Method to control a blood treatment apparatus and devices after the conclusion of treatment

Abstract

The present invention relates to a method for controlling a blood treatment apparatus to automatically move it into a certain state after completion of the treatment of a patient carried out with the blood treatment apparatus. It also relates to a control and regulating device and a treatment apparatus. It further relates to a computer program, a computer program product as well as a digital storage medium.

Claims

1. A method for controlling a blood treatment apparatus, the blood treatment apparatus comprising (i) a blood pump for transporting blood in an extracorporeal blood tube set and (ii) a dialysis fluid pump for conveying dialysis fluid in a dialysis fluid circuit having a dialysis fluid supply tube which is adapted to be interrupted via a dialysis fluid supply tube clamp and a dialysis fluid drain tube which is adapted to be interrupted via a dialysis fluid drain tube clamp, wherein the extracorporeal blood tube set (a) comprises an arterial section comprising or connected to at least one of an arterial needle or an arterial patient tube clamp, (b) comprises a venous section comprising or connected to at least one of a venous needle or a venous patient tube clamp, and (c) comprises or is connected to a blood filter arranged between the arterial section and the venous section, the blood filter comprising a membrane which separates a blood chamber from a dialysis fluid chamber, the method comprising: (a) closing the arterial patient tube clamp and the venous patient tube clamp; (b) conveying the dialysis fluid via the dialysis fluid pump; (c) opening the venous patient tube clamp; (d) closing the dialysis fluid drain tube; (e) inhibiting or stopping a flow of the dialysis fluid, in particular, when a pre-defined or a predetermined first volume has passed through the membrane, wherein the pre-defined or the predetermined first volume is minus or less than a second volume, wherein the second volume corresponds to a volume of the arterial section up to an inlet of the blood filter; (f) closing the venous patient tube clamp; (g) conveying the dialysis fluid via the dialysis fluid pump; (h) opening the arterial patient tube clamp while the dialysis fluid drain tube is closed; (i) optionally reducing the flow rate via the dialysis fluid pump; (j) closing the arterial patient tube clamp; (k) stopping the dialysis fluid pump when the second volume has been delivered or air or clots have been detected via a sensor; the method further comprising: (A) (l) starting the dialysis fluid pump or an ultra-filtration pump located downstream of the blood filter; (m) closing or holding or keeping closed the dialysis fluid supply tube; (n) opening the dialysate fluid supply tube clamp; (o) closing or holding or keeping closed the arterial and the venous patient tube clamps; (p) opening a vent valve; (q) sucking or aspirating dialysis fluid over the membrane and out of the extracorporeal blood tube set via the dialysis fluid pump; (r) opening the dialysis fluid drain tube; (s) introducing gas into a connecting line to a venous pressure sensor, which gas is configured to displace the dialysis fluid through the membrane into the dialysis fluid outlet side; (t) optionally emptying a dry bicarbonate concentrate container; (u) stopping the dialysis fluid pump; (v) closing the arterial patient tube clamp and the venous patient tube clamp if the clamps are open; and (w) outputting an alarm or indication that the method is finished; or (B) (l) starting the dialysis fluid pump or an ultra-filtration pump located downstream of the blood filter; (m) closing or holding or keeping closed the dialysis fluid supply tube; (n) opening the dialysis fluid supply tube clamp; (o) closing or holding or keeping closed the arterial and the venous patient tube clamps; (p) opening a vent valve; and (q) sucking or aspirating dialysis fluid over the membrane and out of the extracorporeal blood tube set via the dialysis fluid pump; or (C) (r) opening the dialysis fluid drain tube; and (s) introducing gas into a connecting line to a venous pressure sensor, which gas is configured to displace the dialysis fluid through the membrane into the dialysis fluid outlet side.

2. The method according to claim 1, further comprising: stopping the blood pump if a predetermined timing, duration of treatment, value of dialysis dose, or amount of ultra-filtration is reached.

3. The method according to claim 1, further comprising: ejecting a blood tube section of the extracorporeal blood tube set.

4. The method according to claim 1, wherein the dialysis fluid rate is automatically adjusted in step (b).

5. The method according to claim 1, further comprising at least one of: separating at least one of a dialysate connector or an on-line connector or inhibiting, via at least one valve, a fluid communication between the connectors and hydraulics; or disconnecting the container with dry bicarbonate concentrate from the hydraulics or preventing fluid communication between the container and the hydraulics.

6. The method according to claim 5, wherein disinfection is continued and terminated after detecting that the dialysate tubes have been connected to the machine, the online connector is in the rinsing position and the container of dry bicarbonate concentrate has been removed.

7. The method according to claim 1, further comprising: calculating the pre-defined or the predetermined first volume to the ultra-filtration amount.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows schematically simplified an apparatus according to the present invention to perform the method according to the present invention.

(2) FIG. 2 shows schematically in a flow diagram, the steps of the method according to the present invention in a first exemplary embodiment.

DETAILED DESCRIPTION

(3) FIG. 1 shows schematically simplified of a blood treatment apparatus 1 according to the present invention which is connected to a blood tube set 3. The blood tube set 3 has an arterial section 5 with an arterial needle 5a and an arterial patient tube clamp 5c. The blood tube set 3 further comprises a venous section 7 with a venous needle 7a and a venous patient tube clamp 7c.

(4) The blood tube set 3 has or comprises a blood filter 9 with a membrane 11, for example a semi-permeable membrane. The membrane 11 divides the blood filter 9 into a blood chamber 13 and a dialysis fluid chamber 15.

(5) The blood treatment apparatus 1 comprises or has a blood pump 17. The blood tube set has or comprises a venous drip chamber 19. The blood treatment apparatus 1 has a control or regulating device 21 or is connected to it. The control or regulating device 21 is connected to all components of the blood treatment apparatus 1 or of the blood tube set 3, or both, on which it must act to perform the method according to the present invention.

(6) Both the arterial needle 5a and the venous needle 7a are connected to the vascular system of a patient 35. The blood tube set 3 comprises optionally an arterial air bubble detector 37 or a venous blood sensor 39 or both.

(7) The blood treatment apparatus 1 further comprises a conveying device with at least one dialysis fluid pump 18 for conveying dialysis fluid within a closed or open dialysis fluid circuit 4. The dialysis fluid circuit 4 has a dialysis fluid supply tube 6 which can be closed by means of a dialysis fluid supply tube clamp 6c of the blood treatment apparatus 1 and a dialysate drain tube 8 which can be closed by means of a dialysate drain tube clamp 8c of the blood treatment apparatus 1. The control or regulation device 21 is connected to all components of the conveying device or the dialysis fluid circuit 4, or both, with which it must interact to carry out the method according to the present invention.

(8) The arterial section 5 of the blood tube set 3 has or comprises a blood tube section 5d.

(9) The venous drip chamber 19 has a venting valve 19d.

(10) Additionally, the venous drip chamber 19 is connected with a tube or connecting tube, which is connected to a compressor 19g via an optionally provided sterile filter 19e and an optional present valve 19f. Additionally, this same tube is connected to a venous pressure sensor 19h in the exemplary embodiment shown here.

(11) The elements 19e to 19h are shown for illustration purposes within the blood tube set 3. They can also, however, separately or together be part of the blood treatment apparatus 1. This is especially true for the compressor 19g, the valve 19f and pressure sensor 19h.

(12) FIG. 2 shows schematically simplified a flow diagram of the sequence of the method according to the present invention in a first exemplary embodiment.

(13) The method begins in this embodiment, in step a) with the closing of the arterial patient tube clamp 5c and of the venous patient tube clamp 7c.

(14) In step b) the flow of dialysis fluid delivered by means of the dialysis fluid pump 18 is reduced or adjusted automatically to a pre-determined value.

(15) The pre-determined value can correspond to that of the known rinse back process (e.g. 100 ml/min). Step b) can in particular directly follow step a).

(16) The optional step b1) provides for the dialysis fluid flow being constant or not constant in step b). The latter can for example be effected by means of a pulsating variation, with the aim of freeing cell and protein elements deposited in the fibre volume of the blood filter 9.

(17) In step c) the venous patient tube clamp 7c is opened, which has been closed in step a) to obtain a so-called safe condition of the blood treatment apparatus at the close of the blood treatment.

(18) In step d) the dialysate outlet of the blood filter 9 is closed. This can be done by, for example, closing a dialysate supply tube 8 with dialysate supply tube clamp 8c. Thus dialysis fluid enters the lumen of the blood filter 9 through the membrane 11 out of or from the dialysis fluid circuit 4 and finally from there through the venous section 7 into vascular system of the patient 35.

(19) Step e) provides for stopping, interrupting or inhibiting flow of dialysis fluid reached or conveyed or delivered by the dialysis fluid pump 18. This can be done by controlling or altering or stopping the dialysis fluid pump 18. Alternatively or additionally, this can also be done by altering or closing the flow path of the dialysis fluid.

(20) The stopping interrupting or inhibiting in certain embodiments according to the present invention is achieved in particular when (if) a first volume less a second volume has passed over or through the membrane 11. The first volume may correspond to a pre-determined value which would be set for example by the staff of the dialysis treatment apparatus. Its value may be defined as above. Its size can be determined automatically by the treatment apparatus and/or taken from lists. The second volume, also referred to as a delta, corresponds to the volume of the entire arterial section 5 of the extracorporeal blood circuit 3 as far as the inlet of the blood filter 9.

(21) Before, with or after step e) the venous patient tube clamp 7c is closed in a step f).

(22) In turn, in optional step f1)as part of an alternative possibilitya blood tube section 5d of the blood tube set 3 inserted into the blood pump 17, is ejected by a suitable device, for example, the so-called ALPHA-clip, or released automatically from the blood pump 17 by other means.

(23) In the subsequent step g) dialysis fluid is conveyed by means of the dialysis fluid pump 18 with previously, simultaneously or subsequently opened arterial patient tube clamp 5c (step h), and further closed dialysate drain, such as closed dialysate drain tube 8.

(24) In optional step i), the conveying rate of the dialysis liquid pump 18 is reduced. It thus advantageously releases as few clots as possible. The reduced conveying rate may in turn be for example, 50% of the treatment conveying rate, see above.

(25) In step j), the arterial patient tube clamp 5c is closed.

(26) In step k) the dialysis fluid 18 is stopped oralternatively or additionallyanother measure to prohibit the dialysis fluid flow is taken as soon as the second pre-determined volume has been delivered by means of dialysis fluid pump 18. The second pre-determined volume may be the arterial rinse back volume. Alternatively the detection of air bubbles or blood clots by means of the corresponding sensors is promoted.

(27) The method further comprises, optionally, the following steps, or alternatively the steps l) to q), or the steps r) and s):

(28) In step l), for example situated downstream of the blood filter 9, a not shown, ultra filtration pump or an also not shown dialysis fluid pump (or, more correctly dialysate pump) is started. The dialysis fluid supply tube 6 is kept or held closed (step m)). The dialysis fluid tube clamp 8c is opened. The arterial and venous patient tube clamps 5c, 7c are kept or held closed (step o)).

(29) In some embodiments according to the present invention, for step l) the ultra-filtration pump (not shown in the figures) is set in operation to empty according to step l. Again, alternatively, in certain embodiments of the present invention for step l) the compressor 19g (see FIG. 1) is put into operation. Finally, a combined use of (any) two or three of the aforementioned pumps may be used for emptying the lumen in step l).

(30) In step p) a vent valve 19d is opened. By way of example, the vent valve can be provided in the venous drip chamber 19 or in a connecting line to the venous drip chamber 19 which comprises a venous pressure transducer and/or a venous pressure sensor 19h.

(31) In step q), by means of the dialysis fluid pump 18, the dialysis fluid is sucked over the membrane 11 out of the blood tube set 3.

(32) In optional step t) the container of dry bicarbonate concentrate (not illustrated) is emptied.

(33) In the alternative or complementary steps r) to s) the dialysate drain tube 8 is opened (step r)).

(34) In step s) gas, such as air, is introduced into the connecting tube comprising the venous pressure sensor 19h, or in another position, for example by means of the compressor 19g. The gas displaces the dialysate through the membrane 11 into the dialysis fluid chamber 15. From there it passes through the dialysate drain tube and an opened valve into the drain.

(35) With step t) the container with dry bicarbonate concentrate is emptied

(36) Afterwards the method comprises stopping the dialysis fluid pump 18 (step u)), the closing of arterial patient tube clamp 5c, venous patient tube clamp 7c, possibly also of substituate clamp (infusate clamp), if not already accomplished (step v), and outputting an alarm or indication to inform the dialysis staff of the end of the process (step w). The step w) is in certain embodiments according to the present invention the final step of the method. In some embodiments according to the present invention, it is provided for the process to be already finished at one of the steps k) to u).

(37) It should be noted that the sequence of steps, as set forth with reference to FIG. 2 is exemplary only. In fact, steps, though they are described successively, according to the present invention may also occur in other or reverse order, in so far as this is valid from the perspective of one skilled in the art. This is especially true for or particularly applies to the steps c), d) and e). The present invention also comprises other sequences and parallel course of the steps. The foregoing also applies to the steps i) and g). They can also be performed in parallel or in reverse order.

REFERENCE NUMBER LIST

(38) TABLE-US-00001 Reference number Description 1 Blood treatment apparatus 3 Blood tube set 4 Dialysis fluid circuit 5 Arterial section 5a Arterial needle 5c Arterial patient tube clamp 5d Blood tube section 6 Dialysis fluid supply tube 6c Dialysis fluid supply tube clamp 7 Venous section 7a Venous needle 7c Venous patient tube clamp 8 Dialysate drain tube 8c Dialysate drain tube clamp 9 Blood filter 11 Membrane 13 Blood chamber 15 Dialysis fluid chamber 17 Blood pump 18 Dialysis fluid pump 19 Venous drip chamber 19d Vent valve 19e Sterile filter 19f Valve 19g Compressor 19h Pressure sensor 21 Control or regulating device 35 Patient 37 Air bubble detector 39 Venous blood sensor