TWI629076B - 整合離子導入與微針之穿戴式注射裝置 - Google Patents
整合離子導入與微針之穿戴式注射裝置 Download PDFInfo
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
- A61N1/303—Constructional details
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
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- A—HUMAN NECESSITIES
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- A61M2210/00—Anatomical parts of the body
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Abstract
一種穿戴式注射裝置,包含:一驅動單元;一微針注射貼片,內含注射劑且位於驅動單元之一側表面;以及一穿戴環,具有兩端分別連接於驅動單元之兩端側;其中,驅動單元帶有第一電性,穿戴環相對驅動單元之一區段帶有第二電性;其中,該微針注射貼片包含一微針陣列連通於注射劑且伸入生物肢體的皮膚中,而穿戴環係環套生物肢體,驅動單元帶有之第一電性與穿戴環之區段帶有之第二電性係產生一直流電流,以將注射劑透過微針陣列注入生物肢體內。
Description
本發明係有關於一種穿戴裝置,尤指一種整合離子導入與微針之穿戴式注射裝置。
傳統上,藥物施放多採皮下注射或口服的治療方式,雖能有效地輸送藥物,但卻容易引起感染和疼痛,不但較為耗時,亦造成病人在臨床治療上的痛苦。因此,近年來經皮給藥系統(Transdermal Drug Delivery System)的診療方式開始快速發展,微針(Microneedle;MN)陣列即為此概念下應運而生的新型生醫注射技術,此方法能降低病人的組織破壞,減輕病人在治療上的疼痛。
微針陣列是利用微機電製程技術將針頭微小化,由數十微米的針頭以矩陣排列方式組成,此微小針頭不但能穿透皮膚的角質層,亦不會刺激深層組織的痛覺神經,使病人在臨床接受藥物注射時大幅地降低疼痛感,實現了無痛注射的目的。
微針可依其構造分為實心微針、中空微針及半中空微針。中空微針適合於更精準的藥物劑量控制,可以配合藥物釋放控制進行長期給藥,也可以結合加壓注射將藥物快速送出;而實心微針主要經由擴散讓塗抹於針頭的藥物傳送。藉由不同的製程技術,各種功能性的微針陣列被發展出來,廣泛用於藥物注射、血液萃取、癌症診斷與微透析等醫療技術。
一種穿戴式注射裝置,包含:一驅動單元;一微針注射貼片,內含注射劑且位於驅動單元之一側表面;以及一穿戴環,具有兩端分別連接於驅動單元之兩端側;其中,驅動單元帶有第一電性,穿戴環相對驅動單元之一區段帶有第二電性;其中,該微針注射貼片包含一微針陣列連通於注射劑且貼附於一生物肢體的皮膚上,而穿戴環係環套生物肢體,驅動單元帶有之第一電性與穿戴環之區段帶有之第二電性係產生一直流電流,以將注射劑透過微針陣列注入生物肢體內。
100‧‧‧穿戴式注射裝置
102‧‧‧驅動單元
104‧‧‧微針注射貼片
104a‧‧‧儲存槽
104b‧‧‧微針陣列
106‧‧‧穿戴環
108‧‧‧啟動開關
110‧‧‧注射劑
110a‧‧‧離子化的注射劑
400‧‧‧電源供應器
401‧‧‧第一電極
403‧‧‧第二電極
500‧‧‧皮膚
502‧‧‧血管
圖1係顯示本發明整合離子導入與微針之穿戴式注射裝置之一側視圖。
圖2A及2B係顯示本發明整合離子導入與微針之穿戴式注射裝置之微針注射貼片示意圖,其中圖2A為一側視剖面圖,而圖2B為一俯視圖。
圖3係顯示本發明整合離子導入與微針之穿戴式注射裝置之一離子導入機制示意圖。
請參閱圖1,係顯示本發明整合離子導入與微針之穿戴式注射裝置之一側視圖。本發明之穿戴式注射裝置100可包含:一驅動單元102帶有第一電性;一微針注射貼片104,位於驅動單元102之一側表面;以及一穿戴環106,具有兩端分別連接於驅動單元102之兩端側,且相對驅動單元102之一區段可帶有第二電性。
於一實施例中,驅動單元102可包含一電極(圖未示)以提供第一電性例如為正電,而該穿戴環106中可包含另一電極(圖未示)以提供第二電性例如為負電。
於一實施例中,驅動單元102於相對微針注射貼片104之一側表面上可包含一啟動開關108以啟動驅動單元102與穿戴環106間之直流電場。
於一實施例中,驅動單元102內可包含一電池模組(圖未示)以提供電力。
於一實施例中,穿戴環106之材料可包含彈性可撓材料例如橡膠或皮革。
於一實施例中,微針貼片104係結合於驅動單元102;於另一實施例中,微針貼片104可分離於驅動單元102,即對於一驅動單元102而言,微針貼片104具可置換性。
請參閱圖2A及2B,係顯示本發明整合離子導入與微針之穿戴式注射裝置之微針注射貼片示意圖,並同時參考圖1。微針注射貼片104可包含:一儲存槽104a可儲存有一注射劑110;以及一微針陣列104b。儲存槽104a可供接觸於驅動單元102且鄰近於驅動單元102的電極。微針陣列104b具有複數微針其尖端朝向遠離於驅動單元102之方向,複數微針可分別呈中空且連通於儲存槽104a。注射劑110可例如為胰島素。微針的材料可例如為二氧化矽(SiO2)。
在實際應用時,在微針注射貼片104分離於驅動單元102的實施例中,可先將微針貼片104敷貼於一生物肢體例如為人類手腕的皮膚上,並稍微加壓使得複數微針穿透生物肢體的皮膚;接著把驅動單元102接著於微針貼片104上,同時穿戴環106環套生物肢體;最後按下啟動開關108,使得驅動單元102與穿戴環106間產生一直流電場,而在生物肢體內形成一直流電流,使得注射劑離子化而透過微針貼片的微針陣列進入生物肢體中。
而在微針貼片104結合於驅動單元102的實施例中,可將本發明之整合離子導入與微針之穿戴式注射裝置100以微針貼片104敷貼於一生物肢體例如為人類手腕的皮膚上並稍微加壓,同時穿戴環106也環套生物肢體,此時複數微針穿透生物肢體的皮膚,接著按下啟動開關108,使得驅動單元102與穿戴環106間產生一直流電場,而在生物肢體內形成一直流電流,使得注射劑離子化而透過微針貼片的微針穿透生物肢體的皮膚。
請參閱圖3,係顯示本發明整合離子導入與微針之穿戴式注射裝置之一離子導入機制示意圖。一電源供應單元400其正負接點可分別以電
路連接一第一電極401例如帶正電以及一第二電極403例如帶負電。第一電極401可黏貼有一微針貼片內含例如為胰島素之注射劑。電源供應單元400可供應一電流自第一電極401穿過生物肢體的皮膚500流向第二電極403,而離子化後的注射劑110a則被電流帶往生物肢體內而被血管502所吸收。
於一實施例中,各微針長度範圍為100μm至1500μm,可穿透10μm至20μm厚度的角質層並可自表皮穿透至70μm至200μm的深度。
於一實施例中,驅動單元102可更包含一電流調整單元(圖未示)以調控直流電流大小,進而決定該注射劑進入生物肢體內的速度。
於一實施例中,當注射劑為胰島素時,驅動單元102可更包含一血糖偵測模組(圖未示),電流調整單元可根據血糖偵測模組自動調整電流以調控胰島素注入生物肢體,如注入人類手腕之速度。
微米貼片的微針可透過微機電(MEMS)製程來達成,以製造出較大面積的微針陣列。常用的製程方法有改良過的LIGA微製造技術、反應式離子蝕刻(RIE)和等向性蝕刻技術的組合、飛秒雷射雙光子聚合、X-ray深光刻術製程(DXRL)、黃光微影(Photolithography)製程、感應耦合電漿(ICP)蝕刻或聚焦離子束(FIB)輔助技術等。
習知技術中,大分子類藥物例如胰島素,單純透過微針貼片經皮吸收不容易,而透過本發明之穿戴式注射裝置,微針貼片若加上離子導入作用驅動裝置的幫助,大分子類藥物例如胰島素比較容易穿透皮膚而經皮吸收,進而使糖尿病病人體內的血糖保持穩定。
上述實施例僅為例示性說明本發明之原理及其功效,而非用於限制本發明。任何本領域中具有一般技藝之人士均可在不違背本發明之精神及範疇下,對上述實施例進行修改。因此本發明之權利保護範圍,應如後述之申請專利範圍所列。
Claims (11)
- 一種穿戴式注射裝置,包含:一驅動單元;一微針注射貼片,內含注射劑且位於該驅動單元之一側表面;以及一穿戴環,具有兩端分別連接於該驅動單元之兩端側;其中,該驅動單元帶有第一電性,該穿戴環相對該驅動單元之一區段帶有第二電性;其中,該微針注射貼片包含一微針陣列連通於該注射劑,並貼附一生物肢體的皮膚上,而該穿戴環係環套該生物肢體,該驅動單元帶有該第一電性與該穿戴環之該區段帶有該第二電性係產生形成於該生物肢體內的一直流電流,以將該注射劑透過該微針陣列進行遞送。
- 如請求項1之一種穿戴式注射裝置,其中該驅動單元相對該微針注射貼片之一側表面上包含一啟動開關,以啟動該驅動單元與該穿戴環間的直流電流。
- 如請求項1之一種穿戴式注射裝置,其中該第一電性係為正電,該第二電性係為負電。
- 如請求項1之一種穿戴式注射裝置,其中該注射劑包含胰島素。
- 如請求項1之一種穿戴式注射裝置,其中該微針注射貼片更包含一儲存槽儲存該注射劑。
- 如請求項1之一種穿戴式注射裝置,其中該驅動單元包含一電流調整單元以調控該直流電流大小,進而決定該注射劑遞送的速度。
- 如請求項1之一種穿戴式注射裝置,其中該生物肢體包含一人類手腕。
- 如請求項1之一種穿戴式注射裝置,其中該穿戴環之材料係為一彈性材料。
- 如請求項1之一種穿戴式注射裝置,其中該驅動單元包含一第一電極以提供該第一電性,該穿戴環包含一第二電極以提供該第二電性。
- 如請求項1之一種穿戴式注射裝置,其中該驅動單元包含一電池模組。
- 如請求項1之一種穿戴式注射裝置,其中該微針注射貼片係可分離於該驅動單元。
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EP2162182A1 (en) * | 2007-06-15 | 2010-03-17 | Transport Pharmaceuticals, Inc. | Method and system for mitigating current concentration in electrokinetic drug delivery |
US8439896B2 (en) * | 2009-11-13 | 2013-05-14 | The Invention Science Fund I, Llc | Device, system, and method for targeted delivery of anti-inflammatory medicaments to a mammalian subject |
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2017
- 2017-01-12 TW TW106101006A patent/TWI629076B/zh active
- 2017-04-20 US US15/492,416 patent/US20180193638A1/en not_active Abandoned
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TW200526286A (en) * | 2003-11-13 | 2005-08-16 | Alza Corp | System and method for transdermal delivery |
CN101125086A (zh) * | 2006-08-18 | 2008-02-20 | 刘胜 | 闭环自动控制胰岛素注射系统 |
CN103370617A (zh) * | 2010-10-01 | 2013-10-23 | 牛津纳米孔技术有限公司 | 利用纳米孔的生物化学分析设备 |
TW201250243A (en) * | 2011-05-05 | 2012-12-16 | Anpac Bio Medical Science Co Ltd | Apparatus for detecting tumor cells |
US20160231236A1 (en) * | 2014-09-29 | 2016-08-11 | Zyomed Corp. | Systems and methods for control of illumination or radiation collection for blood glucose and other analyte detection and measurement using collision computing |
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US20180193638A1 (en) | 2018-07-12 |
TW201825131A (zh) | 2018-07-16 |
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