MEDICAL TREATMENT APPARATUS WITH OVERPRESSURE IN THE PORT
20230398273 · 2023-12-14
Inventors
- Juergen Haecker (Bad Homburg, DE)
- Burkard Keller (Bad Homburg, DE)
- Peter Kloeffel (Bad Homburg, DE)
- Martin Thys (Bad Homburg, DE)
- Nico Roemmelt (Bad Homburg, DE)
- Alfred Gagel (Bad Homburg, DE)
- Soeren Gronau (Bad Homburg, DE)
Cpc classification
A61M2205/3337
HUMAN NECESSITIES
International classification
Abstract
The present disclosure relates to a medical treatment apparatus which includes at least one port, a device for closing, a compressed-air source and a control device and/or closed-loop control device. The port serves to establish fluid communication between at least one fluid line of the treatment apparatus associated with the interior of a treatment apparatus and a connector of a fluid line of a disposable associated with the exterior of the treatment apparatus. The sealing device is designed as a rinsing cap and serves to seal an interior of the port with respect to an exterior of the treatment apparatus. The compressed-air source is used to introduce air into the port along at least one sterile-air line. The control device and/or closed-loop control device is programmed to cause the compressed-air source to build-up and/or maintain a predetermined minimum overpressure in the sterile-air line, the compressed-air source and/or inside the port.
Claims
1-15. (canceled)
16. A medical treatment apparatus comprising: at least one port for establishing fluid communication between at least one fluid line of the medical treatment apparatus assigned to an interior of the medical treatment apparatus and a connector of a fluid line of a disposable assigned to an exterior of the medical treatment apparatus; a sealing device for sealing an interior of the port vis-à-vis the exterior of the treatment apparatus; a compressed-air source for introducing air or sterile-air into the port along at least one sterile-air line; and a control device and/or closed-loop control device programmed to cause the compressed-air source to build-up and/or maintain a predetermined minimum overpressure in the sterile-air line, in the compressed-air source and/or inside the port.
17. The medical treatment apparatus according to claim 16, wherein the sealing device comprises a rinsing cap.
18. The medical treatment apparatus according to claim 16, wherein the control device and/or closed-loop control device is programmed, upon reaching a predetermined program section of a program run by the control device and/or closed-loop control device for controlling or regulating the treatment apparatus, to cause the compressed-air source to build-up and/or maintain the predetermined minimum overpressure in the sterile-air line, in the compressed-air source, and/or inside the port.
19. The medical treatment apparatus according to claim 16, wherein the compressed-air source comprises or is a compressor and/or a compliance vessel.
20. The medical treatment apparatus according to claim 16, wherein the control device and/or closed-loop control device is programmed to not further increase the pressure in the sterile-air line, the compressed-air source, and/or the port once the predetermined minimum overpressure is reached.
21. The medical treatment apparatus according to claim 16, further comprising a detection device for detecting that an action to close and/or to open the port vis-à-vis the exterior of the treatment apparatus is about to happen, is taking place, or has just taken place, and for emitting a corresponding signal to the control device and/or closed-loop control device which is programmed, upon receiving the signal, to cause the compressed-air source to build-up and/or maintain the predetermined minimum overpressure.
22. The medical treatment apparatus according to claim 21, wherein the detection device comprises: a pressure sensor arranged for determining the pressure prevailing in the sterile-air line, the compressed-air source, and/or the port and for collecting a pressure value when doing so; and/or a switch; and wherein the detection device evaluates a pressure profile or a pressure change that results from pressure values measured via the pressure sensor at different times, and/or registers the actuation of the switch, in order to emit a signal based on the evaluation of the pressure profile or the pressure change and/or based on the actuation of the switch.
23. The medical treatment apparatus according to claim 16, wherein the control device and/or closed-loop control device is programmed to generate an overpressure in the sterile-air line, the compressed-air source, and/or in the port, after the overpressure has been generated, to determine a pressure drop or a pressure drop rate, and based on the determined pressure drop or pressure drop rate, to determine when pressure is to be built up again using the compressed-air source in order to achieve or maintain at least or precisely the minimum overpressure.
24. The medical treatment apparatus according to claim 23, wherein the overpressure comprises the predetermined minimum overpressure.
25. The medical treatment apparatus according to claim 16, further comprising a negative pressure source which is in fluid communication with the port, wherein the control device and/or closed-loop control device is programmed to generate negative pressure in the port or to lower a pressure prevailing in the port.
26. The medical treatment apparatus according to claim 25, wherein the control device and/or closed-loop control device is programmed to generate the negative pressure in the port or to lower the pressure prevailing in the port down to the minimum overpressure.
27. The medical treatment apparatus according to claim 26, wherein the control device and/or closed-loop control device is programmed to generate the negative pressure in the port or to lower the pressure prevailing in the port such that the pressure in the port is not lower than the minimum overpressure.
28. The medical treatment apparatus according to claim 26, wherein the control device and/or closed-loop control device is programmed to generate the negative pressure in the port or to lower the pressure prevailing in the port if the pressure in the sterile-air line, the compressed-air source, and/or in the port exceeds a predetermined threshold or maximum pressure.
29. A method for preparing the operation of or for operating a medical treatment apparatus according to claim 16, the method comprising: generating a closed volume or space comprising the interior of the port or a partial volume thereof, including lines which are in fluid communication with the interior of the port, by actuating components of the treatment apparatus, or by generating an overpressure in the closed volume via the compressed-air source.
30. The method according to claim 29, further comprising pumping off liquid from the interior of the port.
31. The method according to claim 30, wherein pumping off the liquid comprises using the ultrafiltration pump and/or pumping with the sterile-air line open to the atmosphere.
32. The method according to claim 29, wherein the overpressure comprises at least the pre-determined minimum overpressure.
33. The method according to claim 29, further comprising: measuring the pressure prevailing in the port and/or in the sterile-air line after a pre-determined time has been allowed to elapse; and determining a pressure loss or rate of pressure loss based on generated overpressure and measured pressure.
34. The method according to claim 33, further comprising: calculating a repetition time after which, once the repetition time has elapsed, the pressure in the port and/or in the sterile-air line is increased again at least up to the minimum overpressure via the compressed-air source.
35. The method according to claim 34, further comprising repeatedly building-up pressure via the compressed-air source at intervals based on the calculated repetition time.
36. A control device and/or closed-loop control device which is programmed to initiate the execution of a method according to claim 29 in interaction with a medical treatment apparatus.
37. A medical blood treatment apparatus having a control device and/or closed-loop control device according to claim 36.
38. A computer program product with a program code stored on a machine-readable carrier, configured to configure a control device and/or closed-loop control device of a conventional medical treatment apparatus in such a way that the medical treatment apparatus becomes a medical treatment apparatus with a control device and/or closed-loop control device according to claim 36.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0130] The present disclosure will be explained in the following with reference to the accompanying drawing. In the figures identical reference numerals designate the same or similar components.
[0131]
[0132]
[0133]
[0134]
[0135]
[0136]
[0137] The port 100 includes a first fluid conduit 3 with at least one first lumen 31 and a first end opening 32. The first lumen 31 can be flowed through in its longitudinal direction, indicated by its center line M. Fluid that is present in the first lumen 31 can leave the first fluid conduit 3 via the first end opening 32.
[0138] In the embodiment shown here, the port 100 also optionally includes a second fluid conduit 5 with at least one second lumen 51 and a second end opening 52. For the purpose of reference, the second end opening 52 in the embodiment of
[0139] The first fluid conduit 3 is located, for example, in an interior of the second fluid conduit 5 and, with respect to the port 100, its first opening 32 is optionally located further inside the port 100 or the medical treatment apparatus 2000 only indicated in
[0140] The second end opening 52, which can be an opening plane, is provided in order to pass a section of a connector of a disposable, such as for example, the connector of a substitute fluid line 105 through it (see
[0141] As intended the port 100 serves to establish a fluid communication between at least one fluid line 2002 of the treatment apparatus 2000, which is assigned to or faces or herein is included in the interior I of a medical treatment apparatus 2000, on the one hand, and the connector 4001 of a fluid line of a fluid-carrying disposable assigned to the exterior Ä of the treatment apparatus 2000, on the other hand. The connection is preferably made in an end section 1 of the port 100.
[0142]
DETAILED DESCRIPTION
[0143]
[0144] The rinsing cap 200, which is placed on the port 100, closes the second end opening 52 and thus the interior of the port 100 as well as the two fluid conduits 3, 5 against an exterior Ä of the port 100 and/or the medical treatment apparatus 2000. For this purpose, an outer edge 202 of the rinsing cap 200 is placed fluid-tightly on or in the port 100. Thereby one front side 205 of the rinsing cap 200 faces the interior.
[0145] The rinsing cap 200 may have a groove 204 on or at its circumferential side, as explained in more detail below.
[0146] The housing 2001 optionally includes a rim 2007 completely or at least partially surrounding the fastening section 2003. The rim 2007 in turn includes a first section 2007a and a second section 2007b.
[0147] In an end region of the second lumen 51 opposite the second opening 52, at least one opening 54 may be provided on or in its side wall, which in
[0148] A leakage sensor is optionally provided to provide early notification in the event of a leakage, for example from the fluid communication established between the fluid line 2002 of the treatment apparatus 2000 on the one hand and the fluid line, such as the substitute fluid line 105, on the other hand. Appropriate voltage sources, lines, evaluation devices and alarm devices may be provided and suitably programmed where required.
[0149] The leakage sensor can be used to check whether the port 100 has been emptied of fluid as intended. Corresponding test routines, which evaluate signals from the leakage sensor, if present, and if necessary output actions or messages depending on the result of the check, can be programmed in the control device 150, for example.
[0150]
[0151] Furthermore, an optional handle section 2013 of the pivot lever can be seen. It is used by the user to pull the rinsing cap 200 out of the port 100 by pulling on the handle section 2013 and in an axial direction (i.e., to the left in
[0152] It can be seen that the second lumen 51 of the second fluid conduit 5 in the optional embodiment shown includes at least one longitudinal section whose side walls (top and bottom in the sectional view of
[0153] The second lumen 51 optionally includes a first cross-sectional area limited by the side walls of the lumen 51, which is smaller than any other cross-sectional area of the second lumen 51 limited by the side walls of the lumen 51, which lies further towards the interior of the second lumen 51 than the first cross-sectional area, as can be seen at least from an area shortly before the first end opening 32, further to the right in
[0154]
[0155] A mouth of a sterile-air line 185 which is connected to a compressed-air source, for example, the second compressor 175′, see
[0156] After cleaning or disinfection and before opening the rinsing cap 200, sterile-air can be introduced via the sterile-air line 185 for connecting the disposable, and the cleaning or rinsing solution present in the port 100 can thus be largely removed. Compressed-air can also be introduced into the port 100 via the sterile-air line 185 for the reasons mentioned below and in particular as part of the methods or method steps mentioned herein.
[0157] From a cross-section in which also lies the opening plane of the first end opening 32 of the first lumen 31, the cross-sectional area of the second lumen 51 increases in the axial direction up to the beginning of an opening of the port which radially widens the second lumen 51 in at least one cross-section and/or in which the opening of the sterile-air line 185 lies, in the present example preferably always and/or steadily.
[0158] As can be seen from
[0159]
[0160] Pumps, actuators and/or valves in the area of the blood circuit 300 are connected to the treatment apparatus 2000 or for example to a control device 150 included by it.
[0161] The blood circuit 300 includes (or is connected to) an arterial patient tubing clamp 302 and an arterial connection needle of an arterial section or an arterial patient line, blood withdrawal line or of first line 301. The blood circuit 300 further includes (or is connected to) a venous patient tubing clamp 306 and a venous connection needle of a venous section, of a venous patient line, blood return line, or second line 305.
[0162] A blood pump 101 is provided in or on the first line 301, a substitute fluid pump 111 is connected to a dialysis liquid inlet line 104 for conveying fresh dialysis liquid, which is filtered in a further filter stage (F2) (substitute fluid). A substitute fluid line 105 can be fluidically connected to the inlet line 104. Via the substitute fluid pump 111, substitute fluid can be introduced by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109, via associated lines 107a or 109a into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or venous blood chamber 329) of the blood circuit 300.
[0163] The blood filter 303 includes the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305. A dialysis liquid chamber 303a of the blood filter 303 is connected to the dialysis liquid inlet line 104 leading to the dialysis liquid chamber 303a and to a dialysate outlet line 102, which guides dialysate, i.e., spent dialysis liquid, leading away from the dialysis liquid chamber 303a. Dialysis liquid chamber 303a and blood chamber 303b are separated from each other by a mostly semi-permeable membrane 303c. It represents the partition between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis liquid or dialysate circuit, which is shown in
[0164] The arrangement in
[0165] An optional single-needle chamber 317 is used in
[0166] The arrangement of
[0167] An optional addition site 325 for Heparin may be provided.
[0168] On the left in
[0169] A pump 171, which can be referred to as concentrate pump or sodium pump, is fluidically connected to the mixing device 163 and a source of sodium, for example the container A, and/or coveys out of it. An optional pump 173, which is assigned to the container B, for example for bicarbonate, can be seen.
[0170] The compressed-air source for building-up pressure in the port 100 can be embodied, for example, by the optional compressor with the reference numeral 175′, which is also referred to herein non-restrictively as further compressor, and may be connected to the port 100 via the fluid line 185. Alternative sources of compressed-air may be provided for this purpose.
[0171] Furthermore,
[0172] A further pressure sensor may be provided as PS4 downstream of the blood filter 303 on the water side, but preferably upstream of the ultrafiltration pump 131 in the dialysate outlet line 102 for measuring the filtrate pressure or membrane pressure of the blood filter 303. Additional, optional pressure measuring points P may also be provided.
[0173] Blood leaving the blood filter 303 flows through an optional venous blood chamber 329, which may include a de-aeration device 318 and may be in fluid communication with the pressure sensor PS3.
[0174] The exemplary arrangement shown in
[0175] By using the device for on-line mixing of the dialysis liquid, a variation of its sodium content, controlled by the control device or closed-loop control device 150, is possible within certain limits. For this purpose, in particular the measured values determined by conductivity sensors 163a, 163b may be taken into account. Should an adjustment of the sodium content of the dialysis liquid (sodium concentration) or of the substitute fluid turn out to be necessary or desired, this can be done by adjusting the conveying rate of the sodium pump 171.
[0176] In addition, the treatment apparatus 2000 includes devices for conveying fresh dialysis liquid and dialysate. A first valve may be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inflow towards the blood filter 303 on the inlet side. A second, optional flow pump 169 is provided, e.g., downstream of the blood filter 303 which conveys dialysate to the drain line 153. A second valve may be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outflow on the outlet side.
[0177] Furthermore, the treatment apparatus 2000 optionally includes a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side. The device 161 for balancing is preferably arranged in a line section between the first flow pump 159 and the second flow pump 169.
[0178] The treatment apparatus 2000 further includes devices, such as the ultrafiltration pump 131, for the precise removal of a volume of liquid from the balanced circuit, as predetermined by the user and/or by the control device or closed-loop control device 150.
[0179] Sensors such as the optional conductivity sensors 163a, 163b may be provided and serve to determine the conductivity, which in some embodiments is temperature-compensated, as well as the fluid flow upstream and downstream of the dialyzer 303.
[0180] Temperature sensors 165a, 165b may be provided as one or a plurality thereof. Temperature values supplied by them may be used to determine a temperature-compensated conductivity.
[0181] Further flow pumps in addition to or alternatively to, for example, the one with the reference numeral 169 may also be provided.
[0182] A number of optional valves are each denoted with V in
[0183] In some embodiments, the control device 150 determines the electrolyte balance and/or liquid balance based on the measured values from the aforementioned optional sensors.
[0184] Filters F1 and F2 can be connected in series.
[0185] Even when using non-pure water, the filter F1 exemplarily serves herein to generate sufficiently pure dialysis liquid by the mixing device 163, which then flows through the blood filter 303, e.g. using the counter-current principle.
[0186] The filter F2 exemplarily serves here to generate sterile or sufficiently filtered substitute fluid from the sufficiently pure dialysis liquid leaving the first filter F1, by filtering, e.g., pyrogenic substances, in order to introduce it without hesitation into the patient's blood flowing extracorporeally and thus, finally, into the patient's body.
[0187] The treatment apparatus 2000 is optionally shown in
[0188] A possible position of the port 100 within the treatment apparatus 2000 according to the present disclosure can be seen.
[0189] The present invention is not limited to the embodiment described above; this serves for illustrative purposes only.
[0190] The arrows shown in
[0191] As can be seen in
[0192] The port 100 is, by way of example only, arranged at the end of the substitute fluid line 105.
[0193] The pressure sensor S07 is optionally used here for the pressure measurement in or to both ports 100, 100′. For this purpose, the valve V32 on the one hand and the valve V44 and/or the valve V33 on the other hand are opened.
[0194] In the example of
[0195] In particular, the valves V24 in the line 104 upstream of the blood filter 303, the valve V25 in the line 102 downstream of the blood filter 303 and the V33, V44, V43, V42, V45 at the locations shown can be provided as valves.
[0196] What is stated herein, and in particular with respect to
[0197] The compressors 175 and 175′ can be implemented using a common component or, as shown in
[0198]
[0199] The compressed-air system 180 includes the compressor 175′, preferably a filter F3, optionally the filter F4 shown in
[0200] The backflow of compressed-air from the compliance vessel 181 in the direction of the compressor 175′ is prevented by the non-return stop 179.
[0201] The pressure is fixed via the pressure reducer 183, preferably by a value between 20 hPa and 500 hPa, in such a way that as the port 100 is opened there is an uninterrupted flow of air out of the interior of the port 100 and into the atmosphere. The air flow quasi forms a “protective (gas) atmosphere” around the hygienically sensitive area of the first end opening 32.
[0202] Optionally, it may be provided that the compressor 175′ only starts after the optional signal has been emitted or received and the compressor 175′ has been prompted accordingly by the control device 150. In such embodiments, the compliance vessel 181 can serve to bridge the time until the compressor 175′ builds up pressure by providing pressure from the compliance vessel 181.
[0203]
[0204] Here, method step N1 represents a pumping out of liquid from the interior of the port 100, 100′, preferably by the ultrafiltration pump 131 and/or with the sterile-air line 185 which is open to the atmosphere.
[0205] N2 represents closing the opening of the sterile-air line 185 to the atmosphere, for example by actuating one or more corresponding valves.
[0206] The method step N3 represents generating an overpressure in the second lumen 51 by the compressor 175′, preferably at least the minimum overpressure.
[0207] N4 stands for the optional method step of checking whether the generated overpressure exceeds a predetermined threshold or maximum pressure. If this is the case, preferably after waiting for a stabilisation period, the method step N4 may possibly encompass an active lowering of the pressure, for example via the ultrafiltration pump 131.
[0208] The checking of step N4 can be carried out, for example, by a pressure sensor such as the pressure sensor S07 shown in
[0209]
[0210] Method step M1 thereby represents the removal of remaining (sterile) air from the balancing circuit of the treatment apparatus 2000. This removal can be carried out by rinsing the fluid lines of the balancing circuit. Here, the balancing circuit can be, include or be formed by the connection of the components balancing device 161, filter F1, filter F2, valve V24, valve V25, second flow pump 169. A bypass can be connected between valve V24 and valve V25 when the blood circuit is not connected, in particular before the port 100, 100′ is opened (not shown in
[0211] Method step M2 stands for venting the balancing circuit with sterile air in the direction of the drain.
[0212] The method steps M1 and M2 may also be referred to as preparation steps. They may be encompassed by the method in several embodiments, but not in other embodiments.
[0213] Method step M3 represents the venting, of both online ports 100, 100′ and the dialysate outlet line 102 by switching on the compressor 175′, while the valves V45, V42, V32 and V44 are opened, in particular by opening then to the atmosphere. Venting is continued until atmospheric pressure prevails inside the lines and the ports 100, 100′.
[0214] Method step M4 represents a closing of valve V45, which results in an increase in pressure within ports 100, 100′ and the connected lines. When the pressure inside the lines and the ports reaches a predetermined threshold, for example 200 hPa, the compressor is stopped and the valve V42 is closed to prevent the pressure from increasing further, but also to prevent it from falling.
[0215] In method step M5, the pressure in the port is measured, preferably after a predetermined stabilisation time, i.e., a time that takes into account fluctuations and initial measurement inaccuracies due to pressure changes. If this pressure, also referred to herein as the final pressure, exceeds an upper threshold or an upper maximum pressure, for example 300 hPa, the pressure is reduced, for example by individual strokes of the ultrafiltration pump 131, until it is again below this maximum pressure.
[0216] The method step M6 represents a waiting time of, e.g., five seconds.
[0217] In method step M7, a first average pressure P1 is determined over one second.
[0218] The method step M8 represents a waiting time of, e.g., 24 seconds.
[0219] In method step M9, a second average pressure P2 is determined over one second.
[0220] Method step M10 represents the calculation of a repetition time T according to the following formula:
[0221] where 50 hPa is the permissible pressure drop, selected as an example, until the next pressure increase in the port.
[0222] Method step M11 represents evaluating the result of the calculation from method step M10 with subsequent output of the evaluation, for example, namely [0223] Error, if T<60 s, as then the leakage is too large; [0224] T, if 60 s≤T≤1800 s; and [0225] T=1800 s, if T>1800 s
[0226] and causing the compressor 175′ to repeatedly build-up pressure based on the times resulting from the evaluation, provided there is no error.
LIST OF REFERENCE NUMERALS
[0227] 100 port [0228] 100′ port [0229] 3 first fluid conduit (inside) [0230] 5 second fluid conduit (outside) [0231] 31 first lumen [0232] 32 first end opening [0233] 51 second lumen [0234] 52 second end opening [0235] 54 opening, e.g. groove [0236] Ä exterior [0237] I interior [0238] M mid line or centre line [0239] 2000 medical treatment apparatus [0240] 2001 housing [0241] 2002 fluid line [0242] 2003 fastening section [0243] 2005 adjacent housing sections [0244] 2007 edge [0245] 2007a first section [0246] 2007b second section [0247] 2013 handle section [0248] 2015 receiving section [0249] 4001 fluid line connector [0250] 101 blood pump [0251] 102 dialysate outlet line [0252] 104 dialysis liquid inlet line [0253] 105 substitute fluid line [0254] 107 pre-dilution valve [0255] 107a line belonging to pre-dilution valve [0256] 109 post-dilution valve [0257] 109a line belonging to post dilution pump [0258] 111 substitute fluid pump [0259] 131 ultrafiltration pump [0260] 150 control device [0261] 153 drain or waste line [0262] 155 water source [0263] 157 heat exchanger [0264] 159 first flow pump [0265] 161 balancing device [0266] 163a conductivity sensor [0267] 163b conductivity sensor [0268] 165a temperature sensor [0269] 165b temperature sensor [0270] 166 concentrate supply [0271] 168 concentrate supply [0272] 169 second flow pump [0273] 171 pump, sodium pump [0274] 173 pump, bicarbonate pump [0275] 175 compressor [0276] 175′ compressor [0277] 179 non-return stop [0278] 180 compressed-air system [0279] 181 compliance vessel [0280] 183 pressure reducer [0281] 185 sterile-air line [0282] 200 rinsing cap [0283] 202 outer edge of rinsing cap [0284] 204 first groove [0285] 205 front side of rinsing cap [0286] 300 extracorporeal blood circuit [0287] 301 first line (arterial line section) [0288] 302 first tubing clamp [0289] 303 blood filter or dialyzer [0290] 303a dialysis liquid chamber [0291] 303b blood chamber [0292] 303c semi-permeable membrane [0293] 305 second line (venous line section) [0294] 306 second tubing clamp [0295] 315 detector [0296] 317 single-needle chamber [0297] 318 de-aeration device [0298] 319 detector [0299] 325 addition site for Heparin [0300] 329 venous blood chamber (optional); venous bubble chamber (optional) [0301] F1 filter [0302] F2 filter [0303] F3 sterile-air filter [0304] F4 sterile-air filter [0305] A container [0306] B container [0307] D predetermined time period [0308] P pressure measurement sites [0309] PS1 arterial pressure sensor (optional) [0310] PS2 arterial pressure sensor (optional) [0311] PS3 pressure sensor (optional) [0312] PS4 pressure sensor for measuring the filtrate [0313] pressure (optional) [0314] N1 to N4 method steps [0315] M1 to M11 method steps [0316] V valves [0317] V24 valve [0318] V25 valve [0319] V31 valve [0320] V32 valve [0321] V33 valve [0322] V42 valve [0323] V43 valve [0324] V44 valve [0325] V45 valve [0326] Y Y-connector