Biospecific hemosorption on the device Hemofenix

Therapeutic apheresis is increasingly used in clinical practice. Many human diseases are accompanied by disturbances of the internal environment, which largely determine the severity of the disease and even are the main causes of adverse outcomes, despite the use of the most modern medications or surgery. Such problems arise in acute inflammatory diseases of the thoracic and abdominal cavities, severe trauma and burns, poisoning and infectious diseases, when the syndrome of endogenous intoxication is arise. Under these conditions, detoxification with endotoxins and other pathological products removal allows to achieve a breakthrough in the course of the disease.


This primarily relates to acute pancreatitis, which occurs on a background of severe endotoxemia on the basis of a sharp increase in the level of proteolytic enzymes and the resulting increase in the content of an average molecular weight substances, activation of lipid peroxidation with the suppression of the antioxidant defense system. In this case, the liver first takes the brunt of the enzyme eluted into the blood from the pancreas, to a certain point, while maintaining the ability to inactivate them. Then comes the depletion of its detoxifying function, which determines the transition to the decompensated phase of endotoxemia with the increase in the level of transferases, phenol, ammonia, fatty acids and other toxic metabolites.

One of the most effective methods of detoxification is hemosorbtion. This method is based on the ability of certain compounds to bind a variety of substances, including pathogenic, due to surface (adsorption), volume (absorption) or chemical interactions (chemisorption). It should be noted that many of the natural metabolites –    protein molecules, lipids, mucopolysaccharides – have "closed" structure of the molecules that are electrically, and therefore – and biologically inert. Therefore, the majority of physiological metabolites contact with sorbents is not terrible, they quietly pass by them and remain in circulation, which minimizes the possible harmful effects of the procedure.

By passing through a column of 1-2 BCV occurs fairly complete elimination of many pathological products and even delay and fixation of live bacteria that, for example, when an infection caused by Pseudomonas aeruginosa, represent the only truly effective method of treatment because of the low adequacy of antibiotic therapy. Reduced the level of middle molecules, blood toxicity in general (for protozoa survival time), the general condition improves.

Hemosorbtion proved effective at destructive processes also, and even gangrene of the lungs. Naturally subjected ichorization areas lungs could not restore the structure, but decreased perifocal changes and intoxication that allows you to quickly prepare patients for the inevitable surgery, which are easier to carry.

Biospecific hemosorbtion based on the ability of some sorbents, in particular, "Ovosorb" selectively removing the activated forms of serine proteases that accompanies many of the critical state in clinical practice – from allergies to sepsis. Correction proteinase inhibitory imbalance there is allows to interrupt the development of organ disorders, reduce and improve the results of treatment.  
Device Hemofenix is designed for not only the membrane plasmapheresis, but hemosorption on one needle method using any hemosorption columns permitted for medical use, including the column "OVOSORB", and a set of lines KMAP-01.

The basis of the device "Hemofenix" is a type of ventricular pump driven by an electromagnet. The device works biphasic. While squeezing the tube pumping blood to the sorption column and then back into the vein. At this point, is carried out the hemosorption process. Upon termination of compression pump tube passively straightened due to its flexibility, which helps blood sampling from the same vein. Translational motion of the blood is promoted by two solenoid valves, each of which is compressed by the three tube line simultaneously. During the phase of the return of blood the right valve is opened – open line of blood flow in the column and the branch of the anticoagulant, which allows to fill a special collapsed bag of the dosing device. In order to reduce the recirculation of blood in the system during hemosorption expedient return line blood M5 put in the nest of the right valve, designed for line, escaping the plasma (it is not used at hemosorption). During the phase of blood sampling valve left open – open line of blood sampling, the branch supply isotonic sodium chloride solution and branch guide anticoagulant from dosing bag into the pump tube.  
STRUCTURE, PRINCIPLES OF DEVICE
AND SAFETY  
The process of return of blood is controlled by a pressure gauge that measures the pressure of blood in front of the sorption column. Patient safety is ensured by means of ultrasonic and capacitive sensors, stopping the machine with the appearance of air inclusions (bubbles or falling blood level in the filter trap) in the return line of blood.

The main body of the device has special rack-holders on which are mounted filters – air trap, air inclusions ultrasonic transducer, two clamps for mounting the sorption column, vials or packets with the solutions, as well as special slotted dosing device.

Pumping compartment for security is under a removable protective cover.

The control panel consists of a two-line alphanumeric scoreboard indicator, which displays the basic parameters of the device, reports of it condition and of emergency situations that may arise during the operation.
For more information about using the "Hemofenix" is in the instructions for this unit.  
Logistical support
- Portable device for single-needle membrane plasmapheresis "Hemofenix"
- Main line single use "KMAP-01"
- Biospecific antiproteazny hydrogel hemosorbent "OVOSORB" in the mass exchange module for hemosorption (MMG)
- Adapters (disposable - come with hemosorbent).
- Sterile styling with scissors, clamps Billroth, swabs and balls, bottles or bags with isotonic sodium chloride solution and a solution of sodium citrate (ASD-A).
METHODS of HEMOSORPTION

Preparations for hemosorption
1 For the hemosorption necessary to prepare the workplace, are located there, with the laying of sterile (sterile "Plain", scissors, clip Billroth, a glass of alcohol, gauze balls and swabs, bandages), adhesive tape, tonometer.
2. Check the expiration date of the sorption column, tightness of individual containers. Check the expiration date set lines KMAP-01, sealed individual containers. Unpack the package, remove the line and put in the workplace (sorption column and line must be used immediately after opening the package, in violation of its integrity products use is prohibited).
3. Building the system is carried out under aseptic conditions in accordance with the scheme shown in Fig. 1.
4. Lay the lines on the unit Hemofenix, remove the top of protecting cover and place according to the scheme pump element H in its bed, and then cover protection put in place again.
5. Fold the cover of the left fastening device ЭMK1 and fix in it the line for blood collection M1 and tubes M2, M3, leading to the packages with anticoagulant and isotonic sodium chloride solution, and then re-lock this cover.
6. Soft dosing bag of anticoagulant MД ins erted into one of the slots of the dosing device UVso that the flow direction is upwards.
7. Filter – air trap ЛВset into the appropriate slot of the sensor air of filter holder, and the return line M5 fix then over the sensor in the air in the direction of line ДB2 not from right to left, as in plasmapheresis, and the left-to-right (!!!).
8Fold the cover right pinch device ЭMK2 and fix leading line M4 blood flow to the adsorption column, repeat the branch leading from the metering device to the package with an anticoagulant and blood return line.
9 Remove the protective caps from the connectors leading branch line, transition ins ert with red nipples П1and input (red) fitting sorption columns КГ and connect them.
10Remove the protective caps from the connector outlet branch line, ins ert transition П2 with blue fittings and output (blue) fitting sorption columns КГ and connect them.
11 Close all the clips on the line "!".
12Branch line that goes to the pressure sensor ДД connected to the latest tightly bolted to the union.
13 Remove the protective cap and filter dropper needle K1 connect with bottle E1with an anticoagulant and install it into the right slot transfusion rack unit. Filter dropper K1 fill half the volume.
14 Remove the protective cap and filter dropper needle K2 connected to  bottle E2with isotonic sodium chloride solution. Se t last in the nest on the left transfusion rack unit. Filter dropper K2 fill to half volume. Attention is drawn to the desirability of pre-warming the sorption column and solutions used.
15 Do not removing the protective cap from the infusion site УИ, immerse it in a sterile empty vial.
16 Open the clamp on the branch blood sampling Ж1 and clampЖ4on a branch feeding anticoagulant and fill this branch together with a bag-dispenser until the pump tube. Close clamps Ж1andЖ4.
17 Open theclampЖ5 on the branch supplying isotonic sodium chloride solution and clip Ж1on branchof drawing blood and fill the latter. Close clamp Ж1.
18Continue filling the pump segment, lifting the right side of the latter in order to completely remove air from it.
19Turn on the device, which plug the power cord into electric socket  mains voltage of 220 V, 50 Hz. At the rear of the device turn on the power switch to «I». Subsequent filling of the extracorporeal circuit should begin in the "pumping" mode.
20 Press "Start" button and continue the displacement of air from the adsorption column by fluid flow from bottom to top, and then fasten the column in the special slot in the position of the fluid flow "top-down". Leave the device working a few more minutes to complete cessation of the air intake from the sorption column in to a trap, and then open the clamp Ж3Duct air trap and remove air from the latter. Close the clamp Ж3 on the airvent.
Attention! Draws attention to the need for the widest possible removal of air from all parts of the extracorporeal circuit. Otherwise, there is excessive recirculation of blood in the device and reducing the actual perfusion rate compared with the rate on the display board. Besides, the sorption column "Ovosorb" is able to be compressed at a negative pressure and over distended at positive. That is why it is connected to the device other than a membrane plasma filter that provides therein a constant positive pressure.
21 Continue laundering sorption column isotonic sodium chloride solution according
to the instructions attached to the column.
22 After the implementation of the program of the laundering the sorption column stop device (press the "Stop"). Remove the protective cap from the infusion part УИ, connect the needle (attached to a se t of line) and enter it in a bottle with isotonic sodium chloride solution.
23In a bottle with isotonic sodium chloride enter 5000 IU of heparin (if there are no contraindications to it), press the "Start" button and start recycling in the extracorporeal circuit of devicefor sorbent saturation with heparin for 10 minutes (according to the instructions for use of this hemosorbent).
24 Press the "Stop" button. The device is put on "work" regime when involving all security and lock the device in this mode, and at this regime it should work until the end of the procedure.
25 Touchstone alternate clamping jaws Ж1andЖ2onbranchts intake and return blood to check the reliability of the automatic locking and sealing compounds in the system as a whole. Switch off the machine. Again pinch all the clips.

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