I 200520805 玖、發明說明： 【發明所屬之技術領域】 本發明係闕於一種生臀料絲說a ^ 王诸锨致動及收放裝置，尤指一種 植入生物體内之醫藥用釋放、 5 ^ ^ 果次偵須!/裝置，用以釋 放、收集、或偵測特定物質。 【先前技術】 =遞送的途徑在藥物疾病治療中是相當重要的— 衣。目㈣藥物遞送方式係以口 送障礙性、_度控制 以制方便性等諸多均限制了藥物遞送之應用。 15因胃酸或::::=，藥物由食道進入胃中時，容易 效降低，尤旦是蛋=曰而破壞藥物本身之結構，使得療 劑型:故::二這些藥物目 藥一服;:::::用一 2〇 範圍内，而一护 又、准持在有效的治療濃度 維持藥物的濃度射：藥方式係以頻率性方式來 物在血液中的:農户、* ^頁率性方式有其缺點，亦即藥 液中的辰度變化比較大且濃度不穩定。再者，在給I 200520805 发明 Description of the invention: [Technical field to which the invention belongs] The present invention is based on a raw buttock wire, a ^ Wang Zhuzheng actuating and retracting device, especially a medical release, 5 ^ ^ Scout! / Device for releasing, collecting, or detecting specific substances. [Prior art] = The route of delivery is quite important in the treatment of drug diseases-clothing. Many drug delivery methods have restricted the application of drug delivery, such as oral obstruction and control for convenience. 15 Due to gastric acid or :::: =, when the drug enters the stomach from the esophagus, the effect is easily reduced. Youdan is an egg = that destroys the structure of the drug itself, making the therapeutic dosage form: therefore: two of these drugs, one drug; :::: Use a range of -20 to maintain the concentration of the drug at a therapeutic concentration that is accurate and effective. The method of medicine is to feed the blood in a frequency manner: farmers, * ^ Page rate The sexual method has its shortcomings, that is, the degree of change in the medicinal solution is relatively large and the concentration is unstable. Moreover, giving
I 200520805 予藥物的初期，藥物在 毒性而影響身體。但同時高，則會呈現 則又達不到治療效果太低 5 10 15 治療效果，對二==:濃度，或大幅降低 要的課題。 服或注射給藥方式而言，是非常重 最有==學而言，將藥物直接作用在目標區域係為 &樂方法μ旦是一般的口服或注 =全身性的遞送方式將藥物送到治療區域，所=達 =性f特定性的治療方式。更且採用口服或注射^ /日•實際上需要較直接投藥至目標區域更大的， =投藥效率較低’且藥物需全身遞送而容易引起藥物二作 用0 此外，傳統口服或注射之給藥治療方式對於 :藥：:療的患者而言是相當不方便的。以糖尿上 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 服藥知方式吊'因人為因素而導致藥物使用過量或藥量間斷 使用，且若採用注射式藥物治療，對於病患而言不僅伴隨 疼痛的負擔’更存有潛在注射汗染所造成感染的危機。現 义由於口服及注射方式來遞送藥物有上述缺點，因此， 目别已開發出吞入式或植入式之藥物釋放系統，下述將介 紹目前的幾種解決方案。美國專利案號US645,8U8係揭露 植入式藥物釋放系統，其係利用數種微流體裝置以及導管 20 200520805 來將某物分子注入治療區域，然而，此種植入式藥物釋放 系統大部分只能遞送液態藥物，其所遞送之藥物可能堵夷 在裝置中或導管出口，且導管出口可能有纖維包覆問題， 所以使用上尚有諸多缺點待改善。而且此種植入式藥物釋 5放系統之設計與製作複雜度很高，通常具有複雜的機械結 構設計，其所需元件多，所以使得系統故障之風險提高。 而目前所知者多為單槽式設計，若其單一導管出口或儲存 槽故障卽造成裝置失效或錯誤給藥，危險性較高。 美國專利案號US517,0801揭露一種可吞入式藥物釋 1〇放系統，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，且在内 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。 15該熱旋轉機構為利用形狀記憶合金（Shape Mem〇ryI 200520805 In the early days of administering drugs, the drugs were toxic and affected the body. But at the same time, it will show that the treatment effect is too low. 5 10 15 The treatment effect is too high. If the concentration is high, the problem will be significantly reduced. For oral administration or injection, it is very important. == In terms of science, the direct action of the drug on the target area is & le method μ once is a general oral or injection = systemic delivery method to send the drug Go to the treatment area, so = = sex f specific treatment. Oral or injection ^ / day • In fact, it needs to be larger than the direct injection to the target area, = lower efficiency of administration 'and the drug needs to be delivered systemically, which easily causes secondary effects of the drug. 0 In addition, traditional oral or injection administration The treatment is quite inconvenient for patients who are treated with: Patients on diabetes must use oral hypoglycemic drugs daily or by injection to control their condition. And in terms of the dangers of drug use, self / oral medicine is known to suspend 'overdose or intermittent use of drugs due to human factors, and if injectable medication is used, it will not only accompany the patient's burden of pain' There is also a crisis of potential infections caused by injection of sweat. It is because of the above-mentioned disadvantages of oral and injection drug delivery. Therefore, a swallowable or implantable drug release system has been developed. The following solutions will be introduced. US patent case number US645,8U8 discloses an implantable drug release system, which uses several microfluidic devices and catheters 20 200520805 to inject certain molecules into the treatment area. However, most of such implantable drug release systems are only It can deliver liquid drugs, and the drugs delivered may be blocked in the device or the outlet of the catheter, and the outlet of the catheter may have the problem of fiber coating, so there are still many shortcomings in use to be improved. In addition, the design and manufacturing complexity of such an implantable drug release system is very high. Usually it has a complicated mechanical structure design, and it requires many components, so the risk of system failure is increased. The most known ones are single-tank designs. If the single catheter outlet or storage tank fails, the device will fail or the medicine will be misadministrated, which is more dangerous. U.S. Patent No. US517,0801 discloses a swallowable drug delivery system to improve the disadvantages of oral administration. Its effect is to release the drug in specific areas of the digestive tract. The case uses a swallowable capsule design to achieve the swallowing function. Its main structure can be divided into two layers, the inner and outer layers are designed to release open pores, and the inner and outer layers of open pores are phased by a thermal rotation mechanism. Corresponds so that drug molecules can be released from the pores. 15 The thermal rotation mechanism uses a shape memory alloy (Shape Memory).
Alloys，SMA )來驅動旋轉機構，並利用無線傳輸來控制 藥物釋放。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 其旋轉開口之設計可能造成釋放出口之堵塞，且開口僅可 20為一次全開或全關。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u.S6,527,762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 200520805 ic製程技術來實現微型多藥槽等功能❹此種設計以矽為基 材而重複顯影、银刻、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 開處理，河後製程易互相牵制，困難許多。填藥之後的槽 5蓋製作，程更可能因温度或其他反應而破壞藥物原有的特 ! 生。其藥物分子之釋放機制分為被動式及主動式，其中， 被動式釋放機制係以滲透方式為主，主動式釋放機制係透 過外部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 1〇通性的開蓋設計在微機電製程中複雜且耗時。而因為係以 渗透方式或破裂藥槽開蓋而釋放物質，所以無法解決細胞 隹化而導致堵塞之問題，且會有藥物遞送的障礙存在。 當然，其出口還有纖維包覆之問題。 自上述說明可知，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，因此如何談計 種釋藥系統，以避免在傳統藥物遞送途徑上的限制與不 方便H，並克服植入式釋藥方式所面臨之生理免疫反應所 造成的組織包覆（纖維化）堵塞釋藥出口之問題，俾使得 藥物遞送達到高可靠性、微量化以及準確性，且減少其他 0非目的之藥物副作用，已成為一亟需解決之課題。 【發明内容】 —有鐘前述習知技藝之缺失，本發明之目的係在於提供 —種生醫微致動及收放裝置，俾能植人生物體内釋放化合 200520805 ’‘ 物（如醫藥化合物）、組合物（如醫藥組合物）等特定物 貝，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，俾能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、 20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。 依據本發明之一特色，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隼一特定物質，包含： 存放槽係由聚合物構成，用於存放特定物質；一致動器Alloys (SMA) to drive the rotating mechanism and use wireless transmission to control drug release. However, this design has many shortcomings to be overcome. For example, it can only be put into the stomach for short-term treatment. Currently, it can only be loaded with a single therapeutic drug. The design of its rotating opening may cause the release outlet to be blocked, and the opening can only be fully opened or fully closed at one time. If the opening is used repeatedly, it is easy for the body fluid to penetrate into the medicine tank, which will 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 u.S6,527,762 disclose an implantable drug release system, which uses micro-electromechanical (MEMS) technology and 200520805 ic process technology to achieve functions such as a miniature multi-drug tank. This design uses silicon Complex processes such as development, silver engraving, and deposition can be completed for the substrate, and its cavity, electrical control layer, filling, and slot cover must be made in sequence. They cannot be processed separately in parallel. The Hehou process is easy to check each other, which is difficult. a lot of. After the filling of the groove 5 cover is made, the process 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. Among them, the passive release mechanism is mainly osmotic, and the active release mechanism is to change the lid of the drug tank into a permeable structure through external control of temperature changes to change the drug. Release it. There are also many disadvantages to this design. For example, open lid designs with different permeability are complex and time-consuming in the MEMS manufacturing process. And because the material is released by osmosis or rupture of the drug tank, the problem of blockage caused by cell dysfunction cannot be solved, and there will be obstacles to drug delivery. Of course, its export also has the problem of fiber coating. As can be seen from the above description, although there are many ways to solve the problem of drug release, there are still many shortcomings described above. Therefore, how to talk about a drug release system to avoid restrictions and inconveniences on traditional drug delivery routes. It also overcomes the problem of tissue coating (fibrosis) blocking the drug release outlet caused by the physiological and immune response faced by the implantable drug release method, which enables drug delivery to achieve high reliability, miniaturization and accuracy, and reduces other 0 Non-purpose drug side effects have become a problem that needs to be solved urgently. [Summary of the Invention]-There is a lack of the aforementioned conventional techniques. The purpose of the present invention is to provide-a biomedical micro-actuating and retracting device that can release compounds 200520805 '' (such as pharmaceutical compounds) in human living organisms. And other specific substances (such as pharmaceutical compositions), improve the drug release effect, reduce the risk of blocking the storage tank from failure to release the drug, 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-actuating 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 to reduce barriers to drug delivery. Yet another object of the present invention is to provide a biomedical micro-actuating and retracting device that can collect specific substances such as secretions, enzymes, proteins, genes, 15-cell tissues in the body, or carry out biological secretions, enzymes, Sensing specific substances such as proteins, genes, and cell tissues. Still another object of the present invention is to provide a biomedical micro-actuating and retracting device, which can be implanted in 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 Enzymes, proteins, genes, cell tissues and other specific substances are collected and sensed; or specific substances are released or collected at regular locations outside the organism. According to a feature 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, and includes: a storage tank composed of a polymer for storing a specific substance Substance
I 200520805 (Actuator ) ’ 係由形狀記憶合金（shape Memory Alloy， SMA )或形狀記憶聚合物（shape Memory Polymer，SMP ) 構成’藉由該形狀記憶合金或形狀記憶聚合物變形產生之 機械力來控制存放槽之開關；一能量訊號供應裝置，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 接存放槽與能量訊號供應裝置，藉由接收能量訊號供應裝 置所提供之電、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。 10 依據本發明之另一特色，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 少一個存放槽，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；一能量訊號供應裝置， 係提供電或磁訊號以驅動致動器形變。前述的致動器，係 15由形狀記憶合金或形狀記憶聚合物所構，分別連接存放槽 與能量訊號供應裝置，並藉由其結構形變產生的機械力來 開關存放槽。 本舍月之生西祕致動及收放裝置，其可應用於植入一 生物體（例如：人體、動物體）N，在植入之特定區域將 20特定物質（例如：藥物）釋放出來，或進行特定部位之樣 本（例如.酵素、分泌物）採集；或是應用於生物體外之 特定物質（例如：芳香劑）之釋放，或環境中樣本（例如： 廢水）採集。 11 200520805 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 一能篁訊號供應裝置，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 一甲基石夕氧烧（Polydimetylysiloxane，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。該模具可以經由習用之方法製造，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 槽之程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 陣列形式，且M*N為整數，此設計在製程上較為簡單。 忒存放槽係用以儲存化合物，組合物，感測器或一採樣機 構’其每一槽體結構係設有置放致動器之區域，可將致動 裔固定於其間，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。 本發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， 八中乂欽鎳B金（丁卜犯）或鈦猛鎵舍金（Ti_Mn-Ga )較佳。 $致動器控制存放槽之開關，係利用形狀記憶合金或形狀 200520805 記憶聚合物之形狀結構可 5 之特點來達成。本發明致動;關=)定義 定義致動器於特定溫度之結構子^開關方式，係先 動器固定置放於前述每押其完成定義之致 致動益結構形狀及溫度和先定義之予=之 待致動器溫度回覆至特定溫 ，疋:度不同， 成為事先定義杜構形妝η * 八、，·。構形即產生形變而 述藉由致動器形變打開存放 汗14關閉存放槽。别 10 15 20 頁開存放槽槽盖，而達釋放特定一 動器形變打開存放槽之另 4 ’。别述猎由致 放槽槽體結構，可W破係以機械力方式破壞存 破裂，而達釋放=之!：、_等方式，造成槽體 閉存放梓方4 目的。前述藉由致動器形變關 缩，將二/之―’係可將致動器設計成彈簧狀進行收 二:ΪΓ存放槽槽蓋拉下蓋上，以封閉存放槽，達 m t目的。本發明致動器係以溫度升高至特定 2方式來發生形變而回復至事先定義之結構形狀，其溫 j南方切以⑽種f用方式達成，其巾以外加熱源、 I、利用本身電阻生熱較佳。本發明致動器之形變係可利 ^磁場效應來達成，其中鈇般鎵合金（Ti-Mn_Ga)材質較 本t月之此®訊號供應裝置，；ί系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 號供應裝置，係可提供電、熱或磁等能量訊號給單一特定 夂動器或同時多個致動器，定時定址控制前述陣列式存放 13 200520805 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，較佳為以石夕晶片、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。 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p a r y丨e n e (^ 對二曱苯）較佳，係為醫藥用生醫微致動及收放裝置，可以 5 10 15 作為藥物，試劑之釋放或體内分泌物、酵素、蛋白質、基 因、細胞組織等特定物質收集、感測。其存放槽内之藥物二 試劑形式，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 集生醫微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， 係可以空的且未封閉之存放槽植人，或以存放槽内放置採 樣機構進仃收集。前述體内物質之感測，係可於存放槽内 放置感測Hit行感測。本發明生諸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人於特定部位， 或在其他特定時機將其植入於生物韓内，以釋放藥物分子 ^達到治療之功效。該植入之生物體無限制，較佳為動物， ^為人體。當本發明生醫微致動及收放裝置植入於動物 =、，並内含藥物組合物或藥物化合物時，其可以於動物 以無線電傳，控制方法，定時妹地啟動該裝置之致 -以釋放適篁之藥物於該動物體内之目標部位。而因 20 200520805 為本發明生醫微致動及收放裝置為主以形狀記憶合金或形 狀δ己憶聚合物撐破存放槽之多藥槽結構，所以因為纖維化 堵塞之風險大為降低。而以存放槽作為置放藥物之所在， 則可以降低藥物形式之限制，適用於各種型態之藥物或醫 5藥組成物。再者，由於本發明之致羚器之機構簡單，僅為 簡單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 複雜度，提高系統信賴度。另一方面，因為形狀記憶合金 或形狀記憶聚合物之機械變形量遠大於其他材質，所以本 1〇發明生醫微致動及收放裝置以形狀記憶合金或形狀記憶聚 合物撐破存放槽之多_結構具有較高之操作方便優里 性0 〆、 本發明生醫微致動及收放裝置，其應用於生物體 15 20 ===化學物質之釋放。例如芳香劑之釋放 备存放槽内配合感測器或採樣機構時，本發明生醫微致 乍為人體或環境之監測或採樣之用：若 配合無線電雙向收發傳輸，控制並回I 200520805 (Actuator) 'is composed of shape memory alloy (SMA) or shape memory polymer (SMP)' is controlled by the mechanical force generated by the shape memory alloy or shape memory polymer deformation Storage tank switch; an energy signal supply device that supplies 5 power, thermal or magnetic signals to drive the actuator to deform. The aforementioned actuators are respectively connected to the storage tank and the energy signal supply device, and are driven to generate deformation by receiving electric, thermal or magnetic signals provided by the energy signal supply device, and the storage tank is closed by the deformation mechanical force to achieve release or collection. The purpose of a particular substance. 10 According to 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 one storage tank for storing a specific substance; at least An actuator controls the storage tank switch by its deformation; an energy signal supply device provides an electric or magnetic signal to drive the actuator to deform. The aforementioned actuator 15 is composed of a shape memory alloy or a shape memory polymer, and is connected to the storage tank and the energy signal supply device respectively, and the storage tank is opened and closed by the mechanical force generated by the structural deformation. The Secret Secret Actuating and Retracting Device of this Month's Life can be applied to implant an organism (eg, human body, animal body) N, and release 20 specific substances (eg, drugs) in a specific area of implantation, Or collect samples from specific parts (such as enzymes, secretions); or release specific substances (such as fragrances) that are applied outside the organism, or collect samples from the environment (such as wastewater). 11 200520805 The biomedical micro-actuating and retracting device of the present invention mainly uses at least one storage slot as a storage place for collecting and collecting specific substances, and cooperates with at least one of a shape memory alloy or a shape memory polymer. Actuator to open and close the storage slot. The aforementioned biomedical micro-actuating and retracting device further includes 5 energy signal supply devices, which are used to provide electric, thermal, or magnetic energy signals to the actuator, and drive the actuator to deform to open and close the storage slot. The storage tank of the present invention is preferably composed of a polymer, and a polydimetyly siloxane (PDMS) is more preferred. The storage tank can be processed by conventional techniques, and it is better to make 10 by a mold turning method. The aforementioned mold turning is performed by using a previously prepared mold and injecting a polymer. The mold can be manufactured by a conventional method, and is preferably manufactured by a micro-electromechanical processing method or a precision machining process. The process of turning the storage tank of the mold may be that the structure of the tank body can be separately manufactured and then joined, or it can be manufactured in an integrated manner. Because the storage tank is made of a mold, the storage tank on the 15th medical micro-actuating and retracting device of the present invention can be arrayed by a plurality of tanks, and M * N is an integer. This design is in the manufacturing process. Simpler.忒 The storage tank is used to store compounds, compositions, sensors or a sampling mechanism. Each of its tank structures is provided with an area for placing an actuator, and the actuator can be fixed there in order to control the storage tank. The switch. In addition, the storage tank 20 can be further combined with a flow channel design to control or facilitate the release of the stored items. The actuator of the present invention is composed of a shape memory alloy or a shape memory polymer, which can be a conventional shape memory alloy or a shape memory polymer, Bazhong Qin Nickel B Gold (Timbu), or Titanium Gallium Gold. (Ti_Mn-Ga) is preferred. $ Actuator controls the switch of the storage tank by using shape memory alloy or shape 200520805. The shape structure of the memory polymer can be achieved. This invention actuates; Off =) defines the structure that defines the actuator at a specific temperature. ^ The switching mode is that the first actuator is fixedly placed in the shape and temperature of the actuating structure and the previously defined one. == The temperature of the actuator to be returned to a specific temperature, 疋: Different degrees, it becomes a pre-defined Du structure shape makeup η * VIII ,,. The configuration is deformed, and the storage is opened by the deformation of the actuator. The sweat 14 closes the storage tank. Do not open the storage tank slot cover on pages 10, 15 and 20, and release the specific actuator to open the other 4 'of the storage tank. In other words, the structure of the tank is caused by hunting. The mechanical system can be used to break the storage rupture, and release ==!:, _, Etc., causing the tank to be closed and stored. In the foregoing, the actuator is deformed and contracted, and the second / the “-” system can be designed as a spring to close the actuator: ΪΓ storage tank slot cover is pulled down to close the storage tank to achieve the purpose of m t. The actuator of the present invention is deformed by increasing the temperature to a specific 2 manner and returns to a previously defined structural shape. Its temperature and temperature are achieved in a variety of ways. The heating source other than the towel, I, and its own resistance are used. Better heat generation. The deformation system of the actuator of the present invention can be achieved by utilizing the magnetic field effect, in which the material of ordinary gallium alloy (Ti-Mn_Ga) is better than this ® signal supply device of this month; it is connected to each actuator to transmit electricity. Signals such as heat, magnetic or magnetic energy are used to deform the actuator. The energy signal supply device can provide electric, thermal or magnetic energy signals to a single specific actuator or multiple actuators at the same time, and periodically address and control the aforementioned array storage 13 200520805 slot switch. The energy signal supply device may be a circuit layer of any conventional substrate, and is preferably a circuit layer based on Shi Xi wafer and printed circuit board. 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. 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, pary 丨 ene (^ p-diphenylbenzene) is preferred, which is a micro-actuation and collection of medical biomedical. The device can be used as a medicine, reagent, or body secretions, enzymes, proteins, genes, cell tissues and other specific materials to collect and sense. The form of the medicine two reagent in the storage tank may be in the form of any conventional composition or compound, preferably liquid, block, powder or gel. In the present invention, the compound or composition contained in the storage tank for releasing and collecting the biomedical microactuating and retracting device in the living body is preferably a medicinal compound or medicinal composition. The aforementioned material collection in the body can be implanted in an empty and unclosed storage tank, or collected by placing a sampling mechanism in the storage tank. The aforementioned body material sensing can be performed by placing a sensing Hit in a storage tank. The timing when the actuating and retracting device of the present invention is implanted in a living body can be implanted in a specific place during surgery, or implanted in a biological Han at other specific times to release drug molecules ^ To achieve the effect of treatment. The implanted organism is not limited, preferably an animal, and is a human body. When the biomedical micro-actuating and retracting device of the present invention is implanted in an animal, and contains a pharmaceutical composition or a drug compound, it can be transmitted to the animal by radio, a control method, and the device can be activated regularly- To release a suitable drug to a target site in the animal. Since 20 200520805 is the biomedical micro-actuating and retracting device of the present invention, the shape-memory alloy or the shape δ-hexyl polymer supports the multi-drug tank structure of the storage tank, so the risk of fibrosis blockage is greatly reduced. Using the storage tank as a place for placing medicines can reduce the restrictions on the form of medicines and is suitable for various types of medicines or medical composition. Furthermore, because the mechanism of the gazelle of the present invention is simple, only the shape memory alloy or shape memory polymer with a simple structure destroys the storage slot, so the complexity of complex mechanical structures (such as motors, pumps, gears) can be eliminated. Increase system reliability. On the other hand, because the amount of mechanical deformation of the shape memory alloy or shape memory polymer is much larger than other materials, the biomedical micro-actuating and retracting device of the present invention uses the shape memory alloy or shape memory polymer to break the storage groove. The multi-structure has high operating convenience and excellent performance. 〆 The biomedical micro-actuating and retracting device of the present invention is applied to the biological body 15 20 === release of chemical substances. For example, when the fragrance is released and the sensor or sampling mechanism is equipped in the storage tank, the biomedical device of the present invention is used for monitoring or sampling of the human body or the environment.
醫微致動及收放裝置可以以遠距控制化：：1 5明 監測之結果’降低空間及時間之限制。D <釋出並偵 以本專利所製作的藥物遞送 送藥物，並允許植入前或植：:可植入體内直接 動調控或程式設定藥物遞送之時間、：：間點二由體外 個人化、客製化的藥物遞送方式。A及劑量，是- 15 200520805 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、餘刻、沈積等複雜製程，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，電路層與存放 槽分開同時並行製造，電路層之材料可以選用之範圍增 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，: =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，以圖丨說明其一實施方式， 請參照圖1。圖1顯示本發明生醫微致動及收放裝置丨之部分 不思圖，其係由陣列式存放槽層丨丨及能量訊號供應裝置層 12所構成。其中陣列式存放槽層具有複數個陣列排列 2〇之存放槽m，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1112及特定物質1113。於本實 苑例中，特疋物質1丨丨3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， 200520805 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1訊號供應裝置層12可用銀膠或點焊 專方式接合。該陣列式存放槽層11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，以聚二甲基石夕氧烧較 佳。該能量訊號供應裝置層12係為電路層，以矽晶片或印 刷電路板（PCB)較佳，係具有複數電子元件121，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 籲 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1 i i 3能夠釋放。 15 圖2係用來進一步說明圖1實施例之陣列式存放槽層u 與月b里sfl號供應裝置層1 2分解圖。於本例中，陣列式存放 槽層11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n之存 20放槽中致動器1112相互對應。本圖之控制節點i 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丨）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 200520805 點122係可以接受能量訊號供應裝置層12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ill，·亦或是提供電能至相對應致動器ιιΐ2，利用 孩致動益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丨丨丨之其中一種結構示意 圖，存放槽111具有槽底31、槽壁32、以及特定物質存放區 34及致動器1112之置放區311。其中，致動器⑴化經預先 進行形變記憶，亦即已預先記憶該特定溫度（例如：45<t ) 10時的形狀結構，然;^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lu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1112係具 有於特疋條件（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U1的下方通電加熱， 20以使得致動器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1113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U1而克服存放槽U1被細胞 18 200520805 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u之製造，可以以模具 5翻製方法先製造具有複數個存放槽111槽體之陣列式存放 槽層11，其存放槽111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！ 22接連欲 置放於各存放槽内之致動器1112 (見圖5 (B))。隨之先填 10入特定物質1113(例如：藥物）於存放槽lu中（見圖5( c)》 再於存放槽之開口上覆蓋已完成連接致動器1112之能量訊 號供應装置層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與能 里Λ號供應裝置層12完成麵合（例如：膠合）後，再將整 15個生醫微致動及收放裝置1翻轉，如此便可完成圖丨所未生 醫微致動及收放裝置1 (見圖5 (D))。 由以上之說明可知，本發明係可將存放槽丨丨丨植入生體 内，以在特定區域釋放藥物分子，其釋放機制係利用能量 訊號供應裝置層12上的該等控制節點122來使得具有形變 20特性致動器1112利用該形變機械力將存放槽lu撐破，以簡 化釋放機構之設計，俾能解決藥物遞送途徑中的各種障 礙、降低藥量使用以及減少藥物副作用，並能遞送液態、 固態、塊狀、粉末或膠體等各種型式的藥劑，以提供全身 或局部性治療，且透過生體外無線操控來控管該裝置釋出 200520805 5 藥量’並設定治療藥物釋放速度， 濃度，並能提升藥物治療之方便性 上述實施例僅係為了方便說明 主張之權利範圍自應以申請專利範 於上述實施例。 以4控藥物在生體内的 以及效率。 而舉例而已，本發明所 圍所述為準，而非僅限 10 【圖式簡單說明】 圖1係本發明一 圖2係本發明一 圖3係本發明一 意圖。 較佳實施例之結構示意圖。 較佳實施例之立體分解圖。 較佳實施狀麵槽的第—種結構示 圖4係本發明一較佳實施例之存放槽的第 二種結構示 圖5(A)至圖5(D)係製作本發明陣列 15較佳實施例的存放槽之流程圖。 x子槽層 【圖號說明】 生醫微致動及收放装置 1 陣列式存放槽層 11 能量訊號供應裝置層 12 槽底 31 槽壁 U 特定物質存放區 34 存放槽 ！】 200520805 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 21The medical micro-actuating and retracting device can be controlled from a long distance: 15 minutes The results of monitoring ’reduce space and time constraints. D < release and detect the drug delivery with the drug produced by this patent, and allow pre-implantation or implantation :: implantable directly in the body to regulate or program the time of drug delivery, Personalized and customized drug delivery. A and dose, yes-15 200520805 Because the biomedical micro-actuating and retracting device of the present invention can use molds and be remade, it can avoid complicated processes such as repeated development, engraving, deposition, etc. The manufacturing method is simple, the manufacturing time is shortened and the manufacturing low cost. The present invention can even manufacture the circuit layer of the energy signal supply device and a plurality of storage slots at the same time in parallel and simultaneously, so as to save the manufacturing time. In addition, the circuit layer and the storage tank are manufactured separately and in parallel, and the material of the circuit layer can be selected from a wider range. Any conventional material (such as a flexible printed circuit board) can be used. Second, the cost can be reduced or special requirements can be met. In addition, when the biomedical micro-actuating and retracting device of the present invention carries a drug in a living body, the biocompatible coating layer 10 is isolated from the outside, so that the medicine in the storage tank can be protected from enzymes or other body fluids: = Decomposition or destruction of things. Therefore, when it is administered, its drug delivery obstacle, drug concentration control, treatment site selectivity, and drug control convenience can be greatly improved. 15 [Embodiment] To make the content of the present invention clear, one embodiment will be described with reference to FIG. 1, and please refer to FIG. 1. Fig. 1 shows a part of the biomedical micro-actuating and retracting device of the present invention, which is composed of an array storage tank layer and an energy signal supply device layer. The array-type storage tank layer has a plurality of storage tanks m arranged in an array of 20, and is used for installing one or more specific substances. An actuator 1112 and a specific substance 1113 composed of a shape memory alloy or a shape memory polymer are arranged in the structural tank body of each storage tank 111. In this example, the special substance 1 丨 3 is a liquid, solid, lumpy, powdery, or gelatinous drug, and the actuator 1112 is composed of a titanium-nickel alloy. In this embodiment, the 200520805 array storage tank layer 11 and the energy signal supply device layer 12 are manufactured separately. The actuator 1112 and the signal supply device layer 12 can be joined by silver glue or spot welding. The array-type storage tank layer 11 can be made into a micro mold by a micro-electromechanical (Mems) process, and then the micro mold can be quickly and massively turned 5 ′ to greatly reduce the cost and increase the speed of mass production. The material of the array-type storage tank layer 11 is a biocompatible polymer, and polydimethyl stone is better for sintering. The energy signal supply device layer 12 is a circuit layer, preferably a silicon wafer or a printed circuit board (PCB), and has a plurality of electronic components 121. These electronic components 121 are used to form a control circuit and a power circuit. Fenyu 10 can be used with an external controller to store energy to generate power, that is, to generate power by using an electromagnetic signal or a charging signal from an 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 to damage the storage tank 111, so that the specific substance 1 i i 3 can be released. 15 FIG. 2 is an exploded view of the array storage tank layer u and the sfl supply device layer 12 in the embodiment of FIG. 1 for further explanation. In this example, the array storage tank layer 11 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 n. The control node i 22 in this figure is for illustration only, 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 periodically to destroy the storage tank 111 to release a specific substance (such as a drug). The aforementioned control sections 17 200520805 point 122 can receive the control circuit signal on the energy signal supply device layer 12 to supply heat to the corresponding actuator 1112, which will cause the heating and deformation to damage the storage tank ill, or Provide electric energy to the corresponding actuator ιι2, and use the resistance effect of the actuator 1112 to heat up and deform to destroy the storage tank 5 111. FIG. 3 is a schematic diagram showing a further structure of the storage tank 丨 丨 丨. The storage tank 111 has a tank bottom 31, a tank wall 32, a specific substance storage area 34, and a placement area 311 for the actuator 1112. Among them, the actuator is subjected to deformation memory in advance, that is, the shape structure at a specific temperature (for example: 45 < t) at 10 has been memorized in advance, and then the actuator 1112 that has processed the memorized deformation structure is then memorized. 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 lu and releases the specific substance 1113 contained therein. Because the actuator 1112 used in the present invention has a characteristic of deforming under special conditions (such as temperature), it is electrically heated under the storage tank U1 through the aforementioned control nodes 122, 20 to enable actuation. The temperature of the device 1112 reaches a specific preset temperature (that is, the temperature at which deformation occurs) ', and the storage tank 111 is broken by the mechanical force generated by the deformation to release the specific substance 1113 contained in the body. To achieve the purpose of treatment. Due to the very large mechanical force generated by this deformation, the storage tank U1 of the present invention can be easily broken to overcome the problem of fibrosis of the storage tank U1 by the cells 18 200520805 to solve the problem of drug blocking caused by the known 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 u having a plurality of storage tanks according to the present invention, an array storage tank layer 11 having a plurality of storage tanks 111 can be first manufactured by the mold 5 turning method. The storage tank 111 contains 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 on the energy signal supply device layer 12 is prepared! 22 Actuators 1112 to be successively placed in each storage tank (see Fig. 5 (B)). Then fill in 10 specific substances 1113 (eg, medicines) in the storage tank lu (see Figure 5 (c) >>), and then cover the opening of the storage tank with the energy signal supply device layer 12 that has been connected to the actuator 1112. At this time, the actuator 1112 is correspondingly placed in the actuator placement area 311 in each storage tank 111. The array storage tank layer u and the No. Λ supply device layer 12 are completely bonded (eg, glued) ), Then turn the entire 15 biomedical micro-actuating and retracting device 1 over, so that you can complete the micro-actuating and retracting device 1 (see Figure 5 (D)). It can be seen that the present invention can be implanted into the living body to release drug molecules in a specific area. The release mechanism uses the control nodes 122 on the energy signal supply device layer 12 to make the deformation 20 The characteristic actuator 1112 uses the deformation mechanical force to break the storage tank lu to simplify the design of the release mechanism, and can solve various obstacles in the drug delivery route, reduce the use of the drug amount and reduce the side effects of the drug, and can deliver liquid and solid , Block, powder or colloid To provide systemic or local treatment, and to control the device to release 200520805 5 doses through wireless control in vitro and set the release rate and concentration of the treatment drug, and can improve the convenience of drug treatment. The above examples are only In order to facilitate the explanation of the scope of the claimed rights, the patent application should be applied to the above embodiments. The 4 drugs in the body and the efficiency are given. For example, the scope of the present invention is not limited to 10 [ Brief description of the drawings] Fig. 1 is the present invention, Fig. 2 is the present invention, and Fig. 3 is the intention of the present invention. Schematic diagram of the preferred embodiment. An exploded perspective view of the preferred embodiment. —Structure Diagram 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 flowcharts of manufacturing a storage groove of a preferred embodiment of an array 15 according to the present invention. .X sub-slot layer [Illustration of the drawing number] Biomedical micro-actuating and retracting device 1 Array storage slot layer 11 Energy signal supply device layer 12 Slot bottom 31 Slot wall U Specific substance storage area 34 Storage slot!] 200520805 Electronic components 12 1 Control node 122 Actuator placement area 311 Actuator 1112 Specific substances 1113 21