TWI239859B - Cartridges useful in cleaning dialysis solutions - Google Patents
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- TWI239859B TWI239859B TW91134086A TW91134086A TWI239859B TW I239859 B TWI239859 B TW I239859B TW 91134086 A TW91134086 A TW 91134086A TW 91134086 A TW91134086 A TW 91134086A TW I239859 B TWI239859 B TW I239859B
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(i) 1239859 玫、發明說明 (發明說明應敘明:發明所屬之技術領域、先前技術、内容、實施方式及圖式簡單說明) 發明背景 本文為2000年11月28曰發文美國專利申請字號第 09/723,396號之部份承續申請書,其全體内容為併入參考。 本發明係關於一種如離子交換筒柱或吸收筒柱之筒柱, 用於如透析方面。細言之,本發明係關係對於用後透析液 之再生或純化。本發明亦關於使用某些筒柱進行透析的方 法,以及關於製作該筒柱之方法。 透析為一種針對腎衰竭導致血中累積廢物及過量液體移 除的處理。嚴重腎衰竭指腎功能衰敗到僅存有正常值之 25%。此種衰敗使血中化學狀態嚴重變化,且時機會使人 體不適到必須以醫療處理。若醫療及時,衰敗可減緩。晚 期腎衰竭指腎功能降到15%。最終腎衰竭指腎功能為正常 值的5%。未經醫療處理則在此時造成死亡。到1998年為止, 美國有430,000人經診斷有腎衰竭。平均腎衰竭病患生命期 為2年半。有些人可以活到20年或更久。同時,每年約有 同樣數目急性腎衰竭病患,這些人中有約一半需要治療。 整體而言,急性病患較腎臟病人病症更重且更不穩定。他 們通常處在ICU或CCU中不能移動。急性患者死亡,恢復 腎功能,或成為析腎病患。腎臟病無藥可醫。然而可以作 移植治療,以外科方式將人的腎置於體内,並連到腎葉。 每日需加藥物保持人體不致排斥被移植的腎。另外有所謂 腹膜透析(PD)。此治療中,以和緩鹽水溶液中包含右旋糖 及電解液,稱透析液者,進入腹膜腔中。尤於以富血供應 1239859 發明說明續頁 到腹腔’尿素與其它血中毒物及液體可移到透析液中,由 此清潔血液。此透析液再由腹膜排出。稍後再以,,新鮮,,透 析液送入腹膜。 另外有析腎。這是一種純化血的方法,血液不斷自人體 移出,通過一透析益(人工腎),代謝廢物與過量水移出, 同時調整pH及酸/鹼平衡到正常值。血液同步回流體内。 该透析器為一種小型含有半穿透性膜之裝置。該膜容許廢 物’電解液’及水通過’但阻止大分子量蛋白質及血細胞 通過。血液在膜之一側加壓送過,而透析液以反方向在膜 另一側加壓通過。透析夜為高純化水,加入鹽類及電解質。 該機械係一控制單元,作用泵,控制壓力’溫度,及血與 透析液中電解質濃度。平均析腎時間為3-5小時。 析腎型式有數種· a) 單通過一析腎為腎衰竭最普通治療。大多數析腎治療 以單通過一透析機械進行。稱為單通過原因在於透析液(清 潔液)於透析器中通過血一次即拋棄。單通過透析機通常 需要: 1) 供應至少1000·1500 ml/min之水源(假設R.〇.系統排除率 為 50%) 2) 供應連續為500-800 ml/min純化水之純化糸統。 3) 至少丨5安培電路以泵送及收回500-800 ml/min的水。 4) 能夠處理至少500 ml/min使用後透析液及R.O·系統排於 水之排水口或任何其它接收容器。 b) 吸著遂析 1239859 (句 @明說明讀頁 並 生 性 及 透 析 此 筒 析 同 中 程 及 的 别 % 氨(i) 1239859 Description of the invention (The description of the invention should state: the technical field to which the invention belongs, the prior art, the content, the embodiments, and a brief description of the drawings) BACKGROUND OF THE INVENTION This article was issued on November 28, 2000. Partial application for serial number 09 / 723,396, the entire content of which is incorporated by reference. The present invention relates to a cartridge such as an ion exchange cartridge or an absorption cartridge for use in, for example, dialysis. In particular, the present invention relates to regeneration or purification of a dialysate after use. The invention also relates to a method for performing dialysis using certain cartridges, and to a method for making the same. Dialysis is a treatment for the accumulation of waste in the blood and the removal of excess fluid from kidney failure. Severe renal failure refers to renal failure to only 25% of normal values. Such decay causes severe changes in the chemical state of the blood and occasionally makes the body uncomfortable and must be treated medically. If the medical treatment is timely, the decline can be reduced. Late renal failure refers to a decrease in renal function to 15%. Final renal failure means that renal function is 5% of normal. Without medical treatment, death was caused at this time. As of 1998, 430,000 people in the United States had been diagnosed with kidney failure. The average life span of renal failure patients is 2 1/2 years. Some people can live for 20 years or more. At the same time, about the same number of patients with acute renal failure each year, about half of these people need treatment. Overall, acute patients are more severe and less stable than kidney patients. They are usually immobile in the ICU or CCU. Acute patients die, restore renal function, or become kidney dialysis patients. There is no cure for kidney disease. However, transplantation can be used to surgically place the human kidney in the body and connect it to the kidney lobe. Medications should be added daily to keep the body from rejecting the transplanted kidney. There is also so-called peritoneal dialysis (PD). In this treatment, those with a mild saline solution containing dextrose and electrolyte, called dialysate, enter the peritoneal cavity. Especially rich blood supply 1239859 Description of the invention continued to the abdominal cavity 'urea and other blood poisons and liquids can be transferred to the dialysate, thereby cleaning the blood. This dialysate is then discharged from the peritoneum. Later, the fresh, dialysate is sent to the peritoneum. There is also kidney analysis. This is a method of purifying blood. The blood is continuously removed from the human body. Through a dialysis (artificial kidney), metabolic waste and excess water are removed, and the pH and acid / base balance are adjusted to normal values. Blood returns to the body simultaneously. The dialyzer is a small device containing a semi-permeable membrane. This membrane allows waste 'electrolyte' and water to pass' but prevents large molecular weight proteins and blood cells from passing. Blood is pumped through on one side of the membrane, while dialysate is forced through the other side of the membrane in the opposite direction. Dialyzed night is highly purified water, adding salts and electrolytes. The machine is a control unit that acts as a pump to control the pressure 'temperature and the electrolyte concentration in the blood and dialysate. The average kidney analysis time is 3-5 hours. There are several types of kidney analysis. A) Single kidney analysis is the most common treatment for kidney failure. Most kidney dialysis treatments are performed by a dialysis machine alone. The reason for this single pass is that the dialysate (cleaning solution) is discarded after passing the blood once in the dialyzer. A single-pass dialysis machine usually requires: 1) Supply of at least 1000 · 1500 ml / min of water (assuming that the R.〇. System rejection rate is 50%) 2) Supply of purified systems of 500-800 ml / min purified water continuously 3) At least 5 amp circuits to pump and recover 500-800 ml / min of water. 4) Capable of handling at least 500 ml / min of dialysate and R.O. system drained to the water drain or any other receiving container after use. b) Sustained analysis of 1239859 (sentence @ 明明 Paraffin readability and analysis
移出水中毒性陰離子(例如氟),其可能在透析中病患產 傷害。離子交換放出之醋酸鹽亦為調整醋酸鹽代謝之酸 之鹼。筒枉中粒狀活性石反負貝移出病患肌肉酸,尿酸, 氮素代謝廢物,以及水中之氣及氣胺。因此REDY再生 析系統町有效提供水處理之安全性與簡單性,同時提供 腎的衛生要求。此系統早已建立有效及安全紀錄。然而 REDY筒枉可能在治療對透析液組合及PH產生變化, 柱不斷放出Na+。因此在REDY透析治療必須提供數種透 液預配方,以平衡病人Na+程度以調整高及低鈉血症。 時系統通常有導電度警告系統’以適當稀釋保持透析液 Na+低於安全限度。透析液中Na+與重碳酸鹽會隨病人BUN 度改變。 腹膜透析(PD)方面’應特別注意GWD治療中透析液組合 0最小變化,及(2)筒柱成本與尺寸。舉例而言,吸著PD 价能力要求,可低於REDY筒柱。透析液組合變化特 重要,因為PD治療緩慢,每天達2-4小時。治療中應避 〆β放出過多Na+到病人。為控制Na+釋出,需暸解ZrP中 工與透析液陽離子(Ca,Mg,K及Na)的離子交換機轉。 Zrp屬無機陽離子交換材料’分子結構如下:Removes toxic anions (such as fluorine) from the water, which can cause injury to patients during dialysis. The acetate released by ion exchange is also the base of the acid that regulates the metabolism of acetate. The granulated activated stone in the cymbal urn removes the patient's muscle acid, uric acid, nitrogen metabolic waste, and gas and amines in water. Therefore, REDY regeneration analysis system effectively provides the safety and simplicity of water treatment, while providing the sanitary requirements of the kidney. This system has already established a valid and safe record. However, the REDY cartridge may change the dialysate combination and pH during treatment, and the column continuously emits Na +. Therefore, in the REDY dialysis treatment, several pre-formulations must be provided to balance the Na + level of the patient to adjust the hypernatremia and hyponatremia. The system usually has a conductivity warning system 'to properly dilute the dialysate Na + below the safety limit. Na + and bicarbonate in the dialysate will change with the patient's BUN degree. With regard to peritoneal dialysis (PD), special attention should be paid to minimal changes in the dialysate combination during GWD treatment, and (2) the cost and size of the cylinder. For example, the sorption capacity requirement of PD can be lower than that of REDY cylinders. The change in dialysate composition is particularly important because PD treatment is slow, reaching 2-4 hours per day. During treatment, 〆β should be avoided to release too much Na + to the patient. In order to control the release of Na +, it is necessary to understand the ion exchange of ZrP and dialysate cations (Ca, Mg, K and Na). The molecular structure of Zrp is an inorganic cation exchange material:
on 0|>0,丨丨々’/Oil: on oiuon 0 | > 0, 丨 丨 々 ’/ Oil: on oiu
()Ρ〇'ΙΙ Na OPO^II Nu() P〇'ΙΙ Na OPO ^ II Nu
離 滴 其含有H+及Na+為對應離子,作為離子交換。ZrP中這些 手之相對含量可由PH控制,以NaOH滴定ZrP (或H+ZrP)。 2所得產物組合, 1239859 (5) 發明說明績頁It contains H + and Na + as the corresponding ions and acts as ion exchange. The relative content of these hands in ZrP can be controlled by pH, and ZrP (or H + ZrP) is titrated with NaOH. 2 product combination, 1239859 (5) Summary page of the invention
Nax+H2_/ZrP,可能隨著透析液下列離子交換過程而改變: (i) (ϋ) IVT + Nair/.r 丨)Na1 + ΜΊΓΖγΡ 其 t (VT=NH/: C〆:Mg2+: H + M+ + NaKZrl’、· ··^· H *" + M+Na"*ZrP X 其中 NT=Na-: Ca2'. Mg2+; NH/ (Na"| H7.rP| [Μ * ] [Ν3 Ή+ΖγΙ>1 [H fJ [M' Na^ZrP] (M+] [Na^H^ZrP] (iii)Nax + H2_ / ZrP, may change with the following ion exchange processes of the dialysate: (i) (ϋ) IVT + Nair / .r 丨) Na1 + ΜΊΓZγΡ t (VT = NH /: C〆: Mg2 +: H + M + + NaKZrl ', ··· ^ · H * " + M + Na " * ZrP X where NT = Na-: Ca2'. Mg2 +; NH / (Na " | H7.rP | [Μ *] [Ν3 Ή + ZγΙ > 1 [H fJ [M 'Na ^ ZrP] (M +) [Na ^ H ^ ZrP] (iii)
Na2CO:1 + Na'irZrP NaHCO^ + Na'H'ZrPNa2CO: 1 + Na'irZrP NaHCO ^ + Na'H'ZrP
Na,ZrP Na2+ ZrP + NaHCO;, + H2CO:) il20 + C02 離子交換時,ZrP對Na+及H+的相對釋出,視ZrP中這些離 子與液相中其它陽離子的離子交換平衡。平衡可隨Na+H+ZrP 組合及液相在離子交換過程中變化而移轉。 根據離子交換原理,ZrP放出之Na+,可由有利H+離子支 導條件轉移而控制。此觀念在設計PD液再生之吸著筒柱配 方方面十分重要。目前製造供REDY筒柱Ζι*Ρ方法,係對於 在NaCl/NaAc緩衝液中滴定酸ZrP (H+ZrP)到pH值為6.25-6.45, 以得到高Na+量之Na+H+ZrP。此點會啟動Na+釋放,尤其是具 低緩衝能力及低pH值之醋酸鹽或乳酸鹽透析液。如此可使 REDY筒柱之ZrP品質不適於應用在PD液再生。為去除此一 限制,如本發明所示,調整採用具低特定Na+量之Na+H+ZrP > 此材料可由在去離子水中滴定酸ZrP (H+ZrP)到較低之5.5-6.0 pH 值範圍而得。PD處理使用REDY筒柱另項限制,在於盛有 醋酸鹽之水合氧化錯為酸性物質。因此此物質酸性造成之 低pH值透析液,會啟動Na+釋放,造成因以下反應產生之 重碳酸鹽損失。 1239859 _ (6) I發明說明續頁 \κο:; co: 71 + 11:0 若以目前REDY筒柱用於PD處理,可能因主要Na+在處理 中的交換,使Na+濃度升到170 mEq/'l。此外,因短時間之 交換,可能開始時Na+.HC〇3降低。 因此在透析方面,尤其是在PD處理上,能克服以上所述 之一項或多項缺點將可得到助益。 發明摘要Na, ZrP Na2 + ZrP + NaHCO ;, + H2CO :) il20 + C02 During ion exchange, the relative release of Na + and H + by ZrP depends on the ion exchange equilibrium between these ions in ZrP and other cations in the liquid phase. The equilibrium can shift with the combination of Na + H + ZrP and the change of the liquid phase during the ion exchange process. According to the principle of ion exchange, the Na + released by ZrP can be controlled by favorable H + ion transfer conditions. This concept is important in designing a sorbent cartridge formulation for PD fluid regeneration. At present, the method for producing ZRYP cartridges for REDY cartridges is to titrate the acid ZrP (H + ZrP) in NaCl / NaAc buffer to a pH of 6.25 to 6.45 to obtain Na + H + ZrP with a high Na + content. This will initiate the release of Na +, especially acetate or lactate dialysate with low buffering capacity and low pH. This makes the ZrP quality of REDY cylinders unsuitable for the application of PD fluid regeneration. In order to remove this limitation, as shown in the present invention, it is adjusted to use Na + H + ZrP with a low specific Na + content. This material can titrate the acid ZrP (H + ZrP) to a lower 5.5-6.0 pH in deionized water. Value range. Another limitation of PD treatment using REDY cartridges is that the hydration oxidation of acetate is acidic. Therefore, the low pH dialysate caused by the acidity of this substance will initiate the release of Na +, causing the loss of bicarbonate due to the following reactions. 1239859 _ (6) I Description of the Invention Continuation Page \ κο :; co: 71 + 11: 0 If the current REDY cartridge is used for PD treatment, the Na + concentration may increase to 170 mEq / due to the exchange of main Na + in the treatment. 'l. In addition, due to a short time exchange, Na + .HC03 may decrease at the beginning. Therefore, in terms of dialysis, especially in PD treatment, it can be helpful to overcome one or more of the disadvantages described above. Summary of the invention
本發明一項特點,在於提供用於再生或純化含廢物溶液 之材料。 本發明另一項特點,在於提供用於再生或純化透析液之 材料,例如腹膜透析液,或其它用於腹膜透析所用透析溶 液。 本發明另一項特點,在於提供一種系統,其能夠再生透 析液,以避免大量透析液,及避免抛棄用後透析液。A feature of the present invention is to provide a material for regenerating or purifying a waste-containing solution. Another feature of the present invention is to provide materials for regenerating or purifying dialysate, such as peritoneal dialysate, or other dialysis solutions for peritoneal dialysis. Another feature of the present invention is to provide a system capable of regenerating the dialysate to avoid a large amount of dialysate and to discard the post-use dialysate.
本發明另一項特點,在於克服上述之一項或更多項之困 難點。 本發明其它特點與優點可由以下敘述列出,且由以下敘 述表明,或藉由操作本發明而習得。本發明目的與其它優 點,均可由所述說明與所附申請專利範圍指出之方案或組 合方式認知與獲得。 為達到其它優點及符合本發明目的,本發明包含及所述 者,係相關於一種包含至少碳酸鍅鈉之吸著筒柱。一項較 佳具體實例中,該碳酸锆鈉係以至少一層存在於該吸著筒 -10- 1239859 (11) r~~----- 發明說明績頁 靖酸錯,沸石,磷酸鈦,矽酸錘,有機離子交換樹脂等等。 車父佳使用者為磷酸锆(ZrP),且較佳為滴定磷酸鍅。較佳該 嗔酸錯為Na+及/或H+型式之滴定ZrP。較佳該ZrP中存在Na+ 與FT混合物。 更佳者,該磷酸錯具一或多項以下特徵: 由約1.4到約2.0 wt%之H+量; 由約4到約6 wt%之Na+量; 由約34到約37 wt%之Zr02量;Another feature of the present invention is to overcome one or more of the difficulties mentioned above. Other features and advantages of the present invention can be listed and described by the following description, or learned by operating the present invention. The objectives and other advantages of the present invention can be recognized and obtained from the solutions or combinations indicated in the description and the scope of the attached patent application. In order to achieve other advantages and in accordance with the purpose of the present invention, the present invention includes and relates to a sorption column containing at least sodium sulphate carbonate. In a preferred embodiment, the sodium zirconium carbonate is present in the suction tube in at least one layer -10- 1239859 (11) r ~~ ----- Description of the invention Silicic acid hammer, organic ion exchange resin, etc. Chevrolet users are zirconium phosphate (ZrP), and it is preferred to titrate europium phosphate. Preferably, the titanate is a titrated ZrP of the Na + and / or H + type. Preferably, a mixture of Na + and FT is present in the ZrP. More preferably, the phosphoric acid has one or more of the following characteristics: an amount of H + from about 1.4 to about 2.0 wt%; an amount of Na + from about 4 to about 6 wt%; an amount of Zr02 from about 34 to about 37 wt%;
由約41到約43 wt%之Ρ〇4·量;及 由約14到約18糾%之H20量;均以磷酸锆重量為基礎計 异。各項特徵之其它含量亦可使用。 此外,本發明磷酸鍅較佳有對氨,Ca2+,Mg2+,K+,及 毒素重金屬之吸收能力。更佳者,該吸收力約為由2〇 mgThe amount of PO4 · from about 41 to about 43 wt%; and the amount of H20 from about 14 to about 18%; all are based on the weight of zirconium phosphate. Other contents of each characteristic can also be used. In addition, the europium phosphate of the present invention preferably has the ability to absorb ammonia, Ca2 +, Mg2 +, K +, and toxin heavy metals. Even better, the absorption is about 20 mg
NH4-N/gm ZrPfiJ 約 45 mg或更高 NH4-N/gm ZrP,更佳至少約 30 mg NH4-N/gm ZrP ;由約 2 mEq Ca2+/gm ZrP 到約 7 mEq Ca2+/gm ZrP, 更佳至少約 3 mEq Ca2+/gm ZrP ;由約 1 mEq Mg2+/gm ZrP 到約 5 mEq Mg2+/gm ZrP,且較佳至少約 2 mEq Mg2+/gm ZrP ;及由約 3 mEq HM/gm ZrP 到約 9 mEq HM/gm ZrP,而更佳至少約 6 mEq HM/gm ZrP 之重金屬(HM)。 此外,該磷酸锆較佳Na+量由至少約1.8 mEq Na+/gm ZrP到 約3 mEq NaVgm ZrP,更佳約2.4 mEq Na+/gm及由約5.5到約6之 pH值。其它pH值亦可用,不同Na+量亦可用。 同時,本發明磷酸锆較佳含最少滲出P〇,量,更佳小於 約0.05 mg P0 43Vgm ZrP。其它量亦可使用。 -15- 1239859 發明說明續頁 gm到約250 gm。較佳該酶(例如尿素酶)以與填料等如氧化 ί呂者’吧a °較仏之—尿素酶供應源為jack Bean Meal,由sigma 提供之商品’較佳量在約8 gm或更少到約20 gm或更多。一 般而言,尿素酶存在量由約22,000 11;或更少到約55,〇〇〇出或 更多’更佳是由約28,〇〇〇 IU到約42,000 IU。Jack Bean Meal粒 徑可為任何有效粒徑,如約4〇網目或更小(或小於約〇 4 mm)。活性碳存在量可為任意量,較佳由約1〇〇 gm或更少 到約500 gm或更多,較佳由約200 gm到約300 gm,尤佳在約 250 gm。泫活性碳可由如Caig〇n供應。這些選用材料均為一 般商品,而各種不同類型均述於專利與出版物中,均併為 本文之參考。以上材料粒徑均與szc及/或Zrp範圍相同, 除了活性碳與不移動酶以外,較佳範圍為氧化鋁在由汕到 約120微求;而活性碳在由約〇 4到約12 _(或a%網目 篩)。NH4-N / gm ZrPfiJ about 45 mg or higher NH4-N / gm ZrP, more preferably at least about 30 mg NH4-N / gm ZrP; from about 2 mEq Ca2 + / gm ZrP to about 7 mEq Ca2 + / gm ZrP, more Preferably at least about 3 mEq Ca2 + / gm ZrP; from about 1 mEq Mg2 + / gm ZrP to about 5 mEq Mg2 + / gm ZrP, and preferably at least about 2 mEq Mg2 + / gm ZrP; and from about 3 mEq HM / gm ZrP to about 9 mEq HM / gm ZrP, and more preferably at least about 6 mEq HM / gm ZrP. In addition, the zirconium phosphate preferably has a Na + content of at least about 1.8 mEq Na + / gm ZrP to about 3 mEq NaVgm ZrP, more preferably about 2.4 mEq Na + / gm and a pH value from about 5.5 to about 6. Other pH values can be used, and different amounts of Na + can also be used. At the same time, the zirconium phosphate of the present invention preferably contains a minimum amount of exudation P0, more preferably less than about 0.05 mg P0 43Vgm ZrP. Other amounts can also be used. -15-1239859 Description of the invention Continued gm to about 250 gm. It is preferred that the enzyme (such as urease) be compared with fillers, such as oxidizers. ° The urease supply source is jack Bean Meal, and the commercial product provided by sigma is preferably in an amount of about 8 gm or more. As little as about 20 gm or more. Generally, the urease is present in an amount from about 22,000 11; or less to about 55,000 or more, and more preferably from about 28,000 IU to about 42,000 IU. The Jack Bean Meal particle size can be any effective particle size, such as about 40 mesh or less (or less than about 0.4 mm). The activated carbon may be present in any amount, preferably from about 100 gm or less to about 500 gm or more, preferably from about 200 gm to about 300 gm, and more preferably about 250 gm. Europium activated carbon can be supplied, for example, by Caigon. These selected materials are general merchandise, and various types are described in patents and publications, all of which are incorporated herein by reference. The particle sizes of the above materials are in the same range as szc and / or Zrp. Except for activated carbon and immobile enzymes, the preferred range is alumina from Shantou to about 120 micrometers; and activated carbon from about 〇4 to about 12 _ (Or a% mesh sieve).
圖4到6提供本發明吸收筒柱較佳材料展開圖以及該 收筒柱所含各層之較佳安排方式。較佳者,用後透析液 自該筒柱底部進入,而由筒柱頂部離開,如圖8所較佳 示。圖4為處理PD液用後透析液之更佳茼柱安排方式,圖5 及6提供處理HD系統用後透析液較佳筒柱安排方式。圖5 為4小時處理所用較佳筒枉安排方式,而圖6為8小時處理 較佳方式。此圖提供較佳量與材料層排列方式。然而如本 文内容所述,各不同層可由其它適當材料取代,或各層可 有它種安排方式。如圖5及6所示,含活性碳或它種吸收劑 層’可位在筒柱底部及/或筒·柱頂部。 1239859 (18) 發明說明續頁 障礙層。障礙層較佳位在不移動酶層與氧化鋁層之間。障 礙層實例包含濾紙等等。 本發明另一項具體實例中,本發明係關於一種存在於吸 著筒柱材料特定順序,如下所示: 一吸收層Figures 4 to 6 provide an expanded view of the preferred material of the absorber column of the present invention and a preferred arrangement of the layers contained in the column. Preferably, the dialysate enters from the bottom of the column after use, and leaves from the top of the column, as shown in FIG. 8. Figure 4 shows a better column arrangement of the dialysate after processing the PD solution. Figures 5 and 6 provide a better column arrangement of the dialysate after the HD system. Figure 5 shows the preferred arrangement for the four-hour process, and Figure 6 shows the preferred way for the eight-hour process. This figure provides better quantity and arrangement of material layers. However, as described herein, the different layers may be replaced by other suitable materials, or the layers may have other arrangements. As shown in Figs. 5 and 6, the activated carbon or other absorbent-containing layer 'may be located at the bottom of the column and / or the top of the column. 1239859 (18) Description of the Invention Continued Barrier layer. The barrier layer is preferably positioned between the immobile enzyme layer and the alumina layer. Examples of barrier layers include filter paper and the like. In another specific example of the present invention, the present invention relates to a specific order of materials existing in the adsorption column, as shown below: An absorbing layer
一不移動酶層或其它轉化尿素為氨材料 —選用障礙層 —選用氧化鋁層 一氨吸收劑 一磷酸鹽吸收劑 一選用濾片 i 如上所述,氨吸收劑以磷酸錘較佳,而磷酸鹽吸收劑較佳 為碳酸锆鈉。此特定層排列提供最佳純化或再生用後透析 液結果。更詳細之以下對這些材料及/或層及它種材料之 說明,可於本發明作任何組合。A non-moving enzyme layer or other conversion of urea to ammonia material—select barrier layer—select aluminum oxide layer—ammonia absorbent—phosphate absorbent—select filter i. The salt absorbent is preferably sodium zirconium carbonate. This particular layer arrangement provides the best dialysate results after purification or regeneration. More detailed descriptions of these materials and / or layers and other materials can be made in any combination in the present invention.
1.不移動尿素酶或其它酶層以酶轉化尿素為碳酸氨。固 定尿素酶方式可歸類如下: a. 吸附,例如氧化鋁,活性碳,陰離子交換樹脂,矽藻 土,或其它傳統使用之吸附劑。 b. 與不溶水聚合物成共價鍵,經活化或反應性聚合物形 成酶一聚合物共軛物。一般用來供與酶成共價結合之不溶 水支撐物包含以下: 合成支撐物,如一丙醯胺基聚合物 一順-丁烯二酸酐 -22- (19) 1239859 發明說明續頁 一聚肽酶 天然支撐物 一苯乙烯基聚合物 如瓊脂糖(商品名sepharose) 永ϋ萄糠(商品名sephadex) 一纖維素 一激粉 C 夕 / 把基反應物如戊二醛,環己烷二胺對酶形分子 結,°鍵結多數在對多孔支㈣吸附之後。 d·以鍵結聚合物包覆’如聚丙醯胺膠。 e·微包臂,义 ',〇尼龍,硝酸纖維,乙基纖維,聚醯胺等。 f*存在於半透過膜 . 纖維燒杯裝置。胞,Dow争空 透二N: A H+型式之陽離子交換材料’作為NH4-清除物及 透析液陽離子丄+ 久1. Do not move urease or other enzyme layers to convert urea to ammonia carbonate. Methods for fixing urease can be classified as follows: a. Adsorption, such as alumina, activated carbon, anion exchange resin, diatomaceous earth, or other traditionally used adsorbents. b. Form a covalent bond with an insoluble water polymer, and form an enzyme-polymer conjugate through an activated or reactive polymer. Insoluble water supports commonly used for covalent binding with enzymes include the following: Synthetic supports, such as monopropylamine polymer-maleic anhydride- 22- (19) 1239859 Description of the invention continued on a polypeptide Enzyme natural support-Styrene-based polymer such as agarose (brand name sepharose) Permanent grape bran (brand name sepphadex)-Cellulose-exciting powder C / Reactants such as glutaraldehyde, cyclohexanediamine For enzyme-shaped molecular junctions, ° bonds are mostly after adsorption to porous branches. d. Covered with a bonding polymer such as polypropylene glue. e. Micro-encapsulated arms, nylon, nitrocellulose, ethyl fiber, polyamide, etc. f * is found in semi-permeable membranes. Fiber beaker devices. Cells, Dow fights through the air N2: A H + type cation exchange material ’as NH4- scavenger and dialysate cation + +
At 子,、自來水中毒性微量金屬吸收劑。其另_ 月b為轉化後酸鹽由尿素 > ’义解為重妷I鹽。此可包含陽離 父換树脂及無機離子交 卞又換及者(險離子型式),如磷酸錯, &酸鈇,彿石等等。 呈Act ’ HC〇3- ’ C1-,或〇H-型式之陰離子交換材料,作 為墙酸鹽清除物及自來水中如F-及銘酸鹽毒性陰離子吸附 M丨此材料另—功能為提供如醋酸鹽及重碳酸鹽之鹼補充 物,以修正病人代謝酸。其可包含陰離子交換樹脂及無機 離子交換吸著(陰離子开〗彳、,I, LA. ^ ^ ' 苓(雕于型式),如水性錘氧化物,水性氧化 石夕’氧化錫,氧化鈦,料,纟性氧化鶴,峻酸錯鈉等等。 4.供移除肌肉酸,尿酸,及中分子尿毒素,與自來水中 -23- 1239859 _ (20) I發明說明績頁 有機物之吸附劑。其中活性碳雖是最有效移除氮基廢代謝 物者,然其它可用者包含部份離子交換樹脂及類似層析材 料,如纖維素衍生物,聚苯乙烯膠,聚丙醯胺膠,多孔玻 璃與瓊脂糖等等。 5.對析腎而言,另一成份需加入以去除透析用自來水中 氣,或使用極高純度水。該材料可為含碳片,粒狀活性碳 等等。At, a toxic trace metal absorbent in tap water. The other _ month b is the conversion of the acid salt from urea > ′ to the heavy salt I. This may include cation exchange resins and inorganic ion exchanges and exchanges (dangerous ion types), such as phosphoric acid, & acid osmium, Buddha stones, and so on. Anion exchange materials in Act 'HC〇3-' C1-, or OH-types, as wall salt scavengers and tap water, such as F- and Ming salt toxic anion adsorption M 丨 This material also provides functions such as Acetate and bicarbonate base supplements to correct patients' metabolic acidity. It can include anion exchange resin and inorganic ion exchange sorption (anion opening), I, LA. ^ ^ 'Ling (carved in type), such as water-based hammer oxide, water-based oxide stone' tin oxide, titanium oxide, Materials, alkaline oxidizing cranes, sodium bicarbonate, etc. 4. For removal of muscle acid, uric acid, and urinary toxin in water, and tap water-23-1239859 _ (20) I invention description page adsorbent for organic matter Although activated carbon is the most effective in removing nitrogen-based waste metabolites, other useful ones include some ion exchange resins and similar chromatography materials, such as cellulose derivatives, polystyrene gum, polypropylene gum, and porous Glass and agarose, etc. 5. For the kidney analysis, another component needs to be added to remove the gas in dialysis tap water, or use very high purity water. The material can be carbon-containing tablets, granular activated carbon, etc.
該吸著筒柱中各成份材料可以混合式或個別以濾紙或纖 維紙分隔層式置入,然效率與效果不同。各層構造可各不 同。該氣移除層,若加以使用時,較佳接在尿素酶不移動 層之前,因氣可使酶失去活性。NH4-清除物或陽離子交換 層較佳接著該尿素酶不移動層。Each component material in the suction cylinder can be mixed or individually placed in a filter paper or fiber paper separation layer, but the efficiency and effect are different. Each layer structure can be different. The gas removal layer, if used, is preferably placed before the urease non-moving layer, because the gas can deactivate the enzyme. The NH4- scavenger or cation exchange layer is preferably followed by the urease immobile layer.
本發明筒柱如上述,可用於多種分離系統,較佳使用於 析腎(如HD)或PD液之再生或純化。最單純設計中,用後透 析液或PD液僅需通過一或多只筒柱以純化或再生該用後流 體。此系統可簡單設置,僅使用單一柱體,用後液由頂部 向下部通過,其中重力使用後液通過筒柱,或用後液在壓 力下通過筒柱,使用後液體流入各方向,例如圖1所示。 在較複雜系統中,可使用圖2系統,尤其是析腎方面;圖3 為單通過透析系統,或較佳為封密系統。在圖2系統中, 用後透析液不流入排水溝中,反而可選擇性於一容器中收 集,通過如上述一或多只筒柱而再生或純化該用後透析 液。更佳者,圖3吸著透析系統使用如上述筒柱,位於如 圖3所示處。此系統可以在病人透析過程中繼續使用再生 -24- (21)1239859 發明説明績頁 透析液 腹膜 後腹膜 後腹膜 析腎時 析液中 或純化 系統中 因接連 參考 一通過 a丨亡少搞淺頊。首先是與析腎相同’將用 透析方面則有多種選戸、 ▲ —Μ 4戎多只筒枉,以純化或再生該用 透析液直接通過一或’ μ ^吻。另外,用後腹膜透析液可與 透析液,以去除廢為 ^ ΓAs described above, the cartridge of the present invention can be used in a variety of separation systems, and is preferably used for regeneration or purification of kidney dialysis (such as HD) or PD fluid. In the simplest design, the post-use dialysate or PD solution only needs to pass through one or more cartridges to purify or regenerate the used fluid. This system can be simply set up, using only a single cylinder, and the after-use liquid passes from the top to the bottom, where gravity uses the after-use liquid to pass through the barrel, or after-use liquid passes through the barrel under pressure, and the liquid flows in all directions after use, such as the figure 1 is shown. In more complex systems, the system of Figure 2 can be used, especially the kidney analysis; Figure 3 is a single-pass dialysis system, or preferably a sealed system. In the system of Fig. 2, the post-use dialysate does not flow into the drainage ditch, but can be selectively collected in a container, and the post-use dialysate is regenerated or purified through one or more cartridges as described above. More preferably, the suction dialysis system of FIG. 3 uses the column as described above and is located as shown in FIG. 3. This system can continue to use regeneration during the patient's dialysis process. (21) 1239859 Description of the invention: dialysate, retroperitoneal, retroperitoneal, and peritoneal dialysis during kidney dialysis or purification system. Alas. First of all, it is the same as kidney analysis. There are many options for dialysis. There are many choices for dialysis, so as to purify or regenerate the dialysate for direct use. In addition, peritoneal dialysis fluid can be used with dialysis fluid to remove waste as ^ Γ
血流-樣通過-只透析器’透析液在此移出腹膜透 廢物等等,再令該使用後透析液通過該筒枉而再生 。本發明這兩種系統均可使用。在如圖3之封閉PD ,本發明一項具體實例能夠避免傳統系統中’經常 腹腔與透析液容器間導管損失體液之風險。 圖2詳細說明單一通過透析系統’ 15代表操作該單 4-ri. ^ ,. . 主 4 喜斗,志道 ,丨 2 1代表溫度計,而23代表加熱器,以上均為傳統單〆通過 透析系統所用項目,為熟諳此藝者熟知,可用於本發明系The blood flow-like passage-only dialyzer 'dialysate here removes peritoneal dialysis waste and the like, and then the dialysate is regenerated through the cartridge after use. Both systems of the present invention can be used. In the closed PD shown in Fig. 3, a specific example of the present invention can avoid the risk of losing fluid in the catheter between the abdominal cavity and the dialysate container in the conventional system. Figure 2 details the single-pass dialysis system. '15 represents the operation of the single 4-ri. ^,... Main 4 Xidou, Zhidao, 2 1 represents a thermometer, and 23 represents a heater. The above are traditional single-through dialysis systems. The items used are well known to those skilled in the art and can be used in the present invention.
統。25代表漏血偵測器,而27代表UF計,其亦為傳統單, 通過透析系統所用項目,為熟諳此藝者所知。29為透析器’ 亦為熟諳此藝者所知,一般為含膜層以使廢物通過膜到達 透析液之系統。不同之透析器商品甚多,均可用在本發明。 3 1代表用後透析液通過,33代表新鮮進入透析器29之透析 液。35代表UF控制,為熟諳此藝者所知,且為傳統透析系 統所用項目,亦可用在本發明。37代表UF泵,39代表比例 栗’為傳統透析系統項目。41代表形成新鮮透析液之濃縮 物’ 43代表用以混合濃縮物形成新鮮透析液之水,45代表 在水與濃縮物混合前所經純化之水處理系統。同樣的,這 些均屬傳統透析系統商品項目,而均可用在本發明。47代 -25- 1239859 一 發明說明續頁 -'—---- 表容器或排水口 ,以收集用後透析液供本發明筒柱純化或 再生之用。System. 25 is a blood leak detector, and 27 is a UF meter, which is also a traditional single. It is known to those skilled in the art through the items used in the dialysis system. 29 is a dialyzer 'is also known to those skilled in the art, and is generally a system containing a membrane layer to allow waste to pass through the membrane to the dialysate. Many different dialyzer products are available for use in the present invention. 3 1 indicates that the dialysate has passed after use, and 33 indicates that the dialysate has entered the dialyzer 29 freshly. 35 stands for UF control, which is known to those skilled in the art and is used in traditional dialysis systems, and can also be used in the present invention. 37 represents the UF pump, 39 represents the proportion Li 'is a traditional dialysis system project. 41 represents a concentrate to form a fresh dialysate ' 43 represents water used to mix the concentrate to form a fresh dialysate, and 45 represents a water treatment system purified before water is mixed with the concentrate. Again, these are all commercial items of conventional dialysis systems and can be used in the present invention. 47th generation -25- 1239859 A description of the invention continued -'----- table container or drain to collect used dialysate for purification or regeneration of the cartridge of the present invention.
參考圖3 ’ 49代表圖3透析系統操作電源。51代表加熱器, 53代表流量計,55代表導電計,57代表溫度計,59代表UF 控制。這些均屬傳統吸著透析系統項目,為熟諳此藝者所 知,益可如圖3用於本發明。61為灌注泵,系入新鮮濃縮 液79混合進入儲槽77之再生透析液,儲槽較佳為6公升。63 代表漏血偵測器,65代表UF計,其為傳統透析系統項目, 可用於此處。67代表透析器,同圖2者。同樣的’ 69代表 離開該透析器之用後透析液,71代表進入透析器67之新鮮 透析液。73為透析器泵送用後透析液到筒柱75之泵’其為 本發明申請書之筒柱。 一項較佳具體實例中,本發明筒柱作為4小時透析處理 或8小時透析處理之用途。此外,該8小時筒枉為一般家用 型,而4小時筒柱一般為醫學處理或析腎中心所用Reference to Figure 3'49 represents the operating power supply of the dialysis system of Figure 3. 51 stands for heater, 53 stands for flow meter, 55 stands for conductivity meter, 57 stands for thermometer, and 59 stands for UF control. These are all traditional sorption dialysis system items and are known to those skilled in the art. Reference numeral 61 is a perfusion pump, which is fed with fresh concentrated solution 79 and regenerated dialysate mixed into a storage tank 77. The storage tank is preferably 6 liters. 63 stands for blood leak detector and 65 stands for UF meter, which is a traditional dialysis system project and can be used here. Reference numeral 67 represents a dialyzer, as in FIG. 2. The same '69 represents the dialysate after leaving the dialyzer, and 71 represents the fresh dialysate entering the dialyzer 67. Reference numeral 73 denotes a pump for dialyser pumping the dialysate to the column 75 after being used by the dialyzer, which is the column of the present application. In a preferred embodiment, the cartridge of the present invention is used as a 4-hour dialysis treatment or an 8-hour dialysis treatment. In addition, the 8-hour cartridge is a general household type, and the 4-hour cartridge is generally used for medical treatment or kidney analysis centers.
本發明筒柱一般可用於上述任何一種可式透析系統。通 過筒柱流為任何傳統流。例如,由約50 或更少到500 ml/min或更高之透析液可流過筒枉,用於本發明系統。其 它流亦可視筒柱尺寸及操作系統而使用。 本發明筒柱具有保持及/或回復新祥透析液中Na及/或 hco3-量之能力,以及依本發明透析系統方式處理之病人 血中程度。因此,本發明可恢復用後透析液中Na+及/或HC〇3· 程度到適當可接受程度(如Na+由約135到約145 mEq/L及HCCV 由約24 mEq/L到約32 mEq/L)。所以此恢復能力可使病人血 -26- (23)1239859 發明說明續頁 中恢復及/或維持於這些程度内。此為一項重要能力。 以下專利所述透析系統或成份可用於本發明,且這些系 統可併入本發明材料及/或筒柱:美國專利字號第 6,309,673; 6,306,836; 6,196,992; 6,117,122; 6,074,359; 6,017,942 ; 5,984,891; 5,955,450; 5,938,634; 5,782,796; 5,631,025; 5,597,805 ; 4,560,472; 6,299,769; 6,284,131; 6,146,536; 5,968,966; 5,704,915 ; 5,824,213 ; 5,641,405 ; 4,738,668 ; 6,293,921 ; 6,284,139 ; 6,274,103 ;The cylinder of the present invention can be generally used in any of the above-mentioned dialysis systems. The flow through the barrel is any conventional flow. For example, dialysate from about 50 or less to 500 ml / min or more can flow through the cartridge for use in the system of the present invention. Other streams can also be used depending on the size of the cylinder and the operating system. The cylinder of the present invention has the ability to maintain and / or restore the amount of Na and / or hco3- in Xinxiang dialysate, and the blood level of the patient treated in accordance with the dialysis system of the present invention. Therefore, the present invention can restore the degree of Na + and / or HC03 · in the dialysate to an appropriate acceptable level (such as Na + from about 135 to about 145 mEq / L and HCCV from about 24 mEq / L to about 32 mEq / L). Therefore, this recovery ability can restore and / or maintain the patient's blood in these levels. This is an important capability. The dialysis systems or components described in the following patents can be used in the present invention, and these systems can incorporate materials and / or cylinders of the present invention: US Patent No. 6,309,673; 6,306,836; 6,196,992; 6,117,122; 6,074,359; 6,017,942; 5,984,891; 5,955,450; 5,938,634; 5,782,796; 5,631,025; 5,597,805; 4,560,472; 6,299,769; 6,284,131; 6,146,536; 5,968,966; 5,704,915; 5,824,213; 5,641,405; 4,738,668; 6,293,921; 6,284,139; 6,274,103 ;;
5,980,481 ;及5,498,338。所有以上專利均以整體併入本文為 本發明之一部份。 本發明材料用途甚廣,特別是本發明筒柱,均可用在如 上述之透析液再生。另外,該筒柱可i用在任何個別分離, 其需要自一流體或它種媒體移除不純物或廢物者,可自本 發明材料通過。同時,本發明可用於治療藥物過量病人或 其它需自人體系統移除不欲或危險污染物者。因此,本發 明提供可有效用於再生透析液式流體及它種流體之具體實 例。5,980,481; and 5,498,338. All of the above patents are incorporated herein in their entirety as part of this invention. The material of the present invention has a wide range of uses, and in particular the cartridge of the present invention can be used for the regeneration of dialysate as described above. In addition, the cartridge can be used for any individual separation, which requires the removal of impurities or waste from a fluid or other media, and can be passed through the material of the present invention. At the same time, the present invention can be used to treat patients with overdose or others who need to remove unwanted or dangerous pollutants from the human system. Therefore, the present invention provides specific examples that can be effectively used to regenerate dialysate-type fluids and other fluids.
本發明以下藉數例進一步說明,其係僅作為本發明之範 例性。The present invention is further illustrated by the following examples, which are merely exemplary of the present invention.
設立如圖7所示透析液再生系統。如圖7所示,可建立一 套試驗系統,具不同位置可使產生對透析液取樣,以及對 模擬病人液取樣,其可模擬血中或PD液中出現之廢產物。 詳細言之,取樣1號提供對用後透析液PD液於進入筒柱前 成份取樣。取樣2號可取由本發明筒柱再生之透析液或PD -27- 1239859 _ (24) 發明說明績頁 液測試。取樣3號可對再生透析液或PD液在以加入鈣及鎂 離子以恢復到正常接受程度灌注液之標準成份後之取樣。 其它成份亦可以該灌柱液恢復。取樣4號可對病人模擬液 經過透析器後成份取樣,而取樣5號允許對含一般血或PD 液等等中廢物之模擬病人液成份測試。其它圖7所示項目 為傳統機械安排及對取樣點,流量計,流量控制,泵,動 力控制,透析器等等之使用。 實例1 一 HD再生用筒柱 此項模型中,病人以37 °C ,60公升,下列組合之模擬液 槽表示:Set up the dialysate regeneration system as shown in Figure 7. As shown in Figure 7, a test system can be established with different locations to allow sampling of dialysate and sampling of simulated patient fluid, which can simulate waste products appearing in blood or PD fluid. In detail, Sampling No. 1 provides sampling of the components of the PD solution after use before entering the column. Sampling No. 2 can be taken from the dialysate regenerated from the cartridge of the present invention or PD -27-1239859 _ (24) invention description page liquid test. Sampling No. 3 can sample the regenerated dialysate or PD solution after adding calcium and magnesium ions to restore the normal composition of the perfusion solution. Other components can also be recovered from the column liquid. Sampling No. 4 can be used to sample the patient's simulated solution after passing through the dialyzer, while Sampling No. 5 allows the testing of the simulated patient's solution containing wastes such as general blood or PD solution. The other items shown in Figure 7 are the traditional mechanical arrangements and the use of sampling points, flow meters, flow control, pumps, power control, dialyzers, and so on. Example 1 A cylinder for HD regeneration In this model, the patient is represented by a simulated fluid tank at 37 ° C, 60 liters, and the following combinations:
NaHC03 25 mEq/L NaCl 115 mEq/L CaAc2_H2〇 3 mEq/L MgAc2#4H20 1 mEq/L KAc (脫水) 2 mEq/L 右旋糖 100 mg% pH 7-7.4 尿毒值: BUN 〜8 5 mg% 肌肉酸 〜9 mg% P〇4-P 〜6 mg% 此模擬病人以Baxter PSN-120透析器透析,血流率(BFR)為 180 ml/min。該6公升透析液係以自來水與下列起始濃度製 1239859 _ (25) I發明說明續頁NaHC03 25 mEq / L NaCl 115 mEq / L CaAc2_H2〇3 mEq / L MgAc2 # 4H20 1 mEq / L KAc (dehydrated) 2 mEq / L dextrose 100 mg% pH 7-7.4 Urine value: BUN ~ 8 5 mg% Muscle acid ~ 9 mg% P04-P ~ 6 mg% This simulated patient was dialyzed with a Baxter PSN-120 dialyzer with a blood flow rate (BFR) of 180 ml / min. The 6 liter dialysate is made from tap water and the following starting concentrations: 1239859 _ (25) I Description of the invention continued page
NaHC03 140 mEq/L NaCl 0 mEq/L 右旋糖 100 mg% pH 8.1 一項實驗中,用後之透析液以下列結構,透析液流率 (DFR)為250 ml/min之吸著筒柱再生。NaHC03 140 mEq / L NaCl 0 mEq / L Dextrose 100 mg% pH 8.1 In one experiment, the dialysate after use had the following structure and the dialysis fluid flow rate (DFR) was 250 ml / min. .
250 gm氧化鋁及不移動尿素酶 - 185 gm 碳 以計量之流率提供灌注液,以在再生透析液中保持Ca2+, Mg2+,K+,及K+平衡。處理效率與功能如下所示:250 gm alumina and non-moving urease-185 gm carbon Provide perfusion fluid at a metered flow rate to maintain Ca2 +, Mg2 +, K +, and K + balance in the regenerated dialysate. The processing efficiency and function are as follows:
尿毒程度 、 效率 透析前BUN值 85 mg% 透析後BUN值 36.6 mg% 透析前肌肉酸值 9.5 mg% 透析後肌肉酸值 5.2 mg% 透析前Ρ04-Ρ值 4.7 mg% 透析後Ρ04-Ρ值 2,8 mg% 自病人移出之尿毒量及筒柱吸收能力 BUN 29 gm 肌肉酸 2.6 gm Ρ04-Ρ 1.16 gm -29- 1239859 _ (26) 發明說明續頁 此等尿毒移出量,應可符合以kT/v為基之透析需求。 功能 筒柱產生之壓力 24 psi max。 處理中筒柱析出物組合: nh4-n 0 mg% BUN <0.2 mg% Ca2+ 0 mEq/L Mg2+ 0.2 mEq/L K+ <0.3 mEq/L P〇4-P 0 mg% 肌肉酸 <0.8 mg%Degree of uremia, efficiency BUN value before dialysis 85 mg% BUN value after dialysis 36.6 mg% Muscle acid value before dialysis 9.5 mg% Muscle acid value after dialysis 5.2 mg% P04-P value 4.7 mg% dialysis P04-P value 2 8 mg% of uremia removed from the patient and the absorption capacity of the cylinder BUN 29 gm Muscle acid 2.6 gm P04-P 1.16 gm -29-1239859 _ (26) Description of the invention Continued These uremic removal amounts should be in kT / v is based on dialysis needs. Function The pressure generated by the barrel is 24 psi max. Precipitate combination during processing: nh4-n 0 mg% BUN < 0.2 mg% Ca2 + 0 mEq / L Mg2 + 0.2 mEq / L K + < 0.3 mEq / LP〇4-P 0 mg% muscle acid < 0.8 mg %
透析液及病人體液中Na+及重碳酸鹽平衡 處理中在筒柱出口之Na+變化範圍為132-155 mEq/L。Na + and bicarbonate balance in dialysate and patient's body fluid The Na + change at the exit of the cylinder during the treatment ranged from 132-155 mEq / L.
透析前病人Na+ 136 mEq/LPre-dialysis patient Na + 136 mEq / L
透析後病人Na+ 138 mEq/LPost-dialysis patient Na + 138 mEq / L
透析前病人重碳酸鹽 24 mEq/LPatient bicarbonate 24 mEq / L before dialysis
透析後病人重碳酸鹽 25 mEq/L 以上HD實驗又以不同參數重複進行。變化參數如下表。 各例中,具不同材料筒柱均在透析液再生之可接受參數内 操作。 -30- 1239859 (27) 發明說明讀頁 言式 驗 號 透析條件 HZO/SZC ZP Amt ZP pH NaHC03 透析前 病人體液 透析液 BUN 量 DfR/BfR 透析器 k (mi/rnin) gm gm mEq/L mg/DL 公升 3 400/400 Fresenius 7NR 256 75/125 1300 5.5 40 87.5 40 4 400/400 Fresenius 7NR 256 100/100 1600 5.5 60 104.7 55 5 250/180 PSN-120 125 140/60 1400 6 140 71.9 40 6 250/180 PSN-120 125 100/100 1600 5.75 140 46 42 7 250/180 PSN-120 200 100/100 1600 5.75 140 85 61After dialysis, the patients' bicarbonate HD experiments above 25 mEq / L were repeated with different parameters. The change parameters are as follows. In each case, cylinders with different materials were operated within acceptable parameters for dialysate regeneration. -30- 1239859 (27) Description of the invention Read page language check number Dialysis conditions HZO / SZC ZP Amt ZP pH NaHC03 BUN volume of patient's body fluid before dialysis DfR / BfR dialyzer k (mi / rnin) gm gm mEq / L mg / DL Liter 3 400/400 Fresenius 7NR 256 75/125 1300 5.5 40 87.5 40 4 400/400 Fresenius 7NR 256 100/100 1600 5.5 60 104.7 55 5 250/180 PSN-120 125 140/60 1400 6 140 71.9 40 6 250/180 PSN-120 125 100/100 1600 5.75 140 46 42 7 250/180 PSN-120 200 100/100 1600 5.75 140 85 61
結果 試 驗 號 處理時間 水解之尿素-N Na+ 重碳酸鹽 後 前 後 前 分 gm mEq/L mEq/L mEq/L mEq/L 3 173 23.4 144 137 26 25 4 235 38 142 139 26 21 5 420 20.71 142 135 31 24 6 >480 14.7 141 138 20 25 7 420 29.5 138 136 26 24Result Test No .: Hydrolyzed urea-N Na + bicarbonate before and after treatment gm mEq / L mEq / L mEq / L mEq / L 3 173 23.4 144 137 26 25 4 235 38 142 139 26 21 5 420 20.71 142 135 31 24 6 > 480 14.7 141 138 20 25 7 420 29.5 138 136 26 24
-31- 1239859 (28) 發明說明績頁 平均每mEq陽離子放出之Na+或吸收之NH4+: ZrP pH 5.5,0.106 mEq Na+-31- 1239859 (28) Summary sheet of the invention Na + or NH4 + released per mEq cations: ZrP pH 5.5, 0.106 mEq Na +
ZrP pH 6.25,0.2266 mEq Na+ 言式 驗 號 Zrp量 Zrp pH ZrP總灌注液陽離子及吸收之NH4+離子 Ca2卞,Mg2+,JC NH, 總量 (公克) (m£q) (mEq) (mEq) 3 1300 5.5 415 1671 2086 4 1600 5.5 564 2714 3278 5 1400 6 630 1479 2109 6 1600 5.75 720 1050 1770 7 1600 5.75 630 2109 2739 試 病人Na+平衡 每mEq陽離子放出之Na7吸收之NH4+ 驗 後 前 增損 號 mEq/L mEq/L mEq/L mEq Na+ 3 144 137 +280 0.1342 4 142 139 +165 0.0503 5 142 135 280 0.1328 6 141 138 126 0.0712 7 138 136 122 0.0445ZrP pH 6.25, 0.2266 mEq Na + Verification number Zrp Zrp pH ZrP Total perfusate cation and absorbed NH4 + ion Ca2 卞, Mg2 +, JC NH, total amount (g) (m £ q) (mEq) (mEq) 3 1300 5.5 415 1671 2086 4 1600 5.5 564 2714 3278 5 1400 6 630 1479 2109 6 1600 5.75 720 1050 1770 7 1600 5.75 630 2109 2739 Test patient Na + balance NH4 absorbed by Na7 released per mEq cation + pre-test gain number mEq / L mEq / L mEq / L mEq Na + 3 144 137 +280 0.1342 4 142 139 +165 0.0503 5 142 135 280 0.1328 6 141 138 126 0.0712 7 138 136 122 0.0445
增損=(透析後Na+值-透析前Na+) x病人可透析體液量V 範例2-PD液再生用筒柱 如圖7設置使用一只透析器之雙環PD再生系統。該用後 PD液以具下列組合之模擬浴代表: -32- 1239859 發明說明續頁Loss = (Na + value after dialysis-Na + before dialysis) x Dialyzable body fluid volume of patient V Example 2-PD column for regeneration of PD fluid As shown in Figure 7, a dual-ring PD regeneration system using a dialyzer is set up. After use, the PD fluid is represented by a simulated bath with the following combinations: -32-1239859 Description of the Invention Continued
(29) 右旋糖 100 mg% Na+ 138 mEq/L λ丄 Ua" 2.5 mEq/L Mg2+ 1.0 mEq/L Cl· 113 mEq/L hco3- 25 mEq/L BUN 20 mg% 肌肉酸 3.6 mg% P〇4-P 4.1 mg% pH 7.4(29) Dextrose 100 mg% Na + 138 mEq / L λ 丄 Ua " 2.5 mEq / L Mg2 + 1.0 mEq / L Cl113 mEq / L hco3- 25 mEq / L BUN 20 mg% muscle acid 3.6 mg% P. 4-P 4.1 mg% pH 7.4
用後PD液盛於15 L PD袋内,以Baxter CA50透析器透析, 以100 ml/min流率以泵循環。不斷加入尿毒(尿素,肌肉酸, 及磷酸鹽)到再生PD液,以模擬使用中腹膜透析,取代由 再生透析移出之量。再生透析所用透析液為具以下組成, 盛於4 L PD袋之重碳酸鹽溶液。 右旋糖 1.5% Na+ 135 mEq/L Ca2+ 2.9 mEq/L Mg2+ 0.5 mEq/L ci- 92 mEq/L hco3* 31 mEq/L pH 7.4 透析液以流率100 ml/min循環通過吸著筒柱純化,並不斷 -33- 1239859 _ (30) 發明說明續頁 在再生後供應灌注液,以取代筒柱移出之Ca2+及Mg2+,以 保持並控制PD液中之Ca2+及Mg2+值。 純化PD透析液之吸著筒柱具以下結構: — 3,’D 過濾板 過濾紙 過濾紙 過濾紙 過濾板 160gmSZCpH 6.0 600 gm ZrP pH 6.25 75 gm氧化紹 50 gm氧化I呂及不移動尿毒酶 140 gm活性碳 過濾板 ❿ 流散器After use, the PD solution was contained in a 15 L PD bag, dialyzed with a Baxter CA50 dialyzer, and circulated by a pump at a flow rate of 100 ml / min. Urine (urea, muscle acid, and phosphate) was continuously added to the regenerating PD fluid to simulate peritoneal dialysis during use, replacing the amount removed by regenerative dialysis. The dialysate used for regeneration dialysis is a bicarbonate solution with the following composition and contained in a 4 L PD bag. Dextrose 1.5% Na + 135 mEq / L Ca2 + 2.9 mEq / L Mg2 + 0.5 mEq / L ci- 92 mEq / L hco3 * 31 mEq / L pH 7.4 The dialysate was purified through a suction column at a flow rate of 100 ml / min. And continue to -33-1239859 _ (30) Description of the invention The continuation page supplies perfusion fluid after regeneration to replace the Ca2 + and Mg2 + removed from the cylinder to maintain and control the Ca2 + and Mg2 + values in the PD fluid. The suction column of purified PD dialysate has the following structure: — 3, 'D filter plate filter paper filter paper filter paper filter paper 160gmSZCpH 6.0 600 gm ZrP pH 6.25 75 gm oxide 50 gm oxide I Lu and non-moving urase enzyme 140 gm activated carbon filter ❿ diffuser
此筒柱係不斷將用後PD液透過透析器到透析液中尿毒移 出(尿素,肌肉酸,及磷酸鹽)。同時,將透析液中Ca2+及Mg2+ 移出,以在配合灌注液中,得以保持PD液中這些離子的平 衡。 此筒柱效率與功能: 效率 100 ml/min透析液流率處理8小時後,尿毒移除如下: BUN 4.8 gm 肌肉酸 0.96 gm Ρ04-Ρ 0.48 gm -34-This column system continuously removes uremic poisons (urea, muscle acid, and phosphate) from the PD fluid through the dialyzer into the dialysate after use. At the same time, Ca2 + and Mg2 + in the dialysate were removed to maintain the balance of these ions in the PD solution in the perfusion solution. Efficiency and function of this column: Efficiency After 8 hours of treatment with dialysate flow rate of 100 ml / min, uremic removal is as follows: BUN 4.8 gm muscle acid 0.96 gm 04-0.4 0.48 gm -34-
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TWI482659B (en) * | 2008-06-23 | 2015-05-01 | Temasek Polytechnic | A sorbent for a dialysis device |
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AU2010328630B2 (en) * | 2009-12-07 | 2014-05-15 | Fresenius Medical Care Holdings, Inc. | Water purification cartridge using zirconium ion-exchange sorbents |
ES2647775T3 (en) * | 2011-08-02 | 2017-12-26 | Medtronic, Inc. | Hemodialysis system that has a flow path with a controlled distensible volume |
US9962477B2 (en) * | 2015-12-30 | 2018-05-08 | Fresenius Medical Care Holdings, Inc. | Cartridge systems useful in cleaning dialysis solutions |
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TWI482659B (en) * | 2008-06-23 | 2015-05-01 | Temasek Polytechnic | A sorbent for a dialysis device |
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