TW476640B - Disposable article, article for detecting the presence of vaginal infections, and absorbent interlabial device - Google Patents

Disposable article, article for detecting the presence of vaginal infections, and absorbent interlabial device Download PDF

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Publication number
TW476640B
TW476640B TW089114348A TW89114348A TW476640B TW 476640 B TW476640 B TW 476640B TW 089114348 A TW089114348 A TW 089114348A TW 89114348 A TW89114348 A TW 89114348A TW 476640 B TW476640 B TW 476640B
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TW
Taiwan
Prior art keywords
disposable
patent application
item
scope
biosensor
Prior art date
Application number
TW089114348A
Other languages
Chinese (zh)
Inventor
Donald Carroll Roe
Andreas Muscat
John Lee Hammons
Thomas Ward Osborn Iii
Donna R Hill
Original Assignee
Procter & Gamble
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Publication of TW476640B publication Critical patent/TW476640B/en

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Abstract

A disposable article to be fitted to a wearer and other types of articles having a detection device, such as a diagnostic panel that may, in one set of embodiments, include at least one biosensor, each including at least one bio-recognition element. The biosensor is adapted to detect a target biological analyte in body substances, and on/or through the wearer's skin. The diagnostic panel may be adapted to determine the physical condition or state of well being of a mammal, or the cause of a particular disease state, such as diarrhea, vaginal infections, sexually transmitted diseases (STD's), and other diseases, and to signal the caretaker, the wearer, or an actuator of the occurrence. Examples of physical conditions of the state of well being include, but are not limited to, ovulation and the onset of menstruation.

Description

476640 A7 -—_______ B7 五、發明說明(1 ) 發明領域 本發明有關可棄式物件及具有一偵測裝置之其他型物件 ’譬如在一組實施例中之一個診斷面板係包括生物感測器 ’此生物感測器具有一個生物識別元件以偵測哺乳動物身 體中出現之微生物及/或其他生物分子,特別是具有一個用 於偵測身體物質中及/或通過皮膚可出現之微生物及/或其 他生物分子之物件,本發明亦有關其他型偵測裝置及其使 用方法。 發明背景 現今,譬如尿布、成人失禁褲、衛生棉及衛生棉條等可― 棄式物件係廣泛用於日常使用及嬰兒與幼童照顧、且用以 照顧失禁或月經中成人作爲一種圍堵、隔離及棄置身體廢 物之裝置。這些物件概具有可更換的可重覆使用可洗式布 料衣物,由於其便利性及可靠性而作爲這些應用之較佳裝 置。可棄式物件係吸收或圍堵在物件上沉積的體排泄物以 對排便、排尿或排放事件作出反應。部份可棄式物件亦在 排糞、排尿或排放事件之後發出訊號通知(譬如濕度指示器 、溫度變化偵測),本技藝習知之其他可棄式吸收物件包含 一種偵測穿戴者排泄物中的各種物質之化學反應性裝置。 然而其並未特定偵測可能致病的微生物目標,譬如細菌、 病毒、眞菌及寄生物(如原生動物)及/或相關的微分子,其 相較於純化學劑均需要高度選擇性(亦即專用性)及敏感度 。此外,該物件並未預測健康相關事件何時將發生並在臨 床可觀察症狀開始前告知穿戴者或看護者需要採取預防或 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注音?事項再填寫本頁) · I I I I n I H 一σ],I d ϋ ιϋ n ϋ ϋ n . 經濟部智慧財產局員工消費合作社印製 476640 第89114348號專利申請案 中文說明書修正頁(90年5月) 五、發明説明(2 ) 補救措施。 發明概論 本發明針對可棄式物件及包含一個偵測裝置之其他物件 ’譬如在一組實施例中可包括至少一個生物感測器及至少 一個生物識別元件之一個診斷面板。生物感測器適於偵測 哺乳動物身體釋出的身體物質中及皮膚上/或通過皮膚之一 個目標生物性分析物(包括體液、身體排泄物、其他身體排 放物),可棄式物件可包含一個診斷面板以適於決定哺乳動 物的生理狀況或健康狀態、或特定疾病(如腹瀉、陰道感染 、性傳染病(STD)及其他疾病)狀態的原因,並通知看護者 或穿戴者或發生事件之致動器。健康狀態或生理狀況範例 包括但不限於:排卵及月經開始。 圖式簡單說明 圖1為本發明的尿布實施例之平面圖,處於展開狀態並切 除部份結構以更清楚顯示尿布構造; 圖1 B為具有兩個生物感測器之診斷面板範例之平面圖; 圖1 C為沿圖丨b的線1 c -1 c所取之圖1 B所示診斷面板之 剖視圖; 經濟部中央標準局員工消費合作社印製 ----------- (請先閲讀背面之注意事項再填寫本頁) 圖1 D為類似圖1 b及1 C的診斷面板範例之平面圖,但設 置有一個擦拭機構; 圖1 E為沿圖1 D的線1 E- 1 E所取之圖1 D所示診斷面板之 剖视圖; 圖2顯示本發明的一身體排泄物隔離裝置在啟動前處於壓 縮狀態之立體圖; -5-476640 A7 -_______ B7 V. Description of the Invention (1) Field of the Invention The present invention relates to disposable objects and other types of objects having a detection device. For example, a diagnostic panel in a set of embodiments includes a biosensor 'This biosensor has a biometric element to detect micro-organisms and / or other biomolecules present in the mammal's body, and in particular has a means for detecting micro-organisms that can be present in body substances and / or through the skin and / Or other biological molecules, the present invention also relates to other types of detection devices and methods of using the same. BACKGROUND OF THE INVENTION Nowadays, disposable items such as diapers, adult incontinence pants, tampons and tampons are widely used in daily use and the care of infants and young children, and are used to care for incontinence or menstrual adults as a kind of containment, Device for isolating and disposing of body waste. These items all have replaceable, reusable, washable fabrics, which make them a better device for these applications due to their convenience and reliability. Disposable objects are those that absorb or contain body waste deposited on the object in response to a defecation, urination or discharge event. Some disposable objects also send signal notifications after defecation, urination, or discharge events (such as humidity indicators, temperature change detection). Other disposable absorbent objects known in the art include a method for detecting wearer excreta. Chemically reactive device for various substances. However, it does not specifically detect microbial targets that may cause disease, such as bacteria, viruses, tadpoles and parasites (such as protozoa) and / or related micromolecules, which require a high degree of selectivity compared to pure chemicals ( (Ie specificity) and sensitivity. In addition, the article does not predict when health-related events will occur and informs the wearer or caregiver of the need to take precautions before clinical observable symptoms begin or this paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) (Please read the phonetic on the back? Matters before filling out this page) · IIII n IH σ], I d ϋ ιϋ n ϋ ϋ n. Printed by the Consumer Property Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 476640 No. 89114348 Chinese Patent Application Revised page (May 90) 5. Description of invention (2) Remedial measures. SUMMARY OF THE INVENTION The present invention is directed to disposable objects and other objects including a detection device, such as a diagnostic panel that can include at least one biosensor and at least one biometric element in a set of embodiments. Biosensors are suitable for detecting a target biological analyte (including body fluids, body excretion, other body emissions) in and / or through the skin released from mammalian bodies. Disposable objects can be Includes a diagnostic panel suitable for determining the physiological or health status of a mammal, or the cause of a particular disease such as diarrhea, vaginal infections, sexually transmitted diseases (STD), and other diseases, and notifying the caregiver or wearer or the occurrence of Event actuator. Examples of health or physiological conditions include, but are not limited to: ovulation and onset of menstruation. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of an embodiment of a diaper of the present invention, in an unfolded state and part of a structure is cut out to more clearly show the structure of the diaper; 1 C is a cross-sectional view of the diagnostic panel shown in Figure 1 B taken along line 1 c -1 c in Figure 丨 b; printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs ----------- (Please Read the precautions on the back before filling this page) Figure 1D is a plan view of an example of a diagnostic panel similar to Figures 1b and 1C, but with a wiping mechanism; Figure 1E is along the line 1D of Figure 1D A cross-sectional view of the diagnostic panel shown in FIG. 1D taken by E; FIG. 2 shows a perspective view of a body excrement isolation device of the present invention in a compressed state before starting; -5-

4/〇b4U A74 / 〇b4U A7

圖2 A顯tf沿圖2的線2 a-2 a所取之剖視圖; 圖J A顯示本發明的不連續回應系統具有單一低限値之理 想輸出函數; 圖3B顯示本發明的不連續回應系統具有多重低限値之理 想輪出函數; 圖4A顯示本發明的不連續回應系統之示範性輸出函數及 此輸出函數之第一階、第二階及第三階導函數; ^ 4 B顯示具有相等時間常數之一系列第一階時間遲滯之 技制系統之轉移函數; 圖5 A及5B顯示具有一電敏感性膠質之本發明的回應系統 實施例; 圖6A、6B、6C顯示包括一電敏感性膠質之本發明的回 應系統的另一實施例; 圖7爲本發明之排泄物袋之立體圖; 圖8爲包括一排泄物袋之吸收物件的立體圖; H 9爲本發明的褲墊實施例之平面圖; 圖9 A爲沿圖9的線9 A - 9 A所取的圖9 A所示褲墊實施例之 剖視圖,詳細顯示裤塾上之診斷面板; 圖1 0顯示可用於偵測微生物、生物分子或其他相關物質 的量値之色度指示劑實施例; 圖1 1釋示可用於指示所出現物質的量値之顏色比較圖; 會1 2爲本發明的衛生棉實施例之平面圖; 圖1 3爲本發明的陰唇間裝置之平面圖; 圖1 ^爲沿圖1 3的線1 4 -1 4所取之圖1 3所示陰唇間裝置之 -6 - 本紙張尺度適用中國國家標準<CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝---- 經濟部智慧財產局員工消费合作社印製 476640 第89114348號專利申請案 A7 中文說明書修正頁(90年5月) B7 五、發明説明(4 ) 剖視圖; 圖1 5為圖1 3所示陰唇間裝置之侧視圖; 圖1 6為圖1 3所示陰唇間裝置之侧視圖,顯示陰唇間裝置 如何固持插入穿戴者陰唇間之空間中; 圖17顯示陰唇間裝置對於穿戴者身體之穿戴方式; 圖1 8為本發明的衛生棉條實施例之立體圖。 元件符號說明 10 診斷面板 37 跨區 12 生物感測器 38 第二腰區 14 生物感測器 40 緊固系統 16 生物感測器 45 吸收核心28之向衣物表面 17 罩幕 50 尿布20之縱緣 18 基材 52 尿布20之端緣 19 擦拭機構 60 生物感測器 20 尿布 62 吸收核心28之腰緣 22 底座 80 控制器 24 液體可滲透頂層 90 致動器 26 液體不可滲透底層 91 壓力差異裝置 28 吸收核心 92 可溶袋 30 側片 94 壓縮彈性材料 32 腳翻邊 96 空隙空間 34 彈性腰特徵 100 尿布20之縱中線 36 第一腰區 102 尿布20之橫中線 經濟部中央標準局員工消費合作社印製 (請先閲讀背面之注意事項再填寫本頁) 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 476640 經濟部中央標準局員工消費合作社印製 第89114348號專利申請案 中文說明書修正頁(90年5月) 五、發明説明(4a ) 110 排泄物處理裝置 968 感測器元件 111 排泄物袋 970 感測器元件 112 凸緣 980 覆蓋部 120 尿布 982 毛細條 121 開孔 1090 比較表 124 頂層 1220 衛生棉實施例 485 接腳 1260 診斷面板 494 電敏感性膠質 1320 陰唇間裝置實施例 594 電敏感性膠質 1338 底層 595 網狀格柵型 1342 頂層 920 褲墊實施例 1344 吸收核心 924 褲墊頂層 1352 握柄 960 診斷面板 1360 診斷面板 962 感測器元件 1820 衛生棉條 964 感測器元件 1860 診斷面板 966 感測器元件 發明詳細描述 本文“吸收物件”係指吸收及圍堵身體排放物之裝置,尤 指放置抵住穿戴者身體或附近吸收及圍堵身體排出的各種 排放物之裝置。本文“可棄式”係·指一般無意洗滌或取回或 再度作為吸收物件之吸收物件(亦即預定單次使用之後即棄 置,較佳回收、掩埋或以其他環保方式配置)(本文“配置” 係指物件之元件形成(接合並定位)於一特定部位或位置中 -7a - (請先閱讀背面之注意事項再填寫本頁) 衣· 訂 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 476640 第89114348號專利申請案 中文說明書修正頁(90年5月) 五、發明説明(4b ) ,作為對於物件的其他元件之一個單元性結構、或作為一 個接合至物件的另一元件之分離的元件;本文“接合”包括 藉由將一元件直接附接至另一元件使該元件直接固定至另 一元件之構造、及藉由將一元件附接至中間構件再將該中 間構件附接至另一元件而使該元件間接固定至另一元件之 構造)。“單元性”吸收物件係指由分離的元件聯合構成一個 相配合實體而不需要譬如分離的固持件及襯墊等分離的操 縱元件之吸收物件。本文“身體物質”係指自哺乳動物身體 釋出的物質,“身體物質”包括體液及生物性流體,譬如陰 道排放物、月經、汗及唾液、身體排泄物譬如尿液及糞便 、及任何其他身體排放物譬如淚水及精液。 (請先閱讀背面之注意事項再填寫本頁) 經濟部中央標準局員工消費合作社印製 7b 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 476640 A7 B7 五、發明說明(5 ) (請先閱讀背面之注意事項再填寫本頁) 根據本發明可具有一個生物感測器診斷面板之吸收物件 實施例係爲單元性可棄式吸收物件,譬如圖丨所示的尿布 20。本文尿布係指一般穿在嬰兒及失禁者下身軀周圍之 吸收物件。本發明亦適用於其他吸收性及非吸收性物件, 譬如失禁短褲、失禁底褲、吸收嵌件、尿布固持件及觀墊 、自然或人工肛門用之結腸造口袋、女性衛生裝置(包括但 不限於褲墊、衛生棉、陰唇間裝置及衛生棉條)、擦拭件、 可棄式巾、薄紙(包括衛生紙)、採取唾液樣本之物件、吸 水物件、吸油物件、嘔吐袋、脱水袋、可棄式抹布、繃帶 、治療性包覆材、支撑部、可棄式加熱墊或類似物。 經濟部智慧財產局員工消費合作社印製 圖1爲尿布2 0展開狀態之平面圖,其中切除部份結構以 更清楚顯示尿布20構造。尿布20朝向穿戴者的部份係朝向 觀察者。如圖1所示,尿布2 〇較佳包含一個液體可滲透頂 層2 4,一個液體不可滲透底層2 6 ; —個吸收核心2 8,較佳 介於至少一部份頂層2 4與底層2 6之間;側片3 0 ;彈性化腳 翻邊32 ; —個彈性腰特徵34 ;及一個緊固系統4〇。尿布 20在圖1具有一個第一腰區36、與第一腰區36相對之一個 第二腰區38、及介於第一腰區與第二腰區之間的一個胯區 3 7。尿布2 0周邊由尿布2 0外緣所界定,其中縱緣5 〇概括 與尿布2 0縱中線100呈平行狀,且在縱緣5 〇間行進之端緣 5 2係與尿布2 0橫中線1 〇 2概呈平行狀。 尿布20的底座22包含尿布20的主體部,底座22包含至少 一部份吸收核心2 8及較佳一個外覆蓋層,此外覆蓋部係包 括頂層24及底層26。若吸收物件包含一個分離的固持件及 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 476640 A7 B7 五、發明說明(6 ) 一個襯塾,則底座22概包含固持件及襯墊(譬如,固持件可 包含一或多層材料以形成物件的外蓋,且襯墊可包含一個 吸收總成,此吸收總成包括一頂層、一底層及一吸收核心 。此情形中,固持件及/或襯墊可包括一個繁固元件以在使 用全私將襯塾固持定位)。對於單元性吸收物件,底座22包 含尿布之主要結構並添加其他特徵以形成複合尿布結構。 雖然頂層2 4、底層2 6、及吸收核心2 6可組裝成多種習知構 造’較佳的尿布構造一般描述於下列各案:丨975年1月i 4 日發證予肯尼斯B ·別爾名爲“可棄式尿布用之可收縮側部” 之美國專利3,860,003號;1992年9月9日發證予別爾之美國 專利5,151,092號;1993年6月22日發證予別爾之美國專利 5,221,274號;1996年9月10日發證予洛等人名爲“具有多區 結構性彈性狀薄膜織物可伸展腰特徵之吸收物件,,之美國專 利5,554,145號;1996年1 0月29日發證予別爾等人名爲“可 棄式拉穿式褲件’’之美國專利5,569,234號;1996年1 2月3日 發邊丁尼始等人名爲“用於製造吸收物件用側片之零廢料方 法”之美國專利5,580,411號;1997年8月20曰羅伯等人名爲 “具有可多向伸展性側片之吸收物件,,之美國專利申請 08/915,471號;各案以提及方式併入本文中。 底層26概爲尿布20中鄰近吸收核心28的向衣物表面45之 部份’可用以防止所吸收及圍堵的排泄物弄辩可能接觸尿 布20之物件’譬如床單及内褲。底層26可由本技藝習知之 任何附接裝置接合至頂層2 4、吸收核心2 8或尿布2 〇的任何 其他元件。適當的底層膜係包括印地安納州特瑞荷特的確 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項存填寫本 « n n n ϋ. ϋ «ϋ ·ϋ 訂------- .參 經濟部智慧財產局員工消費合作社印製 476640 A7 B7 經濟部智慧財產局員工消費合作社印製 五、發明說明(7 迪格工業公司製售的xl53〇6、Χ10962&Χ10964產品。其他 的適當底層材料可包括可呼吸性材料,譬如織造物、非織 造物、複合材料譬如薄膜塗覆非織造物、及微孔膜,譬如 曰本三井東壓公司製造之ESPOIR NO ;德州灣市的EXXON 化學公司的EXXAIRE ;或單體性薄膜,譬如俄亥俄州辛辛 那提的克羅佩公司製造之HYTREL混合物P18- 3097。此等可 呼吸性複合材料詳述於1995年6月22日公告之E.I.杜邦的 PCT申請W095/16746號;1999年2月2日發證予庫若之美國 專利5,865,823號;1996年11月5日發證予多伯林等人之美國 專利5,571,096號,各案以提及方式併入本文中。 底層2 6或其部份可在一或多方向彈性伸展。一項實施例 中,底層2 6可包含一個結構性彈性狀膜(SELF)織物。結構 性彈性狀膜織物係為不需添加彈性材料即可在伸長方向呈 現彈性狀表現之可伸展性材料。本發明適用的SELF織物描 述於1996年5月21日發證予夏佩爾等人名為“呈現彈性狀表 現之織物材料,,之美國專利5,518,8〇1號,以提及方式併入本 又中。另一實施例中,底層2 6可包含彈性體膜、泡棉、線 束'或以上組合或具有非織造物或合成膜之其他適當材料。 頂層24較佳為順服性、觸感柔軟且不刺激穿戴者皮膚。 -適當頂層24可由多種材料製造,#如孔狀泡+帛;網狀泡 綿;開孔狀塑膜;或天然纖維(如木纖或棉纖)、合成纖維( 如聚酯或聚丙烯纖維)之織造或非織造物、或天然及合成纖 維的組合。若頂層包括纖維,此等纖維可經由紗結:梳理 、濕置(wet-Uid)、融吹、水纏結、或本技藝習知的其他處 -to. (請先閱讀背面之注意事項再填寫本頁) •裝FIG. 2 is a cross-sectional view taken along line 2a-2a of FIG. 2 in FIG. 2; FIG. JA shows that the discontinuous response system of the present invention has an ideal output function with a single low limit; FIG. 3B shows the discontinuous response system of the present invention An ideal rotation function with multiple low bounds; Figure 4A shows an exemplary output function of the discontinuous response system of the present invention and first, second and third order derivative functions of this output function; ^ 4 B shows The transfer function of a series of first-order time-lag technology systems with equal time constants; Figures 5 A and 5B show an embodiment of the response system of the present invention with an electrically sensitive colloid; Figures 6A, 6B, and 6C show a system including an electrical Another embodiment of the response system of the present invention with sensitive colloid; FIG. 7 is a perspective view of an excrement bag of the present invention; FIG. 8 is a perspective view of an absorbent article including an excrement bag; H 9 is an implementation of the pant pad of the present invention A plan view of the example; Figure 9 A is a cross-sectional view of the pants pad embodiment shown in Figure 9 A taken along line 9 A-9 A of Figure 9, showing the diagnostic panel on the pants in detail; Figure 10 shows that it can be used for detection Microorganisms, biomolecules or other phases Examples of the chromaticity indicator of the amount of substance; Figure 11 illustrates a color comparison chart that can be used to indicate the amount of substance that appears; Hui 12 is a plan view of an embodiment of a sanitary napkin of the present invention; Plan view of the invented interlabial device; Figure 1 ^ shows the interlabial device shown in Figure 13 taken along the line 1 4-1 4 of Figure 13-6-This paper size applies the Chinese national standard < CNS) A4 Specifications (210 X 297 mm) (Please read the notes on the back before filling out this page) Packing ---- Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 No. 89114348 Patent Application A7 Chinese Manual Correction Page (90 May 2015) B7 V. Description of the invention (4) Sectional view; Figure 15 is a side view of the interlabial device shown in Figure 13; Figure 16 is a side view of the interlabial device shown in Figure 13 showing the interlabial device How to hold and insert into the space between the labia of the wearer; FIG. 17 shows how the interlabial device is worn by the wearer's body; and FIG. 18 is a perspective view of a tampon embodiment of the present invention. Description of component symbols 10 Diagnostic panel 37 Cross-region 12 Biosensor 38 Second waist region 14 Biosensor 40 Fastening system 16 Biosensor 45 Absorbent core 28 facing to the clothing surface 17 Mask 50 Diameter of diaper 20 18 Base material 52 End edge of diaper 20 19 Wiping mechanism 60 Biosensor 20 Diaper 62 Absorbent core 28 Waist edge 22 Base 80 Controller 24 Liquid permeable top layer 90 Actuator 26 Liquid impermeable bottom layer 91 Pressure difference device 28 Absorptive core 92 Soluble bag 30 Side panel 94 Compressed elastic material 32 Foot flanging 96 Gap space 34 Elastic waist feature 100 Diaper 20 midline 36 First waist area 102 Diaper 20 Midline Midwest Bureau of Economics Staff Consumption Printed by the cooperative (please read the precautions on the back before filling this page) This paper size applies to the Chinese National Standard (CNS) A4 (210X297 mm) 476640 Patent Application No. 89114348 printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs Revised page of the Chinese manual (May 90) 5. Description of the invention (4a) 110 Excrement disposal device 968 Sensor element 111 Excrement 970 sensor element 112 flange 980 cover 120 diaper 982 capillary strip 121 opening 1090 comparison table 124 top layer 1220 sanitary napkin example 485 pin 1260 diagnostic panel 494 electrosensitive gel 1320 interlabial device embodiment 594 electrosensitivity Gel 1338 Bottom layer 595 Mesh grill type 1342 Top layer 920 Pant pad embodiment 1344 Absorbent core 924 Pant top layer 1352 Handle 960 Diagnostic panel 1360 Diagnostic panel 962 Sensor element 1820 Sanitary tampon 964 Sensor element 1860 Diagnostic panel 966 Detailed description of the invention of the sensor element "Absorbent article" herein refers to a device that absorbs and blocks body emissions, especially a device that is placed against or near the wearer's body to absorb and block various emissions from the body. "Disposable" in this article means an absorbent article that is generally unintentionally washed or retrieved or re-used as an absorbent article (that is, it is disposed of after a single use, preferably recycled, buried or disposed of in other environmentally friendly ways) (this article "configured ”Means that the components of the object are formed (joined and positioned) in a specific part or location-7a-(Please read the precautions on the back before filling in this page) Clothes · The size of the paper applies to the Chinese National Standard (CNS) A4 (210X297 mm) 476640 No. 89114348 Patent Application Chinese Specification Revised Page (May 90) 5. Description of Invention (4b), as a unitary structure for other elements of an object, or as another joint to an object Separate components of an element; "joining" herein includes the construction of directly fixing one element to another element by directly attaching the element to another element, and attaching the element to an intermediate element and then attaching the element A configuration in which an intermediate member is attached to another element so that the element is indirectly fixed to the other element). A "unitary" absorbent article refers to an absorbent article in which separate elements combine to form a cooperating entity without the need for separate manipulation elements such as separate holders and pads. The term "body substance" refers to substances released from the mammal's body. "Body substance" includes bodily fluids and biological fluids such as vaginal discharge, menstruation, sweat and saliva, body excretions such as urine and feces, and any other Body emissions such as tears and semen. (Please read the notes on the back before filling this page) Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs 7b This paper is sized for the Chinese National Standard (CNS) A4 (210X297 mm) 476640 A7 B7 V. Description of the invention (5 ) (Please read the precautions on the back before filling out this page) An embodiment of an absorbent article that can have a biosensor diagnostic panel according to the present invention is a unitary disposable absorbent article, such as the diaper 20 shown in Figure 丨. A diaper herein refers to an absorbent article generally worn around the lower body of infants and incontinent persons. The present invention is also applicable to other absorbent and non-absorbent articles, such as incontinence shorts, incontinence bottoms, absorbent inserts, diaper holders and pads, colostomy bags for natural or artificial anus, feminine hygiene devices (including but not Limited to panty pads, sanitary napkins, interlabial devices and tampons), wipers, disposable towels, tissue paper (including toilet paper), saliva samples, water-absorbing articles, oil-absorbing articles, vomiting bags, dehydration bags, disposable Wipes, bandages, therapeutic coverings, supports, disposable heating pads or the like. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. Figure 1 is a plan view of the diaper 20 in the unfolded state. Part of the structure is cut out to show the structure of the diaper 20 more clearly. The portion of the diaper 20 facing the wearer is oriented toward the viewer. As shown in FIG. 1, the diaper 20 preferably includes a liquid-permeable top layer 2 4 and a liquid-impermeable bottom layer 2 6; an absorbent core 28, preferably between at least a part of the top layer 2 4 and the bottom layer 26. Side; 30 side panels; elasticized foot cuffs 32;-an elastic waist feature 34; and a fastening system 40. The diaper 20 has a first waist region 36, a second waist region 38 opposite to the first waist region 36, and a crotch region 37 between the first and second waist regions in FIG. The periphery of the diaper 20 is defined by the outer edge of the diaper 20, wherein the longitudinal edge 50 is generally parallel to the longitudinal centerline 100 of the diaper 20, and the end edge 5 2 running between the longitudinal edges 50 is transverse to the diaper 20 The center line 1 02 is almost parallel. The base 22 of the diaper 20 includes a main body portion of the diaper 20. The base 22 includes at least a part of the absorbent core 28 and preferably an outer cover layer. In addition, the cover portion includes a top layer 24 and a bottom layer 26. If the absorbent article contains a separate holder and the paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) 476640 A7 B7 V. Description of the invention (6) A lining, the base 22 contains the holder And the pad (for example, the holder may include one or more layers of material to form the outer cover of the article, and the pad may include an absorbent assembly that includes a top layer, a bottom layer, and an absorbent core. In this case, The holder and / or the pad may include a bulky element to hold the pad in place using a private person). For unitary absorbent articles, the base 22 contains the main structure of a diaper and adds other features to form a composite diaper structure. Although the top layer 2 4, the bottom layer 26, and the absorbent core 26 can be assembled into a variety of conventional structures, the better diaper structure is generally described in the following cases: 丨 January 4, 975 issued to Kenneth B. Be U.S. Patent No. 3,860,003 entitled "Contractible Sides for Disposable Diapers"; U.S. Patent No. 5,151,092 issued to Beale on September 9, 1992; issued on June 22, 1993 U.S. Patent No. 5,221,274 to Beyer; U.S. Patent No. 5,554,145 issued to Luo et al. On September 10, 1996, entitled "Absorbent Articles with Stretchable Waist Features of a Multi-Zone Structural Elastic Film Fabric," ; On October 29, 1996, issued a certificate to U.S. Patent No. 5,569,234 entitled "Disposable Pull-On Pants" issued by Beale et al .; U.S. Patent No. 5,580,411 for a method of manufacturing a zero waste material for side panels for absorbent articles "; U.S. Patent Application No. 08 / 915,471 entitled" Absorbent articles with multidirectionally stretchable side panels ", said by Robert et al. Each case is incorporated herein by reference. The bottom layer 26 is generally the adjacent absorbent core 2 in the diaper 20 The portion of the garment facing surface 45 that is 'used to prevent absorbed and enclosed excrement from arguing objects that may come in contact with the diaper 20', such as sheets and panties. The bottom layer 26 may be joined to the top layer by any attachment means known in the art. 2 4. Absorbent core 2 8 or any other element of diaper 2 0. Appropriate backing film system including Teraherd, Indiana. The actual paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm). (Please read the precautions on the back and fill in this form «nnn ϋ. Ϋ« ϋ ·-Order -------. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 A7 B7 Employee Consumption of the Intellectual Property Bureau of the Ministry of Economy Printed by the cooperative V. Description of the invention (7 x5310, X10962 & X10964 manufactured and sold by Dig Industries. Other suitable substrate materials may include breathable materials such as wovens, nonwovens, composite materials such as film coating Non-woven fabrics and microporous membranes, such as ESPOIR NO manufactured by Mitsui Tokai Co., Ltd .; EXXAIRE of EXXON Chemical Co., Texas; or monomeric films, such as Cincinnati, Ohio HYTREL Blend P18-3097 manufactured by Crope Company. These breathable composite materials are detailed in EI DuPont's PCT Application No. W095 / 16746 published on June 22, 1995; issued on February 2, 1999 U.S. Patent No. 5,865,823 to Curo; U.S. Patent No. 5,571,096 issued to Doblin et al. On November 5, 1996, each of which is incorporated herein by reference. The bottom layer 26 or a part thereof may be elastically stretched in one or more directions. In one embodiment, the bottom layer 26 may include a structural elastic film (SELF) fabric. The structural elastic film fabric is a stretchable material that can exhibit elasticity in the elongation direction without adding an elastic material. The SELF fabrics suitable for the present invention are described in May 21, 1996, issued to Sharpel et al., Entitled "Fabric material exhibiting elasticity," US Patent No. 5,518,801, incorporated by reference In another embodiment, in another embodiment, the bottom layer 26 may include an elastomer film, foam, wire harness, or a combination thereof, or other suitable materials with a nonwoven or synthetic film. The top layer 24 is preferably compliant and tactile Soft and non-irritating to the wearer's skin.-Appropriate top layer 24 can be made from a variety of materials, such as cell-shaped foam + 帛; mesh foam; open-cell plastic film; or natural fibers (such as wood fibers or cotton fibers), synthetic fibers (Such as polyester or polypropylene fibers) woven or non-woven fabrics, or a combination of natural and synthetic fibers. If the top layer includes fibers, these fibers can be knotted: carded, wet-Uid, meltblown, Water tangles, or other places known to the art-to. (Please read the precautions on the back before filling this page)

•ϋ ϋ ϋ ϋ i I ·ϋ n n an I n I— I ^/b64〇 A7 ------- B7 -----' -----— 五、發明說明(8 ) 理方式。一個包含一人造段聚丙烯纖維的織物之適當的頂 層2 4係為麻州瓦波爾的國際紙業公司所屬之菲瑞特克公司 製造的P - 8。 適當的成形膜頂層描述於1975年12月30日發證予湯普森 名為“具有推拔狀毛細管之吸附結構”之美國專利3,929,135 號;1982年4月13日發證予穆蘭等人名為“具有一抗污潰頂 層之可棄式吸收物件,,之美國專利4,324,246號;1982年8月3 曰發證予雷多爾等人名為“呈現纖維狀性質之彈性塑膜,,之 美國專利4,342,3 14號;1984年7月31日發證予亞爾等人名為 “呈現無視覺光澤表面及布狀觸感之巨觀性膨漲立體塑膜織 物’’之美國專利4,463,045號;1991年4月9日發證予拜德名為 “多層聚合膜’’之美國專利5,006,394號。其他適當的頂層24 係分別根據1986年9月2日及1986年12月16日發證予庫若等 人之美國專利號4,609,518及4,629,643號及美國專利 4,695,422號及美國專利5,520,875號製造,各案以提及方式 併入本文中。此等成形膜得自俄亥俄州辛辛那提的寶驗公 司的“DRI- WEAVE”及印地安納州特瑞荷特的確迪格公司的 “ CLIFF-丁’’。 頂層24可由一斥水性材料製造或可處理成斥水性,以使 穿戴者皮膚與吸收核心28所含液體相隔離。若頂層24由一 斥水性材料製造,較佳將至少頂層24上表面處理為親水性 以使液體更快傳送通過頂層。頂層24可藉由一介面活性劑 處理或在頂層中採用一介面活性劑而成為親水性。以一介 面活性劑處理頂層24之適當方法包括:以介面活性劑喷 -11 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) c請先閱讀背面之注意事項再填寫本頁) ▼丨裝• ϋ ϋ ϋ ϋ i I · ϋ nn an I n I— I ^ / b64〇A7 ------- B7 ----- '-----— V. Description of the invention (8) Principle . A suitable top layer 24 of a fabric containing a man-made segment of polypropylene fibers is P-8 manufactured by Ferretk Corporation, an international paper company of Wapel, Mass. A suitable top layer of the shaped film is described in US Patent No. 3,929,135 issued to Thompson on December 30, 1975, entitled "Adsorption Structure with Push-out Capillaries"; on April 13, 1982, issued to Mulan et al. "Disposable absorbent article with an antifouling top layer, US Patent No. 4,324,246; issued on August 3, 1982 to Reddall et al., Entitled" Elastic Plastic Film Showing Fibrous Properties, "the United States Patent No. 4,342,3 No. 14; U.S. Patent No. 4,463,045, issued on July 31, 1984, to Yaer et al., Entitled "Grand-view swelling three-dimensional plastic film fabric with no visual gloss surface and cloth-like touch" ; U.S. Patent No. 5,006,394 entitled "Multilayer Polymer Film" issued to BYD on April 9, 1991. Other suitable top layers 24 are manufactured in accordance with U.S. Patent Nos. 4,609,518 and 4,629,643 and U.S. Patent No. 4,695,422 and U.S. Patent No. 5,520,875 issued to Kuruo et al. On September 2, 1986 and December 16, 1986, respectively. Incorporated herein by reference. These formed films are available from "DRI-WEAVE" of Protest Corporation of Cincinnati, Ohio, and "CLIFF-D" of Trudiger, Indiana, Indiana. The top layer 24 may be made of a water-repellent material or may be Processed to be water repellent to isolate the wearer's skin from the liquid contained in the absorbent core 28. If the top layer 24 is made of a water repellent material, it is preferred to treat at least the upper surface of the top layer 24 to be hydrophilic to allow liquid to pass through the top layer faster The top layer 24 can be made hydrophilic by treating it with a surfactant or using a surfactant in the top layer. Appropriate methods of treating the top layer 24 with a surfactant include spraying with a surfactant -11-This paper size applies China National Standard (CNS) A4 (210 X 297 mm) c Please read the precautions on the back before filling in this page) ▼ 丨 Installation

tmMm team i n ^ · MM· whm a··· w··· I 經濟部智慧財產局員工消費合作社印製 476640 A7 B7 五、發明說明(9 ) >麗頂層2 4、及將材料浸入介面活性劑中。此處理及親水性 之更詳細描述請見:1991年1月29日發證予瑞新等人名爲‘‘ 具有多層吸收層之吸收物件”之美國專利4,988,344號、及 1991年1月29日發證予瑞新名爲“具有快速獲取吸收核心之 吸收物件”之美國專利4,988,345號。在頂層中採用介面活性 劑之某些適當方法的詳細描述請見亞濟茲等人在丨997年7月 1曰公告的美國法令發明註册H1670號,各參考文件以提及 方式併入本文中。 頂層2 4的任何部份或物件的其他組件係可塗有本技藝習 知之一液劑,適當液劑範例包括下列所述:1997年3月4日 發證予洛名爲“具有一個含軟化劑及多烴基化合物的聚酉旨固 定劑的液劑所塗佈頂層之可棄式吸收物件,,之美國專利 5,607,760號;1997年3月11日發證予洛名爲“具有一個含一 液體多烴基化合物聚酯軟化劑及一固定劑之液劑頂層之尿 布’’之美國專利5,609,587號;1997年6月3日發證予洛等人名 爲“具有一個含一聚矽氧烷軟化劑之液劑塗佈頂層之尿布,, 之美國專利5,635,191號;1997年7月1日發證予洛等人名爲“ 具有一個液劑塗佈頂層之尿布,,之美國專利5,643,588號。在 上述斥水化處理時,液劑可單獨作用或與另一劑共同作用 。頂層亦可包括抗菌劑或由抗菌劑處理,部份範例揭示於 1995年9月14日特瑞莎強森名爲“頂層含抗菌劑以控制臭味 之吸收物件,,之PCT公告W095/24173號。並且,頂層24、底 層2 6或頂層或底層的任何部份可作浮雕及/或毛面光製,以 提供更像布狀的外觀。 (請先閱讀背面之注意事項再填寫本頁) I ---I----^ ----— II-- 經濟部智慧財產局員工消費合作社印製 -12tmMm team in ^ · MM · whm a ·· w ··· I Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs and Consumer Cooperatives 476640 A7 B7 V. Description of the Invention (9) > Li Top 2 4 and the activity of immersing the material in the interface Agent. For a more detailed description of this treatment and hydrophilicity, please refer to: U.S. Patent No. 4,988,344 entitled "Absorbent Articles with Multilayer Absorptive Layers" issued to Ruixin et al. On January 29, 1991, and issued on January 29, 1991 US Patent No. 4,988,345 issued to Ruixin entitled "Absorbent article with fast-acquiring absorbent core". For a detailed description of some suitable methods of using a surfactant in the top layer, see Aziz et al., July 997 The United States Decree Invention Registration No. H1670 announced 1st, each reference is incorporated herein by reference. Any part of the top layer 24 or other components of the object may be coated with a liquid agent known in the art, a suitable liquid agent Examples include the following: Disposable absorbent articles coated with a topcoat coated with a liquid having a softener and a polyhydrocarbyl compound-containing fixative on March 4, 1997, U.S. Patent No. 5,607,760; U.S. Patent No. 5,609,587 entitled "A Diaper with a Liquid Top Layer Containing a Liquid Polyhydrocarbon-Based Polyester Softener and a Fixative" issued on March 11, 1997; 1997 June 3 Issued a certificate to Luo et al., "A diaper with a liquid-coated top layer containing a polysiloxane softener ,, US Patent No. 5,635,191; issued to Luo et al. On July 1, 1997, entitled" A diaper with a liquid coating top layer, US Patent No. 5,643,588. During the above-mentioned water repellent treatment, the liquid solution can work alone or in combination with another agent. The top layer can also include or be treated with an antibacterial agent. Some examples are disclosed in Teresa Johnson's PCT Publication No. W095 / 24173 titled "Absorbent Articles Containing Antibacterial Agents to Control Odor," September 14, 1995. Also, the top layer 24, the bottom layer 26, or any portion of the top layer or bottom layer may be embossed and / or matte polished to provide a more cloth-like appearance. (Please read the notes on the back before filling out this page) I --- I ---- ^ ----— II-- Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs -12

4/004U A7 B7 經濟部智慧財產局員工消費合作社印制衣 五、發明說明(1〇 吸收核心28可包含概呈可壓縮性、順服性、不刺激穿戴 、 吸收及留置如尿液及其他特定身體排泄物等 ^豆义任何吸收材料。吸收核心28可製成多種尺寸及形狀( 3如長万形、沙漏形、τ形、不對稱形等)且可包含可棄式 尿布及,、他吸收物件用之多種液體吸收性碎木漿(概稱為氣 絨)。其他適當吸收材料的範例包括:槽續纖維性填料;融 吹聚合物包括共形成物;化學硬化、修改或交聯纖維素纖 維;溥紙,包括薄紙包材及薄紙疊層;吸收泡棉;吸收海 梯;超吸收聚合物;吸收膠材料;或任何其他習知吸收材 料或材料組合。 吸收核心2 8的型態及構造亦可改變(譬如,吸收核心或其 他吸收結構可具有變化的卡徑區、親水梯度、超吸收梯度 、或較低的平均密度及較低的平均基重獲取區;或可包含 一或多層結構)。 ° 作為吸收總成的示範性吸收結構描述於1986年9月9日發 證予魏斯門等人名為“高密度吸收結構,,之美國專利 4,610,678號;1987年6月16日發證予魏斯門等人名為“具有 雙層核心之吸收物件”之美國專利4,673,402號;1989年5月 30日發證予亞樂曼尼等人名為“具有較低密度及較低基重獲 取區之高密度吸收構件’’之美國專利4,834,735號;1989年12 月19日發證予安格斯特名為“具有一擦拭層之吸收核心,,之 美國專利4,888,231號;1992年8月11日發證予哈倫等人名為 “包含個體化聚羰酸交聯木漿纖維素纖維之吸收結構,,之美 國專利5,137,537號;1992年9月15日發證予楊格等人名為‘‘ -13- $紙張尺度適时_家標準(CNS)A4規格(210 X 297公釐) ·-裝—----丨訂--------- (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 476640 -------- 1 ---------B7__ 五、發明說明(11 ) 失‘處理用足咼效率吸收物件,,之美國專利5,147,345號; 1994年8月30日發證予洛名為“低黏度排泄物質用之可棄式 吸收物件之美國專利5,342,338號;1993年丨1月9日發證予 迪馬瑞等人名為“水性體液用之吸收泡棉材料及包含此材料 之吸收物件之美國專利5,26〇,345號;1995年2月7日發證予 戴爾等人名為“水性體液用之濕潤前保持薄型之吸收泡綿材 料及其製造万法,,之美國專利5,387,2〇7號;1997年7月22日 發證予迪馬瑞等人名為“具有極高水油比之高内相乳劑製造 的水性流體用之吸收泡绵材料,,之美國專利5,625,222號;各 案以提及方式併入本文中。 尿布2 0亦可包含至少一個彈性腰特徵3 4,而有助於提供 改良的配合及圍堵。彈性腰特徵3 4較佳從吸收核心2 8的至 少一腰緣62至少縱向往外延伸且一般形成至少一部份的尿 布2 0袖緣5 2。可棄式尿布的構造時常具有兩個彈性腰特徵 •一者位於第一腰區36中,另一者位於第二腰區38中。並 且,彈性腰特徵3 4或其任何構成元件係可含有附接至尿布 20之一或多個分離的元件,彈性腰特徵34可構成尿布2〇的 其他元件(譬如底層26、頂層24、或底層26及底層24)之一 個延伸部。 彈性腰特徵34可構成包括下述等數種不同之構造:1985 年5月7日發證予基威特等人之美國專利4,515,595號; 年12月1日發證予拉西之美國專利七?…」的號;1992年9月 9日發證予別爾之美國專利5,151,〇92號;1993年6月22日發 證予別爾之美國專利5,221,274號。其他適當腰構造可包括 本紙張尺度適用中國國家標準(CNS)A4規格(2_1Q χ撕公楚〉 (請先閱讀背面之注意事項再填寫本頁) -裝--------訂--------- 0 476640 經濟部智慧財產局員工消費合作社印製 五、發明說明(12 ) A74 / 004U A7 B7 Printed clothing for employees' cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the invention (10 Absorbent core 28 may include general compressibility, compliance, non-irritating wear, absorption and indwelling such as urine and other specific Body excretion, etc. Any absorbent material. The absorbent core 28 can be made in a variety of sizes and shapes (such as long, hourglass, τ, asymmetric, etc.) and can include disposable diapers and, etc. Various liquid-absorptive wood pulps (abbreviated as air fleece) for absorbent articles. Examples of other suitable absorbent materials include: grooved continuous fibrous fillers; meltblown polymers including coforms; chemically hardened, modified, or crosslinked fibers Plain fiber; paper, including tissue wrapping materials and tissue stacks; absorbent foam; absorbent sea ladder; superabsorbent polymer; absorbent glue material; or any other conventional absorbent material or combination of materials. Type of absorbent core 28 And structure can also be changed (for example, the absorbent core or other absorbent structures can have varying card diameter regions, hydrophilic gradients, superabsorbent gradients, or lower average density and lower average basis weight acquisition (Or may include one or more layers). ° An exemplary absorbent structure described as an absorber assembly was issued to Weissman et al. On September 9, 1986, entitled "High Density Absorbent Structure," US Patent 4,610,678. No .; US Patent No. 4,673,402 issued to Weismen et al. On June 16, 1987, entitled "Absorbent Article with Double Core"; issued to Alor Manny, et al. On May 30, 1989, named US Patent No. 4,834,735, "High-Density Absorptive Member with Lower Density and Lower Basis Weight Acquisition Area"; issued on December 19, 1989 to Angustel, "Absorbing core with a wiping layer, U.S. Patent No. 4,888,231; issued to Harlan et al. On August 11, 1992 entitled "Absorbing Structure Containing Individualized Polycarboxylic Acid Crosslinked Wood Pulp Cellulose Fibers," U.S. Patent No. 5,137,537; 1992 September 15 issued a certificate to Yang Ge and others named `` -13- $ paper size timely _ home standard (CNS) A4 size (210 X 297 mm) ·-installed ------ 丨 order- ------- (Please read the notes on the back before filling out this page) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 47 6640 -------- 1 --------- B7__ V. Description of the invention (11) Loss of efficiency for absorbing objects with sufficient plantar, US Patent No. 5,147,345; August 1994 On the 30th, the company issued a certificate entitled "U.S. Patent No. 5,342,338 for disposable absorbent articles for low-viscosity excretory substances; on January 9, 1993, it issued a certificate to Dimari et al. For" absorbent bubbles for aqueous body fluids " U.S. Patent No. 5,26,345, cotton material and absorbent articles containing the material; issued to Dell et al. On February 7, 1995, entitled "Absorbent Foam Material Maintaining a Thin Type Before Wetting for Aqueous Body Fluids and Its Manufacturing method, U.S. Patent No. 5,387,207; July 22, 1997 issued a certificate to Dimarry et al. Entitled "Absorption for aqueous fluids made with high internal phase emulsions with extremely high water-oil ratios" Foam material, US Patent No. 5,625,222; each case is incorporated herein by reference. The diaper 20 may also include at least one elastic waist feature 34, which helps provide improved fit and containment. The elastic waist feature 34 preferably extends at least longitudinally outwardly from at least one waist edge 62 of the absorbent core 28 and generally forms at least a portion of the diaper 2 0 sleeve 5 2. Disposable diapers are often constructed with two elastic waist features. One is located in the first waist region 36 and the other is located in the second waist region 38. Also, the elastic waist feature 34 or any of its constituent elements may contain one or more separate elements attached to the diaper 20, and the elastic waist feature 34 may constitute other elements of the diaper 20 (such as the bottom layer 26, the top layer 24, or An extension of the bottom layer 26 and the bottom layer 24). The elastic waist feature 34 can be composed of several different structures including: US Patent No. 4,515,595 issued to Kiewit et al. On May 7, 1985; US Patent No. VII issued to Laxi on December 1, 1985? ... "; U.S. Patent No. 5,151,092 issued to Beale on September 9, 1992; U.S. Patent No. 5,221,274 issued to Beale on June 22, 1993. Other suitable waist structures may include the Chinese standard (CNS) A4 specifications (2_1Q χ tear public Chu>) for this paper size (please read the precautions on the back before filling this page) -install -------- order- -------- 0 476640 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the invention (12) A7

腰蓋特徵,譬如描述於1991年6月2 5日發證予羅柏森之美 國專利5,026,364號及1989年3月28日發證予福爾門之美國專 利4,816,025號;上述各案以提及方式併入本文中。 尿布20亦可包括一個緊固系統40,緊固系統4〇較佳包含 膠帶片及/或鉤與環緊固組件,但一般亦可接受使用任何其 他的習知緊固裝置。邵份示範緊固系統揭示於i 974年i 1月 1 9日發證予別爾名爲“可棄式尿布用之帶式緊固系統,,之美 國專利3,848,594號;1987年5月5日發證予廣津等人名爲“吸 收物件”之美國專利B1 4,662,875號;1989年7月11曰發證予 史魁普名爲“具有一改良的緊固裝置之可棄式尿布,,之美國 專利4,846,815號;1990年1月16日發證予奈司特葛名爲“具 有改良的鉤扣件部之可棄式尿布,,之美國專利4,894,〇6〇號; 1990年8月7日發證予巴垂爾名爲“壓力敏感性黏扣件及其製 造方法’’之美國專利4,946,527號;及上述1992年9月9日發證 予別爾之美國專利5,151,092號;及1993年6月22日發證予別 爾之美國專利5,221,274號。緊固系統亦可提供一種以可棄 式構造固持物件之裝置,如1990年1 0月1 6日發證予羅柏森 等人之美國專利4,963,140號,各案以提及方式併入本文中 。另一實施例中,衣物的相對側可缝合或熔接成褲件,這 可使物件作爲拉穿式尿布,譬如學習褲。 尿布2 0亦可包含側片3 〇,側片3 〇可爲彈性或可伸展,因 爲彈性化側片3 0可使尿布2 0側邊膨脹及收縮,以藉由起初 將尿布20舒適地配合至穿戴者且在尿布20負荷有棑泄物全 程與後續期間維持此配合,而提供更舒適及符合輪廓的配 -15- 本紙張尺度適用中國國家標準(CNS)A4規格(210 x 297公釐) (請先閱讀背面之注音?事項再填寫本頁) .裝 ^/6640 五、 發明說明(13 經濟部智慧財產局員工消費合作社印製 合。 雖然尿布2 0較佳具有配置於第二 布20可且有配班£38中之侧片3〇,尿 呷π』吳喟配且於罘_腰區36中、 區38中之側片30加&quot; 一乂弟—腰區36與第二腰 甲I側片〇0。側片3〇可構成任 化铜Η &gt;苽t γ η加 &lt; 田構k,具有彈性 化側片I尿布靶例揭示於:1989 人么&amp; “1古於执贯 千月15日發證予伍德等 人名局具有鬆子、耳部之可棄式尿 ^ · iqqq ^ ^ π 〇 &lt; 吴國專利 4,857,067 唬,1983年5月3日發證予夏拉法等 號;胸年7月3日㈣予 〈關專利4,381,781 哚 丁汜鞏博寺人 &lt; 美國專利4,938,753 破;上述1992年9月9日發證予別爾之美國專利^ ;测年6月22日發證予別爾之美國專利5,22i,mi997 年9月23日發證予拉馮等人名爲“提供維持動態配合之吸收 物件’’之美國專利5,669,897號;1997年8月2〇曰羅博等人名 爲“具有可多向伸展性側片之吸收物件,,之美國專利申請 〇8/915,471號;各案以提及方式併入本文中。 丹 尿布20較佳進一步包括腳翻邊32,可改良對於液體及其 他體液的圍堵。腳翻邊亦可稱爲腳帶、側片、障礙翻邊、 或彈性翻邊。美國專利3,860,003號描述一種可棄式尿布, 尿布具有可收縮性腳開口,腳開口具有一個側片及一或多 個彈性構件以提供一個彈性化腳翻邊(墊片翻邊)。分別在 1989年2月28日及1990年3月20日發證予亞濟茲等人之美國 專利4,808,178及4,909,803號描述具有“站立”彈性化翼部(障 礙翻邊)以改良腳區的圍堵性之可棄式尿布。分別於1987年 9月22日發證予洛森及1989年1月3日發證予爵古之美國專 利4,695,278號及4,795,454號中描述具有包括墊片翻邊及障 -16- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) Τ裝---- Φ 476640 A7 B7 五、發明說明(14 ) 礙翻邊等雙翻邊之可棄式尿布。部份實施例中,可如上述 需以一個液劑處理所有或一部份的腳翻邊。 尿布2 0亦可包括:囊部,用於收納及圍堵排泄物;固定 件’用於對排泄物提供空隙;障礙,用於限制排泄物在物 件中的移動;隔室或空隙,用於接受及容納尿布中沉積的 排泄物i,及類似物;或任何組合。吸收用品所用之囊部 及固足件的範例描述於1996年5月7日發證予洛等人名爲‘‘具 有驅逐性固定件之尿布,,之美國專利5,514,121號;1992年12 月15日發證予爵爾名爲“具有核心固定件之可棄式吸收物 件’之美國專利5,171,236號;1995年3月14日發證予爵爾名 爲‘具有一囊部翻邊之吸收物件,,之美國專利5,397,318號; 1996年7月3 0日發證予爵爾名爲“具有一頂點的一囊部翻邊 之吸收物件”之美國專利5,540,671號;1993年12月3曰公告 名爲“用於衛生吸收物件中之固定件及具有此固定件之可棄 式吸收物件,,之PCT申請W093/25172號;1994年4月26日發 證予福里蘭名爲“用於可棄式吸收物件之可撓固定件,,之美 國專利5,306,266號。隔室或空隙的範例揭示於1990年1 1月6 曰發證予關名爲“可棄式排泄物隔室式尿布,,之美國專利 4,968,312號;1991年2月5曰發證予福里蘭名爲“具有排泄物 質隔離用之彈性襯塾之吸收物件”之美國專利4,99〇,147號; 1991年11月5曰發證予賀特等人名爲“可棄式尿布,,之美國 專利5,62,840號;1993年12月14日發證予福里蘭名爲“可棄 式吸收物件用之三段式頂層及具有此等三段式頂層之可棄 式吸收物件”之美國專利5,269,755號。適當橫向障礙範例描 -17- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公麓) (請先閱讀背面之注意事項再填寫本頁)Waist cover features, such as described in US Patent No. 5,026,364 issued to Robertson on June 25, 1991 and US Patent No. 4,816,025 issued to Formman on March 28, 1989; the above cases are mentioned by reference Incorporated herein. The diaper 20 may also include a fastening system 40. The fastening system 40 preferably includes a tape and / or hook and loop fastening assembly, but any other conventional fastening device is generally acceptable. The Shaofen Demonstration Fastening System was issued on January 19, 974, i.e., issued a certificate to Bel named "belt fastening system for disposable diapers," US Patent No. 3,848,594; May 5, 1987 Issued to Guangjin et al. US Patent No. 4,662,875 entitled "Absorbing Articles"; July 11, 1989 Issued to Sequip, entitled "Disposable Diapers with Improved Fastening Device," US Patent No. 4,846,815 ; Issued on January 16, 1990 to Nestegor, US Pat. No. 4,894,060, entitled "Disposable diapers with improved hook-and-loop fasteners," issued on August 7, 1990 Baltic's U.S. Patent No. 4,946,527 entitled "Pressure Sensitive Fasteners and Manufacturing Method"; and U.S. Patent No. 5,151,092 issued to Bel on September 9, 1992; and 1993 US Patent No. 5,221,274 issued to Beale on June 22. The fastening system can also provide a device for holding objects in a disposable configuration, such as US Patent No. 4,963,140 issued to Robertson et al. On October 16, 1990, each of which is incorporated herein by reference. in. In another embodiment, the opposite sides of the garment may be stitched or welded to form pants, which may allow the article to be used as a pull-on diaper, such as school pants. The diaper 20 may also include a side panel 30, and the side panel 30 may be elastic or stretchable, because the elasticized side panel 30 may expand and contract the side of the diaper 20 to fit the diaper 20 comfortably at first To the wearer and maintain this cooperation throughout the diaper 20 with laxative discharge, and to provide a more comfortable and contoured fit. -15- This paper size applies to China National Standard (CNS) A4 (210 x 297 mm) ) (Please read the note on the back? Matters before filling out this page). Equipment ^ / 6640 V. Description of the invention (13 Printed and printed by the Employees' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. Although diapers 20 are better equipped with second cloth 20 can be accompanied with side panels of 30 in the 38, urinary pi 』Wu Wu with and in the _ waist area 36 in the middle, the side 30 in the area 38 plus" one brother-waist area 36 and the first Two waistband I side panels 0. The side panels 30 can constitute any chemical copper Η &gt; 苽 t γ η plus &lt; Tian Gou k, a target example of a diaper with elasticized side panels I was disclosed in: 1989 What &amp; " 1Gu Yu issued a certificate to Wood et al. On the 15th to have a disposable urine with pine nuts and ears ^ · iqqq ^ ^ π &lt; Wu Guo Lee 4,857,067, issued a certificate to Sharaphat on May 3, 1983; issued on July 3, 1989, and was granted a patent of <4,381,781 indole of Gongbo Temple & U.S. Patent 4,938,753; above 1992 US patent issued to Beale on September 9 ^; US patent 5,22i issued to Beale on June 22, and issued to Lavong et al. US Patent No. 5,669,897 for "Matching Absorbent Articles"; US Patent Application No. 08 / 915,471 entitled "Absorbent Articles with Multi-Directional Extensible Side Panels" by Robo et al. August 20, 1997; Incorporated herein by reference. The diaper 20 preferably further includes a foot cuff 32 to improve containment of liquids and other body fluids. The foot cuff can also be referred to as a foot strap, side panel, barrier cuff, or Elastic Flanging. U.S. Patent No. 3,860,003 describes a disposable diaper having a retractable foot opening with a side panel and one or more elastic members to provide an elasticized foot flanging (gasket flanging) .Issued to Yaziz on February 28, 1989 and March 20, 1990 U.S. Patent Nos. 4,808,178 and 4,909,803, et al. Describe disposable diapers with "standing" elasticized wings (barrier cuffs) to improve the containment of the foot area. Issued on September 22, 1987, respectively Lawson and U.S. Patent Nos. 4,695,278 and 4,795,454 issued to J.C. on January 3, 1989, have the following descriptions: including gasket flanging and barriers. 16- This paper standard is applicable to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling out this page) Τ Pack ---- 476 640 A7 B7 V. Description of the Invention (14) Disposable diapers with double flanging and other flanging. In some embodiments, all or a part of the foot flanging may be treated with one liquid as described above. The diaper 20 may also include: a pouch for receiving and enclosing excreta; a fixing member for providing a space for the excreta; an obstacle for restricting the movement of the excreta in the object; a compartment or a gap for the Receiving and containing fecal matter i, and the like deposited in the diaper; or any combination. An example of a bladder and a foot fastener used in an absorbent article is described in a U.S. Patent No. 5,514,121 entitled `` diaper with repellent fasteners, '' issued to Luo et al. On May 7, 1996, and issued in December 1992. Issued a license on 15th to U.S. Patent No. 5,171,236 entitled "Disposable Absorbent Article with Core Fixings"; issued a certificate on 14th March 1995 to "Absorbent Article with Capsule Flanging" US Patent No. 5,397,318 issued on July 30, 1996; US Patent No. 5,540,671 entitled "Absorbent article with a apex and a clamshell clamshell" issued to Juer on July 30, 1996; published on December 3, 1993 For "fixtures used in sanitary absorbent articles and disposable absorbent articles with such fixations, PCT Application No. W093 / 25172; Certificate issued to Freeland on April 26, 1994 entitled" For Disposable Flexible fixings for absorbent articles, US Patent No. 5,306,266. Examples of compartments or voids are disclosed on January 6, 1990, and are issued to the Customs with the name "disposable excrement compartment diapers," US Patent No. 4,968,312; issued to Freeland on February 5, 1991, entitled U.S. Patent No. 4,990.00,147 for an elastic lining absorbent article for excretory substance isolation; U.S. Patent No. 5,62,840 issued to Hert et al. On November 5, 1991, entitled "Disposable diapers," ; Issued on December 14, 1993 to Freeland US Patent No. 5,269,755 entitled "Three-Segment Top Layers for Disposable Absorptive Articles and Disposable Absorptive Articles With Such Three-Segment Top Layers". Appropriate Horizontal Barriers Example Description-17- This paper size applies to China National Standard (CNS) A4 (210 X 297 feet) (Please read the precautions on the back before filling this page)

I &lt; I 1 t n n n I^OJ· I I I I 1 I I I Φ 經濟部智慧財產局員工消費合作社印製 476640 A7 B7 五、發明說明(15 述於1996年9月10日爵爾等人名為‘‘具有多重有效高度橫向 隔間之吸收物件”之美國專利5,554,142號;1994年7月7日發 證予褐里蘭等人名為“具有一直立橫向隔間之吸收物件,,之 PCT專利W094/14395號;1997年8月5日發證予洛等人名為“ 具有斜角狀直三橫向隔間之吸收物件,,之美國專利5,653,7〇3 號’上述各案皆以提及方式併入本文中。 本發明實施例亦可包括一個排泄物處理裝置丨丨〇,如圖7 所示’排泄物處理裝置110可包括一個排泄物袋11()以收集 糞便、尿液或兩者。排泄物袋11丨可具有一個開孔12丨及圍 繞開口之一個凸緣U2以較佳黏接至穿戴者的肛門周圍區域 。並且,排泄物處理裝置11〇已知在配合衣物或尿布(較佳 為可棄式尿布)使用時係特別有效且有益。一個包括一排泄 物袋111的吸收物件範例(如尿布12〇)顯示於圖8中。若與一 個尿布120或其他衣物相聯結,則排泄物袋丨丨1可配置於物 件的任何表面上或相接合。一項實施例中,排泄物袋u丨接 合至尿布120的頂層124。 排泄物袋111較佳為一個用於圍堵排便或尿液之可撓容器 。因此,排泄物袋1 1 1較佳係為不可透液,或可呼吸之特性 。因此,排泄物袋丨丨丨設計具有足夠強度以承受一般的磨損 狀況(如坐下時)。 排泄物袋111可包含一或多層,一實施例中,排泄物袋111 可包含三層,較佳為一個膜及兩個非織造層。袋材料層可 包含任何材料,較佳使得袋為液體不可滲透性。本發明的 一項較佳實施例中,可由一非織造層及一膜形成一疊層。 -18- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) -裝 ----訂--------«—^wi. 經濟部智慧財產局員工消費合作社印製I &lt; I 1 tnnn I ^ OJ · IIII 1 III Φ Printed by the Consumers' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 A7 B7 V. Description of the invention (15 described on September 10, 1996 US Patent No. 5,554,142 of "Multiple Effective Height Horizontal Compartment Absorptive Articles"; July 7, 1994, issued a certificate to Mouri et al., Entitled "Absorbent Articles with Upright Horizontal Compartments," PCT Patent W094 No. 14395; issued on August 5, 1997 to Luo et al., Entitled "absorptive article with oblique straight three horizontal compartments," US Patent No. 5,653,703. The method is incorporated herein. The embodiment of the present invention may also include an excrement disposal device, as shown in FIG. 7 'The excrement disposal device 110 may include an excrement bag 11 () to collect feces, urine, or two The excrement bag 11 丨 may have an opening 12 丨 and a flange U2 surrounding the opening to better adhere to the area around the anus of the wearer. Also, the excrement treatment device 11 is known to be fitted with clothing or a diaper (Preferably disposable diapers) is particularly effective when used Beneficial. An example of an absorbent article (such as a diaper 12) including a fecal bag 111 is shown in Figure 8. If attached to a diaper 120 or other clothing, the fecal bag 1 can be placed on any surface of the article In one embodiment, the excrement bag u 丨 is joined to the top layer 124 of the diaper 120. The excrement bag 111 is preferably a flexible container for containing defecation or urine. Therefore, the excrement bag 1 1 1 is preferably liquid impermeable or breathable. Therefore, the excrement bag 丨 丨 丨 is designed to have sufficient strength to withstand general wear and tear conditions (such as when sitting down). The excrement bag 111 may contain one or Multi-layer, in one embodiment, the excrement bag 111 may include three layers, preferably one film and two nonwoven layers. The bag material layer may include any material, preferably making the bag liquid-impermeable. One of the invention In a preferred embodiment, a non-woven layer and a film can be used to form a stack. -18- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back first (Fill in this page again) -------- «— ^ wi. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs

476640 五、發明說明(16 ) 任何膜層用之適當膜材料較佳包含一熱塑性材料,此熱 塑性材料可為蒸氣可滲透性或不可滲透性,且可選自各型 熱融黏劑、聚晞烴特別是聚乙烯、聚丙烯、非晶系聚烯烴 、及類似物;包含可融組份之材料,可融組份則含有纖維 或聚合性結合劑,其中包括天然纖維,譬如纖維素_木漿、 棉、黃麻纖維、大麻纖維;合成纖維,譬如玻璃纖維、人 造絲、聚酯、聚晞烴、丙烯酸樹脂、聚醯胺、聚四氟乙烯 金屬、聚醯亞胺;結合劑,譬如雙組份高融/低融聚合物、 共聚物聚酯、聚氯乙缔、聚醋酸/氣乙缔共聚物、共聚物聚 酿胺’包含部份不可融構成材料的混合物之材料;空氣及 蒸氣可滲透性材料,包括微孔膜,譬如上述底層及單體性 可呼吸性材料,譬如杜邦公司的HYTRELtm及法國elf476640 V. Description of the invention (16) A suitable film material for any film layer preferably includes a thermoplastic material. The thermoplastic material may be vapor permeable or impervious, and may be selected from various types of hot-melt adhesives, polymer Hydrocarbons, especially polyethylene, polypropylene, amorphous polyolefins, and the like; materials containing fusible components, and fusible components containing fibers or polymerizable binders, including natural fibers such as cellulose Pulp, cotton, jute fiber, hemp fiber; synthetic fibers, such as glass fiber, rayon, polyester, polyalkylene, acrylic resin, polyamide, polytetrafluoroethylene, polyimide; binders such as Two-component high-melting / low-melting polymers, copolymer polyesters, polyvinyl chloride, polyacetic acid / gas ethylene copolymers, copolymers polyamines' materials containing a mixture of partially infusible constituent materials; air and Vapor permeable materials, including microporous membranes, such as the above substrates and monomeric breathable materials, such as HYTRELtm from DuPont and elf from France

Atochem公司的 Pebax™ 排泄物袋111可具有任何形狀及尺寸,較佳形狀包含扁平 圓形袋、圓錐形袋、截頭圓錐形袋及角錐形或截頭角錐形 袋及扁平T形袋。並且,排泄物袋lu可由一整件材料或數 件相同或不同且在各周邊密封之分離材料製造。 排泄物袋111亦可包含吸收材料,吸收材料可包含任何能 夠吸收及留置液體之吸收材料,吸收材料可包含可棄式尿 布及其他吸收物件常用之多種液體吸收性材料,本文對於 吸收核心描述部份的範例。 排泄物袋111具有一開孔121 ,因此在儲存於袋腔中之前先 從身體接收排泄物或尿液。開孔121較佳受到一個凸緣ιΐ2 所包圍且可具有任何形狀或尺寸,譬如圓形、橢圓形、 ----------I 裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製Atochem's Pebax ™ fecal bag 111 can have any shape and size. Preferred shapes include flat round bags, conical bags, truncated conical bags, pyramidal or truncated pyramidal bags, and flat T-shaped bags. Also, the excrement bag lu may be made of a single piece of material or several pieces of the same or different separating material sealed at each periphery. The excrement bag 111 may also contain an absorbent material. The absorbent material may include any absorbent material capable of absorbing and retaining liquids. The absorbent material may include various liquid absorbent materials commonly used in disposable diapers and other absorbent articles. Copy example. The excrement bag 111 has an opening 121, so that excreta or urine is received from the body before being stored in the bag cavity. The opening 121 is preferably surrounded by a flange 2 and can have any shape or size, such as circular, oval, ---------- I equipment -------- order-- ------- (Please read the precautions on the back before filling out this page) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs

經濟部智慧財產局員工消費合作社印製 4/6640 A7 ----------B7__ χ _____________ Α、發明說明(17 ) 心形且可呈對稱或不對稱狀,開孔較佳在縱向或橫向具有 橢圓形構造。凸緣可含有設計用於配合穿戴者會陰、生殖 及/或尾骨區域之突部。 凸緣112應由柔軟可撓及可塑性材料製造以易將凸緣112 置於肛門周圍或泌尿生殖區域。典型材料包括:非織造材 料Υ織造物、開格室熱塑性泡绵、閉格室熱塑性泡绵、開 格室泡绵及拉伸非織造物之複合物、及膜。 排泄物袋111較佳進一步包含一個附接裝置以將裝置固定 =穿戴者。此裝置可包含帶條、及或施加至排泄物袋iu向 穿戴者部或凸緣之一個與身體相容的壓力敏感性黏劑。可 使用任何對於皮膚友善的防水壓力敏感性黏劑(譬如水膠體 黏劑及水凝膠黏劑)將裝置附接至穿戴者的肛門周圍或泌尿 生殖區域。利用具有一塑化劑以形成立體基體之交聯聚合 物所,來構成特別有效提供所需黏著性質以在敏感的肛門 周圍區域將凸緣固定至穿戴者皮膚且可較不痛地施加及移 除之黏劑。 本發明亦可實施於其他吸收性或非吸收性物件中及/或上 ’此類物件譬如爲失禁褲、失禁内褲、吸收嵌件、尿布固 持件及襯墊、自然或人造肛門之結腸造口袋、女性衛生裝 置(包括但不限於褲塾、衛生棉、陰唇間裝置及衛生棉條) 、擦拭件、可棄式巾、薄紙(面紙及衛生紙)、可採取唾液 樣本的物件譬如牙刷、口紅棒或唇膏、吸水物件、吸油物 件、喔吐袋、脱水袋、可棄式抹布、端帶、治療性包覆材 支撑#、可棠式加熱墊或類似物。診斷面板位置亦可與 -20 - 本紙張尺度適用中國國家標準(CNS)A4規格(210Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 4/6640 A7 ---------- B7__ χ _____________ Α, Description of the invention (17) Heart-shaped and can be symmetrical or asymmetrical, the opening is better Oval configuration in longitudinal or transverse direction. The flange may contain protrusions designed to fit the wearer's perineal, reproductive and / or coccyx regions. The flange 112 should be made of a soft, flexible and plastic material to easily place the flange 112 around the anus or urogenital area. Typical materials include non-woven materials, woven fabrics, open-cell thermoplastic foams, closed-cell thermoplastic foams, composites of open-cell foams and stretch nonwovens, and films. The fecal bag 111 preferably further includes an attachment device to secure the device = wearer. The device may include a strap, and / or a body-compatible pressure sensitive adhesive applied to the excrement pouch towards the wearer's part or flange. The device can be attached to the wearer's anus or urogenital area using any skin-friendly, water-resistant pressure-sensitive adhesive, such as hydrocolloid and hydrogel adhesives. A crosslinked polymer having a plasticizer to form a three-dimensional matrix is used to construct a particularly effective provision of the required adhesive properties to secure the flange to the wearer's skin in the sensitive anal area and can be applied and moved less painfully. In addition to the adhesive. The present invention may also be implemented in and / or on other absorbent or non-absorbent articles. Such articles are, for example, incontinence pants, incontinence underwear, absorbent inserts, diaper holders and pads, natural or artificial anal colon production Pockets, feminine hygiene devices (including but not limited to pants, sanitary napkins, interlabial devices and tampons), wipes, disposable towels, tissue (tissue and toilet paper), items that can take saliva samples such as toothbrushes, Lipstick or lipstick, absorbent article, oil absorbent article, vomit bag, dehydration bag, disposable rag, end band, therapeutic covering support #, tangible heating pad or the like. The position of the diagnosis panel can also be -20-This paper size is applicable to China National Standard (CNS) A4 specification (210

----^--------- (請先閱讀背面之注意事項再填寫本頁) 裝 經濟部智慧財產局員工消費合作社印製 476640 A7 B7 五、發明說明(18) 一或多型上述物件相分離,且一或多個上述物件可作為一 個用於收集相關體液之收集裝置,此方式收集的體液可隨 後接觸一個診斷面板。此外,部份其他實施例中可使用棉 花棒、小片、液體容器及類似物來收集相關體液。 可具有一診斷裝置之褲墊及衛生棉的非限制性範例係包 括俄亥俄州辛辛那提寶鹼公司製造之下列各物:根據美國 專利 4,324,246、4,463,045及6,004,893 號製造具有 DriWeave® 的ALWAYS® ALLDAYS®褲墊;根據美國專利4,342,3 14、 4,463,045、4,556,146、B1 4,589,876、4,687,478、4,950,264、 5,009,653、5,267,992、Re.32,649 號製造的 ALWAYS® 超薄細 長加大具有翼部型;ALWAYS®超大具有翼部型; ALWAYS® —般加大型;ALWAYS®超大具有翼部型; ALWAYS®加大具有翼部型;ALWAYS®超長加大具有翼部 型;ALWAYS®長形超大具有翼部型;ALWAYS®隔夜加大 具有翼部型。具有一診斷裝置之褲墊範例顯示於圖9及9A 中,具有一診斷裝置之衛生棉範例顯示於圖1 2中。 可具有一診斷裝置的陰唇間裝置之非限制性範例描述於 :美國專利 5,762,644、5,885,265、5,891,126、5,895,381、 5,916,205、5,951,537、5,964,689、5,968,026號、Des· 404,814 、及413,669號,具有一診斷裝置之陰唇間裝置範例顯示於 圖1 3 - 1 7中。 可具有一診斷裝置之衛生棉條及其施用器的非限制性範 例描述於美國專利 4,726,805、4,846,802、4,960,417、 5,087,239、5,279,541、5,346,468、5,348,534、5,531,674、 -21 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝 tr--------- 476640 A7 B7 五、發明說明(19 ) 5,566,435號。此外,診斷裝置亦可設置於數位式插入衛生 棉條上’具有診斷裝置的衛生棉條範例顯示於圖1 8中。 物件2 0較佳亦包括至少一個指示器或偵測裝置譬如生物 感測裔6 0。本文“生物感測器,,包括一個含有適於偵測一或 多個目標微生物或相關生物分子(如酶感測器、感測器、組 織感測器、微生物感測器、免疫測定或電化感測器)的一或 多個元件之組份,微生物可能致病或可能不會致病,生物 感測器元件較佳能將該偵測訊號提供至穿戴者、看護者或 致動器。特定實施例中,元件可爲生物反應性、化學反應 性、束縛性、或可能以物理謗捕而操作。本文“生物反應性 ’’定義爲能夠與所述目標微生物及/或相關生物分子選擇性 相互作用且較佳將之束縛住。本文“生物反應性,,包括但不 限於偵測酶出現之元件,一般而言,生物感測器藉由提供 一種特定束縛因而偵測一目標生物活性分析物之裝置而產 生功能。因此,生物感測器具有高度選擇性,甚至在出現 一個包含許多化學及生物實體(如糞便、月經、汗及唾液) 的混合物時仍如此。化學感測器另一方面仰賴化學反應性 裝置,且一般不具有高度選擇性且不具有生物感測器的放 大性質,因而不太適合偵測生物反應性分析物,特別是在 出現低濃度及/或在一複雜媒體(譬如體液、身體廢物、及 其他身體排放物)時。目標生物性分析物時常爲一種包括多 種生物性及其他組份的複雜混合物之一個次要組份。因此 ,許多生物感測器應用中,需要對於目標分析物偵測到十 億分之一、兆分之一、或更低値。爲此,生物感測器在複 -22- 本紙張尺度適用中國國家標準(CNS)A4規格(21〇 x 297公釐〉 (請先閱讀背面之注意事項再填寫本頁) i n an i 一 δ、( i mt I n ϋ ϋ —i I - 經濟部智慧財產局員工消費合作社印製 476640 A7 -- —----—_ —__B7__________ 五、發明說明(20 ) 雜此合物中可能需要將目標生物性分析物識別至約 或更大之辨別比値。 本發明的生物感測器較佳包含一個生物識別元件或分子 識別元件,以提供對於一特定分析物之極特定的束缚 測選擇性。生物識別元件或系統可爲一種生物衍生物質; 譬如一酶或酶序列;—抗體;一薄膜受體蛋白質;dna; ’·’田胞器,一天然或合成細胞膜;一完整或部份的可存活 或不可存活細菌、植物或動物細胞;或一塊植物或哺乳動 物’且、歲且其一般功能係特別與一目標生物性分析物相互 作用。生物識別元件負責選擇性識別分析物及可作爲輸出 訊號基礎之物理化學訊號。 生物感測器可包括生物催化性生物感測器及生物親和力 生物感測器。生物催化性生物感測器的實施例中,生物識 別元爲“生物催化性,,且可包含一酶、細胞器、植物或哺乳 動物的組織塊、或全體細胞。選擇性束縛部位係“迴轉,,(亦 極可在偵測程序期間再次使用),使輸入訊號顯著放大。此 等生物催化性感測器一般有效用於即時連續感測。 生物親和力感測器一般適用於細菌、病毒及毒素且包括 化學感受體爲基礎的生物感測器及/或免疫學感測器(亦即 免疫感測器)。化學感受體爲複雜的生物分子性巨集合,其 部份負責使一個可存活有機體具有以高度選擇方式來感測 環境中化學物的能力。以化學感受體爲基礎的生物感測器 係包含一或多個天然或合成的化學感受體,其與一裝置相 聯以提供出現一目標生物性分析物或其濃度之一訊號(目视 -23- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁)---- ^ --------- (Please read the precautions on the back before filling out this page) Installed by the Intellectual Property Bureau of the Ministry of Economic Affairs and printed by the Consumer Cooperatives 476640 A7 B7 V. Description of the invention (18) One or Multiple types of the above-mentioned objects are separated, and one or more of the above-mentioned objects can be used as a collection device for collecting related body fluids, and the body fluids collected in this way can then contact a diagnostic panel. In addition, some other embodiments may use cotton swabs, tablets, liquid containers, and the like to collect relevant body fluids. Non-limiting examples of pant pads and sanitary napkins that may have a diagnostic device include the following made by Breguet, Inc. of Cincinnati, Ohio: ALWAYS® ALLDAYS® pant with DriWeave® manufactured according to U.S. Patents 4,324,246, 4,463,045, and 6,004,893 ; ALWAYS® Ultra-Thin Slim Enlargement with Wing Type manufactured according to U.S. Patents 4,342,3 14, 4,463,045, 4,556,146, B1 4,589,876, 4,687,478, 4,950,264, 5,009,653, 5,267,992, Re. 32,649; ALWAYS® Extra Large with Wings Type; ALWAYS® — as large as possible; ALWAYS® oversized with wing type; ALWAYS® oversized with wing type; ALWAYS® oversized with wing type; ALWAYS® oversized with wing type; ALWAYS® overnight Increased with wing type. Examples of panties with a diagnostic device are shown in FIGS. 9 and 9A, and examples of sanitary napkins with a diagnostic device are shown in FIG. Non-limiting examples of interlabial devices that may have a diagnostic device are described in: U.S. Patents 5,762,644, 5,885,265, 5,891,126, 5,895,381, 5,916,205, 5,951,537, 5,964,689, 5,968,026, Des. 404,814, and 413,669, with one Examples of interlabial devices for diagnostic devices are shown in Figs. Non-limiting examples of tampons and their applicators that can have a diagnostic device are described in U.S. Patents 4,726,805, 4,846,802, 4,960,417, 5,087,239, 5,279,541, 5,346,468, 5,348,534, 5,531,674, -21-This paper is sized to Chinese national standards (CNS) A4 specification (210 X 297 mm) (Please read the precautions on the back before filling this page) Install tr --------- 476640 A7 B7 V. Description of the invention (19) 5,566,435. In addition, the diagnostic device can also be placed on a digitally inserted tampon. An example of a tampon with a diagnostic device is shown in FIG. The object 20 preferably also includes at least one indicator or detection device such as a biosensor 60. A "biosensor" includes a biosensor that contains a biosensor suitable for the detection of one or more target microorganisms or related biomolecules (such as enzyme sensors, sensors, tissue sensors, microbial sensors, immunoassays, or electrochemistry). The component of one or more components of the sensor) may or may not cause microbes. The biosensor component preferably provides the detection signal to the wearer, caregiver or actuator. Specific In an embodiment, the element may be bioreactive, chemically reactive, tethered, or may be operated by physical slander. The term "bioreactive" is defined herein as being capable of being selectively selective to the target microorganism and / or related biomolecules. Interaction and preferably restrain it. This article "bioreactivity, including but not limited to elements that detect the presence of enzymes. In general, biosensors function by providing a device that specifically binds and thus detects a target biologically active analyte. Therefore, biological Sensors are highly selective, even in the presence of a mixture of many chemical and biological entities such as feces, menses, sweat, and saliva. Chemical sensors, on the other hand, rely on chemically reactive devices and generally do not Highly selective and without the magnifying properties of biosensors, it is not suitable for detecting bioreactive analytes, especially in the presence of low concentrations and / or in a complex medium such as body fluids, body waste, and other bodies Emissions). The target biological analyte is often a secondary component of a complex mixture of multiple biological and other components. Therefore, in many biosensor applications, it is necessary to detect ten target analytes. One billionth, one trillionth, or lower 为此 For this reason, biosensors in Fu-22- This paper standard applies to China Standard (CNS) A4 Specification (21〇x297mm) (Please read the precautions on the back before filling in this page) in an i δ, (i mt I n ϋ ϋ —i I-employee of Intellectual Property Bureau, Ministry of Economic Affairs Printed by the Consumer Cooperative 476640 A7-—----—_ —__ B7__________ V. Description of the invention (20) Miscellaneous This compound may need to identify the target biological analyte to a discrimination ratio of approximately or greater. 本The biosensor preferably includes a biometric recognition element or molecular recognition element to provide a very specific binding detection selectivity for a specific analyte. The biometric recognition element or system can be a biological derivative; such as an enzyme or enzyme Sequence;-antibody; a membrane receptor protein; DNA; '·' cell organelle, a natural or synthetic cell membrane; a complete or partial viable or non-viable bacterial, plant or animal cell; or a piece of plant or mammal 'And, the age and its general function is to specifically interact with a target biological analyte. The biometric identification element is responsible for selectively identifying the analyte and the physical and chemical signal that can be used as the basis for the output signal. The detector may include a biocatalytic biosensor and a bioaffinity biosensor. In the embodiment of the biocatalytic biosensor, the biometric element is “biocatalytic, and may include an enzyme, an organelle, Plant or mammalian tissue blocks, or whole cells. Selective restraint sites are “turned around,” (also very likely to be used again during the detection process) to significantly magnify the input signal. These biocatalytic sensors are generally effective For real-time continuous sensing. Bioaffinity sensors are generally applicable to bacteria, viruses and toxins and include chemosensor-based biosensors and / or immunological sensors (ie, immunosensors). Chemical sensing A body is a complex collection of biomolecular molecules, part of which is responsible for making a viable organism capable of sensing chemicals in the environment in a highly selective manner. Chemosensor-based biosensors include one or more natural or synthetic chemosensors that are associated with a device to provide a signal of the presence of a target biological analyte or one of its concentrations (visual- 23- This paper size applies to Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page)

II · n -n Ha ϋι I In —ϋ 一0,,· n ·ϋ ϋ n ·ϋ it in I 春 經濟部智慧財產局員工消費合作社印製 A7 ^---------B7___ 五、發明說明(-口 (請先閱讀背面之注意事項再填寫本頁) 訊唬、%訊號等)。特定實施例中,化學感受體可與一電極 (亦即電訊唬電測轉換器)相聯,以提供一可偵測的電訊號 化予感文體可包括整體或部份的神經束(譬如來自觸角或 /、他感”、彳杂g )及/或整體或部份的天然或合成細胞膜。另 一方面,免疫感測器的生物識別元件一般爲抗體,抗體極 A特足且可針對細菌、病毒、微生物斷片(如細菌細胞壁、 ,生蟲^或其部份等)、及大的生物分子。適當的抗體可爲 單克Ik或义克隆性。任何情形中,生物親和力生物感測器 般爲不可逆性,因爲生物感測器的受體部位暴露於目標 生物性分析物時將變得飽和。 特足實施例中,可合併生物催化性與生物親和力生物感 測器,譬如RNA/DNA探針或其他高親和力束縛系統,其^ 在初始的生物識別事件之後則爲訊號的生物性放大。譬如 可由一個含有作爲生物識別元件以偵測少量有機體(較佳小 於或等於約500)之基因物質(如DNA)的生物感測器及pcR( 亦即聚合酶連鎖反應)放大來偵測一特定的細菌。生物催化 性及生物親和力生物感測器系統詳述於色層分析法期刊, 510(1990)347-354’ &amp;赴歐德瑪化皋技術百科仝書,第4 經濟部智慧財產局員工消費合作社印製 版( 1992),紐約的約翰外里書店,其中揭示以提及方式併 入本文中。 本發明的生物感測器較佳偵測即將發生(亦即未來可能出 現症狀)或目前人體全身疾病狀態相關之生物活性分析物, 包括但不限於致病細菌、寄生蟲(譬如生命週期的任何階段 ,包括卵或卵的部份、囊胞、或成熟生物)、病毒、眞菌譬 -24- 本紙張尺度適用中國國家標準(CNS)A4規格(21〇 X 297公爱) 476640 A7 B7__ 五、發明說明(22 ) 如白色念珠菌(Candlda alblcans)、對病原體的抗體、及/或 微生物產生的毒素。此外,生物感測器可針對即將發生或 目前的局部健康問題相關之生物活性分析物,譬如可在臨 床出現皮膚刺激或發炎前出現的應激蛋白質(如細胞素)及 IL —1 α (白細胞介素1- alpha)。較佳實施例中,生物感測器 以前攝感測器方式運作而偵測及告知穿戴者或看護者在臨 床出現徵候群之前即將來臨的狀況,而可有時間給予穿戴 者預防或補救治療而防止或顯著降低徵候群的嚴重程度及 時間。並且,生物感測器6 〇藉由偵測穿戴者身體排放物(如 糞便)中出現的目標生物性分析物而可偵測與生物感測器相 接觸的(如皮膚)表面上的殘留污染物,並提供適當的訊號。 一或多個生物識別元件所產生之物理化學性訊號可與穿 戴者或看護者視覺相溝通(亦即譬如在色度性感測器中,透 過人眼可見的變色)。其他實施例可產生光學訊號,可能需 要其他儀器來加強訊號,包括螢光、生物發光、全内反射 共振、表面電漿共振、拉曼法及其他雷射基礎方法。可含 有生物共軛表面作爲生物識別元件之示範性表面電漿共振 生物感測器係得自德國孟斯特的XanTec分析系統之IBIS工及 IBIS II。另外,可經由一相關的訊號電測轉換器來處理訊 號,訊號電測轉換器譬如可產生一電訊號(譬如電流、電位 、電感或阻抗)而顯示(譬如可在LED或LCD顯示器上讀取) 或觸發一聽覺或觸覺(如振動)訊號或觸發致動器,如本文 所述。訊號可爲定性(譬如指示出現目標生物性分析物)或 定量(亦即測量目標生物性分析物的量或濃度),此等實施 -25- (請先閱讀背面之注意事項再填寫本頁) ,裝 一-1&gt;,·111111. 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS)A4規格(210 x 297公釐) 經濟部智慧財產局員工消費合作社印製 476640 A7 __B7____ 五、發明說明(23 ) 例中,訊號電測轉換器可選擇性產生一光學、熱、或聲音 訊號。 任何情形中,訊號亦可爲持續性(亦即通常至少與物件使 用壽命等長呈穩定及可讀取)或爲暫態性(亦即記錄一個即 時測量値)。此外,訊號可傳輸至一遠端指示器部位(譬如 經由電線、發送器如紅外線或射頻發送器),包括遠端裝置 或物件内或物件上的其他位置。並且,生物感測器6 〇或任 何組份可適於僅偵測及/或告知目標生物性分析物的濃度超 過預定低限値(譬如在目標生物性分析物正常出現在身體物 質或當分析物濃度低於已知“危險”値之情形)。 如上述,本發明的生物感測器適於偵測的目標分析物可 爲致病微生物,譬如人體胃腸病相關的致病微生物,尤其 是造成腹瀉者。由於每年因腹瀉疾病而重病或死亡的兒童 人數,此型病原體在監測時特別重要,已知嚴重的慢性腹 瀉可造成體重喪失及永久性生理及精神發育障礙。生物感 測器6 0可偵測之致病細菌的非限制名單包括任何下列大腸 桿菌(常稱爲E · Coli)的各種致病菌株:,包括致腸病性大 腸桿菌(EPEC)、腸毒性大腸桿菌(ETEC)、腸出血性大腸桿 菌(EHEC)、腸侵襲性大腸桿菌(EIEC)、及腸黏性大腸桿菌 (EAEC)菌株;沙門氏菌菌株,包括鼠傷寒沙門氏菌、副傷 寒沙門氏菌、S.enteriditis、S.typhimurium 及 S.heidelberg ;志 賀氏菌菌株,譬如 Shigella sonnei、Shigella flexneri、Shigella boydii及Shigella dysenteriae ;霍亂弧菌;結核病分枝桿菌; Yersinia enterocolitica ; Aeromonas hydrophila ; Plesiomonas -26- 本紙張尺度適用中國國家標準(CNS)A4規格(210 x 297公爱) (請先閱讀背面之注意事項再填寫本頁) i裝II · n -n Ha ϋι I In —ϋ 一 0,, · n · ϋ ϋ n · ϋ it in I Printed by A7 in the Consumer Property Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs ^ --------- B7___ Five 、 Explanation of the invention (-mouth (please read the notes on the back before filling this page), bluff,% signal, etc.). In a specific embodiment, the chemoreceptor may be connected to an electrode (ie, a telecommunication transducer) to provide a detectable electrical signal to the sensory body which may include a whole or a part of a nerve bundle (such as from the antennae). Or /, other senses ", doped g) and / or whole or part of natural or synthetic cell membranes. On the other hand, the biorecognition elements of immunosensors are generally antibodies, and the antibodies are very specific and can target bacteria, Viruses, microbial fragments (such as bacterial cell walls, worms, or parts thereof), and large biomolecules. Suitable antibodies can be single gram Ik or sense clones. In any case, bioaffinity biosensors It is irreversible, because the receptor part of the biosensor will become saturated when exposed to the target biological analyte. In a special embodiment, biocatalytic and bioaffinity biosensors can be combined, such as RNA / DNA detection Pin or other high-affinity binding system, which is a biological amplification of the signal after the initial biometric event. For example, a small amount of organisms (preferably small Biosensors with genetic material (such as DNA) at or equal to about 500) and pcR (ie, polymerase chain reaction) amplification to detect a specific bacterium. Biocatalytic and bioaffinity biosensor system details Journal of Chromatographic Analysis, 510 (1990) 347-354 '&amp; Encyclopedia of Odmar Chemical Technology Encyclopedia, 4th Edition Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs (1992), John Wailey, New York Bookstore, where the disclosure is incorporated herein by reference. The biosensor of the present invention preferably detects biologically active analytes that are imminent (i.e., symptoms may occur in the future) or are related to the current state of the body's disease, including but not Limited to pathogenic bacteria, parasites (such as any stage of the life cycle, including eggs or parts of eggs, cysts, or mature organisms), viruses, tadpoles such as -24- This paper applies Chinese National Standard (CNS) A4 Specifications (21〇X 297 public love) 476640 A7 B7__ 5. Description of the invention (22) Such as Candlda alblcans, antibodies to pathogens, and / or toxins produced by microorganisms. In addition, biosensors Targets bioactive analytes related to upcoming or current local health issues, such as stress proteins (such as cytokines) and IL-1 alpha (interleukin 1-alpha) that can appear before clinical skin irritation or inflammation In a preferred embodiment, the biosensor operates in a pre-sensing mode to detect and inform the wearer or caregiver of a condition that is imminent before a clinical syndrome appears, and there is time to prevent or remediate the wearer. Preventing or significantly reducing the severity and time of the syndrome. Furthermore, the biosensor 60 can detect and biosensor by detecting the target biological analytes present in the wearer's body emissions (such as feces). Contaminants on surfaces that are in contact with the device (such as skin) and provide appropriate signals. The physicochemical signals generated by the one or more biometric elements can be visually communicated to the wearer or caregiver (ie, for example, in a chroma sensor, discoloration visible through the human eye). Other embodiments may generate optical signals, and other instruments may be required to enhance the signals, including fluorescence, bioluminescence, total internal reflection resonance, surface plasma resonance, Raman method, and other laser-based methods. Exemplary surface plasmon resonance biosensors that can contain bioconjugated surfaces as biometric identification elements are IBIS and IBIS II from the XanTec analysis system in Munster, Germany. In addition, the signal can be processed by a related signal electrical measurement converter. For example, the signal electrical measurement converter can generate an electrical signal (such as current, potential, inductance or impedance) and display it (such as can be read on an LED or LCD display). ) Or trigger an audible or tactile (such as vibration) signal or trigger an actuator, as described herein. The signal can be qualitative (such as indicating the presence of the target biological analyte) or quantitative (that is, measuring the amount or concentration of the target biological analyte). These implementations-25- (Please read the precautions on the back before filling this page) , 装 一 -1 &gt;, · 111111. Printed by the Intellectual Property Bureau Staff Consumer Cooperatives of the Ministry of Economics This paper is printed in accordance with China National Standard (CNS) A4 (210 x 297 mm). A7 __B7____ 5. Description of the Invention (23) In the example, the signal electrical measuring converter can selectively generate an optical, thermal, or acoustic signal. In any case, the signal can also be continuous (i.e. usually stable and readable at least as long as the lifetime of the object) or transient (i.e., recording an instant measurement 値). In addition, the signal can be transmitted to a remote indicator (for example, via a wire, a transmitter such as an infrared or radio frequency transmitter), including a remote device or object or other locations on the object. Furthermore, the biosensor 600 or any component may be adapted to detect and / or notify only that the concentration of the target biological analyte exceeds a predetermined low limit (for example, when the target biological analyte normally appears in a body substance or when analyzed Concentrations lower than those known to be "dangerous". As described above, the target analyte suitable for detection by the biosensor of the present invention may be a pathogenic microorganism, such as a pathogenic microorganism related to human gastrointestinal diseases, especially those who cause diarrhea. Due to the number of children who are seriously ill or die each year due to diarrheal diseases, this type of pathogen is particularly important in monitoring. It is known that severe chronic diarrhea can cause weight loss and permanent physical and mental development disorders. The non-restricted list of pathogenic bacteria detected by Biosensor 60 includes any of the following pathogenic strains of E. coli (commonly known as E. Coli): including enteropathogenic E. coli (EPEC), enterotoxicity E. coli (ETEC), enterohemorrhagic E.coli (EHEC), enteroinvasive E.coli (EIEC), and enteroadhesive E.coli (EAEC) strains; Salmonella strains, including Salmonella typhimurium, Salmonella paratyphoid, S. enterididitis , S.typhimurium and S.heidelberg; Shigella strains such as Shigella sonnei, Shigella flexneri, Shigella boydii and Shigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas -26- China National Standard (CNS) A4 Specification (210 x 297 Public Love) (Please read the precautions on the back before filling this page)

n n n n 一OJ· n n· an n n «ϋ §§§ I 476640 A7 _____B7 ___ 五、發明說明(24 ) (請先閱讀背面之注意事項再填寫本頁) shigelloides ; Campylobacter菌株,譬如 c.jejuni 及 C.coli ; Bacteroides fragilis ;及梭菌菌株,包括 C.septicum、 C.perfringens、C.botulinum及C·difficile。適於偵測大腸样菌 之市售生物感測器的非限制範例係購自北卡州德恩的安德 凱爾公司之測試組# 4001及俄亥俄州辛辛那提的梅瑞迪恩診 斷公司之ImmunoCard®STAT!大腸样菌〇l57Plus測定。適於 偵測輪狀病毒之市售生物感測器的另一非限制範例得自俄 亥俄州辛辛那提的梅瑞迪恩診斷公司之Immun〇Card® S TAT! 輪狀病毒測定。適於偵測Cryptosporidium及蘭伯氏鞭毛蟲之 市售生物感測器的另一非限制範例得自俄亥俄州辛辛那提 的梅瑞迪恩診斷公司之Merifluor Crypto/Giardia測定。適於 偵測C .素的市售生物感測器的另一非限制範例得 自俄亥俄州辛辛那提的梅瑞迪恩診斷公司之高級c.difficile 毒素A測定。賓州亞德利的ABTECH科學公司提供“生物分 析性生物訊號電測轉換器”,品名爲Au_1〇5〇.5-FD-X ’ 其可藉由濟多吹、酶、抗體或DNA片斷共價固定至表面而 具有生物特定性(對於本文所述微生物或其他目標生物性分 析物)。對於一或多個相關病原體之其他適當微生物感測器 經濟部智慧財產局員工消費合作社印製 或感測系,统請見美國專利5,948,694、6,〇01,556 ; 5,1〇6,965( 腺病毒);5,869,272(克負有機體);5,795,717(志賀氏桿菌) ;5,830,341 ; 5,795,453 ; 5,354,661 ; 5,783,399 ; 5,840,488 ; ; 5,723,330 ; 5,496,700號,各案以提及方式併入本 本發明生物感測器適於偵測之目標分析物亦可爲病毒, -27- 本紙張尺度適用t 準(CNS)A4規格(210了完^) 476640 A7 B7nnnn-OJ · nn · an nn «ϋ §§§ I 476640 A7 _____B7 ___ V. Description of the invention (24) (Please read the notes on the back before filling this page) shigelloides; Campylobacter strains, such as c.jejuni and C. coli; Bacteroides fragilis; and Clostridium strains, including C. septicum, C. perfringens, C. botulinum, and C. difficile. Non-limiting examples of commercially available biosensors suitable for the detection of coliform bacteria are Test Group # 4001 from Underkell Corporation of Dern, North Carolina and ImmunoCard from Meridian Diagnostics, Cincinnati, Ohio. ®STAT! Coliform Plus 057Plus Assay. Another non-limiting example of a commercially available biosensor suitable for detecting rotavirus is available from the ImmunoCard® S TAT! Rotavirus Assay of Meridian Diagnostics, Inc. of Cincinnati, Ohio. Another non-limiting example of commercially available biosensors suitable for detecting Cryptosporidium and Lambert's flagellates is available from the Merifluor Crypto / Giardia assay at Meridian Diagnostics, Inc. of Cincinnati, Ohio. Another non-limiting example of a commercially available biosensor suitable for detecting C. vulgaris is available from Meridian Diagnostics' Advanced C.difficile toxin A assay in Cincinnati, Ohio. ABTECH Scientific, Yardley, PA, offers "Analytical Bio-Signal Signal Transducers" with the name Au_1105.5-FD-X 'which can be co-opted by Zidflo, enzymes, antibodies or DNA fragments. The valence is fixed to the surface and is biologically specific (for the microorganism or other target biological analyte described herein). For other suitable microbiological sensors, please refer to US Patent Nos. 5,948,694, 6,0001,556; 5,106,965 (Adenoids) Virus); 5,869,272 (gram-negative organisms); 5,795,717 (Shigella); 5,830,341; 5,795,453; 5,354,661; 5,783,399; 5,840,488;; 5,723,330; 5,496,700, each of which is incorporated by reference into the biosensor of the present invention is suitable for detection The target analyte to be measured can also be a virus. -27- This paper size is applicable to the standard (CNS) A4 (end of 210 ^) 476640 A7 B7

五、發明說明(25 ) 可包括引發腹瀉的病毒,譬如輪狀病毒、腺病毒(_種 dsDNA病毒)、星形病毒(astrovirus)( —種RNA病毒)、舞病 -----------裝— (請先閱讀背面之注意事項再填寫本頁) 毒(calcivirus)( —種RNA病毒)、及語沃克因子病毒(幻仏广 毒)、或譬如鼻病毒及人體免疫缺乏病毒(HIV)等其他病毒 。適於偵測HIV的示範性生物感測器請見上述美國專利 5,830,341及5,795,453號,各案揭示以提及方式併入本文中。 其他實施例中,本發明生物感測器適於偵測之目標分析 物亦可偵測寄生蟲,尤其是在生命週期某點(譬如卵或部份 的卵、卵囊、營養體、成蟲)住在腸胃道的寄生蟲。此等寄 生蟲可包括原生動物、蠕蟲及其他腸胃寄生蟲。其他可偵 測的寄生蟲範例包括Entamoeba histolytica(造成阿米巴痢疾) 、Cryptosporidium、蘭伯氏鞭毛蟲、Dientomeba fragilis、 Trypana cruzi(可造成查力口 斯氏病)、Plasmodium falciparum 〇 其他實施例中,本發明生物感測器適於偵測之目標分析 物可爲眞菌,譬如Candida albicans。除了致病細菌之外, 可偵測及/測量特定的結腸益菌而作爲健康指示器,譬如 Bifidobacteria 及 Lactobacillus菌株。 經濟部智慧財產局員工消費合作社印製 本發明生物感測器適於偵測之目標分析物可爲有關皮膚 不適的蛋白質或抗原,較佳在出現臨床可觀察到的皮膚刺 激之前,即可較佳在皮膚表面或表面之上偵測到這些分析 物,可包括應激蛋白質譬如細胞素、組織胺、及其他免應 反應因子,包括白細胞介素(譬如IL-1從、IL-2、IL-3、 IL-4及IL-8)及干擾素(包括干擾素a及g)。再者,較佳在 開始出現可臨床觀察的紅疹、刺激或皮膚炎之前即可由生 -28- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 4/004U Α7V. The description of the invention (25) may include viruses that cause diarrhea, such as rotavirus, adenovirus (_ dsDNA virus), astrovirus (_ RNA virus), dance disease ------- ---- Equipment— (Please read the precautions on the reverse side before filling out this page) calcivirus (—an RNA virus), and Walker factor virus (Panthora vulgaris), or rhinovirus and human immunodeficiency Viruses (HIV) and other viruses. Exemplary biosensors suitable for detecting HIV are described in the aforementioned U.S. Patents 5,830,341 and 5,795,453, each of which is incorporated herein by reference. In other embodiments, the target analyte suitable for detection by the biosensor of the present invention can also detect parasites, especially at a certain point in the life cycle (such as eggs or parts of eggs, oocysts, vegetative bodies, adults) Parasites that live in the gastrointestinal tract. Such parasites can include protozoa, worms and other gastrointestinal parasites. Other examples of detectable parasites include Entamoeba histolytica (causing amoeba dysentery), Cryptosporidium, Lambert flagellates, Dientomeba fragilis, Trypana cruzi (causing Charles disease), Plasmodium falciparum 〇 In other embodiments The target analyte suitable for detection by the biosensor of the present invention may be a fungus, such as Candida albicans. In addition to pathogenic bacteria, specific colonic bacteria can be detected and / or measured as health indicators, such as Bifidobacteria and Lactobacillus strains. The consumer cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs printed the target analyte suitable for detection of the biosensor of the present invention may be a protein or antigen related to skin discomfort, preferably before clinically observable skin irritation occurs. These analytes are preferably detected on or above the skin surface and may include stress proteins such as cytokines, histamines, and other immune response factors, including interleukins (such as IL-1 from, IL-2, IL -3, IL-4 and IL-8) and interferons (including interferons a and g). Furthermore, it is better to start before clinically observable rash, irritation, or dermatitis occurs. -28- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 4 / 004U Α7

經濟部智慧財產局員工消費合作社印製 ==。偵測。此外,本發明生物感測器適於偵測酶或 激相關的其他生物性因子(如尿布皮膚炎),包括 胰蛋白酶、麋胰蛋白酶及脂肪酶。 本發」明特定較佳實施例中,物件可包含-個診斷面板, 本又“診斷面板”包含適於偵測是否出現一組特定物質中至 T兩物質之兩個或更多生物感測器的組合、或其他型指示 ^這些物質可爲哺乳動物的身體狀況或健康狀態、或特 =疾病(如腹瀉、陰道感染、性傳染病(STD)及其他疾病)狀 悲的原因t指示器。譬如,生物感測器適於偵測是否出現 一組特定病原體中的至少兩者以決定病原體種類或造成特 足疾病狀悲之特定病原體,而大致作出診斷並開始補救性 療程。譬如,物件可包含一個適於決定腹瀉或陰道感染的 一或多個致病原因之診斷面板,診斷面板適於偵測之身體 狀況或健康狀惡範例包括但不限於排卵及經期開始,診斷 面板適於偵測以決定月經開始之物質範例包括但不限於: 黃體酮、p Η、及紅血細胞(血紅素)。 本發明物件特別適合的診斷面板實施例中,診斷面板可 對使用者指示出現一種常見的腹瀉病毒性原因。此物件提 供的指示係用於警告使用者、看護者或醫療人員腹瀉原因 爲病毒性質。此診斷面板可包含適於偵測下列至少兩病毒 之生物感測器:輪狀病毒、腺病毒、星形病毒、舞病毒、 及語沃克因子病毒。然而,診斷面板較佳能偵測盡可能多 種上述病毒性腹瀉原因。任何情形中,診斷面板提供使用 者、看護者或醫療人員的訊號可指出特定的病毒性腹瀉原 -29 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公爱) (請先閱讀背面之注意事項再填寫本頁) 裝Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs ==. Detect. In addition, the biosensor of the present invention is suitable for detecting enzymes or other biological factors related to stress (such as diaper dermatitis), including trypsin, elk trypsin, and lipase. According to a specific preferred embodiment of the present invention, the object may include a diagnostic panel, and the "diagnostic panel" includes two or more biosensors suitable for detecting whether a group of specific substances up to two substances is present. Combination of organs, or other types of indicators ^ These substances can be the physical condition or health status of mammals, or specific causes of sadness (such as diarrhea, vaginal infections, sexually transmitted diseases (STD) and other diseases) t indicator . For example, biosensors are suitable for detecting the presence of at least two of a specific set of pathogens to determine the type of pathogen or a particular pathogen that causes a specific disease condition, and make a rough diagnosis and initiate a remedial course. For example, the object may include a diagnostic panel suitable for determining one or more causes of diarrhea or vaginal infection. The diagnostic panel is suitable for detecting physical conditions or health symptoms. Examples include, but are not limited to, ovulation and menstrual period. Examples of substances suitable for detection to determine the onset of menstruation include, but are not limited to, progesterone, peptone, and red blood cells (heme). In the embodiment of the diagnostic panel in which the object of the present invention is particularly suitable, the diagnostic panel can indicate to the user a common cause of diarrhea virus. This article provides instructions to warn users, caregivers, or medical personnel that the cause of diarrhea is viral. The diagnostic panel may include a biosensor suitable for detecting at least two of the following viruses: rotavirus, adenovirus, astrovirus, dance virus, and Walker factor virus. However, the diagnostic panel is better able to detect as many of the above causes of viral diarrhea as possible. In any case, the diagnostic panel provides a signal from the user, caregiver, or medical staff to indicate the specific viral diarrhea.-29 This paper size applies to China National Standard (CNS) A4 (210 X 297 public love) (Please read first (Notes on the back then fill out this page)

m n in n I l n Bn 11 *1 tn I 參 476640 第89114348號專利申請案 中文說明書修正頁(90年5月) ^五、發明説明(27 ) 經濟部中央標準局員工消費合作社印製 因、或僅指出原因為病毒性。 另外,物件可包含一個適於偵測腹瀉或陰道感染的任何 潛在細菌原因之診斷面板。特定較佳實施例中,診斷面板 可包含適於偵測下列各物中至少兩者之生物感測器:致腸 病性大腸捍菌(EPEC)、腸毒性大腸捍菌(ETEC)、腸出血性 大腸桿菌(EHEC)、腸侵襲性大腸捍菌(EIEC)、及腸黏性大 腸桿菌(EAEC)菌、傑竹尼彎曲桿菌(Campyl〇bacterjejuni)、霍 亂弧菌及志贺氏样菌菌株包括索氏志贺氏菌(S· sonnei)及弗 氏志贺氏菌(S· flexned)。但診斷面板較佳能偵測盡可能多種 上述細菌性腹/鳥或陰道感染原因。較佳以診斷面板指示是 否出現造成腹瀉或陰道感染的任何上述細菌性原因,任何 情況中,診斷面板對於使用者、看護者或醫療人員提供之 訊號較佳係指出腹瀉或陰道感染之特定原因(亦即細菌病原 體),而可對於健康狀況作早期特定治療。 另外,物件可包含一個適於偵測造成腹瀉(或)陰道感染 之任何潛在病毒及細菌性原因之診斷面板,特定較佳實施 例中’#斷面板可包含一或多個適於偵測至少一個病毒之 生物感測器及一或多個適於偵測至少一細菌之生物感測 。但診斷面板較佳能偵測盡可能多種上述細菌性及病毒 腹/爲(或陰道感染)原因。任何情形中,診斷面板提供使 者、看護者或醫療人員的訊號較佳係指示腹瀉(或陰道感 )之特定原因(亦即病毒或細菌性病原體),故可早期作出 康狀況的特別治療。 另外,物件可包含一個診斷面板,此診斷面板適於偵1 腹瀉的特定原生動物原因。此實施例中,診斷面板可包含 適於债測一或多項下列各物之生物感測器:Crypt〇sp〇ddium 器 性 用 染 健 測 ----------- (請先閲讀背面之注意事項再填寫本頁) 訂 ·· 30 本紙張尺度適用中國國家標準(CNS ) M規格(210X297公釐) 476640 A7 B7 五、發明說明(28 ) 、蘭伯氏鞭毛蟲、Dientomeba fragilis及 Entamoeba histolytica 。並且,診斷面板較佳能夠偵測盡可能多種上述原生動物 腹瀉原因之出現。此情形中,對於使用者、看護者或醫療 人員的訊號較佳指出造成腹瀉之特定的原生動物原因,而 可早期對健康狀況作出特定治療。 當然,診斷面板亦可適於偵測腹瀉致病原因的任何組合 ’譬如’診斷面板可包含適於偵測兩或更多上述腹瀉的病 毒性、細菌性及原生動物原因之生物感測器。 物件可包含一個適於以類似前兩段腹瀉所述方式偵測並 通知陰道感染的特定原生動物或致病原因之診斷面板。 用於可棄式尿布之示範性診斷面板1 〇的非限制實施例顯 不於圖1B-1E中。診斷面板1〇包括兩個生物感測器I]: 一 個生物感測器1 4適於偵測大腸桿菌H0157而一個生物感測 器1 6適於偵測輪狀病毒。可從上述梅瑞迪恩診斷公司的mn in n I ln Bn 11 * 1 tn I See 476640 No. 89114348 Patent Application Chinese Specification Revision Page (May 90) ^ V. Description of Invention (27) Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs, or Only the cause is indicated as viral. Alternatively, the object may include a diagnostic panel suitable for detecting any underlying bacterial cause of diarrhea or vaginal infection. In a particularly preferred embodiment, the diagnostic panel may include a biosensor adapted to detect at least two of the following: enteropathogenic coliform (EPEC), enterotoxic coliform (ETEC), intestinal bleeding E. coli (EHEC), intestinal invasive coliform (EIEC), and entero-adhesive E. coli (EAEC), Campylobacter (Campylobabacterjejuni), Vibrio cholerae and Shigella-like bacteria S. sonnei and S. flexned. However, the diagnostic panel is better able to detect as many of the above-mentioned causes of bacterial abdominal / bird or vaginal infections as possible. The diagnostic panel preferably indicates whether any of the aforementioned bacterial causes of diarrhea or vaginal infection have occurred. In any case, the signal provided by the diagnostic panel to the user, caregiver, or medical staff is preferably to indicate the specific cause of diarrhea or vaginal infection ( (I.e., bacterial pathogens), and can be used for specific early treatment of health conditions. In addition, the object may include a diagnostic panel suitable for detecting any potential viral and bacterial causes of diarrhea (or) vaginal infections. In certain preferred embodiments, the '#break panel may include one or more suitable for detecting at least A virus biosensor and one or more biosensors adapted to detect at least one bacterium. However, the diagnostic panel is better able to detect as many of the above bacterial and viral causes as possible (or vaginal infections). In any case, the signal provided by the diagnostic panel to the messenger, caregiver, or medical staff is preferably indicative of a specific cause of diarrhea (or vaginal sensation) (ie, a viral or bacterial pathogen), so special treatment for health conditions can be made early. Alternatively, the object may include a diagnostic panel that is suitable for detecting specific protozoan causes of diarrhea. In this embodiment, the diagnostic panel may include a biosensor suitable for debt measurement of one or more of the following: Crypt〇sp〇ddium organic dye test ----------- (please first Read the notes on the back and fill in this page again.) ·· 30 This paper size applies the Chinese National Standard (CNS) M specification (210X297 mm) 476640 A7 B7 V. Description of the invention (28), Lambert flagellate, Dientomeba fragilis And Entamoeba histolytica. Moreover, the diagnostic panel is preferably able to detect the occurrence of as many of the above-mentioned protozoan diarrhea causes as possible. In this case, the signal to the user, caregiver, or medical staff is better to point out the specific protozoan cause of diarrhea, and specific treatment for the health condition can be made early. Of course, the diagnostic panel may be adapted to detect any combination of the causes of diarrhea. For example, the diagnostic panel may include a biosensor suitable for detecting the toxicity, bacterial and protozoan causes of two or more of the aforementioned diarrhea. The object may include a diagnostic panel suitable for detecting and notifying specific protozoa or causative agents of a vaginal infection in a manner similar to that described in the previous two paragraphs of diarrhea. A non-limiting example of an exemplary diagnostic panel 10 for a disposable diaper is shown in Figs. 1B-1E. The diagnostic panel 10 includes two biosensors I]: a biosensor 14 is suitable for detecting E. coli H0157 and a biosensor 16 is suitable for detecting rotavirus. Available from Meridian Diagnostics

Imimm〇Card®STAT!大腸桿菌 0157P1US及ImmunoCard®ST at ! 輪狀病毒組獲得生物感測器1 2,以製造診斷面板1 〇。生物 感測器取出各自的“卡,,並由本技藝習知之任何附接或結合 裝置(如黏劑)附接至一個基材丨8的一外露表面,基材丨8較 佳可包含譬如紙、硬紙板、聚烯烴膜等任何適當材料。一 實施例中,基材i 8爲一較硬紙板材料。如圖1 C所示,將一 個具有與生物感測器丨2相對應的開口之罩幕丨7係施加至基 材1 8表面以確使排泄物僅接觸生物感測器1 2本身、而非基 材18表面的其餘部份。基材18或罩幕17可由譬如塑膠、硬 紙板或紙等任何材料製造,且可包含標示、使用說明、或 -31 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) Ϊ裝 ----訂--------- 參 經濟部智慧財產局員工消費合作社印製 476640 ..A7Imimmo Card® STAT! E. coli 0157P1US and ImmunoCard® ST at! Rotavirus group obtained biosensor 12 to manufacture diagnostic panel 10. The biosensors take out their respective "cards" and are attached to an exposed surface of a substrate by any attachment or bonding device (such as an adhesive) known in the art. The substrate 8 may preferably include, for example, paper , Cardboard, polyolefin film, etc., any suitable material. In one embodiment, the substrate i 8 is a relatively hard cardboard material. As shown in FIG. 1C, one having an opening corresponding to the biosensor 2 The mask 7 is applied to the surface of the substrate 18 to ensure that the excrement only contacts the biosensor 12 itself and not the rest of the surface of the substrate 18. The substrate 18 or the mask 17 can be made of, for example, plastic, hard Made of any material such as cardboard or paper, and can include labels, instructions for use, or -31-This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling in this Page) Outfitting ---- Order --------- Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 .. A7

五、發明說明(29 ) 經濟部智慧財產局員工消費合作社印制衣 /、他指標以幫助進行測試或解釋結果。譬如,基材18可包 含-變色“键’’以幫助使用者正確解釋結果。診斷面板10經 由本技藝習知的任何附接或結合裝置(如黏劑)附接至與穿 戴者肛Η位置相對應之尿布胯區中之尿布頂層的向穿戴面。 另外,可藉由訂述大腸捍菌犯別喊工麵職〜㈣篇丨 輪狀病毒生物感測器直接附接至與穿戴者肛門位置相對應 之尿布胯區中的尿布頂層的向穿戴表面,而製造診斷面板。 任何上述實施例中,尿布頂層可包含至少一開孔,而診 斷面板10可附接至與頂層開孔相對應之下方的吸收核心= 域。不論選擇何種構造,# ;世物在排出時均將接觸兩個生 物感測器12的“樣本,,區。當從穿戴者移除尿布或將排泄物 樣本施加至生物感測器丨2時,排泄物樣本可用嬖如 Immun〇Card®STAT!組中的稀釋劑等稀釋劑作選擇性稀釋, 這在排泄物樣本爲固體時特別有用。任何情形中,可在排 便後約10分鐘,若添加稀釋劑則在樣本稀釋10分鐘之後, 自生物感測器1 2讀取結果。特別的其他實施例中,生物感 測器1 2可附接至尿布的任何區域,譬如頂層、底層、翻邊 、及扣件。這些實施例中,在打開尿布或從穿戴者移除尿 布時,排泄物樣本必須在選擇性稀釋之後由穿戴者或看護 者施加至兩個生物感測器丨2的測試區。任何上述實施例中 ,兩個生物感測器1 2的組合係依腹瀉的常見病毒性(輪狀病 毒)及細菌性(大腸样菌)原因提供診斷。 如圖1D及1E所示,上述診斷面板1〇亦可包含一個整合 擦拭機構1 9,以從生物感測器丨2移除多餘排泄物而有利於 -32- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) 訂 經濟部智慧財產局員工消費合作社印製 476640 A7 - ~—-— B7_______ 五、發明說明(3〇 ) =確解讀結果。另外,擦拭機構19可包含一個滑捍,此滑 扣包括與生物感測器丨2頂表面不具有間隙或有極小間隙之 二個可撓擦拭翼部,而可用人工方式滑下診斷面板1〇面以 從生物感測器i 2表面刮除多餘排泄物。 另外,可使用美國專利6,001,556號所述及申請適於偵測 輪狀病毒及大腸样菌及選擇性其他本文所述腹瀉病原體的 發色性生物感測器來取代上述尿布實施例之梅瑞迪恩診斷 公司之Immun〇Card®STAT!生物感測器。這些膜具有比^多 其他生物感測器系統更薄及更小面積之優點,應額外 ••本文所述的任何其他生物感測器可取代或添加至上述範 例’包括發色性及電化性生物感測器。 本發明的生物感測器亦可.包含生物識別系統,包括酶或 束縛蛋白質,譬如固定在物理化學訊號電測轉換器的表面 上之抗體。譬如,可採用對一菌株培養的抗體之生物咸測 器來偵測該特定細菌菌株。另外,可藉由針對目標細菌的 細胞外產物(譬如該菌株(如大腸样菌)產 物識別元件來(包括抗體及合成或天然分子受^ = ^ 標細菌。可用於偵測(譬如尿或排泄物中的)酚之示範性酶 電極包括酪氨酸酶爲基礎的電極或多酚氧化酶電極,分別 請見1997年10月14日發證予約瑟夫王等人名爲“遠端電化 感測器”之美國專利5,676,820號及1992年2月2 5日發證予安 東尼P.F.透那等人名爲“用於有機溶劑中之酶電極,,之美國 專利5,091,299號,兩案均以提及方式併入本文中。 任何上述範例中,可直接偵測特定微生物、或藉由束縛 -33- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) ^--------tl--------- (請先閱讀背面之注意事項再填寫本頁) 經濟部中央標準局員工消費合作社印製 476640 第89114348號專利申請案 中文說明書修正頁(90年5月) ^ 五、發明説明(3〗) 一有機體或一抗體(譬如針對該有機體的單克隆抗體)產生 的一毒素、酶或其他蛋白質所偵測p示範性生物感測器適 於偵測美國專利5,607,567號所述之蛋白水解酶及美國專利 5,496,452、5,521,101、5,567,301 號之毒素。 陰道感染用之示範性診斷面板的非限制實施例中,生物 感測裔可適於偵測各種可能造成細菌性陰道病(vagin〇sis)之 特足類型細菌’包括陰道加德諾菌(Gardnerella vaginalis)、 普佛特拉碧菲亞(Prevotella bivia)、類桿菌種、人型枝原體 (Mycoplasma hominis)、莫必盧可斯(Mobiluncus)種。生物感 測器可適於偵測可造成細菌性陰道病(vaginosis)的非特定類 型細囷。生物感測器亦可適於偵測真菌,譬如假絲酵母種 ,其可造成酵母菌陰道炎(或酵母菌感染)。生物感測器亦 適於偵測原生動物譬如陰道滴蟲,其可造成難啟齒的性傳 染病之滴蟲病、或其他性傳染病。適於彳貞測G . vaginalis的市 售生物感測器的非限制範例為得自加州聖塔卡拉樂之里特 馬斯概念公司之FEM EXAM®G vaginalis PIP活動測試卡, FEM EXAM®G vaginalis測試卡描述於美國專利5,571,684號 。適於偵測細菌性vaginosis不特定原因之市售生物感測器的 非限制範例為得自里特馬斯概念公司之FEM EXAM® p Η及 胺測試卡,FEM EXAM® pH及胺測試卡描述於美國專利 5,660,790號,其他相關的里特馬斯概念公司專利案及專利 公告包括:5,268,146 ; 5,416,003 ; 5,585,273 ; 5,897,834 ;及 PCT公告WO94/24306。適合偵測假絲酵母及衣原體之生物感 測器的非限制範例分別描述於發證予加州聖地牙哥魁德爾 公司之美國專利5,741,662及5,773,234號。 -34- 本紙張尺度適用中國國家標準(CNS ) Α4規格(210X297公釐) ----------I (請先閲讀背面之注意事項再填寫本頁) 、?τ 476640 A7 B7_ 五、發明說明(32 ) 其他較佳實施例中,診斷面板可包含適於偵測至少兩個 下列細菌之生物感測器:各種可造成細菌性vaginosis之細 菌,包括 Gardnerella vaginalis、Prevotella bivia、類样菌種、 Mycoplasma hominis、Mobiluncus種 〇 圖9顯示非限制褲墊實施例920,包含一個示範性診斷面 板960以偵測陰道炎的各種致病原因。圖9所示的診斷面板 960包含五個感測器元件962、964、966、968、970,上述感 測器可適合單獨使用以偵測一或多個陰道炎致病原因、或 與一或多個其他感測器元件合併。感測器元件962適於偵測 p Η,感測器元件964適於偵測胺的出現,感測器元件966適 於偵測G . vaginalis,感測器元件968適於偵測假絲酵母種, 感測器元件970適於偵測陰道滴蟲。感測器元件可爲任何適 當形狀及任何適當配置且不限於圖示的正方形感測器排列。 感測器元件962及964的組合可用以债測細菌性vaginosis的 非特定原因,一項細菌性vaginosis(BV)的早期研究係包含 將已知患有B V女性與未染病者之陰道流體pH値相比較, 請見加德納 H.L.等人的 Am. J. Obstet. Gynecol. 69 ·· 962(1955)。研究之所有陽性BV女性判定具有大於4.5的陰 道流體pH値,且其中91%女性具有大於5.0的陰道流體pH 値,現今的研究則將p Η低限値調整爲4.7。 除了 pH 之外,Amesel,R.等人在 Am. J. Med.74 : 14-22 (1983)制定三項其他的B V指示器:陰道流體均質性、嗅覺 測試(以強鹼處理,然後嗅覺測試偵測胺臭味)、及線索細 胞的出現。其中若出現兩項指示(pH及胺)則高度符合測試 -35- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝 訂i 經濟部智慧財產局員工消費合作社印製 476640 五、發明說明(33 ) B V的所有四項指示獲得的結果。 較佳的pH指示劑A :溴驗藍 '漠氯驗藍、溪甲酚綠、溪 (請先閱讀背面之注意事項再填寫本頁) 甲酚紫、漠百里朌藍、耀黃、及則黃。特佳pH指示劑爲 硝夏,合併季铵根時,當pH升高時在約〇1 pH單位的狹 笮PH範圍中直接從黃綠色變成藍色,轉變集中於 η 4.7處。 “’、Ρ 孚銨根可爲能施加足以與指示劑中負根形成離子引力之 任何正根,較佳的季銨根爲較低的烷基銨根,其中烷基根 爲C 1 - C 4燒基根,特佳爲三甲铵根。V. Description of the invention (29) Employees of the Intellectual Property Bureau of the Ministry of Economic Affairs print clothing and other indicators to help test or interpret the results. For example, the substrate 18 may include-discoloring "keys" to help the user interpret the results correctly. The diagnostic panel 10 is attached to the anal condyle location of the wearer via any attachment or bonding device (such as an adhesive) known in the art. Corresponding to the wearing surface of the top layer of the diaper in the diaper area. In addition, you can add the Rotavirus biosensor directly to the anus of the wearer. The diaper top surface in the diaper area corresponds to the wear-facing surface of the diaper pouch corresponding to the position to manufacture a diagnostic panel. In any of the above embodiments, the diaper top layer may include at least one opening, and the diagnostic panel 10 may be attached corresponding to the top opening The absorption core below = domain. Regardless of the chosen structure, the world object will contact the "sample," area of the two biosensors 12 when it is discharged. When the diaper is removed from the wearer or the fecal sample is applied to the biosensor, the fecal sample can be selectively diluted with a diluent such as the diluent in the ImmunoCard® STAT! Group. This is especially useful when the sample is solid. In any case, the results can be read from the biosensor 12 approximately 10 minutes after defecation, or 10 minutes after the sample is diluted with the addition of a diluent. In particular other embodiments, the biosensor 12 can be attached to any area of the diaper, such as a top layer, a bottom layer, a flange, and a fastener. In these embodiments, when the diaper is opened or removed from the wearer, the fecal sample must be applied by the wearer or caregiver to the test area of the two biosensors 2 after selective dilution. In any of the above embodiments, the combination of the two biosensors 12 provides a diagnosis based on common viral (rotavirus) and bacterial (coliform) causes of diarrhea. As shown in FIGS. 1D and 1E, the diagnostic panel 10 may also include an integrated wiping mechanism 19 to remove excess excrement from the biosensor 2 and facilitate the use of -32- This paper size applies Chinese national standards ( CNS) A4 specification (210 X 297 mm) (Please read the notes on the back before filling out this page) Order printed by the Intellectual Property Bureau Employee Consumer Cooperatives of the Ministry of Economic Affairs 476640 A7-~---B7_______ V. Description of the invention (3〇 ) = Explain the result. In addition, the wiping mechanism 19 may include a sliding guard. The sliding buckle includes two flexible wiping wings that have no gap with the top surface of the biosensor 2 or have a small gap, and the diagnostic panel 1 can be manually slid down. Face to scrape excess feces from the surface of the biosensor i 2. In addition, the chromogenic biosensor described in U.S. Patent No. 6,001,556 and applied to detect rotavirus and coliform bacteria and selective other diarrhea pathogens described herein may be used in place of the plums of the diaper embodiments described above. ImmunoCard® STAT! Biosensor from Radiant Diagnostics. These films have the advantage of being thinner and smaller in area than other biosensor systems, and should be additional • Any other biosensor described in this article can be replaced or added to the examples above, including color and electrochemical properties Biosensor. The biosensor of the present invention may also include a biometric recognition system, including an enzyme or a tethered protein, such as an antibody immobilized on the surface of a physico-chemical signal transducer. For example, a biosalinity detector of antibodies raised against a strain can be used to detect that particular bacterial strain. In addition, it can be used to identify extracellular products of target bacteria (such as the strain (such as coliform)) product recognition elements (including antibodies and synthetic or natural molecules subject to ^ = ^ target bacteria. Can be used to detect (such as urine or excretion) Exemplary enzyme electrodes of phenol include tyrosinase-based electrodes or polyphenol oxidase electrodes. Please see the certificate issued to King Joseph et al. "U.S. Patent No. 5,676,820 and February 25, 1992 issued to Anthony PF Turner et al." Enzyme Electrodes for Organic Solvents, "U.S. Patent No. 5,091,299, both of which are proposed And methods are incorporated in this article. In any of the above examples, specific microorganisms can be detected directly, or by means of restraint -33- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) ^ ---- ---- tl --------- (Please read the notes on the back before filling out this page) Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 476640 No. 89114348 Patent Application Chinese Manual Correction Page (90 May 2015) ^ V. Description of the invention (3) An exemplary toxin, enzyme or other protein produced by an organism or an antibody (such as a monoclonal antibody directed against the organism). An exemplary biosensor is suitable for detecting the proteolytic enzymes described in US Patent No. 5,607,567 and the US Patent Toxins Nos. 5,496,452, 5,521,101, 5,567,301. In a non-limiting example of an exemplary diagnostic panel for vaginal infections, biosensors can be adapted to detect a variety of specialties that may cause bacterial vaginosis Type bacteria include Gardnerella vaginalis, Prevotella bivia, Bacteroides, Mycoplasma hominis, Mobiluncus. Biosensors can be used to detect non-specific types of cells that can cause vaginosis. Biosensors can also be used to detect fungi, such as Candida species, which can cause yeast vaginitis (Or yeast infection). Biosensors are also suitable for detecting protozoa such as Trichomonas vaginalis, which can cause difficult-to-open sexually transmitted diseases such as trichomoniasis, or other sexually transmitted diseases. Non-limiting examples of commercially available biosensors by Yu Zhenzheng G. vaginalis are FEM EXAM®G vaginalis PIP activity test cards, FEM EXAM®G vaginalis test The card is described in U.S. Patent No. 5,571,684. A non-limiting example of a commercially available biosensor suitable for the detection of bacterial vaginosis for an unspecified reason is the FEM EXAM® p (R) and Amine Test Card from Rittermas Concepts FEM EXAM® pH and amine test cards are described in US Patent No. 5,660,790. Other related Ritmas Concept patents and patent announcements include: 5,268,146; 5,416,003; 5,585,273; 5,897,834; and PCT Publication WO94 / 24306. Non-limiting examples of biosensors suitable for detecting Candida and Chlamydia are described in U.S. Patent Nos. 5,741,662 and 5,773,234 issued to Quiddell, San Diego, California, respectively. -34- This paper size applies to Chinese National Standard (CNS) A4 specification (210X297 mm) ---------- I (Please read the precautions on the back before filling this page),? Τ 476640 A7 B7_ 5. Description of the Invention (32) In other preferred embodiments, the diagnostic panel may include a biosensor suitable for detecting at least two of the following bacteria: various bacteria that can cause bacterial vaginosis, including Gardnerella vaginalis, Prevotella bivia, and similar Species, Mycoplasma hominis, Mobiluncus species. FIG. 9 shows an embodiment 920 of a non-restrictive pant, including an exemplary diagnostic panel 960 to detect various causes of vaginitis. The diagnostic panel 960 shown in FIG. 9 includes five sensor elements 962, 964, 966, 968, and 970. The above-mentioned sensors may be suitable for being used alone to detect one or more causes of vaginitis, or to be combined with one or more Multiple other sensor elements are merged. Sensor element 962 is suitable for detecting p Η, sensor element 964 is suitable for detecting the presence of amine, sensor element 966 is suitable for detecting G. vaginalis, and sensor element 968 is suitable for detecting Candida In particular, the sensor element 970 is adapted to detect Trichomonas vaginalis. The sensor elements may be of any suitable shape and any suitable configuration and are not limited to the square sensor arrangement shown. The combination of sensor elements 962 and 964 can be used to measure non-specific causes of bacterial vaginosis. An early study of bacterial vaginosis (BV) included the pH value of vaginal fluid in women with BV and unaffected patients. For comparison, see Am. J. Obstet. Gynecol. Gardner HL et al. 69 · 962 (1955). All women with positive BV in the study were judged to have a vaginal fluid pH 値 greater than 4.5, and 91% of them had a vaginal fluid pH 大于 greater than 5.0. The current study adjusted the p Η lower limit 为 to 4.7. In addition to pH, Amesel, R., et al. Developed three other BV indicators in Am. J. Med. 74: 14-22 (1983): vaginal fluid homogeneity, olfactory test (treated with strong base, then olfactory The test detects amine odor), and the appearance of clue cells. If there are two indications (pH and amine), the test is highly in line with -35- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) Binding i Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 V. Invention Description (33) Results obtained from all four instructions of BV. Better pH indicator A: bromine test blue, molybdenum test blue, brook cresol green, brook (please read the precautions on the back before filling out this page) cresol purple, murray blue, bright yellow, and Is yellow. A particularly good pH indicator is nitrate. When the quaternary ammonium roots are combined, when the pH is raised, it changes directly from yellow-green to blue in a narrow pH range of about 0.1 pH units, and the transformation is concentrated at η 4.7. "', P. The ammonium radical can be any positive root capable of exerting ionic attraction with the negative root in the indicator. The preferred quaternary ammonium radical is a lower alkyl ammonium radical, wherein the alkyl radical is C 1 -C 4 Basic root, particularly preferably trimethylammonium.

Amsel判斷標準的一項嗅覺測試係得自費佛等人的研究, 新英格蘭醫學期刊,298 ; 1429-1434(1978),其中在1〇% KOH加入患有B V女性的陰道流體樣本時將出現特殊魚腥胺 臭味,臭味係由患有B V的女性陰道流體出現的胺鹽驗性揮 發物所造成。 經濟部智慧財產局員工消費合作社印製 使用胺測試來辨別受強鹼揮發之胺及不受強鹼揮發之胺 ,其中在相同裝置中採用可用於試樣之固體強鹼、可用於 液體試樣的指示劑、及僅可用於試樣發出的蒸氣之一指示 劑。因此,試樣首先接觸固體強鹼,然後施加至兩個指示 劑,其中一個指示劑不論是否出現揮發性胺均進行顏色變 化,另一個指示劑僅在出現揮發性胺時才變色。 釋放氣體薄片之固體強鹼的選擇並不重要且可改變,一 般可使用強鹼及鹼土金屬鋁酸鹽、碳酸鹽及氫氧化物,最 常採用銘酸鈉、碳酸鈉或氫氧化鎂來達成最佳結果,特佳 爲鋁酸鈉。 36 ^紙張尺度顧巾賴家群(CNS)A4規格(2i0 X 297公釐) 476640 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明(34) 可使用暴露於胺(較佳爲原可爲酸性的流體試樣中之胺) 則變色之任何指示劑,溴甲酚綠係爲一種範例且可用於此 處及p Η測試,其他範例爲溴酚藍、溴甲酚紫、溴氯驗藍、 石肖黃及各種其他指示劑。 感測器元件962及964可包含上述里特馬斯被念公司之 EXAM® pH及胺測試卡感測器,以偵測細菌性vagin〇sis非特 定原因,其中採用美國專利5,91〇,447號所述技術。 感測器元件966適於偵測G. vaginalis,198 8年時,湯姆森等 人的報告(ObStet.Gynec〇l.,7l(4):6〇7(1988))顯示:陰道流體 中的細菌性酶活性尤其脯氨酸呔酶可能爲B V的適當指標。 脯氨酸呔酶提供水解酶的作用,“水解酶,,在本文係指一種 能藉由加水將一化合物分裂成斷片之觸媒。 舲樣本接觸一個固相共軛物進行測定,此固相共軛物在 指示劑接觸樣本期間或之後易由水解酶作卵裂,在身爲共 軛物且因水解酶作用而自共軛物部份或完全放出的一部份 的一個仏息基團產生作用時進行可偵測變化。 共軛物在本文係指耦合至一基質殘留物但在接觸已偵 測到的一觸媒活性水解酶時可#裂或脱鶴之一種信息基團^ 本又“信息基團”或相通用的“標示基團,,係指可由一水解酶 從基質殘留物水解釋放且在自由型式時可與一指示劑起反 應產生可偵測變化之部份。此等信息基團包括但不限於下 列各物:驗、茶檢、芳胺、氨基酸、其衍生物及類似物。 一項特佳實施例係使用萘胺及其衍生物或類似物作爲信束 ιφΤ a (請先閱讀背面之注意事項再填寫本頁) 裝--------訂--------- 本紙張尺度顧t關冢鮮(CNS)A4規格(21_〇_ 297公釐) -37- /0040 A7 B7 五、發明說明(35 ) 若相關水解酶在釋放信息基團以外的任何其他點使共軏 物進行水解時,水解酶本身無法主動式釋放信息基團。僅 與相關水解酶共同作用之一或多個輔助水解酶則可用於測 足以元王主動狀釋放#息基團。因此輔助水解酶必須爲 典去從70好共轆物直接釋放信息基團而僅能從相關水解酶 產生的印裂產物釋放信息基團之水解酶。下列係爲所用反 應順序之範例。 首先,無法直接釋放信息基團之相關水解酶係特定水解 位於共軛物中之一或多個键,因此釋放一個含無活性信息 基團之分子斷片。 然後,一或多個輔助水解酶藉由一或多步碟中將基質殘 田物斷片與^息基團之間的鍵進行水解而釋放信息基團。 上述反應順序之淨效果爲·僅在;f目關水解酶出現在樣本 中時,才會釋放信息基團。 爲了示範實行用於偵測脯氨酸吹酶活性之本發明,將樣 本置於一種包含第一及第二固體支撑部的裝置中,第一固 體支撑部爲一個Mylar®聚乙缔疊層,其上可沉積一個經基_ L -丙基- 莕g蠢胺共概物之L -丙基- /?-萘胺、l_丙基· 曱氧基莕醯胺;第二固體支撑部爲一個Mylar®聚乙締疊 層,其上可沉積一個當/?-莕醯胺時進行可偵測變化之發色 指示劑Fast Garnet GBC。樣本放置在裝置中的方式可使樣 本接觸第一及第二固體支撑部,而使樣本中的脯氨酸呔酶 活動釋放之任何/?-莕醯胺得以擴散通過樣本到達第二固體 支撑部。Fast Garnet GBC隨後觀察用以指示樣本中有g每出規 -38- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) -裝--------訂-------- Φ 經濟部智慧財產局員工消費合作社印製 476640 A7 B7 五、發明說明(36) 之可偵測變化。共軛物可用於譬如羥丙基纖維素等水溶性 聚合物的基體中。Fast Garnet GBC指示劑可用於含有嬖如 氯化鎂:等渗透劑之乙基纖維素的非水溶性基體中。 感測器元件966可包含上述里特馬斯概念公司之fem EXAM®G vaginalis PIP活動測試卡,其中採用美國專利 之571,684 號。 感測器元件968適於偵測假絲酵母種,已發現在具有外陰 念珠菌病之陰道流體中出現具有酶活性的白色念珠菌天冬 氨酸蛋白酶。進一步瞭解:在樣本或試樣中出現具有酶活 性的天冬氨酸蛋白酶則可作爲偵測及診斷念珠菌病之標示 。因此,已發展出藉由測定樣本中是否出現具有酶活性的 天冬氨酸蛋白酶來偵測念珠菌病之方法。 此方法中,樣本(如陰道流體)係與一固體支撑部相接觸 ,樣本所接觸的固體支撑部係固定有一個信息酶(亦即訊號 產生酶),此信息酶固定在固體支撑部上,故可在具有酶活 性的天冬氨酸蛋白酶(若具有酶活性的天冬氨酸蛋白酶實際 出現在樣本中)產生作用時從固體支撑部釋放。與固體支撑 部相接觸之後的樣本係與一指不劑相合併,此指示劑係爲 在信息酶起作用時易有可見或可偵測變化(譬如顏色變化) 之任何化學種類。若指示劑在接觸樣本之後進行可偵測變 化,則具有酶活性的天冬氨酸蛋白酶出現在樣本,可判定 已患念珠菌病。 本文“信息酶”或相通用的“標示酶”係指一個訊號產生酶 ,亦即其活性將引發可偵測變化之酶。此信息酶包含但不 •39- 本紙張尺度適用中國國家標準(CNS)A4規格(210 x 297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝 訂--------- 經濟部智慧財產局員工消費合作社印製 476640 經濟部智慧財產局員工消費合作社印製 A7 ______B7_— 玉、發明說明(37 ) 限於下列各物:過氧化物酶、麟酸酶、氧化還原酶、脱氣 酶、轉移酶、異構酶、激酶、還原酶、脱氨酶、觸酶、尿 素酶、葡萄糖苍酸酶。較佳的信息酶爲過氧化氫酶,譬如 辣根過氧化氫酶。 信息酶固定在一固體支撑部上,此固體支撑物亦即爲不 可溶性聚合物質、無機或有機基體、膠質、聚集體、沉澱 物或樹脂’因而可在測定是否出現的水解酶起作用時釋出 信息酶。較佳的固體支撑部包括但不限於下列各物:纖維 素、瘦知糖、葡聚醋、聚丙晞酸酯、聚丙晞酸酿胺、或其 衍生物、幾丁質、瓊脂糖、氧叹丙烯酸珠及聚合性二趁、 澱粉、膠原、角質、彈性蛋白、牛皮粉、細菌細胞壁呔聚 醣或其斷片、尼龍、聚對苯二甲酸乙二酯、聚碳酸酯、及 文控制的孔玻璃。利用熟悉本技藝者瞭解之習知方式及程 序’將化息酶固定在固體支撑部上。 本文“指示劑”係指由於在具有酶活性的水解酶出現在樣 本或試樣中時發生反應、或由於反應升高而進行可偵測變 化之任何化學物種類。所生成的可偵測變化係指示具有酶 活性的水解酶出現在樣本或試樣中。 較佳的指示劑係爲目視指示劑,尤爲發色指示劑(亦即可 看到麦色)’其中包括當所作測 吓1、別到 &lt; 具有活性的水解酶將信 息或標示酶從固體支撑部釋放 丨俘攻而唼作用時,在原無色材料 中形成顏色。另外,信自g备·+ 心每了月匕在以水解酶作用而從固體 支撑部釋放時催化形成螫朵却 砜蛍先矾唬、磷光訊號、生物發光訊 號、化學發光訊號、或雷彳p却 Λ %化訊唬。此外,信息酶可能產生 (請先閱讀背面之注意事項再填寫本頁) 裝 tr---------·An olfactory test by Amsel's criteria was derived from a study by Feffer et al., The New England Journal of Medicine, 298; 1429-1434 (1978), where 10% KOH will be special when added to vaginal fluid samples from women with BV. Fishy amine odor, caused by amine salt test volatiles present in vaginal fluids of women with BV. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, using the amine test to identify amines that are volatilized by strong alkalis and amines that are not volatilized by strong alkalis. Among them, solid strong alkalis that can be used for samples and liquid samples can be used in the same device An indicator that can only be used for the vapor emitted by the sample. Therefore, the sample is first exposed to a strong solid base and then applied to two indicators, one of which changes color regardless of the presence of volatile amines, and the other indicator changes color only when volatile amines are present. The choice of a solid strong base that releases gas flakes is not important and can be changed. Generally, strong bases and alkaline earth metal aluminates, carbonates, and hydroxides can be used. The most commonly used is sodium aluminate, sodium carbonate, or magnesium hydroxide. For best results, sodium aluminate is particularly preferred. 36 ^ Paper size Gu Jin Lai Jiaqun (CNS) A4 specification (2i0 X 297 mm) 476640 Printed by A7 B7, Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the invention (34) Can be used and exposed to amines (preferably the original It is an amine in an acidic fluid sample.) Any indicator that changes color. Bromocresol green is an example and can be used here and p Η test. Other examples are bromophenol blue, bromocresol purple, bromochlorine test. Blue, Shi Xiaohuang and various other indicators. The sensor elements 962 and 964 may include the above-mentioned Ritamasen ’s EXAM® pH and amine test card sensors to detect non-specific causes of bacterial vagin〇sis, which uses US patent 5,91〇, Technique No. 447. The sensor element 966 is suitable for detecting G. vaginalis. In 1988, a report by Thomson et al. (ObStet. Gynec.l., 7l (4): 606 (1988)) showed that: Bacterial enzyme activity, especially proline proteases, may be an appropriate indicator of BV. Proline protease provides the action of a hydrolase, "a hydrolase, as used herein, refers to a catalyst capable of splitting a compound into fragments by adding water. 舲 A sample is contacted with a solid phase conjugate for measurement. This solid phase The conjugate is susceptible to cleavage by the hydrolase during or after the indicator is in contact with the sample. A cleavage group in the conjugate that is partially or completely released from the conjugate by the action of the hydrolase A detectable change is effected when it is in effect. A conjugate refers herein to an information group that is coupled to a matrix residue but can be cleaved or dislodged when exposed to a catalytically active hydrolase that has been detected. The "information group" or the generic "labeling group" refers to the part that can be hydrolyzed and released from the matrix residue by a hydrolase and can react with an indicator to generate a detectable change in the free form. These information groups include, but are not limited to, the following: test, tea test, aromatic amines, amino acids, their derivatives, and the like. A particularly preferred embodiment is the use of naphthylamine and its derivatives or analogues as a beam ιφΤ a (please read the precautions on the back before filling this page). -------- Order ----- ---- This paper is standardized by Guan Tsuan-Xuan (CNS) A4 (21_〇_ 297 mm) -37- / 0040 A7 B7 V. Description of the invention (35) If the relevant hydrolase is outside the release information group Any other point makes the hydrolase itself unable to actively release the information group when the conjugate is hydrolyzed. One or more co-hydrolyzing enzymes that only interact with the relevant hydrolase can be used to measure enough to release the #interest group. Therefore, the auxiliary hydrolase must be a hydrolase that can directly release the information group from the 70 good conjugate and only release the information group from the cleavage product produced by the related hydrolase. The following is an example of the reaction sequence used. First, the relevant hydrolase that cannot directly release the information group is specifically hydrolyzed by one or more bonds located in the conjugate, thus releasing a fragment of the molecule containing the inactive information group. Then, one or more auxiliary hydrolase releases the information group by hydrolyzing the bond between the substrate residue fragment and the amino group in one or more steps. The net effect of the above reaction sequence is that information groups will only be released when the fmeguanase is present in the sample. To demonstrate the practice of the present invention for detecting the activity of a proline blowing enzyme, a sample is placed in a device comprising a first and a second solid support, the first solid support being a Mylar® polyethylene laminate, An L-propyl-/?-Naphthylamine and l-propyl · methoxypyrrolidine can be deposited on the vial-L-propyl-fluorenyl gallamine co-synthesis; the second solid support is A Mylar® polyethylene laminate with a Fast Garnet GBC color change indicator that can detect changes when /?-Amidamine is deposited. The sample is placed in the device in such a way that the sample contacts the first and second solid support portions, and any /?-Amidine released by the proline amylase activity in the sample can diffuse through the sample to the second solid support portion. . Fast Garnet GBC then observed to indicate that there are g per specification in the sample -38- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) -Installation -------- Order -------- Φ Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 A7 B7 V. Detectable change of invention description (36). The conjugate can be used in a matrix of a water-soluble polymer such as hydroxypropyl cellulose. Fast Garnet GBC indicator can be used in water-insoluble matrix of ethyl cellulose containing penetrants such as magnesium chloride :. The sensor element 966 may include the fem EXAM®G vaginalis PIP activity test card of the above-mentioned Ritmas Concept Company, which uses US Patent No. 571,684. The sensor element 968 is suitable for detecting Candida species, and it has been found that an enzyme-active Candida albicans protease is present in vaginal fluid with vulvar candidiasis. Further understanding: the presence of aspartic protease with enzyme activity in the sample or sample can be used as a marker for detecting and diagnosing candidiasis. Therefore, a method has been developed for detecting candidiasis by determining whether an aspartic protease having an enzyme activity is present in a sample. In this method, the sample (such as vaginal fluid) is in contact with a solid support, and the solid support that the sample is in contact with is fixed with an information enzyme (that is, a signal generating enzyme), and the information enzyme is fixed on the solid support. Therefore, it can be released from the solid support when the aspartic protease with enzymatic activity (if the aspartic protease with enzymatic activity actually appears in the sample) acts. The sample in contact with the solid support is combined with a fingerless agent. This indicator is any chemical species that is susceptible to visible or detectable changes (such as color changes) when the information enzyme functions. If the indicator undergoes a detectable change after contact with the sample, an aspartic protease with enzymatic activity appears in the sample and can be judged to have candidiasis. The term "information enzyme" or "labeling enzyme" as used herein refers to a signal-generating enzyme, that is, an enzyme whose activity will cause a detectable change. This information enzyme contains but not • 39- This paper size applies to China National Standard (CNS) A4 (210 x 297 mm) (Please read the precautions on the back before filling this page) Binding -------- -Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, printed 476640 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, A7 ______ B7_— Jade, Invention Description (37) Limited to the following: peroxidase, linase, oxidoreductase, Degassing enzymes, transferases, isomerases, kinases, reductases, deaminase, catalase, urease, glucosidase. A preferred information enzyme is catalase, such as horseradish catalase. The information enzyme is immobilized on a solid support, which is an insoluble polymeric substance, an inorganic or organic matrix, a colloid, an aggregate, a precipitate, or a resin ', so that it can be released when the presence of a hydrolytic enzyme is detected. Out of information enzymes. Preferred solid supports include, but are not limited to, the following: cellulose, leptose, dextran, polypropionate, polypropionate, or derivatives thereof, chitin, agarose, and oxygen Acrylic beads and polymerizable starch, starch, collagen, keratin, elastin, cowhide powder, bacterial cell wall polysaccharides or fragments thereof, nylon, polyethylene terephthalate, polycarbonate, and controlled glass . The zymase is immobilized on a solid support using a conventional method and procedure known to those skilled in the art. As used herein, "indicator" refers to any chemical species that undergoes a detectable change due to a reaction when an enzymatically active hydrolase is present in a sample or sample, or due to an increased reaction. The detectable change generated indicates the presence of an enzymatically active hydrolase in the sample or specimen. The preferred indicator is a visual indicator, especially a color indicator (you can also see the wheat color). 'Including when the test is done. 1. Do not connect to the active hydrolase. When the solid support part releases and captures and acts, it forms a color in the original colorless material. In addition, the letter from G + · Xinxiu catalyzes the formation of sulphur but sulfone when it is released from the solid support by the action of hydrolytic enzymes. It is firstly aluminous, phosphorescent, bioluminescent, chemiluminescent, or thunder. p is Λ% to bluff. In addition, the information enzyme may be generated (please read the precautions on the back before filling this page). Install tr --------- ·

476640 A7 B7 五、發明說明(38 ) 其他可目視或可偵測訊號,譬如一個阻塞、黏結、沉澱或 清理區。 (請先閱讀背面之注意事項再填寫本頁) 可使用眾多發色指示劑(亦即發色物)及其他具有類似效 果的種類以辣根過氧化物酶作爲信息酶而成爲目視指示劑 。根據本發明之較佳發色指示劑包含一過氧化氫及一發色 物,包括但不限於下列一項:零陵香、2 _ 2,-畊并-雙(3 -乙 基-苯井嘍唑啉_6-磺酸)、四甲聯苯胺、酚、4 -氨基安替比 林、及4,5-二羥莕-2,7-二磺酸。一種特佳發色指示劑係包 含一過氧化氫及零陵香、一發色物,此發色物在還原狀態 呈無色且在氧化狀態呈深藍色。 感測器元件968可使用美國專利5,416,003號所述技術。 經濟部智慧財產局員工消費合作社印製 感測器元件970適於偵測陰道滴蟲。提供一種藉由測定樣 本中出現具有酶活性的硫醇蛋白酶以偵測陰道滴蟲之方法 ,此方法包含:(a)以一固體支撑部接觸樣本,該固體支撑 部固定有一個信息酶,使得當具有酶活性的硫醇蛋白酶起 作用時將釋放信息酶;(b)在一指示劑已經接觸固體支撑部 之後,則與樣本合併,在信息酶起作用時,指示劑易具有 可&quot;ί貞測麦化,及(C )觀祭指7JC劑是否進行可偵測變化,此可 偵測變化係指示樣本中出現具有酶活性的硫醇蛋白酶,因 而出現陰道滴蟲。 依需要,一或多個感測器962、964、966、968、970可由一 個驗孕感測器所取代,此感測器可用色譜條,譬如,丨988 年導入一種由優尼珮斯發展出且申請專利的新型非處方驗 孕測試(Clearblue Easy),該測試採用夹心式的染色微球體 -41 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 476640 A7 B7 五、發明說明(39) 以提供單步驟的測試。爲了準備測試,小的暗藍染色微球 體(〇 )首先塗有對HCG(人體絨毛膜促性腺激素)的抗體 (AbD ;微球體(O-Ab!)在一部份硝化纖維素條上乾燥;對 HCG的一第二抗體(Ab2)固定在另一段的條上。 該條使用時在一端以尿濕潤,以毛細作用移動尿液時, 將獲取監色微球體(0 - Ab 1)並帶到下游處;尿液中的任何 HCG均與微球體(O-Abi-HCG)上的Ah起反應。當流抵達固 定的Aby 1時,已由HCG(0· AVHCG)染色的微球體係由 Ab2-1所獲取而形成HCG夾心(0 - Ab!_ HCG- Ab2-1 )造成之一 條藍線,藍線代表陽性的驗孕測試。另一條固定的蛋白質 (Ab:r 1 )線位於更下游處,固定的蛋白質(从3- 1 )係攫取未 共軏的O-Abi作爲(O-Abi-AbylM與HCG無關)以形成另一 藍線,另一藍線作爲一陽性程序控制組,若未形成第二線 ,則測試結果無效。 亦具有L Η (促黃體激素)之家用測試及鏈球菌a及衣原體 的相似臨床測試,其他來源尚包括:人體絨毛膜促性腺激 素(HCG)、常見傳染病及DAU(尿液中藥物濫用),其中係 利用此色層分析原理之實驗室單分析物測試。476640 A7 B7 V. Description of the invention (38) Other visual or detectable signals, such as a blocked, stuck, deposited or cleared area. (Please read the precautions on the back before filling out this page.) Many hair color indicators (ie hair color substances) and other types with similar effects can be used with horseradish peroxidase as the information enzyme to become visual indicators. A preferred chromogenic indicator according to the present invention comprises a hydrogen peroxide and a chromophor, including but not limited to the following: tonka, 2_2, -plow-and-bis (3-ethyl-benzene well Oxazoline-6-sulfonic acid), tetramethylbenzidine, phenol, 4-aminoantipyrine, and 4,5-dihydroxyfluorene-2,7-disulfonic acid. A particularly good color indicator is a mixture of hydrogen peroxide, tonka, and a hair color, which is colorless in the reduced state and dark blue in the oxidized state. The sensor element 968 may use the technology described in US Patent No. 5,416,003. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economics The sensor element 970 is suitable for detecting trichomonas vaginalis. A method for detecting trichomonas vaginalis by measuring the presence of an enzyme-active thiol protease in the sample is provided. The method includes: (a) contacting the sample with a solid support, and the solid support is immobilized with an information enzyme, so that When the thiol protease with enzymatic activity functions, the information enzyme will be released; (b) after an indicator has contacted the solid support, it will be merged with the sample, and when the information enzyme is active, the indicator is prone to have &quot; ί Measure the wheat and (C) observe the sacrifice whether the 7JC agent has detectable changes. This detectable change indicates the presence of thiol protease with enzymatic activity in the sample, thus the occurrence of Trichomonas vaginalis. As needed, one or more sensors 962, 964, 966, 968, 970 can be replaced by a pregnancy test sensor. This sensor can be a chromatographic strip. For example, 丨 introduced in 988 a The patented new type of over-the-counter pregnancy test (Clearblue Easy), which uses sandwich-type dyed microspheres -41-This paper is sized for China National Standard (CNS) A4 (210 X 297 mm) 476640 A7 B7 V. Description of Invention (39) to provide a single step test. To prepare for the test, small dark blue stained microspheres (0) are first coated with antibodies to HCG (human chorionic gonadotropin) (AbD; microspheres (O-Ab!) Are dried on a portion of nitrocellulose strips A secondary antibody (Ab2) to HCG is fixed on the strip of the other segment. When this strip is used, the urine is moistened at one end and the urine is moved by capillary action, and the monitoring microspheres (0-Ab 1) will be obtained and Taken downstream; any HCG in the urine reacts with Ah on the microspheres (O-Abi-HCG). When the flow reaches the fixed Aby 1, the microsphere system has been stained with HCG (0 · AVHCG) An HCG sandwich (0-Ab! _ HCG- Ab2-1) obtained from Ab2-1 results in a blue line, which represents a positive pregnancy test. Another fixed protein (Ab: r 1) line is located at Further downstream, the immobilized protein (from 3- 1) takes uncoordinated O-Abi as (O-Abi-AbylM has nothing to do with HCG) to form another blue line, and the other blue line serves as a positive program control group If the second line is not formed, the test result is invalid. It also has the household test of L Η (luteinizing hormone) and the phase of streptococcus a and chlamydia Clinical tests, yet other sources include: human chorionic gonadotropin (HCG), common infectious diseases and DAU (urine drug abuse), in which the principles of this system using a laboratory chromatography analysis of single analyte testing.

卡特-華勒斯家用懷孕測試First Response®採用塗有一 hCG 抗體之單微球體(〜1微米)及塗有另一 hCG抗原決定基的 一抗體之極小(&lt; 5 0毫微米)紅金溶膠粒子。與尿液樣本相 混合時’若樣本含有hCG則粒子凝結而產生紅塊。混合物 傾倒通過一個攫取紅塊時呈粉紅色之濾件。對於陰性反應 的尿液,未凝結的紅粒子通過濾件而不變色。 -42- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) -裝 訂· . 經濟部智慧財產局員工消費合作社印製 476640 A7Carter-Wallace Home Pregnancy Test First Response® uses a single microsphere (~ 1 micron) coated with hCG antibody and an extremely small (&lt; 50 nm) red gold sol coated with another hCG epitope particle. When mixed with a urine sample ', if the sample contains hCG, the particles coagulate and a red block is generated. The mixture is poured through a pink filter which scoops the red block. For negative urine, uncondensed red particles pass through the filter without discoloration. -42- This paper size is in accordance with China National Standard (CNS) A4 (210 X 297 mm) (Please read the notes on the back before filling out this page)-Binding · Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs and Consumer Cooperative 476640 A7

五、發明說明(4〇 ) 經濟部智慧財產局員工消費合作社印製 另一免疫測定方法包含將一個含有分析物抗原的水性溶 液施加至一個多區測試條裝置之一端,使得溶液以毛細作 用沿條移動,區的排列方式使得溶液(a)首先接觸及重新組 成乾燥的可擴散性標示的組份,該組份包含共軏至一個針 對該分析物抗原的抗體之膠狀金,且然後(b)接觸及重新组 成針對該分析物抗原之乾燥的可擴散性生物素化 (biotinylated)第二抗體,故形成一個可擴散性散佈的夾心 反應產物。反應產物隨溶液沿條擴散並進入一個包含攫取 組份的區中,攫取組份包含一乳膠及卵白素絡合物,卵白 素藉由與其維生素H部份起反應以收集反應產物,因此, 金粒子收集及集中在偵測區中以供目視判定。 可作複合式分析物分析的技術因此可用於本發明,包括 但不限於:以抗體爲標示的微珠、Silas( TR)表面分析、或 薄膜爲基礎的生物感測器。 實際上,可將一陣列的感測器置於將接觸適當樣本之一 表面上,樣本包括但不限於尿液、唾液、汗、及陰道排放 物。各別感測器係回應於各別分析物且產生一可偵測訊號 ,可僅爲一顏色或折射率變化、或可包含由於流過一生物 感測器薄膜的電流造成之電訊號變化。 譬如,可由本技藝習知方法將對於適當激素的抗體固定 在Silas光學晶圓的表面上,這些晶圓接著可由習知圖案分 隔且排列在一偵測物件(如褲墊)上。同樣地,這些抗體可 固定在微珠上、且排列在適合尿液或唾液基質之一橫向流 動測定裝置中。並且,可在一陣列中採用多個試劑以同時 -43- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) -裝 ----訂---------· 經濟部智慧財產局員工消費合作社印製 476640 A7 -----B7____ 五、發明說明(41 ) 提供所有分析物的讀數。 同樣地’可連同激素偵測其他分析物,包括對於其他目 標狀況(如感染、骨質疏鬆等)之生物標記。科羅拉多州玻 德的拜歐斯達公司的SILAS™或SILICON分析表面技術係爲 偵測特定目標分子之已知方法。拜歐斯達公司對於此技藝 的專利包括:美國專利 5,955,377、5,869,272、5,639,671、 5,629,214、5,541,057、5,482,830、5,468,606、5,418,136號, 以薄膜爲基礎的此技術已成功用於發展診斷性測試,以偵 測來自基團A鏈球菌、基團B鏈球菌、衣原體、及流行性感 冒A及B(光學免疫測定(0Ia®))之細菌性及病毒性抗原。 晶圓係含有一個具有一光學塗層與附接層之矽支架,此 晶圓表面技術可直接目視彳貞測分子薄膜的光學厚度之物理 變化,此厚度變化係由於在表面上特定攫取一個分析物所 造成。當添加基材時,放大此束縛事件且再度增加分子薄 膜的表面厚度’此厚度變化改變了反射光徑且目視辨認爲 一顏色變化。光學厚度的略微改變將產生一明顯的目視變 色,陽性結果將顯現爲概呈金色背景上之一紫色點。當樣 本中未出現目標時,則不產生束縛,因此,光學厚度保持 不變,且表面保持原來的金色而顯現陰性結果。 因此,第一型態中,在用以偵測所針對的一分析物的出 現量之裝置中採用SILASTM技術,該裝置包括一個具有一光 學主動表面之基材,該光學主動表面回應於衝擊其上的光 線而呈現出一第一色,此第一色定義爲發射光線之—光譜 分佈,基材亦呈現與第一色不同之一第二色(該第二色具有 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) --------« — — — — — — I— -44-V. Description of the invention (40) Another immunoassay method printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economics includes applying an aqueous solution containing an analyte antigen to one end of a multi-zone test strip device, so that the solution acts with capillary action along the The strips are moved and the zones are arranged such that solution (a) first contacts and reconstitutes a dry, diffusible labeled component that contains colloidal gold conjugated to an antibody against the analyte antigen and then b) contacting and reconstituting a dry, diffusible biotinylated secondary antibody against the analyte antigen, thus forming a diffusible sandwich reaction product. The reaction product diffuses along the strip along the solution and enters a zone containing a scavenging component, which contains a latex and an avidin complex. Avidin collects the reaction product by reacting with its vitamin H portion. Therefore, gold Particles are collected and concentrated in the detection area for visual determination. Techniques that can be used for composite analyte analysis can therefore be used in the present invention, including but not limited to: microbeads labeled with antibodies, Silas (TR) surface analysis, or thin film-based biosensors. In practice, an array of sensors can be placed on a surface that will contact an appropriate sample, including, but not limited to, urine, saliva, sweat, and vaginal discharge. Each sensor responds to each analyte and generates a detectable signal, which may be only a color or refractive index change, or may include an electrical signal change due to a current flowing through a biosensor film. For example, antibodies to appropriate hormones can be immobilized on the surface of Silas optical wafers by methods known in the art. These wafers can then be separated by conventional patterns and arranged on a detection object (such as a pant). Similarly, these antibodies can be immobilized on microbeads and arranged in a lateral flow measurement device suitable for one of the urine or saliva matrices. And, multiple reagents can be used in an array at the same time -43- This paper size is applicable to Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) -Pack ---- Order --------- · Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 A7 ----- B7____ V. Invention Description (41) Provide readings for all analytes. Similarly, it can be used in conjunction with hormones to detect other analytes, including biomarkers for other target conditions (such as infection, osteoporosis, etc.). The SILAS ™ or SILICON analytical surface technology from Biostar in Bod, Colorado is a known method for detecting specific target molecules. Biostar's patents for this technology include: U.S. Patents 5,955,377, 5,869,272, 5,639,671, 5,629,214, 5,541,057, 5,482,830, 5,468,606, 5,418,136. This thin film-based technology has been successfully used in the development of diagnostic tests To detect bacterial and viral antigens from group A streptococcus, group B streptococcus, chlamydia, and influenza A and B (optical immunoassay (0Ia®)). The wafer contains a silicon support with an optical coating and an attachment layer. This wafer surface technology can directly visually detect the physical change in the optical thickness of the molecular film. This thickness change is due to a specific analysis on the surface. Caused by things. When the substrate is added, the binding event is enlarged and the surface thickness of the molecular film is increased again. This thickness change changes the reflected light path and visually recognizes a color change. A slight change in optical thickness will produce a noticeable visual discoloration, and a positive result will appear as a purple dot on a roughly golden background. When no target appears in the sample, there is no restraint, so the optical thickness remains the same, and the surface remains the original golden color, showing a negative result. Therefore, in the first type, SILASTM technology is used in a device for detecting the occurrence of an analyte being targeted. The device includes a substrate having an optically active surface, and the optically active surface responds to impacts on the substrate. The first light is a first color. This first color is defined as the spectral distribution of the emitted light. The substrate also shows a second color that is different from the first color. Standard (CNS) A4 specification (210 X 297 mm) (Please read the notes on the back before filling out this page) -------- «— — — — — — I— -44-

/UO4U 五、發明說明(42 ) 與第一色所出現組合不同之光線波長的組合、或具有一不 同光譜分佈、或具有與第一色所出現不同的一或多個波長 足強度)’當表面上出現分析物時,係回應於相同光線而呈 現第二色。 光學王動表面’’係爲參與生成光學效應之一表面,使得 衝擊在該表面上之光線部份受到變更。此光學主動表面適 可回應多色光(如白光)及單色光(如可爲先天性偏振之雷射 光)。本發明的裝置較佳產生—個使未反應測試表面與一已 反應表面的背景干擾色呈強烈對比之顏色訊號。 詳述心,本發明的特徵爲:基材具有由選自下列各物的 一個化學物構成之一附接層之類似裝置:樹形聚合物、星 形聚合物、分子自行聚集聚合物、聚合性矽氧烷、及薄膜 成形膠乳;基材本身由選自下列各物的一材料所構成:單 晶矽、玻璃上的非晶矽、塑膠上的非晶矽、陶瓷、多晶矽 、及以上材料的複合物;且基材可有由選自下列各物之_ 材料構成之一光學薄膜:氮化硬、碎/二氧化矽複合物、鈦 酸鹽、鑽石、#氧化物、及碳化矽。 基材係選自玻璃及塑膠且在表面上包含—層非晶碎,因 而產生一個光學主動表面;光學主録㊣包括單晶矽或金 屬;金屬中的基材進一步具有一層非晶矽;一個可感受一 分析物之受體層係設有對於分析物之一個特定束縛^體; 受體層由選自下列各物的材料所構成:抗原、抗體、寡聚 核芸酸、螯合劑、*、細菌、細菌毛、細菌鞭毛物質、: 酸、多醣、脂類、蛋白質、竣水化合物、金屬、病毒、敎 -45- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝--------訂---------Φ. 經濟部智慧財產局員工消費合作社印製/ UO4U V. Description of the Invention (42) A combination of light wavelengths different from the combination of the first color, or a different spectral distribution, or one or more wavelengths of sufficient intensity different from that of the first color) 'When When an analyte appears on the surface, it appears in a second color in response to the same light. The optical moving surface is a surface that participates in generating optical effects, so that a portion of the light impinging on the surface is changed. This optical active surface is suitable for responding to polychromatic light (such as white light) and monochromatic light (such as laser light that can be inherently polarized). The device of the present invention preferably generates a color signal that causes the background interference color of the unreacted test surface to be strongly contrasted with a reacted surface. In detail, the present invention is characterized in that the substrate has a similar device with an attachment layer consisting of a chemical selected from the following: a tree polymer, a star polymer, a molecular self-aggregating polymer, a polymer Siloxane, and film forming latex; the substrate itself is composed of a material selected from the following: monocrystalline silicon, amorphous silicon on glass, amorphous silicon on plastic, ceramic, polycrystalline silicon, and more And the substrate may have an optical film made of a material selected from the group consisting of: nitrided hard, broken / silicon dioxide composite, titanate, diamond, #oxide, and silicon carbide. The substrate is selected from glass and plastic and contains a layer of amorphous debris on the surface, thus creating an optically active surface; the optical master record includes single crystal silicon or metal; the substrate in the metal further has a layer of amorphous silicon; a The receptor layer that can sense an analyte is provided with a specific binding body for the analyte; the receptor layer is composed of a material selected from the group consisting of an antigen, an antibody, an oligonucleotide, a chelating agent, * , Bacteria, bacterial hair, bacterial flagellum material: acid, polysaccharide, lipid, protein, water compound, metal, virus, thorium-45- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) ) (Please read the notes on the back before filling out this page) -------- Order --------- Φ. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs

4/(3b4U A7 B7 五、發明說明(43 ) 素、及該等物質之受體;且目视時第—顏色具有金色外觀 ,第二顏色具有紫或藍色外觀。 另-相關型態中,此技術有關—種偵測樣本中的一相關 分析物之方法,包括以下步驟:提供具有一基材之一個薄 膜光學免疫測定裝置,該基材具有_上表面與一下表面, 且在上表面上支撑有與基材結合之—未標示的抗體層,至 少-層含有來自樣本的分析物’該含有分析物層係支撑住 具有與分析物共耗絡合的-酶之至少—層;接觸與一沉殿 劑共軛之酶;培養足以藉由沉澱劑與酶相作甩而使產物沉 澱之-段時間;及光學方式測量酶共輕層卩未標示抗體層 之質量改變,以指示測試樣本中之分析物量。 較佳,酶共軏物具有一固定化過氧化物酶或一抗菌抗體_ 辣根過f化物酶絡合物;或者酶共軛物爲鹼性磷酸酶且包 含杬菌杬體鹼性磷酸酶絡合物;且沉澱劑爲含有5溴_ 4氣 -3 4卜朵基嶙酸鹽之一基材。 圖9所褲墊920包含如范迪柏的美國專利6,〇〇4,893號所 述之一複合頂層,含有一個具有沿褲墊側邊接合至開孔膜 的條狀非織造材料的開孔膜。頂層的组份可由任何適當 万式接合,譬如圖9所示方式(藉由正弦型式排列之多數圓· 形溶接)。 感測态兀件962、964、966、968、970可附接至褲墊頂層 924心向穿戴表面。感測器可附接在褲墊與穿戴者陰道位置 對應的區域中,感測器可藉由本技藝習知的任何附接或結 合裝置(如黏劑)加以附接。另外,頂層924可包含至少一個 (請先閱讀背面之注意事項再填寫本頁) n I n n n n It》一«»4« ai· tl an ·1 n n I - 經濟部智慧財產局員工消費合作社印製 -46 - 476640 五、發明說明(44 ) 開孔’且感測器可附垃$脅 心 、、 、 /、’、層開孔相對應位於吸收核 下方之區域。 感測器凡件可爲—正或負標記性質,以如圖9及9A指于 出現或未出現超出特定低限値的量値之測試分析物。另曰外 5F可通於如圖10的診斷面板所示提供測試分析物量之色产 指示,且感測器元件上的顏色暗度可與比較表ι〇9〇相比ς ’如圖11所不,以指示所出現測試分析物値。可以數種適 田I式提t、比較表,包括但不限於與具有感測器#物件&amp; 裝在一起或位於包裝外部之卡片。 感測备兀件可覆有一個覆蓋部980,#出現測試試劑時, :防止感測器中之測試試劑接觸到穿戴者身體。較佳,覆 風4 980*色且可撓’若物件係爲穿在穿戴者身體鄭近處的 類型,將不會干擾物件的穿戴。覆蓋部98〇可由任何適當材 料製造,譬如塑膠、SARAN⑧包裝件、MYLAR@、或類似 物。覆蓋部980可具有開孔以使體液接觸到感測器、或可能 呈無開孔狀。 若使用一覆蓋部980,可能需要提供一流體運送元件,譬 如毛、、’田條982,其仏於感測器底下及/或側邊上,使相關體 液接觸到感測器。 經濟部智慧財產局員工消費合作社印製 圖1 2顯不一個包含一示範性診斷面板126〇之非限制衛生 棉實施例1220。圖12所示衛生棉1220亦具有呈缝被狀圖案 排列在其向身體表面上之多數圓形熔接。衛生棉122〇亦具 有含有波褶之翼部或翅膀。但應瞭解本發明可用於具有許 多其他適當構造之衛生棉。 -47- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 4/〇ϋ4ϋ 五、發明說明(―45 ) 圖1 3 - 1 5顯示包含一示範性診斷面板136〇之非限制性陰唇 間裝置實施例Π20。陰唇間裝置1320包含一頂層1342、接 否土頂層之一底層1338、及位於頂層13 42與底層1338之間 的一吸收核心13 44。陰唇間裝置的此實施例亦包括一個握 柄1352’讓使用者握持該裝置以插入及依需要移除。圖示 其他物件情形中,此裝置可爲多種適當構造。圖16顯示使 用者如何固持陰唇間裝置132〇插入穿戴者陰唇間的空間中 ’圖1 7顯示陰唇間裝置與穿戴者身體之相對位置。 圖17所示穿戴者身體部份w描述如下:膀胱b、陰蒂c、 尿道U、小陰唇N、大陰唇J、陰道v、陰道口 VI、肛門A 、處女膜環Η、及大腸I。陰唇間裝置1320插入並穿在穿戴 者小陰唇Ν與大陰唇J之間並阻擋穿戴者的陰道口 νι而不進 入陰道超過處女膜環Η。亦即,穿戴此裝置時,陰唇間裝 置1320至少部份位於小陰唇圍繞之前腔中。理想情形中, 陰唇間裝置1320盡可能保持接觸大量的穿戴者小陰唇ν及 大陰唇J的内表面積,這將確保陰唇間裝置132〇盡量攔截穿 戴者身體排放物。 圖示特定實施例中,陰唇間裝置1320較佳由摺疊構造至 少留置在適當位置中,造成陰唇間裝置將輕微的側向往外 壓力施加在穿戴者的小陰唇、大陰唇或兩者内表面上。此 外,亦由自然濕潤的陰唇表面對於頂層1342的吸引力來固 持住產品。依需要,頂層1342可具有一生物相容黏劑以幫 助頂層1342黏至穿戴者陰唇的内側表面。 此外,其他實施例中,並非具有單一個偵測器或如圖1 3 _ -48- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注音?事項再填寫本頁) .裝 tr--------- 經濟部智慧財產局員工消費合作社印製 476640 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明(46 ) 1 6所tf含有多個位於頂層1342中央偵測器之診斷面板136〇 ’而是,陰唇間裝置132〇可具有多種配置方式之偵測器。 一項非限制性範例中,陰唇間裝置132〇可具有相隔的偵測 器或診斷面板。譬如,陰唇間裝置可具有兩個偵測器,一 個偵測器可朝向陰唇間裝置前方(譬如用以偵測成人失禁或 泌尿道感染的原因),且一者朝向裝置後方(譬如偵測陰道 感染)°本文所述其他型吸收物件亦適合可能將多個偵測器 放置在各種不同位置中。然而,陰唇間裝置情形中,此配 置相信特別有利,因爲陰唇間裝置在使用時靠近穿戴者尿 道及陰道口’此靠近作用使相關身體物質更可能接觸到適 當的偵測器。 其他實施例中,具有不只一個偵測裝置類型或位置之陰 唇間裝置可成組銷售以偵測不只一個狀況。其他實施例中 ’本文所述不只一型物件可成組銷售以偵測不只一個狀況。 圖1 8顯示包含一個示範性診斷面板1860之非限制性衛生 棉條1820實施例。 本發明所用的生物感測器6 0可包含一或多個“前攝式感測 器”,這在臨床可觀察到的健康症狀開始之前偵測目標生物 反應性分析物實施例中係特別有效,本文“前攝式感測器” 係指一種能夠偵測穿戴者身上(亦即皮膚)或身體物質中(亦 即輸入)的變化或訊號之感測器,這些訊號係與即將產生或 潛在的健康或皮膚相關事件直接有關或至少相關聯,前攝 式感測器可能如上述回應於一或多個特定輸入。(可瞭解“ 生物感測器6 0 ”的所有相關描述亦可適用於圖中物件所示 -49- 本紙張尺度適用中國國家標準(CNS)A4規格〈210 X 297公釐) ----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 4766404 / (3b4U A7 B7 V. Explanation of the invention (43) and its receptors; and when viewed visually, the first color has a golden appearance, and the second color has a purple or blue appearance. In addition-related types This technology is related to a method for detecting a related analyte in a sample, including the following steps: providing a thin-film optical immunoassay device having a substrate having an upper surface and a lower surface, and on the upper surface An unlabeled antibody layer bound to the substrate is supported on the substrate, and at least-the layer contains the analyte from the sample. The analyte-containing layer supports at least the -enzyme layer having co-depleted complexes with the analyte; contact Enzyme conjugated with a sinking agent; culture for a period of time sufficient to precipitate the product by shaking the precipitant with the enzyme phase; and optically measure the mass change of the enzyme co-light layer 卩 unlabeled antibody layer to indicate the test The amount of analyte in the sample. Preferably, the enzyme conjugate has an immobilized peroxidase or an antibacterial antibody _ horseradish perfase complex; or the enzyme conjugate is alkaline phosphatase and contains a bacterium Corpus callosum alkaline phosphatase complex And the precipitating agent is a substrate containing 5 bromo-4 gas-3 4 podoylarsinate. The pant 920 in FIG. 9 includes a composite top layer as described in Van Dibor's US Patent No. 6,04,893, An apertured film containing a strip of nonwoven material joined to the apertured film along the sides of the pantilin. The components of the top layer can be joined in any suitable manner, such as shown in Figure 9 (most circles arranged in a sinusoidal pattern) · Shape-welding). The sensing element 962, 964, 966, 968, 970 can be attached to the 924 heart-wearing surface of the top of the panty pad. The sensor can be attached to the region of the panty pad corresponding to the wearer's vaginal position The sensor can be attached by any attachment or bonding device (such as adhesive) known in the art. In addition, the top layer 924 can contain at least one (please read the precautions on the back before filling this page) n I nnnn It》 一 «» 4 «ai · tl an · 1 nn I-Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs -46-476640 V. Description of the invention (44) Holes and sensors can be attached ,,, /, ', and the layer openings are corresponding to the area below the absorption core. All parts can be-positive or negative marking nature, as shown in Figures 9 and 9A refer to the presence or absence of a test analyte in a quantity exceeding a specific low limit. Another 5F can be passed through the diagnostic panel shown in Figure 10 The display provides a color production indicator for the amount of test analyte, and the color darkness on the sensor element can be compared with the comparison table ι09〇 'as shown in Figure 11 to indicate the presence of test analytes. There are several types The Shida I type comparison table includes, but is not limited to, a card that is packaged with the sensor # object &amp; or located on the outside of the package. The sensing device may be covered with a covering portion 980, where the test reagent appears : Prevent the test reagent in the sensor from touching the wearer's body. Preferably, the wind-covered 4 980 * color and flexible 'will not interfere with the wearing of the article if the article is of the type worn near the wearer's body. The cover 98 may be made of any suitable material, such as plastic, SARAN (R) packaging, MYLAR @, or the like. The cover 980 may have an opening to allow the body fluid to contact the sensor, or may be non-opening. If a covering portion 980 is used, it may be necessary to provide a fluid transport element, such as a woolen, 'field bar' 982, which is placed under and / or on the side of the sensor to allow the relevant body fluids to contact the sensor. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Figure 12 shows an example 1220 of an unrestricted sanitary napkin including an exemplary diagnostic panel 1260. The sanitary napkin 1220 shown in Fig. 12 also has a plurality of circular welds arranged in a quilt-like pattern on the body surface. The sanitary napkin 1220 also has corrugated wings or wings. It should be understood, however, that the present invention can be used with tampons having many other suitable configurations. -47- This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) 4 / 〇ϋ4ϋ 5. Description of the invention (―45) Figure 1 3-1 5 shows an exemplary diagnostic panel 136〇 Non-limiting interlabial device embodiment Π20. The interlabial device 1320 includes a top layer 1342, a bottom layer 1338 which is a top soil layer, and an absorbent core 13 44 located between the top layer 13 42 and the bottom layer 1338. This embodiment of the interlabial device also includes a handle 1352 'for the user to hold the device for insertion and removal as needed. Illustration In the case of other objects, the device may be of various suitable constructions. Fig. 16 shows how the user holds the interlabial device 1320 and inserts it into the space between the wearers 'labia.' Fig. 17 shows the relative position of the interlabial device and the wearer's body. The body part w of the wearer shown in FIG. 17 is described as follows: bladder b, clitoris c, urethra U, labia minora N, labia majora J, vagina v, vaginal opening VI, anus A, hymen ring, and large intestine I. The interlabial device 1320 is inserted and worn between the wearer's labia minora N and the labia majora J and blocks the wearer's vaginal opening νι without entering the vagina beyond the hymen ring. That is, when the device is worn, the interlabial device 1320 is located at least partially in the anterior cavity surrounding the labia minora. Ideally, the interlabial device 1320 is kept as close as possible to the internal surface area of the wearer's labia minora ν and the labia majora J, which will ensure that the interlabial device 1320 intercepts the wearer's body emissions as much as possible. In the specific embodiment shown, the interlabial device 1320 is preferably at least in place in a folded configuration, causing the interlabial device to exert a slight lateral pressure on the inner surfaces of the wearer's labia majora, labia majora, or both . In addition, the attractiveness of the naturally wet labial surface to the top layer 1342 holds the product. As needed, the top layer 1342 may have a biocompatible adhesive to help the top layer 1342 adhere to the medial surface of the wearer's labia. In addition, in other embodiments, it does not have a single detector or as shown in Figure 1 3 _ -48- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) (Please read the note on the back first? Please fill in this page for further information.) Install tr --------- Printed by the Consumers' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of Invention (46) 1 6 The tf includes a plurality of diagnostic panels 136 ′ located at the center of the 1342 central detector. Instead, the interlabial device 1320 may have detectors in various configurations. In one non-limiting example, the interlabial device 132 may have separate detectors or diagnostic panels. For example, an interlabial device can have two detectors, one detector can be directed toward the front of the interlabial device (for example, to detect the cause of adult incontinence or a urinary tract infection), and one can be directed behind the device (for example, to detect the vagina). Infection) ° Other types of absorbent articles described herein are also suitable for the possibility of placing multiple detectors in a variety of different locations. However, in the case of interlabial devices, this configuration is believed to be particularly advantageous, as the interlabial device is used in close proximity to the wearer's urethra and vaginal opening '. This proximity action makes the relevant body substances more likely to come into contact with appropriate detectors. In other embodiments, labial devices with more than one detection device type or location may be sold in groups to detect more than one condition. In other embodiments, 'more than one type of article described herein can be sold in groups to detect more than one condition. Figure 18 shows a non-limiting tampon 1820 embodiment including an exemplary diagnostic panel 1860. The biosensor 60 used in the present invention may include one or more "proactive sensors", which is particularly effective in the embodiment of detecting a target bioreactive analyte before clinically observable health symptoms begin. "Proactive sensor" in this article refers to a sensor that can detect changes or signals on the wearer's body (i.e., the skin) or in body material (i.e., inputs). These signals are related to the upcoming or potential The health or skin-related events are directly related or at least related, and a proactive sensor may respond to one or more specific inputs as described above. (You can understand all the relevant descriptions of "Biosensor 6 0" can also be applied to the objects shown in the figure -49- This paper size applies to China National Standard (CNS) A4 specifications <210 X 297 mm) ---- ------ Install -------- Order --------- (Please read the precautions on the back before filling this page) 476640

經濟部智慧財產局員工消費合作社印製 五、發明說明(47 ) 的其他感測器,如診斷面板96〇、126〇、136〇及186〇中)。 前攝式感測器6 0可能偵測即將發生的事件、或偵測與即 將發生的事件直接有關或至少相關聯之一項參數,特別是 一種全身或皮膚健康事件或狀況(亦即出現可臨床觀察的指 示或症狀)。可由本發明前攝式感測器6〇偵測或預測的即將 發生的事件可包括:穿戴者之腹瀉疾病、皮膚刺激或發疹( 包括念珠菌病)、及/或其他型病症或醫療狀況,譬如寄生 蟲感染。所偵測的生物性分析物可爲從實際出現臨床症狀 移除之一或多個步骤’譬如’生物感測器可偵測上述狀況 之潛在前兆(譬如引起應激蛋白質之前出現之皮膚的排泄物 污染’應激蛋白質則在可臨床觀察皮膚刺激之前出現)。與 一事件相關之一項參數係爲任何可測量的輸入,譬如與全 身參考架構内之事件發生相關之一或多個上述訊號(亦即, 排泄物或穿戴者造成之一項訊號)。物件中之前攝式感測器 可測量一或多個不同輸入以預測事件。譬如,前攝式感測 器6 0可監測排泄物中之Candida albicans及皮膚上的殘留結 腸細菌(亦即偵測殘留的污染),兩者均爲可在皮膚刺激之 前出現的訊號。 在生物識別元件不產生容易目視訊號(如變色)之生物感 測器實施例中,生物感測器6 0可包括一個與生物識別元件 相導通之訊號電測轉換器,將來自生物識別元件之物理化 學訊號轉換成穿戴者、看護者或物件組件(如致動器)可使 用之訊號。示範性訊號電測轉換器可包括本技藝習知之電 化訊號電測轉換器(包括電位性、電流性、及電導性訊號電 -50- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) ------------------—訂—I--I--- (請先閱讀背面之注意事項再填寫本頁) 476640 第89114348號專利申請案 中文說明書修正頁(90年5月) A7 _ _____ B7 五、發明説明(48) 測轉換器)、光學訊號電測轉換器(包括螢光、生物發光、 全内反射共振、及表面電漿共振)、熱訊號電測轉換器、及 聲訊號電測轉換器。一個電源(譬如微型3伏錶電池或印刷 薄膜鋰私池)可與生物感測器60相連接以提供任何所需電力。 可用下述測試方法中的回應因子測試來測量本發明生物 感測器的效能,回應因子係描述生物感測器暴露於排泄物 測試物質時之回應與生物感測器暴露於生理食鹽水溶液的 回應之比值,且可用於評估生物感測器對於預定優先在排 泄物而非尿中發現的生物活性分析物之敏感度。當暴露於 具有每1克生理食鹽水溶液丨克排泄物測試材料濃度之水性 洛液中的排泄物測試材料或測試尿液時,本發明的生物感 測器杈佳具有至少2、3或5、更佳至少丨〇、更佳至少2 〇之 回應因子(使用生理食鹽水來代表大多數譬如水性體液等自 然壤境中出現的背景輸入訊號)。此生物感測器對於一種針 對排泄物的目標生物活性分析物係能夠清楚分辨所出現的 排泄物質及所出現的生理食鹽水溶液。 經濟部中央標準局員工消費合作社印製 (請先閲讀背面之注意事項再填寫本頁) 一種偵測排泄物的方式係偵測糞臭素,糞臭素係為糞便中的常 見物質’已知排泄物中的糞臭素濃度約為每克排泄物質中18〇微克 ,且尿中的糞臭素值明顯較低。糞臭素通常為來自於腸系中的色 氨酸代謝作用之微生物分解的產物。 糞臭素偵測生物感測器的一較佳實施例中,生物感測器包含基 因工程的微生物以吸收糞臭素及或其他物質,可譬如經由吸收程 序期間的耗氧來測量糞臭素特定物質之吸收,適合偵測糞臭素的 微生物包括鮑曼尼不動桿菌(Acinetobacter baumannii) -51- 本紙張尺度適用中國國家榡準(CNS ) A4規格(21〇X29&lt;/公釐) 經濟部智慧財產局員工消費合作社印制衣 476640 A7 ___ B7_____ 五、發明說明(49 ) TOI36(FERM P-12891,曰本專利公告JP05304947)及芽胞桿 菌屬sp TOI41(FERM P-12914,揭示於日本專利公告 JP05304948)。包括此微生物之適當生物感測器譬如購自德 國孟斯特的 Institut fur Chemound Biosensorik 之 Mikrobielle Sensoren ° 若微生物用於生物感測器中,則可由譬如捕獲、吸附、 交聯、包封、共價附接、以上任何組合或類似方式等本技 藝所知技術固定在生物感測器中。並且,可在譬如本技藝 所知許多不同基質上進行固定。特定較佳實施例中,固定 基質可選自下列各物:聚合物基礎的物質、水凝膠、薄紙 、非織造物質、織造物質、及矽半導體。 特定實施例中,包括任何生物感測器實施例之生物感測 器ό 0可包含、配置於、或操作性聯結一個微晶片(如矽晶片 )、MEMs(亦即微電化系統)裝置、或積體電路。以微晶片 爲基礎的生物感測器習知可爲“生物晶片,,。不論爲何種感 測器,微晶片可包含在適於偵測該(等)分析物的不同量値 或組合之任何陣列中具有相似或不同敏感度、運動學、及/ 或目標分析物(亦即標示)之多數感測器組件。並且,此陣 列中之各生物感測器可提供不同型訊號,包括本文所述類 型,且可與不同致動器及/或控制器相聯結。並且,一陣列 中之各生物感測器可獨立操作或與陣列中的任何數量的其 他感測器相聯結(譬如並聯、合併或字聯)。 生物感測器6 0可配置於及/或操作性連接至可棄式物件( 如圖1的尿布20)中暴露於生物感測器預定偵測的輸入之任 -52- 本紙張尺度_中國國家標準(CNS)A4規格(21G X 297公髮) (請先閱讀背面之注意事項再填寫本頁) n in n Ha n in n 一:· ϋ 1 n n I n I - 476640 五、發明說明(so ) 何部份(應瞭解即使編號20主要用於代表此描述物件,有關 生物感測器的所有描述亦適用於其他圖示物件本發明中 ,“操作性1%接”係指可使生物感測器6〇偵測到輸入時則通 :物件20某部份之通信裝置。生物感測器⑼可與生物感測 器60的另一部份、另一生物感測器6〇、一致動器一控制 器或物件20之組件某其他部份相隔離及操作性連接操 作性連接”譬如可包括譬如經由-導線或構件、經由-個譬 如射頻、紅外線或另一發送頻率通信等發送訊號之電連接 部等通信裝置。另外,生物感測器6〇可經由一個譬如氣動 或液壓連接部等機械連接部呈操作性連接。 圖1所示尿布中,生物感測器60可位於物件2〇的前腰區 36、後腰區38或胯區37中,且可整合、鄰近配置、接合、 或包含一部份的底座22、頂層24、底層26、及吸收核心 28、側片30、腳翻邊32、一腰特徵34、一緊固系统4〇、 縱緣50或端緣52等。目標生物性分析物與身體排泄物相關 之特定較佳實施例中,生物感測器6〇可配置於物件2〇胯區 中,以盡量增加身體排泄物接觸生物感測器6 〇的機率。在 生物感測器適於偵測或測量穿戴者皮膚上的一目標分析物 劑之其他較佳實施例中,生物感測器6〇可配置於頂層、翻 邊、一腰特徵、一排泄物接收囊部、固定件或使用程序期 間物件與牙戴者皮膚相接觸的任何其他部份上。特定實施 例中,生物感測器亦可與液劑或物件中之其他皮膚保養組 合物相關。 生物感測器60可與物件20相整合,或可由看護者或穿戴 (請先閱讀背面之注意事項再填寫本頁) -裝 ----1---------. 經濟部智慧財產局員工消費合作社印製 -53- 經濟部智慧財產局員工消費合作社印製 A7 ' :-*------ B7____ 五、發明說明( 51) 、女。穿戴物件期間之生物感測器亦可至少與物件呈 二、、脫離且可黏至穿戴者皮膚。生物感測器可永久或可 二離占式附接(譬如經由機械緊固系、、统,如Velcro™或水溶黏 :一支撐結構,包括黏膠帶、纖維素或合成織物、非織 垅:膨鬆物、薄膜、織物、泡棉及類似物。並且,生物感 測咨6 0可芫全容納在譬如物件2 〇等物件中、或可具有一個 位於物件中之收納部以接觸所需輸入,並具有位於物件中 或物件外之譬如發送部等另一部份。生物感測器6〇可位於 物件2 0外部但仍操作性連接至物件2 〇的某部份,使得生物 感4器6 0可偵測在物件2 〇外部之一個輸入並對於一控制器 及/或一致動器提供一訊號。部份實施例中,生物感測器可 與物件相隔離,譬如經由黏劑或本技藝習知的其他裝置分 離式她加至穿戴者某部份、及/或可具有與物件相分離之一 或多個組件。 部份實施例中,可提供—個擦拭裝置或元件,使穿戴者 或f護者自生物感測器60清潔足夠的排泄物,以目視評估 或讀取訊號(尤其對於提供此訊號之生物感測器實施例)。 擦拭兀件可包括配置於物件中之一個織物(纖維素性或合成 性)、非織造高膨鬆物、薄膜、泡棉、剛性或半剛性橡皮輥 狀元件、及類似物,且使元件可用於清潔生物感測器顯示 器。擦拭元件可用本技藝的任何習知裝置至少部分附接至 物件中罪近生物感測器6 0之一個元件(如頂層、底層、吸收 核心)。擦拭裝置可依需要含有水或任何習知清潔輔助,以 便於清理穿戴者或生物感測器顯示器。 •54· 尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) ^--------^--------- (請先閱讀背面之注意事項再填寫本頁) Α7Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Other sensors of the invention description (47), such as diagnostic panels 96, 12, 60, 1360, and 1860). The proactive sensor 60 may detect an upcoming event, or detect a parameter that is directly related or at least related to the upcoming event, especially a systemic or skin health event or condition (that is, a Indications or symptoms of clinical observation). Imminent events that can be detected or predicted by the proactive sensor 60 of the present invention may include: diarrheal disease, skin irritation or rash (including candidiasis), and / or other types of illness or medical condition of the wearer , Such as a parasite infection. Detected biological analytes can be one or more steps to remove clinical symptoms that actually occur. For example, a biosensor can detect potential precursors to the conditions described above (such as excretion of the skin before causing stress proteins). (Contaminant 'stress proteins appear before skin irritation can be observed clinically). A parameter related to an event is any measurable input, such as one or more of the above signals (ie, a signal caused by fecal matter or the wearer) related to the occurrence of an event in the whole body reference frame. Proactive sensors in objects can measure one or more different inputs to predict events. For example, a proactive sensor 60 can monitor Candida albicans in feces and residual coliform bacteria on the skin (that is, detect residual pollution), both of which are signals that can appear before skin irritation. In the embodiment of the biosensor that does not generate an easy visual signal (such as discoloration), the biosensor 60 may include a signal electrical measurement converter that is in communication with the biometrics component, and will come from the biometrics component. Physical signals are converted into signals that can be used by the wearer, caregiver, or object component (such as an actuator). Exemplary signal electrical measurement converters may include electrical signal electrical measurement converters known in the art (including potential, current, and conductivity signals -50-This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 mm) ------------------- Order-I--I --- (Please read the notes on the back before filling out this page) 476640 Patent No. 89114348 Amendment page of the Chinese manual of the application (May 90) A7 _ _____ B7 V. Description of the invention (48) Measuring converter), optical signal electrical measuring converter (including fluorescence, bioluminescence, total internal reflection resonance, and surface electricity Plasma resonance), thermal signal electrical measurement converter, and acoustic signal electrical measurement converter. A power source (such as a miniature 3 volt meter battery or a printed thin film lithium battery) can be connected to the biosensor 60 to provide any required power. The response factor test in the following test method can be used to measure the effectiveness of the biosensor of the present invention. The response factor describes the response of the biosensor when exposed to a fecal test substance and the response of the biosensor to a physiological saline solution. Ratio and can be used to evaluate the sensitivity of the biosensor to bioactive analytes that are scheduled to be preferentially found in excreta rather than urine. The biosensor fork of the present invention preferably has at least 2, 3 or 5, when it is exposed to fecal test material or urine in an aqueous solution having a concentration of 1 g of a physiological saline solution and 1 g of fecal test material. A better response factor of at least 丨 0 and more preferably at least 20 (using physiological saline to represent most background input signals such as those found in natural soils such as aqueous body fluids). The biosensor is able to clearly discern the emergence of excreta and the presence of physiological saline solution for a target bioactive analyte system for excreta. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautions on the back before filling this page). One way to detect fecal matter is to detect fecal odor, which is a common substance in feces. The concentration of skatole in the urine is about 18 micrograms per gram of excretion, and the skatole value in urine is significantly lower. Scopolamine is usually a product of microbial decomposition from tryptophan metabolism in the intestine. In a preferred embodiment of the skatole detection biosensor, the biosensor contains genetically engineered microorganisms to absorb skatole and other substances. For example, the measurement of skatole specific substances can be measured by oxygen consumption during the absorption process. Microorganisms that are absorbed and suitable for detecting skatole include Acinetobacter baumannii -51- This paper standard is applicable to China National Standards (CNS) A4 specification (21 × 29 &lt; / mm) Staff of Intellectual Property Bureau, Ministry of Economic Affairs Consumption cooperative printed clothing 476640 A7 ___ B7_____ 5. Description of the invention (49) TOI36 (FERM P-12891, Japanese Patent Publication JP05304947) and Bacillus sp TOI41 (FERM P-12914, disclosed in Japanese Patent Publication JP05304948). Appropriate biosensors that include this microorganism, such as Mikrobielle Sensoren from Institut fur Chemound Biosensorik, Munster, Germany. If a microorganism is used in a biosensor, it can be captured, adsorbed, crosslinked, encapsulated, covalently Attachments, any combination of the above, or the like are fixed in the biosensor by techniques known in the art. Also, fixation can be performed on, for example, many different substrates known in the art. In a particularly preferred embodiment, the immobilization matrix may be selected from the group consisting of a polymer-based substance, a hydrogel, tissue paper, a nonwoven material, a woven material, and a silicon semiconductor. In a specific embodiment, a biosensor including any biosensor embodiment may include, be configured in, or be operatively connected to a microchip (such as a silicon chip), a MEMs (ie, a micro-electrochemical system) device, or Integrated circuit. Microchip-based biosensors are conventionally known as "biochips." Regardless of the sensor, the microchip may be included in any of a variety of quantities or combinations suitable for detecting the analyte (s). Most sensor components in the array have similar or different sensitivities, kinematics, and / or target analytes (ie, labeling). And each biosensor in this array can provide different types of signals, including those described herein. These types can be connected to different actuators and / or controllers. Moreover, each biosensor in an array can be operated independently or connected to any number of other sensors in the array (such as parallel, Combined or typed). Biosensor 60 can be configured and / or operatively connected to disposable objects (such as diaper 20 in Figure 1) exposed to any input of biosensor scheduled detection -52 -This paper size_Chinese National Standard (CNS) A4 specification (21G X 297) (Please read the precautions on the back before filling in this page) 476640 V. What is the description of the invention (so)? 20 is mainly used to represent this description object. All descriptions about the biosensor are also applicable to other illustrated objects. In the present invention, "operability 1% connection" means that when the biosensor 60 detects an input, Then pass: a communication device of a certain part of the object 20. The biosensor can be connected to another part of the biosensor 60, another biosensor 60, a controller or a component of the object 20 Some other parts are isolated and operatively connected. "Operatively connected" may include, for example, communication devices such as via wires or components, via an electrical connection that sends signals such as radio frequency, infrared, or another transmission frequency communication. In addition, The biosensor 60 can be operatively connected through a mechanical connection such as a pneumatic or hydraulic connection. In the diaper shown in FIG. 1, the biosensor 60 can be located at the front waist region 36 and the rear waist region of the object 20. 38 or sacral region 37, and can be integrated, adjacently arranged, joined, or include a portion of the base 22, top layer 24, bottom layer 26, and absorbent core 28, side panels 30, foot cuffs 32, a waist feature 34, One fastening system 40, longitudinal edge 50 or end 52, etc. In a specific preferred embodiment in which the target biological analyte is related to body excreta, the biosensor 60 can be disposed in the object 20 胯 area to maximize the contact of the body excreta with the biosensor 6 〇 Probability. In other preferred embodiments where the biosensor is suitable for detecting or measuring a target analyte agent on the wearer's skin, the biosensor 60 can be configured on the top layer, flanging, a waist feature, An excrement receiving capsule, fixture, or any other part of the object that comes into contact with the wearer's skin during the procedure. In certain embodiments, the biosensor can also be combined with liquids or other skin care in the object The biosensor 60 can be integrated with the object 20, or it can be worn by a caregiver or wearer (please read the precautions on the back before filling out this page)-equipment ---- 1 --------- Printed by the Employees' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs-53- Printed by the Consumers' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 ':-* ------ B7____ 5. Description of Invention (51), female. The biosensor during the wearing of the object can also be at least two away from the object, be detached, and adhere to the skin of the wearer. The biosensor can be attached permanently or detachably (for example, via a mechanical fastening system, such as Velcro ™ or water-soluble adhesive: a supporting structure, including adhesive tape, cellulose or synthetic fabric, non-woven fabric: Bumps, films, fabrics, foams, and the like. Also, the biosensors 60 can be fully housed in objects such as object 20, or they can have a storage portion in the object to access the required input. And has another part such as the sending department located in or outside the object. The biosensor 60 can be located outside the object 20 but still operatively connected to a part of the object 20, making the biosensor 4 60 can detect an input external to the object 20 and provide a signal to a controller and / or actuator. In some embodiments, the biosensor can be isolated from the object, such as via an adhesive or Other devices known to the art are separated and added to a part of the wearer, and / or may have one or more components separated from the object. In some embodiments, a wiping device or element may be provided to enable wear. Or protector self biosensor 60 Clean enough feces to visually evaluate or read the signal (especially for the biosensor embodiment that provides this signal). The wiper element may include a fabric (cellulose or synthetic), non-woven disposed in the object High bulk, film, foam, rigid or semi-rigid rubber roller-like elements, and the like, and make the element useful for cleaning the biosensor display. The wiping element can be at least partially attached to any conventional device of the art The object is near a component of the biosensor 60 (such as the top layer, the bottom layer, and the absorbent core). The wiping device may contain water or any conventional cleaning aid as needed to facilitate cleaning of the wearer or the biosensor display. 54 · The scale applies to China National Standard (CNS) A4 (210 X 297 mm) ^ -------- ^ --------- (Please read the precautions on the back before filling this page ) Α7

經濟部智慧財產局員工消費合作社印製 η / υυ^-υ 五、潑^明說明(52 ) 特定較佳實施例中,物件20亦可包含一個致動器,本文“ 致動器’’係指一種包含“潛能,,之裝置及-種用於轉換潛能進 :或。動回應功能”之裝置°致動器的潛能可包含儲存 或t flb或儲存材料。致動器因此可藉由將位能轉爲動能 、或精由釋放或運送—料材料來進行或啓動—個回應功 能。本文“回應功能,,在本發明定義爲一種對於排泄物、穿 戴者、物件或其組份或對穿戴者或看護者的-訊號進行之 力此身月且物貝之組份可譬如包括濕氣、電解質、酶、揮 發f氣to ',·田菌、血液等。穿戴者的組份可包括皮膚、外 生殖器、及外陰部、肛門、肛門括約肌等。物件的組件可 包括腳,邊 '腰翻邊或其他排泄物障礙及/或圍堵組件、側 耳I5 底座、—吸收核心、一獲取組件、一緊固系 統、縱緣或端緣等。位能可儲存爲機械能、電能、化學能 或熱能。本文“動能”係'指如上述作功或進行回應功能(譬如 ’受壓縮裝置之膨漲、扭曲裝置之旋轉、變相時移動的膠 質、皮膚之塗佈或處理、酶的抑制、PH的調整等)的能量。/ 觸發生成1體結構以攫取身體物質時係譬如包含:對於 物件的,.且件及最後對於身體物質進行回應功能。搜取 體物質、擦拭穿戴者皮膚、或以皮膚保養組合物、抗微生 或酶抑制劑來處理皮膚等係爲對於身體物 二或牙戴者所進行之回應功能。調整物件的幾何結構 -維、二維、或三維)或物理性質(譬如彎曲模數: 狀等)係爲可對於物件進行之回應功能範例。告/ /或穿戴者已發生或即將發生_事件純爲本發明的 ------------^1^·裝---------訂·-------- f請先閱讀背面之注音?事項再填寫本頁) -55- 476640 經濟部智慧財產局員工消費合作社印製 A7 ----------BZ____—— 五、發明說明(53 ) 應功能。訊號可為視覺、聽覺、觸覺、電性、化學性或生 物性。譬如,可棄式物件的致動器可釋放或輸送一除臭劑 、鉍抑制劑、抗微生物劑、抗真菌劑、皮膚保養組合物或 P&gt;H控制劑;攫取、擦拭、覆蓋、捕取、固定、密封、系輸 或儲存身體排泄物;或觸發釋放或生成一個設計進行一= 多項以上功能或對身體物質、穿戴者、物件或其_組件進 行任何其他回應功能之結構或元件。 本發明的致動器可釋放位能而對於身體物質、穿戴者、 物件、或其-組件進行或啟動_回應功能。位能的釋放可 將機械性、電性、化學性或熱性位能轉變成機械性、電性 、或化學性動能進行回應功能。可由一輸入低限值觸發致 動器以釋放位能進行一回應功能、或可如下述連續回應於 一輸入。譬如,壓縮的泡棉已儲存壓縮性機械位能且可在 釋放時提供機械性動能。扭曲泡绵已儲存可在釋放時提供 機械性動能(亦即旋轉)之扭轉機械性位能。此外,所儲存 的化學能、電能、或熱能可用於釋放電性、機械性、化學 性或熱性動能。可棄式物件的致動器譬如可包括下列一或 多項·儲存液劑、抗真菌或抗微生物劑、排泄物修改劑、 酶抑制劑、pH緩衝劑、染料、加壓氣體、一壓縮泡綿、一 扭曲泡綿、一泵、一閉合系統液體運送構件、一電敏感,性 膠質、一pH敏感性膠質、一鹽濃度膠質等。可用任何足•以 在鸨要之如加以維持或限制的方式來儲存位能,維持及/或 限制此能量的適當裝置包括:電池及/或電容器、彈性、扭 曲、壓縮性拉張材料或未反應試劑形式的結構、及能夠進 -56- 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公f ) ^--------^--------- (請先閱讀背面之注意事項再填寫本頁) 4/0(340 Α7Printed by the Consumers' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs η / υυ ^ -υ 5. Instruction (52) In a specific preferred embodiment, the object 20 may also include an actuator. The "actuator" in this article is Refers to a device containing "potential," and a device for converting potential into: or. The "dynamic response function" of the device ° the potential of the actuator can include storage or t flb or storage material. The actuator can therefore be carried out or activated by converting potential energy into kinetic energy, or by releasing or transporting-material- Response function. The "response function" in this article is defined in the present invention as a component of fecal matter, wearer, object or its component, or the signal of wearer or caregiver. Examples include moisture, electrolytes, enzymes, volatile toxins, field bacteria, and blood. The components of the wearer may include skin, external genitalia, and vulva, anus, anal sphincter, and the like. The components of the article may include feet, side hem or other fecal obstruction and / or containment components, side ear I5 base,-absorbent core, an acquisition component, a fastening system, longitudinal or end edges, etc. Potential energy can be stored as mechanical, electrical, chemical or thermal energy. "Kinematic energy" herein refers to the work or response function as described above (such as' inflated by the compression device, the rotation of the twisted device, the gelatin that moves during the phase change, the application or treatment of the skin, the inhibition of enzymes, and the adjustment of pH Etc.) of energy. / When triggering to generate a 1-body structure to capture body matter, for example, it includes: for objects, and finally responds to body matter. Retrieving body material, wiping the wearer's skin, or treating the skin with skin care compositions, anti-microbiotics, or enzyme inhibitors are all response functions for body objects or tooth wearers. Adjusting the object's geometry-two-dimensional, two-dimensional, or three-dimensional) or physical properties (such as bending modulus: shape, etc.) are examples of functions that can be performed on objects. Announcement // or the wearer has happened or is about to happen_ the event is purely for the present invention ------------ ^ 1 ^ · 装 --------- order · ---- ---- f Please read the Zhuyin on the back? Please fill in this page again for matters) -55- 476640 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 ---------- BZ ____—— V. Description of the invention (53) Function. The signal can be visual, auditory, tactile, electrical, chemical or biological. For example, actuators for disposable objects can release or deliver a deodorant, bismuth inhibitor, antimicrobial, antifungal, skin care composition, or P & H control agent; grab, wipe, cover, capture , Fix, seal, lose or store body waste; or trigger the release or generation of a structure or element designed to perform more than one function or to perform any other responsive function on body substances, wearers, objects, or their components. The actuator of the present invention can release potential energy to perform or activate a response function to a body substance, a wearer, an object, or a component thereof. Potential energy release can convert mechanical, electrical, chemical or thermal potential energy into mechanical, electrical, or chemical kinetic energy in response. The actuator can be triggered by an input low limit to release a bit to perform a response function, or it can continuously respond to an input as described below. For example, compressed foam has stored compressive mechanical potential and can provide mechanical kinetic energy when released. Twisted foam has stored torsional mechanical potential that provides mechanical kinetic energy (ie, rotation) when released. In addition, the stored chemical, electrical, or thermal energy can be used to release electrical, mechanical, chemical, or thermal kinetic energy. Disposable actuators may include, for example, one or more of the following: storage solutions, antifungal or antimicrobial agents, excrement modifiers, enzyme inhibitors, pH buffers, dyes, pressurized gases, compressed foam , A twisted foam, a pump, a closed system liquid transport member, an electrical sensitive, a gelatin, a pH sensitive gel, a salt concentration gel, etc. Any sufficient • Potential energy can be stored in a way that is maintained or limited as required, and suitable devices to maintain and / or limit this energy include: batteries and / or capacitors, elastic, twisted, compressive tensile materials, or The structure of the reaction reagent form and the ability to enter -56- This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 male f) ^ -------- ^ --------- (Please read the notes on the back before filling this page) 4/0 (340 Α7

仃物理或化學功能之材料(譬如吸收劑、軟化劑、緩衝劑 酉母抑制劑、排泄物修改劑;壓力氣體等)。 另外,本發明的致動器可包含具有對於身體物質、穿戴 者、物件或其任何組件進行或啟動一回應功能的能量之儲 存材料量。一實施例中,譬如,致動器可釋放或輸送進行 一回應功能之一儲存材料,此實施例中,可藉由一輸入Z 限值來觸發致動器,以在已知時間不連續釋放或輸送儲存 材料、或可連續釋放或輸送材料。譬如,致動器可包括儲 存液劑、皮膚保養組合物、抗真菌劑或抗微生物劑、^泄 物修改劑、酶抑制劑、PH緩衝劑、染料等。特定較佳實施 例中’可由一致動器輸送譬如一膨漲的彈性材料、一釋放 的高壓氣體等材料。 圖2及2A顯示一個包含至少在壓力差異裝置91内的部份 真空下密封之一壓縮彈性材料94(如泡棉)之致動器9〇。本 又所用之一個壓力差異裝置為可將一彈性材料維持在一壓 力狀態(譬如可藉由在壓縮彈性材料94上提供一限制壓力來 儲存能量)之任何裝置或結構。“壓縮狀態”係界定為將材料 維持在比材料未受限制且處於零施壓情形下具有更小容積 &lt;狀況。對於彈性材料,一般可由施壓至材料表面或經由 本技藝習知任何其他裝置達成壓縮狀態。譬如,壓力差異 裝置可包含真空密封袋或拉張材料,譬如為限制住彈性材 科之彈性或非彈性帶或束、條、膜、非織造物、織物、或 泡棉。較佳可由觸發機構至少部份降低壓力差異裝置9 i所 維持之彈性材料的壓縮(亦即,壓縮的彈性材料9 4可至少部 (請先閱讀背面之注咅?事項再填寫本頁) 裝--------訂--------- 經濟部智慧財產局員工消費合作社印製 -57- 本紙張尺度適用中國國家標準(CNS)A4規格⑽χ 297公爱)仃 Materials with physical or chemical functions (such as absorbents, softeners, buffers, mother inhibitors, excrement modifiers; pressurized gases, etc.). In addition, the actuator of the present invention may include an amount of stored material having energy to perform or activate a response function to a body substance, a wearer, an object, or any component thereof. In one embodiment, for example, the actuator can be released or transported to store material for one of the response functions. In this embodiment, the actuator can be triggered by an input Z limit value to release discontinuously at a known time. Either the storage material is delivered, or the material can be continuously released or delivered. For example, the actuator may include a storage solution, a skin care composition, an antifungal or antimicrobial agent, a diarrhea modifier, an enzyme inhibitor, a pH buffer, a dye, and the like. In a particularly preferred embodiment, materials such as an inflated elastic material, a released high-pressure gas, etc. can be delivered by an actuator. Figures 2 and 2A show an actuator 90 comprising a compression elastic material 94 (e.g., foam) sealed under a vacuum at least in a portion of the pressure difference device 91. A pressure difference device used herein is any device or structure that can maintain an elastic material under a pressure state (for example, energy can be stored by providing a limited pressure on the compressed elastic material 94). A "compressed state" is defined as a condition that maintains a material with a smaller volume &lt; than when the material is unrestricted and under zero pressure. For elastic materials, compression can generally be achieved by applying pressure to the surface of the material or by any other means known in the art. For example, the pressure differential device may include a vacuum-sealed bag or a stretched material, such as an elastic or non-elastic band or band, strip, film, nonwoven, fabric, or foam to limit the elastic material. Preferably, the trigger mechanism can at least partially reduce the compression of the elastic material maintained by the pressure difference device 9 i (that is, the compressed elastic material 9 4 can be at least partially (please read the note on the back? Matters before filling out this page). -------- Order --------- Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs-57- This paper size applies to China National Standard (CNS) A4 Specification ⑽χ 297 Public Love)

五、發明說明(55 ) 經濟部智慧財產局員工消費合作社印製 伤膨漲)。一觸發機構係為回應於一輸入以進行壓力差異裝 置9 1中的壓力等化並可使壓縮的彈性材料9 4至少部份膨漲 足任何兀件或裝置,譬如感測器、致動器、或其組合。壓 縮材料釋放時,譬如在偵測到一目標生物活性分析物時了 壓縮的彈性材料可膨漲並輸送所儲存材料。部份實施例中 ,致動斋9 0可有利地包含一個空隙空間9 6。 彈性材料94可包含任何彈性材料,包括但不限於:一種 EVA泡綿,譬如得自賓州艾迪司東的佛綿絲公司的 SIF/210PPI或Aquazone 80A ;或為得自麻州海尼斯的森得尼 爾產品公司的MC1900 EVA2磅/立方呎;或一種HIpE泡綿, 係描述於1993年11月9日發證予迪馬瑞等人名為“水性體液 用的吸收泡棉材料及含有此材料的吸收物件,,之美國專利 5,260,345號;1995年2月7日發證予迪馬瑞等人名為“水性體 液用之濕潤前保持薄型吸收泡棉材料及其製造方法,,之美國 專利5,387,207號;1997年7月22日發證予迪馬瑞等人名為“ 具有極高水油比的高内相乳劑製造之水性流體用的吸收泡 棉材料’’之美國專利5,625,222號(上述各案以提及方式併入 本文中)。 本發明部份實施例中,壓力差異裝置91可包含一個袋(如 可溶袋92)。可溶袋92可在出現一或多種不同輸入(如水、 尿、排泄物酶、pH值等)時溶化,且可具有設計用於設定袋 溶化所需低限值之物理及/或化學特徵(如厚度)。譬如,可 溶袋可包含一個可溶於水的塑膜,譬如得自依利諾州南荷 蘭的克里斯工蟄工業產品公司的pVA膜 m〇n〇s〇l M7〇31 -58 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公爱) 裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 476640 A7 ___ B7 五、發明說明(56 ) 、M7030、M8630、M85344E6030膜、或明尼蘇達州聖保羅 的H.B·富勒公司HL 1636*hl 1669-X。譬如亦可修改膜厚 度以提供所需啓動,所用的膜譬如亦可具有約〇 〇〇〇5至約 0.0015吋厚度。譬如,一個約〇 〇〇1厚的HL 1636膜將由約 0.049克每平方吋濕含量所啓動。 致動器可另包含一個電敏感性膠質,電敏感性膠質係爲 聚合性膠質網路,當至少部份因水脹大時,則在施加電流 或電場下改變容積及/或幾何形狀。譬如,特定的部份離子 化聚丙晞酸酿胺膠質浸入丙酮及水時,在弱電場下(譬如 0.5伏/公分)將進行約50%的異向性收縮。另外,電敏感性 膠質可在出現水及一介面活性劑時進行電引發性彎曲、或 可在受到一振盪電場時進行振盪波動作。相信可能在一部 份的膠質中(譬如膠質元件的一側)藉由在一電場中將正電 介面活性劑聚集在負電膠質聚合物上而引發局部收縮。改 變電場的強度及/或極性將在一側長度減少時(譬如條中形 成的膠質可能蜷曲)引發膠質的移動。電敏感性膠可包含可 變化的幾何形狀,譬如長方形、圓形、網狀格栅等圖^, 以當改變容積及/或幾何形狀時提供一閥來釋放一材料、使 身體物貝/荒過、防止一身體物質流過、包封一身體物質 等。譬如,一條中形成的一電敏感性膠質可彎曲,以在偵 測到排便或排尿之前出現的外肛括約肌中的電活動時,提 供可用的空隙空間。 圖5 A及5 B中,譬如,一條電敏感性膠質494在圖中爲一 電路,其中排泄物濕度可跨接接腳485並使電流流到電敏感 -59- 本紙張尺度適用中.國國家標準(CNS)A4規格(210 X 297公爱) I— n ϋ —ϋ ϋ n n * in ϋ ·ϋ n ϋ n ϋ 一a 1 MmmKm n n n 1 I Φ (請先閱讀背面之注意事項再填寫本頁) 476640 A7 Β7 五、發明說明(57 ) 性膠使條變彎或變直。另外,如圖6 A、6 B、6 C所示形成 網狀格柵型的一個電敏感性膠質59 4可在偵測到即將排尿 形成一個可使及/或防止尿流到物件2 0另一部份之閥時,由 電性方式引發脹大或收縮。圖6 A譬如顯示一個包括一網狀 格柵型式的電敏感性膠質的電路。圖6B及6C進一步分別顯 示收縮及脹大構造的格栅之微觀圖,一種示範材料爲弱交 聯PAMPs膠質(聚(丙烯酸氨基-2-甲基丙垸)確酸)。此型膠 質可進行各種功能,譬如施加或輸送一化學排泄物處理劑 。其他示範電敏感性膠質描述於1990年3月3 1日發證予 Tanaka之美國專利5,1〇〇,933號及w〇 9202005號,兩案以提 及方式併入本文中。另外,可使用分別在特SpH或鹽濃度 改變容積及/或幾何形狀的p Η敏感性膠質或鹽濃度敏感度 膠質作爲本發明致動器。 致動器可配置於及/或操作性連接至可棄式物件中可使致 動器對於身體物質、穿戴者、物件或其組件進行一回應功 能之任何邵份。物件2 0中,譬如,致動器可位於物件2 〇的 削腰區36、後腰區38或胯區37中,且可與底座22、頂層 2 4、底層2 6、吸收核心2 8、側片3 0、腳翻邊3 2、一腰特 徵34、一緊固系統40、縱緣50或端緣52等相整合、鄰近 配置、或接合。致動器亦可完全容納在譬如物件2 〇等物件 内、可具有一部份位於物件中及一部份位於物件2 〇外、或 可完全位於物件20外部。一致動器或一部份致動器可操作 性連接至一或多個生物感測器6〇、一或多個控制器8〇、另 一部份的致動器或另一部份的物件2〇。並且,致動器可與 (請先閱讀背面之注意事項再填寫本頁) 裝--------訂------- 參 經濟部智慧財產局員工消費合作社印製 適 度 張 紙 本 釐 公 97 2 X 10 2Ι-Ϊ 規 Α4 S)A N (C 準 標 家 國 國 -60- 476640 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明(58 ) 物件20相整合、或可由看護者或穿戴者安裝。 物件20亦可包括一個控制器,本文“控制器,,定義爲一種 自一生物感測态接受一輸入並決定是否採取一或多項作用 之裝置,控制器可從生物感測器60接受一訊號並指示致動 器對於身體物質、穿戴者、物件或其組份進行一項回應功 能。另外,致動器可從生物感測器60直接接受訊號並對於 穿戴者、身體物質、物件或其組份進行一項回應功能。控 制器可包括進行化學或物理變化之材料、可爲從一生物感 測益等處理資訊之一項化學、機械或電裝置。控制器可包 括含有一個多層蘭牧爾_布拉吉特(Langmui卜m〇dgett)膜之 訊號電測轉換器,其中一或多層包括一個生物識別元件。 蘭牧爾-布拉吉特膜與水相接觸時已知會瞬間重組,造成具 有比原來的膜更多層之區域及其他較少層區域,此重組作 用可使生物識別元件在有水出現(譬如在可能包含目標生物 性分析物之生物物質中)時係優先暴露於環境。因此可減少 假陽性數量且可延長生物感測器之貨架壽命。另外,一個 自一電化感測器接受譬如電位等訊號之電控制器係可接受 及監測多個電訊號、且可重覆觸動致動器。控制器可與生 物感測器組件相整合、與致動器組件相整合、或爲系統之 一個分離組件。 控制器可配置於及/或操作性連接至可棄式物件之任何部 份,可使控制器從生物感測器6〇接受一訊號及對於致動器 提供訊號。物件2 〇中,譬如,控制器可位於物件2 0的前 腰區、後腰區38或胯區37中,且可與底座、頂層μ 裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) -61 - 476640 經濟部智慧財產局員工消費合作社印製 A7 B7_______ 五、發明說明(59 ) 、底層2 6、吸收核心2 8、側片3 0、腳翻邊3 2、一腰特徵 3 4、一緊固系統4 0、縱緣5 〇或端緣5 2等相整合、鄰近配 置或接合。控制器亦可完全容納在譬如物件2 0等物件内、 可具有一部份位於物件中及一部份位於物件外、或可完全 位於物件2 0外部。一致動器或一部份致動器可操作性連接 至一或多個生物感測器6 0、一或多個致動器9 0、另一部份 的致動器或另一部份的物件2 0。譬如,控制器可自生物感 測器6 0接受一訊號、並譬如由一射頻(rf)傳輸對致動器提 供一訊號。 雖然不同的結構性元件可進行生物感測器6 0、致動器及 控制器功能,並不需由不同的結構性元件來進行本發明之 生物感測器6 0、致動器及/或控制器功能。譬如可由相同的 結構性元件進行生物感測器6 0及控制器功能。 本文“回應系統,,定義爲一種包括一個生物感測器6 〇及當 生物感測器6 0偵測到適當觸發輸入時對於身體物質、穿戴 者、物件或其組份起作用之一個致動器之系統。當感測到 一已知輸入參數時,致動器釋放所儲存能量或釋放或輸送 儲存材料以進行一回應功能。譬如,當包括一訊號電測轉 換器的一個前攝式感測器6 0偵測到一即將發生的事件時, 訊號電測轉換器係對用於釋放儲存能量之致動器提供一訊 號藉由在即將發生事件之前偵測一輸入訊號,可觸發物 件中 &lt; 一回應系統以對事件預作準備、或告知看護者或穿 戴者即將發生事件。如此可構成身體物質管理或處理技術 初步“隱藏”或未受阻但在需要時或需要之前片刻才之 (請先閱讀背面之注意事項再填寫本頁) 裝--------訂--------- -62- 476640 A7 B7 經濟部智慧財產局員工消費合作社印製 五、發明說明(6〇 ) 物件、及/或可提供看護者或穿戴者有機會對於事件提前準 備(譬如偵測到致病微生物或殘留排㈣污染時對㈣戴者 施加預防治療)之物件。不論特定輸入爲何,這些實施例中 之生物感測器60可觸發致動器進行對物件、穿戴者或環产 之作用’以對事件發生預作準備或對於看護者提供即將= 生事件之訊號。若生物感測器6〇包含—個感測系統,可由 不同生物感測器及/或訊號觸發—致動器,或可由不同的生 物感測器及/或訊號觸發不同致動器。另外,—個生物感測 器及/或訊號可觸發多個致動器。 一個回應系統可以“連續,,或‘‘不連續,,方式作回應,本文“ 連績回應系統”係指一種隨輸入量呈定量性因變之輸出之回 應系統(亦即,需要連續增加的輸入量以連續增加輸出量) 、或者其中回應系統的輸出係包含被動釋放儲存材料之輸 出。置於物件的吸收核心中之一個超吸收聚合物譬如係提 供一連續回應,其中輸出係隨輸入量呈定量性因變(亦即當 增加的液體身體物質量接觸到超吸收聚合物時,增量的^ 合物係容納該液體直到聚合物容量用完爲止)。一個化學一= 量反應係爲具有對於增加輸出的一連續回應的系統之另^ 項範例,譬如,在Α +過量B + c反應中,轉變爲c之過量Β 量係爲理想配比,因此“連續性,,與系統中可用之Α量相關。 然而,本發明的“不連續回應系統,,係指一種具有與超過 低限値的輸入量大致無關之一輸出函數之回應系統。譬如 ,當達到已知輸入之一或多個低限値時,回應系統可釋放 所有或預定部份的儲存能量、或輸送(亦即主動運送)所有 -63- 本紙張尺度刺中國國家標準(CNS)A4規格_ (21〇 X 297公爱) -----------裝--------訂---------^^1 (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 476640 五、發明說明(61 ) 或預定部份的儲存材料,以進行一特定回應功能。本發明 的一項理想實施例中,輸出函數f(x)包括如圖3八所示的一 鳴級函數’此實施例中,當輸入量超過或低於低限値時 ,對於增加的輸入値之輸出變化率(d(輸出)/d(輸入))亦即 輸出Θ數f ( X )的第一階導函數f,( X )的斜率較佳概爲零。但 在低限値時,麦化率d (輸出)/ d (輸入)較佳接近無限大。因 此,理想的不連續回應中,在時函數f(x-s)的極限 不等於在ε +0時函數£(χ+ε)之極限,亦即: lim f(x- ε ) * lim f(x+ ε ) ε ε -&gt;〇 然而,本發明瞭解在現實環境中,不需要在低限値之理 想的瞬間階級變化,且在許多情形中甚至不可能發生。— 項較佳實旅例中,僅需使輸出函數具有在輸入處極少的變 化、或輸入低限値附近之概呈階級狀變化。因此,本發明 預見本發明之-種具有在過渡區域中以充分不連續方式回 應的輸出函數之不連續回應系統,使得輪出函數在過渡區 ^具有至少-個最小的相對陡度。雖無意受限於描述: 擬不連續系統之特定方法,在一項用於決定是否以本發明 足義的充分不連續方式進行已知輸出函數之較佳方法中, 1曲點處之輸出曲線斜率係與過渡區域的第:及最後畔之 =的直線之相對斜率相比較。譬如,圖4A_示—個示範輪 出函數f(x)、及示範輸出函數的第一階 ^ , -C »» / \ (X) 弟一&quot;階 U)、弟三階f,”(x)導函數的對正圖。輪出函數 述對於輸出的輸入(X或I)或響應(R(I))之玫果。本發明= 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐 裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) -64 476640 五、發明說明(62) 過渡區定義爲輸出函數f(x)的第二階導大値R(Ii)與最小値R(I2)之間的區域。相^^相對取 與相對最小値R (12)係爲第三階導函數f,&quot; \,、 L尺(11) , (X )等於零之Wi。 反曲點1〇界足爲過渡區中第二階導函數£ ^ 双1 U)寺於零之點, 亦即:V. Description of the invention (55) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. A triggering mechanism responds to an input to equalize the pressure in the pressure difference device 91 and can at least partially swell the compressed elastic material 9 4 to any element or device, such as a sensor, an actuator , Or a combination thereof. When the compressed material is released, such as when a target bioactive analyte is detected, the compressed elastic material can swell and transport the stored material. In some embodiments, the actuation fast 90 may advantageously include a void space 96. The elastic material 94 may include any elastic material, including but not limited to: an EVA foam, such as SIF / 210PPI or Aquazone 80A from Vermillion, Inc. of Addison, PA; or from Hynes, Mass. Sendnell Products ’MC1900 EVA 2 lbs / cu. Ft .; or a HIpE foam, described on November 9, 1993 and issued to Dimarry et al. Entitled" Absorbent foam material for aqueous body fluids and containing Absorbent article of this material, US Patent No. 5,260,345; February 7, 1995 issued a certificate to Dimarry et al. "Preserving a thin absorbent foam material for wet body fluids before wetting and its manufacturing method," Patent No. 5,387,207; U.S. Patent No. 5,625,222, issued to Dimari et al. On July 22, 1997, entitled "Absorbent Foam Material for Aqueous Fluids Made from High Internal Phase Emulsions with Very High Water-Oil Ratio" ( The above-mentioned cases are incorporated herein by reference.) In some embodiments of the present invention, the pressure difference device 91 may include a bag (such as a soluble bag 92). The soluble bag 92 may have one or more different inputs ( Such as water, urine, fecal enzymes, pH, etc. ) Melts, and may have physical and / or chemical characteristics (such as thickness) designed to set the lower limit required for the bag to melt. For example, a soluble bag may contain a plastic film that is soluble in water, such as from Yili PVA film m〇n〇s〇l M7〇31 -58 of Chris Industrial Co., Ltd. in South Holland, North Holland-This paper size applies to China National Standard (CNS) A4 (210 X 297) ------ Order --------- (Please read the precautions on the back before filling out this page) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 A7 ___ B7 V. Description of Invention (56) , M7030, M8630, M85344E6030 membranes, or HB Fuller Corporation HL 1636 * hl 1669-X in St. Paul, Minnesota. For example, the thickness of the membrane can also be modified to provide the required activation, and the membrane used, for example, can also have about 0.0000. 5 to about 0.0015 inches thick. For example, a HL 1636 film with a thickness of about 001 will be activated by a moisture content of about 0.049 grams per square inch. The actuator may additionally include an electro-sensitive gel, which is Polymeric colloidal networks, when at least partially swollen by water, Change the volume and / or geometry under the electric field. For example, when a certain part of the ionized polyacrylamide is immersed in acetone and water, about 50% of the anisotropy will be performed under a weak electric field (such as 0.5 V / cm). In addition, electrosensitive colloids can be electrically induced bending in the presence of water and a surfactant, or they can perform oscillating wave action when subjected to an oscillating electric field. It is believed that it may be in a part of the colloid (such as colloid One side of the element) initiates local shrinkage by accumulating a positive dielectric surfactant on a negatively charged colloidal polymer in an electric field. Changing the strength and / or polarity of the electric field will cause the gel to move when the length of one side is reduced (for example, the gel formed in the strip may buckle). The electro-sensitive adhesive may contain a variety of geometric shapes, such as rectangles, circles, mesh grids, etc., to provide a valve to release a material when the volume and / or geometry is changed, so that Passing, preventing a body substance from flowing through, enclosing a body substance, etc. For example, an electrically sensitive gel formed in a strip can be bent to provide usable void space when electrical activity in the external anal sphincter that occurs prior to defecation or urination is detected. In Figures 5 A and 5 B, for example, a piece of electrically sensitive gel 494 is a circuit in the figure, in which the humidity of excrement can bridge the pin 485 and make the current flow to the electrically sensitive -59- This paper standard is applicable. China National Standard (CNS) A4 Specification (210 X 297 Public Love) I— n ϋ —ϋ ϋ nn * in ϋ · ϋ n ϋ n ϋ a 1 MmmKm nnn 1 I Φ (Please read the notes on the back before filling this (Page) 476640 A7 B7 V. Description of the invention (57) The adhesive glue bends or straightens the strip. In addition, as shown in Figs. 6A, 6B, and 6C, an electrosensitive gel 59 4 forming a mesh grid type can detect that imminent urination will form a contact and / or prevent urine from flowing to the object 2 0 When a part of the valve is inflated or contracted electrically. FIG. 6A shows, for example, a circuit including a grid-like type of electrosensitive gel. Figures 6B and 6C further show micrographs of the grid of the contracted and expanded structure, respectively. One exemplary material is a weakly crosslinked PAMPs colloid (poly (aminoacrylic acid-2-methylpropionamidine) acid). This type of gel can perform various functions, such as applying or delivering a chemical excrement treating agent. Other exemplary electro-sensitive colloids are described in U.S. Patent Nos. 5,100,933 and WO9202005 issued to Tanaka on March 31, 1990, both of which are incorporated herein by reference. In addition, as the actuator of the present invention, p (R) sensitive gels or salt concentration-sensitive gels whose volume and / or geometry are changed at specific pH or salt concentration, respectively, can be used. The actuator may be configured and / or operatively connected to any part of the disposable object that enables the actuator to perform a response function to a body substance, a wearer, an object, or a component thereof. In the object 20, for example, the actuator may be located in the waist region 36, the back waist region 38, or the hip region 37 of the object 20, and may be connected to the base 22, the top layer 2 4, the bottom layer 2 6, the absorption core 2 8, The side panels 30, the foot cuffs 32, a waist feature 34, a fastening system 40, a longitudinal edge 50 or an end edge 52, etc. are integrated, adjacently arranged, or joined. The actuator may also be completely contained in an object such as the object 20, may have a portion in the object and a portion outside the object 20, or may be completely outside the object 20. Actuators or parts of actuators are operatively connected to one or more biosensors 60, one or more controllers 80, another part of an actuator or another part of an object 2〇. In addition, the actuator can be installed with (Please read the precautions on the back before filling out this page) -------- Order ------- Participate in the Consumer Property Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs to print appropriate sheets Printed paper 97 2 X 10 2 Ι-Ϊ Regulation A4 S) AN (C quasi-standard home country-60- 476640 A7 B7 printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs V. Description of the invention (58) Object 20 integrated Or may be installed by a caregiver or wearer. The object 20 may also include a controller. The "controller" herein is defined as a device that accepts an input from a biosensor state and decides whether to take one or more actions. The controller A signal may be received from the biosensor 60 and instruct the actuator to perform a response function to a body substance, a wearer, an object, or a component thereof. In addition, the actuator may directly receive the signal from the biosensor 60 and perform a response to the The wearer, body substance, object, or component thereof performs a response function. The controller may include a material that undergoes chemical or physical changes, a chemical, mechanical, or electrical device that may process information from a biosensor. Controller can be packaged Includes a signal electrical transducer that includes a multilayer Langmui_Bomgett film, where one or more layers include a biometric element. The Lanmüller-Blaget film is in contact with water It is known to instantly reorganize, resulting in areas with more layers than the original membrane and other areas with fewer layers. This reorganization allows the biometric recognition element to appear in the presence of water (for example, in a biological substance that may contain the target biological analyte) ) Is preferentially exposed to the environment. Therefore, the number of false positives can be reduced and the shelf life of the biosensor can be extended. In addition, an electric controller that receives signals such as potential from an electrochemical sensor can accept and monitor multiple The electrical signal can repeatedly trigger the actuator. The controller can be integrated with the biosensor component, integrated with the actuator component, or a separate component of the system. The controller can be configured and / or operable Connecting to any part of a disposable object enables the controller to receive a signal from the biosensor 60 and provide a signal to the actuator. In the object 20, for example, the controller can be located on the object 2 0 in the front waist area, back waist area 38 or hip area 37, and can be installed with the base and top μ -------- order --------- (Please read the note on the back first Please fill in this page again for matters) -61-476640 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7_______ V. Invention Description (59), Bottom 2 6, Absorbing Core 2 8, Side Panel 3 0, Foot Flanging 3 2, One waist feature 3 4, one fastening system 40, longitudinal edge 50 or end edge 52 are integrated, adjacently arranged or joined. The controller can also be completely accommodated in objects such as object 20, and can have one The share is located in the object and a part is outside the object, or it may be completely outside the object 20. The actuator or part of the actuator is operatively connected to one or more biosensors 60, one or more actuators 90, another part of the actuator or another part of the Object 2 0. For example, the controller may receive a signal from the biosensor 60 and provide a signal to the actuator, such as by a radio frequency (rf) transmission. Although different structural elements can perform the functions of the biosensor 60, the actuator and the controller, it is not necessary to use different structural elements to perform the biosensor 60, the actuator and / or the present invention. Controller functions. For example, biosensor 60 and controller functions can be performed by the same structural elements. This article "response system" is defined as an actuation that includes a biosensor 6 0 and acts on a body substance, wearer, object or component thereof when the biosensor 6 0 detects an appropriate trigger input. Actuator system. When a known input parameter is sensed, the actuator releases the stored energy or releases or transports the stored material to perform a response function. For example, when it includes a proactive sensor of a signal electrical transducer When the detector 60 detects an upcoming event, the signal electrical measuring converter provides a signal to the actuator for releasing stored energy. By detecting an input signal before the upcoming event, the signal can be triggered in the object. &lt; A response system to prepare for an event in advance, or to inform a caregiver or wearer that an event is imminent. This may constitute a preliminary "hidden" or unobstructed physical material management or processing technique but only when needed or a short time before ( (Please read the precautions on the back before filling out this page) -------- Order --------- -62- 476640 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Say (60) Objects, and / or objects that can provide a caregiver or wearer with the opportunity to prepare for the event in advance (such as applying preventive treatment to the wearer when disease-causing microorganisms or residual waste contamination is detected). Regardless of the specific input Why, the biosensor 60 in these embodiments can trigger an actuator to act on an object, a wearer, or a childbirth 'to prepare for an event or to provide a signal to the caregiver about an upcoming event. The sensor 60 includes a sensing system that can be triggered by different biosensors and / or signals-actuators, or different actuators can be triggered by different biosensors and / or signals. In addition, a Biosensors and / or signals can trigger multiple actuators. A response system can respond “continuously,” or “discontinuously,” in this article. The response system of sexually dependent output (that is, the continuously increasing input volume is required to continuously increase the output volume), or the output of the response system includes the output of passively releasing the storage material. A superabsorbent polymer placed in the absorbent core of the article, for example, provides a continuous response, where the output is quantitatively dependent on the input (i.e., when the increased liquid body mass contacts the superabsorbent polymer, the The amount of compound is to hold the liquid until the polymer capacity is used up). A chemical one = quantity reaction system is another example of a system with a continuous response to increasing output. For example, in the A + excess B + c reaction, the excess B quantity converted to c is an ideal ratio, so "Continuity is related to the amount of A available in the system. However, the" discontinuous response system "of the present invention refers to a response system having an output function that is substantially unrelated to an input amount exceeding a low threshold. For example, when one or more low thresholds of known inputs are reached, the response system can release all or a predetermined portion of the stored energy, or transport (ie, actively transport) all -63- CNS) A4 specifications_ (21〇X 297 public love) ----------- install -------- order --------- ^^ 1 (Please read first Note on the back, please fill out this page again) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 476640 V. Inventory (61) or the storage materials of the predetermined part for a specific response function. In an ideal embodiment of the present invention, the output function f (x) includes a one-step function as shown in FIG. 3A. In this embodiment, when the input amount exceeds or falls below the low limit, for an increased input The output change rate of ((d (output) / d (input)), that is, the first derivative function f of the output Θ number f (X), the slope of (X) is preferably almost zero. However, at the lower limit, the ratio d (output) / d (input) is preferably close to infinity. Therefore, in an ideal discontinuous response, the limit of the function f (xs) at time is not equal to the limit of the function £ (χ + ε) at ε +0, that is: lim f (x- ε) * lim f (x + ε) ε ε-&gt; 〇 However, the present invention understands that in a real environment, the ideal instantaneous class change at the low limit is not necessary, and in many cases it is not even possible. — In the preferred practical example, it is only necessary to make the output function have little change at the input, or almost class-like change near the input low limit. Therefore, the present invention foresees a discontinuous response system having an output function that responds in a sufficiently discontinuous manner in the transition region, so that the roll-out function has at least one minimum relative steepness in the transition region. Although not intentionally limited by the description: a specific method of a quasi-discontinuous system, in a preferred method for determining whether to perform a known output function in a sufficiently discontinuous manner as is sufficient in the present invention, the output curve at a curve The slope is compared with the relative slope of the straight line at the bottom of the transition zone: and =. For example, Fig. 4A_ shows a sample rotation function f (x), and the first order of the sample output function ^, -C »» / \ (X) Diyi &quot; order U), third order f, " (X) Contrast graph of the derivative function. The rotation function describes the result of the input (X or I) or response (R (I)) to the output. The present invention = This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm pack -------- Order --------- (Please read the notes on the back before filling this page) -64 476640 V. Description of the invention (62) Transition area Defined as the area between the second derivative 値 R (Ii) and the minimum 値 R (I2) of the output function f (x). The phase ^^ is relatively the third derivative The function f, &quot; \ ,, L rule (11), (X) is equal to zero Wi. The inflection point 10 bound is the second order derivative function in the transition zone. £ ^ double 1 U) is at the point of zero, also which is:

d2R Ο dl 1 = 1丨 可由下式描錢曲點處之輸出函數斜率與㊣渡區的第一與 最後點之間的直線之比較:d2R Ο dl 1 = 1 丨 The following can be used to describe the slope of the output function at the point of the money curve and the straight line between the first and last points of the crossing area:

dR (△ RT) (請先閱讀背面之注意事項再填寫本頁) l·裝 k dl (△It) 經濟部智慧財產局員工消費合作社印製 此式中,反曲點之dR/dl係爲該點之輸出函數的第一階導 函數;△ Ιτ係指過渡區的第一點L與最後點l2之間的回應 系統之輸入變化,亦即; △&amp;7爲過渡區之第一與最後 點之間的輸出函數之回應變化,亦即R(l2)-R(Ii);係數k 係爲描述反曲點I 〇上輸出函數斜率相較於過渡區之第一與 最後點之間的一直線斜率之相對陡度之比例常數。爲了使 回應系統具有一個不連續輸出函數,比例常數k必須至少約 -65 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公爱) 訂--------- 476640 Α7 Β7 五、發明說明(63 ) 爲2.0、較佳至少約3 . 〇、更佳至少約5 〇、更佳至少約1 〇 〇 、最佳至少約100.0。 特定實施例中,亦可由具有一系列整數n(具有一相等時 間常數的第一階遲滯)的一控制系統的一轉移函數,來模擬 一不連續回應系統之過渡區中之相對陡度,本發明中回應 系統的轉移函數定義爲輸出(響應變數)對於輸入(擾亂變數 )之拉普拉斯轉換的比値,譬如請見羅伯Η.裴利及唐葛林的 第六版’ 22章(麥克葛羅希爾公司1984) 。如圖4B所示,可由公式:KG(s) = K/(Ts+l)n來概算一輸 出函數之相對陡度,其中KG(s)爲轉移函數,κ爲一比値。 Τ爲系統的時間常數,η爲第一階時間遲滯之整數。此模型 中,當數字η增加,則過渡區中之輸出函數的陡度增加,且 模型開始趨近一不連續回應系統。較佳當11大於或等於約 25,則可由上式模擬本發明特定的不連續回應系統,更佳 η大於或等於約5 0、最佳η大於或等於約1〇〇。 經濟部智慧財產局員工消費合作社印製 如圖3Α所示,本發明之一回應系統可包括單一低限値, 回應系統在此低限値可釋放所有所儲存能量以進行一特定 回應函數;或可包括多個低限値,系、统在各個此等低限値 可釋放-預定料的所儲存能量以進行一或多則争定回應 函數。譬如,-個具有單-低限値之實施例中,當達到该 低限値時,回應系統可釋放所有所儲存能量以進行整體回 應函數,此單-低限値實施例中,此範例中,不連續回麻 系統包括-個具有譬如開或關兩狀態之系統。當吸收物; 中出現譬如目標生物物質等—輸人之低限量時,回應系統 -66- ?7一 經濟部智慧財產局員工消費合作社印製 A7 ---一 _ Β7 __ 發明說明(64 ) 可對於身體物質、穿戴者、其物件或組份進行單一回應函 數,、譬如包圍身體物質而與使用者皮膚相隔離、或對穿戴 者或看護者提供容易偵測的目視訊號。因此,不連續的回 應j統可在出現一輸入的低限値時進行從一狀態變成另一 狀怨作一次的“切換狀,,功能。 另外,如圖3 B所示,回應系統可具有多個低限値,當達 到各個低限値時,系統可釋放一已知“額度,,的能量或輸送 已知材料量以進行特定的回應函數。此實施例中,當達到 各個低限値時,可進行整體回應函數的一部份及/或^回應 於所達到的不同低限値而進行不同獨立的回應函數。譬如 ,一個回應系統可監測一排泄物酶,且當達到各個低限酶 値時可輸送相等或不相等的酶抑制劑或液劑量、或以第一 低限値輸送一個pH緩衝劑並進行另一回應函數,譬如以第 二低限値輸送酶抑制劑量。各過渡區中,回應系統具有與 上述單一低限値實施例中的過渡區之大致相同回應方式。 此外,一個回應系統可監測多個輸入,譬如一或多個致 病細菌及/或一或多個排泄物酶,並當到達不同輸入的低限 値時進行一或多個回應函數,或可僅在達到不同輸入之兩 個或更多低限値時進行一個回應函數。因此,一控制器可 監測多個不同輸入並當達到不同輸入的低限値時進行一不 同的回應函數。另外,控制器可進行一邏輯0 R -閘型功能 ,故可在達到多個輸入的一或多個低限値時進行一回應函 數。控制器亦可進行一邏輯AND-閘型功能,故可在達到兩 個或更多輸入的各個低限値時進行一回應函數。 -67- 本紙張尺度_ t _ &quot;豕標準(CNS)A4規格(2ΙΓΧ_297公 I----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 476640 ^ ____I_ 經濟部智慧財產局員工消费合作社印製 A7 B7 發明說明(65 ) 回應系統亦可包含一 “閉迴路”或一“開迴路,,系統,亦稱 爲“回饋控制迴路’’之‘‘閉迴路,,系統係包含不同的生物感^ 器6 0及致動器組件且對輸入進行一回應函數。部份較佳實 施例中,系統亦可使用一元件之偵測或測量或輪出條件之 一參數作爲對輸入進行的回應函數之至少一個觸發。輸出 條件可爲在致動器已有機會對於輸入條件進行一回應函數 1後的輸入條件心狀態。當輸出條件到達低限値時可進行 回應函數、或僅在到達輸出條件及一或多個其他條件時進 行。對於輸入起作用者可包括:對於所感測元件起作用, 譬如感測一微生物及對於微生物起作用、或可包括對於一 個其感測元件爲一整合組件之组合物起作用,譬如感測到 一個排泄物細菌及對於排泄物塊或穿戴者皮膚上的殘留排 泄物起作用。如上述,回饋控制迴路系統包含至少兩個不 同組件:生物感測器6 0及致動器。生物感測器6 〇係偵測一 事件:或與該事件才目關之一參數。*冑器接受一訊號並對 生物感測器6 0偵測到的輸入條件進行一回應函數。回饋控 制迴路可進-步包括一個控制器。此情形巾,生物咸測器 60可對控制器提供-訊號,控制器可指示致動器對於輸入 條件進行一回應函數。控制器可爲回應系統之一分離的組 件,或者可由生物感測器60及/或致動器進行控制功能。 回饋控制迴路可爲“非調變,,或“調變,,式,“非調變,,回饋 控制迴路回應系統中,回應系統作爲一次開關之用,其中 當到達輸出條件的低限値時,致動器對輸入進行一回應函 數。譬如,生物感測器60可偵測出現一特定致病微生物或 68 本紙張尺度適用中國國豕標準(CNS)A4規格(210 X 297公釐) ----------^--------^--------- (請先閱讀背面之注意事項再填寫本頁) _ ο 64 6 7 五 經濟部智慧財產局員工消費合作社印製 A7 ____^__ 發明說明(66 ) 測量其濃度,且致動器可通知看護者已具有潛在初期感染 。此範例中,致動器對於生物感測器6 〇所偵測的輸入起作 用。但是’“調變”回饋控制迴路係包括一生物感測器6 〇、 一致動器及一控制器。調變回饋控制迴路中,不斷地或重 覆地監測輸出條件,且控制器指示致動器對於輸入進行一 回應函數以將輸出條件保持在所需設定點或所需範圍内, 或連續測量目標生物性分析物値或濃度。 但是’‘開迴路”系統係爲一種回應於輸入以不用回馈方 式進行一回應函數之系統,亦即輸出對於進入系統的所感 測輸入沒有影響。開迴路系統可包括一回應系統,其中具 有進行生物感測器6 0及致動器功能之單一裝置,或可具有 不同的生物感測器60及致動器組件,其中致動器係對於輸 入以外的項目起作用。因爲聚合物僅包括進行生物感測器 6 0及致動器功此之單一裝置’置於可棄式吸收物件的吸收 核心中之一個超吸收聚合物譬如係提供一開迴路回應。另 外,開迴路回應系統可包括一個偵測身體物質或該身體物 質的一組份之生物感測器6 0 ’及一個以連續或不連續方式 對於生物感測器6 0所偵測的輸入以外的項目進行一回應函 數之致動器。 本發明包括提供一個不連續或連續回應之回應系統(不論 是開迴路或閉迴路)。其他回應系統描述於1998年6月29日 名爲具有不連續回應系統之可棄式物件”之美國專利申請 09/106,424號(?&amp;〇案號7197);1998年6月29日名爲“具有 包括回饋控制迴路的回應系統之可棄式物件,,之美國專利申 -69- 本紙張尺度適用中國國家標準(CNS)A4規格(210 x 297公釐) (請先閱讀背面之注意事項再填寫本頁) ▼丨裝--------訂--------- 476640 經濟部智慧財產局員工消費合作社印製 A7 —____B7___ 五、發明說明(67 ) 請〇9/107,563號(P&amp;G案號7198) ; 1998年6月29日名爲“包 括機械致動器之回應系統之可棄式物件,,之美國專利申請 〇9/106,225號(P&amp;G案號7199);各案以提及方式併入本文中。 本發明的尿布2 0範例可包括一個包含一個如圖1所示生 物感測器ό 0及一個如圖2所示致動器之回應系統。此實施 例中’生物感測器6 0可包含一個訊號電測轉換器,此訊號 電測轉換器與一個適於偵測排泄物中的大腸桿菌的生物識 別元件呈操作性相聯。當生物識別元件特別偵測到大腸桿 菌之低限値時,訊號電測轉換器以一電流通知致動器。圖i 所示物件可包括一個包含一壓縮彈性材料94之致動器,此 壓縮彈性材料94係眞空壓縮在一水溶膜91 (如pvA膜)下方 ,如圖2所示。從生物感測器6〇接收到適當訊號時,致動 器可關閉-開關,譬如可^放少量儲存水以接觸並溶解水 溶膜91,因此釋出壓縮泡@中之儲存機械能^彈性材料94 膨漲並形成一固定件以對於初期排泄物提供空隙容積。另 外,開關的關閉可另釋出一抗微生物劑以控二大腸^菌、 及/或-可目視染料以通知穿戴者或看護者出現大腸桿菌。 另-實施例中,回應系統可包括一個致動器,Μ土穿戴 者譬如腹涛感染或皮膚刺激(如念珠菌病)等即將發:的事 件0 測試方法 回應因子測試: 在下列回應因子測試中,可測量作爲暴露於特定物質或 組合物的反應之定量感測器的回應。 木紙張尺度適用中國國家標準(CNS)Α4規格(加χ 297公爱dR (△ RT) (Please read the precautions on the back before filling out this page) l · Install k dl (△ It) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs In this formula, the dR / dl of the inflection point is The first derivative of the output function at this point; △ τ refers to the input change of the response system between the first point L and the last point l2 of the transition zone, that is, △ &amp; 7 is the first sum of the transition zone The response change of the output function between the last points, that is, R (l2) -R (Ii); the coefficient k is used to describe the slope of the output function at the inflection point I 〇 compared to the first and last points of the transition zone The proportionality constant of the relative steepness of the slope of the line. In order for the response system to have a discontinuous output function, the proportionality constant k must be at least about -65. This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 public love). Order --------- 476640 Α7 B7 V. Invention description (63) is 2.0, preferably at least about 3.0, more preferably at least about 50, more preferably at least about 100, and most preferably at least about 100.0. In a specific embodiment, the relative steepness in the transition zone of a discontinuous response system can also be simulated by a transfer function of a control system having a series of integers n (a first-order hysteresis with an equal time constant). In the invention, the transfer function of the response system is defined as the ratio of the Laplace transform of the output (response variable) to the input (disturbance variable). For example, see Robert B. Perry and Tang Gelin's sixth edition. (McGrow Hill Corporation 1984). As shown in Figure 4B, the relative steepness of an output function can be approximated by the formula: KG (s) = K / (Ts + l) n, where KG (s) is the transfer function and κ is a ratio 値. T is the time constant of the system, and n is an integer of the first-order time lag. In this model, as the number η increases, the steepness of the output function in the transition zone increases, and the model begins to approach a discontinuous response system. Preferably, when 11 is greater than or equal to about 25, the specific discontinuous response system of the present invention can be simulated by the above formula, more preferably η is greater than or equal to about 50, and optimal η is greater than or equal to about 100. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs as shown in FIG. 3A, a response system of the present invention may include a single low limit, where the response system may release all stored energy to perform a specific response function; or It may include a plurality of low-limit thresholds, at which each of these low-limit thresholds may release the stored energy of a predetermined material to perform one or more determined response functions. For example, in an embodiment with a single-low threshold, when the low-limit threshold is reached, the response system can release all stored energy to perform the overall response function. In this single-low-limit embodiment, in this example, The discontinuous anaesthesia system includes a system with two states such as on or off. Response system -66-? 7 printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs when there is a low limit of the input biological substance, such as the target biological substance, in the absorbent; Invention Note (64) A single response function can be performed on the body substance, the wearer, its objects or components, such as isolating the body substance from the user's skin, or providing an easily detectable visual signal to the wearer or caregiver. Therefore, the discontinuous response system can perform a "switching state" from one state to another when a low limit of an input occurs. In addition, as shown in Figure 3B, the response system may have Multiple low limit thresholds. When each low limit threshold is reached, the system can release a known amount of energy or deliver a known amount of material to perform a specific response function. In this embodiment, when the respective low limit values are reached, a part of the overall response function and / or ^ may be performed in response to different low limit values reached and different independent response functions may be performed. For example, a response system can monitor an excreta enzyme and deliver equal or unequal enzyme inhibitors or fluid doses when each lower limit enzyme is reached, or deliver a pH buffer at the first lower limit and perform another A response function, such as the amount of enzyme inhibitor delivered at the second lower limit. In each transition zone, the response system has substantially the same response mode as the transition zone in the single low-limit embodiment described above. In addition, a response system can monitor multiple inputs, such as one or more pathogenic bacteria and / or one or more fecal enzymes, and perform one or more response functions when the low limit of different inputs is reached, or A response function is performed only when two or more low limits of different inputs are reached. Therefore, a controller can monitor multiple different inputs and perform a different response function when the low limits of different inputs are reached. In addition, the controller can perform a logic 0 R-gate type function, so it can perform a response function when one or more low thresholds of multiple inputs are reached. The controller can also perform a logical AND-gate function, so it can perform a response function when each low limit of two or more inputs is reached. -67- This paper size _ t _ 豕 Standard (CNS) A4 specification (2ΙΓχ_297 male I ---------- installed -------- ordered -------- -(Please read the notes on the back before filling out this page) 476640 ^ ____I_ Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 Invention Description (65) The response system may also include a“ closed loop ”or an“ open loop, The system, also known as the "closed loop" of "feedback control loop", the system includes different biosensors 60 and actuator components and performs a response function to the input. In some preferred embodiments The system can also use a parameter of a component's detection or measurement or rotation condition as at least one trigger of the response function to the input. The output condition can be a response function to the input condition when the actuator already has an opportunity1 After the input condition is reached, the response function can be performed when the output condition reaches the low limit, or only when the output condition and one or more other conditions are reached. Those who act on the input can include: act on the sensing element , Such as sensing a microorganism and Acting, or may include acting on a composition whose sensing element is an integrated component, such as sensing a fecal bacterium and acting on fecal mass or residual feces on the wearer's skin. As described above, feedback The control loop system includes at least two different components: a biosensor 60 and an actuator. The biosensor 60 detects an event: or a parameter related to the event. * The device accepts a signal And a response function is performed on the input conditions detected by the biosensor 60. The feedback control loop may further include a controller. In this case, the biosensor 60 may provide a signal to the controller, the controller The actuator can be instructed to perform a response function to the input conditions. The controller can be a separate component of the response system or can be controlled by the biosensor 60 and / or the actuator. The feedback control loop can be "non-adjustable" Change, or "modulation," "non-modulation," feedback control loop response system, the response system is used as a primary switch, where the actuator reaches the lower limit of the output conditions, the actuator Perform a response function on the input. For example, the biosensor 60 can detect the presence of a specific pathogenic microorganism or 68 paper sizes that comply with China National Standard (CNS) A4 (210 X 297 mm) ----- ----- ^ -------- ^ --------- (Please read the notes on the back before filling this page) _ ο 64 6 7 Employees of the Intellectual Property Bureau of the Ministry of Economic Affairs Cooperative prints A7 ____ ^ __ Description of the invention (66) The concentration is measured, and the actuator can notify the caregiver that there is a potential initial infection. In this example, the actuator responds to the input detected by the biosensor 600. Function. But the "" modulation "feedback control loop system includes a biosensor 600, an actuator and a controller. In the modulation feedback control loop, the output conditions are continuously or repeatedly monitored, and the controller instructs the actuator to perform a response function to the input to maintain the output conditions within the required setpoint or range, or continuously measure the target Biological analytes or concentrations. However, the "open loop" system is a system that performs a response function in response to the input without feedback, that is, the output has no effect on the sensed input into the system. The open loop system can include a response system, which has a biological function. A single device with sensor 60 and actuator functions, or may have different biosensors 60 and actuator components, where the actuators work for items other than input. Because polymers only include biological A single device that functions as a sensor 60 and an actuator is placed in a superabsorbent polymer in the absorbent core of a disposable absorbent article, for example, to provide an open-loop response. In addition, the open-loop response system may include a detector Biosensor 6 0 ′ for measuring a body substance or a component of the body substance and an actuator for performing a response function on items other than the input detected by the biosensor 60 in a continuous or discontinuous manner The invention includes a response system that provides a discontinuous or continuous response (whether open-loop or closed-loop). Other response systems were described in June 1998. 2 9th US Patent Application No. 09 / 106,424 (? &Amp; 0 Case No. 7197) entitled "Disposable Object with Discontinuous Response System"; June 29, 1998 entitled "Response System with Feedback Control Loop Included Disposable items, US patent application -69- This paper size is applicable to China National Standard (CNS) A4 (210 x 297 mm) (Please read the precautions on the back before filling this page) ▼ 丨- ------- Order --------- 476640 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 —____ B7___ V. Description of Invention (67) Please No. 09 / 107,563 (P &amp; G case number 7198); US Patent Application No. 09 / 106,225 (P &amp; G Case No. 7199), entitled "Disposable Articles Including Response System of Mechanical Actuators, June 29, 1998; Ways are incorporated herein. The diaper 20 example of the present invention may include a response system including a biosensor as shown in FIG. 1 and an actuator as shown in FIG. In this embodiment, the 'biosensor 60' may include an electrical signal transducer, and the electrical signal transducer is operatively linked to a biometric element suitable for detecting E. coli in fecal matter. When the bio-recognition element specifically detects the low limit of coliform bacteria, the signal electrical measuring converter notifies the actuator with a current. The object shown in FIG. I may include an actuator including a compressive elastic material 94, which is compressively compressed under a water-soluble film 91 (such as a pvA film), as shown in FIG. 2. Upon receiving an appropriate signal from the biosensor 60, the actuator can be turned off-on. For example, a small amount of stored water can be placed to contact and dissolve the water-soluble film 91, so the compression bubble @ 中 的 Storage mechanical energy is released. Elastic material 94 Swells and forms a fixture to provide a void volume for initial excreta. In addition, the closing of the switch can release another antimicrobial agent to control the two coliform bacteria, and / or-visually detect the dye to notify the wearer or caregiver of the presence of E. coli. In another embodiment, the response system may include an actuator, such as an abdominal wave infection or a skin irritation (such as candidiasis), which is about to occur: Event 0 Test Method Response Factor Test: The following response factor tests The response of a quantitative sensor as a response to exposure to a particular substance or composition can be measured. Wood paper scale is applicable to China National Standard (CNS) A4 specifications (plus χ 297 public love

Awl Μ--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 70. 476640 經濟部智慧財產局員工消費合作社印製 ----------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) A7 B7 五、發明說明(68 ) 此測試適合之特定物質或組合物包括:每1克生理食鹽水 中具有1克排泄物測試材料的濃度之水性溶液中之排泄物測 試材料;每1克測試尿液溶液中具有i克排泄物材料之測試 尿液;各液中之排泄物測拭材料;測試尿液溶液;每克生理 食鹽水中具有180微克糞臭素濃度之生理食鹽水中之糞臭素 溶液;生理食鹽水溶液。 在體溫(3 7 °C )進行所有測量,該方法包括依照下列順序 之下列步驟: 1) 在暴露於生理食鹽水24小時之後,記錄感測器之定量 回應,背景回應係爲最大記錄回應。 2) 使感測器暴露於指定的物質或組合物。 J )¼感測器暴露於指定物質或組合物2 4小時,記錄感測 器之定量回應,物質回應係爲最大記錄回應。 藉由將物質回應與背景回應進行正規化以獲得回應因子 ,若回應因子小於1,則將回應因子的倒數値記錄爲回應因 子(亦即,回應可與輸入呈反比相關)。 所有專利案的揭示及任何對應的已公告外國專利案及此 專利申請案全文提及之公告係以提及方式併入本文中,但 是,以提及方式併入本文中的任何文件顯然未必指示或揭 露本發明。 雖已圖示及描述本發明之特定實施例及/或各特徵,熟系 本技藝者瞭解可作出各種其他變化及修改,而不背離本發 明之精神與範圍。譬如,本發明的型態雖圖示及描述爲可 棄式尿布,本發明不限於此實施例。本發明亦 J j詈如用於 -71 - 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公愛Ί --—--- 476640 —---—--_____ 五、發明說明(69) 在施加可棄式尿布之前或取代可棄式尿布、拉穿式尿布、 尿布嵌件、衛生棉、衛生棉條等而直接施加至穿戴者(譬如 穿戴者的肛門附近或會陰區域)之物件中。並且,此等實施 例及特徵的所有組合顯然均應可能且可較佳實施本發明。 本發明亦可包括所述物件中與所述其他特徵可互爲獨立使 用t郅份。譬如,本發明亦可包括感測器及偵測器、此等 感測器及偵測器之製備方法、及此等感測器及偵測器之使 用方法。該等感測器及偵測器不論位於一特定類型物件上 或單獨使用或爲其他感測器之診斷面板,均用於特定目的 而且非先則所習知。因此,申請專利範圍預定涵蓋本發明 範圍内之所有此等變化及修改。 ------------裝--------訂--------- (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 72-Awl Μ -------- Order --------- (Please read the notes on the back before filling out this page) 70. 476640 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs ---- ------ Equipment -------- Order --------- (Please read the notes on the back before filling this page) A7 B7 V. Description of the invention (68) This test is suitable The specific substance or composition includes: fecal test material in an aqueous solution having a concentration of 1 gram of fecal test material per 1 gram of physiological saline solution; test urine having i gram of fecal material per 1 gram of test urine solution Liquid; fecal material in each liquid; test urine solution; skatole solution in physiological saline with a concentration of 180 micrograms of skatole per gram of physiological saline; physiological saline solution. All measurements were performed at body temperature (37 ° C). The method included the following steps in the following order: 1) After 24 hours of exposure to physiological saline, the sensor's quantitative response was recorded. The background response was the maximum recorded response. 2) Expose the sensor to the specified substance or composition. J) The sensor is exposed to the specified substance or composition for 24 hours, and the quantitative response of the sensor is recorded. The material response is the maximum recorded response. The response factor is obtained by normalizing the material response and the background response. If the response factor is less than 1, the reciprocal of the response factor is recorded as the response factor (that is, the response can be inversely related to the input). The disclosure of all patent cases and any corresponding published foreign patent cases and the publications mentioned in the full text of this patent application are incorporated herein by reference, however, any document incorporated by reference herein does not necessarily indicate Or disclose the present invention. Although particular embodiments and / or features of the invention have been illustrated and described, those skilled in the art will recognize that various other changes and modifications may be made without departing from the spirit and scope of the invention. For example, although the form of the present invention is illustrated and described as a disposable diaper, the present invention is not limited to this embodiment. The present invention is also applicable to -71-This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 public love) ------ 476640 ------ ---____ (69) Apply directly to the wearer before applying or replacing disposable diapers, pull-through diapers, diaper inserts, tampons, tampons, etc. (eg near the anus or perineal area of the wearer) In addition, it is obvious that all combinations of these embodiments and features should be possible and can better implement the present invention. The present invention may also include the use of other independent features in the object and the other features. For example, the present invention may also include sensors and detectors, methods for preparing the sensors and detectors, and methods for using the sensors and detectors. The sensors and detection The device, whether on a specific type of object or used alone or as a diagnostic panel for other sensors, is used for a specific purpose and is not known. Therefore, the scope of the patent application is intended to cover all such changes within the scope of the present invention. And modification. ------------ install -------- --------- (Please read the back of the precautions to fill out this page) Ministry of Economic Affairs Intellectual Property Office employees consumer cooperatives printed 72-

Claims (1)

第89114348號專利申請案 AS J 中文申请專利範圍修正本(9〇年5月〕昼9申請專利範圍 1 . 種可棄式物件,包含: 一生物感測器,白姑@ ^ . τ 括至〆一個生物識別元件,該生 器適广貞測身體物質中、或穿戴者皮膚上或场 過皮膚乏一個目標生物性分析物, 其中該物件選自下列各物:一尿布、一學習褲、一 =物袋、-女性衛生裝置、—可棄式擦及一 可棄式巾。 2. 6. 經濟部中央橾準局員工消費合作社印製 如申請專利範圍第”員之可棄式物件 性分析物為輪狀病毒。 如申請專利範圍第丨項之可棄式物件 器為一個前攝式感測器。 如申請專利範園第1項之可棄式物件 器為一個色度性感測器。 如申請專利範圍第1項之可棄式物件 動力源。 一種可棄式物件,其係、可供穿戴者穿用包含一個診斷 面板以偵測身體物質中或使用者皮膚上或通過皮膚之 生物性分析物,該診斷面板包括: 至少一個第一生物感測器及一個第二生物感測器, 該第一生物感測器適於偵測至少一個第一目標生物性 分析物,而該第二生物感測器適於偵測與該第一目標 生物性分析物不同之至少一個第二目標生物性分析物 其中該目標生私 其中該生物感泪 其中該生物感須 進一步包含一 a 如申請專利範圍第6項之可棄式物件,其中該等生物感 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閲讀背面之注意事項再填寫本頁) 476640 ABCD 經濟部中央標隼局員工消費合作社印製 六、申請專利範圍 測器包括含有生物性反應劑之生物識別元件。 8 ·如申請專利範圍第6項之可棄式物件,其中至少一個生 物感測器係選自下列各物:一個生物催化性生物感測 器及一個生物親和力生物感測器。 9 ·如申請專利範圍第8項之可棄式物件,其中該親和力生 物感測器係選自:一個化學感受體為基礎的生物感測 器及/或一個免疫感測器。 I 0 ·如申請專利範圍第6項之可棄式物件,其中至少一個生 物識別元件選自下列各物:一酶或酶的序列;一抗體 ;DNA ; —細胞器;一薄膜受體蛋白質;一天然或合 成薄膜’可存活或不可存活細菌性、植物、動物的細 胞;至少一部份的一神經束;至少一部份的一感測器 官。 II ·如申請專利範圍第1 〇項之可棄式物件,其中該生物識 別元件係選自鮑曼尼不動桿菌T〇I36 (Acinet〇bacter baumannii TOI36)及芽胞桿菌屬 sp τόπι。 1 2 ·如申請專利範圍第1 〇項之可棄式物件,其中該生物識 別元件係配置於選自下列各物之一個基材上:聚合物 為基礎的材料、水凝膠、薄紙、非織造材料、織造材 料、及矽半導體。 13·如申請專利範圍第6項之可棄式物件,其中該生物感測 器用於偵測選自下列各物之目標生物性分析物··致病 細菌、結腸細菌、病毒、寄生蟲、細菌性毒素、真菌、 酉每。 1 4 ·如申請專利範圍第6項之可棄式物件,其中該診斷面板 本紙張尺度適用中國國家標準(CNS〉A4規格(210 X 297公釐) --------秦I — (請先閲讀背面之注意事項再填寫本頁) 訂 476640 經濟部中央標準局員工消費合作社印製 A8 B8 C8 D8 六、申請專利範圍 適於偵測腹瀉的致病原因。 1 5 ·如申請專利範圍第6項之可棄式物件,其中該等第一及 第二生物感測器各適於偵測腹瀉之一或多個病毒性原 因,以對於使用者、.看護者或醫療人員指示已出現一 或多個病毒性原因。 1 6 ·如申請專利範圍第1 5項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測下列至少一项·輪狀病 毒、星形病毒、鈣病毒、腺病毒及諾沃克因子病毒。 1 7 ·如申請專利範圍第6項之可棄式物件,其中該等第一及 第二生物感測器各適於偵測腹瀉之一或多個細菌性原 因,以對於使用者、看護者或醫療人員指示已出現一 或多個細菌性原因。 1 8 ·如申請專利範圍第1 7項之可棄式物件,其中該等第— 及弟一生物感測器各適於偵測下列至少一項:致腸病 性大腸样菌(EPEC)、腸毒性大腸样菌(ETEC)、腸出血 性大腸样菌(EHEC)、腸侵襲性大腸样菌(EIEC)、及腸 黏性大腸样菌(EAEC)、傑竹尼彎曲捍菌(Campyl〇bacter jejuni)、霍亂弧菌及志賀氏样菌菌株包括索氏志賀氏菌 (S. sonnei)及弗氏志賀氏菌(S· flexneri)。 1 9 ·如申請專利範圍第6項之可棄式物件,其中該等第一及 第二生物感測器各適於偵測腹瀉之一或多個致病原因 ,以對於使用者、看護者或醫療人員指示已出現_或 多個原因。 2 0 ·如申請專利範圍第1 9項之可棄式物件,其中該第_生 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁) 訂 f 476640 A8 B8 C8 D8 經濟部中央標率局員工消費合作社印製 六、申請專利範圍 物識別元件適於偵測腹瀉的至少一個病毒性原因,而 該第二生物識別元件適於偵測腹瀉的至少一個細菌性 原因。 2 1 ·如申請專利範圍第6項之可棄式物件,其中該等第一及 第二生物感測器各適於偵測腹瀉之—或多個原生 性原因,以對於使用者、看護者或醫療人員指示已出 現一或多個原生動物性原因。 2 2 ·如申請專利範圍第6項之可棄式物件,其中該物件選自 下列各物:尿布、學習褲、排泄物袋、女性衛生梯、 褲墊、衛生棉條、可棄式擦拭部、及可棄式巾。 23 ·如申請專利範圍第6項之可棄式物件,其中該等第一或 第一生物感測器的至少一者係偵測僅超過一預定低1 值之目標生物性分析物。 2 4 .如申請專利範圍第6項之可棄式物件,其中該等第一或 第一生物感測器的至少一者額外包含一個訊號電測^ 換器。 25 ·如申請專利範圍第24項之可棄式物件,其中該訊號電 測轉換器選自下列各物:電化性、光學性、熱性、及 聲音性訊號電測轉換器。 26 ·如申請專利範園第24項之可棄式物件,其中僅在目標 生物性分析物超過一預定低限值時,該等訊號電測轉 換器才會發出訊號。 2 7 ·如申請專利範圍第6項之可棄式物件,其中該等第一或 第二生物感測器的至少一者提供一訊號予下列至少一 4- 私纸張尺度14财目S家標準(CNS ) A4· dTx297&amp;^ )_ (請先閲讀背面之注意事項再填寫本頁) 訂 f 0 —^ϋ I 476640 A8 B8 C8 D8 申請專利範圍 經濟部中央標準局員工消費合作社印製 者:穿戴者、看護者'致動器。 A如申請專利範圍第27項之可棄式 一個目視指示。 29.如申請專利範圍第27項之可棄式物 定性性質。 3 0.如申請專利範圍第27項之可棄式物件 定量性質。 31·如申請專利範圍第27項之可棄式物件 至少持續於該物件使用壽命的全程。 3 2 ·如申請專利範圍第6項之可杳 、 j案式物件,其中該物件額 包含該等第一或第二生物咸、、目丨丨w山 ^玍物感測态中至少一者所用之 個清潔元件。 3 3 ·如申请專利範圍第6項之可杳彳 」案式物件,其中該等第一 第二生物感測器係附接至一個支撐元件。 3 4 ·如申清專利範圍第3 3項之可委斗^ 闲不月义了棄式物件,其中該支撐 件黏著至穿戴者皮膚。 35·如申請專利範圍第33項之可棄式物件,其中該支撐 件為一個黏膠帶。 3 6·如申請專利範圍第6項之可棄式物件 第二生物感測器可從物件脫離。 3 7 ·如申請專利範圍第6項之可棄式物件 第一生物感測器黏著至穿戴者皮膚。 3 8 ·如申請專利範圍第6項之可棄式物件 為排泄物、尿液、月經、陰道排放物 其中該訊號為 其中該訊號為 其中該訊號為 其中該訊號可 --------,#! (請先閱讀背面之注意事項再填寫本頁) 外 或 元 元 其中該等第一或 其中該等第一或 其中該身體物 汗、唾液或精液 質 、1Τ f 5- π- / UUHW申請專利範圍 A8 B8 C8 D8 經濟部中央標隼局員工消費合作社印製 3 9 ·如申:青專利範圍第j項之可棄式物件,其中該身體物質 為位於穿戴者皮膚上之殘留排泄物冷染。 4〇.如中=專利範圍第6頃之可棄式物件,進_步包含一個 致動器,以在該等第一或第二生物感測器的至少一者 41 目標生物性分析物時,進行-回應功能。 •:、清專利範圍第40項之可棄式物件,其中該回應功 能為提供看護者或穿戴者之一訊號。 4 2 .如申請專利範圍第4 , 員 &lt; 可棄式物件,其中該致動器 係轉變一位能以進行 、、 丁 U應功把,孩位能選自下列之一 或夕項:機械能、電能及化學能。 4;3 .如申請專利範圍第6項 案式物件,進一步包含一 接收器。 % 7 b。 44 ·如申請專利範圍第Μ 、&lt; 了棄式物件,其中該接收 與孩物件為一體。 4 5 ·如申請專利範園第4 3項 個發送器。 貝…式物件,進一步包含一 46·如申請專利範圍第6項之 μ显咖、k * 案式物件’其中該生物感測 态暴路於排泄物時具有至少 啯主為回應因子。 4 7 ·如申請專利範圍第6項之可鲞々 哭異咖古* 負疋了棄式物件,其中該生物感測 為暴路於每克生理食鹽水中 夺㈣今趟f、、吐 T i8〇M克糞臭素濃度的糞 素H谷夜時具有至少為5之回應因子。 4 8 ·如申請專利範圍第6項之可查彳4 π &amp;丨夂榀· e t 棄式物件,其中該物件選 下列各物·尿布、學習族、4 排泄物袋、女性衛生梢 褲墊、衛生棉條。 文味俾了生棉 個 器 臭 (請先閲讀背面之注意事項再填寫本頁) 、1T -6- 本紙張尺度適用中國國家標準(CNS ) Α4^^|7ΐ〇χ297^^· 476640 經濟部中央標隼局員工消費合作社印製 A8 B8 C8 D8 々、申請專利範圍 49.如中請專利範圍第6項之可棄式物件,其中該物件為一 個由穿戴者穿用的物件,包含: 一頂層; 一底層,與該頂層相接合; 及一吸收核心,配置於該頂層與該底層之間。 5 0· —種可棄式物件,包含一個診斷面板以適於偵測腹瀉 的常見原因,該診斷面板包括: 至少一個第一生物感測器及一個第二生物感測器, 該第一生物感測器適於偵測至少一個第一目標生物性 分析物,而該第二生物感測器適於偵測與該第一目標 生物性分析物不同之至少一個第二目標生物性分析物 〇 5 1 .如申請專利範圍第5 〇項之可棄式物件,其中該物件選 自:一個可棄式擦拭部及一個可棄式巾。 5 2 ·如申請專利範圍第5 〇項之可棄式物件,其中該等生物 識別元件包含生物反應劑。 53·如申請專利範圍第50項之可棄式物件,其中至少一個 生物識別元件選自下列各物··一酶或酶的序列;一抗 體’去氧核酷核酸(D N A); —細胞器;一薄膜受體蛋 白質,一天然或合成薄膜;可存活或不可存活細菌性 、植物、動物的細胞;至少一部份的一神經束;至少 一部份的一感測器官。 5 4 .如申請專利範圍第5 0項之可棄式物件,其中該生物識 別元件選自鮑曼尼不動捍菌ΤΟΠ6 (Acinet〇bacter 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) ---------d------IT------0— (請先閱讀背面之注意事項再填寫本頁) 476640 A8 B8 C8 D8 經濟部中央標準局員工消費合作社印製 六、申請專利範圍 baumanniiT0136)及芽胞桿菌屬sp το⑷。 55·如申請專利範圍第5〇項之可棄式物件,纟中該生物識 別元件配置於選自下列各物之一個基材上:聚合物為 基礎的材料、水凝膠、薄紙、非織造材料、及織造材 料。 56.如申請專利範圍第50項之可棄式物件,其中該診斷面 板適於偵測腹瀉的致病原因。 57·如申請專利範園第5〇項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測腹瀉之一或多個病毒性 原因,以對於使用者、看護者或醫療人員指示已出現 一或多個病毒性原因。 58·如申請專利範圍第57項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測下列至少一項:輪狀病 毒、星形病毒、鈣病毒、腺病毒及諾沃克因子病毒。 5 9 .如申請專利範圍第5 0項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測腹瀉之一或多個細菌性 原因,以對於使用者、看護者或醫療人員指示已出現 一或多個細菌性原因。 60·如申請專利範圍第59項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測下列至少一項··致腸病 性大腸捍菌(EPEC)、腸毒性大腸桿菌(ETEC)、腸出血 性大腸样菌(EHEC)、腸侵襲性大腸桿菌(EIEc)、及腸 黏性大腸样菌(EAEC)、傑竹尼彎曲桿菌(Campyl〇bacter jejuni)、霍亂弧菌及志贺氏桿菌菌株包括索氏志賀氏菌 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐) --------如— (請先閲讀背面之注意事項再填寫本頁) 訂 f 476640 經濟部中央標準局員工消費合作社印製 A8 B8 C8 D8 六、申請專利範圍 (S· sonnei)及弗氏志贺氏菌(S· flexneri)。 6 1 ·如申請專利範圍第5 0項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測腹瀉之一或多個致病原 因,以對於使用者、看護者或醫療人員指示已出現一 或多個原因。 6 2 ·如申請專利範圍第6 1項之可棄式物件,其中該第一生 物感測器適於偵測腹瀉的至少一個病毒性原因,而該 第二生物感測器適於偵測腹瀉的至少一個細菌性原因 〇 6 3 ·如申請專利範圍第5 0項之可棄式物件,其中該等第一 及第二生物感測器各適於偵測腹瀉之一或多個原生動 物性原因,以對於使用者、看護者或醫療人員指示已 出現一或多個原生動物性原因。 6 4 · —種用於偵測出現陰道感染之物件,包含: 一個生物感測器,包括至少一個生物識別元件,該 生物感測器適於偵測身體物質中之一個目標生物性分 析物’其中該生物性分析物可指示已出現陰道感染, 其中該物件選自下列各物:女性衛生裝置、貼片、 可棄式擦拭部、可棄式巾、衛生紙、液體收集裝置。 6 5 ·如申請專利範圍第6 4項之物件,其中該生物性分析物 係指示已出現細菌性陰道病。 6 6 ·如申請專利範園第6 5項之物件,其中該等生物感測器 係偵測可说造成細菌性陰道病(vagin〇sis)之各種特定類 1、,田Η ’包括陰道加德諾菌(Gardnerella vaginalis)、普 -9- 張尺麟财關家縣(CNS )T^721QX297公疫)- ----------- (請先閲讀背面之注意事項再填寫本頁) 訂- ^/0040 ^/0040 經濟部中央榡隼局員工消費合作社印製 Α8 Β8 C8 D8 六、申請專利範圍 佛特拉碧菲亞(prevotella bivia)、類样菌種、人型枝原體 (Mycoplasma hominis)、莫必盧可斯(Mobiluncus)種。 67· —種用於偵測出現陰道感染之物件,包含: 一個診斷面板,適於偵測可能造成細菌性陰道病 (vaginosis)之非特定類型細菌, 其中該物件選自下列各物:女性衛生裝置、貼片、 可棄式擦拭部、可棄式巾、衛生紙、及液體收集装置 〇 68·如申請專利範圍第67項之物件,其中該診斷面板係偵 測體液的p Η及體液中出現之胺。 6 9 .如申请專利範圍第6 4項之物件,其中該生物性分析物 係指示出現酵母菌感染。 7〇·如申请專利範圍第64項之物件,其中該生物性分析物 係指示出現性傳染病。 7 1 ·如申清專利範圍第7 〇項之物件,其中該生物性分析物 係指示出現陰道滴蟲病。 72.如申請專利範圍第64項之物件,丨中該生物感測器設 置於一個女性衛生裝置的向身體側上。 73·如申請專利範圍第72項之物件,丨中該生物感測器包 含至少一個覆有一覆蓋元件之感測器元件。 74.如申請專利範圍第73項之物件,丨中該覆蓋元件為可 撓性。 Μ.如申請專利範圍第73項之物件,進—步包本擞該至少 -個感測器相鄰之—個毛細元件,以使身體物質接觸 -10- 家標準(CNS ) 公楚)-------- ----------- (請先閲讀背面之注意事項再填寫本頁) 訂 476640 A8 B8 C8 D8 六、申請專利範圍 該至少一個感測器元件。 7 6 . —種吸收性陰唇間裝置,具有一個接觸身體表面且包 含一個吸收核心,且在該陰唇間裝置的接觸身體表面 上相隔狀配置有至少兩個偵測裝置,其中一個該等偵 測裝置能夠偵測尿液中之一物質,且至少一個該等偵 測裝置能夠偵測月經中之一物質。 (請先閲讀背面之注意事項再填寫本頁) 經濟部中央標隼局員工消費合作社印製 -11 - 本紙張尺度適用中國國家標準(CNS ) A4規格(210 X 297公釐)No. 89114348 Patent Application AS J Chinese Patent Application Amendment (May 90) Day 9 Application for Patent Scope 1. Disposable objects, including: a biosensor, Baigu @ ^. Τ Enclose to 〆 A biometric identification element, which is suitable for detecting a substance in the body, or on or over the skin of a wearer, without a target biological analyte, wherein the object is selected from the following: a diaper, a study pants, One = bag,-feminine hygiene device,-disposable wipes and a disposable towel. 2. 6. Printed by the Consumer Cooperative of the Central Procurement Bureau of the Ministry of Economic Affairs as a “disposable item” The analyte is rotavirus. For example, the disposable object device of the scope of patent application is a proactive sensor. For example, the disposable object device of the patent application scope is a chroma sensor. A power source for disposable objects, such as the scope of patent application item 1. A disposable object that is worn by a wearer and includes a diagnostic panel to detect body substances or on or through the skin of a user Biological analytes, the The fault panel includes: at least one first biosensor and a second biosensor, the first biosensor is adapted to detect at least one first target biological analyte, and the second biosensor Suitable for detecting at least one second target biological analyte that is different from the first target biological analyte, wherein the target is private, the biological sense tears, and the biological sense further includes a. Disposable objects, in which the biosensor paper size is applicable to Chinese National Standard (CNS) A4 specifications (210X297 mm) (Please read the precautions on the back before filling this page) 476640 ABCD Employees, Central Bureau of Standards, Ministry of Economic Affairs Printed by Consumer Cooperatives 6. The scope of the patent application includes a bio-recognition element containing a biological reactant. 8 • For the disposable item of scope 6 of the patent application, at least one of the biosensors is selected from the following : A biocatalytic biosensor and a bioaffinity biosensor. 9 · Disposable objects such as item 8 of the patent application scope, where Affinity biosensor is selected from the group consisting of: a chemosensor-based biosensor and / or an immune sensor. I 0 · At least one biometric, such as a disposable object in the scope of patent application 6 The element is selected from the following: an enzyme or sequence of enzymes; an antibody; DNA;-organelles; a membrane receptor protein; a natural or synthetic membrane 'viable or non-viable bacterial, plant, animal cells; at least A part of a nerve bundle; at least a part of a sensing organ. II. A disposable object such as the scope of application for patent No. 10, wherein the biometric recognition element is selected from Acinetobacter baumannii TOI 36 (Acinetobacter baumannii TOI36) and Bacillus sp. 1 2 · The disposable article as claimed in item 10, wherein the biometric identification device is arranged on a substrate selected from the group consisting of a polymer-based material, a hydrogel, a thin paper, a non- Weaving materials, weaving materials, and silicon semiconductors. 13. The disposable object according to item 6 of the application, wherein the biosensor is used to detect a target biological analyte selected from the following: pathogenic bacteria, colon bacteria, viruses, parasites, bacteria Sexual toxins, fungi, slugs. 1 4 · If the disposable item in the scope of patent application No. 6 is used, the paper size of the diagnostic panel is applicable to the Chinese national standard (CNS> A4 specification (210 X 297 mm) -------- Qin I — (Please read the notes on the back before filling this page) Order 476640 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs A8 B8 C8 D8 6. The scope of patent application is suitable for detecting the cause of diarrhea. 1 5 · If applying for a patent Disposable items of scope 6 wherein the first and second biosensors are each adapted to detect one or more viral causes of diarrhea to indicate to a user, caregiver or medical staff that One or more viral reasons have occurred. 1 6 · Disposable objects such as the scope of patent application No. 15 wherein the first and second biosensors are each adapted to detect at least one of the following: Viruses, Astroviruses, Calcium Viruses, Adenoviruses and Norwalk Factor Viruses. 1 7 • Disposable items such as the scope of patent application No. 6, wherein the first and second biosensors are each suitable for detection One or more bacterial causes of diarrhea The user, caregiver, or medical staff indicates that one or more bacterial causes have occurred. 1 8 • If the disposable item in the scope of patent application No. 17 is used, where the first and second biosensors are applicable. Detects at least one of the following: enteropathogenic coliform (EPEC), enterotoxic coliform (ETEC), enterohemorrhagic coliform (EHEC), enteroinvasive coliform (EIEC), and intestines Coliform bacteria (EAEC), Campylobabacter jejuni, Vibrio cholerae and Shigella-like strains include S. sonnei and Shigella · Flexneri). 1 9 · The disposable item according to item 6 of the patent application, wherein each of the first and second biosensors is adapted to detect one or more causes of diarrhea, and Instructors, caregivers, or medical personnel have indicated that _ or more reasons have occurred. 2 0 · If the disposable item in the scope of patent application No. 19, where the paper size of the _then original paper is applicable to China National Standard (CNS) A4 specifications (210X297mm) (Please read the notes on the back before filling this page) Order f 476640 A8 B8 C8 D8 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 6. Patent application scope The object identification element is suitable for detecting at least one viral cause of diarrhea, and the second biometric element is suitable for detecting at least one viral cause of diarrhea. A bacterial cause. 2 1 · The disposable item as claimed in item 6 of the patent application, wherein the first and second biosensors are each adapted to detect the cause of diarrhea—or multiple primary causes—for The user, caregiver, or medical staff indicates that one or more protozoan causes have occurred. 2 2 · Disposable items as claimed in item 6 of the scope of patent application, wherein the items are selected from the following: diapers, study pants, fecal bags, feminine hygiene ladders, pants pads, tampons, disposable wipes , And disposable towels. 23-The disposable object according to item 6 of the patent application, wherein at least one of the first or first biosensors detects a target biological analyte that exceeds only a predetermined low 1 value. 24. The disposable article according to item 6 of the patent application scope, wherein at least one of the first or first biosensors additionally includes an electrical signal transducer. 25. The disposable object according to item 24 of the patent application, wherein the signal electrical transducer is selected from the group consisting of electrochemical, optical, thermal, and acoustic signal electrical transducers. 26. If the disposable object of the patent application park No. 24 is used, only when the target biological analyte exceeds a predetermined low limit, these signal electrical converters will send a signal. 2 7 · If the disposable item in the scope of patent application No. 6 is applied, at least one of the first or second biosensors provides a signal to at least one of the following: Standard (CNS) A4 · dTx297 & ^) _ (Please read the notes on the back before filling out this page) Order f 0 — ^ I 476640 A8 B8 C8 D8 Application for Patent Scope Printed by the Central Consumers Bureau Employees Cooperatives of the Ministry of Economic Affairs : Wearer, caregiver 'actuator. A. A visual indication, such as disposable item 27 in the scope of patent application. 29. The qualitative properties of the disposables as claimed in item 27 of the patent application. 3 0. Quantitative properties of disposable objects as claimed in item 27. 31. Disposable objects such as those in the scope of patent application No. 27 shall continue for at least the entire life of the object. 3 2 · If the patentable item j in item 6 of the scope of the patent application, the item amount includes at least one of the first or second biological salt, the object, and the object sensing state. One cleaning element used. 3 3 · As for the case of the patentable item No. 6, the first and second biosensors are attached to a supporting element. 3 4 · If you can claim the item No. 33 in the scope of the patent, you can fight it. ^ It is an indisputable object, in which the support is adhered to the skin of the wearer. 35. The disposable article according to item 33 of the patent application, wherein the support member is an adhesive tape. 3 6 · Disposable objects such as the scope of patent application No. 6 The second biosensor can be detached from the object. 3 7 · Disposable article as described in item 6 of the patent application The first biosensor is adhered to the wearer's skin. 3 8 · If the disposable items in the scope of application for patent No. 6 are excreta, urine, menstruation, vaginal discharge, where the signal is where the signal is where the signal is where the signal may be ------- -, #! (Please read the notes on the back before filling out this page) Wai or Yuan Yuan Which of the first or which of the first or of the body sweat, saliva or semen quality, 1Τ f 5- π- / UUHW patent application scope A8 B8 C8 D8 Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 3 9 · Rushen: Disposable article in the scope of j patent scope, where the body substance is a residue on the skin of the wearer Feces are cold-stained. 40. If the medium = disposable object in the 6th item of the patent scope, further includes an actuator to at least one of the first or second biosensors when the target biological analyte is 41 , Carry-response function. •: Disposable object in item 40 of the patent, where the response function is to provide a signal for the caregiver or wearer. 4 2. If the scope of the patent application is No. 4, the member &lt; disposable object, in which the actuator is converted to a position, which can be used to handle power, the position can be selected from one or the following items: Mechanical, electrical and chemical energy. 4; 3. The item of claim 6 further includes a receiver. % 7 b. 44. If the scope of application for patent M, &lt; discarded objects, wherein the receiving and child objects are integrated. 4 5 · If the patent application Fanyuan Item 4 3 transmitters. The shell-type object further includes a 46. For example, the μ-appearance and k * case-type object of item 6 of the patent application range, wherein the biosensory state road has at least the main factor as the response factor in the excrement. 4 7 · If you can cry crying different coffee in item 6 of the scope of application for patent * Disposable objects, in which the biosensor is violently lost the current trip f, spit T i8 per gram of physiological saline The faecal H at a concentration of OM gram skatole has a response factor of at least 5 at night. 4 8 · If you can find 4 π &amp; 丨 夂 榀 · et disposable items in the scope of the patent application, the items include the following items: diapers, learning clan, 4 excrement bags, feminine sanitary trousers , Tampons. The text smelled of raw cotton odor (please read the precautions on the back before filling in this page), 1T -6- This paper size applies Chinese National Standard (CNS) Α4 ^^ | 7ΐ〇χ297 ^^ · 476640 Ministry of Economic Affairs A8 B8 C8 D8 printed by the Central Bureau of Consumers' Cooperatives, patent application scope 49. Disposable items such as item 6 of the patent scope, where the item is an item worn by the wearer, including: A top layer; a bottom layer coupled to the top layer; and an absorbent core disposed between the top layer and the bottom layer. 5 0 · — A disposable object, including a diagnostic panel suitable for detecting common causes of diarrhea, the diagnostic panel includes: at least a first biosensor and a second biosensor, the first biological sensor The sensor is adapted to detect at least one first target biological analyte, and the second biosensor is adapted to detect at least one second target biological analyte that is different from the first target biological analyte. 51. The disposable article as claimed in claim 50, wherein the article is selected from a disposable wiper and a disposable towel. 5 2 · The disposable article as claimed in claim 50, wherein the bio-identifying element contains a biological reactant. 53. The disposable object as claimed in claim 50, wherein at least one biometric element is selected from the following: an enzyme or an enzyme sequence; an antibody 'deoxyribonucleic acid (DNA);-organelle A membrane receptor protein, a natural or synthetic membrane; viable or non-viable bacterial, plant, animal cells; at least a part of a nerve bundle; at least a part of a sensing organ. 5 4. If the disposable object of the scope of application for the item 50 of the patent, wherein the biometric identification element is selected from Baumannii Acinetobacter ΤΟΠ6 (Acinet〇bacter This paper size applies Chinese National Standard (CNS) A4 specification (210X297 public ) --------- d ------ IT ------ 0— (Please read the notes on the back before filling this page) 476640 A8 B8 C8 D8 Central Bureau of Standards, Ministry of Economic Affairs Printed by the Consumer Consumption Cooperative 6. The scope of patent applications (baumanniiT0136) and Bacillus sp. Το⑷. 55. If the disposable object in the scope of application for the item 50, the biometric identification element is arranged on a substrate selected from the following: polymer-based material, hydrogel, tissue, nonwoven Materials, and weaving materials. 56. The disposable object according to claim 50, wherein the diagnostic panel is suitable for detecting the cause of diarrhea. 57. For example, the disposable object of the patent application No. 50, wherein the first and second biosensors are each suitable for detecting one or more viral causes of diarrhea, for the user, care The person or medical staff indicates that one or more viral causes have occurred. 58. The disposable object according to item 57 of the patent application scope, wherein the first and second biosensors are each suitable for detecting at least one of the following: rotavirus, astrovirus, calcium virus, adenovirus And Norwalk factor virus. 59. The disposable object according to item 50 of the scope of patent application, wherein the first and second biosensors are each suitable for detecting one or more bacterial causes of diarrhea, so as to provide users, care The person or medical staff indicates that one or more bacterial causes have occurred. 60. If the disposable object in the scope of patent application No. 59, wherein the first and second biosensors are each suitable for detecting at least one of the following: · enteropathogenic coliform (EPEC), intestine Toxic Escherichia coli (ETEC), Enterohemorrhagic coliform (EHEC), Enteroinvasive E.coli (EIEc), and Enterococcus coliform (EAEC), Campylobacter jejuni, Cholera Vibrio and Shigella strains include Shigella Sox. The paper size is applicable to the Chinese National Standard (CNS) A4 specification (210X 297 mm) -------- if— (Please read the precautions on the back first Refill this page) Order f 476640 A8 B8 C8 D8 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 6. Application for patents (S · sonnei) and Shigella flexneri (S · flexneri). 6 1 · If the disposable object in the scope of patent application No. 50, wherein the first and second biosensors are each suitable for detecting one or more causes of diarrhea, for the user, care The person or medical staff indicates that one or more reasons have occurred. 6 2 · The disposable article according to item 61 of the patent application scope, wherein the first biosensor is suitable for detecting at least one viral cause of diarrhea, and the second biosensor is suitable for detecting diarrhea At least one bacterial cause of the disease. 063. The disposable object as described in claim 50, wherein each of the first and second biosensors is adapted to detect one or more protozoa of diarrhea. The reason to indicate to the user, caregiver, or medical staff that one or more protozoan causes have occurred. 6 4 · —An object for detecting the occurrence of a vaginal infection, comprising: a biosensor including at least one biometric element, the biosensor is adapted to detect a target biological analyte in a substance of the body ' The biological analyte may indicate that a vaginal infection has occurred. The object is selected from the following: feminine hygiene devices, patches, disposable wipes, disposable towels, toilet paper, and liquid collection devices. 65. The item according to item 64 of the patent application scope, wherein the biological analyte indicates that bacterial vaginosis has occurred. 6 6 · If the object of the patent application No. 65 item, these biosensors detect a variety of specific types that can be said to cause bacterial vaginosis (vagin〇sis) 1, Tian Tian 'including vagina plus Denorella (Gardnerella vaginalis), Pu-9-Zhang Chilin Caiguanjia County (CNS) T ^ 721QX297 public epidemic)------------ (Please read the precautions on the back before filling (This page) Order-^ / 0040 ^ / 0040 Printed by the Consumer Affairs Cooperative of the Central Government Bureau of the Ministry of Economic Affairs Α8 Β8 C8 D8 VI. Patent Application Scope Prevotella bivia, Mycoplasma, Humanoid Mycoplasma hominis, Mobiluncus species. 67 · —An object for detecting a vaginal infection, including: a diagnostic panel suitable for detecting non-specific types of bacteria that may cause vaginosis, wherein the object is selected from the following: feminine hygiene Device, patch, disposable wiper, disposable towel, toilet paper, and liquid collection device 68. Such as the object of the patent application No. 67, wherein the diagnostic panel detects p Of amine. 69. The article according to item 64 of the patent application scope, wherein the biological analyte indicates an yeast infection. 70. The article under the scope of patent application 64, wherein the biological analyte indicates the occurrence of a sexually transmitted disease. 7 1 · The article of scope 70 in the patent application, wherein the biological analyte indicates the presence of trichomoniasis. 72. The item according to item 64 of the application, wherein the biosensor is placed on the body-facing side of a feminine hygiene device. 73. If the object of the scope of patent application No. 72, the biosensor includes at least one sensor element covered with a covering element. 74. In the case of the item No. 73 of the scope of patent application, the covering element is flexible. M. If the item in the scope of patent application No. 73, further steps include a capillary element which is adjacent to at least one sensor, so that the body material can contact the -10- House Standard (CNS). ------- ----------- (Please read the notes on the back before filling out this page) Order 476640 A8 B8 C8 D8 VI. Patent application scope This at least one sensor element. 7 6. An absorptive interlabial device, which has a body-contacting surface and includes an absorption core, and at least two detection devices are arranged on the body-contacting surface of the interlabial device, one of which detects The device can detect one substance in the urine, and at least one of these detection devices can detect one substance in the menstrual period. (Please read the notes on the back before filling out this page) Printed by the Employees' Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs -11-This paper size applies to China National Standard (CNS) A4 (210 X 297 mm)
TW089114348A 2000-03-02 2000-07-18 Disposable article, article for detecting the presence of vaginal infections, and absorbent interlabial device TW476640B (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI552734B (en) * 2011-12-27 2016-10-11 Kao Corp Absorbent items
CN106999164A (en) * 2014-08-21 2017-08-01 古拉森斯股份有限公司 For the system and method for the non-invasive analysis for carrying out body fluid
US10973496B2 (en) 2016-03-18 2021-04-13 Qurasense, Inc. Collection device for diagnostics of vaginal discharge

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI552734B (en) * 2011-12-27 2016-10-11 Kao Corp Absorbent items
CN106999164A (en) * 2014-08-21 2017-08-01 古拉森斯股份有限公司 For the system and method for the non-invasive analysis for carrying out body fluid
US10993645B2 (en) 2014-08-21 2021-05-04 Qurasense Inc. System and method for non-invasive analysis of bodily fluids
CN106999164B (en) * 2014-08-21 2023-08-22 古拉森斯股份有限公司 System and method for performing non-invasive analysis of body fluids
US10973496B2 (en) 2016-03-18 2021-04-13 Qurasense, Inc. Collection device for diagnostics of vaginal discharge

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