DE2825134A1 - Dialysis unit for human blood treatment - circuit includes analytical system using computer to check blood parameters and adjust purifier to give optimum performance - Google Patents

Abstract

Automatic intermitted blood purificn. process removes inpurities from blood and uses intermittent blood dialysis. The process involves (1) connection of blood to a circulation system outside the body containing an artificial kidney esp.dialyser, with suitable lines; (2) connection of a suitable supply of dialysis soln. esp. water and an outlet for the dialysate containing the impurities from the blood stream, (3) performing the dialysis operation across a suitable membrane. The automation has the following steps (a) analysis of the arterial blood stream to determine the correct rate of water removal and how many impurities are present for removal, components to measure being Na, K, Mg, HCO3-, CH3COO-, the concn. of CO2 and O2, and the general dilution w.r.t. the water content; (b) calculation of the throughput, rate for the blood and dialysate, the operating pressure to determine the required trans membrane pressure. Provides a rapid service to the patient, is easy and economic to operate for hispitals. It performs the operation with a min. of time and help by using a computer or central processor.

Description

The invention relates in a broader sense to the

tion of waste products from the blood, particularly on blood dialysis. In particular, the invention is concerned with an improved automated gear Method for dialysis of the blood in chronic or acute kidney diseases suffering patients with little or no normal residual kidney function.

The procedure of hemodialysis is relatively new; it got practical started in 1943 when an artificial kidney device was clinically used for the first time was used, which worked with cellulose pipes mounted on a drum, the drum rotating in a supply of dialysate solution. Since then, blood dialysis has been used increasing among doctors and patients in the treatment of insufficient kidney function Has been included and is currently in widespread use. To such an i The good reception both in clinics and in home use contributed numerous improvements in semi-permeable membranes and structures of artificial kidneys. Noteworthy Advances were made by the disposable diaper diaper in the mid-1950s Years, the improved blood collection devices, especially arteriovenous diversions and a number of plate-shaped kidneys in the 1960s, as well as the artificial ones Hollow fiber first commercialized in the United States in the early 1970s were introduced. At present it appears as if the artificial hollow fiber kidney earlier types increasingly supplanted, although the rocker and plate types are still in use are.

Regardless of the particular type of artificial one being used Kidney, the blood dialysis procedure used previously has basically remained the same. In this ancestor, a portion of the patient's blood is continuously outside circulated through an artificial kidney, which certain of the poisonous components, normally excreted in the urine of a healthy person transferred to the blood in a dialysate solution. The blood thus purified is given to the patient continuously fed back. When initially performed, one required clinical blood dialysis treatment of about 7 to 20 hours on an average of about 12 hours. Improvements in the membranes, kidney construction and of the methodology have reduced the time required to a range of around 8 hours. Currently requires using the best artificial ones currently available Kidney designs and the best practices currently used clinically a blood dialysis of about 4 to 6 hours to be carried out three times a week iLt, to make the patients with chronic or acute kidney disease effective supply. During this time shortening of each hemodialysis is significant and for both parties is important, but blood dialysis remains a lengthy process, which the The entire life style of a patient is interrupted, as there are three of every week 5 to 8 hours on the five usual days of the week.

There is still time to the actual dialysis time of 4 to 6 hours for the e trip to and from the clinic, and <t'.c 'becomes both in the clinic as well as in the home love for them Prepare the circulatory segments outside that body including the artificial ones Kidney for the brand as well as for the positioning of the kidney and the associated entertaining the next need dialysis, including the preparation of the kidney to receive Usage can include. It is the case with the currently available künchlichen kidneys pre-processing for use involves a number of complicated procedural cuts, so demanding that most patients do not have their own hemodialysis can do it yourself and the farms require technically trained staff is. Complications also occur when the circulatory system is outside of the circulatory system Body, namely when rinsing the kidney with sterile saline solution and when preparing for loading with the patient's blood; also with the transfer of blood lines from the sterile salt source for drawing blood in the patient's arm and upon initial loading of the circulation outside the body, as well as when the anticoagulant is added before the start of upflow dialysis, etc. Also during dialysis, as a result of the Illness of the patient, as a result of considerable fluctuations in blood pressure, more significant Fluid intake and the like, especially complications in house patients occur which, if not remedied immediately, have serious consequences, even can be fatal. In addition, patients have inadequate kidney function the tendency to have an ever-increasing prejudice against the effects and Dialysis complications build up due to the discomfort are caused by the repeated persistent Therapy failed would also have arduous requirements. Understanding the diet between the Put in dialysis bags are a part of it, as well as changes in the upkeep caused by the host Waste materials and their subsequent faster and more unnatural removal the body fluid.

It is therefore the majority of patients with insufficient kidney function not being able to be full-time, and only part of the patients with whom Intermittent dialysis is able to work part-time to pursue. The cost of clinical or in-house hemodialysis is additional to the loss of ability to work poses for the patient with insufficient kidney function and his family are a problem; it is therefore evident that improvements in the process of hemodialysis would be extremely valuable and desirable that it would be allow such intermittent dialysis patients to receive adequate dialysis to receive in order to maintain his health and still give him re-entry into regular working life. The object of the invention is in the creation of a procedure that includes at least part of the complex preparatory and subsequent steps, which up to now can be carried out with the help of experienced technicians was required, carried out automatically and thereby the overall required Time decreases.

Extensive research has been ongoing since the early 1940s regarding kidney disease and blood dialysis procedure. It becomes present nonetheless approved for blood dialysis, that the functions of healthy children are extremely complex, and the best-formed miscreanters and in this field active heirs on, that there is still much that is unknown. For example, some of the numerous compounds involved in the energy production process in the body from protein formed and supplied to the kidneys by the blood and in the Rooster to be excreted to identify.

It is known that the semipermeable membranes, which until now have been used clinically in blood dialysis, low molecular weight components like urea, creatinine, uric acid, etc.

secrete and components of higher molecular weight such as albumin left in the blood; however, it is not known with certainty whether connections intermediate molecular weight removed from or from the hemodialysis membrane her should be removed. Clinical experience has shown that removal excessive water and certain of the most concentrated catabolites minor Molecular weight like urea a patient with insufficient kidney function can get for a number of years. Nevertheless, the best-informed circles give without hesitation to the intermittent clinical hemodialysis in its current application using the best artificial kidneys available and the best known monitoring and procedures is a relatively crude procedure, however, only is a partial substitute for the functions performed by healthy kidneys and further improvement is needed.

A detailed description of the hemodialysis process at his present Application by advanced clinics in the United States is covered in Chapter 41 of the treatise under the title "Die Niere", Volume 2 under the heading "Herodialysiss Technical and Kinetic Considerations ", by Frank A. Gotch, 1976. This description identifies a number of important problems that are currently in use with best procedures are in place at the start of any dialysis regarding the determination of the duration of the hemodialysis and the speed of the waters and waste removal during dialysis as well as removal of the chemically solubilized Substance. Such control parameters of time and speed are of the The clinician or technician will determine and make the best estimates available for any patient; however, it has been known to result in inaccurate values the water to be removed and the substances chemically dissolved in the blood. The water to be removed is determined by weighing the patient and by the Assumption that the excess over a previous normal weight of the patient Is water that should be removed.

The amount of solute to be removed, such as Urea, creatinine, uric acid etc. are based on the empirical assumption, that blood urine nitrogen (BUN) at a level of less than about 80 mg /% is and will be an acceptable value for adequate dialysis therapy determined by comparing the value of about 80 mg /% with a BUN value of the Analysis of a patient's blood sample is obtained during the month before the start was withdrawn from hemodialysis. The difference in these BUN values is called the Determining factor used for determining the operational activities which the Henge and the Control the speed at which the ekentisch dissolved waste materials during blood dialysis, but the difference that is fixed in this way is flawed in which I hate how the patient's BUN value changes at the time of starting hemodialysis subsided by the previously determined BUN value. It is known that BUN values at Protein intake. Swiftly and well-behaved in the best kier activity etc., and it is likely that the one given at the start of a given hemodialysis BUN value is erroneous to some extent.

When using the quantities specified in the above description on the water to be removed and the BUN, certain other assumptions are required before the length of the hemodialysis and the extent of water removal and removal chemically dissolved substances can be determined. The first and most important assumption is that the rate of withdrawal of blood from the patient and the speed of blood flow through the artificial kidney for the total period of 4 to 6 hours of hemodialysis is constant. This assumption an ideal situation introduces a significant error as the blood flow during the entire hemodialysis is never constant and an error of 20 to 40% can occur. Such errors occur because of the currently available Blood pumps and devices for measuring the speed of blood flow are known are subject to great abbotions. Step over it at any time during the four to six hours of dialysis interruptions usually caused by the patient on and Such interruptions can occur before the interruption of the Dialysis cannot always be adequately balanced or corrected.

A second assumption that is made is that the Flow rate, pressure and composition of the dialysate solution, those on the other side of the semi-permeable membrane opposite the blood side flows, is constant throughout the blood dialysis; those currently available Institutions are unable to ensure such constant conditions. The final aspect of this problem of the pre-set operating conditions is that operational fluctuations that are certain to occur during hemodialysis is ignored or not noticed at all; one last The assumption at the end of the hemodialysis is that the intended Hengen of water and chemically dissolved substances have been removed, and in in most cases this assumption is very likely to some extent incorrect.

Blood dialysis could be improved in many other ways, namely with regard to blood collection from the patient, blood sampling and analysis procedures, the monitoring of the anticoagulant therapy, as well as regarding the preparation the artificial kidney for possible reuse. During hemodialysis There are currently operational controls to protect against health-damaging Errors in the blood collection device or the kidney or the dialysate feed egg assurance however, in the process currently being carried out, the Ve @@@@@@@@@ en in the operating parameters during dialysis, the measurements of the actually removed tessers and the actually removed chemically solute Reproduce material to best suit the needs of the patient and to ensure the originally preset operational control parameters Either to carry out the treatment in a minimum time.

There is therefore another important feature of this invention in creating a method of purifying blood, which is the quality or the adequacy of hemodialysis compared to previously available and from clinics economically viable blood dialysis procedures are improved at a minimum in time and a minimum of assistance by trained technicians in preparation the blood dialysis treatment, during this treatment and when the treatment is stopped.

The invention provides an automated blood dialysis process for Blood purification, which is done shortly before the start of the purification process, such as the hemodialysis, takes a sample of the blood of a patient and this analyzes and automatically optimized operating conditions for the process the analysis results are created in relation to the specified medical goals, delivered by the patient's doctor for this treatment. The procedure monitors the Speed of water experience the pressures and flow rate of blood and dialysate, as well as the acid content of the dialyzed blood and dialysate, and analyzed at least once during dialysis at least either the dialyzed blood or the used dialysis set to determine the amount of removal of at least one chemically dissolved Control substance; Based on this interim analysis, the necessary settings are made made automatically in order to achieve a preselected concentration of the chemically to ensure dissolved control substance after dialysis in the shortest possible time. The method optionally includes the steps for automatic preparation the blood contact components outside the body for connection to the blood sampling device for the patient's blood, as well as steps to clean the used dialysate and for recirculating the same, further steps for rinsing and sterilizing an artificial kidney to preserve and reprocess the patient's blood for possible reuse of the same. The procedure generally includes the step of determining the concentration of the chemically dissolved control substance after dialysis and creates based on this analysis and in comparison with the one on it Established giving the doctor instructions for the patient to monitor his or her Diet in the meantime before the next planned blood dialysis.

The method may also include steps to automatically determine the Blood clotting time at the start of or during treatment and to create the necessary Anticoagulant additives ) th @@@ @@@ @@@ zeit ge @@ before introduction indicate the blood clotting time, @@@@ the addition of anticoagulants @@@ as well as the determination of the time to end, through of Artigerinnungsmittelels during dialysis or the time that the @ang of the coagulant addition, which to restore the blood @ littleness for the blood until the dialysis is finished.

The clotting time difference makes the methods of this invention and the previously practiced blood purification process, especially blood dialysis, consists of the sections of the blood analysis kerz before, during and after the blood analysis and the subsequent definition, the operating parameters of the segments in the circulation outside the body based on the analysis results after a comparison the same with the goals best provided by the attending physician after dialysis, as well as with regard to the technical operational capabilities of the kidney and the for Use coming groove-supporting segments outside of the body.

The improved method makes use of highly sensitive analytical Facilities which require extremely small amounts of the party's blood, as well as computers that are able to provide the analytical results with theirs Determination instantly with the values for water, blood components and chemical compare dissolved control substances that were previously in the computer or the central processing unit are fed. The computer gets lost for every moment. the blood analysis due to the severity Vorgeru @@@ riert that during the 4 to 6 hours required for this treatment in the eye was taken @, constant. Conditions exist. Such a reference adhesive analysis is defined by the heels set forth in Chapter 41 of Geleb, as just given.

The differences thus determined contribute to the operation envisaged steady state will be the basis for the correction signals from the central Processing unit for the relevant circulatory segment outside the body to change the necessary operating parameters and to correct such errors and thus to ensure the achievement of the goals for the patient after the Dialysis for the content of water, blood components and chemically dissolved Control substance in a child operating period.

When used in this description and in the claims the term blood "constituents" refers to those chemically dissolved in the blood Substances other than the chemically dissolved metabolic waste, namely Natrius, Potassium, calcium, magnesium, dissolved oxygen, dissolved carbon dioxide, bicarbonate, Acetate and the resulting pH. The expression "chemically dissolved control substance" refers to an endogenous or exogenous substance in a body fluid or to a measurable physiological response that directly or indirectly has one Change in the concentration of metabolic waste materials to be removed from the blood or catabolites @@ gä @ or is related to him. This Expression refers to the kind that grows in and in the blood chemically dissolved substances such as urea, creatinine, margsfare etc. or on in lymph fluid or other dividers of the greedy body chemically dissolved substances, as well as on exogenous substances such as trace elements, colored or when present materials in the body that produce color, etc. The term includes any possibly sensed response that can be made by the body and showing the progress of the removal of waste materials from the blood during the Purification process reflects quantitatively, such as measurable changes in the response of the nerves, etc.

The principles of this invention are applicable to various specific ones Methods for purifying the blood or removing waste from the Blood including, for example, abdominal cavity dialysis, adsorption, absorption and hemodialysis, which is the preferred method. When applied to the Blood dialysis can be carried out using the method according to the invention any type of artificial kidney already available including flat ones Plate, helix or preferably hollow fiber types. A new hollow fiber art kidney, which are particularly suitable for use in the method according to this invention and is therefore preferred, is in the application of the same applicant under the title "improved Course tournaments and method of making them, "Serial No .......... disclosed. This Invention is preferred in some of its details with reference to certain Embodiments the notification mentioned above.

They show: FIG. 1 a perspective illustration of a hollow fiber artificial kidney when stored tightly on and connected to a dialysate supply and a control device, in a manner typical of the practice of the invention is connected to a patient with insufficient kidney activity, Fig.2 a Above view of a preferred embodiment of the hollow fiber artificial kidney, which in particular is suitable for use in the method according to the invention, Fig.3 a Top view of another preferred artificial kidney construction with requested segments, which are suitable for carrying out the improved blood dialysis method according to of the invention including certain of the optionally possible process steps to realize the same, Fig. 4 shows schematically elements of the components and control devices, which are suitable, the basic method of the invention, as well as some of its optional to carry out possible embodiments automatically, Fig. 5 the speed movement of Fig. 4 with alternation to @glierung the practical implementation other driving a possible embodiment of the method of the invention.

6 shows a flow diagram for the production of the automated traverse sections in a vorrichter temporal sequence, which the @@@ errgie form of the blood dialysis of the Proceed yellow of the invention characterizer.

The strength becomes clear in its individual characteristics when referring primarily to the flow chart shown in Fig. 6, secondly at Reference to the schematic representation of the coating of the circuit segments outside the body to the analyzer and process control unit after Representation in Figures 4 and 5.

As best from fig. 6 are the more important or primary automated steps shown in solid lines in box shape, namely, specifying the time sequence of the implementation of the procedure in the direction of Arrows; the secondary automated process steps included are contained in the boxes shown in dotted lines and in a corresponding time sequence with dotted lines on the boxes of the primary Process steps connected. 6 sets a previous one according to the manufacture Connection of the artificial kidney 10 with a supply of dialysate and one generally with 12 designated control machine ahead, as shown in Fig. 1 again. The artificial kidney 10 is, as shown, of the carbon fiber type and may be the fort from outside the body s @ ac @ the thinnest segments according to the representation in Fig.2 or 3 and include them. The particular one shown in Figs Artificial kidneys will be traced, in the concurrent registration Serial No. .... disclosed in detail and are here as an explanatory embodiment of the here recorded for a use as the kidney 10 according to the illustration 4 and 5 besorders well suited in the circulatory system outside of the body are.

Referring now very again to Figure 6, the first and most essential steps of the automated method according to the invention in taking a blood sample from the patient and delivering that sample to the analyzer of existing ver. Carry out this essential first step other preparatory steps in establishing the circulatory system outside the body for use, and these steps shown in FIG. 6 as optional are automatically presented consist of the saline rinse and the initial one Loading with the patient's blood. It is a sterile irrigation with saline solution required if the segments are not received from the manufacturer filled with saline solution and segments of the circulatory system outside the body and certain artificial kidneys are typically delivered dry-packed; other hollow fiber artificial kidneys are supplied filled with an aqueous formaldehyde solution. During the procedural steps. of Flisik's technician is usually responsible for the flushing process and the initial dispatch are, an automatic implementation is shown in Figures 4 and 5 and will now be described. The venous blood line 14 and the saline return line 15 are connected to one another by the valve 16. The arterial blood line 18 and the saline solution supply line 19 are connected by the valve 20, and the sterile saline lines 19 and 15, respectively, receive saline solution from the saline solution tank 22 and lead them back there. After the valves 16, 20 have been actuated, in order to connect the salt lines 15, 19 to the circuit, the blood pump 24 started to draw brine from the tank 22 and the same through the Blood pressure measuring device 25, the blood flow measuring device 26, the fibers in the Artificial kidney 10, the blood meter 27, the constant air vent trap and the Filter 28, bubble meter 30 and back to saline tank 22. This circulation is continued for a predetermined time, for example for 10 to 20 minutes, and at the end of the predetermined period of time, the blow measuring device 30 activated by a signal from the central processing unit (CPU) 32 to determine whether all gas bubbles have been removed from the circuit. As well as the Measuring device 30, which is able to determine the presence or absence of Detect gas bubbles and normally on detection during the purging cycle the absence of bubbles is set for a predetermined period of 2 the rinsing cycle is ended until 3 minutes have confirmed the absence of bubbles and the valves 16, 20 are actuated to divert the blood lines 14, 18 into the surgical circuit bring in.

After connecting the blood lines 14, 18 to the patient, the blood pump 24 operated to aid blood flow and circulation outside the body the first time to charge or fill with the patient's blood after the measuring device 30 has been returned to her normal blood dialysis position to confirm its presence to detect bubbles and the valve 34 automatically when detected to close, thereby introducing gas bubbles into a patient's vein to prevent. When the circuit outside the body is filled, then it is through a signal from the central unit taken a sample of arterial blood and for example fed to analyzer 36 through a non-thrombogenic capillary tube 38. The analyzer 36 is physically in close proximity to the back of the kidney 10 and within of the housing of the control machine 12 and the tube 38 draws blood the blood line 18 at the location 40, as can be seen from FIG.

Depending on the signal from the central unit's memory bank 32 based on the input of the doctor for the patient in question is through the Infusion device 42, which is physically arranged in the kidney 10 at the place 44 can be (Fig. 2) a ball of anticoagulant, typically Hoparnn, instilled into the arterial blood line 18.

As shown in Fig. 6, the analyzer 36 analyzes the patient's blood after the concentration of sodium, potassium, calcium, magnesium, chloride, bicarbonate, Acetate, dissolved oxygen, dissolved carbon dioxide and determines the acidity or the pH value, Dissolved S @@@@@@, dissolved carbon dioxide, bicarbonate and pH are more determined from a single microblood sample, e.g. B.

175 a 500 Miscolites, within seconds of introduction the sample in authentic facility, which is part of the analysis of an image, The example one is available from Cor @ ipe @@@@@@ of Kidfield, Masschusettts and Instrumentation Laboratier, Ins. of ringed, Massachusetts. Part of the blood sample is filtered through a microporous filter, and a small sample of about 0.3 l of the resulting plasma is connected to the collective electrodes for Sodium, potassium, bicarbonate and chloride analyzer; such electrodes and circuit accessories, which represent another part of the analyzer 36 are from that of M @ atevolt Corporation of New York type available. The concentration of calcium and magnesium is analyzed in a similar way with ion-specific electrodes and circuit accessories, those available from Orion Research Incorporated of Cambridge, Massachusetts are. Urea or blood genetics (@ ÜH), which has so far been considered to be chemical dissolved control substance has been used in advanced clinics that use the Geleb's system explained in Chapter 41 of "The Kidney" is determined from a 20 microliter sample using an ammonium sensitive electrode and Kubhörteile, which constitute another part of the analyzer 36, and the from Kimble Instruments of Toledo, Ohio. The mind time determined from a small sample of all connected blood any of the peeled thrombeplastin time test reagents how for example Thrombofax, in an instrument with direct time indication such as the fibrometer available from Becton-Dickinson Co.

The water in the patient's body is determined by weighing of the patient prior to starting blood dialysis while seated in the chair 42 which rests on a scale 44, which is connected to the central processing unit, during the to provide a weight display at every moment throughout dialysis. For this Scales 44 which work satisfactorily are available from Aimex Co., of Boston, Massachusetts.

The analyzer 36 reports the results to each of the above Analyzes on the central processing unit 32, which is preprogrammed in such a way that they are in their various memory banks containing a first set of data pertaining to blood purification goals for the started blood dialysis treatment according to the information provided by the treating person Physician obtain a second set of data showing the operating characteristics of the circulatory system outside of the body, as well as a third sentence, which the program represents which the composite central processing unit inputs in one instant Performance profile to be carried out at the moment for the 4 to 6-hour treatment integrated; this program is based on the above-mentioned premise of the steady Operation within the entire treatment and roughly consists of the formulas the way they are described by Gotch in Chapter 41 of "The Kidney" is what experts say on this area will be clear. The profile data of the central treatment unit for mainly contain information regarding the concentrations for the patient Components, as well as for the content of chemically dissolved control substance and water of the patient after dialysis.

Centrally tt process unit 32 completed essentially instantaneously or in a short time the comparison between the blood analyzes and the concentrations for the post-dialysis ingredients and activates circuit 46 for formulation the optimized dialysate composition; this circuit contains a water tap source 48, a pressure regulator 50, a heater 52 and for that shown in FIG Singlepass dialysate system has a heat exchanger 54, a dialysate flow control valve 56, venting devices with a coil 58 and a venting pump 60 and a constant ventilation air trap 62. In the dialysate circuit of FIG. 5, which includes the dialysate regeneration device 64, controls the central unit the appropriate information to modify the previously regenerated dialysate composition to form the optimized composition with regard to the components of the blood analysis of the patient. When the dialysate is formed, there is a circulation in the circuit started bypassing the artificial kidney dialyzer 10; this cycle becomes controlled by the bypass valve 66 and includes a back pressure regulator 68, a Dialysate temperature measuring device 69, as well as a dialysate pressure measuring device 70, a dialysate pressure pump 72 and a blood drop detector 74.

If there is enough dialysate in the case of the single-pass system in FIG has formed, as well as when actuated in the case of the regeneration system in FIG. 5 the bypass valve 66 is actuated in order to pass the dialysate through the dialyzer 10.

In order to start the blood test, the central unit creates the program the length of the blood dilyysis by comparing the control analysis values of the resolved Substance entered with the doctor after dialysis, after integration of control parameters of the circulatory system outside the body including the possibilities of the blood flow rate taking blood from the patient and the possibilities of removing the dissolved Dialyzer control substance as a function of flux and blood flow rate. Generally, however, blood flow rates may approach 200 ml / minute with improved blood collection devices in / certain patients or for limited Time spans within the treatment up to significantly higher speeds about 500ml / minute can be used. After determining the length of the hemodialysis transfers the central unit control signals to the dialysate pressure pump 72, the dialysate flow device 76, the pressure regulators 68 and 70, and the blood pump 24, the blood flow meter 26 and the blood pressure meter 27 for venous blood to the flow rate and versus the terms of standby made during blood sample analysis exist, modify, in order thereby the transmembrane pressure to erect the necessary to water through ultrafiltration at the correct Speed of removing the blood; such a speed it is Result that is achieved by the central unit by comparing the Weight of the patient seated in the chair 42 and that prescribed by the doctor Weight after dialysis, after integration of possible speeds as a result the reflection of the patient to avoid unwanted blood reactions, as well as the ultrafiltration capacity of the kidney at the established blood flow rate to ensure the deforming of the dissolved control substance in the allocated Time.

Activate the CFU signals (Central Processing Unit signals) also the measuring device 69 for the temperature of the dialysate, the flow measuring device 76 for monitoring the constant flow rate of the ultrafiltrate in the dialysate inlet line and the corresponding ultrafiltrate flow meter 78 in the dialysate outlet line. In the regeneration circuit for the dialysate according to FIG. 5, the ultrafiltrate is also the ultrafiltrate collected visually through the ultrafiltrate overflow measuring device 80 82 measured.

On the basis of the clotting time results, the central unit determines the Necessity or non-necessity for the instillation of an antigerinn @@ means in addition to the one in the ball at the beginning, who @ erferderlick determines the centrality the correct speed of memorization as one function the selected blood flow rate and actuates the anticoagulant pump 42, to the established indentation at the moment or shortly after the moment to begin with the blood pump 24 to effect its starting rate for blood flow is activated during the operation.

The central processing unit is uninterrupted during dialysis with operational data regarding the in vivo blood pressure in the arterial blood line of of the measuring device 25 and in the venous blood line by the measuring device 27. The patient's in vivo blood pressure is satisfactorily monitored and monitored Use one of the many commercially available fastening devices on the arm or on the leg, such as the programmed electro-sphygmomanometer PE-300 available from NARCO Bio-Systems, Inc. In vivo blood pressure is monitored to prevent fluctuations greater than about # 35 mm of mercury, and the central unit responds to deviations of about # 25 mm to lower the transmembrane pressure and thus a reduction in the rate of water removal, until the patient's in vivo blood pressure returns to normal, i.e. to about # 10 mm mercury column deviation from the patient's blood pressure at the beginning of the Surgery. The transmembrane pressure is preferably through correction signals from the central unit is reduced to the dialysate pressure pump 72, but it can be used in an emergency Correction signals running at the same time to the blood pump 24 may also be present.

The central processing unit also continuously receives data from the normal temperature of the dialysate from the dialysate measuring device 69 and holds by means of correction signals to the heating device 52 and / or to the heat exchanger 54 or by signals to actuate the bypass valve 66 in extreme situations Temperat @@@ isttegs the dialysate temperature in the range of 37 ° C # 3 ° C.

The water removal rate is continuously determined by the UFR-I @@ chflussmeßeinrichtung 76 and 78 monitors which of the central unit data constant speed for comparison with the current performance profile deliver. If deviations are found, then generate appropriate correction signals for the dialysate pressure pump 72 the required change in the transmembrane pressure. The total weight the patient is also constantly monitored by supplying data from the weighing device 44 to the central unit.

The dialysate composition is constantly monitored, and there will be for this purpose the central unit takes the analysis data of the components from the above described ion-selective electrodes supplied, optionally can continuously monitored conductivity data from known devices are supplied to indicate the maintenance of the desired dialysate composition. Deviations are instantly sent by correction signals from the central unit to the dialysate formation facility 46 or to the dialysate regenerator 64 corrected.

For the best monitoring and the most accurate achievement of the pre-programmed The performance profile for the dissolved control substance, for example BUN, becomes an uninterrupted one or frequent analysis of blood samples performed. For this purpose, a sample is made arterial blood from line 18 at point 40 and simultaneously a venous sample or dialyzed blood from line 14 at point 84 to analyzer 36 via the Capillary lines 38 and 86 supplied. After the analyzer 36 the ammonium anode analysis has finished and transferred the results to the central processing unit 32, an instantaneous Comparison made with the preprogrammed instantaneous values or the performance profile. Deviations from the expected profile are corrected by signals to the blood pump 24 and to change the blood flow rate as required. Even if extremely small blood samples are required for this purpose, it is desirable continuously monitor the dissolved control substance by analyzing the dialysate samples, taken from the dialysate outlet line 88 at point 90 and via the sample line 92 are fed to the analyzer 36. At the same time, the line 94 at A dialysate input sample is taken at point 96 and fed to the analyzer 36 via the line 98 supplied. After receiving the analysis results, the central unit delivers the appropriate correction signals to the blood pump 24, and where the speed the removal of the dissolved control substance, the expected profile speeds the length of the treatment time can be modified by the central unit to shorten the preprogrammed treatment time and vice versa.

During a continuous or frequent analysis of the dissolved control substance is desirable, the method according to the invention provides the desired improvement compared to known blood dialysis treatments, if a single analysis of the dissolved Control substance during dialysis is performed and changes in operating parameters the segments thus displayed outside the body depending on those analytic see Results are made. In many cases, one to four control analyzes are sufficient of the solute during treatment in order to achieve goals dialysis to grhl @@ that come close to the results of more frequent ones or continuous analyzes of instantaneous concentrations of the dissolved control substance are achievable, and thus are preferred from a practical standpoint.

Periodic clotting time tests are performed during dialysis treatment type described above, for example in a ratio of 1: 4 is desirable. at The central unit corrects the additional speed when determining changes in the coagulation time the anticoagulant with signals to the anticoagulant pump 42.

Signals delivered by the central unit based on the clotting time samples after 2 or 3 hours of dialysis stop the addition of anticoagulants too such a time that the blood remains until the end of the programmed dialysis treatment is roughly returned to its normal working time. If necessary actuated the central unit, the coagulant pump 100 for bringing the required Amount of coagulant to order for a beforehand added anticoagulant to create a balance, which in turn will return the blood to its normal Is used to clot until the end of dialysis.

When the central processing unit receives analysis data for the dissolved control substance, the achievement of the concentration for the dissolved control substance after dialysis indicate, then appropriate signals are sent to the blood flow and the dialysate flow to beeden and those assigned. Control segments shut down automatically when starting the signals from the central unit were activated. At Point 40, an arterial blood sample is taken and the analyzer 36 via the Line 38 is fed to the clotting time, the concentration of blood components and determine the final concentration of the solute in the blood.

The next step, which can optionally be automatic, is in the flushing of blood from the circuit outside the body to the patient. An improved artificial kidney 10 that enables automatic flushing is shown in fig. The kidney of FIG. 3 is generally similar to that shown in FIG and above-mentioned kidney, however, is modified in that they are integral bodies to enable such flushing. As shown there, is in the area the common blood inlet and outlet opening 104, which the blood inlet line 18 and receiving blood outlet line 14, a sterile salt bag 102 disposed. The pouch 102 has a flexible topsheet layer and is expandable to accommodate different sizes amounts apply to sterile salary solutions; it is also through a valve 100 is separated from the outlet blood line 118. After termination and isolation of the blood pump 24, the valve 106 is opened on a signal from the central unit, the pocket 102 ab @ lecht o @@@ pressed together in order to remove the saline solution contained therein to push out and thereby the blood in the hollow fibers of the kidney 10, the blood in the lines 18, 14 and associated segmenters 40, 42 into the patient's others traced back. The mense of the saline solution used by Darchspälen can vary depending on the Request the Gesan @@ close or a part controlled by the central unit the same be.

The clotted from the arterial blood sample taken at termination Auslytische information as well as a summary of the data regarding the completed Dialysis treatment with regard to length, water content of the patient at termination, as well as, for example, abnormalities in the patient's responses to the Time of such reactions given operating parameters for the input of the doctor are relevant for the following treatments, are given by appropriate means to the treating person Doctor delivered. A preferred method is to use the automatic telephone Transmission to a magnetic card or punch card receiver of the same type as the doctor uses it to transmit the data to the central unit. An expression Such data in the doctor's office for an overview and immediately a later one The doctor's response and transmission to the central unit increases overall performance that procedure

Instructions of the patient regarding his diet, in particular with with regard to water and protein intake for the period between now and the next dialysis treatment can be sent directly to the patient as printouts from the central unit, to reproduce the existing or modified medical instructions. Target information for the following dialysis it is advantageous to take place at the same time and in a similar manner wisely delivered to the central processing unit's memory banks.

The final step of the process, which can optionally be automatic may consists in sterilizing the kidney 10 for possible reuse. Satisfactory sterilization is achieved by using recirculated. Steam for about 30 to 60 minutes. Other sterilizing agents can be used if desired to be used.

While the steps described above are advantageously carried out with the 1 to 3 and that shown in FIGS. 4 to 6 Sequence can be executed, it should be noted that other devices and other conditions suitable for application to them used and also Modifications made in the order of the steps in a satisfactory manner without deviating from the invention.

L e r s e i l e

Claims (8)

Automatic intermittent blood purification process A n s p r About: 1. Automatic intermittent blood purification process for removal blood waste, including intermittent hemodialysis, characterized by the following steps: 1) Providing blood circulation outside the body with an artificial kidney in which there is a membrane, which is able to deform waste materials from the blood, as well as an associated one Blood supply device for supplying blood to the kidney and a blood return device for returning blood from the kidney to the patient, 2) providing a source of dialysate with an associated dialysate device for supplying dialysate to the kidney and for deforming dialysate from the kidney, I @@@@@ n dialysis Umwälaung of arterial blood and dialysate in the poisonous free of dissolved control substance to opposite sides of the membrane and through the artificial kidney. to thereby dialyzed blood and dialysate with increased amounts of dissolved control substance to generate and initiate and carry out the dialysis with automatic effect the following steps a) Analyze the arterial blood and determine which to the amount of water to be removed and the concentration of the constituents it contains, which are selected from the group consisting of sodium, potassium, calcium, magnesium, Bicarbonate, acetate, as well as the partial pressure of the dissolved oxygen and the partial pressure the dissolved carbon dioxide and at least one dissolved control substance, as well as Compare the determined values for water, the specified components and the named dissolved control substance with at least one predetermined value dialysis for the dissolved control substance, water and constituents, and thereby the dialysis time for the hemodialysis and the amount of water, ingredients as well the amount of dissolved control substance to be removed during hemodialysis, and to determine the rate of dialysis of their removal, including the aforesaid Word to reach after dialysis in a minimum time, and b) Establish the flow rates for the blood and dialysate and the pressure of at least one of the two, blood and dialysate, and thereby a transmembrane To generate pressure for use during dialysis time, in order to achieve the in step a) Establish a fixed dialysis rate and initiate blood dialysis using the transmembrane pressure and the flow rates mentioned. 2. The method according to claim 1, characterized in that in step a) specified concentrations of the constituent and the dissolved control substances as a basis for forming the new dialysate composition for use in the Blood dialysis can be used to thereby remove unwanted waste optimize in the blood during hemodialysis. 3. Improved automatic intermittent blood dialysis procedure according to claim 1, characterized in that the chemically dissolved control substance in Method step 3a) is selected from the group consisting of blood urine nitrogen, Creatinine, uric acid, as well as chemically dissolved substances with a molecular weight less than 59,000, and then at step 3 b) automatically at least one of the steps to be performed, which is selected from the group of steps, consisting of the end c) measuring the angularity at which the water from the Blood is removed during hemodialysis, as well as automatic adjustment at least one of the most popular: blood flow rate, dialysis flow rate and des Pressure of the blood, as well as the pressure of the dialysate, to thereby the speed the removal of the water in the essentials specified in step a) for this purpose Maintain speed; and d) the step of determining concentration at least one chemically dissolved substance, which in step a) as chemically dissolved Control substance was chosen in at least one, namely the venous blood and the used dialysate during blood dialysis and the automatic setting at least one of the following: blood flow rate, dialysate flow rate and dialysate composition to thereby reduce the value after dialysis in a minimum time to reach. 4. The method according to claim 3, characterized in that both step 3c) as well as 3d) can be carried out. Method according to Claim 3, characterized in that the determination of the chemically dissolved control substance according to step 3d) during blood dialysis in Intervals is repeated and the automatic settings after each such Determination to be carried out. 6. The method according to claim 4, characterized in that in step 3c) automatically during blood dialysis and the speed of water removal in step 3d) is measured continuously during the dialysis time. 7. Improved automated intermittent blood dialysis procedures according to claim 4 and following step 3d). characterized by e) flushing the circuit outside the body and then supplying the circuit with blood, f) determining and monitoring the temperature of at least one, namely blood and dialyst, as well as setting the Dialysate temperature, the blood temperature in the physiological range for blood and g) monitor the acidity of the venous blood during dialysis and adjusting the dialysate delivered to the kidney to maintain the pH of venous blood in the range of about 6.8 to 7745. 8. Improved Automated Intermittent Blood Dialysis Process according to claim 4 and in connection with step 3d), characterized by e) Determination of blood clotting, the blood in the circulation outside the body and comparing the determined time with a predetermined clotting time that occurred during dialysis is to be maintained, thereby reducing the initial cheek of the anticoagulant to determine what is required to adhere the blood to the desired short time to bring and the speed of adding a binding amount of anticoagulant set to maintain the desired clotting time of the blood during dialysis, f) monitoring the clotting time of the dialyzed bleeding during dialysis and Establish the time required during dialysis for the addition to complete of the anticoagulant and to automatically terminate the addition to the specified Time to thereby the dialyzed blood until the end of the given dialysis time essentially reproduce the normal clotting time of the dialyzed blood, g) Prepare the artificial kidney for reuse by flushing out the blood from her with sterile saline solution and subsequent sterilization of the kidney and Check the same for the presence of bacteria and fever pathogens, as well as h) periodic monitoring of blood pressure in the patient's body during dialysis and comparing it to a predetermined one during hemodialysis range of body blood pressure to be maintained, as well as adjusting at least one, namely the blood flow rate or the transmembrane pressure, to substantially maintain the predetermined range of body blood pressure.