DE19835294C1 - Regulating method of extra corporeal dialysis - Google Patents

Abstract

The method of regulating extracorporeal dialysis involves filtering the dialysis fluid and flushing at least one processing chamber (3a,3b) of the apparatus. The filtrate produced by the operation can be used as a flushing medium.

Description

The invention relates to a method for maintenance the usability of an already used facility for extracorporeal hemotherapy, in the used dialysis machine liquid or filtrate is accumulated and in which the Ein direction at least one blood-side and one not blood egg term chamber and at the end of therapy operation through at least one chamber of a rinsing liquid is directed.  

Possible areas of application of the method according to the invention are u. a. the filtration, hemodiafiltration and above al lem dialysis therapy. The core of a dialysis machine is a dialyzer with a blood-side chamber as a component an extracorporeal circulation and not a blood -side chamber through which a dialysis fluid is supplied is tested. Both chambers are through a semipermeable membrane bran separated. Such a device is known from DE 31 15 665 C2, the content of which is express is included. In the known device Dialysis fluid stored in a storage container and after passing through the dialyzer back into the Be fed back.  

When using extracorporeal devices for hemothera pie clogs the membrane with blood components, causing the permeability is reduced. For this reason and from a hygiene point of view, it is common practice to set up to be used only once and then disposed of. It is still common, including those required for therapy Hoses only once for the same reasons use. Apart from cost and environmental considerations is the use of such disposable components also under medical aspects of disadvantage:

It is known that the human immune system with blood con starts with the surfaces of the dialyzers used initially reacted with defense reactions. During dialysis process is performed on the contacted surfaces the protein layer originating from the blood is deposited. This protein shift leads - because the body owns - with a new contact to a significant decrease in immunological reactions. If new system com components are used, always occur at the beginning biological reactions (e.g. with fever as a symptom) to what putting strain on the health of each patient affects. The aim is therefore to use the components Use blood contact not only once, but several times. For this purpose, cleaning and preservation processes required.

There are procedures for reusing dialyzers knows where a cleaning liquid through the dialy generators and then with a preserve be filled and stored. With the be Known cleaning processes become the desired patient individual protein layers, however, at least partially  removed or chemically / biologically modified. Through this Changes in turn can result in immunological reactions be solved.

A protein can also be used in the tubing used layer reduces the risk of an immunological reaction become. In addition, common hoses (e.g. from PVC) partly using plasticizer additives poses. Small amounts of these plasticizers can be used during the Dialysis treatment in the patient's bloodstream hen. By maintaining a patient-specific len protein layer can plasticizer migration from the Tubes are reduced for the benefit of the patient.

The aim of the present invention is to represent a hygienically safe reusability or permanent usability of extracorporeal devices  len hemotherapy (including the tubing) ensure, removing and / or changing the patient-specific protein deposits can be avoided should.

For this purpose, a method according to the features is according to the invention of patient claim 1 provided.  

Expedient refinements of the invention result from the subclaims.

The fact that according to the invention as rinsing liquid at egg Used slide that has already been used lysing liquid or the used filtrate used will remain the desired patient-specific pro Tein deposits largely unchanged and whoever  Be at the same time clogging the dialyzer membrane parts washed out. Although it is "used" Dialysing fluid is hygienically not be conceivable, since the dialysis fluid is largely aseptic is and remains as long as it is extremely low in germs and low in pyrogens was applied and then no germs or pyro from the outside genes could get into the system. During dialysis itself no germs get into the dialysis fluid; much more has passed from the blood into the dialysis fluid gene urea on the contrary an additional bacteriostati effect.

Experiments have shown that the inventive method to maintain the usability of an already ver also applied equipment for extracorporeal hemotherapy compared to known methods, the risk of immunology reduced reactions. The facilities can therefore be used continuously (up to about 150 times).

Important for the successful application of the invention The procedure is that the entire facility during the Ver driving is kept almost germ-free. Germs can ent are associated with endotoxins and other substances, who also develop a fever without the presence of a bacterial germ can solve and known under the collective term "pyrogens" are. If the nucleation in the entire system fails to suppress is safe multiple use or Continuous use of the device for extracorporeal hemothe therapy and also the tubing is not possible because pyrogens have negative property, at the in the facilities add used membranes.  

However, the process according to the invention is almost germ Freedom guaranteed as contact with the ambient air negligible during the treatment and cleaning processes is low and the system is easy to clean.  

The invention is described below with reference to the drawing explained in detail.

The single figure shows a schematic representation of a Hemodialysis machine with a device for extracorporeal Hemotherapy and associated tubing, which after clotting gene modifications to carry out the invention Process is suitable.  

By using the same facility for both hemo dialysis as well as the subsequent preparation of the extra corporal device for hemotherapy is unnecessary Disassembly of the extracorporeal hemotherapy facility from the hemodialysis machine and subsequent assembly of the extracorporeal facility for hemotherapy on a geson derte treatment device, which means such fluid, saves time and also opens of the closed system with the risk of intrusion is largely avoided by germs.

In the device shown, the arterial blood is supplied through a line 1 during the dialysis process, is conveyed by a peristaltic pump 2 through a first flow path 3 a of a dialyzer and is returned to the patient via a line 4 , as indicated by the arrows in the drawing . In a second flow path 3 b of the dialyzer, a dialysis fluid flows. This is taken through a line 5 with a connector 6 opening into a container 5 a, a container 6 removed, passed through the flow path 3 b of the dialyzer and by means of a hose pump 7 arranged behind the flow path 3 b via a line 8 and a at 9a in the unte ren container area pipe 9 leading back into the container. The container is double-walled and has an inner container 6 a with an additional shell 6 b. The inner container 6 a and the sleeve 6 b are preferably made of transparent materials, for. B. the inner container made of glass and the shell made of a transparent polymer, so that a visual inspection is possible.

The line 5 for removing the dialysis fluid begins at 5 a in the upper container area. The return line 8 opens into the tube 9 arranged centrally in the container. So with the used dialysis fluid is filled with liquid liquid inside the container near the bottom of the container through the open end 9 a of the tube 9 is supplied. Wei terhin is the container for receiving an ultraviolet lamp 11 designed to ensure low germ and pyrogen ge.

In the dialysis process, excess liquid quantity is drained from the circuit of the dialysis fluid through an overflow 12 and is collected in a measuring vessel 13 .

The following will be used for modification before disconnecting the patient Steps performed to keep the dialyzer upright keeping the deposited protein layers to clean and to preserve so that multiple use or permanent use Use preferably with a new therapy of the concerned the patient:

Instead of the arterial patient connection, a bag with preferably physiological saline solution is connected at 1 . The hose pump 2 is operated until the flow path in the 3 a and in the supply lines 1 and 4 blood present is recycled into the bloodstream of the patient and are only small residual amounts of blood in the system.

Then the venous connection is also disconnected from the patient and the line 4 is also connected to the at least partially empty saline solution bag. This subsequently serves as a collecting reservoir for the backwashed liquid. In order to allow a flow through the hose connection 1 into the bag, the hose 1 is removed from the pump 2 . To carry out the backwashing process, the hose 5 is still completely closed by means of a clamp 14 a and the end of the circuit 5 a is removed from the container 6 , so that air as pressure compensation for the backwashing liquid removed through the open connection piece at 5 a in the container 6 can flow in. In addition, the overflow line 12 is closed ver. Finally, the conveying direction of the pump 7 is reversed by the direction of rotation of the pump motor is reversed or the tube 8 in the reverse direction in the impeller pump is inserted. 7

By working in the opposite direction pump 7 is now dialysis fluid from the lower part of the container 6 is removed. Air can flow into the container 6 through the open connection 5 a. In the chamber 3 b, a pressure gradient is built up relative to the chamber 3 a, whereby dialysis fluid is backwashed into the chamber 3 a. In this backwashing process, the corpuscular components present in the facility for extra corporal hemotherapy are loosened and flushed via lines 1 and 4 into the reservoir tank, while at the same time existing and desired patient-specific protein deposits in the facility for extracorporeal hemotherapy and in the Hoses 1 and 4 are retained. This process is carried out until further usability is ensured.

After the backwashing is completed, the Re is servoirbeutel removed, the hose 8 except that of the pump 7 forth and the terminal a 14 opened in the conduit 5, so that the end of the tube 5 is open. Since the device for extracorporeal hemotherapy is arranged higher than the container 6 , the chamber 3 b, which is still filled with backwash dialysis liquid, is emptied into the container 6 by gravity, which prevents unnecessary dilution of the disinfectant or corrosion agent to be added.

Finally, both chambers of the facility become extra corporal hemotherapy and the tubing with a desin Fection or preservation solution filled so that all critical areas of the system with disinfection or con come into contact with the food. In doing so, the conc tration of the disinfectant or preservative 0.01 to 0.02% per-acetic acid essential (approximately by the factor four to twenty) lower than for disinfectant solutions common for comparable applications. Since during the entire dialysis and preparation process due to the closed system in general no or only very small number of germs are introduced into the system, a weakly concentrated disinfectant solution is sufficient Kill these germs completely. This will make the spares desired protein deposits, d. H. e.g. B. un desired oxidation reactions avoided, whereby the Ver inertness for the patient is increased. Besides, that is Risk of disinfectant residues inadvertently in the A priori, the patient's bloodstream is reduced the lower the concentration of the disinfectant  is selected. The application staff has the commitment a lower disinfectant concentration speaking lower physical impairments to fol ge.

The device filled with disinfectant for extra corporal hemotherapy as well as the lead associated with it hoses are used until the next use preferably the same patient with whom the therapy was previously was carried out with the same device. The hose ends are disinfected and ver with adapters closed stored, with storage on use cooling devices can be dispensed with.

Before the next use of the facility for extrakorpo oral hemotherapy in preferably the same patient the disinfectant or preservative is removed. For safety reasons, this is preferably a three stage The first step is disinfection or preservative with pure water or a cook salt solution rinsed out. Then a vitamin C Solution added. Vitamin C may react before existing disinfectant residues to physiological sub punch (provitamin C and acetic acid). As a third step the blood side is then ge again before the start of therapy dialyzed against fresh dialysis fluid. Subsequently can start a new dialysis in the patient concerned be performed. In a procedure other than hemodia lyse is the third step through an adequate procedure to replace wisely.

Claims (7)

1. A method for maintaining the usability of an already used device for extracorporeal hemotherapy, in which used dialysis fluid or filtrate is obtained and in which at least one blood-side ( 3 a) and one non-blood-side ( 3 b) chamber is present and at that after the end of the therapy process, a rinsing liquid is passed through at least one chamber, characterized in that the used dialysis liquid or the filtrate which has been formed is used as the rinsing liquid. 2. The method according to claim 1, characterized in that the facility for extracorporeal hemotherapy during hoses assigned to the intended use even during the process of maintaining the Usability remain on this and with the rinse be flushed through liquid, so that a further usability of the hoses is guaranteed.   3. The method according to claim 1 or 2, characterized in that the non-blood-side chamber ( 3 b) in a container ( 6 ) collected rinsing liquid under greater pressure than that in the blood-side chamber ( 3 a), so that the rinsing liquid passes through the membrane and the blood-side chamber is thereby freed of components to be relieved or cleaned. 4. The method according to claim 1 or 2, characterized in that the blood-side chamber ( 3 a) in a loading container ( 6 ) collected rinsing liquid is supplied so that at least this chamber is freed from components to be relieved or cleaned. 5. The method according to claim 3 or 4, characterized in that the rinsing liquid from the blood-side chamber ( 3 a) through at least one line ( 1 , 4 ) is guided, which during the use of the device for the ex trakorporal hemotherapy process with the bloodstream communicated with the patient. 6. The method according to any one of claims 1 to 5, characterized ge indicates that the device for extracorporeal Hemotherapy and any tubing connected to it after rinsing with a compared to usual Disinfectant solutions of weakly concentrated disinfectants ons or preservation solution brought in contact the.   7. The method according to claim 6, characterized in that the disinfection or preservation solution as essential component about 0.01 to about 0.02% per Contains acetic acid.