TWI324525B - Hemodialysis filtration device for repeatedly remittent perfusion - Google Patents

Hemodialysis filtration device for repeatedly remittent perfusion Download PDF

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TWI324525B
TWI324525B TW93117310A TW93117310A TWI324525B TW I324525 B TWI324525 B TW I324525B TW 93117310 A TW93117310 A TW 93117310A TW 93117310 A TW93117310 A TW 93117310A TW I324525 B TWI324525 B TW I324525B
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cycle
liquid
injection
reverse osmosis
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TW200600125A (en
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Sung-Teh Kim
Kunihiko Yamanaka
Naritomi Maeda
Katsunori Masaoka
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Kitakyushu Inst Of Bioinfomatics And Bioevolution Inc
Jms Co
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1324525 玖、發明說明: 【發明所屬之技術領域】 本發明係關於一種血液透析(過濾)裝置,尤其關於一 種血液淨化裝置,於血液透析操作上,藉由定期且間歇進行 過濾與逆滲透,從患者體內進行廢物或水份之移除。 【先前技術】 爲了腎不全症患者之治療,已提出將患者體內所取出的 血液予以淨化,再回到體內之各種血液淨化法的建議。爲了 進行血液淨化,使用於機座內容納中空纖維狀之纖維素膜、 聚丙烯腈膜、聚砸膜等之半透膜(以下,也稱爲透析膜)的 血液透析器,根據患者之病情或狀況,所採用之淨化法的實 施態樣將有所不同。 例如,血液透析法(HD )之情形,透過血液透析器之 透析膜而使血液與透析液接觸,藉由因擴散而造成的物質移 動,強制移除累積於患者血液中之尿素、尿酸等,另外,血 液過濾法(HF )之情形,藉由透過透析膜已開孔之膜孔的過 濾,能夠移除血液中之水份或廢物與毒素。 該治療法上,雖然HD (血液透析)對於小分子之廢物 與溶質具有優異的移除特性,但是尙有欠缺中、大分子之移 除性能的缺點。另一方面,雖然HF(血液過濾)對於中(大) 分子之廢物具有優異的移除特性,但是仍有小分子之移除性 能低或血中蛋白質漏出的_缺點。另外,不論HD與HF均對 血液透析器之中空纖維膜的特性影響極大。 兼具該HD與HF二者之優點,亦即,二者優異的移除 1324525 特性的療法,有人提出血液透析過濾(Hemodiafiltration: HDF)法,期待有效之溶質移除,但是習知之瓶型HDF系統 的話,僅能進行約5 ~ 1 0L之液體置換,效果並未明顯出現。 因此,利用線上HDF或推&拉式HDF的大量液體置換HDF 便備受矚目,能夠較容易地構築系統之前者線上HDF已逐 漸普及。 已公開之技術文獻,揭示於如下所示之日本公開專利第 平6-134031與平7-313589號公報等。 然而,爲了實施HDF(包含線上HDF、推&拉式HDF), 必須具有補液(置換液)注入用之專用血液迴路,再者,瓶 型HDF必須準備專用補液。 針對於此,本發明提供一種血液透析裝置,並無必要進 行專用血液迴路或專用補液等之準備,能夠容易地由HD治 療時轉移至HDF,或由HDF治療時轉移至HD。 【發明內容】 發明之揭示 本發明利用如下所示之構造,解決了該課題。 亦即,本發明之血液透析裝置1的構造對於血液透析(過 濾),使用容納中空纖維膜之血液透析器8,透過該血液透 析器8之送液幫浦P6與送液幫浦P3之任一種,或是藉由二 者幫浦之聯動式控制的強制逆滲透,使透析液由透析液供應 迴路1 2側流入第2血液迴路1 1側,另外,進行同樣方式, 藉由透過該血液透析器8的過濾,使第1血液迴路10內之 液體向透析液排出迴路1 3側流出,其特徵爲:間歇且至少 1324525 反覆數次進行由利用該逆滲透之透析液供應迴路1 2側而向 第2血液迴路11側之液體流入操作(以下,也稱爲逆滲透 操作);及由利用該過濾之第1血液迴路10側而向透析液 排出迴路1 3側之液體流出操作(以下,也稱爲滲透操作)^ 於本發明專利說明書’將間歇且至少反覆數次進行逆滲 透操作與過濾操作的處理,方便簡稱爲潮式HDF ( Tidal : 仿照潮汐漲落而反覆進行液體之流入、流出的狀態)。 本發明之血液透析(過濾)裝置係作成該構造,以逆滲 透直到流入體內之液體利用過濾而被抽出體外爲止,亦即, 藉由透過透析器8而連接血液循環系與透析液供應排液系, 藉由壓差而直到使血液循環系的水份向透析液供應排液系 統進行移動爲止,由於產生時差,滲透至患者之細胞內或細 胞組織間之後,進行溶質移除(交換)。其結果,明顯提高 溶質之移除效率或是中、大分子之移除效果。 利用本發明之血液透析(過濾)裝置藉以提高過濾效 果,中、大分子量物質之移除便爲可能。另外,藉由提高過 濾效果,能夠改善依存於血液透析器之中空纖維膜特性的效 率 〇 再者,藉由逆滲透流入血液迴路之置換液將滲透至患者 之細胞內或細胞組織間’因爲於此進行物質交換後移除水份 (以體液基準進行補液或移除水份)’較現行之HDF、HF, 特別能提高血液的淨化效果。 【實施方式】 以下,根據圖示之實施態樣’詳細說明本發明。 1324525 第1圖係顯示本發明血液透析裝置之—實施例的構造 槪略之方塊圖。於圖中’ 1爲血液透析裝置,構造上包含: 透析實際運轉裝置2、對於該透析裝置1進行動作或處理之 控制的控制裝置3、輸入命令與條件或操作的血液輸入裝置 4、顯示輸入狀態或控制機構的顯示裝置5與顯示控制裝置 之動作狀態的監視器6等。 另外’該輸入裝置4'實際運轉裝置之監視器6係藉由 傳達系統7而與控制裝置3相連結,一面以監視器6確認透 析實際運轉裝置2的動作狀態,也一面以輸入裝置4變更設 定條件’透過傳達系統7與控制裝置3,便可能變更透析實 際運轉裝置2之操作。於第1圖,藉由傳達系統7,輸入裝 置4與監視器6 一者與控制裝置3相連結,所有該輸入裝置 4、監視器6、控制裝置3也可以與傳達系統7相連結。 根據第4圖,於後詳細敘述透析實際運轉裝置2,例如, 除水幫浦或血液幫浦、透析液之供應或排出裝置、透析液迴 路、血液迴路等之液體流路以及開關此等之流路開關裝置、 進行過濾與逆滲透之血液透析器等實際進行血液透析處理 之際,具備進行運轉之裝置。 於輸入處理條件或命令之輸入裝置4內,具有:爲了設 定或增減來自於患者之總過濾量與治療時間、流入患者體內 之逆滲透液量的裝置;或是將除水與注水(利用逆滲透)設 爲一循環時,設定每一循環大約所需求之時間,或者進行增 減的裝置等。此等裝置較宜設定爲利用一個面板能夠進行各 條件之輸入、變更,但是並非受此等裝置之限制。 丄以4525 另外’顯示裝置5係針對該輸入裝置4之命令與條件、 此等之輸入狀態、控制機構,於透析實際運轉裝置2運轉前, 操作者可以進行確認(把握),此顯示裝置5也可以與輸入 裝置4形成一體之面板的構造。另外,如上所述,監視透析 實際運轉裝置2之動作狀態的監視器6係與透析實際運轉裝 置2相連結,顯示透析實際運轉裝置2之動作狀態,同時未 依所設定的條件進行運轉之情形,能夠藉由傳達系統7與控 制裝置3,詳細調整透析實際運轉裝置2。 第2圖係利用本發明之血液透析裝置,進行血液透析處 理的順序,亦即,顯示下列各步驟的流程圖:(a )條件設 定(輸入)-> (b )輸入確認—(c )血液透析條件之顯示-(d)確認與決定—(e)實行(血液透析處理)e (f)透 析裝置動作狀態之監視—(g )調整與變更—(h )對透析裝 置之回饋控制。 首先,對輸入裝置4進行體液移除量與治療時間、置換 液注入量(也稱爲流入患者體內的逆滲透液體量、置換液總 量)之總量的設定與入力。另外,於血液透析所花費的時間 內,將利用血液透析器之逆滲透的置換液注入與利用過濾之 除水的組合而設爲一循環,也可以設定合計反覆進行幾個循 環。由於治療時間/循環係一循環所需求之時間,也可以設 定其時間。例如,可以將一循環的時間調整於1分鐘至60 分鐘的範圍。 於此,於一循環,根據逆滲透之置換液注入的時間與根 據過濾之除水時間的關係,一般設爲[置換液注入時間] < [除 -10- 1324525 水時間],若設定對血液透析裝置之輸入限制的話,對生體 並無不適,能夠有效移除溶質或血液淨化。另外,於置換液 注入量與除水量之關係,滿足丨置換液注入量丨+ I患者之 除水量丨=丨總過濾量I,血液透析裝置若進行輸入限制的 話,藉由設定置換液注入量與體液移除量,自動算出除水幫 浦之進行排液的量,因爲受除水幫浦控制而爲便利的。 關於血液透析裝置之輸入操作,如第2圖所示,若不輸 入體液移除量與置換液(注入)總量的話’則無法向下一步 驟進行推進,治療時間與循環次數之設定,即使無輸入之情 形,因爲預先之初設値(初期値)完成設定,以其初設値之 條件,操作將被控制。顯示確認是否已將個別設定之値輸入 的畫面,此等設定値是否良好,進行確認之後’顯示如第3 圖所示之每個循環的置換液注入量與體液移除量、除水幫浦 排液量之式樣β 此處,Α設爲初次之總過濾量,Α’設爲初次之置換液注 入量,A’’設爲初次之體液移除量,另外’ B設爲第2次之 總過濾量,B’設爲第2次之置換液注入量,B’’設爲第2次 之體液移除量,依然維持A = A’+A’’’ B = B’+B’’之關係,能 夠設定、變更各循環之總濾過濾量、除水時間、置換液注入 量與置換液注入時間。 實際上進行的除水-注入式樣的變更係依照如下之順序 進行的。藉由決定(輸入)體液移除量 '除水時間' 置換液 總量與循環數,自動計算每一循環之時間或每一循環所需求 之除水時間,於其結果畫面上設定[置換液注入時間/循環] -11 - 1324525 =[―循環之時間]一[除水時間/循環]_ [空白時間]。 於此畫面,依然維持既定(置換液注入量、體液移除量 或除水幫浦排液量成爲定値)的關係,藉由使[置換液注入 時間/循環]增減而決定[除水幫浦之排液時間/循環]除水幫 浦之排液量 '置換液注入速度。相反地,也可以藉以增減設 定[除水幫浦之排液時間/循環],聯動式變更[置換液注入時 間/循環]等。 藉由變更每_循環之時間設定,同時也變更[置換液注 入量/循環],便可能變更每個循環之置換液注入量。另外, 也可以變更整個循環之時間。利用如上變更之置換液量或時 間的變更,時間上反映至後續之循環。而且,藉由變更每一 循環之式樣,剩餘之循環式樣也變更爲與此相同之式樣,也 可以進行每個式樣之設定。 再者,配合利用量測血球比値之血球比監視器或額外過 濾的體液移除式樣,於各循環也可以變更體液移除量。 但是,相較於一般之推&拉式HDF,由於本發明之潮式 HDF療法之每次的置換液注入量大,可能影響患者之血液循 環動態。因此,希望進行利用自動血壓計、血球比監視器等 之監視,或進行與此等監視之聯動式控制。其他之安全機構 上,也可以藉由血液迴路內壓、透析液壓、氣泡檢測器等之 異常檢測,停止除水操作或置換液注入操作。 本發明之潮式HDF係根據零換液之注入時間點,由於 血液迴路內發生壓力變動,希望分別設定靜脈壓與透析液壓 之警報基準値。 -12- 1324525 接著,將本發明之血液透析裝置的整體槪略圖顯示於第 4圖。 血液透析裝置1具備:血液透析器8,隔著半透膜使血 液與透析液相接觸而進行血液之淨化:第1血液迴路10,具 有將生體9所取出的血液導入透析器8之血液幫浦P1;第2 血液迴路11,具有將由透析器8流出的血液導入生體9的裝 置;透析液供應迴路12,具有將透析器導入透析器8之透析 液供應幫浦P5;以及透析液排出迴路13,具有將由透析器 8流出的透析液予以排出的透析液排出幫浦Ρ4»爲了改善透 析液之清淨化,希望於血液透析器8上流側之透析液供應迴 路12,設置內毒素移除濾器16。 血液透析裝置1內,於該透析液供應迴路12之透析液 供應幫浦P5設置部與透析液排出迴路13之透析液排出幫浦 P4設置部之任一個或二個,設置具有與該幫浦不同的送液 幫浦P3、P6之旁通迴路14、15,設置於此(或是此等)旁 通迴路14、15的送液幫浦P3、P6與該血液幫浦P1均爲可 順逆旋轉的幫浦。 於此,若將送液幫浦P3與透析液排出幫浦P4進行同方 向旋轉的話,進行利用過濾之除水,相反地,使送液幫浦 P3與透析液排出幫浦P4進行反方向旋轉的話,進行利用逆 滲透之置換液注入。或者,將送液幫浦P6與透析液供應幫 浦P5進行同方向旋轉的話,進行利用逆滲透之置換液注 入’相反地’若將送液幫浦P6與透析液供應幫浦P5進行反 方向旋轉的話,進行利用過濾之除水。 -13- 1324525 血液幫浦P1與(設置於旁通迴路2之)該送液幫浦P3' P6之任一個,或二者之幫浦,或是未以圖示,開關透析液 迴路或血液迴路之流路開關裝置等之透析實際運轉裝置2, 藉由傳達系統7而與控制裝置3相連結(第1圖)。控制裝 置3係對於送液幫浦P3、P6之任一個,進行透過血液透析 器8的強制逆滲透而使之運轉。 藉由此逆滲透操作,將透析液流入血液迴路側,經過既 定時間之後,接著再藉由送液幫浦P3或P6,進行透過血液 透析器8的過濾而使之運轉。藉由此過濾操作,血液迴路內 之液體將於透析液側進行除水。此時,送液幫浦P3或P6, 僅將體液移除量加上先前所流入之逆滲透液(置換液)量部 分相加的量進行排液、設定排液量。 以下,說明本發明之實施態樣。 如上所述之本發明係設定藉由一面確認顯示裝置5上 的設定條件,一面將設定値輸入輸入裝置4後而開始運轉。 使用容納中空纖維之血液透析器8,將透析液供應幫浦P5 與透析液排出幫浦P4之送液量調整爲相同之透析液供應排 放系統,藉由將送液幫浦P3朝相同於透析液排出幫浦P4的 送液方向進行驅動,能夠進行透過血液透析器8之過濾(除 水)。另外,藉由將此送液幫浦P3朝相反於過濾(除水) 的方向進行驅動,能夠進行透過透析器8之逆滲透。 或者,使送液幫浦P6與於透析液供應幫浦P5進行同方 向旋轉的話,利用逆滲透之置換液進行注入,相反地,將送 液幫浦P6與透析液供應幫浦P5之進行反方向旋轉的話,利 -14- 1324525 用過爐進行除水。或者,藉由進行送液幫浦p3、P6之聯動 式控制,可以進行同樣的操作。 由利用該逆滲透之透析液側的朝血液迴路側之液體流 入操作(以下,也稱爲逆滲透操作)係利用預先設定之流入 速度與流入量進行的,由利用該過濾之血液迴路側的朝透析 液迴路側之液體流出操作(以下,也稱爲過濾操作)係利用 預先設定之流出速度與流出量進行的。本發明係一種間歇且 反覆交替進行如此之流入操作與流出操作的血液透析裝置。 本發明之血液透析裝置除了能夠保有此特徵,也採行如 下所示之各種實施態樣。 亦即,本發明係一種反覆交替進行如上所述之過濾操作 與逆滲透操作的血液透析裝置,藉此,便可能有效的移除溶 質。 本發明之該血液透析裝置能夠於該逆滲透操作與該過 濾操作之間,設定既不進行過濾操作也不進行逆滲透操作的 空白時間。此空白時間係一面利用顯示裝置5進行確認,一 面將設定値預先輸入於輸入裝置4。藉此,經逆滲透的液體 便容易滲透至細胞組織間或細胞層次。 該血液透析裝置之各操作的液體移動量(過濾液量或逆 滲透液量)係由各操作之液體移動速度(過濾速度或逆滲透 速度)與各操作所需求之時間的乘積而算出的。本發明實施 之際’以置換液量爲標準而爲了量測血液透析過濾治療之程 度,有必要預先算出過濾液量或逆滲透過濾量之移動量。藉 此,設定或控制將變得容易° -15- 1324525 該血液透析裝置之該過濾操作與其後所進行之該逆滲 透操作的組合設爲一個單位(循環)時,進行各循環之逆滲 透操作的時間,限制較相同循環內之進行過濾操作的時間爲 少。藉由血液透析(過濾)之治療時間中的循環次數,算出 每一次之循環時間。此一次循環時間,藉由預先設定的過濾 時間(除水時間)、空白時間與逆滲透時間(注入時間)的 比例,算出各製程之時間。藉此,能夠對生體進行非強制之 除水,並且能夠有效移除溶質。 該血液透析裝置係將血液透析操作期間中所需求之整 體時間設爲治療時間之時,能夠任意設定於治療時間內所進 行的該循環之次數。該循環之次數係因應於患者之狀態、狀 況而所設定的,由於必需治療日之體液移除量等每次不同, 其設定一面利用本裝置之顯示裝置5進行確認,一面將輸入 値輸入輸入裝置4。藉此,能夠進行因應於患者之病情與當 時之狀況的血液淨化處理。 該血液透析裝置係將利用血液淨化處理所移除之患者 的體液量設爲體液移除量、將利用該逆滲透操作而流入的液 體量之總量設爲置換液總量、至少將由該過濾操作與接續的 該逆滲透操作所構成的該循環的次數設爲循環次數之時,藉 由設定該治療時間、體液移除量、置換液總量與循環次數之 各項目,進行潮式HDF處理之操作或控制。該各項目之設 定値係一面由顯示裝置5進行確認’一面進行輸入裝置4之 輸入。 藉此,能夠詳細設定對患者之適切治療、或醫生認爲最 -16- 1324525 佳之治療。 該血液透析裝置之該體液移除量、置換液總量係藉由對 輸入裝置4進行輸入,進行潮式HDF之操作或控制。由於 此係因應於各患者而爲不同的重要項目,其輸入操作爲必須 的。 該血液透析裝置若無該治療時間'或該循環次數之輸入 的情形’以預先設定於輸入裝置4的初設値進行操作或控 制。由於該項目係視患者而定,並不致於太影響治療,也可 以僅於必要之情形下進行輸入。藉此,因爲能夠省略人力操 作’減少醫療人員之負擔。 藉由送液幫浦P6與送液幫浦P3之聯動式控制,能夠進 行該過濾操作與體液移除。亦即,過濾操作係藉由使送液幫 浦P6產生逆向旋轉或是使送液幫浦p3產生順向旋轉,逆滲 透操作係藉由使送液幫浦P6產生順向旋轉或是使送液幫浦 P3產生逆向旋轉。此時,限制體液移除量爲根據逆滲透之 注入量(負値)與根據過濾之排液量的和。 能夠利用送液幫浦P6之逆向旋轉的除水而藉以達成該 過濾操作,並利用送液幫浦P6之順向旋轉的注入而藉以達 成該逆滲透操作。於此,若將注入量設爲與除水量相等的 話,限制送液幫浦P3之排液量與體液移除量相等。 能夠利用送液幫浦P6之逆向旋轉的除水而藉以達成該 過濾操作,並利用送液幫浦P6之順向旋轉的注入而藉以達 成該逆滲透操作。於此,若設定每一循環之送液幫浦P6的 逆向旋轉> 順向旋轉數,蔣利用送液幫浦P6之逆向旋轉所 -17- 1324525 過濾的液量設爲總過濾量(負値)的話,限制體液移除量爲 總過濾量與注入量(負値)之和。 該血液透析裝置之該過濾操作與逆滲透操作係於利用 設置於透析液迴路的送液幫浦Ρ3所進行的情形下,若將送 液幫浦Ρ3由透析液排出迴路13排液至迴路外的液量設爲幫 浦排液量的話,限制此幫浦排液量爲根據該過濾操作,從第 1血液側迴路朝透析液排出側迴路1 3所流出的過濾液量(除 水量),與根據該逆滲透操作,從透析液供應側迴路1 2朝 第2血液迴路側所流入的逆滲透液量(置換注入量)的和。 藉此,經常所設定之體液移除量於經確認之狀態下,進行血 液透析過濾。 限制該血液透析裝置該各循環之該送液幫浦Ρ3排液量 爲各循環之該過濾液量與該逆滲透液量之和。此係藉由計算 送液幫浦Ρ3之旋轉量,進行各循環之過濾液量與逆滲透液 量(負値)之相加與監視。藉此,各循環於確保已設定之患 者除水量的狀態下進行血液透析過濾,能夠控制經時性的除 水。 該血液透析裝置藉由該各循環之額外過濾操作,將已除 水之量設爲每一循環之體液移除量時,每一循環之體液移除 量係將該體液移除量均等除以該循環次數之値。由於此操作 係將第2圖中符號(c)之推與拉式之時間、數量予以均等 分配的階段,體液移除量爲除以循環次數之均等値。藉此, 輸入操作能夠予以簡化。 該血液透析裝置係藉由該各循環之過濾操作,將所除水 -18- 1324525 分變, 由。形 係的情 量出的 水算} 除而間 之積時 環乘入 循的注 一 間 X 每時度 ,透速 時滲透 之逆滲 量與逆 水度丨 除速量 的透液 環滲換 循逆置 1 的之 每環環 爲循循 設各一 量於每 之配更 自動變更除水量與置換液量相等。變更治療條件之情形,也 自動變更體液移除式樣。遵照經變更後之體液移除式樣之各 循環構造的比例,藉由將對各循環之體液移除量予以再分 配,輸入操作將變得容易。 該血液透析裝置之將該各循環的過濾操作所需求之時 間設爲每一循環之除水時間,藉由相同過濾操作而將除水幫 浦進行排液的量設爲每一循環之幫浦排液量,將該各循環之 逆滲透操作所需求之時間設爲每一循環之置換液注入時 間,將利用相同逆滲透操作而將流入液體的量設爲每一循環 之置換液(注入)量時,藉由增減每一循環之置換液注入時 間而自動設定每一循環之除水時間或每一循環之除去量與 每一循環之幫浦排液量。 若逆滲透操作存在逆滲透時間與逆滲透量的二個參數 變更一個(時間)的話,將變更前所算出的速度(量/時間) 設爲不變,而使另一邊的參數(量)改變,因而利用自動計 算而變更隨時値。如此方式,利用二個參數與由此參數所算 出結果之關係而藉以進行自動計算,並進行自動設定。所設 定之參數便記憶於裝置內部之記憶體。此情形下,藉由設爲 不變之參數,便可能改變自動設定之參數。 藉此,能夠因應於各患者或當時之狀況而採取周詳之對 應’再者,能夠減輕醫療人員之人力操作。 -19- 1324525 該血液透析裝置係藉由增減該每一循環之除水時間’如 上所述而自動設定每一循環之置換液注水時間或每一循環 之置換液注入量、每一循環之幫浦排液量。藉此’能夠因應 於各患者或當時之狀況而採取周詳之對應’再者,能夠減輕 醫療人員之人力操作。 該血液透析裝置係藉由上述方式增減該每一循環之置 換液注入量或每一循環之除水量,能夠變更各循環之置換液 量、或各循環之除水量。藉此,能夠因應於各患者或當時之 狀況而採取周詳之對應。再者,能夠減輕醫療人員之人力操 作。 該血液透析裝置之該各循環,可以任意變更一循環所需 求之時間。能夠因應於各患者或當時之狀況而採取周詳之對 應。 該血液透析裝置,一旦將該每一循環之除水時間或除水 量的設定狀態、相同循環下之置換液注入時間或置換液量之 設定狀態設爲每一循環之除水-注水式樣,則於設定或變更 每一循環之除水-注水式樣之情形下,將已設定之循環以後 的各循環之除水-注水式樣設定或變更爲相同之式樣。藉 此,能夠減輕醫療人員之人力操作。 該血液透析裝置係藉由血球比容値測定裝置(一種利用 光學式感測器的定量法,其利用構成血液之成分的紅血球、 血小板、血漿等具有個別特有之吸光特性)能夠變更所設定 之除水條件’或是藉由血球比容値測定裝置之血液的狀態顯 示,能夠變更各循環之除水-注水式樣。藉此,能夠因應於 -20- 1324525 各患者或當時之狀況而採取周詳之對應° 該血液透析裝置係遵循利用額外過濾的體液移除程式 所設定的體液移除條件,能夠變更各循環之總過濾-注入樣 式。亦即,將此次之血液透析(過濾)治療的體液移除量予 以時間分割,利用設定每個階段(每個經過時間)之總過濾 速度的一種方法,且隨時間之經過’自動變更總過濾速度之 機能(程式),一面以顯示裝置5進行確認’ 一面於輸入裝 置4進行設定,於內部記憶體進行調整。藉此’能夠因應於 各患者之狀況而採取周詳之對應。 該血液透析裝置之該過濾操作或該逆滲透操作之任一 項,或是兩操作均爲數次、連續進行,至少反覆2次以上由 數次或單次之過濾操作與數次或單次之逆滲透操作構成的 循環。藉此,藉由配合各患者之病情,設定更適當的條件, 能夠採取有效而周詳之對應。 該血液透析裝置之該各操作的液體移動量(過濾液量或 逆滲透液量)係以各操作之液體移動速度(過濾速度或逆滲 透速度)與各操作所需求之時間的乘積而算出的。本發明能 夠藉此而容易進行輸入與設定。 【產業上之利用可能性】 如上所述,有關本發明之裝置係一種藉由定期且間歇進 行過濾與逆滲透,適合於有效進行患者體內之廢物或水份的 移除,進行血被淨化的透析裝置。 【圖式簡單說明】 第1圖係顯示本發明血液透析裝置之一實施例的構造 -21 - 與控制槪略之方塊圖。 第2圖係顯示利用本發明一例之血液透析裝置的處理 璨作流程槪略之流程圖。 第3圖係顯示利用本發明血液透析裝置的一除水-注入 式樣例之示意圖。 第4圖係顯示本發明—例之血液透析裝置的整體構造 槪略之示意圖。 元_件符號說明: 1 血 液 透 析 裝 置 2 透 析 運 轉 裝 置 3 控 制 裝 置 4 血 液 輸 入 裝 置 5 顯 示 裝 置 6 監 視 器 7 傳 達 系 統 8 血 液 透 析 器 9 生 體 10 第 1 血 液 迴 路 11 第 2 血 液 迴 路 1 2 透 析 液 供 應 迴 路 13 透 析 液 排 出 迴 路 14 旁 通 迴 路 15 旁 通 迴 路 16 內 毒 素 移 除 濾 器BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a hemodialysis (filtration) device, and more particularly to a blood purification device for performing filtration and reverse osmosis on a hemodialysis operation by periodic and intermittent. The waste or water is removed from the patient. [Prior Art] For the treatment of patients with renal insufficiency, it has been proposed to purify the blood taken out of the patient and return to various blood purification methods in the body. In order to perform blood purification, a hemodialyzer containing a semi-permeable membrane (hereinafter, also referred to as a dialysis membrane) such as a hollow fiber-like cellulose membrane, a polyacrylonitrile membrane, or a polyfluorene membrane is used in the holder, depending on the condition of the patient. Or the situation, the implementation of the purification method used will be different. For example, in the case of hemodialysis (HD), the blood is contacted with the dialysate through the dialysis membrane of the hemodialyzer, and the urea, uric acid, etc. accumulated in the blood of the patient are forcibly removed by the movement of the substance due to diffusion. In addition, in the case of the blood filtration method (HF), water or waste and toxins in the blood can be removed by filtering through the pores of the membrane through which the dialysis membrane has been perforated. In this treatment, although HD (hemodialysis) has excellent removal characteristics for small molecules of waste and solute, it has the disadvantage of lacking the removal performance of medium and large molecules. On the other hand, although HF (blood filtration) has excellent removal characteristics for medium (large) molecular waste, there are still disadvantages of low molecular removal performance or leakage of blood proteins. In addition, both HD and HF have a great influence on the characteristics of the hollow fiber membrane of the hemodialyzer. Combining the advantages of both HD and HF, that is, the excellent treatment for removing 1324525 characteristics, a Hemodiafiltration (HDF) method has been proposed, and effective solute removal is expected, but the conventional bottle type HDF In the system, only about 5 ~ 10L of liquid replacement can be performed, and the effect is not obvious. Therefore, the large-scale liquid replacement HDF using the online HDF or the push-and-pull HDF has attracted attention, and it has become easier to construct the system. The published technical documents are disclosed in Japanese Laid-Open Patent Publication No. Hei 6-134031 and No. Hei 7-313589, and the like. However, in order to implement HDF (including online HDF, push & pull HDF), it is necessary to have a dedicated blood circuit for refilling (replacement fluid) injection. Further, the bottle type HDF must be prepared with special rehydration. Accordingly, the present invention provides a hemodialysis apparatus which does not require preparation for a dedicated blood circuit or a dedicated fluid replacement, and can be easily transferred to HDF during HD treatment or transferred to HD when treated with HDF. Disclosure of the Invention The present invention solves this problem by utilizing the structure shown below. That is, the structure of the hemodialysis apparatus 1 of the present invention is used for hemodialysis (filtration), using a hemodialyzer 8 for accommodating a hollow fiber membrane, and a liquid delivery pump P6 and a liquid delivery pump P3 through the hemodialyzer 8. One type, or a forced reverse osmosis controlled by the linkage of the two pumps, causes the dialysate to flow from the dialysate supply circuit 12 side to the second blood circuit 1 1 side, and in the same manner, by transmitting the blood The filtration of the dialyzer 8 causes the liquid in the first blood circuit 10 to flow out toward the dialysate discharge circuit 13 side, and is characterized in that intermittently and at least 1322525 is repeatedly performed several times by the dialysate supply circuit 1 2 side using the reverse osmosis. The liquid inflow operation to the second blood circuit 11 side (hereinafter also referred to as reverse osmosis operation); and the liquid outflow operation to the dialysate discharge circuit 13 side by the first blood circuit 10 side by the filtration (hereinafter , also known as infiltration operation) ^ In the patent specification of the present invention, the reverse osmosis operation and the filtration operation are performed intermittently and at least several times, which is conveniently referred to as tidal HDF (Tidal: imitation of tidal fluctuations The liquid inflow, outflow state). The hemodialysis (filtration) device of the present invention is constructed in such a manner that reverse osmosis until the liquid flowing into the body is extracted out of the body by filtration, that is, the blood circulation system and the dialysate supply liquid are connected by permeating the dialyzer 8. The solute is removed (exchanged) by the pressure difference until the water in the blood circulation system is moved to the dialysate supply and discharge system, and the time difference is caused to permeate into the cells of the patient or between the cells. As a result, the removal efficiency of the solute or the removal effect of the medium and large molecules is remarkably improved. The hemodialysis (filtration) device of the present invention is utilized to enhance the filtration effect, and the removal of medium and large molecular weight substances is possible. In addition, by increasing the filtration effect, the efficiency of the characteristics of the hollow fiber membrane depending on the hemodialyzer can be improved. Further, the replacement fluid that flows into the blood circuit by reverse osmosis will permeate into the cells of the patient or between the tissues. This removes water after substance exchange (rehydration or removal of water on a body fluid basis). Compared with current HDF and HF, it can improve blood purification. [Embodiment] Hereinafter, the present invention will be described in detail based on the embodiments shown in the drawings. 1324525 Fig. 1 is a block diagram showing the construction of an embodiment of the hemodialysis apparatus of the present invention. In the figure, '1 is a hemodialysis apparatus, and the structure includes: a dialysis actual operation device 2, a control device 3 for controlling the operation or treatment of the dialysis device 1, a blood input device 4 for inputting commands and conditions or operations, and a display input. The display device 5 of the state or control mechanism and the monitor 6 or the like for displaying the operating state of the control device. Further, the monitor 6 of the actual operation device of the input device 4 is connected to the control device 3 by the communication system 7, and the operation state of the dialysis actual operation device 2 is confirmed by the monitor 6, and the input device 4 is also changed. The setting condition 'transmitting the system 7 and the control device 3 makes it possible to change the operation of the dialysis actual operation device 2. In Fig. 1, the input device 4 and the monitor 6 are connected to the control device 3 by the communication system 7, and all of the input device 4, the monitor 6, and the control device 3 can be connected to the communication system 7. According to Fig. 4, the dialysis actual operation device 2, for example, a water supply pump or a blood pump, a supply or discharge device for dialysate, a dialysate circuit, a blood circuit, etc., and a switch, etc., will be described in detail later. When the flow path switching device and the hemodialyzer for performing filtration and reverse osmosis are actually subjected to hemodialysis treatment, a device for performing operation is provided. In the input device 4 for inputting processing conditions or commands, there are: means for setting or increasing or decreasing the total filtration amount and treatment time from the patient, and the amount of reverse osmosis fluid flowing into the patient; or water removal and water injection (utilization) When reverse osmosis is set to one cycle, set the time required for each cycle, or the device for increasing or decreasing. It is preferable that such devices are capable of inputting and changing various conditions using one panel, but are not limited by such devices. In addition, the display device 5 is configured to confirm and grasp the command and conditions of the input device 4, the input state of the input device, and the control mechanism before the operation of the dialysis actual operation device 2, and the display device 5 It is also possible to form the structure of the panel integrated with the input device 4. Further, as described above, the monitor 6 that monitors the operation state of the dialysis actual operation device 2 is connected to the dialysis actual operation device 2, and displays the operation state of the dialysis actual operation device 2, and does not operate according to the set conditions. The dialysis actual operation device 2 can be adjusted in detail by the communication system 7 and the control device 3. Fig. 2 is a flow chart showing the steps of performing hemodialysis treatment using the hemodialysis apparatus of the present invention, that is, a flow chart showing the following steps: (a) Condition setting (input) - > (b) Input confirmation - (c) Display of hemodialysis conditions - (d) Confirmation and decision - (e) Implementation (hemodialysis treatment) e (f) Monitoring of the operating state of the dialysis apparatus - (g) Adjustment and change - (h) Feedback control of the dialysis apparatus. First, the input device 4 is set and input for the total amount of body fluid removal and treatment time, the amount of replacement fluid injected (also referred to as the amount of reverse osmosis liquid flowing into the patient, and the total amount of replacement fluid). Further, in the time taken for hemodialysis, a combination of a reverse osmosis replacement solution of a hemodialyzer and a water removal by filtration is used as one cycle, and a plurality of cycles may be set in succession. The time can also be set due to the time required for the treatment time/cycle cycle. For example, the time of one cycle can be adjusted to a range of 1 minute to 60 minutes. Here, in one cycle, the time of the replacement liquid injection according to the reverse osmosis and the time of the water removal according to the filtration are generally set to [replacement liquid injection time] < [except -10- 1324525 water time], if the pair is set If the input of the hemodialysis device is limited, there is no discomfort to the living body, and the solute or blood purification can be effectively removed. In addition, the relationship between the amount of the replacement liquid injection and the amount of water to be removed satisfies the amount of water to be replaced by the amount of the replacement liquid injection 丨 + I 丨 = total filtration amount I, and if the hemodialysis apparatus performs input restriction, the amount of replacement liquid injection is set. With the amount of body fluid removed, the amount of draining of the dewatering pump is automatically calculated, which is facilitated by the control of the water removal pump. Regarding the input operation of the hemodialysis device, as shown in Fig. 2, if the amount of body fluid removal and the total amount of replacement fluid (injection) are not input, then it is impossible to advance to the next step, and the treatment time and the number of cycles are set even if In the case of no input, since the setting is completed in advance (initial 値), the operation will be controlled under the condition that it is initially set. The screen for confirming whether or not the individual settings have been input is displayed. If these settings are good, after confirming, 'display the displacement liquid injection amount and body fluid removal amount for each cycle as shown in Fig. 3, and the water removal pump. The type of liquid discharge β Here, Α is set as the initial total filtration amount, Α' is set as the initial replacement liquid injection amount, A'' is set as the initial body fluid removal amount, and 'B is set as the second time. The total amount of filtration, B' is set to the second replacement fluid injection amount, B'' is set to the second fluid removal amount, and still maintains A = A' + A''' B = B' + B'' In the relationship, it is possible to set and change the total filtration amount, the water removal time, the replacement liquid injection amount, and the replacement liquid injection time for each cycle. The actual water removal-injection pattern change was carried out in the following order. By determining (input) the body fluid removal amount 'water removal time', the total amount of replacement fluid and the number of cycles, automatically calculate the time of each cycle or the water removal time required for each cycle, and set [replacement fluid] on the result screen. Injection time / cycle] -11 - 1324525 = [- time of cycle] - [water removal time / cycle] _ [blank time]. In this screen, the relationship (replacement fluid injection amount, body fluid removal amount, or water removal pump discharge amount becomes constant) is maintained, and it is determined by increasing or decreasing [replacement fluid injection time/cycle]. Pu's drainage time / cycle] water removal pump discharge volume 'replacement fluid injection speed. On the contrary, it is also possible to increase or decrease the setting [discharge time/cycle of the water removal pump], and change the [replacement time/cycle] of the replacement liquid. By changing the time setting for each _ cycle and also changing the [replacement fluid injection amount/cycle], it is possible to change the amount of replacement liquid injection per cycle. In addition, the time of the entire cycle can also be changed. The change in the amount or time of the replacement liquid as described above is reflected in the subsequent cycle. Further, by changing the pattern of each cycle, the remaining cyclic pattern is also changed to the same pattern, and the setting of each pattern can be performed. Furthermore, the amount of body fluid removed can also be changed in each cycle by using a blood cell to measure blood cell ratio compared to a monitor or an additional filtered body fluid removal pattern. However, compared with the conventional push & pull type HDF, the amount of replacement fluid injected per time of the tidal HDF therapy of the present invention may affect the blood circulation dynamics of the patient. Therefore, it is desirable to perform monitoring using an automatic sphygmomanometer, a hematocrit monitor, or the like, or to perform interlocking control with such monitoring. In other safety mechanisms, it is also possible to stop the water removal operation or the replacement liquid injection operation by abnormal detection of blood circuit internal pressure, dialysis hydraulic pressure, bubble detector, and the like. In the tidal HDF of the present invention, it is desirable to set the alarm reference 静脉 of the venous pressure and the dialysis hydraulic pressure, respectively, depending on the pressure fluctuation in the blood circuit. -12- 1324525 Next, the overall schematic view of the hemodialysis apparatus of the present invention is shown in Fig. 4. The hemodialysis apparatus 1 includes a hemodialyzer 8 that performs blood purification by bringing blood into contact with a dialysis liquid medium via a semipermeable membrane. The first blood circuit 10 has blood that is introduced into the dialyzer 8 from the blood taken out by the living body 9. a pump P1; a second blood circuit 11 having means for introducing blood flowing out of the dialyzer 8 into the body 9; a dialysate supply circuit 12 having a dialysate supply pump P5 for introducing the dialyzer into the dialyzer 8; and a dialysate The discharge circuit 13 has a dialysate for discharging the dialysate which is discharged from the dialyzer 8 to discharge the pump. 4» In order to improve the purification of the dialysate, it is desirable to set the endotoxin shift to the dialysate supply circuit 12 on the upstream side of the hemodialyzer 8. The filter 16 is removed. In the hemodialysis apparatus 1, one or both of the dialysate supply pump P5 setting portion of the dialysate supply circuit 12 and the dialysate discharge pump P4 setting portion of the dialysate discharge circuit 13 are provided with the pump. Different bypass pumps 14, 15 of the liquid supply pump P3, P6, the liquid supply pumps P3, P6 disposed in the bypass circuit 14, 15 and the blood pump P1 are both reversible Rotating pump. Here, when the liquid delivery pump P3 and the dialysate discharge pump P4 are rotated in the same direction, the water removal by filtration is performed, and conversely, the liquid delivery pump P3 and the dialysate discharge pump P4 are rotated in the opposite direction. In this case, a replacement liquid injection using reverse osmosis is performed. Alternatively, if the liquid-feeding pump P6 and the dialysate supply pump P5 are rotated in the same direction, the replacement liquid is injected by reverse osmosis, and the opposite is true. If the liquid-feeding pump P6 and the dialysate supply pump P5 are reversed, When it is rotated, water removal by filtration is performed. -13- 1324525 Blood pump P1 and (set in bypass circuit 2) any of the liquid delivery pump P3' P6, or both of them, or not shown, switch dialysate circuit or blood The dialysis actual operation device 2 such as the flow path switching device of the circuit is connected to the control device 3 by the communication system 7 (Fig. 1). The control unit 3 operates the perfusion pump P3 and P6 to perform reverse osmosis through the hemodialyzer 8 to operate. By this reverse osmosis operation, the dialysate is flown to the blood circuit side, and after a predetermined period of time, it is then filtered by the blood dialyzer 8 to be operated by the liquid delivery pump P3 or P6. By this filtering operation, the liquid in the blood circuit is dehydrated from the dialysate side. At this time, the liquid delivery pump P3 or P6 discharges only the amount of the body fluid removal plus the amount of the reverse permeate (replacement liquid) that has flowed in before, and sets the discharge amount. Hereinafter, embodiments of the present invention will be described. As described above, the present invention sets the setting operation to the input device 4 while confirming the setting conditions on the display device 5, and starts the operation. Using the hemodialyzer 8 containing the hollow fiber, the dialysate supply pump P5 and the dialysate discharge pump P4 are adjusted to the same dialysate supply discharge system, with the feed pump P3 facing the same dialysis The liquid discharge pump P4 is driven in the liquid supply direction to perform filtration (water removal) through the hemodialyzer 8. Further, by driving the liquid delivery pump P3 in the opposite direction to the filtration (water removal), reverse osmosis through the dialyzer 8 can be performed. Alternatively, when the liquid supply pump P6 is rotated in the same direction as the dialysate supply pump P5, the reverse osmosis replacement liquid is used for the injection, and conversely, the liquid supply pump P6 and the dialysate supply pump P5 are reversed. If the direction is rotated, the Li-14-1324525 is used to remove water. Alternatively, the same operation can be performed by performing the linkage control of the liquid feeding pumps p3 and P6. The liquid inflow operation toward the blood circuit side on the dialysate side by the reverse osmosis (hereinafter also referred to as reverse osmosis operation) is performed by using a predetermined inflow velocity and inflow amount, and the blood circuit side using the filtration is used. The liquid outflow operation (hereinafter, also referred to as a filtration operation) toward the dialysate circuit side is performed using a preset outflow rate and outflow amount. The present invention is a hemodialysis apparatus that intermittently and repeatedly alternates such inflow and outflow operations. In addition to the feature of the hemodialysis apparatus of the present invention, various embodiments as shown below are also employed. That is, the present invention is a hemodialysis apparatus which alternately performs the filtration operation and the reverse osmosis operation as described above, whereby the solute can be effectively removed. The hemodialysis apparatus of the present invention can set a blank time between the reverse osmosis operation and the filtration operation without performing a filtering operation or a reverse osmosis operation. This blank time is confirmed by the display device 5, and the setting 値 is input to the input device 4 in advance. Thereby, the reverse osmotic liquid easily penetrates into the intercellular tissues or the cell level. The amount of liquid movement (the amount of filtrate or the amount of reverse osmosis) for each operation of the hemodialysis apparatus is calculated from the product of the liquid moving speed (filtering speed or reverse osmosis speed) of each operation and the time required for each operation. In the practice of the present invention, in order to measure the degree of hemodiafiltration treatment by the amount of replacement fluid, it is necessary to calculate the amount of filtration or the amount of movement of the reverse osmosis filtration amount in advance. Thereby, the setting or the control will become easy. -15 - 1324525 The combination of the filtering operation of the hemodialysis device and the reverse osmosis operation performed thereafter is set to one unit (cycle), and the reverse osmosis operation of each cycle is performed. The time is limited to less time than the filtering operation in the same cycle. The cycle time per cycle was calculated by the number of cycles in the hemodialysis (filtration) treatment time. In this one cycle time, the time of each process is calculated by the ratio of the preset filter time (water removal time), blank time, and reverse osmosis time (injection time). Thereby, the living body can be subjected to non-mandatory water removal, and the solute can be effectively removed. The hemodialysis apparatus can arbitrarily set the number of cycles performed during the treatment time when the entire time required for the hemodialysis operation period is the treatment time. The number of times of the cycle is set according to the state and condition of the patient, and the amount of body fluid removal required for the treatment day is different, and the setting is input and input by the display device 5 of the device. Device 4. Thereby, blood purification treatment in response to the condition of the patient and the current situation can be performed. The hemodialysis apparatus sets the amount of body fluid of the patient removed by the blood purification treatment as the amount of body fluid removal, and the total amount of the liquid that flows in by the reverse osmosis operation as the total amount of the replacement liquid, at least by the filtration. When the number of cycles of the operation and the reverse osmosis operation is set to the number of cycles, the tidal HDF treatment is performed by setting each of the treatment time, the amount of body fluid removed, the total amount of replacement fluid, and the number of cycles. Operation or control. The setting of each item is input by the display device 5 while the input device 4 is being input. In this way, it is possible to set in detail the appropriate treatment for the patient, or the doctor thinks that the best treatment is -16-1324525. The amount of the body fluid removal and the total amount of the replacement fluid in the hemodialysis apparatus are operated or controlled by the input device 4 by the input of the tidal HDF. Since this is a different important item for each patient, its input operation is necessary. The hemodialysis apparatus is operated or controlled without the treatment time 'or the input of the number of cycles' preset in the initial setting of the input device 4. Since the program is patient-dependent and does not affect treatment too much, it can be entered only when necessary. Thereby, the manpower operation can be omitted, and the burden on medical personnel can be reduced. The filtration operation and body fluid removal can be performed by the linkage control of the liquid delivery pump P6 and the liquid delivery pump P3. That is, the filtering operation is performed by causing the liquid feeding pump P6 to rotate in the reverse direction or to cause the liquid feeding pump p3 to rotate in the forward direction. The reverse osmosis operation is performed by causing the liquid feeding pump P6 to rotate in the forward direction or send it. The liquid pump P3 produces a reverse rotation. At this time, the amount of body fluid removal is limited to the sum of the amount of injection according to reverse osmosis (negative enthalpy) and the amount of liquid discharged according to filtration. This filtration operation can be achieved by the reverse rotation of the liquid feed pump P6 to remove the water, and the reverse osmosis operation can be achieved by the injection of the forward rotation of the liquid feed pump P6. Here, if the injection amount is made equal to the amount of water removal, the liquid discharge amount of the liquid supply pump P3 is limited to be equal to the body fluid removal amount. This filtration operation can be achieved by the reverse rotation of the liquid feed pump P6 to remove the water, and the reverse osmosis operation can be achieved by the injection of the forward rotation of the liquid feed pump P6. Here, if the reverse rotation of the liquid supply pump P6 is set for each cycle > the number of forward rotations, the amount of liquid filtered by the -17-1324525 by the reverse rotation of the liquid supply pump P6 is set as the total filtration amount (negative値), the amount of body fluid removal is limited to the sum of the total amount of filtration and the amount of injection (negative enthalpy). In the case where the filtration operation and the reverse osmosis operation of the hemodialysis apparatus are performed by the liquid delivery pump 3 provided in the dialysate circuit, if the liquid delivery pump 3 is drained from the dialysate discharge circuit 13 to the outside of the circuit When the amount of liquid is set to the discharge amount of the pump, the amount of the liquid discharged from the first blood side circuit toward the dialysate discharge side circuit 13 (the amount of water removal) is limited according to the filtration operation. The sum of the amount of reverse permeate (displacement amount) flowing from the dialysate supply side circuit 12 toward the second blood circuit side according to the reverse osmosis operation. Thereby, the amount of body fluid removal that is often set is subjected to blood diafiltration under the confirmed state. The amount of the liquid delivery pump 3 that restricts the circulation of the hemodialysis device is the sum of the amount of the filtrate and the amount of the reverse permeate. This is done by calculating the amount of rotation of the liquid supply pump 3 and adding and monitoring the amount of filtrate and the amount of reverse osmosis (negative enthalpy) for each cycle. Thereby, each cycle performs hemodiafiltration while ensuring the amount of water removed by the patient, and it is possible to control the dehydration over time. The hemodialysis device uses the additional filtration operation of each cycle to set the amount of water removed to the amount of body fluid removed per cycle, and the amount of body fluid removed per cycle is divided by the amount of body fluid removed equally. The number of cycles. Since this operation is a stage in which the time and quantity of the symbol (c) in Fig. 2 are equally distributed, the amount of body fluid removal is divided by the number of cycles. Thereby, the input operation can be simplified. The hemodialysis device divides the water to be removed -18-1324525 by the filtration operation of the respective cycles. The water of the shape of the system is calculated by the amount of water in the cycle. When the product is multiplied by the cycle, the percolation of the infiltration and the reverse degree of the percolation Each loop of the reverse set is set to follow the set of each quantity, and the amount of water removed is automatically equal to the amount of replacement liquid. When the treatment conditions are changed, the body fluid removal pattern is also automatically changed. The input operation will be facilitated by redistributing the amount of body fluid removed for each cycle in accordance with the proportion of each of the cyclic structures of the modified body fluid removal pattern. The hemodialysis device sets the time required for the filtration operation of each cycle as the water removal time of each cycle, and sets the amount of drainage of the water removal pump to the pump of each cycle by the same filtering operation. The amount of liquid discharged, the time required for the reverse osmosis operation of each cycle is set as the replacement liquid injection time per cycle, and the amount of the inflow liquid is set as the replacement liquid (injection) per cycle by the same reverse osmosis operation. In the case of volume, the water removal time of each cycle or the removal amount of each cycle and the amount of pump discharge per cycle are automatically set by increasing or decreasing the replacement liquid injection time of each cycle. If the two parameters of the reverse osmosis time and the reverse osmosis amount are changed by one (time) in the reverse osmosis operation, the speed (quantity/time) calculated before the change is set to be constant, and the parameter (quantity) of the other side is changed. Therefore, it is changed at any time by using automatic calculation. In this way, the automatic calculation is performed by using the relationship between the two parameters and the results calculated by the parameters, and the automatic setting is performed. The set parameters are stored in the memory inside the device. In this case, it is possible to change the parameters of the automatic setting by setting the parameters unchanged. In this way, it is possible to take a detailed response to each patient or the situation at the time, and the manual operation of the medical staff can be reduced. -19- 1324525 The hemodialysis device automatically sets the replacement liquid injection time of each cycle or the replacement liquid injection amount per cycle by increasing or decreasing the water removal time of each cycle as described above, each cycle The amount of drainage in the pump. In this way, it is possible to take a detailed response in response to the situation of each patient or the situation at the time, and the manual operation of the medical staff can be alleviated. In the hemodialysis apparatus, the amount of the replacement liquid to be injected or the amount of the water to be removed per cycle can be increased or decreased as described above, and the amount of replacement liquid in each cycle or the amount of water to be removed in each cycle can be changed. In this way, it is possible to take a detailed response in response to each patient or the situation at the time. Furthermore, it is possible to reduce the manual operation of medical personnel. The respective cycles of the hemodialysis apparatus can arbitrarily change the time required for one cycle. It is possible to respond to each patient or the situation at the time. When the blood dialysis device sets the set state of the water removal time or the water removal amount for each cycle, the replacement liquid injection time under the same cycle, or the replacement liquid amount as the water removal-water injection pattern for each cycle, In the case of setting or changing the water removal-injection pattern for each cycle, the water removal-water injection pattern of each cycle after the set cycle is set or changed to the same pattern. As a result, the manual operation of medical personnel can be alleviated. The hemodialysis apparatus is capable of changing the set by a hematocrit measurement apparatus (a quantitative method using an optical sensor that uses individual characteristic light absorption characteristics such as red blood cells, platelets, and plasma constituting blood components). The water removal condition 'or the state of the blood by the hematocrit measuring device can change the water removal-water injection pattern of each cycle. In this way, it is possible to take a detailed response in response to the -20-1324525 patient or the situation at the time. The hemodialysis device follows the body fluid removal conditions set by the additional fluid removal program, and can change the total of each cycle. Filter-injection style. That is, the amount of body fluid removal of the hemodialysis (filtration) treatment is time-divided, using a method of setting the total filtration speed of each stage (each elapsed time), and 'automatically changing the total over time The function of the filter speed (program) is checked by the display device 5, and is set in the input device 4, and is adjusted in the internal memory. In this way, it is possible to take a detailed response in response to the situation of each patient. The filtering operation or the reverse osmosis operation of the hemodialysis device, or both operations are performed several times in succession, at least repeated two times or more by several or single filtering operations and several times or single times The cycle of reverse osmosis operation. Thereby, by setting the more appropriate conditions in accordance with the condition of each patient, an effective and detailed correspondence can be taken. The amount of liquid movement (the amount of filtrate or the amount of reverse osmosis) of each operation of the hemodialysis apparatus is calculated by multiplying the liquid moving speed (filtering speed or reverse osmosis speed) of each operation by the time required for each operation. . The present invention can be easily input and set by this. [Industrial Applicability] As described above, the apparatus according to the present invention is suitable for effectively removing waste or moisture in a patient by performing filtration and reverse osmosis periodically and intermittently, and purifying the blood. Dialysis device. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a block diagram showing the construction of an embodiment of the hemodialysis apparatus of the present invention. Fig. 2 is a flow chart showing the flow of the processing of the hemodialysis apparatus according to an example of the present invention. Fig. 3 is a schematic view showing an example of a water removal-injection type using the hemodialysis apparatus of the present invention. Fig. 4 is a schematic view showing the overall construction of the hemodialysis apparatus of the present invention. Description of the symbol: 1 Hemodialysis device 2 Dialysis operation device 3 Control device 4 Blood input device 5 Display device 6 Monitor 7 Communication system 8 Hemodialyzer 9 Bio 10 First blood circuit 11 Second blood circuit 1 2 Dialysis Liquid supply circuit 13 dialysate discharge circuit 14 bypass circuit 15 bypass circuit 16 endotoxin removal filter

-22- 1324525 PI 血 液 幫 浦 P2 血 液 P3 送 液 幫 浦 P4 透 析 液 排 出 幫 浦 P5 透 析 液 供 應 幫 浦 P6 送 液 幫 浦-22- 1324525 PI blood pump P2 blood liquid P3 liquid supply pump P4 dialysis liquid discharge pump P5 dialysis solution supply pump P6 liquid supply pump

-23--twenty three-

Claims (1)

1324525 脾μ月你修⑵正替換頁I ^ 第93 1 1 73 1 0號「反覆間歇注藻作之血液透析裝置」 專利案 (2009年11月25日修正) 拾、申請專利範圍: 1. 一種血液透析裝置,血液透析(過濾)使用容納中空纖維 膜之血液透析器(8),藉由透過該血液透析器(8)之強制逆 滲透(也稱爲注入),使透析液由透析液供應迴路(1 2)側 流入第2血液迴路(11)側,另外,藉由透過該血液透析器 (8)的過濾(也稱爲除水),使第1血液迴路(10)內之液體 流出透析液排出迴路(13)側;其特徵爲間歇且至少反覆數 次進行: 由利用該逆滲透之透析液供應迴路(12)側而向第2血 液迴路(1 1)側之液體流入操作(以下,也稱爲逆滲透操作 ):及 由利用該過濾之第1血液迴路(10)側而向透析液排出 迴路(1 3)側之液體流出操作(以下,也稱爲過濾操作)。 2. 如申請專利範圍第1項之血液透析裝置,其中反覆交替進 行該過濾操作與該逆滲透操作。 3. 如申請專利範圍第1項之血液透析裝置,其中於該逆滲透 操作與該過濾操作之間,設定不進行過濾操作與逆滲透操 作之空白時間。 4. 如申請專利範圍第1項之血液透析裝置,其中各操作之液 體移動量(順向之過濾量或除水量,與逆向之逆滲透量或 注入量)係以各操作之液體移動速度(過濾速度或除水速 1324525 度、或是逆滲透速度與注水速度)與各操作所需求之時間 的乘積而計算出。 5. 如申請專利範圍第1項之血液透析裝置,其中將該過濾操 作與其後所進行的該逆滲透操作之組合設爲一個單位(循 環)之時,相較於相同循環內之進行過濾操作之時間,限 制於各循環之進行逆滲透操作的時間變少。 6. 如申請專利範圍第5項之血液透析裝置,其中將血液透析 處理所需求之整個時間設爲治療時間之時,能夠任意設定 處理時間內所進行之該循環的次數。 7. 如申請專利範圍第5項之血液透析裝置,其中利用血液透 析處理所移除之患者的體液量設爲體液移除量,藉由該逆 滲透操作所流入之液體總量設爲置換液總量,由至少該過 濾操作與接續之該逆滲透操作所構成的該治療時間之循 環次數設爲循環次數之時,藉由設定該治療時間、體液移 除量、置換液總量、循環次數之各項目,進行潮式血液透 析過濾(HDF)處理之操作或控制。 8. 如申請專利範圍第5項之血液透析裝置,其中藉由輸入該 體液移除量、置換液總量,進行潮式HDF之操作或控制。 9. 如申請專利範圍第7或8項之血液透析裝置,其中若無該 治療時間、或該循環次數之輸入的情形,以預先設定於輸 入裝置的初設値進行操作或控制。 10.如申請專利範圍第5至8項中任一項之血液透析裝置,其 中限制該各循環之體液移除量爲利用送液幫浦(P6)之注入 量(負値)與利用送液幫浦(P3)之排液量的和。 1324525 11·如申請專利範圍第9項之血液透析裝置,其中限制該各循 環之體液移除量爲利用送液幫浦(Ρ6)之注入量(負値)與 利用送液幫浦(Ρ 3)之排液量的和。 12. 如申請專利範圍第1項之血液透析裝置,其中該逆滲透操 作係藉由設置於透析液排出迴路(13)之送液幫浦(Ρ3)(也 稱爲除水幫浦)所進行的,若將該送液幫浦(Ρ3)由透析液 排出迴路排液至迴路外的液量設爲送液幫浦(Ρ3)排液量, 限制此送液幫浦(Ρ3)排液量爲根據該過濾操作所流出的總 過濾量(除水量與體液移除量之和)與該逆滲透操作所流 入的逆滲透量(置換液量或注入量)的和。 13. 如申請專利範圍第5至8項中任一項之血液透析裝置,其 中限制利用該循環之送液幫浦(Ρ 6)的注入量與除水量之絕 對値相等,送液幫浦(Ρ3)之排液量爲體液移除量。 1 4 ·如申請專利範圍第9項之血液透析裝置,其中限制利用該 循環之送液幫浦(Ρ6)的注入量與除水量之絕對値相等,送 液幫浦(Ρ3)之排液量爲體液移除量。 15. 如申請專利範圍第5至8項中任一項之血液透析裝置,其 中限制該循環之體液移除量爲送液幫浦(Ρ6)之注入量(負 値)與總過濾量之和》 16. 如申請專利範圍第9項之血液透析裝置,其中限制該循環 之體液移除量爲送液幫浦(Ρ6)之注入量(負値)與總過濾 量之和。 17. 如申請專利範圍第5至8項中任一項之血液透析裝置,其 中限制該各循環之該送液幫浦(Ρ 3)排液量爲各循環之該過 1324525 濾液量與該逆滲透液量(負値)之和。 18. 如申請專利範圍第9項之血液透析裝置,其中限制該各循 環之該送液幫浦(P3)排液量爲各循環之該過濾液量與該逆 滲透液量(負値)之和。 19. 如申請專利範圍第10項之血液透析裝置,其中限制該各 循環之該送液幫浦(P3)排液量爲各循環之該過濾液量與該 逆滲透液量(負値)之和。 20·如申請專利範圍第12項之血液透析裝置,其中限制該各 循環之該送液幫浦(P3)排液量爲各循環之該過濾液量與該 逆滲透液量(負値)之和。 21.如申請專利範圍第5至8項中任一項之血液透析裝置,其 中於該各循環之過濾操作期間,每一循環之體液移除量係 將該體液移除量均等除以該循環次數之値。 22·如申請專利範圍第5至8項中任一項之血液透析裝置,其 中藉由該各循環之過濾操作,將所除水之量設爲每一循環 的除水量之時,每一循環之除水量係由分配於各循環的逆 滲透速度與逆滲透時間的乘積而算出的。 23·如申請專利範圍第5至8項中任一項之血液透析裝置,其 中將該各循環之過濾操作所需求之時間設爲每一循環之 除水時間,將藉由相同過濾操作而將送液幫浦(P3)進行排 液的量設爲每一循環之送液幫浦(P 3)排液量,將該各循環 之逆滲透操作所需求之時間設爲每一循環之注入時間,將 藉由相同逆滲透操作而流入液體的量設爲每一循環之置 換液量(注入量)之時,藉由增減每一循環之注入時間而 -4- 1324525 自動設定每一循環之除水時間或每一循環之除去量、每一 循環之幫浦排液量。 24.如申請專利範圍第23項之血液透析裝置,其中藉由增減 該每一循環之除水時間,自動設定每一循環之注水時間或 每一循環之注入量、每一循環之送液幫浦(P 3)排液量。 2 5.如申請專利範圍第23項之血液透析裝置,其中藉由增減 該每一循環之注入量或每一循環之除水量,能夠自動變更 各循環之除水量或各循環之注入量。 26.如申請專利範圍第24項之血液透析裝置,其中藉由增減 該每一循環之注入量或每一循環之除水量,能夠自動變更 各循環之除水量或各循環之注入量。 2 7.如申請專利範圍第5至8項中任一項之血液透析裝置,其 中該各循環可以任意變更一循環所需求之時間。 2 8.如申請專利範圍第5至8項中任一項之血液透析裝置,其 中一旦將該每一循環之除水時間或除水量的設定狀態、相 同循環下之注入時間或置換液量之設定狀態設爲每一循 環之除水-注水式樣,則於設定或變更每一循環之除水·注 水式樣之情形下,將已設定之循環以後的各循環之除水-注水式樣設定或變更爲相同之式樣。 29·如申請專利範圍第22項之血液透析裝置,其中一旦將該 每一循環之除水時間或除水量的設定狀態、相同循環下之 注入時間或置換液量之設定狀態設爲每一循環之除水-注 水式樣’則於設定或變更每一循環之除水-注水式樣之情 形下’將已設定之循環以後的各循環之除水·注水式樣設 1324525 定或變更爲相同之式樣。 3 0.如申請專利範圍第5至8項中任一項之血液透析裝置,其 中藉由血球比容値測定裝置能夠變更所設定之除水條件 ,或是藉由血球比容値測定裝置之血液的狀顯示,能夠變 更各循環之除水-注水式樣。 31. 如申請專利範圍第24項之血液透析裝置,其中藉由血球 比容値測定裝置能夠變更所設定之除水條件,或是藉由血 球比容値測定裝置之血液的狀顯示,能夠變更各循環之除 水-注水式樣。 32. 如申請專利範圍第5至8項中任一項之血液透析裝置,其 中遵循額外過濾的體液移除程式所設定的體液移除條件 ,能夠變更各循環之總過濾-注入樣式。 33. 如申請專利範圍第24項之血液透析裝置,其中遵循額外 過濾的體液移除程式所設定的體液移除條件,能夠變更各 循環之總過濾-注入樣式。 34. 如申請專利範圍第1項之血液透析裝置,其中該過濾操作 或該逆滲透操作之任一項,或是兩操作均爲數次、連續進 行,至少反覆2次以上由數次或單次之過濾操作與數次或 單次之逆滲透操作構成的循環。 35. 如申請專利範圍第34項之血液透析裝置,其中該各操作 的液體移動量(過濾液量或逆滲透液量)係以各操作之液 體移動速度(過濾速度或逆滲透速度)與各操作所需求之 時間的乘積而算出的。1324525 Spleen μ month You repair (2) Replacement page I ^ No. 93 1 1 73 1 0 "Repeated intermittent hemolysis device for blood injection" Patent case (amended on November 25, 2009) Pick up, apply for patent scope: 1. A hemodialysis device for hemodialysis (filtration) using a hemodialyzer (8) containing a hollow fiber membrane, the dialysate being dialyzed by forced reverse osmosis (also called injection) through the hemodialyzer (8) The supply circuit (12) side flows into the second blood circuit (11) side, and the liquid in the first blood circuit (10) is filtered by the hemodialyzer (8) (also referred to as water removal). Flowing out of the dialysate discharge circuit (13) side; characterized by intermittent and at least several times: liquid inflow operation from the side of the dialysate supply circuit (12) using the reverse osmosis to the side of the second blood circuit (1 1) (hereinafter, also referred to as reverse osmosis operation): and a liquid outflow operation (hereinafter also referred to as a filtration operation) on the side of the dialysate discharge circuit (13) by the first blood circuit (10) side of the filtration. 2. The hemodialysis apparatus of claim 1, wherein the filtering operation and the reverse osmosis operation are alternately repeated. 3. The hemodialysis apparatus of claim 1, wherein a blank time between the filtration operation and the reverse osmosis operation is set between the reverse osmosis operation and the filtration operation. 4. The hemodialysis device according to claim 1, wherein the liquid movement amount (the forward filtration amount or the water removal amount, and the reverse reverse osmosis amount or the injection amount) of each operation is the liquid movement speed of each operation ( The product of the filtration rate or the water removal rate of 1,245,525 degrees, or the reverse osmosis rate and the water injection rate, and the time required for each operation is calculated. 5. The hemodialysis apparatus according to claim 1, wherein the combination of the filtering operation and the reverse osmosis operation performed thereafter is one unit (cycle), and the filtering operation is performed in comparison with the same cycle. At the time, the time for performing the reverse osmosis operation for each cycle is reduced. 6. The hemodialysis apparatus according to item 5 of the patent application, wherein the entire time required for the hemodialysis treatment is set as the treatment time, the number of times of the cycle performed during the treatment time can be arbitrarily set. 7. The hemodialysis device according to claim 5, wherein the amount of body fluid removed by the hemodialysis treatment is set as the body fluid removal amount, and the total amount of the liquid flowing in through the reverse osmosis operation is set as the replacement fluid. The total amount, when at least the number of cycles of the treatment time constituted by the filtration operation and the subsequent reverse osmosis operation is set as the number of cycles, by setting the treatment time, the amount of body fluid removal, the total amount of replacement fluid, and the number of cycles For each item, the operation or control of tidal hemodiafiltration (HDF) treatment. 8. The hemodialysis apparatus of claim 5, wherein the operation or control of the tidal HDF is performed by inputting the amount of the body fluid removed and the total amount of the replacement fluid. 9. The hemodialysis apparatus according to claim 7 or 8, wherein if the treatment time or the input of the number of cycles is absent, the operation or control is set in advance at an initial setting of the input device. 10. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the amount of body fluid removal of the respective cycles is limited to the amount of injection (negative enthalpy) and the use of liquid feeding by the liquid feeding pump (P6). The sum of the discharge volume of the pump (P3). 1324525 11. The hemodialysis device according to claim 9, wherein the amount of body fluid removal in each cycle is limited by the injection amount (negative 値) of the liquid feeding pump (Ρ6) and the use of the liquid feeding pump (Ρ 3 The sum of the liquid discharges. 12. The hemodialysis apparatus of claim 1, wherein the reverse osmosis operation is performed by a liquid supply pump (Ρ3) (also referred to as a water removal pump) disposed in the dialysate discharge circuit (13). If the liquid supply pump (Ρ3) is drained from the dialysate discharge circuit to the outside of the circuit, the amount of liquid is set to the liquid delivery pump (Ρ3) discharge amount, and the liquid supply pump (Ρ3) discharge amount is limited. The sum of the total filtration amount (the sum of the water removal amount and the body fluid removal amount) flowing out according to the filtration operation and the reverse permeation amount (the replacement liquid amount or the injection amount) flowing into the reverse osmosis operation. 13. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the injection amount of the liquid supply pump (Ρ6) that restricts the use of the circulation is equal to the absolute value of the water removal amount, and the liquid delivery pump (排 3) The amount of fluid discharged is the amount of body fluid removed. 1 4 · The hemodialysis apparatus according to claim 9 of the patent application, wherein the injection amount of the liquid supply pump (Ρ6) which restricts the use of the circulation is equal to the absolute value of the water removal amount, and the liquid discharge amount of the liquid supply pump (Ρ3) For body fluid removal. 15. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the amount of body fluid removal limiting the circulation is the sum of the injection amount (negative enthalpy) of the liquid delivery pump (Ρ6) and the total filtration amount. 16. The hemodialysis apparatus according to claim 9, wherein the amount of body fluid removed by the circulation is the sum of the injection amount (negative enthalpy) of the liquid delivery pump (Ρ6) and the total filtration amount. 17. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the liquid delivery pump (Ρ 3) discharge amount of the respective cycles is limited to the amount of the 1322525 filtrate and the inverse of each cycle The sum of the amount of permeate (negative enthalpy). 18. The hemodialysis apparatus according to claim 9, wherein the liquid delivery pump (P3) discharge amount of the respective cycles is the amount of the filtrate and the amount of the reverse permeate (negative enthalpy) of each cycle. with. 19. The hemodialysis apparatus of claim 10, wherein the liquid delivery pump (P3) discharge amount of each cycle is limited to the amount of the filtrate and the amount of the reverse permeate (negative enthalpy) of each cycle. with. 20. The hemodialysis apparatus according to claim 12, wherein the liquid delivery pump (P3) discharge amount of each cycle is limited to the amount of the filtrate and the amount of the reverse permeate (negative enthalpy) of each cycle. with. The hemodialysis apparatus according to any one of claims 5 to 8, wherein during the filtration operation of the respective cycles, the amount of body fluid removed per cycle is equalized by dividing the body fluid removal amount by the cycle. The number of times. The hemodialysis apparatus according to any one of claims 5 to 8, wherein, by the filtration operation of the respective cycles, the amount of water to be removed is set as the amount of water removed per cycle, each cycle The amount of water removal is calculated from the product of the reverse osmosis rate and the reverse osmosis time assigned to each cycle. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the time required for the filtration operation of each cycle is set to the water removal time of each cycle, and the same filtration operation will be performed. The amount of liquid discharged by the liquid feeding pump (P3) is set to the liquid discharging amount of the liquid feeding pump (P 3) for each cycle, and the time required for the reverse osmosis operation of each cycle is set as the injection time per cycle. When the amount of liquid flowing in by the same reverse osmosis operation is set as the amount of replacement liquid (injection amount) per cycle, the injection time of each cycle is increased or decreased by -4- 1324525, and each cycle is automatically set. The amount of water removal or the amount of removal per cycle, and the amount of drainage per cycle. 24. The hemodialysis device according to claim 23, wherein the water injection time of each cycle or the injection amount per cycle and the liquid supply per cycle are automatically set by increasing or decreasing the water removal time of each cycle. Pump (P 3) discharge volume. 2. The hemodialysis apparatus according to claim 23, wherein the amount of water removed per cycle or the amount of injection per cycle can be automatically changed by increasing or decreasing the amount of injection per cycle or the amount of water removed per cycle. 26. The hemodialysis apparatus according to claim 24, wherein the amount of water removed per cycle or the amount of each cycle is automatically changed by increasing or decreasing the amount of injection per cycle or the amount of water removed per cycle. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the respective cycles can be arbitrarily changed for the time required for one cycle. 2. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the set time of the water removal time or the water removal amount of each cycle, the injection time under the same cycle, or the amount of replacement liquid is used. When the setting state is set to the water removal-water injection pattern for each cycle, the water removal-water injection pattern of each cycle after the set cycle is set or changed in the case of setting or changing the water removal/water injection pattern for each cycle. For the same style. 29. The hemodialysis apparatus according to claim 22, wherein the setting state of the water removal time or the water removal amount of each cycle, the injection time under the same cycle, or the setting amount of the replacement liquid amount is set to each cycle. In the case of setting or changing the water removal-injection pattern for each cycle, the water removal/water injection pattern setting 1324525 of each cycle after the set cycle is changed or changed to the same pattern. The hemodialysis device according to any one of claims 5 to 8, wherein the hemispherical volume measurement device is capable of changing the set water removal condition or by the hematocrit measurement device. The shape of the blood shows that the water removal-water injection pattern of each cycle can be changed. 31. The hemodialysis apparatus according to claim 24, wherein the hematocrit measuring device is capable of changing the set water removal condition or the blood display of the hematocrit measuring device, and can be changed. Water removal-water injection pattern for each cycle. The hemodialysis apparatus according to any one of claims 5 to 8, wherein the total filtration-injection pattern of each cycle can be changed by following the body fluid removal condition set by the additionally filtered body fluid removal program. 33. The hemodialysis device of claim 24, wherein the total filtration-injection pattern of each cycle can be changed by following the body fluid removal conditions set by the additional filtered body fluid removal program. 34. The hemodialysis device according to claim 1, wherein the filtering operation or the reverse osmosis operation, or both operations are performed several times in succession, at least two times or more by several times or single The second filtration operation and the cycle consisting of several or a single reverse osmosis operation. 35. The hemodialysis device according to claim 34, wherein the amount of liquid movement (the amount of filtrate or the amount of reverse osmosis) of each operation is a liquid moving speed (filtration speed or reverse osmosis speed) of each operation and each Calculated by the product of the time required for the operation.
TW93117310A 2004-06-16 2004-06-16 Hemodialysis filtration device for repeatedly remittent perfusion TWI324525B (en)

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