏡浸泡在蒸餾水中，自水移除，並測定關於水膜自鏡片表面倒退所花費之時間長度(例如水破碎時間(水BUT))。此檢測係以1－10之線性尺度將鏡片分級，其中10之評分係指其中液滴花費20秒或更多以自鏡片倒退之鏡片。具有水BUT大於5秒，譬如至少10秒或更期望地為至少約15秒之矽氧水凝膠隱形眼鏡，可為具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡。可潤溼性亦可藉由度量在一或兩個鏡片表面上之接觸角而測得。接觸角可為動態或靜態接觸角。較低接觸角一般係指隱形眼鏡表面之增加可潤溼性。例如，矽氧水凝膠隱形眼鏡之可潤溼表面可具有接觸角小於約120度。但是，在本發明鏡片之某些具體實施例中，鏡片具有接觸角不大於90度，而在進一步具體實施例中，本發明矽氧水凝膠隱形眼鏡具有前進接觸角小於約80度。The oxygenated hydrogel contact lenses of the present invention comprise a lens object having a surface that is hygroscopically acceptable to the eye, such as a front surface and a back surface. Wetability refers to the hydrophilicity of one or more surfaces of a contact lens. As used herein, the surface of the lens can be considered wettable or ocularly acceptable if the lens achieves a score of 3 or more in the wettability test as described below. Sex. The contact lens is immersed in distilled water, removed from the water, and the length of time it takes for the water film to recede from the lens surface (eg, water break time (water BUT)) is determined. This test classifies the lenses on a linear scale of 1-10, with a score of 10 referring to lenses in which the droplets take 20 seconds or more to retreat from the lens. Hydroxyl hydrogel contact lenses having a water BUT greater than 5 seconds, such as at least 10 seconds or more desirably at least about 15 seconds, may be a hydrogel contact lens having an ocularly acceptable surface wettability . Wettability can also be measured by measuring the contact angle on one or both lens surfaces. The contact angle can be a dynamic or static contact angle. Lower contact angle generally refers to increased wettability of the contact lens surface. For example, the wettable surface of the helium oxygen hydrogel contact lens can have a contact angle of less than about 120 degrees. However, in certain embodiments of the lenses of the present invention, the lenses have a contact angle of no greater than 90 degrees, while in further embodiments, the oxygenated hydrogel contact lenses of the present invention have an advancing contact angle of less than about 80 degrees.

已發現藉由控制本發明可聚合組合物譬如本發明可聚合矽氧水凝膠隱形眼鏡先質組合物，與本發明經聚合組合物譬如萃取前經聚合之矽氧水凝膠隱形眼鏡產物中之可反應成份或可反應與不可反應成份之組合之量或類型，可獲得具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡。具有眼睛上可接受之表面可潤溼性之本發明矽氧水凝膠隱形眼鏡，不需要表面處理或聚合體潤溼劑IPN以提供表面可潤溼性，且不需要於極性樹脂隱形眼鏡模中製造以提供表面可潤溼性。例如，具有眼睛上可接受之表面可潤溼性之本發明矽氧水凝膠隱形眼鏡，可得自非極性樹脂隱形眼鏡模或疏水性樹脂隱形眼鏡模，而無需表面處理或聚合體潤溼劑IPN。It has been discovered that by controlling the polymerizable composition of the present invention, such as the polymerizable silicone hydrogel contact lens precursor composition of the present invention, and the polymerized composition of the present invention, such as a polymerized hydrogel contact lens product prior to extraction, Oxygenated hydrogel contact lenses having ocularly acceptable surface wettability can be obtained in the amount or type of reactive component or combination of reactive and non-reactive components. The oxygenated hydrogel contact lens of the present invention having an ocularly acceptable surface wettability does not require a surface treatment or polymeric wetting agent IPN to provide surface wettability and does not require polar resin contact lens molds. Made in order to provide surface wettability. For example, the oxygenated hydrogel contact lenses of the present invention having ocularly acceptable surface wettability can be obtained from non-polar resin contact lens molds or hydrophobic resin contact lens molds without surface treatment or polymer wetting. Agent IPN.

於本文中使用之"非極性樹脂隱形眼鏡模"或"疏水性樹脂隱形眼鏡模"，係指形成或產生自非極性或疏水性樹脂之隱形眼鏡模。因此，非極性樹脂為基料之隱形眼鏡模可包含非極性或疏水性樹脂。例如，此種隱形眼鏡模可包含一或多種聚烯烴，或可製自聚烯烴樹脂材料。就本申請案而論，所使用之非極性樹脂隱形眼鏡模之實例包括聚乙烯隱形眼鏡模、聚丙烯隱形眼鏡模及聚苯乙烯隱形眼鏡模。非極性樹脂為基料之隱形眼鏡模典型上具有疏水性表面。例如，當使用俘獲氣泡方法測定時，非極性樹脂模具或疏水性樹脂模具可具有靜態接觸角為約90度或較大。以此種接觸角，在此種模具中製成之習用矽氧水凝膠隱形眼鏡係具有臨床上無法令人接受之表面可潤溼性。As used herein, "non-polar resin contact lens mold" or "hydrophobic resin contact lens mold" refers to a contact lens mold that is formed or produced from a non-polar or hydrophobic resin. Therefore, the contact lens mold in which the non-polar resin is a binder may contain a non-polar or hydrophobic resin. For example, such contact lens molds can comprise one or more polyolefins or can be made from a polyolefin resin material. For the purposes of this application, examples of non-polar resin contact lens molds used include polyethylene contact lens molds, polypropylene contact lens molds, and polystyrene contact lens molds. Contact lens molds in which a non-polar resin is a base typically have a hydrophobic surface. For example, the non-polar resin mold or the hydrophobic resin mold may have a static contact angle of about 90 degrees or more when measured using the trapping bubble method. With such contact angles, conventional oxygenated hydrogel contact lens lenses made in such molds have clinically unacceptable surface wettability.

藉由提供相對較緩慢反應單體於可聚合組合物中，譬如藉由提供具有不同反應性比之兩種或多種單體類型於相同可聚合組合物中，可控制萃取前經聚合之矽氧水凝膠隱形眼鏡產物中之可移除成份量。緩慢反應單體，譬如在可聚合組合物中之單體，其在熟化程序期間不會完全交聯成網狀組織，可提供相對較大量之可移除成份於經聚合之矽氧水凝膠隱形眼鏡產物中。未經完全交聯之作用劑，譬如未經反應或僅經部份反應之單體、寡聚物、線性聚合體、經稍微交聯之成份等，係自經聚合矽氧水凝膠隱形眼鏡產物之經聚合成份萃取。By providing relatively slow reactive monomers in the polymerizable composition, such as by providing two or more monomer types having different reactivity ratios in the same polymerizable composition, the pre-extracted polymerized oxygen can be controlled. The amount of removable component in the hydrogel contact lens product. Slowly reacting monomers, such as monomers in the polymerizable composition, which do not completely crosslink into a network during the curing process, provide a relatively large amount of removable component to the polymerized hydrogel. In the contact lens product. Agents that are not fully crosslinked, such as unreacted or partially reacted monomers, oligomers, linear polymers, slightly crosslinked components, etc., are self-polymerized silicone hydrogel contact lenses The product is extracted by polymerization.

在某些本發明可聚合組合物與經聚合矽氧水凝膠隱形眼鏡產物中，可移除添加劑係存在。例如，一些本發明可聚合組合物與經聚合矽氧水凝膠隱形眼鏡產物係包含一或多種添加劑，其可在萃取程序期間自經聚合矽氧水凝膠隱形眼鏡產物移除。In certain of the polymerizable compositions of the present invention and the polymerized hydrogel hydrogel contact lens products, a removable additive is present. For example, some of the polymerizable compositions of the present invention and the polymerized hydrogel hydrogel contact lens product comprise one or more additives that are removable from the polymerized hydrogel contact lens product during the extraction procedure.

就本申請案而論，"添加劑"一詞係意謂在本發明可聚合矽氧水凝膠隱形眼鏡先質組合物或萃取前經聚合之矽氧水凝膠隱形眼鏡產物中所提供之化合物或化學劑，但其並非製造矽氧水凝膠隱形眼鏡所必須。但是，與得自未具有添加劑或其組合之相同先質組合物之矽氧水凝膠隱形眼鏡比較，可移除添加劑之加入可幫助隱形眼鏡在其製造期間之處理，可增強矽氧水凝膠隱形眼鏡之一或多種性質。當於本文中使用時，添加劑係可自萃取前經聚合之矽氧水凝膠隱形眼鏡產物移除。例如，添加劑可為實質上非反應性，或不與可聚合矽氧水凝膠鏡片先質組合物之其他成份反應。例如，添加劑不會實質上變成所形成經聚合鏡片產物之共價結合完整部份。依其分子量與形狀而定，大部份(若非全部時)本發明添加劑可自經聚合之矽氧水凝膠隱形眼鏡產物萃取。因此，於本發明組合物中之添加劑可在萃取程序期間萃取自經聚合之矽氧水凝膠隱形眼鏡產物。For the purposes of this application, the term "additive" means a compound provided in the polymerizable hydrogel contact lens precursor composition of the present invention or the polymerized hydroxyl hydrogel contact lens product prior to extraction. Or a chemical agent, but it is not necessary to make a silicone hydrogel contact lens. However, the addition of a removable additive can aid in the handling of the contact lens during its manufacture, as compared to a silicone hydrogel contact lens obtained from the same precursor composition that does not have an additive or combination thereof, which enhances the hydrophobization of the contact lens. One or more properties of a plastic contact lens. As used herein, the additive can be removed from the polymerized oxygenated hydrogel contact lens product prior to extraction. For example, the additive can be substantially non-reactive or does not react with other components of the polymerizable hydrogel lens precursor composition. For example, the additive does not substantially become a covalently bonded intact portion of the formed polymerized lens product. Depending on its molecular weight and shape, most, if not all, of the additives of the invention may be extracted from the polymerized hydrogel contact lens product. Thus, the additives in the compositions of the present invention can be extracted from the polymerized oxygenated hydrogel contact lens product during the extraction procedure.

在某些具體實施例中，添加劑可被稱為稀釋劑、實質上非反應性劑或可萃取物質。稀釋劑可為醇類或非醇作用劑。稀釋劑可以鏡片先質組合物之約1%至約60%(w/w)之量存在。若需要，則其他非稀釋劑為基礎之添加劑可以低於10%(w/w)之量存在。與得自未包含添加劑之鏡片產物之隱形眼鏡比較，在本發明組合物中所提供之添加劑，可輔助可聚合矽氧水凝膠隱形眼鏡先質組合物之形成，譬如藉由幫助均勻組合物或非相分離組合物之形成；可增強本發明萃取前經聚合之矽氧水凝膠隱形眼鏡產物之加工性能，譬如藉由幫助含有隱形眼鏡產物之隱形眼鏡模之脫模，及/或幫助隱形眼鏡產物自隱形眼鏡模之脫除鏡片；可在隱形眼鏡之個體群中，例如在不同批次之隱形眼鏡中，改良隱形眼鏡之物理參數之控制，譬如藉由降低隱形眼鏡物理參數中之變異性；可增強隱形眼鏡之可潤溼性，譬如藉由增強隱形眼鏡表面之可潤溼性；可正面地影響隱形眼鏡之模數，譬如藉由降低模數或增加模數，按需要而定；及可正面地影響隱形眼鏡之離子通量，譬如藉由降低隱形眼鏡之離子通量。因此，可明瞭在本發明組合物中所提供之添加劑係為相容劑、脫模助劑、脫除鏡片助劑、物理參數控制劑、可潤溼性增強劑、模數影響劑、離子通量降低劑或其組合。當與缺乏此種添加劑之相同可聚合矽氧水凝膠隱形眼鏡先質組合物或萃取前經聚合之矽氧水凝膠隱形眼鏡產物，或得自此種可聚合組合物或經聚合產物之矽氧水凝膠隱形眼鏡比較時，以本發明添加劑所獲得之增強或改良係為顯而易見。In certain embodiments, the additive can be referred to as a diluent, a substantially non-reactive agent, or an extractable material. The diluent can be an alcohol or a non-alcoholic agent. The diluent can be present in an amount from about 1% to about 60% (w/w) of the lens precursor composition. If desired, other non-diluent based additives may be present in amounts less than 10% (w/w). Additives provided in the compositions of the present invention may aid in the formation of polymerizable silicone hydrogel contact lens precursor compositions, such as by aiding in uniform compositions, as compared to contact lenses obtained from lens products that do not contain additives. Or the formation of a non-phase-separating composition; enhancing the processing properties of the polymerized hydroxyl hydrogel contact lens product of the present invention, for example, by assisting in the release of a contact lens mold containing a contact lens product, and/or aiding The contact lens product is a lens for removing contact lenses; the control of the physical parameters of the contact lens can be improved in individual groups of contact lenses, for example in different batches of contact lenses, for example by reducing the physical parameters of the contact lens Variability; enhances the wettability of contact lenses, for example by enhancing the wettability of contact lens surfaces; can positively affect the modulus of contact lenses, for example by reducing the modulus or increasing the modulus, as needed And can positively affect the ion flux of the contact lens, for example by reducing the ion flux of the contact lens. Therefore, it is understood that the additives provided in the composition of the present invention are a compatibilizer, a mold release aid, a lens removal aid, a physical parameter control agent, a wettability enhancer, a modulus influencer, an ion pass. A reducing agent or a combination thereof. When the same polymerizable hydrogel contact lens precursor composition or pre-extracted polymerized hydroxyl hydrogel contact lens product, or from such polymerizable composition or polymerized product, is absent from the lack of such an additive Enhancements or improvements obtained with the additives of the present invention are apparent when comparing hydroxyl hydrogel contact lenses.

於本文中所揭示之相容劑係改良或增強本發明先質組合物之成份之溶混性。例如，與未使用相容劑之配方比較，相容劑可降低與含矽聚合體及其他形成鏡片之成份有關聯之相分離。Compatibilizers disclosed herein modify or enhance the miscibility of the ingredients of the precursor compositions of the present invention. For example, compatibilizers can reduce phase separation associated with ruthenium containing polymers and other lens forming components as compared to formulations that do not use compatibilizers.

在某些本發明可聚合組合物與經聚合之產物中提供可移除之添加劑，係有助於其中特別是具有眼睛上可相容表面可潤溼性之矽氧水凝膠隱形眼鏡之製造，而無需將隱形眼鏡或鏡片產物曝露至表面處理，或無需加入聚合體潤溼劑譬如PVP之IPN。例如，添加劑係均勻地被分佈於整個聚合反應組合物中，且實質上(若非完全地)在萃取程序期間自整個經聚合之產物移除。此外，本文中所述之添加劑並非聚合體潤溼劑，其係與經預聚合之組合物混合，且接著混合至經聚合之物體中，以形成IPN。本發明隱形眼鏡可以幾乎無物理或尺寸變異性逐批製造，藉以改良臨床上可接受之眼睛上可相容矽氧水凝膠隱形眼鏡之產率。添加劑可呈液體或固體形式，且包括疏水性或兩親性化合物或作用劑。The provision of a removable additive in certain of the polymerizable compositions of the present invention and the polymerized product aids in the manufacture of indolent hydrogel contact lenses, particularly having eye-compatible surface wettability. There is no need to expose the contact lens or lens product to the surface treatment, or to add a polymeric wetting agent such as the IPN of PVP. For example, the additive is uniformly distributed throughout the polymerization composition and is substantially, if not completely, removed from the entire polymerized product during the extraction procedure. Moreover, the additives described herein are not polymeric wetting agents that are mixed with the prepolymerized composition and then mixed into the polymerized object to form an IPN. The contact lenses of the present invention can be manufactured batchwise with little physical or dimensional variability to improve the yield of clinically acceptable eye compatible hydroxyl hydrogel contact lenses. The additives may be in liquid or solid form and include hydrophobic or amphiphilic compounds or agents.

可用於本發明組合物與鏡片產物中之添加劑，包括稀釋劑，可具有與疏水性基團連結之親水性基團，例如具有烷鏈之羥基，與親水性PEG區段連結之矽氧烷分子主鏈等。添加劑之實例，包括但不限於分子量約10,000道爾吞或較少之聚二甲基矽氧烷－共－PEG聚合體、硬脂酸乙二醇酯、單月桂酸二乙二醇酯、C2 －C24 醇類及/或C2 －C24 胺類。添加劑亦可含有一或多個極性或親水性末端基，譬如但不限於羥基、胺基、氫硫基、磷酸鹽及羧基團，以幫助添加劑與存在於組合物中之其他物質之溶混性。添加劑可存在於可聚合矽氧水凝膠先質組合物中，其量為約2%(w/w)至約60%(w/w)。例如，組合物可包含以約5%至約50%(w/w)之量存在之一或多種添加劑。可聚合組合物之進一步實例係包含以約20%，或約25%，或約30%，或約35%，或約40%，或約45%，或約50%，或約55%之量存在之一或多種添加劑。Additives useful in the compositions of the present invention and lens products, including diluents, may have a hydrophilic group attached to a hydrophobic group, such as a hydroxyl group having an alkyl chain, a oxoxane molecule attached to a hydrophilic PEG segment. Main chain and so on. Examples of additives include, but are not limited to, polydimethyl methoxy oxane-co-PEG polymers having a molecular weight of about 10,000 doxane or less, ethylene glycol stearate, diethylene glycol monolaurate, C 2 - C 24 alcohols and / or C 2 - C 24 amines. The additive may also contain one or more polar or hydrophilic end groups such as, but not limited to, hydroxyl, amine, thiol, phosphate and carboxyl groups to aid in the miscibility of the additive with other materials present in the composition. . The additive may be present in the polymerizable hydroxyl hydrogel precursor composition in an amount from about 2% (w/w) to about 60% (w/w). For example, the composition can comprise one or more additives in an amount from about 5% to about 50% (w/w). Further examples of polymerizable compositions comprise an amount of about 20%, or about 25%, or about 30%, or about 35%, or about 40%, or about 45%, or about 50%, or about 55%. One or more additives are present.

本發明矽氧水凝膠隱形眼鏡包括具有眼睛上可接受之表面可潤溼性之鏡片物體。例如，本發明矽氧水凝膠隱形眼鏡之鏡片物體可具有前表面與後表面，各表面具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses of the present invention comprise a lens object having an acceptable surface wettability to the eye. For example, the lens object of the oxygenated hydrogel contact lens of the present invention can have a front surface and a back surface, each surface having an ocularly acceptable surface wettability.

在一項具體實施例中，矽氧水凝膠隱形眼鏡之鏡片物體係包含矽氧水凝膠材料。此鏡片物體具有乾重不大於萃取前鏡片物體乾重之90%。例如，萃取前經聚合之矽氧水凝膠隱形眼鏡產物之鏡片物體可具有乾重X。於萃取程序後，經萃取聚合之矽氧水凝膠隱形眼鏡產物之鏡片物體係具有乾重低於或等於0.9X。如本文中所討論，萃取前經聚合之矽氧水凝膠隱形眼鏡產物可與數體積之多種有機溶劑接觸，且經水合，以製造矽氧水凝膠隱形眼鏡。然後，可使經水合之矽氧水凝膠隱形眼鏡脫水，並稱重，以測定矽氧水凝膠隱形眼鏡之鏡片物體之乾重。例如，在某些方法中，將萃取前經聚合之矽氧水凝膠隱形眼鏡產物自隱形眼鏡模構件脫除鏡片，並稱重，以提供萃取前經聚合之矽氧水凝膠隱形眼鏡產物之乾重。然後，使萃取前之鏡片產物與醇接觸約6小時，接著以水進行水合。然後，使經水合之鏡片在約80℃下乾燥約1小時，接著於真空下，在約80℃下乾燥約2小時。將經乾燥之鏡片稱重，以測定矽氧水凝膠隱形眼鏡之鏡片物體之乾重。比較乾重，以測定存在於萃取前經聚合之矽氧水凝膠隱形眼鏡產物中之可萃取物質之量。具有可萃取成份含量約40%之萃取前經聚合之鏡片產物，係產生具有乾重為萃取前鏡片產物之約60%之矽氧水凝膠隱形眼鏡之鏡片物體。具有可萃取成份含量約70%之萃取前經聚合鏡片產物，係產生具有乾重為萃取前鏡片產物之約30%之矽氧水凝膠隱形眼鏡之鏡片物體。In a specific embodiment, the lens system of the helium oxygen hydrogel contact lens comprises a helium oxygen hydrogel material. The lens object has a dry weight no greater than 90% of the dry weight of the lens object prior to extraction. For example, the lens object of the polymerized hydroxyl hydrogel contact lens product prior to extraction can have a dry weight X. After the extraction procedure, the lens system of the extracted polymerized hydrogel contact lens product has a dry weight of less than or equal to 0.9X. As discussed herein, the pre-extracted polymerized hydroxyl hydrogel contact lens product can be contacted with several volumes of various organic solvents and hydrated to produce a hydroxyl hydrogel contact lens. The hydrated oxygenated hydrogel contact lens can then be dehydrated and weighed to determine the dry weight of the lens object of the helium oxygen hydrogel contact lens. For example, in some methods, the pre-extracted polymerized oxygenated hydrogel contact lens product is removed from the contact lens mold member and weighed to provide a polymerized hydrogel contact lens product prior to extraction. Dry weight. The lens product prior to extraction is then contacted with the alcohol for about 6 hours, followed by hydration with water. The hydrated lens is then dried at about 80 ° C for about 1 hour, followed by drying at about 80 ° C for about 2 hours under vacuum. The dried lens is weighed to determine the dry weight of the lens object of the helium oxygen hydrogel contact lens. The dry weight is compared to determine the amount of extractable material present in the polymerized hydrogel contact lens product prior to extraction. The pre-extracted polymerized lens product having an extractable component content of about 40% produces a lens object having a dry weight of about 60% of the oxygenated hydrogel contact lens of the pre-extracted lens product. The pre-extracted polymerized lens product having an extractable component content of about 70% produces a lens object having a dry weight of about 30% of the oxygenated hydrogel contact lens of the pre-extracted lens product.

存在於萃取前經聚合之矽氧水凝膠隱形眼鏡產物中之可萃取物質之量或可萃取成份含量，可使用下列方程式測得：E＝((萃取前鏡片產物之乾重－經萃取與水合隱形眼鏡之乾重)/萃取前之鏡片產物之乾重)x 100The amount of extractable material or extractable component present in the polymerized hydroxyl hydrogel contact lens product prior to extraction can be measured using the following equation: E = ((dry weight of the lens product before extraction - extracted and Dry weight of hydrated contact lenses) / dry weight of lens product before extraction) x 100

E為存在於萃取前鏡片產物中之可萃取物質之百分比。E is the percentage of extractable material present in the lens product prior to extraction.

例如，萃取前經聚合之矽氧水凝膠隱形眼鏡產物可具有乾重為約20毫克。若得自該產物之矽氧水凝膠隱形眼鏡具有乾重為約17毫克，則該矽氧水凝膠隱形眼鏡係包括具有乾重為萃取前鏡片產物乾重之85%之鏡片物體。可明瞭的是，此種萃取前鏡片產物係具有可萃取成份含量為約15%(w/w)。作為另一項實例，萃取前經聚合之矽氧水凝膠隱形眼鏡產物可具有乾重為約18毫克，而若得自鏡片產物之經脫水矽氧水凝膠隱形眼鏡具有乾重為約13毫克，則矽氧水凝膠隱形眼鏡包括具有乾重為萃取前鏡片產物之約72%之鏡片物體。此種萃取前經聚合之矽氧水凝膠隱形眼鏡產物係具有可萃取成份含量為約28%(w/w)。For example, the polymerized hydroxyl hydrogel contact lens product prior to extraction can have a dry weight of about 20 mg. If the oxygenated hydrogel contact lens from the product has a dry weight of about 17 mg, the silicone hydrogel contact lens comprises a lens object having a dry weight of 85% of the dry weight of the pre-extracted lens product. It will be appreciated that the pre-extraction lens product has an extractable ingredient content of about 15% (w/w). As another example, the pre-extracted polymerized hydrogel contact lens product can have a dry weight of about 18 mg, while the dehydrated hydrogel contact lens from the lens product has a dry weight of about 13 In milligrams, the hydrogel contact lens comprises a lens object having a dry weight of about 72% of the pre-extracted lens product. The pre-extracted polymerized hydrothermal hydrogel contact lens product has an extractable ingredient content of about 28% (w/w).

在某些具體實施例中，矽氧水凝膠隱形眼鏡(意即已進行萃取與水合程序之矽氧水凝膠隱形眼鏡)之鏡片物體之乾重，係大於萃取前之鏡片物體乾重之25%。例如，經萃取後鏡片物體之乾重可為萃取前鏡片物體乾重之約25%至約90%。本發明鏡片之一些具體實施例包括具有乾重為萃取前鏡片物體乾重之約50%至約85%之鏡片物體。In some embodiments, the dry weight of the lens object of the helium oxygen hydrogel contact lens (ie, the oxygenated hydrogel contact lens that has been subjected to the extraction and hydration procedures) is greater than the dry weight of the lens object prior to extraction. 25%. For example, the dry weight of the lens object after extraction can be from about 25% to about 90% of the dry weight of the lens object prior to extraction. Some embodiments of the lenses of the present invention comprise lens objects having a dry weight of from about 50% to about 85% of the dry weight of the lens object prior to extraction.

如本文中所討論，當萃取前鏡片產物中之可萃取成份含量大於10%，譬如至少15%，至少20%，至少25%，或更多時，得自不含可移除添加劑之鏡片先質組合物或萃取前矽氧水凝膠隱形眼鏡產物之矽氧水凝膠隱形眼鏡(例如得自"總體配方"之鏡片產物)，可具有眼睛上可接受之表面可潤溼性。與總體配方鏡片產物比較，一或多種可移除添加劑之加入先質組合物或經聚合萃取前之鏡片產物中，會增加可萃取成份含量，且會造成具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡。因此，可明瞭本發明矽氧水凝膠隱形眼鏡，其包括具有乾重不大於萃取前鏡片物體乾重之90%之鏡片物體，係為得自總體配方之隱形眼鏡，與得自包含一或多種可移除劑之配方或鏡片產物之隱形眼鏡。As discussed herein, when the extractable component content in the pre-extracted lens product is greater than 10%, such as at least 15%, at least 20%, at least 25%, or more, it is obtained from a lens that does not contain a removable additive. Hydrophobic hydrogel contact lenses (e.g., lens products derived from "overall formulas") of the composition or pre-extracted hydroxyl hydrogel contact lens product can have ocularly acceptable surface wettability. Compared to the overall formulated lens product, the addition of one or more removable additives to the precursor composition or the lens product prior to polymerization extraction increases the extractable component content and results in an ocularly acceptable surface wettable Sexual oxygen hydrogel contact lenses. Thus, it is apparent that the oxygenated hydrogel contact lens of the present invention comprises a lens object having a dry weight no greater than 90% of the dry weight of the lens object prior to extraction, and is a contact lens obtained from the overall formulation, and is derived from the inclusion of one or A variety of removable agent formulations or lens products for contact lenses.

在比較上，得自含稀釋劑配方之矽氧水凝膠隱形眼鏡之前述說明，並不包括具有高可萃取成份含量之不含稀釋劑之配方。此種鏡片經常需要表面處理或聚合體IPN，以提供眼睛上可接受之表面可潤溼性於矽氧水凝膠隱形眼鏡上。In comparison, the foregoing description of a silicone hydrogel contact lens from a diluent-containing formulation does not include a diluent-free formulation having a high extractable component content. Such lenses often require a surface treatment or polymeric IPN to provide an ocularly acceptable surface wettability to the hydroxyl hydrogel contact lens.

雖然本發明萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有相對較大量之可萃取物質，但本發明矽氧水凝膠隱形眼鏡之經萃取形式在鏡片物體中具有極少量之可萃取物質。在某些具體實施例中，留在經萃取鏡片中之可萃取物質之量為約0.1%至約4%，譬如約0.4%至約2%(w/w)。此等其他可萃取物質可經由使經萃取之隱形眼鏡與另一體積之強溶劑譬如氯仿接觸而測得。Although the pre-extracted polymerized hydrogel contact lens product of the present invention has a relatively large amount of extractable material, the extracted form of the hydroxyl hydrogel contact lens of the present invention has a very small amount of extractable material in the lens object. . In certain embodiments, the amount of extractable material remaining in the extracted lens is from about 0.1% to about 4%, such as from about 0.4% to about 2% (w/w). These other extractable materials can be measured by contacting the extracted contact lens with another volume of a strong solvent such as chloroform.

當矽氧水凝膠隱形眼鏡之鏡片物體具有乾重不大於萃取前鏡片物體乾重之90%時，矽氧水凝膠隱形眼鏡之經水合鏡片物體係為眼睛上可相容，且具有眼睛上可接受之表面可潤溼性。在比較上，當萃取前之矽氧水凝膠隱形眼鏡產物,其具有可移除成份含量低於鏡片產物之10%(w/w)，譬如約5－8%(w/w)，係得自非極性樹脂隱形眼鏡模時，如此製成之經水合矽氧水凝膠隱形眼鏡不具有眼睛上可接受之表面可潤溼性。因此，可明瞭此種不可潤溼鏡片係為包括具有乾重大於萃取前鏡片物體乾重之90%(譬如92%)之鏡片物體之鏡片。When the lens of the oxygenated hydrogel contact lens has a dry weight of no more than 90% of the dry weight of the lens before extraction, the hydrated lens system of the hydrogenated hydrogel contact lens is compatible on the eye and has an eye Acceptable surface wettability. In comparison, when the pre-extracted neohydrogen hydrogel contact lens product has a removable component content of less than 10% (w/w) of the lens product, such as about 5-8% (w/w), The hydrated silicone hydrogel contact lenses thus produced do not have acceptable surface wettability on the eye when obtained from a non-polar resin contact lens mold. Thus, it will be appreciated that such non-wettable lenses are those comprising a lens object having a dry weight greater than 90% (e.g., 92%) of the dry weight of the lens object prior to extraction.

此外，由於可萃取成份係存在於且分佈於整個可聚合矽氧水凝膠鏡片先質組合物與萃取前經聚合之矽氧水凝膠隱形眼鏡產物中，故本發明鏡片產物與隱形眼鏡可與經表面處理之矽氧水凝膠隱形眼鏡區別。由於可萃取成份可自鏡片產物萃取，且實質上不存在於經水合之隱形眼鏡中，故本發明鏡片產物與隱形眼鏡可與具有聚合體潤溼劑IPN之矽氧水凝膠隱形眼鏡區別。In addition, since the extractable component is present in and distributed throughout the polymerizable hydrogel lens precursor composition and the pre-extracted polymerized hydrogel contact lens product, the lens product and contact lens of the present invention can be It is distinguished from surface treated hydrogel contact lenses. Since the extractable component can be extracted from the lens product and is substantially absent from the hydrated contact lens, the lens product of the present invention and the contact lens can be distinguished from the oxygenated hydrogel contact lens having the polymeric wetting agent IPN.

本發明矽氧水凝膠隱形眼鏡可包括得自非極性樹脂隱形眼鏡模之鏡片物體，當其呈經水合與脫水狀態檢驗時，具有實質上相同之表面形態學。此外，此種經水合之鏡片物體可具有表面粗糙度稍低於經脫水鏡片物體之表面粗糙度。例如，本發明鏡片之鏡片物體可具有包括毫微米大小尖峰之表面，當分析鏡片表面之均方根(RMS)粗糙度數據時，其係顯而易見。鏡片物體可包括在此種尖峰間之區域，與該尖峰比較，其係差別膨潤，以提供降低之粗糙度，但實質上類似之表面形態學。例如，雖然當鏡片物體被水合時，尖峰之高度可被降低，但尖峰之形狀實質上仍然保持相同。The oxygenated hydrogel contact lenses of the present invention may comprise lens objects obtained from non-polar resin contact lens molds having substantially the same surface morphology when tested for hydration and dehydration. In addition, such hydrated lens objects may have a surface roughness that is slightly lower than the surface roughness of the dehydrated lens object. For example, a lens object of the lens of the present invention can have a surface comprising a nanometer-sized spike that is apparent when analyzing the root mean square (RMS) roughness data of the lens surface. The lens object can include a region between such peaks that, compared to the spike, is differentially swollen to provide reduced roughness, but is substantially similar to surface morphology. For example, although the height of the spikes can be lowered when the lens object is hydrated, the shape of the spikes remains substantially the same.

另外或替代地，本發明非極性樹脂所模製之矽氧水凝膠隱形眼鏡之具體實施例，當以電子顯微鏡觀看時，譬如掃描式電子顯微鏡、透射式電子顯微鏡或掃描透射式電子顯微鏡，可包括具有視覺上可確認之富含矽相域與缺乏矽相域之鏡片物體。以化學分析為基礎，可明瞭缺乏矽相域係為實質上或完全不含矽之鏡片內之區域。此等缺乏矽相域可大於經表面處理之矽氧水凝膠隱形眼鏡或包含聚合體潤溼劑之IPN之矽氧水凝膠隱形眼鏡中之此種相域。富含矽相域、缺乏矽相域或兩者之大小可使用習用影像分析軟體與裝置測定，譬如可得自Bioquant(Tennessee)之影像分析系統。影像分析軟體系統可用以畫出富含矽與缺乏矽相域邊緣之輪廓，且測定相域之橫截面面積、直徑、體積等。在某些具體實施例中，缺乏矽相域係具有橫截面面積為至少50%，至少60%，至少70%，至少80%，或至少90%大於其他矽氧水凝膠隱形眼鏡之缺乏矽相域。Additionally or alternatively, a specific embodiment of a silicone hydrogel contact lens molded by the non-polar resin of the present invention, when viewed with an electron microscope, such as a scanning electron microscope, a transmission electron microscope, or a scanning transmission electron microscope, A lens object having a visually identifiable 矽-rich phase domain and a lack of 矽 phase domain may be included. Based on chemical analysis, it is clear that there is a lack of areas in the lens that are substantially or completely free of defects. Such lack of 矽 phase domains may be greater than such phase domains in surface treated helium hydrogel contact lenses or IPN hydroxyl gel contact lenses comprising polymeric wetting agents. The size of the 矽-rich phase, the lack of 矽 phase, or both can be measured using conventional image analysis software and devices, such as the image analysis system available from Bioquant (Tennessee). The image analysis software system can be used to draw a contour rich in 矽 and lacking the edge of the 矽 phase, and measure the cross-sectional area, diameter, volume, etc. of the phase domain. In certain embodiments, the lack of a 矽 phase domain has a cross-sectional area of at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% greater than the lack of other hydrogenated hydrogel contact lenses. Phase domain.

在另一項具體實施例中，矽氧水凝膠隱形眼鏡包括得自萃取前經聚合之矽氧水凝膠隱形眼鏡產物之鏡片物體，其具有可移除成份含量為鏡片產物之至少10%(w/w)。萃取前經聚合之矽氧水凝膠隱形眼鏡產物之鏡片物體，可不含或未包含可移除或非反應性添加劑，譬如稀釋劑、相容劑等。此種鏡片物體可得自總體配方，如本文中所討論。此等鏡片物體係具有可移除成份含量為至少10%(w/w)，而在某些具體實施例中，鏡片物體具有可移除成份含量為至少15%(w/w)，至少20%(w/w)，至少25%(w/w)，約30%(w/w)或更多。例如，在某些具體實施例中，萃取前經聚合之隱形眼鏡產物具有可萃取成份含量為10%(w/w)至約30%(w/w)，且不含非反應性添加劑。在其他具體實施例中，萃取前經聚合之隱形眼鏡產物係具有可萃取成份含量為15%(w/w)至約30%(w/w)，且不含非反應性添加劑。在其他具體實施例中，鏡片物體可包含一或多種非反應性添加劑，且可具有可移除成份含量大於存在於不含非反應性添加劑之類似鏡片物體中之量。在某些具體實施例中，可移除成份含量係不大於鏡片產物之75%(w/w)。因此，本發明矽氧水凝膠隱形眼鏡之具體實施例係包括得自萃取前經聚合之矽氧水凝膠隱形眼鏡產物之鏡片物體，其具有可移除成份含量大於10%(w/w)，而不大於75%(w/w)。例如，一些萃取前經聚合之矽氧水凝膠隱形眼鏡產物可具有可移除成份含量約15%(w/w)至約65%(w/w)。可移除成份包括可萃取物質或可萃取物，其係在萃取程序期間被萃取。此外，可移除成份可包含其他物質，譬如揮發性物質，其可在萃取之前，被動地或主動地自萃取前經聚合之矽氧水凝膠隱形眼鏡產物移除。例如，可移除成份之一部份可在脫模步驟與萃取步驟之間蒸發。In another specific embodiment, the helium oxygen hydrogel contact lens comprises a lens object derived from a polymerized hydroxyl hydrogel contact lens product having a removable component content of at least 10% of the lens product. (w/w). The lens object of the polymerized hydroxyl hydrogel contact lens product prior to extraction may or may not contain removable or non-reactive additives such as diluents, compatibilizers, and the like. Such lens objects can be obtained from the overall formulation, as discussed herein. The lens systems have a removable component content of at least 10% (w/w), and in some embodiments, the lens object has a removable component content of at least 15% (w/w), at least 20 %(w/w), at least 25% (w/w), about 30% (w/w) or more. For example, in certain embodiments, the pre-extracted polymerized contact lens product has an extractable ingredient content of from 10% (w/w) to about 30% (w/w) and is free of non-reactive additives. In other embodiments, the pre-extracted polymerized contact lens product has an extractable ingredient content of from 15% (w/w) to about 30% (w/w) and is free of non-reactive additives. In other embodiments, the lens object can comprise one or more non-reactive additives and can have an amount of removable component greater than that present in a similar lens object that does not contain a non-reactive additive. In some embodiments, the removable component content is no greater than 75% (w/w) of the lens product. Accordingly, a specific embodiment of the oxygenated hydrogel contact lens of the present invention comprises a lens object obtained from a polymerized hydroxyl hydrogel contact lens product having a removable component content greater than 10% (w/w) ), not more than 75% (w/w). For example, some pre-extracted polymerized oxygenated hydrogel contact lens products can have a removable component content of from about 15% (w/w) to about 65% (w/w). Removable ingredients include extractables or extractables that are extracted during the extraction procedure. In addition, the removable component can comprise other materials, such as volatile materials, which can be passively or actively removed from the polymerized hydrogel contact lens product prior to extraction prior to extraction. For example, a portion of the removable component can be evaporated between the demolding step and the extraction step.

在某些具體實施例中，萃取前經聚合之矽氧水凝膠隱形眼鏡產物之可移除成份係包括至少一種可移除添加劑。如本文中所討論，可移除添加劑可為非反應性添加劑，或反應性添加劑，其會產生可自萃取前經聚合之矽氧水凝膠隱形眼鏡產物移除之產物。被包含在本發明萃取前經聚合之矽氧水凝膠隱形眼鏡產物之具體實施例中之可移除添加劑之實例，係包括相容劑、脫模助劑、脫除鏡片助劑、可潤溼性增強劑、離子通量降低劑、模數影響劑、鏈轉移劑及其組合。In certain embodiments, the removable component of the polymerized hydroxyl hydrogel contact lens product prior to extraction comprises at least one removable additive. As discussed herein, the removable additive can be a non-reactive additive, or a reactive additive that produces a product that can be removed from the polymerized hydrogel contact lens product prior to extraction. Examples of the removable additive included in the specific embodiment of the polymerized hydroxyl hydrogel contact lens product of the present invention include a compatibilizer, a mold release aid, a lens removal aid, and a moisturizing agent. Wetness enhancer, ion flux reducer, modulus influencer, chain transfer agent, and combinations thereof.

在某些具體實施例中，可移除成份包括疏水性添加劑、兩親性添加劑或其組合。例如，可移除成份可包括一或多種添加劑，選自包括非反應性醇類、非反應性親水性矽氧聚合體及其組合。作為進一步實例，添加劑可選自包括硬脂酸乙二醇酯、單月桂酸二乙二醇酯、C2 －C24 醇類、C2 －C24 胺類、聚二甲基矽氧烷－共－PEG及其組合。在一些具體實施例中，添加劑係選自包括癸醇、乙氧基乙醇、聚二甲基矽氧烷－共－PEG及其組合。可明瞭的是，在至少一些具體實施例中，添加劑係為經聚合組合物以外之作用劑，其係在鏡片物體形成期間，與可聚合矽氧水凝膠隱形眼鏡先質組合物混合。In certain embodiments, the removable component comprises a hydrophobic additive, an amphiphilic additive, or a combination thereof. For example, the removable component can include one or more additives selected from the group consisting of non-reactive alcohols, non-reactive hydrophilic oxygen polymers, and combinations thereof. As a further example, the additive may be selected from the group consisting of ethylene glycol stearate, diethylene glycol monolaurate, C 2 -C 24 alcohols, C 2 -C 24 amines, polydimethyl methoxyoxane - Co-PEG and combinations thereof. In some embodiments, the additive is selected from the group consisting of decyl alcohol, ethoxyethanol, polydimethyl decane-co-PEG, and combinations thereof. It will be appreciated that in at least some embodiments, the additive is an agent other than the polymeric composition that is mixed with the polymerizable silicone hydrogel contact lens precursor composition during formation of the lens object.

可明瞭聚二甲基矽氧烷－共－PEG(PDMS－共－PEG)係為親水性含矽氧劑，且於本文中稱為矽氧油。一般而言，此等親水性矽氧劑可溶於水與醇類中。可明瞭可用於本發明組合物與鏡片產物中之親水性含矽氧劑係為相容劑。此外，可明瞭此種作用劑係為脫模助劑與脫除鏡片助劑。例如，以親水性含矽氧劑製成之經聚合矽氧水凝膠隱形眼鏡產物，係選擇性地黏附至單一模具構件，譬如隱形眼鏡模之公模構件，且較易自模具構件脫除鏡片。此外，與製自未具有矽氧油之組合物之鏡片比較，矽氧油可降低矽氧水凝膠隱形眼鏡中之水含量，可幫助保持矽氧水凝膠隱形眼鏡之可潤溼性，且可降低隱形眼鏡之離子通量。典型上，於本發明配方與鏡片產物中所提供之矽氧油，係具有分子量小於約3000道爾吞。例如，本發明組合物與產物中之矽氧油類可具有分子量約100道爾吞至約3000道爾吞。在一些具體實施例中，矽氧油具有分子量約300道爾吞至約1000道爾吞。在一些特殊具體實施例中，矽氧油具有分子量約600道爾吞，且具有非矽氧烷含量約75%。可明瞭矽氧油為界面活性劑，且可明瞭係為具有經偶合至長PEG鏈之含矽主鏈之作用劑。It is understood that the polydimethyloxane-co-PEG (PDMS-co-PEG) system is a hydrophilic oxygen-containing agent and is referred to herein as a helium-oxygen oil. In general, such hydrophilic oxygenates are soluble in water and alcohols. It is understood that the hydrophilic oxygen-containing agent useful in the compositions of the present invention and the lens product is a compatibilizer. In addition, it is understood that such an agent is a release aid and a lens removal aid. For example, a polymeric oxygenated hydrogel contact lens product made from a hydrophilic oxygen-containing agent is selectively adhered to a single mold member, such as a male mold member of a contact lens mold, and is more easily removed from the mold member. lens. In addition, the oxime oil reduces the water content of the oxirane hydrogel contact lens as compared to lenses made from compositions that do not have a silicone oil, and helps maintain the wettability of the oxygenated hydrogel contact lens. And can reduce the ion flux of the contact lens. Typically, the ophthalmic oil provided in the formulations of the invention and the lens product has a molecular weight of less than about 3,000 Torr. For example, the compositions of the present invention and the heliox oils in the product can have a molecular weight of from about 100 Dow to about 3000 Dow. In some embodiments, the helium oxide oil has a molecular weight of from about 300 dox to about 1000 doxor. In some particular embodiments, the helium oxide oil has a molecular weight of about 600 doxane and has a non-oxyxane content of about 75%. It is clear that the oxime oil is a surfactant, and it is understood that it is an agent having a ruthenium-containing main chain coupled to a long PEG chain.

在另一項具體實施例中，矽氧水凝膠隱形眼鏡包括藉由一種方法製成之鏡片物體，該方法包括自萃取前經聚合之矽氧水凝膠隱形眼鏡產物萃取可萃取成份，以製造經萃取聚合之矽氧水凝膠隱形眼鏡產物。可萃取成份係以萃取前經聚合之矽氧水凝膠隱形眼鏡產物之至少10%(w/w)之量提供。製造鏡片物體之方法進一步包括使經萃取聚合之矽氧水凝膠隱形眼鏡產物水合，以製造具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡。In another specific embodiment, the helium oxygen hydrogel contact lens comprises a lens object made by a method comprising extracting an extractable component from a polymerized oxygenated hydrogel contact lens product prior to extraction, An extract polymerized hydrothermal hydrogel contact lens product is produced. The extractable component is provided in an amount of at least 10% (w/w) of the polymerized hydroxyl hydrogel contact lens product prior to extraction. The method of making a lens object further comprises hydrating the extracted polymeric oxygenated hydrogel contact lens product to produce a silicone hydrogel contact lens having an ocularly acceptable surface wettability.

如本文中所討論，可萃取成份可以萃取前經聚合之矽氧水凝膠隱形眼鏡產物之10%至約75%(w/w)之量存在。或者，可明瞭萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有可萃取成份含量為10%至約75%(w/w)。例如，可萃取成份可以萃取前經聚合之矽氧水凝膠隱形眼鏡產物之約15%至約65%(w/w)之量存在。As discussed herein, the extractable component can be present in an amount from 10% to about 75% (w/w) of the polymerized hydroxyl hydrogel contact lens product. Alternatively, it is understood that the polymerized hydrogel contact lens product prior to extraction has an extractable ingredient content of from 10% to about 75% (w/w). For example, the extractable component can be present in an amount from about 15% to about 65% (w/w) of the previously polymerized hydrogel contact lens product.

在某些具體實施例中，萃取前經聚合之矽氧水凝膠隱形眼鏡產物之可萃取成份包括至少一種可移除添加劑，如本文中所述。例如，可萃取成份可包括相容劑、脫模助劑、脫除鏡片助劑、可潤溼性增強劑、離子通量降低劑、模數影響劑及其組合，如本文中所述。In certain embodiments, the extractable component of the polymerized hydroxyl hydrogel contact lens product prior to extraction comprises at least one removable additive, as described herein. For example, the extractable components can include compatibilizers, release aids, lens release aids, wettability enhancers, ion flux reducers, modulus influencing agents, and combinations thereof, as described herein.

本發明鏡片之某些具體實施例包括無表面處理之鏡片物體，該表面處理係提供眼睛上可接受之表面可潤溼性。換言之，本發明矽氧水凝膠隱形眼鏡之鏡片物體可為未經表面處理之鏡片物體。或者，鏡片物體係經製造，而無需表面處理鏡片物體，以提供眼睛上可接受之表面可潤溼性。例如，本發明鏡片之具體實施例之鏡片物體未包括經提供以使得鏡片物體之表面較為眼睛上可接受之電漿處理或另一種塗層。但是，因為本發明鏡片具有眼睛上可接受之表面可潤溼性，此係由於存在於萃取前經聚合之矽氧水凝膠隱形眼鏡產物中之可移除物質之量所致，故若需要，則一些具體實施例可包括表面處理。Some specific embodiments of the lenses of the present invention include non-surface treated lens objects that provide acceptable surface wettability to the eye. In other words, the lens object of the oxygenated hydrogel contact lens of the present invention can be a lens object that has not been surface treated. Alternatively, the lens system can be fabricated without surface treatment of the lens object to provide acceptable surface wettability on the eye. For example, a lens object of a particular embodiment of the lens of the present invention does not include a plasma treatment or another coating that is provided such that the surface of the lens object is more ocularly acceptable. However, because the lenses of the present invention have an ocularly acceptable surface wettability due to the amount of removable material present in the polymerized hydrogel contact lens product prior to extraction, if desired, Some specific embodiments may include surface treatment.

此外，本發明鏡片之具體實施例包括不含聚合體潤溼劑之互穿聚合體網狀組織之鏡片物體，該潤溼劑係提供眼睛上可接受之表面可潤溼性。換言之，本發明鏡片之具體實施例之鏡片物體係具有眼睛上可接受之表面可潤溼性，且不包含聚合體潤溼劑譬如聚乙烯基四氫吡咯酮(PVP)之IPN。例如，本發明鏡片之鏡片物體可經製造，而無需使本發明可聚合矽氧水凝膠鏡片先質組合物與聚合體潤溼劑接觸以形成互穿聚合體網狀組織。Moreover, specific embodiments of the lenses of the present invention include lens objects that are free of interpolymeric polymeric network structures of polymeric wetting agents that provide ocular acceptable surface wettability. In other words, the lens system of a particular embodiment of the lens of the present invention has an ocularly acceptable surface wettability and does not comprise an IPN of a polymeric wetting agent such as polyvinyltetrahydropyrrolidone (PVP). For example, the lens object of the lenses of the present invention can be fabricated without contacting the polymerizable silicone hydrogel lens precursor composition of the present invention with a polymeric wetting agent to form an interpenetrating polymer network.

本發明鏡片之某些具體實施例包括鏡片物體，其係為得自非極性樹脂隱形眼鏡模之經鑄造模製元件。可明瞭的是，經聚合之矽氧水凝膠隱形眼鏡產物為在非極性樹脂隱形眼鏡模中經聚合或熟化之產物。或者，以另一種方式敘述，經聚合之矽氧水凝膠隱形眼鏡產物係在非極性樹脂隱形眼鏡模中製造。如本文中所討論，此種隱形眼鏡模係為使用非極性或疏水性樹脂材料所製成，或以其為基料之模具。此種材料典型上係在其形成鏡片之表面上具有相對較大接觸角。例如，非極性樹脂或疏水性樹脂模具可具有接觸角大於約90度。可用於鏡片之此等具體實施例之適當非極性樹脂模具材料之實例係包括樹脂材料，其包括一或多種聚烯烴。適當樹脂材料之一些實例包括聚乙烯、聚丙烯及聚苯乙烯，以及其他具有類似疏水性質之材料。非極性樹脂為基料之模具並不以極性樹脂為基料，譬如聚乙烯醇或乙烯乙烯醇共聚物。Some specific embodiments of the lenses of the present invention comprise a lens object that is a cast molded component from a non-polar resin contact lens mold. It will be appreciated that the polymerized oxygenated hydrogel contact lens product is the product of polymerization or ripening in a non-polar resin contact lens mold. Alternatively, in another manner, the polymerized oxygenated hydrogel contact lens product is made in a non-polar resin contact lens mold. As discussed herein, such contact lens molds are made of a non-polar or hydrophobic resin material, or a mold based thereon. Such materials typically have a relatively large contact angle on the surface on which the lens is formed. For example, the non-polar resin or hydrophobic resin mold can have a contact angle greater than about 90 degrees. Examples of suitable non-polar resin mold materials that can be used in these particular embodiments of the lens include resin materials that include one or more polyolefins. Some examples of suitable resin materials include polyethylene, polypropylene, and polystyrene, as well as other materials having similar hydrophobic properties. The mold in which the non-polar resin is a binder is not based on a polar resin such as polyvinyl alcohol or ethylene vinyl alcohol copolymer.

在進一步具體實施例中，本發明鏡片包括含有前文特徵之組合之鏡片物體。例如，矽氧水凝膠隱形眼鏡可包括無表面處理且不含聚合體潤溼劑之IPN之鏡片物體。作為另一項實例，矽氧水凝膠隱形眼鏡可包括一種鏡片物體，其不具有表面處理，不含聚合體潤溼劑之IPN，且為得自非極性樹脂隱形眼鏡模之經鑄造模製元件。In a further embodiment, the lenses of the present invention comprise a lens object comprising a combination of the foregoing features. For example, a helium oxygen hydrogel contact lens can include a lens object that is surface treated and does not contain an IPN of a polymeric wetting agent. As another example, a helium oxygen hydrogel contact lens can include a lens object that does not have a surface treatment, does not contain an IPN of a polymeric wetting agent, and is cast molded from a non-polar resin contact lens mold. element.

本發明矽氧水凝膠隱形眼鏡之一些具體實施例亦可包含一或多種舒適性增強劑，相對於未使用舒適性增強劑之矽氧水凝膠隱形眼鏡，其係增強鏡片配戴者或鏡片配戴者組群所感覺之隱形眼鏡之舒適性。可被包含在本發明鏡片中之舒適性增強劑之一項實例，為脫水作用降低劑。舒適性增強劑之另一項實例為淚膜安定劑。舒適性增強劑之另一項實例為降低脫水作用，且使隱形眼鏡置於其上之眼睛之淚膜安定化之作用劑。舒適性增強劑包含對水具有親和力之聚合材料。在某些具體實施例中，該聚合材料係衍生自兩親性材料之單位。適當材料之實例包括可聚合磷脂類，譬如包含磷醯膽鹼成份之材料。在某些具體實施例中，本發明鏡片包括含有甲基丙烯酸酯磷醯膽鹼－單體單位之鏡片物體。在進一步具體實施例中，鏡片物體包含2－甲基丙烯醯基氧基乙基磷醯膽鹼(MPC)。MPC可得自一些公司，譬如Biocompatibles有限公司(英國)與NOF公司(Tokyo,Japan)，或可按美國專利5,981,786；6,420,453；及6,423,761中所述製成。Some embodiments of the oxygenated hydrogel contact lenses of the present invention may also comprise one or more comfort enhancers that are enhanced lens wearers or relative to oxygenated hydrogel contact lenses that do not use comfort enhancers. The comfort of the contact lens felt by the lens wearer group. An example of a comfort enhancer that can be included in the lenses of the present invention is a dehydration reducing agent. Another example of a comfort enhancer is a tear film stabilizer. Another example of a comfort enhancer is an agent that reduces dehydration and stabilizes the tear film of the eye on which the contact lens is placed. The comfort enhancer comprises a polymeric material that has an affinity for water. In some embodiments, the polymeric material is derived from units of amphiphilic materials. Examples of suitable materials include polymerizable phospholipids, such as materials comprising a phosphonium choline component. In certain embodiments, the lenses of the present invention comprise a lens object comprising a methacrylate choline-monomer unit. In a further embodiment, the lens object comprises 2-methylpropenyloxyethylphosphonium choline (MPC). MPCs are available from companies such as Biocompatibles, Inc. (UK) and NOF (Tokyo, Japan), or can be made as described in U.S. Patents 5,981,786; 6,420,453; and 6,423,761.

如本文中所討論，本發明矽氧水凝膠鏡片之舒適性亦可藉由加入一或多種可移除之舒適性增強劑在鏡片先質組合物與萃取前之矽氧水凝膠隱形眼鏡產物中而被增強。例如，本文中所述之一些可移除物質包括會降低本發明鏡片之離子通量之作用劑，與得自未具有可移除物質之相同組合物之鏡片比較。降低鏡片之離子通量可幫助降低鏡片配戴者之角膜脫水作用，及降低由於配戴鏡片所造成之角膜染色。As discussed herein, the comfort of the oxygenated hydrogel lens of the present invention can also be achieved by incorporating one or more removable comfort enhancers in the lens precursor composition and the oxygenated hydrogel contact lens prior to extraction. It is enhanced in the product. For example, some of the removable materials described herein include agents that reduce the ionic flux of the lenses of the present invention, as compared to lenses obtained from the same compositions that do not have a removable material. Reducing the ion flux of the lens can help reduce the corneal dehydration of the lens wearer and reduce the corneal staining caused by wearing the lens.

如本文中所討論，本發明鏡片係具有允許鏡片被配戴歷經長時期之特徵與性質。例如，本發明鏡片可以每日配戴鏡片、每週配戴鏡片、每兩週配戴鏡片或每月配戴鏡片被配戴。本發明鏡片包括經水合之鏡片物體，其具有表面可潤溼性、模數、離子通量、氧透氣性及水含量，其係有助於鏡片之舒適性與可用性。在某些具體實施例中，本發明鏡片包括經水合之鏡片物體，其具有特徵，選自包括前進接觸角小於約95度、抗張模數小於約1.6 MPa、離子通量小於約7 x 10－3 平方毫米/分鐘、氧透氣性(Dk)至少約70巴勒(barrer)、水含量至少約30重量%及其組合。但是，在其他具體實施例中，離子通量可為大於7 x 10－3 平方毫米/分鐘，而又不會造成角膜脫水染色或其他臨床問題。例如，當矽氧水凝膠隱形眼鏡包含舒適性增強劑時，譬如磷醯膽鹼成份，譬如MPC，離子通量可為約25 x 10－3 平方毫米/分鐘，而仍為臨床上可接受。As discussed herein, the lenses of the present invention have the characteristics and properties that allow the lens to be worn over a long period of time. For example, the lenses of the present invention can be worn daily with lenses, with lenses worn every week, with lenses worn every two weeks or with monthly lenses. The lenses of the present invention comprise a hydrated lens object having surface wettability, modulus, ionic flux, oxygen gas permeability and water content which contribute to the comfort and usability of the lens. In some embodiments, the lenses of the present invention comprise a hydrated lens object having a feature selected from the group consisting of an advance contact angle of less than about 95 degrees, a tensile modulus of less than about 1.6 MPa, and an ion flux of less than about 7 x 10 -3 square millimeters per minute, oxygen gas permeability (Dk) of at least about 70 barrers, water content of at least about 30 weight percent, and combinations thereof. However, in other embodiments, the ion flux can be greater than 7 x 10 -3 square millimeters per minute without causing corneal dehydration staining or other clinical problems. For example, when a silicone hydrogel contact lens contains a comfort enhancer, such as a phosphonium choline component, such as MPC, the ion flux can be about 25 x 10 -3 square millimeters per minute while still being clinically acceptable. .

本發明鏡片可包括經水合之鏡片物體，其在前表面、後表面或前與後表面上具有前進接觸角小於120度。在某些具體實施例中，鏡片物體具有鏡片表面前進接觸角小於90度，例如鏡片物體具有鏡片表面前進接觸角約85度，約80度，約75度，約70度，約65度，約60度，約55度，或約50度。鏡片物體亦可具有鏡片表面倒退接觸角小於80度，例如，鏡片物體可具有鏡片表面倒退接觸角約75度，約70度，約65度，約60度，約55度，約50度，或約45度。遲滯現象，意即前進接觸角與倒退接觸角間之差異，可為約5度至約35度。但是，在某些具體實施例中，遲滯現象可大於25度，而仍然為臨床上可接受。例如，當矽氧水凝膠隱形眼鏡包含舒適性增強劑時，譬如磷醯膽鹼成份，譬如MPC，遲滯現象可為約60度，而鏡片可仍然為臨床上可接受。The lenses of the present invention can include a hydrated lens object having an advancing contact angle of less than 120 degrees on the front surface, the back surface, or the front and back surfaces. In some embodiments, the lens object has a lens surface advancing contact angle of less than 90 degrees, such as a lens object having a lens surface advancing contact angle of about 85 degrees, about 80 degrees, about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, or about 50 degrees. The lens object may also have a reverse surface contact angle of the lens surface of less than 80 degrees. For example, the lens object may have a reverse surface contact angle of the lens surface of about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, about 50 degrees, or About 45 degrees. Hysteresis, which means that the difference between the advancing contact angle and the receding contact angle may be from about 5 degrees to about 35 degrees. However, in some embodiments, the hysteresis can be greater than 25 degrees while still being clinically acceptable. For example, when a silicone hydrogel contact lens contains a comfort enhancer, such as a phosphonium choline component, such as MPC, the hysteresis can be about 60 degrees, while the lens can still be clinically acceptable.

前進接觸角可使用一般熟諳此藝者所已知之例行方法測定。例如，隱形眼鏡之前進接觸角與倒退接觸角可使用習用滴液形狀方法度量，譬如固定滴法或俘獲氣泡方法。矽氧水凝膠隱形眼鏡之前進與倒退水接觸角可使用Kruss DSA 100儀器(Kruss GmbH,Hamburg)，及按D.A.Brandreth："動態接觸角與接觸角遲滯現象",膠體與界面科學期刊,第62卷,1977,第205－212頁，與R.Knapikowski,M.Kudra：Kontaktwinkel messungen nach dem Wilhelmy－Prinzip－Ein statistischer Ansatz zur Fehierbeurteilung",Chem.Technik,第45卷,1993,第179－185頁，以及美國專利6,436,481中所述測定。The advancing contact angle can be determined using routine methods known to those skilled in the art. For example, the contact angle and the reverse contact angle of the contact lens can be measured using a conventional drop shape method, such as a fixed drop method or a trap bubble method. The Kruss DSA 100 instrument (Kruss GmbH, Hamburg) and the DABrandreth: "Dynamic contact angle and contact angle hysteresis" can be used for the contact angle of the deionized hydrogel contact lens. Colloid and Interface Science Journal Vol. 62, 1977, pp. 205-212, and R. Knapikowski, M. Kudra: Kontaktwinkel messungen nach dem Wilhelmy-Prinzip-Ein statistischer Ansatz zur Fehierbeurteilung", Chem. Technik, Vol. 45, 1993, pp. 179-185 And as determined in U.S. Patent 6,436,481.

作為一項實例，前進接觸角與倒退接觸角可使用俘獲氣泡方法，使用磷酸鹽緩衝之鹽水(PBS；pH＝7.2)測定。於測試前，將鏡片平展在石英表面上，並以PBS再水合10分鐘。氣泡係使用自動化注射器系統放置至鏡片表面上。可增加與降低氣泡之大小，以獲得倒退角度(當增加氣泡大小時所獲得之高原區)與前進角度(當降低氣泡大小時所獲得之高原區)。As an example, the advancing contact angle and the reverse contact angle can be determined using a trapped bubble method using phosphate buffered saline (PBS; pH = 7.2). Prior to testing, the lenses were spread flat on a quartz surface and rehydrated for 10 minutes in PBS. The bubbles are placed onto the surface of the lens using an automated syringe system. The size of the bubble can be increased and decreased to obtain a retreat angle (a plateau region obtained when the bubble size is increased) and an advancing angle (a plateau region obtained when the bubble size is reduced).

本發明鏡片可另外或替代地包括顯示水破碎時間(BUT)大於5秒之鏡片物體。例如，包括具有水BUT至少15秒，譬如20秒或更多之鏡片物體之本發明鏡片之具體實施例，可具有眼睛上可接受之表面可潤溼性。The lenses of the present invention may additionally or alternatively include lens objects that exhibit a water break time (BUT) of greater than 5 seconds. For example, a particular embodiment of the lens of the present invention comprising a lens object having a water BUT of at least 15 seconds, such as 20 seconds or more, can have an ocularly acceptable surface wettability.

本發明鏡片可包括具有模數小於1.6 MPa之鏡片物體。在某些具體實施例中，鏡片物體之模數係小於1.0 MPa。例如，鏡片物體可具有模數約0.9 MPa，約0.8 MPa，約0.7 MPa，約0.6 MPa，約0.5 MPa，約0.4 MPa，或約0.3 MPa。本發明矽氧水凝膠隱形眼鏡之一項實例係具有模數為0.55 MPa。鏡片物體之模數係經選擇，以在被放置於眼睛上時提供舒適鏡片，且順應鏡片被鏡片配戴者之處理。The lenses of the present invention can include lens objects having a modulus of less than 1.6 MPa. In some embodiments, the lens object has a modulus of less than 1.0 MPa. For example, the lens object can have a modulus of about 0.9 MPa, about 0.8 MPa, about 0.7 MPa, about 0.6 MPa, about 0.5 MPa, about 0.4 MPa, or about 0.3 MPa. An example of a helium oxygen hydrogel contact lens of the present invention has a modulus of 0.55 MPa. The modulus of the lens object is selected to provide a comfortable lens when placed on the eye, and the compliant lens is treated by the lens wearer.

鏡片物體之模數可使用一般熟諳此藝者所已知之例行方法測定。例如，具有約4毫米寬度之隱形眼鏡之片塊可從鏡片之中心部份切除，且抗張模數(單位；MPa)可自應力應變曲線之起始斜率測得，該曲線係藉由張力試驗，在10毫米/分鐘之速率下，於空氣中，在至少75%之溼度下，於25℃下，使用Instron 3342(Instron公司)獲得。The modulus of the lens object can be determined using routine methods known to those skilled in the art. For example, a piece of contact lens having a width of about 4 mm can be removed from the central portion of the lens, and the tensile modulus (unit; MPa) can be measured from the initial slope of the stress-strain curve, which is obtained by tension The test was carried out using Instron 3342 (Instron) at a rate of 10 mm/min in air at a humidity of at least 75% at 25 °C.

本發明鏡片之鏡片物體之離子通量可小於5 x 10－3 平方毫米/分鐘。雖然一些本發明鏡片之鏡片物體可具有離子通量至高達約7 x 10－3 平方毫米/分鐘，但咸信當離子通量小於約5 x 10－3 平方毫米/分鐘時，且當隱形眼鏡未包含MPC時，角膜脫水作用與染色可被降低。在某些具體實施例中，鏡片物體之離子通量為約4.5 x 10－3 平方毫米/分鐘，約4 x 10－3 平方毫米/分鐘，約3.5 x 10－3 平方毫米/分鐘，約3 x 10－3 平方毫米/分鐘，或較小。但是，如本文中所述，離子通量可大於7 x 10－3 平方毫米/分鐘，而仍不會造成角膜脫水作用、染色或其他臨床問題。例如，當矽氧水凝膠隱形眼鏡包含舒適性增強劑時，譬如磷醯膽鹼成份，譬如MPC，離子通量可為約25 x 10－3 平方毫米/分鐘，而仍然為臨床上可接受。The ionic flux of the lens object of the lens of the present invention can be less than 5 x 10 -3 mm 2 /min. While some lens objects of the lenses of the present invention may have an ion flux of up to about 7 x 10 -3 square millimeters per minute, the flux is less than about 5 x 10 -3 square millimeters per minute, and when the contact lens is Corneal dehydration and staining can be reduced when MPC is not included. In some embodiments, the ionic flux of the lens object is about 4.5 x 10 -3 square millimeters per minute, about 4 x 10 -3 square millimeters per minute, about 3.5 x 10 -3 square millimeters per minute, about 3 x 10 -3 mm 2 /min, or smaller. However, as described herein, the ion flux can be greater than 7 x 10 -3 square millimeters per minute without causing corneal dehydration, staining, or other clinical problems. For example, when a silicone hydrogel contact lens contains a comfort enhancer, such as a phosphonium choline component, such as MPC, the ion flux can be about 25 x 10 -3 square millimeters per minute while still being clinically acceptable. .

本發明鏡片之鏡片物體之離子通量可使用一般熟諳此藝者所已知之例行方法測定。例如，隱形眼鏡或鏡片物體之離子通量可使用實質上類似美國專利5,849,811中所述之"離子通量技術"之技術進行度量。例如，可將欲被度量之鏡片放置在公與母部份間之鏡片保持裝置中。公與母部份包含可撓性密封環，其係位在鏡片與個別公或母部份之間。將鏡片定位在鏡片保持裝置中之後，將鏡片保持裝置放置在有螺紋蓋中。將蓋螺旋至玻璃管上，以界定供體室。供體室可以16毫升0.1莫耳濃度之NaCl溶液充填。接收室可以80毫升去離子水充填。將電導率計之導線浸沒在接收室之去離子水中，並將攪拌棒加入接收室中。將接收室放置在恒溫器中，並將溫度保持在約35℃下。最後，將供體室浸沒在接收室中。可每2分鐘取得導電率之度量值，歷經約20分鐘，於供體室之浸沒至接收室中後10分鐘開始。導電率對時間數據應為實質上線性。The ionic flux of the lens object of the lens of the present invention can be determined using routine methods known to those skilled in the art. For example, the ionic flux of a contact lens or lens object can be measured using techniques substantially similar to the "Ion Flux Technology" described in U.S. Patent 5,849,811. For example, the lens to be measured can be placed in a lens holder between the male and female portions. The male and female portions contain a flexible sealing ring that is positioned between the lens and the individual male or female portions. After positioning the lens in the lens holder, the lens holder is placed in a threaded cover. The lid is screwed onto the glass tube to define the donor chamber. The donor chamber can be filled with 16 ml of 0.1 molar NaCl solution. The receiving chamber can be filled with 80 ml of deionized water. The conductor of the conductivity meter is immersed in deionized water in the receiving chamber and the stir bar is added to the receiving chamber. The receiving chamber was placed in a thermostat and the temperature was maintained at about 35 °C. Finally, the donor chamber is submerged in the receiving chamber. The measure of conductivity can be taken every 2 minutes, starting about 10 minutes after immersion in the donor chamber into the receiving chamber for about 20 minutes. Conductivity versus time data should be substantially linear.

本發明鏡片之鏡片物體典型上具有高氧透氣性。例如，鏡片物體具有氧透氣性Dk不小於60巴勒(barrer)。本發明鏡片之具體實施例包括具有Dk約80巴勒，約90巴勒，約100巴勒，約110巴勒，約120巴勒，約130巴勒，約140巴勒或較大之鏡片物體。The lens object of the lens of the present invention typically has high oxygen permeability. For example, the lens object has an oxygen permeability Dk of not less than 60 barrers. Specific embodiments of the lenses of the present invention include lens objects having a Dk of about 80 barr, about 90 barr, about 100 barr, about 110 barr, about 120 barr, about 130 barr, about 140 barr or larger. .

本發明鏡片之Dk可使用一般熟諳此藝者所已知之例行方法測定。例如，Dk值可使用Mocon方法測定，如美國專利5,817,924中所述。Dk值可在Mocon Ox－Tran系統之模式指示下，使用市購可得儀器測定。The Dk of the lenses of the present invention can be determined using routine methods known to those skilled in the art. For example, the Dk value can be determined using the Mocon method as described in U.S. Patent 5,817,924. The Dk value can be determined using a commercially available instrument under the mode indication of the Mocon Ox-Tran system.

本發明鏡片亦包括具有眼睛上可接受之水含量之鏡片物體。例如，本發明鏡片之具體實施例包括具有水含量不低於30%之鏡片物體。在某些具體實施例中，鏡片物體係具有水含量約35%，約40%，約45%，約50%，約55%，約60%，或約65%。The lenses of the present invention also include lens objects having an acceptable water content on the eye. For example, a specific embodiment of the lens of the present invention includes a lens object having a water content of not less than 30%. In certain embodiments, the lens system has a water content of about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, or about 65%.

本發明鏡片之水含量可使用一般熟諳此藝者所已知之例行方法測定。例如，可將經水合之矽氧水凝膠隱形眼鏡自含水液體移除，擦拭以移除過量表面水，並稱重。然後，可將經稱重之鏡片於80℃下，在真空下，於烘箱中乾燥，接著可將經乾燥之鏡片稱重。重量差係經由從經水合鏡片之重量減去乾燥鏡片之重量而測得。水含量(%)為(重量差/經水合之重量)x 100。The water content of the lenses of the present invention can be determined using routine methods known to those skilled in the art. For example, a hydrated oxygenated hydrogel contact lens can be removed from the aqueous liquid, wiped to remove excess surface water, and weighed. The weighed lens can then be dried in an oven at 80 ° C under vacuum and the dried lens can then be weighed. The difference in weight is measured by subtracting the weight of the dried lens from the weight of the hydrated lens. The water content (%) is (weight difference / hydrated weight) x 100.

除了上文確認之特定數值以外，本發明鏡片可具有在上文所確認特定數值之任何組合間之範圍內之數值。例如，本發明隱形眼鏡可具有水含量約45%至約55%，離子通量值約3.9至約5.3，靜態接觸角約35度至約45度，前進接觸角約55度至約75度，倒退接觸角約47度至約55度，遲滯現象約11度至約25度，楊氏模數約0.47 MPa至約0.51 MPa，伸長率約140%至約245%，及其組合。In addition to the specific values identified above, the lenses of the present invention may have values within the range between any combination of the specific values identified above. For example, the present contact lens can have a water content of from about 45% to about 55%, an ion flux value of from about 3.9 to about 5.3, a static contact angle of from about 35 degrees to about 45 degrees, and an advancing contact angle of from about 55 degrees to about 75 degrees. The reverse contact angle is from about 47 degrees to about 55 degrees, the hysteresis is from about 11 degrees to about 25 degrees, the Young's modulus is from about 0.47 MPa to about 0.51 MPa, the elongation is from about 140% to about 245%, and combinations thereof.

在本發明矽氧水凝膠隱形眼鏡之一些特殊具體實施例中，鏡片物體係具有水BUT大於20秒，模數小於0.5 MPa，離子通量小於5，及水含量約55%。In some particular embodiments of the oxygenated hydrogel contact lenses of the present invention, the lens system has a water BUT of greater than 20 seconds, a modulus of less than 0.5 MPa, an ion flux of less than 5, and a water content of about 55%.

本發明矽氧水凝膠隱形眼鏡係為視覺矯正或視覺增強之隱形眼鏡。鏡片可為球面鏡片或非球面鏡片。鏡片可為單焦點鏡片或多焦點鏡片，包括雙焦點鏡片。在某些具體實施例中，本發明鏡片為旋轉安定化鏡片，譬如旋轉安定化之圓環體隱形眼鏡。旋轉安定化之隱形眼鏡可為包括含有整定物之鏡片物體之隱形眼鏡。例如，鏡片物體可具有稜鏡整定物、周圍整定物及/或一或多個薄化上與下區域。The oxygenated hydrogel contact lens of the present invention is a contact corrected or visually enhanced contact lens. The lens can be a spherical lens or an aspherical lens. The lens can be a monofocal lens or a multifocal lens, including a bifocal lens. In some embodiments, the lenses of the present invention are rotationally stabilized lenses, such as rotationally stabilized toroidal contact lenses. The rotationally stabilized contact lens can be a contact lens comprising a lens object containing the setting. For example, the lens object can have a sputum setting, a surrounding setting, and/or one or more thinned upper and lower regions.

本發明鏡片亦包括含有周圍邊緣區域之鏡片物體。周圍邊緣區域可包括圓化部份。例如，周圍邊緣區域可包括圓化後邊緣表面、圓化前邊緣表面或其組合。在某些具體實施例中，周圍邊緣係從前表面至後表面完全圓化。因此，可明瞭的是，本發明鏡片之鏡片物體可包括圓化周圍邊緣。The lenses of the present invention also include lens objects containing peripheral edge regions. The peripheral edge region may include a rounded portion. For example, the peripheral edge region can include a rounded rear edge surface, a rounded front edge surface, or a combination thereof. In some embodiments, the peripheral edge is completely rounded from the front surface to the back surface. Thus, it will be appreciated that the lens object of the lens of the present invention can include rounded peripheral edges.

本發明鏡片可包括具有厚度分佈形態之鏡片物體，其係尋求解決與現行矽氧水凝膠隱形眼鏡有關聯之問題，但其對鏡片配戴者仍然為舒適的。藉由改變鏡片物體之厚度與鏡片物體之模數，鏡片物體之剛性可加以控制。例如，對於隱形眼鏡之一個區域之剛性，可被定義為在所指定之區域上，鏡片之楊氏模數與鏡片厚度平方之乘積。因此，本發明鏡片之某些具體實施例可包括具有中心剛性(例如在鏡片之中心或光學區帶之中心之剛性)小於約0.007 MPa－平方毫米，晶狀體接面剛性小於約0.03 MPa－平方毫米或其組合之鏡片物體。晶狀體接面可被定義為具有斜面之晶狀體區帶之接面，或對於未具有斜面之鏡片，為距鏡片邊緣約1.2毫米之點(參閱美國專利6,849,671)。在其他具體實施例中，本發明鏡片可包括具有中心剛性大於0.007 MPa－平方毫米，晶狀體接面剛性大於約0.03 MPa－平方毫米或其組合之鏡片物體。The lenses of the present invention can include lens objects having a thickness profile that seek to address the problems associated with current helium oxygen hydrogel contact lenses, but which are still comfortable for lens wearers. The stiffness of the lens object can be controlled by varying the thickness of the lens object and the modulus of the lens object. For example, the stiffness of an area of a contact lens can be defined as the product of the Young's modulus of the lens and the square of the thickness of the lens over the designated area. Thus, certain embodiments of the lenses of the present invention can include a central stiffness (e.g., a stiffness at the center of the lens or the center of the optical zone) of less than about 0.007 MPa-square millimeter, and a lens joint stiffness of less than about 0.03 MPa-square millimeter. Or a combination of lens objects. The lens junction can be defined as the junction of the beveled lens zone or, for a lens that does not have a bevel, about 1.2 mm from the edge of the lens (see U.S. Patent 6,849,671). In other embodiments, the lenses of the present invention can comprise a lens object having a central stiffness greater than 0.007 MPa-square millimeter, a lens junction stiffness greater than about 0.03 MPa-square millimeters, or a combination thereof.

本發明矽氧水凝膠隱形眼鏡可在鏡片中或在鏡片之批次中，於物理參數上，譬如物理尺寸等，幾乎無變異性。例如，在某些具體實施例中，添加劑可被添加至可聚合矽氧水凝膠隱形眼鏡先質組合物中，以降低鏡片物理屬性上之變異性。使用此種物理參數控制添加劑，於鏡片之任何兩批次間之變異性可低於2%。例如，對於一或多個批次之本發明鏡片之變異性，可為約0.5%至約1.9%。例如，本發明鏡片之直徑與基本曲線可被控制在預定值之1.6%內。更明確言之，若標的隱形眼鏡直徑為14.0毫米，且若在隱形眼鏡批次中之隱形眼鏡之實際直徑係從約13.6毫米變化至約14.4毫米，則可在隱形眼鏡之製造期間使用一或多種添加劑，以降低變異性，並製造具有直徑範圍從約13.8毫米至約14.2毫米之隱形眼鏡。可提供類似控制，以降低鏡片厚度、矢狀深度、基底曲率等之偏差。添加劑可為稀釋劑或相容劑，且可以至高約5%(w/w)之量提供。因此，添加稀釋劑或其他添加劑，可用以降低或控制本發明隱形眼鏡中之變形。此外，稀釋劑或添加劑，以及改變存在於可聚合組合物中之活性或反應性成份，可用以在不同批次之鏡片中，以鏡片之物理性質作為標的，譬如模數。The oxygenated hydrogel contact lenses of the present invention can be used in lenses or in batches of lenses, with virtually no variability in physical parameters such as physical dimensions and the like. For example, in certain embodiments, an additive can be added to the polymerizable silicone hydrogel contact lens precursor composition to reduce variability in the physical properties of the lens. Using such physical parameters to control the additive, the variability between any two batches of the lens can be less than 2%. For example, the variability of one or more batches of the lenses of the present invention can range from about 0.5% to about 1.9%. For example, the diameter and base curve of the lenses of the present invention can be controlled to within 1.6% of the predetermined value. More specifically, if the target contact lens has a diameter of 14.0 mm, and if the actual diameter of the contact lens in the contact lens batch varies from about 13.6 mm to about 14.4 mm, then one or both of the contact lenses can be used during manufacture. A variety of additives to reduce variability and to manufacture contact lenses having a diameter ranging from about 13.8 mm to about 14.2 mm. Similar controls can be provided to reduce variations in lens thickness, sagittal depth, base curvature, and the like. The additive can be a diluent or compatibilizer and can be provided in an amount up to about 5% (w/w). Thus, the addition of diluents or other additives can be used to reduce or control the deformation in the contact lenses of the present invention. In addition, diluents or additives, as well as modifying the active or reactive ingredients present in the polymerizable composition, can be used to characterize the physical properties of the lens, such as modulus, in different batches of lenses.

本發明矽氧水凝膠隱形眼鏡可被提供於經密封之包裝中。例如，本發明矽氧水凝膠隱形眼鏡可被提供在適合輸送至鏡片配戴者之經密封氣泡包裝或其他類似容器中。鏡片可在包裝內被儲存於水溶液中，譬如鹽水溶液。一些適當溶液包括磷酸鹽緩衝之鹽水溶液與硼酸鹽緩衝之溶液。若需要，則溶液可包含殺菌劑，或可不含消毒或保存劑。若需要，則溶液亦可包含界面活性劑，譬如聚氧體(poloxamer)等。The oxygenated hydrogel contact lenses of the present invention can be provided in a sealed package. For example, the oxygenated hydrogel contact lenses of the present invention can be provided in a sealed bubble wrap or other similar container suitable for delivery to a lens wearer. The lens can be stored in an aqueous solution in a package, such as a saline solution. Some suitable solutions include a phosphate buffered saline solution and a borate buffered solution. If desired, the solution may contain a bactericide or may be free of disinfecting or preservatives. If desired, the solution may also contain a surfactant such as a poloxamer or the like.

在經密封包裝中之鏡片較佳為無菌。例如，鏡片可在將包裝密封之前經滅菌，或可在經密封包裝中滅菌。經滅菌之鏡片可為已被曝露至滅菌量之輻射之鏡片。例如，鏡片可為經熱壓處理之鏡片、經γ輻射之鏡片、經紫外線輻射曝露之鏡片等。The lens in the sealed package is preferably sterile. For example, the lens can be sterilized prior to sealing the package, or can be sterilized in a sealed package. The sterilized lens can be a lens that has been exposed to a sterile amount of radiation. For example, the lens may be a heat-treated lens, a gamma-irradiated lens, a lens exposed to ultraviolet radiation, or the like.

本發明之另一方面係關於萃取前經聚合之矽氧水凝膠隱形眼鏡產物。例如，已被聚合而尚未進行萃取程序之鏡片產物，如本文中所述。Another aspect of the invention relates to a hydrogenated hydrogel contact lens product that is polymerized prior to extraction. For example, lens products that have been polymerized without an extraction procedure, as described herein.

如上文所討論，以相對較高量之可移除物質，譬如可萃取物質等，製造萃取前經聚合之矽氧水凝膠隱形眼鏡產物，會造成具有眼睛上可接受之表面可潤溼性之矽氧水凝膠隱形眼鏡，即使當鏡片係使用非極性樹脂隱形眼鏡模製造，且未包括聚合體潤溼劑之IPN之表面處理時亦然。As discussed above, the production of pre-extracted polymerized hydrogel hydrogel contact lens products with relatively high amounts of removable materials, such as extractable materials, results in ocularly acceptable surface wettability. Oxygen hydrogel contact lenses, even when the lenses are made using a non-polar resin contact lens mold, and which does not include the surface treatment of the IPN of the polymeric wetting agent.

本發明萃取前經聚合之矽氧水凝膠隱形眼鏡產物之具體實施例，係包括萃取前之物體構件，其具有乾重為至少10%大於使物體構件接受萃取程序以形成經萃取聚合之矽氧水凝膠隱形眼鏡產物後之物體構件乾重。例如，萃取前經聚合之矽氧水凝膠隱形眼鏡產物係具有可萃取成份含量為鏡片產物之至少10%(w/w)。在某些具體實施例中，萃取前經聚合之矽氧水凝膠隱形眼鏡產物係具有可萃取成份含量不大於鏡片產物之75%。在進一步具體實施例中，可萃取成份含量為經萃取鏡片產物之約15%至約65%(w/w)。在又進一步具體實施例中，可萃取成份含量為經萃取鏡片產物之約15%至約50%(w/w)。A specific embodiment of the pre-extracted polymerized hydrogel contact lens product of the present invention comprises an object member prior to extraction having a dry weight of at least 10% greater than the subject member undergoing an extraction procedure to form an extracted polymer. The dry weight of the component after the oxygen hydrogel contact lens product. For example, the pre-extracted polymerized hydrogel contact lens product has an extractable ingredient content of at least 10% (w/w) of the lens product. In certain embodiments, the pre-extracted polymerized hydrogel contact lens product has an extractable ingredient content of no greater than 75% of the lens product. In further embodiments, the extractable ingredient is present in an amount from about 15% to about 65% (w/w) of the extracted lens product. In still further embodiments, the extractable ingredient is present in an amount from about 15% to about 50% (w/w) of the extracted lens product.

由於本發明鏡片可得自非極性樹脂隱形眼鏡模構件，故本發明萃取前之矽氧水凝膠隱形眼鏡產物之具體實施例，係包括此種與非極性樹脂隱形眼鏡模構件接觸所提供之產物。例如，具體實施例可為在經密閉之隱形眼鏡模中所提供之萃取前產物，或在經脫模隱形眼鏡模之一個模具構件上所提供之萃取前產物。在一些具體實施例中，萃取前之鏡片產物係與隱形眼鏡公模構件接觸。Since the lens of the present invention can be obtained from a non-polar resin contact lens mold member, a specific embodiment of the oxygenated hydrogel contact lens product of the present invention prior to extraction includes such contact with a non-polar resin contact lens mold member. product. For example, a specific embodiment can be a pre-extraction product provided in a sealed contact lens mold, or a pre-extraction product provided on a mold member of a release contact lens mold. In some embodiments, the lens product prior to extraction is in contact with the contact lens male mold member.

本發明萃取前之矽氧水凝膠隱形眼鏡產物之具體實施例，亦包括含有一或多種可移除添加劑，譬如非反應性添加劑之物體構件。添加劑係包括上述之每一種與各添加劑，包括此種添加劑之組合。因此，可明瞭的是，萃取前之鏡片產物可包含一或多種添加劑，選自包括相容劑、脫模助劑、脫除鏡片助劑、可潤溼性增強劑、離子通量降低劑、舒適性劑及其組合。Specific embodiments of the oxygenated hydrogel contact lens products of the present invention prior to extraction also include object members containing one or more removable additives, such as non-reactive additives. Additives include each of the above and various additives, including combinations of such additives. Therefore, it is clear that the lens product before extraction may comprise one or more additives selected from the group consisting of compatibilizers, mold release aids, lens removal aids, wettability enhancers, ion flux reducers, Comfort agents and combinations thereof.

在某些具體實施例中，鏡片產物係包括含有甲基丙烯酸酯磷醯膽鹼－單體之單位，譬如2－甲基丙烯醯基氧基乙基磷醯膽鹼之萃取前物體構件。In certain embodiments, the lens product comprises a pre-extracted object member comprising a methacrylate choline-monomer unit, such as 2-methylpropenyl methoxyethylphosphonium choline.

本發明之另一方面係關於可聚合矽氧水凝膠隱形眼鏡先質組合物。本發明先質組合物可包含可聚合含矽成份與可聚合非含矽成份。此兩種成份係被合併為可聚合矽氧水凝膠隱形眼鏡先質組合物。先質組合物之一部份可從製自先質組合物之經聚合矽氧水凝膠隱形眼鏡產物移除。可移除部份係以經聚合之矽氧水凝膠隱形眼鏡產物之至少10%(w/w)之量存在。Another aspect of the invention pertains to a polymerizable silicone hydrogel contact lens precursor composition. The precursor composition of the present invention may comprise a polymerizable cerium-containing component and a polymerizable non-cerium-containing component. These two components are combined into a polymerizable silicone hydrogel contact lens precursor composition. A portion of the precursor composition can be removed from the polymerized hydrogel contact lens product from the precursor composition. The removable portion is present in an amount of at least 10% (w/w) of the polymerized hydrogel contact lens product.

在某些具體實施例中，先質組合物之非含矽成份係包含具有第一個反應性比之第一種單體，與具有低於第一個反應性比之第二個反應性比之第二種單體。例如，若第一種單體具有反應性比為約3，則第二種單體具有反應性比低於約3。第二個反應性比可為約10%低於，約20%低於，約30%低於，約40%低於，約50%低於，約60%低於，約70%低於，約80%低於，或約90%低於第一個反應性比。在一項具體實施例中，第二種單體係具有反應性比為0.5，而第一種單體具有反應性比為3。本發明鏡片產物與鏡片可在經聚合產物之形成期間，利用具有不同反應性比之反應性成份製成。可明瞭的是，具有較高反應性比之成份通常比具有較低反應性比之成份較具反應性，且因此較多具有較高反應性比之第一種成份將在特定量之時間內反應。在某些具體實施例中，先質組合物亦包含交聯劑，其具有比第二個反應性比，較類似第一個反應性比之反應性比。因此，在本發明先質組合物中之反應性成份之類型，可影響存在於經聚合鏡片產物中之可移除成份量、本發明矽氧水凝膠隱形眼鏡之乾重及鏡片之可潤溼性。In certain embodiments, the non-ruthenium containing component of the precursor composition comprises a first monomer having a first reactivity ratio and a second reactivity ratio having a lower than first reactivity ratio. The second monomer. For example, if the first monomer has a reactivity ratio of about 3, the second monomer has a reactivity ratio of less than about 3. The second reactivity ratio may be less than about 10%, about 20% lower, about 30% lower, about 40% lower, about 50% lower, about 60% lower, and about 70% lower. About 80% is below, or about 90% is lower than the first reactivity ratio. In a specific embodiment, the second single system has a reactivity ratio of 0.5 and the first monomer has a reactivity ratio of 3. The lens products and lenses of the present invention can be made using reactive components having different reactivity ratios during formation of the polymerized product. It is clear that components with a higher reactivity ratio are generally more reactive than components with a lower reactivity ratio, and therefore the first component with a higher reactivity ratio will be within a certain amount of time. reaction. In certain embodiments, the precursor composition also includes a crosslinking agent having a reactivity ratio that is more similar to the first reactivity ratio than the second reactivity ratio. Thus, the type of reactive component in the precursor composition of the present invention can affect the amount of removable component present in the polymerized lens product, the dry weight of the oxygenated hydrogel contact lens of the present invention, and the lubricity of the lens. Wet.

此外，本發明先質組合物可包含一或多種引發劑。可明瞭熱引發劑係具有"開始"溫度。藉由選擇具有較高開始溫度之熱引發劑，及使用相對較低量之引發劑，可降低本發明鏡片之離子通量，且影響本文中所述之可移除成份量。例如，在本發明先質組合物中所使用之一種熱引發劑為2,2'－偶氮雙(2,4－二甲基戊腈)(VAZO－52)，其具有開始溫度為約50℃，此時，反應性成份係開始聚合。在本發明先質組合物中所使用之第二種熱引發劑為偶氮雙異丁腈(VAZO－88)，其具有開始溫度為約90℃。眼睛上可相容之矽氧水凝膠隱形眼鏡可得自包含約0.2份VAZO－52或約0.1份VAZO－88之先質組合物。此外，於本文中所揭示用以聚合可聚合組合物之熟化方法，可包括一或多個溫度步驟。Furthermore, the precursor compositions of the present invention may comprise one or more initiators. It is clear that the thermal initiator has a "start" temperature. By selecting a thermal initiator having a higher onset temperature and using a relatively lower amount of initiator, the ionic flux of the lenses of the present invention can be reduced and affect the amount of removable components described herein. For example, one of the thermal initiators used in the precursor compositions of the present invention is 2,2'-azobis(2,4-dimethylvaleronitrile) (VAZO-52) having a starting temperature of about 50. °C, at this time, the reactive components begin to polymerize. The second thermal initiator used in the precursor compositions of the present invention is azobisisobutyronitrile (VAZO-88) having a starting temperature of about 90 °C. The ocular compatible hydroxyl hydrogel contact lens can be obtained from a precursor composition comprising about 0.2 part VAZO-52 or about 0.1 part VAZO-88. Moreover, the curing process disclosed herein for polymerizing the polymerizable composition can include one or more temperature steps.

本發明先質組合物之具體實施例可包含一或多種可移除或可萃取之疏水性或兩親性添加劑，譬如上述特定添加劑。一或多種添加劑可以約1%至約60%(w/w)之量存在。在一些具體實施例中，一或多種添加劑係以約30%(w/w)至約60%(w/w)之量存在。在某些組合物中，係提供至少兩種不同添加劑。Particular embodiments of the precursor compositions of the present invention may comprise one or more removable or extractable hydrophobic or amphiphilic additives, such as the specific additives described above. One or more additives may be present in an amount from about 1% to about 60% (w/w). In some embodiments, the one or more additives are present in an amount from about 30% (w/w) to about 60% (w/w). In certain compositions, at least two different additives are provided.

本發明先質組合物之某些具體實施例，係包括在非極性樹脂隱形眼鏡模中所提供之可聚合矽氧水凝膠隱形眼鏡先質組合物。其他具體實施例包括在儲存容器譬如瓶子等之中，或在分配裝置譬如手動或自動化吸量裝置中之此種組合物。Some specific embodiments of the precursor compositions of the present invention comprise a polymerizable silicone hydrogel contact lens precursor composition provided in a non-polar resin contact lens mold. Other embodiments include such compositions in storage containers such as bottles or the like, or in dispensing devices such as manual or automated pipetting devices.

本發明先質組合物之一項實例包含可聚合含矽成份，其包括二甲基丙烯醯基含矽氧巨體、α－ω－雙(甲基丙烯醯基氧基乙基亞胺基羧乙基氧基丙基)－聚(二甲基矽氧烷)－聚(三氟丙基甲基矽氧烷)－聚(ω－甲氧基－聚(乙二醇)丙基甲基矽氧烷)(M3U)，與可聚合非含矽成份，其包括N－乙烯基－N－甲基乙醯胺(VMA)、甲基丙烯酸異酯(IBM)、甲基丙烯酸乙氧基乙酯(EOEMA)、二甲基丙烯酸三(乙二醇)酯(TEGDMA)、三乙二醇二乙烯醚(TEGDVE)及2,2'－偶氮雙(2,4－二甲基戊腈)(VAZO－52)。與實質上相同而未具有IBM之鏡片比較，在此組合物中之IBM係顯示會增加經萃取之矽氧水凝膠隱形眼鏡之剛度。含矽成份可佔組合物之約30－40%(w/w)，而非含矽成份可佔組合物之約60－70%(w/w)。在某些具體實施例中，M3U係以約30－40%之量提供，VMA係以約45－50%之量提供，MMA係以15－20%之量提供，IBM係以約5%之量提供，EOEMA係以15%之量提供，TEGDMA或TEGDMA與TEGDVE係以約0.2%之量提供，且VAZO－52係以約0.5%之量提供。An example of a precursor composition of the present invention comprises a polymerizable ruthenium-containing component comprising a dimethyl propylene sulfonium-containing oxime macro, an α-ω-bis(methacryl oxiranyloxyethylimino carboxy group) Ethyloxypropyl)-poly(dimethyloxane)-poly(trifluoropropylmethyloxirane)-poly(ω-methoxy-poly(ethylene glycol)propylmethylhydrazine Oxane) (M3U), with a polymerizable non-ruthenium containing component, including N-vinyl-N-methylacetamide (VMA), methacrylic acid Ester (IBM), ethoxyethyl methacrylate (EOEMA), tris(ethylene glycol) dimethacrylate (TEGDMA), triethylene glycol divinyl ether (TEGDVE) and 2,2'-azo Bis(2,4-dimethylvaleronitrile) (VAZO-52). The IBM line in this composition is shown to increase the stiffness of the extracted hydroxyl hydrogel contact lens as compared to a lens that is substantially identical to IBM. The cerium-containing component may comprise from about 30% to about 40% (w/w) of the composition, and the non-containing cerium component may comprise from about 60% to about 70% (w/w) of the composition. In some embodiments, the M3U is provided in an amount of about 30-40%, the VMA is provided in an amount of about 45-50%, the MMA is provided in an amount of 15-20%, and the IBM is about 5%. Provided, EOEMA is provided in an amount of 15%, TEGDMA or TEGDMA and TEGDVE are provided in an amount of about 0.2%, and VAZO-52 is provided in an amount of about 0.5%.

本發明先質組合物之另一項實例係包含前述成份與紫外線吸收劑，及微染劑，其可為反應性染料或顏料粒子。UV吸收劑可以約0.9%之量提供，而微染劑可以約0.1%之量提供。UV吸收劑可為強UV吸收劑，其係顯示相對較高吸收值在約320－380毫微米之UV－A範圍內，但高於約380毫微米係相對較透明。例如，UV吸收劑可包括可光聚合之羥基二苯甲酮類與可光聚合之苯并***類，譬如可以CYASORBUV416市購得自Cytec工業之2－羥基－4－丙烯醯基氧基乙氧基二苯甲酮，2－羥基－4－(2－羥基－3－甲基丙烯醯基基氧基)丙氧基二苯甲酮，及可以NORBLOC7966市購得自Noramco之可光聚合苯并***。其他可光聚合之UV吸收劑可包括可聚合之乙烯系不飽和三類、柳酸酯類、芳基取代之丙烯酸酯類及其他有效UV吸收劑之可聚合變型，以及此等UV吸收劑之混合物。Another example of the precursor composition of the present invention comprises the aforementioned components and an ultraviolet absorber, and a microdye which may be a reactive dye or pigment particle. The UV absorber can be provided in an amount of about 0.9%, and the micro dye can be provided in an amount of about 0.1%. The UV absorber can be a strong UV absorber which exhibits a relatively high absorption value in the UV-A range of about 320-380 nm, but is relatively more transparent than about 380 nm. For example, the UV absorber may include photopolymerizable hydroxybenzophenones and photopolymerizable benzotriazoles, such as CYASORB. UV416 is commercially available from Cytec Industries as 2-hydroxy-4-propenyloxyethoxybenzophenone, 2-hydroxy-4-(2-hydroxy-3-methylpropenyloxy)propane Oxybenzophenone, and can be NORBLOC Photopolymerizable benzotriazole from Noramco was purchased from 7966. Other photopolymerizable UV absorbers may include polymerizable ethylenic unsaturated three Polymerizable variants of acrylates, aryl esters, aryl substituted acrylates and other effective UV absorbers, and mixtures of such UV absorbers.

本發明先質組合物之另一項具體實施例，係包含可聚合含矽成份，其包括M3U，與可聚合非含矽成份，其包括VMA、甲基丙烯酸甲酯(MMA)、TEGDMA及VAZO－52。Another embodiment of the precursor composition of the present invention comprises a polymerizable ruthenium-containing component comprising M3U, and a polymerizable non-ruthenium-containing component comprising VMA, methyl methacrylate (MMA), TEGDMA and VAZO -52.

本發明先質組合物之另一個實例，係包含前述具體實施例之成份與紫外線吸收劑及微染劑。此具體實施例亦可包含聚二甲基矽氧烷(PDMS)與聚乙二醇(PEG)之嵌段共聚物。此嵌段共聚物係於本文中縮寫成PDMS－共－PEG。PDMS－共－PEG之一項實例係具有PEG含量為75%，且分子量為約1400。可使用之PDMS－共－PEG材料之其他實例係具有分子量約300至約3000道爾吞。PDMS－共－PEG可以約10%(w/w)至約40%(w/w)之量存在。例如，先質組合物可包含PDMS－共－PEG，其量為12%(w/w)，20%(w/w)，25%(w/w)，29%(w/w)，或30%(w/w)。Another example of the precursor composition of the present invention comprises the components of the foregoing specific examples and an ultraviolet absorber and a microdye. This embodiment may also comprise a block copolymer of polydimethyl siloxane (PDMS) and polyethylene glycol (PEG). This block copolymer is abbreviated herein to PDMS-co-PEG. An example of PDMS-co-PEG has a PEG content of 75% and a molecular weight of about 1400. Other examples of PDMS-co-PEG materials that can be used have a molecular weight of from about 300 to about 3000 dolphins. PDMS-co-PEG may be present in an amount from about 10% (w/w) to about 40% (w/w). For example, the precursor composition may comprise PDMS-co-PEG in an amount of 12% (w/w), 20% (w/w), 25% (w/w), 29% (w/w), or 30% (w/w).

本發明先質組合物之另一項具體實施例，係包含可聚合含矽成份，其包括M3U，與可聚合非含矽成份，其包括VMA、IBM、MMA、TEGDMA，紫外線吸收劑、微染劑及VAZO－64。此等組合物之具體實施例可具有模數大於本文中所揭示之其他具體實施例。Another embodiment of the precursor composition of the present invention comprises a polymerizable ruthenium-containing component comprising M3U, and a polymerizable non-ruthenium-containing component, which comprises VMA, IBM, MMA, TEGDMA, UV absorber, micro-dye And VAZO-64. Particular embodiments of such compositions can have a modulus greater than other specific embodiments disclosed herein.

本發明先質組合物之另一項具體實施例，係包含可聚合含矽成份，其包括M3U，與可聚合非含矽成份，其包括1－乙烯基－2－四氫吡咯酮(NVP)、MMA、TEGDMA及VAZO－52。在此種具體實施例中，含矽成份係佔組合物之約30－40%(w/w)，而非含矽成份係佔組合物之約60－70%(w/w)。例如，M3U可以約35%至約38%之量存在。NVP可以約45－50%之量存在，MMA可以約15－20%之量存在，TEGDMA可以約0.1－0.8%之量存在，且VAZO－52可以約0.1－0.6%之量存在。Another embodiment of the precursor composition of the present invention comprises a polymerizable ruthenium-containing component comprising M3U, and a polymerizable non-ruthenium-containing component comprising 1-vinyl-2-tetrahydropyrrolidone (NVP) , MMA, TEGDMA and VAZO-52. In such embodiments, the cerium-containing component is present in an amount of from about 30% to about 40% (w/w) of the composition, and the non-containing cerium component is present in an amount of from about 60% to about 70% (w/w) of the composition. For example, M3U can be present in an amount from about 35% to about 38%. The NVP may be present in an amount of about 45-50%, the MMA may be present in an amount of about 15-20%, the TEGDMA may be present in an amount from about 0.1% to about 0.8%, and the VAZO-52 may be present in an amount from about 0.1% to about 0.6%.

另一項具體實施例係包含先前經確認之成份與癸醇。癸醇可以約5%(w/w)至約30%(w/w)之量提供。例如，具體實施例可包含癸醇，其量為約5%(w/w)，約10%(w/w)，約15%(w/w)，約20%(w/w)，約25%(w/w)，或約30%(w/w)。癸醇可有效作為相容劑與稀釋劑兩者。因此，癸醇可幫助降低鏡片先質組合物之諸成份之相分離。含癸醇配方之一項特殊實例係包含35% M3U，約45%至約55% NVP，約13%至約20% MMA，約0.1% TEGDMA，約0.6%(VAZO－52)，及約30%癸醇或較低。Another embodiment includes previously identified ingredients and sterols. The sterol may be provided in an amount of from about 5% (w/w) to about 30% (w/w). For example, particular embodiments may comprise sterols in an amount of about 5% (w/w), about 10% (w/w), about 15% (w/w), about 20% (w/w), about 25% (w/w), or about 30% (w/w). Sterols are effective as both a compatibilizer and a diluent. Thus, sterols can help reduce the phase separation of the components of the lens precursor composition. A particular example of a sterol-containing formulation comprises 35% M3U, from about 45% to about 55% NVP, from about 13% to about 20% MMA, about 0.1% TEGDMA, about 0.6% (VAZO-52), and about 30. % sterol or lower.

本發明含NVP之先質組合物亦可包含脫模助劑，譬如包含親水性矽氧成份、聚氧化烯成份或其組合之脫模助劑。The NVP-containing precursor composition of the present invention may also comprise a release aid such as a release aid comprising a hydrophilic rhodium component, a polyoxyalkylene component or a combination thereof.

本發明含NVP之先質組合物亦可包含稀釋劑，選自包括己醇、乙氧基乙醇、異丙醇(IPA)、丙醇、癸醇、矽氧油類及其組合。稀釋劑可以約10%至約30%(w/w)之量存在。具有相對較高濃度稀釋劑之組合物，係顯示具有較低離子通量值、降低之模數、增加之伸長率及大於20秒之水BUT。The NVP-containing precursor composition of the present invention may further comprise a diluent selected from the group consisting of hexanol, ethoxyethanol, isopropanol (IPA), propanol, decyl alcohol, decane oil, and combinations thereof. The diluent can be present in an amount from about 10% to about 30% (w/w). A composition having a relatively high concentration of diluent exhibits a lower ionic flux value, a reduced modulus, an increased elongation, and a water BUT greater than 20 seconds.

含有稀釋劑之含NVP先質組合物之某些具體實施例，係包含甲基丙烯酸酯磷醯膽鹼－單體之單位，譬如2－甲基丙烯醯基氧基乙基磷醯膽鹼。MPC可以組合物之約1%(w/w)至約15%(w/w)之量存在。例如，當本發明組合物包含約2.5% MPC,約5% MPC，約7% MPC，約10% MPC，或約12% MPC時，可製成眼睛上可相容之矽氧水凝膠隱形眼鏡。此種組合物亦可包含醇為基礎之稀釋劑。例如，一些組合物可包含約5%癸醇。Some specific embodiments of the NVP-containing precursor composition containing a diluent comprise units of methacrylate choline-monomer, such as 2-methylpropenyloxyethylphosphonium. The MPC can be present in an amount from about 1% (w/w) to about 15% (w/w) of the composition. For example, when the composition of the present invention comprises about 2.5% MPC, about 5% MPC, about 7% MPC, about 10% MPC, or about 12% MPC, it can be made into an incompatible ophthalmic hydrogel in the eye. glasses. Such compositions may also contain an alcohol based diluent. For example, some compositions may contain about 5% sterol.

本發明含NVP組合物之具體實施例，包括上述具體實施例，亦包含(3－甲基丙烯醯氧基－2－羥丙基氧基)丙基雙(三甲基矽烷氧基)甲基矽烷(SiGMA)。Specific examples of the NVP-containing composition of the present invention, including the above specific examples, also include (3-methacryloxy-2-hydroxypropyloxy)propylbis(trimethyldecyloxy)methyl Decane (SiGMA).

本發明之另一方面係關於製造矽氧水凝膠隱形眼鏡之方法。Another aspect of the invention relates to a method of making a silicone hydrogel contact lens.

在某些具體實施例中，本發明方法係包括自具有可移除成份含量為鏡片產物之至少10%(w/w)之萃取前矽氧水凝膠隱形眼鏡產物，形成具有乾重不大於萃取前鏡片物體乾重之90%與眼睛上可接受表面可潤溼性之矽氧水凝膠隱形眼鏡物體。In certain embodiments, the method of the invention comprises extracting a pro-hydroxamed hydrogel contact lens product having a removable component content of at least 10% (w/w) of the lens product, formed to have a dry weight of no greater than An oxygenated hydrogel contact lens object that is 90% of the dry weight of the lens object before extraction and which has acceptable surface wettability on the eye.

此種方法之形成步驟可包括自萃取前矽氧水凝膠隱形眼鏡產物萃取可萃取物質之步驟。The step of forming such a method can include the step of extracting the extractable material from the oxygenated hydrogel contact lens product prior to extraction.

該方法亦可包括使可聚合矽氧水凝膠隱形眼鏡先質組合物熟化，以形成具有可移除成份含量為鏡片產物之至少10%(w/w)之萃取前經聚合之矽氧水凝膠隱形眼鏡產物。如本文中所討論，熟化可為熱熟化或紫外光熟化。熟化可在非極性樹脂隱形眼鏡模中發生，譬如聚烯烴為基料之隱形眼鏡模。The method can also include curing the polymerizable silicone hydrogel contact lens precursor composition to form a pre-extracted polymerized water having a removable component content of at least 10% (w/w) of the lens product. Gel contact lens product. As discussed herein, the ripening can be thermal curing or UV curing. Curing can occur in non-polar resin contact lens molds, such as polyolefin-based contact lens molds.

方法亦可包括將可聚合含矽成份與可聚合非含矽成份合併，以形成可聚合矽氧水凝膠隱形眼鏡先質組合物。此方法之具體實施例亦可包括添加可移除添加劑至可聚合矽氧水凝膠隱形眼鏡先質組合物中之步驟。添加劑可被添加至最後單體混合物中，或其可在混合含矽成份與非含矽成份之前，被添加至該兩種成份之任一種中。添加劑可為本文中所述添加劑之任一種，包括此種添加劑之組合。The method can also include combining the polymerizable cerium-containing component with the polymerizable non-cerium-containing component to form a polymerizable oxime hydrogel contact lens precursor composition. Particular embodiments of the method can also include the step of adding a removable additive to the polymerizable silicone hydrogel contact lens precursor composition. The additive may be added to the final monomer mixture, or it may be added to either of the two components prior to mixing the bismuth-containing component with the non-ruthenium-containing component. The additive can be any of the additives described herein, including combinations of such additives.

方法亦可包括添加紫外線吸收劑、微染劑及其組合至鏡片先質組合物中之步驟。正如可自前文說明所明瞭者，可實施此等方法，以製造矽氧水凝膠隱形眼鏡，而無需表面處理鏡片、形成具有聚合體潤溼劑之IPN之鏡片，不需使用極性樹脂模具或其組合。The method can also include the steps of adding a UV absorber, a microdye, and combinations thereof to the lens precursor composition. As can be seen from the foregoing description, such methods can be implemented to produce a silicone hydrogel contact lens without the need for a surface treatment lens, an IPN lens having a polymeric wetting agent, without the use of a polar resin mold or Its combination.

鑒於本文之揭示內容，可明瞭本發明矽氧水凝膠隱形眼鏡之具體實施例係包括鏡片物體，其已進行萃取程序，以有效地自經聚丙烯模製、經氮熟化、經聚合之矽氧水凝膠隱形眼鏡產物移除可萃取物質，該隱形眼鏡產物係製自可聚合矽氧水凝膠隱形眼鏡先質組合物，其具有經分佈於整個組合物與鏡片產物中之可潤溼性增強單體、促相容量之一或多種添加劑及高量之可萃取物質。鏡片物體係具有眼睛上可接受之表面可潤溼性。In view of the disclosure herein, it will be apparent that particular embodiments of the oxygenated hydrogel contact lenses of the present invention include lens bodies that have been subjected to an extraction procedure to effectively mold from polypropylene, nitrogen cure, and polymerization. The oxygen hydrogel contact lens product removes an extractable material from a polymerizable silicone hydrogel contact lens precursor composition having a wettable distribution throughout the composition and lens product One or more additives and a high amount of extractable material. Lens systems have ocularly acceptable surface wettability.

使用本發明組合物與方法，已發明眼睛上可相容之矽氧水凝膠隱形眼鏡，同時避免與利用極性樹脂模具有關聯之問題，譬如在聚合反應時，於分離半模上之困難；與精巧且昂貴之後聚合程序有關聯之問題，譬如電漿蝕刻、照射、化學改質；及與聚合體潤溼劑之IPN有關聯之問題。Using the compositions and methods of the present invention, eye-compatible neodymium hydrogel contact lenses have been invented while avoiding the problems associated with the use of polar resin molds, such as the difficulty of separating the mold halves during polymerization; Problems associated with ingenious and expensive post-polymerization procedures, such as plasma etching, irradiation, chemical upgrading; and problems associated with the IPN of polymeric wetting agents.

實例Instance

下述實例係說明本發明之某些方面與優點，應明瞭其並非藉以限制。The following examples are illustrative of certain aspects and advantages of the invention and are not intended to be limiting.

下列習知化學品係在實例中被引用，且可藉其縮寫指稱。PP：聚丙烯PEG：聚乙二醇IBM：甲基丙烯酸異酯VMA：N－乙烯基－N－甲基乙醯胺(剛在真空下蒸餾)M3U：M3－U；α－ω－雙(甲基丙烯醯基氧基乙基亞胺基羧乙基氧基丙基)－聚(二甲基矽氧烷)－聚(三氟丙基甲基矽氧烷)－聚(ω－甲氧基－聚(乙二醇)丙基甲基矽氧烷)；二甲基丙烯醯基含矽氧巨體The following conventional chemicals are cited in the examples and may be referred to by their abbreviations. PP: Polypropylene PEG: Polyethylene glycol IBM: Methacrylic acid Ester VMA: N-vinyl-N-methylacetamide (distilled under vacuum) M3U: M3-U; α-ω-bis(methacryloyloxyethyliminocarboethyloxy) Propyl)-poly(dimethyloxane)-poly(trifluoropropylmethyloxirane)-poly(ω-methoxy-poly(ethylene glycol) propylmethyloxane) Dimethyl propylene sulfhydryl group

於下述實例中使用之M3U係以下式表示，其中n為121，m為7.6，h為4.4，且Mn＝12,800，及Mw＝16,200。The M3U used in the following examples is represented by the following formula wherein n is 121, m is 7.6, h is 4.4, and Mn = 12,800, and Mw = 16,200.

EOEMA：乙氧基乙基甲基丙烯醯胺Vazo－52：2,2'－偶氮雙(2,4－二甲基戊腈)(V－52；熱引發劑)Vazo－64：偶氮雙異丁腈(V－64；熱引發劑)PDMS：聚二甲基矽氧烷PDMS－共－PEG：聚二甲基矽氧烷與PEG之嵌段共聚物，含有75% PEG，且MW為600(DBE712，得自Gelest)HEMA：甲基丙烯酸2－羥乙酯NVP：1－乙烯基－2－四氫吡咯酮(剛在真空下蒸餾)HOB：甲基丙烯酸2－羥基丁酯FM0411M：FM－0411M；a－甲基丙烯醯基氧基乙基亞胺基羧乙基氧基丙基－聚(二甲基矽烷氧基)－丁基二甲基矽烷EOEMA: ethoxyethyl methacrylamide Vazo-52: 2,2'-azobis(2,4-dimethylvaleronitrile) (V-52; thermal initiator) Vazo-64: azo Double isobutyronitrile (V-64; thermal initiator) PDMS: polydimethyloxane PDMS-co-PEG: block copolymer of polydimethyloxane and PEG, containing 75% PEG, and MW 600 (DBE712 from Gelest) HEMA: 2-hydroxyethyl methacrylate NVP: 1-vinyl-2-tetrahydropyrrolidone (distilled under vacuum) HOB: 2-hydroxybutyl methacrylate FM0411M :FM-0411M; a-methacryloyloxyethyliminocarboxyethyloxypropyl-poly(dimethylnonyloxy)-butyldimethylsilane

於下述實例中使用之FM0411M係以下式表示，其中n＝13－16，且Mw為1500。FM0411M used in the following examples is represented by the following formula, wherein n = 13-16 and Mw is 1500.

TAIC：1,3,5－三烯丙基－1,3,5－三－2,4,6(1H,3H,5H)－三酮(異三聚氰酸三烯丙酯)AOT：氣溶膠OT；雙(2－乙基己基)磺酸基琥珀酸鈉鹽TPO：聯苯基(2,4,6－三甲基苯甲醯基)氧化膦IPA：異丙醇N,N－DMF：DMF；N,N－二甲基甲醯胺HMP：4－羥基－4－甲基－2－戊酮TEGDMA：二甲基丙烯酸三乙二醇酯TEGDVE：三乙二醇二乙烯醚MMA：甲基丙烯酸甲酯VM：甲基丙烯酸乙烯酯PTA：三丙烯酸異戊四醇酯TPTMA：三甲基丙烯酸三羥甲基丙烷酯SiGMA：(3－甲基丙烯醯氧基－2－羥丙基氧基)丙基雙(三甲基矽烷氧基)甲基矽烷Pr：丙醇Hx：己醇DA：癸醇DVG：二乙烯基二醇EE：乙氧基乙醇UV416：丙烯酸2－(4－苯甲醯基－3－羥基苯氧基)乙酯TAIC: 1,3,5-Triallyl-1,3,5-three -2,4,6(1H,3H,5H)-trione (triallyl isocyanurate) AOT: Aerosol OT; bis(2-ethylhexyl)sulfonate sodium succinate salt TPO: Biphenyl (2,4,6-trimethylbenzylidene) phosphine oxide IPA: isopropanol N,N-DMF:DMF; N,N-dimethylformamide HMP: 4-hydroxy-4 -Methyl-2-pentanone TEGDMA: Triethylene glycol dimethacrylate TEGDVE: Triethylene glycol divinyl ether MMA: Methyl methacrylate VM: Vinyl methacrylate PTA: Isoamyl triacrylate Ester TPTMA: Trimethylolpropane trimethacrylate SiGMA: (3-methylpropenyloxy-2-hydroxypropyloxy)propyl bis(trimethyldecyloxy)methyldecane Pr: C Alcohol Hx: hexanol DA: decyl alcohol DVG: divinyl glycol EE: ethoxyethanol UV416: 2-(4-benzylidene-3-hydroxyphenoxy)ethyl acrylate

M3U微染劑：βCu－苯二甲藍素在M3U中之分散液(% w/w)。Cu－苯二甲藍素可以Heliogen Blue K7090得自BASF。M3U micro-dye: dispersion of βCu-phthalicin in M3U (% w/w). Cu-phthalmidine can be obtained from BASF by Heliogen Blue K7090.

實例1Example 1 矽氧水凝膠隱形眼鏡製造Hydroxyl hydrogel contact lens manufacturing

將實例2－55中所提出之化學化合物稱重並混合，以形成混合物。使混合物經過0.2－5.0微米注射濾器過濾進入瓶中。將混合物儲存高達約2週。應明瞭此等混合物係為可聚合矽氧水凝膠隱形眼鏡先質組合物。在實例2－55中，除了其個別重量百分比(以重量比重量表示；w/w)以外，係提供各化合物之單位量。於最後矽氧水凝膠隱形眼鏡中，化學化合物之重量百分比係更密切地關於存在於先質組合物中之單位量。The chemical compounds set forth in Examples 2-55 were weighed and mixed to form a mixture. The mixture was filtered through a 0.2-5.0 micron syringe filter into the bottle. The mixture was stored for up to about 2 weeks. It should be understood that such mixtures are polymerizable silicone hydrogel contact lens precursor compositions. In Examples 2-55, unit amounts of each compound are provided in addition to their individual weight percentages (expressed in weight to weight; w/w). In the final oxygenated hydrogel contact lenses, the weight percent of chemical compound is more closely related to the unit amount present in the precursor composition.

放置一體積之先質組合物，與界定非極性樹脂母模構件表面之鏡片接觸，譬如聚丙烯模具構件。放置非極性樹脂公模構件，譬如聚丙烯公模構件，與母模構件接觸，以形成包含隱形眼鏡成形模穴之隱形眼鏡模，含有先質組合物。A volume of the precursor composition is placed in contact with a lens defining the surface of the non-polar resin master member, such as a polypropylene mold member. A non-polar resin male mold member, such as a polypropylene male mold member, is placed in contact with the female mold member to form a contact lens mold comprising a contact lens forming cavity containing a precursor composition.

將隱形眼鏡模置於經氮沖洗之烘箱中，以允許先質組合物以熱方式熟化。使隱形眼鏡模曝露至約80℃之溫度，歷經約1小時或更久。The contact lens mold is placed in a nitrogen rinsed oven to allow the precursor composition to be cured thermally. The contact lens mold is exposed to a temperature of about 80 ° C for about one hour or more.

在使先質組合物聚合後，將隱形眼鏡模脫模，並將萃取前經聚合之矽氧水凝膠隱形眼鏡產物自模具構件之一脫除鏡片。將萃取前脫除之鏡片產物稱重，以測定其乾重。After polymerizing the precursor composition, the contact lens mold is demolded and the polymerized hydroxyl hydrogel contact lens product is removed from the mold member prior to extraction. The lens product removed before extraction was weighed to determine its dry weight.

然後，將脫除之鏡片產物萃取與水合，其方式是使鏡片產物與多份體積之醇譬如乙醇及去離子水接觸。將已水合之矽氧水凝膠隱形眼鏡稱重，接著在烘箱中脫水，並再一次稱重，以測定經脫水矽氧水凝膠隱形眼鏡之乾重。The removed lens product is then extracted and hydrated by contacting the lens product with a plurality of volumes of alcohol such as ethanol and deionized water. The hydrated hydrothermal hydrogel contact lenses were weighed, then dehydrated in an oven and weighed again to determine the dry weight of the dehydrated hydrogel hydrogel contact lenses.

一些性質，譬如接觸角，包括動態與靜態接觸角、氧透氣性、離子通量、模數、伸長率、抗張強度、水含量等，係按本文中所述進行測定。亦檢驗經水合矽氧水凝膠隱形眼鏡之可潤溼性，其方式是度量鏡片之水破碎時間。在配用研究期間，進一步檢驗眼睛相容性，其中係將隱形眼鏡放置在人們之一個眼睛上，歷經1小時、3小時或6小時或更久，並施行臨床評估。Some properties, such as contact angles, including dynamic and static contact angles, oxygen permeability, ionic flux, modulus, elongation, tensile strength, water content, etc., are determined as described herein. The wettability of the hydrated hydrogel hydrogel contact lenses was also tested by measuring the water break time of the lenses. Eye compatibility was further tested during the formulation study, in which the contact lenses were placed on one of the eyes of the person for 1 hour, 3 hours or 6 hours or more and clinical evaluation was performed.

實例2Example 2

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係相對較容易處理，且具有可接受之相容性。此等隱形眼鏡具有平衡水含量為約54%，水BUT大於20秒，靜態接觸角為約48°，離子通量為約3.8，楊氏模數為約0.5 MPa，及伸長率為約227%。此等矽氧水凝膠隱形眼鏡具有可萃取量為16.9 ＋/－ 0.3%。The oxygenated hydrogel contact lenses from this formulation are relatively easy to handle and have acceptable compatibility. These contact lenses have an equilibrium water content of about 54%, a water BUT of greater than 20 seconds, a static contact angle of about 48°, an ion flux of about 3.8, a Young's modulus of about 0.5 MPa, and an elongation of about 227%. . These helium-hydrogel contact lenses have an extractable amount of 16.9 +/- 0.3%.

實例3Example 3

可聚合矽氧水凝膠隱形眼鏡先質組合物經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係相對較容易處理，且具有可接受之相容性。此等隱形眼鏡具有平衡水含量為約54%，水BUT大於30秒，靜態接觸角為約34°，前進接觸角為78°，倒退接觸角為48°，離子通量為約6，楊氏模數為約0.7 MPa，及伸長率為約186%。此等矽氧水凝膠隱形眼鏡具有可萃取量為17.5 ＋/－ 0.5%。The oxygenated hydrogel contact lenses from this formulation are relatively easy to handle and have acceptable compatibility. These contact lenses have an equilibrium water content of about 54%, a water BUT of greater than 30 seconds, a static contact angle of about 34°, an advancing contact angle of 78°, a reverse contact angle of 48°, and an ion flux of about 6, Young's. The modulus is about 0.7 MPa and the elongation is about 186%. These helium-hydrogel contact lenses have an extractable amount of 17.5 +/- 0.5%.

實例4Example 4

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係相對較容易處理，且可與mPC相容。此等隱形眼鏡具有平衡水含量為約52%，水BUT大於18秒，靜態接觸角為約36°，前進接觸角為76°，倒退接觸角為49°，離子通量為約6，楊氏模數為約0.7 MPa，及伸長率為約167%。The oxygenated hydrogel contact lenses from this formulation are relatively easy to handle and are compatible with mPC. These contact lenses have an equilibrium water content of about 52%, a water BUT of greater than 18 seconds, a static contact angle of about 36°, an advancing contact angle of 76°, a reverse contact angle of 49°, and an ion flux of about 6, Young's. The modulus is about 0.7 MPa and the elongation is about 167%.

實例5Example 5

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係相對較容易處理，且可與mPC相容。此等隱形眼鏡具有平衡水含量為約54%，水BUT大於20秒，靜態接觸角為約37°，前進接觸角為76°，倒退接觸角為48°，離子通量為約3.5，楊氏模數為約0.6 MPa，及伸長率為約304%。The oxygenated hydrogel contact lenses from this formulation are relatively easy to handle and are compatible with mPC. These contact lenses have an equilibrium water content of about 54%, a water BUT of greater than 20 seconds, a static contact angle of about 37°, an advancing contact angle of 76°, a reverse contact angle of 48°, and an ion flux of about 3.5, Young's. The modulus is about 0.6 MPa and the elongation is about 304%.

實例6Example 6

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡顯示可接受之可脫模性與可脫除鏡片性。此等隱形眼鏡具有平衡水含量為約53%，水BUT大於20秒，靜態接觸角為約34°，離子通量為約5，楊氏模數為約0.4 MPa，及伸長率為約197%。The oxygenated hydrogel contact lenses from this formulation exhibit acceptable releasability and releasability. These contact lenses have an equilibrium water content of about 53%, a water BUT of greater than 20 seconds, a static contact angle of about 34°, an ion flux of about 5, a Young's modulus of about 0.4 MPa, and an elongation of about 197%. .

實例7Example 7

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有模數約0.6 MPa至約0.9 MPa。The oxygenated hydrogel contact lenses from this formulation have a modulus of from about 0.6 MPa to about 0.9 MPa.

實例8Example 8

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約52%，水BUT大於20秒，接觸角為約42°，前進接觸角為約73°，倒退接觸角為約48°，離子通量為約3.9，楊氏模數為約0.5 MPa，及伸長率為約242%。此等矽氧水凝膠隱形眼鏡具有可萃取量為43.4 ＋/－ 3.1%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 52%, a water BUT of greater than 20 seconds, a contact angle of about 42°, an advancing contact angle of about 73°, a reverse contact angle of about 48°, and an ion flux of about 3.9, Yang. The modulus is about 0.5 MPa and the elongation is about 242%. These helium-hydrogel contact lenses have an extractable amount of 43.4 +/- 3.1%.

實例9Example 9

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有可萃取成份含量為約26%。得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The pre-extracted polymerized oxygenated hydrogel contact lens product from this formulation has an extractable ingredient content of about 26%. The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例10Example 10

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有可萃取成份含量為約45%。得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約56%，水BUT大於20秒，接觸角為約45°，離子通量為約5.3，楊氏模數為約0.3 MPa，及伸長率為約351%。The pre-extracted polymerized oxygenated hydrogel contact lens product from this formulation has an extractable ingredient content of about 45%. The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 56%, a water BUT of greater than 20 seconds, a contact angle of about 45, an ion flux of about 5.3, a Young's modulus of about 0.3 MPa, and an elongation of about 351%.

實例11Example 11

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例12Example 12

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例13Example 13

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

以此配方所獲得之萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有可萃取成份含量為約17%。The pre-extracted polymerized hydrogel contact lens product obtained in this formulation has an extractable ingredient content of about 17%.

實例14Example 14

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之萃取前經聚合之矽氧水凝膠隱形眼鏡產物具有可萃取成份含量為約36%。得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The pre-extracted polymerized oxygenated hydrogel contact lens product from this formulation has an extractable ingredient content of about 36%. The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例15Example 15

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係顯示水BUT大於20秒。The oxygenated hydrogel contact lens system from this formulation showed a water BUT greater than 20 seconds.

實例16Example 16

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係顯示水BUT小於5秒。The oxygenated hydrogel contact lens system from this formulation showed a water BUT of less than 5 seconds.

實例17Example 17

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡係顯示水BUT小於5秒。The oxygenated hydrogel contact lens system from this formulation showed a water BUT of less than 5 seconds.

實例18Example 18

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例19Example 19

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例20Example 20

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例21Example 21

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例22Example 22

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例23Example 23

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約63%，水BUT大於19秒，靜態接觸角為約39°，前進接觸角為93°，倒退接觸角為46，楊氏模數為約0.4 MPa，伸長率為約109%，及抗張強度為約0.2。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 63%, a water BUT of greater than 19 seconds, a static contact angle of about 39°, an advancing contact angle of 93°, a reverse contact angle of 46, and a Young's modulus of about 0.4 MPa. The rate is about 109% and the tensile strength is about 0.2.

實例24Example 24

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例25Example 25

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例26Example 26

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例27Example 27

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約63%，水BUT大於25秒，離子通量為約17，靜態接觸角為約43°，前進接觸角為94°，倒退接觸角為48°，楊氏模數為約0.3 MPa，伸長率為約166%，及抗張強度為約0.3。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 63%, a water BUT of greater than 25 seconds, an ion flux of about 17, a static contact angle of about 43°, an advancing contact angle of 94°, and a reverse contact angle of 48°, Young's. The modulus is about 0.3 MPa, the elongation is about 166%, and the tensile strength is about 0.3.

實例28Example 28

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例29Example 29

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡，其係以UV輻射熟化，具有眼睛上可接受之表面可潤溼性。Oxygenated hydrogel contact lenses from this formulation which are cured by UV radiation and have an ocularly acceptable surface wettability.

實例30Example 30

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例31Example 31

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約54%，水BUT大於17秒，靜態接觸角為約36°，前進接觸角為87°，倒退接觸角為44°，離子通量為約8，楊氏模數為約0.5 MPa，伸長率為約335%，及抗張強度為約0.4。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 54%, a water BUT of greater than 17 seconds, a static contact angle of about 36°, an advancing contact angle of 87°, a reverse contact angle of 44°, and an ion flux of about 8, Young's. The modulus is about 0.5 MPa, the elongation is about 335%, and the tensile strength is about 0.4.

實例32Example 32

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約66%，水BUT大於17秒，靜態接觸角為約33°，前進接觸角為81°，倒退接觸角為45°，楊氏模數為約0.4 MPa，伸長率為約131%，及抗張強度為約0.3。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 66%, a water BUT of greater than 17 seconds, a static contact angle of about 33°, an advancing contact angle of 81°, a reverse contact angle of 45°, and a Young's modulus of about 0.4 MPa. The elongation was about 131% and the tensile strength was about 0.3.

實例33Example 33

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約63%，水BUT大於19秒，離子通量為約18，靜態接觸角為約37°，前進接觸角為101°，倒退接觸角為46°，楊氏模數為約0.4 MPa，伸長率為約155%，及抗張強度為約0.4。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 63%, a water BUT of greater than 19 seconds, an ion flux of about 18, a static contact angle of about 37°, an advancing contact angle of 101°, and a reverse contact angle of 46°, Young's. The modulus is about 0.4 MPa, the elongation is about 155%, and the tensile strength is about 0.4.

實例34Example 34

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。存在於經聚合鏡片產物中之可萃取物質之量係大於10%，且經估計為約40至42%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. The amount of extractable material present in the polymerized lens product is greater than 10% and is estimated to be from about 40 to 42%.

實例35Example 35

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。存在於經聚合鏡片產物中之可萃取物質之量係大於10%，且經估計為約40至42%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. The amount of extractable material present in the polymerized lens product is greater than 10% and is estimated to be from about 40 to 42%.

實例36Example 36

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等矽氧水凝膠隱形眼鏡具有平衡水濃度為61.3 ＋/－ 0.05%，及具有可萃取量為17.5 ＋/－ 0.5%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These hydrogel contact lenses have an equilibrium water concentration of 61.3 +/- 0.05% and an extractable amount of 17.5 +/- 0.5%.

實例37Example 37

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等矽氧水凝膠隱形眼鏡具有平衡水濃度為61.3 ＋/－ 0.05%，及具有可萃取量為17.5 ＋/－ 0.5%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These hydrogel contact lenses have an equilibrium water concentration of 61.3 +/- 0.05% and an extractable amount of 17.5 +/- 0.5%.

實例38Example 38

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等矽氧水凝膠隱形眼鏡具有平衡水濃度為54.6 ＋/－ 1.27%，及具有可萃取量為23.6 ＋/－ 0.1%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These helium-hydrogel contact lenses have an equilibrium water concentration of 54.6 +/- 1.27% and an extractable amount of 23.6 +/- 0.1%.

實例39Example 39

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約55%，離子通量為約7，靜態接觸角為約34°，前進接觸角為約65°，倒退接觸角為50°，楊氏模數為約0.6 MPa，伸長率為約238%，及Dk為約109。此等矽氧水凝膠隱形眼鏡具有可萃取量為23.6 ＋/－ 0.1%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 55%, an ion flux of about 7, a static contact angle of about 34, an advancing contact angle of about 65, a reverse contact angle of 50, and a Young's modulus of about 0.6. MPa, elongation is about 238%, and Dk is about 109. These helium-hydrogel contact lenses have an extractable amount of 23.6 +/- 0.1%.

實例40Example 40

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等矽氧水凝膠隱形眼鏡具有平衡水濃度為47.6 ＋/－ 0.5%，及具有可萃取量為48.9 ＋/－ 0.7%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These helium-hydrogel contact lenses have an equilibrium water concentration of 47.6 +/- 0.5% and an extractable amount of 48.9 +/- 0.7%.

實例41Example 41

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約55%，離子通量為約6，靜態接觸角為約35°，前進接觸角為約73°，倒退接觸角為49°，楊氏模數為約0.3 MPa，伸長率為約265%，及Dk為約98。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 55%, an ion flux of about 6, a static contact angle of about 35, an advancing contact angle of about 73, a reverse contact angle of 49, and a Young's modulus of about 0.3. MPa, elongation is about 265%, and Dk is about 98.

實例42Example 42

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約46%，離子通量為約4，靜態接觸角為約40°，前進接觸角為約78°，倒退接觸角為約54°，楊氏模數為約0.4 MPa，伸長率為約219%，及Dk為約129。此等矽氧水凝膠隱形眼鏡具有可萃取量為50.2 ＋/－ 0.8%。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 46%, an ion flux of about 4, a static contact angle of about 40°, an advancing contact angle of about 78°, a reverse contact angle of about 54°, and a Young's modulus of about 0.4 MPa, elongation is about 219%, and Dk is about 129. These helium-hydrogel contact lenses have an extractable amount of 50.2 +/- 0.8%.

實例43Example 43

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例44Example 44

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例45Example 45

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例46Example 46

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例47Example 47

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約60%，離子通量為約11，靜態接觸角為約46°，前進接觸角為約102°，倒退接觸角為約51°，楊氏模數為約0.2 MPa，伸長率為約150%，及抗張強度為約0.2。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 60%, an ion flux of about 11, a static contact angle of about 46°, an advancing contact angle of about 102°, a reverse contact angle of about 51°, and a Young's modulus of about 0.2 MPa, elongation is about 150%, and tensile strength is about 0.2.

實例48Example 48

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。此等隱形眼鏡具有平衡水含量為約61%，離子通量為約14，靜態接觸角為約40°，前進接觸角為約106°，倒退接觸角為約52°，楊氏模數為約0.2 MPa，伸長率為約224%，抗張強度為約0.3，及Dk為約69。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability. These contact lenses have an equilibrium water content of about 61%, an ion flux of about 14, a static contact angle of about 40, an advancing contact angle of about 106, a reverse contact angle of about 52, and a Young's modulus of about 0.2 MPa, an elongation of about 224%, a tensile strength of about 0.3, and a Dk of about 69.

實例49Example 49

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

得自此配方之矽氧水凝膠隱形眼鏡具有眼睛上可接受之表面可潤溼性。The oxygenated hydrogel contact lenses from this formulation have an ocularly acceptable surface wettability.

實例50Example 50

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例51Example 51

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例52Example 52

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例53Example 53

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例54Example 54

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例55Example 55

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例56Example 56

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例57Example 57

可聚合矽氧水凝膠隱形眼鏡先質組合物係經由將下列化學化合物以所指定之量並按實例1中所述混合與過濾而獲得。The polymerizable silicone hydrogel contact lens precursor composition was obtained by mixing and filtering the following chemical compounds in the amounts specified and as described in Example 1.

實例58Example 58

矽氧水凝膠隱形眼鏡係得自非極性樹脂鏡片模，且製自經由將下列化學化合物以所指定之量，按實例1中所述混合與過濾所獲得之鏡片先質組合物。The hydroxyl hydrogel contact lenses were obtained from a non-polar resin lens mold and prepared from a lens precursor composition obtained by mixing and filtering the following chemical compounds in the amounts specified, as described in Example 1.

R1鏡片具有平衡水含量為63.1%，且顯示水BUT於24小時後為4.7秒，而於4天後為9秒。R1鏡片產物具有可萃取含量為約16%。The R1 lens had an equilibrium water content of 63.1% and showed a water BUT of 4.7 seconds after 24 hours and 9 seconds after 4 days. The R1 lens product has an extractable content of about 16%.

R3鏡片具有平衡水含量為56%，且顯示水BUT於24小時後為18秒，而於4天後為20秒。R3鏡片產物具有可萃取含量為約26%。R3鏡片具有接觸角為34.1℃，前進接觸角為106.3℃，倒退接觸角為52.4℃，遲滯現象為53.9℃，離子通量為5.5 10－3 平方毫米/分鐘，模數為0.42 MPa，伸長率為135%，及抗張強度為0.27 MPa。The R3 lens had an equilibrium water content of 56% and showed a water BUT of 18 seconds after 24 hours and 20 seconds after 4 days. The R3 lens product has an extractable content of about 26%. The R3 lens has a contact angle of 34.1 ° C, an advancing contact angle of 106.3 ° C, a reverse contact angle of 52.4 ° C, a hysteresis of 53.9 ° C, an ion flux of 5.5 10 -3 mm 2 /min, and a modulus of 0.42 MPa. It is 135% and the tensile strength is 0.27 MPa.

R7鏡片具有平衡水含量為60.8%，且顯示水BUT於24小時後為20秒，而於4天後為20秒。R7鏡片產物具有可萃取含量為約25%。R7鏡片具有接觸角為33.7°，前進接觸角為103.7°，倒退接觸角為53.9°，遲滯現象為49.8°，離子通量為8.1 10－3 平方毫米/分鐘，模數為0.33 MPa，伸長率為139%，及抗張強度為0.24 MPa。The R7 lens had an equilibrium water content of 60.8% and showed a water BUT of 20 seconds after 24 hours and 20 seconds after 4 days. The R7 lens product has an extractable content of about 25%. The R7 lens has a contact angle of 33.7°, an advancing contact angle of 103.7°, a reverse contact angle of 53.9°, a hysteresis of 49.8°, an ion flux of 8.1 10 -3 mm 2 /min, and a modulus of 0.33 MPa. It is 139% and the tensile strength is 0.24 MPa.

R8鏡片具有平衡水含量為64.2%，且顯示水BUT於24小時後為4.3秒，而於4天後為9秒。R8鏡片產物具有可萃取含量為約15%。The R8 lens had an equilibrium water content of 64.2% and showed a water BUT of 4.3 seconds after 24 hours and 9 seconds after 4 days. The R8 lens product has an extractable content of about 15%.

R9鏡片具有平衡水含量為63.9%，且顯示水BUT於24小時後為1.3秒，而於4天後為7秒。R9鏡片產物具有可萃取含量為約13%。The R9 lens had an equilibrium water content of 63.9% and showed a water BUT of 1.3 seconds after 24 hours and 7 seconds after 4 days. The R9 lens product has an extractable content of about 13%.

R0鏡片具有平衡水含量為63.8%，且顯示水BUT於24小時後為15秒，而於4天後為20秒。R0鏡片產物具有可萃取含量為約22%。R0鏡片具有接觸角為38°，前進接觸角為101.3°，倒退接觸角為48.7°，遲滯現象為52.6°，離子通量為11.7 10－3 平方毫米/分鐘，模數為42 MPa，伸長率為191%，及抗張強度為0.35 MPa。The R0 lens had an equilibrium water content of 63.8% and showed a water BUT of 15 seconds after 24 hours and 20 seconds after 4 days. The R0 lens product has an extractable content of about 22%. The R0 lens has a contact angle of 38°, an advancing contact angle of 101.3°, a reverse contact angle of 48.7°, a hysteresis of 52.6°, an ion flux of 11.7 10 -3 mm 2 /min, and a modulus of 42 MPa. It is 191% and the tensile strength is 0.35 MPa.

實例59Example 59

亦評估不同交聯劑對於可萃取成份含量之作用。矽氧水凝膠隱形眼鏡係在非極性樹脂鏡片模中製成，而無需表面處理，且未使用聚合體IPN。鏡片配方之成份係提供於下表中。交聯劑類型與濃度係經改變，並測定可萃取成份含量。The effect of different crosslinkers on the extractable component content was also evaluated. Hydroxyl hydrogel contact lenses are made in a non-polar resin lens mold without surface treatment and without the use of polymeric IPN. The ingredients of the lens formulation are provided in the table below. The type and concentration of the crosslinker were varied and the extractable component content was determined.

此等結果証實矽氧水凝膠隱形眼鏡，其包含衍生自VMA與IBM之單位，且其係利用二－甲基丙烯酸酯或三－甲基丙烯酸酯為基礎之交聯劑，係得自具有高可萃取成份含量(例如，大於16.9%)之矽氧水凝膠隱形眼鏡產物。於比較上，包含衍生自VMA與IBM之單位，且其係利用甲基丙烯酸乙烯酯或異三聚氰酸三烯丙酯交聯劑之鏡片產物，係具有較低可萃取成份含量(例如，小於10%)。使用三乙二醇二乙烯醚作為交聯劑之鏡片產物具有可萃取成份含量為10.3%。These results confirm the oxygenated hydrogel contact lenses comprising units derived from VMA and IBM, and which utilize a di-methacrylate or tri-methacrylate based crosslinker derived from A hydrolyzable hydrogel contact lens product having a high extractable ingredient content (eg, greater than 16.9%). For comparison, a lens product derived from VMA and IBM, which utilizes a copolymer of vinyl methacrylate or triallyl cyanurate, has a lower extractable component content (eg, Less than 10%). The lens product using triethylene glycol divinyl ether as a crosslinking agent has an extractable component content of 10.3%.

在此項研究中，以各配方名稱T31A；T31C；T31C1；T31C2；T31E；T31F；及T31G所獲得隱形眼鏡之80%，係顯示水BUT大於20秒。於T31鏡片中，60%顯示水BUT為10秒。於T31B鏡片中，僅40%顯示水BUT為5秒。In this study, 80% of the contact lenses obtained with each of the formulation names T31A; T31C; T31C1; T31C2; T31E; T31F; and T31G showed a water BUT greater than 20 seconds. In the T31 lens, 60% showed a water BUT of 10 seconds. In the T31B lens, only 40% showed a water BUT of 5 seconds.

因此，對於此等鏡片配方，二－甲基丙烯酸酯與三－甲基丙烯酸酯為基礎之交聯劑可一致地提供具有高可萃取成份含量之矽氧水凝膠隱形眼鏡產物。得自此等鏡片產物之矽氧水凝膠隱形眼鏡，具有所要之表面可潤溼性。Thus, for these lens formulations, the di-methacrylate and tri-methacrylate based crosslinkers consistently provide a hydroxyl hydrogel contact lens product having a high extractable component content. Hydroxyl hydrogel contact lenses derived from such lens products have desirable surface wettability.

此等數據亦支持以下發現，當此等矽氧水凝膠鏡片產物具有可萃取成份含量大於10%時，或當自其獲得之矽氧水凝膠隱形眼鏡具有乾重不大於個別鏡片產物乾重之90%時，矽氧水凝膠隱形眼鏡可具有眼睛上可接受之表面可潤溼性。These data also support the discovery that when such helium-oxygel lens products have an extractable component content greater than 10%, or when the hemohydrogel contact lens obtained therefrom has a dry weight no greater than the individual lens product dry At 90% weight, the oxygenated hydrogel contact lenses can have acceptable surface wettability on the eye.

實例60Example 60

將本發明矽氧水凝膠隱形眼鏡之實例與現行矽氧水凝膠隱形眼鏡比較，如下表中所示。鏡片A為Acuvue Advance隱形眼鏡(Johnson & Johnson)；鏡片B為Acuvue Oasys隱形眼鏡(Johnson & Johnson)，鏡片C為O2 Optix隱形眼鏡(Ciba Vision)；及鏡片D為Biofinity隱形眼鏡(CooperVision)。An example of a deoxyhydrogel contact lens of the present invention is compared to current oxygenated hydrogel contact lenses as shown in the following table. Lens A is Acuvue Advance contact lenses (Johnson &Johnson); Lens B is Acuvue Oasys contact lenses (Johnson & Johnson), Lens C is O 2 Optix contact lenses (Ciba Vision); and Lens D is Biofinity contact lenses (CooperVision).

EWC：平衡水含量(百分比)ACA：前進接觸角(度)RCA：倒退接觸角(度)PSHCLP：經聚合之矽氧水凝膠隱形眼鏡產物SHCL：矽氧水凝膠隱形眼鏡(萃取後與水合作用) EWC: Balanced water content (percent) ACA: Advancing contact angle (degrees) RCA: Retrograde contact angle (degrees) PSHCLP: Polymerized hydrogenated hydrogel contact lens product SHCL: Hydrogenated hydrogel contact lens (after extraction and Hydration)

實例61Example 61

將本發明矽氧水凝膠隱形眼鏡之實例，與使用Biofinity矽氧水凝膠隱形眼鏡之鏡片先質組合物，得自非極性樹脂隱形眼鏡模之矽氧水凝膠隱形眼鏡比較。於Biofinity矽氧水凝膠隱形眼鏡製造中所使用之鏡片先質組合物，係產生具有可萃取量小於10%(w/w)(譬如約8%(w/w))之萃取前經聚合之矽氧水凝膠隱形眼鏡產物。當先質組合物在非極性樹脂隱形眼鏡模中熟化及萃取與水合時，所形成之矽氧水凝膠隱形眼鏡具有鏡片物體，其具有萃取前鏡片產物之約92%之乾重。如此製成之經水合隱形眼鏡具有眼睛上無法令人接受之表面可潤溼性。比較上而言，本發明鏡片係包含鏡片物體，其具有乾重不大於萃取前經聚合之矽氧水凝膠隱形眼鏡產物乾重之90%，且具有眼睛上可接受之表面可潤溼性，如上述。An example of a silicone hydrogel contact lens of the present invention is compared to a lens precursor composition using a Biofinity hydrogel contact lens, a non-polar resin contact lens mold for a hydrogel contact lens. A lens precursor composition for use in the manufacture of Biofinity hydrogel contact lenses is produced by pre-extraction polymerization having an extractable amount of less than 10% (w/w), such as about 8% (w/w). The oxygen hydrogel contact lens product. When the precursor composition is aged and extracted and hydrated in a non-polar resin contact lens mold, the formed hydroxyl hydrogel contact lens has a lens object having a dry weight of about 92% of the pre-extract lens product. The hydrated contact lenses thus produced have unacceptable surface wettability on the eye. In comparison, the lenses of the present invention comprise a lens object having a dry weight no greater than 90% of the dry weight of the polymerized hydrogel contact lens product prior to extraction and having an ocularly acceptable surface wettability ,As above.

雖然本文之揭示內容係指某些所示之具體實施例，但應明瞭的是，此等具體實施例係以舉例方式提出，而非作為限制。前文詳細說明之意圖，雖然討論列舉具體實施例，但係欲被解釋為涵蓋該具體實施例之所有修正、替代方式及相當事物，其可落在本發明之精神與範圍內，如所藉由其他揭示內容所定義者。Although the present disclosure has been described with respect to the specific embodiments shown, it should be understood that The detailed description is intended to be illustrative, and is intended to be in the scope of the scope of the invention Other definitions are defined.

許多刊物與專利已被引用於上文。所引用刊物與專利之每一項，均據此以其全文併入供參考。Many publications and patents have been cited above. Each of the cited publications and patents is hereby incorporated by reference in its entirety.

102．．．將鏡片先質組合物放置在隱形眼鏡模構件上或其中之步驟102. . . Step of placing the lens precursor composition on or in the contact lens mold member

104．．．閉合隱形眼鏡模之步驟104. . . Steps to close the contact lens

106．．．熟化步驟106. . . Maturing step

108．．．脫模步驟108. . . Demolding step

110．．．脫除鏡片步驟110. . . Removing the lens step

112．．．萃取步驟112. . . Extraction step

114．．．水合步驟114. . . Hydration step

116．．．包裝步驟116. . . Packaging step

118．．．滅菌步驟118. . . Sterilization step

202．．．可聚合矽氧水凝膠鏡片先質組合物202. . . Polymerizable helium hydrogel lens precursor composition

204．．．萃取前經聚合之矽氧水凝膠隱形眼鏡產物204. . . Polymerized hydrogen peroxide gel contact lens product before extraction

206．．．經萃取之矽氧水凝膠隱形眼鏡產物206. . . Extracted Hydrogen Hydrogel Contact Lens Products

208．．．經水合之矽氧水凝膠隱形眼鏡208. . . Hydrogelated hydrogel contact lens

圖1為流程圖，說明一種製造矽氧水凝膠隱形眼鏡方法之步驟。BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a flow chart illustrating the steps of a method of making a silicone hydrogel contact lens.

圖2為流程圖，說明本發明組合物、鏡片產物及隱形眼鏡。Figure 2 is a flow diagram illustrating the compositions, lens products and contact lenses of the present invention.

102．．．將鏡片先質組合物放置在隱形眼鏡模構件上或其中之步驟102. . . Step of placing the lens precursor composition on or in the contact lens mold member

104．．．閉合隱形眼鏡模之步驟104. . . Steps to close the contact lens

106．．．熟化步驟106. . . Maturing step

108．．．脫模步驟108. . . Demolding step

110．．．脫除鏡片步驟110. . . Removing the lens step

112．．．萃取步驟112. . . Extraction step

114．．．水合步驟114. . . Hydration step

116．．．包裝步驟116. . . Packaging step

118．．．滅菌步驟118. . . Sterilization step

Claims (56)

一種可聚合矽氧水凝膠隱形眼鏡先質組合物，其包含：可聚合非含矽成份與可聚合含矽成份合併成為可聚合矽氧水凝膠隱形眼鏡先質組合物，該可聚合矽氧水凝膠隱形眼鏡先質組合物之一部份可從製自可聚合矽氧水凝膠隱形眼鏡先質組合物之經聚合矽氧水凝膠隱形眼鏡產物移除，且以經聚合矽氧水凝膠隱形眼鏡產物之至少10%(w/w)之量存在，其中該部分具有以經聚合矽氧水凝膠隱形眼鏡產物之重量計，含量為至少10%(w/w)之未反應之單體、經部分反應之單體或二者。 A polymerizable silicone hydrogel contact lens precursor composition comprising: a polymerizable non-ruthenium-containing component and a polymerizable barium-containing component combined into a polymerizable silicone hydrogel contact lens precursor composition, the polymerizable germanium One portion of the oxygen hydrogel contact lens precursor composition can be removed from the polymerized hydroxyl hydrogel contact lens product of the polymerizable silicone hydrogel contact lens precursor composition and polymerized. At least 10% (w/w) of the oxygen hydrogel contact lens product is present, wherein the portion has a content of at least 10% (w/w) based on the weight of the polymerized hydrogel hydrogel contact lens product Unreacted monomer, partially reacted monomer or both. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合非含矽成份係包含具有第一個反應性比之第一種單體，與具有小於第一個反應性比之第二個反應性比之第二種單體。 The polymerizable silicone hydrogel contact lens precursor composition of claim 1, wherein the polymerizable non-ruthenium containing component comprises a first monomer having a first reactivity ratio and having a less than the first reaction The second reactivity is better than the second monomer. 如請求項2之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合非含矽成份係進一步包含具有類似第一個反應性比之反應性比之交聯劑。 The polymerizable silicone hydrogel contact lens precursor composition of claim 2, wherein the polymerizable non-ruthenium containing component further comprises a crosslinking agent having a reactivity ratio similar to the first reactivity ratio. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合含矽成份為α-ω-雙(甲基丙烯醯基氧基乙基亞胺基羧乙基氧基丙基)-聚(二甲基矽氧烷)-聚(三氟丙基甲基矽氧烷)-聚(ω-甲氧基-聚(乙二醇)丙基甲基矽氧烷)；或二甲基丙烯醯基含矽氧巨體，而該可聚合非含矽成份係包括N-乙烯基-N-甲基乙醯胺、甲基丙烯酸甲酯、二甲基丙烯酸三 (乙二醇)酯，及引發劑。 The polymerizable silicone hydrogel contact lens precursor composition of claim 1, wherein the polymerizable rhodium-containing component is α-ω-bis(methacryloyloxyethyliminocarboethyloxy) Propyl)-poly(dimethyloxane)-poly(trifluoropropylmethyloxirane)-poly(ω-methoxy-poly(ethylene glycol) propylmethyl decane); Or a dimethyl methacrylate group containing a ruthenium alkoxide, and the polymerizable non ruthenium containing component comprises N-vinyl-N-methylacetamide, methyl methacrylate, dimethacrylate (Glycol) ester, and initiator. 如請求項4之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該非含矽成份係進一步包含紫外線吸收劑與微染劑。 The polymerizable silicone hydrogel contact lens precursor composition of claim 4, wherein the non-ruthenium-containing component further comprises a UV absorber and a micro-dye. 如請求項5之可聚合矽氧水凝膠隱形眼鏡先質組合物，其係進一步包含聚二甲基矽氧烷與聚乙二醇之嵌段共聚物。 The polymerizable silicone hydrogel contact lens precursor composition of claim 5, further comprising a block copolymer of polydimethyl siloxane and polyethylene glycol. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合含矽成份為α-ω-雙(甲基丙烯醯基氧基乙基亞胺基羧乙基氧基丙基)-聚(二甲基矽氧烷)-聚(三氟丙基甲基矽氧烷)-聚(ω-甲氧基-聚(乙二醇)丙基甲基矽氧烷)；或二甲基丙烯醯基含矽氧巨體，而該可聚合非含矽成份係包括1-乙烯基-2-四氫吡咯酮、甲基丙烯酸甲酯、二甲基丙烯酸三(乙二醇)酯，及引發劑。 The polymerizable silicone hydrogel contact lens precursor composition of claim 1, wherein the polymerizable rhodium-containing component is α-ω-bis(methacryloyloxyethyliminocarboethyloxy) Propyl)-poly(dimethyloxane)-poly(trifluoropropylmethyloxirane)-poly(ω-methoxy-poly(ethylene glycol) propylmethyl decane); Or a dimethyl methacrylate group containing a ruthenium alkoxide, and the polymerizable non ruthenium containing component includes 1-vinyl-2-tetrahydropyrrolidone, methyl methacrylate, and dimethyl methacrylate ) esters, and initiators. 如請求項7之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該非含矽成份係進一步包含癸醇。 The polymerizable silicone hydrogel contact lens precursor composition of claim 7, wherein the non-garium-containing component further comprises decyl alcohol. 如請求項8之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該癸醇係以組合物之約5%(w/w)至約30%(w/w)之量存在。 A polymerizable silicone hydrogel contact lens precursor composition according to claim 8 wherein the sterol is present in an amount from about 5% (w/w) to about 30% (w/w) of the composition. 如請求項7之可聚合矽氧水凝膠隱形眼鏡先質組合物，其進一步包含聚二甲基矽氧烷與聚乙二醇之嵌段共聚物。 The polymerizable silicone hydrogel contact lens precursor composition of claim 7, further comprising a block copolymer of polydimethyl siloxane and polyethylene glycol. 如請求項7之可聚合矽氧水凝膠隱形眼鏡先質組合物，其進一步包含親水性含矽氧脫模助劑或聚氧化烯脫模助劑。 The polymerizable silicone hydrogel contact lens precursor composition of claim 7, which further comprises a hydrophilic oxime-containing mold release aid or a polyoxyalkylene mold release aid. 如請求項7之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該非含矽成份進一步包含稀釋劑，選自包括己醇、乙氧基乙醇、異丙醇、丙醇、癸醇及其組合。 The polymerizable silicone hydrogel contact lens precursor composition of claim 7, wherein the non-ruthenium-containing component further comprises a diluent selected from the group consisting of hexanol, ethoxyethanol, isopropanol, propanol, sterol and Its combination. 如請求項12之可聚合矽氧水凝膠隱形眼鏡先質組合物，其進一步包含甲基丙烯酸酯磷醯膽鹼-單體之單位。 The polymerizable silicone hydrogel contact lens precursor composition of claim 12, further comprising a unit of methacrylate choline-monomer. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其進一步包含可萃取疏水性添加劑或可萃取兩親性添加劑。 The polymerizable silicone hydrogel contact lens precursor composition of claim 1 further comprising an extractable hydrophobic additive or an extractable amphiphilic additive. 如請求項14之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該添加劑係硬脂酸乙二醇酯、單月桂酸二乙二醇酯、C2 -C24 醇、C2 -C24 胺或聚二甲基矽氧烷-共-PEG或其組合。The polymerizable silicone hydrogel contact lens precursor composition of claim 14, wherein the additive is ethylene glycol stearate, diethylene glycol monolaurate, C 2 -C 24 alcohol, C 2 - C24 amine or polydimethyloxane-co-PEG or a combination thereof. 如請求項15之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該添加劑為癸醇、聚二甲基矽氧烷-共-PEG或其組合。 A polymerizable silicone hydrogel contact lens precursor composition according to claim 15 wherein the additive is decyl alcohol, polydimethyl siloxane-co-PEG or a combination thereof. 如請求項16之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該添加劑係包括具有分子量在約300至約30,000道爾吞之範圍內之聚二甲基矽氧烷-共-PEG。 The polymerizable silicone hydrogel contact lens precursor composition of claim 16, wherein the additive comprises polydimethyloxane-co-PEG having a molecular weight in the range of from about 300 to about 30,000 doxantane. . 如請求項16之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該添加劑係包括具有分子量小於約3,000道爾吞之聚二甲基矽氧烷-共-PEG。 The polymerizable silicone hydrogel contact lens precursor composition of claim 16, wherein the additive comprises polydimethyloxane-co-PEG having a molecular weight of less than about 3,000 dox. 如請求項14之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該添加劑係以組合物之約1%至約60%(w/w)之範圍內之 量存在。 The polymerizable silicone hydrogel contact lens precursor composition of claim 14, wherein the additive is in the range of from about 1% to about 60% (w/w) of the composition. The quantity exists. 如請求項14之可聚合矽氧水凝膠隱形眼鏡先質組合物，其係包含至少兩種不同添加劑。 A polymerizable silicone hydrogel contact lens precursor composition according to claim 14 which comprises at least two different additives. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合矽氧水凝膠隱形眼鏡先質組合物包含至少兩種包含有不同反應性比之單體種類之反應性成分。 The polymerizable hydroxyl hydrogel contact lens precursor composition of claim 1, wherein the polymerizable hydrogel contact lens precursor composition comprises at least two monomers comprising different reactivity ratios. Sexual ingredients. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合非含矽成分包含親水性含乙烯基單體。 The polymerizable silicone hydrogel contact lens precursor composition of claim 1, wherein the polymerizable non-ruthenium containing component comprises a hydrophilic vinyl-containing monomer. 如請求項1之可聚合矽氧水凝膠隱形眼鏡先質組合物，其中該可聚合矽氧水凝膠隱形眼鏡先質組合物之一部份可從製自可聚合矽氧水凝膠隱形眼鏡先質組合物之經聚合矽氧水凝膠隱形眼鏡產物移除，且以經聚合矽氧水凝膠隱形眼鏡產物之至少15%(w/w)之量存在，且以經聚合矽氧水凝膠隱形眼鏡產物之重量計，該部分具有含量為至少15%(w/w)之未反應之單體、經部分反應之單體或二者。 The polymerizable silicone hydrogel contact lens precursor composition of claim 1, wherein a portion of the polymerizable silicone hydrogel contact lens precursor composition is invisible from a polymerizable silicone hydrogel. The polymeric pro-hydrogel contact lens product of the lens precursor composition is removed and present in an amount of at least 15% (w/w) of the polymerized hydrogel hydrogel contact lens product, and polymerized to oxygen The portion has an unreacted monomer, a partially reacted monomer, or both, at a level of at least 15% (w/w) by weight of the hydrogel contact lens product. 一種矽氧水凝膠隱形眼鏡，其包含：包含矽氧水凝膠材料之鏡片物體，此鏡片物體具有眼睛上可接受之表面可潤溼性，且乾重不大於萃取前鏡片物體乾重之90%，其中以萃取前鏡片物體之乾重計，該鏡片物體具有至少15%(w/w)經萃取而移除之可移除成份，且以萃取前鏡片物體之乾重計，該可移除成分具有含量為至少15%(w/w)之未反 應之單體、經部分反應之單體或二者，且其中該鏡片物體係為得自非極性樹脂隱形眼鏡模之經鑄造模製元件。 A helium oxygen hydrogel contact lens comprising: a lens object comprising a helium oxygen hydrogel material, the lens object having an acceptable surface wettability on the eye, and the dry weight is no greater than the dry weight of the lens object before extraction 90%, wherein the lens object has at least 15% (w/w) of the removable component removed by extraction, based on the dry weight of the pre-extracted lens object, and based on the dry weight of the lens object before extraction, The removed component has a non-reverse content of at least 15% (w/w) The monomer, the partially reacted monomer, or both, and wherein the lens system is a cast molded component from a non-polar resin contact lens mold. 如請求項24之矽氧水凝膠隱形眼鏡，其中該鏡片物體係不經提供眼睛上可接受之表面可潤溼性之表面處理。 The oxygenated hydrogel contact lens of claim 24, wherein the lens system is provided without surface treatment to provide acceptable surface wettability to the eye. 如請求項24之矽氧水凝膠隱形眼鏡，其中該鏡片物體係不含提供眼睛上可接受表面可潤溼性之聚合體潤溼劑之互穿聚合體網狀組織。 The oxygenated hydrogel contact lens of claim 24, wherein the lens system is free of interpenetrating polymeric network structures that provide polymeric wetting agents that are acceptable for surface wettability on the eye. 如請求項24之矽氧水凝膠隱形眼鏡，其中該鏡片物體係經水合，且包括：前進接觸角小於約120度，抗張模數小於約1.6MPa，離子通量小於約7 x 10-3 平方毫米/分鐘，氧透氣性至少約70巴勒(barrer)，或水含量至少約30重量%或其組合。The oxygenated hydrogel contact lens of claim 24, wherein the lens system is hydrated and comprises: an advancing contact angle of less than about 120 degrees, a tensile modulus of less than about 1.6 MPa, and an ion flux of less than about 7 x 10 - 3 square millimeters per minute, oxygen gas permeability of at least about 70 barrers, or water content of at least about 30 weight percent or a combination thereof. 如請求項24之矽氧水凝膠隱形眼鏡，其中該鏡片物體係包含得自甲基丙烯酸酯磷醯膽鹼-單體之單位。 The oxime hydrogel contact lens of claim 24, wherein the lens system comprises units derived from methacrylate choline-monomer. 如請求項28之矽氧水凝膠隱形眼鏡，其中該鏡片物體係包含得自2-甲基丙烯醯基氧基乙基磷醯膽鹼之單位。 The oxygenated hydrogel contact lens of claim 28, wherein the lens system comprises units derived from 2-methylpropenyloxyethylphosphonium. 如請求項24之矽氧水凝膠隱形眼鏡，其中該鏡片物體具有平衡水含量為約35%至約65%。 The oxygenated hydrogel contact lens of claim 24, wherein the lens object has an equilibrium water content of from about 35% to about 65%. 如請求項24之矽氧水凝膠隱形眼鏡，其中該鏡片物體包含至少兩種包含有不同反應性比之單體種類之反應性成分。 The oxygenated hydrogel contact lens of claim 24, wherein the lens object comprises at least two reactive components comprising monomer species of different reactivity ratios. 如請求項24之矽氧水凝膠隱形眼鏡，其中以乙醇作為液體 萃取媒質完成該萃取步驟。 The oxygenated hydrogel contact lens of claim 24, wherein ethanol is used as the liquid The extraction medium completes the extraction step. 如請求項24之矽氧水凝膠隱形眼鏡，其中以氯仿作為液體萃取媒質完成該萃取步驟。 The oxygenated hydrogel contact lens of claim 24, wherein the extracting step is carried out using chloroform as the liquid extraction medium. 如請求項24之矽氧水凝膠隱形眼鏡，其中該矽氧水凝膠材料包含親水性含乙烯基單體。 The oxime hydrogel contact lens of claim 24, wherein the oxime hydrogel material comprises a hydrophilic vinyl-containing monomer. 一種矽氧水凝膠隱形眼鏡，其包含矽氧水凝膠材料之鏡片物體，此鏡片物體具有眼睛上可接受之表面可潤溼性，且乾重不大於萃取前鏡片物體之乾重之90%，其中以萃取前鏡片物體乾重計，該鏡片物體具有至少10%(w/w)經萃取而移除之可移除成份，且以萃取前鏡片物體之乾重計，該可移除成分具有含量為至少10%(w/w)之未反應之單體、經部分反應之單體或二者，且其中該鏡片物體係為得自非極性樹脂隱形眼鏡模之經鑄造模製元件，其中該矽氧水凝膠材料包含親水性含乙烯基單體。 A silicone hydrogel contact lens comprising a lens object of a hydroxyl hydrogel material having an acceptable surface wettability on the eye and a dry weight no greater than 90% of the dry weight of the lens object prior to extraction %, wherein the lens object has at least 10% (w/w) of the removable component removed by extraction, based on the dry weight of the pre-extracted lens object, and is removable based on the dry weight of the pre-extracted lens object The composition has an unreacted monomer, a partially reacted monomer or both in an amount of at least 10% (w/w), and wherein the lens system is a cast molded component from a non-polar resin contact lens mold Wherein the neon hydrogel material comprises a hydrophilic vinyl-containing monomer. 如請求項35之矽氧水凝膠隱形眼鏡，其中該萃取前之物體構件具有可移除成份含量為該物體構件之10%(w/w)至約75%(w/w)。 The oxygenated hydrogel contact lens of claim 35, wherein the pre-extracted object member has a removable component content of from 10% (w/w) to about 75% (w/w) of the object member. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體具有平衡水含量為約35%至約65%。 The oxygenated hydrogel contact lens of claim 35, wherein the lens object has an equilibrium water content of from about 35% to about 65%. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體包含至少兩種包含有不同反應性比例之單體種類之反應性成 分。 The oxygenated hydrogel contact lens of claim 35, wherein the lens object comprises at least two reactive species comprising monomer species having different reactivity ratios. Minute. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體係不含提供眼睛上可接受之表面可潤溼性之表面處理。 The oxygenated hydrogel contact lens of claim 35, wherein the lens system is free of surface treatments that provide acceptable surface wettability to the eye. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體係不含提供眼睛上可接受表面可潤溼性之聚合體潤溼劑之互穿聚合體網狀組織。 The oxygenated hydrogel contact lens of claim 35, wherein the lens system is free of interpenetrating polymeric network structures that provide polymeric wetting agents that are acceptable for surface wettability on the eye. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體係經水合，且包括：前進接觸角小於約120度，抗張模數小於約1.6MPa，離子通量小於約7 x 10-3 平方毫米/分鐘，氧透氣性至少約70巴勒(barrer)，或水含量至少約30重量%或其組合。The oxime hydrogel contact lens of claim 35, wherein the lens system is hydrated and comprises: an advancing contact angle of less than about 120 degrees, a tensile modulus of less than about 1.6 MPa, and an ion flux of less than about 7 x 10 - 3 square millimeters per minute, oxygen gas permeability of at least about 70 barrers, or water content of at least about 30 weight percent or a combination thereof. 如請求項35之矽氧水凝膠隱形眼鏡，其中以乙醇作為液體萃取媒質完成該萃取步驟。 The oxygenated hydrogel contact lens of claim 35, wherein the extracting step is carried out using ethanol as the liquid extraction medium. 如請求項35之矽氧水凝膠隱形眼鏡，其中以氯仿作為液體萃取媒質完成該萃取步驟。 The oxygenated hydrogel contact lens of claim 35, wherein the extracting step is carried out using chloroform as the liquid extraction medium. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體係包含得自甲基丙烯酸酯磷醯膽鹼-單體之單位。 The oxime hydrogel contact lens of claim 35, wherein the lens system comprises units derived from methacrylate choline-monomer. 如請求項35之矽氧水凝膠隱形眼鏡，其中該鏡片物體係包含得自2-甲基丙烯醯基氧基乙基磷醯膽鹼之單位。 The oxygenated hydrogel contact lens of claim 35, wherein the lens system comprises units derived from 2-methylpropenyloxyethylphosphonium. 一種萃取前經聚合之矽氧水凝膠隱形眼鏡產物，其包含：萃取前之物體構件，其具有乾重至少10%大於使該物體構 件接受萃取程序以形成經萃取聚合之矽氧水凝膠隱形眼鏡產物後之物體構件之乾重，其中以萃取前物體構件之乾重計，該萃取前物體構件具有至少10%(w/w)經萃取而移除之可移除成份，且以萃取前物體構件之乾重計，該可移除成分具有含量為至少10%(w/w)之未反應之單體、經部分反應之單體或二者，且其中該萃取前物體構件係為得自非極性樹脂隱形眼鏡模之經鑄造模製元件，其中該萃取前物體構件係包含至少兩種反應性成分之聚合組合物之聚合產物，該反應性成分包含有不同反應性比之單體種類。 A pre-extracted polymerized hydrothermal hydrogel contact lens product comprising: an object member prior to extraction having a dry weight of at least 10% greater than the structure of the object The part is subjected to an extraction procedure to form a dry weight of the object component after the extracted polymeric hydrogel contact lens product, wherein the pre-extracted object member has at least 10% (w/w) based on the dry weight of the pre-extracted object member a removable component removed by extraction, and having an unreacted monomer in an amount of at least 10% (w/w), partially reacted, based on the dry weight of the component prior to extraction Monomer or both, and wherein the pre-extracting object member is a cast molded component from a non-polar resin contact lens mold, wherein the pre-extracting object member is a polymerization of a polymeric composition comprising at least two reactive components The product, the reactive component comprises a monomer species having a different reactivity ratio. 一種製造矽氧水凝膠隱形眼鏡之方法，其包括：自具有可移除成份含量為鏡片產物之至少10%(w/w)之萃取前矽氧水凝膠隱形眼鏡產物形成矽氧水凝膠隱形眼鏡物體，其具有乾重不大於萃取前鏡片物體乾重之90%，與眼睛上可接受之表面可潤溼性，其中以萃取前矽氧水凝膠隱形眼鏡物體之乾重計，該可移除成分具有含量為至少10%(w/w)之未反應之單體、經部分反應之單體或二者，且其中該鏡片物體係為得自非極性樹脂隱形眼鏡模之經鑄造模製元件。 A method of making a hydroxyl hydrogel contact lens comprising: forming a helium oxygen hydrogel from a pre-extracted helium oxygen hydrogel contact lens product having a removable component content of at least 10% (w/w) of the lens product A contact lens object having a dry weight of no more than 90% of the dry weight of the lens body prior to extraction and an acceptable surface wettability to the eye, wherein the dry weight of the contact lens of the oxygenated hydrogel prior to extraction is The removable component has an unreacted monomer, a partially reacted monomer, or both in an amount of at least 10% (w/w), and wherein the lens system is a non-polar resin contact lens mold. Cast molding components. 如請求項47之方法，其中該形成係包括自萃取前之矽氧水凝膠隱形眼鏡產物萃取可萃取物質。 The method of claim 47, wherein the forming comprises extracting the extractable material from the oxygenated hydrogel contact lens product prior to extraction. 如請求項47之方法，其進一步包括使可聚合矽氧水凝膠隱形眼鏡先質組合物熟化，以形成具有可移除成份含量為鏡片產物之至少10%(w/w)之萃取前經聚合之矽氧水凝膠隱形眼鏡產物。 The method of claim 47, further comprising aging the polymerizable silicone hydrogel contact lens precursor composition to form a pre-extraction process having a removable component content of at least 10% (w/w) of the lens product. Polymerized oxygenated hydrogel contact lens product. 如請求項49之方法，其進一步包括添加可移除之添加劑至可聚合矽氧水凝膠隱形眼鏡先質組合物中。 The method of claim 49, further comprising adding a removable additive to the polymerizable silicone hydrogel contact lens precursor composition. 如請求項50之方法，其中該可移除之添加劑係選自包括相容劑、脫模助劑、脫除鏡片助劑、可潤溼性增強劑、模數降低劑、離子通量降低劑及其組合。 The method of claim 50, wherein the removable additive is selected from the group consisting of a compatibilizer, a mold release aid, a lens removal aid, a wettability enhancer, a modulus reducer, and an ion flux reducer. And their combinations. 如請求項49之方法，其進一步包括將作用劑添加至鏡片先質組合物中，該作用劑係選自包括紫外線吸收劑、微染劑及其組合。 The method of claim 49, further comprising adding an agent to the lens precursor composition selected from the group consisting of ultraviolet absorbers, microdyes, and combinations thereof. 如請求項49之方法，其中該可聚合矽氧水凝膠隱形眼鏡先質組合物包含親水性含乙烯基單體。 The method of claim 49, wherein the polymerizable silicone hydrogel contact lens precursor composition comprises a hydrophilic vinyl-containing monomer. 如請求項47之方法，其中該矽氧水凝膠隱形眼鏡係經製造，而無需表面處理鏡片或形成具有聚合體潤溼劑之互穿聚合體網狀組織之鏡片。 The method of claim 47, wherein the silicone hydrogel contact lens is manufactured without the need for a surface treatment lens or a lens that forms an interpenetrating polymer network having a polymeric wetting agent. 如請求項47之方法，其中該矽氧水凝膠隱形眼鏡係包含至少兩種反應性成分之聚合組合物之聚合產物，該反應性成分包含有不同反應性比之單體種類。 The method of claim 47, wherein the hydroxyl hydrogel contact lens comprises a polymeric product comprising a polymeric composition of at least two reactive components, the reactive component comprising a monomer species having a different reactivity ratio. 如請求項47之方法，其中該萃取前矽氧水凝膠隱形眼鏡產物具有為鏡片產物之至少15%(w/w)之可移除成分含量，且 該可移除成分含量以矽氧水凝膠隱形鏡片物體乾重計，該可移除成分含量具有含量為至少15%(w/w)之未反應之單體、經部分反應之單體或二者。The method of claim 47, wherein the pre-extracted oxygenated hydrogel contact lens product has a removable component content of at least 15% (w/w) of the lens product, and The removable component is present in an amount of at least 15% (w/w) of unreacted monomer, partially reacted monomer, or dry weight of the hydroxyl contact lens. both.
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TWI429713B (en) 2014-03-11
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JP5224090B2 (en) 2013-07-03
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TWI443116B (en) 2014-07-01
TW201434885A (en) 2014-09-16

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