4252 92 at -B7 五、發明說明(1 ) (請先閱讀背面之注专爹項再填寫本頁) 本發明大體上係有關於藥品之輸送的領域,尤其是藥 品之肺部輸送》特別是,本發明係有關於用在被病人吸入 的藥品之氣霧化。 有效的藥品輸送給病人對於藥品之治療是十分重要的 °目前已有不同的輸送方式存在,且各有其優缺點。藥片 ’膠囊,藥物酵剤之口服藥輸送可能是最方便的輸送方法 ’但很多藥會在其吸收之前在消化道中會被消化酶分解β 此種對於會快速地在消化道中被消化酶分解之現代的蛋白 質藥品尤其會產生問題。皮下注射經常是系統藥品輸送的 一種有效方法,包括蛋白質之輸送,但病人接受度低β由 於藥品,如胰島素,之注射,一天一次或數次經常造成病 人的痛苦,很多不同的服藥方式已發展出來了,包括經廣 輸送,鼻内,輸送陰道内輸送以及肺部輸送β 經濟部暫慧財產局貝工消t合作社印製 本發明最有興趣的是肺部藥品輸送依賴一驅散或霧化 的藥品被病人吸入,使得在驅散中的活性藥品可達到肺部 之遠(肺泡)區。已發現某些藥品可經由肺泡區直接吸收進 入血液循環β肺部輸送特別對於以其他吸入方式較困難輪 送的蛋白質及聚缩氨酸特別有效。此種肺部輸送對系統輸 送及局部輸送以治療肺病均十分有效。 肺部藥品輸送(包括系統及局部)可自行以不同的方式 完成,包括流體中和器,定劑量吸入器(MDI’s)以及乾粉 分散裝置。乾粉軀散裝置對於輸送製作成乾粉的蛋白質及 聚縮氨酸藥品特別有效。許多其他不安定蛋白質及聚缩氣 酸可穩定地藉由其本身配合適當的粉末載饉而以冷凍乾燥 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) Α7 Β74252 92 at -B7 V. Description of the invention (1) (please read the note on the back before filling in this page) The present invention generally relates to the field of drug delivery, especially drug delivery to the lungs ", especially The present invention relates to aerosolization of medicines for inhalation by patients. Effective drug delivery to patients is very important for the treatment of drugs. ° Currently, different delivery methods exist, each with its own advantages and disadvantages. Tablets 'capsules, oral drug delivery of drug fermentation may be the most convenient method of delivery', but many drugs will be broken down by digestive enzymes in the digestive tract before they are absorbed. Modern protein medicines are especially problematic. Subcutaneous injection is often an effective method of systemic drug delivery, including protein delivery, but patient acceptance is low β. Because drugs, such as insulin, injections, often cause pain to patients once or several times a day, many different forms of medication have been developed It comes out, including trans-canal delivery, intranasal, intra-vaginal delivery, and pulmonary delivery. Β Printed by the Cooperative Society of the Ministry of Economic Affairs, temporary intellectual property bureau. The most interesting aspect of the present invention is that pulmonary drug delivery depends on dispersing or nebulization. The drug is inhaled by the patient so that the active drug in the dispersal can reach the far (alveolar) area of the lungs. It has been found that certain drugs can be directly absorbed into the blood circulation through the alveolar region and β-pulmonary delivery is particularly effective for proteins and polypeptides which are more difficult to rotate by other inhalation methods. This type of pulmonary delivery is very effective for systemic and local delivery to treat lung disease. Pulmonary drug delivery (both systemic and local) can be performed in different ways on its own, including fluid neutralizers, fixed dose inhalers (MDI's), and dry powder dispersing devices. The dry powder body powder device is particularly effective for delivering protein and poly (peptide) medicines made into dry powder. Many other unstable proteins and polycondensation acids can be freeze-dried stably by themselves with proper powder loading. The paper size is in accordance with China National Standard (CNS) A4 (210 X 297 mm) Α7 Β7
C h 經濟邹智慧財產局員工消费合作钍印製 五、發明說明(2 或喷式乾粉形式儲藏。然而,輸送乾粉蛋白質及聚縮氨酸 在某些方面是有問題的β許多蛋白質及聚縮氨酸之劑董通 常是十分重要的,因此任何乾粉輸送系統必須精確且重覆 地輸送定量的藥品。此外,許多蛋白質及聚缩氨睃均十分 昂貴,與傳統單劑量藥品責許多倍。於是,有效地輸送乾 粉至肺部目標區而損失最少的藥品是十分重要的。最妤在 乾粉中的粉末結塊必須在病人吸入之前先打破,以確保系 統吸收或其他肺部輸送之有效性。 美國專利5,785,049及5,740,794揭露例示裝置及方法 用以氣霧化維持在一容器中的粉末狀藥品》這些專利之完 整的揭露均加入本文中作為參考資料。這些裝置及方法使 用一高壓力氣流以自一容器中萃取出一粉末藥品,以分散 粉末至氣流中製造一霧氣。此種裝置及方法已證明對製造 輸送至肺部的氣霧化藥品大艎有效。 美國專利4,534,343揭露一典型的定劑量吸入器,其 中壓力下的藥品儲存在一容器中》藥品支持在容器内的加 歷流體推進劑中。藥品必須在整個系統使用壽命中以此狀 態維持穩定。但是’諸如蛋白及消化酶之許多不穩定藥品 均無法在流體中保持長時間的儲存穩定性β 如下述,本發明備置另一種系統,裝置及方法,用以 氣霧化藥品,藥劑。如此,可備置另一種策略有助於藥品 藥劑輸送至肺部。 本發明備置例示系統,方法及裝置,用以基本上裝在 一容器中的霧氣化藥劑。廣義而言,本發明使用一推進劑 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公爱) I I-----1!-裝· I I I l·--—訂---------線 (請先閱讀背面之注意事項再填寫本頁) 4 2 5 2 9 2 a: ____ ... Β7 經濟部智慧財產局貝工消费合作社印製 五、發明說明(3 ) 的能力以氣霧化一藥劑。來自推進劑的藥劑可分別地儲存 直到其氣霧化為止,以延長藥刺的壽命β藥劑可為粉末或 流體形式’運用推進劑之能量置放氣霧化形式的藥劑,使 得它可吸入並輸送至肺部。依據本發明之第一特徵,先前 舆一液態部份保持平衡的一推進氣的一氣態部份可用來製 化霧氣。 依據一例示方法,備置先前舆一液艟保持平衡之一計 量的加壓氣體。警如,加壓氣艘可包括先前與推進劑之一 液態部份保持平衡的一推進劑之一氣態部份。此計量之氣 體釋放出來以創造一高壓氣流。然後,此氣流流經一霧氣 化機構’以自容器中萃取藥劑,並在氣流中分散藥劑,以 形成一霧氣。 本方法使用的推進劑可包括HFCs(氩氟烴),尤其是 HFAs(氩氟烷烴),如HFC 134a或HFC 227ea。其他可使用 的推進劑包括C02及CFCs(氯氟烴)11,12及114 »由於CFCs 已被認定為儲存同溫臭氧層的物質,HFCs以及HFAs為較 佳的。加壓氣體較佳的計量在大約0.5ml至大約2.Oml的範 圍内。計量氣體的壓々較佳在大約40psig至大約120psig之 範圍内,而更好在大約40psig至大約120psig之範圍内,而 最佳在大約50psig至80psig之範園内。當使用(:02時,計 量氣體之壓力最好在大約800psig至大約1200psig之間。 本發明另備置一例示裝置,用以氣霧化支持於一容器 中的一藥劑。本裝置包括支持具有一液態部份及一氣態部 份的一推進劑之一容器。定位一計量室以容納並計測一定 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閲讀背面之注意事項再填寫本5 > ΓΓ 裝 tSJ· 經濟部智慧財產局貝工消费合作社印製 A7 B7 玉:、發明說明(4 ) 量的推進劑之氣態部份*備置一釋放閥以釋出計測出的推 進劑並形成一高壓氣流。本裝置另包括一氣霧化機構,用 以容納高壓氣流’自容器中窣取藥劑,並在氣流中分散粉 末以形成一霧氣。 依據本發明的一特徵,一計量閥配置在儲存槽及計量 室之間。計量閥可移動至一打開位置,以允許推進氣之氣 D 態部份進入計量室。一旦計量室填充後,計量閥最好移動 至一關閉位置。作為一實施例,計量閥最好移動至一關閉 位置。作為一實例,計量閥可包括一氣門閥,它被推動以 移動閥至打開位置。當室填充完後,氣門閥被鬆開以允許 閥移動至關閉位置。 便利地,可備置一桿,它可移動以關上釋放閥並打開 計量閥》當桿移動回到其開始位置時,計量閥關上,而釋 放閥維持關上。如此,計量之推進劑維持在計量室内β最 好’備置一大益以打開釋放閥並允許計量氣體流出。依據 —特殊之特徵,備置一殼體以支持儲存槽,計量室以及氣 霧化機構。最好,一捕捉室可操作地連接殼體。該捕捉室 包括一嘴’經由它氣霧化粉末可流出。 * 在一實施例中,備置一系統,用以氣霧化一藥劑。該 . 系統包括一推進劑源,它包括與一液態部份保持平衡的一 氣態部份。一藥劑在已與液態部份分開的推進劑之至少一 氣態部份内分散。於是,備置一氣態推氣劑之一部份的此 種系統用作為且能源以氣霧化一藥劑。 第1圖為用以氣霧化容納在依據本發明的一容器内之 本紙張尺度適用中關冢標準(CNS)A4規格⑽X 297公爱) ---------I — I— - I I I l· I I I 訂------I-- (請先閱讀背面之注意事項再填寫本頁) 4252 92 Α7 .^ Β7 五、發明說明(5 ) 一粉末的一例示系統之一概略圖; 第2圖為依據本發明之一氣霧化裝置的一實施例之一 右側視圖; 第3圖為第2圖之裝置的一左側橫載面圖; 第3A圖為第3圖之裝置的一底半部之一放大圊; 第4圖為第2圖之裝置的一底單元之一底視立體圖,其 蓋移開以便於說明; 第5圖為第4圖之底單元之一部份左視橫載面圖; 第6圖為第4圖之底單元,移動一槓桿以關上释放閥; 第7圈為第5圈之底單元,槓桿在第6圖之位置; 第8圖為第7圖之底單元,移動槓桿以打開一計量閥; 第9圖為第3圖之一儲存槽單元之一底視部份的一頂立 體圖; 第lOAffl為儲存槽之一頂部的一底立體囷; 第10B圖為第10A®之頂部份的一頂立體囷; 第11圊為第3圖之裝置的一計董閥般艘之一頂立艘国 > 第12圖為第3圖之裝置的一啟動器之一頂立體圖; 第13A圈為第4圈之底單元的一左臂的一側視圖; 第13B圈為第4圖之底單元的一右臂側視圖: 第14A及14B®為第4圖之底單元的釋放閥之一啟動臂 的後及前視圈; 第15圖為用以再填充第3圓之储存槽的一填充單元。 本發明備置氣霧化藥劑的例示裝置及方法。這些藥制 本紙張尺度適用中國國家標準(CNS>A4規格(210 297公釐) --------------- 裝 i — (諝先閱讀背面之注意事項再填寫本頁} 訂· 經濟部智慧財產局員工消費合作社印製 經 濟 部 智 慧 財 產 局 具 工 消 费 合 作 社 印 A7 B7 主、發明說明(6 ) 可為乾粉或液體形式。例示之粉末藥劑可依據PCT公告號 W0 96/32149所揭露之發明氣霧化,其完整揭露均加入本 文中作為參考資料。以本發明所氣霧化之粉末較佳的尺寸 一 在大約0.5# m至大約50 A m之間’且最好是大約0.5以m至 大約5 v m之間。可選擇地’藥劑可為液態形態β藥劑可 維持在具有一可穿孔的接觸表面之容器中,且有時被稱之 ΓΝ 為“水泡包裝”。 本發明最好利用一高壓氣流以自容器中萃取粉末,並 氣霧化粉末,使得它可被病人吸入。可用於本發明之氣霧 化機構之例子包括揭露於加入本文作為參考資料的美國專 利5,785,049及5,740,794中,以及申請於1998年6月4日提 申且已加入本文作為參考資料的美國暫時專利申請案 60/087,929中。至少以下所述之特殊實施例之—使用—氣 霧化機構,以及其他相關與加入本文中作為參考資料的美 、 國臨時專利申請案60/087,929中所揭露的類似方法構成。 - 然而,須瞭解的是亦可使用需使用一高壓氣流以自一容器 中萃取一粉末並可將在氣流中的粉末吸走的其他形式氣霧 機構。 依據一特徵,本發明使用來自一推進劑的能量以氣霧 化一藥劑。推進器可包括與一液態部份保持平衡的一氣態 部份°某些氣態部份可萃取出並作為一能源以氣霧化藥劑 。譬如’萃取出之氣態推進劑可用來自一容器中萃取一粉 末,以分散粉末,並置放粉末於霧狀形式下的氣流中。 現在參看第1圖’用以氣霧化容納在一容器12中的粉 本紙張尺度適用中國國家標準(CNS)A4規格(210 χ 297公爱) n n n n I I ^ SI I ^ ^ t I * n I f L· ^ I I > i n n f I ^ n I (請先閲讀背面之注^w#項再填寫本頁> Λ 2 5 2 9 2 Α7 Β7 五、發明說明(7 ) 末之一例示系統10將在下文中說明》系統1〇包括一儲存槽 14,它填充具有一液態部份18及一氣態部份2〇的一推進劑 16。自儲存槽14之一頂端延伸的是一管22,而一計量聞24 連接於其上一計量室亦連接於一計量閥24 〇 8己置在計量 室26之另一端的是一釋放閥28,而一營30連接於其上。管 延伸至一氣霧化機構32,它舆餘存槽相互作用以萃取並氣 霧化在容器12中的粉末β 推進劑16被選出,使得氣態部份20在壓力下》因此, 當計量閥24被打開時,加壓推進劑進入計量室26 ρ釋放閱 28被關上以防止加壓推進劑進入氣霧化機構32。當計量室 26填充後’計量閥24被關上以維持一計量之加壓氣體於計 量室26中。因此,計量室26以一計量之氣體填充,氣體在 由推進谢種類以及計量室之溫度所決定的壓力下。 當須要氣霧化粉末時,氣霧化機構32插入容器12中以 接觸粉末。然後,释放閥28被快速地打開以急速釋放在計 量室26中的計量氣體。計量氣體通過管30並進入氣霧化機 構32’萃取容器12中的粉末,並吸走在一高壓氣流中的粉 末以形成一霧氣。霧氣可捕捉在一捕捉室中,使得它可被 一病人吸入。 因此,系統101構形成可簡單地藉由釋出一計量之加壓 氣體而操作,而加壓氣體係藉由萃取先前與一液態部份保 持平衡的一推進劑之_氣態部份而獲得。系統10構形成可 以一固定壓力計董一固定量之氣醴。以此方法,氣霧化機 構32可均勻地容納在一已知壓力下的一已知量氣艘,使得 本紙張尺度適用中國國家標準(CNS>A4規格(210x297公爱〉 .J〇 ---I I I I---lul· , ] 1 (請先《讀背面之注意事項再填寫本頁) 訂: 經濟部智慧財產局貝工消t合作社印製 經濟部智慧財產局員工消費合作社印製 A7 _____B7 _ 五、發明說明(8 ) 它可理想地萃取並氣霧化在容器12中的粉末·具備此種構 形可備置數種優點*譬如’系統10易於操作,因為在計量 氣體時僅須打開計量閥24並打開釋放閥28以氣霧化粉末。 另一優點為藉由使用一推進劑可減少系統10的尺寸》基本 上’僅須要一小量的推進劑,使得儲存槽14之尺寸可相當 地小。此一構形減少系統10之整個尺寸,使得使用者可方 巧 便且容易地攜帶並儲存它》 基本上,系統10與MDI裝置相較使用壽命較長,因為 系統10僅運用推進劑的一氣態部份以氣霧化粉末,而非 MDI裝置所使用的液態部份。此外,系統丨〇與MDI裝置比 較’製造及使用較容易(因為病人不須搖動推進劑),因為 不須將藥品懸弔在推進劑之液態部份内。 可用於系統10之較佳的推進劑包括HFA或HFC,如氫 氟烴134a(HFC-134a,1,1,2-四氟乙烷及氫氟烴227ea 出卩(:-2276&,1,1,1,2,3,3,3-七氟丙烷)。這些推進劑為習知 技藝,並可由 Minnesota Mining & Manufacturing Co.以及 Dupont公司購買。此種推進劑特別有用,因為它們不須使 用CFCs。其他可用於本發明的推進劑包括C02,CFC3等 〇 現在參看第2圊,一例示之用以氣霧化一粉末藥品的 τ 裝置34將在下文中說明。裝置34包括一底單元36及可移開 地連接底單元36的一捕捉室38。捕捉室構形成可在底單元 36上滑動以減少在儲存時裝置34的整個尺寸,以對於底單 元36内元件提供某種程度的保護》捕捉室38亦包括一嘴管 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 11 -------------裝 ill·! — 訂!-----線 (請先«讀背面之注i項再填寫本頁) 425292 a? B7 經濟部智慧財產局負工消费合作杜印製 五、發明說明(9 ) 40,它可轉動在一關上及打開位置之間。在氣霧化時,嘴 管.40在如第2圖所示的關上位置。當病人準備吸入氣霧化 藥品時,嘴管40轉180度以至打開位置,使病人可置放其 嘴在嘴管上,並吸入捕捉室38中的粉末藥品。 除尺寸較小外,捕捉室38及底元件36之整個形狀及外 形與申請案60/087,929中所揭露者相似》藉由使用一推進 劑以氣霧化一藥品時,底元件36不須一圓筒以筒一大董的 氣體中壓縮氣體,且不須要一槓桿安置病人的手以備置壓 縮氣體的能量。因此,底單元36之尺寸可減少。僅作為例 示,底單元36的高度可在大約8公分至12公分之間》捕捉 室38之高度大約至9公分至13公分之間。 再參看第2圖,底單元36包括一孔42,容納一粉末藥 品的一容器插入其中。底單元36亦包括一火紐44,它被磨 下以穿孔容器,並釋放出一定量加壓氣體,以氣霧化在如 下述之容器中的藥品。備置一釋放鈕46以允許容器在藥品 氣霧化之後可自孔42中移開。底單元36另包括一槓桿48, 它可被操作以計董定量之加壓氣體,細節如下述。 現在參看第3及3A圖,將說明在底單元36内的元件。 配置在底單元36内的是一氣霧化機構50,它用來自一容器 52中萃取藥品,以吸走在一高壓氣流内的藥品,並輪送氣 霧化藥品至捕捉室38中。底單元36亦包括一台架總成54, 當火鈕44按壓下時,它移動容器52以銜接氣霧化機構50· 氣霧化機構50,台架總成54以及其相關元件之構形大體上 舆60/087,929專利中所揭露者相同。如此,其構造之方法 <請先閱讀背面之注意事項再填寫本頁) h 裝 訂 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 12 A7 B7 主、發明說明(i〇) 僅在此簡單地描述。 為操作裝置34,如上述’容器52插入孔42(參看第2圖) 。然後’推進火鈕44以銜接容器52及氣霧化機構5Ό。尤其 是*當推進火鈕44時,齒輪齒56繞著一樞轉栓58轉動,造 成台架總成54的一頂推件60移動容器52朝向氣霧化機構50 。當火鈕44完全按下時,一尖端62及側打洞器64通過容器 52而穿孔’而進入容器中。火鈕44之按下亦操作一閥66以 允許一計量高壓氣體釋放至氣霧化機構50中,使得在容器 52中的粉末可氣霧化。尤其是,火钮44之按下造成一啟動 臂70的閥啟動器68自一中心位置上鬆開,以打開閥66 » 經濟部智慧財產局員工消费合作社印製 一旦閥66打開’在底單元36中的計量之高壓氣體造成 閥66“突然打開。尤其是’閥啟動器68之鬆開造成計量之 高壓氣體與薄膜72之下面接觸而造成一閥座74自一槽76中 舉起。以此方式’推進劑可通過槽76流動並進入氣霧化機 構50。然後,高壓氣體自容器52中萃取粉末藥品,分散粉 末藥品並驅趕粉末藥器至如上述之捕捉室38中。因此,為 操作裝置34,使用者僅須插入容器52,然後壓下火鈕44, 它會造成氣霧化藥品進入捕捉室38中,且可經由嘴管40撤 出。 再參看第3及3A圖,以下將說明經由閥66加壓氣體供 應至氣霧化機構50的方法。底單元3<5包括一儲存槽單元78 ,它由一底元件80及一頂元件82構成。底元件80亦顯示於 第9圖中,頂元件82顯示於第10A及10B圖令。鈕元件80包 括一孔84而頂元件82包括一孔86。當頂元件82固定於底元 13 ------------- . I I {請先閱讀背面之注意事項再填寫本頁) 線 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 05292 A7 ------ -SI_ 五、發明說明(11 ) 件80時,孔84及86—起形成支持推進劑的一孔穴88 a <請先《讀背面之注意事項再填寫本頁) 方便地,頂元件82包括支持一〇字環形封口 92的凹槽 90,使得推進劑不會自孔穴88中流出。通過底元件80的是 —槽94。孔穴88被構形成使得它可支持與一氣態部份保持 平衡的推進劑之一液態部份。推進劑的氣態部份延伸至槽 94,藉由一計量閥96而避免推進劑自其中流出。 如第11圖所示’計f閥96包括一殼體98,它容納在底 元件80(參看第9圖)的一孔中。般體98有一中心槽102,它 與底元件80之槽94相通。如第3及3A®所示,一閥氣門104 定位在槽102中。一彈簧106向上偏動閥氣門104使得配置 成繞著閥氣門104的一 〇形環1〇8銜接殼體98。以此'方式, 計量閥96構形成在關閉的位置,在該位置下氣態推進劑無 法移動超過間氣門104。 經濟部智慧財產局員工消费合作社印製 殼體98可便利地分隔成一底部份11〇及一頂部份112 ^ 當計量閥96在關閉位置時,氣態推進劑維持在底部份11〇 内。當計董閥96打開時,氣態推進劑快速進入頂部份112 中,並進入一計量管114中。如此,在頂部份112以及計量 管114中的體積界定一計量室116。在計量室116之相對端 上的是閥66,其功能為防止加壓氣體自計量室116中流出 ’直到閥啟動器68如上述地鬆開"當閥66打開時,計量室 116中的氣艟快速地進入槽76中,在該處氣體進入氣霧化 機構50 » 如第3, 4及12圖所示,一閥啟動器118配置在般體98 上。閥啟動器118有一槽120,它允許在内部122及計量管114 14 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 經濟部智慧財產局貝工消費合作钍印製 A7 B7 蓋、發明說明(η) 之間的氣體通過。如第3及3Α圖所示,閣氣門1〇4垂直地 在殼體98上延伸。以此方式,當閥啟動器U8向下移動時 ,它會銜接閥氣門104以造成彈簧106壓下並自殼體98移動 ◦形環108。以此方式,在底部份11〇中的加壓氣體可流入 計量室116中。 如第4及10Α圖所示’頂元件82包括一孔123,經由它 插入一活門閥124。活門閥124可便利地構形成具有一 〇形 環的一螺釘》當以一液態推進劑填充孔穴88時,活門閥124 被打開。最好,孔穴88藉由經殼體之槽1〇2插入推進劑而 填充,其細節將配合第15圈加以說明。 現在參看第4及5圚,底元件36之構造有利於閥66及96 之打開及關上(參看第3A圖),以下將細述。如第4圖所示 ’底單元36包括連接一框架128的一底盤126雖然未顯示, 一類似框架亦連接於底單元36之另一側上的底盤126。可 移動地連接於框架128上的是一左臂130及一右臂132 »臂 ; 13〇及132分別顯示於第13A及13B圖中。臂130及132包括 一孔134,一栓136通過它而插入,如第4圖所示。栓136通 過框架128中的孔(未顯示)延伸,使得臂130及132可垂直 . 地上下相對於框架128移動。槓桿48藉由一栓樞軸地連接 在臂130及132之間。槓桿48包括在槓桿轉動時銜接底元件 80的一延伸部138 »如此,槓桿48自底元件80移開以相對 於框架128向下垂直移動。 亦樞接於框架128的是一啟動器臂140,如第4圖所示 ,一栓142用來樞接啟動器臂140至框架128。啟動器臂14〇 本紙張尺度適用中國國家標準(CNS>A4規格(210 X 297公II ) 15 n I I * 1 n |> I [ n I I I (請先閲讀背面之注意事項再填窝本頁) 425292 A7 B7 經濟部智慧財產局貝工消费合作社印製 五、發明說明(13 ) 亦顯示於第14A及14B圖中。如第MA及14B圏所示,啟動 器臂140包括一孔144 ’右臂132上的一栓(參看第13Β圖)在 右臂132相對於框架128移動時經由孔而移動》以此方法, 臂132相對於框架128之移動造成啟動器臂140繞著栓142而 柜轉。 如第4圖所示,啟動器臂140銜接一釋放閥組臂148。 閥組臂148構形成可與啟動器臂140 —起樞轉。此外,閥組 臂148用來移動啟動器臂70(參看第3Α圖),使得閥66可維 持在一關閉位置,直到閥組臂148移開以允許閥66打開* 便利地,閥組臂148及啟動器臂70可構形成可大體上與加 入本文中作為參考資料的專利申請案60/087,929中的元件 相同β 底盤126包括一突出部150,閥組臂148可定位在其下 以維持閥66在關閉位置下》閥組臂148藉由移動槓桿48在 突出部150之下移動,造成閥組臂148轉動直到承接於突出 部150之下。在此位置下,閥66在一中心位置上,在該處 維持關閉位置直到閥組臂148自突出部150之下移開》 火鈕44包括一垂片152,當火鈕44壓下時,它術接在 閥組臂148上的一柱154。當垂片152壓下閥組臂148自在突 出部150下移開時,閥啟動器臂7〇(參看第3Α圖)被允許自 其中心位置上移動回來,釋放隔膜72。以此方法,在計量 室116中的加壓氣體被允許離開閥啟動器並快速進入如上 述之槽76中。 如第4圖所示,栓136亦連接右臂132至閥啟動器118» 本紙張尺度適用中國國家標準(CMS)Α4規格(210 *297公釐) 16 <請先«讀背面之注$項再填寫本頁) h 裝 訂·- ,ς A7 B7 h 經濟部智慧財產局貝工消費合作社印製 主、發明說明(η) 左臂130以相似的方法連接閥啟動器。以此方法,當槓桿48 移動時,閥啟動器118向下移動以打開閥96(參看第3A圖) 。因此,槓桿48之操作關上閥66,並接著打開計量閥96。 以此方法,計量室可以加壓氣體填充。當槓桿48向後移動 時’計量閥96被關上,使得加壓氣體維持在計量室中。 如第4及5圖中所示,底單元36有在一原來位置上的槓 桿48。如前述,在此位置下,計量閥96在其正常的關閉位 置。當火鈕44已壓下後,閥66在其正常的打開位置。如第 6及7圖所示,槓桿48開始自其原來位置移開。如此,延伸 部138銜接底元件80以向下移動臂130及132。依次,閥組 臂148移動至突出部150之下而關上閥66。同時,閥啟動器 118向下移動直到它銜接閥氣門1〇4(參看第7圖),如第5圖 所示,閥啟動器118在槓桿48在其原來位置時與閥氣門1〇4 分開。於是,當到達第7圖之位置時,啟動器118尚未向下 推動閥氣門104。如此,閥66在計量閥96打開前已關上。 如第8圖所示,槓桿48完全樞轉,造成閥啟動器us強 迫閥氣門104向下。如此,計量閥96被打開以允許在底部 份110中的加壓氣體流出進入計量室116。然後,槓桿48可 移動回其原來位置以關上計量閥96 <*當槓桿48移動回其原 來位置時,閥組臂148維持在突出部150之下,使得加壓氣 體維持在計量室116中。然後火鈕44被壓下以打開閥66, 允許粉末藥品如上述地被氣霧化。雖未顯示,備置一連鎖 以確使火鈕44不啟動直到一容器已置於裝置34中。以此方 式’可防止推進劑被釋放出直到一容器插入。 本紙張尺度適用中囷國家標準(CNS>A4規格(210 X 297公釐) -------!* 裝 * I I I l· I ί 訂·! * 線 (請先閱讀背面之注意事項再填寫本頁) 17 A7 B7 425292 五、發明說明(l5) <請先明讀背面之注項再填寫本頁) 使用儲存槽單元78以支持一推進劑的優點在於底單元 36之整個尺寸可減少。同時,儲存槽單元78可支持一足夠 量的推進劑,使得許多劑量可供應給病人。僅藉由例示, 孔穴88可構形成支持大約2cc的HFC液。如此允許裝置34 使用大約0.65_cc之氣態HFC可啟動100次•如此,計量室116 最好構形成可支持大約0.65cc的氣態HFC。然而,須瞭解 的是儲存槽單元78及計量室16可構形成支持其他量的推進 劑。 雖然圖中所示的是儲存槽單元78,須瞭解的是可備置 推進劑源的其他實施例。譬如,儲存槽單元78可以一容器 或其他可替換槽置換,如此在推進劑用完時可替換容器或 槽。由於最好週期地置換氣霧化機構50,推進劑源可構形 成連接氣霧化機構,使得兩者在推進制用完時均可移開及 替換。 經濟部暫慧財產扃員工消费合作社印製 當使用HFA作為推進劑時,在計量室116中的氣態部 份之壓力最好在大約40psi至大約120psi間,更佳是大約 50psi至大約SOpsi間。使裝置34構形成可使用一大範圍之 壓力而操作是十分有好處的,因為HFC之壓力可依靠大氣 溫度而改變。如此,裝置34可用在許多不同的環境及氣候 中〇 第15囫顯示可用來以一推進剤填充儲存槽單元78之一 填充單元200。填k單元200包括一供應槽202以儲存推進 劑。一閥204連接一槽202,而閥204可被打開以允許推進 劑自槽202中傳遞。管206自閥204延伸,並構形成可配合 18 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 笠、發明說明(!6) Α7 Β7 • 計量閥殼體98(亦參看第11圖)。 在使用時,管206配置在殼體98上,而閥204被打開。 推進劑通過殼體98進入孔穴88(參看第10A圖)中。活門閥 124可打開以備置一通風孔。 *·. 可選擇地,裝置34可包括一視覺展示器,其使用之次 " 數為裝置使用的次數之數倍,使得須要再填充以及/或替 ^ 換推進劑之前均可使用該展示器β便利地,一計算系統可 連接於火鈕44或槓桿48以計算啟動之次數。 本發明已詳細說明如上。然而,須瞭解在申請專利範 圍内可實施其他某些改變及改良。 元件標號對照 ---1-----裝--- (請先閱讀背面之注意事項再填寫本頁) 訂 ^ ,_ 經濟部智慧財產局員工消費合作社印製 12. 14' 16 20. 22. 26· 28. 30' 32. 34· 系統 36·*+底單元 容器 38…捕捉室 儲存槽 40…嘴管 推進劑 42…孔 氣態部份 44…火紐 管 48…槓桿 計量室 5〇…氣霧化機構 釋放閥 52…容器 管 54…台架總成 氣霧化機構 6〇…升高機 裝置 62…尖端 線 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297^^ 19 經濟部智慧財產局貝工消f合作社印製 4 25 2 9 2 a? _'_B7 五、發明說明(Π) 66·· 閥 114· 計量管 68- 啟動器 116. •計量室 70-· 啟動器臂 118· •啟動器 72- 薄膜 123. .孔 76·· 槽 126· •底盤 80 * 底元件 128- •框架 82 ·· 頂元件 130- •臂 88·· 孔穴 132· •臂 92·· 封口 136· •栓 94·· 槽 138. •延伸部 96 .· 計量閥 140. •啟動器臂 98·· 殼體 148· •閥組臂 102 ••中心槽; 150· •突出部 104 ••閥氣門 202· •槽 106 ••彈黃 204. .閥 108 ··0形環 206- •管 {請先閲讀背面之注意事項再填寫本頁} 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) 20C h Economy Zou Intellectual Property Bureau employee consumption cooperation print 5. Invention Description (2 or spray dry powder storage. However, the transport of dry powder protein and polypeptide is problematic in some aspects β Many proteins and polycondensation Dosage of amino acids is usually very important, so any dry powder delivery system must accurately and repeatedly deliver a certain amount of medicine. In addition, many proteins and polyamidamines are very expensive, many times as much as traditional single-dose medicines. So It is very important to effectively deliver the dry powder to the target area of the lung with the least loss of medicines. The agglomeration of the powder in the dry powder must be broken before the patient inhales to ensure the effectiveness of system absorption or other pulmonary delivery. U.S. Patents 5,785,049 and 5,740,794 disclose examples of devices and methods for aerosolizing powdered medicines maintained in a container. The complete disclosures of these patents are incorporated herein by reference. These devices and methods use a high pressure gas stream to A powder medicine is extracted from a container to disperse the powder into the air stream to make a mist. This device and method It has proven effective in making aerosolized drug pupae delivered to the lungs. US Patent No. 4,534,343 discloses a typical fixed-dose inhaler in which a drug under pressure is stored in a container. The drug supports calendar fluid advancement in the container. The drug must remain stable in this state throughout the life of the system. However, many unstable drugs such as proteins and digestive enzymes cannot maintain long-term storage stability in fluids. Β As described below, the present invention prepares another System, device and method for aerosolizing medicines and medicaments. In this way, another strategy can be prepared to facilitate the delivery of medicines and medicaments to the lungs. The present invention prepares an exemplary system, method and device for basically containing a container In the broad sense, the present invention uses a propellant. The paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 public love). I I ----- 1! -Pack · III l · --- Order --------- line (please read the notes on the back before filling out this page) 4 2 5 2 9 2 a: ____ ... Β7 Printed by the Shellfish Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs System five, Explain the ability of (3) to aerosolize a medicament. The medicament from the propellant can be stored separately until it is aerosolized to extend the life of the thorn. The medicament can be in powder or fluid form. The medicament in aerosolized form is placed so that it can be inhaled and delivered to the lungs. According to the first feature of the present invention, a gaseous part of a propulsion gas that previously had a liquid part in balance can be used to make the aerosol. According to an exemplary method, prepare a metered pressurized gas that is previously balanced by a liquid plutonium. For example, a pressurized gas vessel may include a gaseous portion of a propellant that was previously balanced with a liquid portion of the propellant. The metered gas is released to create a high-pressure airflow. The airflow then passes through a mist gasification mechanism to extract the medicament from the container and disperse the medicament in the airflow to form a mist. The propellants used in this method may include HFCs (argon fluorocarbons), especially HFAs (argon fluoroalkanes), such as HFC 134a or HFC 227ea. Other propellants that can be used include C02 and CFCs (chlorofluorocarbons) 11, 12, and 114 »As CFCs have been identified as substances that store the ozone layer at the same temperature, HFCs and HFAs are preferred. The pressurized gas is preferably metered in the range of about 0.5 ml to about 2.0 ml. The pressure of the metering gas is preferably in the range of about 40 psig to about 120 psig, more preferably in the range of about 40 psig to about 120 psig, and most preferably in the range of about 50 psig to 80 psig. When (: 02 is used, the pressure of the metering gas is preferably between about 800 psig and about 1200 psig. The invention also provides an exemplary device for aerosolizing a medicament supported in a container. The device includes a support having a A container of a propellant for the liquid part and a gaseous part. Position a measuring room to accommodate and measure a certain paper size. Applicable to China National Standard (CNS) A4 (210 X 297 mm) (Please read the back Please fill in this note 5 > ΓΓ Install tSJ · Printed by A7 B7, Shellfish Consumer Cooperative, Intellectual Property Bureau, Ministry of Economic Affairs, Jade: 、 Invention Note (4) Gas phase part of the amount of propellant The produced propellant forms a high-pressure airflow. The device further includes an aerosolization mechanism for accommodating the high-pressure airflow from the container, and disperses the powder in the airflow to form a mist. According to a feature of the present invention, A metering valve is arranged between the storage tank and the metering chamber. The metering valve can be moved to an open position to allow the gas D-state portion of the propulsion gas to enter the metering chamber. Once the metering chamber is filled, The metering valve is preferably moved to a closed position. As an embodiment, the metering valve is preferably moved to a closed position. As an example, the metering valve may include a valve valve that is pushed to move the valve to the open position. When the chamber is filled After that, the valve is released to allow the valve to move to the closed position. Conveniently, a lever can be provided which can be moved to close the release valve and open the metering valve. When the lever moves back to its starting position, the metering valve closes, and The release valve remains closed. In this way, the metered propellant is maintained in the metering chamber. It is best to 'prepare' a large benefit to open the release valve and allow the metering gas to flow out. According to-special features, a casing is provided to support the storage tank, the metering chamber And an aerosolization mechanism. Preferably, a capture chamber is operatively connected to the housing. The capture chamber includes a mouth through which the aerosolized powder can flow out. * In one embodiment, a system is provided for aerosolization A medicament. The system includes a propellant source that includes a gaseous portion that is in equilibrium with a liquid portion. A medicament is in at least one of the propellants that has been separated from the liquid portion. A gaseous part is dispersed. Therefore, such a system that prepares a part of a gaseous propellant is used as an energy source to aerosolize a medicament. Fig. 1 is a view showing a gas aerosol containing a drug according to the present invention. The paper size in the container is applicable to Zhongguanzuka Standard (CNS) A4 Specification ⑽X 297 Public Love) --------- I — I—-III l · III Order ------ I-- ( Please read the precautions on the back before filling this page) 4252 92 Α7. ^ Β7 V. Description of the invention (5) A schematic diagram of an example system of a powder; Figure 2 is a schematic diagram of an aerosolization device according to the present invention. A right side view of one embodiment; FIG. 3 is a left cross-sectional view of the device of FIG. 2; FIG. 3A is an enlarged view of one of the bottom half of the device of FIG. 3; FIG. 4 is a view of FIG. A bottom perspective view of one of the bottom units of the device, with the cover removed for easy explanation; Figure 5 is a left side cross-sectional view of a portion of the bottom unit of Figure 4; Figure 6 is the bottom of Figure 4 Unit, move a lever to close the release valve; the seventh circle is the bottom unit of the fifth circle, and the lever is in the position shown in FIG. 6; Open a metering valve; Figure 9 is a top perspective view of a bottom view of one of the storage tank units of Figure 3; Figure 10Afl is a bottom perspective view of the top of one of the storage tanks; Figure 10B is a drawing of 10A® A top perspective view of the top part; FIG. 11 is a top perspective view of a state-of-the-art vessel of the device of FIG. 3 > FIG. 12 is a top perspective view of a starter of the device of FIG. 3; Circle 13A is a side view of a left arm of the base unit of circle 4; Circle 13B is a side view of a right arm of the base unit of circle 4: 14A and 14B® are releases of the base unit of circle 4 One of the valves activates the rear and front view circles of the arm; FIG. 15 is a filling unit for refilling the storage tank of the third circle. Exemplary devices and methods for preparing aerosolized medicaments in the present invention. The paper size of these medicinal preparations is in accordance with the Chinese national standard (CNS > A4 specification (210 297 mm)) --------------- i— (谞 read the precautions on the back before filling in this Page} Order · Printed by the Consumer Property Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 Printed by the Consumers' Cooperative of the Ministry of Economic Affairs The main and description of the invention (6) can be in dry powder or liquid form. The powder medicines exemplified can be based on PCT bulletin number W0 The aerosolization of the invention disclosed in 96/32149, the complete disclosure of which is incorporated herein by reference. The preferred size of the aerosolized powder of the present invention is between about 0.5 # m to about 50 A m ', and Preferably between about 0.5 and m to about 5 vm. Alternatively, the medicament may be in a liquid form, and the medicament may be maintained in a container having a perforable contact surface, and is sometimes referred to as ΓΝ "blister pack The present invention preferably utilizes a high-pressure gas stream to extract powder from the container and aerosolize the powder so that it can be inhaled by a patient. Examples of aerosolization mechanisms that can be used in the present invention include those disclosed herein that are incorporated herein by reference National Patent Nos. 5,785,049 and 5,740,794, and US Provisional Patent Application No. 60 / 087,929, filed on June 4, 1998 and incorporated herein by reference. At least the special embodiments described below-use-aerosol Mechanism, and other related and disclosed methods similar to those disclosed in US / US Provisional Patent Application 60 / 087,929, which is incorporated herein by reference.-However, it must be understood that a high-pressure air flow may be used to Other forms of aerosol mechanism that extract a powder from a container and suck the powder in a gas stream. According to a feature, the present invention uses energy from a propellant to aerosolize a medicament. The propeller may include a liquid portion A gaseous part that keeps a balance ° Some gaseous parts can be extracted and used as an energy source to aerosolize the agent. For example, the 'extracted gaseous propellant can be extracted from a container to disperse the powder, and placed The powder is in an air stream in a mist form. Now refer to FIG. 1 'for aerosolizing the powder contained in a container 12 The paper size is applicable to the country of China Standard (CNS) A4 (210 χ 297 public love) nnnn II ^ SI I ^ ^ t I * n I f L · ^ II > innf I ^ n I This page > Λ 2 5 2 9 2 Α7 Β7 V. Description of the invention (7) The last example system 10 will be described below "System 10 includes a storage tank 14 which is filled with a liquid portion 18 and a gaseous state A propellant 16 from part 20. A tube 22 extends from the top of one of the storage tanks 14, and a metering chamber 24 is connected to the previous metering chamber and a metering valve 24 08 is placed in the metering chamber. At the other end of 26 is a release valve 28 to which a battalion 30 is connected. The tube extends to an aerosolization mechanism 32, which interacts with the remaining reservoir to extract and aerosolize the powder β propellant 16 in the container 12, so that the gaseous portion 20 is under pressure. Therefore, when the metering valve 24 When opened, the pressurized propellant enters the metering chamber 26, and the release 28 is closed to prevent the pressurized propellant from entering the aerosolization mechanism 32. When the metering chamber 26 is filled, the metering valve 24 is closed to maintain a metered pressurized gas in the metering chamber 26. Therefore, the metering chamber 26 is filled with a metering gas, and the gas is under a pressure determined by the type of the thruster and the temperature of the metering chamber. When aerosolizing the powder is required, the aerosolizing mechanism 32 is inserted into the container 12 to contact the powder. Then, the release valve 28 is quickly opened to quickly release the metered gas in the metering chamber 26. The metering gas passes through the tube 30 and enters the powder in the gas atomizing mechanism 32 'extraction container 12, and sucks the powder in a high-pressure gas stream to form a mist. The mist can be captured in a capture chamber so that it can be inhaled by a patient. Therefore, the system 101 is constructed to operate simply by releasing a metered amount of pressurized gas, and the pressurized gas system is obtained by extracting the gaseous portion of a propellant that has previously been in equilibrium with a liquid portion. The system 10 is structured to allow a fixed pressure gauge to a fixed amount of gas. In this way, the gas atomizing mechanism 32 can evenly accommodate a known gas vessel under a known pressure, so that this paper size is applicable to the Chinese national standard (CNS > A4 specification (210x297 public love). J〇-- -III I --- lul ·,] 1 (Please read the “Notes on the back page before filling out this page”) Order: Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs, printed by the co-operative society, printed by the Intellectual Property Bureau of the Ministry of Economic Affairs, printed by the consumer consumer cooperative A7 _____B7 _ V. Description of the invention (8) It can ideally extract and aerosolize the powder in the container 12. With this configuration, several advantages can be prepared * For example, 'The system 10 is easy to operate, because only The metering valve 24 is opened and the release valve 28 is opened to aerosolize the powder. Another advantage is that the size of the system 10 can be reduced by using a propellant. "Basically" only a small amount of propellant is needed to make the size of the storage tank 14 It can be quite small. This configuration reduces the overall size of the system 10, so that the user can conveniently and easily carry and store it "Basically, the system 10 has a longer service life than the MDI device because the system 10 only One gaseous state using propellant Some are aerosolized powder, not the liquid part used in MDI devices. In addition, the system is easier to manufacture and use than MDI devices (because the patient does not need to shake the propellant) because the drug does not need to be suspended Hanging in the liquid portion of the propellant. Preferred propellants that can be used in system 10 include HFA or HFC, such as hydrofluorocarbon 134a (HFC-134a, 1,1,2-tetrafluoroethane and hydrofluorocarbon 227ea Deuterium (: -2276 &, 1,1,1,2,3,3,3-heptafluoropropane). These propellants are of conventional skill and can be purchased from Minnesota Mining & Manufacturing Co. and Dupont. Such propulsion Agents are particularly useful because they do not require the use of CFCs. Other propellants that can be used in the present invention include C02, CFC3, etc. Now referring to Section 2A, an exemplary τ device 34 for aerosolizing a powder drug will be described below The device 34 includes a base unit 36 and a capture chamber 38 removably connected to the base unit 36. The capture chamber is configured to slide on the base unit 36 to reduce the entire size of the device 34 during storage, so that Internal components provide some level of protection Room 38 also includes a mouth tube. The paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) 11 ------------- Installation ill ·! — Order! --- --Line (please read «Note i on the back side before filling out this page) 425292 a? B7 Duplicate work and consumer cooperation of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Printed inventor (9) 40, it can be turned on a level and Between the open position. When the gas is atomized, the nozzle tube .40 is in the closed position as shown in Figure 2. When the patient is ready to inhale the aerosolized medicine, the mouthpiece 40 is rotated 180 degrees to the open position so that the patient can place his mouth on the mouthpiece and inhale the powder medicine in the capture chamber 38. Except for the small size, the overall shape and appearance of the capture chamber 38 and the bottom element 36 are similar to those disclosed in the application 60 / 087,929. "When using a propellant to aerosolize a medicine, the bottom element 36 does not need to be round. The cylinder compresses the gas in the gas of the cylinder, and does not require a lever to place the patient's hand to prepare the energy of the compressed gas. Therefore, the size of the bottom unit 36 can be reduced. By way of example only, the height of the bottom unit 36 may be between about 8 cm and 12 cm. The height of the capture chamber 38 is between about 9 cm and 13 cm. Referring again to Fig. 2, the bottom unit 36 includes a hole 42 into which a container containing a powder medicine is inserted. The base unit 36 also includes a fire button 44 which is ground to perforate the container and releases a certain amount of pressurized gas to aerosolize the medicine in a container such as described below. A release button 46 is provided to allow the container to be removed from the hole 42 after aerosolization of the drug. The bottom unit 36 further includes a lever 48, which can be operated to calculate the amount of pressurized gas as described below. Referring now to Figures 3 and 3A, the elements within the base unit 36 will be explained. Arranged in the bottom unit 36 is an aerosolization mechanism 50, which extracts medicines from a container 52 to suck away the medicines in a high-pressure air stream, and sends the aerosolized medicines to the capture chamber 38 by turns. The base unit 36 also includes a rack assembly 54. When the fire button 44 is pressed down, it moves the container 52 to connect the gas atomizing mechanism 50, the gas atomizing mechanism 50, the stage assembly 54 and the related components. In general, the disclosures in the 60 / 087,929 patent are the same. In this way, the method of its construction < Please read the notes on the back before filling this page) h The size of the bound paper is applicable to the Chinese National Standard (CNS) A4 (210 X 297 mm) 12 A7 B7 Main and Invention Description (i 〇) Only briefly described here. To operate the device 34, the container 52 is inserted into the hole 42 as described above (see Fig. 2). Then, push the fire button 44 to engage the container 52 and the aerosolization mechanism 5 '. In particular * when the fire button 44 is pushed, the gear teeth 56 rotate around a pivot pin 58, causing a pusher 60 of the stage assembly 54 to move the container 52 toward the aerosolization mechanism 50. When the fire button 44 is fully depressed, a tip 62 and a side punch 64 are perforated 'through the container 52 and enter the container. Pressing the fire button 44 also operates a valve 66 to allow a metered high-pressure gas to be released into the gas atomizing mechanism 50, so that the powder in the container 52 can be gas atomized. In particular, the pressing of the fire button 44 caused the valve actuator 68 of a starting arm 70 to be released from a center position to open the valve 66 »Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs once the valve 66 is opened 'on the bottom unit The metered high-pressure gas in 36 caused the valve 66 to "open suddenly. In particular, the release of the valve actuator 68 caused the metered high-pressure gas to contact the underside of the membrane 72, causing a valve seat 74 to lift from a slot 76. In this way, the propellant can flow through the tank 76 and enter the aerosolization mechanism 50. Then, the high-pressure gas extracts the powder medicine from the container 52, disperses the powder medicine, and drives the powder medicine device into the capture chamber 38 as described above. To operate the device 34, the user only needs to insert the container 52, and then press the fire button 44, which will cause the aerosolized medicine to enter the capture chamber 38, and can be withdrawn through the mouth tube 40. Referring again to FIGS. 3 and 3A, the following A method for supplying pressurized gas to the gas atomizing mechanism 50 through the valve 66 will be explained. The bottom unit 3 < 5 includes a storage tank unit 78, which is composed of a bottom element 80 and a top element 82. The bottom element 80 is also shown in the first In the figure, the top element 82 Shown in Figures 10A and 10B. The button element 80 includes a hole 84 and the top element 82 includes a hole 86. When the top element 82 is fixed to the bottom element 13 -------------. II { Please read the precautions on the back before filling this page) The size of the paper is applicable to the Chinese National Standard (CNS) A4 (210 X 297 mm) 05292 A7 ------ -SI_ 5. Description of the invention (11) At 80 o'clock, the holes 84 and 86 form a hole supporting the propellant. 88 a < Please read the precautions on the back before filling in this page.) Conveniently, the top element 82 includes a groove supporting a 10-shaped ring seal 92. 90, so that the propellant does not flow out of the cavity 88. It is through the bottom element 80-the slot 94. The cavity 88 is formed so that it can support a liquid portion of the propellant that is in equilibrium with a gaseous portion. The propellant The gaseous portion extends to the groove 94 and prevents the propellant from flowing out of it by a metering valve 96. As shown in Fig. 11, the meter valve 96 includes a housing 98 which is housed in the bottom member 80 (see section 9). Figure) in a hole. The general body 98 has a central groove 102 which communicates with the groove 94 of the bottom element 80. As shown in Figures 3 and 3A®, a valve 104 Located in the groove 102. A spring 106 biases the valve valve 104 upward so that it is configured to engage the housing 98 around an O-ring 108 of the valve valve 104. In this way, the metering valve 96 is formed in a closed position In this position, the gaseous propellant cannot move beyond the intermediate valve 104. The printed housing 98 of the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs can be conveniently divided into a bottom portion 11 and a top portion 112 ^ when the metering valve 96 is closed When in position, the gaseous propellant is maintained within 11% of the bottom portion. When the counter valve 96 is opened, the gaseous propellant quickly enters the top portion 112 and enters a metering tube 114. Thus, the volume in the top portion 112 and the metering tube 114 defines a metering chamber 116. On the opposite end of the metering chamber 116 is a valve 66 whose function is to prevent pressurized gas from flowing out of the metering chamber 116 until the valve actuator 68 is released as described above. When the valve 66 opens, the The gas pan rapidly enters the groove 76, where the gas enters the gas atomizing mechanism 50 »As shown in Figs. 3, 4 and 12, a valve actuator 118 is disposed on the general body 98. The valve starter 118 has a slot 120, which allows an internal 122 and a measuring tube 114. 14 This paper size applies to the Chinese National Standard (CNS) A4 (210 X 297 mm). Printed by A7. Gas passes between the B7 cover and the invention description (η). As shown in Figs. 3 and 3A, the cabinet valve 104 extends vertically on the casing 98. In this way, when the valve starter U8 moves down, it will engage the valve valve 104 to cause the spring 106 to be depressed and move from the housing 98. The ring 108. In this manner, the pressurized gas in the bottom portion 11 can flow into the metering chamber 116. As shown in Figs. 4 and 10A, the top member 82 includes a hole 123 through which a shutter valve 124 is inserted. The shutter valve 124 may conveniently be formed as a screw with an O-ring. When the cavity 88 is filled with a liquid propellant, the shutter valve 124 is opened. Preferably, the cavity 88 is filled by inserting the propellant through the groove 102 of the housing, and the details will be explained in conjunction with the 15th circle. Referring now to Sections 4 and 5), the configuration of the bottom member 36 facilitates opening and closing of the valves 66 and 96 (see FIG. 3A), which will be described in detail below. As shown in FIG. 4, the bottom unit 36 includes a chassis 126 connected to a frame 128. Although not shown, a similar frame is also connected to the chassis 126 on the other side of the base unit 36. Removably connected to the frame 128 are a left arm 130 and a right arm 132 »arm; 13 and 132 are shown in Figures 13A and 13B, respectively. The arms 130 and 132 include a hole 134 through which a bolt 136 is inserted, as shown in FIG. The bolt 136 extends through a hole (not shown) in the frame 128, so that the arms 130 and 132 can move vertically relative to the frame 128. The lever 48 is pivotally connected between the arms 130 and 132 by a bolt. The lever 48 includes an extension 138 that engages the base member 80 when the lever is rotated. As such, the lever 48 moves away from the base member 80 to move vertically downward relative to the frame 128. Also connected to the frame 128 is an actuator arm 140. As shown in FIG. 4, a bolt 142 is used to pivot the actuator arm 140 to the frame 128. Starter arm 140. This paper size applies to Chinese national standard (CNS > A4 size (210 X 297 male II) 15 n II * 1 n | > I [n III (Please read the precautions on the back before filling in this page) ) 425292 A7 B7 Printed by Shelley Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 5. The invention description (13) is also shown in Figures 14A and 14B. As shown in Figures MA and 14B 圏, the starter arm 140 includes a hole 144 ' A bolt on the right arm 132 (see FIG. 13B) moves through the hole when the right arm 132 moves relative to the frame 128. In this way, the movement of the arm 132 relative to the frame 128 causes the starter arm 140 to surround the bolt 142. Cabinet rotation. As shown in Figure 4, the starter arm 140 engages a release valve group arm 148. The valve group arm 148 is configured to pivot with the starter arm 140. In addition, the valve group arm 148 is used to move the starter Arm 70 (see FIG. 3A) so that the valve 66 can be maintained in a closed position until the valve group arm 148 is removed to allow the valve 66 to open * Conveniently, the valve group arm 148 and the starter arm 70 can be configured to substantially Same base as element in patent application 60 / 087,929, incorporated herein by reference The disc 126 includes a protrusion 150 under which the valve group arm 148 can be positioned to maintain the valve 66 in the closed position. The valve group arm 148 moves below the protrusion 150 by moving the lever 48, causing the valve group arm 148 to rotate until Undertakes the protruding portion 150. In this position, the valve 66 is in a central position, where it remains closed until the valve arm 148 is removed from below the protruding portion 150. The fire button 44 includes a flap 152, When the fire button 44 is depressed, it is connected to a post 154 on the valve group arm 148. When the tab 152 presses the valve group arm 148 and moves freely under the protrusion 150, the valve starter arm 70 (see (Figure 3A) is allowed to move back from its center position, releasing the diaphragm 72. In this way, the pressurized gas in the metering chamber 116 is allowed to leave the valve actuator and quickly enter the groove 76 as described above. As shown in Figure 4 As shown, the bolt 136 is also connected to the right arm 132 to the valve starter 118. »This paper size is applicable to the Chinese National Standard (CMS) A4 specification (210 * 297 mm) 16 < Please read the note on the back side before filling in this (Page) h Binding ·-, A A7 B7 h Printed by the Intellectual Property Bureau of the Ministry of Economy Note (η) The left arm 130 is connected to the valve actuator in a similar manner. In this way, when the lever 48 is moved, the valve actuator 118 is moved down to open the valve 96 (see FIG. 3A). Therefore, the operation of the lever 48 closes the valve 66 and then opens the metering valve 96. In this way, the metering chamber can be filled with pressurized gas. When the lever 48 is moved backward, the 'metering valve 96 is closed, so that the pressurized gas is maintained in the metering chamber. As shown in Figures 4 and 5, the base unit 36 has a lever 48 in an original position. As before, in this position, the metering valve 96 is in its normal closed position. When the fire button 44 has been depressed, the valve 66 is in its normal open position. As shown in Figures 6 and 7, the lever 48 begins to move away from its original position. As such, the extension 138 engages the bottom member 80 to move the arms 130 and 132 downward. In turn, the valve block arm 148 moves below the protrusion 150 to close the valve 66. At the same time, the valve actuator 118 moves downwards until it engages the valve valve 104 (see FIG. 7). As shown in FIG. 5, the valve actuator 118 is separated from the valve valve 104 when the lever 48 is in its original position. . Thus, when the position of Fig. 7 is reached, the starter 118 has not pushed the valve valve 104 downward. As such, the valve 66 is closed before the metering valve 96 is opened. As shown in Fig. 8, the lever 48 is fully pivoted, causing the valve actuator us to force the valve valve 104 downward. As such, the metering valve 96 is opened to allow the pressurized gas in the bottom portion 110 to flow out into the metering chamber 116. Then, the lever 48 can be moved back to its original position to close the metering valve 96 < * When the lever 48 is moved back to its original position, the valve group arm 148 is maintained below the protrusion 150 so that the pressurized gas is maintained in the metering chamber 116 . The fire button 44 is then depressed to open the valve 66, allowing the powdered medicine to be aerosolized as described above. Although not shown, a chain is provided to ensure that the fire button 44 is not activated until a container has been placed in the device 34. In this way, the propellant is prevented from being released until a container is inserted. This paper size applies to the China National Standard (CNS > A4 size (210 X 297 mm) -------! * Packing * III l · I Ordering!! Thread (please read the precautions on the back first) (Fill this page) 17 A7 B7 425292 V. Description of the invention (l5) < Please read the note on the back before filling this page) The advantage of using the storage tank unit 78 to support a propellant is that the entire size of the bottom unit 36 can be cut back. At the same time, the storage tank unit 78 can support a sufficient amount of propellant so that many doses can be supplied to the patient. By way of example only, the holes 88 may be configured to support HFC fluids of approximately 2cc. This allows the device 34 to be activated 100 times using a gaseous HFC of about 0.65 cc. Thus, the metering chamber 116 is preferably configured to support a gaseous HFC of about 0.65 cc. It should be understood, however, that the storage tank unit 78 and the metering chamber 16 may be configured to support other amounts of propellant. Although the storage tank unit 78 is shown in the figure, it should be understood that other embodiments of the propellant source may be provided. For example, the storage tank unit 78 may be replaced with a container or other replaceable tank, so that the container or tank can be replaced when the propellant runs out. Since the aerosolization mechanism 50 is preferably replaced periodically, the propellant source can be configured to connect to the aerosolization mechanism so that both can be removed and replaced when the propulsion system is used up. Printed by Temporary Property of the Ministry of Economic Affairs and Employee Consumer Cooperatives. When HFA is used as the propellant, the pressure of the gaseous portion in the metering chamber 116 is preferably between about 40 psi and about 120 psi, more preferably between about 50 psi and about SOpsi. It is advantageous to configure the device 34 to operate with a wide range of pressures, as the pressure of the HFC can be changed depending on the atmospheric temperature. In this way, the device 34 can be used in many different environments and climates. The 15th display shows that the filling unit 200 can be used to fill one of the storage tank units 78 with a pusher. The k-filling unit 200 includes a supply tank 202 for storing propellant. A valve 204 is connected to a tank 202, and the valve 204 can be opened to allow propellant to pass from the tank 202. The tube 206 extends from the valve 204 and is structured to fit 18 paper sizes. Applicable to China National Standard (CNS) A4 (210 X 297 mm). 发明 Description of the invention (! 6) Α7 Β7 • Metering valve housing 98 (also (See Figure 11). In use, the tube 206 is disposed on the housing 98 and the valve 204 is opened. The propellant enters the cavity 88 (see Fig. 10A) through the housing 98. The shutter valve 124 can be opened to provide a vent hole. * ·. Optionally, the device 34 may include a visual display, the number of times of use " is several times the number of times the device is used, so that the display can be used before refilling and / or replacement of the propellant Conveniently, a computing system can be connected to the fire button 44 or the lever 48 to count the number of activations. The invention has been described in detail above. However, it must be understood that certain other changes and improvements can be implemented within the scope of a patent application. Comparison of component labeling --- 1 ----- install --- (Please read the precautions on the back before filling out this page) Order ^, _ Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs, Consumer Cooperatives 12. 14 '16 20. 22. 26 · 28. 30 '32. 34 · System 36 · * + bottom unit container 38 ... capture chamber storage tank 40 ... nozzle tube propellant 42 ... hole gaseous portion 44 ... fire button 48 ... lever metering chamber 5〇 … Gas atomizing mechanism release valve 52… container tube 54… bench assembly gas atomizing mechanism 60… lifter device 62… tip line The paper size applies to China National Standard (CNS) A4 (210 X 297 ^^ 19 Printed by the Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs 4 25 2 9 2 a? _'_ B7 V. Description of invention (Π) 66 ·· Valve 114 · Metering tube 68- Starter 116. • Metering room 70- · Starter arm 118 · • Starter 72- Membrane 123 .. Hole 76 ·· Slot 126 · • Chassis 80 * Bottom element 128- • Frame 82 ·· Top element 130- • Arm 88 ·· Hole 132 · • Arm 92 · · Seal 136 · · Plug 94 ·· Slot 138 · · Extension 96 ·· Dosing valve 140 · · Actuator arm 98 ·· Housing 148 · • Manifold arm 102 •• Central groove; 150 · • Protrusion 104 •• Valve valve 202 · • Slot 106 •• Yellow 204. .Valve 108 ·· 0-ring 206- • Pipe {Please read the precautions on the back before filling this page } This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 20