RU93276U1 - EXTRACORPORAL BLOOD CLEANING DEVICE - Google Patents

Abstract

 1. Apparatus for extracorporeal blood purification, containing a dialyzer, divided by a semipermeable membrane into a blood section, designed for communication via connecting communications with the patient's circulatory system, and a dialysis fluid section connected to a treatment loop filled with dialysis fluid, provided with at least one column with a carbon sorbent, the input of which is the input of the spent dialysis fluid, and the output is communicated directly or through intermediate elements a treatment circuit with a dialysis fluid container or an inlet of a dialyser dialysis fluid section, characterized in that a plasma filter is additionally introduced into the communication connection for communication with the patient’s circulatory system, the input of which is connected to the patient’s circulatory system through the first control valve-distributor, the first exit through the second control valve-distributor and the pump is connected to the patient’s circulatory system at the entrance to it, the second exit through the third control the valve valve is connected to the inlet of the column with carbon hemosorbent, and the treatment circuit further comprises a fourth control valve distributor, which is installed at the outlet of the dialysis fluid tank before entering the dialyzer fluid section, the treatment circuit is provided with a fifth control valve distributor, which is associated with the output of the dialysing fluid section of the dialyzer, the input of the column with carbon hemosorbent, and is installed with the possibility of communication with the atmosphere

Description

The utility model relates to medical equipment, namely, devices for the exchange of blood during the pathological condition of the patient to replace the impaired or lost function of removing metabolites and toxic substances from the body.

A known apparatus for extracorporeal blood purification, containing a dialyzer, divided by a semipermeable membrane into a section for blood intended for connection to the patient's circulatory system, and a section for dialysis fluid connected to a closed treatment loop filled with 20% human albumin solution. The closed purification circuit contains an additional dialyzer for regeneration of albumin against a bicarbonate buffer and two sequentially installed after the additional dialyzer absorption cartridge, filled with anion exchange resin IE 250 and activated carbon AC 250. The additional dialyzer is connected with an open circuit for the analyzing liquid.

See the prospectus of LLC Medfarmoservice, which is a representative of TEAKLIN AG Germany (Rostock), "Brief instructions for the therapeutic complex MARS", 2004; prospectus of KBV GmbH & Co.KG., also a representative of TEAKLIN AG Germany (Rostock) “Supporting liver therapy (artificial liver) MARS”, 2003

The known apparatus provides effective removal of water-soluble and protein-bound toxins from the body. However, the widespread use of this apparatus for detoxification limits the complexity of the design and the high cost of the apparatus and its consumables such as absorption cartridges and a highly concentrated albumin solution.

The closest in technical essence, the achieved effect and selected as a prototype is an apparatus for extracorporeal blood purification, containing a dialyzer, divided by a semipermeable membrane into a blood section, designed for communication via connecting communications with the patient's circulatory system, and a dialysis fluid section connected to a closed a treatment loop filled with dialysis fluid, equipped with at least one carbon sorbent column, the input of which is tsya spent dialysis fluid inlet and outlet communicated directly or via intermediate elements to a cleaning circuit for the dialysis liquid container and the entrance section to the dialyzer the dialysis liquid.

See patent for utility model No. 56191 by class. A61M 1/14, claimed August 15, 2005, publ. September 10, 2006. “Dialysis apparatus”.

However, this apparatus provides the implementation of only the dialysis process in recirculation mode in a closed treatment loop.

The objective of this utility model is to create an apparatus for extracorporeal blood purification with enhanced functionality, which allows for various methods of extracorporeal blood purification such as hemodialysis, plasmapheresis, plasma filtration, plasma absorption, hemofiltration and hemodiafiltration.

The technical result that allows us to solve this problem is to optimize the design of the apparatus for extracorporeal blood purification.

The problem is achieved in that in the known apparatus for extracorporeal blood purification, containing a dialyzer, divided by a semi-permeable membrane into a blood section, designed for communication by means of connecting communications with the patient's circulatory system, and a dialysis fluid section connected to a treatment circuit filled with dialysis fluid, equipped with at least one column with a carbon sorbent, the input of which is the input of the spent dialysis fluid, and the output is directly or through intermediate elements of the treatment circuit with a dialysis fluid container or an inlet of a dialyser dialysis fluid section, according to a utility model, a plasma filter is additionally introduced into the communication line for communication with the patient’s circulatory system, the input of which is connected to the patient’s circulatory system through the first control valve-distributor, the first output through the second control valve-distributor and pump connected to the circulatory system cents at the inlet to it, the second outlet through the third control valve-distributor is connected to the inlet of the column with carbon hemosorbent, and the treatment circuit additionally contains a fourth control valve-dispenser, which is installed at the outlet of the dialysing fluid tank before entering the dialysing fluid section of the dialyzer, This purification circuit is equipped with a fifth control valve-distributor, which is connected with the output section of the dialysing fluid of the dialyzer, the inlet of the column with carbon heme sorbent and installed with the possibility of communication with the atmosphere.

As a dialysis fluid, it is possible to use a 10-12% solution of human albumin or a cytosol of the liver of a pig, or donor plasma.

Studies conducted on patent and scientific and technical sources of information indicate that the proposed apparatus for extracorporeal blood purification is unknown, and therefore meets the criterion of "novelty."

The proposed apparatus for extracorporeal blood purification can be manufactured at any enterprise specializing in this industry since this requires known materials and standard equipment widely produced by domestic and foreign industry.

Thus, the claimed apparatus for extracorporeal purification of blood meets the criterion of "industrial applicability".

The proposed set of essential features informs the claimed apparatus for extracorporeal blood purification with new properties that allow us to solve the problem, namely, the creation of an apparatus for extracorporeal blood purification with advanced functionality, which allows for various methods of extracorporeal blood purification such as hemodialysis, plasmapheresis, plasma filtration, plasma absorption, hemofiltration and hemodiafiltration.

Introduction to connecting communication for communication with the patient’s circulatory system, a plasma filter whose input is connected to the patient’s circulatory system at the outlet through the first control valve-distributor, the first output through the second control valve-distributor and the pump is connected to the patient’s circulatory system at the entrance to it, the second the output through the third control valve-distributor is connected to the input of the column with carbon hemosorbent allows additional extracorporeal methods purifications other than hemodialysis such as plasmapheresis, plasmafiltration and plasmosorption.

The installation in the treatment loop of the fourth and fifth control valves - dispensers allows you to carry out such methods of extracorporeal blood purification as hemofiltration and hemodiafiltration, wherein hemodiafiltration can be carried out with simultaneous hemodialysis and hemofiltration.

The installation of the fifth control valve-distributor with the possibility of communication with the atmosphere allows you to remove toxic substances passing through the hemodialyzer membrane, and thereby ensures the system works to "discharge" if necessary, remove the filtrate from the hemodialyzer and waste from the carbon sorbent column, which also extends the functionality apparatus for extracorporal purification of blood.

The proposed utility model is illustrated in the drawing, which shows a diagram of the inventive apparatus.

The apparatus for extracorporeal blood purification contains a dialyzer (hemodialyzer) 1, divided by a semipermeable membrane into a blood section 2, intended for communication through a connecting communications with the patient's circulatory system, and a dialysis fluid section 3 connected to a treatment circuit 4 filled with dialysis fluid. The apparatus is equipped with at least one carbon sorbent column 5, the input of which is the input of spent dialysis fluid, and the output is communicated directly or through intermediate elements of the treatment circuit with capacity 6 for dialysis fluid or the input of section 3 for dialysis fluid of dialyzer 1, into the connecting communication for communication with the patient’s circulatory system is additionally introduced plasma filter 7, the input of which is connected to the patient’s circulatory system at the exit from it through the first adjustment ventile distributor 8, the first outlet through the second control valve distributor 9 and the pump 10 is connected to the patient’s circulatory system at the entrance to it, the second output of the plasma filter 7 through the third control valve distributor 11 is connected to the input of the column 5 with carbon hemosorbent, circuit 4 further comprises a fourth control valve-distributor 12, which is installed at the outlet of the dialysis fluid container 6 before entering the dialysis fluid section 3 of the dialyzer 1, while circuit 4 is equipped with a fifth control valve-distributor 13, which is connected to the output of the dialysis fluid section 3 of the dialyzer 1, the input of the column 5 with carbon hemosorbent and is installed with the possibility of communication with the atmosphere.

Pumps 10 and 14 are installed for transporting dialysis fluid.

A 10-12% solution of human albumin or a pig liver cytosol or donor plasma was used as a dialysis fluid in the apparatus.

The apparatus for extracorporeal blood purification in hemodialysis mode is used as follows:

The patient’s blood enters the hemodialyzer 1, where it is cleaned by the oncoming flow of dialysis fluid from the reservoir 6 using the pump 14 with the control valve open 12 and again comes to the patient with the control valve open 9 due to the operation of the pump 10. toxic substances pass through the membrane of the hemodialyzer 1 and are removed when the control valve-distributor 13 is opened in the communication position with the atmosphere.

In the regime of plasmapheresis, plasma filtration and plasma sorption, the apparatus is used as follows:

The patient’s blood is sent to the plasma filter 7 using the control valve 8, where they are separated into blood cells, which are returned to the patient using the control valve 9 and pump 10, and the blood plasma, which is sent through the control valve 11 for cleaning, to column 5 with hemosorbent, and from there to the storage tank 6 or through the control valve 9 using the pump 10 is also returned to the patient. After preliminary adjustment of the degree of occlusion of the pump 10, it becomes possible to place a thinner-walled pump segment of a standard set of highways for two-needle plasmapheresis with a PFM plasma filter in its bed. In this embodiment, the apparatus allows you to abandon the additional intermediate capacity since it becomes possible to directly return erythromass to another vein due to the driving force of the pump.

In the hemofiltration and hemodiafiltration mode, the blood from the patient passes through hemodialyzer 1 with highly permeable membranes (hemofilters) and is returned to the patient through the control valve-distributor 9 using the pump 10 while the filtrate is removed through the control valves 11 and 13 and at the same time the replacement solution is introduced. Hemodiafiltration is carried out with simultaneous hemodialysis and hemofiltration.

The ability to remove water-soluble and protein-bound toxins in the inventive apparatus was confirmed by experiments.

For this, model experiments were carried out using donor blood in an experimental setup. The experiments were carried out as follows. Lyophilized dried cytosol was dissolved in double-distilled water, and with constant stirring of the resulting suspension, it was passed through a hemodialyzer through dialysis fluid connectors using a perfusion pump using the recirculation principle. At the same time, perfusion of donated blood was carried out, which was also submitted according to the principle of recirculation using a perfusion pump through the hemodialyzer connectors by blood.

To simulate hepatic insufficiency, ammonium chloride was added to the donor blood, and throughout the entire experiment the concentration of ammonia in the blood and cytosol was measured. During the experiment, blood contact with the material was carried out through a semipermeable hemodialyzer membrane for 6-8 hours at a perfusion rate of the material and blood of 100 ml / min.

Studies, the results of which are presented in the table, showed that already 1 hour after the start of the experiment, 84% of ammonia was removed from the blood. The data on the concentration of urea in the blood and cytosol indicate an increase in the concentration of urea in the latter, which reflects the synthesis of urea from ammonia.

The concentration of ammonia and urea in the blood and cytosol during model experiments using an extracorporeal blood purification apparatus.

t (hour) Blood Cytosol Ammonia (mmol / L) Urea (mmol / L) Ammonia (mmol / L) Urea (mmol / L) 0 0.96 4.20 0.219 2.63 one 0.15 2.67 0.668 2,55 2 0,088 2.40 0,990 2.69 3 0.004 2,51 1,04 2.76 four 0,031 2,36 1.18 2.76 5 0.004 2.42 1.10 3.22

6 0.058 2.40 1.42 2.99 7 0,000 2,30 1,54 2.76

One of the most important pathogenetic mechanisms for the development of liver failure is hyperammonemia, which develops as a result of impaired ability of hepatocytes to synthesize urea. The data obtained suggest that the use of the inventive apparatus is accompanied by the diffusion of ammonia in a concentration gradient from blood to the cytosol and its binding in the ornithine urea synthesis cycle. Thus, the connection to the circulatory system of patients with an apparatus for extracorporeal blood purification provides detoxification and normalization of metabolic processes.

The technology of using albumin in the extracorporeal circuit in the recirculation mode through a charcoal sorbent can effectively reduce the concentration of toxic compounds in the blood in patients. For model studies, donor plasma was used in which high initial concentrations of toxic substances were created: sodium salicylate, 2,4-dinitrophenol (2,4-DNP), aniline, ammonia and medium-sized molecules. The contact of plasma and albumin was carried out through a semipermeable hemodialyzer membrane for 3 hours at a perfusion rate of plasma and albumin of 150 ml / min at a temperature of 37 ° C. Plasma and albumin samples were taken at regular intervals to identify the dynamics of changes in the concentrations of substances of endogenous and exogenous origin.

Dynamics of the effectiveness of albumin dialysis plasma.

Perfusion time, min. Concentration 2,4-DNP, mcmol / l Sodium salicylate, μmol / L Ammonia, μmol / L Aniline, μmol / L Medium molecules, cu pl. Alb. pl. Alb. pl. Alb. pl. Alb. pl. Alb. 0 5000 0 5000 0 117 0 0 280 0 0 2,203 0.15 fifteen 2790 2448 2768 2499 792 352 135 0 145 0 1,181 0.86 thirty 1920 3270 2180 3072 256 612 944 185 0 0.785 1.15 60 1337 3652 1748 3369 284 723 693 210 0 0.512 1.38 90 1363 3692 1914 3196 244 774 580 222 3 0.402 1.46 120 1188 3713 2054 3229 190 630 450 234 7 0.355 1,56 180 1080 4026 1644 3194 99 623 255 256 0 0.241 1.78

pl. - donor plasma; Alb. - albumin solution.

According to the data received, after 30 minutes. after the start of the experiment, 56% of sodium salicylate, 62% of 2,4-DNP, 78% of ammonia, 66% of aniline and 64% of average molecules are removed from plasma. After 60 minutes - 65% sodium salicylate, 73% 2,4-DNP, 84% ammonia, 75% aniline and 77% medium molecules. At the same time, a proportional increase in the concentration of these compounds in a solution of serum albumin is observed, which indicates the binding of toxins to albumin in comparison with conventional dialysis. By the end of the experiment, albumin bound 67% sodium salicylate, 78% 2,4-DNP, 92% ammonia, 91% aniline and 89% medium molecules.

At the next stage of the study, albumin after albumin dialysis was perfused through the carbon hemosorbent VNIITU-1 for 3 hours. The results are presented in the table.

The dynamics of the effectiveness of the purification of albumin.

Perfusion time, min. Concentration in Albumin. 2,4-DNP, mcmol / l Sodium salicylate, μmol / L Ammonia, μmol / L Aniline, μmol / L Medium molecules, cu 0 3611 4056 600 2560 1,627 fifteen 2117 1725 282 1525 1,028 thirty 1536 1294 one hundred 1024 0.827 60 1062 755 17 512 0.627 90 830 688 13 332 0.528 120 714 525 13 282 0.491 180 581 356 0 one hundred 0.398

The results showed that after 30 min. 68% of salicylate, 58% of 2,4-DNP, 83% of ammonia, 60% of aniline and 49% of average molecules are adsorbed. After 60 minutes, 71% of 2,4-DNP, 81% of sodium salicylate, 97% of ammonia, 80% of aniline and 62% of medium molecules. After 180 minutes 91% of sodium salicylate, 84% of 2,4-DNP, 100% of ammonia, 96% of aniline and 76% of average molecules remain on the sorbent. Similar results were obtained when donor plasma was used instead of albumin.

Examples of clinical use of an extracorporeal blood purification apparatus:

Patient A, 68 years old, was admitted to the hospital with a diagnosis of cirrhosis of the liver, acute phase, unknown etiology, class C according to Child-Pugh. Portal hypertension in the stage of decompensation, hepatosplenomegaly, ascites, jaundice. At the time of inspection, the condition is serious, clear consciousness. The patient underwent standard conservative therapy, as well as a hemosorption and transfusion session of freshly frozen plasma with a total volume of 2000 ml. Given the ineffectiveness of conservative treatment, the patient had a session of albumin dialysis. Before the session HELL 140/90, heart rate 98; after 130/70, heart rate 72. The patient’s health improved subjectively. The following trends were observed in biochemical parameters: ACT activity decreased by 31%, LDH - by 61%, GGTP - by 9%, alkaline phosphatase - by 9%. The content of total bilirubin decreased by 34%, its direct fraction - by 12.5%, indirect - by 56.5%. The content of medium molecular peptides (SMP) in the blood decreased by 4%. Against the background of the treatment, the patient's condition remained stable and severe, bilirubin remained high, cholestasis syndrome prevailed over cytolysis syndrome, ascites, and jaundice were observed.

Patient B, 50 years old, was admitted to the hospital with a diagnosis of toxic hepatitis, which developed after the operation of safenectomy, carried out under fluorotan anesthesia. A history of cholecystectomy. The patient's condition is moderate, stable, clear consciousness, jaundice, drowsiness. The patient underwent conservative therapy and extracorporeal treatment methods: two sessions of exchange plasmapheresis, one session of hemosorption. A session of albumin dialysis. The following results were obtained: ALT activity decreased by 19.5%, GGTP - by 2.5%, alkaline phosphatase - by 27%. The content of total bilirubin decreased by 14%, its direct fraction - by 58%, the content of the indirect fraction increased by 2.8 times. The content of SMP in the blood decreased by 4.6%. The patient was discharged with improvement and positive dynamics of biochemical parameters.

Patient D., 47 years old, was admitted to the hospital with a diagnosis of acute toxic hepatitis caused by ingestion of Crystal fluid. The concomitant diagnosis is chronic alcoholism. The general condition is severe, jaundice, drowsiness, lethargy, encephalopathy of 2 degrees, superficial stunning. Soreness in the right hypochondrium, the liver is not palpable, percussion its size is normal, ascites is not. 2 hemodiafiltration sessions were conducted with a volume of 16 liters and a duration of 6 hours. Positive dynamics of the general condition and biochemical parameters was noted. The activities of ALT and ACT decreased by 34% and 6%, significantly decreased the activity of alkaline phosphatase and GGTP - by 79% and 92%, respectively. The content of total bilirubin decreased by 24%, cholesterol - by 31%, SMP - by 33%. The concentration of ammonia in the blood decreased by 50%, and the urea content increased by 69%, which is associated with an increase in the detoxifying ability of the patient's liver.

Claims (2)

1. Apparatus for extracorporeal blood purification, containing a dialyzer, divided by a semipermeable membrane into a blood section, designed for communication via connecting communications with the patient's circulatory system, and a dialysis fluid section connected to a treatment loop filled with dialysis fluid, provided with at least one column with a carbon sorbent, the input of which is the input of the spent dialysis fluid, and the output is communicated directly or through intermediate elements a treatment circuit with a dialysis fluid container or an inlet of a dialyser dialysis fluid section, characterized in that a plasma filter is additionally introduced into the communication connection for communication with the patient’s circulatory system, the input of which is connected to the patient’s circulatory system through the first control valve-distributor, the first exit through the second control valve-distributor and the pump is connected to the patient’s circulatory system at the entrance to it, the second exit through the third control the valve valve is connected to the inlet of the column with carbon hemosorbent, and the treatment circuit additionally contains a fourth control valve distributor, which is installed at the outlet of the dialysis fluid tank before entering the dialyzer fluid section of the dialyzer, while the treatment circuit is equipped with a fifth control valve distributor, which is associated with the output of the dialysing fluid section of the dialyzer, the input of the column with carbon hemosorbent, and is installed with the possibility of communication with the atmosphere eroy. 2. The apparatus according to claim 1, characterized in that a 10-12% solution of human albumin or a pig liver cytosol or donor plasma is used as a dialysis fluid.