WO2013000777A1 - Filtering of a time-dependent pressure signal - Google Patents
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- WO2013000777A1 WO2013000777A1 PCT/EP2012/061765 EP2012061765W WO2013000777A1 WO 2013000777 A1 WO2013000777 A1 WO 2013000777A1 EP 2012061765 W EP2012061765 W EP 2012061765W WO 2013000777 A1 WO2013000777 A1 WO 2013000777A1
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6866—Extracorporeal blood circuits, e.g. dialysis circuits
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
- A61B5/7217—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
-
- 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
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
-
- 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
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3403—Regulation parameters
-
- 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
- A61M1/3621—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
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
-
- 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
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
-
- 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
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3659—Cannulae pertaining to extracorporeal circulation
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/30—Accessories; Auxiliary operation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/32—Controlling or regulating
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
- G01L19/00—Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
-
- 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
- A61M2205/3331—Pressure; Flow
-
- 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 present invention generally relates to processing of a time-dependent pressure signal obtained from a fluid containing system, and in particular to filtering of such a pressure signal for removal of a signal component originating from a specific pulse generator.
- the present invention is e.g. applicable in fluid containing systems for extracorporeal blood treatment.
- the above-mentioned pressure signal contains both an information component, e.g. pressure variations representing heart pulses, and a disturbance component, e.g. pressure variation caused by a blood pump. It is a challenging task to extract the information component by removing the disturbance component. For this purpose, existing methods have for instance employed an additional pressure signal which only contains the disturbance component, which may be referred to as a "pump pressure profile".
- the pump pressure profile is either directly subtracted from the pressure signal or used as input to an adaptive filter structure.
- the pump pressure profile is a predicted time resolved profile of pressure pulses from a dedicated pulse generator (e.g. a blood pump).
- the predicted profile has been either mathematically deduced or previously recorded under controlled
- WO2010/066405 proposes eliminating a pump disturbance in a pressure signal by subtracting a mathematically modelled pump contribution from the pressure signal.
- WO2010/066405 proposes repeatedly sampling pressure values at a time point when the pump contribution is known to be minimal and estimating an average heart pulse magnitude based on the standard deviation of the sampled pressure values. The latter technique is only able to generate an estimate of the average heart pulse magnitude, and provides neither information on the shape of the heart pulse, nor data on the magnitude or timing of individual heart pulses.
- a field in which the present invention is relevant is extracorporeal blood treatment.
- extracorporeal blood treatment blood is taken out of a patient, treated and then reintroduced into the patient by means of an extracorporeal blood flow circuit.
- the blood is circulated through the circuit by one or more pumping devices.
- the circuit is connected to a blood vessel access of the patient, typically via one or more access devices, such as needles or catheters, which are inserted into the blood vessel access.
- Such extracorporeal blood treatments include hemodialysis, hemodiafiltration, hemofiltration, plasmapheresis, etc.
- physiological pressure generators such as the heart or respiratory system, e.g.
- VND Venous Needle Dislodgement
- the fluid containing system may comprise a first sub-system which comprises (or is associated with) the first pulse generator and the pressure sensor, a second sub-system which comprises (or is associated with) the second pulse generator, and a fluid connection between the first and second sub-systems.
- One objective is to provide a technique that enables extraction of an information component in a pressure signal obtained in a fluid containing system, by removal or suppression of a disturbance component in the pressure signal.
- Another objective is to provide such a technique that is simple to implement in a fluid containing system.
- Yet another objective is to provide such a technique capable of being used for monitoring of one or more properties of the cardiovascular system of a human subject.
- the invention provides filtering techniques that are designed with knowledge about the pulse generation process in the first pulse generator.
- the inventive filtering is based on the knowledge that the pressure signal includes consecutive pulse cycles, and that each pulse cycle has a known occurrence of first pulses, even if the shape of the first pulse(s) within the individual pulse cycle is unknown (e.g. depending on the operating conditions of the fluid containing system and the first pulse generator).
- a "pulse cycle" is tied to the construction of the first pulse generator and is manifested as a repeating structure of a predetermined number of first pulses in the pressure signal. The second pulses are overlaid or superposed on the pulse cycles in the pressure signal.
- each current data sample obtained from the pressure signal
- a current pulse cycle By relating each current data sample, obtained from the pressure signal, to a current pulse cycle, it is possible to generate an appropriate reference value for each current data sample by selecting and processing a set of preceding and/or subsequent data samples in the pressure signal for each current data sample.
- the invention in its various aspects may be designed to generate each reference value such that the resulting time-sequence of reference values form an estimated temporal profile of the first pulse(s) within the current pulse cycle.
- each reference value will represent an estimation of the instant signal contribution from the first pulse(s) within the current pulse cycle.
- a time- sequence of output samples can be generated for the current pulse cycle so as to be essentially free of first pulses.
- the inventive filtering is based on the presumption that the shape of the first pulses is approximately unchanged over a number of successive pulse cycles, so that it is possible to derive appropriate reference values for current data samples based on preceding and/or subsequent data samples.
- the inventive filtering also presumes that the first and second pulses are generated at different rates, so that the location of the second pulses differ between consecutive pulse cycles. Thereby, the resulting output samples will contain a signal contribution of second pulses, if present in the pressure signal, while the signal contribution of first pulses is eliminated or at least significantly suppressed.
- the inventive filtering is simple to implement in a fluid containing system, since it only requires a single pressure sensor.
- the inventive filtering obviates the complexity of obtaining a reference profile from another pressure sensor, as well as the complexity of using and possibly adapting this reference profile for appropriate filtering of the pressure signal, as suggested in the prior art.
- the inventive filtering also obviates the need to pre-record or pre-calculate reference profiles, the need to store these reference profiles, and the complexity of using such stored reference profiles for filtering of the pressure signal.
- the inventive filtering may improve usage of at least one of processing capacity and memory capacity.
- inventive filtering is defined in terms of two different approaches, namely a cycle- synchronization (CS) approach and a proximity prediction (PP) approach. It should be emphasized that both of these approaches fall within the general inventive concept discussed in the foregoing.
- CS cycle- synchronization
- PP proximity prediction
- a first aspect of the CS approach is a device for processing a time-dependent pressure signal obtained from a pressure sensor in a fluid containing system associated with a first pulse generator and a second pulse generator.
- the pressure sensor is arranged in the fluid containing system to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, wherein the first pulse generator operates in a sequence of pulse cycles, each pulse cycle resulting in at least one first pulse.
- the device comprises: an input for the pressure signal, and a signal processor connected to the input and configured to: repetitively obtain a current data sample within a current pulse cycle in the pressure signal; calculate, for each current data sample within the current pulse cycle, a reference value as a function of a cycle- synchronized data sample in one or more other pulse cycles in the pressure signal, the cycle- synchronized data sample being obtained to have a location in said one or more other pulse cycles that corresponds to a location of the current data sample in the current pulse cycle; and operate a subtraction algorithm on the current data sample, using said reference value obtained for the current data sample as input, so as to generate a current output sample which is essentially free of a signal component attributable to said at least one first pulse.
- the "other" pulse cycle denotes another pulse cycle than the current pulse cycle.
- the one or more other pulse cycles may be preceding or subsequent to the current pulse cycle in the pressure signal, or both.
- the use of subsequent pulse cycles generally requires some form of buffering of the data samples.
- the signal processor is configured to calculate the reference value as a function of the cycle- synchronized data sample in an adjacent pulse cycle, e.g. an immediately preceding pulse cycle.
- the signal processor may be further configured to set the reference value equal to the cycle- synchronized data sample in the adjacent pulse cycle.
- the signal processor is configured to calculate the reference value as an aggregation of the cycle- synchronized data sample and one or more adjacent data samples to the cycle- synchronized data sample in an adjacent pulse cycle, e.g. an immediately preceding pulse cycle.
- the signal processor is configured to calculate the reference value as an aggregation of cycle- synchronized data samples in at least two other pulse cycles.
- the signal processor may be further configured to calculate the aggregation to include one or more adjacent data samples to each cycle- synchronized data sample in said at least two other pulse cycles.
- the signal processor is configured to calculate the aggregation as a summation of data samples.
- the signal processor may be further configured to apply a weight factor to each data sample in said summation.
- the signal processor may further comprise an adaptive filter configured to adaptively determine each weight factor based on a difference between the current data sample and the output sample.
- the signal processor is configured to calculate the aggregation recursively, by updating a preceding reference value, which corresponds to the reference value and is calculated in a preceding pulse cycle.
- the signal processor may be further configured to calculate the reference value as a function of the preceding reference value and a difference between the cycle- synchronized data sample in the preceding pulse cycle and the preceding reference value.
- the difference is thus calculated between a cycle- synchronized data sample and a reference value obtained in the same preceding pulse cycle, which may be the immediately preceding pulse cycle.
- the device further comprises a Kalman filter, which is configured to receive the time sequence of current data samples obtained within the current pulse cycle as input and estimate a set of states that represent a time sequence of reference values in the current pulse cycle.
- the signal processor may be configured to calculate a difference value between the current data sample and the cycle- synchronized data sample; generate a weighted feedback value by applying a weight factor to a cycle- synchronized output sample which is obtained to have a location in one or more preceding pulse cycles that corresponds to a location of the current data sample within the current pulse cycle; and generate the current output sample as a sum of the difference value and the weighted feedback value, wherein the weight factor may be selected such that the signal processor implements said Kalman filter.
- the signal processor is configured to obtain the current data sample as a pressure value in the pressure signal.
- the signal processor is configured to obtain the current data sample as a difference between proximate (e.g.
- the recursive embodiment may be configured to account for drifts in the operation of the first pulse generator.
- the signal processor is configured to obtain first data samples from the pressure signal and obtain each current data sample by interpolation among the first data samples with respect to a respective location within the current pulse cycle. This embodiment thus allows each current data sample to be generated with a well-defined location in the current pulse cycle, while relaxing the requirements on the data sampling equipment that generates the first data samples.
- the signal processor is configured to obtain the current data sample in synchronization with the pulse cycles.
- the device further comprises an input for a synchronization signal that represents the pulse cycles of the first pulse generator, and the signal processor is responsive to the synchronization signal in at least one of obtaining the current data sample, calculating the reference value, and operating the subtraction algorithm.
- the fluid containing system comprises an extracorporeal blood processing apparatus, a cardiovascular system of a human subject, and a fluid connection between the extracorporeal blood processing apparatus and the cardiovascular system, wherein the first pulse generator is associated with the extracorporeal blood processing apparatus and the second pulse generator is associated with the human subject.
- the signal processor is configured to repetitively obtain the current data sample and calculate the reference value so as to generate a time- sequence of reference values that form an estimated temporal profile of said at least one first pulse within the current pulse cycle.
- the signal processor is configured to operate the subtraction algorithm so as to generate a time-sequence of current output samples which form a temporal profile of the second pulse.
- the signal processor is configured to generate at least three output samples for each current pulse cycle.
- the first pulse generator comprises a peristaltic pump comprising a rotor with at least one roller, and wherein each pulse cycle corresponds to a full rotation of the rotor.
- the first pulse generator comprises a peristaltic pump comprising a rotor with a number of rollers, and wherein each full rotation of the rotor generates the same number of pulse cycles as the number of rollers.
- a second aspect of the CS approach is a device for processing a time- dependent pressure signal obtained from a pressure sensor in a fluid containing system associated with a first pulse generator and a second pulse generator.
- the pressure sensor is arranged in the fluid containing system to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, wherein the first pulse generator operates in a sequence of pulse cycles, each pulse cycle resulting in at least one first pulse.
- the device comprises: means for repetitively obtaining a current data sample within a current pulse cycle in the pressure signal; means for calculating, for each current data sample in the current pulse cycle, a reference value as a function of a cycle- synchronized data sample in one or more other pulse cycles in the pressure signal, the cycle- synchronized data sample being obtained to have a location in said one or more other pulse cycles that corresponds to a location of the current data sample in the current pulse cycle; and means for operating a subtraction algorithm on the current data sample, using said reference value obtained for the current data sample as input, so as to generate a current output sample which is essentially free of a signal component attributable to said at least one first pulse.
- a third aspect of the CS approach is an apparatus for blood treatment, comprising an extracorporeal fluid circuit configured to be connected in fluid communication with a vascular access of a human subject and operable to circulate blood from the cardiovascular system of the human subject through a blood processing device and back to the
- cardiovascular system and a device of the first or second aspects.
- a fourth aspect of the CS approach is a method of processing a time-dependent pressure signal obtained from a pressure sensor in a fluid containing system associated with a first pulse generator and a second pulse generator.
- the pressure sensor is arranged in the fluid containing system to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, wherein the first pulse generator operates in a sequence of pulse cycles, each pulse cycle resulting in at least one first pulse.
- the method comprises: repetitively obtaining a current data sample within a current pulse cycle in the pressure signal; calculating, for each current data sample within the current pulse cycle, a reference value as a function of a cycle- synchronized data sample in one or more other pulse cycles in the pressure signal, the cycle- synchronized data sample being obtained to have a location in said one or more other pulse cycles that corresponds to a location of the current data sample in the current pulse cycle; and operating a subtraction algorithm on the current data sample, using said reference value obtained for the current data sample as input, so as to generate a current output sample which is essentially free of a signal component attributable to said at least one first pulse.
- a fifth aspect of the CS approach is a computer-readable medium comprising computer instructions which, when executed by a processor, cause the processor to perform the method of the fourth aspect.
- any one of the above-identified embodiments of the first aspect of the CS approach may be adapted and implemented as an embodiment of the above-identified second to fifth aspects of the CS approach.
- a first aspect of the PP approach is a device for processing a time-dependent pressure signal obtained from a pressure sensor in a fluid containing system associated with a first pulse generator and a second pulse generator.
- the pressure sensor is arranged in the fluid containing system to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, wherein the first pulse generator operates in a sequence of pulse cycles, each pulse cycle resulting in at least one first pulse.
- the device comprises: an input for the pressure signal, and a signal processor connected to said input and configured to: repetitively obtain a current data sample within the current pulse cycle in the pressure signal; calculate, for each current data sample within the current pulse cycle, a reference value as an estimate of the current data sample, the estimate being calculated by prediction based on at least two data samples in proximity to the current data sample in the pressure signal; and operate a subtraction algorithm on the current data sample, using said reference value obtained for the current data sample as input, so as to generate a current output sample which is essentially free of a signal component attributable to said at least one first pulse.
- the at least two data samples may be preceding and/or subsequent to the current data sample in the pressure signal.
- the use of subsequent data sample(s) generally requires some form of buffering of the data samples.
- the signal processor is configured to calculate the prediction by applying a weight factor to each of the at least two data samples.
- the signal processor may further comprise an adaptive filter configured to adaptively determine each weight factor based on a difference between the current data sample and the current output sample.
- a second aspect of the PP approach is a device for processing a time-dependent pressure signal obtained from a pressure sensor in a fluid containing system associated with a first pulse generator and a second pulse generator.
- the pressure sensor is arranged in the fluid containing system to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, wherein the first pulse generator operates in a sequence of pulse cycles, each pulse cycle resulting in at least one first pulse.
- the device comprises: means for repetitively obtaining a current data sample within the current pulse cycle in the pressure signal; means for calculating, for each current data sample within the current pulse cycle, a reference value as an estimate of the current data sample, the estimate being calculated by prediction based on at least two data samples in proximity to the current data sample in the pressure signal; and means for operating a subtraction algorithm on the current data sample, using said reference value obtained for the current data sample as input, so as to generate a current output sample which is essentially free of a signal component attributable to said at least one first pulse.
- a third aspect of the PP approach is an apparatus for blood treatment, comprising an extracorporeal fluid circuit configured to be connected in fluid communication with a vascular access of a human subject and operable to circulate blood from the cardiovascular system of the human subject through a blood processing device and back to the
- cardiovascular system and a device of the first or second aspects.
- a fourth aspect of the PP approach is a method of processing a time-dependent pressure signal obtained from a pressure sensor in a fluid containing system associated with a first pulse generator and a second pulse generator.
- the pressure sensor is arranged in the fluid containing system to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, wherein the first pulse generator operates in a sequence of pulse cycles, each pulse cycle resulting in at least one first pulse.
- the method comprises: repetitively obtaining a current data sample within a current pulse cycle in the pressure signal; calculating, for each current data sample within the current pulse cycle, a reference value as an estimate of the current data sample, the estimate being calculated by prediction based on at least two data samples in proximity to the current data sample in the pressure signal; and operating a subtraction algorithm on the current data sample, using said reference value obtained for the current data sample as input, so as to generate a current output sample which is essentially free of a signal component attributable to said at least one first pulse.
- a fifth aspect of the PP approach is a computer-readable medium comprising computer instructions which, when executed by a processor, cause the processor to perform the method of the fourth aspect.
- any one of the above-identified embodiments of the first aspect of the PP approach may be adapted and implemented as an embodiment of the above-identified second to fifth aspects of the PP approach.
- FIG. 1 is a schematic view of a general fluid containing system in which the inventive data processing may be used for filtering a pressure signal.
- Fig. 2 is a flow chart for an embodiment of an inventive filtering process.
- Fig. 3A is a plot of a pressure signal with selected data samples indicated, and Figs 3B-3H show sub-sets of the data samples of Fig. 3A for the purpose of exemplifying different embodiments of the present invention.
- Fig. 4 is a schematic view of a system for hemodialysis treatment including an extracorporeal blood flow circuit.
- Fig. 5 A is a plot of a pressure signal as a function of time
- Fig. 5B is a plot of the pressure signal after filtering.
- Figs 6-14 are schematic views of filter structures according to different embodiments of the present invention.
- Fig. 1 illustrates a fluid containing system in which a fluid connection C is established between a first fluid containing sub-system SI and a second fluid containing sub-system S2.
- the fluid connection C may or may not transfer fluid from one sub-system to the other.
- a first pulse generator 3 is arranged to generate a series of pressure waves in the fluid within the first sub-system SI
- a second pulse generator 3' is arranged to generate a series of pressure waves in the fluid within the second sub-system S2.
- a pressure sensor 4a is arranged to measure the fluid pressure in the first sub- system SI.
- the system of Fig. 1 further includes a surveillance device 25 which is connected to one or more of the pressure sensors 4a, 4b, 4c, 4d as indicated in Fig. 1. Thereby, the surveillance device 25 acquires one or more pressure signals that are time- dependent to provide a real time representation of the fluid pressure in the first sub-system SI.
- the surveillance device 25 is configured to monitor a functional state or functional parameter of the fluid containing system by isolating and analysing one or more second pulses in one of the pressure signals.
- the functional state or parameter may be monitored for various characteristics of the second sub-system S2. If the second subsystem S2 is a human subject, as described further below, the functional state or parameter may be monitored for assessing heart pulse rate or blood pressure of the human subject. Additionally, as will be further exemplified in the following, the functional state or parameter may be monitored to identify a fault condition, e.g. in the first or second subsystems SI, S2, the second pulse generator 3' or the fluid connection C.
- the surveillance device 25 may issue an alarm or warning signal and/or alert a control system of the first or second sub-systems SI, S2 to take appropriate action.
- the surveillance device 25 may be configured to store or output (e.g. for display) a time sequence of values of the functional state or parameter.
- the surveillance device 25 may use digital components or analog components, or a combination thereof, for receiving and processing the pressure signal.
- the device 25 may be a computer, or a similar data processing device, with adequate hardware for acquiring and processing the pressure signal in accordance with different embodiments of the invention.
- Embodiments of the invention may e.g. be implemented by software instructions that are supplied on a computer-readable medium for execution by a processor 25a in conjunction with an electronic memory 25b in the device 25.
- the surveillance device 25 is configured to repeatedly process the time- dependent pressure signal(s) to isolate the second pulses, if present in the pressure signal. This processing is schematically depicted in the flow chart of Fig. 2.
- the process in Fig. 2 operates on a time-dependent pressure signal which is measured by e.g. the pressure sensor 4a in the fluid containing system of Fig. 1, which is associated with the first pulse generator 3 and the second pulse generator 3'.
- the pressure signal is processed in order to monitor a functional state or parameter of the fluid containing system by isolating a signal component originating from the second pulse generator 3' among signal components originating from the first and second pulse generators 3, 3'.
- the processing involves a step 202 of obtaining a current data sample from the pressure signal, and a step 203 of obtaining a reference value representative of at least one preceding data sample in the pressure signal.
- a subtraction algorithm is operated on the current data sample, using the reference value as input, so as to essentially eliminate any signal component attributable to the first pulse (first pulse contribution).
- the result of step 204 is an output sample which is essentially free of the signal component attributable to the first pulse.
- essentially free is meant that the first pulse contribution is removed from the pressure signal to such an extent that any signal contribution from second pulses may be detected and analysed for the purpose of monitoring the aforesaid functional state or parameter.
- the steps 202-204 are repeated at consecutive time steps, whereby step 202 is advanced one time step in the pressure signal for each repetition.
- the incoming pressure signal is digital and formed by a time sequence of data samples, where the steps 202-204 may, but need not, be repeated for every data sample in the pressure signal.
- the incoming pressure signal is analogue, and the steps 202-204 comprises an initial analog-to- digital conversion for extraction of the current data sample from the pressure signal.
- steps 202-204 may implement an analog process, in which a pressure value in the pressure signal at a selected time point forms the current data sample.
- the process in Fig. 2 operates on a sequence of data samples in the pressure signal and generates a corresponding sequence of output samples.
- the sequence of output samples includes the one or more second pulses, or part thereof, which may be evaluated for various characteristics in a step 205 for monitoring a functional state or functional parameter of the fluid containing system.
- the reference value is representative of at least one preceding data sample in the pressure signal.
- the "preceding data sample” is thus an earlier data sample, relative to the current data sample, in the pressure signal.
- the preceding data sample may, e.g., be located immediately preceding the current data sample or one or more pulse cycles previously.
- a “pulse cycle” or “cycle” is defined in relation to the operation of the first pulse generator 3, and each cycle contains at least one first pulse. It should be noted that the definition of a cycle may be somewhat arbitrary, and a cycle may contain any number of first pulses, as long as each first pulse has a known and/or predictable location within the cycle.
- the first generator is a peristaltic pump
- the cycle may represent one complete pump member revolution or a partial pump member revolution corresponding to a rotor angle interval (cf. rotor 30 of pump 3 in Fig. 4).
- a peristaltic pump may comprise any number of rollers, although a typical number is two or three.
- each cycle is defined as a full revolution (360 degrees) of the rotor and its rollers and comprises two first pulses, each pulse being generated when one of the two rollers engages a tube segment to push fluid through the tube segment, as is well-known to the skilled person.
- rollers may be distributed evenly around a circle and symmetries could be used to divide a complete roller rotation into cycles between each roller, manufacturing and design differences may render it advantageous to use a complete pump member rotation rather than to rely on symmetries.
- the cycle may be defined to include a single first pulse, such that consecutive cycles are associated with different rollers.
- a preceding data sample which has the same, or at least closely similar, timing within the cycle as the current data sample is denoted a "cycle- synchronized data sample”. Stated otherwise, a cycle- synchronized data sample has a relative location in a preceding cycle that corresponds to the relative location of the current data sample in a current cycle.
- the reference value may be an averaged value, possibly weighted, of two or more immediately preceding samples, or of two or more cycle- synchronized data samples, which thus may be obtained from two or more preceding cycles.
- the cycle- synchronized data samples are taken from one or more immediately preceding cycles.
- the cycle- synchronized samples may be taken from any preceding cycle(s), although greater accuracy may be achieved by using the cycle(s) closest in time to the current data sample, since it is likely that the these cycle(s) are generated at similar operational conditions as the current cycle, e.g. with respect to pumping rate, average fluid pressure, compliance volumes, pump occlusion, etc.
- the reference value is generated based on cycle- synchronized samples taken from preceding cycle(s) with a fixed and predetermined relation to the current cycle.
- a selection mechanism may be implemented to dynamically select the preceding cycle(s) to be used for obtaining the cycle- synchronized samples, e.g. by comparing the operational conditions (pumping rate, average fluid pressure, etc) of the current cycle to each of a set of preceding cycles.
- the dynamic selection of preceding cycle(s) may be simply implemented by dynamically setting a weight factor for each cycle- synchronized sample when calculating the average value (cf. the filter structures in Figs 9, 10, 11 and 12).
- Fig. 5A shows an example of a time-dependent pressure signal d(n) containing first and second pulses with a relative magnitude of 10: 1.
- the first and second pulses have a frequency of 1 Hz and 1.33 Hz, respectively. Due to the difference in magnitude, the pressure signal is dominated by the first pulses.
- Fig. 5B shows the time- dependent filtered signal e(n) that is obtained after applying the inventive filtering technique to the pressure signal d(n).
- the filtered signal e(n) is made up of second pulses and noise. It should be noted that there is an absence of second pulses after about 4 seconds, which may be observed by the surveillance device (25 in Fig. 1) and identified as a fault condition of the fluid containing system, e.g. a disruption of the fluid connection C.
- Fig. 3A illustrates an example of a time- dependent pressure signal measured by the pressure sensor 4a in Fig. 1.
- the pressure signal comprises superimposed contributions from the first pulse generator 3 and the second pulse generator 3', where the first pulse generator 3 dominates the shape of the pressure signal.
- a number of samples have been indicated with e.g. CI, C2, C3, etc for current data samples, Pi l, Pi2, Pi3 for cycle- synchronized data samples in a first preceding pulse cycle, P 2 1, P 2 2, P 2 3 for cycle- synchronized data samples in a second preceding pulse cycle, etc.
- N represents the number of data samples in each pulse cycle.
- the indicated data samples will be explained in connection with Figs 3B-3H in the following.
- the pressure signal has been subdivided into a number of consecutive sections corresponding to durations of consecutive pulse cycles of the first pulse generator 3.
- the first pulse generator 3 is a peristaltic pump with two rollers, and each pulse cycle is defined to comprise two first pulses.
- each pulse cycle thereby corresponds to a full rotation of the rotor.
- the pulse cycles have been denoted a current pulse cycle, a first preceding pulse cycle, a second preceding pulse cycle and a third preceding pulse cycle. Any number of preceding pulse cycles may be used, although only three are shown for simplicity.
- Example I Reference value based on a corresponding cycle-synchronized sample of the immediately preceding pulse cycle
- Fig. 3B illustrates a first example where a reference value is obtained based on a corresponding cycle- synchronized sample of the immediately preceding pulse cycle.
- Fig. 3B shows a current data sample CI from a first position in the current pulse cycle and one preceding cycle- synchronized data sample Pi l from a first position in the first preceding pulse cycle corresponding to the relative location of the current data sample in the current pulse cycle.
- the cycle- synchronized data sample Pi 1 has been obtained at an instance in time corresponding to one full rotation earlier of the rotor, i.e. 360 degrees earlier.
- Fig. 6 is a schematic diagram of a filter structure 31 that implements the process in Fig. 2 to achieve the data processing indicated in Fig. 3B.
- a block ⁇ _ ⁇ is included to implement a step of obtaining, in the pressure signal, a preceding data sample u(n) with a suitable negative delay (- ⁇ ) to a current data sample d(n).
- the delay is suitably selected such that the preceding data sample u(n) is a cycle- synchronized data sample.
- ⁇ is set to a time value corresponding to 360°.
- the preceding data sample is multiplied in the multiplication block X with a weight factor Wi which generates the reference value d(n), here by directly using the preceding data sample (indicated by a weight factor Wi being set to 1).
- the resulting reference value d(n) is input to a summation block ⁇ that performs the subtraction (step 204 in Fig. 2) of the reference value d(n) from the current data sample d(n) to generate the output sample e(n).
- a subtraction algorithm is operated on a current data sample CI, using the preceding data sample Pi 1 as a reference value, to generate an output sample which is essentially free of a signal component attributable to the first pulse.
- sequence of output samples generated as the process in Fig. 3B is repeated for a sequence of consecutive current data samples will however generally not be a true representation of the second pulse, since the second pulse typically is present, at least partly, in both the current pulse cycle and the preceding pulse cycle but at different locations (since the first and second pulses generally are generated at different rates).
- the sequence of output samples generates a filtered signal that comprises (the part of) the second pulse in the current pulse cycle and a negative version of (the part of) the second pulse in the preceding cycle, i.e. the latter is overlaid on the former but with reversed sign and delayed one complete first pulse generator cycle.
- the filter structure 31 in Fig. 6, as well as the filter structures 31 in Figs 7- 12 to be described below, are given to conceptually explain different embodiments.
- the functions of applying a negative delay and generate the reference value may be implemented by the signal processor (25a in Fig. 1) while repeatedly executing steps 202-204 of the process in Fig. 2, such that the reference value is generated during one iteration of steps 202-204 and stored in electronic memory (cf. 25b in Fig. 1) and retrieved from the electronic memory in a subsequent iteration of steps 202- 204. It is also possible to use a combination of electronic components that creates actual delayed versions of the signal.
- Fig. 3C illustrates a variation of the first example where the reference value is calculated as an aggregation ("neighbourhood aggregation") of the cycle- synchronized data sample Pi l and two adjacent data samples Pi2 and P 2 N to the cycle- synchronized data sample in the immediately preceding pulse cycle.
- the neighbourhood aggregation may yield a better approximation of the reference value and describes a combination of data samples and may involve a weighted or non-weighted summation of the data samples, e.g. an averaging of Pi 1, Pi2 and P 2 N.
- Fig. 7 is a schematic diagram of a filter structure 31 similar to that of Fig. 6, where the multiplication block X which is implemented to generate the reference value has been replaced by an aggregation block 32 ("filter") that implements the neighbourhood aggregation, e.g. by summation, possibly involving weight factors which may be set individually to achieve an improved reference value.
- filter an aggregation block 32
- the aggregation block 32 may be configured to process the incoming stream of cycle- synchronized data samples so as to generate the reference value d(n) for each current data sample d(n) by aggregation of the cycle- synchronized value (of the current data sample) with adjacent data samples, on one or both sides of the cycle- synchronized value.
- Fig. 8 is a schematic diagram of a filter structure 31 similar to that of Fig. 7, where the aggregation block 32 has been supplemented by an adaptive block 34 configured to adaptively determine each weight factor based on the cycle- synchronized sample u(n) and the output sample e(n).
- the aggregation block 32 and the adaptive block 34 define an adaptive filter indicated by 36.
- the algorithm of the adaptive block 34 may be configured to automatically and adaptively adjust the weight factors of the aggregation block 32 to achieve a best-fit for the approximated reference value d(n) so as to minimize or otherwise optimize the output sample e(n).
- Adaptive algorithms include for instance the Recursive Least Square (RLS) method and the Least Mean Square (LMS) method.
- Example II Reference value based on corresponding cycle-synchronized samples of multiple preceding pulse cycles
- Fig. 3D illustrates a second example with corresponding cycle- synchronized samples of multiple preceding pulse cycles used for obtaining the reference value.
- Fig. 3D shows a first current data sample CI from a first position in the current pulse cycle and first, second and third preceding cycle- synchronized data samples Pi l, P 2 1 and P 3 1 from positions in the first, second and third preceding pulse cycles corresponding to the location of the first current data sample in the first current pulse cycle.
- the reference value is calculated as an aggregation of the first, second and third data samples Pi l, P 2 1 and P 3 I .
- a subtraction algorithm is operated on the current data sample, using the reference value, to generate an output sample which is essentially free of a signal component attributable to the first pulse.
- the first preceding cycle- synchronized data sample Pi l, Pi2 and Pi3, respectively (cf. Figs 3D-3F), has been obtained at an instance in time corresponding to one full rotation earlier of the rotor, i.e. 360 degrees earlier.
- Fig. 9 is a schematic diagram of a filter structure 31 that implements the process in
- blocks ⁇ _ ⁇ , ⁇ _2 ⁇ to z ⁇ MA are included in an aggregation block 32 and configured to obtain, in the pressure signal, preceding data samples with suitable negative delays (- ⁇ ), (-2 ⁇ ) to (- ⁇ ) to the current data sample d(n).
- the delays are suitably selected such that the preceding data samples are cycle- synchronized data samples.
- ⁇ is set to a time value corresponding to 360°.
- Each preceding data sample is multiplied in the multiplication blocks X with a respective weight factor (Wi to WM) and added together by the summation blocks ⁇ to generate the reference value d(n) .
- the resulting reference value d(n) is input to a downstream summation block ⁇ that implements the subtraction (step 204 in Fig. 2) of the reference value d(n) from the current data sample d(n) to generate the output sample e(n).
- a filter structure 31 with such a feedback loop is shown in Fig. 13, in which the cycle- synchronized output sample e(n-A) of a preceding cycle (generated by block ⁇ _ ⁇ ) is added to the current data sample d(n) in a summation block ⁇ , after applying the weight factor W to the cycle- synchronized output sample e(n-A) in a multiplication block X.
- Fig. 10 is a schematic diagram of a filter structure 31 similar to that of Fig. 9, where the aggregation block 32 has been supplemented by an adaptive block 34 that implements an adaptive function configured to adaptively determine the weight factors Wi to WM of the aggregation block 32 to achieve a best-fit for the approximated reference value d(n) .
- the adaptive block 34 may be configured as described in relation to Fig. 8.
- Fig. 3G illustrates a variation of the second example where the reference value is calculated as an aggregation of the cycle- synchronized data samples Pi l, P 2 1 and P 3 1, each in turn aggregated (by neighbourhood aggregation) with two adjacent data samples Pi2 and P 2 N; P 2 2, P 3 N; and P 3 2, P 4 N respectively.
- this variation represents a combination of the example in Fig. 3C involving adjacent data samples, and the example in Figs 3D-3F involving cycle- synchronized samples of multiple preceding pulse cycles.
- Fig. 11 is a schematic diagram of a filter structure 31 that implements the process in
- the aggregation block 32 is configured to aggregate preceding (cycle- synchronized) data samples, which are obtained by blocks ⁇ _ ⁇ , ⁇ _2 ⁇ to z ⁇ MA with suitable negative delays (- ⁇ ), (-2 ⁇ ) to (- ⁇ ), and respective adjacent data samples, which are obtained by blocks Z- ⁇ to aggregate preceding (cycle- synchronized) data samples, which are obtained by blocks ⁇ _ ⁇ , ⁇ _2 ⁇ to z ⁇ MA with suitable negative delays (- ⁇ ), (-2 ⁇ ) to (- ⁇ ), and respective adjacent data samples, which are obtained by blocks Z- ⁇ to
- the preceding data samples are aggregated using the summation blocks ⁇ while applying weight factors Wi to W MK -
- the resulting reference value d(n) is input to a downstream summation block ⁇ that performs the subtraction (step 204 in Fig. 2) of the reference value d(n) from the current data sample d(n) to generate the output sample e(n).
- the filter structure 31 in Fig. 11 may operate a subtraction algorithm on a current data sample CI, using an aggregation of the neighbourhood aggregated preceding data samples around Pi l, P 2 1 and P 3 1 as a reference value, to generate an output sample which is essentially free of a signal component attributable to the first pulse.
- Fig. 12 is a schematic diagram of a filter structure 31 similar to that of Fig. 11, where the aggregation block 32 has been supplemented by an adaptive block 34 that implements an adaptive function configured to determine the weight factors Wi to W MK of the aggregation block 32 to achieve a best-fit for the approximated reference value d(n) .
- the adaptive block 34 may be configured as described in relation to Fig. 8.
- Example III Reference value based on prediction of samples adjacent to the current sample
- Fig. 3H illustrates a third example where the reference value is obtained based on the two preceding data samples PiN and PiN-1 that are adjacent to the current data sample CI in the pressure signal.
- the reference value is calculated by extrapolating the two preceding data samples PiN and PiN-1.
- Each preceding data sample is multiplied in the multiplication blocks X with a respective weight factor (Wi to W M ) and added together in the summation blocks ⁇ to generate an extrapolated or predicted reference value d(n) .
- a subtraction algorithm is operated on a current data sample CI, using the predicted reference value d(n) , to generate an output sample e(n) which is essentially free of a signal component attributable to the first pulse.
- Two or more immediately preceding data samples may be used for the prediction or extrapolation.
- any previous values may be taken as basis for the prediction or extrapolation of the current data sample, although greater accuracy may be achieved by selecting the preceding data samples closest in time to the current data sample.
- the weight factors are suitably set such that the predicted reference value is generated as a function of both the rate of change (derivative) among the preceding data samples and the absolute level among the preceding data samples. For example, reverting to Fig.
- the filtering technique according to the third example may be particularly useful when the second pulses are weak relative to the first pulses, e.g. when the magnitude (amplitude) ratio of second pulses to first pulses is less than about 10%, 5% or 1%. With increasing M, the ability of this filtering technique to remove relatively stronger second pulses may be improved.
- a variant is obtained by including a block 34 that adaptively determines the weight factors, e.g. as shown and described in relation to Fig. 10.
- a general property of including an adaptive filter 36 in the filter structure 31, e.g. as shown in Figs 8, 10 and 12, is that the filter structure 31 may be caused, if the preceding data samples comprise both first pulse contributions and second pulse contributions, to converge towards eliminating the first pulse contributions while retaining the second pulse contributions.
- the output sample e(n) will contain the second pulse contribution since the filter 36 is unable to reproduce the second pulse contribution in the reference value d(n) .
- a fourth example involves a recursive method where the average from previous calculations of the reference values is re-used as a first part together with an additional value as a second part to derive a new average which is then subtracted from a current data sample. This procedure may be repeated for each consecutive time step to isolate the second pulses, if present in the pressure signal.
- Such a recursive filtering may be implemented by a filter structure 31 as shown in Fig. 7, in which the filter 32 is configured to recursively generate the reference value d( n ) for each time point n based on a cycle- synchronized data sample d( n - ⁇ ) .
- the filter 32 may be implemented as a Kalman filter.
- Denial of a Kalman filter A Kalman filter is in general used to estimate the states in a dynamic system from measurements. Depending on the structure of the dynamic system it may be possible to estimate any number of states from just a single measurement using knowledge about the system structure. As used herein, m designates the number of states.
- d( n ) C( n ) ⁇ x( n ) + e( n )
- the m states are collected in the vector x, and the measurement d is in our case a scalar, but may in the general case be a vector of any length.
- the matrix A and vector C determine the structure of the system, and may (as indicated in Eq.1) be time varying.
- the disturbances v and e are random vectors of the same dimensions as x and d respectively, and have zero mean values and covariances R and ⁇ , respectively.
- the Kalman filter may be configured such that each element in state vector x(n) corresponds to one of the reference values within a current pulse cycle.
- the Kalman filter is thereby configured to, during each pulse cycle, estimate m reference values collected in the vector x :
- x(n + l ) A(n)-x(n) + K(n)-[d( n)— d(n)
- d( n ) is the estimation made at time n- 1 of the first pulse contribution at time n
- d( n ) is the current data sample at time n.
- the expression for K(n) contains a matrix P(n) which is the co variance of the estimation error at time n, i.e. an estimate of the size of the error. It is calculated from: v ⁇ . 7 » 4 , p , ⁇ T A(n)-P(n)-C(n) T ⁇ C( n ) ⁇ P( n ) ⁇ A( n ) T , p
- P(n + l) A(n)-P(n)-A(n) + R (3) ⁇ ⁇ +C(n)- P(n)-Qn) 1
- Each data sample d within the pulse cycle is associated with one state in the model to be estimated. At each point in time, one of these data samples is measured with an error that also includes the effect of the second pulses.
- the model of the states is that the states are constant.
- matrix A is not only constant, but also identical to the identity matrix, which is a particularly simple matrix that will disappear in all of Equations 1-3 above.
- the vector C will not be constant and will change between each measurement.
- the vector C When measuring the first state xi the vector C will be (1 0 0 0 0...0), and when the next state x 2 is measured it will be (0 1 0 0 ... 0) and so on.
- R may be set to a very small number.
- Eq. 2 and Eq. 3 it is only the ratio of the covariances R and ⁇ that matters.
- the actual value that should be used for this ratio may be determined from practical tests so that the mobility of the profile estimates become reasonable.
- the first pulse profile estimates x are determined by the initial values for the estimate and for P, and by the measurements (data samples) d.
- the initial state estimate is normally not known, and the initial value of P may be set to a very large number since it should reflect the uncertainty in the initial estimate. With a very large P, the initial state estimate may be set to zero, since it will immediately be corrected in the next time step. Normally P is thus initially set to a diagonal matrix with large elements, e.g. 1000.
- Kalman filter above may then be replaced with a set of m first order filters with a time constant of 1 / k sample intervals.
- Fig. 14 illustrates a filter structure 31 that implements the filter structure 31 in Fig. 7 when the filter 32 is a Kalman filter.
- the filter structure 31 in Fig. 14 includes a summation block ⁇ for calculating a difference value between the current data sample d(n) and a cycle- synchronized data sample u(n), which is obtained by block ⁇ _ ⁇ .
- a downstream summation block ⁇ generates the current output sample e(n) as a sum of the difference value and a cycle- synchronized output sample e(n- ⁇ ), which has been generated by block ⁇ _ ⁇ and then appropriately weighted in by a multiplication block X.
- the multiplication block X is configured to apply the weight factor W given by 1— k , 0 ⁇ k ⁇ 1 , such that the filter structure 31 in Fig. 14 implements the above-described Kalman filter.
- a component may also be present which is attributable to a slow drift from, e.g., influence from the dialysis fluid side of the dialyzer (cf. 6 in Fig. 4), or movements of blood lines and the pressure sensor.
- the slow drift may be included in the model by using one or two extra states in the Kalman filter.
- One extra state may be used to represent the current magnitude of the drift, and the model may then adjust this parameter as a state just as the other states. It is also possible to assume that this extra state moves around slightly by adding white noise (v) in each step.
- the covariance of this noise may be set much higher than the covariance of the other states, since the first pulse is likely to be more constant than the changing drift.
- yet another state may be used to estimate the slope of the drift.
- the model would then assume that the level of the drift is not constant, but is changed by its slope at each new point in time. Instead, the slope would be assumed to be a constant with added noise at each new point in time.
- This model is incorporated in the total model by adding two rows and two columns to the original A matrix, where all elements in the first m rows and columns are zero, the two last columns of the penultimate row are both 1, and of the last row 0 and 1
- the co variance value in the matrix R for element m+l is zero.
- the measurement equation is only changed by adding one more zero to the C vector since the slope does not enter directly, only through the magnitude.
- the drift in the first pulse profile is estimated as a separate state, which is not coupled to the first pulse. This state cannot be allowed to change too quickly since it incorporates all the measurement noise as well. Additionally, the P matrix will no longer be diagonal, even if the initial value is diagonal, when the extra state is included in the model, rendering the computations more complex and processor demanding.
- step 202 in Fig. 2 may include a sub-step of converting the incoming pressure values by taking the difference between proximate pressure values (e.g. a current pressure value and an immediately preceding pressure value), such that the data samples that are subsequently processed by the Kalman filter (in step 203) are represented as pressure change values instead of pressure values.
- proximate pressure values e.g. a current pressure value and an immediately preceding pressure value
- d( n ) is the estimation of the change in the first pulse contribution at time n.
- the predicted value of the current first pulse contribution will be the sum of the previously measured pressure value and the current estimate of the state xi, instead of only the current estimate of the state xi.
- d( n ) may be subtracted from the change in pressure value, d(n)-d(n-l).
- any previous values may be taken as basis for the prediction or extrapolation of the current data sample, although greater accuracy may be achieved by selecting the preceding data sample closest in time to the current data sample.
- a heart and other slower physiological phenomena such as the effect of breathing
- the cut off frequency of the high pass filter may have to be well below any low heart rate, e.g. at 0.6 Hz.
- a further possibility, possibly in combination with the removal of slow disturbances, may be to use a notch filter to eliminate any undesirable residual signal contributions that may remain in the output samples from the Kalman filter.
- the pressure signal may be said to contain a sequence of "apparent pulses", which are pressure pulses formed by a superposition of first pulses and second pulses when the connection system C is intact, i.e. when a fluid connection is established between the first subsystem SI, e.g. an extracorporeal blood circuit, and the second subsystem S2, e.g. the cardiovascular system of a human subject.
- the apparent pulses are defined in relation to the above-mentioned pulse cycles, such that each pulse cycle includes one and only one apparent pulse which extends a full pulse cycle.
- the apparent pulses are dominated by the first pulses, such that the first pulses provide a basic shape of the apparent pulses which is modified by the second pulses. However, it is not necessary that the first pulses dominate over the second pulses.
- the apparent pulses are made up of only first pulses (and measurement noise).
- Each pressure sensor 4a-4d in Fig. 1 detects a consecutive time sequence of pressure values. Plotting the sequence of pressure values creates profiles of the pulses, i.e. apparent profiles of the apparent pulses, where the resolution is dependent on the sample rate by which the pressure values are collected.
- the apparent profiles may be referred to as a "current apparent profile" and
- first pulses that originate from a (peristaltic) blood pump in an extracorporeal blood treatment system
- second pulses that originate from the beating of the heart of a human subject connected to the extracorporeal blood treatment system, e.g. via a vascular access.
- first pulses may also be denoted “pump pulses” or “pump profiles” (or more generally, “interference pulses” and interference profiles”)
- second pulses may also be denoted “heart pulses” and “heart profiles” (or more generally, “physiological pulses” or “physiological profiles”).
- the embodiment in Fig. 2 may be regarded as a subtraction of preceding apparent pulses from current apparent pulses.
- the apparent pulses are composed by a number of pressure values or samples.
- the subtraction is generally performed sample by sample for each apparent pulse and repeated for each consecutive apparent pulse.
- the sample by sample calculations may be performed in realtime and on-line during a treatment, although equally applicable off-line, at any part of a pressure signal.
- Fig. 2 may thus be seen as a filtering process in which a pump profile is estimated based on one or more preceding apparent pulses and subtracted from the current apparent pulse while leaving the physiological profile in the remaining signal.
- the level of detail in the resulting physiological profile depends on the number of data samples per cycle, i.e. the number of repetitions of steps 202-204 for each cycle.
- a "profile" is made up of at least three data samples, and preferably at least 5, 10 or 20 data samples, and possibly 100 data samples or more.
- Fig. 3 shows a theoretical example of apparent profiles comprising contributions from first and second pulses.
- the first pulse generator is cyclic with a period of 360 degrees, but with dual members equally
- each cycle and thus each complete apparent profile comprises two similar pump profiles, which are illustrated with essentially identical shape for simplicity, and overlaid physiological profiles (heart pulses).
- timing of the pump rotations may not always be constant
- the preceding data samples may not always have the same timing within the cycle as the current data sample.
- this is remedied by post-processing to adjust the time scale, i.e. by resampling among the data samples, in order to obtain alignment of the current and preceding data samples on the respective cycles.
- first data samples that are acquired (sampled) from the pressure signal without (or with insufficient) synchronization with the pump rotation are subjected to a resampling that generates signal values at a respective given timing (location) within each cycle using interpolation among the first data samples.
- the resampling may be facilitated by the use of a timing signal (denoted "tacho- signal” in the following) which is synchronised with the operation of the first pulse generator, e.g. with the angular rotation of the pump rollers of a peristaltic pump.
- tacho-signal the data samples are associated with a consecutive count which is reset to zero at the same location within each cycle. The total count is the same for each cycle, e.g. in the order of ten thousand counts per cycle.
- the use of a tacho-signal may improve the time determination of roller revolutions, and thereby also the subtraction process.
- the pressure signal is resampled to a rate which is associated with the rotational velocity of the rollers. If the tacho-signal is reset at a same location of the rollers for each cycle, a predefined number of desired sampling points, e.g. 50, may be defined equally distributed between consecutive zero-settings of the tacho-signal, and an interpolation may be performed to find the pressure values (data samples) at these intermediate time points.
- desired sampling points e.g. 50
- the sampling time points When sampling a high frequency signal slowly, the sampling time points will appear to be spread out randomly along the signal, which will result in that the sampled signal will comprise a low frequency instead.
- This aliasing phenomenon is avoided if the highest frequency in the pressure signal is less than half the sampling frequency, commonly referred to as the Nyquist frequency.
- recorded pressure data may instead be analysed for peak detection to determine roller cycle intervals. This may however be obstructed by physical pulses shifting the peaks slightly in time, adding uncertainty to the detection.
- the data samples are sampled synchronously with the motion of the pump revolutions, i.e. at the same respective locations along the circle spanned by the rollers of the pump.
- the synchronous sampling may be controlled based on the above-mentioned tacho-signal.
- Synchronous sampling or resembled synchronous sampling may be of less importance when the sample rate is sufficiently high.
- a sample rate of 1000 Hz may be sufficient, i.e. 1000 measurement values or samples registered each second, which represents 1 ms between each sample.
- a signal with a sample rate of 1000 Hz which is not resampled to exactly match the exact pump cycles would generate a maximum error, or deviation from the correct value, of only 0.5 ms.
- the inventive technique may be implemented without synchronous sampling or resembled synchronous sampling such that the one or more cycle- synchronized data samples in one or more preceding cycles have a respective location ("best approximation") that may deviate slightly from the exact location of a current data sample in a current pulse cycle.
- the use of neighbourhood aggregation may further reduce the need for synchronous sampling or resembled synchronous sampling.
- the extracorporeal blood flow circuit 20 is of the type which is used for dialysis.
- the extracorporeal blood flow circuit 20 is connected to the cardiovascular system of a human subject (patient) by means of a connection system C.
- the cardiovascular system corresponds to the second sub-system S2 in Fig. 1.
- the connection system C comprises an arterial access device 1 for blood extraction (here in the form of an arterial needle), a connection tube segment 2a and a connector Cla.
- the connection system C also comprises a venous access device 14 for blood reintroduction (here in the form of a venous needle), a connection tube segment 12b, and a connector C2a.
- the connectors Cla, C2a are arranged to provide a releasable or permanent engagement with a corresponding connector Clb, C2b in the circuit 20 so as to form a blood path between the circuit 20 and the arterial needle 1 and the venous needle 14, respectively.
- the connectors Cla, Clb, C2a, C2b may be of any known type.
- the extracorporeal circuit 20 comprises the connector Clb, an arterial tube segment 2b, and a blood pump 3 which may be of peristaltic type, as indicated in Fig. 1.
- the pump 3 comprises a rotor 30 with two rollers 3a, 3b.
- a pressure sensor 4a hereafter referred to as "arterial sensor” which measures the pressure before the pump in the arterial tube segment 2b.
- the blood pump 3 forces the blood, via a tube segment 5, to the blood-side of a dialyser 6.
- Many dialysis machines are additionally provided with a pressure sensor 4b that measures the pressure between the blood pump 3 and the dialyser 6.
- the blood is led via a tube segment 10 from the blood-side of the dialyser 6 to a venous drip chamber or deaeration chamber 11 and from there back to the connection system C via a venous tube segment 12a and the connector C2b.
- a pressure sensor 4c (hereafter referred to as "venous sensor”) is provided to measure the pressure on the venous side of the dialyser 6.
- the venous sensor 4c measures the pressure in the venous drip chamber 11.
- Both the arterial needle 1 and the venous needle 14 are connected to the cardiovascular system of a human or animal patient by means of a blood vessel access.
- the blood vessel access may be of any suitable type, e.g. a fistula, a Scribner- shunt, a graft, etc.
- other types of access devices may be used instead of needles, e.g. catheters.
- a pressure sensor 4d may also be present in a dialysis machine to measure the pressure in a dialysis fluid circuit.
- the "venous side” of the extracorporeal circuit 20 refers to the part of the blood path located downstream of the blood pump 3 whereas the “arterial side” of the extracorporeal circuit 20 refers to the part of the blood path located upstream of the blood pump 3.
- the venous side is made up of tube segment 5
- the blood- side of the dialyser 6 tube segment 10
- drip chamber 11 and tube segment 12a the arterial side is made up of tube segment 2b.
- a control unit 23 is provided, inter alia, to control the blood flow in the circuit 20 by controlling the revolution speed of the blood pump 3.
- the extracorporeal blood flow circuit 20 and the control unit 23 may form part of an apparatus for
- extracorporeal blood treatment such as a dialysis machine.
- a dialysis machine performs many other functions, e.g. controlling the flow of dialysis fluid, controlling the temperature and composition of the dialysis fluid, etc.
- a surveillance/monitoring device 25 is configured to monitor operation of the circuit 20 and/or the physiological state of the patient, specifically by processing a pressure signal obtained from one or more of the pressure sensors 4a-4d in accordance with the process illustrated in Fig. 2.
- the processing may involve a process for essentially eliminating or sufficiently suppressing pump pulses originating from the pump 3 in the pressure signal from one of the pressure sensors 4a-4d, while retaining physiological pulses originating from a physiological pulse generator in the patient.
- the first pulse generator 3 in Fig. 1 may correspond not only to the pump 3 in Fig. 4, but also to other mechanical pulse generators (not shown) in the circuit 20, such as valves, a pump for dialysis fluid, etc.
- the physiological pulse generator (corresponding to the second pulse generator 3' in Fig. 1) may be one or a combination of the patient's heart, reflexes, voluntary muscle contractions, non- voluntary muscle contractions, a breathing system, an autonomous system for blood pressure regulation and an autonomous system for body temperature regulation. It is also possible that the physiological pulses originate from a mechanical pulse generator attached to the patient.
- a detection of a fault condition may bring the device 25 to activate an alarm and/or stop the blood flow, e.g. by stopping the blood pump 3 and activating one or more clamping devices 13 (only one shown) on the tube segments 2a, 2b, 5, 10, 12a, 12b.
- the device 25 may also be connected to the control unit 23.
- the device 25 may be connected to a pump sensor 26, such as a rotary encoder (e.g. conductive, optical or magnetic) or the like, that provides the above- mentioned tacho-signal that indicates the frequency and phase of the blood pump 3.
- the pump sensor 26 may be arranged to sense the frequency and phase based on the current or power fed to the motor driving the blood pump 3.
- the device 25 is tethered or wirelessly connected to a local or remote device 27 for generating an audible/visual/tactile alarm or warning signal.
- the surveillance device 25 and/or the alarm device 27 may alternatively be incorporated as part of a dialysis apparatus.
- the surveillance device 25 comprises a data acquisition part 28 for receiving one or more pressure signals from the pressure sensor(s) 4a-4d and, optionally, for pre-processing the incoming pressure signal(s).
- the data acquisition part 28 may include an A/D converter with a required minimum sampling rate and resolution, one or more signal amplifiers, one or more filters to remove undesired signal components in the measurement data, such as offset, high frequency noise and supply voltage disturbances.
- data acquisition part 28 acquires the pressure signal as a time sequence of data samples, each representing an instantaneous pressure of the blood in the circuit at the location of the relevant pressure sensor 4a-4d.
- the data samples are provided as input to a data analysis part 29 that executes the inventive filtering and subsequent monitoring according to the steps in Fig. 2.
- the steps of filtering and monitoring may be implemented by a combination of a signal processor (25a in Fig. 1) and a memory (25b in Fig. 1).
- Embodiments of the invention relate to the monitoring/surveillance carried out by the surveillance device 25, based on the pressure signal.
- the monitoring may aim at detecting a disruption of the connection system C between the circuit 20 and the vascular system of the patient, i.e. on either the venous-side or the arterial- side, or both.
- the disruption may be caused by a dislodgement of the venous or arterial access device 1, 14 from the blood vessel access, i.e. that the access device 1, 14 comes loose from the vascular system of the patient.
- the disruption may be caused by a
- a functional state or functional parameter of the fluid containing system may be monitored by analysing the filtered signal formed by the above-mentioned sequence of output samples, e.g. by isolating and analysing one or more second pulses in the filtered signal.
- Valuable information concerning the fluid containing system may also be derived from a detected absence of second pulses.
- venous needle dislodgment may be detected by recognizing that the filtered signal, obtained by processing the pressure signal from the venous pressure sensor 4c, ceases to comprise second (heart and/or breathing) pulses.
- Various techniques for analysing the filtered signal may be used, for instance by recognizing that the signal magnitude in the filtered signal is below a predetermined threshold, by recognizing that the energy in the filtered signal falls and remains below a threshold for a certain period of time, by identifying a reduced correlation between second pulses in filtered signals obtained from venous and arterial pressure signals indicating loss of the second pulses in the venous pressure signal, by operating statistical techniques on the filtered signal, e.g. to identify a decreased spread of signal values in the filtered signal caused by a lack of second pulses. Additional details of these and other techniques for detecting dislodgment are disclosed in WO97/10013 and
- the filtered signal will include the second pulses, or part thereof, which may be evaluated for various characteristics for monitoring a functional state or functional parameter of the cardiovascular system of the subject in the case where the second pulses comprise physiological pulses, such as heart pulses, breathing pulses or blood pressure regulating pulses.
- physiological pulses such as heart pulses, breathing pulses or blood pressure regulating pulses.
- uses of the filtered signal include detecting, presenting, tracking and predicting vital signs, e.g.
- cardiac or respiratory related such as hypotension prediction, cardiac output and access flow monitoring and blood pressure monitoring, or disordered conditions of the subject such as sneezing, hiccups, vomiting, coughing, blood pressure turbulence, ectopic beats, lack of autonomous regulation, hypotension, disordered breathing, sleep apnea, periodic breathing, hyperventilation, asthmatic attacks, dyspnea, and Cheyne-Stokes respiration. All of these uses or applications may be based on an extraction and analysis of the shape and/or the magnitude and/or the timing of the second pulses in the filtered signal, e.g. as disclosed in WO2010/149726, WO2011/080186, WO2011/080189, WO2011/080190, WO2011/080191 and WO2011/080194, all of which are incorporated herein by reference.
- Analysis of the second pulses may also be used to identify a fault condition, e.g. in the connection system C , such as reversed positioning of the access needles 1, 14, where e.g. the shape and/or timing of second pulses may be evaluated for determining the positioning of the needles 1, 14, e.g. as disclosed in WO2011/080188, which is
- the reference value may be calculated as a function of subsequent data samples instead of (or in addition to) preceding data samples, e.g. if a time sequence of data samples is continuously or intermittently buffered in electronic memory (cf. 25b in Fig. 1).
- the incoming stream of data samples may be entered in a FIFO (First- In, First-Out) buffer in memory (which thus stores a given number of the most recent data samples) and processed to generate a reference value for a current data sample among the data samples in the buffer.
- the "current" data sample denotes the data sample which is currently being processed to generate a filtered output sample.
- the reference value may be calculated as a function of only preceding data samples (i.e. data samples that are measured earlier in time than the current data sample), only subsequent data samples (i.e. data samples that are measured later in time than the current data sample), or both preceding and subsequent data samples.
- the cycle- synchronized data sample may be obtained in one or more preceding pulse cycles and/or one or more subsequent pulse cycles.
- the predicted reference value may be generated as a function of two or more immediately subsequent data samples (i.e. by backward projection instead of forward projection), or as a function of data samples on both sides of the current data sample (e.g.
- the filter structures 31 in Figs 6- 12 may be modified to use both preceding and subsequent data samples, e.g. by duplicating the r eessppeeictive aggregation block 32 so as to include both blocks Z , Z andZ ,MA
- the pressure signal may originate from any conceivable type of pressure sensor, e.g.
- Fig. 1 indicates that the device 25 is connected to (at least one of) pressure sensors 4a-4d installed in the first sub- system SI
- the device 25 may instead be connected to one or more pressure sensors (not shown) installed to measure the fluid pressure in the second sub-system S2.
- the fluid containing system need not be partitioned into first and second sub- systems SI, S2 connected via a fluid connection C, but could instead be a unitary fluid containing system associated with a first pulse generator and a second pulse generator, and the device 25 may be connected to a pressure sensor installed in the fluid containing system to detect a first pulse originating from the first pulse generator and a second pulse originating from the second pulse generator.
- inventive technique is applicable for monitoring in all types of extracorporeal blood flow circuits in which blood is taken from the systemic blood circuit of the patient to have a process applied to it before it is returned to the patient.
- blood flow circuits include circuits for hemodialysis, hemofiltration, hemodiafiltration, plasmapheresis, apheresis, extracorporeal membrane oxygenation, assisted blood circulation, and extracorporeal liver support/dialysis.
- the inventive technique is likewise applicable for monitoring in other types of extracorporeal blood flow circuits, such as circuits for blood transfusion, infusion, as well as heart-lung-machines.
- the inventive technique is also applicable to fluid systems containing other liquids than blood.
- inventive technique is applicable to remove pressure pulses originating from any type of pumping device, not only rotary peristaltic pumps as disclosed above, but also other types of positive displacement pumps, such as linear peristaltic pumps, diaphragm pumps, as well as centrifugal pumps.
- inventive technique is applicable for removing pressure pulses that originate from any type of periodic pulse generator, be it mechanic or human.
- inventive technique is applicable to isolate pressure pulses originating from any type of pulse generator, be it human or mechanic.
- the inventive technique need not operate on real-time data, but could be used for processing off-line data, such as a previously recorded measurement signal.
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- Chemical Kinetics & Catalysis (AREA)
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Abstract
Description
Claims
Priority Applications (8)
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JP2014517596A JP6038910B2 (en) | 2011-06-30 | 2012-06-20 | Time-dependent pressure signal filtering |
CN201280032696.5A CN103635133B (en) | 2011-06-30 | 2012-06-20 | The filtering of time correlation pressure signal |
PL12728286T PL2725971T3 (en) | 2011-06-30 | 2012-06-20 | Filtering of a time-dependent pressure signal |
AU2012278038A AU2012278038B2 (en) | 2011-06-30 | 2012-06-20 | Filtering of a time-dependent pressure signal |
CA2836852A CA2836852A1 (en) | 2011-06-30 | 2012-06-20 | Filtering of a time-dependent pressure signal |
US14/234,527 US9636447B2 (en) | 2011-06-30 | 2012-06-20 | Filtering of a time-dependent pressure signal |
EP12728286.1A EP2725971B1 (en) | 2011-06-30 | 2012-06-20 | Filtering of a time-dependent pressure signal |
KR1020147000255A KR20140043432A (en) | 2011-06-30 | 2012-06-20 | Filtering of a time-dependent pressure signal |
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EP (1) | EP2725971B1 (en) |
JP (1) | JP6038910B2 (en) |
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EP2725971A1 (en) | 2014-05-07 |
CN103635133B (en) | 2016-01-20 |
CA2836852A1 (en) | 2013-01-03 |
JP6038910B2 (en) | 2016-12-07 |
US9636447B2 (en) | 2017-05-02 |
EP2725971B1 (en) | 2020-01-22 |
AU2012278038B2 (en) | 2014-11-13 |
US20140231319A1 (en) | 2014-08-21 |
KR20140043432A (en) | 2014-04-09 |
WO2013000777A9 (en) | 2013-10-03 |
AU2012278038A1 (en) | 2013-04-04 |
JP2014524793A (en) | 2014-09-25 |
PL2725971T3 (en) | 2020-06-29 |
CN103635133A (en) | 2014-03-12 |
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