WO2013030350A1 - Dialysatfluss-regelung - Google Patents
Dialysatfluss-regelung Download PDFInfo
- Publication number
- WO2013030350A1 WO2013030350A1 PCT/EP2012/066978 EP2012066978W WO2013030350A1 WO 2013030350 A1 WO2013030350 A1 WO 2013030350A1 EP 2012066978 W EP2012066978 W EP 2012066978W WO 2013030350 A1 WO2013030350 A1 WO 2013030350A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- dialysate
- change
- blood
- value
- dialyzer
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1603—Regulation parameters
- A61M1/1605—Physical characteristics of the dialysate fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1615—Control or regulation using measurements made at different flow rates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3607—Regulation parameters
- A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3324—PH measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
Definitions
- the invention relates to a method and a device for regulating the dialysate flow in a dialysis machine.
- dialysis devices are, in particular, devices for extracorporeal blood treatment, which can be set up, for example, for hemodialysis and / or ultrafiltration.
- the blood of a patient in an extracorporeal circuit is passed through a blood chamber of a dialyzer.
- the blood chamber is separated by a semipermeable membrane from a dialysate chamber of the dialyzer.
- the dialysate chamber is flowed through by a dialysate.
- the dialysate contains blood electrolytes in a concentration that corresponds to the concentration in the blood of a healthy person.
- the blood and dialysate on opposite sides of the semipermeable membrane are generally passed countercurrently at a predetermined flow rate.
- the urinary substances diffuse through the membrane from the blood chamber into the dialysate chamber while electrolytes present in the blood and dialysate simultaneously diffuse from the chamber of higher concentration to the chamber of lower concentration.
- the blood can be dehydrated by establishing a pressure gradient on the semipermeable membrane of the dialyzer, as a result of which water from the blood is forced onto the side of the dialysate chamber. This process is called ultrafiltration.
- the effectiveness of the dialyzer in the dialysis apparatus and thus the blood treatment depends, inter alia, on the size of the dialysate flow, ie the flow rate of the dialysate.
- One high dialysate flow can increase the effectiveness of blood treatment to an upper limit, but also leads to an increase in the consumption of dialysate and energy.
- a blood chamber of a dialyzer with blood and a dialysate chamber of the dialyzer separated from the blood chamber by a semipermeable membrane are flowed through with a dialysate.
- a change in the value of a control variable caused by a variation of a property of the dialysate or of the blood or by a change in the dialysate flow is determined. If the change in the value of the control exceeds a threshold, the dialysate flow is increased. By contrast, the dialysate flow is reduced if the change in the value of the control variable falls below the limit range.
- the control variable preferably has a ratio or a difference of values of a property of the dialysate or of the blood after the dialyzer that can be assigned before and after the change in the dialysate flow.
- the ratio or the difference the value of a property of the dialysate or of the blood at the outlet from the dialyzer of dialysate or blood, when it entered the dialyzer, the change in the dialysate flow had already taken place, and Value of dialysate or blood, in whose entry into the dialyzer the change of the dialysate had not yet taken place, is used.
- the control quantity preferably has a ratio or a difference of values of the property after and in front of the dialyzer. That is, in a variation of a property of the dialysate, the ratio or the difference of, on the one hand, the value of the property of the dialysate after the dialyzer or the value of the property of the blood after the dialyzer and the other the value of the property of the dialysate before the dialyzer or the value of the property of the blood before the dialyzer can be determined.
- the ratio or the difference likewise prevails on the one hand to the value of the property of the dialysate after the dialyzer or the value of the property of the blood after the dialyzer and, on the other hand, to the value of the property of the dialysate the dialyzer or the value of the property of the blood before the dialyzer can be determined.
- the control variable preferably has the ratio of the value of a property of the dialysate after the dialyzer to the value of the property of the dialysate in front of the dialyzer.
- a difference contained in the expression of the control variable is preferably formed from the value of a property of the dialysate after the dialyzer and the value of the property of the dialysate in front of the dialyzer.
- the property of the dialysate is preferably the electrical conductivity or the temperature of the dialysate and the property of the blood is preferably the electrical conductivity or the temperature of the blood.
- the property of the dialysate or of the blood is preferably continuously varied at least for a time interval.
- the change in the value of the control variable itself is preferably determined by a derivation of the control variable after the dialysate flow.
- the limit range preferably corresponds to a tolerance range around a value of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 percent of the value of the control variable per change of the dialysate flow by 100 ml / min.
- the tolerance range is preferably one percent of the value of the control variable per change of the dialysate flow by 100 ml / min, so that at a value of 10 percent of the value of the control variable per change of the dialysate flow by 100 ml / min, the limit of 9.5 to 10, 5 percent of the value of the control variable per change of the dialysate flow by 100 ml / min is enough.
- the tolerance range may also be zero such that the limit range coincides with a threshold such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 percent of the value of the control variable per change in dialysate flux 100ml / min.
- a device according to the invention for regulating a dialysate flow is used in a device for extracorporeal blood treatment, such as, for example, a dialysis device.
- the control variable k d Q d * (A d , out (Q d ) - Ad, ou t (0)) / Adjn serve.
- Q d describes the dialysate flow in the dialyzer
- a dJn and A d , ou t describe a property of the dialysate, such as the electrical conductivity or the temperature of the dialysate before and after the dialyzer.
- a d , ou t (0) indicates the value of the property of the dialysate in the absence of cleaning power, for example in the absence of blood flow.
- the control variable k d increases, as long as a cleaning performance exists.
- the derivation of the divided by the dialysate flow Q d control quantity k d after the dialysate flow Q d is the change in the control quantity k d / Q d and thus the normalized gain of the effectiveness of the dialyzer because of a change of the dialysate flow Q d.
- the property of the dialysate before the dialyzer A d in does not depend on the dialysate flow Q d . If the property of the dialysate is, for example, the electrical conductivity of the dialysate, a constant value of the electrical conductivity of the dialysate in front of the dialyzer can be obtained, for example, by a corresponding adaptation of the amount of electrolyte injected into the dialysate. This is especially important in the case where, for determining the change in the value of the control quantity, the property of the dialysate is continuously varied, as shown below.
- the term A d , ou t (0) is omitted, which simplifies a determination of the derivative.
- the dialysate flow is varied and the change in the control variable k d / Q d determined.
- the variation of the dialysate flow may result from a deliberate change in the dialysate flow or from parameters that change during the blood treatment.
- the determination of the change in the control variable k d / Q d can be carried out as part of a targeted change in the dialysate by a determination of the control variable k d / Q d before and after the change in the dialysate or by a continuous determination of the derivative of the control variable k d / Q d after the dialysate flow Q d .
- the previously determined change in the control quantity is then compared with a limit value or a limit range with an upper limit and a lower limit. If the change in the control quantity falls below the limit value or the lower limit of the limit range, the dialysate flow is reduced. On the other hand, the dialysate flow is increased if the change in the control quantity exceeds the limit value or the upper limit of the limit range.
- a value between 10 percent and 20 percent of the value of the control variable per change of the dialysate flow by 100 ml / min has proven to be particularly advantageous.
- a corresponding limit range can also be defined whose upper and lower limits specify a tolerance range around the limit value.
- the tolerance range is preferably one percent of the value of the control variable per change of the dialysate flow by 100 ml / min, so that at a limit of 20 percent of the value of the control variable per change of dialysate flow by 1 00ml / min, the lower and upper limits of the limit range a value of 19.5 and 20.5 percent, respectively, of the value of the control variable per change in the dialysate flow by 100 ml / min.
- This regulation optimizes the dialysate flow in relation to the effectiveness of the dialyzer as well as the consumption of dialysate and energy.
- a characteristic of the blood of a patient such as the electrical conductivity, temperature or the concentration of a marker substance such as Na ions, urea, uric acid, beta-2-microglobulin, an associated ratio of the value of the corresponding property of Dialysate after the dialyzer, ie when exiting the dialyzer, to the value of the corresponding property of the dialysate in front of the dialyzer, ie when entering the dialyzer, a.
- a change in the dialysate flow causes a change in the value of the corresponding property of the dialysate at the outlet from the dialyzer.
- a determination of the change in the control variable due to a targeted change in the dialysate flow can be obtained by determining the control size before and after the targeted change of the dialysate.
- the value of the corresponding Determine the property of the dialysate after exiting the dialyzer. Accordingly, it must also be determined when the targeted change of the dialysate flow has arrived at the outlet from the dialyzer, ie it must be known the hydraulic delay of the dialyzer for each dialysate flow to assign a change in the control variable of a particular change in the dialysate can.
- the prior art discloses methods for determining the hydraulic delay of a dialyzer.
- the targeted change in the dialysate flow may consist of a short-term, ie a short time interval lasting, periodic or pulse-like change in the flow rate of the dialysate.
- the characteristic of the dialysate can also be varied continuously, for example periodically, prior to entry into the dialyzer in order to determine a change in the control variable.
- a continuous modulation of the value of the property of the dialysate entering the dialyzer A diin results in a modulation of the value of the property of the dialysate at the outlet from the dialyzer A d, out .
- the property of the dialysate is the electrical conductivity or the temperature of the dialysate
- the time courses of the electrical conductivity (left ordinate axis) or the temperature (right ordinate axis) of the dialysate before (curve C1) and after (curve C2) the dialyzer at a dialysate flow of 800 ml / min in the image according to FIG. 1 for a dialysis treatment in the laboratory (in vitro) the time courses of the electrical conductivity (left ordinate axis) or the temperature (right ordinate axis) of the dialysate before (curve C1) and after (curve C2) the dialyzer at a dialysate flow of 800 ml / min.
- the almost harmonic variation of the electrical conductivity or the temperature of the dialysate at the inlet to the dialyzer was generated by a volume-dependent variation of the concentrate injection, ie the injection of electrolyte into the dialysate, or by a variation of the heating of the dialysate
- the changes in the concentrations of the electrolytes or the concentration of a single electrolyte in the dialysate or the thermal modulation of the dialysate takes place within the physiologically harmless for a patient limits. Due to the size of the dialyzer volume, there is a mixing in the dialyzer between volumes of different concentrations, ie volumes with different values of the property of the dialysate. This mixing leads to a damping of the modulation, ie the variation of the electrical conductivity or the temperature of the dialysate leaving the dialyzer, so that the amplitude of the electrical conductivity or the temperature of the dialysate leaving the dialyzer depends on the modulation period and the dialyzer volume is reduced.
- part of the modulated volume passes through the semipermeable membrane into the extracorporeal circulation (blood circulation), whereby the modulation of the electrical conductivity or the temperature of the dialysate emerging from the dialyzer is additionally reduced.
- the attenuation of the modulation can be clearly seen in the figure of FIG. 1 by comparing the curves C1 and C2, in particular by comparing the amplitudes.
- the values of the electrical conductivity or the temperature of the dialysate before and after the dialyzer can be detected by means of measuring cells. From the data of the measuring cells, the effect of a change in the dialysate flow can be recognized directly, so that a control and thus optimization of the dialysate flow can be carried out within a very short time.
- a transmitted in the dialyzer from the dialysate to the blood property on the blood side can be measured, ie by detecting the corresponding property of the blood at the outlet from the dialyzer and before entering the dialyzer.
- the transmission of a temperature bolus in the dialysate via the dialyzer to the blood in the venous tubing can be measured.
- Q b is referred to the blood flow, ie the flow rate of the blood, and the dialysate flow Q d in the dialyzer.
- a b, in FIG. 10 describes a property of the blood, such as the electrical conductivity or the temperature of the blood, before entering the dialyzer and A b , ou t the corresponding property of the blood at the outlet from the dialyzer.
- a b , ou t (0) indicates the value of the property of the blood exiting the dialyzer in the absence of cleaning power.
- control size k b not directly, but the derivative of the divided by the blood flow Q b control size k b after the dialysate Q d , ie the change in the control size k b / Q b due to a change in the dialysate Q d , to use.
- the invention thus also allows a regulation of a dialysate flow by means of a variation of a property of the dialysate and detection of a change in the corresponding property of the blood on the blood side. Even when determining the change in the control variable due to a targeted change in the dialysate, the required detection of a change in a property of the dialysate or the blood on the dialysate side or on the blood side can be performed.
- a property of the blood prior to entry into the dialyzer may be varied continuously, for example periodically, and the effect of the treatment on this property of the blood exiting the dialyzer on the blood side or alternatively on the dialysate side are measured.
- the variation of a property of the blood before entering the dialyzer in a small, patient-friendly variation of the Temperature of the blood exist.
- the variation of Hepanneintrags in the blood before entering the dialyzer is also possible.
- heparin or an alternative anticoagulant drug is continuously added to the patient's blood prior to entering the dialyzer to prevent clotting of the dialyzer.
- the flow rate of this pump (heparin pump) can be modulated accordingly.
- the substituate rate can also be modulated.
- sterile substituate is added to the blood of a patient before it enters the dialyzer. The excess water is withdrawn from the patient's blood by ultrafiltration through the dialyzer.
- the constituents of the substituate in the blood pass from the blood side to the dialysate side within the dialyzer and are at least indirectly detectable there, for example the electrolytes through conductivity measuring cells.
- the invention thus also allows a regulation of a dialysate flow by means of a variation of a property of the blood and detection of a change in the property of the blood on the blood side or the dialysate side.
- the simplest method for determining the amplitude ratio of the values of the electrical conductivity of the dialysate before (LF dJn ) and after the dialyzer (LF d, 0Ut ) is to increase the amplitude or peak-to-peak values of the electrical conductivity of the dialysate at the entrance into the dialysate Dialyzer (LF dJn ) and at the outlet from the dialyzer (LF d, 0Ut ) to compare.
- this approach has the disadvantage that noise and / or disturbances lead directly to measurement errors, which in turn reduces the accuracy of the specific amplitude ratio.
- the disturbances in the value of the electrical conductivity of the dialysate at the outlet from the dialyzer amount to approximately 10 percent.
- T / 2 In order to increase the accuracy, T / 2 must therefore be averaged over a corresponding number of half-cycles.
- the dialysate flow can be generated and changed by means such as pumps and / or valves.
- control variable For the determination of the control variable from the values of the property of the dialysate or of the blood before and after the dialyzer as well as for the determination of the derivation of the control variable after the dialysate flow, for example programmable microprocessors can be used. These can also be used within a control device for the regulation of the dialysate flow and the associated generation of control commands for pumps and / or valves.
- the control device advantageously contains a memory for storing the specifications for the limit or the limit range and for a program that the inventive method can perform.
- the specifications for the limit value or the limit range at the start or during the execution of the program can be changed, so that instead of a preset value of, for example, 20 percent of the value of the control variable per change of the dialysate flow by 100 ml a value of, for example, 5 percent of the value of the control variable per change in the dialysate flow can be adjusted by 100 ml / min.
- the tolerance range of a border area ie the upper and / or lower limit of the border area, can be changed at the start or during the execution of the program.
- dialysate flow in a dialysis machine is optimized with regard to the effectiveness of the dialyzer and thus also the blood treatment independently of the knowledge of the type of dialyzer used, the blood flow or certain patient parameters.
- a further increase in the dialysate flow does not lead to a significant increase in the effectiveness of the dialyzer.
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2014527677A JP6139529B2 (ja) | 2011-09-01 | 2012-08-31 | 透析液流制御 |
BR112014004870-3A BR112014004870B1 (pt) | 2011-09-01 | 2012-08-31 | dispositivo para controle de fluxo de dialisado |
EP12755988.8A EP2750730B1 (de) | 2011-09-01 | 2012-08-31 | Dialysatfluss-regelung |
CN201280042814.0A CN103857419B (zh) | 2011-09-01 | 2012-08-31 | 透析液流调节 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161529965P | 2011-09-01 | 2011-09-01 | |
DE102011053200A DE102011053200A1 (de) | 2011-09-01 | 2011-09-01 | Dialysatfluss-Regelung |
US61/529,965 | 2011-09-01 | ||
DE102011053200.5 | 2011-09-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2013030350A1 true WO2013030350A1 (de) | 2013-03-07 |
Family
ID=47710400
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2012/066978 WO2013030350A1 (de) | 2011-09-01 | 2012-08-31 | Dialysatfluss-regelung |
Country Status (7)
Country | Link |
---|---|
US (1) | US9724455B2 (de) |
EP (1) | EP2750730B1 (de) |
JP (1) | JP6139529B2 (de) |
CN (1) | CN103857419B (de) |
BR (1) | BR112014004870B1 (de) |
DE (1) | DE102011053200A1 (de) |
WO (1) | WO2013030350A1 (de) |
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Also Published As
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JP6139529B2 (ja) | 2017-05-31 |
CN103857419B (zh) | 2016-03-02 |
CN103857419A (zh) | 2014-06-11 |
JP2014529453A (ja) | 2014-11-13 |
US20130056418A1 (en) | 2013-03-07 |
EP2750730B1 (de) | 2018-05-16 |
US9724455B2 (en) | 2017-08-08 |
BR112014004870A2 (pt) | 2017-04-04 |
BR112014004870B1 (pt) | 2021-03-09 |
EP2750730A1 (de) | 2014-07-09 |
DE102011053200A1 (de) | 2013-03-07 |
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