CN116850362A - blood purification system - Google Patents
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- CN116850362A CN116850362A CN202311129627.2A CN202311129627A CN116850362A CN 116850362 A CN116850362 A CN 116850362A CN 202311129627 A CN202311129627 A CN 202311129627A CN 116850362 A CN116850362 A CN 116850362A
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- 210000004369 blood Anatomy 0.000 title claims abstract description 238
- 239000008280 blood Substances 0.000 title claims abstract description 238
- 238000000746 purification Methods 0.000 title claims abstract description 171
- 238000004088 simulation Methods 0.000 claims abstract description 30
- 238000002626 targeted therapy Methods 0.000 claims abstract description 7
- 230000002093 peripheral effect Effects 0.000 claims description 42
- 238000010801 machine learning Methods 0.000 claims description 35
- 238000000502 dialysis Methods 0.000 claims description 31
- 238000004891 communication Methods 0.000 claims description 27
- 238000001631 haemodialysis Methods 0.000 claims description 27
- 230000000322 hemodialysis Effects 0.000 claims description 27
- 238000012544 monitoring process Methods 0.000 claims description 16
- 230000017531 blood circulation Effects 0.000 claims description 15
- 238000001514 detection method Methods 0.000 claims description 15
- 230000004044 response Effects 0.000 claims description 14
- 238000012545 processing Methods 0.000 claims description 13
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- 239000004202 carbamide Substances 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 9
- 230000004872 arterial blood pressure Effects 0.000 claims description 6
- 238000012549 training Methods 0.000 claims description 5
- 238000000108 ultra-filtration Methods 0.000 claims description 5
- 238000012417 linear regression Methods 0.000 claims description 3
- 238000007477 logistic regression Methods 0.000 claims description 3
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- 229910001415 sodium ion Inorganic materials 0.000 claims description 3
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Classifications
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
-
- 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
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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
- A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
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- A—HUMAN NECESSITIES
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- 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
- A61M1/3623—Means for actively controlling temperature of blood
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- A—HUMAN NECESSITIES
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- 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
- A61M1/3663—Flow rate transducers; Flow integrators
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
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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
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- A61M2205/3327—Measuring
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
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Abstract
The present invention provides a blood purification system comprising a user input configured to provide an input signal to a blood purification device corresponding to a target treatment parameter of a user; the blood purification device includes a plurality of sensors configured to generate sensor data indicative of the blood purification device during a treatment; the controller includes a data processor and a memory including a human simulation database for execution by the data processor, the controller configured to receive a target therapy parameter; receiving sensor data; reconstructing sensor data using a data processor; an output based on the reconstructed sensor data is generated using the human simulation database, the output including one or more physiological sign parameters, and the target therapy parameters are controlled or whether a preset event or a predisposition for the occurrence of the preset event is determined based on the generated output. The technical scheme can adapt to the condition or application of the blood purification device which is continuously changed during the operation, and is helpful for detecting and responding to more complex conditions.
Description
Technical Field
The invention relates to medical equipment, in particular to a blood purification system.
Background
The traditional blood purification devices are functionally composed of two systems, namely a dialysate supply system, a dialysate flow control system, a temperature control system, a conductivity monitoring system and an acid-base value monitoring system; and secondly, a blood monitoring alarm system comprises arterial pressure monitoring, air bubble monitoring, blood leakage monitoring and the like.
First, regarding dialysate flow rate
In hemodialysis, the dialysate flow rate is important for the hemodialysis effect in order to achieve the purposes of blood purification and electrolyte acid-base balance. The too large or too small flow rate per unit time may make the blood purification not reach the treatment requirement. The dialysate flow rate of a dialysis machine is generally set to be 0, 300, 500, 800 (unit: mL/min), the clinical dialysate flow rate is generally set to be 500mL/min, and the ratio of the dialysate flow rate to the blood flow rate is 2:1, otherwise, the dialysis effect is affected. The flow detection probes of the mass detector of the hemodialysis machine are commonly used for detecting the hemodialysis machine.
2. With respect to temperature
During normal dialysis, reverse osmosis water meeting the treatment standard is heated to 35-40 ℃ generally, and the temperature value is detected by a temperature sensor after the reverse osmosis water is mixed with the concentrated solution, so that the temperature of the dialysate is basically consistent with the set temperature by controlling a heating system. The temperature of the dialysate is usually controlled at about 37 ℃, and can be properly adjusted according to the specific situation of the patient. The higher and lower temperatures of the dialysate can cause discomfort and even death of the patient, so the dialysate can be used as a dialysis machine to generate high and low temperature baseline alarm temperatures at the temperature of less than 34 ℃ and more than 41 ℃. The temperature probe of the quality detector of the hemodialysis machine is commonly used for detecting the hemodialysis machine.
Third, regarding conductivity
The concentration of the dialysate is typically obtained by detecting the conductivity of the dialysate. The unit of conductivity is mS/cm. In clinical practice, the conductivity is generally set to 14mS/cm, and in practice, the total concentration of cations is set to 140mmol (conductivity value x 10=millimoles of cations), and the alarm limit of the hemodialysis machine is set to ±5%. In order to successfully carry out dialysis clinically and maintain the stability of blood pressure of a patient, the conductivity value is often finely adjusted to carry out high-sodium dialysis. However, too high or too low a conductivity value may cause life hazards to the patient. Thus, the accuracy of the hemodialysis machine electrical conductivity parameter is directly related to the clinical control of that parameter. The conductivity probe of the quality detector of the hemodialysis machine is commonly used for detecting the hemodialysis machine.
Fourth, regarding pH value
In hemodialysis, the pH is important in the hydrolysis and digestion of gastric hormones, in the interaction of the hydrochloric acid mixture with proteins, etc. In addition, through the monitoring to the pH value of the dialysate, misplacing the concentrated liquid medicine for dialysis can be prevented, and danger and even death of patients are avoided. The pH value of the treatment range is between (7.2 and 7.5), and when the pH value is more than 7.5, calcium deposition can occur, so that the life of a patient is influenced, and equipment is damaged. The pH detection electrode of the mass detector of the hemodialysis machine is commonly used for detecting the dialysate of the hemodialysis machine.
Fifthly, blood monitoring alarm
The hemodialysis machine can give an alarm by creating an alarm condition.
The air bubble monitoring and alarming system can generate bubbles (the volume of the gas is not too large) in the pipeline by using the gas injection device, when the hemodialysis machine monitors the bubbles, an audible and visual alarm is given out, and the monitoring system can drive the arterial and venous blood clamps to block blood flow, so that dangers are prevented.
The blood leakage monitoring and alarming system adopts a photoelectric sensor to measure whether blood components exist in the dialysate, so that the blood leakage alarm gives out audible and visual alarm when the blood leakage per minute is greater than 0.5mL under the maximum dialysate flow rate of the hemodialysis machine.
Arterial pressure and venous pressure are monitored and displayed by pressure sensors, respectively. The purpose of arteriovenous pressure monitoring is to monitor thrombus, coagulation and pressure change in the dialyzer, so that the pressure value in the pipeline is changed by the methods of blocking the pipeline, pulling out a reflux needle and the like, and the instrument gives out audible and visual alarm.
As such, it can be seen that some conventional blood purification devices include a sensor that alters or adjusts the operation of the blood purification device by a preset hard-coded threshold, for example, the sensor may detect that the dialysate flow or temperature or conductivity or pH value is below or above a predetermined hard-coded threshold, and a control system that controls the blood purification device to alarm and/or shut down to protect the user. While these types of thresholds may be easily implemented and provide some benefits to the operation of the blood purification device, these types of hard coded thresholds cannot accommodate the changing conditions or applications of the blood purification device during operation and may ultimately not be conducive to detecting and responding to more complex conditions. In particular, the patient has complicated, serious and changeable conditions.
Disclosure of Invention
In view of the above, the present invention provides a blood purifying system to solve the above-mentioned technical problems.
The invention provides a blood purification system, which comprises a blood purification device and further comprises:
a user input configured to provide an input signal to the blood purification device corresponding to a target treatment parameter of a user;
the blood purification device includes a plurality of sensors configured to generate sensor data indicative of the blood purification device during hemodialysis treatment operation;
a controller comprising a data processor and a memory, the memory comprising a human simulation database for execution by the data processor, the controller configured to:
receiving the target treatment parameters;
receiving the sensor data;
reconstructing the sensor data using the data processor;
generating, using the human simulation database, an output based on the reconstructed sensor data, the output comprising one or more physiological sign parameters, and;
and controlling the target treatment parameters or judging whether a preset event or the occurrence tendency of the preset event occurs according to the generated output.
Further, wherein the human body simulation database comprises at least one pre-stored human body simulation model; the manikin is adapted for integrated training by a machine learning method.
Further, wherein the machine learning method comprises one or more of linear regression, logistic regression, random forest multiple learning methods.
Further, wherein the human simulation database is further configured to:
receiving feedback regarding control of the target therapy parameter based on the output;
the feedback is provided to the mannequin to train the mannequin.
Further, wherein further sensor data is received from the sensor;
processing the further sensor data using the mannequin trained with the feedback, and;
a further output is generated based on the further sensor data using the human simulation model trained with the feedback.
Further, wherein the input signals corresponding to the target treatment parameters of the user include ultrafiltration volume UFV, dialysis duration t, dialysate urea clearance K d Dialysate flow rate Q d Prescribed blood flow rate Q br One or more of the following.
Further, wherein the sensor data comprises one or more of dialysate flow, dialysate temperature, dialysate conductivity, dialysate pH, blood flow rate.
Further, wherein the physiological parameters include relative blood volume RBV, post-dialysis blood temperature T b Concentration of sodium ions [ Na ] in blood after dialysis + ] p Actual blood flow rate Q after dialysis bt Effective urea clearance K eff One or more of heart rate HR, mean arterial blood pressure BP after dialysis.
Further, wherein the system further comprises:
a peripheral medical accessory adapted to be worn by a user, configured to detect acquisition of a physiological sign parameter of the user.
Further, wherein the peripheral medical accessory is adapted to be communicatively connected to the blood purification device and/or the controller and to control the peripheral medical accessory to perform an action specified by the control command in response to a control command received from the blood purification device and/or the controller.
Further, wherein the action specified by the control command is to start or stop the peripheral medical accessory or instruct the peripheral medical accessory to send data to the blood purification device and/or the controller.
Further, wherein the controller is adapted to compare physiological sign parameters acquired by the peripheral medical accessory detection with physiological sign parameters generated by the human simulation database based on the reconstructed output of the sensor data;
And if the comparison result exceeds a preset safety threshold, an alarm module of the blood purification device generates an alarm.
Further, wherein the controller is adapted to connect with a clinician terminal or a monitoring terminal by means of wireless communication.
The invention also relates to a further blood purification system comprising a blood purification device, further comprising:
a user input configured to provide an input signal to the blood purification device corresponding to a target treatment parameter of a user;
the blood purification device includes a plurality of sensors configured to generate sensor data indicative of the blood purification device during hemodialysis treatment operation;
a controller comprising an electronic processor and a memory, the memory comprising a machine learning control program for execution by the electronic processor, the controller configured to:
receiving the target treatment parameters;
receiving the sensor data;
processing the sensor data using the machine learning control program;
generating, using the machine learning control program, an output based on the processed sensor data, the output including one or more physiological sign parameters, and;
And controlling the target treatment parameters or judging whether a preset event or the occurrence tendency of the preset event occurs according to the generated output.
Further, wherein the controller is adapted to construct a human simulated mathematical model by the machine learning control program.
Further, wherein the controller is further configured to:
receiving feedback regarding control of the target therapy parameter based on the output,
the feedback is provided to the machine learning control program to train the machine learning control program.
Further, wherein further sensor data is received from the sensor,
processing the further sensor data using the machine learning control program trained with the feedback, and
a further output is generated based on the further sensor data using the machine learning control program trained with the feedback.
Further, wherein the system further comprises:
a peripheral medical accessory adapted to be worn by a user, configured to detect acquisition of a physiological sign parameter of the user.
Further, wherein the peripheral medical accessory is adapted to be communicatively connected to the blood purification device and/or the controller and to control the peripheral medical accessory to perform an action specified by the control command in response to a control command received from the blood purification device and/or the controller.
Further, wherein the action specified by the control command is to start or stop the peripheral medical accessory or instruct the peripheral medical accessory to send data to the blood purification device and/or the controller.
Further, wherein the controller is adapted to compare physiological sign parameters acquired by the peripheral medical accessory detection with physiological sign parameters generated by the machine learning control program based on the processed output of the sensor data;
and if the comparison result exceeds a preset safety threshold, an alarm module of the blood purification device generates an alarm.
Compared with the prior art, the technical scheme of the invention has the beneficial technical effects that:
the controller of the blood purification system provided by the present invention does not implement the hard-coded threshold value determined and programmed in advance as described in the background art, but adjusts the output of the operation control blood purification device based on the sensor data detected during the execution of the hemodialysis treatment by the blood purification device, and controls the target treatment parameter or judges whether a preset event or the occurrence tendency of the preset event according to the generated output, and thus, the threshold value in the present invention is based on the previous operation of the blood purification device and can be changed based on the input received from the user and the further operation of the blood purification device to adapt to the condition or application of the blood purification device that is constantly changing during the operation, contributing to the detection and response of more complicated situations. In particular, the patient has complicated, serious and changeable conditions.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a flow chart of a method according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a communication system including a portable terminal, peripheral medical accessories, a blood purification device, and a server according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of a communication system in which a blood purification device and a server are bridged by a portable terminal according to an embodiment of the present invention;
FIG. 4 is a flow chart of a blood pressure cuff response to a blood purification device in accordance with an embodiment of the present invention;
FIG. 5 is a schematic diagram of a communication system between a blood purification device and a server according to another embodiment of the present invention;
FIG. 6 is a schematic block diagram of another embodiment of the present invention;
FIG. 7 is a fluid circuit diagram of a blood purification device according to an embodiment of the present invention;
FIG. 8a is a schematic view of a kettle body according to an embodiment of the present invention;
FIG. 8b is a cross-sectional view of a kettle body according to an embodiment of the present invention;
fig. 9 is a schematic diagram of a communication system according to another embodiment of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Referring to fig. 1 and 2, a blood purification system 100 includes a blood purification device 10, which further includes:
a user input configured to provide an input signal to the blood purification device 10 corresponding to a target treatment parameter of the user;
the blood purification device 10 includes a plurality of sensors configured to generate sensor data indicative of the blood purification device 10 during hemodialysis treatment operations;
a controller 20 comprising a data processor 20a and a memory 20b, the memory 20b comprising a human simulation database for execution by the data processor, the controller 20 being configured to:
receiving a target treatment parameter;
Receiving sensor data;
reconstructing sensor data using the data processor 20 a;
generating an output based on the reconstructed sensor data using the human simulation database, the output comprising one or more physiological sign parameters, and;
and controlling the target treatment parameters or judging whether a preset event or the occurrence tendency of the preset event occurs according to the generated output.
The user input may be input through the control unit 10a of the blood purification apparatus 10, for example: the touch display screen 10a or a combination of touch screen and control panel manages and controls the target treatment parameters of the blood purification apparatus 10, such as: allowing an operator to input various treatment parameters to the blood purification device 10 through the touch display screen 10a or through the touch screen and the control panel, and additionally control the blood purification device 10; the touch screen displays information to an operator of the blood purification device 10.
In addition, the touch display screen 10a or touch screen may also indicate whether or not peripheral accessory devices such as the keyboard 60, the portable terminal 40, and the blood pressure cuff 50 are connected to the blood purification apparatus 10. Wherein the keyboard 60, the portable terminal 40, and the blood pressure cuff 50 are connected to the blood purification apparatus 10 by direct or indirect communication with a communication system of the blood purification apparatus 10. During treatment, keyboard 60 and other peripheral accessory devices may be used to control, monitor and determine treatment parameters and variables. For example, the operator inputs various treatment parameters to the blood purification device 10 through the keyboard 60 or the portable terminal 40, and additionally controls the blood purification device 10, and the blood pressure cuff 50 detects the blood pressure of the patient and transmits the blood pressure measurement value to the blood purification device 10.
Specifically, peripheral accessory devices such as the keyboard 60, the portable terminal 40, and the blood pressure cuff 50 communicate with the blood purification apparatus 10, for example, to transmit at least a portion of the treatment parameter information for the blood purification apparatus 10 to receive the treatment parameter configuration information for the blood purification apparatus 10. In some embodiments, the keyboard 60, the portable terminal 40, and the blood pressure cuff 50 may each include a short-range transceiver in communication with the blood purification apparatus 10, and a long-range transceiver in communication with the server 30. In the embodiment shown in fig. 2, the blood purification device 10 includes a transceiver that communicates with the keyboard 60, the portable terminal 40, and the blood pressure cuff 50 via a short range communication protocol (e.g., bluetooth, wifi).
In other embodiments, particularly as shown in fig. 3, peripheral accessory devices such as a keyboard 60, a portable terminal 40, and a blood pressure cuff 50, particularly a portable terminal 40 (e.g., a smart phone) bridge communication between the blood purification apparatus 10 and the server 30. That is, the blood purification apparatus 10 transmits the sensor data during the treatment to the portable terminal 40, and the portable terminal 40 forwards the sensor data from the blood purification apparatus 10 to the server 30 through the network. The network may be a remote wireless network, such as the Internet, a local area network ("LAN"), a wide area network ("WAN"), or a combination thereof.
What needs to be further explained is:
the server 30 includes a controller 20, the controller 20 including a data processor 20a and a memory 20b, and a transceiver 20c, the memory 20b including a human simulation database for execution by the data processor. The transceiver allows the server 30 to communicate with the blood purification apparatus 10 and peripheral accessory devices such as the keyboard 60, the portable terminal 40, and the blood pressure cuff 50, or both. The data processor 20a receives therapy parameters or sensor data from the blood purification device 10, stores the received data in the memory 20b, and in some embodiments, uses the received data to build or adjust a human simulation database.
Specifically, in some embodiments, the mannequin database includes at least one pre-stored mannequin model; the manikin is suitable for integrated training by a machine learning method. The human body simulation model is integrated and trained through the machine learning method, the prior knowledge of the model is not required to be completely relied on, the precision of each model is estimated through the test set, and the generalization capability of the model can be ensured. Specifically, the machine learning method comprises one or more of linear regression, logistic regression and random forest learning methods, and the final model is integrated in a certain way such as cascading, stacking and other integrated ways.
Furthermore, in some embodiments, the human simulation database is further configured to:
receiving feedback regarding control of the target therapy parameter based on the output;
feedback is provided to the mannequin to train the mannequin.
Further, receiving further sensor data from the sensor;
processing further sensor data using a human simulation model trained with feedback, and;
further outputs are generated based on further sensor data using a human simulation model trained with feedback.
The manikin being trained may vary based on the user's selections or the user's condition. For example, training examples of a plurality of different conditions, different complications are provided to a human simulation model, which uses these training examples to generate a model that facilitates classification or estimation of output based on new input data.
In the preferred embodiment, the input signals corresponding to the target treatment parameters of the user include ultrafiltration volume UFV, dialysis duration t, and dialysate urea removal rate K d Dialysate flow rate Q d Prescribed blood flow rate Q br One or more of the following.
The operator passes through the control unit 10a, for example: the touch display screen 10a or the combination of the touch screen and the control panel inputs the ultrafiltration volume UFV, the dialysis duration t and the dialysis fluid urea removal rate K to the blood purification apparatus 10 d Dialysate flow rate Q d Prescribed blood flow rate Q br One or more of the following.
The plurality of sensors of the blood purification device 10 generate sensor data indicative of the blood purification device 10 during hemodialysis treatment operation, including one or more of dialysate flow rate, dialysate temperature, dialysate conductivity, dialysate pH, blood flow rate.
The controller receives target treatment parameters (such as ultrafiltration volume UFV, dialysis duration t, and dialysate urea clearance K) d Dialysate flow rate Q d Prescribed blood flow rate Q br One or more of the following;
receiving sensor data (such as one or more of dialysate flow, dialysate temperature, dialysate conductivity, dialysate pH, blood flow rate);
reconstructing sensor data using a data processor;
generating an output based on the reconstructed sensor data using the human simulation database, the output comprising one or more physiological parameters including a relative blood volume RBV, a post-dialysis blood temperature T b Concentration of sodium ions [ Na ] in blood after dialysis + ] p Actual blood flow rate Q after dialysis bt Effective urea clearance K eff One or more of heart rate HR, mean arterial blood pressure BP after dialysis;
And controlling the target treatment parameter according to the generated output. For example: by effective urea clearance K eff To control the dialysate flow rate Q d And dialysis duration t, too low clearance rate, the system stops the current circulating water, switches to the drainage flow, supplements fresh liquid for treatment, and adjusts the flow rate Q of the dialysis liquid d And dialysis duration t to ensure dialysis adequacy; conversely, if the clearance is better, it willThe circulation time is automatically prolonged, thereby maximizing the utilization rate of the dialysate.
Or judging whether a preset event or the occurrence tendency of the preset event occurs or not according to the generated output. The preset event may be configured as a complication of hemodialysis, such as: whether or not dialysis hypotension or tendency of occurrence of dialysis hypotension is judged by the relative blood volume RBV and the output of the average arterial blood pressure BP after dialysis, or whether or not arrhythmia or tendency of occurrence of arrhythmia is judged by the heart rate HR.
In addition, it is also worth mentioning that: the system further comprises:
a peripheral medical accessory adapted to be worn by a user, configured to detect acquisition of a physiological sign parameter of the user. Such as the blood pressure cuff 50 described above that detects the blood pressure of a patient.
Wherein the peripheral medical accessory (e.g., blood pressure cuff 50) is adapted to be communicatively coupled to the blood purification device and/or the controller (server) and, in response to control commands received from the blood purification device and/or the controller, to control the peripheral medical accessory to perform actions specified by the control commands.
Wherein the control command specifies an action to start or stop the peripheral medical accessory or instruct the peripheral medical accessory to send data to the blood purification device and/or the controller.
Further, the controller is adapted to compare physiological sign parameters acquired by the peripheral medical accessory detection with physiological sign parameters generated by the human body simulation database based on the output of the reconstructed sensor data;
and if the comparison result exceeds the preset safety threshold, an alarm module of the blood purifying device generates an alarm.
Specifically, taking the blood pressure cuff 50 as an example, referring to fig. 2 and 4, the blood pressure cuff 50 is connected to the blood purification apparatus 10 by a short range communication protocol (e.g., bluetooth, wifi), and when it is determined that the blood purification apparatus 10 is operating, a control command is sent to the blood pressure cuff 50 by the blood purification apparatus 10, and the blood pressure cuff 50 receives the control command to start the operation in response to the control command, so that the blood pressure cuff 50 is controlled to start the operation. Thus, the blood pressure cuff 50 may be operated simultaneously with the blood purification device 10 without any user intervention. In other words, when the blood purification apparatus 10 is activated to run by the user, the blood pressure cuff 50 is also activated to start, which allows the process of blood pressure detection to be automated, reduces the user's operations, and provides more efficient blood pressure detection.
In some other embodiments, the blood pressure cuff 50 may also be deactivated in response to the deactivation of the blood purification device 10 by the user, i.e., when it is determined that the blood purification device 10 has stopped functioning, a control command is sent to the blood pressure cuff 50 by the blood purification device 10, the blood pressure cuff 50 receiving the control command to begin responding, controlling the blood pressure cuff 50 to stop functioning.
In some further embodiments, when it is determined that the blood purification device 10 is operating, a control command is sent by the blood purification device 10 to the blood pressure cuff 50, the blood pressure cuff 50 is controlled to send data to the blood purification device 10, such as periodically detecting blood pressure every 10 minutes, in response to receipt of the control command start response, and the detected blood pressure data is sent to the blood purification device 10. In the specific embodiment shown in fig. 2, the blood purification apparatus 10 further transmits the blood pressure data to the controller 20 in the server 30 via a network.
Further, the controller 20 compares the blood pressure data detected and collected by the blood pressure cuff 50 with the blood pressure data generated by the human simulation database based on the output of the reconstructed sensor data;
if the comparison result exceeds the preset safety threshold, the alarm module of the blood purification apparatus 10 generates an alarm to ensure the safety of the blood purification system 100.
In other embodiments, as shown in fig. 5, a portable terminal 40 (e.g., a smart phone) bridges the communication between the blood purification apparatus 10 and the server 30. That is, the blood purification apparatus 10 transmits the sensor data during the treatment to the portable terminal 40, and the portable terminal 40 forwards the sensor data from the blood purification apparatus 10 to the server 30 through the network. The network may be a remote wireless network, such as the Internet, a local area network ("LAN"), a wide area network ("WAN"), or a combination thereof.
At this time, the blood pressure cuff 50 and the portable terminal 40 are preferably connected by a short-range communication protocol (e.g., bluetooth, wifi), but a network connection may be adopted, and when it is determined that the blood purification apparatus 10 is operating, the blood purification apparatus 10 transmits a control command to the blood pressure cuff 50 through the portable terminal 40, and the blood pressure cuff 50 receives the control command to start the operation, and controls the blood pressure cuff 50 to start the operation. Thus, the blood pressure cuff 50 may be operated simultaneously with the blood purification device 10 without any user intervention. In other words, when the blood purification apparatus 10 is activated to run by the user, the blood pressure cuff 50 is also activated to start, which allows the process of blood pressure detection to be automated, reduces the user's operations, and provides more efficient blood pressure detection.
In some other embodiments, the blood pressure cuff 50 may also be deactivated in response to the deactivation of the blood purification device 10 by the user, i.e., when it is determined that the blood purification device 10 has stopped functioning, the blood purification device 10 sends a control command to the blood pressure cuff 50 via the portable terminal 40, the blood pressure cuff 50 receiving the control command to start responding, and the blood pressure cuff 50 is controlled to stop functioning.
In some further embodiments, when it is determined that the blood purification device 10 is operating, the blood purification device 10 sends a control command to the blood pressure cuff 50 through the portable terminal 40, the blood pressure cuff 50 receives a control command start response, and the blood pressure cuff 50 is controlled to send data to the controller 20 in the server 30 through the portable terminal 40, for example, to detect blood pressure periodically every 10 minutes.
Further, the controller 20 compares the blood pressure data detected and collected by the blood pressure cuff 50 with the blood pressure data generated by the human simulation database based on the output of the reconstructed sensor data;
if the comparison result exceeds the preset safety threshold, the alarm module of the blood purification apparatus 10 generates an alarm to ensure the safety of the blood purification system 100.
Further, the controller 20 is adapted to connect with a clinician terminal or a monitoring terminal by means of wireless communication (such as network communication), so that the clinician or the monitoring person can quickly and conveniently observe the hemodialysis treatment process of the patient or receive the early warning information.
Further, as shown in fig. 2 and 6, in the first embodiment of the blood purification apparatus 10, the blood purification apparatus 10 is connected to the server 30 via a network, and the controller 20 is disposed in the server 30.
As shown in fig. 6, the blood purification device 10 of the present embodiment includes a manipulation unit 10a that receives user input, a main body unit 10b that is provided with a processing unit, a wireless communication unit, a sensor, a controller, and a memory, and a power supply unit.
The control part 10a receives user input, and issues an instruction through a controller in the main body part 10b, the processing part receives the instruction, and outputs a control instruction through the instruction output part to control the opening/closing and adjustment of the blood pump, the water pump, the drug pump, the valve and the heater; for example, the instruction output unit may output a control instruction to start or stop the blood pump, or to increase or decrease the speed of the blood pump.
The wireless communication unit is capable of communicating with an external device via a communication network, and includes a long-range communication mode and a short-range communication mode; the method comprises the steps of,
a power supply unit for connecting an external power supply and supplying power to the control unit and the main body 10 b;
further, the information acquisition unit included in the processing unit acquires sensor data related to the manipulation unit 10a, including one or more of a dialysate flow rate, a dialysate temperature, a dialysate conductivity, a dialysate pH value, and a blood flow rate.
The determination unit of the processing unit determines whether or not an event has occurred in which communication with an external device (such as the keyboard 60, the portable terminal 40, the blood pressure cuff 50, and the server) of the communication network is performed, and, for example, when the determination unit determines that an event has occurred in which communication with the server should be started, notifies the wireless communication unit of the start of communication with the server.
Referring to fig. 7, referring to fig. 7 more specifically for the blood purification apparatus 10, the blood purification apparatus 10 includes a blood circuit 1, a waterway circuit 2, and a blood purification mechanism 3 (such as a hemodialyzer):
the blood circuit 1 is configured to extracorporeal circulate blood of a patient, including an arterial-side blood circuit and a venous-side blood circuit; the waterway circuit 2 includes a dialysate introduction line for introducing dialysate into the blood purification mechanism 3 and a dialysate discharge line for discharging discharged liquid from the blood purification mechanism 3; the blood purifying means 3 is interposed between the arterial side blood circuit and the venous side blood circuit, and is adapted to purify the blood flowing through the blood circuit 1.
The above-mentioned arterial side blood circuit is provided with a blood pump, and the arterial side blood circuit and the venous side blood circuit of the blood circuit 1 are provided with an arterial pot 4a and a venous pot 4b, respectively, the pot body 41 structure of the arterial pot 4a and the venous pot 4b is shown with reference to fig. 8a and 8b, the pot body 41 is provided with a cavity 42, a blood inlet 43 and a blood outlet 45 which are communicated with the cavity 42, the inner opening direction of the blood inlet 43 communicated with the cavity 42 is tangent to the inner wall surface 44 of the cavity 42, so that the blood enters from the blood inlet 43 and flows down along the inner wall surface 44 or swirls down along the inner wall surface 44, and then is discharged from the blood outlet 45, thereby avoiding the rupture of red blood cells and preventing the coagulation. Further, a spiral flow path tangential to and penetrating the opening direction of the inner side of the blood inlet 43 may be provided on the inner wall surface 44, so that the blood inlet 43 enters the spiral flow path along the inner wall surface 44 to flow down, and further, the rupture of red blood cells can be effectively avoided, and the coagulation can be prevented.
In addition, in some other embodiments, the air discharge port 46 and the pressure detection port 47 are also provided at the upper end of the pot body 41, and the chamber 42 is used as an air trapping chamber at this time, and the blood of the patient reaches the blood purifying means 3 through the arterial side blood circuit while removing air bubbles through the air trapping chamber of the arterial pot 4a, and returns to the patient through the venous side blood circuit while removing air bubbles through the air trapping chamber of the venous pot 4b after purifying the blood by the blood purifying means 3. This allows the blood of the patient to be purified by the blood purification means 3 while circulating the blood of the patient from the front end of the arterial blood circuit to the front end of the venous blood circuit in vitro in the blood circuit 1.
Further, as shown in fig. 7, a bubble sensor 6 is connected to the venous-side blood circuit in the present embodiment, and the bubble sensor 6 can detect bubbles in blood flowing through the arterial-side blood circuit or the venous-side blood circuit during blood purification treatment, and when air bubbles are detected, the blood pump is operated backward in the reverse direction so that the air bubbles are moved upward toward the air-bubble discharge port 46 and discharged.
In addition, the pressure detecting ports 47 in the arterial and venous kettles 4a and 4b are connected to pulse pressure sensors capable of detecting pressure from the fluid pressures at the arterial and venous ends of the blood circuit 1, and the pulse pressure sensors are electrically connected to the control means so as to output detection values. Thus, the pulse pressure of the blood circulating through the blood circuit 1 in the extracorporeal circulation can be monitored, and the change in the condition of the patient under treatment can be grasped.
In the second-type embodiment of the blood purification apparatus 10, the blood purification apparatus 10 is similar to the first-type embodiment, and the blood purification apparatus 10 is connected to the server 30 via a network, except that: the controller 20 is disposed in the blood purification apparatus 10, as shown in fig. 9.
In addition, the invention also relates to another blood purifying system based on the machine learning control program, which comprises a blood purifying device, and further comprises:
a user input configured to provide an input signal to the blood purification device corresponding to a target treatment parameter of the user;
the blood purification device includes a plurality of sensors configured to generate sensor data indicative of the blood purification device during hemodialysis treatment operations;
a controller comprising an electronic processor and a memory, the memory comprising a machine learning control program for execution by the electronic processor, the controller configured to:
receiving a target treatment parameter;
receiving sensor data;
processing the sensor data using a machine learning control program;
generating an output based on the processed sensor data using a machine learning control program, the output including one or more physiological sign parameters, and;
And controlling the target treatment parameters or judging whether a preset event or the occurrence tendency of the preset event occurs according to the generated output.
Further, wherein the controller is adapted to construct the human body simulation mathematical model by a machine learning control program.
Further, wherein the controller is further configured to:
feedback regarding control of the target treatment parameter is received based on the output,
feedback is provided to the machine learning control program to train the machine learning control program.
Further, wherein further sensor data is received from the sensor,
processing further sensor data using a machine learning control program trained with feedback, and
further outputs are generated based on further sensor data using a machine learning control program trained with feedback.
Further, wherein the system further comprises:
a peripheral medical accessory adapted to be worn by a user, configured to detect acquisition of a physiological sign parameter of the user.
Further, wherein the peripheral medical accessory is adapted to be communicatively coupled to the blood purification device and/or the controller and to control the peripheral medical accessory to perform an action specified by the control command in response to the control command received from the blood purification device and/or the controller.
Further, wherein the control command specifies an action to start or stop the peripheral medical accessory or instruct the peripheral medical accessory to send data to the blood purification device and/or the controller.
Further, wherein the controller is adapted to compare physiological sign parameters acquired by the peripheral medical accessory detection with physiological sign parameters generated by the machine learning control program based on the processed sensor data;
and if the comparison result exceeds the preset safety threshold, an alarm module of the blood purifying device generates an alarm.
In general, the controller of the blood purification system provided by the present invention, rather than implementing the hard-coded threshold values previously determined and programmed as described in the background art, adjusts the output of the operation control blood purification device based on sensor data detected during execution of hemodialysis treatment by the blood purification device, and controls the target treatment parameters or determines whether a preset event or the tendency of the occurrence of the preset event according to the generated output, and thus the threshold values in the present invention are based on the previous operation of the blood purification device and can be changed based on the input received from the user and the further operation of the blood purification device to adapt to the conditions or applications in which the blood purification device is constantly changing during the operation, contributing to detecting and responding to more complicated situations. In particular, the patient has complicated, serious and changeable conditions.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced with equivalents; such modifications and substitutions do not depart from the spirit of the technical solutions according to the embodiments of the present invention.
Claims (21)
1. A blood purification system comprising a blood purification device, further comprising:
a user input configured to provide an input signal to the blood purification device corresponding to a target treatment parameter of a user;
the blood purification device includes a plurality of sensors configured to generate sensor data indicative of the blood purification device during hemodialysis treatment operation;
a controller comprising a data processor and a memory, the memory comprising a human simulation database for execution by the data processor, the controller configured to:
receiving the target treatment parameters;
receiving the sensor data;
Reconstructing the sensor data using the data processor;
generating, using the human simulation database, an output based on the reconstructed sensor data, the output comprising one or more physiological sign parameters, and;
and controlling the target treatment parameters or judging whether a preset event or the occurrence tendency of the preset event occurs according to the generated output.
2. The blood purification system of claim 1, wherein the human simulation database comprises at least one pre-stored human simulation model; the manikin is adapted for integrated training by a machine learning method.
3. The blood purification system of claim 2, wherein the machine learning method comprises one or more of linear regression, logistic regression, random forest multiple learning methods.
4. A blood purification system according to claim 2 or 3, wherein the human simulation database is further configured to:
receiving feedback regarding control of the target therapy parameter based on the output;
the feedback is provided to the mannequin to train the mannequin.
5. The blood purification system according to claim 4, wherein,
Receiving further sensor data from the sensor;
processing the further sensor data using the mannequin trained with the feedback, and;
a further output is generated based on the further sensor data using the human simulation model trained with the feedback.
6. The blood purification system of claim 1, wherein the input signals corresponding to the target treatment parameters of the user include ultrafiltration volume UFV, dialysis duration t, dialysate urea clearance K d Dialysate flow rate Q d Prescribed blood flow rate Q br One or more of the following.
7. The blood purification system of claim 1, wherein the sensor data comprises one or more of dialysate flow, dialysate temperature, dialysate conductivity, dialysate pH, blood flow rate.
8. The blood purification system of claim 1, wherein the physiological parameters include relative blood volume RBV, post-dialysis blood temperature T b Concentration of sodium ion in blood after dialysis and actual blood flow rate Q after dialysis bt Effective urea clearance K eff One or more of heart rate HR, mean arterial blood pressure BP after dialysis.
9. The blood purification system of claim 1, further comprising:
a peripheral medical accessory adapted to be worn by a user, configured to detect acquisition of a physiological sign parameter of the user.
10. The blood purification system of claim 9, wherein the peripheral medical accessory is adapted to be communicatively coupled to the blood purification device and/or the controller and to control the peripheral medical accessory to perform an action specified by the control command in response to a control command received from the blood purification device and/or the controller.
11. The blood purification system of claim 10, wherein the control command specifies an action to start or stop the peripheral medical accessory or instruct the peripheral medical accessory to send data to the blood purification device and/or the controller.
12. The blood purification system of any one of claims 9 to 11, wherein the controller is adapted to compare physiological sign parameters collected by the peripheral medical accessory detection with physiological sign parameters generated by the human simulation database based on the reconstructed output of the sensor data;
And if the comparison result exceeds a preset safety threshold, an alarm module of the blood purification device generates an alarm.
13. The blood purification system of claim 1, wherein the controller is adapted to connect with a clinician terminal or a monitoring terminal by means of wireless communication.
14. A blood purification system comprising a blood purification device, further comprising:
a user input configured to provide an input signal to the blood purification device corresponding to a target treatment parameter of a user;
the blood purification device includes a plurality of sensors configured to generate sensor data indicative of the blood purification device during hemodialysis treatment operation;
a controller comprising an electronic processor and a memory, the memory comprising a machine learning control program for execution by the electronic processor, the controller configured to:
receiving the target treatment parameters;
receiving the sensor data;
processing the sensor data using the machine learning control program;
generating, using the machine learning control program, an output based on the processed sensor data, the output including one or more physiological sign parameters, and;
And controlling the target treatment parameters or judging whether a preset event or the occurrence tendency of the preset event occurs according to the generated output.
15. The blood purification system of claim 14, wherein the controller is adapted to construct a human simulated mathematical model by the machine learning control program.
16. The blood purification system of claim 14 or 15, wherein the controller is further configured to:
receiving feedback regarding control of the target therapy parameter based on the output,
the feedback is provided to the machine learning control program to train the machine learning control program.
17. The blood purification system of claim 16, wherein the blood purification system comprises a blood purification device,
further sensor data is received from the sensor,
processing the further sensor data using the machine learning control program trained with the feedback, and
a further output is generated based on the further sensor data using the machine learning control program trained with the feedback.
18. The blood purification system of claim 14, wherein the system further comprises:
A peripheral medical accessory adapted to be worn by a user, configured to detect acquisition of a physiological sign parameter of the user.
19. The blood purification system of claim 18, wherein the peripheral medical accessory is adapted to be communicatively coupled to the blood purification device and/or the controller and to control the peripheral medical accessory to perform an action specified by the control command in response to a control command received from the blood purification device and/or the controller.
20. The blood purification system of claim 19, wherein the control command specifies an action to start or stop the peripheral medical accessory or instruct the peripheral medical accessory to send data to the blood purification device and/or the controller.
21. A blood purification system according to any one of claims 18 to 20, wherein the controller is adapted to compare physiological parameters collected by the peripheral medical accessory detection with physiological parameters generated by the machine learning control program based on the processed output of the sensor data;
and if the comparison result exceeds a preset safety threshold, an alarm module of the blood purification device generates an alarm.
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