TWI548395B - 連續經皮微針監測系統 - Google Patents

連續經皮微針監測系統 Download PDF

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TWI548395B
TWI548395B TW103103314A TW103103314A TWI548395B TW I548395 B TWI548395 B TW I548395B TW 103103314 A TW103103314 A TW 103103314A TW 103103314 A TW103103314 A TW 103103314A TW I548395 B TWI548395 B TW I548395B
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microneedle
sheet
spur
monitoring system
perforation
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TW103103314A
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TW201529039A (zh
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黃榮堂
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微凸科技股份有限公司
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Priority to TW103103314A priority Critical patent/TWI548395B/zh
Priority to US14/265,234 priority patent/US10070820B2/en
Priority to EP14171687.8A priority patent/EP2898921B1/en
Publication of TW201529039A publication Critical patent/TW201529039A/zh
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Publication of TWI548395B publication Critical patent/TWI548395B/zh
Priority to US16/111,618 priority patent/US11569399B2/en
Priority to US18/086,066 priority patent/US11830955B2/en

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Description

連續經皮微針監測系統
本發明係與經皮感測器有關，特別有關於一種量測皮下的目標分子濃度以獲知人體生理訊號之經皮微針感測器。
皮下組織是人類組織液流動分佈的主要地方，組織液中富含有胺基酸、糖、脂肪酸、輔酶、激素、神經遞質、鹽及細胞產生之廢物等，是細胞與血液交流的主要管道，因此透過組織液中各成份的濃度，是用以判斷生理狀況的方法之一。
服用或施打藥物時，藥物會在組織液中長時間且緩慢的釋放，在藥物開發及使用的臨床實驗過程中，往往需不斷地監控藥物於組織液中濃度的變化，也因此取樣組織液以進行檢測或分析，在醫療程序中是隨處可見的。
現今市面所見之生理檢測器材，或醫護人員採樣組織液的方法，多半採扎針並穿破角質層，來抽取組織液以進行分析檢測，然而此種破壞皮膚表層的取樣方法，除了容易使患者感覺疼痛，進而萌生排斥感外，皮膚表層的大量微生物，也容易在皮膚表層遭破壞的情況下，進入人體進而感染。為了改善扎針並穿破角質層取樣的缺點，有提出經皮感測器，其係利用陣列形式之微針進行皮膚穿刺，低侵入性的穿刺能夠有效減輕使用者的疼痛感，又同時達到取樣組織液的目的。
經皮感測器之微針製作常見有利用微影及蝕刻等半導體製程，例如美國專利US7,344,499B1的說明書第12欄第2段揭示一種矽微針的製程。首先，提供其上覆蓋有圖案化的第一光阻層之一矽晶圓。接著，利用等向性蝕刻方式進行蝕刻，形成一穿孔。接著，於晶圓表面塗佈一鉻層，之後塗佈圖案化的一第二光阻層，以至於覆蓋在穿孔上，及形成一圓形遮罩供後續蝕刻。接著，進行蝕刻以形成微針的外錐壁。然而，由於含矽半導體材料的脆性，當微 針穿刺皮膚進行感測時，微針容易斷裂。
另外，有提出使用雷射微加工的方式，對樹脂形成的突刺鑽孔，以製作中空微針。首先，使用例如聚醯亞胺樹脂或聚醚醚酮樹脂進行擠出成型，形成其上具有複數個突刺的薄片，接著使用雷射對突刺鑽孔，即可得到中空微針。然而，由於微針尺寸極細小，擠出成型時突刺可能產生毛邊，而且不論是偏軸穿孔或中心穿孔，使用雷射形成統一的孔徑並非容易。
有鑑於此，本發明人為改善並解決上述之缺失，乃特潛心研究並配合學理之運用，終於提出一種設計合理且有效改善上述缺失之本發明。
本發明之一目的，在於提供一種連續經皮微針監測系統，其微針組的微針係藉由衝壓或蝕刻製程形成，具有足夠的機械強度，當微針組之微針穿刺皮膚進行感測時，微針能保持完好。而且，本發明之工作電極微針組之結構有利於將感測高分子塗佈在微針尖端部之內 表面，於工作電極微針組之微針穿刺皮膚進行感測時，可減少感測高分子之剝落。
為了達成上述之目的，本發明係為一種連續經皮微針監測系統，此監測系統包含：基板、微針單元、訊號處理單元及電源單元。微針單元至少包含排列於基板上作為工作電極的第一微針組，以及作為參考電極的第二微針組，每一微針組至少包含一微針，第一微針組係包含至少一薄片，每一薄片上至少設置一穿孔，穿孔邊緣設置有一突刺，其中一薄片上的穿孔係供其餘的薄片上相對位置的穿孔邊緣的突刺穿過，且該些突刺互相分離。
本發明之另一目的，在於提供一種間質液的感測裝置，其微針組的微針係藉由衝壓或蝕刻製程形成，具有足夠的機械強度，當微針組之微針穿刺皮膚進行感測時，微針能保持完好。而且，本發明之工作電極微針組之結構有利於將感測高分子塗佈在微針尖端部之內表面，於工作電極微針組之微針穿刺皮膚進行感測時，可減少感測高分子之剝落。
為了達成上述之目的，本發明係為一種間質液的感測裝置，此裝置包含基板及微針單元。微針單元至少包含排列於基板上的第一微針組和第二微針組，其中第一微針組作為工作電極，第一微針組的該些微針係以陣列形式排列於該基板上，第二微針組作為參考電極，第二微針組至少包含一微針，第一微針組包含至少一薄片，每一薄片上至少設置一穿孔，穿孔邊緣設置有一突刺，其中一薄片上的穿孔係供其餘的薄片上相對位置的穿孔邊緣的突刺穿過，且該些突刺互相分離。
相較於習知，本發明之微針具有足夠的機械強度，當微針組之微針穿刺皮膚進行感測時，微針能保持完好。而且，本發明之微針單元的製程簡單，有利於大量生產。
10‧‧‧基板
20‧‧‧微針單元
21‧‧‧導電柱
22‧‧‧第一微針組
23‧‧‧導電柱
24‧‧‧第二微針組
25‧‧‧導電柱
26‧‧‧第三微針組
30‧‧‧可撓性墊片
32‧‧‧開口
40‧‧‧電路板
41‧‧‧訊號處理單元
42‧‧‧電接點
43‧‧‧電源單元
44‧‧‧電接點
46‧‧‧電接點
50‧‧‧外蓋
102‧‧‧孔穴
104‧‧‧插槽
222‧‧‧第一薄片
224‧‧‧第二薄片
226‧‧‧第三薄片
228‧‧‧第四薄片
242‧‧‧第一薄片
262‧‧‧第一薄片
2221‧‧‧尖端部
2222‧‧‧第一穿孔
2223‧‧‧基底
2242‧‧‧第二穿孔
2262‧‧‧第三穿孔
2282‧‧‧第四穿孔
2422‧‧‧第一穿孔
2622‧‧‧第一穿孔
2224‧‧‧第一突刺
2244‧‧‧第二突刺
2264‧‧‧第三突刺
2284‧‧‧第四突刺
2424‧‧‧第一突刺
2624‧‧‧第一突刺
2246‧‧‧倒鉤
2426‧‧‧倒鉤
2626‧‧‧倒鉤
2248‧‧‧導柄
2428‧‧‧導柄
2628‧‧‧導柄
92‧‧‧導電層
94‧‧‧測試區域
96‧‧‧樹脂片
98‧‧‧黏著層
第一圖係本發明之一實施例連續經皮微針監測系統的爆炸分解圖﹔
第二圖係與第一圖不同觀看方向之本發明之一實施例連續經皮微針監測系統的爆炸分解圖；
第三圖係本發明之一實施例微針單元的示意圖﹔
第四圖係本發明之一實施例工作電極微針組的結構局部上視圖；
第五圖係本發明之另一實施例工作電極微針組的結構局部上視圖；
第六圖係本發明之又一實施例工作電極微針組的結構局部上視圖；
第七圖係本發明之又另一實施例工作電極微針組的結構局部上視圖；
第八圖係本發明之一實施例連續經皮微針監測系統的組合外觀示意圖；
第九圖係本發明之一實施例連續經皮微針監測系統的組合剖面示意圖；
第十圖係第九圖之局部剖面示意圖，其中感測高分子係塗佈在微針的突刺上；
第十一圖係第九圖之局部剖面示意圖，其中感測高分子係塗佈在試紙片上；及
第十二圖係本發明之一實施例連續經皮微針監測系統的組合局部剖面示意圖，其中導柄經部分彎折直接與電路板上的接點電性連接，而不使用導電柱。
有關本發明之詳細說明及技術內容，配合圖式說明如下，然而所附圖式僅提供參考與說明用，並非用來對本發明加以限制者。
請參照第一圖和第二圖，第一圖和第二圖係分別由不同方向觀看本發明之一實施例連續經皮微針監測系統的爆炸分解圖。本發明之連續經皮微針監測系統包含：基板10、微針單元20、可撓性墊片30、訊號處理單元41、電源單元43 及外蓋50，其中訊號處理單元41和電源單元43係設置於電路板40上。
根據本發明之一實施例，微針單元20包含排列於基板10上作為工作電極的第一微針組22、作為參考電極的第二微針組24，以及作為反電極的第三微針組26。第一微針組22的該些微針可以例如是陣列形式排列於基板10上。可撓性墊片30上具有一開口32供微針單元20通過，且微針單元20以導電柱21、23、25與電路板40上的電接點42、44、46電性連接。由於本發明具有可撓性墊片30，操作時可與使用者的肌肉輪廓共型，緊密接觸。
訊號處理單元41與微針單元20電性連接以接收微針感測的目標分子濃度，經運算判定後，將資訊轉換成一感測訊號，也是一種能夠反映使用者當下的生理狀態的訊號。電源單元43係供應工作電力至本發明之連續經皮微針監測系統。
請參照第三圖，第三圖係本發明之一實施例微針單元的示意圖。第一微針組22係由第一薄片222和第二薄片224疊置而成，第一薄片222上至少設置一第一穿孔2222，該第一穿孔2222邊緣設置有一第一突刺2224，及第二薄片224上至少設置一第二穿孔2242，第二穿孔邊緣設置有一第二突刺2244，第二突刺2244穿過第一薄片222上相對位置的第一穿孔2222與第一突刺2224相對。此外，第一微針組22的第二薄片224邊緣上可設置倒鉤2246與基板10上的孔穴102卡合。在一實施例，第一微針組22的第二薄片224邊緣上可設置導柄2248插入基板10上的插槽104，藉由電路與導電柱21電性連接。
同理，第二微針組24也具有第一薄片242，第一薄片242上至少設置一第一穿孔2422，第一穿孔邊緣設置有一第一突刺2424。此外，第二微針組24的第一薄片242邊緣上可設置倒鉤2426與基板10上的孔穴102卡合。在一實施例，第二微針組24的第一薄片242邊緣上可設置導柄2428插入基板10上的插槽104，藉由電路與導電柱23電性連接。
同理，第三微針組26也具有第一薄片262，第一薄片262上至少設置一第一穿孔2622，第一穿孔2622邊緣設置有一第一突刺2624。此外，第三微針組26的第一薄片262邊緣上可設置倒鉤2626與基板10上的孔穴102卡合。在一實施例，第三微針組26的第一薄片262邊緣上可設置導柄2628插入基板10上的插槽104，藉由電路與導電柱25電性連接。
本發明之一實施例，第一微針組22、第二微針組24和第三微針組26的微針係藉由衝壓或蝕刻製程形成。該些突刺的材料係選自不鏽鋼、鎳、鎳合金、鈦、鈦合金、奈米碳管或矽材料，且於表面沉積具有生物相容性的金屬。該些突刺的材料也可以是樹脂例如是聚碳酸酯、聚甲基丙烯酸共聚物、乙烯/醋酸乙烯酯共聚物、鐵氟龍或聚酯類，並於表面沉積具有生物相容性的金屬。該些突刺的高度為300-600微米、基底寬度為150-450微米。該些突刺的尖端部的間隔為500-3000微米。
請參考第四圖至第七圖。第四圖係本發明之一實施例工作電極微針組的結構局部上視圖。第一微針組22係由第一薄片222和第二薄片224疊置而成，第一薄片222上至少設置一第一穿孔2222，第一穿孔2222邊緣設置有一第一突刺2224，及第二薄片224上至少設置一第二穿孔2242，第二穿孔邊緣設置有一第二突刺2244，第二突刺2244穿過第一薄片222上相對位置的第一穿孔2222與第一突刺2224相對。
第五圖係本發明之另一實施例工作電極微針組的結構局部上視圖。第一微針組22係由第一薄片222、第二薄片224和第三薄片226疊置而成，第一薄片222上至少設置第一穿孔2222，第一穿孔2222邊緣設置有一第一突刺2224，第二薄片224上至少設置一第二穿孔2242，第二穿孔2242邊緣設置有一第二突刺2244，及第三薄片226上至少設置一第三穿孔2262，第三穿孔2262邊緣設置有一第三突刺2264，第二突刺2244和第三突刺2264穿過第一薄片222上的第一穿孔2222與第一突刺2224呈正三角錐形。
第六圖係本發明之又一實施例工作電極微針組的結構局部上視圖。第一微針組22係由第一薄片222、第二薄片224、第三薄片226疊置而成，其中第一薄片222上至少設置一第一穿孔2222，第一穿孔2222邊緣設置有一第一突刺2224；第二薄片224上至少設置一第二穿孔2242，第二穿孔2242邊緣設置有一第二突刺2244；及第三薄片226上至少設置一第三穿孔2262，第三穿孔2262邊緣設置有一第三突刺2264，將第二突刺2244和第三突刺2264穿過第一薄片222上的第一穿孔2222與第一突刺2224相鄰排列，呈等腰直角三角錐形。
第七圖係本發明之又另一實施例工作電極 微針組的結構局部上視圖。第一微針組22係由第一薄片222、第二薄片224、第三薄片226和第四薄片228疊置而成，第一薄片222上至少設置一第一穿孔2222，第一穿孔2222邊緣設置有一第一突刺2224，第二薄片224上至少設置一第二穿孔2242，第二穿孔2242邊緣設置有一第二突刺2244，第三薄片226上至少設置一第三穿孔2262，第三穿孔2262邊緣設置有一第三突刺2264及第四薄片228上至少設置一第四穿孔2282，第四穿孔2282邊緣設置有一第四突刺2284，第二突刺2244、第三突刺2264和第四突刺2284穿過第一薄片222上的第一穿孔2222與第一突刺2224呈四角錐形。
第四至七圖所示的四個實施例中，第一微針組22之每一突刺2224包含一尖端部2221及一基底2223，其中一薄片上的穿孔經其餘的薄片上相對位置的穿孔邊緣的突刺穿過後形成的該微針的該些尖端部的頂部不在同一高度。或者，可以依照該些薄片重疊的次序，預先設計其突刺的高度，使其中一薄片上的穿孔經其餘的薄片上相對位置的穿孔邊緣的突刺穿過後形成的該微針的該些尖端部的頂部具有同一高度。
接著，請參考第八圖和第九圖。第八圖係本發明之一實施例連續經皮微針監測系統的組合外觀示意圖。第九圖係本發明之一實施例連續經皮微針監測系統的組合剖面示意圖。本實施例中的第一微針組22係由第一薄片222和第二薄片224疊置而成，可例如施加一衝壓力於第一薄片222和第二薄片224的四周以結合兩者。第二微針組24只具有第一薄片242。第三微針組26也只具有第一薄片262。由於本發明具有可撓性墊片30，操作時可與使用者的肌肉輪廓共型，緊密接觸。
接著，請參考第十圖，第十圖係第九圖之局部剖面示意圖，其中感測高分子係塗佈在微針的突刺上。具體而言，感測高分子係塗佈在突刺的內表面上，突刺的外表面上塗佈有 抗皮膚過敏的藥物。本實施例中，感測高分子例如是抗體、適體、重組單體(ScFv)、醣類、葡萄糖氧化酶（Glucose Oxidase）或羥基丁酸脫氫酶（HBHD）。一個表面塗有感測高分子的微針的連續經皮微針監測系統，可用以偵測皮膚表層中的目標分子濃度，且此濃度可作為判定生理狀態的指標之一。
第十一圖係第九圖之局部剖面示意圖，其中感測高分子係塗佈在試紙片上。本實施例與第十圖所示實施例之差異在於，本實施例之第一微針組22係作為萃取間質液的工具，突刺上並不塗佈感測高分子，感測高分子係塗佈在位於第一微針組22下方之試紙片的表面上。本實施例中，試紙片係安置於第一微針組22與基板10之間，試紙片包含一導電層92及位於導電層92上的複數個測試區域94，該些測試區域94上係塗佈感測高分子，且與第一微針組22上的穿孔2222對齊。本實施例係使用樹脂片96於其上定義出該些測試區域94。此外，第一微針組22係藉由一黏著層98與試紙片接合。為了避免感測高分子 或抗皮膚過敏的藥物受到環境污染， 可於感測高分子或抗皮膚過敏的藥物之表面上形成一保護層，保護層例如是環氧樹脂-聚胺酯甲酸基樹脂（Epoxy- PU）膜。
接著，請參考第十二圖，第十二圖係本發明之一實施例連續經皮微針監測系統的組合局部剖面示意圖。本實施例中，導柄2248係經部分彎折直接與電路板40上的接點42電性連接，而不使用導電柱。
以上所述僅為本發明之較佳實施例，非用以限定本發明之專利範圍，其他運用本發明之專利精神之等效變化，均應俱屬本發明之專利範圍。
 
10‧‧‧基板
20‧‧‧微針單元
22‧‧‧第一微針組
24‧‧‧第二微針組
26‧‧‧第三微針組
30‧‧‧可撓性墊片
32‧‧‧開口
40‧‧‧電路板
42‧‧‧電接點
44‧‧‧電接點
46‧‧‧電接點
50‧‧‧外蓋

Claims (25)

  1. 一種連續經皮微針監測系統，包括：一基板；一微針單元，至少包含排列於該基板上的一第一微針組和一第二微針組，該第一微針組作為工作電極，該第二微針組作為參考電極，每一微針組至少包含一微針，該第一微針組係包含複數個薄片互相重疊，每一薄片上至少設置一穿孔，該穿孔邊緣設置有一突刺，其中一薄片上的穿孔係供其餘的薄片上相對位置的穿孔邊緣的突刺穿過，且該些突刺互相分離；一訊號處理單元，係設置於該基板上並與該第一和第二微針組電性連接；及一電源單元，係供應工作電源予該監測系統。
  2. 如請求項1所述之連續經皮微針監測系統，其中該第一微針組係由一第一薄片和一第二薄片疊置而成，該第一薄片上至少設置一第一穿孔，該第一穿孔邊緣設置有一第一突刺，及該第二薄片上至少設置一第二穿孔，該第二穿孔邊緣設置有一第二突刺，該第二突刺穿過該第一薄片上相對位置的該第一穿孔與該第一突刺相對。
  3. 如請求項1所述之連續經皮微針監測系統， 其中該第一微針組係由一第一薄片、一第二薄片和一第三薄片疊置而成，該第一薄片上至少設置一第一穿孔，該第一穿孔邊緣設置有一第一突刺，該第二薄片上至少設置一第二穿孔，該第二穿孔邊緣設置有一第二突刺，及該第三薄片上至少設置一第三穿孔，該第三穿孔邊緣設置有一第三突刺，該第二突刺和該第三突刺穿過該第一薄片上的該第一穿孔與該第一突刺呈三角錐形。
  4. 如請求項1所述之連續經皮微針監測系統，其中該第一微針組係由一第一薄片、一第二薄片、一第三薄片和一第四薄片疊置而成，該第一薄片上至少設置一第一穿孔，該第一穿孔邊緣設置有一第一突刺，該第二薄片上至少設置一第二穿孔，該第二穿孔邊緣設置有一第二突刺，該第三薄片上至少設置一第三穿孔，該第三穿孔邊緣設置有一第三突刺及該第四薄片上至少設置一第四穿孔，該第四穿孔邊緣設置有一第四突刺，該第二突刺、該第三突刺和該第四突刺穿過該第一薄片上的該第一穿孔與該第一突刺呈四角錐形。
  5. 如請求項1至4所述之連續經皮微針監測系統，其中該第一微針組之每一突刺包含一尖端部及一基底，其中一薄片上的穿孔經其餘的薄片上相對 位置的穿孔邊緣的突刺穿過後形成的該微針的該些尖端部的頂部不在同一高度。
  6. 如請求項1至4所述之連續經皮微針監測系統，其中該第一微針組之每一突刺包含一尖端部及一基底，其中一薄片上的穿孔經其餘的薄片上相對位置的穿孔邊緣的突刺穿過後形成的該微針的該些尖端部的頂部具有同一高度。
  7. 如請求項1所述之連續經皮微針監測系統，其中該第一和第二微針組的微針係藉由衝壓或蝕刻製程形成。
  8. 如請求項1所述之連續經皮微針監測系統，其中該些突刺的內表面上塗有感測高分子。
  9. 如請求項1所述之連續經皮微針監測系統，其中該些突刺的外表面上塗有抗皮膚過敏的藥物。
  10. 如請求項1所述之連續經皮微針監測系統，更包含一試紙片，安置於該第一微針組與該基板之間，該試紙片包含一導電層及位於該導電層上的複數個測試區域，該些測試區域上係塗佈感測高分子，且與該第一微針組上的該穿孔對齊。
  11. 如請求項8至10中任一項所述之連續經 皮微針監測系統，更包含一保護層形成於感測高分子或抗皮膚過敏的藥物上。
  12. 如請求項1所述之連續經皮微針監測系統，其中該些突刺的材料係選自不鏽鋼、鎳、鎳合金、鈦、鈦合金、奈米碳管或矽材料，且於表面沉積具有生物相容性的金屬。
  13. 如請求項1所述之連續經皮微針監測系統，其中該些突刺的材料係樹脂，且於表面沉積具有生物相容性的金屬。
  14. 如請求項5所述之連續經皮微針監測系統，其中該些突刺的高度為300-600微米。
  15. 如請求項5所述之連續經皮微針監測系統，其中該些突刺的基底寬度為150-450微米。
  16. 如請求項5所述之連續經皮微針監測系統，其中該些突刺的尖端部的間隔為500-3000微米。
  17. 如請求項6所述之連續經皮微針監測系統，其中該些突刺的高度為300-600微米。
  18. 如請求項6所述之連續經皮微針監測系統，其中該些突刺的基底寬度為150-450微米。
  19. 如請求項6所述之連續經皮微針監測系統，其中該些突刺的尖端部的間隔為500-3000微米。
  20. 如請求項1所述之連續經皮微針監測系統，更包含一第三微針組作為反電極。
  21. 一種間質液的感測裝置，包含：一基板；及一微針單元，至少包含排列於該基板上的一第一微針組和一第二微針組，該第一微針組作為工作電極，該第一微針組的該些微針係以陣列形式排列於該基板上，該第二微針組作為參考電極，該第二微針組至少包含一微針，該第一微針組係由複數個薄片疊置而成，每一薄片上至少設置一穿孔，該穿孔邊緣設置有一突刺，其中一薄片上的穿孔係供其餘的薄片上相對位置的穿孔邊緣的突刺穿過，且該些突刺互相分離。
  22. 如請求項21所述之間質液的感測裝置，其中該些突刺的內表面上塗有感測高分子。
  23. 如請求項21所述之間質液的感測裝置，其中該第一和第二微針組的微針係藉由衝壓或蝕刻製程形成。
  24. 如請求項21所述之間質液的感測裝置， 其中該些突刺的外表面上塗有抗皮膚過敏的藥物。
  25. 如請求項21所述之間質液的感測裝置，更包含一試紙片，安置於該第一微針組與該基板之間該試紙片包含一導電層及位於該導電層上的複數個測試區域，該些測試區域上係塗佈感測高分子，且與該第一微針組上的該穿孔對齊。
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