1242455 玖、發明說明： 【發明所屬之技術領域】 本發明係關於一種生罄妈鉍备 裡玍面μ致動及收放裝置，尤指一 植入生物體内之醫筚用遯 於^』 收集、或侦測裝置，用以釋 放、收木、或偵測特定物質。 【先前技術】 藥物遞送的途徑在藥物疾病治療中是 %。目前的華物谈洋士 4 y 田置要的 10 15 口服及、、= 係以口服及注射方式為主，然而 =筚：樂物遞送方式，因為有諸多之缺點，所以限 明顯的如藥物遞送障礙；樂物遞送之缺點，較 擇性、藥物控制方便性等諸控制性、治療部位選 吏性4啫多均限制了藥物遞送之應用。 以口服藥物方式為例’藥物由食道進入胃中時， 效降低，尤二壞藥物本身之結構，使得療 劑型，故η %、、貝、貝型樂物。這些藥物目前沒有口服 tA " ^ /主射方式來給藥，所以因而窄化了、、Λ療 樂物種類以π服藥物方式的使用。 /σ療 中，常必::筚Si:到有效的治療作用，在給藥的控制 範圍内，而一 ίΓ 的濃度維持在有效的治療濃度 維持藥物的濃二射給11方式係以頻率性方式來 在4中_變化比較大且濃度不料。再者= 20 1242455 予藥物的初期，藥物在血液中的濃度如果太高，則合呈現 毒性而影響身體。但同時在藥物持續之末期， 則又達不到治療效果。所以如何控制藥物在血液^的濃 5 10 15 二及避免無法控制藥物在血液中的濃度，或大幅降低 治療效果’對一般的口服或注射給藥方式而言 要的課題。 疋非承重 純就以藥理學而言’將藥物直接作用在目標區域係為 取效率之投藥方法。但是一般的口服或注射投藥方式， 係以全身性的遞送方式將藥物送到治療區域，所以並非達 2㈣，特定性的治療方式。更且採用口服或注射投藥 /打，貫際上需要較直接投藥至目標區域更大的藥量， 其投藥效率較低，且藥物需全身遞送而容易引起藥物副作 用0 此外傳統口服或注射之給藥治療方式對於 :藥物：療的患者而言是相當不方便的。以糖尿病U 病患必須每天經長性的使用口服降血糖藥物，或以注 射:式來控制病情。而且以藥物使用危險性而言，自行口 服藥劑方式常因人為因素而導致藥物使用過量或藥量間斷 使用，且右採用注射式藥物治療，對於病患而言不僅伴隨 疼痛的負擔’更存有潛在注射汙染所造成感染的危機。 义由於口服及注射方式來遞送藥物有上述缺點，因此， 目刀則=開發出吞入式或植入式之藥物釋放系統，下述將介 二目刚=幾種解決方案。美國專利案號仍⑷，川8係揭露 入式藥物釋放系統，其係利用數種微流體裝置以及導管 20 1242455 來將藥物刀子左入治療區域’然而’此種植 系統大部分只能遞送液態藥物，其所遞送之藥 在裝置中或導管出口，且導管出口可能有纖維 土 所以使用上尚有諸多缺點待改善。而且此種植人式=釋 放系統之設計與製作複雜度很高’通常具有 機 構設計，其所需元件多，所以使得系、統故障之風險^了 而目前所知者多為單槽式設計，若其單一導管出口或： 槽故障卽造絲置失效或錯誤給藥，危險性較高/ ίο 15 /美國專利案號US517,〇8()1 _露—種可吞入式藥物釋 放系統’以改善口服投藥之缺點。其作用係在特定的消化 道區域中將藥物釋放出來。該案利用可吞入式膠囊狀之設 計來達成吞入功能，其主要結構可分為内外兩層，且在= 外兩層設計有釋放開口孔隙，並以熱旋轉機構使内外兩層 開口孔隙相對應，以使得藥物分子能夠由孔隙釋放出來。曰 該熱旋轉機構為利用形狀記憶合金（Shape Memory Alloys，SMA)來驅動旋轉機構，並利用無線傳輸來控制 $物釋放。然而此種設計尚有諸多缺點待克服。例如其僅 能短期放入腸胃中治療，目前只能裝載單一治療藥物，而 ％轉開口之設計可能造成釋放出口之堵塞，且開口僅可 為—次全開或全關。若開口重複開啟使用，容易使體液滲 入藥槽’而使得藥物變質毀壞，且出口可能有纖維包覆之 問題。再者，其為單槽式設計，危險性較高。 另美國專利案US579,7898及US6,5；27,762揭露一種植 入式藥物釋放系統’其係利用微機電（MEMS )技術以及 20 I242455 ίο 15 κ製程技術來實現微型多藥槽等功能。此種設計以石夕為基 材，需重複顯影、钮刻、沈積等複雜的製程才能完成，且 其腔體、電控層、填藥及槽蓋必需依序製作，不能平行分 ^處理，前後製程易互相牵制，困難許多。填藥之後的槽 盖製作過程更可能因温度或其他反應而破壞藥物原有的特 性。其藥物分子之釋放機制分為被動式及主動式，盆中， =動式釋放機制係以渗透方式為主，主動式釋放機制係透 匕外：控制溫度變化來使得藥槽蓋子變成可透通性結構， 以將藥物釋放出來。此種設計也有諸多缺點。例如不同透 2的開蓋設計在微機電製程中複雜且耗時。而因為係以 :::式或破裂藥槽開蓋而釋放物質，所以無法解決細胞 2化而導致堵塞之問題，且會有藥物遞送的障礙存在。 田…、、，其出口還有纖維包覆之問題。 釋放2述說明可知’雖然目前已有諸多方式來解決藥物 釋放之問題’但仍然有上述諸多缺點存在’因此如何設計 樂系統’以避免在傳統藥物遞送途徑上 克服植入式釋藥方式所面臨之生理免疫反應所 藥物遞覆（纖維化）堵塞釋藥出口之問題，俾使得 非目的可靠性、微量化以及準確性，且減少其他 的之樂物副作用，已成為一亟需解決之課題。 【發明内容】 -種^ 知技藝之缺失，本發明之目的係在於提供 以致動及收放裝置’俾能植入生物體内釋放化合 20 1242455 物（如醫藥化合物）、組合物（如醫藥組合物）等特定物 質，提昇藥物釋放效果，降低存放槽堵塞故障無法釋藥風 險，簡化釋放收集結構，降低製程複雜度，減少量產成本。 本發明另一目的係在提供一種生醫微致動及收放裝 5置，俾能於生物體内定時定址且以穩定速率釋放化合物（如 醫藥化合物）、組合物（如醫藥組合物）等特定物質，並 控制釋出藥物在體内的濃度，提升藥物治療之方便性以及 效率。 本發明又一目的係在提供一種生醫微致動及收放裝 10置，俾能遞送液態、固態、塊狀、粉末或膠體等各種型式 之藥物化合物、藥物組合物，以提供生物體局部性或全身 性治療’減少藥物遞送途徑障礙。 本發明再一目的係在提供一種生醫微致動及收放裝 置’俾能於生物體内收集分泌物、酵素、蛋白質、基因、 15細胞組織等特定物質或進行生物體内分泌物、酵素、蛋白 質、基因、細胞組織等特定物質物質感測。 本發明再一目的係在於提供一生醫微致動及收放裝 置，俾此植入生物體内定時定址進行特定物質之釋放或收 集，尤以藥物化合物或藥物組合物之釋放及體内分泌物、 2〇酵素、蛋白質、基因、細胞組織等特定物質收集、感測； 或於生物體外定時定址進行特定物質釋放或收集。 依據本發明之-特色，本發明之生醫微致動及收放裝 置，係用於植入生物體内釋放或收集一特定物質，包含： -存放槽係由聚合物構成，用於存放特定物質；_致動器 1242455 ) 係由形狀記憶合金（Shape Memory Alloy， SMA )或形狀圮憶聚合物（shape ，SMp ) 構成藉由4形狀記憶合金或形狀記憶聚合物變形產生之 $械力來控制存放槽之開關；_能量訊號供應裝置，係提 5供電、熱或磁訊號以驅動致動器形變。前述致動器分別連 接存，槽與成量訊號供應裝置，藉由接收能量訊號供應裝 置斤長:ί、之電、熱或磁訊號來驅動產生形變，透過形變之 機械力來關閉存放槽，以達到釋放或收集一特定物質之目 的0 10 15 又本發明之另一特色，本發明提供一種生醫微致動 及收放裝置’係用於釋放或收集一特定物質，包含：一至 少：個存放槽’係用於存放特定物質；一至少一個致動器， 係藉由其形變來控制存放槽開關；-能量訊號供應裝置， 係提供電或磁訊號以驅動致動器形變。前述的致動器，係 由^^己憶合金或形狀記憶聚合物所構，分別連接存放槽 二^ 紅應&置，並藉由其結構形變產生 開關存放槽。 ^發明之生醫微致動及收放裝置，其可應用於植入一 口：父如：人體、動物體）β，在植入之特定區域將 :貝.(例如：藥物）釋放出*，或進行特定部位之樣 本（例如·酵素、分泌物）採隼· 特定物質(例如:芳香劑)二放，用於生物體外之 廢水）採集。 釋放，或環境中樣本(例如： 20 1242455 本發明之生醫微致動及收放裝置主要係以一至少一 個存放槽作為欲釋放收集特定物質之存放處，並配合至少 一由形狀記憶合金或一形狀記憶聚合物所構成之致動器以 打開關閉存放槽。前述生醫微致動及收放裝置進一步包含 5 一能量訊號供應裝置，係以提供電、熱或磁等能量訊號至 致動器’驅動致動器產生形變以開關存放槽。 本發明之存放槽構成材質以聚合物為較佳，其中以聚 一曱基矽氧烷（p〇lydimetyiysil〇xane，pdms)更佳。該 存放槽可以習知技藝加工而成，其中以模具翻製方式製作 _ 10為較佳。前述模具翻製係利用預先製成之模具，經模注聚 合物而成。該模具可以經由習之方法製造，較佳係由微 機電加工方法，或精密機械加工而製成。該模具翻製存放 槽之耘序可為槽體之結構可分開製作再接合，或以一體成 型方式製造。由於存放槽係採用模具翻製，故本發明之生 15醫微致動及收放裝置上存放槽可以由複數個槽體排列而成 Μ N陣列形式，且M*N為整數，此設計在製程上較為簡單。 該存放槽係用以儲存化合物，組合物，感測器或一採樣機 構/、母槽體結構係設有置放致動器之區域，可將致動 器固定於其間，以便控制存放槽之開關。此外，該存放槽 20可進一步結合流道設計，以控制或便利儲存物之釋出。 本1¾明之致動器係由形狀記憶合金或形狀記憶聚合 物所構成’可為習用之形狀記憶合金或形狀記憶聚合物， -中以鈦鎳合金（τ卜Ni)或鈦錳鎵舍金（Ti_Mn-Ga)較佳。 該致動器控制存放槽之開關，係利用形狀記憶合金或形狀 12 1242455 記憶聚合物之形狀結構可 之特點來達成。本發 疋条件（例如··溫度）定義 5 10 15 定義致動器於特定』:控:存:槽開闕方式’係先 動器固定置放於前述每—存體;:其完成定義之致 致動器結構形狀及溫度和先定』：：：構間，此時固定之 待致動器溫度回覆至 ± 4、特定溫度不同， 成為事先定義結構m '皿1 ’其結構形即產生形變而 ，致動_打開存::::::或:::::方= =槽槽蓋，放特定物質之目=方； 動盗形變打開存放槽之另 & κ錯由致 放槽槽體結構，可=係•械力方式破壞存 破裂，而達釋放：=: 、撕裂等方式’造成槽體 閉存放槽方式之一疋目的。。前述藉由致動器形變關 縮，將未_之存放沖'成彈簧狀進行收 ㈣以封閉存放槽，達 溫戶方★貝之目的。本發明致動器係以溫度升高至特定 二ϋ來發生形變而回復至事先定義之結構形狀，其溫 ^二方式可以用諸種習用方式達成，其中以外加熱源、 、7用本身電阻生熱較佳。本發明致動器之形變係可利 20 佳。 =兹％效應來達成，其中鈦錳鎵合金（Ti_Mn_Ga)材質較 本發明之能量訊號供應裝置，俦連接於每一致動器以 傳遞電、熱或磁等能量訊號供致動器發生形變。該能量訊 谠供應裝置’係可提供電、熱或磁等能量訊號給單一特定 欠動為或同時多個致動器，定時定址控制前述陣列式存放 13 !242455 槽開關。該能量訊號供應裝置，可為任何習用之基材之電 路層，較佳為以矽晶片、印刷電路板為基材之電路層。本 發明能量訊號供應裝置可視需要包含一無線收發電路，接 收外部指示訊號，以定時定址控制存放槽開關。 5 本發明生醫微致動及收放裝置，其可以應用於生物體 内或生物體外。其應用於生物體内時，可視需要可進一步 包覆一層任何習用之生物相容性物質，其中以Parylene (聚 對二甲苯）較佳，係為醫藥用生醫微致動及收放裝置，可以 作為藥物’試劑之釋放或體内分泌物、酵素、蛋白質、基 10因、細胞組織等特定物質收集、感測。其存放槽内之藥物、 減劑开> 式’可為任何習用之組合物或化合物之形式，較佳 為液狀、塊狀、粉狀或膠狀。本發明置於生物體内釋放收 木生面议致動及收放裝置的存放槽之内含化合物或組合 物，較佳為醫藥化合物或醫藥組合物。前述體内物質收集， 15係可以空的且未封閉之存放槽植入，或以存放槽内放置採 樣機構進行收集。前述體内物質之感測，係可於存放槽内 放置感測器進行感測。本發明生醫微致動及收放裝置植入 生物體内之時機，可為手術時順便將其植入於特定部位， 或在其他特定時機將其植入於生物體内，以釋放藥物分子 20來達到治療之功效。該植入之生物體無限制，較佳為動物， 更佳為人體。當本發明生醫微致動及收放裝置植入於動物 體内，並内含藥物組合物或藥物化合物時，其可以於動物 體二以無線電傳輸控制方法，定時定址地啟動該裝置之致 動為，以釋放適量之藥物於該動物體内之目標部位。而因 1242455 5 10 15 20 為本發明生醫微致動及收放裝置為主以形狀記憶合 狀記憶聚合物撐破存放槽之多藥槽結構，所以因為纖 堵塞之風險大為降低。而以存放槽作為置放藥物之所 則可以降低藥物形式之限制，適用於各種型態之藥物或醫 =成物。再者，由於本發明之致動器之機構簡單，僅為 間早結構之形狀記憶合金或形狀記憶聚合物破壞存放槽: 所以可以免除複雜機械結構（例如馬達，幫浦，齒輪/之 =度，提南系統信賴度。另一方面，因為形狀記憶合全 或形狀s己憶聚合物之機械變形量遠木於其他材質 發明生醫微致動及收放裝置以形狀記憶合金或形狀 合物撐破存放槽之多藥槽結 性。 僻八令竿又问之輛作方便優異 時，致動及收放裝置，其應用於生物體外 日寸，可以作為特殊化學物曾 當存放槽内配合感測器或採樣機禮：例如芳香劑之釋放。 及收放裝置可以作為人::=料，本發明生醫微致動 配合無線電雙向收發傳輪 ^右再 龄測之-果，二！ 退距控制化合物之釋出並偵知 孤測之、、、°果降低空間及時間之限制。 以本專利所製作的 ，並 =或=設定藥物遞送，、次數二由= 個人化、各製化的藥物遞送方式。 w里疋禋 15 1242455 本發明生醫微致動及收放裝置因為可以利用模且翻 製’所以可以免除重複顯影、㈣、沈積等複雜製程了製 造方法簡單，製造時間縮短且製造成本低。而本發明甚至 可以將能量訊號供應裝置之電路層與具有複數個存放槽分 5開同時並行製造，以節省製造時程。再者，電路層盘存放 槽分開同時並行製造，電路層之材料可以選用之範圍與 大，可以採用任何習用之材質（例如軟性印刷電路板）二 降低成本或因應特殊需求。另外本發明生醫微致動及收放 裝置於生物體内載送藥物時，因為外有生物相容性包覆層 10之隔絕，可以使存放槽内之藥物免於酵素或其他體液，二 =物之分解或破壞。所以在給藥時，其藥物遞送障礙性、 藥物濃度控制性、治療部位選擇性、藥物控制方便性均可 以獲得大幅之改善。 15【實施方式】 為使本發明内容清楚了解，以圖i說明其一實施方式， 請參照圖1。圖1顯示本發明生醫微致動及收放裝置1之部分 不意圖，其係由陣列式存放槽層Π及能量訊號供應裝置層 12所構成。其中陣列式存放槽層丨丨上具有複數個陣列排列 20之存放槽111，俾供用來裝設一種或多種特定物質。每一個 存放槽111之結構槽體内中係置放有由形狀記憶合金或形 狀記憶聚合物構成之致動器丨丨12及特定物質丨丨丨3。於本實 轭例中，特疋物質1113為液狀、固狀、塊狀、粉狀或膠狀 之藥物，致動器1112係為鈦鎳合金所構成。於本實施例中， 16 1242455 陣列式存放槽層11及能量訊號供應裝置層12係為分開製 作。致動器1112與能量訊號供應裝置層12可用銀膠或點焊 等方式接合。該陣列式存放槽層U可透過微機電（MEMS) 製程先製作微型模具，繼而以該微型模具快速且大量翻 5製，以大幅地降低成本並增加量產速度。該陣列式存放槽 層11之材質係為生物相容性聚合物，以聚二曱基矽氧院較 佳。該能量訊號供應裝置層12係為電路層，以石夕晶片或印 刷電路板（PCB)較佳，係具有複數電子元件12卜該等電 子元件121用以形成控制電路及電源電路，在電源電路部份 10係可搭配一外部控制器來儲能產生電源，亦即藉由外部控 制器發出之電磁信號或充電信號來產生電源。當然，電源 電路上亦可設置電池單元或電容，俾供用來提供電源給控 制電路，使得控制電路驅使制動器1112發生形變，以破壞 存放槽111，使得特定物質1113能夠釋放。1242455 发明, Description of the invention: [Technical field to which the invention belongs] The present invention relates to a device for actuating and retracting a mu-fat surface of a bismuth, in particular, a medical device which is implanted in a living body. A collection or detection device used to release, collect, or detect specific substances. [Prior art] The route of drug delivery is% in the treatment of drug diseases. At present, Huawu Tanyangshi 4 y Tian Zhiyao 10 15 Oral and injection are mainly oral and injection, but = 筚: Pleasure delivery method, because there are many shortcomings, so the limitation is obvious, such as drug delivery Disadvantages; disadvantages of music delivery, such as selectivity, control of drug control convenience, and selection of the treatment site all limit the application of drug delivery. Taking the oral drug method as an example, when the drug enters the stomach from the esophagus, the effect is reduced. Especially the structure of the second bad drug makes the therapeutic dosage form, so η%, shellfish, and shellfish. These drugs are currently not administered by oral tA " ^ / primary injection mode, so the use of π-medicine drugs has been narrowed. / σ treatment, often must :: 筚 Si: to an effective therapeutic effect, within the control range of drug administration, while the concentration of ΓΓ is maintained at an effective therapeutic concentration to maintain the concentration of the drug. Way to come in 4_ The change is relatively large and the concentration is unexpected. Furthermore = 20 1242455 In the early stage of administering the drug, if the concentration of the drug in the blood is too high, it may be toxic and affect the body. But at the same time, at the end of the drug's duration, the therapeutic effect is not achieved. Therefore, how to control the concentration of the drug in the blood ^ 5 10 15 and to avoid the inability to control the concentration of the drug in the blood, or to significantly reduce the therapeutic effect, are topics that are important for general oral or injection administration methods.疋 Non-load-bearing Purely in terms of pharmacology, ‘directing the drug to the target area is an effective method of administration. However, the general oral or injection drug delivery method is to deliver the drug to the treatment area through a systemic delivery method, so it is not a specific treatment method. In addition, oral or injection administration / dosage is required, which requires a larger amount of medicine than direct administration to the target area. Its administration efficiency is low, and the drug needs to be delivered systemically, which easily causes drug side effects. 0 In addition, traditional oral or injection administration Drug treatment is quite inconvenient for patients who are treated with drugs. Patients with diabetes U must take oral hypoglycemic drugs daily or by injection: to control their condition. And in terms of the dangers of drug use, self-oral medicament methods often cause excessive use of drugs or intermittent use of drugs due to human factors, and the right use of injectable drugs for treatment, for patients not only accompanied by the burden of pain ' Crisis of infection caused by potential injection contamination. Because of the above-mentioned disadvantages of delivering drugs by oral and injection methods, mesh knife = development of swallowable or implantable drug release systems, the following will be two eyesight = several solutions. U.S. patent case number is still rampant, Chuan 8 series disclosed injectable drug release system, which uses several microfluidic devices and catheters 20 1242455 to left the drug knife into the treatment area 'however' most of this implant system can only deliver liquid drugs The drug delivered is in the device or the outlet of the catheter, and there may be fibrous soil at the outlet of the catheter, so there are still many shortcomings to be improved in use. Moreover, the design and production complexity of this planting type = release system is very high. 'Usually it has a mechanism design, which requires a lot of components, so the risk of system and system failure is increased, and most of the current known people are single-slot design. If its single catheter outlet or: trough failure, failure of the placement of silk or misadministration, the risk is higher / ίο 15 / US Patent Case No. US517, 〇8 () 1 _Lu-a swallowable drug release system ' To improve the disadvantages of oral administration. Its effect is to release the drug in specific areas of the digestive tract. This case uses a swallowable capsule design to achieve the swallowing function. Its main structure can be divided into two layers, the outer and outer layers are designed to release opening pores, and the inner and outer layers have open pores with a thermal rotation mechanism. Correspondingly, so that the drug molecules can be released from the pores. The thermal rotation mechanism uses shape memory alloys (Shape Memory Alloys, SMA) to drive the rotation mechanism, and uses wireless transmission to control the release of objects. However, this design has many shortcomings to be overcome. For example, it can only be put into the stomach for treatment for a short time. Currently, it can only be loaded with a single therapeutic drug, and the design of the revolving opening may cause blockage of the release outlet, and the opening can only be-fully open or fully closed. If the opening is repeatedly opened for use, it is easy for the body fluid to penetrate into the medicine tank 'and cause the medicine to deteriorate and destroy, and the outlet may have the problem of fiber coating. Furthermore, it has a single-slot design and is highly dangerous. In addition, US patent cases US579,7898 and US6,5; 27,762 disclose an implantable drug release system, which uses micro-electromechanical (MEMS) technology and 20 I242455 15 κ process technology to achieve functions such as a miniature multi-drug tank. This design uses Shi Xi as the base material, which can be completed by repeating complex processes such as development, button engraving, and deposition. The cavity, electrical control layer, filling, and tank cover must be made in sequence, and cannot be processed in parallel. The front-to-back process is easy to restrain each other, which is much more difficult. The process of making the cap after filling is more likely to destroy the original characteristics of the drug due to temperature or other reactions. The drug molecule release mechanism is divided into passive and active. In the basin, the = dynamic release mechanism is mainly osmotic, and the active release mechanism is transparent. The temperature change is controlled to make the lid of the drug tank transparent. Structure to release the drug. There are also many disadvantages to this design. For example, different transparent cover designs are complicated and time-consuming in the MEMS manufacturing process. And because the ::: type or rupture drug tank is opened to release the material, it cannot solve the problem of cell blockage and blockage, and there will be obstacles to drug delivery. Tian ..., the export also has the problem of fiber coating. The description of the release 2 shows that “Although there are many ways to solve the problem of drug release”, there are still many shortcomings mentioned above. Therefore, “how to design the Le system” to avoid the problems faced by the implantable release method on the traditional drug delivery route. The problem of drug delivery (fibrosis) clogging the drug release outlet of the physiological and immune response has made non-purpose reliability, miniaturization, and accuracy, and reducing other side effects of fun, has become an urgent problem. [Summary of the Invention]-A lack of know-how, the purpose of the present invention is to provide an actuating and retracting device that can be implanted in a living body to release a compound 20 1242455 (such as a pharmaceutical compound) or a composition (such as a pharmaceutical combination). And other specific substances to improve the drug release effect, reduce the risk of failure to release drugs due to blockage of storage tanks, simplify the release collection structure, reduce the complexity of the process, and reduce the cost of mass production. Another object of the present invention is to provide a biomedical micro-actuation and retractable device, which can be periodically addressed in a living body and release a compound (such as a pharmaceutical compound), a composition (such as a pharmaceutical composition), etc. at a stable rate. Specific substances, and control the concentration of released drugs in the body, improve the convenience and efficiency of drug treatment. Still another object of the present invention is to provide a biomedical micro-actuating and retracting device, capable of delivering various types of pharmaceutical compounds, pharmaceutical compositions, such as liquid, solid, block, powder, or colloid, so as to provide localized parts of the organism. Sexual or systemic treatment 'reduces barriers to drug delivery. Still another object of the present invention is to provide a biomedical micro-actuating and retracting device, which can collect specific substances such as secretions, enzymes, proteins, genes, 15-cell tissues or carry out biological secretions, enzymes, Sensing specific substances such as proteins, genes, and cell tissues. Yet another object of the present invention is to provide a biomedical micro-actuating and retracting device, which is then implanted into a living body at a regular address for the release or collection of specific substances, especially the release of pharmaceutical compounds or pharmaceutical compositions and the secretions in the body, 20 Collection, sensing of specific substances such as enzymes, proteins, genes, cell tissues, etc .; or regular release or collection of specific substances from outside the organism at regular locations. According to the features of the present invention, the biomedical micro-actuating and retracting device of the present invention is used to implant or release a specific substance in a living body, including:-The storage tank is composed of a polymer and is used to store a specific substance. Substance; _actuator 1242455) is composed of shape memory alloy (SMA) or shape memory polymer (shape, SMp). The $ mechanical force generated by 4 shape memory alloy or shape memory polymer deformation Control the switch of the storage tank; _ energy signal supply device, which provides 5 power, thermal or magnetic signals to drive the deformation of the actuator. The aforementioned actuators are respectively connected to the storage, the tank and the quantity signal supply device, and the deformation is driven by receiving the energy signal supply device: electric, thermal or magnetic signals, and the storage tank is closed by the mechanical force of the deformation. In order to achieve the purpose of releasing or collecting a specific substance, 0 10 15 and another feature of the present invention, the present invention provides a biomedical micro-actuating and retracting device 'for releasing or collecting a specific substance, including: at least: A storage tank 'is used to store a specific substance; at least one actuator is used to control the storage tank switch by its deformation;-an energy signal supply device is provided with an electrical or magnetic signal to drive the actuator to deform. The aforementioned actuators are made of ^^ alloy or shape memory polymer, and are respectively connected to the storage tanks, and the switch storage tanks are generated by the structural deformation. ^ Invented biomedical micro-actuating and retracting device, which can be applied to implant a mouthpiece: father such as human body, animal body) β, release: shellfish (for example: drug) in a specific area of implantation **, Or collect samples of specific parts (such as enzymes and secretions) and collect specific substances (such as fragrances) for biological waste water outside the body. Release, or samples in the environment (for example: 20 1242455 The biomedical micro-actuating and retracting device of the present invention mainly uses at least one storage tank as a storage place for collecting specific substances to be released, and cooperates with at least one shape memory alloy or An actuator made of a shape memory polymer is used to open and close the storage tank. The aforementioned biomedical micro-actuating and retracting device further includes an energy signal supply device for supplying electrical, thermal or magnetic energy signals to the activation. The actuator drives the actuator to deform to open and close the storage tank. The storage tank of the present invention is preferably made of a polymer, and polydimethyiysiloxane (pdms) is more preferred. The storage The groove can be processed by known techniques, and it is better to use a mold turning method _ 10. The aforementioned mold turning is made by using a pre-made mold and polymer injection molding. The mold can be manufactured by conventional methods. Preferably, it is made by micro-electromechanical processing method or precision machining. The working sequence of the mold turning storage tank can be the structure of the tank body can be made separately and then joined, or integrated into one The storage tank is made of a mold. Therefore, the storage tank on the 15 medical micro-actuating and retracting device of the present invention can be arranged in a MN array form by a plurality of tanks, and M * N is an integer. This design is relatively simple in terms of manufacturing process. The storage tank is used to store compounds, compositions, sensors or a sampling mechanism, and the mother tank structure is provided with an area where the actuator is placed, which can be used to place the actuator. It is fixed in between to control the opening and closing of the storage tank. In addition, the storage tank 20 can be further combined with the flow channel design to control or facilitate the release of the stored items. The actuator of this invention is made of shape memory alloy or shape memory polymer. The composition can be a conventional shape memory alloy or a shape memory polymer. -Titanium nickel alloy (τ 卜 Ni) or titanium manganese gallium gold (Ti_Mn-Ga) is preferred. The actuator controls the switch of the storage tank. It is achieved by using the shape memory alloy or shape 12 1242455 shape characteristics of the memory polymer. The conditions (for example, temperature) are defined 5 10 15 Define the actuator to be specific ": Control: Storage: Slot opening 'The way' is first move Fixedly placed in each of the above-mentioned bodies ;: the actuator structure shape and temperature and its pre-definition after its definition is completed ":: between the structures, at this time, the temperature of the actuator to be fixed is returned to ± 4, the specific temperature is different , Becomes the pre-defined structure m 'dish 1' whose structural shape is deformed, and actuates _ to open the storage :::::: or :::::: square = = slot cover, put the purpose of a specific substance = square; The pirate deforms to open the storage tank and causes the storage tank structure to be broken. It can be broken by mechanical force, and can be released: =:, tearing, etc. 'causing the storage tank to close the storage tank. One of the purposes ... The aforementioned purpose is to close the storage tank by closing the storage ridges into a spring shape by closing and shrinking the actuator. The actuator of the present invention deforms and returns to a previously defined structural shape when the temperature rises to a specific temperature, and the temperature method can be achieved by various conventional methods. Among them, the external heating source,, and 7 generate heat with their own resistance. Better. The deformation system of the actuator of the present invention is advantageous. =% Effect is achieved, in which the material of titanium manganese gallium alloy (Ti_Mn_Ga) is compared with the energy signal supply device of the present invention, and is connected to each actuator to transmit energy signals such as electricity, heat or magnetism for the actuator to deform. The energy signal “supply device” is capable of providing electrical, thermal or magnetic energy signals to a single specific underacting or multiple actuators at the same time, and regularly addresses and controls the aforementioned array storage 13! 242455 slot switch. The energy signal supply device may be a circuit layer of any conventional substrate, preferably a circuit layer using a silicon wafer or a printed circuit board as a substrate. The energy signal supply device of the present invention may include a wireless transceiver circuit as required, and receives an external instruction signal to control the storage slot switch by timing addressing. 5 The biomedical micro-actuating and retracting device of the present invention can be applied in a living body or outside a living body. When it is applied in the living body, it can be further coated with any conventional biocompatible material as required. Among them, Parylene (Parylene) is preferred, which is a biomedical micro-actuating and retracting device for medical use. It can be used as the release of drugs' reagents or the collection and sensing of specific substances such as body secretions, enzymes, proteins, genes, and cell tissues. The medicine and reducing agent in the storage tank can be in the form of any conventional composition or compound, and is preferably liquid, lumpy, powdery or gelatinous. The compound or composition contained in the storage tank of the present invention for releasing the receiving and activating actuating and retracting device is preferably a medicinal compound or medicinal composition. The aforementioned collection of in-vivo materials can be implanted in an empty and unclosed storage tank, or collected by placing a sampling mechanism in the storage tank. The aforementioned sensing of substances in the body can be performed by placing a sensor in the storage tank. When the biomedical micro-actuating and retracting device of the present invention is implanted in a living body, it can be implanted in a specific place during surgery, or it can be implanted in a living body at other specific times to release drug molecules. 20 to achieve healing effects. The implanted organism is not limited, preferably an animal, and more preferably a human body. When the biomedical micro-actuating and retracting device of the present invention is implanted in an animal body and contains a pharmaceutical composition or a pharmaceutical compound, it can be activated periodically by the radio transmission control method in the animal body. Act to release an appropriate amount of a drug to a target site in the animal. Because 1242455 5 10 15 20 is the biomedical micro-actuating and retracting device of the present invention, the multi-drug tank structure of the storage tank is broken by the shape-memory synthetic memory polymer, so the risk of fiber clogging is greatly reduced. The use of storage tanks as a place to store medicines can reduce the restrictions on the form of medicines, and is suitable for various types of medicines or medical products. Furthermore, because the mechanism of the actuator of the present invention is simple, only the shape memory alloy or shape memory polymer of the early structure destroys the storage tank: so that complicated mechanical structures (such as motors, pumps, gears, etc.) can be eliminated. The reliability of Tinan system. On the other hand, because the shape memory is full or the mechanical deformation of the shape memory polymer is much higher than other materials, the biomedical micro-actuating and retracting device is invented, and the shape memory alloy or shape compound is used. It can break the multi-medicine tank structure of the storage tank. When the remote control bar has excellent workmanship, it can be actuated and retracted. It is applied to the outside of the living body and can be used as a special chemical. Sensor or sampler gift: For example, the release of fragrance. And the retractable device can be used as a human :: = material, the biomedical micro-actuation of the present invention cooperates with the two-way radio transmission and reception transmission wheel. Release of backlash control compounds and detection of orphan test results reduce space and time constraints. Manufactured with this patent and = or = set drug delivery, number of times = personalization, each Chemical drugs W 里 疋 禋 15 1242455 Because the biomedical micro-actuating and retracting device of the present invention can use a mold and be remade, it can avoid the complicated processes of repeated development, dysplasia, deposition, etc. The manufacturing method is simple, the manufacturing time is shortened and the manufacturing The cost is low. The invention can even manufacture the circuit layer of the energy signal supply device and a plurality of storage slots in parallel at the same time to save the manufacturing time. Furthermore, the circuit layer disk storage slots are separated and manufactured in parallel and the circuit layer The range of materials that can be used is large and large, and any conventional material (such as a flexible printed circuit board) can be used. Second, the cost can be reduced or special needs can be met. In addition, the biomedical micro-actuating and retracting device of the present invention can be used to carry medicines in vivo Because the outer biocompatible coating layer 10 is isolated, the medicine in the storage tank can be protected from enzymes or other body fluids, and the substance can be decomposed or destroyed. Therefore, during drug administration, the drug delivery is obstructive and the drug Significant improvements can be achieved in concentration control, selectivity of the treatment site, and convenience of drug control. 15 [Embodiment] To make the present invention For a clear understanding, one embodiment will be described with reference to FIG. I. Please refer to FIG. 1. FIG. 1 shows a part of the biomedical micro-actuating and retracting device 1 of the present invention, which is an array type storage tank layer Π and an energy signal. The supply device layer 12. The array storage tank layer has a plurality of storage tanks 111 in an array arrangement 20 for mounting one or more specific substances. The structure of each storage tank 111 is in the middle of the tank. An actuator composed of a shape memory alloy or a shape memory polymer is placed. 12 and a specific substance are provided. In the actual yoke example, the special substance 1113 is liquid, solid, block, or powder. In the case of a medicament or gel, the actuator 1112 is made of titanium nickel alloy. In this embodiment, the 16 1242455 array storage tank layer 11 and the energy signal supply device layer 12 are made separately. The actuator 1112 and The energy signal supply device layer 12 can be joined by means of silver glue or spot welding. The array storage tank layer U can be made into a micro mold first through a micro-electromechanical (MEMS) process, and then the micro mold can be quickly and massively turned into five systems to greatly reduce costs and increase mass production speed. The material of the array-type storage tank layer 11 is a biocompatible polymer, and a polydimethysiloxane is preferred. The energy signal supply device layer 12 is a circuit layer, preferably a Shi Xi wafer or a printed circuit board (PCB). It has a plurality of electronic components 12 and the electronic components 121 are used to form a control circuit and a power circuit. Part 10 can be used with an external controller to store energy to generate power, that is, to generate power by electromagnetic signals or charging signals sent by the external controller. Of course, a battery unit or a capacitor may also be provided on the power supply circuit for supplying power to the control circuit, so that the control circuit drives the brake 1112 to deform, thereby damaging the storage tank 111 and allowing the specific substance 1113 to be released.
15 圖2係用來進一步說明圖1實施例之陣列式存放槽唐j J 與此S §fl號供應裝置層12分解圖。於本例中，陣列式存放 槽層Π與能量訊號供應裝置層12係上下相連接所組成。在 能量訊號供應裝置層12上所形成之控制電路，係呈現複數 控制節點122，每一控制節點122與陣列式存放槽層u之存 20放槽中致動器1112相互對應。本圖之控制節點^ 22僅為示 意’以方便說明，在實際的電路設計上，控制節點122可能 為電阻或其他電子元件。因此透過能量訊號供應裝置層12 的控制節點122即可輕易定時定址啟動致動器丨丨12破壞存 放槽111，以釋放特定物質（例如藥物）。前述該等控制節 17 1242455 點122係可以接受能量訊號供應裝置層。上之控制電路信 號’供熱至相對應之致動器1112，使其加熱升溫形變而破 壞存放槽111 ;亦或是提供電能至相對應致動器⑴2,利用 5亥致動益1112本身電阻效應而加熱升溫形變來破壞存放槽 5 111。 圖3係為進一步顯示存放槽lu之其中一種結構示意 圖，存放槽⑴具有槽底3卜槽壁32、以及特定物質存放區 34及致動态1112之置放區311。其中，致動器丨丨以已經預先 進订形變記憶，亦即已預先記憶該特定溫度（例如：45它） 10時的形狀結構，然後再將已經處理過記憶形變結構之致動 器1112置放於存放槽lu之槽體結構中（即致動器置放區 311)，以作為開啟存放槽ln之裝置。於本實施例中，其致 動器1112的形狀結構為環形，但亦可為各種形狀，例如彈 簧狀、柱狀等各種形態，以達成撕裂、穿孔、頂開或推擠 15等破壞存放槽111之功效，如圖4之示意圖所示。 圖4係顯示致動器1112破壞存放槽丨丨丨而釋放内含特定 物質1113之示意圖。由於本發明所採用之致動器丨112係具 有於特定條件（例如：溫度）而產生形變之特性，因此透 過前述之該等控制節點122在存放槽ill的下方通電加熱， 20以使付致動态1112之溫度達到特定預設溫度（亦即產生形 變之溫度），而發生形變，藉由形變所產生之機械力將存放 槽111予以撐破，以將内含特定物質.m 3釋放到體内，以達 到治療之目的。由於該變形產生之機械力非常大，因此能 夠輕易地撐破本發明之存放槽111而克服存放槽U1被細胞 18 1242455 纖維化之問題，以解決習知細胞纖維化所造成藥物釋放堵 塞之問題。 圖5為本發明之其中一種製造方法示意圖。本發明之具 有複數個存放槽之陣列式存放槽層11之製造，可以以模具 10 15 翻製方法先製造具有複數個存放槽U丨槽體之陣列式存放 槽層11 ’其存放槽lu槽體含槽底與槽壁（見圖5(A))。於 此同時，並平行製備複數個致動器1112及能量訊號供應裝 置層12,將能量訊號供應裝置層12上各控制結點122接連欲 置放於各存放槽内之致動器1112 (見圖5 (B))。隨之先填 入特定物質1113(例如：藥物）於存放槽ln中（見圖5( 再於存放槽之開口上覆蓋已完成連接致自器1112之能量訊 號供應裝置層12，此時致動器1112乃對應置放入每一存放 槽111内之致動器置放區311中。待陣列式存放槽層u盘能 量訊號供應裝置層12完絲合（例如：膠合）&，再將整 個生醫微致動及收放裝置！翻轉’如此便可完成^所示生 醫微致動及收放裝置丨（見圖5 (D))。 由以上之說明可知，本發明係可將存放槽iu植入生體 内，以在料區域釋放藥物分子’其釋放機制係利用能量 訊5虎供應裝置層12上的該等控制節點122來使得具有形變 特性致動器1112利用該形變機械力將存放槽iu撐破， 化釋放機構之設計，俾能解決藥物遞送職中的各種障 礙、降低樂量使用以及減少藥物副作用，並能遞送液能、 =、塊狀、粉末或膠體等各種型式的藥劑，以提供^ 或局部性治療，且透過生髀冰么 ％ ^生體外無線操控來控管該裝置釋出 20 1242455 某畺’並没疋治療藥物釋放速度，以掌控藥物在生體内的 濃度’並能提升藥物治療之方便性以及效率。 上述實施例僅係為了方便說明而舉例而已，本發明所 主張之權利範圍自應以申請專利範圍所述為準，而非僅限 5 於上述實施例。 【圖式簡單說明】 圖1係本發明一較佳實施例之結構示意圖。 圖2係本發明一較佳實施例之立體分解圖。 10 圖3係本發明一較佳實施例之存放槽的第一種結構示 意圖。 圖4係本發明一較佳實施例之存放槽的第二種結構示 圖。 圖5 (A)至圖5 (D)係製作本發明陣列式存放槽層一 15較佳實施例的存放槽之流程圖。 【圖號說明】 生醫微致動及收放裝置 1 陣列式存放槽層 11 能量訊號供應裝置層 12 槽底 31 槽壁 32 特定物質存放區 34 存放槽 111 1242455 電子元件 121 控制節點 122 致動器置放區 311 致動器 1112 特定物質 1113 2115 FIG. 2 is an exploded view of the array storage tank Tang j J and the supply device layer No. 12 of FIG. 1 for further explaining the embodiment of FIG. 1. In this example, the array storage tank layer Π and the energy signal supply device layer 12 are connected up and down. The control circuit formed on the energy signal supply device layer 12 presents a plurality of control nodes 122, and each control node 122 corresponds to the actuator 1112 in the storage tank 20 of the array storage tank layer u. The control node ^ 22 in this figure is only for illustration 'for convenience of explanation. In actual circuit design, the control node 122 may be a resistor or other electronic components. Therefore, through the control node 122 of the energy signal supply device layer 12, the actuator can be easily addressed and activated at a specified time to damage the storage tank 111 to release a specific substance (such as a drug). The aforementioned control sections 17 1242455 point 122 are capable of receiving the energy signal supply device layer. The above control circuit signal 'provides heat to the corresponding actuator 1112, causing it to heat up and deform to destroy the storage tank 111; or to provide electrical energy to the corresponding actuator ⑴2, and use the resistance of 5HAI to actuate 1112 itself. The effect is that the storage tank 5 111 is damaged due to the heating and deformation. Fig. 3 is a schematic diagram showing a further structure of the storage tank lu. The storage tank has a tank bottom 3, a tank wall 32, a specific substance storage area 34, and a placement area 311 for the dynamic state 1112. Among them, the actuator 丨 丨 has been pre-determined deformation memory, that is, the shape and structure of the specific temperature (for example: 45 it) at 10 o'clock, and then the actuator 1112 that has processed the memory deformation structure is set. It is placed in the groove structure of the storage groove lu (ie, the actuator placement area 311) as a device for opening the storage groove ln. In this embodiment, the shape and structure of the actuator 1112 is ring-shaped, but it can also be in various shapes, such as spring-shaped, column-shaped, and other forms, to achieve tearing, perforation, ejection, or pushing 15 for damage and storage. The effect of the groove 111 is shown in the schematic diagram of FIG. 4. Fig. 4 is a schematic view showing that the actuator 1112 destroys the storage tank 丨 丨 丨 and releases the specific substance 1113 contained therein. Because the actuator used in the present invention has the characteristics of deformation under specific conditions (such as temperature), the above-mentioned control nodes 122 are electrically heated under the storage tank ill, and 20 The temperature of the dynamic 1112 reaches a specific preset temperature (that is, the temperature at which deformation occurs), and deformation occurs, and the storage tank 111 is broken by the mechanical force generated by the deformation to release the specific substance .m 3 to In vivo for therapeutic purposes. Because the mechanical force generated by the deformation is very large, the storage tank 111 of the present invention can be easily broken to overcome the problem of fibrosis of the storage tank U1 by cells 18 1242455, so as to solve the problem of blocking drug release caused by conventional cell fibrosis. . FIG. 5 is a schematic diagram of one of the manufacturing methods of the present invention. In the manufacturing of the array storage tank layer 11 having a plurality of storage tanks according to the present invention, an array storage tank layer 11 having a plurality of storage tanks U 丨 tank body can be first manufactured by a mold 10 15 turning method. The body contains the tank bottom and tank wall (see Figure 5 (A)). At the same time, a plurality of actuators 1112 and the energy signal supply device layer 12 are prepared in parallel, and each control node 122 on the energy signal supply device layer 12 is successively placed in the actuator 1112 in each storage tank (see Figure 5 (B)). Then, a specific substance 1113 (for example, a drug) is first filled in the storage tank ln (see FIG. 5 (and then the opening of the storage tank is covered with the energy signal supply device layer 12 that has been completely connected to the autogenerator 1112. The device 1112 is correspondingly placed in the actuator placement area 311 in each storage tank 111. After the array-type storage tank layer u disk energy signal supply device layer 12 is completed (eg, glued) & The entire biomedical micro-actuating and retracting device! Flip 'so you can complete the biomedical micro-actuating and retracting device shown in Figure ^ (see Figure 5 (D)). As can be seen from the above description, the present invention can The storage slot iu is implanted in the living body to release the drug molecules in the material area. The release mechanism is to use the control nodes 122 on the energy supply device layer 12 to make the actuator 1112 with deformation characteristics to use the deformation mechanism. The storage tank iu is broken, and the design of the release mechanism can solve various obstacles in drug delivery, reduce the amount of music used and reduce the side effects of drugs, and can deliver a variety of liquid energy, =, block, powder or colloid. Type of medicament to provide ^ or topical Treatment, and control of the device's release through the in vitro wireless control of the raw syrup 20 1242455 Some 畺 'did not control the release rate of the therapeutic drug, in order to control the concentration of the drug in the living body' and improve the drug treatment. Convenience and efficiency. The above embodiments are just examples for the convenience of explanation. The scope of the rights claimed in the present invention should be based on the scope of the patent application, not limited to the above embodiments. [Schematic description of the drawings Fig. 1 is a schematic structural diagram of a preferred embodiment of the present invention. Fig. 2 is an exploded perspective view of a preferred embodiment of the present invention. 10 Fig. 3 is a first structural schematic diagram of a storage tank of a preferred embodiment of the present invention. Fig. 4 is a diagram showing a second structure of a storage tank according to a preferred embodiment of the present invention. Figs. 5 (A) to 5 (D) are storage of a preferred embodiment of an array storage tank layer 15 of the present invention. Flow chart of the tank. [Illustration of drawing number] Biomedical micro-actuating and retracting device 1 Array storage tank layer 11 Energy signal supply device layer 12 Tank bottom 31 Tank wall 32 Specific substance storage area 34 Storage tank 111 1242455 Electronic component 121 control Node 122 actuator placement area 311 actuator 1112 specific substance 1113 21