Smart self-monitored syringe infusion pump The world of medical devices responsible for giving care and various services for patients to enhance their health and life is expanding, nowadays the focus is on smart systems that can communicate together in order to minimize the dependence on medical staffs and nurses and to avoid mistakes done by them.
There are two important medical devices that an intensive care unit inside a hospital can't be complete without: a therapeutic device which is the syringe pump and diagnostic device which is the patient monitor.
A syringe pump is a small infusion pump capable of delivering fluids of nutrients or medications in specific amount such as insulin or other hormones, antibiotics, chemotherapy drugs and pain relievers. Drugs are given invasively to a patient through a vein in cases of emergency so that the drug reaches the bloodstream within seconds. Also, medications are given intravenously in intensive care unit rooms and operation rooms during surgeries and when patients can no longer take drugs orally or when the digestive tract malfunctions.
As for a patient monitor, it is a diagnostic device that performs continuous measurements of patient parameters such as heart rate, respiration rate, blood pressure, blood-oxygen saturation and many other critical parameters. Such parameters are collected non-invasively using different sensors placed on patient's skin for those whose situation is less severe. The patients connected to sensors of patient monitors could be placed in different areas according to their situation such as medical surgical units of hospitals, labor and delivery rooms, nursing homes or even their own homes.
Intravenous medications and IV (Intravenous) infusion pumps are lifesavers, however they can prove fatal if not administered properly Medication administration errors involving infusion pumps are among the top technology hazards in hospitals today. The Food and Drug Administration has received reports of more than 700 patient deaths linked to infusion pumps over the past five years in USA.
"The problem is the way pumps are programmed and used", according to Thomas Richter, Phar D, Pharmacy IT Manager, Oklahoma Heart Hospital, Oklahoma City, Okla Most hospitals use pumps that require manual programming, and every keystroke is a potential medication error.
Richter then goes on to say, "We wanted to take as many of these keystroke error points out of the system as possible...
Any time you can get fingers and manual programming out and substitute automation, you are getting safer" Faulty syringe pumps may have led to the deaths of thousands of elderly patients nationwide amid fears of a widening health scandal after a report into hundreds of deaths at Gasport War Memorial Hospital.
The administration of high alert medication via a syringe infusion is risky and could lead to a serious patient injury or even death. This is due to the absence of the patient's response for the drug being delivered during the infusion. A patient monitor can assist in finding of such feedback and thus make the delivery of such essential and vital drugs safer and more efficient.
Because of the large number of medical devices available nowadays and especially those present in the intensive care unit, each having specific configuration of data output, it has been cumbersome to interface with most of them. Entering data was limited by their specific manuals, most computerized patient data management systems have failed to deliver the productivity gains their users expected.
Cardiac surgeons who concentrate on patient's welfare presented a hypothesis that even if the number of patient loads is great, there is a possibility to maintain the quality of care. This can be done economically, with the aid of existing nursing staff, if automation can be successfully employed to help the physicians and the nurses with their care-related duties.
For example, for a patient suffering from a high glucose level in blood, the nurse has to compute the parameters manually in order to provide him/her with the appropriate insulin flow responsible for decreasing the high glucose level. Also, she has to watch over him every 3 hours to decrease, increase or stop the drug flow.
Several reports have suggested that medication errors occurring in the administration phase of the medication process may now be the most frequent type of mistake occurring in hospitals Administration errors clearly are frequent and have considerable potential for injury. Among administration errors, IV medication errors have been identified as the most dangerous and can cause considerable patient harm.
Below is a table for some error types that happen while using a syringe pump with the definition of each error.
The same medication but there is a difference in the dose mentioned in the prescribed order. an
Error Type Definition -4 -Definition The drug rate displayed on the pump differs from that prescribed in the medical record. Also refers to doses based on patient's weight calculated incorrectly including using a wrong weight.
no ion An amount of a medication in a unit of solution that is different from the prescribed order.
A different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record.
Medication is prescribed/administered without making sure if the patient had a known allergy to the drug or not.
The ordered medication was not administered to a patient.
7. Delay R Medication/Fluid Change The order to change medication or rate was not carried out during the 4 passed hours of the written order per institution policy.
No e Applies both to items sent from the pharmacy and floor stocked Documented on Label items per institution policy.
on Rate documented on the medication label is different from that programmed into the pump.
or Type Definition Patient> Patient either has no ID band on wrist or information on the ID ntifioatton Error band is incorrect.
ted Fluids or medications are being administered but without an order present in medical record. This includes failure to document a verbal order. Ei Ide
So, in order to reduce or avoid such errors an automated communication is needed for these errors to be automatically corrected to decrease risks on patients and obviously death rates.
The automation of the process could minimize the errors made by the medical staff as a result of high pressure workload created by the condition of a critically ill patient, to save the nurses' time for other demanding tasks, and consequently increases their efficiency. An integrated system between a patient monitor and a smart syringe infusion pump "Automated Smart Patient Monitor Syringe Pump Communication Unit". The patient's parameters from the patient monitor along with the syringe pump are recorded simultaneously for the estimation of the patient's condition to determine the need of the medical staffs intervention. This work is a forward step to reach a fully automated monitoring and treatment of a critical ill patient in the intensive care environments.
The development of auto communication between a smart syringe pump and a patient monitor in intensive care unit will reduce errors caused by nurses or any medical staff. This invention can automatically correct any mistake made by medical staff (ex: flow rate, time, drug) before putting the patient in danger with the availability of further communication with the doctor who's following up the patient's situation. This technology enables medication error-reduction capabilities through programmed dose limit notifications with audio/visual feedback to employees, wrong dose calculations and programming errors. -6 -
The patient monitor will be measuring the vital signs of the patient non-invasively and the appropriate command will be taken by communicating with the smart syringe pump having a built-in drug library and reference curves to stop, increase or decrease drug flow automatically. This will also depend on the information entered about the patient aswell as the additional sensors.
The development of the auto communication between smart syringe pump and patient monitor in intensive care unit limiting the number of hemodynamic incidents and in reducing the nursing workload and it is a new clinical methods that can highly reduce the speed of IV (Intravenous) medication mistakes in hospital.
The design of an automated system will reduce the need for a large number of nurses specified for watching over patients in ICU (Intensive Care Unit). It will also decrease the risk of human error and help to prevent more patient deaths.
This invention solves the reporting problem and error by saving all the vital signs, entered information and additional sensors while using this machine each one second to SD card and to the ICU server. This may help in correcting some reference curves and can be in the future works as artificial intelligent system that make this invention learn from the previous cases.
A common problem is related to Battery life. The syringe pumps must be plugged except during transport or other portable use so the battery will be charged. A deep discharge can lead to premature failure. Electrical safety should be well considered to neglect any harm on the patient. This device is considered of class II. The power is driven from a 12V battery that should run the device for 3 days.
In the future, a bar code scanner will be added to limit the mistake and errors which lead to giving a patient the wrong drug, so the doctor will give the name of drugs (drugs and their bar codes must be built-in the device) must be added and any drug outside the list can't be given to the patient. Also any sensors that can help can be added to the device.
The Automated Smart Patient Monitor Syringe Pump Communication Unit (ASPMSP) only requires the placement and removal of the syringe and inputting the patient's information. All data will be sent to the nurse station to be monitored by the staff and sent also to EMR (Electronic Medical Record) system for further storage of patient's medical situation. An alarm system is also added in case of any error or misreading caused by any of the sensors that took the place of a patient monitor.
This can be done as one complete device containing a syringe pump and a patient monitor with the communication unit or as a module that contains the communication unit to connect separate syringe pump and patient monitor that programed with the same language to work together as one system
Brief description of drawings
One embodiment of the invention will now be described with reference to the accompanying figures in which: Figure 1 is an illustrative image showing how the system works; Figure 2 is an illustrative image of an ESPO1 WIFI Module; Figure 3 is an illustrative example of an AD8232 ECG Module with electrodes; Figure 4 is an illustrative example of an SPO2 Module; Figure 5 is an illustrative example of an easy pulse Module; Figure 6 is an illustrative example of an LM35 Temperature Sensor; Figure 7 is an illustrative example of a DHT21 sensor; -8 -Figure 8 is an illustrative example of a real time clock DS1302; Figure 9 is an illustrative example of a MG995 servo motor and threaded rod linear guide rail; Figure 10 is an illustrative example of a buzzer and RGB module; Figure 11 is an illustrative example of an SD card module; Figure 12 is an illustrative example of a Linear potentiometer.
Figure 13 is an illustrative example of a Rotary encoder.
Figure 14 is an illustrative example of a Limit switch.
Figure 15 is an illustrative example of a Touch Switch.
Figure 16 is an illustrative example of an Arduino mega R3.
Figure 17 is an illustrative of an example Arduino pro micro.
Figure 18 is an illustrative example of a Battery.
Figure 19 is an illustrative of image of the components' connections.
Figure 20 is a block diagram showing the components' connections.
Figure 21 is an illustrative image of the electrical circuits showing the components' connections.
Figure 22 is an illustrative image of the outer case of the screen, drawn using Fusion360.
Figure 23 is an illustrative image of a syringe holder case, drawn using Fusion 360.
Figure 24 is an illustrative image of the arm that pushes the syringe's plunger, drawn using Fusion 360.
Figure 25 is an illustrative image of the external design parts.
Figure 34 is an example of the logging page.
Figure 35 is an example of the patient's information section.
Figure 36 is an example of the patient's information.
Figure 37 is an example of the room temperature and humidity readings.
Figure 38 is an example of the results signals and parameters.
Figure 39 is the parameters' results upon calibration. -9 -
Figure 40 is the parameters' results after calibration.
As we can see in figure 1, the Syringe pump / patient Monitor Communication unit (1) is connected to the patient hand (3) to read the data from the patient and to deliver the drug to him. The nurse (2) must connect the device to the patient (3) and insert the needed information on the device (1). The Syringe pump / patient Monitor Communication unit (1) will send all the data displayed on device screen (1) through a Wi-Fi module to the EMR server (4) to save the data on it and at the same time send the data again to the nurse station (5) where the nurses can see everything related to patient parameters (vital signs) and the syringe parameters (flow rate, time, volume remains,...). If any emergency happened the device (1) will give alarm (sound and light) in patient room (0) and at the same time a notification (alarm) (6) will be sent to nurse's room (5) to announce them to check the device (1). At this time the device will make an action (for example decrease the flow rate) depending to the reference curve of the used drug and to all the other parameters and reading inside its program to save patient life until the nurse is able to reach it.
Different components and modules were used to accomplish this project especially the sensors used to detect the different parameters taken from patient's body to be displayed on a clear easy touch screen. In addition to the parts related to the syringe pump, the detection of the syringe's volume and the movement of the syringe's plunger according to a specific needed flow based on patient's situation.
* Everything displayed in the screen is saved on the SD card every 1 second.
* All the components are discussed below according to their function and are shown in figures and have function that complete the system goal. Other equivalent part that feeds the same functioning goal can be used.
Wi-Fi Transceiver Module, a helpful way to connect the Arduino or other microcontroller projects to a WIFI network. This module is connected with the micro controller to send data to the EMR and to send notifications and alarms to Doctor Phone and nurse station. Other equivalent part that feeds the same functioning goal can be used. The ESP-01 module is shown in figure 2.
-10 -The AD8232 is a module used for ECG measurement applications. It extracts, amplifies, and filters bio-potential signals having noise, such as motion artifact or remote electrode placement. This design is made to acquire the output signal easily through an analog-to-digital converter (ADC) or an embedded microcontroller. The module is shown in figure 3 with 3 pad electrodes placed on the skin for signal detection. Other equivalent part that feeds the same functioning goal can be used.
Nellcor SpO2 sensor shown in figure 4 is for non-invasive measurement of oxygen saturation of patients. Supply for patient monitor, one side clipped on the fingertip of patient and the other side is linked to the patient monitor. Other equivalent part that feeds the same functioning goal can be used.
The Pulse Sensor shown in figure 5 is a heart-rate (HR) sensor for Arduino. Its output gives a fast and accurate pulse reading because of important connections of the optical heart rate sensor with amplifiers and essential circuit for noise removal. Other equivalent parts that feed the same functioning goal can be used.
An LM35 is a temperature sensor with an embedded circuit that enables the detection of temperature in Celsius (Centigrade) or Fahrenheit that is proportional to the output voltage. It is used for the detection of the patient's temperature (Skin temperature). Other equivalent part that feeds the same functioning goal can be used. LM35 is shown in figure 6.
A DHT21 is digital humidity and temperature sensor placed on one side of the device for the detection of patient room Temperature and Humidity, helps in some program calculations. Other equivalent part that feeds the same functioning goal can be used. DHT21 is shown in figure 7 below.
A DS1302 is a real time clock shown in figure 8 counts seconds, minutes, hours, date of the month, month, day of the week, and year that will be all displayed on the screen and saved with the parameters and vital signs to the final report. Other equivalent part that feeds the same functioning goal can be used.
An MG995 threaded rod liner guide rail is the most famous digital metal gear high torque servo used here for the rotation of the threaded rod linear guide rail axis responsible for pushing the syringe s arm. Threaded Rod Linear Guide Rail is a robotic arm kit with ball screw for CNC. Its linear module is used for the movement of the arm that pushes the syringe's plunger. Both the servo motor and the linear guide rail are shown in figure 9. Other equivalent part that feeds the same functioning goal can be used.
The buzzer and RGB module is an Alarm system that gives alarm sound and different light color. Other equivalent part that feeds the same functioning goal can be used.
l he SD Card Module is an easy useful way to transfer data to and from a standard SD card.
The module shown in figure 11 has SP! interface which is compatibie with any SD card. This module used to save a report the that contains all the needed information about the patient, vital signs, and flow rate each second. Other equivalent part that feeds the same functioning goal can be used.
The Linear Potentiometer used for linear position or displacement measurements. It is placed inside the syringe's holder to detect the size of the syringe being placed. It is shown in figure 12. Other equivalent part that feeds the same functioning goal can be used.
A rotary encoder, shown in figure 13, is both an electrical and mechanical device that changes the angular position or motion of a shaft to an analog or digital signal. The use of the rotary encoder is to calculate the moving distance of the plunger, Calibration, and calculating the volume of drug inside the syringe. Other equivalent part that feeds the same functioning goal can be used.
-12 -The limit switch Is an electro-mechanical device shown in figure 14 used continue or break an electrical connection. It consists of an actuator that is mechanically connected to a set of contacts. It is used in this project for calibration, Safety, and detection of volume of drug inside the syringe. Other equivalent part that feeds the same functioning goal can be used.
The touch screen is a Human Machine Interface (HMI) solution that provides a control and visualization interface between an individual and a process, machine, application or appliance. It is used to enter and display patient's information and detected results. The screen is shown in figure 15. Other equivalent part that feeds the same functioning goal can be used.
The Ardu no Mega is a mi rocontroller board based on the ATmegal2 (datasheet). It has 54 digital input/output pins (of which 14 can be used as PWM outputs), 16 analog inputs, 4 UARTs (hardware serial ports), a 16 MHz crystal oscillator, a USB connection, a power jack, an ICSP header, and a reset button.
The Pro Micro [3.3V/8MHz and 5V/16MHz] is essentially a development board. It's an Arduino-compatible microcontrolier, micro-sized, and it accomplishes with one single chip what old Arduino Uno's, Duemilanoves, and Diecimeillas could never dream of: true USB functionality.
The battery is a 12V 100AH lithium ion battery.
As we can see in figure 20 and 21, there are 3 micro controllers (A-B-C) that are the brain of this invention and connected to all the other parts. (A) and (C) are known by Arduino pro micro-5v while (B) is an Arduino mega. The 3 Arduinos are connected together by 12C connection to act as one system. The two Arduino pro micro (A & C) will be the master micro controllers that give the commands to the slave micro controller which is Arduino mega (B). SDA (data line) and SCL (clock line) pins in each Arduino must connected to the other Arduino SDA / SCL pins to have the 12C connection that leads to the communication between -13 -the three Arduinos. The three micro controllers are powered by 12v battery and all the other parts (1-2-3-4-5) except the motor (6) are powered from the Arduinos.
The first box (1) contains all the sensors (a-b-c-d) used to read the vital signs from the patient therefore, the input of those sensors is the patient. The output of those sensors will be the input of the micro controllers, we can see that the ECG module (a) and LM35 temperature sensor (d) are connected to the input of Arduino mega (B) where processing and calculation took place, while the SPO2 sensor (b) and the pulse sensor (c) are connected to the input of the two Arduino pro micro (A) & (C) respectively where processing and calculation took place.
After processing and calculation done in (A & C) the data will be sent to Arduino mega (B) through the 12C connection.
Now all the work will be focused on Arduino mega (B), so as previously mentioned the ECG module (a) and Lm35 temperature sensor (d) are connected to the input analog pins of Arduino mega. in addition to the components included in box number 4 (Limit switches (i), encoder (h), and the linear potentiometer (g)) that are also connected to the input pins of Arduino mega to give the system information about the displacement of the plunger, Calibration, Volume and type of the used syringe, and for safety in case of any emergency or error happened the plunger will stop moving and it will go back to its initial position.
An alarm system that contains the RGB (e) and Buzzer (f) in the red box (2) are used to alert the nurse for an error happened, each error has a certain light color and tone. Alarm system is connected with Arduino mega (B) that controls it, in addition to another alarm system connected by WIFI module (j) that alarm the nurse in the nurses room if any error happened.
RTC (k) in box number (5) is a Real Time Clock, it gives the clock and date, and it is connected to Arduino mega (B). SD card module (I) also connected to Arduino mega (B) and its main function is to save {write \read} a report that contains all the data of all sensors, entered data and information's each 1 second, so in the report we will have the time of each reading of the sensors which help doctors to make curves that help them in diagnoses.
-14 -DHT21 (m) in box number (5) is a Humidity and Temperature sensor that reads patient room temperature and humidity, this is an additional sensor connected to Arduino mega (B) that help in some calculation in the program (patient skin temperature affected by the room temperature).
Touch screen (3) function is to display the reading and data of all the components and sensors used in this device, also it allows the nurse to enter information's and commands to the device, so touch screen allows the communication between nurses and the device. the input of the touch screen (3) is the commands / entered information from the nurse, the entered information will transferred to the serial port of the Arduino mega (B) where processing will take place. When the data reaches Arduino mega (B) it will be transferred to the SD card (m) to be saved in the final report and to the Wi-Fi module (I) to be transferred to the EMR server, nurse station, and doctor phone application.
The motor (6) is connected to Arduino mega (B). This motor can be a servo motor with a high torque or a stepper motor (motor with small degree of rotation). After reading all the data and commands from the sensors and touch screen. Arduino mega (B) will give command to the motor shield to control motor (6) speed to give the suitable flow rate according to drug library, reference curves, patient information, vital signs reading and nurse commands.
The programing code of this invention is very complicated having hundreds of definitions, matrixes, reference data' libraries, equations, loops and calculations.
The long Arduino code is the point of communication between all the components used, so the final command to drive the motor (6) at the correct flow rate will come from the long Arduino code after all the calculations done.
-15 -Figure 22 shows the outer case, where the Nextion LCD 7-inch screen will be inserted and placed above the threaded rod linear guide rail to cover it, in addition to the cases on the right and left sides, which cover the encoder and servo motor respectively.
Figure 23 shows the syringe holder case, where the syringe will be placed in addition to the potentiometer that detects its diameter.
Figure 24 shows the arm that is connected to the movable part of the linear guide rail and is responsible for pushing the plunger according to the calculated flow. The circle part contains the limit switch to measure the distance from the zero start of the linear guide rail to the plunger.
The Nurse should place the syringe with the appropriate drug inside the syringe holder (8) and fill all the needed information related to the patient, i.e. (name, age, drug name, date...) on the display screen (9) having a username and password for the access of medical staff only as shown in figures 34 and 35.
The syringe holder (8) contains a linear potentiometer (g) inside, connected to the Micro controller (B) to detect the size of the placed syringe since this holder is made compatible to all syringe sizes under 70 ml. Also, the arm which is adhered to the movable part of the linear guide rail that moves the plunger (2) of the syringe contains a limit switch (i). The zero reference is set constant for all syringe sizes at the end of the guide rail. When the arm moves from the reference, the limit switch (i) will be pressed when the arm reaches the plunger (2).
The encoder (h) connected to the linear guide rail measures the distance passed from the zero reference until the limit switch (i) inside the arm is pressed. Volume of syringe will be calculated according to the equation of volume of cylinder V= irr-21., where Lis the maximum length of the selected syringe subtracted from measured distance.
-16 -A drug library and reference curves that contain information about most common drugs given by syringe pump is added to help calculate at what flow the drug should be given and also help nurses read about drug specifications to avoid any negative reactions from the patient.
AU the sensors that replaced the patient monitor are connected to two Arduino pro micro (A) and (C) that serve as master and one MEGA that serves as slave. Readings are acquired due to a large Arduino code with multi libraries in addition to specific functions in order to control the flow of drug according to the acquired readings, After logging into the system with a username and password known by the nurse only then adding the documentations, patient's information should be entered as shown in figure 36 such name, age, gender, height, etc....
The patient's room number, temperature and humidity are shown in figure 37 with parameters and signals taken from temperate and humidity sensors (m).This is an additional sensor that helps in som equations in the program. The temperature sensor read 26 degrees celcuis and the humidity sensor read 30%.
Three ECG electrodes were placed on patient chest to record his heart's activity. SPO2, pulse sensor and temperature sensors were placed on his finger. The output signals and readings are shown in figure 38 in addition to the drug's flow, volume and time shown below the signals where the flow is calculated based on the equation flow=volume/time.
In figure 39 for example, a Paracetamol drug was selected and directly its limits will be shown on the right side of the drug based on information added to the drug library. The limits are maximum and minimum flow, maximum volume and maximum and minimum time of infusion. The zero readings of the volume, flow, time and syringe size indicate that the syringe arm is doing calibration (after pressing calibrate) and didn't reach the plunger of the syringe yet in order to detect its size and start the flow of drug.
-17 -In figure 40, a calibration has been done and the start button was pressed which means that the plunger will start to push the syringe at a certain flow rate. The syringe size was detected as 20 ml in addition to the calculated flow from volume and time.
* Nurse can select either time or flow rate to change within the limit of the drug and the other will be automatically calculated by the system.
* The MONITOR key displays the patient monitor screen.
* The STOP key used if the nurse needs to stop the process, so the plunger will stop and go to its initial position.
* The volume at the upper corner of the screen will change as the volume inside the syringe change.
* The parameters in this page will also be displayed on the patient monitor screen (figure 38). C)