DE3448262C2 - Method of testing sterilising filters of a haemodial filtration apparatus - Google Patents

Abstract

Published without abstract.

Description

The invention is based on a hemodia filtration device with the in the preamble of the patent demanding specified features as it from the Trans. Am. Soc. Artif. Intern. Organ (ASAIO), 1979, pp. 404-408, and has a method for testing sterile filters such an object.

In hemodiafiltration - similar to that in Hemodialysis - blood on the membrane of a hemofilter bypassed, with part of the serum through the Membrane is withdrawn. This share is through replaced a sterile substitution fluid that either upstream of the dialyzer (predilution) or downstream of the dialyzer (post dilution) extracorporeal bloodstream is added. In addition becomes the usual one in diafiltration Hemodialysis performed, d. H. it will be at the Membrane of the hemodialyzer dialysis fluid passed by, so that across the membrane Substitution of urinary substances takes place can.

Substitute solutions from Provided to manufacturers that Prepare infusion solutions and the like. As a result become relatively large-volume containers, the sterile and contain pyrogen-free substituate, from the manufacturer manufactured and then brought to the patient, which entails high costs, with the result that hemofiltration due to high Do not enforce substituate costs particularly well could.

Attempts have therefore already been made to Substitute solution on-line, i.e. H. bedside thereby produce that the usual dialysis fluid converted to the sterile and pyrogen-free state and the substituate thus obtained then the Feeds patients.  

According to the aforementioned ASAIO 1979, pp. 404-408, however, the feed pump is downstream of the two filters in the substituate pathway turned on, which is disadvantageous because the pressure drop across the two ultrafilters increases is high, with the result that this pump in Vacuum area works. This leads to the fact that usually flexible substituate line coincides, therefore no further funding for substitute solutions is more possible. In addition, this Degas the substituate solution again, what from medical reasons is highly undesirable.

Also from Trans. Am. Soc. Artif. Intern. Organ (ASAIO), 1978, Pp. 465-467, is the online production of a sterile and pyrogen-free substituate known, which thereby is made that the usual Proportioning unit for the production of the usual Dialysis fluids. In doing so, a Concentrate in a ratio of 1:34 with water mixed, the resulting The dialysis fluid is then degassed and heated and then fed two ultrafilters in series are switched. At the end of the second filter obtain sterile and pyrogen-free substituate, the is then supplied to the bloodstream.

In this type of production is the Feed pump upstream of the two ultrafilters, which is however, has also proven to be unsuitable. The Feed pump is namely on the pressure side of the first filter and thus promotes the upstream of the Ultrafilter contained in the dialysis fluid Particles and germs under pressure in the first Ultrafilter. As a result, the so-called "closed-end effect" achieved, d. H. the under pressure supplied particles put the ultrafilter relatively quickly, so that this arrangement does not work Has.  

These two articles do not describe how leakage in the sterile filters is guaranteed can be determined.

A hemofiltration system is known from EP-OS 42 939 known by the facilities mentioned above goes out, with the proviso that only an ultrafilter for Sterilization of the dialysis fluid is used. This filter needs to be monitored in order to detect any leak immediately. This relative complicated setup is used in the above systems mentioned by the arrangement of two filters eliminated what is essential for economic reasons more advantageous and also technically still is easier.

The invention is based on the object Procedure for checking the sterile filter Hemodiafiltration device of the type mentioned to create with these filters quickly and safely can be checked for leaks.

This object is achieved with the method according to the patent claim.

Accordingly, to check the tightness of the Sterile filter of the hemodiafiltration device Commissioning of the ultrafiltration pump air over a hydrophobic, microporous filter in the first Chamber of the second sterile filter and in the second  Conveyed chamber of the first sterile filter, wherein by means of a pressure gauge, the negative pressure in the Sterile filters are measured.

Here, the connecting line from the Substitute pump taken.  

Based on the following description tion examples of the invention with reference to the drawing, tert.

The drawing shows a schematic representation of a hemodiafiltra tion device with two sterile filters, between which a substituate pump is arranged.

In the figure, 10 shows a hemodiafiltration device which has a conventional dialyzer 12 , which is separated by a membrane 14 into a chamber through which dialysis fluid 16 flows and into a chamber 18 through which blood flows.

The chamber 16 is switched into a dialysis fluid path 20 , which consists of a supply line 22 and a line 24 from .

While one end of the feed line 22 is connected to the input of the dialyzer 12 , the other end of the feed line 22 is connected to a unit 26 for providing dialysis fluid.

This unit 26 provides the usual dialysis fluid, for example based on bicarbonate.

In the supply line 22 a due to standardize Bilanzierein 28 balance chamber 30 is further turned on. This balancing chamber 30 is connected on the one hand via the line section 32 to the unit 26 for providing the dialysing liquid and, on the other hand, via a line section 34 with a dialysator valve 36 connected to the supply line 22 . Upstream of the dialyzer valve 36 , a bypass line 38 extends from the line piece 34 , into which a bypass valve 40 is switched on and which is connected to the discharge line 24 .

From the dialyzer valve 36 a further line piece 42 goes off, which is connected to a first sterile filter 44 . This sterile filter is divided by a membrane 46 into a first chamber 48 and a second chamber 50 .

From the outlet of the first chamber 48 a further line piece 52 goes off, which can be connected to the input of the dialyzer 12 by means of a connector 54 located at its end. In the drawing, this connector piece 54 is shown in the disconnected state, while the connection state is shown by a dashed line.

Downstream of the chamber 16 there is a derivation 24 , which can be connected to the chamber 16 via a connector part 56 located at the end of the derivation 24 .

Both connector parts 54 and 26 - as shown by the dash-dotted line - can be connected, ie the supply line 22 and the discharge line 24 can be short-circuited to bypass the dialyzer 12 .

Furthermore branches off from the derivative 24 a connec tion line 58 , the end of which is provided with a connector 60 which is closed in the unoccupied state.

The supply line 24 is also connected to a pressure measuring device 62 , via a branch line 64 with an ultrafiltration device 66 and with a circulating pump 68 .

Finally, downstream of the connection of the derivation 24 to the bypass line 38, the second balancing chamber 70 of the balancing chamber system 28 is switched into the derivation 24 , to which the drain 72 of the derivation 24 is connected.

Accordingly, the line system extending from the balancing unit 28 , which is guided through the dialyzer 12 , is a hydraulically closed unit, as has already been described in DE-PS 28 38 414, reference is made to the explanations thereof and to the subject of this Description is made.

As already mentioned above, a first sterile filter 44 is arranged in the feed line 22 . From the second chamber 50 of this sterile filter 44 a connecting line 74 goes into which a substituate pump 76 is switched on and which is connected to a second sterile filter 78 .

This second sterile filter has a membrane 80 which divides the second sterile filter 78 into a first chamber 82 and a second chamber 84 . The first chamber 82 is connected to the connecting line 74 . Furthermore, the first chamber 82 is connected to a compensation chamber 86 , the upper end of which is closed with a hydrophobic sterile filter 88 .

The second chamber 84 of the second sterile filter 78 has a derivative 90 which has a connec tion piece 92 at its end. This derivation 90 can be connected to a further line piece 94 via a complementary connecting piece 96 , into which a further sterile filter 98 is switched on. The membrane provided in this sterile filter 98 advantageously has a pore size of approximately 0.2 μm. Finally, the end of the line piece 94 is provided with a connector 100 which is complementary to the connector 60 .

The line piece 94 , the connector 96 , the sterile filter 98 and the connector 100 form a disposable disposable item.

The chamber 18 of the dialyzer 12 through which blood flows has a blood path 102 which is composed of a supply line 104 and a discharge line 106 . To line 104 has at its end a connector 108 which can be connected to the patient's body. Furthermore, a blood pump 10 is switched on in the feed line 104 .

The derivative 106 also has at its end a connector 112 , which in turn can be connected to the patient's body. Furthermore, both connectors 108 and 112 can be combined to form a connector (single-needle).

In the derivation 106 , a venous drip chamber 114 is also turned on, which contains on its upper side a connector 116 which is complementary to the connector 100 of the substituate line.

The hemodiafiltration device 10 is operated in the following way:

The unit 26 first provides dialysis fluid in the usual way. The balance chamber 30 promotes a certain volume of dialysis fluid speed in the closed circuit, provided that the dialyzer valve 36 is open and the bypass valve 40 are closed. The balanced amount of dialysis fluid flows through the line section 42 , the first chamber 48 of the sterile filter 44 , the line section 52 , through the first chamber 16 of the dialyzer 12 and through the derivation 24 to the second balancing chamber 70 and from there into the drain 72 . The balance chamber 70 delivers the same volume from the closed circuit.

In addition, the ultrafiltration device 66 can be operated. As a result of the constant volume of the dialysis fluid circuit, the amount of fluid pumped out through the ultrafiltration device 66 is immediately removed from the bloodstream through the membrane 14 of the dialyzer 12 .

This mode of operation thus corresponds to a normal one Hemodialysis, as described for example in DE-PS 28 38 414 is described.

In order to carry out the hemodiafiltration, the connector 100 is connected to the venous drip chamber 114 via the connector 116 . Thus, a direct connection between the supply line 22 of the dialysis fluid circuit and the blood path 102 is thus created. This direct connection is thus via the connec tion line 74 , the derivative 90 and the line piece 94 , these lines being connected to sterile filters 44, 78 and 98 , respectively.

The substituate pump 76 is now started up at a specific pumping rate. Thus, a certain amount of dialysis fluid is sucked from the first chamber 48 through the membrane 46 into the second chamber 50 of the first sterile filter 44 , from there through the connecting line 74 into the first chamber 82 of the second sterile filter 78 , from there through the Membrane 80 into the second chamber 84 of the sterile filter 78 and finally through the discharge line 90 , the line piece 94 and through the sterile filter 98 switched into the line piece 94 into the venous drip chamber 114 , as indicated by the dash-dotted line (connection of the connection pieces 100 and 116 ) is shown. However, it is also conceivable that the line piece 94 is connected upstream of the dialyzer 12 to the blood path 102 , as is also shown by the dashed line.

As already explained above, the dialysis liquid circuit between the balancing system 28 and the dialyzer 12 is a closed system. Due to the action of the substituate pump 76 , a certain amount of liquid is withdrawn from this closed system, which inevitably from the blood through the membrane 14 in turn is removed. Accordingly, a certain amount of serum liquid is taken from the patient's blood in the dialyzer 12 and is replaced downstream of the dialyzer in the venous drip chamber 114 by an equivalent amount of substituate solution (diafiltration). In a similar way, however - as already explained above - a certain amount of substituate solution can be added to the blood upstream of the dialyzer, which solution is withdrawn again in the dialyzer.

It has now been found that the particles can be effectively trapped in the first sterile filter without fear of clogging or a significant drop in performance in the first sterile filter 44 after several treatments.

Furthermore, in the second sterile filter 78 , the pyrogens passed through the first sterile filter 44 are effectively intercepted, with the result that no side effects generated by pyrogens could be determined in the patient.

The interposition of the substituate pump between the two sterile filters 44 and 78 does not add up the negative pressures with which the two sterile filters would have to be operated. As explained at the outset, this leads to a total negative pressure downstream of the two sterile filters through the summation of the individual negative pressures, which leads to undesired further degassing of the substituate solution and, moreover, to a collapse of the hose system.

In addition to the diafiltration a conventional ultrafiltration who, so that not only the blood with substituate can be "washed" to, but also the blood of one be agreed ultrafiltration amount can be withdrawn can made with the inventive hemodiafiltration by ultra filtration device 66th

This hemodiafiltration device 10 is - as explained below - disinfected, rinsed, checked and vented in the following way:

Disinfect

It is assumed that dialysis and rinsing were carried out beforehand; the first time you set up or change the sterile filter 44 and 78 , you must start with the "venting" procedure. For this purpose, the connector 100 is connected to the connector 60 . At the same time, the dialysis fluid circuit has been short-circuited by the connection of the two connector pieces 54 and 56 . The blood system itself is out of order. The hemodialysis machine 10 is now infected in accordance with the disinfection program, the substituate pump 76 being operated at a certain rate, for example about 200 ml / min. Advantageously, the substituate pump 76 moves in time to the bypass valve 40 , which is connected to the dialyzer valve 36 in push-pull. Accordingly, the substituate pump 76 sucks disinfectant solution provided by the unit 26 from the first Sterilfil ter 44 into the second sterile filter 78 , in which the liquid level in the compensation chamber 86 is up to the hydrophobic ben sterile filter 88 . Then disinfectant solution from the second sterile filter 78 is pressed through the sterile filter 98 into the derivative 24 of the dialysis fluid path 20 . In this disinfection step, the balance in the closed system is retained.

do the washing up

The hemodiafiltration device 10 is then switched to "rinsing", the unit 26 now providing fresh water. It is rinsed until the disinfectant solution has been safely replaced with fresh water from the entire system.

Check

In order to check the hemodiafiltration device 10 , the tubular connecting line 74 is taken out of the sub stituate pump 76 . Otherwise the arrangement mentioned above (short circuit; without switching on the dialyzer) is retained.

In order to check whether the two sterile filters 44 and 78 are intact, the ultrafiltration pump 66 is put into operation when the balancing chamber system 28 is switched off. Since the closed system is only connected to the environment via the hydrophobic micro-porous sterile filter 88 , air flows into the first chamber 82 of the second sterile filter 78 and through line 74 into the second chamber 50 of the first sterile filter 44 . Since the two membranes 46 and 80 of the two sterile filters 44 and 78 are wetted with water, the inflow of air cannot escape through the wetted filters, so that there is the possibility of any cracks present in the membranes 46 and 80 using the Check negative pressure, which is generated by the ultrafiltration pump 66 he. This can be followed ver on the pressure gauge 62 .

With the dialysis fluid circuit intact and the sterile filters intact, a certain time (for example about 2 minutes) is waited for after a negative pressure of about 520 mm Hg has been reached. The pressure on the pressure measuring device 62 is then observed and the time it takes for the pressure to rise to a negative pressure from about 500 to 400 is stopped. If this time is greater than about 1 minute, the sterile filters 44 and 78 are considered to be tight. If the time should be shorter, either one or both filters and / or the dialysis fluid system are leaking. This step is practically identical to the first step of the pressure maintenance test to check the integrity of the balancing system.

Vent

After the test stage, the ventilation takes place. H. the The entire system is filled again with dialysis fluids liquidity.

For this purpose, the connector 100 remains on the downstream of the dialyzer 12 in the derivative 24 arranged Ver connecting line 58 , while the connecting line 74 is again inserted into the substituate pump 76 . To line 22 and derivative 24 remain in the short circuit.

The balance chamber system 28 is operated with a normal program and the unit 26 in turn provides dialysis liquid.

Furthermore, the blood side is filled with physiological saline solution in that the two connections 108 and 112 are connected with a bag filled with saline solution and the blood pump 110 is started up. This bag must contain so much solution that the entire blood system can be filled with it, with additional storage of about half a liter of saline solution should remain in the bag.

As soon as the supply and discharge lines 22 and 24 are filled with dialysis liquid, the two chambers 50 and 82 of the sterile filter 44 and 78 remaining filled with air, the short-circuit connection between the connector pieces 54 and 56 is canceled, this with the chamber 16 of the chamber Dialyzer 12 are connected. Furthermore, the connector 100 is separated from the connector 60 , where the latter is closed.

Now the dialysis fluid circuit is switched on again and the substituate pump 76 is started up at a predetermined rate (about 100-200 ml / min). The end of the sterile filter 98 or the connector 100 remains open and is brought into a position which is above that of the hydrophobic sterile filter 88 . Furthermore, the connection 100 is connected to a collecting container since liquid will escape from the sterile filter 98 .

During normal operation of the balancing system 28 , the substituate pump 76 first conveys the air from the chambers 50 and 82 through the hydrophobic, microporous sterile filter 88 , at the same time the volume of air conveyed out being replaced by dialysis liquid which is removed from the chamber 44 . As a result of the constant volume of the closed system, a corresponding amount is removed by ultrafiltration from the chamber 18 of the dialyzer 12 , ie directly from the saline bag.

After removal of the air from the chamber 50 , the air is also forced out of the chamber 82 through the sterile filter 88 . The compensation chamber 86 provided between the chamber 82 and the sterile filter is intended to prevent the hydrophobic sterile filter 88 from becoming tight even through the first drops of liquid.

As soon as the chamber 82 is completely filled with dialysis liquid or substituate solution, liquid emerges from the sterile filter 98 . The substituate pump 76 and the blood pump 110 are stopped when this escaping liquid is substantially free of air. The connection between the connecting pieces 92 and 96 is then separated, the sterile filter 98 being discarded and replaced by a new sterile filter. At closing, the new connector 100 is connected to the venö sen drip chamber 114 via the connector 116 .

In order for this procedure to work, you must At the beginning of the filling phase the blood circulation is put into operation be and recirculate the saline.

If necessary, a sample can be taken to replace the sterile filter 98 and the connection of the connector 100 to the venous drip chamber 114 in order to check it for the sodium content, or the conductivity can be determined. For this purpose, a conductivity cell, as shown in broken lines at 118 , can be permanently provided in the lead 90 , if necessary.

As mentioned below, a peristaltic peristaltic pump is advantageously used as the substituate pump 76 . On the other hand, however, instead of one of the hose pumps like this, another pump, for example a gear pump that is not fully occluding, can be used. In this case, it is no longer necessary to check that the hose is removed from the pump. Thus, both the supply hose and the discharge hose remain connected to one of the pumps.

As shown in the figure, the connector 100 can be connected both to the connector 116 of the drip chamber 114 (post-dilution) and to the supply line 104 downstream of the blood pump 110 . For this purpose, a hose line 118 branches off from the supply line 104 and is connected to a connecting piece 120 . This connector 120 can be connected to both the connector 92 of the derivative 90 and the connector 100 in a complementary manner.

In such a case, there is a pre-dilution.

According to a further embodiment, both the pre-dilution and the post-dilution can be carried out, the substituate liquid generated being divided accordingly. For this purpose, a y-shaped line piece 122 is provided, in which the main branch 124 is divided into the two side branches 126 and 128 . Each of these branches 124-128 is provided at its end with a connector 130, 132 and 134 , respectively.

The connector 130 can either be connected to the connecting piece 92 or to the connecting piece 100 , while the connecting pieces 132 or 134 can be connected to the connecting piece 116 of the drip chamber 114 or to the connecting piece 120 of the supply line 104 .

In order to be able to use the substituate stream generated both for pre-dilution and for post-dilution, at least one pump is switched into one of the side branches 126 or 128 . As shown in the figure, a pump 136 , which is advantageously designed as a peristaltic pump, is switched into the pre-dilution side branch 128 . This pump 136 takes a certain partial flow from the total substate stream, while the rest is fed through the second side branch 126 to the drip chamber 114 . On the other hand, however, the pump 136 in the other branch 126 can also be switched on or two pumps can be seen in both side branches.

According to a further exemplary embodiment, the pump 136 can be dispensed with if the pump 76 is designed as a peristaltic double-hose pump. In this case, one of the side branches 126 or 128 is inserted into the hose pump 76 simultaneously with the hose-shaped connecting line 74 , it being necessary to ensure that the ratio of the total flow to the partial flow is determined on the basis of the differences in the hose inner diameter or hose cross-section.

Claims (1)

Method for checking sterile filters of a hemodiafiltration device which has a dialyzer ( 12 ) which is divided by a membrane ( 14 ) into two chambers ( 16, 18 ), of which the first chamber ( 16 ) into a dialysis fluid path ( 20 ) and the second chamber ( 18 ) is connected into a blood path ( 102 ), and the dialysis fluid path ( 20 ) comprises a feed line ( 22 ) which extends from a device ( 26 ) for providing dialysis fluid to the dialyzer ( 12 ) and a discharge line ( 24 ), which extends from the dialyzer ( 12 ) to the drain ( 72 ), and which further comprises a pump ( 68 ) for conveying the dialysis fluid in the dialysis fluid path ( 20 ), an ultrafiltration device ( 64, 66 ) provided in the dialysis fluid path ( 20 ) , a connecting line ( 74 ) leading from the supply line ( 22 ), which is connected to the blood path ( 102 ), a first sterile filter ( 44 ), one chamber ( 48 ) of which in d he supply line ( 22 ) is placed and from the other chamber ( 50 ) the connecting line ( 74 ) goes out, a second sterile filter ( 78 ) which is connected in the connecting line ( 74 ) such that the interior of the connecting line ( 74 ), the the second chamber ( 50 ) of the first sterile filter ( 44 ) and the first chamber ( 82 ) of the second sterile filter ( 78 ) are in flow communication with one another to form a common space ( 50, 74, 82 ), and a substituate pump ( 76 ) in the connecting line ( 74 ), characterized in that

• - The membranes ( 46, 80 ) of the sterile filter ( 44, 78 ) are wetted with liquid,
• - the dialysis fluid path ( 20 ) is short-circuited to a closed circuit,
• - The end of the connecting line ( 74 ) is connected to the dialysis fluid path ( 20 ),
• the closed space ( 50, 74, 82 ) is connected to the surroundings via a hydrophobic microfilter ( 88 ),
• - The ultrafiltration device ( 66 ) pumps out the liquid present in the dialysis fluid path, so that the space ( 50, 74, 82 ) fills with air until a certain lower pressure occurs,
• - And that the negative pressure is observed over a certain period of time by means of a pressure measuring device ( 62 ) connected to the closed dialysis circuit ( 20 ).