CN101897997A - Method for preparing dialysate concentrate from highly-thickened concentrate precursor and device used at dialysis place - Google Patents
Method for preparing dialysate concentrate from highly-thickened concentrate precursor and device used at dialysis place Download PDFInfo
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- CN101897997A CN101897997A CN2009102523205A CN200910252320A CN101897997A CN 101897997 A CN101897997 A CN 101897997A CN 2009102523205 A CN2009102523205 A CN 2009102523205A CN 200910252320 A CN200910252320 A CN 200910252320A CN 101897997 A CN101897997 A CN 101897997A
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Abstract
The invention discloses a method for preparing a dialysate concentrate from a highly-thickened concentrate precursor and a device used at dialysis place. Different from those of the prior art, the necessary ingredients of the dialysate of the invention are not supplied to a dialysis place in the form of dry concentrate or true solution and the necessary ingredients are undissolved or partially dissolved substances, the preferable substance is sodium chloride, the unnecessary substance is sodium acetate and the other components exist in the form of slurry. The slurry is prepared, stored, transported and used in the form of an acidic medicament barrel or acetate medicament barrel. At the dialysis place, liquid dialysate concentrate is prepared from the slurry by means of a device; and the concentrate can be metered by using a conventional merchant dialyzer and processed into dialysate by a safety system. The method and the device have the advantage of saving cost without reducing the normal standard on safety of patients in the use of the conventional liquid concentrate during the transportation, storage and processing.
Description
The application is dividing an application of Chinese patent application 03824534.2.
The present invention relates to a kind of novel supply form of necessary component of the dialysis solution that is used for hemodialysis, wherein said component is not supplied to dialysis apparatus according to prior art as liquid concentrate or as the form of dried concentrate, but supplies with to have than the slurry form of high-consistency.Visual gauge lattice and deciding, the material content in this slurry is the 72%-90% of gross mass approximately.From the container of this slurry is housed, as cartridge case, prepare dialysate concentrate at dialysis place by the device of describing among the present invention, it can be mixed into dialysis solution by dialysis machine in a usual manner.
Dialysis solution by the dialysate concentrate preparation, wherein mixed the water of dialysate concentrate with the scheduled volume of appropriate mass before patient is dialysed.
Dialysis solution generally can have following component, the existence of these components or do not exist with quantity ratios can be according to corresponding occasion and different: sodium chloride, sodium bicarbonate, glucose, potassium chloride, calcium chloride, magnesium chloride, acetic acid, hydrochloric acid, sodium acetate, calcium gluconate, ascorbic acid, citric acid, the hydrate of these chemical compounds, be applicable to water and non-essential other component of dialysis qualitatively.
Under the application form that generally is called the bicarbonate hemodialysis, so-called " acid concentrate " and so-called " alkaline concentrate " mixes the formation dialysis solution with predetermined ratio with the water of scheduled volume.The alkalescence concentrate always comprises the component that sodium bicarbonate maybe can change into bicarbonate, optionally also contains other component, but gets rid of alkali salt and acid.
Acid concentrate can comprise the component that is necessary except that sodium bicarbonate.
In so-called acetate dialysis, use a kind of acetate concentrate, its only by with water in accordance with regulations ratio mix and obtain dialysis solution.
Component in the dialysate concentrate is dissolved in production equipment in the water of ormal weight usually obtaining a kind of true solution, and is transported to the dialysis station as dialysate concentrate.Because water content height in the solution, this is accompanied by significant transportation and storage cost.
Therefore, for a period of time, preferably be used to prepare the basic component of dialysis solution, it is sodium bicarbonate, be supplied to dialyser as powder type more and more, and dissolve by adding entry in the alcaliotropism concentrate therein, wherein both can adopt discontinuous method, also can adopt product line method.
The component of acid concentrate that is used to prepare dialysis solution of powder type in fact also is provided in the dialysis place among a small circle, reduces transportation and storage cost thus.But each component must be subsequently with the high accuracy situ metrology.This needs huge technology and personnel cost.Under the specified criteria of dialysis apparatus, can not prove conclusively reliably and whether in fact contain each component with predetermined blending ratio.In addition, this method is because hygienic reason but controversial.Brought excessive risk to patient thus, because the insalubrity of the dialysis solution of inaccurate composition possibility, even under extreme case, cause death.
The invention provides the method for novel precursor of a kind of low-cost commercial production of acetic acid salt concentrate and acid dialysate concentrate and they are used to prepare the purposes of dialysate concentrate at dialysis place.The dialysate concentrate that forms can be used to prepare dialysis solution by dialysis machine subsequently in a usual manner.
The denseness that the described precursor of dialysate concentrate has is higher than according to the known hemodialysis of prior art any other supply form with component, causes reduction effect thus in transportation, storage and processing procedure, and can not limit the safety of dialysis treatment.
Described purpose realizes by claim 1,2 and 8 feature according to the present invention.This favourable improvement on the one hand of the present invention shows in the dependent claims.
The present invention of showing in claim 1 regulation, all components of acid concentrate are called below a kind of in the container of " acid cartridge case " and exist as slurry form.The volume of the component of the feasible acid concentrate that will transport, store and handle of the acid cartridge case of this preferred version reduces to 1/5th to sixth with respect to the acid dialysate concentrate of routine, this can be easily on the one hand by controlled commercial production with guarantee necessary uniformity on the physiology of the concentrate that preparing on the dialysis machine by being described in device in the claim 8 on the other hand.
The embodiment of acid cartridge case
Prepare a kind of solution with following composition:
35.58g magnesium chloride hexahydrate PH.EUR.
104.4g potassium chloride PH.EUR.
90.04g calcium chloride dihydrate PH.EUR.
73.62g acetic acid 100%PH.EUR.
385.0g glucose monohydrate PH.EUR.
Under agitation, in 1 liter of volumetric flask, be dissolved to 1 liter with pure water.
This solution of 600ml and 1264g sodium chloride PH.EUR. are metered in the plastic containers of similar flask.Form tangible two-phase system, wherein the wetted deposit of liquid mainly comprises sodium chloride, and the transparent supernatant mainly comprises all other components of acid dialysate concentrate.The cumulative volume of described slurry is 1200-1210ml.Material content among this embodiment is 83.11%, and water content correspondingly is 16.89%.
In described device according to Claim 8, prepare in the manner described above if having the acid cartridge case of said components, then form 6 liters of conventional acid dialysate concentrates (35 times) that are used for the bicarbonate hemodialysis.
This concentrate can be mixed into 210 liters in known manner by dialysis machine and have the following dialysis solution of forming:
Sodium 138.00mmol/l
Potassium 4.00mmol/l
Calcium 1.75mmol/l
Magnesium 0.50mmol/l
Acetate 3.50mmol/l
Chloride ion 111.50mmol/l
Bicarbonate radical 31.50mmol/l
Glucose 5.55mmol/l (being equivalent to 1g/l).
The present invention's regulation that shows in claim 2, all the components of acetate concentrate exists as slurry in a kind of container of following being called " acetate cartridge case ".
Use above-mentioned cartridge case can keep the known advantage that from conventional industrial liquid concentrate preparation, obtains: to measure accuracy, detectability until the tracing back property that requires legally, but realized the remarkable decline of volume and quality.
The invention enables and to have the component in the dialysate concentrate of being included in of low quality content, in industrial manufacture process, with low cost, as from after tested the solution form that obtains than large batch, with being metered in the cartridge body of necessity with verifiable accuracy.Guarantee the dialysate concentrate for preparing by this cartridge case thus and have constant controlled quality and patient safety by the blended dialysis solution of dialysis machine subsequently.
Preferably, slurry comprises sodium chloride as solid constituent, what this may suit is, also has other component to exist with solid form.Solid constituent is suspended in the solution of all the other components.By described slurry be described further below on dialysis machine or in the device therein, prepare a kind of liquid concentrate by the water that in batch process, adds the ormal weight of appropriate mass, it is comparable to conventional finished product concentrate, and the metering and the security system of its available existing commercially available dialyser are processed into dialysis solution.
Be to be used for acid and to contain the supply form with high-consistency of component of the dialysis solution of acetate as the precursor of the described dialysate concentrate of slurry form among the present invention.
The container that is used to make acid cartridge case or acetate cartridge case can be the molded item of the dimensionally stable made by plastics or glass, or the flexible pouch of and air tight manner sealing close with liquid after being filled with slurry.Stipulate according to the present invention at this, the entrance and exit of cartridge case is designed in a certain way, make the not dissolved substance component that in working fluid, exists when leaving cartridge case, stay, or device according to Claim 8 has this filter function by filter.
In addition, the present invention relates to a kind ofly be used to handle cartridge case to obtain the device of concentrate.This device comprises a receiving device that is used for cartridge case of can the liquid closely packed going in the blood circulation.In addition, it comprises a batch of material container that preferably has filling level pick off (blocking water after reaching the predetermined filling liquid level further flows into), and the pipeline that the entrance and exit of cartridge case is connected with the entrance and exit of batch of material container, water inlet and dialysate concentrate outlet, and pump, this pump makes water or the solution supplied with preferably resist gravity and cycle through this batch system, has dissolved with homogeneous phase solution until all solids component of slurry to be present in this system.This system can be monitored by pick off or control in real time by control unit, and stops by a signal that is used for " opening outlet valve ".
Described device can be integrated in the dialyser or can be used as a kind of accessory device on the dialyser and be provided with, and maybe can be independent of dialysis place and is used to make concentrate.
By following to the description of preferred embodiment and with reference to the accompanying drawings, draw other details of the device that is used to handle cartridge case.This accompanying drawing shows this device in a kind of mode of pure signal.
Water with appropriate mass is fed to this device by connector 1.Preferably, through the degassing and thermoregulated water from dialyser.Do not having under the operational situation of such water, can use available water in addition, its preferably heating in this device with appropriate mass.
After cartridge case 4 has been connected on two connectors 3, open inlet valve 2, make water preferably by the following cartridge case that enters.Two connectors 3 are preferably mounted at the opposite side of cartridge case, but also can and come the same side or be provided with any alternate manner.The entrance and exit of cartridge case has filter 4a respectively, to prevent that dissolved constituent does not leave cartridge case.In addition, filter function can be transferred in the device at intermittence.After water flowed into cartridge case, formed solution flowed into batch of material container 5.Filling level pick off 6 stops the inflow of water.This filling level pick off makes the dilution ratio can set different accurate qualifications, and wherein whole batch system volume is corresponding to the volumetrical summation of batch of material container 5, cartridge case 4 and relevant hose system.Alternatively, the volume of empty cartridge case is not counted in the batch system volume in another program.
Filling level pick off 6 is preferably designed to conductivity sensor, and can add the control solution concentration thus.
After filling whole batch system volume, primer pump 10, it can make liquid circulate in system, thus the dissolving fully of accelerating solid and cause uniformity in the time dependence mode.
Pressure transducer 11 provides as safety monitoring assembly.Preferably, this device further comprises and is used for the dissolved heater 12 of accelerating solid, and temperature sensor 13.On the one hand, temperature sensor 13 is used to regulate and control heater, can combine the completeness that detects the solid course of dissolution on the other hand with the conductivity measurement unit 6 with necessary degree of accuracy.
Solid dissolve fully and the component uniform distribution after, form a kind of applicable dialysate concentrate.At this moment, open outlet valve 20, so that dialysate concentrate transfers to dialyser by outlet line 21.
Outlet valve 20 can be arranged in before or after the pump 10.
In addition, this device can comprise liquid level sensor 22, and it indicates minimum liquid level.
Claims (11)
1. prepare the method for acid dialysate concentrate, comprise the steps:
A) aqueous solution of all components of the acid dialysate concentrate of preparation except that sodium bicarbonate and NaCl;
B) this aqueous solution and powder or granular NaCl are packed into container, make this component exist as the slurry in the container, this component exists with the material content of the 72%-90% of gross mass and the water yield is the 28%-10% of gross mass, depends on the required composition of this concentrate;
C) container is inserted the mechanism that accepts of the equipment be used for preparing this dialysate concentrate; With
D) water is dissolved up to solid constituent by this container circulation.
2. prepare the method for acetate dialysis concentrate, comprise the steps:
A) aqueous solution of all components of the acetate dialysis concentrate of preparation except that NaCl;
B) this aqueous solution and powder or granular NaCl are packed into container, make this component exist as the slurry in the container, this component exists with the material content of the 72%-90% of gross mass and the water yield is the 28%-10% of gross mass, depends on the required composition of this concentrate;
C) container is inserted the mechanism that accepts of the equipment be used for preparing this dialysate concentrate; With
D) water is dissolved up to solid constituent by this container circulation.
3. be used to implement the step c) and the d of the method for claim 1) have a container of all components of acid dialysate concentrate, wherein powder or granular NaCl and remaining ingredient soluble in water are metered into container, make this component in container, exist as suspension.
4. be used to implement the step c) and the d of the method for claim 2) have a container of all components of acetate dialysis concentrate, wherein powder or granular NaCl and remaining ingredient soluble in water are metered into container, make this component in container, exist as suspension.
5. be used to implement the step c) and the d of the method for claim 1 or 2) device, it is characterized in that claim 3 or 4 described containers of detachably inserting, batch of material container (5), connecting line, water inlet (1) and outlet (21) and pump (10), described pump is used to make the concentrate circulation of the water supplied with or formation, with complete dissolved solid component and it is evenly distributed in the blood circulation.
6. according to the device of claim 5, it is characterized in that described device is integrated in the dialyser.
7. according to the device of claim 5, it is characterized in that described device can be connected with dialyser as accessory device.
8. according to each device of claim 5-7, it is characterized in that this device comprises the filling level control device, it makes it possible to accurately be metered into the water of appropriate mass.
9. according to each device of claim 5-8, it is characterized in that this device comprises liquid metering device, it makes it possible to accurately be metered into the water of appropriate mass.
10. according to each device of claim 5-9, the cleaning device and the decontaminating apparatus that are used for whole device cleaning and disinfection have been it is characterized in that providing.
11., it is characterized in that control device is brought into play all adjustings and control function, and guarantee the safety of described device according to each device of claim 5-10.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102523205A CN101897997A (en) | 2002-01-15 | 2002-01-15 | Method for preparing dialysate concentrate from highly-thickened concentrate precursor and device used at dialysis place |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102523205A CN101897997A (en) | 2002-01-15 | 2002-01-15 | Method for preparing dialysate concentrate from highly-thickened concentrate precursor and device used at dialysis place |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA028245342A Division CN1602210A (en) | 2002-01-15 | 2002-01-15 | Prodn of dialysis concentrate from highly densified concentrate precursouand device for using on site of dialysis |
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| CN101897997A true CN101897997A (en) | 2010-12-01 |
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| CN2009102523205A Pending CN101897997A (en) | 2002-01-15 | 2002-01-15 | Method for preparing dialysate concentrate from highly-thickened concentrate precursor and device used at dialysis place |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105268337A (en) * | 2014-07-15 | 2016-01-27 | 日机装株式会社 | Dissolution device |
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2002
- 2002-01-15 CN CN2009102523205A patent/CN101897997A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105268337A (en) * | 2014-07-15 | 2016-01-27 | 日机装株式会社 | Dissolution device |
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Application publication date: 20101201 |