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TWI758937B - Contact lenses for intraocular pressure monitoring and manufacturing method thereof - Google Patents

Contact lenses for intraocular pressure monitoring and manufacturing method thereof Download PDF

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Publication number
TWI758937B
TWI758937B TW109138782A TW109138782A TWI758937B TW I758937 B TWI758937 B TW I758937B TW 109138782 A TW109138782 A TW 109138782A TW 109138782 A TW109138782 A TW 109138782A TW I758937 B TWI758937 B TW I758937B
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lens layer
pattern
layer
outer lens
inner lens
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TW109138782A
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TW202218619A (en
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張美雲
張修豪
林栢青
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明基材料股份有限公司
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Abstract

The invention discloses a contact lens for intraocular pressure monitoring, comprising an outer lens layer, an adhesive layer and an inner lens layer, wherein the elastic modulus of the outer lens layer is greater than the elastic modulus of the inner lens layer, and the elastic modulus of the outer lens layer is greater than 0.8 MPa and less than 1.7 MPa, the elastic modulus of the inner lens layer is not less than 0.2 MPa and not more than 0.8 MPa, and the difference between the degree of swelling of the outer lens layer and the inner lens layer is in the range of 0% to 1%. The outer lens layer and the inner lens layer are respectively provided with a first pattern layer and a second pattern layer, wherein the second pattern layer will appear relative deviation with the fixed first pattern layer with the change of intraocular pressure to achieve the purpose of intraocular pressure monitoring.

Description

用於眼壓監測的隱形眼鏡及其製造方法 Contact lens for intraocular pressure monitoring and method of making the same

本發明係有關於一種隱形眼鏡,且特別是有關於一種用於眼壓監測的隱形眼鏡。 The present invention relates to a contact lens, and in particular to a contact lens for intraocular pressure monitoring.

眼壓為眼球對眼球壁所施加的均衡壓力,一般健康眼睛內會維持恆定的壓力而使視網膜的感光視神經系統正常運作。當眼壓上升時,眼睛將會出現酸澀或看到虹暈的症狀;情況加劇時則有眼脹、頭痛等現象。長期高眼壓將因壓迫視神經,使視神經萎縮、病變,進而造成視力下降與視野變小等症狀,而形成青光眼,其為目前造成人類後天失明的最主要原因。然而,青光眼初期常因不會產生明顯的症狀,故常在被發現時視神經已喪失功能。因此,長期眼壓的測量是必須的,尤其擁有高青光眼危險因子如高度近視、高血壓、肥胖或有青光眼家族病史的族群更需密切監測。並且,青光眼患者亦可藉由眼壓的長時間監測來避免病情惡化甚至失明。 Intraocular pressure is the balanced pressure exerted by the eyeball on the wall of the eyeball. Generally, a constant pressure is maintained in a healthy eye so that the photoreceptor optic nerve system of the retina can function normally. When the intraocular pressure rises, the eyes will be sore or see the symptoms of rainbow halo; when the situation is aggravated, there will be eye swelling, headache and other phenomena. Long-term high intraocular pressure will cause optic nerve atrophy and lesions due to compression of the optic nerve, resulting in symptoms such as decreased vision and reduced visual field, resulting in the formation of glaucoma, which is currently the main cause of acquired blindness in humans. However, in the early stage of glaucoma, there are often no obvious symptoms, so the optic nerve is often found to have lost function. Therefore, long-term IOP measurement is necessary, especially in groups with high glaucoma risk factors such as high myopia, hypertension, obesity, or a family history of glaucoma, which requires close monitoring. In addition, glaucoma patients can avoid deterioration or even blindness by monitoring the intraocular pressure for a long time.

目前監測眼壓的方法主要是利用壓阻式眼壓計或非接觸式光學儀器對眼球壓力進行定期但單次式量測,無法長時間監測。若須長時間監測,現有技術可透過在患者眼中植入微型晶片或微流體感測器,或使用電阻或電容 式的非侵入眼壓感測元件來達成。然而,前者需透過眼科手術來植入晶片或感測器,風險高;而後者作動原理為透過非侵入式感測元件確認因眼壓變化而出現的電阻值或電容改變,並透過後端訊號處理,程序繁複且干擾源多。 The current methods for monitoring intraocular pressure mainly use piezoresistive tonometers or non-contact optical instruments to measure eye pressure on a regular but single-time basis, which cannot be monitored for a long time. For long-term monitoring, existing technologies can be achieved by implanting microchips or microfluidic sensors in the patient's eye, or using resistive or capacitive It is achieved by a non-invasive intraocular pressure sensing element. However, the former requires implantation of chips or sensors through ophthalmic surgery, which is of high risk; while the operating principle of the latter is to confirm the change in resistance or capacitance due to changes in intraocular pressure through a non-invasive sensing element, and through the back-end signal processing, the procedures are complicated and there are many sources of interference.

有鑑於此,需要一種新式簡便且適合長時間的眼壓監測隱形眼鏡。 In view of this, there is a need for a new simple and suitable for long-term intraocular pressure monitoring contact lenses.

本發明之一目的係提供一種用於監測眼壓變化之眼壓感測的隱形眼鏡。本發明之眼壓感測隱形眼鏡採用外鏡片層與內鏡片層疊合,因內鏡片層與外鏡片層之拉伸模數差異,當在配戴時,內鏡片層因眼球的眼壓發生變化而產生形變,造成內鏡片層的圖案與外鏡片層的圖案發生偏差,故可經由監測圖案之偏差量以評估眼壓的變化。 An object of the present invention is to provide a contact lens for intraocular pressure sensing for monitoring intraocular pressure changes. The eye pressure sensing contact lens of the present invention adopts the outer lens layer and the inner lens layer to be laminated. Due to the difference in tensile modulus between the inner lens layer and the outer lens layer, when wearing, the inner lens layer changes due to the intraocular pressure of the eyeball. As a result of the deformation, the pattern of the inner lens layer and the pattern of the outer lens layer are deviated, so the variation of the intraocular pressure can be evaluated by monitoring the deviation of the patterns.

本發明之眼壓感測隱形眼鏡包括:一外鏡片層,該外鏡片層含一對應眼球角膜區域的第一光學區及一具有第一圖案且對應該眼球角膜區域以外區域的第一周邊區,且該外鏡片層具有彼此相對的一第一外表面與一第一內表面,該第一圖案是位在該第一外表面或該第一內表面,且該外鏡片層的拉伸模數大於0.8MPa且小於1.7MPa;一內鏡片層,該內鏡片層含有一對應眼球角膜區域的第二光學區及一具有第二圖案且對應該眼球角膜區域以外區域的第二周邊區,且該內鏡片層具有相對的一第二外表面與一第二內表面,該第二圖案是位在該第二外表面,且該內鏡片層的拉伸模數小於該外鏡片層之拉伸模數且不小於0.2MPa且不大於0.8MPa;以及一黏著層,其設置於該外鏡片層的該第一內表面與內鏡片層的該第二外表面之間,且該黏著層與該外鏡片層的該第一內表面與該內鏡片層的該第二外表面相鄰接以黏合該外鏡片層及內鏡片層,其中該第一圖案與第二圖案為彼此重疊或設定偏差一預定距離或一預定角度d。 The intraocular pressure sensing contact lens of the present invention comprises: an outer lens layer, the outer lens layer includes a first optical zone corresponding to the cornea area and a first peripheral area having a first pattern and corresponding to the area outside the cornea area , and the outer lens layer has a first outer surface and a first inner surface opposite to each other, the first pattern is located on the first outer surface or the first inner surface, and the stretching mold of the outer lens layer The number is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer comprising a second optical zone corresponding to the corneal region and a second peripheral region having a second pattern and corresponding to the region outside the corneal region, and The inner lens layer has an opposite second outer surface and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than that of the outer lens layer modulus and not less than 0.2MPa and not more than 0.8MPa; and an adhesive layer disposed between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and the adhesive layer and the The first inner surface of the outer lens layer is adjacent to the second outer surface of the inner lens layer to bond the outer lens layer and the inner lens layer, wherein the first pattern and the second pattern are overlapped with each other or set a deviation of a A predetermined distance or a predetermined angle d.

根據本發明之用於眼壓監測的隱形眼鏡的一較佳實施例,其中該外鏡片層對該內鏡片層之拉伸模數比值大於1且小於4.5,且該外鏡片層對該內鏡片層之膨潤脹縮率差值介於0%至1%。 A preferred embodiment of the contact lens for intraocular pressure monitoring according to the present invention, wherein the tensile modulus ratio of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and the outer lens layer to the inner lens The difference in swelling and shrinkage of the layers is between 0% and 1%.

根據本發明之用於眼壓監測的隱形眼鏡的較佳實施例,其中該第一圖案位於外鏡片層之該第一外表面或與該黏著層相鄰接的該第一內表面,該第二圖案位於該內鏡片層與黏著層相鄰接之該第二外表面。 A preferred embodiment of the contact lens for intraocular pressure monitoring according to the present invention, wherein the first pattern is located on the first outer surface of the outer lens layer or the first inner surface adjacent to the adhesive layer, and the first pattern is located on the first outer surface of the outer lens layer or the first inner surface adjacent to the adhesive layer. Two patterns are located on the second outer surface adjacent to the inner lens layer and the adhesive layer.

根據本發明之用於眼壓監測的隱形眼鏡的較佳實施例,該內鏡片層的該第二內表面直接接觸眼球,當該內鏡片層隨眼壓變化而產生形變時,該第二圖案亦產生變化,而該外鏡片層未與眼球接觸且具有較高拉伸模數,不易形變,故造成形變的該第二圖案之圖案與該外鏡片層之該第一圖案之圖案出現可供肉眼辨識或儀器偵測之相對位偏差或角偏差,故可據此評估眼壓的變化。 According to a preferred embodiment of the contact lens for intraocular pressure monitoring of the present invention, the second inner surface of the inner lens layer directly contacts the eyeball, and when the inner lens layer is deformed with the change of intraocular pressure, the second pattern Changes also occur, and the outer lens layer is not in contact with the eyeball and has a higher tensile modulus, which is not easy to deform, so the pattern of the second pattern that causes the deformation and the pattern of the first pattern of the outer lens layer appear for The relative position deviation or angular deviation detected by the naked eye or the instrument can be used to evaluate the change of intraocular pressure.

根據本發明之用於眼壓監測的隱形眼鏡的較佳實施例,其中該黏著層為黏合該外鏡片層的該第一周邊區與該內鏡片層之該第二周邊區以維持該外鏡片層與該內鏡片層的結合性及保留該內鏡片層的形變空間。在本發明隱形眼鏡的另一較佳實施例,該黏著層黏合該外鏡片層的該第一周邊區與該內鏡片層之該第二周邊區外,非該第一、第二周邊區部份較佳亦含有黏著層,但未完全佈滿該外鏡片層與該內鏡片層間之空間,以保留該內鏡片層的形變空間,但維持該外鏡片層與該內鏡片層間黏合穩定性。 According to a preferred embodiment of the contact lens for intraocular pressure monitoring of the present invention, the adhesive layer is for bonding the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer to maintain the outer lens The bonding between the layer and the inner lens layer and the deformation space of the inner lens layer is reserved. In another preferred embodiment of the contact lens of the present invention, the adhesive layer is outside the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer, not the first and second peripheral regions The part preferably also contains an adhesive layer, but does not completely fill the space between the outer lens layer and the inner lens layer, so as to retain the deformation space of the inner lens layer, but maintain the adhesion stability between the outer lens layer and the inner lens layer.

根據本發明的較佳實施例,如上所述之用於眼壓監測的隱形眼鏡,其中該黏著層之占有區域為始於該外鏡片層之該第一周邊區域外緣,並終於自該外鏡片層之軸心外推距離介於10%至95%之該外鏡片層之直徑的位置。 According to a preferred embodiment of the present invention, the contact lens for intraocular pressure monitoring as described above, wherein the occupied area of the adhesive layer starts from the outer edge of the first peripheral area of the outer lens layer and ends at the outer edge of the outer lens layer. The axis of the lens layer is extrapolated from a position between 10% and 95% of the diameter of the outer lens layer.

本發明之另一目的係提供一種製造用於眼壓監測的隱形眼鏡的方法,其包含以下步驟:提供一外鏡片層,該外鏡片層含一對應眼球角膜區域的第一光學區及一具有第一圖案且對應該眼球角膜區域以外區域的第一周邊 區,且該外鏡片層具有彼此相對的一第一外表面與一第一內表面,該第一圖案是位在該第一外表面或該第一內表面,且該外鏡片層的拉伸模數大於0.8MPa且小於1.7MPa;提供一內鏡片層,該內鏡片層含有一對應眼球角膜區域的第二光學區及一具有第二圖案且對應該眼球角膜區域以外區域的第二周邊區,且該內鏡片層具有相對的一第二外表面與一第二內表面,該第二圖案是位在該第二外表面,且該內鏡片層的拉伸模數小於該外鏡片層之拉伸模數,且不小於0.2MPa且不大於0.8MPa;提供一黏著層組成物,並將該黏著層組成物印刷於該外鏡片層的該第一內表面及/或該內鏡片層的該第二外表面;以及對位貼合該外鏡片層與該內鏡片層,使該黏著層組成物形成一黏著層於該外鏡片層的該第一內表面與該內鏡片層的該第二外表面之間,且該黏著層與該外鏡片層的該第一內表面與該內鏡片層的該第二外表面相鄰接,藉由該黏著層以黏合該外鏡片層及該內鏡片層,完成該用於眼壓監測的隱形眼鏡的製造;其中,該第一圖案與該第二圖案為彼此重疊或設定偏差一預定距離或一預定角度d。 Another object of the present invention is to provide a method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of: providing an outer lens layer, the outer lens layer comprising a first optical zone corresponding to the corneal region and a the first pattern and corresponding to the first periphery of the area other than the corneal area of the eyeball area, and the outer lens layer has a first outer surface and a first inner surface opposite to each other, the first pattern is located on the first outer surface or the first inner surface, and the stretching of the outer lens layer The modulus is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer is provided, the inner lens layer contains a second optical zone corresponding to the corneal region and a second peripheral region having a second pattern and corresponding to the region outside the corneal region , and the inner lens layer has an opposite second outer surface and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than that of the outer lens layer The tensile modulus is not less than 0.2MPa and not more than 0.8MPa; an adhesive layer composition is provided, and the adhesive layer composition is printed on the first inner surface of the outer lens layer and/or the inner lens layer. the second outer surface; and aligning the outer lens layer and the inner lens layer, so that the adhesive layer composition forms an adhesive layer on the first inner surface of the outer lens layer and the first inner surface of the inner lens layer Between two outer surfaces, and the adhesive layer is adjacent to the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, the outer lens layer and the inner lens layer are bonded by the adhesive layer The lens layer completes the manufacture of the contact lens for intraocular pressure monitoring; wherein, the first pattern and the second pattern are overlapped with each other or offset by a predetermined distance or a predetermined angle d.

根據本發明的較佳實施例,如上所述之製造用於眼壓監測的隱形眼鏡的方法,其中該外鏡片層之製造步驟包括:提供一第一組合物及一圖案色料組成物;將該第一組合物置入一隱形眼鏡模具中,固化該第一組合物以形成一外鏡片層本體,該外鏡片層本體具有彼此相對的一第一外表面與一第一內表面;以及將該圖案色料組成物印刷至該外鏡片層本體的該第一外表面或該第一內表面以在該外鏡片層本體上形成一第一圖案,完成該外鏡片層的製作。 According to a preferred embodiment of the present invention, the method for manufacturing a contact lens for intraocular pressure monitoring as described above, wherein the manufacturing steps of the outer lens layer include: providing a first composition and a pattern colorant composition; The first composition is placed in a contact lens mold, the first composition is cured to form an outer lens layer body, the outer lens layer body has a first outer surface and a first inner surface opposite to each other; and the The pattern colorant composition is printed on the first outer surface or the first inner surface of the outer lens layer body to form a first pattern on the outer lens layer body, and the fabrication of the outer lens layer is completed.

根據本發明的較佳實施例,如上所述之製造用於眼壓監測的隱形眼鏡的方法,其中該內鏡片層之製造步驟包括:提供一第二組合物及一圖案色料組成物;將該第二組合物置入一隱形眼鏡模具中,固化該第二組合物以形成一內鏡片層本體,該內鏡片層本體具有彼此相對的一第二外表面與一第二內表面;以 及將該圖案色料組成物印刷至該內鏡片層本體的該第二外表面以在該內鏡片層本體上形成一第二圖案,完成該內鏡片層的製作。 According to a preferred embodiment of the present invention, the above-mentioned method for manufacturing a contact lens for intraocular pressure monitoring, wherein the manufacturing step of the inner lens layer comprises: providing a second composition and a pattern colorant composition; The second composition is placed in a contact lens mold, and the second composition is cured to form an inner lens layer body, the inner lens layer body having a second outer surface and a second inner surface opposite to each other; to and printing the pattern colorant composition on the second outer surface of the inner lens layer body to form a second pattern on the inner lens layer body to complete the manufacture of the inner lens layer.

根據本發明的較佳實施例,如上所述之製造用於眼壓監測的隱形眼鏡的方法,該固化該第一、第二組合物的步驟可分別為加熱固化、光固化或微波固化。 According to a preferred embodiment of the present invention, in the method for manufacturing a contact lens for intraocular pressure monitoring as described above, the steps of curing the first and second compositions may be heat curing, light curing or microwave curing, respectively.

根據本發明的較佳實施例之製造用於眼壓監測的隱形眼鏡的方法,該第一圖案及第二圖案之印刷方式可為噴墨印刷(inkjet printing)、雷射印刷(laser printing)、移印(pad printing)或轉印(transfer printing)。 According to the method for manufacturing a contact lens for intraocular pressure monitoring according to a preferred embodiment of the present invention, the printing methods of the first pattern and the second pattern can be inkjet printing, laser printing, Pad printing or transfer printing.

根據本發明的較佳實施例,如上所述之製造用於眼壓監測的隱形眼鏡的方法,該黏著層之印刷為噴墨印刷(inkjet printing)、雷射印刷(laser printing)、移印(pad printing)或轉印(transfer printing)。 According to a preferred embodiment of the present invention, the method for manufacturing a contact lens for intraocular pressure monitoring as described above, the printing of the adhesive layer is inkjet printing, laser printing, pad printing ( pad printing) or transfer printing.

根據本發明的較佳實施例,如上所述之製造用於眼壓監測的隱形眼鏡的方法,該外鏡片層與內鏡片層之對位貼合,使該第一圖案之圖案與第二圖案之圖案重疊或設定偏差一預定距離或一預定角度d。 According to a preferred embodiment of the present invention, in the method for manufacturing a contact lens for intraocular pressure monitoring as described above, the outer lens layer and the inner lens layer are aligned and adhered so that the pattern of the first pattern and the pattern of the second pattern are The patterns overlap or are set to deviate by a predetermined distance or a predetermined angle d.

上述發明內容旨在提供本揭示內容的簡化摘要,以使閱讀者對本揭示內容具備基本的理解。此發明內容並非本揭示內容的完整概述,且其用意並非在指出本發明實施例的重要/關鍵元件或界定本發明的範圍。在參閱下文實施方式後,本發明所屬技術領域中具有通常知識者當可輕易瞭解本發明之基本精神以及本發明所採用之技術手段與實施態樣。 The above summary is intended to provide a simplified summary of the disclosure to provide the reader with a basic understanding of the disclosure. This summary is not an exhaustive overview of the disclosure, and it is not intended to identify key/critical elements of embodiments of the invention or to delineate the scope of the invention. After referring to the following embodiments, those with ordinary knowledge in the technical field to which the present invention pertains can easily understand the basic spirit of the present invention, as well as the technical means and implementation aspects adopted by the present invention.

10、310a、310b:用於眼壓監測的隱形眼鏡隱形眼鏡 10, 310a, 310b: Contact lenses for intraocular pressure monitoring

10a:光學區 10a: Optical Zone

10b:周邊區 10b: Surrounding area

11:眼球 11: Eyeballs

111:眼球角膜區域 111: Corneal area of the eye

113:眼球角膜區域以外區域 113: Area outside the cornea area of the eye

21、321a、321b:外鏡片層 21, 321a, 321b: outer lens layer

210a:第一光學區 210a: First Optical Zone

210b:第一周邊區 210b: First peripheral area

211:第一外表面 211: First outer surface

213:第一內表面 213: First inner surface

22、322a、322b:第一圖案 22, 322a, 322b: the first pattern

23:黏著層 23: Adhesive layer

24、324a、324b:第二圖案 24, 324a, 324b: the second pattern

25、325a、325b:內鏡片層 25, 325a, 325b: inner lens layer

250a:第二光學區 250a: Second Optical Zone

250b:第二周邊區 250b: Second Perimeter

251:第二外表面 251: Second outer surface

253:第二內表面 253: Second inner surface

d:設定偏差的距離或角度 d: Set the distance or angle of the deviation

圖1為根據本發明一實施例所繪製之具有光學區10a與周邊區10b之用於眼壓監測的隱形眼鏡10對應眼球11位置之示意圖。 1 is a schematic diagram of a contact lens 10 having an optical zone 10a and a peripheral zone 10b for intraocular pressure monitoring corresponding to the position of the eyeball 11 according to an embodiment of the present invention.

圖2A至2B分別為根據本發明一實施例所繪製用於眼壓監測的隱形眼鏡10之剖面示意圖及俯視圖。 2A to 2B are a schematic cross-sectional view and a top view of a contact lens 10 for intraocular pressure monitoring drawn according to an embodiment of the present invention, respectively.

圖3A為根據本發明另一實施例所繪製之用於眼壓監測的隱形眼鏡310a之外鏡片層321a與內鏡片層325a對位之示意圖;圖3B為根據本發明另一實施例所繪製之用於眼壓監測的隱形眼鏡310b之外鏡片層321b與內鏡片層325b對位之示意圖。 3A is a schematic diagram of the alignment of the outer lens layer 321a and the inner lens layer 325a of the contact lens 310a used for intraocular pressure monitoring according to another embodiment of the present invention; FIG. 3B is drawn according to another embodiment of the present invention. A schematic diagram of the alignment of the outer lens layer 321b and the inner lens layer 325b of the contact lens 310b used for intraocular pressure monitoring.

圖4A~4C為根據本發明另一實施例所繪製之用於眼壓監測的隱形眼鏡310之第一圖案322a及322b與第二圖案324a及324b之圖案示意圖。 4A-4C are schematic diagrams of the first patterns 322a and 322b and the second patterns 324a and 324b of the contact lens 310 for intraocular pressure monitoring drawn according to another embodiment of the present invention.

為了使本發明揭示內容的敘述更加詳盡與完備,下文針對了本發明的實施態樣與具體實施例提出了說明性的描述;但這並非實施或運用本發明具體實施例的唯一形式。以下所揭露的各實施例,在有益的情形下可相互組合或取代,也可在一實施例中附加其他的實施例,而無須進一步的記載或說明。 In order to make the description of the disclosure of the present invention more detailed and complete, the following provides an illustrative description for the embodiments and specific embodiments of the present invention; but this is not the only form of implementing or using the specific embodiments of the present invention. The embodiments disclosed below can be combined or substituted with each other under beneficial circumstances, and other embodiments can also be added to one embodiment without further description or explanation.

本發明之優點、特徵以及達到之技術方法將參照例示性實施例進行更詳細地描述而更容易理解,且本發明或可以不同形式來實現,故不應被理解僅限於此處所陳述的實施例,相反地,對所屬技術領域具有通常知識者而言,所提供的實施例將使本揭露更加透徹與全面且完整地傳達本發明的範疇,且本發明將僅為所附加的申請專利範圍所定義。 The advantages, features and technical means of achieving the present invention will be more easily understood by being described in more detail with reference to the exemplary embodiments, and the present invention may be implemented in different forms, so it should not be construed as limited to the embodiments set forth herein. On the contrary, to those skilled in the art, the provided embodiments will make the present disclosure more thorough, complete and complete to convey the scope of the present invention, and the present invention will only be covered by the appended claims. definition.

而除非另外定義,所有使適用於後文的術語(包含科技及科學術語)與專有名詞,於實質上係與本發明所屬該領域的技術人士一般所理解之意思相同,而例如於一般所使用的字典所定義的那些術語應被理解為具有與相關領域的內容一致的意思,且除非明顯地定義於後文,將不以過度理想化或過度正式的意思理解。 Unless otherwise defined, all terms (including technical and scientific terms) and proper nouns used hereinafter have substantially the same meaning as commonly understood by those skilled in the art to which this invention belongs, and, for example, Those terms defined by the dictionary used should be construed to have meanings consistent with those in the relevant art, and should not be construed in an overly idealized or overly formal meaning unless clearly defined hereinafter.

再者,於本文中所謂「拉伸模數」係指施加力於材料上時,其彈性變形的數學描述,定義為應力(stress)對材料受力後應變(strain)的比值。「膨潤脹縮率」係指高分子物質於溶劑中因溶劑分子進入分子鏈間而使尺寸變化之比例。 Furthermore, the term "tensile modulus" as used herein refers to a mathematical description of the elastic deformation of a material when a force is applied to it, and is defined as the ratio of stress to the strain of the material after being subjected to the force. "Swelling and shrinkage ratio" refers to the ratio of the size change of a polymer substance in a solvent due to the entry of solvent molecules into the molecular chains.

以下透過圖示來說明本發明之用於眼壓監測之隱形眼鏡。首先,請參照圖1及圖2A~2B。如圖1所示,本發明之用於眼壓監測的隱形眼鏡10包含一對應眼球11之角膜區域111的光學區10a及一對應眼球11之角膜區域111以外區域113的一周邊區10b。又如圖2A所示,本發明之用於眼壓監測的隱形眼鏡10依序包括一外鏡片層21、一黏著層23及一直接接觸眼球之內鏡片層25。其中,該外鏡片層21含一對應眼球角膜區域111的第一光學區210a及一對應眼球角膜區域111以外區域113的第一周邊區210b,且該外鏡片層具有彼此相對的一第一外表面211與一第一內表面213;該內鏡片層25含一對應眼球角膜區域111的第二光學區250a及一對應眼球角膜區域111以外區域113的第二周邊區250b,且該內鏡片層25具有彼此相對的一第二外表面251與一第二內表面253。再進一步如圖2B示,其中外鏡片層21與內鏡片層25於第一周邊區210b及第二周邊區250b分別具備用於眼壓監測之第一圖案22與第二圖案24。 The contact lens for intraocular pressure monitoring of the present invention will be described below by way of diagrams. First, please refer to FIG. 1 and FIGS. 2A-2B. As shown in FIG. 1 , the contact lens 10 for intraocular pressure monitoring of the present invention includes an optical zone 10a corresponding to the corneal region 111 of the eyeball 11 and a peripheral region 10b corresponding to the region 113 outside the corneal region 111 of the eyeball 11 . As also shown in FIG. 2A , the contact lens 10 for intraocular pressure monitoring of the present invention sequentially includes an outer lens layer 21 , an adhesive layer 23 and an inner lens layer 25 directly contacting the eyeball. The outer lens layer 21 includes a first optical zone 210a corresponding to the corneal area 111 and a first peripheral area 210b corresponding to the area 113 outside the cornea area 111, and the outer lens layer has a first outer lens opposite to each other. surface 211 and a first inner surface 213; the inner lens layer 25 includes a second optical zone 250a corresponding to the corneal area 111 and a second peripheral area 250b corresponding to the area 113 outside the corneal area 111, and the inner lens layer 25 has a second outer surface 251 and a second inner surface 253 opposite to each other. Further as shown in FIG. 2B , the outer lens layer 21 and the inner lens layer 25 respectively have a first pattern 22 and a second pattern 24 for intraocular pressure monitoring in the first peripheral area 210b and the second peripheral area 250b.

在本發明之較佳實施例中,外鏡片層21之拉伸模數大於0.8MPa且小於1.7MPa,內鏡片層25之拉伸模數小於外鏡片層21之拉伸模數且不小於0.2MPa且不大於0.8MPa。用於眼壓監測的隱形眼鏡10採用外鏡片層21與內鏡片層25疊合,因內鏡片層25與外層鏡片21之拉伸模數差異,當在配戴時,內鏡片層25將因眼球的眼壓發生變化而產生形變。外鏡片層21之拉伸模數過低時,無法提供外鏡片層21抗形變性與整體隱形眼鏡10的支撐度;過高時則隱形眼鏡10難以順應角膜弧度而增加配戴時異物感。而內鏡片25層之拉伸模數過低時材料不易獨立成形;過高則可形變性不足。 In a preferred embodiment of the present invention, the tensile modulus of the outer lens layer 21 is greater than 0.8 MPa and less than 1.7 MPa, and the tensile modulus of the inner lens layer 25 is smaller than the tensile modulus of the outer lens layer 21 and not less than 0.2 MPa and not more than 0.8MPa. The contact lens 10 used for intraocular pressure monitoring adopts the outer lens layer 21 and the inner lens layer 25 to be superimposed. Due to the difference in tensile modulus between the inner lens layer 25 and the outer lens layer 21, when wearing, the inner lens layer 25 will The eyeball's intraocular pressure changes and deforms. When the tensile modulus of the outer lens layer 21 is too low, it cannot provide the outer lens layer 21 with resistance to deformation and the support of the contact lens 10 as a whole; When the tensile modulus of the 25 layers of the inner lens is too low, the material cannot be formed independently; if it is too high, the deformability is insufficient.

在本發明之較佳實施例中,外鏡片層21對內鏡片層25之拉伸模數比值大於1且小於4.5,膨潤脹縮率差值介於0%至1%。於此外鏡片層21對該內鏡片層25之拉伸模數比值及膨潤脹縮率差值定義範圍中,隱形眼鏡10之內鏡片層25在因眼壓造成眼球形變時,可與外鏡片層21產生形變差異且外鏡片層21與內鏡片層25可藉黏著層23良好結合而不發生剝離。 In a preferred embodiment of the present invention, the tensile modulus ratio of the outer lens layer 21 to the inner lens layer 25 is greater than 1 and less than 4.5, and the difference in expansion and shrinkage is between 0% and 1%. Within the defined range of the ratio of tensile modulus and the difference between the expansion and shrinkage ratios of the outer lens layer 21 to the inner lens layer 25, the inner lens layer 25 of the contact lens 10 can interact with the outer lens layer when the eyeball is deformed due to intraocular pressure. 21 produces a difference in deformation, and the outer lens layer 21 and the inner lens layer 25 can be well bonded by the adhesive layer 23 without peeling.

接著,請參照圖3A與3B。圖3A為說明本發明之另一實施例的用於眼壓監測的隱形眼鏡310a之外鏡片層321a與內鏡片層325a對位示意圖;圖3B為說明本發明之另一實施例的用於眼壓監測的隱形眼鏡310b之外鏡片層321b與內鏡片層325b對位示意圖。在圖3A中,該第一圖案322a與第二圖案324a於初始對位時彼此重疊;在圖3B中該第一圖案322b之圖案與第二圖案324b之圖案於初始對位時設定偏差一預定距離或一預定角度d。 Next, please refer to FIGS. 3A and 3B . 3A is a schematic diagram illustrating the alignment of the outer lens layer 321a and the inner lens layer 325a of a contact lens 310a for intraocular pressure monitoring according to another embodiment of the present invention; FIG. 3B is a schematic diagram illustrating another embodiment of the present invention. A schematic diagram of the alignment of the outer lens layer 321b and the inner lens layer 325b of the contact lens 310b for pressure monitoring. In FIG. 3A, the first pattern 322a and the second pattern 324a overlap each other during the initial alignment; in FIG. 3B, the pattern of the first pattern 322b and the pattern of the second pattern 324b are set to a predetermined deviation during the initial alignment distance or a predetermined angle d.

進一步參照圖4A~4C,適用於根據本發明實施例之用於眼壓監測的隱形眼鏡310a、310b的第一圖案322a及322b與第二圖案324a及324b之圖案可分別由複數個相同或不同之子圖形組成,且子圖形樣貌並無限定,例如但未限制為如圖4A所示之線條、或如圖4B所示之同心圓、或如圖4C所示之幾何圖案、或其等之組合,只要內鏡片層325a或325b隨眼壓變化而產生形變後可觀察出第二圖案324a及324b之圖案分別與第一圖案322a及322b之圖案產生相對位偏差或角偏差即可。 Further referring to FIGS. 4A-4C , the patterns of the first patterns 322a and 322b and the second patterns 324a and 324b suitable for the contact lenses 310a and 310b for intraocular pressure monitoring according to embodiments of the present invention may be the same or different, respectively. It is composed of sub-graphics, and the appearance of the sub-graphics is not limited, such as but not limited to lines as shown in FIG. 4A , or concentric circles as shown in FIG. 4B , or geometric patterns as shown in FIG. 4C , or the like. Combination, as long as the inner lens layer 325a or 325b deforms with the change of intraocular pressure, it can be observed that the patterns of the second patterns 324a and 324b and the patterns of the first patterns 322a and 322b produce relative positional deviation or angular deviation respectively.

用於眼壓監測的隱形眼鏡310a及310b分別採用外鏡片層321a及321b分別與內鏡片層325a及325b疊合,當在配戴時,內鏡片層325a及325b因眼球的眼壓發生變化而產生形變,造成內鏡片層325a及325b的第二圖案324a及324b分別與外鏡片層321a及321b的第一圖案322a及322b發生可供肉眼辨識或儀器偵測之相對位偏差或角偏差,故可經由監測偏差量以評估眼壓的變化。 The contact lenses 310a and 310b used for intraocular pressure monitoring use outer lens layers 321a and 321b to overlap with inner lens layers 325a and 325b respectively. When wearing, the inner lens layers 325a and 325b change due to changes in the intraocular pressure of the eyeball. Deformation occurs, causing the second patterns 324a and 324b of the inner lens layers 325a and 325b and the first patterns 322a and 322b of the outer lens layers 321a and 321b, respectively, to have relative positional deviation or angular deviation that can be recognized by the naked eye or detected by an instrument. Therefore, Changes in intraocular pressure can be assessed by monitoring the amount of deviation.

本發明之用於眼壓監測的隱形眼鏡的黏著層為用以黏著外鏡片層及內鏡片層。在本發明之實施例中,如圖2A所示用於眼壓監測的隱形眼鏡10的該黏著層23,可貼合外鏡片層21的第一內表面213的第一周邊區域210b及內鏡片層25的第二外表面251的第二周邊區域250b,較佳為增加黏合穩定性及保持內鏡片層25的形變空間,該黏著層23可為點狀、線條狀、規則或不規則幾何形狀分布於內鏡片層25與外鏡片層21間。如圖2B所示,該第一圖案22可位於外鏡片層21之第一外表面211或與黏著層23相鄰的第一內表面213,第二圖案24則位於內鏡片層25與黏著層23相接接之第二外表面251。 The adhesive layer of the contact lens for intraocular pressure monitoring of the present invention is used for adhering the outer lens layer and the inner lens layer. In an embodiment of the present invention, as shown in FIG. 2A , the adhesive layer 23 of the contact lens 10 used for intraocular pressure monitoring can adhere to the first peripheral region 210 b of the first inner surface 213 of the outer lens layer 21 and the inner lens The second peripheral region 250b of the second outer surface 251 of the layer 25 is preferably used to increase the adhesive stability and maintain the deformation space of the inner lens layer 25. The adhesive layer 23 can be in the shape of dots, lines, regular or irregular geometric shapes Distributed between the inner lens layer 25 and the outer lens layer 21 . As shown in FIG. 2B , the first pattern 22 can be located on the first outer surface 211 of the outer lens layer 21 or the first inner surface 213 adjacent to the adhesive layer 23 , and the second pattern 24 can be located on the inner lens layer 25 and the adhesive layer 23 is connected to the second outer surface 251.

該黏著層23之占有區域為始於該外鏡片層21之第一周邊區域的外緣,並迄於自該外鏡片層21之軸心外推距離介於10%至95%之該外鏡片層21之直徑的位置。黏著層23之占有區域過小將影響固定外鏡片層21與內鏡片層25效果;占有區域過大則限制內鏡片層25隨眼壓變化而產生形變的比例。 The occupied area of the adhesive layer 23 starts from the outer edge of the first peripheral area of the outer lens layer 21 and ends at the outer lens with an extrapolation distance from the axis of the outer lens layer 21 ranging from 10% to 95% The location of the diameter of layer 21 . If the occupied area of the adhesive layer 23 is too small, the effect of fixing the outer lens layer 21 and the inner lens layer 25 will be affected; if the occupied area is too large, the deformation ratio of the inner lens layer 25 with the change of intraocular pressure will be limited.

本發明之又一目的係提供一種製造用於眼壓監測的隱形眼鏡的方法,其包含以下步驟:提供一外鏡片層21,該外鏡片層21含一對應眼球角膜區域111的第一光學區210a及一具有第一圖案22且對應該眼球角膜區域111以外區域113的第一周邊區210b,且該外鏡片層21具有彼此相對的一第一外表面211與一第一內表面213,該第一圖案22是位在該第一外表面211或該第一內表面213,且該外鏡片層21的拉伸模數大於0.8MPa且小於1.7MPa;提供一內鏡片層25,該內鏡片層25含有一對應眼球角膜區域111的第二光學區250a及一具有第二圖案24且對應該眼球角膜區域111以外區域113的第二周邊區250b,且該內鏡片層25具有相對的一第二外表面251與一第二內表面253,該第二圖案24是位在該第二外表面251,且該內鏡片層25的拉伸模數小於該外鏡片層21之拉伸模數,且不小於0.2MPa且不大於0.8MPa;提供一黏著層組成物,並將該黏著層組成物印刷於該外鏡片層21的該第一內表面213及/或該內鏡片層25的該第二外表面251;以 及對位貼合該外鏡片層21與該內鏡片層25,使該黏著層組成物形成一黏著層23於該外鏡片層21的該第一內表面213與該內鏡片層25的該第二外表面251之間,且該黏著層23與該外鏡片層21的該第一內表面213與該內鏡片層25的該第二外表面251相鄰接,藉由該黏著層23以黏合該外鏡片層21及該內鏡片層25,完成該用於眼壓監測的隱形眼鏡10的製造;其中,該第一圖案22與該第二圖案24為彼此重疊或設定偏差一預定距離或一預定角度d。 Another object of the present invention is to provide a method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of: providing an outer lens layer 21 containing a first optical zone corresponding to the corneal region 111 of the eyeball 210a and a first peripheral area 210b having the first pattern 22 and corresponding to the area 113 outside the cornea area 111 of the eyeball, and the outer lens layer 21 has a first outer surface 211 and a first inner surface 213 opposite to each other, the The first pattern 22 is located on the first outer surface 211 or the first inner surface 213, and the tensile modulus of the outer lens layer 21 is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer 25 is provided, the inner lens layer 25 The layer 25 includes a second optical zone 250a corresponding to the corneal area 111 and a second peripheral area 250b having the second pattern 24 and corresponding to the area 113 outside the corneal area 111, and the inner lens layer 25 has an opposite first optical zone 250b. Two outer surfaces 251 and a second inner surface 253, the second pattern 24 is located on the second outer surface 251, and the tensile modulus of the inner lens layer 25 is smaller than the tensile modulus of the outer lens layer 21, and not less than 0.2MPa and not more than 0.8MPa; provide an adhesive layer composition, and print the adhesive layer composition on the first inner surface 213 of the outer lens layer 21 and/or the first inner surface of the inner lens layer 25 Two outer surfaces 251; with and aligning the outer lens layer 21 and the inner lens layer 25 , so that the adhesive layer composition forms an adhesive layer 23 on the first inner surface 213 of the outer lens layer 21 and the first inner surface 213 of the inner lens layer 25 Between the two outer surfaces 251 , the adhesive layer 23 is adjacent to the first inner surface 213 of the outer lens layer 21 and the second outer surface 251 of the inner lens layer 25 , and the adhesive layer 23 is used for bonding The outer lens layer 21 and the inner lens layer 25 complete the manufacture of the contact lens 10 for intraocular pressure monitoring; wherein, the first pattern 22 and the second pattern 24 overlap each other or are offset by a predetermined distance or a predetermined angle d.

根據本發明製造方法之一實施方式,上述該外鏡片層21之製造步驟包括:提供一第一組合物及一圖案色料組成物;將該第一組合物置入一隱形眼鏡模具(未繪示)中,固化該第一組合物以形成一外鏡片層本體(未繪示),該外鏡片層本體具有彼此相對的一第一外表面211與一第一內表面213;以及將該圖案色料組成物印刷至該外鏡片層本體的該第一外表面211或該第一內表面213以在該外鏡片層本體上形成一第一圖案22,完成該外鏡片層21的製作。 According to an embodiment of the manufacturing method of the present invention, the manufacturing steps of the outer lens layer 21 include: providing a first composition and a pattern colorant composition; placing the first composition in a contact lens mold (not shown). ), curing the first composition to form an outer lens layer body (not shown), the outer lens layer body having a first outer surface 211 and a first inner surface 213 opposite to each other; and the pattern color The material composition is printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer body to form a first pattern 22 on the outer lens layer body, and the fabrication of the outer lens layer 21 is completed.

根據本發明製造方法之一實施方式,上述內鏡片層25之製造步驟包括:提供一第二組合物及一圖案色料組成物;將該第二組合物置入一隱形眼鏡模具(未繪示)中,固化該第二組合物以形成一內鏡片層本體(未繪示),該內鏡片層本體具有彼此相對的一第二外表面251與一第二內表面253;以及將該圖案色料組成物印刷至該內鏡片層本體的該第二外表面251以在該內鏡片層本體上形成一第二圖案24,完成該內鏡片層25的製作。 According to an embodiment of the manufacturing method of the present invention, the manufacturing steps of the inner lens layer 25 include: providing a second composition and a pattern colorant composition; placing the second composition in a contact lens mold (not shown) , the second composition is cured to form an inner lens layer body (not shown), the inner lens layer body has a second outer surface 251 and a second inner surface 253 opposite to each other; and the pattern colorant The composition is printed on the second outer surface 251 of the inner lens layer body to form a second pattern 24 on the inner lens layer body, and the fabrication of the inner lens layer 25 is completed.

根據本發明製造方法之一實施方式,前述用於形成外鏡片層21及內鏡片層25的第一、第二組成物可由水膠組合物或矽水膠組成物經固化後形成。水膠組成物包含,例如但不限於親水性單體、交聯劑以及起始劑。矽水膠組成物可包含,例如但不限於聚矽氧烷巨體、親水性單體、交聯劑以及起始劑。 According to an embodiment of the manufacturing method of the present invention, the aforementioned first and second compositions for forming the outer lens layer 21 and the inner lens layer 25 can be formed by curing a hydrogel composition or a silicone hydrogel composition. The hydrogel composition includes, for example, but not limited to, hydrophilic monomers, cross-linking agents, and initiators. The silicone hydrogel composition may include, for example, but not limited to, polysiloxane macromers, hydrophilic monomers, cross-linking agents, and initiators.

適用於形成本發明之外鏡片層21及內鏡片層25的第一、第二組成物中可使用一種或一種以上之親水單體,例如甲基丙烯酸縮水甘油酯(GMA)、2- 羥乙酯(HEMA)、N-乙烯基吡咯酮(NVP)、N,N-二甲基丙烯醯胺(DMA)、甲基丙烯酸(MAA)、甲基丙烯酸六氟異丙酯(HFMA)等。在鏡片層的組成物中適用之交聯劑可為例如二甲基丙烯酸甘油酯(GDMA)、二甲基丙烯酸乙二醇酯(EGDMA)、三羥甲基丙烷三丙烯酸酯(TMPTA)、四乙二醇二甲基丙烯酸酯(TrEGDMA)、三乙二醇二甲基丙烯酸酯(TEGDMA)、三羥甲基丙烷三甲基丙烯酸酯(TMPTMA)、聚乙二醇二甲基丙烯酸酯(PEGDMA)、甲基丙烯酸乙烯酯、乙二胺二甲基丙烯醯胺、二甲基丙烯酸甘油酯、異氰尿酸三烯丙基酯、三聚氰酸三烯丙酯或上述之組合,使其高分子鏈交錯結合而調整強度,以製備本發明鏡片層所需之拉伸模數及膨潤脹縮率範圍之鏡片層。在水膠組成物中適用的起始劑可為熱起始劑或光起始劑。熱起始劑例如可為但不限於偶氮二異庚腈(ADVN)、2,2’-偶氮雙異丁腈(AIBN)、2,2’-偶氮基雙(2,4-二甲基)戊腈、2,2’-偶氮基雙、2,2’-偶氮基雙(2-甲基-丁腈)、或過氧化苯甲醯;光起始劑可包括,但不限於2,4,6-三甲基苯甲醯基-二苯基氧化膦、2-羥基-2-甲基苯基丙烷-1-酮、2,4,6-三甲基苯甲醯基苯基膦酸乙酯、或2,2-二乙氧基苯乙酮等。 One or more hydrophilic monomers, such as glycidyl methacrylate (GMA), 2- Hydroxyethyl ester (HEMA), N-vinylpyrrolidone (NVP), N,N-dimethylacrylamide (DMA), methacrylic acid (MAA), hexafluoroisopropyl methacrylate (HFMA), etc. . Suitable cross-linking agents in the composition of the lens layers may be, for example, glycerol dimethacrylate (GDMA), ethylene glycol dimethacrylate (EGDMA), trimethylolpropane triacrylate (TMPTA), tetra Ethylene glycol dimethacrylate (TrEGDMA), triethylene glycol dimethacrylate (TEGDMA), trimethylolpropane trimethacrylate (TMPTMA), polyethylene glycol dimethacrylate (PEGDMA) ), vinyl methacrylate, ethylenediamine dimethyl acrylamide, glycerol dimethacrylate, triallyl isocyanurate, triallyl cyanurate, or a combination of the above to make it high The molecular chains are interlaced and combined to adjust the strength, so as to prepare the lens layer with the required tensile modulus and expansion and shrinkage ratio of the lens layer of the present invention. Suitable initiators in the hydrogel composition may be thermal initiators or photoinitiators. The thermal initiator can be, for example, but not limited to, azobisisoheptanenitrile (ADVN), 2,2'-azobisisobutyronitrile (AIBN), 2,2'-azobis(2,4-bis(2,4-bis) Methyl)valeronitrile, 2,2'-azobis, 2,2'-azobis(2-methyl-butyronitrile), or benzyl peroxide; photoinitiators may include, but Not limited to 2,4,6-trimethylbenzyl-diphenylphosphine oxide, 2-hydroxy-2-methylphenylpropan-1-one, 2,4,6-trimethylbenzyl ethyl phenylphosphonate, or 2,2-diethoxyacetophenone, etc.

前述產生外鏡片層21及內鏡片層25使用隱形眼鏡模具成型的方法對本領域技術人員來說通常是眾所周知的。本發明的製造方法不限於任何特定的模具成型方式。 The foregoing methods of producing outer lens layer 21 and inner lens layer 25 using contact lens mold molding are generally well known to those skilled in the art. The manufacturing method of the present invention is not limited to any particular mold forming method.

根據本發明製造方法之一實施方式,前述固化程序是指通過加熱、光照射,例如UV照射、離子輻射(舉例為,γ射線或X射線輻射)、微波照射等來實現的固化(舉例為,交聯或聚合)。 According to one embodiment of the manufacturing method of the present invention, the aforementioned curing procedure refers to curing (eg, UV radiation, ion radiation (eg, γ-ray or X-ray radiation), microwave radiation, etc.) by heating, light irradiation, etc. (eg, cross-linking or polymerization).

根據本發明製造方法之一實施方式,該第一圖案22及第二圖案24之印刷,可通過使用已知的印刷技術,可以但不限制為噴墨印刷(inkjet printing)、雷射印刷(laser printing)、移印(pad printing)或轉印(transfer printing)。其中第一圖案22可印刷至外鏡片層21的第一外表面211或第一內表面213,而第二圖案則印 刷至該內鏡片層25之第二外表面251,優選為該第一圖案22印刷至該外鏡片層21的第一內表面213,而該第二圖案24印刷至該內鏡片層25的第二外表面251。 According to an embodiment of the manufacturing method of the present invention, the printing of the first pattern 22 and the second pattern 24 can be performed by using known printing techniques, such as inkjet printing, laser printing, but not limited to. printing), pad printing or transfer printing. The first pattern 22 can be printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer 21, while the second pattern is printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer 21. Brush onto the second outer surface 251 of the inner lens layer 25 , preferably the first pattern 22 is printed on the first inner surface 213 of the outer lens layer 21 , and the second pattern 24 is printed on the first inner surface 213 of the inner lens layer 25 . Two outer surfaces 251 .

適用於本發明之外鏡片層21與內鏡片層25之黏著層23之黏著劑組成物可包含至少一親水單體、增黏劑、交聯劑與起始劑組成。適用之親水單體、交聯劑及起始劑如前述用於製備水膠組成物者,適用之增黏劑為聚乙烯基吡咯烷酮或改質之聚乙烯基吡咯烷酮,其中改質的聚乙烯基吡咯烷酮,其係由乙烯基乙醯胺單體、乙烯基吡咯烷酮單體及甲基丙烯酸-2-羥乙酯單體經聚合反應後,與(甲基)丙烯酸-2-異氰酸基乙酯反應而製得。根據本發明製造方法之一實施方式,該黏著層23之印刷,可通過使用已知的印刷技術,可以但不限制為為噴墨印刷(inkjet printing)、雷射印刷(laser printing)、移印(pad printing)或轉印(transfer printing),還可以視黏著層23印刷上的附著或潤濕情況或的狀況,而增加印刷反覆次數 The adhesive composition suitable for the adhesive layer 23 of the outer lens layer 21 and the inner lens layer 25 of the present invention may comprise at least one hydrophilic monomer, a tackifier, a cross-linking agent and an initiator. Suitable hydrophilic monomers, cross-linking agents and initiators are the same as those used in the preparation of the hydrogel composition, and the suitable tackifier is polyvinylpyrrolidone or modified polyvinylpyrrolidone, wherein the modified polyvinylpyrrolidone Pyrrolidone, which is composed of vinylacetamide monomer, vinylpyrrolidone monomer and 2-hydroxyethyl methacrylate monomer after polymerization reaction, and (meth)acrylic acid-2-isocyanatoethyl ester produced by the reaction. According to an embodiment of the manufacturing method of the present invention, the printing of the adhesive layer 23 can be performed by using known printing techniques, which can be, but are not limited to, inkjet printing, laser printing, pad printing (pad printing) or transfer printing (transfer printing), it is also possible to increase the number of printing repetitions depending on the adhesion or wetting conditions or conditions on the printing of the adhesive layer 23

根據本發明製造方法之一實施方式,該外鏡片層21與內鏡片層25之對位貼合,可以選擇高對位精度、並可控制貼合不良(舉例為,貼合氣泡或內髒污)的貼合方法,可以是但不限於人工貼合、治具貼合或自動設備貼合。更具體地說,選取第一圖案22或第二圖案24其一作為基準,未被選取的圖案之圖案分佈範圍相對基準圖案之圖案分佈範圍作已知位置的疊覆貼合,使該第一圖案22之圖案與第二圖案24圖案之分佈範圍重疊或偏差已知的距離或角度。 According to an embodiment of the manufacturing method of the present invention, the alignment and bonding of the outer lens layer 21 and the inner lens layer 25 can be selected with high alignment accuracy and can control poor bonding (for example, bonding air bubbles or internal dirt) The bonding method can be, but not limited to, manual bonding, jig bonding or automatic equipment bonding. More specifically, one of the first pattern 22 or the second pattern 24 is selected as a reference, and the pattern distribution range of the unselected pattern is overlapped with a known position relative to the pattern distribution range of the reference pattern, so that the first pattern The pattern of the pattern 22 overlaps or deviates from the distribution range of the pattern of the second pattern 24 by a known distance or angle.

適用於本發明之第一、第二圖案22、24的色料組成物包含少一親水性單體、一黏著樹脂、一色料、起始劑及交聯劑。在色料中使用的親水性單體、起始劑及交聯劑可採用如前述水膠組成物者。適用之黏著樹脂可以例如是聚胺酯樹脂、丙烯酸樹脂或酚醛樹脂。適用的色料可為有機或無機的染料。有機染料例如可為但不限於C.I.Reactive Yellow 14、C.I.Reactive Orange 7、C.I.Reactive Red 23、C.I.Reactive Blue 19。無機染料例如可為但不限於氧化鐵黑、氧化鐵棕、氧化鐵黃、氧化鐵紅、二氧化鈦等。 The colorant composition suitable for the first and second patterns 22 and 24 of the present invention comprises at least one hydrophilic monomer, one adhesive resin, one colorant, initiator and crosslinking agent. The hydrophilic monomers, initiators and cross-linking agents used in the colorant can be those of the aforementioned hydrogel composition. Suitable adhesive resins may be, for example, polyurethane resins, acrylic resins or phenolic resins. Suitable colorants may be organic or inorganic dyes. The organic dye can be, for example, but not limited to, C.I.Reactive Yellow 14, C.I.Reactive Orange 7, C.I.Reactive Red 23. C.I. Reactive Blue 19. Inorganic dyes can be, for example, but not limited to, black iron oxide, brown iron oxide, yellow iron oxide, red iron oxide, titanium dioxide, and the like.

下述實施例係用以進一步說明本發明,但本發明並不受其限制。 The following examples are used to further illustrate the present invention, but the present invention is not limited thereto.

實施例 Example

製備實施例1:用以形成外鏡片層的水膠組成物之製備 Preparation Example 1: Preparation of Hydrogel Composition for Forming Outer Lens Layer

將67.6648克之甲基丙烯酸2-羥乙酯(HEMA)、1.6408克之乙二醇二甲基丙烯酸酯(EDGMA)溶劑、0.0749克之TWEEN80(購自英國Croda International PLC公司)、0.4053克之偶氮二異丁腈(AIBN)作為催化劑於0.5936克之甘油中進行混合攪拌約2小時後,將產物進行過濾,獲得一用以形成外鏡片層的水膠組成物。 67.6648 g of 2-hydroxyethyl methacrylate (HEMA), 1.6408 g of ethylene glycol dimethacrylate (EDGMA) solvent, 0.0749 g of TWEEN80 (purchased from Croda International PLC, UK), 0.4053 g of azodiisobutylene Nitrile (AIBN) was mixed in 0.5936 g of glycerol as a catalyst and stirred for about 2 hours, and the product was filtered to obtain a hydrogel composition for forming an outer lens layer.

製備實施例2:用以形成外鏡片層的矽水膠組成物之製備 Preparation Example 2: Preparation of Silicone Hydrogel Composition for Forming Outer Lens Layer

將4.44克之異佛爾酮二異氰酸酯、0.0025克之二丁錫二月桂酸酯作為催化劑以及40毫升之二氯甲烷加入至一圓底瓶中,並於氮氣環境下進行攪拌。精確稱取20克α-丁基-ω-[3-(2,2-(二羥甲基)丁氧基)丙基]聚二甲基矽氧烷,並費時約1小時將其滴加入圓底瓶中。反應12小時後,另外稱取0.0025克二丁錫二月桂酸酯與7.2克聚乙二醇單甲基丙烯酸酯,並費時約1小時將其滴加入圓底瓶中。反應12小時後,加入大量水清洗所形成之產物,且之後再將產物進行脫水及過濾。接著,從產物移除二氯甲烷溶劑,以獲得一第一聚二甲基矽氧烷巨體。 4.44 g of isophorone diisocyanate, 0.0025 g of dibutyltin dilaurate as catalyst and 40 ml of dichloromethane were added to a round bottom flask and stirred under nitrogen atmosphere. Accurately weigh 20 grams of α-butyl-ω-[3-(2,2-(dimethylol)butoxy)propyl]polydimethylsiloxane and add it dropwise over about 1 hour in a round bottom bottle. After 12 hours of reaction, 0.0025 g of dibutyltin dilaurate and 7.2 g of polyethylene glycol monomethacrylate were additionally weighed and added dropwise to a round-bottomed flask over a period of about 1 hour. After 12 hours of reaction, a large amount of water was added to wash the formed product, and then the product was dehydrated and filtered. Next, the dichloromethane solvent was removed from the product to obtain a first polydimethylsiloxane macro.

將8.88克之異佛爾酮二異氰酸酯、0.0025克之二丁錫二月桂酸酯作為催化劑、及40毫升二氯甲烷加入至一圓底瓶中,並於氮氣環境下進行攪拌。精確稱取20克聚矽氧烷化合物,並費時約1小時將其滴加入圓底瓶中。反應12小時後,另外稱取0.0025克二丁錫二月桂酸酯與14.4克聚乙二醇單甲基丙烯酸酯,並費時約1小時將其滴加入圓底瓶中。反應12小時後,加入大量水清洗所形成之 產物,且之後再將產物進行脫水及過濾。接著,從產物移除二氯甲烷溶劑,以獲得一第二聚甲基矽氧烷巨體。 8.88 g of isophorone diisocyanate, 0.0025 g of dibutyltin dilaurate as catalyst, and 40 ml of dichloromethane were added to a round bottom flask and stirred under nitrogen atmosphere. Accurately weigh 20 grams of the polysiloxane compound and add it dropwise to a round bottom bottle over a period of about 1 hour. After 12 hours of reaction, 0.0025 g of dibutyltin dilaurate and 14.4 g of polyethylene glycol monomethacrylate were additionally weighed and added dropwise to a round-bottomed flask over a period of about 1 hour. After 12 hours of reaction, a large amount of water was added to wash the formed product, which was then dehydrated and filtered. Next, the dichloromethane solvent was removed from the product to obtain a second polymethylsiloxane macro.

將41.8克之第一矽氧烷、6.3克之第二矽氧烷巨體、0.52克之偶氮二異庚腈(ADVN)、35.2克之N-乙烯基吡咯酮(NVP)、14.6克之甲基丙烯酸2-羥乙酯(HEMA)、0.3克之甲基丙烯酸六氟異丙酯(HFMA)、0.6克之三羥甲基丙烷三甲基丙烯酸酯(TMPTMA)、0.68克之2-[3-(2H-苯并三唑-2-基)-4-羟基苯基]乙基2-甲基丙烯酸酯於2克的乙醇中進行混合並攪拌約1小時後,形成一用以形成外鏡片層的矽水膠組成物。 41.8 grams of the first siloxane, 6.3 grams of the second siloxane giant, 0.52 grams of azobisisoheptanenitrile (ADVN), 35.2 grams of N-vinylpyrrolidone (NVP), 14.6 grams of methacrylic acid 2- Hydroxyethyl ester (HEMA), 0.3 g of hexafluoroisopropyl methacrylate (HFMA), 0.6 g of trimethylolpropane trimethacrylate (TMPTMA), 0.68 g of 2-[3-(2H-benzotri] Azol-2-yl)-4-hydroxyphenyl]ethyl 2-methacrylate was mixed in 2 g of ethanol and stirred for about 1 hour to form a silicone hydrogel composition for forming the outer lens layer .

製備實施例3:用以形成內鏡片層的水膠組成物之製備 Preparation Example 3: Preparation of Hydrogel Composition for Forming Inner Lens Layer

將66.3964克之甲基丙烯酸2-羥乙酯(HEMA)、0.2989克之乙二醇二甲基丙烯酸酯(EGDMA)溶劑、0.0735克之TWEEN80(購自英國Croda International PLC公司)、0.3983克之偶氮二異丁腈(AIBN)作為催化劑於7.9688克之甘油中進行混合攪拌約2小時後,將產物進行單體過濾,獲得一用以形成內鏡片層的水膠組成物。 66.3964 g of 2-hydroxyethyl methacrylate (HEMA), 0.2989 g of ethylene glycol dimethacrylate (EGDMA) solvent, 0.0735 g of TWEEN80 (purchased from Croda International PLC, UK), 0.3983 g of azodiisobutyl Nitrile (AIBN) was mixed in 7.9688 g of glycerol as a catalyst and stirred for about 2 hours, and the product was subjected to monomer filtration to obtain a hydrogel composition for forming an inner lens layer.

製備實施例4:用以形成內鏡片層的矽水膠組成物之製備 Preparation Example 4: Preparation of Silicone Hydrogel Composition for Forming Inner Lens Layer

如同製備實施例2的方法製備一第一聚甲基矽氧烷巨體及一第二聚甲基矽氧烷巨體。 A first polymethylsiloxane macrobody and a second polymethylsiloxane macrobody were prepared in the same manner as in Preparation Example 2.

將39.8克之第一矽氧烷巨體、11.3克之第二矽氧烷巨體、0.5克之偶氮二異庚腈(ADVN)、33.5克之N-乙烯基吡咯酮(NVP)、14.0克之甲基丙烯酸2-羥乙酯(HEMA)、0.3克之甲基丙烯酸六氟異丙酯(HFMA)、0.60克之2-[3-(2H-苯并三唑-2-基)-4-羟基苯基]乙基2-甲基丙烯酸酯於2克的乙醇中進行混合並攪拌約1小時後,形成一用以形成內鏡片層的矽水膠組成物。 39.8 grams of the first siloxane macro, 11.3 grams of the second siloxane macro, 0.5 grams of azobisisoheptanenitrile (ADVN), 33.5 grams of N-vinylpyrrolidone (NVP), 14.0 grams of methacrylic acid 2-Hydroxyethyl ester (HEMA), 0.3 g of hexafluoroisopropyl methacrylate (HFMA), 0.60 g of 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl The base 2-methacrylate was mixed in 2 grams of ethanol and stirred for about 1 hour to form a silicone hydrogel composition for forming the inner lens layer.

製備實施例5:黏著層組成物之製備 Preparation Example 5: Preparation of Adhesive Layer Composition

將55.152克之甲基丙烯酸2-羥乙酯(HEMA)、1.809克之N-乙烯基吡咯烷酮(NVP)、1.809克之甲基丙烯酸、0.904克之乙二醇二甲基丙烯酸酯(EDGMA)、0.904克之甲基丙烯酸三羥甲基丙烷三丙烯酸酯(TMPTMA)、36.172克之聚乙烯必吡喀烷酮、0.995克之5329(購自Sigma-Aldrich公司)混合以並高速攪拌器攪拌約60分鐘,再加入光起始劑1.583克之1173(購自德國BASF公司)與0.678克之819(購自德國Sigma-Aldrich公司)攪拌30分鐘,形成一黏著層組成物。 55.152 g of 2-hydroxyethyl methacrylate (HEMA), 1.809 g of N-vinylpyrrolidone (NVP), 1.809 g of methacrylic acid, 0.904 g of ethylene glycol dimethacrylate (EDGMA), 0.904 g of methyl Trimethylolpropane triacrylate acrylate (TMPTMA), 36.172 grams of polyvinyl bipyridone, 0.995 grams of 5329 (purchased from Sigma-Aldrich) were mixed and stirred with a high-speed agitator for about 60 minutes before adding light starter 1.583 g of 1173 (purchased from BASF, Germany) and 0.678 g of 819 (purchased from Sigma-Aldrich, Germany) were stirred for 30 minutes to form an adhesive layer composition.

製備實施例6:圖案色料組成物之製備 Preparation Example 6: Preparation of Pattern Colorant Composition

將6.5克之甲基丙烯酸2-羥乙酯(HEMA)、4.5克之N,N’-二乙基丙烯醯胺(DMA)、2.0克之2-羥基-2-甲基-1-苯基-1-丙酮(商品名為UV-1173,購自台灣BASF公司)及37.6克之黑色色料(商品名Sicovit Black 85E172,購自德國BASF公司)放入球磨機(儀器名稱RETSCH PM400)進行研磨,以形成一圖案色料組成物。 6.5 g of 2-hydroxyethyl methacrylate (HEMA), 4.5 g of N,N'-diethylacrylamide (DMA), 2.0 g of 2-hydroxy-2-methyl-1-phenyl-1- Acetone (trade name UV-1173, purchased from Taiwan BASF company) and 37.6 grams of black pigment (trade name Sicovit Black 85E172, purchased from Germany BASF company) were put into a ball mill (apparatus name RETSCH PM400) for grinding to form a pattern Color composition.

實施例1:用於眼壓監測的水膠隱形眼鏡之製備 Example 1: Preparation of hydrogel contact lenses for intraocular pressure monitoring

將製備實施例1形成的用以形成外鏡片層的水膠組成物定量滴入聚丙烯模型中,並於80℃進行固化5小時後,再於115℃固化2小時。待聚合反應完成後,將模型與鏡片本體浸泡乙醇1小時後取出成形之外鏡片層本體,該外鏡片層本體具有相對的第一外表面與第一內表面。並利用移印方式,以移印膠頭沾黏印刷版上帶有的與第一圖案相同圖樣之上述色料組成物,蓋印於外鏡片層內弧側的第一內表面上,進行光聚合反應後形成具備一第一圖案之水膠外鏡片層。 The water gel composition for forming the outer lens layer formed in Preparation Example 1 was quantitatively dropped into a polypropylene mold, and cured at 80° C. for 5 hours, and then cured at 115° C. for 2 hours. After the polymerization reaction is completed, the mold and the lens body are soaked in ethanol for 1 hour, and then the formed outer lens layer body is taken out. The outer lens layer body has opposite first outer surfaces and first inner surfaces. And use the pad printing method to stick the above-mentioned color material composition with the same pattern as the first pattern on the printing plate with the pad printing glue head, and stamp it on the first inner surface of the inner arc side of the outer lens layer, and carry out light treatment. After the polymerization reaction, a water-gel outer lens layer with a first pattern is formed.

並且,將上述色料組成物以與第二圖案相同圖樣轉印於另一聚丙烯模上,進行光聚合反應以形成一第二圖案。接著,製備實施例3形成的用以形成內鏡片層的水膠組成物定量滴入該聚丙烯模型中,並進行固化,固化條件為80℃/5小時及115℃/2小時。待聚合反應完成後,將模型與鏡片浸泡乙醇1小時後取出成形之內鏡片層本體,該內鏡片層本體具有相對的第二外表面與第二內表面,且該第二圖案是形成於該第二外表面上,形成具備一第二圖案之水膠內鏡片層。 In addition, the above-mentioned color material composition is transferred onto another polypropylene mold with the same pattern as the second pattern, and photopolymerization is performed to form a second pattern. Next, the hydrogel composition for forming the inner lens layer formed in Preparation Example 3 was quantitatively dropped into the polypropylene mold and cured under the curing conditions of 80°C/5 hours and 115°C/2 hours. After the polymerization reaction is completed, the mold and the lens are soaked in ethanol for 1 hour, and then the formed inner lens layer body is taken out. The inner lens layer body has an opposite second outer surface and a second inner surface, and the second pattern is formed on the On the second outer surface, a water-gel inner lens layer with a second pattern is formed.

將得到之水膠外鏡片層與水膠內鏡片層依後文描述之量測方法分別進行拉伸模數及膨潤脹縮率測試,結果列於表1中。 The obtained water-gel outer lens layer and water-gel inner lens layer were respectively tested for tensile modulus and expansion and contraction ratio according to the measurement methods described later. The results are listed in Table 1.

接著,印刷版上帶有圈狀黏著材料,其分佈大小相對外鏡片層,始於該外鏡片層之第一周邊區域外緣,並終於自該外鏡片層之軸心外推距離介於20%之該外鏡片層之直徑的位置。利用移印方式,藉移印膠頭沾黏該黏著層材料,對位該外鏡片層之第一周邊區域外緣,蓋印於水膠外鏡片層的第一內表面。選取外鏡片層上第一圖案作為基準,利用精密對位貼合,使水膠內鏡片層上第二圖案之圖案分布與第一圖案之圖案分佈重疊後將水膠內、外鏡片層黏附,得一水膠鏡片層組合物。 Next, there is a ring-shaped adhesive material on the printing plate, the distribution size of which is relative to the outer lens layer, starting from the outer edge of the first peripheral region of the outer lens layer, and finally extending from the axis of the outer lens layer to a distance of 20 % of the diameter of the outer lens layer. Using a pad printing method, the adhesive layer material is adhered with a pad printing glue head, the outer edge of the first peripheral region of the outer lens layer is aligned, and the first inner surface of the water-gel outer lens layer is stamped. Select the first pattern on the outer lens layer as a reference, and use precise alignment and lamination to make the pattern distribution of the second pattern on the inner lens layer of the water glue overlap with the pattern distribution of the first pattern, and then adhere the inner and outer lens layers of the water glue. A water gel lens layer composition is obtained.

該水膠鏡片層組合物通過照光聚合後,可完成黏著層之固化貼合。然後將其進行水化程序,並於121℃進行滅菌30分鐘,形成一用於眼壓監測的水膠隱形眼鏡。 After the water-gel lens layer composition is polymerized by light, curing and lamination of the adhesive layer can be completed. It was then subjected to a hydration procedure and sterilized at 121°C for 30 minutes to form a hydrogel contact lens for intraocular pressure monitoring.

水化程序如下所示:(a)於80%酒精浸泡1小時取出水膠鏡片層組合物:(b)於90%酒精浸泡1小時;(c)於80℃純水加熱1小時;及(d)於緩衝溶液中平衡12小時。 The hydration procedure is as follows: (a) soaking in 80% alcohol for 1 hour to take out the water-gel lens layer composition: (b) soaking in 90% alcohol for 1 hour; (c) heating in 80°C pure water for 1 hour; and ( d) Equilibrate in buffer solution for 12 hours.

實施例2:用於眼壓監測的矽水膠隱形眼鏡之製備 Example 2: Preparation of silicone hydrogel contact lenses for intraocular pressure monitoring

如同實施例1的方法製備外鏡片層與內鏡片層,但改為使用製備實施例2的用於形成外鏡片層的矽水膠組成物以形成具備一第一圖案之矽水膠外鏡片層,且使用製備實施例4的用於形成內鏡片層的矽水膠組成物以形成具備一第二圖案之矽水膠內鏡片層。 The outer lens layer and the inner lens layer were prepared as in Example 1, but the silicone hydrogel composition for forming an outer lens layer of Preparation Example 2 was used instead to form a silicone water gel outer lens layer with a first pattern. , and the silicone hydrogel composition for forming an inner lens layer of Preparation Example 4 is used to form a silicone hydrogel inner lens layer with a second pattern.

將得到之矽水膠外鏡片層與矽水膠內鏡片層依後文描述之量測方法分別進行拉伸模數及膨潤脹縮率測試,結果列於表1中。 The obtained silicone hydrogel outer lens layer and the silicone hydrogel inner lens layer were tested for tensile modulus and expansion and shrinkage respectively according to the measurement methods described later. The results are shown in Table 1.

接著,如同實施例1的方法製備鏡片層組合物,但改使用上述具備第一圖案之矽水膠外鏡片層與具備第二圖案之矽水膠內鏡片層形成一用於眼壓監測的矽水膠隱形眼鏡。 Next, the lens layer composition was prepared as in Example 1, except that the above-mentioned silicone hydrogel outer lens layer with the first pattern and the silicone hydrogel inner lens layer with the second pattern were used to form a silicon hydrogel for intraocular pressure monitoring. Hydrogel contact lenses.

拉伸模數測試 Tensile modulus test

鏡片依如下水化程序水化:(a)於80%酒精浸泡1小時取出矽水膠鏡片層組合物:(b)於90%酒精浸泡1小時;(c)於80℃純水加熱1小時;及(d)於緩衝溶液中平衡12小時。 The lenses were hydrated according to the following hydration procedure: (a) soaked in 80% alcohol for 1 hour to take out the silicone hydrogel lens layer composition: (b) soaked in 90% alcohol for 1 hour; (c) heated in 80 ℃ pure water for 1 hour and (d) equilibrated in buffer solution for 12 hours.

進行水化後,從鏡片之中央部份切取寬度10mm的測試切片。於25℃下,將測試切片浸泡在ISO18369-3 Section 4.7所制定的緩衝液條件,浸泡時間為2小時。於環境溫度20±5℃、55%±10%濕度下,以長纖布快速將試片表面的水溶液去除後,利用測試儀器AI-3000(台灣Gotech Testing Machine Inc.製造),設定拉伸速率10mm/min進行拉伸測試。根據應力-應變曲線之起始斜率判定拉伸模數。 After hydration, test slices with a width of 10 mm were cut from the central portion of the lens. Immerse the test sections in the buffer conditions specified in ISO18369-3 Section 4.7 at 25°C for 2 hours. At an ambient temperature of 20±5°C and a humidity of 55%±10%, the aqueous solution on the surface of the test piece was quickly removed with a long-fiber cloth, and the tensile rate was set using the testing instrument AI-3000 (manufactured by Gotech Testing Machine Inc., Taiwan). 10mm/min for tensile test. The tensile modulus is determined from the initial slope of the stress-strain curve.

膨潤脹縮率測試 Swell and shrink ratio test

鏡片利用隱形眼鏡測量投影儀Chiltern(英國Optimec Ltd.製造)中,進行口徑大小測試,以得鏡片口徑。接著,鏡片將依如下水化程序以得水化後鏡片:(a)於80%酒精浸泡1小時取出鏡片:(b)於90%酒精浸泡1小時;(c)於80℃純水加熱1小時;及(d)於緩衝溶液中平衡12小時。 The lens was measured by a contact lens measuring projector Chiltern (manufactured by Optimec Ltd., UK), and the aperture size test was carried out to obtain the lens aperture. Next, the lens will be hydrated according to the following hydration procedure: (a) soaked in 80% alcohol for 1 hour to take out the lens: (b) soaked in 90% alcohol for 1 hour; (c) heated in 80°C pure water for 1 hour and (d) equilibrated in buffer solution for 12 hours.

水化後鏡片利用隱形眼鏡測量投影儀Chiltern,進行口徑大小測試,以得鏡片水化後口徑。利用以下公式,計算膨潤脹縮率:膨潤脹縮率=(鏡片水化後口徑-鏡片口徑)/鏡片口徑×100(%) After hydration, the contact lens was used to measure the projector Chiltern, and the aperture size was tested to obtain the aperture of the lens after hydration. Use the following formula to calculate the expansion and shrinkage ratio: Swelling and shrinkage ratio = (lens diameter after hydration - lens diameter) / lens diameter × 100 (%)

表1:實施例1與2之鏡片層的拉伸模數與膨潤脹縮率量測結果:

Figure 109138782-A0305-02-0020-1
Table 1: Measurement results of tensile modulus and expansion/shrinkage ratio of the lens layers of Examples 1 and 2:
Figure 109138782-A0305-02-0020-1

並且,實施例1和2之用於眼壓監測的隱形眼鏡於水化後不出現鏡片層間的位移,且以手搓不出現層間剝離現象。配戴時內鏡片層會隨眼壓變化而產生形變,致使第二圖案之圖案出現與第一圖案之圖案對比後可供肉眼辨識或儀器偵測之偏差。 In addition, the contact lenses used for intraocular pressure monitoring of Examples 1 and 2 did not appear to be displaced between the lens layers after hydration, and the interlayer peeling phenomenon did not appear when rubbed by hand. When wearing, the inner lens layer will be deformed with the change of intraocular pressure, resulting in the deviation of the pattern of the second pattern and the pattern of the first pattern, which can be recognized by the naked eye or detected by the instrument.

綜上所述,本發明所揭示的用於眼壓監測的隱形眼鏡包含一外鏡片層,其包含一第一圖案、一內鏡片層,其包含一第二圖案及一黏著層,其中該外鏡片層與內鏡片層具有定義之拉伸模數及膨潤脹縮率範圍,使內鏡片層可於配戴時隨眼壓變化而產生形變,致使第二圖案出現與第一圖案相對位偏差或角偏差以供監測觀察,且具備配戴舒適性,即可在不需眼科手術配合下,提供簡便且適合長時間監測眼壓的手段。 To sum up, the contact lens for intraocular pressure monitoring disclosed in the present invention includes an outer lens layer, which includes a first pattern, an inner lens layer, which includes a second pattern and an adhesive layer, wherein the outer lens layer includes a first pattern and an inner lens layer. The lens layer and the inner lens layer have a defined range of tensile modulus and expansion and contraction ratio, so that the inner lens layer can be deformed with the change of intraocular pressure during wearing, resulting in the relative position deviation of the second pattern and the first pattern or The angular deviation is used for monitoring and observation, and it is comfortable to wear, which can provide a simple and suitable means for monitoring intraocular pressure for a long time without the cooperation of ophthalmic surgery.

雖然本發明已以實施例揭露如上,然其並非用以限定本發明,任何熟習此技藝者,在不脫離本發明之精神和範圍內,當可作各種之更動與潤飾,因此本發明之保護範圍當視後附之申請專利範圍所界定者為準。 Although the present invention has been disclosed as above with examples, it is not intended to limit the present invention. Anyone skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection of the present invention The scope shall be determined by the scope of the appended patent application.

10:用於眼壓監測的隱形眼鏡 10: Contact lenses for intraocular pressure monitoring

10a:光學區 10a: Optical Zone

10b:周邊區 10b: Surrounding area

21:外鏡片層 21: Outer lens layer

210a:第一光學區 210a: First Optical Zone

210b:第一周邊區 210b: First peripheral area

211:第一外表面 211: First outer surface

213:第一內表面 213: First inner surface

22:第一圖案 22: The first pattern

23:黏著層 23: Adhesive layer

24:第二圖案 24: Second pattern

25:內鏡片層 25: inner lens layer

250a:第二光學區 250a: Second Optical Zone

250b:第二周邊區 250b: Second Perimeter

251:第二外表面 251: Second outer surface

253:第二內表面 253: Second inner surface

Claims (10)

一種用於眼壓監測的隱形眼鏡,包括: 一外鏡片層,該外鏡片層含一對應眼球角膜區域的第一光學區及一具有第一圖案且對應該眼球角膜區域以外區域的第一周邊區,且該外鏡片層具有彼此相對的一第一外表面與一第一內表面,該第一圖案是位在該第一外表面或該第一內表面,且該外鏡片層的拉伸模數大於0.8MPa且小於1.7MPa; 一內鏡片層,該內鏡片層含有一對應眼球角膜區域的第二光學區及一具有第二圖案且對應該眼球角膜區域以外區域的第二周邊區,且該內鏡片層具有相對的一第二外表面與一第二內表面,該第二圖案是位在該第二外表面,且該內鏡片層的拉伸模數小於該外鏡片層之拉伸模數,且不小於0.2MPa且不大於0.8MPa;以及 一黏著層,其設置於該外鏡片層的該第一內表面與該內鏡片層的該第二外表面之間,且該黏著層與該外鏡片層的該第一內表面與該內鏡片層的該第二外表面相鄰接,以黏合該外鏡片層及該內鏡片層; 其中,該第一圖案與該第二圖案為彼此重疊或設定偏差一預定距離或一預定角度。 A contact lens for intraocular pressure monitoring, comprising: an outer lens layer, the outer lens layer includes a first optical zone corresponding to the cornea area and a first peripheral area having a first pattern and corresponding to the area outside the cornea area, and the outer lens layer has an opposite to each other a first outer surface and a first inner surface, the first pattern is located on the first outer surface or the first inner surface, and the tensile modulus of the outer lens layer is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer, the inner lens layer includes a second optical zone corresponding to the cornea area and a second peripheral area having a second pattern and corresponding to the area outside the cornea area, and the inner lens layer has an opposite first optical zone Two outer surfaces and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than the tensile modulus of the outer lens layer, and is not less than 0.2MPa and not greater than 0.8MPa; and an adhesive layer disposed between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and the adhesive layer and the first inner surface of the outer lens layer and the inner lens the second outer surface of the layer is adjacent to bond the outer lens layer and the inner lens layer; Wherein, the first pattern and the second pattern are overlapped with each other or offset by a predetermined distance or a predetermined angle. 如請求項1所述之隱形眼鏡,其中該外鏡片層對該內鏡片層之拉伸模數比值介於大於1且小於4.5,且該外鏡片層對該內鏡片層之膨潤脹縮率差值介於0%至1%。The contact lens of claim 1, wherein the ratio of tensile modulus of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and the expansion and shrinkage ratios of the outer lens layer to the inner lens layer are different Values are between 0% and 1%. 如請求項1所述之隱形眼鏡,其中該第一圖案位於該外鏡片層之該第一外表面或與該黏著層相鄰接的該第一內表面,該第二圖案位於該內鏡片層與該黏著層相鄰接之該第二外表面。The contact lens of claim 1, wherein the first pattern is located on the first outer surface of the outer lens layer or the first inner surface adjacent to the adhesive layer, and the second pattern is located on the inner lens layer The second outer surface is adjacent to the adhesive layer. 如請求項1所述之隱形眼鏡,該內鏡片層的該第二內表面直接接觸眼球,當該內鏡片層隨眼壓變化而產生形變時,該第二圖案亦產生變化,而該外鏡片層未與眼球接觸且具有較高拉伸模數,不易形變,故造成形變的該第二圖案之圖案與該外鏡片層之該第一圖案出現可被偵測到的相對位偏差或角偏差,可據此評估眼壓的變化。According to the contact lens of claim 1, the second inner surface of the inner lens layer directly contacts the eyeball, and when the inner lens layer is deformed with changes in intraocular pressure, the second pattern also changes, and the outer lens layer is deformed. The layer is not in contact with the eyeball and has a high tensile modulus, which is not easy to deform, so the pattern of the second pattern that causes the deformation and the first pattern of the outer lens layer have a detectable relative position deviation or angular deviation. , which can be used to assess changes in intraocular pressure. 如請求項1所述之隱形眼鏡,其中該黏著層為黏合該外鏡片層的該第一周邊區與該內鏡片層該第二周邊區,以維持該外鏡片層與該內鏡片層的結合性及保留該內鏡片層的形變空間。The contact lens of claim 1, wherein the adhesive layer is for bonding the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer to maintain the combination of the outer lens layer and the inner lens layer and retain the deformation space of the inner lens layer. 如請求項5所述之隱形眼鏡,其中該黏著層之占有區域為始於該外鏡片層之第一周邊區域外緣,並迄於自該外鏡片層21之軸心外推距離介於10%至95%之該外鏡片層21之直徑的位置。The contact lens of claim 5, wherein the occupied area of the adhesive layer starts from the outer edge of the first peripheral area of the outer lens layer, and extends from the axis of the outer lens layer 21 to a distance of 10 % to 95% of the diameter of the outer lens layer 21. 一種製造用於眼壓監測的隱形眼鏡的方法,其包含以下步驟: 提供一外鏡片層,該外鏡片層含一對應眼球角膜區域的第一光學區及一具有第一圖案且對應該眼球角膜區域以外區域的第一周邊區,且該外鏡片層具有彼此相對的一第一外表面與一第一內表面,該第一圖案是位在該第一外表面或該第一內表面,且該外鏡片層的拉伸模數大於0.8MPa且小於1.7MPa; 提供一內鏡片層,該內鏡片層含有一對應眼球角膜區域的第二光學區及一具有第二圖案且對應該眼球角膜區域以外區域的第二周邊區,且該內鏡片層具有相對的一第二外表面與一第二內表面,該第二圖案是位在該第二外表面,且該內鏡片層的拉伸模數小於該外鏡片層之拉伸模數,且不小於0.2MPa且不大於0.8MPa; 提供一黏著層組成物,並將該黏著層組成物印刷於該外鏡片層的該第一內表面及/或該內鏡片層的該第二外表面;以及 對位貼合該外鏡片層與該內鏡片層,使該黏著層組成物形成一黏著層於該外鏡片層的該第一內表面與該內鏡片層的該第二外表面之間,且該黏著層與該外鏡片層的該第一內表面與該內鏡片層的該第二外表面相鄰接,藉由該黏著層以黏合該外鏡片層及該內鏡片層,完成該用於眼壓監測的隱形眼鏡的製造; 其中,該第一圖案與該第二圖案為彼此重疊或設定偏差一預定距離或一預定角度。 A method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of: An outer lens layer is provided, the outer lens layer includes a first optical zone corresponding to the cornea area and a first peripheral area having a first pattern and corresponding to the area outside the cornea area, and the outer lens layer has mutually opposite a first outer surface and a first inner surface, the first pattern is located on the first outer surface or the first inner surface, and the tensile modulus of the outer lens layer is greater than 0.8 MPa and less than 1.7 MPa; An inner lens layer is provided, the inner lens layer includes a second optical zone corresponding to the cornea region and a second peripheral region having a second pattern and corresponding to the region outside the cornea region, and the inner lens layer has an opposite The second outer surface and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than the tensile modulus of the outer lens layer, and is not less than 0.2MPa and not more than 0.8MPa; providing an adhesive layer composition, and printing the adhesive layer composition on the first inner surface of the outer lens layer and/or the second outer surface of the inner lens layer; and aligning the outer lens layer and the inner lens layer, so that the adhesive layer composition forms an adhesive layer between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and The adhesive layer is adjacent to the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and the outer lens layer and the inner lens layer are bonded by the adhesive layer to complete the application. Manufacture of contact lenses for intraocular pressure monitoring; Wherein, the first pattern and the second pattern are overlapped with each other or offset by a predetermined distance or a predetermined angle. 如請求項7所述之製造用於眼壓監測的隱形眼鏡的方法,其中該外鏡片層之製造步驟包括: 提供一第一組合物及一圖案色料組成物; 將該第一組合物置入一隱形眼鏡模具中,固化該第一組合物以形成一外鏡片層本體,該外鏡片層本體具有彼此相對的一第一外表面與一第一內表面;以及 將該圖案色料組成物印刷至該外鏡片層本體的該第一外表面或該第一內表面以在該外鏡片層本體上形成一第一圖案,完成該外鏡片層的製作。 The method of manufacturing a contact lens for intraocular pressure monitoring as claimed in claim 7, wherein the manufacturing step of the outer lens layer comprises: providing a first composition and a pattern colorant composition; placing the first composition into a contact lens mold, and curing the first composition to form an outer lens layer body having a first outer surface and a first inner surface opposite to each other; and The pattern colorant composition is printed on the first outer surface or the first inner surface of the outer lens layer body to form a first pattern on the outer lens layer body, and the fabrication of the outer lens layer is completed. 如請求項7所述之製造用於眼壓監測的隱形眼鏡的方法,其中該內鏡片層之製造步驟包括: 提供一第二組合物及一圖案色料組成物; 將該第二組合物置入一隱形眼鏡模具中,固化該第二組合物以形成一內鏡片層本體,該內鏡片層本體具有彼此相對的一第二外表面與一第二內表面;以及 將該圖案色料組成物印刷至該內鏡片層本體的該第二外表面以在該內鏡片層本體上形成一第二圖案,完成該內鏡片層的製作。 The method of manufacturing a contact lens for intraocular pressure monitoring as claimed in claim 7, wherein the manufacturing step of the inner lens layer comprises: providing a second composition and a pattern colorant composition; placing the second composition into a contact lens mold, curing the second composition to form an inner lens layer body, the inner lens layer body having a second outer surface and a second inner surface opposite to each other; and The pattern colorant composition is printed on the second outer surface of the inner lens layer body to form a second pattern on the inner lens layer body, and the production of the inner lens layer is completed. 如請求項7至9中任一項所述之製造用於眼壓監測的隱形眼鏡的方法,其中該外鏡片層對該內鏡片層之拉伸模數比值介於大於1且小於4.5,且該外鏡片層對該內鏡片層之膨潤脹縮率差值於0%至1%。The method of manufacturing a contact lens for intraocular pressure monitoring as claimed in any one of claims 7 to 9, wherein the tensile modulus ratio of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and The difference between the expansion and shrinkage of the outer lens layer and the inner lens layer is 0% to 1%.
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